BACKGROUND
This invention relates to puncture device guidance devices for use with medical imaging instruments and more particularly to devices for guiding puncture devices to repeatable locations on a patient relative to a medical imaging instrument probe.
Imaging instruments, such as ultrasound probes, have revolutionized the manner in which many important medical procedures are performed. These medical instruments utilize imaging techniques to explore and assess the condition of human tissue and/or organs. As a result, diagnostic and therapeutic protocols have been developed that allow many highly successful and safe procedures to be performed with minimal disturbance to patients. For example, ultrasound probes have become an accepted modality for exploring endocavities, e.g., the digestive and reproductive tracts, of humans and animals in order to conduct routine examinations, as well as to identify evidence of tumors or other tissue regions of interest.
The outpatient diagnostic procedure of transrectal (TR) ultrasound guided prostate biopsy, where the biopsy needle passes through the rectal wall, has become increasingly dangerous for the patient because, with the appearance of multi-drug resistant bacteria, the use of antibiotic prophylaxis has become less protective against post biopsy sepsis. As a direct consequence, the medical community has been developing a transperineal (TP) approach for biopsy. With this method, the biopsy needle passes through the perineal skin, that may be sterilized, avoiding the risk of infectious complication altogether. Meanwhile, the distinct advantages of transrectal ultrasound imaging for needle guidance are retained. Although a skilled operator may be able to perform a well targeted biopsy using a freehand technique for both the ultrasound imaging and the biopsy, it is quite difficult, often needing an extra set of hands. So, in the interests of patient safety, delivery of anesthesia, standardization of technique for teaching purposes, consistent accuracy of the biopsies, and enabling the procedure being accomplished by a single operator, a mechanical guidance device that is connected to the ultrasound probe/transducer becomes essential, especially as this approach becomes widely relevant and adopted.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1A and 1B are isometric and exploded isometric views, respectively, illustrating a needle guidance device for use with an ultrasound probe, consistent with embodiments described herein;
FIGS. 2A and 2B are bottom and rear views, respectively, of the guide tower of FIGS. 1A and 1B;
FIG. 2C is a side view of the trocar guide device of FIGS. 1A and 1B;
FIGS. 3A and 3B are isometric and exploded isometric views, respectively, illustrating another embodiment of a needle guidance device for use with an ultrasound probe, consistent with embodiments described;
FIGS. 4A, 4B, and 4C are first and second rear plan views and a side plan view, respectively, of the guide tower of FIGS. 3A and 3B;
FIG. 4D is an isometric view of the needle holder device of FIGS. 3A and 3B
FIGS. 5A and 5B are isometric and exploded isometric views, respectively, illustrating another embodiment of a needle guidance device for use with an ultrasound probe, consistent with embodiments described herein;
FIGS. 6A and 6B are isometric and reverse isometric views, respectively, of the guide platform of FIGS. 5A and 5B in an unlatched configuration;
FIG. 6C is an isometric view of another embodiment of the guide platform of FIGS. 5A and 5B;
FIGS. 7A, 7B, and 7C are left and rear side plan and isometric views, respectively, of the guide tower of FIGS. 5A and 5B;
FIGS. 7D and 7E are isometric and top plan views, respectively, of the needle holder device of FIGS. 5A and 5B;
FIG. 8 is an isometric view of an alternative embodiment of a guide tower consistent with implementations described herein; and
FIG. 9 is a proximal isometric view of an example embodiment of a needle guidance device for use with an ultrasound probe, according to an example embodiment;
FIG. 10 is a distal isometric view of the example embodiment of the needle guidance device shown in FIG. 9;
FIG. 11 is an exploded view of the example embodiment of the needle guidance device shown in FIG. 9;
FIG. 12 is a perspective view of an example introducer needle suitable for use with the needle guidance device shown in FIG. 9, according to an example embodiment;
FIGS. 13-15 are perspective views illustrating an example needle guidance device being operatively coupled to an ultrasound probe, according to an example embodiment;
FIG. 16 is a side view of the example needle guidance device of FIG. 9 with an introducer holder in a first path height position, according to an example embodiment;
FIG. 17 is a side view of the example needle guidance device of FIG. 9 with an introducer holder in a second path height position, according to an example embodiment;
FIGS. 18-20 are isometric views of the example needle guidance device of FIG. 9 illustrating assembly of the introducer needle to the needle guidance device, according to an example embodiment;
FIG. 21 is a side view of the example needle guidance device of FIG. 9 with an introducer holder located at a first path angle orientation parallel with a longitudinal axis of the needle guidance device, according to an example embodiment; and
FIG. 22 is a side view of the example needle guidance device of FIG. 9 with an introducer holder located at a second path angle orientation different from the first path angle orientation shown in FIG. 21, according to an example embodiment.
DETAILED DESCRIPTION
The following detailed description refers to the accompanying drawings. The same reference numbers in different drawings may identify the same or similar elements. Also, the following detailed description does not limit the invention.
Implementations described herein relate to guidance devices for facilitating the placement of a puncture device (e.g., a needle) at a defined position relative to an ultrasound probe. More specifically, the guidance devices described below include components that provide a number of path height positions relative to each other and at different defined distances from the ultrasound probe and/or at different defined angle orientations with respect to the longitudinal axis of the ultrasound probe.
In certain example embodiments, a needle guidance device includes a guide base configured to releasably attach to an ultrasound probe. The needle guidance device has a longitudinal axis that extends between a first, e.g., distal end, and a second, e.g., proximal end, of the needle guidance device and coplanar and parallel to, e.g., coaxially aligned with, a longitudinal axis of the ultrasound probe, which extends between a first, e.g., distal end, and a second, e.g., proximal end, of the ultrasound probe. While the example embodiments described herein include a needle guidance device configured to removably couple to an ultrasound probe or transducer, the example needle guidance device can be removably coupled to other suitable probes, and/or medical instruments or devices.
The example guide base includes a platform having a surface. A guide tower is fixedly coupled to or formed with the guide base to form a unitary piece, e.g., a single-piece construction or unitary frame piece. The tension fit of the introducer holder (described below) facilitates providing control for the doctor as the doctor advances and/or retracts the introducer needle positionable within the introducer holder. In example embodiments, the guide tower extends distally from a distal end of the guide base along the longitudinal axis of the needle guidance device and extends from the surface of the platform, e.g., extends upwardly or radially outwardly from the platform surface. In example embodiments, the guide base includes a mount portion fixedly coupled to the guide tower and a strap portion coupled to or formed with the mount portion that provides releasable attachment of the needle guidance device to the ultrasound probe.
The guide tower includes a plurality of attachment positions, each located at a corresponding distance from the platform surface. An introducer holder is removably and rotationally or pivotally coupled to the guide tower at each of the plurality of attachment positions. In example embodiments, the introducer holder is positionable at each of the plurality of attachment positions to prevent movement of the introducer holder in the distal direction and opposite proximal direction with respect to the guide tower, while facilitating rotational or pivotal movement of the introducer holder with respect to the guide tower within a plane including the longitudinal axis of the needle guidance device. The introducer holder includes a body portion having a distal end, an opposite proximal end, and a central passage extending along a centerline of the body portion between the distal end and the proximal end. A pair of opposing engagement shoulders extend radially outwardly from the centerline of the body portion at the distal end of the body portion.
The guide tower includes a plurality of paired arcuate-shaped depressions at each attachment position configured to accept or retain the pair of engagement shoulders in a snap-fit or frictional fit, for example. In example embodiments, each engagement shoulder is removably and pivotably or rotationally positionable within a corresponding arcuate-shaped depression. With the introducer holder pivotably or rotatably coupled to the guide tower at one of the plurality of attachment positions, the introducer holder is pivotably or rotatably movable with respect to the guide tower about a rotational axis perpendicular to the longitudinal axis of the needle guidance device to move an introducer needle positioned within the central passage of the introducer holder from a first path angle orientation within a plane including the longitudinal axis of the needle guidance device to a second path angle orientation within the plane different from the first path angle orientation. The introducer holder is lockable at each path angle orientation to prevent further pivotal or rotational movement of the introducer holder and translational movement of the introducer holder in the distal direction and the proximal direction with respect to the guide tower.
In certain example embodiments, a guide slide clamp is movably positioned within a slot that extends transversely through at least a portion of the guide tower. The guide slide clamp includes a body portion and a plurality of path retaining elements, e.g., a plurality of detents. Each detent, for example, is axially aligned with at least one arcuate-shaped depression of the corresponding pair of arcuate-shaped depressions to facilitate retaining the introducer holder at a corresponding needle path height position through the guide tower. The introducer holder defines a central passage configured to receive an introducer needle and maintain the introducer needle within the plane. In certain example embodiments, the introducer needle includes a distal tip, an opposite proximal end, and a stop at the proximal end configured to limit movement of the introducer needle in the passage in the distal direction with respect to the guide tower. The introducer holder is positionable at a plurality of path height positions, with each path height position of the plurality of path height positions located at a corresponding distance from the surface of the platform. A locking knob is configured to secure the introducer holder at a selected path angle orientation and/or a selected path height position.
For example, in one implementation, the ultrasound probe may be a transrectal ultrasound probe and the guidance device may be configured to facilitate guidance of a biopsy needle at a location relative to the ultrasound probe. Consistent with embodiments described herein, the needle guidance device may include a plurality of selectable guidance paths while simultaneously enabling both fixed and parallel needle paths and angular adjustment of the needle while maintaining the angular orientation and axial relationship between the needle and the ultrasound probe. In addition, consistent with certain implementations described herein, the needle guidance device may be longitudinally advanceable at defined intervals.
FIGS. 1A and 1B are isometric and exploded isometric views, respectively, illustrating a needle guidance device 100 for use with an ultrasound probe, consistent with embodiments described herein. As shown, needle guidance device 100 includes a clamping sleeve 105, a guide tower 110, an alignment plate 115, and a needle holder device 120. Prior to use, clamping sleeve 105 may be secured to an ultrasound probe (not shown) and guide tower 110 may be slidingly coupled to clamping sleeve 105. As shown in FIGS. 1A and 1B, needle holder device 120 may be inserted into one of a plurality of path positions in guide tower 110. A trocar or other puncture device 125, such as a luer lock trocar needle, may be received through needle holder device 120, as described below. Alignment plate 115 may be inserted into guide tower 110 to provide a guidance path that is parallel to the longitudinal axis of the ultrasound probe, as described below. During use, guide tower 110 may be slidingly advanced forward, i.e., distally, relative to clamping sleeve 105 and the ultrasound probe to engage the patient at a selected location. Upon completion of the procedure, the guide tower 110 may be retracted, i.e., moved proximally, relative to clamping sleeve 105 and the ultrasound probe to disengage puncture device 125 from the patient.
As shown in FIG. 1B, clamping sleeve 105 includes a mount portion 130, a strap portion 136, and a securement portion 140. As described herein, mount portion 130 may include an extruded configuration having an upper surface 132 and a lower surface 134. Upper surface 132 of mount portion 130 may be configured to support guide tower 110 in a longitudinally adjustable configuration. For example, as shown in FIG. 1B, upper surface 132 includes a pair of side rails 133 that project upwardly from upper surface 132. As described below, each of side rails 133 are configured for slidable receipt within corresponding side rails 154 in guide tower 110, as shown in FIG. 2A. To prevent guide tower 110 from moving too loosely relative to mount portion 130 during use, tolerances of respective side rails 133 may be such that a frictional relationship exists between mount portion 130 and guide tower 110 that resists undesirable movement.
In another implementation, as shown in FIG. 1B, upper surface 132 of mount portion 130 may include a plurality of longitudinally spaced barbed fixation elements 131 that project upwardly therefrom. Barbed fixation elements 131 are configured for engagement by a spring clip element 200 in guide tower 110, as shown in FIG. 2A. In some implementations, upper surface 132 of mount portion 130 may also include a stop engagement portion 135 for engaging a stop element 205 that projects downwardly from a lower surface of guide tower 110, as shown in FIG. 2A. When stop element 205 in guide tower 110 abuts stop engagement portion 135 in clamping sleeve 105, guide tower 110 is prevented from moving forward relative to clamping sleeve 105 and, thus, relative to the ultrasound probe to which the clamping sleeve is secured.
In other implementations, other mechanisms for securing guide tower 110 to clamping sleeve 105 may be used. For example, a combination of projections and detents or apertures may be used, such as that described above in relation to the embodiments of FIGS. 1B and 2A, to allow for releasable securement of guide tower 110 to mount portion 130.
Lower surface 134 of mount portion 130 includes a generally curved configuration that corresponds to a curved outer configuration of at least a portion of the transducer probe (not shown). Consistent with embodiments described herein, lower surface 134 may include a longitudinal channel or groove to create a defined space between the transducer probe and needle guidance device 100 sufficient to accommodate procedure accessory devices, such as a brachytherapy balloon or the like.
Strap portion 136 of clamping sleeve 105 may include a generally resilient or flexible configuration that adaptively conforms to the outer surface of a portion of the transducer probe on which needle guidance device 100 is mounted. In particular, strap portion 136 may include a first lateral portion 137 extending from a first side of mount portion 130 and a second lateral portion 139 extending from a second side of mount portion 130 opposite to first lateral portion 137. First and second lateral portions 137/139 may collectively terminate in securement portion 140. As shown in FIGS. 1A and 1B, in one implementation, securement portion 140 may include a collar portion 141 formed at the terminus of first lateral portion 137 and a threaded portion 142 formed at the terminus of second lateral portion 139. Collar portion 141 may include an opening adapted to receive an end of threaded portion 142 during mounting of clamping sleeve 105 onto the ultrasound probe.
To secure clamping sleeve 105 to an ultrasound probe, lower surface 134 of the mount portion 130 and the inside surface of first lateral portion 137 are initially brought into contact with an outside surface of the ultrasound probe. The second lateral portion 139 is then flexed such that its inside surface also contacts the outer surface of the ultrasound probe, thereby causing threaded portion 142 to enter collar portion 141. A clamping nut 144 having a mating collar portion 146 is threadedly advanced on threaded portion 142, to cause the collar portion 146 on clamping nut 144 to clampingly engage collar portion 141 in first lateral portion 137, thus securing clamping sleeve 105 to the ultrasound probe. When it is desired to remove clamping sleeve 105, clamping nut 144 may be reversed, thereby releasing collar portion 141.
Consistent with implementations described herein, one or more of lateral portions 137/139 may be formed in a thickness sufficient to allow flexure. In some implementations, only second lateral portion 139 is formed to enable flexure, with first lateral portion 137 having a substantially rigid configuration. In some embodiments, an entirety of clamping sleeve 105, with the exception of clamping nut 144, may be integrally formed, such as via injection molding, 3D printing, etc.
As shown in FIGS. 1A and 1B, guide tower 110 includes a substantially L-shaped configuration for providing a secure interface to clamping sleeve 105 and a plurality of radially spaced (relative to a longitudinal orientation or a longitudinal axis of the ultrasound probe, as depicted by line A-A in FIG. 1B) needle guide paths for engaging needle holder device 120, as described herein. In particular, guide tower 110 includes a sleeve interface portion 150 having a generally planar configuration and a guide path portion 152 that projects upwardly from the sleeve interface portion 200. A lower surface of sleeve interface portion 150 includes opposing side rails 154 that project downwardly therefrom and are configured to interface with side rails 133 in clamping sleeve 105, as described above. In some implementations, side rails 154 have opposing c-shaped configurations that capture side rails 133 and prevent relative radial movement between clamping sleeve 105 and guide tower 110 when side rails 133 in mount portion 130 are positioned within side rails 154 in guide tower 110, while allowing sliding longitudinal movement therebetween.
As described above, and as shown in FIG. 2A, which depicts a bottom view of guide tower 110, sleeve interface portion 150 includes a resilient spring clip element 600 configured to engage barbed fixation elements 131 that project upwardly from clamping sleeve 105.
In one implementation consistent with embodiments described herein, guide path portion 152 projects upwardly substantially perpendicularly from sleeve interface portion 150. As shown, in FIGS. 1A, 1B, and 2B (which depicts a rear view of guide tower 110 with alignment plate 115 position therein), guide path portion 152 includes a vertical guidance slot 156, a plurality of needle holder device receiving cups 158, and an alignment plate receiving slot 160.
Vertical guidance slot 156 is centrally aligned within guide tower 110 so as to be aligned with longitudinal ultrasound imaging crystals within a transducer to which the needle guide device 100 is affixed such that puncture device 125 (e.g., a trocar needle) designed to pass therethrough is consistently visualized in the imaging plane under typical imaging conditions. As shown in FIG. 2B, vertical guidance slot 156 extends substantially the entire height of guide tower 110 to allow an inserted puncture device to be freely moved between needle holder device guide device receiving cup positions.
As shown in FIG. 1B, needle holder device receiving cups 158 comprise pairs of aligned recesses or openings in guide path portion 152 and positioned on opposite sides of vertical guidance slot 156. Each pair of needle holder device receiving cups 158 is vertically spaced relative to the adjacent pair of needle holder device receiving cups 158 to provide a plurality of attachment positions for needle holder device 120, as described in additional detail below. In the present embodiment, five pairs of needle holder device receiving cups 158 are provided, although other implementations may include fewer or additional needle holder device receiving cups 158 may be provided. Consistent with implementations described herein, each needle holder device receiving cup 158 comprises a generally arced opening configured to receive respective portions of needle holder device 120, as described below. In some implementations, the dimensions of each needle holder device receiving cup 158 is such that needle holder device 120 is removable captured therein. For example, each needle holder device receiving cup 158 may be sized to provide a tight frictional fit to needle holder device 120. In other implementations, each needle holder device receiving cup 158 may have an opening whose arc is slightly more than 180°, such that the needle holder device 120 snaps into a respective pair of needle holder device receiving cups 158. In contrast to the needle guidance device 100 of FIGS. 1A-2B, needle holder device receiving cups 158 are positioned forwardly of alignment plate receiving slot 160.
As shown in FIG. 1B, alignment plate receiving slot 160 is configured to extend transversely within guide tower 110 in a position rearward of needle holder device receiving cups 158. Alignment plate receiving slot 160 is sized to receive alignment plate 115 therein. As described in additional detail below, upon receipt of a needle holder device 120 and corresponding puncture device 125 within a particular pair of needle holder device receiving cups 158, alignment plate 115 may be advanced within alignment plate receiving slot 160 to positively support puncture device 125 in a defined path relative to ultrasound probe. For example, in some implementations, the configuration of alignment plate 115 forces puncture device 125 into a parallel path, although different configurations of may be used to accommodate different path angles. As shown in FIG. 1B, in one implementation, alignment plate receiving slot 160 includes an outer rim portion 161 configured to receive a portion of alignment plate 115 at a defined depth within alignment plate receiving slot 160.
FIG. 2C is a side view of needle holder device 120 consistent with embodiments described herein. As shown in FIGS. 1A, 1B, and 2C needle holder device 120 comprises an adapter for coupling to guide tower 110 and for receiving puncture device 125. In some implementations, needle holder device 120 may be configured to receive a trocar puncture device therethrough.
In one implementation, needle holder device 120 includes a body portion 162, engagement shoulders 164, handle portion 166, and flanged portion 168. As shown, body portion 162 includes a generally tubular element having a central aperture 169 therethrough. Body portion 162 is configured to receive puncture device 125 within central aperture 169. A forward or distal end of body portion 162 terminates in engagement shoulders 164 and a rearward or proximal end of body portion terminates in flange portion 162. An outer surface of an intermediate portion of body portion 162 forms handle portion 166, which may be manipulated to effect proper placement of needle holder device 120 during use.
Engagement shoulders 164 include a pair of substantially cylindrical elements that project perpendicularly outwardly from opposing sides of the forward end of body portion 162. As shown in FIG. 1A and described generally above, engagement shoulders 164 are configured to be received within a selected pair of needle holder device receiving cups 158 during use. The cylindrical configuration of engagement shoulders 164 allows for upward and downward rotation of needle holder device 120 within receiving cups 158 via handle portion 166 if desired, and prior to advancement of alignment plate 115 within alignment plate receiving slot 160, which fixes the angular orientation of needle holder device 120.
As shown in FIGS. 1A, 1B, and 2C, consistent with implementations described herein, a funnel member 170 may be affixed to luer lock puncture device 125 prior to inserting within needle holder device 120. Consistent with embodiments described herein, funnel member 170 includes a puncture device interface portion 171 and a funnel aperture 172. Puncture device interface portion 171 includes a concentrically tubular structure for receiving an interface element of a puncture device 125, such as a luer lock. In this configuration, puncture device interface portion 171 includes internal threads (not shown) configured to engage and retain external threads on luer lock puncture device 125. Funnel aperture 172 includes a wide mouth aperture at the rearward end funnel member 170 having a larger inside diameter or circumference than central aperture (not shown) in body portion 162 for enabling easy entrance of a puncture device, such as biopsy needle or the like.
As shown in FIG. 1B, alignment plate 115 includes a body portion 176, an abutment portion 178, a free movement portion 179, and a plurality of path retaining channels 180. In general, body portion 176 includes a substantially planar element sized for receipt within alignment plate receiving slot 160. Abutment portion 178 includes a flange portion 182 that provides a surface for abutting an outer rim portion 161 of alignment plate receiving slot 160 when alignment plate 115 is fully inserted into alignment plate receiving slot 160.
Consistent with implementations described herein, free movement portion 179 includes a slotted opening that communicates with path retaining channels 180. Path retaining channels 180 include a plurality of arcuate recesses spaced to correspond to needle holder device receiving cups 158. The combination of free movement portion 179 and path retaining channels 180 provides two operational positions for alignment plate 115.
In a first position, alignment plate 115 is partially inserted into alignment plate receiving slot 160 such that free movement portion 179 is aligned with vertical guidance slot 160. This allows needle holder device 120 to be inserted into guide tower 110. Once needle holder device 120 has been inserted into guide tower 110 and into a selected pair of needle holder device receiving cups 158, alignment plate 115 is advanced within alignment plate receiving slot 160 (until flange portion 182 abuts outer rim portion 161). In this second position, needle holder device 120 is retained in a parallel path relative to the ultrasound probe. Although the position of the path retaining channels 180 in alignment plate 115 of the embodiment of FIGS. 1A and 1B provides for a parallel path for needle holder device 120, in other implementations, the positions of path retaining channels 180 may be offset with respect to needle holder device receiving cups 158 to provide other angular orientations.
Alignment plate 115 is configured to be persistently retained within alignment plate receiving slot 160. As shown in FIG. 1B, alignment plate 115 may include one or more spring clip portions 184 configured to engage a corresponding rim portion of slot 160 when alignment plate 115 is in the first position to prevent unintended removal of alignment plate 115 from alignment plate receiving slot 160.
During assembly and use, engagement shoulders 164 of needle holder device 120 are initially oriented vertically and needle holder device 120 is inserted into vertical guidance slot 156 and forwardly through alignment plate 115 when the alignment plate is in the first position. Needle holder device 120 is then rotated 90° and inserted into a selected pair of needle holder device receiving cups 158. Alignment plate 115 is then advanced into the second position, thus capturing the needle holder device 120 into a selected parallel path.
After puncture device 125 is seated within a selected parallel path within guide tower 110 (e.g., within a selected pair of needle holder device receiving cups 158 and locked by alignment plate 115), guide tower 110 is slidingly advanced forward relative to clamping sleeve 105 and the ultrasound probe to engage (e.g., puncture) the patient at a selected location. The guide tower is further advanced until a tip of puncture device 125 reaches a desired depth within patient or until stop 205 in guide tower 110 abuts stop engagement portion 135 in clamping sleeve 105.
Consistent with embodiments described herein, following patient puncture, alignment plate 115 may be returned to its first, non-locking position. Needle holder device 120 may then be pivoted about needle holder device receiving cups 158 or removed from needle holder device receiving cups 158 and moved to a new vertical position without requiring a second puncture.
FIGS. 3A and 3B are isometric and exploded isometric views, respectively, illustrating another embodiment of a needle guidance device 300 for use with an ultrasound probe, consistent with embodiments described herein. As shown, needle guidance device 300 includes a guide platform 305, a guide tower 310, an alignment plate 315, and a needle holder device 320. Prior to use, guide platform 305 may be secured to an ultrasound probe (not shown) and guide tower 310 may be slidingly coupled to guide platform 305. As shown in FIGS. 3A and 3B, needle holder device 320 may be inserted into one of a plurality of path positions in guide tower 310. A trocar or other puncture device 325, such as a luer lock trocar needle, may be received through needle holder device 320, as described below. In other implementations, puncture device 325 may be formed together with needle holder device 320, as an integral unit, such that the puncture device 325 is not independently removable from needle holder device 320. Alignment plate 315 may be inserted into guide tower 310 to provide a guidance path that is parallel to the longitudinal axis of the ultrasound probe, as described below. During use, guide tower 310 may be slidingly advanced forward, i.e., distally, relative to guide platform 305 and the ultrasound probe to engage the patient at a selected location. Upon completion of the procedure, the guide tower 310 may be retracted, i.e., moved proximally, relative to guide platform 305 and the ultrasound probe to disengage puncture device 325 from the patient.
As shown in FIG. 3B, guide platform 305 includes a mount portion 330, a strap portion 336, and a securement portion 340. As described herein, mount portion 330 may include a longitudinally extruded configuration having an upper surface 332 and a lower surface 334. Upper surface 332 of mount portion 330 may be configured to support guide tower 310 in a longitudinally adjustable configuration. For example, as shown in FIG. 3B, upper surface 332 includes a pair of side rails 333 that project upwardly from upper surface 332. As described below, each of side rails 333 are configured for slidable receipt within corresponding side rails 354 in guide tower 310, as shown in FIG. 4A. To prevent guide tower 310 from moving too loosely relative to mount portion 330 during use, tolerances of respective side rails 333 may be such that a frictional relationship exists between mount portion 330 and guide tower 310 that resists undesirable movement. In other implementations, other mechanisms for securing guide tower 310 to guide platform 305 may be used. For example, a combination of projections and detents or apertures may be used to allow for releasable securement of guide tower 310 to mount portion 330.
As shown in FIGS. 3A and 3B, the forward end of mount surface 330 may include a stabilization feature 335 that projects perpendicularly upwardly from upper surface 332. Stabilization feature 335 may have a large central aperture therein for allowing puncture device 325 to move freely therethrough. During use, a forward end of stabilization feature 335 is configured to engage a patient (e.g., a patient's perineum) to stabilize the relationship between needle guidance device 300 and the patient. In addition, a rearward end of stabilization feature 335 further provides a positive stop to longitudinal movement of guide tower 310 relative to guide platform 305.
Lower surface 334 of mount portion 330 includes a generally curved configuration that corresponds to a curved outer configuration of at least a portion of the transducer probe (not shown). Strap portion 336 of guide platform 305 may include a generally resilient or flexible configuration that adaptively conforms to the outer surface of a portion of the transducer probe on which needle guidance device 300 is mounted. In particular, strap portion 336 may include a first lateral portion 337 extending from a first side of mount portion 330 and a second lateral portion 339 extending from a second side of mount portion 330 opposite to first lateral portion 337. First and second lateral portions 337/339 may collectively terminate in securement portion 340. As shown in FIGS. 3A and 3B, in one implementation, securement portion 340 may include a collar portion 341 formed at the terminus of first lateral portion 337 and a threaded portion 342 formed at the terminus of second lateral portion 339. Collar portion 341 may include an opening adapted to receive an end of threaded portion 342 during mounting of guide platform 305 onto the ultrasound probe.
To secure guide platform 305 to an ultrasound probe, lower surface 334 of the mount portion 330 and the inside surface of first lateral portion 337 are initially brought into contact with an outside surface of the ultrasound probe. The second lateral portion 339 is then flexed such that its inside surface also contacts the outer surface of the ultrasound probe, thereby causing threaded portion 342 to enter collar portion 341. A clamping nut 344 having a mating collar portion 346 is threadedly advanced on threaded portion 342, to cause the collar portion 346 on clamping nut 344 to clampingly engage collar portion 341 in first lateral portion 337, thus securing guide platform 305 to the ultrasound probe. When it is desired to remove guide platform 305, clamping nut 344 may be reversed, thereby releasing collar portion 341.
Consistent with implementations described herein, one or more of lateral portions 337/339 may be formed in a thickness sufficient to allow flexure. In some implementations, only second lateral portion 339 is formed to enable flexure, with first lateral portion 337 having a substantially rigid configuration. In some embodiments, an entirety of guide platform 305, with the exception of clamping nut 344, may be integrally formed, such as via injection molding, 3D printing, etc.
FIGS. 4A and 4B are rear plan views of guide tower 310 with alignment plate in unlocked and locked positions, respectively. FIG. 4C is a side view of guide tower 310. As shown in FIGS. 3A, 3B, and 4A-4C, guide tower 310 includes a substantially frame-like configuration for providing a secure interface to guide platform 305 and a plurality of spaced (relative to a longitudinal orientation of the ultrasound probe, as depicted by line A-A in FIG. 3A) needle guide paths for engaging needle holder device 320, as described herein. In particular, guide tower 310 includes a platform interface portion 350 and a guide path portion 352 that projects upwardly from the platform interface portion 350. A lower surface of platform interface portion 350 includes opposing side rails 354 that project downwardly therefrom and are configured to interface with side rails 333 in guide platform 305, as described above. In some implementations, side rails 354 have opposing c-shaped configurations that capture side rails 333 and prevent relative radial movement between guide platform 305 and guide tower 310 when side rails 333 in mount portion 330 are positioned within side rails 354 in guide tower 310, while allowing sliding longitudinal movement therebetween.
In one implementation consistent with embodiments described herein, guide path portion 352 projects upwardly substantially perpendicularly from platform interface portion 350. As shown in FIGS. 3A, 3B, and 4B, guide path portion 352 includes a vertical guidance slot 356, a plurality of needle holder device receiving cups 358, tower advancement handles 359, and an alignment plate receiving slot 360.
Vertical guidance slot 356 is centrally aligned within guide tower 310 to be aligned with longitudinal ultrasound imaging crystals within a transducer to which the needle guide device 300 is affixed such that puncture device 325 (e.g., a trocar needle) designed to pass therethrough is consistently visualized in the imaging plane under typical imaging conditions. As shown in FIG. 4B, vertical guidance slot 356 extends substantially the entire height of guide tower 310 to allow an inserted puncture device to be freely moved between needle guide device receiving cup positions.
As shown in FIG. 3B, needle holder device receiving cups 358 comprise pairs of aligned recesses or openings in guide path portion 352 and positioned on opposite sides of vertical guidance slot 356. Each pair of needle holder device receiving cups 358 is vertically spaced relative to the adjacent pair of needle holder device receiving cups 358 to provide a plurality of attachment positions for needle holder device 320, as described in additional detail below. In the present embodiment, five pairs of needle holder device receiving cups 358 are provided, although other implementations may include fewer or additional needle holder device receiving cups 358 may be provided. Consistent with implementations described herein, each needle guide device receiving cup 358 comprises a generally arced opening configured to receive respective portions of needle holder device 320, as described below. In some implementations, the dimensions of each needle guide device receiving cup 358 is such that needle holder device 320 is removable captured therein. For example, each needle guide device receiving cup 358 may be sized to provide a tight frictional fit to needle holder device 320. In other implementations, each needle guide device receiving cup 358 may have an opening whose arc is slightly more than 180°, such that the needle holder device 320 snaps into a respective pair of needle holder device receiving cups 358.
As shown in FIGS. 3A, 3B, and 4B, tower advancement handles 359 project laterally outwardly from guide tower 310 proximate to platform interface portion 350. During use, an operator may advance or retract guide tower 310 longitudinally along guide platform 305 manually by pushing or pulling on tower advancement handles 359, respectively.
As shown in FIG. 3B, alignment plate receiving slot 360 is configured to extend transversely within guide tower 310 in a position rearward of needle holder device receiving cups 358. Alignment plate receiving slot 360 is sized to receive alignment plate 315 therein. As described in additional detail below, upon receipt of a needle holder device 320 and corresponding puncture device 325 within a particular pair of needle holder device receiving cups 358, alignment plate 315 may be advanced within alignment plate receiving slot 360 to positively support puncture device 325 in a defined path relative to ultrasound probe. For example, in some implementations, the configuration of alignment plate 315 forces puncture device 325 into a parallel path, although different configurations may be used to accommodate different path angles. In one implementation, alignment plate receiving slot 360 includes an outer rim portion configured to receive a portion of alignment plate 315 at a defined depth within alignment plate receiving slot 360. FIG. 4D is an isometric view of needle holder device 320 consistent with embodiments described herein. As shown in FIGS. 3A, 3B, and 4D, needle holder device 320 comprises an adapter for coupling to guide tower 310 and for receiving puncture device 325. In some implementations, needle holder device 320 may be configured to receive a puncture device therethrough.
In one implementation, needle holder device 320 includes a body portion 362, engagement shoulders 364, and handle portion 366. As shown, body portion 362 includes a generally tubular element having a central aperture 368 therethrough. Body portion 362 is configured to receive puncture device 325 within central aperture 368. A forward, i.e., distal, end of body portion 362 terminates in engagement shoulders 364 and a rearward, i.e., proximal, end of body portion 362 terminates in handle portion 366, which may be manipulated to effect proper placement of needle holder device 320 during use. As shown in FIG. 4D, intermediate portion of body portion 362 may include an alignment plate engaging surface 370 for engaging path retaining channels 380 in alignment plate 315, as described below.
For example, handle portion 366 may be used to insert and remove engagement shoulders 364 from needle holder device receiving cups 358, to rotate needle guide device to allow removal from guide tower 310, to raise and lower needle holder device 320 between needle holder device receiving cups 358 and to affect manual angular deflection of needle holder device 320.
Engagement shoulders 364 include a pair of substantially cylindrical elements that project perpendicularly outwardly from opposing sides of the forward end of body portion 362. As shown in FIG. 3A and described generally above, engagement shoulders 364 are configured to be received within a selected pair of needle holder device receiving cups 358 during use. The cylindrical configuration of engagement shoulders 364 allows for upward and downward rotation of needle holder device 320 within receiving cups 358 via handle portion 366 if desired, and prior to advancement of alignment plate 315 within alignment plate receiving slot 360, which fixes the angular orientation of needle holder device 320.
As shown in FIGS. 3B, 4A, and 4B, alignment plate 315 includes a body portion 376, an abutment portion 378, a free movement portion 379, and a plurality of path retaining channels 380. In general, body portion 376 includes a substantially planar element sized for receipt within alignment plate receiving slot 360. Abutment portion 378 includes a flange portion 382 that provides a surface for abutting an outer rim portion of alignment plate receiving slot 360 when alignment plate 315 is fully inserted into alignment plate receiving slot 360.
Consistent with implementations described herein, free movement portion 379 includes a slotted opening that communicates with path retaining channels 380. Path retaining channels 380 include a plurality of arcuate recesses spaced to correspond to needle holder device receiving cups 358. The combination of free movement portion 379 and path retaining channels 380 provides two operational positions for alignment plate 315.
In a first position, alignment plate 315 is partially inserted into alignment plate receiving slot 360 such that free movement portion 379 is aligned with vertical guidance slot 356. This allows needle holder device 320 to be inserted into guide tower 310 via handle portion 366. Once needle holder device 320 has been inserted into guide tower 310 and into a selected pair of needle holder device receiving cups 358, alignment plate 315 is advanced within alignment plate receiving slot 360 (until flange portion 382 abuts the outer rim portion of alignment plate receiving slot 360). In this second position, a path retaining channel 380 corresponding to the particular pair of needle holder device receiving cups 358 engages alignment plate engaging surface 370 of needle holder device 320 to retain needle holder device 320 in a parallel path relative to the ultrasound probe.
Although the position of the path retaining channels 380 in alignment plate 315 of the embodiment of FIGS. 3A and 3B provides for a parallel path for needle holder device 320, in other implementations, the positions of path retaining channels 380 may be offset with respect to needle holder device receiving cups 358 to provide other angular orientations.
As shown in FIGS. 3B, 4A, and 4B, alignment plate 315 may include one or more spring clip portions 384 configured to engage a corresponding rim portion of slot 360 when alignment plate 315 is in the first position to prevent unintended removal of alignment plate 315 from alignment plate receiving slot 360.
During assembly and use, engagement shoulders 364 of needle holder device 320 are initially oriented vertically and needle holder device 320 is inserted into vertical guidance slot 356 and forwardly through alignment plate 315 when the alignment plate is in the first position. Needle holder device 320 is then rotated 90° and inserted into a selected pair of needle holder device receiving cups 358. Alignment plate 315 is then advanced into the second position, thus capturing the needle holder device 320 into a selected parallel path.
After puncture device 325 is seated within a selected parallel path within guide tower 310 (e.g., within a selected pair of needle holder device receiving cups 358 and locked by alignment plate 315), guide tower 310 is slidingly advanced forward relative to guide platform 305 and the ultrasound probe to engage (e.g., puncture) the patient at a selected location. Guide tower 310 is further advanced until a tip of puncture device 325 reaches a desired depth within patient or until guide tower 310 abuts stabilization feature 335 at a front portion of guide platform 305.
Consistent with embodiments described herein, following patient puncture, alignment plate 315 may be returned to its first, non-locking position. Needle holder device 320 may then be pivoted about needle holder device receiving cups 358 or removed from needle holder device receiving cups 358 and moved to a new vertical position without requiring a second puncture.
FIGS. 5A and 5B are isometric and exploded isometric views, respectively, illustrating another embodiment of a needle guidance device 500 for use with an ultrasound probe, consistent with embodiments described herein. As shown, needle guidance device 500 includes a guide platform 505, a guide tower 510, an alignment plate 515, and a needle holder device 520. Prior to use, guide platform 505 may be secured to an ultrasound probe (not shown) and guide tower 510 may be slidingly coupled to guide platform 505. Prior to administration, a needle or other type of puncture device 525, such as a trocar needle, may be coupled to a needle holder device 520, as described below. In some implementations, introducer needle 525 may be formed together with needle holder device 520, as an integral unit, such that the introducer needle 525 is not independently removable from needle holder device 520. The combined needle holder device 520 and introducer needle 525 may be oriented within one of a plurality of path positions in guide tower 510. During use, guide tower 510 may be slidingly advanced forward, i.e., distally, relative to guide platform 505 and the ultrasound probe to engage the patient at a selected location. Upon completion of the procedure, guide tower 510 may be retracted, i.e., moved proximally, relative to guide platform 505 and the ultrasound probe to disengage introducer needle 525 from the patient.
As shown in FIG. 5B, guide platform 505 includes a mount portion 530, a strap portion 535, and a securement portion 540. As described herein, mount portion 530 may include a longitudinally extruded configuration to support guide tower 510 in a longitudinally adjustable configuration. For example, as shown in FIG. 5B, lateral edges of mount portion 530 may form a pair of side rails 533. As described below, side rails 533 are configured for slidable receipt within corresponding side rails 554 or channels within in guide tower 510, as shown in FIG. 5A. To prevent guide tower 510 from moving too loosely relative to mount portion 530 during use, tolerances of respective side rails 533 may be such that a frictional relationship exists between mount portion 530 and guide tower 510 that resists undesirable movement. In some implementations, the relative dimension of mount portion 530 may be configured such that frictional resistance increases at a rearward end, to prevent inadvertent removal of guide tower 510 from mount portion 530. In other implementations, one or more stops, detents, or engagement portions may be provided on one or more of rails 533 and 554 to limit relative movement between guide tower 510 and guide platform 505. For example, as shown in FIGS. 5A-6B, a rearward end of mount portion 530 may include a resilient stop clip 534 the prevents removal of guide tower 510 from guide platform 505. When removal is necessary, clip 534 may be manually deflected downwardly, allowing guide tower 510 to be slidingly removed from guide platform 505.
As shown in FIGS. 5A and 5B, the forward end of mount portion 530 may include a stabilization feature 536 that projects perpendicularly upwardly from mount portion 530. In the illustrated embodiment, stabilization feature 536 includes a large central aperture or window 537 therein for allowing introducer needle 525 to move freely therethrough. In other implementations, stabilization feature 536 may be provided on one lateral side of guide platform 505 relative to a puncture device path, such as stabilization feature 636 and aperture 637 shown in FIG. 6C. Although stabilization feature 636 shown in FIG. 6C includes a central aperture 637, in other implementations, no central aperture may be provided because introducer needle 525 does not project through the stabilization feature, but rather passes to the side.
During use, a forward end of stabilization feature 536 is configured to engage a patient (e.g., a patient's perineum) to stabilize the relationship between needle guidance device 500 and the patient. In addition, a rearward end of stabilization feature 536 further provides a positive stop to longitudinal movement of guide tower 510 relative to guide platform 505. In some implementations, stabilization feature 536 may further include indexing indicia (e.g., numbers, markings, etc.) for allowing rapid confirmation of needle path at the point of penetration. In some implementations, such indexing indicia may be provided in a glow-in-the-dark printed format to facilitate visibility during use.
As shown in FIGS. 5A and 5B, strap portion 535 includes a pair of strap members 539 and 540, each of which are configured to at least generally correspond to a curved outer configuration of at least a portion of a transducer probe (not shown). In one implementation, strap members 539/540 are integrally formed with mount portion 530, as shown in FIGS. 5A-6B. In other implementations, lateral sides of mount portion 530 may include slots for receiving upper ends of strap members 539/540 to secure them to mount portion 530 in a pivotal manner.
Consistent with implementations described herein, a distance between strap portion 535 and a front end/stabilizing feature 536 of mount portion 530 is selected to optimize a working length of the ultrasound probe and needle guidance device 500. For example, in one implementation, a distance between a front end of strap portion 535 and a rear edge of stabilization feature 536 may range from about 0.5 to 1.0 inches and may preferably be a distance of 0.687 inches.
As shown, strap members 539/540 form a V platform capable of secure attachment to a variety of ultrasound probes having different diameters and configurations. Strap members 539/540 collectively terminate in securement portion 546. As shown in FIGS. 5A and 5B, in one implementation, securement portion 546 may include a collar portion 547 formed at the terminus of strap member 540 and a lock assembly 549 coupled to the terminus of strap member 539. Collar portion 547 may include an opening 548 adapted to receive a portion of lock assembly 549 during mounting of guide platform 505 onto the ultrasound probe, as described in additional detail below with respect to FIGS. 6A and 6B.
FIGS. 6A and 6B illustrate isometric and reverse isometric views, respectively, of guide platform 505 in an unlatched configuration. As shown in FIGS. 5A, 5B, 6A, and 6B, lock assembly 549 includes a lock mounting portion 600, a threaded rod 602, and a thumb screw element 604. As shown in FIG. 6A, lock mounting portion 600 includes a portion of the terminus of strap member 539 that forms a receiving channel or opening for receiving a first end 606 of threaded rod 602 therein. In one implementation, lock mounting portion 600 includes a pair of opposing slotted apertures 601 for receiving corresponding portions of threaded rod 602, as described below.
As shown in FIG. 6A, threaded rod 602 includes a generally cylindrical threaded configuration having a first end 606 that engages with first strap member 539 and second end 608 that engages with second strap member 540. A pair of pivot elements 610 project outwardly from either side of first end 606 of threaded rod 602. Pivot elements 610 are configured to be received within apertures 601 in lock mounting portion 600 in first strap member 539.
As shown in FIG. 6B, thumb screw element 604 includes a threaded receiving aperture 612, a ball-type engagement interface 614, and a knob portion 616. Receiving channel 612 is configured to receive send end of 608 of threaded rod 602. Ball-type engagement interface 614 is configured to engage a semi-spherical engagement portion 615 in collar portion 547 in a ball-and-socket manner. Such a ball-and-socket type of clamping interface promotes a more uniform clamping force and feel across multiple clamp angles that need to be accommodated for clamping onto a range of probe shaft sizes and shapes.
To secure guide platform 505 to an ultrasound probe, threaded rod 602 is rotated about pivot elements 610 until second end 606 of threaded rod 602 enters opening 548 in collar portion 547. Knob portion 616 is then threadingly advanced on threaded rod 602, causing ball-type engagement interface 614 to engage semi-spherical engagement portion 615 in collar 547.
Consistent with implementations described herein, one or more of strap members 539/540 may be formed in a thickness sufficient to allow flexure. In some implementations, only one of strap members 539/540 is formed to enable flexure, with the other strap member 539/540 having a substantially rigid configuration.
FIGS. 7A, 7B, and 7C are side plan, rear plan, and rear isometric views of guide tower 510 consistent with implementations described herein. As shown in FIGS. 5A, 5B, and 7A-7C, guide tower 510 includes a substantially frame-like configuration for providing a secure interface to guide platform 505 and a plurality of spaced (relative to a longitudinal orientation of the ultrasound probe, as depicted by line A-A in FIG. 5A) needle guide paths for engaging needle holder device 520, as described herein. In particular, guide tower 510 includes a platform interface portion 550 and a guide path portion 552 that projects upwardly from the platform interface portion 550. As briefly described above, a lower surface of platform interface portion 550 includes opposing side rails 554 that project downwardly therefrom and are configured to interface with side rails 533 in guide platform 505. In some implementations, side rails 554 have opposing c-shaped configurations that capture side rails 533 and prevent relative radial movement between guide platform 505 and guide tower 510 when side rails 533 in mount portion 530 are positioned within side rails 554 in guide tower 510, while allowing sliding longitudinal movement therebetween.
In one implementation consistent with embodiments described herein, guide path portion 552 projects upwardly substantially perpendicularly from platform interface portion 550. As shown in FIG. 7B guide path portion 552 includes a vertical guidance slot 556, a plurality of needle holder device receiving cups 558, a plurality of spring element portions 560, a guide tower engagement and indicia portion 561, an alignment plate receiving slot 562, and an alignment plate adjustment assembly 563.
Vertical guidance slot 556 is centrally aligned within guide tower 510 so as to be aligned with longitudinal ultrasound imaging crystals within a transducer to which the needle guide device 500 is affixed such that introducer needle 525 designed to pass therethrough is consistently visualized in the imaging plane under typical imaging conditions. As shown in FIG. 9B, vertical guidance slot 556 extends substantially the entire height of guide tower 510 to allow an inserted puncture device to be freely moved between needle holder device receiving cup positions.
As shown in FIGS. 5B, 7B, and 7C, needle holder device receiving cups 558 comprise pairs of aligned recesses or openings in guide path portion 552 and positioned on opposite sides of vertical guidance slot 556. Consistent with implementations described herein, each needle holder device receiving cup 558 comprises a generally arced or grooved opening configured to receive respective portions of needle holder device 520, as described below. Consistent with embodiments described herein, spring element portions 560 comprise pairs of resilient features positioned adjacent each needle holder receiving cup 558. As shown in FIG. 7C, spring element portions 560 project rearwardly and include a narrow deflecting portion 566 and a larger engagement end portion 568.
As described below, spring element portions 560 are configured to engage portions of needle holder device 520 so as to removably capture needle holder device in a selected pair of needle holder receiving cups 558. Each pair of needle holder device receiving cups 558/spring element portions 560 is vertically spaced relative to the adjacent pair of needle holder device receiving cups 558/spring element portions 560 to provide a plurality of attachment positions for needle holder device 520, as described in additional detail below. In the present embodiment, five pairs of needle holder device receiving cups 558 are provided, although other implementations may include fewer or additional needle holder device receiving cups 558 may be provided.
As shown in FIGS. 5B, 7B, and 7C, guide tower engagement and indicia portion 561 may include a portion of guide tower 510 that projects outwardly adjacent receiving cups 558/spring element portions 560. Guide tower engagement and indicia portion 561 may form an engagement surface for use in advancing or retracting guide tower 510 along guide platform 505. In addition, guide tower engagement and indicia portion 561 may include indicia and or markings indicative of a relative position of an inserted needle holder device 520.
As shown in FIG. 5B, alignment plate receiving slot 562 is formed on one side of guide tower 510 in a position rearward of needle holder device receiving cups 558. Alignment plate receiving slot 562 is sized to receive alignment plate 515 therein. Alignment plate adjustment assembly 563 is formed on an opposite side of guide tower 510 from alignment plate receiving slot 562 and includes a threaded aperture 570 and an adjustment knob 590. Threaded aperture 570 is laterally aligned with alignment plate receiving slot 562 and is configured to receive a threaded bolt 592 that projects from adjustment knob 590.
Upon receipt of a needle holder device 520 and corresponding introducer needle 525 within a particular pair of needle holder device receiving cups 558/spring element portions 560, alignment plate 515 may be advanced within alignment plate receiving slot 562 by rotating adjustment knob 590 to positively support introducer needle 525 at a selected location/orientation relative to ultrasound probe. Consistent with the embodiment of FIGS. 5A-7E, alignment plate 515 may positively retain introducer needle 525 at any selected path.
FIGS. 7D and 7E are isometric and top plan views, respectively, of needle holder device 520 consistent with embodiments described herein. As shown in FIGS. 5A, 5B, 62D, and 7E, needle holder device 520 comprises an adapter for coupling to guide tower 510 and for receiving puncture device 525. In some implementations, needle holder device 520 may be configured to receive a puncture device therethrough. In one implementation, needle holder device 520 includes a body portion 700, engagement shoulders 702, an alignment plate engagement portion 704, and a needle receiving portion 706. As shown, body portion 700 includes a generally tubular element having a central aperture 708 therethrough. Body portion 700 is configured to receive introducer needle 525 within central aperture 708. In some implementations, body portion 700 may include engagement elements 707 (e.g., tabs, ears, etc.) for facilitating insertion into and manipulation within guide tower 510.
A forward, i.e., distal, end of body portion 700 terminates in engagement shoulders 702 and a rearward, i.e., proximal, end of body portion 700 terminates in needle receiving portion 706, which may be manipulated to effect proper placement of needle holder device 520 during use. For example, engagement elements 707 in body portion 700 may be used to insert and remove engagement shoulders 702 from needle holder device receiving cups 558, to rotate needle holder device 520 to allow removal from guide tower 510, to raise and lower needle holder device 520 between needle holder device receiving cups 558 and to affect manual angular deflection of needle holder device 520. In some implementations, needle receiving portion 706 may include one or more rotation-fixing elements, such as slots, keys, clips, threads, etc., for receiving a corresponding structure in introducer needle 525 to prevent axial rotation and/or longitudinal movement of introducer needle 525 relative to needle holder device 520.
Engagement shoulders 702 include a pair of substantially cylindrical elements that project perpendicularly outwardly from opposing sides of the forward end of body portion 700. As shown in FIG. 5A and described generally above, engagement shoulders 702 are configured to be received within a selected pair of needle holder device receiving cups 558 during use. The cylindrical configuration of engagement shoulders 702 allows for upward and downward rotation of needle holder device 520 within receiving cups 558 via body portion 700 if desired, and prior to advancement of alignment plate 515 within alignment plate receiving slot 562, which fixes the angular orientation of needle holder device 520. In some implementations, engagement shoulders 702 may include angle limiting portions 716 that project rearwardly therefrom and are configured to engage portions of needle holder device receiving cups 558 to limit rotational movement of needle holder device 520 within needle holder device receiving cups 558.
As shown in FIGS. 5A and 7E, alignment plate engagement portion 704 is formed in body portion 700 and includes a generally rectangular configuration for engaging a portion of alignment plate at a particular path location. Alignment plate engagement portion 704 may further include a parallel path alignment feature 718 provided longitudinally on one side thereof, as shown in FIG. 7D. As described below, parallel path alignment feature 718 may positively engage one of a plurality of detents or notches 594 in alignment plate 515 that corresponds to needle holder device receiving cups 558/spring element portions 560, as described below.
As shown in FIG. 5B, alignment plate 515 includes a body portion 576, a free movement portion 579 and a needle holder device engagement portion 580. In general, body portion 576 includes a substantially planar element sized for receipt within alignment plate receiving slot 562. Consistent with implementations described herein, free movement portion 579 includes an opening through alignment plate 515 that allows unfettered movement of needle holder device 520. Needle holder device engagement portion 580 includes an inside surface of free movement portion 579 configured to clampingly engage alignment plate engagement portion 704 of needle holder device 520. As described briefly above, needle holder device engagement portion 580 may include a plurality of notches or detents 594 that correspond with needle holder device receiving cups 558/spring element portions 560. Notches 594 are configured to engage path alignment feature 718 in alignment plate engagement portion 704 to maintain needle holder device in a selected parallel path orientation. In some implementations (not shown), alignment plate body portion 576 may include a tab or other engagement means that extends through alignment plate slot 562 for use in moving guide tower 510 longitudinally forward and rearward on guide platform 505.
When a user wishes to establish a parallel needle path, the user may rotate needle holder device 520 so as to align parallel path alignment feature 718 with a particular detent or notch 594 that corresponds to the desired parallel path. Upon tightening of knob 590, alignment plate 515 may be urged toward needle holder device 520, causing parallel path alignment feature 718 to seat within the particular detent or notch 594. Continued tightening of knob 592 effectively clamps needle holder device 520 at the desired position.
Conversely, when a user wishes to establish a non-parallel needle path, the user may rotate needle holder device 520 to a desired non-parallel orientation. In such an orientation, parallel path alignment feature 718 is not aligned with any of notches 594. Upon tightening of knob 590, alignment plate 515 may be urged toward needle holder device 520, causing needle holder device engagement portion 580 to clampingly engage path alignment feature 718. Continued tightening of knob 590 effectively clamps needle holder device 520 at the desired position.
Referring further to FIGS. 5A-7E, in example embodiments, needle guidance device 500 includes guide platform 505 configured to removably couple to an ultrasound probe having a length extending along a longitudinal axis of the ultrasound probe. Guide tower 510 extends perpendicularly from guide platform 505 and needle holder device 520 is rotatably coupled to guide tower 510. Needle holder device 520 defines a central aperture 708 therethrough configured to receive a compatible introducer needle 525, or another suitable puncture device in alternative embodiments. Needle holder device 520 is rotatably movable about a rotational axis perpendicular to the longitudinal axis A-A shown in FIG. 5A with respect to guide tower 510 to move needle holder device 520 and the inserted introducer needle 525 from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis A-A to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation. In example embodiments, needle holder device 520 is lockable with respect to guide tower 510 to prevent further rotational movement of needle holder device 520 with respect to guide tower 510 and/or translational movement of needle holder device 520 in a distal direction and an opposite proximal direction with respect to guide tower 510. In certain example embodiments, adjustment knob 590 is operatively coupled to needle holder device 520 and is configured to secure needle holder device 520 at the first path angle orientation, for example.
Central aperture 708 extends between a distal end of needle holder device 520 and a proximal end of needle holder device 520 and is configured to receive introducer needle 525 and maintain introducer needle 525 within the plane. Introducer needle 525 is movably positioned within central aperture 708 to move in a distal direction and an opposite proximal direction with respect to guide tower 510. Needle holder device 520 is positionable at a plurality of path height positions, wherein each path height position of the plurality of path height positions is located at a corresponding distance from guide platform 505. Adjustment knob 590 is configured to secure needle holder device 520 at a first path height position of the plurality of path height positions. For example, needle holder device 520 is movable between a first path height position and a second path height position with respect to guide platform 505. As such, needle holder device 520 is movable to adjust at least one of a path angle orientation or a path height position of needle holder device 520 in the plane. Further, in certain example embodiments, guide tower 510 is movable with respect to guide platform 505 in a distal direction and an opposite proximal direction with respect to guide platform 505.
As shown in FIG. 7B, for example, guide tower 510 defines vertical guidance slot 556 and needle holder device 520 is movable within vertical guidance slot 556 to adjust at least one of the path angle orientation within the plane or a path height position of needle holder device 520 at a distance with respect to guide platform 505 within the plane. As such, needle holder device 520 is movable, e.g., pivotable or rotatable, within vertical guidance slot 556 between a first path angle orientation and a second path angle orientation and/or needle holder device 520 is movable within vertical guidance slot 556 between a first path height position of needle holder device 520 with respect to guide platform 505 and a second path height position of needle holder device 520 with respect to guide platform 505 different from the first path height position.
FIG. 8 is an isometric view of an alternative embodiment of guide tower 510 and alignment plate 515 consistent with implementations described herein. As shown in FIG. 8, guide tower 510, in contrast to the embodiment of FIGS. 5A-7E, includes alignment plate adjustment assembly 800 formed on an opposite side of guide tower 510 from alignment plate receiving slot 562. As shown, alignment plate adjustment assembly 800 includes an aperture 802, an adjustment knob retaining channel 804, and an adjustment knob 806. Aperture 802 is configured to receive a threaded bolt 808 that projects from alignment plate 515. In this implementation, adjustment knob 806 includes a flange portion 810 and a threaded aperture 812 for receiving threaded bolt 808. Flange portion 810 is received within adjustment knob retaining channel 804 to retain adjustment knob 806 at in a fixed lateral relationship with respect to guide tower 510 while simultaneously allowing adjustment knob 806 to rotate, which causes alignment plate 515 to move laterally within adjustment plate receiving slot 562.
Upon receipt of a needle holder device 520 and corresponding introducer needle 525 within a particular pair of needle holder device receiving cups 558/spring element portions 560, alignment plate 515 may be advanced within alignment plate receiving slot 562 with adjustment knob 806 to positively support introducer needle 525 at a selected location/orientation relative to an ultrasound probe. Consistent with the embodiment of FIGS. 5A-7E, alignment plate 515 may positively retain introducer needle 525 at any selected path.
After introducer needle 525 is seated within a selected parallel path within guide tower 510 (e.g., within a selected pair of needle holder device receiving cups 558 and locked by alignment plate 515), guide tower 510 is slidingly advanced forward relative to guide platform 505 and the ultrasound probe to engage (e.g., puncture) the patient at a selected location. Guide tower 510 is further advanced until a tip of introducer needle 525 reaches a desired depth within patient or until guide tower 510 abuts stabilization feature 536 at a front portion of guide platform 305.
Consistent with embodiments described herein, following patient puncture, adjustment knob 590 may be rotated to return alignment plate 515 to its first, non-locking position. Needle holder device 520 may then be pivoted about needle holder device receiving cups 558 or removed from needle holder device receiving cups 558 and moved to a new vertical position without requiring a second puncture.
FIGS. 9-22 show an example needle guidance device 900 for use with an ultrasound probe 902, shown for example in FIGS. 13-22, or another suitable probe or transducer. In alternative embodiments, needle guidance device 900 is suitable for use with another medical instrument or device. Referring initially to FIGS. 9-12, FIG. 9 is a proximal isometric view of example needle guidance device 900 having a longitudinal axis B-B coplanar with and parallel to, e.g., coaxially aligned with, longitudinal axis A-A of an ultrasound probe 902, according to an example embodiment, and FIG. 10 is a distal isometric view of example needle guidance device 900. FIG. 11 is an exploded view of example needle guidance device 900. FIG. 12 is a perspective view of an example introducer needle suitable for use with needle guidance device 900. As shown in FIGS. 9-11, needle guidance device 900 includes a guide base 905 including or forming a platform 906 having a surface 908 (shown in FIGS. 10 and 11), a guide tower 910, a guide slide clamp 915, such as an introducer plate or alignment plate, having one or more, e.g., a plurality of alignment detents 916, and a needle holder device, such as an introducer holder 920. Referring further to FIG. 11, needle guidance device 900 includes a plurality of alignment detents 916 oriented parallel to longitudinal axis B-B of needle guidance device 900, with guide slide clamp 915 positioned within guide tower 910, as described herein.
In example embodiments, guide base 905 and guide tower 910 are formed as a single piece construction or unit, e.g., cast molded or injection molded in a single mold, such that guide tower 910 is fixedly coupled to or formed with guide base 905 to prevent any relative movement between guide tower 910 and guide base 905, for example, translational movement (e.g., guided or unguided sliding movement) of guide tower 910 in a distal direction or an opposite proximal direction along or parallel with longitudinal axis B-B with respect to guide base 905. With guide tower 910 fixedly coupled to or formed with guide base 905, undesirable translation and/or pivotal or rotational movement of guide tower 910 with respect to guide base 905 is prevented, providing increased stability during the biopsy procedure and allowing the doctor performing the procedure a more reliable and accurate assessment of the puncture or access site and/or one or more biopsy locations within the patient's prostate. In example embodiments, guide base 905 is secured to ultrasound probe 902 as shown in FIGS. 13-15, for example, prior to use during the procedure.
Prior to the procedure, an introducer needle 925 shown in FIG. 12 is removably coupled to introducer holder 920, as described below. In alternative embodiments, introducer holder 920 is configured to accept another suitable puncture device, such as a trocar needle. The introducer holder 920 and introducer needle 925 are oriented within one of a plurality of path positions in guide tower 910. During use, needle guide device 900, with introducer needle 925 locked or secured in position with respect to guide tower 910, is advanced distally with ultrasound probe 902 to contact or engage the patient at a selected puncture or access location, for example, at a desired location of the patient's perineum. Upon completion of the procedure, needle guide device 900 is moved proximally, i.e., away from the selected puncture or access location, with ultrasound probe 902 to disengage or remove introducer needle 925 from the patient.
As shown in FIGS. 9-11, guide base 905 includes a mount portion 930, a strap portion 935, and a securement portion 940. In certain example embodiments, mount portion 930 extends longitudinally, i.e., along longitudinal axis B-B, to at least partially support guide tower 910. As shown in FIG. 10, a distally facing surface 942 at a distal end of guide tower 910 forms or defines a centrally located opening or stabilizer window 944 allowing introducer needle 925 to move freely therethrough and to facilitate visibility of the puncture or access location on the patient to properly position introducer needle 925 with respect to the puncture or access location prior to puncture of the perineum skin.
During the biopsy procedure, distally facing surface 942 of guide tower 910 is configured to engage a patient (e.g., contact or rest against a skin surface of the patient's perineum) to stabilize the relationship between needle guidance device 900 and the patient. In certain example embodiments, guide tower 910 includes indexing indicia 946 (e.g., numbers, letters, and/or markings), as shown in FIG. 9, for allowing rapid confirmation of a needle path at the point of penetration, i.e., the puncture or access location on the patient's perineum. In example embodiments, such indexing indicia is provided in an enhanced, e.g., light reflective or glow-in-the-dark, printed format to facilitate visibility of indexing indicia 946 during the biopsy procedure.
As shown in FIGS. 9 and 10, for example, strap portion 935 includes a pair of opposing attachment legs 948 and 950 or other suitable coupling members, each of which are configured to at least generally correspond to a curved or arcuate outer profile of at least a portion of ultrasound probe 902, not shown in FIGS. 9 and 10. In one embodiment, attachment legs 948, 950 are integrally formed with mount portion 930, as shown in FIGS. 9-11, for example. In example alternative embodiments, lateral sides of mount portion 930 include slots for receiving upper ends of attachment legs 948, 950 to secure respective attachment legs 948, 950 to mount portion 930 in a movable, e.g., pivotal, manner. In example embodiments, a distance between strap portion 935 and distally facing surface 942 of guide tower 910 is optimized to provide a working length of ultrasound probe 902 and needle guidance device 900.
As shown in FIGS. 9-11, attachment legs 948, 950 are configured to secure attachment to a variety of ultrasound probes having different diameters and/or configurations. Attachment legs 948, 950 collectively terminate in securement portion 940. As shown in FIGS. 9 and 10, in example embodiments, securement portion 940 includes a collar portion 954 formed at a terminus of attachment leg 948 and a lock assembly 956 coupled to a terminus of attachment leg 950. Collar portion 954 forms an opening 958 (shown in FIG. 11) adapted or configured to receive a portion of lock assembly 956 during mounting of guide base 905 onto ultrasound probe 902, as described with respect to FIGS. 13-15.
Referring further to FIGS. 11 and 13-15, lock assembly 956 includes a lock mounting portion 960, a clamp screw 962, and a thumb screw element 964. As shown in FIG. 11, lock mounting portion 960 includes a portion of the terminus of attachment leg 950 that forms a receiving channel or opening 965 for receiving a first end 966 of clamp screw 962 therein. In certain embodiments, lock mounting portion 960 forms a pair of opposing slotted apertures 968 for receiving corresponding portions of clamp screw 962, as described herein.
As shown in FIG. 11, clamp screw 962 includes a generally cylindrical threaded configuration having first end 966 that engages with attachment leg 950 and an opposite second end 970 that engages with attachment leg 948. A pair of pivot elements 972 project outwardly from each side of first end 966 of clamp screw 962. Pivot elements 972 are configured to be received within slotted apertures 968 in lock mounting portion 960 in attachment leg 950. Thumb screw element 964 includes a threaded receiving aperture 974, a ball-type engagement interface 976, and a knob portion 978. Opening 958 is configured to receive second end 970 of clamp screw 962. Ball-type engagement interface 976 is configured to engage a semi-spherical engagement portion in collar portion 954 to provide an increased uniform clamping force and feel across multiple clamp angles needed to accommodate for clamping onto a range of ultrasound probe shaft sizes and/or shapes.
Referring further to FIGS. 13-15, in example embodiments, guide base 905 is secured to ultrasound probe 902 by rotating clamp screw 962 about pivot elements 972 until second end 970 of clamp screw 962 enters opening 958 formed or defined in attachment leg 948. Knob portion 978 is then threadingly advanced on clamp screw 962, urging ball-type engagement interface 976 to engage the semi-spherical engagement portion formed or defined in or on a lateral outer surface of attachment leg 948. In example embodiments, one or more of attachment legs 948, 950 are formed of a suitable material and/or having a thickness sufficient to allow flexure of the respective attachment leg 948, 950.
As shown in FIGS. 13-15, in example embodiments, to attach needle guidance device 900 to ultrasound probe 902 or a transducer, knob portion 978 is rotated counterclockwise and pivoted away from attachment leg 948 without removing knob portion 978 from clamp screw 962. Needle guidance device 900 is placed over ultrasound probe 902 and pushed onto ultrasound probe 902 to attach needle guidance device 900 to ultrasound probe 902, as shown in FIG. 13. Stabilizer window 944 is aligned with a sagittal image plane transducer lens and needle guidance device 900 is positioned to allow introducer needle 925 to be visible in a transducer array once inserted. Knob portion 978 is pivoted back into position, as shown in FIG. 14, and knob portion 978 is rotated clockwise to securely attached needle guidance device 900 to ultrasound probe 902 without over tightening, as shown in FIG. 15.
Referring again to FIGS. 9-11, guide tower 910 includes a substantially frame-like configuration for providing a secure interface to guide base 905 and a plurality of spaced needle guide paths for engaging introducer holder 920 (relative to longitudinal axis B-B of needle guidance device 900 in FIGS. 9 and 10 and longitudinal axis A-A of ultrasound probe 902), as described herein. In certain example embodiments, guide tower 910 includes a guide path portion 1002 that projects upwardly from guide base 905.
In example embodiments, guide path portion 1002 projects upwardly substantially perpendicularly from surface 908. As shown in FIGS. 9 and 11, guide path portion 1002 includes a vertical guidance slot 1004, a plurality of paired arcuate-shaped depressions 1006 (or a plurality of paired needle holder device receiving cups, recesses, or openings), a plurality of paired spring elements 1008, a guide tower engagement and indicia portion 1010, a guide slide clamp receiving slot 1012, and a guide slide clamp adjustment assembly 1014.
In example embodiments, depending on attachment of needle guidance device 900 to ultrasound probe 902, vertical guidance slot 1004 is formed in a central portion of guide tower 910 and aligned with longitudinal ultrasound imaging crystals within a transducer of ultrasound probe 902 such that introducer needle 925 designed to pass therethrough via introducer needle holder 920 is consistently visualized in the imaging plane under typical imaging conditions. As shown in FIGS. 9-11, vertical guidance slot 1004 extends substantially an entire height of guide tower 910 to allow an inserted introducer needle 925 via introducer needle holder 920 to be freely moved between arcuate-shaped depression positions.
Referring again to FIGS. 10 and 11, in example embodiments, paired arcuate-shaped depressions 1006 include two aligned arcuate-shaped depressions 1006 formed in guide path portion 1002 and positioned on opposite sides of vertical guidance slot 1004. In example embodiments, each arcuate-shaped depression 1006 includes a generally arcuate opening configured to receive respective portions of introducer needle holder 920, as described below. In certain example embodiments, each arcuate-shaped depression 1006 is configured to snap-fit or frictionally fit between adjacent spring elements 1008. In certain embodiments, the plurality of paired spring elements 1008 includes paired or associated resilient features positioned adjacent a respective arcuate-shaped depression 1006. As shown in FIGS. 21 and 22, for example, each spring element 1008 projects proximally from an inner distal surface of guide tower 910 and includes a narrow deflecting portion 1016 and a larger engagement end portion 1019.
Spring elements 1008 are configured to engage portions of introducer holder 920 to removably secure introducer holder 920 via engagement shoulders 1062 described below in a selected pair of arcuate-shaped depressions 1006. Each pair of spring elements 1008 is vertically spaced relative to the adjacent pair of arcuate-shaped depressions 1006 to provide a plurality of attachment positions for securing introducer holder 920 to guide tower 910. As shown in FIGS. 9 and 11, in example embodiments, a plurality of paired arcuate-shaped depressions 1006, e.g., five paired arcuate-shaped depressions 1006, are provided, although alternative embodiments include fewer or additional paired arcuate-shaped depressions 1006.
As shown in FIG. 9, guide tower engagement and indicia portion 1010 includes a portion of guide tower 910 that projects outwardly adjacent arcuate-shaped depressions 1006 and associated spring element portions 1008. In example embodiments, guide tower engagement and indicia portion 1010 includes indicia and/or markings indicative, as described above, of a relative position of introducer holder 920 secured within paired arcuate-shaped depressions 1006.
As shown in FIG. 11, guide slide clamp receiving slot 1012 is formed on a first side 1020 of guide tower 910 in a position proximal to arcuate-shaped depressions 1006. Guide slide clamp receiving slot 1012 is sized to receive guide slide clamp 915 therein. Guide slide clamp adjustment assembly 1014 is formed on an opposite second side 1022 of guide tower 910 from guide slide clamp receiving slot 1012 and includes a threaded aperture 1024 and an adjustment knob 1026 threadedly coupled within threaded aperture 1024. Threaded aperture 1024 is laterally aligned with guide slide clamp receiving slot 1012 and is configured to receive a threaded screw 1028 that projects from adjustment knob 1026.
Upon receipt of introducer holder 920 and corresponding introducer needle 925 within a particular pair of arcuate-shaped depressions 1006 and spring elements 1008, guide slide clamp 915 is urged to move laterally within guide slide clamp receiving slot 1012 by rotating adjustment knob 1026 to positively support introducer holder 920 and associated introducer needle 925 at a selected path height position or location with respect to longitudinal axis A-A and colinear longitudinal axis B-B, such as h1 shown in FIG. 16 and h2 shown in FIG. 17, and/or a selected path angle orientation within a plane including longitudinal axis A-A and colinear longitudinal axis B-B, such as parallel to longitudinal axis A-A and colinear longitudinal axis B-B shown in FIG. 21 and at angle α1 with respect to longitudinal axis A-A and colinear longitudinal axis B-B shown in FIG. 22, relative to guide tower 910 and ultrasound probe 902 coupled to needle guidance device 900. In example embodiments, guide slide clamp 915 positively retains introducer holder 920 and introducer needle 925 at one of a plurality of selectable path height positions or locations and/or at one of a plurality of selectable path angle orientations. For example, introducer holder 920 may be retained in a first path height position parallel with longitudinal axis B-B, as shown in FIG. 16, a second path height position parallel with longitudinal axis B-B, as shown in FIG. 17, or a different path height position parallel with longitudinal axis B-B.
In example embodiments, guide tower 910 includes a plurality of paired arcuate-shaped depressions 1006 at each attachment position of a plurality of attachment positions, and a first pair of arcuate-shaped depressions of the plurality of paired arcuate-shaped depressions at the first attachment position is positioned at a first distance from surface 908 of platform 906 (see FIG. 16). Introducer holder 920 is removably and pivotably or rotationally movably positionable within a corresponding pair of arcuate-shaped depressions 1006. With introducer holder 920 rotatably coupled to guide tower 910 at the first attachment position, introducer holder 920 is pivotably or rotatably movable with respect to guide tower 910 about a rotational axis perpendicular to longitudinal axis B-B to move introducer needle 925 positioned within a central passage of introducer holder 920 from a first path angle orientation of a plurality of path angle orientations within a plane including longitudinal axis B-B, such as shown in FIG. 21, for example, to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation, such as shown in FIG. 22, for example. Introducer holder 920 is lockable at each path angle orientation of the plurality of path angle orientations to prevent rotational movement of introducer holder 920 within paired arcuate-shaped depressions 1006 with respect to guide tower 910, as well as translational movement of introducer holder 920 in the distal direction and/or the opposite proximal direction with respect to guide tower 910. As described herein, guide slide clamp adjustment assembly 1014, including locking or adjustment knob 1026, is operatively coupled to introducer holder 920 and configured to secure introducer holder 920 in one of the first path angle orientation and the second path angle orientation, for example.
Referring to FIGS. 11 and 12 and 18-20, introducer holder 920 is configured to receive introducer needle 925. In certain example embodiments, introducer holder 920 includes a body portion 1050 having a distal end 1052, an opposite proximal end 1054, and a central passage 1056 extending along a centerline 1058 of body portion 1050 between distal end 1052 and proximal end 1054. Central passage 1056 is configured to receive introducer needle 925 and maintain introducer needle 925 within the plane. Body portion 1050 is configured to receive introducer needle 925 within central passage 1056. In example embodiments, body portion 1050 includes one or more, e.g., a plurality of, engagement elements 1060 (e.g., tabs, ears, or other suitable engagement elements) to facilitate insertion into, translational or rotational movement, and/or manipulation of introducer holder 920 within guide tower 910.
Introducer holder 920 also includes a pair of opposing engagement shoulders 1062. Each engagement shoulder 1062 of the pair of opposing engagement shoulders 1062 extends radially outwardly from centerline 1058 of body portion 1050 at distal end 1052. As described above, in example embodiments, guide tower 910 includes a plurality of paired arcuate-shaped depressions 1006 at each attachment position of the plurality of attachment positions. A first pair of arcuate-shaped depressions 1006 at the first attachment position is positioned at a first distance from surface 908 of platform 906, and each engagement shoulder 1062 is removably and pivotably or rotationally movably positionable within a corresponding arcuate-shaped depression 1006 of the first pair of arcuate-shaped depressions 1006.
Proximal end 1054 of body portion 1050 terminates in needle receiving portion 1070, as shown in FIG. 18, for example, which may be manipulated to effect proper placement of introducer holder 920 during the biopsy procedure. For example, engagement elements 1060 of body portion 1050 may be used to insert engagement shoulders 1062 into corresponding paired arcuate-shaped depressions 1006 and/or remove engagement shoulders 1062 from corresponding paired arcuate-shaped depressions 1006, to rotate introducer holder 920 to allow removal of introducer holder 920 from guide tower 910, to raise and lower introducer holder 920 between adjacent paired arcuate-shaped depressions 1006 and to affect manual angular deflection of introducer holder 920. In example embodiments, needle receiving portion 1070 includes one or more rotation-fixing elements, e.g., one or more slots, keys, clips, or threads, for receiving a corresponding structure in introducer needle 925, such as stop 1072, to prevent axial rotation and/or longitudinal movement of introducer needle 925 relative to introducer holder 920. In certain example embodiments, stop 1072 is configured to limit or prevent further or undesirable movement of introducer needle 925 in central passage 1056 in the distal direction with respect to guide tower 910.
Engagement shoulders 1062 include a pair of substantially cylindrical elements that project perpendicularly outwardly from opposing sides of distal end 1052 of body portion 1050. As shown in FIG. 11, engagement shoulders 1062 are configured to be received within a selected pair of arcuate-shaped depressions 1006 during use of needle guidance device 900. The cylindrical configuration of engagement shoulders 1062 allows for upward and/or downward pivotal or rotational movement of introducer holder 920 in arcuate-shaped depressions 1006 within the plane via body portion 1050 as desired (see FIGS. 21 and 22, for example), and prior to advancement of guide slide clamp 915 within guide slide clamp receiving slot 1012, which fixes or secures the path angle orientation of introducer holder 920 with respect to guide tower 910. In example embodiments, engagement shoulders 1062 include angle limiting portions that project rearwardly therefrom and are configured to engage portions of arcuate-shaped depressions 1006 to limit rotational movement of introducer holder 920 within arcuate-shaped depressions 1006.
Referring again to FIG. 11, a guide slide clamp engagement portion 1082 is formed in body portion 1050 and includes a generally rectangular configuration for engaging a portion of guide slide clamp 915 at a particular path location. In example embodiments, guide slide clamp engagement portion 1082 includes a parallel path alignment feature 1084 provided longitudinally on at least one side thereof, as shown in FIGS. 20, 21, and 22. Parallel path alignment feature 1084 positively engages one of a plurality of detents 916 or notches in guide slide clamp 915. Each detent 916 or notch corresponds to, e.g., is aligned with, a respective pair of arcuate-shaped depressions 1006 and spring elements 1008, as described below.
As shown in FIG. 11, guide slide clamp 915 includes a body portion 1100, a free movement portion 1102 and a needle holder device engagement portion 1104. Body portion 1100 includes a substantially planar element sized for receipt within guide slide clamp receiving slot 1012. In example embodiments, free movement portion 1102 includes an opening through guide slide clamp 915 that allows unfettered movement of introducer holder 920. Needle holder device engagement portion 1104 includes an inside surface of free movement portion 1102 configured to clampingly engage introducer holder 920. In example embodiments, needle holder device engagement portion 1104 includes notches 916 or detents each corresponding with respective arcuate-shaped depressions 1006 and spring elements 1008. Each notch 916 or detent is configured to engage with, e.g., accept or receive, parallel path alignment feature 1084 of guide slide clamp engagement portion 1082 to maintain introducer holder 920 in a selected parallel path height position, i.e., a path height position parallel with longitudinal axis B-B, such as shown in FIGS. 16 and 17.
Referring further to FIG. 21, when a user, e.g., a doctor, wishes to establish a needle path angle orientation parallel with a longitudinal axis B-B of needle guidance device 900 and the associated ultrasound probe 902, the user may pivot, e.g., pivot in an upward direction or pivot in a downward direction, introducer holder 920 so as to align parallel path alignment feature 1084 with a corresponding detent 916 that corresponds to the desired parallel path. Upon tightening of adjustment knob 1026, guide slide clamp 915 is urged toward introducer holder 920, urging parallel path alignment feature 1084 to seat within the particular detent 916. Continued tightening of adjustment knob 1026 effectively clamps introducer holder 920 at the desired path height position.
Conversely, referring further to FIG. 22, when a user, e.g., the doctor, wishes to establish a needle path angle orientation that is not parallel with longitudinal axis B-B of needle guidance device 900 and associated ultrasound probe 902, the user pivots introducer holder 920 to a desired non-parallel needle path angle orientation. In such a path angle orientation, parallel path alignment feature 1084 is not aligned with an associated notch 916. Upon tightening of adjustment knob 1026, guide slide clamp 915 is urged toward introducer holder 920. Continued tightening of adjustment knob 1026 effectively clamps introducer holder 920 at the desired path angle orientation.
Upon receipt of introducer holder 920 and corresponding introducer needle 925 within a particular pair of arcuate-shaped depressions 1006 and spring elements 1008, guide slide clamp 915 is urged within guide slide clamp receiving slot 1012 with adjustment knob 1026 to positively support introducer needle 925 at a selected path height position or location and/or at a selected path angle orientation relative to ultrasound probe 902. In example embodiments, guide slide clamp 915 positively retains introducer needle 925 at any selected path angle orientation with respect to longitudinal axis B-B of needle guidance device 900 and associated ultrasound probe 902.
After introducer needle 925 is seated within a selected parallel path within guide tower 910 (e.g., within a selected pair of arcuate-shaped depressions 1006 and locked by guide slide clamp 915), needle guidance device 900 is moved with ultrasound probe 902 to engage (e.g., puncture) the patient's skin at a selected puncture or access location. In example embodiments, needle guidance device 900 is further advanced with ultrasound probe 902 until a distal tip of introducer needle 925 reaches a desired depth within the patient, e.g., a depth in the perineum such that the biopsy needle is inserted into the patient's prostate at a desired depth within a region or location, or until guide tower 910 contacts the patient's perineum skin surface. With introducer needle 925 properly positioned in the patient's perineum at a desired depth, introducer needle 925 and compatible biopsy needle positioned within introducer needle 925 are movable to a first path height position to a second path height position and/or pivotable from a first path angle orientation to a second path angle orientation to biopsy a second region or location of the patient's prostate with introducer needle 925 remaining in the patient's perineum, i.e., without removing the introducer needle 925 from the patient's perineum and, thus, without requiring additional or multiple punctures through the patient's perineum to complete the biopsy procedure.
In example embodiments, following patient puncture, adjustment knob 1026 is rotated to return guide slide clamp 915 to a first or initial, non-locking position. Introducer holder 920 may then be pivoted about an axis perpendicular to the plane including longitudinal axis B-B within the cooperating arcuate-shaped depressions 1006 or removed from the cooperating arcuate-shaped depressions 1006 and moved to a new path height position and inserted into another pair of cooperating arcuate-shaped depressions 1006 without requiring a second puncture through the patient's skin surface.
Clause 1. A needle guidance device having a longitudinal axis, comprising: a guide base configured to releasably attach to an ultrasound probe, the guide base including a platform; a guide tower fixedly coupled to the guide base, the guide tower extending distally from a distal end of the guide base along the longitudinal axis and extending perpendicularly with respect to the longitudinal axis from the platform, the guide tower comprising a plurality of attachment positions; and an introducer holder removably and pivotably coupled to the guide tower at a first attachment position of the plurality of attachment positions.
Clause 2. The needle guidance device of clause 1, wherein the guide base comprises: a mount portion fixedly coupled to the guide tower; and a strap portion coupled to the mounting portion, the strap portion configured to releasably attach the needle guidance device to the ultrasound probe.
Clause 3. The needle guidance device of clause 1, wherein the introducer holder is positionable at each attachment position of the plurality of attachment position to prevent movement of the introducer holder in a distal direction and an opposite proximal direction with respect to the guide tower.
Clause 4. The needle guidance device of clause 1, wherein the introducer holder comprises: a body portion having a distal end, an opposite proximal end, and a central passage extending along a centerline of the body portion between the distal end and the proximal end; and a pair of opposing engagement shoulders, each engagement shoulder of the pair of opposing engagement shoulders extending radially outwardly from the centerline of the body portion at the distal end of the body portion, wherein the guide tower comprises a plurality of paired arcuate-shaped depressions at each attachment position of the plurality of attachment positions, and a first pair of arcuate-shaped depressions of the plurality of paired arcuate-shaped depressions at the first attachment position is positioned at a first distance from a surface of the platform, and each engagement shoulder of the pair of engagement shoulders is removably and pivotably positionable within a corresponding arcuate-shaped depression of the first pair of arcuate-shaped depressions.
Clause 5. The needle guidance device of clause 4, wherein, with the introducer holder rotatably coupled to the guide tower at one attachment position of the plurality of attachment positions, the introducer holder is pivotably movable with respect to the guide tower about an axis perpendicular to the longitudinal axis to move an introducer needle positioned within the central passage of the introducer holder from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation.
Clause 6. The needle guidance device of clause 5, wherein the introducer holder is lockable at each path angle orientation of the plurality of path angle orientations to prevent movement of the introducer holder in a distal direction and an opposite proximal direction with respect to the guide tower.
Clause 7. The needle guidance device of clause 5, further comprising a locking knob operatively coupled to the introducer holder, the locking knob configured to secure the introducer holder in one of the first path angle orientation and the second path angle orientation.
Clause 8. The needle guidance device of clause 4, further comprising a spring element positioned adjacent a first arcuate-shaped depression of the first pair of arcuate-shaped depressions, the spring element comprising a resilient element configured to removably capture the introducer holder within the adjacent first arcuate-shaped depression.
Clause 9. The needle guidance device of clause 4, wherein the guide tower defines an opening, the needle guidance device further comprising: a guide slide clamp movably positioned within a slot, the slot extending transversely through at least a portion of the guide tower and in communication with the opening, the guide slide clamp comprising a body portion and a plurality of path retaining elements axially aligned with a corresponding pair of arcuate-shaped depressions of the plurality of paired arcuate-shaped depressions to facilitate retaining the introducer holder at a corresponding parallel path position through the guide tower.
Clause 10. The needle guidance device of clause 9, wherein the plurality of path retaining elements comprise a plurality of detents formed within the body portion of the guide slide clamp, and each detent of the plurality of detents is axially aligned with a first arcuate-shaped depression of the corresponding pair of arcuate-shaped depressions.
Clause 11. The needle guidance device of clause 10, wherein the body portion further comprises a parallel path alignment feature, and wherein at least one detent of the plurality of detents is configured to selectively engage the parallel path alignment feature to retain the introducer holder in a parallel path orientation.
Clause 12. The needle guidance device of clause 11, wherein the guide tower comprises a threaded aperture aligned with the slot for receiving a threaded screw, wherein the threaded screw projects from a locking knob and engages the guide slide clamp to urge the at least one detent in the alignment plate into engagement with the introducer holder at a desired parallel path orientation via the parallel path alignment feature.
Clause 13. The needle guidance device of clause 1, further comprising an introducer needle, wherein the introducer holder defines a central passage configured to receive the introducer needle and maintain the introducer needle within the plane.
Clause 14. The needle guidance device of clause 13, wherein the introducer needle comprises a distal tip, an opposite proximal end, and a stop at the proximal end configured to limit movement of the introducer needle within the central passage in the distal direction with respect to the guide tower.
Clause 15. The needle guidance device of clause 1, wherein the introducer holder is positionable at a plurality of path height positions, each path height position of the plurality of path height positions located at a corresponding distance from a surface of the platform.
Clause 16. The needle guidance device of clause 15, further comprising a locking knob operatively coupled to the introducer holder, the locking knob configured to secure the introducer holder at a first path height position of the plurality of path height positions.
Clause 17. The needle guidance device of clause 16, wherein the guide tower defines an opening and the introducer holder is movably positionable within the opening to adjust at least one of a path angle orientation or a path height position of the introducer holder.
Clause 18. The needle guidance device of clause 17, further comprising a locking knob operatively coupled to the introducer holder, the locking knob configured to secure the introducer holder at the at least one of the path angle orientation or the path height position.
Clause 19. A needle guidance device, comprising: a guide platform configured to removably couple to an ultrasound probe, the ultrasound probe having a length extending along a longitudinal axis of the ultrasound probe; a guide tower extending from the guide platform; and a needle holder device rotatably coupled to the guide tower, the needle holder device defining a central aperture therethrough configured to receive a puncture device, the needle holder device rotatably movable about a rotational axis perpendicular to the longitudinal axis with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation.
Clause 20. The needle guidance device of clause 19, wherein the needle holder device is positionable at a plurality of path height positions, each path height position of the plurality of path height positions located at a corresponding distance from a surface of the guide platform.
Clause 21. A needle guidance device, comprising: a guide platform configured to removably couple to an ultrasound probe, the ultrasound probe having a length extending along a longitudinal axis of the ultrasound probe; a guide tower extending from the guide platform; and a needle holder device pivotably coupled to the guide tower, the needle holder device defining a central aperture therethrough configured to receive a puncture device, the needle holder device pivotably movable about a rotational axis perpendicular to the longitudinal axis with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation.
Clause 22. The needle guidance device of clause 21, wherein the needle holder device is lockable with respect to the guide tower to prevent movement of the needle holder device in a distal direction and an opposite proximal direction with respect to the guide tower.
Clause 23. The needle guidance device of clause 21, further comprising an adjustment knob operatively coupled to the needle holder device, the adjustment knob configured to secure the needle holder device at the first path angle orientation.
Clause 24. The needle guidance device of clause 21, wherein the central aperture extends between a distal end of the needle holder device and a proximal end of the needle holder device, the central aperture configured to receive a puncture device and maintain the puncture device within the plane.
Clause 25. The needle guidance device of clause 21, wherein the puncture device is movably positioned within the central aperture to move in a distal direction and an opposite proximal direction with respect to the guide tower.
Clause 26. The needle guidance device of clause 21, wherein the needle holder device is positionable at a plurality of path height positions, each path height position of the plurality of path height positions located at a corresponding distance from the guide platform.
Clause 27. The needle guidance device of clause 26, further comprising an adjustment knob operatively coupled to the needle holder device, the adjustment knob configured to secure the needle holder device at a first path height position of the plurality of path height positions.
Clause 28. The needle guidance device of clause 21, wherein the needle holder device is movable between a first path height position and a second path height position with respect to the guide platform.
Clause 29. The needle guidance device of clause 28, further comprising an adjustment knob operatively coupled to the needle holder device, the adjustment knob configured to secure the needle holder device at one of the first path height position and the second path height position.
Clause 30. The needle guidance device of clause 21, wherein the guide tower defines a central opening and the needle holder device is movably positioned with the central opening, the needle holder device movable to adjust at least one of a path angle orientation or a path height position of the needle holder device in the plane.
Clause 31. The needle guidance device of clause 30, further comprising an adjustment knob operatively coupled to the needle holder device, the adjustment knob configured to secure the needle holder device at the at least one of the path angle orientation or the path height position.
Clause 32. The needle guidance device of clause 21, wherein the guide tower is movable with respect to the guide platform in a distal direction and an opposite proximal direction with respect to the guide platform.
Clause 33. The needle guidance device of clause 21, wherein the guide tower defines a central opening, the needle holder device movable within the central opening to adjust at least one of the path angle orientation within the plane or a path height position of the needle holder device at a distance with respect to the guide platform within the plane.
Clause 34. The needle guidance device of clause 33, wherein the needle holder device is movable within the central opening between a first path angle orientation and a second path angle orientation.
Clause 35. The needle guidance device of clause 33, wherein the needle holder device is movable within the central opening between a first path height position of the needle holder device with respect to the guide platform and a second path height position of the needle holder device with respect to the guide platform.
The foregoing description of exemplary implementations provides illustration and description but is not intended to be exhaustive or to limit the embodiments described herein to the precise form disclosed. Modifications and variations are possible in light of the above teachings or may be acquired from practice of the embodiments.
Although the invention has been described in detail above, it is expressly understood that it will be apparent to persons skilled in the relevant art that the invention may be modified without departing from the spirit of the invention. Various changes of form, design, or arrangement may be made to the invention without departing from the spirit and scope of the invention. Therefore, the above-mentioned description is to be considered exemplary, rather than limiting, and the true scope of the invention is that defined in the following claims.
No element, act, or instruction used in the description of the present application should be construed as critical or essential to the invention unless explicitly described as such. Also, as used herein, the article “a” is intended to include one or more items. Further, the phrase “based on” is intended to mean “based, at least in part, on” unless explicitly stated otherwise.
Use of ordinal terms such as “first,” “second,” “third,” etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another, the temporal order in which acts of a method are performed, the temporal order in which instructions executed by a device are performed, etc., but are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim elements.
Patent Application
20240366260
