Patent Publication Number: US-2023149040-A1

Title: Needle Guide for Ultrasound-Guided Freehand Biopsy and/or Ablation Needle Insertion

Description:
TECHNICAL FIELD 
     The following generally relates to ultrasound and more particularly to a needle guide for ultrasound-guided freehand biopsy and/or ablation needle insertion. The following is also amenable for guiding other instruments. 
     BACKGROUND 
     Ultrasound imaging has provided useful information about the interior characteristics of an object or subject under examination. Such imaging has included transrectal ultrasound-guided freehand transperineal biopsy and ablation needle insertion. For such procedures, a needle guide is attached to the ultrasound probed and includes several distinct channels for guiding biopsy or ablation needles.  FIG.  1    shows an isometric view of an example prior art needle guide  100  attached to an endorectal probe  102 , and  FIG.  2    shows a view of the needle guide  100  and the endorectal probe  102  looking from behind  104  the needle guide  100  and the endorectal probe  102 . 
     The probe  102  includes a handle  106  with a first end  108  and a second end  110 , which opposes the first end  108  (i.e. a second opposing end  110 ). The probe  102  further a cable  112  for transferring signals and/or data to and from the probe  102  that is located at the first end. The probe  102  further includes controls  114  located on a top side  116  of the handle  104  between the first and second opposing ends  108  and  110 . The probe  102  further includes an elongate tubular shaft  118  with a first end  120  and a second end  122 , which opposes the first end  120  (i.e. a second opposing end  122 ). The first end  120  of the elongate tubular shaft  118  is coupled to the second opposing end  110  of the handle  106 . 
     The probe  102  further includes an acoustic window  124  disposed at the second opposing end  122  of the elongate tubular shaft  112   118 . The acoustic window extends partially down a long axis  126  of the probe  102  towards the first end  120  of the elongate tubular shaft  118 . The probe  102  further include a transducer array (not visible) that is housed inside of the elongate tubular shaft  118  under the acoustic window  124  and that is configured to generate an image plane  126 . The long axis  126  extends along a Z-axis, wherein an X-Y plane represents the axial plane, a Z-Y plane represents the sagittal plane, and an X-Z plane represents the coronal plane. 
     The needle guide  100  includes a clamp  128  configured to releasably attach the needle guide  100  to the probe  102 . The needle guide  100  further includes a member  130  that extends away from the clamp  128  in the positive Y-axis direction. The member  130  includes a series of individual distinct channels  132   1 , . . . ,  132   N , where N is a positive integer (collectively referred to herein as channels  132 ). The individual distinct channels  132  are statically positioned, one on top of each other in the positive Y-axis direction, with a predetermined spacing therebetween (e.g., five millimeters, 5 mm). 
     With the needle guide  100 , a clinician is restricted to the paths defined by the static location of the individual distinct channels  132 . Unfortunately, the clinician may encounter an obstruction (e.g., the pubic arch bone or a calcification) that blocks one or more of the biopsy needle paths to tissue of interest (e.g., a certain part of the prostate) through a channel  132 . In such a circumstance, the clinician may have to remove the needle guide  100  and rely on experience to freely move and/or angle the needle without the needle guide  100 . As a consequence, anatomy such as a blood vessel, the urinary tract, etc., may be accidentally punctured during a biopsy, which may result in harm to a patient. 
     Additionally, the clinician may end up moving and/or rotating the ultrasound probe, e.g., to reposition the needle paths to avoid obstructions. However, this may result in deformation of tissue (e.g., the prostate in a prostate examination) from physical contact with and force from the ultrasound probe, which may compromise fusion of any ultrasound images acquired during the examination with pre-procedure images such as magnetic resonance (MR) and/or computed tomography (CT) images, where, due to the deformation, the tissue in the ultrasound images may not align as well with the structure in the pre-procedure images Ablation needle insertion may also encounter such obstructions that block the ablation needle paths through the channels  142 . In addition, with ablation needle insertion, the needle guide  100  will not be able to be removed after ablation needle insertion with ablation needles that have protruding geometry at the back because the protruding geometry will not slide through the channels  142 . If the clinician wants to perform the ablation procedure without the needle guide  100  in the way, the clinician would have to place the ablation needles without the needle guide  100  and rely on experience to carefully insert the ablation needles. 
     In view of the foregoing, there is a need for an improved needle guide at least for ultrasound-guided freehand transperineal biopsy and/or transrectal ablation needle insertion. 
     SUMMARY 
     Aspects of the application address the above matters, and others. 
     In one aspect, a system includes an instrument guide with a length, a width and height, a coupler configured to couple the instrument guide to the ultrasound imaging probe, and a single elongate needle guide slot configured to guide placement of the needle for an ultrasound-guided procedure. 
     In another aspect, a system includes an ultrasound imaging probe with a transducer array including elements configured to generate an image plane in a sagittal plane of the probe, thereby generating a sagittal image plane. The system further includes an instrument guide with a length, a width and height, a coupler configured to couple the instrument guide to the ultrasound imaging probe, and a single elongate needle guide slot configured to guide placement of the needle for an ultrasound-guided procedure. 
     In yet another aspect, a method includes attaching a needle guide to an ultrasound imaging probe, wherein the needle guide includes a single elongate needle guide slot configured to guide placement of a needle during an ultrasound-guided needle placement procedure. The method further includes positioning the probe relative to tissue of interest. The method further includes placing a needle at the tissue of interest using the needle guide. 
     Those skilled in the art will recognize still other aspects of the present application upon reading and understanding the attached description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The application is illustrated by way of example and not limited by the figures of the accompanying drawings, in which like references indicate similar elements and in which: 
         FIG.  1    illustrates an isometric view of a prior art needle guide, which includes a plurality of predetermine individual and distinct static channels with a given spacing therebetween, mounted to an ultrasound probe; 
         FIG.  2    illustrates a view from a back of the ultrasound probe and the needle guide; 
         FIG.  3    diagrammatically illustrates a system including an ultrasound console, an ultrasound probe, an instrument guide and a coupler, in accordance with an embodiment herein; 
         FIG.  4    diagrammatically illustrates the instrument guide showing an elongate needle guide slot therein, in accordance with an embodiment herein; 
         FIG.  5    diagrammatically illustrates the instrument guide of  FIG.  4    showing internal walls of the elongate needle guide slot, in accordance with an embodiment herein; 
         FIG.  6    diagrammatically illustrates needle paths from a top down view of the instrument guide and probe of  FIGS.  4  and  5   , in accordance with an embodiment herein; 
         FIG.  7    diagrammatically illustrates needle paths from a side view of the instrument guide and probe of  FIGS.  4  and  5   , in accordance with an embodiment herein; 
         FIG.  8    diagrammatically illustrates a variation of the instrument guide with first and second legs together, in accordance with an embodiment herein; 
         FIG.  9    diagrammatically illustrates the variation in  FIG.  8    with the first and second legs separated, in accordance with an embodiment herein; 
         FIG.  10    diagrammatically illustrates another variation of the instrument guide with the first and second legs together, in accordance with an embodiment herein; 
         FIG.  11    diagrammatically illustrates the variation in  FIG.  10    with the first and second legs separated, in accordance with an embodiment herein; 
         FIG.  12    diagrammatically illustrates still another variation of the instrument guide with the first and second legs together, in accordance with an embodiment herein; 
         FIG.  13    diagrammatically illustrates the variation in  FIG.  12    with the first and second legs separated, in accordance with an embodiment herein; 
         FIG.  14    diagrammatically illustrates yet another variation of the instrument guide with the first and second legs together, in accordance with an embodiment herein; 
         FIG.  15    diagrammatically illustrates the variation in  FIG.  14    with the first and second legs separated, in accordance with an embodiment herein; 
         FIG.  16    illustrates a method, in accordance with an embodiment herein; and 
         FIG.  17    illustrates another method, in accordance with an embodiment herein. 
     
    
    
     DETAILED DESCRIPTION 
       FIG.  3    illustrates an example imaging system  302  such as an ultrasound imaging system/scanner. The imaging system  302  includes a probe  304  and a console  306 , which interface with each other through suitable complementary hardware (e.g., cable connectors  308  and  310  and a cable  312  as shown, etc.) and/or wireless interfaces (not visible). 
     The probe  304  includes a transducer array  314  with one or more transducer elements  316 . The one or more transducer elements  316  are arranged as a 1-D or 2-D, linear, curved and/or otherwise shaped, fully populated or sparse, etc. array. The elements  316  are configured to convert excitation electrical pulses into an ultrasound pressure field and convert a reflected and received ultrasound pressure field (an echo) into electrical (e.g., a radio frequency (RF)) an echo signal. The probe  304  is configured for at least transperineal and/or transrectal ultrasound-guided procedures. An example of such a probe is the probe  102  of  FIG.  1   . Other probes are also contemplated herein. 
     The console  306  includes transmit circuitry (TX)  318  configured to generate the excitation electrical pulses and receive circuitry (RX)  320  configured to process the RF signals, e.g., amplify, digitize, and/or otherwise process the RF signals. The console  306  further includes a switch (SW)  322  configured to switch between the TX  318  and RX  320  for transmit and receive operations, e.g., by electrically connecting and electrically disconnecting the TX  318  and the RX  320 . In an alternative embodiment, the TX  318  and the RX  320  are each connected to their own switches. 
     The console  306  includes further an echo processor  324  configured to process the signal from the RX  320 . For example, in one instance the echo processor  324  is configured to beamform (e.g., delay-and-sum) the signal to construct a scanplane of scanlines of data. The echo processor  324  can process data from 1-D and/or 2-D probes for 2-D, 3-D and/or 4-D applications. The echo processor  324  can be implemented by a hardware processor such as a central processing unit (CPU), a graphics processing unit (GPU), a microprocessor, etc. 
     The console  306  further includes a scan converter  326  configured to scan convert the output of the echo processor  324  to the coordinate system of a display  328 , which display the scan converted data as images. In one instance, the scan converting includes changing the vertical and/or horizontal scan frequency of signal based on the display  328 . The scan converter  326  can be configured to employ analog scan converting techniques and/or digital scan converting techniques. In one instance, the image are images of the sagittal plane. 
     The console  306  further includes a user interface  330 , which includes one or more input devices (e.g., a button, a touch pad, a touch screen, etc.) and one or more output devices (e.g., a display screen, a speaker, etc.). The console  306  further includes a controller  332  configured to control one or more of the probe  304 , the transmit circuitry  318 , the receive circuitry  320 , the switch  322 , the echo processor  324 , the scan converter  326 , the display  328 , the user interface  330 , and/or one or more other components of the imaging system  302 . 
     In the illustrated embodiment, the imaging system  302  is used in connection with an instrument holder  334  such as a needle guide, e.g., for guiding a biopsy needle, an ablation needle, etc. As such, in one instance, the instrument holder  334  is used to guide a biopsy needle to a target region within an object or subject. In another instance, the instrument holder  334  is used to guide an ablation needle to a target region within an object or subject. A coupler  336  couples the instrument holder  334  and the probe  304 . An example of the coupler  136  is the clamp of  FIGS.  1  and  2   . Other known couplers for attaching a needle guide to a probe are contemplated herein. 
     As described in greater detail below, in one instance the instrument holder  334  allows a biopsy needle and/or an ablation needle to be moved freely within the ultrasound sagittal image plane (in-plane), while limiting out-of-plane movement. In one instance, this is achieved by utilizing a closed elongated slot as a guiding feature. Such a slot mitigates the shortcoming of encountering an obstruction (e.g., pubic arch bone or a calcification) in the path of a channel of a needle guide with static channel locations with predetermined spacing or having to insert the needle without any needle guide and potentially puncturing tissue and causing harm. 
     Also described in greater detail below, in another embodiment, the instrument holder  334  is configured so that it can be removed from the probe  304  after ablation needle placement for the ablation procedure. In one instance, this is achieved through a configuration in which the elongated slot is configured to be a closed slot during placement and then opened after placement so that the instrument holder  334  can be removed while the ablation needle remains in place. This additionally mitigates having to perform the ablation with the procedure instrument holder  334  in place or perform needle placement freehand without the instrument holder  334  and/or add multiple ablation needles with a freehand guide. 
       FIGS.  4  and  5    illustrate an isometric view of a non-limiting example of the instrument holder  334  coupled to a sub-portion  402  of the probe  304  via the coupler  336 . Again, an example of the probe  304  includes the probe  102  of  FIGS.  1  and  2   . In this embodiment, the sub-portion  402  corresponds to part of the handle  104  in  FIG.  1   .  FIGS.  4  and  5    are identical except that  FIG.  5    includes additional dotted lines  400  to show lines of interior walls that are not all visible from the outside from the illustrated viewpoint of  FIG.  4   . For clarity, each reference number will only be shown in one of  FIG.  4  or  5    and not both. 
     In this example, the instrument holder  334  is rectangular prism shaped, with a length  404  in a range of 5 to 50 mm, a width  406  in a range from greater than 0.7176 to greater than 2.108 mm (e.g., 0.75 to 2.2 mm) X to Y mm, and a height  408  in a range of 3 to 65 mm A single elongated slot  410  extends entirely through the width  406  from a first side  412  to a second side  414 , creating openings  416  and  418  at each side. The single elongated slot  410  is entirely enclosed by sides  420 ,  422 ,  424  and  426  respectively by interior walls  436 ,  438 ,  440  and  442 . In this embodiment, the single elongated slot  410  is also rectangular prism shaped. Other shapes of the instrument holder  334  and/or the single elongated slot  410  (including an arc shaped, rounded, curved, irregular, etc. side(s)), lengths  404 , widths  406 , heights  408 , etc. are contemplated herein. In this embodiment, there are no other slots. 
     A length  444  of the slot  410  is the same as the length  404  since the slot  410  extends entirely through the width  406 . A width  446  of the slot  410  is in a range from 0.7176 to 2.108 mm (e.g., to accommodate 22-14 gauge needles). A height  448  of the slot  410  is in a range from fifty (50) to seventy (70) mm. The length  444 , the width  446  and the height  448  are such that a biopsy and/or an ablation needle can be passed from the first side  412  to the second side  414  and freely moved in-plane, while being prohibited from being moved out-of-plane.  FIG.  6    shows the guide  100  limits paths  602 ,  604 ,  606  and  608  along the width  446  from the top 116 of the probe  102 , and  FIG.  7    shows free hand paths  702 ,  704 ,  706  and  708  along the height  448  from a side of the probe  102 . 
       FIGS.  8  and  9    diagrammatically illustrates a variation of the instrument holder  334  from the back  104 . With this variation, the instrument holder  334  includes a first leg  802  and a second leg  804 . A first end  806  of the first leg  802  is coupled to the coupler  336 . A second, opposing end  808  of the first let  802  is coupled to a bearing  810 . A first end  812  of the second leg  804  is also coupled to the bearing  810 . A second, opposing end  814  of the second leg  804  is not coupled to any component. The bearing  810  is configured to allow the first and second legs  802  and  804  to rotate relative to each other in the X-Y plane. 
       FIG.  8    shows the first leg  802  rotated towards the second leg  802  such that the second, opposing end  814  of the second leg  804  is in physical contact with the first end  806  of the first leg  802 , creating the closed slot  410 . In this position, an angle α between the second, opposing end  814  of the second leg  804  and the first end  806  of the first leg  802  is zero (0).  FIG.  9    shows the first leg  802  rotated approximately forty-five degrees (45°) away from the second legs  802  such that the second, opposing end  814  of the second leg  804  is separated from the first end  806  of the first leg  802  by a non-zero distance  816 . 
     Although  FIGS.  8  and  9    show a rotation of approximately 45°, in other embodiments the maximum rotation can be more or less. For example, in one instance the maximum rotation is less than 45°. In another instance, the maximum rotation is 90°. In another instance, the maximum rotation is 180°. In another instance, the maximum rotation is 270°. In another instance, the maximum rotation is greater than 270°, e.g., such that the second, opposing end  814  of the second leg  804  is in physical contact with the first end  806  of the first leg  802  or the coupler  336 . 
     The rotation, in general, is such that after placement of an ablation needle(s) using the instrument guide  334 , the second, opposing end  814  of the second leg  804  can be rotated enough such that the distance  816  provide a gap that allows the instrument guide  334  to be removed, while leaving the ablation needle(s) in place so that the ablation needle(s) can be used to perform an ablation procedure. A non-limiting example of the bearing  810  is a hinge. Examples of suitable hinges include a spring hinge, a barrel hinge, a pivot hinge, and/or other hinges that allow such rotation. 
       FIGS.  10  and  11    diagrammatically illustrates another variation of the instrument holder  334  from the back  104 . With this variation, the ends  812  ends  814  of the second leg  804  includes protrusions  1002 , and the ends  808  and  814  of the first let  802  include recesses  1004 . Each protrusion  1002  is configured to slide into and out of one of the recesses  1004 . When slid into the recesses  1004 , the protrusions  1002  engage the second leg  802  and holds the first and second legs  802  and  804  together. When slid out of the recesses  1004 , the protrusions  1002  disengage the second leg  802  and the second leg  804  can be moved away from the first leg. 
     Similarly, this allows the instrument guide  334  to be removed after ablation needle(s) placement, while leaving the ablation needle(s) so that the ablation needle(s) can be used to perform an ablation procedure. Other configurations of the protrusion and recess are contemplated herein. In addition,  FIGS.  10  and  11    show two sets or pairs of protrusions and recesses  1002  and  1004 . In another embodiment, the instrument guide  334  includes only a single pair of the protrusion and recess  1002  and  1004 . In another embodiment, the instrument guide  334  includes more than two pairs of protrusions and recesses  1002  and  1004 . 
       FIGS.  12  and  13    diagrammatically illustrates another variation of the instrument holder  334  from the back end  104 . With this variation, the ends  806  and  808  and the ends include  812  ends  814  respectively include complementary fasteners  1202  and  1204  that engage when mated together and disengage with pulled apart. Examples of suitable fasteners includes hook-and-loop, hook-and-pile, touch and/or other fasteners. One particular fastener is a VELCRO® Brand fastener, which is a product of Velcro Companies, headquartered in Manchester, N.H., USA. Other fasteners are also contemplated herein. 
     Similarly, separating the complementary fasteners  1202  and  1204  allows the instrument guide  334  to be removed after ablation needle(s) placement, while leaving the ablation needle(s) so that the ablation needle(s) can be used to perform an ablation procedure. Other configurations are contemplated herein. In addition,  FIGS.  12  and  13    show two sets or pairs of fasteners  1202  and  1204 . In another embodiment, the instrument guide  334  includes only a single pair of the fasteners  1202  and  1204 . In another embodiment, the instrument guide  334  includes more than two pairs of the fasteners  1202  and  1204 . 
       FIGS.  14  and  15    diagrammatically illustrates another variation of the instrument holder  334  from the back end  104 . With this variation, the ends  812  ends  814  of the second leg  804  includes hooks  1402 . Each of the hooks  1402  is respectively configured to wrap around and snap onto the first and second ends  806  and  808  of the first leg  802 , which engages the hooks  1402  with a back side  1404  of the first leg  802 . When snapped on, the hooks  1402  engage the second leg  802  and holds the first and second legs  802  and  804  together. When released, the hooks  1402  disengage the second leg  802  and the second leg  804  can be moved away from the first leg  802 . 
     Similarly, this allows the instrument guide  334  to be removed after ablation needle(s) placement, while leaving the ablation needle(s) so that the ablation needle(s) can be used to perform an ablation procedure. Other configurations of the hooks  1402  are contemplated herein. In addition,  FIGS.  14  and  15    show two sets hooks  1402 . In another embodiment, the instrument guide  334  includes only a hook  1402 . In another embodiment, the instrument guide  334  includes more than two hooks  1402 . 
       FIG.  16    illustrates an example method in accordance with an embodiment herein. 
     At  1602 , the instrument guide  334  is attached to the probe  304 , as described herein and/or otherwise. 
     At  1604 , the probe  304  is positioned to image tissue of interest. 
     At  1606 , the instrument guide  334  is used to place an instrument at the tissue of interest, as described herein and/or otherwise. 
     The instrument is then used to perform a procedure. The probe  303  can be removed once the procedure is completed. 
       FIG.  17    illustrates an example method in accordance with an embodiment herein. 
     At  1702 , the instrument guide  334  is attached to the probe  304 , as described herein and/or otherwise. 
     At  1704 , the probe  304  is positioned to image tissue of interest. 
     At  1706 , the instrument guide  334  is used to place at least one ablation needle in the tissue of interest. 
     At  1708 , the first and second legs  802  and  804  of the instrument guide  334  are separated, as described herein and/or otherwise. 
     At  1710 , at least the instrument guide  334  is removed, as described herein and/or otherwise. 
     The ablation procedure is then performed with the at least one ablation needle. 
     The probe  303  can be removed once the procedure is completed. 
     The application has been described with reference to various embodiments. 
     Modifications and alterations will occur to others upon reading the application. It is intended that the invention be construed as including all such modifications and alterations, including insofar as they come within the scope of the appended claims and the equivalents thereof.