Transperineal biopsy guide, system and method of use

Abstract

This invention relates to a transperineal biopsy system for use with a transrectal imaging probe. The transperineal biopsy system includes a puncture needle and a biopsy guide. The biopsy guide includes a mounting base for mounting on the transrectal imaging probe, a patient contact member projecting distally relative to the mounting base, and an opening member. The opening member projecting distally relative to the mounting base includes a plurality of vertically arranged, spaced-apart needle receiving openings. Each of the plurality of needle receiving openings is configured to support the puncture needle at a different height relative to the transrectal imaging probe and is configured to support the puncture needle in the sagittal plane when the biopsy guide is attached to the transrectal imaging probe. At least one of the plurality of needle receiving openings includes a slot extending radially outward from the at least one needle receiving opening.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 564,893, filed March 13, 2024, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0002] Various aspects of this invention relate to biopsy procedures and systems. In particular, this invention relates to methods, systems, and apparatus for planning and performing guided and manual transperineal prostate biopsies. Background Technology

[0003] A biopsy is a medical procedure that involves sampling and removing tissue or cells from a living body for further examination and analysis. Prostate biopsies can be performed by healthcare providers for the diagnosis and treatment of a patient's prostate. For example, the vast majority of patients with abnormal prostate-specific antigen (PSA) levels or questionable digital rectal examination (DRE) results undergo a biopsy. Typical biopsy procedures include transrectal ultrasound-guided (TRUS) biopsy and transperineal ultrasound-guided (TPUS) biopsy.

[0004] TRUS involves obtaining tissue or cell specimens by inserting a biopsy needle or other biopsy instrument through the rectal wall and into various locations of the prostate using sagittal imaging. The biopsy needle or other biopsy instrument can be guided by ultrasound in the sagittal plane. Several disadvantages are associated with TRUS. In particular, patients may need to take antibiotics before the procedure to reduce the risk of infection. Furthermore, TRUS requires bowel preparation, a procedure typically performed before the biopsy to clean the bowels of feces and secretions. Additionally, the biopsy needle penetrating the rectal wall may introduce bacteria from the rectum, such as coliform bacteria, into the prostate, which can lead to infection or other complications. Moreover, many clinically significant prostate cancers are located in locations within the prostate that are typically difficult to access using a transrectal approach.

[0005] TPUS involves obtaining tissue or cell specimens by inserting one or more biopsy needles through the perineum and into the prostate. TRUS is preferred over TPUS. Unlike TRUS, TPUS does not require patients to take antibiotics or undergo bowel preparation before the procedure to reduce the risk of bacterial problems. Furthermore, compared to TRUS, TPUS uses a more efficient route to enter the prostate and can reach target locations that might be difficult to access transrectally. Additionally, the needle does not penetrate the rectal wall, eliminating the risk of coliform bacteria entering the prostate or bloodstream as associated with TRUS.

[0006] Systems configured for TPUS include a biopsy grid, which can be fixed to, for example, a floor, platform, or table where the patient lies during a biopsy. The biopsy grid provides multiple orifices through which biopsy needles or other biopsy instruments can be inserted. An ultrasound imaging probe is directly attached to the device and is used to axially guide the biopsy needle or other instrument, such as other biopsy instruments. Therefore, the TPUS system requires imaging in the axial plane or transverse transducer of the ultrasound to locate the biopsy needle.

[0007] In view of these observations, various aspects of the present invention were conceived and developed. Summary of the Invention

[0008] In one embodiment, the invention disclosed herein takes the form of a transperineal biopsy system for use with a transrectal imaging probe configured to provide imaging at least in the sagittal plane. In one embodiment, the transperineal biopsy system includes a puncture needle and a biopsy guide. The puncture needle includes a hub at a proximal end and a tubular structure extending distally from the hub. The biopsy guide includes a mounting base, a fastening mechanism, a patient contact member, and an opening member. The mounting base is mountable onto the transrectal imaging probe. The mounting base includes a fastening mechanism that releasably attaches the mounting base to the transrectal imaging probe. The patient contact member projects distally relative to the mounting base. The opening member projects distally relative to the mounting base and includes a plurality of needle receiving openings arranged vertically in a spaced-apart manner. Each of the plurality of needle receiving openings is configured to support the puncture needle at a different height relative to the transrectal imaging probe and is also configured to support the puncture needle in the sagittal plane when the biopsy guide is attached to the transrectal imaging probe. At least one of the plurality of needle receiving openings includes a slot extending radially outward from the at least one needle receiving opening.

[0009] In some embodiments of this example, the slot extends between two or more adjacent needle receiving openings in a plurality of needle receiving openings. The slot may open radially outward through the top of the opening member, or it may close at the top and bottom of the opening member.

[0010] When the slot is open at the top of the opening member, the opening member may also include a clamping member that clamps the slot narrow enough to prevent the puncture needle from being forced through the slot unintentionally. The clamping member may include opposing downward projections that receive the sides of the opening member between the opposing downward projections during the process of clamping the slot narrow enough.

[0011] In some implementations, the slot may extend vertically into each of the plurality of needle receiving openings to form a single continuous slot.

[0012] In some embodiments, the slot extends in a lateral, upward, or a combination of lateral and upward directions, located at any point on the clock face between the nine o'clock and three o'clock directions in a clockwise direction, including both the nine o'clock and three o'clock directions.

[0013] In some embodiments, the slot opens radially outward through the side of the opening member and extends uninterruptedly and continuously from the distal end of at least one needle receiving opening to the proximal end of at least one needle receiving opening, together with at least one of a plurality of needle receiving openings.

[0014] In each of the above embodiments of this example, the slot is narrow enough to prevent the puncture needle from passing through the slot unintentionally.

[0015] The patient contact component can translate relative to the fastening mechanism. For example, the patient contact component can slide relative to the fastening mechanism while it can translate relative to the fastening mechanism.

[0016] The patient opening component can be translated relative to the fastening mechanism. For example, the opening component can slide relative to the fastening mechanism while it is translatable relative to the fastening mechanism.

[0017] The patient contact component may include a pair of stabilizing components that extend distally beyond the mounting base.

[0018] The puncture needle can be at least size 16, and each needle receiving opening can receive the puncture needle.

[0019] The transperineal biopsy system may also include biopsy instruments, including biopsy needles configured to extend through a puncture needle.

[0020] The biopsy needle can be 18 gauge. The puncture needle can be 14, 15, or 16 gauge.

[0021] In some embodiments, each of the plurality of needle receiving openings includes a distal segment and a proximal segment, the distal segment including a distal orifice and the proximal segment including a proximal orifice, the diameter of the proximal orifice being larger than the diameter of the distal orifice. Each of the plurality of needle receiving openings may include a hole configured to support a puncture needle.

[0022] In one embodiment, the invention disclosed herein takes the form of a transperineal biopsy system for use with a transrectal imaging probe configured to provide imaging at least in the sagittal plane. In one embodiment, the transperineal biopsy system includes a puncture needle and a biopsy guide. The puncture needle includes a hub at a proximal end and a tubular structure extending distally from the hub. The biopsy guide includes a mounting base, a fastening mechanism, a patient contact member, and an opening member. The mounting base is mountable onto the transrectal imaging probe. The mounting base includes a fastening mechanism that releasably attaches the mounting base to the transrectal imaging probe. The patient contact member projects distally relative to the mounting base and is translatable distally-proximal relative to the fastening mechanism. The opening member projects distally relative to the mounting base and includes a plurality of needle receiving openings arranged vertically in a spaced-apart manner. Each of the plurality of needle receiving openings is configured to support the puncture needle at a different height relative to the transrectal imaging probe and is also configured to support the puncture needle in the sagittal plane when the biopsy guide is attached to the transrectal imaging probe.

[0023] In some embodiments of this example, the patient contact member slides as it translates distally to proximally relative to the fastening mechanism.

[0024] In some embodiments, the patient contact member includes a pair of offset stabilizing bars that project distally relative to the mounting base and translate distally-proximal relative to the fastening mechanism when the patient contact member is translated distally-proximal relative to the fastening mechanism. The pair of offset stabilizing bars may together translate distally-proximal relative to the fastening mechanism as a single structural unit. Alternatively, each of the offset stabilizing bars may translate distally-proximal independently of the others.

[0025] In some embodiments, the opening member can be translated distally to proximally relative to the fastening mechanism. The opening mechanism can slide during the distally to proximal translation relative to the fastening mechanism.

[0026] The puncture needle can be at least size 16, and each needle receiving opening can receive the puncture needle.

[0027] The transperineal biopsy system may also include a biopsy instrument, which includes a biopsy needle configured to extend through a puncture needle.

[0028] The biopsy needle can be 18 gauge. The puncture needle can be 14, 15, or 16 gauge.

[0029] In one embodiment, the invention disclosed herein takes the form of a transperineal biopsy system for use with a transrectal imaging probe configured to provide imaging at least in the sagittal plane. In one embodiment, the transperineal biopsy system includes a puncture needle and a biopsy guide. The puncture needle includes a hub at its proximal end and a tubular structure extending distally from the hub. The biopsy guide includes a mounting base, a fastening mechanism, a patient contact member, an opening member, and an angled needle receiving opening. The mounting base is mountable onto the transrectal imaging probe. The mounting base includes a fastening mechanism that releasably attaches the mounting base to the transrectal imaging probe. The patient contact member projects distally relative to the mounting base. The opening member projects distally relative to the mounting base and includes a plurality of needle receiving openings arranged vertically in a spaced-apart manner. Each of the plurality of needle receiving openings is configured to support the puncture needle at a different height relative to the transrectal imaging probe and is also configured to support the puncture needle in the sagittal plane when the biopsy guide is attached to the transrectal imaging probe. The angled needle receiving opening is located at the top of the opening member. The inclined needle receiving opening is vertically aligned with multiple needle receiving openings in a common vertical plane, but in other cases it is angled relative to the multiple needle receiving openings.

[0030] In some embodiments of this example, the inclined needle receiving opening is at an angle of about 10 degrees to about 45 degrees to the direction parallel to the plurality of needle receiving openings.

[0031] In some embodiments, the angled needle receiving opening is fixed relative to a plurality of needle receiving openings by means of a fixed integral construction that serves as an opening member.

[0032] In some implementations, the angled needle receiving opening pivots relative to a plurality of needle receiving openings. Attached Figure Description

[0033] Figure 1A This is an isometric front view of a transrectal imaging probe (shown in dashed lines) supporting a biopsy guide with a puncture needle connected thereto, according to a first embodiment.

[0034] Figure 1B yes Figure 1A Same components, but the isometric rear view of the transrectal imaging probe has been removed.

[0035] Figure 1C This is an isometric view of the upper and lower mounting bases of a first embodiment of the biopsy guide.

[0036] Figure 1D This is a distal elevation view of the upper and lower mounting bases of the first embodiment of the biopsy guide.

[0037] Figure 1E This is a partially exploded isometric view of a first embodiment of a biopsy guide, wherein the opening or port component is separated from the rest of the biopsy guide.

[0038] Figure 1F This is an isometric view of a first embodiment of a biopsy guide and the puncture needle connected thereto, wherein the translated patient contact member is in a position closest to the side relative to the rest of the biopsy guide.

[0039] Figure 1G This is an isometric view of a first embodiment of a biopsy guide and a puncture needle connected thereto, with the translated patient contact member in a position closest to the side relative to the rest of the biopsy guide.

[0040] Figure 1H This is an isometric view of the first embodiment of the biopsy guide and the transrectal imaging probe (shown in dashed lines) to which the puncture needle is attached, with the translated patient contact member in a mid-proximal / distal position relative to the rest of the biopsy guide.

[0041] Figure 1I This is an isometric view of a first embodiment of a biopsy guide and the puncture needle connected thereto, with the translated patient contact member in a distal-proximal position relative to the rest of the biopsy guide.

[0042] Figure 1J This is a side view of a first embodiment of a biopsy guide, showing the translated patient contact member in the closest lateral position relative to the rest of the biopsy guide.

[0043] Figure 1K This is a side view of a first embodiment of a biopsy guide, showing the translated patient contact member in a mid-proximal / distal position relative to the rest of the biopsy guide.

[0044] Figure 1L This is a side view of a first embodiment of a biopsy guide, showing the translated patient contact member in its most distal position relative to the rest of the biopsy guide.

[0045] Figure 1M It is along Figure 1J The cross-sectional view of the first embodiment of the biopsy guide is taken by section line 1M-1M.

[0046] Figure 1N This is a front isometric view of the puncture needle used with the first embodiment of the biopsy guide.

[0047] Figure 2A This is an isometric view of a transrectal imaging probe (shown in dashed lines) of a second embodiment of a transperineal biopsy guide that supports a puncture needle connected thereto.

[0048] Figure 2B yes Figure 2A Same components, but the posterior isometric view of the transrectal imaging probe has been removed.

[0049] Figure 2C This is a partially exploded isometric view of a second embodiment of the biopsy guide, wherein the opening or port component and the translated patient contact component are separated from the rest of the biopsy guide.

[0050] Figure 2D This is a side view of a second embodiment of the biopsy guide, showing the translated patient contact member in the closest side position relative to the rest of the biopsy guide.

[0051] Figure 2E This is a side view of a second embodiment of the biopsy guide, showing the translated patient contact member in a mid-proximal / distal position relative to the rest of the biopsy guide.

[0052] Figure 2F This is a side view of a second embodiment of the biopsy guide, showing the translated patient contact member in its most distal position relative to the rest of the biopsy guide.

[0053] Figure 2G It is along Figure 2D The cross-sectional elevation view of the second embodiment of the biopsy guide is taken by section line GG.

[0054] Figure 3A This is a front perspective view of the first embodiment of a second embodiment of an opening or port member engaged by a clamping member.

[0055] Figure 3B Is with Figure 3A The same view, except that it shows clamps spaced apart from openings or port components.

[0056] Figure 3C This is a distal elevation view of a first embodiment of a second embodiment of an opening or port member, wherein the clamping member is not engaged with a member extending vertically from the center of the translated opening or port member.

[0057] Figure 3D This is a near-side elevation view of a first embodiment of a second embodiment of an opening or port member, wherein the clamping member is not engaged with a member extending vertically from the center of the translated opening or port member.

[0058] Figure 4A This is a front perspective view of a third embodiment of an opening or port component.

[0059] Figure 4B This is a rear perspective view of a third embodiment of an opening or port component.

[0060] Figure 4C This is a rear elevation view of a third embodiment of an opening or port component.

[0061] Figure 4D This is a near-side elevation view of a third embodiment of an opening or port component.

[0062] Figure 5A This is a front perspective view of a third embodiment of a translational opening or port component.

[0063] Figure 5B This is a rear perspective view of a third embodiment of a translational opening or port component.

[0064] Figure 5C This is a rear elevation view of a third embodiment of a translational opening or port component.

[0065] Figure 5D This is a near-side elevation view of a third embodiment of a translational opening or port component.

[0066] Figure 6A This is a front perspective view of a fourth embodiment of a translational opening or port component.

[0067] Figure 6B This is a rear perspective view of a fourth embodiment of a translational opening or port component.

[0068] Figure 6C This is a distal elevation view of a fourth embodiment of a translational opening or port component.

[0069] Figure 6D This is a near-side elevation view of a fourth embodiment of a translational opening or port component. Detailed Implementation

[0070] This document discloses various embodiments of a transperineal biopsy system for use with a transrectal imaging probe 103 configured to provide imaging. In some cases, imaging is performed in the sagittal plane. In others, imaging is performed in the axial or transverse plane. In still others, imaging is performed via one or more imaging modalities, such as ultrasound or magnetic resonance imaging (e.g., ultrasound-guided, MRI fusion). The transperineal biopsy system includes a puncture needle 112 and a biopsy guide 100. The puncture needle 112 includes a hub 193 at its proximal end and a tubular structure 242 extending distally from the hub. The biopsy guide 100 includes a mounting base 104, a fastening mechanism 106, a patient contact member 110, and an opening member 108. The mounting base 104 is mountable onto the transrectal imaging probe 103. The mounting base 104 includes a fastening mechanism 106 that releasably attaches the mounting base to the transrectal imaging probe. The patient contact member 110 projects distally relative to the mounting base. The opening member 108 projects distally relative to the mounting base and includes a plurality of needle receiving openings 170 arranged vertically at intervals. Each of the plurality of needle receiving openings 170 is configured to support the puncture needle 112 at a different height relative to the transrectal imaging probe 103, and is also configured to support the puncture needle 112 in the sagittal plane when the biopsy guide 100 is attached to the transrectal imaging probe 103.

[0071] According to the specific embodiments discussed below, the patient contact member 110 can be translated distally / proximally relative to the fastening mechanism 106. Alternatively or additionally, the opening member 108 can be translated distally / proximally relative to the fastening mechanism 106.

[0072] The patient contact component 110 may include offset stabilizing bars 126, which can be translated distally / proximally relative to the fastening mechanism 106. These bars 126 may be part of the overall structural construction or may be translated independently of each other.

[0073] In some embodiments, the common vertical slot 302 may extend through the needle receiving openings 170 of at least two adjacent needle receiving ports 168 of the member 160 extending vertically through the center of the opening member 108. The common vertical slot 302 may be open or light-receiving at the top and closed at the bottom, or it may be closed at both the top and the bottom.

[0074] In some embodiments, one or more of the needle receiving openings 170 may include separate slots extending radially outward from the respective opening 170.

[0075] Ultimately, in some embodiments, the angled needle receiving opening 470 is located at the top of the opening member 108. The angled needle receiving opening 470 is vertically aligned with the plurality of needle receiving openings 170 in a common vertical plane, but in other cases it is angled relative to the plurality of needle receiving openings 170. The angled needle receiving opening 470 may be permanently fixed relative to the rest of the opening member 108 or may be part of an angled needle receiving port 400 to which it is pivotally coupled.

[0076] Each of these embodiments has associated advantages, as described below. a. A biopsy guide with a translational patient contact component formed by a stabilizing bar.

[0077] The following text is related to Figures 1A to 1N Let us discuss a first embodiment of the transperineal biopsy guide 100. In this first embodiment, the translatable patient contact member 110 is formed by a stabilizing rod 126, which is translatable distally / proximally relative to the remainder of the transperineal biopsy guide 100. In some embodiments of this first embodiment of the transperineal biopsy guide 100, the opening or port member 108 may also be translatable distally / proximally relative to the remainder of the transperineal biopsy guide 100. In other embodiments of this first embodiment of the transperineal biopsy guide 100, the opening or port member 108 is fixed relative to the remainder of the transperineal biopsy guide 100. In any case, the biopsy guide 100 may be coupled to a transrectal imaging probe 103 and may be used to guide the puncture needle 112 during a transperineal prostate biopsy procedure.

[0078] Although reference Figures 1A to 1N The embodiments described herein and other embodiments disclosed herein, but aspects of other embodiments previously described in U.S. Patents 10,064,681 and 10,743,909, the disclosures of which are incorporated herein by reference in their entirety.

[0079] To begin discussing the first embodiment, refer to... Figure 1A and Figure 1B . Figure 1A This is an isometric view of a transrectal imaging probe 103 (shown in dashed lines) of a first embodiment of a transperineal biopsy guide 100 with a puncture needle 112 connected thereto. Figure 1B It is the same component, but the posterior isometric view of the transrectal imaging probe has been removed.

[0080] like Figure 1A and Figure 1BAs shown, the biopsy guide 100 includes an upper mounting base 102 and a lower mounting base 104. The lower mounting base 104 includes an imaging probe connection or fastening mechanism 106 to connect the lower mounting base 104 to the transrectal imaging probe 103, such as... Figure 1A As shown. In one embodiment of this first embodiment, the upper mounting base 102 and the lower mounting base 104 may be an integral structure, molded or formed from one piece or multiple pieces permanently attached to each other. In another embodiment of this first embodiment, the upper mounting base 102 and the lower mounting base 104 are respectively molded or formed, and the lower mounting base 104 further includes an upper mounting base coupling mechanism (see 2714 in FIG. 30 of U.S. Patent 10,743,909) to connect the lower mounting base 104 to the upper mounting base 102. Although Figure 1A and Figure 1B A single coupling mechanism 106 is depicted, but it is foreseeable that the biopsy guide 100 may also include more than one coupling mechanism 106, as shown and previously described in U.S. Patents 10,064,681 and 10,743,909. It can be said that the upper mounting base 102 and the lower mounting base 104 can be combined to form a superstructure of the biopsy guide 100 that supports the opening or port member 108, and the translatable patient contact member 110 is capable of translating independently distally / proximally relative to the underlying supporting superstructure.

[0081] For reference now Figures 1A to 1N In this first embodiment of the transperineal biopsy guide 100 discussed below, in relation to... Figures 2A to 2G Compared to the second embodiment of the translated patient contact member 110 discussed (which includes a larger portion of the overall transperineal biopsy guide 100), the translated patient contact member 110 includes a smaller portion of the overall transperineal biopsy guide 100.

[0082] According to an embodiment of the first embodiment of the transperineal biopsy guide 100, the opening or port member 108 may be fixed relative to the underlying support superstructure (e.g., welded, glued, molded, or otherwise integrally formed with the underlying support superstructure). Alternatively, the opening or port member 108 may be independently translated distally / proximally relative to the underlying support superstructure.

[0083] The upper mounting base 102 may include an opening or port member 108 and a translatable patient contact member 110. The opening or port member 108 may receive and engage with the puncture needle 112 (see [link to documentation]). Figure 1A , Figure 1B , Figures 1G to 1L and Figure 1NThe opening or port member 108 is fixedly coupled to the rest of the biopsy guide 100 to prevent translation between the opening or port member 108 and the rest of the biopsy guide.

[0084] Alternatively, in another embodiment of the first embodiment, the opening or port member 108 is displaceably coupled to the remainder of the biopsy guide 100, such that the opening or port member 108 can be translated (e.g., slid) relative to the upper mount 102 and / or the lower mount 104. More specifically, depending on whether the opening or port member 108 is a fixed or translatable embodiment of the first embodiment, the opening or port member 108 can be fixed or translated relative to the upper mount 102 and / or the lower mount 104. In the case of the translatable embodiment of the first embodiment, it can be translated relative to the remainder of the biopsy guide 100 via, for example, sliding, and thus, guided along a trajectory fixed relative to the transrectal imaging probe 103 along the opening or port member 108 and the puncture needle 112 coupled thereto. When the biopsy guide 100 is coupled to the imaging probe 103, the trajectory of the puncture needle 112 can be generally parallel to the longitudinal axis 105 of the transrectal imaging probe 103 (see Figure 1H ).

[0085] Figure 1G , Figure 1H and Figure 1I This is an isometric view of the biopsy guide 100, showing the translation process of the translated patient contact member 110 relative to the rest of the biopsy guide 100. Figure 1J , Figure 1K and Figure 1L This is a side view of the biopsy guide 100, showing its relationship with... Figure 1G , Figure 1H and Figure 1I The same translational relationship. As can be understood from these figures, the structural aspects of the translated patient contact member 110 are displaceably (e.g., slidably) coupled to the upper mount 102 and / or the lower mount 104, such that the patient contact member 110 can be positioned parallel to and along the longitudinal axis 105 of the transrectal imaging probe 103 (see figure 104). Figure 1H In the distal / proximal direction, it translates relative to the rest of the biopsy guide. Figure 1G and Figure 1J In this configuration, the translated patient contact component 110 is positioned proximally relative to the rest of the biopsy guide 100. Figure 1H and Figure 1KIn this configuration, the translated patient contact component 110 is positioned at the midpoint or intermediate position between the proximal and distal sides relative to the rest of the biopsy guide 100. Figure 1I and Figure 1L In this configuration, the translated patient contact member 110 is positioned distally relative to the remainder of the biopsy guide 100. This distal / proximal translation capability of the translated patient contact member 110 allows the physician to control the degree to which the distal side 140 of the stabilizing bar 126 of the translated patient contact member 110 contacts the patient's perineum, for use in stabilizing the biopsy guide 100 against the patient's perineum, and allows the distal side 140 to be used for skin manipulation and / or tension contact with the patient's perineum.

[0086] As discussed in more detail below, in some embodiments of the translational patient contact member 110, the stabilizing bars 126 are coupled together to translate distally / proximally as a single unit. In other embodiments of the translational patient contact member 110, the pair of stabilizing bars 126 are independent of each other. As a result, one of the stabilizing bars 126 can be positioned distally / proximally to a greater or lesser degree than the other stabilizing bar 126 in the pair. Physicians may find this capability advantageous for certain patients and procedures. Of course, where this is not required by the patient or procedure, the positioning of each stabilizing bar 126 can mimic the positioning of the other stabilizing bar 126 in the pair, since the stabilizing bars 126 are not a single unit and they only need to achieve the same positioning via individual actions.

[0087] Now for reference Figure 1C and Figure 1D It depicts isometric views of the upper mounting base 102 and the lower mounting base 104, as well as a distance elevation view of the same element. For example... Figure 1C and Figure 1D As seen in the image, the translated patient contact member 110 is supported on the upper mounting base 102. The translated patient contact member 110 includes a distal end 116, a proximal end 118 opposite to the distal end 116, and a longitudinal axis 120 extending through the distal end 116 and the proximal end 118 (see [link to image]). Figure 1C As described herein, the positional orientation of distal and proximal is relative to the patient, or more specifically, relative to the patient's perineum. Therefore, distal generally refers to the side facing the patient, and proximal refers to the side away from the patient.

[0088] Still referencing Figure 1C and Figure 1DThe upper mounting base 102 includes a base platform 122 extending generally horizontally between a pair of vertically extending members 124. The top of each of the vertically extending members 124 is a stabilizing bar 126 for a translatable patient contact member 110. As discussed below, each stabilizing bar 126 is displaceably coupled to the corresponding vertically extending member 124 to translate distally / proximally relative to the vertically extending member 124 of the upper mounting base 102 (e.g., via sliding). Figures 1A to 1D Understandably, these stabilizer bars 126 are not structurally connected to each other. As a result, they can be positioned independently, distally / proximally, on their respective vertically extending members 124, separate from the other stabilizer bar 126 in the pair.

[0089] As the translated patient contact member 110 translates distally relative to the remainder of the biopsy guide 100 and comes into contact with the patient's perineum, the distal surfaces 140 of these stabilizing bars 126 provide adjustable stabilization and skin manipulation / tension contact with the patient's perineum. As per Figures 1G to 1L Understandably, the translating patient contact member 110 is adapted to slide relative to the upper mounting base 102 and the remainder of the biopsy guide 100 along a longitudinal axis 120 parallel to the translating patient contact member 110 (see...). Figure 1C ) and the longitudinal axis 105 of the transrectal imaging probe 103 (see Figure 1H The trajectory translation of ).

[0090] According to Figure 1E (It is a partially exploded isometric view of the biopsy guide, wherein the opening or port member 108 is separated from the rest of the biopsy guide 100.) Best understood, the opening or port member 108 includes a centrally extending vertical member 160 having five needle receiving ports 168 formed therein. Each needle receiving port 168 includes an opening 170 extending distally / proximally through the centrally extending vertical member 160, allowing a puncture needle 112 to extend through it, as... Figure 1A and Figure 1B As depicted in the figure. Each of the openings 170 of the needle receiving port 168 is generally vertically aligned with each other, and each includes a trajectory axis 176 that defines the trajectory of the puncture needle 112 when the puncture needle 112 is positioned in the opening 170.

[0091] According to Figure 1C and Figure 1H The comparison is understandable, as the trajectory axis 176 is generally parallel to the longitudinal axis 120 of the translated patient contact member 110 when the opening or port member 108 is operatively coupled to the translational patient contact member 110 and the remainder of the biopsy guide 100. For example... Figure 1HAs shown, when the biopsy guide 100 is connected to the imaging probe 103, the trajectory axis 176 is also approximately parallel to the longitudinal axis 105 of the imaging probe 103. Therefore, the trajectory axis 176 of the puncture needle 112 can be approximately fixed or constant, in a direction approximately parallel to the aforementioned axes 105, 120, because the opening or port member 108 is displaced distally / proximally relative to the translated patient contact member 110 and the rest of the biopsy guide 100.

[0092] like Figure 1E As shown, in the translational embodiment of the first embodiment, the translational opening or port member 108 further includes at least one track member 177 extending vertically from the center of member 160 to the distal / proximal end plate 179. As per [reference to...] Figure 1F (It is an isometric view of the centrally extending vertical member 160 assembled into the rest of the biopsy guide 100) as can be understood, and as Figure 1M (It is along) Figure 1J More clearly depicted in the cross-sectional elevation view of the biopsy guide 100 taken by section line MM, at least one track member 177 is respectively defined by at least one track slot 181 in the base platform 122 of the upper mounting seat 102 (also shown in Figure 1D (In the middle) it is received by sliding engagement towards the distal / proximal side. As per... Figure 1A , Figure 1B and Figures 1J to 1L Understandably, the proximal plate 179 prevents the translational embodiment of the opening or port member 108 of the first embodiment from being excessively displaced distally relative to the rest of the biopsy guide, such that at least one track member 177 of the opening or port member 108 exits distally from at least one track slot 181, causing the opening or port member 108 to detach distally from the rest of the biopsy guide 100.

[0093] Of course, in other embodiments of the first embodiment, the arrangement of at least one track and its corresponding at least one slot associated with the translational embodiment of the opening or port member 108 and its supporting base platform 122 can be reversed, such that at least one track slot is defined in the bottom of what will become the elongated body 177, and at least one track is defined in the top of the base platform 122 of the upper mounting 102. Regardless of the arrangement, the track / slot arrangement allows for distal / proximal sliding translation between the translational embodiment of the opening or port member 108 and the rest of the biopsy guide 100 in a direction parallel to the aforementioned axes 105, 120, and 176.

[0094] Similarly, Figure 1MAs shown, each stabilizing bar 126 of the translating patient contact member 110 includes at least one downwardly projecting track member 183, which is received in a distal / proximal sliding engagement by at least one track slot 185 in each corresponding vertically extending member 124 defined in the base platform 122 of the upper mounting seat 102. Of course, in other embodiments of the first embodiment, at least one track and its corresponding at least one slot may be inverted, such that at least one track slot is defined in the bottom of each stabilizing bar 126, and at least one track is defined in the top of each corresponding supporting vertically extending member 124. Regardless of the arrangement, the track / slot arrangement allows for distal / proximal sliding translation between the translating patient contact member 110 and the remainder of the biopsy guide 100 in directions parallel to the aforementioned axes 105, 120, and 176.

[0095] For any of the aforementioned track / slot interfaces associated with the translational implementation of the first embodiment of the opening or port member 108 and the translational patient contact member 110, the track / slot interface may be textured to resist slippage without the physician applying sufficient intentional force. In this implementation of the first embodiment, the physician may position any member 108, 110 distally / proximally relative to the remainder of the biopsy guide 100 and the perineal surface of the patient as needed, and these members 108, 110 will maintain the distally / proximal placement made by the physician until the physician forcefully repositions these members 108, 110. Thus, in some embodiments, the port member 108 may be fixed in place, and the subsequently translated patient contact member 110 may be slidably adjusted relative to the port member 108. In some cases, the port member 108 may be positioned distally to the patient contact member 110 (e.g., Figure 1J and Figure 1K In some cases, the port member 108 may be positioned proximal to the patient contact member 110 (e.g., Figure 1L The precise positioning of the patient contact member 110 relative to the port member 108 can be selected by the physician based on the patient's specific anatomy, and facilitates appropriate manipulation of the perineal skin through the patient contact member 110.

[0096] Alternatively or additionally, each track / slot interface of each component 108, 110 may have one or more associated stop features to secure or lock the component 108, 110 in one or more distal or deployed states or positions relative to the remainder of the biopsy guide 100. The one or more stop features may take the form of one or more protrusions or lugs and one or more corresponding ramps that slope distally upwards to the apex of the ramp (at which point the ramp slopes distally downwards). When a physician displaces the associated component 108, 110 distally to the desired distal position relative to the remainder of the biopsy guide 100 and the patient's perineum, the protrusion or lug travels upwards along the ramp slope until reaching the apex of the ramp, and then drops distally in front of the apex to be prevented from retracting proximally, thereby holding the associated component 108, 110 in the distal position relative to the remainder of the biopsy guide 100 and the patient's perineum. When the associated components 108, 110 are maximally positioned distally relative to the rest of the biopsy guide 100, extreme distal restraint features prevent further distal displacement of components 108, 110, and one or more recently encountered stop features prevent components 108, 110 from retracting proximally without the physician intentionally applying sufficient force.

[0097] As an alternative to or complement to the texturization and / or presence of stop features at the track / slot interface, locking mechanisms may be added to any one or more track / slot arrangements to selectively lock associated components into place once positioned by a physician as needed. Such locking mechanisms may take the form of levers, sliders, or other actuating mechanisms to clamp or otherwise apply or release frictional forces between each component 108, 110 and the remainder of the surrounding biopsy guide 100.

[0098] like Figures 1J to 1L As shown, the base platform 122 extends approximately half the total longitudinal distance of the stabilizing bar 126. In this way, the stabilizing bar 126 extends beyond both the base platform 122 and the vertically extending member 124, allowing the stabilizing bar 126 to contact the patient's perineal skin and subcutaneous tissue, but not the distal edge 150 of the base platform 122 or the distal edge 152 of the vertically extending member 124. Furthermore, since the distal portion of the lower mounting base 104 is substantially flush with the distal edge 150 of the base platform 122, the lower mounting base 104 can also be spaced apart from the patient's skin during biopsy procedures. In this way, in some embodiments of the first embodiment, the stabilizing bar 126 can contact the patient's skin, while other portions of the guide 100 remain spaced apart from the patient's skin.

[0099] According to Figures 1J to 1LUnderstandably, the base platform 122 extends approximately half the total longitudinal distance of the opening or port member 108. In this way, the opening or port member 108 extends beyond both the base platform 122 and the vertically extending member 124, allowing the opening or port member 108 to contact the patient's perineal skin and subcutaneous tissue, but not the distal edge 150 of the base platform 122 or the distal edge 152 of the vertically extending member 124. Furthermore, since the distal portion of the lower mounting base 104 is substantially flush with the distal edge 150 of the base platform 122, the lower mounting base 104 can also be spaced apart from the patient's skin during biopsy procedures. In this way, in some embodiments of the first embodiment, the opening or port member 108 can contact the patient's skin, while other portions of the guide 100 remain spaced apart from the patient's skin.

[0100] A specific needle receiving port 168 can be selected based on the desired distance from the imaging probe 103. Therefore, if the physician expects the puncture needle 112 to be positioned closer to the imaging probe 103, a specific needle receiving port 168 located at the bottom of the opening or port member 108 can be selected. In some embodiments of the first embodiment, the openings 170 of the needle receiving ports 168 may be vertically spaced about 5 mm. In some embodiments of the first embodiment, the openings 170 of the needle receiving ports 168 may be vertically spaced about 3 mm. In some embodiments of the first embodiment, the openings 170 of the needle receiving ports 168 may be vertically spaced about 4 mm. In some embodiments of the first embodiment, the openings 170 of the needle receiving ports 168 may be vertically spaced at any interval between about 2 mm and about 6 mm, as well as other distances.

[0101] Although the vertically extending member 160 includes five pin receiving ports 168, it is foreseeable that the opening or port member 108 may include more or fewer ports without limitation.

[0102] While the track / slot arrangement described above is a structural arrangement that allows for translation between the aforementioned components to the distal / proximal sides, it is foreseeable that other mechanisms are also possible to facilitate such translation. For example, the aforementioned track / slot arrangement can be replaced with a longitudinally extending rod (not shown) and a complementary sliding element (e.g., a sleeve) through which the rod passes.

[0103] like Figure 1B As shown, the proximal side 191 of the needle receiving port 168 includes a bonding feature to lock-engage the puncture needle 112 such that it does not rotate once it is connected to the port 168. Specifically, the bonding feature may mate with a compatible feature on the distal side of the hub 193 of the puncture needle 112.

[0104] like Figure 1C and Figure 1DAs shown, the imaging probe coupling mechanism 106 can be a snap-fit ​​or clamp-type hose or clamp. Mechanism 106 may include first and second arm members 204, 206 extending from opposite sides of platform 122. Arm members 204, 206 are flexible and designed to surround a portion of the imaging probe 103 fitted within an opening 205 formed by the first and second arms 204, 206 (see [link to documentation]). Figure 1A The first arm member 204 includes a first clamping structure 210, which includes an upper row of teeth 212 and a lower smooth sliding surface 214. The second arm member 206 includes a second clamping structure 216, which includes an upper smooth sliding surface 218 and a lower row of teeth 220. Each clamping structure 210, 216 includes a textured outer end 222, which an appendage can push against to engage the clamping structures 210, 216 together. The first and second clamping structures 210, 216 work together to provide clamping or gripping functionality to securely support the transrectal imaging probe 103 to the lower mounting base 104, and thus to the upper mounting base 102.

[0105] According to Figures 1A to 1D and Figures 1G to 1L Understandably, during operation, the transrectal imaging probe 103 is positioned within the opening 205 between the first and second clamping structures 210, 216. The physician can determine the desired position on the imaging probe 103 based on the patient's anatomy, the specific transrectal imaging probe, the specific procedure to be performed, and other possible criteria. Once the position on the imaging probe is selected for the lower mounting 104, the physician can retract the first and second arm members 204, 206 relative to each other by pushing the outer ends 222 of the clamping structures 210, 216, respectively. When the clamping structures 210, 216 converge relative to each other, the lower row of teeth 220 on the second clamping structure 216 is received within the opening formed between the upper row of teeth 212 and the lower smooth surface 214 of the first clamping structure 210. The upper row of teeth 212 engages with the lower row of teeth 220. Additionally, the upper smooth surface 218 slides on the inner smooth surface 223 of the first arm member 204. Furthermore, the lower smooth sliding surface 214 slides on the lowest outer smooth surface 225 of the second clamping structure 216. The teeth of the upper and lower rows 212, 218 are arranged in a serrated manner, such that as they gradually engage with each other, the teeth bite together and resist movement in opposite directions. Once engaged, the teeth can be disengaged by pulling the lug 230 on the bottom of the first clamping structure 210. Pulling the lug 230 allows the teeth 212, 218 to disengage from each other, and the flexible nature of the first and second arms 204, 206 causes them to spring back. Figure 1D The shape shown. (As shown) Figures 1C to 1DAs shown, the inner surfaces of the first and second arms 204, 206 include gaskets 232, which may be flexible and deformable to provide a gripping surface between the imaging probe 103 and the lower mounting base 104.

[0106] refer to Figure 1N The figure depicts a front isometric view of a puncture needle 112. As shown, the needle 112 includes a distal end 236 and a proximal end 238 opposite to the distal end 236. A bevel 240 extending distally from a shaft 242 is located at the distal end 236. A cavity 244 for fluid communication is provided within the shaft 242, or, in the case of the puncture needle 112, a cavity 244 for the shaft of a smaller-gauge biopsy needle. The proximal end 238 of the needle 112 includes a hub 193 with a ridge 248 extending longitudinally around the circumference of the hub 246. The ridge 248 can engage with a corresponding concave feature on the proximal side 191 of the needle receiving port 168, as per [reference to previous description]. Figure 1A and Figure 1B That's understandable.

[0107] Now we will discuss Figures 1A to 1N The use of biopsy guide 100. For example... Figure 1C and Figure 1D As shown, the biopsy guide 100 is positioned such that the first and second clamping structures 210, 216 of the first and second arm members 204, 206 are not coupled, allowing the transrectal imaging probe 103 to be positioned between the arm members 204, 206. Although not depicted in the figure, the first and second clamping structures 210, 216 may engage with each other or be coupled as previously described to grip the imaging probe 103 between the arm members 204, 206 and against the washer 232.

[0108] If the upper mounting base 102 and the lower mounting base 104 are integrally formed or molded as single pieces when forming the biopsy guide 100, then these mounting bases 102, 104 do not require field assembly. However, if the upper mounting base and the lower mounting base 102, 104 are separate parts, as depicted in U.S. Patent 10,743,909 (the disclosure of which is hereby incorporated in its entirety into this specific embodiment), then the upper mounting base and the lower mounting base 102, 104 are assembled together as follows. The upper mounting base 102 can be coupled to the lower mounting base 104. More specifically, vertical flanges or other attachment features on the platform of the upper mounting base coupling mechanism can engage, snap together, or otherwise connect with channels or other complementary attachment features on the base platform 122.

[0109] like Figure 1E , Figure 1F and Figure 1MAs shown, in the translational embodiment of the first embodiment, the translational opening or port member 108 can engage with the remainder of the upper mounting base 102. More specifically, the distal end of the track member 177 is longitudinally aligned with and inserted into the proximal end of the track slot 181, and is advanced distally therein, such that the track member 177 is slidably held in the track slot 181.

[0110] like Figure 1A , Figure 1B and Figure 1N As shown, the puncture needle 112 is connected to the opening or port member 108. More specifically, Figure 1N The bevel 240 and shaft 242 of the puncture needle 112 shown extend through the proximal side 191 of a specific opening 170 of the needle receiving port 168 until the hub 193 of the puncture needle 112 engages with the proximal side 191 of the port 168. The ridge 248 of the puncture needle 112 can engage with a corresponding feature within the opening 170 of the port 168, such that the puncture needle 112 remains connected to the opening or port member 108. The ridge 248 can constrain the puncture needle 112 to prevent rotation. In some embodiments of the first embodiment, the puncture needle 112 can be secured to the opening or port member 108 by, for example, threaded features on the hub 193 and the opening 170 of the port 168, such that the needle 112 and the translational opening or port member 108 can be threadedly engaged and disengaged from each other.

[0111] exist Figure 1A and Figure 1B In the illustrated orientation, in the translational embodiment of the first embodiment, the translational opening or port member 108 is in its most farthest position relative to the remainder of the biopsy guide 100. However, the translational opening or port member 108 can slide relative to the remainder of the upper mounting 102, and when the opening or port member 108 is in its most near position relative to the remainder of the biopsy guide 100 (a position not shown in any figure), in one embodiment of the first embodiment, when these rods 126 are in such a position as... Figure 1I and Figure 1L When shown in its most distal position relative to the rest of the biopsy guide 100, the bevel 240 of the puncture needle 112 is approximately flush with the distal plane 140 of the stabilizer bar 126.

[0112] In other embodiments of the first embodiment or using needles 112 of different sizes, when the translated opening or port member 108 is in its proximal position relative to the remainder of the biopsy guide 100 (a position not shown in any figure), when the stabilizing bar 126 is in the proximal position, the bevel 240 of the puncture needle 112 may be substantially flush with the distal side 140 of the stabilizing bar 126, or when the stabilizing bar 126 is in the proximal position, the bevel 240 of the puncture needle 112 may be positioned proximal to the distal side 140 of the stabilizing bar 126, or when the stabilizing bar 126 is in the proximal position, the bevel 240 of the puncture needle 112 may be positioned distal to the distal side 140 of the stabilizing bar 126.

[0113] In some embodiments where the bevel 240 of the puncture needle 112 does not extend beyond the distal side 140 of the stabilizer bar 126, a physician may use the stabilizer bar 126 to manipulate the patient’s perineal skin and subcutaneous tissue while operatively connecting the translational opening or port member 108 to the translational patient contact member 110, without allowing the bevel 240 of the puncture needle 112 to contact the patient’s skin.

[0114] When the displacement member is in any of the proximal, distal, or any other position between the distal and proximal positions relative to the remainder of the biopsy guide 100, the puncture needle 112 can engage the translated opening or port member 108. When the puncture needle 112 is in the proximal position and the stabilizing arm 126 is in the distal position relative to the remainder of the biopsy guide 100, the physician can manipulate the distal plane 140 of the transrectal imaging probe 103 and the stabilizing arm 126 to manipulate the patient's perineal skin and subcutaneous tissue. When the trajectory of the puncture needle 112 is properly positioned relative to the patient's perineal skin and subcutaneous tissue, the physician can drive the puncture needle 112 distally into the patient's tissue by pushing the translated opening or port member 108 distally relative to the remainder of the biopsy guide 100.

[0115] In some embodiments of the first embodiment, the translational opening or port member 108 may be biased or spring-loaded, allowing the physician to actuate a mechanism that advances the translational opening or port member 108 and the puncture needle 112 distally without manual advancement by the physician. As the puncture needle 112 and the translational opening or port member 108 are advanced or displaced distally, the translational opening or port member 108 may be locked or secured to its distalst position via any of the aforementioned position-holding or locking features / mechanisms. Figure 1I and Figure 1LIn the farthest position shown, the translated opening or port member 108 is prevented from further displacement to the farthest side via its proximal plate 179. Specifically, when the translated opening or port member 108 is in the farthest position, the front edge or surface of the proximal plate 179 of the translated opening or port member 108 abuts or is adjacent to the proximal surface of the base platform 122.

[0116] Once the puncture needle 112 is in the appropriate position within the patient's skin and subcutaneous tissue, the biopsy procedure can proceed, as previously described, whereby the physician extends the biopsy needle through the lumen 244 of the puncture needle 112 and into the patient's prostate. Once the procedure is complete, the physician can remove the puncture needle 112 from the patient by pulling or pushing the translational opening or port member 108 or the puncture needle proximally. Alternatively, when the translational opening or port member 108 is in its most distal position, the puncture needle 112 can be disengaged from the translational opening or port member 108 by proximally withdrawing it from the patient. Similarly, in an embodiment where the opening or port member 108 is fixed to the remainder of the biopsy guide 100, the puncture needle 112 can be disengaged from the fixed opening or port member 108 by withdrawing the puncture needle 112 proximally from the patient. In such a fixed embodiment, the opening or port member 108 can be permanently fixed in the most distal position relative to the remainder of the biopsy guide 100. b. A biopsy guide with a translational patient contact component formed by a stabilizing bar and a vertically extending member.

[0117] The following text is related to Figures 2A to 2G Let us discuss a second embodiment of the transperineal biopsy guide 100. In this second embodiment, the translatable patient contact member 110 can be translated distally / proximally relative to the remainder of the transperineal biopsy guide 100. In some embodiments of this second embodiment of the transperineal biopsy guide 100, the opening or port member 108 can also be translated distally / proximally relative to the remainder of the transperineal biopsy guide 100. In other embodiments of this second embodiment of the transperineal biopsy guide 100, the opening or port member 108 is fixed relative to the remainder of the transperineal biopsy guide 100. In any case, the biopsy guide 100 can be coupled to a transrectal imaging probe 103 and can be used to guide the puncture needle 112 during a transperineal prostate biopsy procedure.

[0118] To begin discussing the second embodiment, refer to... Figure 2A and Figure 2B . Figure 2AThis is an isometric view of a transrectal imaging probe 103 (shown in dashed lines) of a first embodiment of a transperineal biopsy guide 100 with a puncture needle 112 connected thereto. Figure 2B It is the same component, but the posterior isometric view of the transrectal imaging probe has been removed.

[0119] like Figure 2A and Figure 2B As shown, the biopsy guide 100 includes an upper mounting base 102 and a lower mounting base 104. The lower mounting base 104 includes an imaging probe connection or fastening mechanism 106 to connect the lower mounting base 104 to the transrectal imaging probe 103, such as... Figure 2A As shown. In one embodiment of this second embodiment, the upper mounting base 102 and the lower mounting base 104 may be an integral structure, molded or formed from one piece or multiple pieces permanently attached to each other. In another embodiment of this second embodiment, the upper mounting base 102 and the lower mounting base 104 are respectively molded or formed, and the lower mounting base 104 further includes an upper mounting base coupling mechanism (see 2714 in FIG. 30 of U.S. Patent 10,743,909) to connect the lower mounting base 104 to the upper mounting base 102. Although Figure 2A and Figure 2B A single coupling mechanism 106 is depicted, but it is foreseeable that the biopsy guide 100 may also include more than one coupling mechanism 106, as shown and previously described in U.S. Patents 10,064,681 and 10,743,909. It can be said that the upper mounting base 102 and the lower mounting base 104 can be combined to form a superstructure of the biopsy guide 100 that supports the opening or port member 108 and the translational patient contact member 110, the translational patient contact member 110 being capable of independent distal / proximal translation relative to the underlying support superstructure. According to an embodiment of the second embodiment, the opening or port member 108 may be fixed relative to the underlying support superstructure (e.g., welded, glued, molded, or otherwise integrally formed with the underlying support superstructure). Alternatively, the opening or port member 108 may be independently distal / proximal translation relative to the underlying support superstructure.

[0120] The upper mounting base 102 may include an opening or port member 108 and a translatable patient contact member 110. The opening or port member 108 may receive and be coupled to the puncture needle 112, and be supported by the upper mounting base 102, the lower mounting base 104, or a portion of both. In one embodiment of the second embodiment, the opening or port member 108 is fixedly coupled to the remainder of the biopsy guide 100 to prevent translation between the opening or port member 108 and the remainder of the biopsy guide.

[0121] Alternatively, in another embodiment of the second embodiment, the opening or port member 108 is displaceably coupled to the remainder of the biopsy guide 100, such that the opening or port member 108 can be translated (e.g., slid) relative to the upper mount 102 and / or the lower mount 104. More specifically, depending on whether the opening or port member 108 is a fixed or translatable embodiment of the second embodiment, the opening or port member 108 can be fixed or translated relative to the upper mount 102 and / or the lower mount 104. In the case of the translatable embodiment of the second embodiment, it can be translated relative to the remainder of the biopsy guide 100 via, for example, sliding, and thus guide the opening or port member 108 and the puncture needle 112 coupled thereto along a trajectory fixed relative to the transrectal imaging probe 103. When the biopsy guide 100 is coupled to the imaging probe 103, the trajectory of the puncture needle 112 can be generally parallel to the longitudinal axis 105 of the transrectal imaging probe 103 (see Figure 2A ).

[0122] Figure 2D , Figure 2E and Figure 2F This is a side elevation view of a second embodiment of the biopsy guide 100, showing the translational process of the translated patient contact member 110 relative to the remainder of the biopsy guide 100. As can be understood from these figures, the translated patient contact member 110 is displaceably (e.g., slidably) coupled to the upper mount 102 and / or the lower mount 104, such that the patient contact member 110 can be positioned parallel to and along the longitudinal axis 105 of the transrectal imaging probe 103 (see...). Figure 2A The biopsy guide is translated relative to the rest of the biopsy guide in the distal / proximal direction. Figure 2D In this configuration, the translated patient contact component 110 is positioned proximally relative to the rest of the biopsy guide 100. Figure 2E In this configuration, the translated patient contact component 110 is positioned at the midpoint or intermediate position between the proximal and distal sides relative to the rest of the biopsy guide 100. Figure 2FIn this embodiment, the translated patient contact member 110 is positioned distally relative to the remainder of the biopsy guide 100. This distal / proximal translation capability of the translated patient contact member 110 allows the physician to control the degree to which the distal side 140 of the stabilizing bar 126 of the translated patient contact member 110 contacts the patient's perineum for stabilizing the biopsy guide 100 against the patient's perineum and allows the distal side 140 for manipulating and / or tensioning contact with the skin of the patient's perineum. In one embodiment, during operation, the port member 108 may be fixed in place relative to the mounting base 104, and the translated patient contact member 110 may subsequently be translated distally relative to the port member 108 to a physician-preferred location. The preferred location may be selected by the physician based on the patient's anatomy or other circumstances. In one embodiment, the physician may choose to use the biopsy guide 100 without using the translated patient contact member 110. In such embodiments, the translated patient contact member 110 will be separated from or simply not included in the biopsy guide 100.

[0123] According to respectively Figures 1A to 1M and Figures 2A to 2G As can be understood from the comparison of the first and second embodiments of the transperineal biopsy guide 100 depicted, the translational patient contact member 110 of the first embodiment is smaller than that of the second embodiment. More specifically, the translational patient contact member 110 of the first embodiment includes a stabilizing bar 126, while a vertically extending member 124 forms part of the base platform 122. Conversely, the translational patient contact member 110 of the second embodiment includes a stabilizing bar 126 and a vertically extending member 124.

[0124] According to Figures 2A to 2G As will be understood and discussed in more detail below, in some embodiments of the second embodiment of the transperineal biopsy guide 100, the translating patient contact member 110 is a single unit, while in other embodiments, the translating patient contact member 110 is a multi-piece unit. In the case of a single unit, one stabilizing bar 126 and its corresponding vertically extending member 124 are structurally coupled to another stabilizing bar 126 and its corresponding vertically extending member 124, such that the entire translating patient contact member 110 is translated distally / proximally relative to the support base platform 122 as a single unit.

[0125] In the context of a multi-piece structure, one stabilizer bar 126 and its corresponding vertically extending member are structurally independent of another stabilizer bar 126 and its corresponding vertically extending member 124. As a result, each stabilizer bar 126 and its corresponding vertically extending member 124 can be independently positioned distally / proximally relative to the support base platform 122, to a greater or smaller extent than the other stabilizer bar 126 and its corresponding vertically extending member 124. Physicians may find this capability advantageous for certain patients and procedures. Of course, when not required by the patient or procedure, the positioning of each stabilizer bar 126 and its corresponding vertically extending member 124 can mimic the positioning of the other stabilizer bar 126 and its corresponding vertically extending member 124, since the stabilizer bars 126 are not a single unit; they only need to achieve the same positioning via individual actions.

[0126] Now for reference Figure 2C This is a partially exploded isometric view of a second embodiment of the biopsy guide, wherein the opening or port component 108 and the translated patient contact component 110 are separated from the rest of the biopsy guide 100. Figure 2C and Figure 2A and Figure 2B As shown, the translational patient contact member 110 is supported on the upper mounting base 102. The translational patient contact member 110 includes a distal end 116, a proximal end 118 opposite to the distal end 116, and a longitudinal axis 120 extending through the distal end 116 and the proximal end 118 (see Figure 120). Figure 2C As described herein, the positional orientation of distal and proximal is relative to the patient, or more specifically, relative to the patient's perineum. Therefore, distal generally refers to the side facing the patient, and proximal refers to the side away from the patient.

[0127] Still referencing Figures 2A to 2CThe upper mounting base 102 includes a generally horizontally extending base platform 102. The translatable patient contact member 110 includes vertically extending members 124, each leading to a corresponding stabilizing rod 126 of the translatable patient contact member 110. As discussed below, each vertically extending member 124 is translatably coupled to a corresponding side of the base platform 122 such that each vertically extending member 124 and its corresponding stabilizing rod 126 are translated distally / proximally relative to the base platform 122 of the upper mounting base 102 (e.g., via sliding). As explained above, according to an embodiment of the second embodiment of the transperineal biopsy guide 100, each stabilizing rod 126 (and / or its corresponding vertically extending member 124) can be structurally engaged with another stabilizing rod 126 and its corresponding vertically extending member 124 to form a translatable patient contact member 110 with an integral structural construction and translatable distally / proximally relative to the base platform 122 as a single integral structure. Alternatively, a pair of such structures 126 / 124 may be structurally separated from another pair of such structures 126 / 124, thereby allowing the pair of such structures 126 / 124 to translate independently of the other pair of such structures 126 / 124 to be positioned independently of each other and the base platform 122 to the distal / proximal side.

[0128] As the translated patient contact member 110 translates distally relative to the remainder of the biopsy guide 100 and comes into contact with the patient's perineum, the distal side 140 of the stabilizing bar 126 provides adjustable stabilization and skin manipulation / tension contact with the patient's perineum. As per Figures 2D to 2F Understandably, the translating patient contact member 110 is adapted to slide relative to the upper mounting base 102 and the remainder of the biopsy guide 100 along a longitudinal axis 120 parallel to the translating patient contact member 110 (see...). Figure 2C ) and the longitudinal axis 105 of the transrectal imaging probe 103 (see Figure 2A The trajectory translation of ).

[0129] According to Figure 2C Best understood, the opening or port member 108 includes a centrally extending vertical member 160 having five needle receiving ports 168 formed therein. Each needle receiving port 168 includes an opening 170 extending distally / proximally through the centrally extending vertical member 160, allowing the puncture needle 112 to extend through it, as... Figure 2A and Figure 2B As depicted in the figure. Each of the openings 170 of the needle receiving port 168 is generally vertically aligned with each other, and each includes a track axis 176 (see [reference]). Figure 2A The trajectory axis 176 defines the trajectory of the puncture needle 112 when it is positioned within the opening 170.

[0130] According to Figure 2A and Figure 2C The comparison is understandable, as the trajectory axis 176 is generally parallel to the longitudinal axis 120 of the translated patient contact member 110 when the opening or port member 108 is operatively coupled to the translational patient contact member 110 and the remainder of the biopsy guide 100 via the base platform 122. Figure 2A As shown, when the biopsy guide 100 is connected to the imaging probe 103, the trajectory axis 176 is also approximately parallel to the longitudinal axis 105 of the imaging probe 103. Therefore, the trajectory axis 176 of the puncture needle 112 can be approximately fixed or constant, in a direction approximately parallel to the aforementioned axes 105, 120, because the opening or port member 108 is displaced distally / proximally relative to the translated patient contact member 110 and the rest of the biopsy guide 100.

[0131] like Figure 2C As shown, in the translational embodiment of the second embodiment, the translational opening or port member 108 further includes at least one track member 177 extending vertically from the center of member 160 to the distal / proximal end plate 179. As per [reference to...] Figure 2G (It is along) Figure 2D As can be understood from the cross-sectional elevation view of the biopsy guide 100 taken by section line GG, at least one track member 177 includes a downwardly extending track 287, which is received by the track slot 281 of the base platform 122 in a distal / proximal sliding engagement. As a result, at least one track member 177 is connected to the base platform 122 in a distal / proximal translational relationship.

[0132] According to Figure 2A , Figure 2B and Figures 2D to 2F Understandably, embodiments of the proximal plate 179 that prevent translation of the opening or port member 108 displace excessively distally relative to the rest of the biopsy guide 100, such that at least one track member 177 of the opening or port member 108 exits distally from at least one track slot 281, causing the opening or port member 108 to detach distally from the rest of the biopsy guide 100.

[0133] Of course, in other embodiments, the arrangement of the track 287 and its corresponding track slot 281 associated with the translational embodiment of the opening or port member 108 and its supporting base platform 122 can be reversed, such that the track slot 281 is defined in the bottom of what will become the elongated body 177, and the track 287 is defined in the top of the base platform 122 of the upper mounting 102. Regardless of the arrangement, the track / slot arrangement allows for distal / proximal sliding translation between the translational embodiment of the opening or port member 108 and the rest of the biopsy guide 100 in directions parallel to the aforementioned axes 105, 120, and 176.

[0134] For example Figure 2G As shown, each side of the translating patient contact member 110 includes a downward-facing track slot 285. Each downward-facing track slot 285 may be defined in the bottom region of the corresponding vertically extending member 124 of the translating patient contact member 110.

[0135] Each side of the base platform 122 includes an upwardly extending track 283. Each upwardly extending track 283 is received by a corresponding downwardly extending track slot 285 in a distally / proximally sliding engagement. As a result, each vertically extending member 124 can be translated distally / proximally on the corresponding upwardly extending track 283 and relative to the base platform 122. As discussed above, according to the implementation of the second embodiment, the vertically extending members 124 can be structurally connected to each other such that they can be translated as a unit relative to the base platform 122. In such an embodiment, the translated patient contact member 110 is translated distally / proximally relative to the base platform 122 as a unit.

[0136] In another embodiment of the second embodiment, the vertically extending members 124 are not structurally connected to each other. Therefore, each vertically extending member 124 can be translated separately from the other vertically extending member 124 relative to the base platform 122.

[0137] Of course, in other embodiments of the second embodiment, the track 283 and the corresponding track slot 285 may be inverted, such that the track slot 285 is defined in the top of the base platform 122, and the track 283 protrudes downward from the bottom of the vertically extending member 124. Regardless of the arrangement, the track / slot arrangement allows for distal / proximal sliding translation between the translating patient contact member 110 and the rest of the biopsy guide 100 in a direction parallel to the aforementioned axes 105, 120, and 176.

[0138] For any of the aforementioned track / slot interfaces associated with the translational embodiment of the opening or port member 108 and the translational patient contact member 110, the track / slot interface may be textured to resist slippage without the physician applying sufficient intentional force. In this embodiment of the second embodiment, the physician may position any member 108, 110 distally / proximally relative to the remainder of the biopsy guide 100 and the perineal surface of the patient as needed, and these members 108, 110 will maintain the distally / proximal placement made by the physician until the physician forcefully repositions these members 108, 110.

[0139] Alternatively or additionally, each track / slot interface of each component 108, 110 may have one or more associated stop features to secure or lock the component 108, 110 in one or more distal or deployed states or positions relative to the remainder of the biopsy guide 100. The one or more stop features may take the form of one or more protrusions or lugs and one or more corresponding ramps that slope distally upwards to the apex of the ramp (at which point the ramp slopes distally downwards). When a physician displaces the associated component 108, 110 distally to the desired distal position relative to the remainder of the biopsy guide 100 and the patient's perineum, the protrusion or lug travels upwards along the ramp slope until reaching the apex of the ramp, and then drops distally in front of the apex to be prevented from retracting proximally, thereby holding the associated component 108, 110 in the distal position relative to the remainder of the biopsy guide 100 and the patient's perineum. When the associated components 108, 110 are maximally positioned distally relative to the rest of the biopsy guide 100, extreme distal restraint features prevent further distal displacement of components 108, 110, and one or more recently encountered stop features prevent components 108, 110 from retracting proximally without the physician intentionally applying sufficient force.

[0140] As an alternative to or complement to the texturization and / or presence of stop features at the track / slot interface, locking mechanisms may be added to any one or more track / slot arrangements to selectively lock associated components into place once positioned by a physician as needed. Such locking mechanisms may take the form of levers, sliders, or other actuating mechanisms to clamp or otherwise apply or release frictional forces between each component 108, 110 and the remainder of the surrounding biopsy guide 100.

[0141] like Figures 2D to 2FAs shown, the base platform 122 extends approximately half the total longitudinal distance of the stabilizing bar 126, and the stabilizing bar 126 has a similar longitudinal distance relationship with the vertically extending member 124. In this way, the stabilizing bar 126 extends beyond both the base platform 122 and the vertically extending member 124, allowing it to contact the patient's perineal skin and subcutaneous tissue, but not the distal edge 150 of the base platform 122 or the distal edge 152 of the vertically extending member 124. Furthermore, since the distal portion of the lower mounting base 104 is substantially flush with the distal edge 150 of the base platform 122, the lower mounting base 104 can also be spaced apart from the patient's skin during biopsy procedures. In this way, in some embodiments, the stabilizing bar 126 can contact the patient's skin, while other portions of the guide 100 remain spaced apart from the patient's skin.

[0142] According to Figures 2D to 2F Understandably, the base platform 122 extends approximately half the total longitudinal distance of the opening or port member 108. A similar longitudinal relationship exists between the opening or port member 108 and the vertically extending member 124. In this way, the opening or port member 108 extends beyond both the base platform 122 and the vertically extending member 124, allowing it to contact the patient's perineal skin and subcutaneous tissue, but not the distal edge 150 of the base platform 122 or the distal edge 152 of the vertically extending member 124. Furthermore, since the distal portion of the lower mounting base 104 is substantially flush with the distal edge 150 of the base platform 122, the lower mounting base 104 can also be spaced apart from the patient's skin during biopsy procedures. In this way, in some embodiments, the opening or port member 108 can contact the patient's skin, while other portions of the guide 100 remain spaced apart from the patient's skin.

[0143] According to Figures 2A to 2F Understandably, a specific needle receiving port 168 can be selected based on the desired distance from the imaging probe 103. Therefore, if a physician expects the puncture needle 112 to be positioned closer to the imaging probe 103, a specific needle receiving port 168 located at the bottom of the opening or port member 108 can be selected. In some embodiments of the second embodiment, the openings 170 of the needle receiving ports 168 may be vertically spaced about 5 mm. In some embodiments of the second embodiment, the openings 170 of the needle receiving ports 168 may be vertically spaced about 3 mm. In some embodiments of this embodiment, the openings 170 of the needle receiving ports 168 may be vertically spaced about 4 mm. In some embodiments of this embodiment, the openings 170 of the needle receiving ports 168 may be vertically spaced at any interval between about 2 mm and about 6 mm, as well as other distances.

[0144] Although the vertically extending member 160 includes five pin receiving ports 168, it is foreseeable that the opening or port member 108 may include more or fewer ports without limitation.

[0145] While the track / slot arrangement described above is a structural arrangement that allows for translation between the aforementioned components to the distal / proximal sides, it is foreseeable that other mechanisms are also possible to facilitate such translation. For example, the aforementioned track / slot arrangement can be replaced with a longitudinally extending rod (not shown) and a complementary sliding element (e.g., a sleeve) through which the rod passes.

[0146] like Figure 2B As shown, the proximal side 191 of the needle receiving port 168 includes a bonding feature to lock-engage the puncture needle 112 so that it will not rotate once it is connected to the port 168. Specifically, the bonding feature may mate with a compatible feature on the distal side of the hub 193 of the puncture needle 112.

[0147] like Figures 2A to 2C As shown, the imaging probe coupling mechanism 106 can be a snap-fit ​​or clamp-type hose or clamp. Mechanism 106 may include first and second arm members 204, 206 extending from opposite sides of platform 122. Arm members 204, 206 are flexible and designed to surround a portion of the imaging probe 103 fitted within an opening 205 formed by the first and second arms 204, 206 (see [link to documentation]). Figure 2A The first arm member 204 includes a first clamping structure 210, which includes an upper row of teeth 212 and a lower smooth sliding surface 214. The second arm member 206 includes a second clamping structure 216, which includes an upper smooth sliding surface 218 and a lower row of teeth 220. Each clamping structure 210, 216 includes a textured outer end 222, which an appendage can push against to engage the clamping structures 210, 216 together. The first and second clamping structures 210, 216 work together to provide clamping or gripping functionality to securely support the transrectal imaging probe 103 to the lower mounting base 104, and thus to the upper mounting base 102.

[0148] According to Figures 2A to 2FUnderstandably, during operation, the transrectal imaging probe 103 is positioned within the opening 205 between the first and second clamping structures 210, 216. The physician can determine the desired position on the imaging probe 103 based on the patient's anatomy, the specific transrectal imaging probe, the specific procedure to be performed, and other possible criteria. Once the position on the imaging probe is selected for the lower mounting 104, the physician can retract the first and second arm members 204, 206 relative to each other by pushing the outer ends 222 of the clamping structures 210, 216, respectively. When the clamping structures 210, 216 converge relative to each other, the lower row of teeth 220 on the second clamping structure 216 is received within the opening formed between the upper row of teeth 212 and the lower smooth surface 214 of the first clamping structure 210. The upper row of teeth 212 engages with the lower row of teeth 220. Additionally, the upper smooth surface 218 slides on the inner smooth surface 223 of the first arm member 204. Furthermore, the lower smooth sliding surface 214 slides on the lowest outer smooth surface 225 of the second clamping structure 216. The teeth of the upper and lower rows 212, 218 are arranged in a serrated manner, such that as they gradually engage with each other, the teeth bite together and resist movement in opposite directions. Once engaged, the teeth can be disengaged by pulling the lug 230 on the bottom of the first clamping structure 210. Pulling the lug 230 allows the teeth 212, 218 to disengage from each other, and the flexible nature of the first and second arms 204, 206 causes the first and second arms 204, 206 to spring back. Figure 2C The shape shown. (As shown) Figure 2C As shown, the inner surfaces of the first and second arms 204, 206 include gaskets 232, which may be flexible and deformable to provide a gripping surface between the imaging probe 103 and the lower mounting base 104.

[0149] Now we will discuss Figures 2A to 2G The use of biopsy guide 100. For example... Figure 2C As shown, the biopsy guide 100 is positioned such that the first and second clamping structures 210, 216 of the first and second arm members 204, 206 are not coupled, allowing the transrectal imaging probe 103 to be positioned between the arm members 204, 206. Although not depicted in the figure, the first and second clamping structures 210, 216 may engage with each other or be coupled as previously described to grip the imaging probe 103 between the arm members 204, 206 and against the washer 232.

[0150] If the upper mounting base 102 and the lower mounting base 104 are integrally formed or molded as single pieces when forming the biopsy guide 100, then these mounting bases 102, 104 do not require field assembly. However, if the upper mounting base and the lower mounting base 102, 104 are separate parts, as depicted in U.S. Patent 10,743,909 (the disclosure of which is hereby incorporated in its entirety into this specific embodiment), then the upper mounting base and the lower mounting base 102, 104 are assembled together as follows. The upper mounting base 102 can be coupled to the lower mounting base 104. More specifically, vertical flanges or other attachment features on the platform of the upper mounting base coupling mechanism can engage, snap together, or otherwise connect with channels or other complementary attachment features on the base platform 122.

[0151] like Figure 2C and Figure 2G As shown, in the translational embodiment of the second embodiment, the translational opening or port member 108 can engage with the remainder of the upper mounting base 102. More specifically, the distal end of the downwardly projecting track 287 of the track member 177 is longitudinally aligned with and inserted into the proximal end of the upward-facing track slot 281 of the base member 122, and is advanced distally therein, such that the track member 177 is slidably held in the track slot 181. This also establishes a connection arrangement for the opening or port member 108 to translate distally / proximally relative to the base member 122.

[0152] like Figure 2A , Figure 2B and Figure 2G As shown, the puncture needle 112 is connected to the opening or port member 108. More specifically, Figure 1N The bevel 240 and shaft 242 of the illustrated puncture needle 112 extend through the proximal side 191 of a specific opening 170 of the needle receiving port 168 until the hub 193 of the puncture needle 112 engages with the proximal side 191 of the port 168. The ridge 248 of the puncture needle 112 can engage with a corresponding feature within the opening 170 of the port 168, such that the puncture needle 112 remains connected to the opening or port member 108. The ridge 248 can constrain the puncture needle 112 to prevent rotation. In some embodiments, the puncture needle 112 can be secured to the opening or port member 108 by, for example, threaded features on the hub 193 and the opening 170 of the port 168, such that the needle 112 and the translational opening or port member 108 can be threadedly engaged and disengaged from each other.

[0153] exist Figure 2A and Figure 2BIn the illustrated orientation, in the translational embodiment of the second embodiment, the translational opening or port member 108 is in its most distal position relative to the remainder of the biopsy guide 100. However, the translational opening or port member 108 can slide relative to the remainder of the upper mounting base 102, and when the opening or port member 108 is in its most distal position relative to the remainder of the biopsy guide 100 (a position not shown in any figure), in one embodiment, when these rods 126 are in such a position as... Figure 2F When shown in its most distal position relative to the rest of the biopsy guide 100, the bevel 240 of the puncture needle 112 is approximately flush with the distal plane 140 of the stabilizer bar 126.

[0154] In other embodiments or using needles 112 of different sizes, when the translated opening or port member 108 is in its proximal position relative to the remainder of the biopsy guide 100 (a position not shown in any figure), when the stabilizing bar 126 is in the proximal position, the bevel 240 of the puncture needle 112 may be substantially flush with the distal side 140 of the stabilizing bar 126, or when the stabilizing bar 126 is in the proximal position, the bevel 240 of the puncture needle 112 may be positioned proximal to the distal side 140 of the stabilizing bar 126, or when the stabilizing bar 126 is in the proximal position, the bevel 240 of the puncture needle 112 may be positioned distal to the distal side 140 of the stabilizing bar 126.

[0155] In some embodiments, the bevel 240 of the puncture needle 112 does not extend beyond the distal side 140 of the stabilizer bar 126, allowing the physician to manipulate the patient’s perineal skin and subcutaneous tissue using the stabilizer bar 126 while operatively connecting the translational opening or port member 108 to the translational patient contact member 110 without allowing the bevel 240 of the puncture needle 112 to contact the patient’s skin.

[0156] When the displacement member is in any of the proximal, distal, or any other position between the distal and proximal positions relative to the remainder of the biopsy guide 100, the puncture needle 112 can engage the translated opening or port member 108. When the puncture needle 112 is in the proximal position and the stabilizing arm 126 is in the distal position relative to the remainder of the biopsy guide 100, the physician can manipulate the distal plane 140 of the transrectal imaging probe 103 and the stabilizing arm 126 to manipulate the patient's perineal skin and subcutaneous tissue. When the trajectory of the puncture needle 112 is properly positioned relative to the patient's perineal skin and subcutaneous tissue, the physician can drive the puncture needle 112 distally into the patient's tissue by pushing the translated opening or port member 108 distally relative to the remainder of the biopsy guide 100.

[0157] In some embodiments of the second embodiment, the translating opening or port member 108 may be biased or spring-loaded, allowing the physician to actuate a mechanism that advances the translating opening or port member 108 and the puncture needle 112 distally without manual advancement by the physician. As the puncture needle 112 and the translating opening or port member 108 are advanced or displaced distally, the translating opening or port member 108 may be locked or secured to its distalst position via any of the aforementioned position-holding or locking features / mechanisms. Figure 2F In the farthest position shown, the translated opening or port member 108 is prevented from further displacement to the farthest side via its proximal plate 179. Specifically, when the translated opening or port member 108 is in the farthest position, the front edge or surface of the proximal plate 179 of the translated opening or port member 108 abuts or is adjacent to the proximal surface of the base platform 122.

[0158] Once the puncture needle 112 is in the appropriate position within the patient's skin and subcutaneous tissue, the biopsy procedure can proceed, as previously described, whereby the physician extends the biopsy needle through the lumen 244 of the puncture needle 112 and into the patient's prostate. Once the procedure is complete, the physician can remove the puncture needle 112 from the patient by pulling or pushing the translational opening or port member 108 or the puncture needle proximally. Alternatively, when the translational opening or port member 108 is in its most distal position, the puncture needle 112 can be disengaged from the translational opening or port member 108 by proximally withdrawing it from the patient. Similarly, in embodiments where the opening or port member 108 is fixed to the remainder of the biopsy guide 100, the puncture needle 112 can be disengaged from the fixed opening or port member 108 by withdrawing the puncture needle 112 proximally from the patient. In such a fixed embodiment, the opening or port member 108 can be permanently fixed in its most distal position relative to the remainder of the biopsy guide 100. c. A translational opening or port member having a common vertical slot extending through openings of at least two adjacent receiving ports.

[0159] The following text is related to Figures 3A to 3D This discussion focuses on a first embodiment of a second embodiment of the translational opening or port member 108. In this first embodiment of the second embodiment, the translational opening or port member 108 includes a centrally extending member 160 having five pin receiving ports 168, each pin receiving port 168 having the features described above. Figures 1A to 2GThe opening 170 is described above. However, a first embodiment of the second embodiment of the translational opening or port member 108 also includes a top opening common vertical slot 302 that extends through the openings 170 of at least two adjacent receiving ports 168 of a member 160 extending vertically through the center of the translational opening or port member 108. The top opening common vertical slot 302 can be clamped narrow enough using a clamping member 300 to prevent the shaft 242 of the needle 112 from unintentionally migrating from one opening 170 to an adjacent opening 170 via the common vertical slot 302 that engages two or more openings 170.

[0160] For example, before the clamping member 300 is applied to the centrally vertically extending member 160, the width of the slot 302 can be between approximately 50% and approximately 85% of the diameter of the opening 170. After the clamping member 300 is applied to the centrally vertically extending member 160, the width of the slot 302 can be reduced to between approximately 40% and approximately 75% of the diameter of the opening 170. In either case, the diameter of the shaft 242 of the needle 112 will be between approximately 14 and approximately 16 gauges. In one embodiment, the width of the slot 302 is approximately 0.065”, the diameter of the opening 170 is approximately 0.084”, and the puncture needle gauge is 14, 15, or 16 gauge.

[0161] Figure 3A This is a front perspective view of a first embodiment of a second embodiment of a translational opening or port member 108 engaged by a clamping member 300. This first embodiment of the second embodiment is adaptable for use with any of the embodiments of the perineal biopsy guide 100 described above or those described in U.S. Patents 10,064,681 and 10,743,909, the disclosures of which are incorporated herein by reference in their entirety.

[0162] For example, in cases suitable for use with any of the above embodiments, a first embodiment of the second embodiment of the translational opening or port member 108 may include a track member 177 and its proximal end plate 179, such as Figure 1E As shown. In the first embodiment of the second embodiment, Figures 3A to 3D The translational opening or port component 108 can be linearly displaced relative to the base platform 122, as described above. Figure 1M and Figure 2G As stated above.

[0163] Alternatively, Figures 3A to 3DThe translational opening or port member 108 can be configured to have lateral support mechanisms 2788, as depicted and described in Figures 30, 32A through 32C, 35C, and 35D of U.S. Patent 10,743,909, which is incorporated herein by reference in its entirety. These lateral support mechanisms 2788 allow the translational opening or port member 108 to translate relative to the rest of the biopsy guide.

[0164] Figure 3B Is with Figure 3A The same view, except that it shows a clamping body 300 spaced apart from the translational opening or port member 108. Figure 3C and Figure 3D These are the far and near perspective views of the first embodiment of the second embodiment of the translational opening or port member 108, respectively, wherein the clamping member 300 is not engaged with the member 160 extending vertically from the center of the translational opening or port member 108.

[0165] like Figures 3A to 3D As shown, in the first embodiment of the second embodiment of the translational opening or port member 108, the slot 302 is open at the top of the member 160 extending vertically from the center of the translational opening or port member 108, but closed at the bottom of the member 160 extending vertically from the center of the translational opening or port member 108, the top and bottom being indicated by arrows A and B, respectively, in these figures. It can be understood from these figures that the clamping member 300 clamps the slot 302 narrowly enough to prevent the puncture needle 112 from passing through the slot 302 unintentionally or without removing the clamping member 300 surrounding the member 160 extending vertically from the center of the translational opening or port member 108. The clamping member 300 may include opposing downward protrusions 305, which receive on both sides of a vertically extending member 160 of a translational opening or port member 108 when the clamping slot 302 is being held. The slot 302 is narrow enough to prevent accidental needle migration between the two sides.

[0166] According to Figure 3D Understandable and as mentioned above Figures 1A to 2G In the discussed embodiments, the proximal side 191 of the needle receiving port 168 of the first embodiment of the second embodiment of the translational opening or port member 108 includes a bonding feature to lockably engage the puncture needle 112 such that it will not rotate once engaged with the port 168. Specifically, the bonding feature may mate with a compatible feature on the distal side of the hub 193 of the puncture needle 112.

[0167] According to Figures 3B to 3DUnderstandably, the top-opening common vertical slot 302 extends vertically through the top of the extension member 160 and, together with the associated needle receiving opening 170, extends uninterruptedly and continuously from its distal end to its proximal end.

[0168] The following text is related to Figures 4A to 4D A second embodiment of the second embodiment of the translational opening or port member 108 is discussed. In this second embodiment, the translational opening or port member 108 includes a centrally extending member 160 having five pin receiving ports 168, each pin receiving port 168 having as described above. Figures 1A to 2G The opening 170 is described above. (As mentioned above, related to...) Figures 3A to 3D The first embodiment of the second embodiment of the described translational opening or port member 108, and the second embodiment of the second embodiment of the translational opening or port member 108, further include a common vertical slot 302 extending through the openings 170 of at least two adjacent receiving ports 168 of a member 160 extending vertically through the center of the translational opening or port member 108. However, with... Figures 3A to 3D Unlike the first embodiment of the translated opening or port member 108 of the second embodiment of the translated opening or port member 108 depicted in the figure, in the second embodiment of the second embodiment of the translated opening or port member 108, the common vertical slot 302 is closed at both the top and bottom of the translated opening or port member 108, as shown in the figure. Figures 4A to 4D That's understandable. The top and bottom are indicated by arrows A and B in these diagrams, respectively.

[0169] The common vertical slot 302 is narrow enough that the shaft 242 of the needle 112 will not inadvertently migrate from one opening 170 to an adjacent opening 170 via the common vertical slot 302 that engages two or more openings 170. For example, the width of the slot can be between approximately 40% and approximately 95% of the diameter of the opening 170, and the diameter of the opening 170 can be between approximately size 13 and approximately size 15. In such a case, the diameter of the shaft 242 of the needle 112 will be between approximately size 14 and approximately size 16.

[0170] Figure 4A This is a front perspective view of a second embodiment of the second embodiment of the translational opening or port member 108. This second embodiment of the second embodiment can be adapted for use with the above-described embodiments of the transperineal biopsy guide 100 or any of those described in U.S. Patents 10,064,681 and 10,743,909, the disclosures of which are incorporated herein by reference in their entirety.

[0171] For example, in cases suitable for use with any of the above embodiments, a second embodiment of the second embodiment of the translational opening or port member 108 may include the track member 177 and its proximal end plate 179, such as Figure 1E As shown. In the second embodiment of the second embodiment, Figures 3A to 3D The translational opening or port component 108 can be linearly displaced relative to the base platform 122, as described above. Figure 1M and Figure 2G As stated above.

[0172] Alternatively, Figures 4A to 4D The translational opening or port member 108 can be configured to have lateral support mechanisms 2788, as depicted and described in Figures 30, 32A through 32C, 35C, and 35D of U.S. Patent 10,743,909, which is incorporated herein by reference in its entirety. These lateral support mechanisms 2788 allow the translational opening or port member 108 to translate relative to the rest of the biopsy guide.

[0173] Figure 4B This is a rear perspective view of a second embodiment of the second embodiment of the translational opening or port member 108. Figure 4C and Figure 4D These are the far and near elevation views of the second embodiment of the second embodiment of the translational opening or port member 108.

[0174] like Figures 4A to 4D As shown, in a second embodiment of the second embodiment of the translational opening or port member 108, the slot 302 closes at both the top and bottom of the member 160 extending vertically from the center of the translational opening or port member 108, indicated by arrows A and B in these figures, respectively. As can be understood from these figures, the slot 302 is narrow enough to prevent the puncture needle 112 from unintentionally forcing its way through the slot 302.

[0175] According to Figure 4D Understandable and as mentioned above Figures 1A to 2G In the discussed embodiments, the proximal 191 of the needle receiving port 168 of the second embodiment of the translational opening or port member 108 includes a bonding feature to lockably engage the puncture needle 112 such that it does not rotate once engaged with the port 168. Specifically, the bonding feature may mate with a compatible feature on the distal side of the hub 193 of the puncture needle 112.

[0176] According to Figures 4A to 4D Understandably, the common vertical slot 302 extends vertically through the extension member 160 and together with the associated needle receiving opening 170 extends uninterruptedly and continuously from its distal end to its proximal end.

[0177] Regarding the above related Figures 3A to 4D In each embodiment of the second embodiment of the discussed translational opening or port member 108, the common vertical slot 302 advantageously allows the puncture needle 112 to be repositioned within the centrally vertically extending member 160 without removal from the patient. Thus, during surgery, the puncture needle 112 can be repositioned between the openings 170 of the needle receiving port 168 without removing and then reinserting the needle from the patient. Alternatively, during surgery, the puncture needle 112 can be completely removed from the openings 170 of the needle receiving port 168 located on the port member 108, thereby leaving the puncture needle 112 in the patient without otherwise engaging with the port member 108. d. A translational opening or port member having a single slot extending radially outward from at least one port.

[0178] The following text is related to Figures 5A to 5D A third embodiment of the translational opening or port member 108 is discussed. In this third embodiment, the translational opening or port member 108 includes the same centrally extending vertical member 160 having five pin receiving ports 168, each pin receiving port 168 having as described above. Figures 1A to 2G The opening 170 is described above. However, one or even all of the needle receiving ports 168 of the third embodiment of the translational opening or port member 108 may also include dedicated or individual slots 304 that extend radially outward from their respective openings 170 in a lateral, upward, or a combination of lateral and upward directions. In other words, such a dedicated or individual slot 304 will extend radially outward from its associated opening 170 to open through the outer circumferential edge of the associated needle receiving port 168, and in this extension, the slot will extend radially outward in a direction located at any point on the clock face clockwise from the nine o'clock direction to the three o'clock direction (inclusive). In some embodiments of this third embodiment of the translational opening or port member 108, each dedicated or individual slot 304 will extend radially outward in a direction located at any point on the clock face clockwise from approximately 10:30 to approximately 1:30 (inclusive).

[0179] Each dedicated or individual slot 304 is narrow enough that the axis 242 of the needle 112 will not inadvertently migrate out of the corresponding opening 170. Furthermore, if the orientation of the dedicated or individual slot 304 includes an upward-facing vector (alone or in combination with a horizontally facing vector), this upward-facing vector will help keep the axis 242 of the needle 112 within the corresponding opening 170. The width of each dedicated or individual slot 304 can be between approximately 60% and approximately 85% of the diameter of the opening 170, and the diameter of the opening 170 can be between approximately size 13 and approximately size 15. In such a case, the diameter of the axis 242 of the needle 112 will be between approximately size 14 and approximately size 16.

[0180] Figure 5A This is a front perspective view of a third embodiment of the translational opening or port member 108. This third embodiment can be adapted for use with the embodiments of the above-described transperineal biopsy guide 100 or any of those described in U.S. Patents 10,064,681 and 10,743,909, the disclosures of which are incorporated herein by reference in their entirety.

[0181] For example, in cases suitable for use with any of the above embodiments, a third embodiment of the translational opening or port member 108 may include a track member 177 and its proximal end plate 179, such as Figure 1E As shown. In the third embodiment, Figures 5A to 5D The translational opening or port component 108 can be linearly displaced relative to the base platform 122, as described above. Figure 1M and Figure 2G As stated above.

[0182] Alternatively, Figures 5A to 5D The translational opening or port member 108 can be configured to have lateral support mechanisms 2788, as depicted and described in Figures 30, 32A through 32C, 35C, and 35D of U.S. Patent 10,743,909, which is incorporated herein by reference in its entirety. These lateral support mechanisms 2788 allow the translational opening or port member 108 to translate relative to the rest of the biopsy guide.

[0183] Figure 5B This is a rear perspective view of a third embodiment of the translational opening or port component 108. Figure 5C and Figure 5D These are the far and near elevation views of the third embodiment of the translational opening or port member 108.

[0184] From the basis Figures 5A to 5DUnderstandably, in the third embodiment of the translational opening or port member 108, each dedicated or individual slot 304 may open radially outward in any of a range of directions from completely vertical upward to completely horizontal laterally or any combination thereof. For example, as according to Figure 5C (As best understood from the distal elevation view to the proximal view in the third embodiment of the translated opening or port member 108) the topmost opening 170 has a slot 304 that opens radially outward in a completely vertically upward direction. The second opening 170 originating from the top has a slot 304 that opens radially outward in a combination of vertical and horizontal vectors at approximately 10:30. In this embodiment of the third embodiment, the vertically centered opening 170 lacks the slot 304, but in other embodiments, it may have a slot 304 oriented in any direction within any range listed above in the third embodiment. The second opening 170 originating from the bottom has a slot 304 that opens radially outward in a combination of vertical and horizontal vectors at approximately 1:30. The bottommost opening 170 has a slot 304 that opens radially outward in a combination of vertical and horizontal vectors at approximately 10:30. Figures 5A to 5D The orientation of the slot 304 depicted is merely an example, and any one of the five openings 170 may have a corresponding slot 304 whose orientation falls within any of the ranges listed above for the third embodiment relating to the translational opening or port member 108.

[0185] According to Figure 5B and Figure 5D Understandable and as mentioned above Figures 1A to 2G In the discussed embodiment, the proximal side 191 of the needle receiving port 168 of the third embodiment of the translational opening or port member 108 includes a bonding feature to lockably engage the puncture needle 112 such that it will not rotate once engaged with the port 168. Specifically, the bonding feature may mate with a compatible feature on the distal side of the hub 193 of the puncture needle 112.

[0186] like Figure 5B and Figure 5D As depicted, in one embodiment of the third embodiment, the central opening 170 of the five openings 170 has a proximal closed end 370, such that the central opening 170 does not extend open along its entire length, but rather closes or shuts at its proximal end. This can be to enhance the structural rigidity of the vertically extending member 160. Of course, in other embodiments of the third embodiment, the central opening 170 may be fully open along its entire length, such that it is open or allows light to pass through at its proximal end, like the other four openings 170 of the vertically extending member 160.

[0187] From the basis Figures 5A to 5DUnderstandably, each dedicated or individual slot 304 extends together with its corresponding opening 170 to open through the side or top of the vertically extending member 160 according to its vector orientation, extending uninterruptedly and continuously from its distal end to its proximal end together with the corresponding needle receiving opening 170.

[0188] Regarding the above related Figures 5A to 5D With regard to the third embodiment of the translational opening or port member 108 discussed, a dedicated or separate slot 304 advantageously allows the puncture needle 112 to be repositioned within the centrally vertically extending member 160 without removal from the patient. Thus, during surgery, the puncture needle 112 can be repositioned with the dedicated or separate slot 304 between the openings 170 of the needle receiving ports 168 without removing the needle from the patient and then reinserting it. For example, the hub 193 of the puncture needle 112 can detach from one needle receiving port 168 and subsequently engage with another of the needle receiving ports 168 via a corresponding dedicated or separate slot 304, while retaining the puncture needle 112 within the patient. e. A translational opening or port component with an uppermost inclined port.

[0189] The following text is related to Figures 6A to 6D A fourth embodiment of the translational opening or port member 108 is discussed. In this fourth embodiment, the translational opening or port member 108 includes the same centrally extending vertical member 160 having five pin receiving ports 168, each pin receiving port 168 having as described above. Figures 1A to 2G The opening 170 is described. However, an additional needle receiving port 400 is located on top of the centrally vertically extending member 160, and this additional needle receiving port 400 is inclined or slanted relative to the other needle receiving ports 168.

[0190] Figure 6A This is a front perspective view of a fourth embodiment of the translational opening or port member 108. This fourth embodiment can be adapted for use with the embodiments of the perineal biopsy guide 100 described above or any of those described in U.S. Patents 10,064,681 and 10,743,909, the disclosures of which are incorporated herein by reference in their entirety.

[0191] For example, in cases suitable for use with any of the above embodiments, a fourth embodiment of the translational opening or port member 108 may include a track member 177 and its proximal end plate 179, such as Figure 1E As shown. In the fourth embodiment, Figures 6A to 6D The translational opening or port component 108 can be linearly displaced relative to the base platform 122, as described above. Figure 1M and Figure 2GAs stated above.

[0192] Alternatively, Figures 6A to 6D The translational opening or port member 108 can be configured to have lateral support mechanisms 2788, as depicted and described in Figures 30, 32A through 32C, 35C, and 35D of U.S. Patent 10,743,909, which is incorporated herein by reference in its entirety. These lateral support mechanisms 2788 allow the translational opening or port member 108 to translate relative to the rest of the biopsy guide.

[0193] Figure 6B This is a rear perspective view of the fourth embodiment of the translational opening or port member 108. Figure 6C and Figure 6D These are the far and near elevation views of the fourth embodiment of the translational opening or port member 108.

[0194] According to Figures 6A to 6D Understandably, in the fourth embodiment of the translational opening or port member 108, each of the five lower pin receiving ports 168 is parallel to each other, such that all corresponding openings 170 have longitudinal central axes that are parallel to each other. Furthermore, the longitudinal central axes of the openings 170 of the five lower pin receiving ports 168 all lie in the same common vertical plane. However, although the longitudinal central axis of its opening 470 also lies in the same common vertical plane as the longitudinal central axes of the openings 170 of the five lower pin receiving ports 168, the tilted pin receiving port 400 located at the top of the centrally vertically extending member 160 is significantly tilted or oblique relative to the five lower pin receiving ports 168, such that the longitudinal central axis of the opening 470 of the tilted pin receiving port 400 is angled upwards / downwards in the common vertical plane of all six openings 170, 470. According to this fourth embodiment, the angle between the longitudinal central axis of the opening 470 of the tilting needle receiving port 400 and the direction parallel to the longitudinal central axis of the opening 170 of the five lower needle receiving ports 168 is between approximately 10 degrees and approximately 45 degrees. In some examples, the angle between the longitudinal central axis of the opening 470 of the tilting needle receiving port 400 and the direction parallel to the longitudinal central axis of the opening 170 of the five lower needle receiving ports 168 is approximately 20 degrees.

[0195] In some embodiments of the fourth embodiment, since the tilting needle receiving port 400 is part of a fixed integral structure of the centrally vertically extending member 160, the angle between the tilting needle receiving port 400 and the other needle receiving ports 168 is fixed.

[0196] In some other embodiments, the angle between the tilting needle receiving port 400 and the remaining needle receiving ports 168 is adjustable due to a pivoting assembly near arrow Z between the tilting needle receiving port 400 and the centrally extending vertical member 160. In such an adjustable configuration, the angle between the tilting needle receiving port 400 and the remaining needle receiving ports 168 can be adjusted by any degree between approximately 0 degrees and approximately 60 degrees in the direction parallel to the longitudinal central axis of the opening 170 of the five lower needle receiving ports 168. In such an adjustable configuration, a locking mechanism may be further provided to act on the pivoting assembly to maintain the desired angle once the tilting needle receiving port 400 is positioned relative to the remaining needle receiving ports 168 at the desired angle.

[0197] Regarding the above related to Figures 6A to 6D With regard to the fourth embodiment of the translational opening or port member 108 discussed, whether fixed or pivotable, the tilted or oblique nature of the tilting needle receiving port 400 advantageously provides improved access to the patient's desired anatomical structures, such as, but not limited to, the anterior portion of the prostate.

[0198] According to Figure 6B and Figure 6D Understandable and as mentioned above Figures 1A to 2G In the discussed embodiment, the proximal 191 of the needle receiving port 168, 400 of the fourth embodiment of the translational opening or port member 108 includes a bonding feature to lockably engage the puncture needle 112 such that it will not rotate once engaged with the port 168. Specifically, the bonding feature may mate with a compatible feature on the distal side of the hub 193 of the puncture needle 112.

[0199] In some embodiments, the needle receiving port 168 and the tilting needle receiving port 400 may be fluidly connected in a single central opening or slot 302, as referenced. Figures 4A to 4D The embodiments shown and described. In such embodiments, the single central opening or slot 302 may be open to allow the puncture needle to disengage from the port member 108 during use, such as Figures 3A to 3D The embodiment is as follows. Alternatively, the needle receiving port 168 and the tilting needle receiving port 400 may have a separate slot 304 communicating with one or more of the needle receiving ports 400 or the tilting needle receiving port 400 to allow the puncture needle 112 to be dislodged therefrom.

[0200] Using the above related Figures 1A to 6D Any method of performing a transperineal prostate biopsy in the discussed embodiments will be at least similar to those previously described in U.S. Patents 10,064,681 and 10,743,909, both of which are incorporated herein without limitation, the disclosures of which are incorporated herein by reference in their entirety.

[0201] The biopsy guides and devices described herein may also include markers or sensors positioned on the biopsy guide or puncture needle, such that movement of the guide or needle, or any device / material placed through the puncture needle, can be visualized via the markers / sensors using an ultrasound device (e.g., an imaging probe) or other devices using different imaging modalities (e.g., MRI, CT). In this way, for example, a marker positioned at the distal end of the puncture needle can provide visual guidance regarding the position of the tip of the puncture needle relative to the boundary of the prostate.

[0202] Although various representative embodiments have been described above with a degree of specificity, those skilled in the art can make many modifications to the disclosed embodiments without departing from the spirit or scope of the inventive subject matter set forth herein. All directional references (e.g., distal, proximal, front, rear, side, top, bottom, front, rear, right, left, etc.) are used for identification purposes only to aid the reader's understanding of these embodiments and do not impose limitations, particularly regarding the location, orientation, or use of the embodiments described herein, unless expressly stated in the claims. Connecting references (e.g., attachment, connection, link, etc.) should be interpreted broadly and may include intermediate members between element connections and relative movement between elements. In this respect, a connecting reference does not necessarily imply that two elements are directly connected and fixed to each other.

[0203] It will be understood from the foregoing description that the invention and its many incidental advantages are clear, and it will be apparent that various changes can be made to the form, construction, and arrangement of the components without departing from the disclosed subject matter or sacrificing all its substantial advantages. The forms described are merely illustrative, and the appended claims are intended to cover and include these changes.

[0204] While the invention has been described with reference to various embodiments, it should be understood that these embodiments are illustrative and the scope of the invention is not limited to these embodiments. Many variations, modifications, additions, and improvements are possible. More generally, embodiments of the invention have been described in the context of specific implementations. Functions may be separated or combined in different ways in various embodiments of the invention, or described using different terms. These and other variations, modifications, additions, and improvements may fall within the scope of the invention as defined by the appended claims.

Claims

1. A transperineal biopsy system for use with a transrectal imaging probe, the transrectal imaging probe being configured to provide imaging in at least the sagittal plane, the transperineal biopsy system comprising: A puncture needle, the puncture needle comprising a hub at a proximal end and a tubular structure extending distally from the hub; as well as Biopsy guide, the biopsy guide comprising: A mounting base that can be mounted on the transrectal imaging probe, the mounting base including a fastening mechanism that releasably attaches the mounting base to the transrectal imaging probe; The patient contact member protrudes distally relative to the mounting base; and An opening member projecting distally relative to the mounting base and including a plurality of spaced-apart, vertically arranged needle receiving openings, each of the plurality of needle receiving openings configured to support the puncture needle at a different height relative to the transrectal imaging probe and configured to support the puncture needle in the sagittal plane when the biopsy guide is attached to the transrectal imaging probe, wherein at least one of the plurality of needle receiving openings includes a slot extending radially outward from the at least one needle receiving opening.

2. The transperineal biopsy system according to claim 1, wherein, The slot extends between two or more adjacent needle receiving openings in the plurality of needle receiving openings.

3. The transperineal biopsy system according to claim 2, wherein, The slot opens radially outward through the top of the opening member.

4. The transperineal biopsy system according to claim 3, wherein, The opening member further includes a clamping member that clamps the slot narrow enough to prevent the puncture needle from unintentionally forcing its way through the slot.

5. The transperineal biopsy system according to claim 4, wherein, The clamping member includes opposing downward protrusions that receive both sides of the opening member between them during the clamping of the slot to a sufficiently narrow position.

6. The transperineal biopsy system according to claim 2, wherein, The slot extends vertically into each of the plurality of needle receiving openings to form a single continuous slot.

7. The transperineal biopsy system according to claim 1, wherein, The slot extends in a lateral, upward, or a combination of lateral and upward directions, located at any point on the clock face between the nine o'clock and three o'clock directions in a clockwise direction, including both the nine o'clock and three o'clock directions.

8. The transperineal biopsy system according to claim 1, wherein, The slot opens radially outward through the side of the opening member and extends uninterruptedly and continuously from the distal end of the at least one needle receiving opening to the proximal end of the at least one needle receiving opening, together with the at least one needle receiving opening of the plurality of needle receiving openings.

9. The transperineal biopsy system according to claim 1, wherein, The slot is narrow enough to prevent the puncture needle from unintentionally forcing its way through the slot.

10. The transperineal biopsy system according to claim 1, wherein, The patient contact component is movable relative to the fastening mechanism.

11. The transperineal biopsy system according to claim 10, wherein, The patient contact component can slide relative to the fastening mechanism when it can be translated relative to the fastening mechanism.

12. The transperineal biopsy system according to claim 1, wherein, The opening member can be translated relative to the fastening mechanism.

13. The transperineal biopsy system according to claim 12, wherein, The opening member can slide relative to the fastening mechanism when it can translate relative to the fastening mechanism.

14. The transperineal biopsy system according to claim 1, wherein, The patient contact component includes a pair of stabilizing members extending distally beyond the mounting base.

15. The transperineal biopsy system according to claim 1, wherein, The puncture needle is at least 16 gauge, and each needle receiving opening is capable of receiving the puncture needle.

16. The transperineal biopsy system of claim 1, further comprising a biopsy instrument including a biopsy needle configured to extend through the puncture needle.

17. The transperineal biopsy system according to claim 1, wherein, The biopsy needle was size 18.

18. The transperineal biopsy system according to claim 1, wherein, The biopsy needle is a size 14, 15, or 16.

19. The transperineal biopsy system according to claim 1, wherein, Each of the plurality of needle receiving openings includes a distal section and a proximal section, the distal section including a distal aperture and the proximal section including a proximal aperture, the diameter of the proximal aperture being larger than the diameter of the distal aperture.

20. A method for performing a transperineal biopsy, comprising: Provide a transperineal biopsy system as described in claim 1; With the tubular structure of the puncture needle at least partially positioned in the patient's perineum, the puncture needle is repositioned from the first support among the plurality of needle receiving openings to the second support among the plurality of needle receiving openings by moving the puncture needle through the slot; The transperineal biopsy procedure is performed by biopsy of the prostate using a biopsy instrument that extends through the puncture needle.

21. A transperineal biopsy system for use with a transrectal imaging probe, the transrectal imaging probe being configured to provide imaging in at least the sagittal plane, the transperineal biopsy system comprising: A puncture needle, the puncture needle comprising a hub at a proximal end and a tubular structure extending distally from the hub; as well as Biopsy guide, the biopsy guide comprising: A mounting base that can be mounted on the transrectal imaging probe, the mounting base including a fastening mechanism that releasably attaches the mounting base to the transrectal imaging probe; A patient contact member, the patient contact member projecting distally relative to the mounting base and being translatable distally-proximally relative to the fastening mechanism; and An opening member, which projects distally relative to the mounting base and includes a plurality of needle receiving openings arranged vertically at intervals, each of the plurality of needle receiving openings being configured to support the puncture needle at a different height relative to the transrectal imaging probe and being configured to support the puncture needle in the sagittal plane when the biopsy guide is attached to the transrectal imaging probe.

22. The transperineal biopsy system according to claim 21, wherein, The patient contact component slides as it translates distally to proximally relative to the fastening mechanism.

23. The transperineal biopsy system according to claim 21, wherein, The patient contact member includes a pair of offset stabilizing bars that project distally relative to the mounting base and translate distally-proximal relative to the fastening mechanism when the patient contact member translates distally-proximal relative to the fastening mechanism.

24. The transperineal biopsy system according to claim 23, wherein, The pair of offset stabilizing bars together, as an integral structural unit, translates relative to the fastening mechanism from the far side to the near side.

25. The transperineal biopsy system according to claim 23, wherein, Each of the pair of offset stabilizing bars can be translated independently of each other from far to near.

26. The transperineal biopsy system according to claim 21, wherein, The opening member can be translated distally to proximally relative to the fastening mechanism.

27. The transperineal biopsy system according to claim 26, wherein, The opening member slides as it translates distally to proximally relative to the fastening mechanism.

28. The transperineal biopsy system according to claim 21, wherein, The puncture needle is at least 16 gauge, and each needle receiving opening is capable of receiving the puncture needle.

29. The transperineal biopsy system of claim 21, further comprising a biopsy instrument including a biopsy needle configured to extend through the puncture needle.

30. The transperineal biopsy system according to claim 29, wherein, The biopsy needle was size 18.

31. The transperineal biopsy system according to claim 21, wherein, The puncture needle is a size 14, 15, or 16.

32. The transperineal biopsy system according to claim 21, wherein, Each of the plurality of needle receiving openings includes a distal section and a proximal section, the distal section including a distal aperture and the proximal section including a proximal aperture, the diameter of the proximal aperture being larger than the diameter of the distal aperture.

33. A method for performing a transperineal biopsy, comprising: Provide a transperineal biopsy system as claimed in claim 21; Fix the position of the opening member relative to the mounting base; The patient contact member is translated distally to proximally relative to the fastening mechanism and relative to the patient's perineum; the puncture needle is inserted into one of the plurality of needle receiving openings; the puncture needle is inserted into the perineum; and the transperineal biopsy is performed by performing a biopsy of the prostate with a biopsy instrument extending through the puncture needle.

34. A transperineal biopsy system for use with a transrectal imaging probe, the transrectal imaging probe being configured to provide imaging in at least the sagittal plane, the transperineal biopsy system comprising: A puncture needle, the puncture needle comprising a hub at a proximal end and a tubular structure extending distally from the hub; as well as Biopsy guide, the biopsy guide comprising: A mounting base that can be mounted on the transrectal imaging probe, the mounting base including a fastening mechanism that releasably attaches the mounting base to the transrectal imaging probe; The patient contact component protrudes distally relative to the mounting base; An opening member projecting distally relative to the mounting base and including a plurality of vertically arranged, spaced-apart needle receiving openings, each of which is configured to support the puncture needle at a different height relative to the transrectal imaging probe and is configured to support the puncture needle in the sagittal plane when the biopsy guide is attached to the transrectal imaging probe; and An inclined needle receiving opening is located at the top of the opening member, which is vertically aligned with the plurality of needle receiving openings in a common vertical plane, but otherwise is inclined relative to the plurality of needle receiving openings.

35. The transperineal biopsy system according to claim 34, wherein, The inclined needle receiving opening is at an angle of about 10 degrees to about 45 degrees to the direction parallel to the plurality of needle receiving openings.

36. The transperineal biopsy system according to claim 34, wherein, The inclined needle receiving opening is fixed relative to the plurality of needle receiving openings by means of a fixed integral structure that is part of the opening member.

37. The transperineal biopsy system according to claim 34, wherein, The tilted needle receiving opening pivots relative to the plurality of needle receiving openings.

38. A method for performing a transperineal biopsy, comprising: Provides a transperineal biopsy system according to claim 34; inserts the puncture needle into the inclined needle receiving opening; The perineal biopsy procedure is performed by inserting the puncture needle into the patient's perineum and by performing a biopsy of the prostate using a biopsy instrument that extends through the puncture needle.

Images