Patent ID: 12251129

DETAILED DESCRIPTION

The apparatus, systems, and methods provided herein enable real-time visualization, free-handed, guided, and multi-sample transperineal methods for performing a biopsy. The methods, systems, and apparatus provided herein also enable a complete biopsy of the prostate with only one perforation, or with minimal perforations of a patient's skin by way of an initial access site, such that the access needle is freely moveable. The biopsy guide may be placed on or fitted to an assortment of ultrasound probes of different sizes and shapes due to an adjustable mounting system. The guide may be configured to fit to the probe using any suitably configured fastening system. For example, the guide may be configured as a sleeve that is formed to slide over an end of a probe and into an operable position. Alternatively, the guide may be configured to fit to a probe using screws, flanges, zip ties, or other temporary, permanent, or semi-permanent fastening systems.

In one embodiment, the guide allows biopsies of one or more tissue or cell samples to be obtained through an initial access needle, while providing direct, real-time ultrasound visualization by, for instance, fixing a position of the access needle relative to an ultrasound probe to provide. For example, the guide is fixed to an ultrasound probe that is not fixed and may be freely moveable in operation. Stabilization bars that are built into the guide facilitate the positioning and holding of the perineal skin and subcutaneous tissue to allow positioning of the access needle. The position of the access needle is facilitated by locking the access needle into the subcutaneous tissue of the perineum using a sliding platform that allows a user, such as a medical practitioner or patient caregiver, to place the access needle along a sagittal transducer plane at optimal positions for obtaining prostate biopsies. In some embodiments, upon placement of the access needle into a locked position, for example, in the pelvic floor, a user may then pass a biopsy needle through the access needle to a desired location of the prostate. In yet further embodiments, the passing of the biopsy needle through the access needle and to the prostate may be facilitated by direct sagittal plane visualization based on the alignment of the access needle.

Methods and systems provided herein do not require a patient to take antibiotics at any point prior to the biopsy procedure, nor do they require a patient to undergo bowel preparation in advance of the procedure. Methods, systems, and apparatus can reduce or eliminate multiple skin perforations by using a single access location or access site, while allowing multiple extractions of tissue or cell specimens from the prostate. Methods, systems, and apparatus in accordance with embodiments allow for real-time visualization during a freehanded, guided, transperineal approach, while also facilitating a complete assessment of the prostate with, for example, only one perforation of the patient's skin wherein the access needle is freely moveable in each plane.

Methods, systems, and apparatus of embodiments may include and facilitate treatment that uses a cryoablation probe for focal therapy of prostate cancer, a radiofrequency instrument, a thermotherapy instrument, any instrument for treatment of the cancerous area, or a combination of any of these instruments.

Methods, systems, and apparatus of embodiments enable planning and performing the free-hand transperineal prostate biopsies under the guidance of a device and of a real-time transducer in the sagittal imaging plane.

The biopsy is performed using a system that includes a biopsy guide, a transducer, an access needle, and a biopsy instrument. The access needle may allow the anesthesia to be injected into the patient, and the tissue or cell specimens of the prostate to be extracted. If anesthesia is used, a syringe may be included in the system. The transducer may be an ultrasound probe or any other type of device that can cause a visualization of the prostate in a display device. In embodiments, the biopsy guide may be disposable. In embodiments, the biopsy guide may be formed of materials intended for a single use. In other embodiments, the biopsy guide is reusable. In some embodiments, the biopsy guide may be formed of materials intended for multiple uses.

The guide may include a sliding platform, stabilization bars, one or more upper and lower mounts, and a fastener. The upper and lower mounts may be curvilinear in shape. The upper and lower mounts may be positioned proximally or distally along an ultrasound probe, such as a transrectal ultrasound probe. The configuration and positioning of the upper and lower mounts are adjustable based on the shape of the ultrasound probe and the patient's body habitus.

The guide may be made of any material such as a plastic or metallic material. The guide may be disposable and made of a biodegradable plastic material. In other embodiments, the guide may be reusable and made of stainless steel. The dimensions, for example, the length, width, height, depth, and breadth of the sliding platform, stabilization bars, upper and lower mounts, and the fastener may vary and may be adjustable. The variable and adjustable dimensions, for example, of the stabilization bars, provide a user with flexibility in achieving and maintaining the guide in an appropriate ultrasound plane while performing biopsy procedures, while the user's patients may vary in size and levels of perineal subcutaneous tissue and fat. In a patient with an excessive amount of perineal subcutaneous tissue and fat, a larger stabilization bar will assist in locking the guide in the proper ultrasound plane.

The adjustable stabilization bars and mounts may be curvilinear in shape, allowing the guide to be placed proximally or distally along any cylindrical instrument, such as the transrectal ultrasound probe, which is determined by the surgeon based on the shape of the probe and the patient's body habitus. This allows the guide to be mounted to any assortment of ultrasound probes. Similarly, the platform may, for example, have various thicknesses.

The stabilization bars may be fixed to a top portion of the upper curvilinear mounts of the guide, and may extend beyond the front edge of the upper mounts. The stabilization bars may extend beyond the front edge of the upper curvilinear mount by approximately 8 mm. The guide may be approximately 60 mm wide, or the guide may be approximately 50 mm long, for example. The stabilization bars may have grooves for accommodating a sliding platform that is shorter in length than the stabilization bars. The grooves being configured to allow the platform to slide forward and backward along the stabilization bars.

An inner portion of the stabilization bars may have built-in grooves. The grooves accommodate a sliding platform which is shorter in length than the stabilization bars. This allows the sliding platform to slide from the back to the front of the stabilization bars. The stabilization bars may include a resistance as to prevent the sliding bar to freely move back and forth on the stabilization bar. This resistance may be introduced by the sliding platform or both the stabilization bar and the sliding platform. The resistance may be provided by a strip of rubber or any other material capable of providing friction or other. The strip may be curvilinear. The resistance may be generated by a mechanical system, such as a spring mechanism.

The sliding platform may have a hole through the platform. In some embodiments, the hole is drilled in the center of the platform. The hole can accommodate various types of needles, including access needles having various diameters, for example, spinal needles having a gauge in the range of 14-18. The hole can also accommodate needles having various lengths. The lengths of the needle may depend, in part, on the body habitus. The needle may be a reusable needle, such as a reusable spinal needle. The needle may be a disposable needle, such as a disposable spinal needle.

A flange of the guide secures the placement of the access needle to the guide. The flange may be configured to snap into the guide to secure the needle. The flange may be secured to the guide by other securing mechanisms. The flange can be of various shapes and configurations. For example, the flange may be u-shaped. As another example, the flange may have a thin or slim configuration. The guide assists in providing the appropriate angle of penetration and direction of the access needle, or other instruments that may be used in combination with the guide.

The hole in the guide is placed so that once the guide is mounted to the ultrasound probe, the drilled hole will be parallel to the sagittal transducer. The drilled hole may also accommodate the tip of a biopsy gun, or any other biopsy instrument. The sliding platform may be interchangeable and may be removed to allow placement of another sliding platform with a different sized to permit different sizes of needles and other instruments. The hole may be configured to accommodate a cryoablation instrument, a radiofrequency instrument, thermotherapy instrument, or any other instrument for diagnosis and treatment of a bodily tissue, including a cancerous area of a prostate.

The platform may have or define a predrilled hole in the center of the platform that can accommodate various sizes of needles and instruments. For example, the hole may be configured to accommodate a needle having a range of 14-18 gauges, such as a reusable 14 gauge spinal needle. Central hole placement on the platform enables alignment of the hole with a sagittal transducer when the guide is mounted to an ultrasound probe. The platform may have multiple holes to accommodate various applications and body habitus. Further, the platform may be of various thicknesses.

Once the one or more upper curvilinear mounts are placed at the desired location on the transrectal ultrasound probe, the access hole for a needle, such as a 14 gauge reusable spinal needle, will remain a fixed distance from the ultrasound probe. In embodiments, having one or more lower curvilinear mounts, the mounts may be positioned to cradle an upper aspect of the ultrasound probe.

At least two lower mounts are provided and may be individually positioned to accommodate various types of probes, which may have variable diameters along their shafts. In embodiments, a probe, such as a transrectal ultrasound probe, may have one or more diameters along the probe's shaft. In yet further embodiments, one end of the guide may be fixed at a location of the probe having a different diameter than the location where the other end of the guide is fixed. The separate lower mounts allow for the fixation of the guide, even with varying probe diameters.

The lower mount of the guide may include a lower right mount and a lower left mount connected by an adjustable mid-joint or fastener. The adjustable mid-joint or fastener allows the guide to be secured to the probe even if the diameter of the shaft of the probe is longer than the width of the lower mount. The mid-joint or fastener may be flexible to allow the right lower mount to form an acute angle with the left lower mount. This also allows for fixation of the guide to a probe shaft that is not circular in shape.

The lateral edges on both ends of the lower mounts may contain a notched post. Corresponding locations of the upper mounts contain holes, such as square shaped holes, to accommodate the notched post of a corresponding lower mount. An upper aspect of each hole includes a flange for locking the notched post in a fixed position. This configuration allows the lower mounts and the upper mounts to be secured to each other and to the probe.

Methods may include locating a suspicious area, positioning an access needle, and obtaining one or more tissue or cell specimens from an accurate point in the prostate. The method allows for multiple tissue or cell specimens to be obtained from a bodily organ, such as the prostate, and permits access to the prostate from different angles through a single initial access needle. The method may include calculating the volume of the prostate by positioning the access needle at a mid-point in the x axis from the lateral edge of the prostate to the urethra.

Methods may be performed using no anesthesia. Alternatively, an anesthetic may be used. For example, the anesthetic may be lidocaine, or any type of local anesthetic. The lidocaine may include 1 or 2% of a lidocaine solution.

The suspicious area or bodily organ may be located by using a transducer. The transducer may be any type of probe for accessing and viewing a targeted site or object, such as an ultrasound probe, or any type of transducer capable of providing visualization of the prostate and/or instruments and devices for diagnosis and treatment of the tissue. The biopsy may be performed using a biopsy gun, a suction device, or any type of instrument that is small enough to be introduced through the access needle and capable of extracting the tissue or cell specimen. The biopsy may be performed while the patient is in a dorsal lobothy position, prone position, or any position that allows for access to the perineal area.

Methods may include applying an antiseptic solution to the perineal area. The antiseptic solution may include betadine, or any other substance that reduces the possibility of infection, sepsis, or putrefaction. Methods may include applying bacitracin to the skin at the puncture site or any other type of topical preparation for preventing the possibility of infection.

Methods may include attaching a needle to a luer lock syringe, which may contain an anesthetic, or any other type of device capable of retaining its contents and dispensing its contents through the needle. A biopsy gun or any other instrument that may be attached to the needle and used for inserting or extracting any substance thru the lumen of the access needle.

Methods may include releasing the syringe from the needle after the anesthetic is injected. Methods may include dividing the prostate in three different regions and designating lateral, mid, apical prostate, and may include labeling the tissue or cell specimen containers, which will identify the tissue or cell specimens.

Methods may include securing the guide to the probe. This will permit the practitioner to take the biopsy gun as many times as necessary using his/her other hand, and, consequently, extract multiple tissue or cell specimens. It is contemplated that this can be done without assistance of any other person, and that the biopsy gun may also be attached to the guide in order to permit the surgeon to, for example, label the container with the tissue or cell specimen while performing the biopsy. Methods may also include monitoring all the actions in the prostate by way of a display device that provides images captured by the probe.

Methods N may include moving the needle in x, y, and z planes. By being able to move the needle in x, y, and z planes, the surgeon is capable of extracting tissue or cell specimens from several different areas of the prostate without having to retrieve the needle and preventing other perforation of the patient's skin. In embodiments, movement of the needle within the patient's body is facilitated by using a display device.

Methods may include removing the access needle from the perineal area. This may be done while the biopsy gun is secured to the access needle or after the biopsy gun has been detached from the access needle.

Methods may include realigning the needle in the desired prostate region. If the surgeon wishes to start at the right lateral prostate region and notices that the needle tip is not directed at the lateral region, the surgeon rolls the ultrasound probe slightly and to note that the needle tip is directed to the desired region, then the surgeon may realign the needle to obtain tissue or cell specimen. The surgeon may realign the needle using one hand while having the needle attached to the biopsy gun, which may be attached to the probe through the guide.

Methods may include identifying the areas in which biopsy have already been performed. After each extraction of tissue or cell specimen during the biopsy, a hyperechoic streak remains visible on ultrasound display. This allows the surgeon to identify the area of the prostate and that an extraction has been made, as to allow the surgeon to prevent overlap of extractions.

In another embodiment, the method includes identifying the path of the urethra. This allows the surgeon from preventing passing the biopsy needle thru or into this path.

FIG.1is a side view of a guide100secured to a probe including a stabilization bar101, fasteners102, probe103, lower mounts104, and an upper mount105. The stabilization bar101is an extension of the upper mount105, as further discussed inFIG.4. In embodiments, the distance between the fasteners102and the upper mount105may be adjustable to accommodate various applications and body habitus.

FIG.2Ais an internal view of a guide's fastener, including an aperture201, teeth202, and a flange203. The flange203may be an extension of the aperture201, which is part of the upper mount105. Aperture201will allow the teeth202to be inserted into the upper mount105, and the flange203will lock the teeth202, which is connected to lower mount104, to the upper mount105. The aperture201with flange203and teeth202allows for adjusting the height of the guide100.

In one embodiment, the fastener (e.g., via the aperture201, flange203, and/or the teeth202) can be configured to fasten the guide100to the probe103with, e.g., varying levels of tension to provide for adjustments of the relative positions of the guide100and the probe103even after the guide100has been mounted to the probe103. For example, the fastener102can provide a first level of tension sufficient to hold the position of an access needle (e.g., introduced through a hole or other needle mount of the guide100) rotationally fixed to the probe103while still allowing for a forward or reverse sliding of the probe103with respect to the guide100. By way of example, the forward or reverse sliding adjustment can be performed to adjust the penetration depth of the probe103with respect to the patient depending on a size of the patient. Once the final adjustment is made, the fastener can be actuated to final position or tension that will then lock further adjustments of the positioning of the guide101relative to the probe103.

It is noted that the guide's fastener as described above is one example embodiment among other possible example fasteners that are applicable to various embodiments of the guide100. Accordingly, it is contemplated that various embodiments of the guide100may use any now known or later developed fastening system that can secure the guide100to the probe103.

By way illustration and not limitation, examples of two fasteners are discussed with respect toFIGS.2B and2C.FIG.2Bshows a sheath-based fastener whereby the fasteners102are attached to a sheath211that is configured to slide over an end of a probe103and into an operable position. Although the sheath211is shown as a closed sheath, in another embodiment, the sheath211can be configured as a sleeve that is open-ended to slide over the probe103. By way of example, the sheath211can be made of a flexible material (e.g., rubber) to provide for stretching and tension on probe103.

In another embodiment, as shown inFIG.2C, the guide100can be configured with a zip-tie style fastener in place of a lower mount mechanism to secure the guide100to the probe100. In other embodiments (now shown), the guide100may be configured to fit to the probe100using screws, flanges, or other temporary, permanent, or semi-permanent fastening systems. In addition, although the fasteners102of the guide100may be configured as generic and adjustable fasteners that can support probes of a variety sizes and shapes, it is also contemplated that the fasteners can be fit to specific models of probes for customized applications.

FIG.3is a top view of a guide secured to a probe. This figure includes a sliding platform301, a drilled hole302, stabilization bars101, fasteners102, an upper mount105, and a probe103. As previously described, in one embodiment, the drilled hole102can accommodate or support various sizes and/or configurations of needles (e.g., straight needles, curved needles, etc.) and instruments for performing a biopsy so that the needle can be aligned relative to the probe103, thereby, also providing an alignment between the needle and an image produced by the ultrasound probe103. In one embodiment, the drilled hole102can support an access needle through which a biopsy needle or other instrument can be introduced at a known alignment with respect to the probe103. In addition, although the hole102to support, e.g., an access needle or other instrument is showed in a central midline position, the location of the hole can be configured at any position of the guide100.

FIG.4is a cross-section view of the back of a guide secured to a probe including a sliding platform301, drilled hole302, stabilization bars101, lower mount104, upper mount105, fasteners102, and probe103.

FIG.5is a magnified view ofFIG.1.FIG.5demonstrates minimum dimensions of preferred embodiments, which includes stabilization bars101and upper mount105from 30 mm to 50 mm long; the upper mount105with a height ranging from 10 mm to 15 mm; the stabilization bars101with a height that is about ⅓ of the height of the upper mount105; fasteners102with a height of about 25 mm and 10 mm wide; a lower mount10410 mm wide. Additionally, the offset501from the distal point of the stabilization bar105to the fasteners102may be 5 mm. It is contemplated that any of these dimensions may vary, including the stabilization bar101, which may be longer than the upper mount105.

FIG.6is a magnified internal view of the guide fastener shown inFIG.2.FIG.6demonstrates minimum dimensions of preferred embodiments. The fasteners102may have an aperture201to accommodate teeth202, wherein the fastener102is 5 mm to 10 mm wide. Additionally, the sliding platform301, which may be from 12 mm to 25 mm wide, is slightly shorter than the distance between the two stabilization bars101as to accommodate the sliding platform while also securing it to the guide100.

FIG.7is a magnified view of the guide depictedFIG.3, without the probe103.FIG.7also demonstrates minimum dimensions of preferred embodiments, wherein the height of the upper mount105ranges from 5 mm to 10 mm; and the teeth202is from 5 mm to 8 mm wide.

FIG.8is a side view of a biopsy instrument that is about to penetrate the prostate, including a prostate801, a probe103, a biopsy instrument802, a perineum skin803, an anus804, and a perforation point805. The probe103is inserted into the anus804to provide real-time images of the biopsy, including images of the biopsy instrument802and the prostate801. It is contemplated that the biopsy instrument802includes a needle and any other instrument capable of performing a biopsy.

FIG.9is a front view of a targeted area902of the prostate801.FIG.10is a side view of a biopsy instrument penetrating the prostate801, including a targeted area902of the prostate801. The targeted area902is reached by biopsy instrument802after perforating perineum skin803.

FIG.11is a front view of a targeted area of the prostate where a biopsy instrument will penetrate with areas in which the cell or tissue specimen has already been extracted.FIG.11depicts both an extracted area1101and a targeted area902. The possibility of viewing the area in which the cell or tissue specimen has already been extracted permits the practitioner to avoid placing the access needle in an area that cell or tissue specimen has already been extracted. This allows the biopsy to be more efficient and more accurate.

FIG.12is a top view ofFIG.8, depicting a prostate801, perineum skin803, a probe103, and a biopsy instrument802.FIG.13is a right side view of a prostate and the path of the biopsy instrument including the path of the biopsy instrument1301and the perforation point805.FIG.13illustrates that only one initial perforation to the skin of the patient is necessary in order to extract one or more cell or tissue specimens.

FIG.14is a front view of a guide determining a lower targeted or suspicious area1401of the prostate in which to penetrate the biopsy instrument, a prostate, and a probe.FIG.16is a front view of a guide determining a mid-target or suspicious area1601of the prostate in which to penetrate the biopsy instrument, a prostate, and a probe.FIG.18is a front view of a guide determining a higher targeted or suspicious area1801of the prostate in which to penetrate the biopsy instrument, a prostate, a probe.FIGS.14,16, and18demonstrates the variety of angles and positions in which a guide may be positioned in order to reach several regions of the prostate, such as the lateral region, mid region, and apical region. In order to the able to reach these areas,FIGS.14,16, and18demonstrate how the upper mount105, the stabilization bars101, or a combination of thereof can adjust in order to reach a lower targeted or suspicious area1401, a mid-targeted or suspicious area1601, or a higher targeted or suspicious area1801of the prostate.

FIGS.15,17, and19demonstrate a side view ofFIGS.14,16, and18and the paths of the biopsy instrument1301taken by a biopsy instrument to reach lower targeted or suspicious area1401, a mid-targeted or suspicious area1601, or a higher targeted or suspicious area1801of the prostate.

FIG.20is a right side view of a guide, and a biopsy instrument firmly penetrating a fat plane of perineum skin, including offset501of a stabilization bar101. This allows for stabilization in a patient with an excessive amount of perineal subcutaneous tissue, fat, or a combination thereof. A larger stabilization bar101will assist in locking the guide in the proper ultrasound plane. Accordingly, the offset501may longer than 5 mm for these purposes.

FIG.21is a front view of a prostate, a probe, a targeted or suspicious area, wherein the biopsy instrument may reach any area of the prostate.FIG.21demonstrates that the biopsy instrument can reach the entire prostate while using only one perforation point805. After obtaining one cell or tissue specimen, the biopsy instrument802may be partially retrieved from the perineum area at a point in which the distal point of the biopsy instrument802is redirected to another targeted or suspicious area. Then, the biopsy instrument (usually the needle of the biopsy instrument) is inserted to the second targeted or suspicious area for obtaining a cell or tissue specimen of another area of the prostate.

FIG.22is a magnified view of the right side of a prostate and a biopsy instrument.FIG.22depicts the location of the biopsy instrument inside the prostate and the other paths in which the biopsy instrument may take utilize for additional samples or retrieval. In embodiments, the biopsy needle or other instruments do not reach the initial part of the penis, which is in a different plane from the prostate.

FIG.23is an image of the front side of a prostate and a biopsy instrument being retrieved from the prostate, and other targeted areas.FIG.23shows a procedure being applied to the apical region of the prostate.

The urethra should be avoided in any part of the procedure, but it is mostly important when extracting cell or tissue specimens from the apical region of the prostate, when the chances of perforation is greater. After several extractions, the practitioner is able to see the blood streak from where the cell or tissue specimen was taken so as to avoid overlapping.

After this procedure, the patient may be put with restriction for no more than 1 day. If the patient is put on restriction for 1 day, after the one-day-restriction, no restriction is made.

In an embodiment, the biopsy system performs the processes2400ofFIG.24. At2401, a patient is prepared for the biopsy procedure by having the patient get into a lithotomic position, prone position, or any position that allows for access to the perineal area. The biopsy procedure may be a prostate biopsy. In some embodiments, the patient's scrotum is elevated using, for example, two strips of plastic tape. The perineum is prepared with an antiseptic solution to the perineal area, for example, the antiseptic solution may include betadine.

At2402, a target area or object, such as the prostate, is imaged. Imaging may be performed with a transducer, such as an ultrasound probe. Imaging of a target area may be in a sagittal and/or axial plane and may be performed in real-time with direct visualization. Utilizing the real-time image, a user can identify areas of interest, e.g. suspicious areas or the target area or object at2403.

The user may determine an access site for positioning an access needle. At2404, an access needle is positioned at an access site in subcutaneous tissue of the perineum. The access site may be at a midpoint between a lateral edge of the prostate and the urethra along an x axis, and a midpoint between an anterior capsule and a posterior capsule along a y axis. The access needle is guided and positioned at the access site by using the guide.

At2405, a biopsy instrument is guided to the target or suspicious areas or object. The biopsy instrument may include a biopsy needle. The guiding of the biopsy instrument can be facilitated by using the real-time visualization provided by the transducer. Real-time visualization also facilitates obtaining tissue or cell specimens from an accurate point in the prostate, for example. The method allows for one or more tissue or cell specimens to be obtained from a bodily organ, such as the prostate at2406, and permits access to the prostate from different angles through a single initial access needle.

At2407, the biopsy instrument may be retrieved and removed from the patient. The method may include calculating the volume of the prostate by positioning the access needle at a mid-point in x axis from the lateral edge of the prostate to the urethra.

FIG.25shows an ultrasound2501showing a transrectal probe2503and an access needle guideline2505. The needle guideline enables the practitioner to observe a needle path whereby the access needle has contacted the prostate2507, thereby enabling the practitioner to avoid overlapping sampling, and to avoid perforating the prostate.

FIGS.26A-26Cshow side views of an alternative embodiment of a guide2600secured to a probe including a stabilization bar101, fasteners102, probe103, lower mount104, and an upper mount105. The stabilization bar101is an extension of the upper mount105, as further discussed inFIG.4. In embodiments, the distance between the fasteners102and the upper mount105may be adjustable to accommodate various applications and body habitus.

The guide2600includes a sliding platform301. The guide is fitted to the probe103by a sleeve2607. The sleeve2607is formed by the lower mount104and the upper mount105. The sleeve2607may be configured to slide over an end of the probe103into an operable position as shown inFIGS.26A-26C. The sleeve2607is a partial sleeve that has an opening at both ends of the sleeve2607to enable slidable mounting to and removal from the probe103.

The sliding platform301of the guide2600may be pivotably mounted to enable movement in a direction perpendicular to a longitudinal axis of the probe103, as shown inFIGS.26A-26C. In particularFIGS.26A-26Cshow that the sliding platform103is fixed to the guide at a pivot point2608. The sliding platform103is configured to pivot at pivot point2608to enable, for example, normal or vertical adjustment of an access needle (not shown) in directions perpendicular to a longitudinal axis of the probe103while ensuring that a longitudinal axis of the access needle (not shown) remains parallel to the longitudinal axis of the probe103.

For example,FIG.26Ashows a sliding platform301in a first position at which a lateral planar surface of the platform301extends in a direction parallel to the longitudinal axis of the probe103.FIG.26Bshows the sliding platform301pivoted to a second position wherein a front end the platform301is disposed a distance from the probe103that is greater than a distance between an opposite rear portion of the platform301and the probe103.FIG.26Cshows the sliding platform301pivoted to a third position wherein the rear end of the platform301is disposed a distance from the probe103that is greater than a distance between the opposite front end of the platform301and the probe103.

In another embodiment, the method may be performed without the patient taking antibiotics or undergoing bowel preparation before having the procedure. During the procedure, the practitioner may administer an anesthetic to the patient, for example, lidocaine, or any type of local, anesthetic. The lidocaine may be included in a solution having 1% of lidocaine.

In an embodiment, the suspicious area is located by using a transducer. The transducer may be any type of transrectal robe for prostate cancer, such as an ultrasound probe, or any type of transducer capable of imaging the prostate and the extraction device. The biopsy may be performed using a biopsy gun, a suction-mechanism, or any type of instrument that is small enough to be introduced through the access needle and capable of extracting the tissue or cell specimen. The biopsy may be performed while the patient is in a lithotomy position, prone position, or any position that allows for access to the perineal area.

In another embodiment, methods may include applying an antiseptic solution to the perineal area such as betadine, or any other substance that reduces the possibility of infection, sepsis, or putrefaction.

In another embodiment, the ultrasound probe may be a B&K 8848 transrectal ultrasound probe, or any other ultrasound capable of causing visualization of the prostate and the extraction device. The frequency range may be 5-12 MHZ, and the focal range may be 3-60 mm. The ultrasound probe may be able to cause the visualization of the prostate and extraction devices at least in the axial plane, sagittal plane, or a combination thereof.

In another embodiment, methods may include attaching a needle to a luer lock syringe, which may contain an anesthetic, or any other type of device capable of retaining its contents and to dispense its contents through the needle. A biopsy gun or any other instrument may be attached to the needle for inserting or extracting any substance through the lumen of the access needle.

In another embodiment, the method includes releasing the syringe from the needle after the anesthetic is injected. The method may include dividing the prostate in three different regions and designating lateral, mid, apical prostate, and may include labeling the tissue or cell specimen containers, which will identify the tissue or cell specimens.

In another embodiment, a biopsy gun may be an 18 gauge biopsy gun, or any other size that is capable of being coaxially inserted thru the lumen of the access needle.

In another embodiment, methods may include securing the guide to the probe. This will permit the practitioner to take the biopsy gun as many times as necessary using his or her other hand, and, consequently, extract multiple tissue or cell specimens. It is contemplated that this can be done without assistance of any other person, and that the biopsy gun may also be attached to the guide in order to permit the surgeon to e.g. label the container with the tissue or cell specimen while performing the biopsy. The method may also include monitoring all the actions in the prostate thru a display device, which will transmit images captured by the probe.

In another embodiment, methods may include moving the needle in x, y, and z planes. By being able to move the need in x, y, and z planes, the surgeon is capable of extracting tissue or cell specimens from several different areas of the prostate without having to retrieve the needle and preventing other perforation of the patient's skin.

Methods may further include removing the access needle from the perennial area. Removal of the access needle may be performed while the biopsy gun is secured to the access needle or after the biopsy gun has been detached from the access needle.

Methods may include realigning the needle in the desired prostate region. If the surgeon wishes to start at the right lateral prostate region and notices that the needle tip is not directed at the lateral region, the surgeon rolls the ultrasound probe slightly and to note that the needle tip is directed to the desired region, then the surgeon may realign the needle to obtain tissue or cell specimen. The surgeon may realign the needle using one hand while having the needle attached to the biopsy gun, which may be attached to the probe through the guide.

Methods may include identifying the area in which a biopsy has already been performed. After each extraction of tissue or cell specimen during the biopsy, a hyperechoic streak remains visible on ultrasound display. This allows the surgeon to identify the area of the prostate and that an extraction has been made, as to allow the surgeon to prevent overlap of extractions.

In another embodiment, methods may include identifying the path of the urethra. This allows the surgeon from preventing passing the biopsy needle thru or into this path. In another embodiment, the method includes pressuring the perineum. In yet another embodiment, the method includes applying bacitracin to the skin at the puncture site or any other type of topical preparation for preventing the possibility of infection. In another embodiment, positioning the access needle is performed without the need of a biopsy grip, wherein the guide provides the precise point for the biopsy.

An apparatus and system in accordance with embodiments discussed above is used to carry out these methods. In an alternative embodiment of apparatus and systems, a guide may not include a lower mount, and may include an access needle. The guide includes a stabilization bar, sliding platform, a hole located in approximately the center of the platform, an upper mount, teeth, aperture, arms, and a connector. The access needle includes a hub and is secured to the guide. The teeth may be part of, or may be attached to, a lower mount. The teeth may be inserted into the aperture in order to secure the guide to a probe, for example. It is contemplated that the combination of the aperture and the teeth may form a fastener mechanism. In embodiments, connector is part of, or may be attached to, an access needle, and may be secured to the upper mount in order to provide stabilization of the access needle and to allow the practitioner to move the access needle by merely moving, for example, a probe that may be secured to the guide.

A connector and a hub permit the use of various other instruments such as, for example, a non-biopsy instrument, to be secured. A biopsy instrument may be inserted into the access needle in order to reach a targeted area. The upper mount may include arms. In embodiments, the arms may be shorter, longer, or may not exists, in which case the aperture is disposed directly in the upper mount. When the aperture is directly in the upper mount, upper mount may be longer, thicker, or a combination thereof.

In some embodiments, the guide may include lower mounts that have teeth. Arms may extend from the upper mount to allow the height of the guide to be adjusted and to be placed farther from or closer to the probe. The arms permit the access needle to be maintained at a certain distance from a probe. In embodiments, the material of the guide may be a plastic or any other material, including other plastic materials, or any other material that is cost effective. In embodiments, the guide may be reusable and may be formed with a stainless steel. The lower mount may be curvilinear and flexible to allow the lower mount to bend if necessary to secure the guide to the probe.

Reference is made toFIGS.27-35D, which depict various views of another embodiment of a transperineal biopsy guide2700. As with the previously described embodiments, the biopsy guide2700may couple with a transrectal probe and may be used in guiding an access needle in a transperineal prostate biopsy procedure. While reference will be made to the embodiment inFIGS.27-35D, aspects of the previously described embodiments may be incorporated into the present embodiment without limitation. And, aspects of the present embodiment may be similarly incorporated into the previously described embodiments without limitation.

To begin, reference is made toFIGS.27-30, which depict, respectively, a front isometric view, a front view, a side view, and a front isometric exploded view of the transperineal biopsy guide2700. As seen in the figures, the biopsy guide2700includes an upper mount2702and a lower mount2704. The lower mount2704includes a probe coupling or fastening mechanism2706to couple the lower mount2704with a transrectal imaging probe (not shown inFIGS.27-28, but shown inFIGS.1,2B, and3-6, for example). The lower mount2704additionally includes an upper mount coupling mechanism2714to couple the lower mount2704with the upper mount2702. WhileFIGS.27-30depict a single coupling mechanism2706, it is foreseen that the biopsy guide2700may include more than one coupling mechanism2706, as shown and described in previous embodiments.

The upper mount2702may couple with the lower mount2704and may include a guide member2708and a displacement member, translating member, access needle support structure, or sliding platform2710. The displacement member2710may couple with an access needle2712and be supported by the guide member2708. More particularly, the displacement member2710may slidingly couple with the guide member2708such that the displacement member2710and the access needle2712are guided along a trajectory that is fixed relative to the guide member2708and the transrectal probe. The trajectory of the access needle2712may be generally parallel with a longitudinal axis of the transrectal probe when the biopsy guide2700is coupled with the probe.

Reference is made toFIGS.31A-31F, which depict various views of the guide member2708of the upper mount2702of the biopsy guide2700.FIG.31Ais a front isometric view of the guide member2708;FIG.31Bis a front view of the guide member2708;FIG.31CIs a back view of the guide member2708;FIG.31Dis a side view of the guide member2708;FIG.31Eis a bottom view of the guide member2708; and,FIG.31Fis a top view of the guide member2708.

As seen in the figures, the guide member2708includes a distal end2716, a proximal end2718opposite the distal end2716, and a longitudinal axis2720extending through the distal and proximal ends2716,2718. As described herein locational orientations of distal and proximal are relative to the patient or, more particularly, the perineum of the patient. As such, distal generally refers to towards the patient and proximal refers to away from the patient.

Referring back to the figures, the guide member2708further includes a base platform2722extending substantially perpendicularly between a pair of vertical extension members2724. Atop each of the vertical extension members2724is a guide rail or stabilization bar2726that is adapted to slidingly engage with and allow the displacement member2710to translate along a trajectory that is parallel with the longitudinal axis2720of the guide member2708.

As best seen inFIGS.31A and31C, each of the guide rails2726includes a generally rectangular member2728that is perpendicularly oriented to the vertical extension members2724. The rectangular member2728extends from the proximal end2718to the distal end2716of the guide member2708. The vertical extension members2724couples with a bottom surface2730of the rectangular member2728. An outer lateral edge of the rectangular member is coupled with a side member2732that extends from the proximal end2718to the distal end2716of the guide member2708. A distal member or flange2734extends inwardly from the rectangular member2728a distance that is equal to the width of the rectangular member2728. More particularly, the distal member2734includes a rounded inner edge2736that is coplanar, at its apex, with an inner edge2738of the rectangular member2728. The distal member2734may include a planar distal face or surface2740with an opening2742formed therein. The opening2742may facilitate an access point for injection molding. As with previously described embodiments, the guide rails2726and, more particularly, the distal face2740of the guide rails2726may facilitate the positioning and holding of the perineal skin and subcutaneous tissue to allow positioning of the access needle2712.

As seen inFIGS.31A,31C, and31F, a top surface2744of the rectangular member2728includes a stop feature2746to secure or lock the displacement member2710in a distal or deployed condition or position. The stop feature2746is a ramp that distally slopes upward until the apex of the ramp at which point the ramp distally slopes downward. In the distal position, the displacement member2710is at a distal-most position and abuts or is adjacent a proximal face2748of the distal member2734. The distal member2734, thus, prevents further distal movement of the displacement member2710and the stop feature2746restrains proximal movement a certain amount. In certain embodiments, as seen in the figures, the proximal end2718of the rectangular member2728is open such that the displacement member2710can be slidingly engaged with the rectangular member2728.

As seen inFIGS.31A and31D-31F, the base platform2722extends about one half of the overall longitudinal distance of the guide rails2726. In this way, the guide rails2726extend beyond both the base platform2722and the vertical extension members2724such that the guide rails2726may contact the perineal skin and subcutaneous tissue of the patient but not a distal edge2750of the base platform2722or a distal edge2752of the vertical extension members2724. And since a distal portion of the lower mount2704lies generally flush with the distal edge2750of the base platform2722, the lower mount2704also may be spaced apart from the skin of the patient during the biopsy procedure. In this way, in certain embodiments, the guide rails2726may contact the skin of the patient while the other portions of the guide2700remain spaced apart from the patient's skin.

As seen inFIG.31D, the distal edge2752of the vertical extension member2724is arcuate and a proximal edge2754of the vertical extension member2724includes a semi-circular path about halfway between the base platform2722and the guide rails2726. As seen inFIGS.31E-31F, the base platform2722includes a pair of channels2756extending parallel to each other and extending longitudinally. These channels2756may coaxially align with snap features2758in the upper mount coupling mechanism2714of the lower mount2704to facilitate the upper mount2702being coupled with the lower mount2704. Once the channels2756and the snap features2758are aligned, the upper and lower mounts2702,2704may be snapped together such that the snap feature2758extends through the channels2756to securely couple the mounts together. While the figures show channels2756and snap features2758, other mechanisms are possible to couple the upper and lower mounts2702,2704. For example, the base platform2722and the upper mount coupling mechanism2714may each include through holes that coaxially align. And, screws or nuts/bolts may be used to secure the mounts2702,2704together.

As seen inFIGS.31B-31C and31E, the bottom surface2762of the base platform2722includes a rectangular rail or protrusion2764extending longitudinally. The top surface of the base platform2722includes a longitudinally extending groove, which may be used to align the guide member2708with the sagittal plane of the ultrasound probe. As seen inFIG.31E, the channels2756extend through the rail2764. As will be described subsequently, the rail2764may engage with a platform2766of the upper mount coupling mechanism2714of the lower mount2704so as to align the upper and lower mounts2702,2704upon coupling together.

Reference is made toFIGS.32A-32C, which depict, respectively, a front isometric view, a front view, and a back view of the displacement member2710. As described previously, the translating or displacement member2710may be coupled with the guide rails2726of the guide member2708so as to be displaceable or slidable between the proximal end2718of the guide member2708to the distal end2716. Thus, when the access needle2712is coupled with the displacement member2710, the access needle2712is also displaceable between the proximal end2718of the guide member2708to the distal end2716.

As seen in the figures, the displacement member2710includes a central vertically extending member2760having five needle receiving ports or passages2768formed therein (e.g., first passage, second passage, third passage, fourth passage, fifth passage). Each needle receiving port2768includes an opening2770extending from a distal end2772to a proximal end2774of the displacement member2710. Each of the openings2770of the needle receiving ports2768are generally vertically aligned with each other and each includes a trajectory axis2776defining a trajectory of the access needle2712when positioned within the opening2770. The trajectory axis2776is generally parallel to the longitudinal axis2720of the guide member2708when the displacement member2710is coupled with the guide member2708. The trajectory axis is also generally parallel with a longitudinal axis of the probe when the biopsy guide2700is coupled with the probe. Thus, the trajectory axis2776of the access needle2712may be generally fixed or constant, in a generally parallel orientation to the previously described axes, as the displacement member2710displaces distal-proximal relative to the guide member2708.

A particular needle receiving port or passage2768may be chosen based on a desired distance from the probe. Thus, if a physician desires that the access needle2712should be positioned nearer the probe, a particular needle receiving port2768may be chosen that is at the bottom of the displacement member2710. Thus, the displacement member2710can support the access needle2712at various discrete vertical positions within the opening or gap between the distal members2734. In certain embodiments, the openings2770of the needle receiving ports2768may be vertically spaced apart about 5 mm. In certain embodiments, the openings2770of the needle receiving ports2768may be vertically spaced apart about 3 mm. In certain embodiments, the openings2770of the needle receiving ports2768may be vertically spaced apart about 4 mm. In certain embodiments, the openings2770of the needle receiving ports2768may be vertically spaced apart at any interval between about 2 mm to about 6 mm, among other distances.

While the vertically extending member2760includes five needle receiving ports2768, it is foreseen that more or less ports may be included in the displacement member2710without limitation.

The displacement member2710further includes a coupling mechanism2778to displaceably couple the displacement member2710and the guide rails2726. The coupling mechanism2778includes a pair of lower tab members2780extending laterally out and away from the vertically extending member2760. When coupled with the guide rails2726, the lower tab members2780may abut or be positioned adjacent the bottom surface2730of the rectangular member2728. The tab members2780include a planar top surface2782that may provide sliding contact with the bottom surface2730of the rectangular member2728. The planar contact between the surfaces may contribute to stability of the displacement member2710relative to the guide rails2726by reducing vertical tilt of the displacement member2710.

The coupling mechanism2778further include an upper member2784positioned above the lower tab members2780. A bottom surface2786of the upper members2784may abut or be positioned adjacent the top surface2744of the rectangular member2728when the displacement member2710is coupled with the guide rails2726. The bottom surface2786of the upper members2784is planar and, thus, the planar contact between the surfaces may contribute to stability of the displacement member2710relative to the guide rails2726by reducing vertical tilt of the displacement member2710. The upper members2784and the lower tab members2780operate to sandwich the rectangular members2728of the guide rails2726when the displacement member2710is coupled with the guide member2708.

The coupling mechanism2778further includes a lateral brace mechanism2788at lateral ends of the upper members2784. The lateral brace mechanism2788includes an upside-down U-shaped member2790having three inner surfaces2792that define a longitudinal extending channel2794therein. The channel2794may receive the side members2732therein when the displacement member2710couples with the guide rails2726. In this way, the lateral brace mechanism2788may contribute to stability of the displacement member2710relative to the guide rails2726by reducing lateral tilt of the displacement member2710. It is foreseen that the displacement member2710may not include the lateral brace mechanism2792and may instead only include the upper member2784and the lower tab members2780. Alternatively, it is foreseen that the displacement member2710may not include the upper member2784and the lower tab members2780, but may only include the lateral brace mechanism2792. Additionally and alternatively, other mechanisms are possible to facilitate the displacement member2710displacing between the proximal and distal ends2718,2716of the guide member2708. For example, the guide member2708could include longitudinally extending rods (not shown) and the displacement member2710may include a sleeve that engages and is guided by the rods. In such an embodiment, the rods may be adapted to slide within the openings2770of the needle receiving ports2768with or without modification to the displacement member2708.

Still referring toFIGS.32A-32C, flanges2796extend laterally from the upside-down U-shaped members2790, which may act as grasping points for the physician. The flanges2796extend inwardly and are coplanar with a back wall member2798that spans between the upside-down U-shaped members2790, the vertically extending member2760, and the upper members2784. The back wall member2798may function to provide rigidity between the various components of the displacement member2710. As seen inFIG.32C, a proximal side2800of the needle receiving ports2768includes keyed features within a recess to receive and lockingly engage the access needle2712such that it does not rotate once it is coupled with the port2768. More particularly, the shaft2842of the access needle2712can extend through the port or passage2768such that the hub2846is received in the recess of the port or passage2768. The surfaces within the recess are complementary to the ridges2848on the hub2846of the access needle2712to lockingly engage the access needle2712to the port or passage2768so rotation is inhibited. As seen inFIG.32C, the recess includes radially outward projecting indents at twelve o'clock, three o'clock, six o'clock, and nine o'clock. The indents are sized to receive the ridges2848on the hub2846of the access needle2712.

Reference is made toFIGS.33A and33B, which depict, respectively, a front isometric view and a front view of the lower mount2704of the biopsy guide2700. As previously described, the upper mount coupling mechanism2714includes the snap features2758to couple with the channel2756in the base platform2722. Each of the snap features2758may be vertical flanges2802with a lip2804at its vertical termination. As the inner surfaces defining the channels2756contact the vertical flanges2802, the inner surfaces compress the lips2804together relative to each other until the flanges2802“snap” or expand outwardly relative to each other such that the lips2804are on a top surface of the base platform2722. The vertical flanges2802extend from the platform2766of the upper mount coupling mechanism2714. The platform2766is coupled with the probe coupling mechanism2706, which, as seen in the figures, may be a snap-grip or snap-clip type of hose or tube clamp. The mechanism2706may include a first and a second arm member2804,2806extending from opposite sides2808of the platform2766. The arm members2804,2806are flexible and designed to wrap around a portion of the probe fitted within the opening formed by the first and second arms2804,2806. The first arm member2804includes a first clamping structure2810including an upper row of teeth2812and a lower smooth sliding surface2814. The second arm member2806includes a second clamping structure2816including an upper smooth sliding surface2818and a lower row of teeth2820. The first and second clamping structures2810,2816work together to provide a clamping or gripping function to securely support the transrectal probe to the lower mount2704and, thus, the upper mount2702.

In operation, a transrectal probe is positioned within the opening between the first and second clamping structures2810,2816. The physician may determine a desired position on the probe based on the patient's anatomy, the particular transrectal probe, or the particular procedure to be performed, among other possible criteria. Once a position for the lower mount2704is chosen, the physician may cause the first and second arm members2804,2806to be contracted relative to each other by pushing on the outer ends2822of the clamping structures2810,2816, respectively. As the clamping structures2810,2816converge relative to each other, the lower row of teeth2820on the second clamping structure2806is received within an opening2824formed between the upper row of teeth2812and the lower smooth surface2814. The upper row of teeth2812are caused to engage with the lower row of teeth2820. Additionally, the upper smooth surface2818is caused to slide on an inner smooth surface2826of the first arm member. And, the lower smooth sliding surface2814is caused to slide on a lowest smooth surface2828on the second clamping structure2816. The teeth of the upper and lower row2812,2820are arranged in a saw tooth like manner such that when they are increasingly engaged with each other the teeth grip each other and resist moving in the opposite direction. Once engaged, the teeth may be disengaged by pulling on a tab2830on a bottom portion of the first clamping structure2810. Pulling on the tab2830allows the teeth2812,2820to disengage with each other and the flexible nature of the first and second arms2804,2806are caused to spring back into the shape shown inFIG.33B. As seen inFIGS.33B-33B, an inner surface2834of the first and second arms2804,2806includes a gasket2832that may be flexible and deformable to provide for a gripping surface between the probe and the lower mount2704.

Reference is made toFIG.34, which depicts a front isometric view of an access needle2712. As seen in the figure, the needle2712includes a distal end2836and a proximal end2838opposite the distal end2836. At the distal end2836is the bevel2840extending distally from a shaft2842. Within the shaft2842is a lumen2844for communication of fluids or, in the case of the access needle2712, a shaft of a smaller gage biopsy needle. The proximal end2838of the needle2712includes a hub2846with ridges2848extending longitudinally around a circumference of the hub2846. The ridges2848may engage with corresponding and negatively shaped features on the proximal side2800of the needle receiving ports2768.

The following discussion will focus on use of the biopsy guide2700and will refer toFIGS.35A-35D, which depict, respectively: a front isometric view of the lower mount2704; a front isometric view of the lower mount2704coupled with the upper mount2702; a front isometric view of the lower mount2704coupled with the upper mount2702and the displacement member2710positioned at a proximal end of the guide member2708; and, a front isometric view of the lower mount2704coupled with the upper mount2702and the displacement member2710positioned at a proximal end of the guide member2708with the access needle2712positioned within one of the needle receiving ports2768.

As seen inFIG.35A, the lower mount2704is positioned with the first and second clamping structures2810,2816of the first and second arm members2804,2806uncoupled such that a transrectal probe may positioned between the arm members2804,2806. While it is not depicted in the figures, the first and second clamping structures2810,2816may be engaged with each other or coupled as described previously to grasp the probe between the arm members2804,2806and against the gasket2832.

As seen inFIG.35B, the upper mount2702may be coupled with the lower mount2704. More particularly, the vertical flanges2802on the platform2766of the upper mount coupling mechanism2714may be engaged with or snapped together with the channels2756on the base platform2722of the guide member2708.

As seen inFIG.35C, the displacement member2710may be engaged with the guide member2708. More particularly, the distal end2772of the displacement member2710is longitudinally aligned with the proximal end2718of the guide member2708such that the proximal ends of the guide rails2726are positioned to extend into the corresponding features of the displacement member2710. That is, the rectangular member2728is aligned with the opening between the upper members2784and the lower tab members2780, and the vertically extending side members2732are aligned with the channels2794between the inner surfaces2792of the upside-down U-shaped member2790of the displacement member2710. Once aligned, the displacement member2710is displaced, moved, or translated into engagement with the guide member2708, as seen inFIG.35C, which depicts the displacement member2710in a proximal-most position.

As seen inFIG.35D, the access needle2712is coupled with the displacement member2710. More particularly, the bevel2840and shaft2842of the access needle2712are extended through the proximal side2800of a particular opening2770of a needle receiving port2768until the hub2846of the access needle2712engages with the proximal side2800of the port2768. The ridges2848of the access needle2712may engaged with corresponding features within the opening2770of the port2768such that the access needle2712remains coupled with the displacement member2710. The access needle2712may be restrained from rotating by the ridges2848. In certain embodiments, the access needle2712may be secured to the displacement member2710by, for example, a threaded features on the hub2846and openings2770of the ports2768such that the needle2712and the displacement member2710may be threadably engaged and disengaged with each other.

In the orientation shown inFIG.35D, the displacement member2710and the access needle2712are in a proximal-most position or condition. As seen in the figure, in this particular embodiment, the bevel2840of the access needle2712lies about flush with the planar distal face2740of the distal member2734. In other embodiments or with a different sized needle2712, the bevel2840of the access needle2712may extend beyond the distal face2740of the distal member2734when the displacement member2710is in the proximal-most position, or the bevel2840of the access needle2712may be positioned proximal of the distal face2740of the distal member2734when the displacement member2710is in the proximal-most position.

In certain embodiments where the bevel2840of the access needle2712does not extend past the distal face2740of the distal member2734, the physician may use the distal member2734to manipulate the perineal skin and subcutaneous tissue of the patient while having the displacement member2710coupled to the guide member2708, but while not having the bevel2840of the access needle2712contact the patient's skin.

WhileFIG.35Ddepicts the access needle2712coupling with the displacement member2710when the displacement member2710is in the proximal-most position, the access needle2712may be engaged with the displacement member2710when the displacement member is at the distal-most position or at any position between the distal-most position and the proximal-most position. When the access needle2712is in the proximal-most position, as shown inFIG.35D, the physician may manipulate the probe and the distal member2734of the upper mount2702to manipulate the perineal skin and subcutaneous tissue of the patient. When the trajectory of the access needle2712is appropriately positioned relative to the patient's perineal skin and subcutaneous tissue, the physician may distally displace the access needle2712by pushing on one or more of the back wall member2798or flanges2796of the displacement member2710, or the hub2846of the access needle2712. In certain embodiments, the displacement member2710may be biased or spring-loaded such that the physician may actuate a mechanism that distally advances the displacement member2710and the access needle2712without a need for manual advancement by the physician. As the access needle2712and the displacement member distally advance or displace, the displacement member2712will lock or be secured into the distal-most position via the ramps of the stop feature2746positioned on the top surface2744of the rectangular member2728. In the distal-most position, as seen inFIG.27, the displacement member2710is prevented from further distal displacement via the distal member2734. In particular, a front edge or surface2850of the distal end2772of the displacement member2710abuts or is adjacent a proximal surface2748of the distal member2734when the displacement member2710is in the distal-most position. In certain embodiments, as seen inFIG.27, the back surface2748may abut or be adjacent the front edge or surface2850of the upper members2784, the lower tab members2780(not seen inFIG.27) and/or part of the upside-down U-shaped member2790.

As further seen inFIG.27, the distal members2734extend inward towards the needle receiving ports2768but may define an opening or gap between the rounded inner edges2736of the two distal members2734(i.e., first distal member and second distal member) for the access needle2712to extend therethrough. That is, the opening extends vertically between the distal member2734and may be referred to as a vertical opening.

Once the access needle2712is in position in the patient's skin and subcutaneous tissue, the biopsy procedure may continue, as described previously, with the physician extending a biopsy needle through the lumen2844of the access needle2712and into the patient's prostate. Once procedure is complete, the physician may remove the access needle2712from the patient's body by proximally displacing the displacement member2710and the access needle2712by pulling or pushing on the displacement member2710or access needle. Alternatively, the access needle2712may be disengaged with the displacement member2710while the displacement member2710is in the distal-most position.

The discussion will now focus on additional and alternative embodiments of the biopsy guide. As seen inFIG.36, the displacement member2710may include the upper members2784and the lower tab members2780for engaging with and sliding or displacing relative to the rectangular members2728of the guide rails2726. The displacement member2710ofFIG.36, however, does not include an upside-down U-shaped member for engaging with the side members2732of the guide rails2726and, further, does not include the back wall member2798and the flanges2796. Features of both embodiments of the displacement member2710may be combined as needed and without limitation.

The lower mount2704, as described herein, may take many forms without departing from the scope of the present disclosure. Other mechanisms to couple the upper mount2702to the probe are possible and contemplated herein. For example, the upper mount2702may couple with or be integrally formed with a thin sheath or sleeve of latex, polyurethane, or other materials, such as a male condom. The sheath may be fitted over the probe in a tight fitting manner such that the upper mount2702is secured in position relative to the probe.

Additional or alternative embodiments of the lower mount2704may include rubber or rubber-type cinch straps that are coupled with or integral with the upper mount2702.

The upper mount2702, as described herein, may take many forms without departing from the scope of the present disclosure. Other mechanisms to guide the access needle2712are possible and contemplated herein. For example, the displacement member2710supporting the access needle2712may be coupled to a platform on a coupler side of a four-bar linkage (e.g., parallelogram linkage) where the fixed portion of the linkage may be coupled with the base platform2722of the guide member2710. The platform may be displaceable distal-proximal by urging the platform distally or proximally, while displacing in an arcuate path. In the case of a parallelogram linkage, the trajectory of the access needle2712may remain parallel to the longitudinal axes of the probe and guide member2710while vertically displacing. In this way, such a linkage may be used for distal-proximal displacement as well as vertical displacement or adjustment, as needed for a particular biopsy procedure. This type of displacement member2710may be used with the guide member2708as described herein with or without modification.

As another example, the displacement member2710supporting the access needle2712may be coupled to a carriage or lead screw nut that is displaced relative to the guide member2708(and probe) via rotation of a lead screw. The lead screw may be positioned parallel to the longitudinal axis of the guide member2708and the probe such that displacement of the lead screw nut and, thus, the displacement member2710and access needle2712displace or translate distal-proximal while maintaining a trajectory of the access needle2712that may be fixed. A bottom side of the lead screw nut may include a feature or protrusion that extends into a channel formed in the base platform2722of the guide member2708such that the lead screw nut does not rotate, but, rather, displaces or translates linearly distal-proximal in response to rotation of the lead screw. The lead screw may be rotatable by hand via, for example, a handle at the proximal end of the lead screw.

Reference is now made toFIGS.37A-37F, which depict various views of another embodiment of the biopsy guide3700. As seen inFIG.37A, which is a front isometric view of the biopsy guide3700, the guide3700is similar to previously described embodiments of the guide in that it includes an upper mount3702and a lower mount3704. The lower mount3704is adapted to secure the guide3700to a transrectal probe and includes the same features as the previously described embodiment. The upper mount3702may releasably couple with the lower mount3704. As seen inFIGS.37B and37C, which are, respectively, front and back isometric exploded views of the upper mount3702, the biopsy guide3700further includes a guide member3710and a displacement member, sliding member, access needle support structure, or translating member3706that is adapted to couple with an access needle3708.

As seen inFIGS.37B-37C and37E-37F, the displacement member3706includes a vertically extending member3712having five needle receiving ports3714formed within the member3712. The ports3714may receive the access needle3708within any of the ports3714, as previously described, to vary the height of the access needle3708relative to the probe (not shown). The access needle3708may couple with the needle receiving ports3714such that they may be displaced together relative to the guide member3710.

As seen in the figures, a bottom end3716of the vertically extending member3712is coupled to a distal end3718of a rail member3720that may slidingly engage with the guide member3710. The rail member3720includes a flange member3722and a web member3724arranged in a T-beam shape. That is, the flange member3722is wider than the web member3724, which projects upward and substantially perpendicularly from a central portion of the flange member3722. From the distal end3718, the rail member3720extends proximally to a proximal end3726. At the proximal end3726is an end plate member3728, which prevents distal displacement of the displacement member3706past a certain point.

As seen inFIGS.37C and37D, the guide member3710includes a rail receiving slot or channel3730having a proximal opening3732, a distal opening3734(seen inFIG.37B), and a top opening3736. The rail receiving slot3730is generally a negative shape of the rail member3720and may receive the rail member3720therein and permit the rail member3720and, thus, the displacement member3706and access needle3708to displace relative to the guide member3710. When the rail member3720is positioned within the rail receiving slot3730, inner surfaces3738of the slot3730may contact the flange and web members3722,3724and restrain the displacement member3706from lateral displacement and vertical tilting while allowing distal-proximal displacement or translation of the displacement member3706. Thus, the displacement member3706may be displaced or translated distally and proximally while maintaining alignment of a trajectory of the access needle3708substantially parallel with a longitudinal axis of the probe when the biopsy guide3700is coupled with the probe.

As seen inFIG.37A, the displacement member3706is in a distal-most position with the distal end3718of the rail member3720and a distal end3740of the vertically extending member3712being about coplanar with a distal face3742of a distal member3744of the guide rail members3746, which may be similar to as previously described in relation to previous embodiments. In the distal-most position, the rail member3720extends past the distal opening3734of the rail receiving slot3730, and the end plate member3728of the rail member3720abuts or is adjacent the proximal opening3732of the rail receiving slot3730. To proximally displace the displacement member3706from the distal-most position, the physician may pull or push on the end plate member3728, the vertically extending member3712, or the access needle3708.

It is noted that the guide rail members3746and, more particularly, the distal members3744may be used by the physician to manipulate the perineal skin and subcutaneous tissue of the patient, as described previously. And while the embodiment of the biopsy guide3700inFIGS.37A-37Fdescribe a rail and slot type of arrangement between the displacement member3706and the guide member3710, other mechanisms are possible to displace the displacement member3706relative to the guide member3710. Additionally or alternatively, features and elements from other embodiments of the biopsy guide may be incorporated into the present embodiment without limitation. Similarly, features and elements from the present embodiment of the biopsy guide may be incorporated into any of the other embodiments of the biopsy guide without limitation.

As seen inFIG.37G, which is a side view of another embodiment of the displacement member3706with the access needle3708partially positioned within the top needle receiving port3714of the vertically extending member3712, the rail member3720may be replaced by a lead screw3748and the bottom end3716of the vertically extending member3712may include a lead screw nut3750that rotationally engages with the lead screw3748to cause the displacement member3706and the access needle3708to displace or linearly translate relative to the probe and the guide member3710(not shown). The lead screw3748may be rotationally coupled with bearings3752at opposite ends which allow the lead screw3748to rotate thereon. The lead screw nut3750may be prevented from rotating by a guide rail3754that extends between the bearings3752and also extends through a passageway in the lead screw nut3750. In this way, as the lead screw3748rotates, the lead screw nut3750, as well as the vertically extending member3712and the access needle3708, are caused to displace or translate distal-proximal because the lead screw nut3750is prevented from rotating by the guide rail3754. The lead screw3748may include a handle3756for rotating the lead screw3748. The displacement member3706shown inFIG.37Gmay be coupled with the guide member3710shown in the previous figures such that the lead screw3748is generally parallel with the longitudinal axis of the guide member3710and the probe. The displacement member3706may, for example, couple with the base platform of the guide member3710at the bearings3752, or at other parts of the member3706.

As seen inFIGS.37H-37I, which are, respectively, an isometric front view and a side view of another embodiment of the biopsy guide3900, it includes a probe coupling mechanism3902in the form of collars that may be adjustably secured to the probe3904. Four arm members3906are pivotally coupled at bottom ends3908to the probe coupling mechanism3902and pivotally coupled at top ends3910to a platform member3912. The arm members3906may be of equal length such that the platform member3912is capable of displacing distal-proximal while maintaining a parallel orientation relative to the probe3904. More particularly, as seen inFIG.37I, the platform member3912may include a longitudinal axis that is generally parallel to a longitudinal axis of the probe3904in all distal-proximal orientations of the platform member3912relative to the probe3904. The platform member3912may include a longitudinally extending channel3914for receiving and guiding a displacement member3916having a needle receiving port3918. The displacement member3916may include a flanged lower body portion3920that matches a shape of the channel3914such that the displacement member3916may slide within the channel3914or displace relative to the platform member3912while maintaining an orientation of a needle positioned within the needle receiving port3918that is generally parallel to the longitudinal axis of the probe3904.

As seen inFIG.37I, the biopsy guide3900may function as a four bar parallel or parallelogram linkage during displacement of the platform member3912. In particular,FIG.37Ishows three positions of the platform member3912as it displaces. A first position3922shows the platform member3912at a highest position relative to the probe3904where the arm members3906are vertically extended to their maximum. A second position3924shows the platform member3912as it distally displaces while rotating clockwise and lowering the platform member3912relative to the probe. A third position3926shows the platform member3912as it further distally displaces while rotating clockwise and lowering the platform member3912relative to the probe. As seen in all positions3922,3924,3926, a longitudinal axis of the platform member3912may remain generally parallel with a longitudinal axis of the probe3904.

Reference is now made toFIG.37J, which is a front isometric view of another embodiment of an upper mount4000. As seen in the figure, the upper mount4000includes a guide member4002that is similar to previously described embodiments in that it includes a pair of guide rails4004that extend longitudinally and are spaced apart from each other. This embodiment of the upper mount4000, however, does not include a displacement member. Rather, the guide mount4002of the upper mount4000ofFIG.37Jincludes a vertically oriented member4008including needle receiving ports4006that are also vertically aligned. The member4008may not be displaceable relative to the guide member4002in this particular embodiment.

That is, the needle receiving ports4006may align a trajectory of an access needle in any of the ports4006such that a trajectory of the access needle may be generally parallel to a longitudinal axis of the probe. The needle receiving ports4006may be integrally formed with the guide member4002. Or, the vertical member4008including the needle receiving ports4006may be releasably coupled to the guide member. In a releasable arrangement, the vertical member4008may be coupled with the guide member via any coupling mechanism described herein or known in the art. As seen in the figure, the needle receiving ports4006are cylindrical and extend generally from a proximal end4010to a distal end4012of the guide member4002. The distal tip4014of the needle receiving ports4006may be about coplanar with a distal face4016of the distal members4018of the guide rails4004.

Reference is made toFIGS.37K-37L, which are, respectively, front and side views of another embodiment of a biopsy guide4100. As seen in the figures, the biopsy guide4100includes displacement member4102including a vertically oriented body4104having five vertically aligned needle receiving ports4106for receiving, supporting, and orienting an access needle. At a bottom end4108of the vertical body4104is a probe coupling mechanism4110including a collar4112having a guide rail or protrusion4114extending from an inner surface4116of the collar4112. The guide rail4114extends longitudinally in the collar4112and may be received by a correspondingly shaped channel or slot4120in a transrectal probe4118. In this way, the displacement member4102may slide, displace, or translate relative to the probe4118while being restrained from certain movements by the interaction between the guide rail4114and the channel4120. As such, the access needle supported by the needle receiving port4106may displace or translate distal-proximal relative to the probe4118while maintaining a trajectory that is generally parallel with a longitudinal axis of the probe4118.

The inner surface4116may include roller bearings or similar structures to permit the collar4112to roll, translate, or displace relative to the probe4118. While the channel4120is described as being formed in the probe4118, the channel4120may be formed in a separate member that is coupled to the probe4118. In this case, a specialized probe having a channel may not be needed; rather, any off-the-shelf ultrasound probe may be used with the separate member having the channel4120to utilize the biopsy guide4100of the present embodiment.

Reference is made toFIGS.37M-37U, which depict various views of alternative embodiments of the lower mount. To begin, reference is made toFIGS.37M-37Q.FIG.37Mis a front isometric view of a biopsy guide4200.FIG.37Nis a front view of the biopsy guide4200.FIG.37Ois a front isometric view of a cinch strap4202.FIG.37Pis a front isometric view of a V-block insert4204.FIG.37Qis a front view of the biopsy guide4200ofFIG.37Mwith an insert4204ofFIG.37P.

As seen inFIG.37M, the biopsy guide4200includes an upper mount4206and a lower mount4208. The upper mount4206may include a base platform4210and a pair of guide rails4212extending longitudinally from the base platform4210. The guide rails4212may guide a displacement member (not shown), which may support an access needle (not shown), as described in previous embodiments. The lower mount4208may include a cinch strap4202, as shown inFIG.37), which may include a flange4214at one end4216and a series of transversely extending ridges4218. The cinch strap4202may be fitted or positioned within a slot4220in the base platform4210such that the flange4214abuts the surfaces of the slot4220and is prevented from extending through the slot4220. The cinch strap4202may be fitted around the transrectal probe4222and positioned within a locking opening4224opposite the slot4220in the base platform4210. The cinch strap4202, which may be rubber or otherwise made of a flexible material, may be pulled tightly at the free end4226such that the ridges4218are progressively locked by the locking opening4224. Once appropriately tightened, the upper mount4206is now secured to the probe4222.

As seen inFIGS.37P-37Q, the lower mount4208of the biopsy guide4200may include a V-block insert4204positioned between the probe4222and the cinch strap4202. The V-block insert4204may include a pair of slots4228on opposite sides of the insert4204that may be sized to receive the cinch strap4202therethrough to secure the V-block insert4204into position relative to the cinch strap4202. The V-block insert4204ensures at least three points of contact between the probe and the biopsy guide4200: one point of contact between the probe4222and an underside of the base platform4210; and, two points of contact between the probe4222and the V-block insert4204.

Reference is made toFIGS.37R-37S, which depict, respectively, a front isometric view and a front view of another embodiment of a biopsy guide4300. Similar to the previously described embodiments, the biopsy guide4300includes an upper mount4302and a lower mount4304. The upper mount4302may include a base platform4306and a pair of guide rails4308extending longitudinally and spaced apart from each other. The guide rails4308may guide a displacement member (not shown), which may support an access needle (not shown), as described in previous embodiments. The lower mount4304may include a curvilinear shaped inner surface4310opposite the base platform4306and pair of opposing arms4312extending downward. The arms4312may converge on a bottom side4314of the lower mount4304. A V-block insert4316may be positioned an opening4318of the lower mount4304. The opening4318may be sized and shaped to receive the transrectal probe4322therein. The V-block insert4316may be vertically adjustable within the opening4318via a thumb-screw4320. When actuated or rotated, the thumb-screw4320may push the V-block insert4316vertically to exert a force on the probe4322, which, in turn, exerts a force on the inner surface4310of the base platform4306of the lower mount4304.

Reference is made toFIGS.37T-37U, which depict, respectively, a front isometric view and a front view of another embodiment of a biopsy guide4400. As seen in the figures, the device4400includes an upper mount4402and a lower mount4404. The upper mount4402may include a base platform4406and a pair of guide rails4408extending longitudinally and spaced apart from each other. The guide rails4408may guide a displacement member (not shown), which may support an access needle (not shown), as described in previous embodiments. The lower mount4404couples the upper mount4402to the probe4410and may include a strap4412that is affixed at one side4414via a pair of fasteners (e.g., screws, bolts)4416. The strap4412may wrap around the probe4410and be secured in place via a worm gear mount4418. The worm gear mount4418may include a thumb-knob4420that is rotatable and extending to a threaded feature (e.g., ACME threads)4422that threadably engage with slots4424on the second end4426of the strap4412. As the thumb-knob4420is tightened, the thread feature4422advances on the slots4424and pulls the strap4412tighter on the probe4410(similar to a hose clamp). This embodiment may include a V-block insert (not shown). As seen in the figures, an underside4426of the base platform4406may be curvilinear to match the shape of the probe4410. These features among features from other embodiments may be combined as needed to modify any of the features of any of the biopsy guides described herein.

Reference is made toFIGS.37V-37X, which depict additional and alternative embodiments of a lower mount4502of a biopsy guide4500. As seen inFIG.37V, which is a front view of a lower mount4502, the upper mount4504may be similar to previously describe embodiments in that it includes a base platform4506and a pair of guide rails4508. The lower mount may include a pair of semi-circular arm members, clamps, or collars4510that are pivotally coupled together at a joint4512(e.g., pin). The pair of semi-circular arm members4510may open and close about the joint4512in a clam-shell type manner. Opposite the joint4512, the arm members4510are adjustably secured together via a thumb-screw4514that extends between a pair of flanges4516. Thus, turning the thumb-screw4514in a first direction may cause the pair of arm members4510to constrict against a probe (not shown) positioned within the opening4518between the arm members4510. And, turning the thumb-screw4514in a second direction may cause the pair of arm members4510to loosen against the probe positioned within the opening4518.

FIG.37Wdepicts a front isometric view of the lower mount4504including a flexible spring band or biasing collar4520extending circumferentially and terminating in a pair of flanges or tabs4522that may be compressed together, relative to each other, to selectively enlarge the opening4518. The probe (not shown) may be positioned within the opening4518and the spring band4520may compress against the probe and cause a constant force to be exerted on the probe, allowing it to be used on probes of multiple diameters. The flat spring band4520may be replaced by a wire spring band (i.e., dumbbell clamp) without departing from the scope of the disclosure.

FIG.37Xdepicts a front view of a lower mount4504having a pair of semi-circular arm members, clamps, or collars4510that are pivotally coupled together at a joint4512(e.g., pin). The pair of semi-circular arm members4510may open and close about the joint4512in a clam-shell type manner. Opposite the joint4512, the arm members4510are adjustably secured together via a snap-clip, ratchet, or clamp assembly4524including a lever arm handle4526a wire arm or loop4528. The lever arm handle4526is attached to one free end4534of the arm members4510and the wire arm4528is attached to the lever arm handle4526. The other free end4530of the other arm member4510includes a lip4532such that the wire arm4528may be fitted around the lip4532with the lever arm handle4526in an opened position. Once the wire arm4528is positioned within the lip4532, the lever arm handle4526may be pivoted towards the arm member4510, which pulls the free ends4534,4530together to secure the arm members4510against the probe (not shown). To remove the probe from the lower mount4504, the lever arm handle4526may be pivoted outward away from the arm member4510of the free end4534and the arm members4510will expand relative to each other and release the probe.

As with many of the embodiments of the biopsy guide described herein, there may be a particular type of mechanical arrangement between the guide member and the displacement member that at least facilitates the displacement of the access needle along at least a portion of the length of the guide member. As discussed in relation to each of the embodiments, the mechanical arrangement may include at least one of a sliding arrangement, a lead screw, or a parallel bar linkage. And, as described with reference to the various embodiments of the biopsy guide, the guide member may operably couple with the transrectal probe via at least one of a sheath arrangement, a ratchet arrangement, a biased collar arrangement, a flexible strap arrangement, a clamping arrangement, or a clamshell collar arrangement.

Reference is now made toFIGS.38A-38D, which depict, respectively, a transverse plane or slice image of a prostate3800and a urethra3804, a sagittal plane or slice image of a prostate3800and a urethra3804, a transverse plane or slice image of a prostate3800and a urethra3804with a marking device3824positioned within the urethra3804, and a sagittal plane or slice image of a prostate3800and a urethra3804with a marking device3824positioned within the urethra3804. As mentioned previously, during a prostate biopsy procedure it may important for the physician to identify the path of the urethra so that he or she can avoid puncturing the urethra with the access needle and the biopsy needle. The biopsy guides described herein may be used with various systems to locate the urethra via the transrectal probe in sagittal and axial planes.

As described previously, the probe or transducer provides imaging in axial and sagittal planes so as to provide real-time images of the prostate. As seen inFIG.38A, which is a transverse plane showing the prostate3800and the probe3802, the urethra3804is shown, as well as a path3806of the urethra3804, as would be seen in a sagittal plane. As seen inFIG.38B, which is a sagittal plane showing the prostate3800and the probe3802, the urethra3804is shown extending over the prostate3800and connecting with the bladder3808.

When the prostate is viewed, as seen inFIGS.38A and38B, the physician may then position the access needle2712in an access site3810in the subcutaneous tissue3812of the perineum3814, where the access site3810is at a midpoint between a lateral edge of the prostate3816and the urethral path3806along a first axis and a midpoint between an anterior capsule3818and a posterior capsule3820along a second axis. The physician may guide the probe3802and the biopsy guide (not shown) along a sagittal plane to the target using the real-time image from the probe3802, and the physician may obtain one or more specimens3822of the prostate3800through the access needle2712being guided by the biopsy guide.

Identifying the urethra may be accomplished via a number of methods. First, as seen inFIGS.38C-38D, a marking device3824such as, for example, a balloon catheter can be inserted into the urethra3804and used by the physician to locate the urethra3804. As seen inFIG.38C-38D, the marking device3824may include a catheter3826and a balloon3828. The balloon3828may be expanded in the bladder3808and the catheter3826may extend through the urethra3804and out of the patient's body. The balloon3828and/or catheter3826may be visible in certain planes during the biopsy procedure and may aid in identifying the urethra3804.

Additionally, or alternatively, the marking device3824may include markers3830such as physical or chemical markers that are visible in an ultrasound environment (e.g., pellets of polylactic and polyglycolic acids containing carbon dioxide, polyglycolic acid pads) along the length of the catheter3826so that the physician can view the path of the urethra3804as viewed in transverse or sagittal planes. Thus, the physician may be able to position a trajectory of the access needle2712to be adjacent and not intersecting with the path of the urethra as indicated by the markers3830on the catheter3826. The markers3830may be positioned on the catheter at certain intervals so as to provide a way to estimate the size or volume of the prostate3800. Additionally or alternatively, the catheter3826may include a contrast medium (e.g., dye) for visualization purposes and may otherwise function similarly to markers3830positioned on the catheter3826.

The biopsy guides and devices described herein may additionally include markers or sensors positioned on the biopsy guide or access needle such that movement of the guide or needle, or any device/material placed through the access needle, may be visualized via the markers/sensors by ultrasound equipment (e.g., probe) or other equipment using different imaging modalities (e.g., MRI, CT). In this way, for example, a marker positioned at a distal end of the access needle may provide visual guidance as to the location of the tip of the access needle relative to the boundaries of the prostate.

Although various representative implementations have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of the inventive subject matter set forth in the specification. All directional references (e.g., distal, proximal, front, back, side, top, bottom, fore, aft, right, left, etc.) are only used for identification purposes to aid the reader's understanding of the implementations, and do not create limitations, particularly as to the position, orientation, or use of the embodiments described herein unless specifically set forth in the claims. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other.

It is believed that the present disclosure and many of its attendant advantages will be understood by the foregoing description, and it will be apparent that various changes may be made in the form, construction and arrangement of the components without departing from the disclosed subject matter or without sacrificing all of its material advantages. The form described is merely explanatory, and it is the intention of the following claims to encompass and include such changes.

While the present disclosure has been described with reference to various embodiments, it will be understood that these embodiments are illustrative and that the scope of the disclosure is not limited to them. Many variations, modifications, additions, and improvements are possible. More generally, embodiments in accordance with the present disclosure have been described in the context of particular implementations. Functionality may be separated or combined in blocks differently in various embodiments of the disclosure or described with different terminology. These and other variations, modifications, additions, and improvements may fall within the scope of the disclosure as defined in the claims that follow.