Transperineal puncture instrument guiding device

Abstract

The puncture device guide device includes a guide platform configured to removably attach to the ultrasound probe, a guide tower slidingly coupled to the guide platform, and a needle holder device for coupling to the puncture device, the guide tower projecting upwardly from the guide platform and including a vertical guide slot and a plurality of mounting locations for engaging the needle holder device.

Description

Technical Field

[0001] The present invention relates to a puncture instrument guiding device for use with a medical imaging device, and more particularly, to a device for guiding a puncture instrument to a repeatable position on a patient with respect to a medical imaging device probe.

Background Art

[0002] Imaging devices such as ultrasonic probes have revolutionized the way many important medical procedures are performed. These medical devices utilize imaging technology to investigate and evaluate the condition of human tissues and / or organs. As a result, diagnostic and treatment protocols have been developed that allow many very favorable and safe procedures to be performed while minimizing harm to the patient. For example, ultrasonic probes have become an acceptable modality for investigating endocavities, such as the gastrointestinal and reproductive organs of humans and animals, for performing regular health checkups and for identifying signs of tumors or other target tissue areas.

[0003] The diagnostic procedure for outpatients undergoing transrectal (TR) ultrasound-guided prostate biopsy, where the biopsy needle passes through the rectal wall, has become increasingly risky for patients because the emergence of multidrug-resistant bacteria has made it difficult to prevent post-biopsy sepsis even with prophylactic administration of antibiotics. As a direct result, the medical community has been developing a transperineal (TP) approach for biopsies. In this method, the biopsy needle passes through the perineal skin, which can be sterilized, completely avoiding the risk of infectious complications. On the other hand, the clear advantages of transrectal ultrasound imaging for needle guidance are maintained. Although a skilled operator may be able to perform a well-targeted biopsy using freehand techniques for both ultrasound imaging and biopsy, this is very difficult and often requires assistance. Therefore, due to patient safety, the implementation of appropriate anesthesia, the standardization of techniques for teaching purposes, the consistent accuracy of biopsies, and the ability to perform the procedure with just one operator, especially as this approach becomes more widely relevant and adopted, a mechanical guidance device connected to an ultrasound probe / transducer becomes essential.

Summary of the Invention

[0004] The present invention relates to a puncture instrument guidance device for use with a medical imaging device. More particularly, it relates to a device for guiding a puncture instrument to a repeatable position on a patient relative to a medical imaging device probe.

Brief Description of the Drawings

[0005]

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DETAILED DESCRIPTION OF THE INVENTION

[0006] 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 is not intended to limit the present invention.

[0007] The embodiments described herein relate to a guiding device for facilitating the placement of a puncturing instrument (e.g., a needle) at a prescribed position relative to an ultrasonic probe. More specifically, the guiding device described below includes components that provide a number of paths at different prescribed distances from the ultrasonic probe relative to each other.

[0008] For example, in one embodiment, the ultrasonic probe may be a transrectal ultrasonic probe, and the guiding device may be configured to facilitate the guidance of a biopsy needle at a position relative to the ultrasonic probe. Consistent with the examples described herein, the needle guiding device can include a plurality of selectable guiding paths and, at the same time, can enable both a fixed parallel needle path and adjustment of the needle angle while maintaining the angular orientation and axial relationship between the needle and the ultrasonic probe. Further, consistent with the embodiments described herein, the needle guiding device may be longitudinally advanceable at prescribed intervals.

[0009] Figures 1A and 1B are an isometric view and an exploded isometric view, respectively, showing a needle guidance device 100 for use with an ultrasonic probe that conforms to the embodiments described herein. As shown, the needle guidance device 100 includes a clamp sleeve 105, a guide tower 110, an alignment plate 115, and a needle holder device 120. Prior to use, the clamp sleeve 105 can be fixed to an ultrasonic probe (not shown), and the guide tower 110 can be slidably coupled to the clamp sleeve 105. As shown in FIGS. 1A and 1B, the needle holder device 120 can be inserted into one of a plurality of path positions within the guide tower 110. A trocar or other puncture instrument 125, such as a Luer lock trocar needle, can be received through the needle holder device 120 as described below. The alignment plate 115 can be inserted into the guide tower 110 as described below to provide a guidance path parallel to the longitudinal axis of the ultrasonic probe. During use, the guide tower 110 can slide forward relative to the clamp sleeve 105 and the ultrasonic probe and engage the patient at a selected position. When the procedure is complete, the guide tower 110 retracts relative to the clamp sleeve 105 and the ultrasonic probe to remove the puncture instrument 125 from the patient.

[0010] As shown in FIG. 1B, the clamp sleeve 105 includes a mounting portion 130, a strap portion 136, and a fixing portion 140. As described herein, the mounting portion 130 can include an extruded configuration having an upper surface 132 and a lower surface 134. The upper surface 132 of the mounting portion 130 can be configured to support the guide tower 110 in a longitudinally adjustable configuration. For example, as shown in FIG. 1B, the upper surface 132 includes a pair of side rails 133 that project upward from the upper surface 132. As will be described below, each of the side rails 133 is configured to be slidably received within a corresponding side rail 154 within the guide tower 110, as shown in FIG. 2A. During use, the tolerance of each side rail 133 may be such that there is a frictional relationship between the mounting portion 130 and the guide tower 110 that resists unwanted movement to prevent the guide tower 110 from moving too loosely relative to the mounting portion 130.

[0011] In another embodiment, as shown in FIG. 1B, the upper surface 132 of the mounting portion 130 may include a plurality of longitudinally spaced return fixing elements 131 that project upward from the upper surface 132 of the mounting portion 130. The return fixing elements 131 are configured to be engaged by a spring clip element 200 within the guide tower 110, as shown in FIG. 2A. In some embodiments, the upper surface 132 of the mounting portion 130 may also include a stop engagement portion 135 for engaging a stop element 205 that projects downward from the lower surface of the guide tower 110, as shown in FIG. 2A. When the stop element 205 within the guide tower 110 abuts against the stop engagement portion 135, the guide tower 110 is prevented from moving forward relative to the clamp sleeve 105 and thus relative to the ultrasonic probe to which the clamp sleeve is fixed.

[0012] In other embodiments, other mechanisms for securing the guide tower 110 to the clamp sleeve 105 may be used. For example, by using a combination of protrusions and detents or apertures, as described above in connection with the embodiments of FIGS. 1B and 2A, the guide tower 110 can be removably secured to the attachment portion 130.

[0013] The lower surface 134 of the attachment portion 130 includes a generally curved shape corresponding to at least a portion of the curved outer shape of a transducer probe (not shown). Consistent with the embodiments described herein, the lower surface 134 may include a longitudinal channel or groove to form a space defined between the transducer probe and the needle guidance device 100 sufficient to accommodate a treatment accessory device such as a brachyballoon.

[0014] The strap portion 136 of the clamp sleeve 105 may include a generally elastic or flexible shape that optimally conforms to a portion of the outer surface of the transducer probe to which the needle guidance device 100 is attached. In particular, the strap portion 136 may include a first lateral portion 137 extending from a first side of the attachment portion 130 and a second lateral portion 139 extending from a second side of the attachment portion 130 opposite the first lateral portion 137. The first and second lateral portions 137 / 139 may terminate together at a fixing portion 140. As shown in FIGS. 1A and 1B, in one embodiment, the fixing portion 140 may include a collar portion 140 formed at the end of the first lateral portion 137 and a threaded portion 142 formed at the end of the second lateral portion 139. The collar portion 140 may include an opening adapted to receive the end of the threaded portion 142 while mounting the clamp sleeve 105 onto the ultrasonic probe.

[0015] To fix the clamp sleeve 105 to the ultrasonic probe, the lower surface 134 of the mounting portion 130 and the inner surface of the first side portion 137 first contact the outer surface of the ultrasonic probe. Then, the second side portion 139 is bent so that its inner surface also contacts the outer surface of the ultrasonic probe, whereby the threaded portion 142 enters the collar portion 140. A clamp nut 144 having a mating collar portion 146 is screwed onto the threaded portion 142 to clamp-engage the collar portion 146 on the clamp nut 144 with the collar portion 140 within the first side portion 137, thus fixing the clamp sleeve 105 to the ultrasonic probe. When it is desired to remove the clamp sleeve 105, the collar portion 140 can be removed by reversing the clamp nut 144.

[0016] In accordance with the embodiments described herein, one or more of the side portions 137 / 139 can be formed with a thickness sufficient to allow for flexure. In some embodiments, only the second side portion 139 is formed to allow for flexure and the first side portion 137 has a substantially rigid configuration. In some examples, the entire clamp sleeve 105 except for the clamp nut 144 can be integrally formed by injection molding, 3D printing, or the like.

[0017] As shown in FIGS. 1A and 1B, the guide tower 110 has a substantially L-shaped configuration for providing a stable interface to the clamp sleeve 105, as described herein, and a plurality of radially spaced needle guide paths for engaging the needle holder device 120 (as shown by line A-A in FIG. 1B, with respect to the longitudinal orientation of the ultrasonic probe). In particular, the guide tower 110 includes a sleeve interface portion 150 having a generally planar configuration and a guide path portion 152 projecting upwardly from the sleeve interface portion 200. The lower surface of the sleeve interface portion 150 includes opposing side rails 154 configured to project downwardly from the lower surface of the sleeve interface portion 150 and interface with the side rails 133 within the clamp sleeve 105. In some embodiments, the side rails 154 have an opposing C-shaped configuration that captures the side rails 133 and prevents relative radial movement between the clamp sleeve 105 and the guide tower 110 while allowing longitudinal movement therebetween when the side rails 133 within the attachment portion 130 are positioned within the side rails 154 within the guide tower 110.

[0018] As described above, as shown in FIG. 2A showing a bottom view of the guide tower 110, the sleeve interface portion 150 includes a resilient spring clip element 600 configured to engage a return fixing element 131 projecting upwardly from the clamp sleeve 105.

[0019] In one embodiment consistent with the examples described herein, the guide path portion 152 projects substantially vertically upward from the sleeve interface portion 150. As shown in FIGS. 1A, 1B, and 2B (showing a rear view of the guide tower 110 with the alignment plate 115 positioned therein), the guide path portion 152 includes a vertical guide slot 156, a plurality of needle holder device receiving cups 158, and an alignment plate receiving slot 160.

[0020] The vertical guidance slot 156 is centered within the guide tower 110 so as to be in line with the longitudinal ultrasound imaging crystals within the transducer, and the needle guidance device 100 is secured such that a piercing instrument 125 (e.g., a trocar needle) designed to penetrate is consistently visualized within the imaging plane under typical imaging conditions. As shown in FIG. 2B, the vertical guidance slot 156 extends substantially the entire height of the guide tower 110 such that an inserted piercing instrument can move freely between the positions of the needle holder device induction device receiving cup.

[0021] As shown in FIG. 1B, the needle holder device receiving cup 158 includes a plurality of pairs of aligned recesses or openings disposed within the guidance path portion 152 and on the opposite side of the vertical guidance slot 156. Each pair of needle holder device receiving cups 158 is vertically spaced relative to an adjacent pair of needle holder device receiving cups 158 to provide a plurality of mounting positions for the needle holder device 120, as will be described in further detail below. In this embodiment, five pairs of needle holder device receiving cups 158 are provided, although other embodiments may include fewer needle holder device receiving cups 158 or additional needle holder device receiving cups 158 may be provided. Consistent with the embodiments described herein, each needle holder device receiving cup 158 includes a generally arcuate opening configured to receive a respective portion of the needle holder device 120, as will be described below. In some embodiments, the dimensions of each needle holder device receiving cup 158 are such that the needle holder device 120 is removably capturable therein. For example, each needle holder device receiving cup 158 may be sized to provide a tight friction fit with the needle holder device 120. In other embodiments, each needle holder device receiving cup 158 can have an opening with an arc slightly larger than 180°, such that the needle holder device 120 is snap-fitted into each pair of needle holder device receiving cups 158. In contrast to the needle guidance device 100 of FIGS. 1A - 2B, the needle holder device receiving cup 158 is disposed in front of the alignment plate receiving slot 160.

[0022] As shown in FIG. 1B, the alignment plate receiving slot 160 is configured to extend laterally within the guide tower 110 at a position behind the needle holder device receiving cup 158. The alignment plate receiving slot 160 is sized to receive the alignment plate 115 therein. As will be described in more detail below, when the needle holder device 120 and the corresponding puncture instrument 125 are received within a particular pair of needle holder device receiving cups 158, the alignment plate 115 can be advanced within the alignment plate receiving slot 160 to securely support the puncture instrument 125 in a defined path relative to the ultrasonic probe. For example, in some embodiments, the shape of the alignment plate 115 causes the puncture instrument 125 to be pushed within a parallel path, although different shapes may be used to accommodate different path angles. As shown in FIG. 1B, in one embodiment, the alignment plate receiving slot 160 includes an outer rim portion 161 configured to receive a portion of the alignment plate 115 at a defined depth within the alignment plate receiving slot 160.

[0023] FIG. 2C is a side view of the needle holder device 120 consistent with the embodiments described herein. As shown in FIGS. 1A, 1B, and 2C, the needle holder device 120 includes an adapter for coupling to the guide tower 110 and for receiving the puncture instrument 125. In some embodiments, the needle holder device 120 may be configured to receive a trocar puncture instrument therethrough.

[0024] In one embodiment, the needle holder device 120 includes a body portion 162, an engagement shoulder portion 164, a handle portion 166, and a flange portion 168. As shown, the body portion 162 includes a generally tubular element having a through central opening 169. The body portion 162 is configured to receive a puncture instrument 125 within the central opening 169. The front end of the body portion 162 terminates at the engagement shoulder portion 164, and the rear end of the body portion 162 terminates at the flange portion 162. The outer surface of the middle portion of the body portion 162 forms the handle portion 166, which can be manipulated to effect proper placement of the needle holder device 120 during use.

[0025] The engagement shoulder portion 164 includes a pair of generally cylindrical elements that project outwardly and perpendicularly from both sides of the front end of the body portion 162. As shown in FIG. 1A and generally as described above, the engagement shoulder portion 164 is configured to be received within a selected pair of needle holder device receiving cups 158 during use. The cylindrical shape of the engagement shoulder portion 164 allows for rotation of the needle holder device 120 upwardly and downwardly within the receiving cup 158 by the handle portion 166, if desired, prior to advancing the alignment plate 115 within the alignment plate receiving slot 160, thereby fixing the angular orientation of the needle holder device 120.

[0026] As shown in FIGS. 1A, 1B, and 2C and consistent with the embodiments described herein, the funnel member 170 can be secured to a Luer-lock puncture instrument 125 prior to insertion into the needle holder device 120. Consistent with the examples described herein, the funnel member 170 includes a puncture instrument interface portion 171 and a funnel opening 172. The puncture instrument interface portion 171 includes a concentric tubular structure for receiving an interface element of a puncture instrument 125, such as a Luer-lock. In this configuration, the puncture instrument interface portion 171 includes an internal thread (not shown) configured to engage and hold a male thread on the Luer-lock puncture instrument 125. The funnel opening 172 includes a wide-mouth opening at the rear end of the funnel member 170 having an inner diameter or circumference that is larger than a central opening (not shown) within the body portion 162 to allow for easy access of a puncture instrument, such as a biopsy needle.

[0027] As shown in FIG. 1B, the alignment plate 115 includes a main body portion 176, an abutting portion 178, a freely movable portion 179, and a plurality of path holding channels 180. Generally, the main body portion 176 includes a substantially flat element sized to be received within the alignment plate receiving slot 160. The abutting portion 178 includes a flange portion 182 that provides a surface for abutting against the outer rim portion 161 of the alignment plate receiving slot 160 when the alignment plate 115 is fully inserted into the alignment plate receiving slot 160.

[0028] In accordance with the embodiments described herein, the freely movable portion 179 includes a slotted opening that communicates with the path holding channels 180. The path holding channels 180 include a plurality of arcuate recesses spaced apart to correspond to the needle holder device receiving cups 158. The combination of the freely movable portion 179 and the path holding channels 180 provides two operating positions for the alignment plate 115.

[0029] In a first position, the alignment plate 115 is partially inserted into the alignment plate receiving slot 160 such that the freely movable portion 179 is aligned with the vertical guide slot 160. This enables the needle holder device 120 to be inserted into the guide tower 110. When the needle holder device 120 is inserted into the guide tower 110 and within a selected pair of needle holder device receiving cups 158, the alignment plate 115 advances within the alignment plate receiving slot 160 (until the flange portion 182 abuts against the outer rim portion 161). In this second position, the needle holder device 120 is held in a path parallel to the ultrasonic probe. The position of the path holding channels 180 within the alignment plate 115 of the embodiments of FIGS. 1A and 1B provides a parallel path for the needle holder device 120, although in other embodiments, the position of the path holding channels 180 may be offset relative to the needle holder device receiving cups 158 to provide other angular orientations.

[0030] The alignment plate 115 is configured to be continuously held within the alignment plate receiving slot 160. As shown in FIG. 1B, the alignment plate 115 can include one or more spring clip portions 184 configured to engage corresponding rim portions of the slot 160 to prevent the alignment plate 115 from unintentionally disengaging from the alignment plate receiving slot 160 when the alignment plate 115 is in the first position.

[0031] During assembly and use, the engaging shoulder 164 of the needle holder device 120 is initially oriented in the vertical direction, and the needle holder device 120 is inserted into the vertical guide slot 156 and forwardly inserted through the alignment plate 115 when the alignment plate is in the first position. The needle holder device 120 is then rotated 90° and inserted into a selected pair of needle holder device receiving cups 158. The alignment plate 115 then advances to the second position, thereby capturing the needle holder device 120 within a selected parallel path.

[0032] After the piercing instrument 125 is positioned (e.g., within a selected pair of needle holder device receiving cups 158 and locked by the alignment plate 115) within a selected parallel path within the guide tower 110, the guide tower 110 slides forward relative to the clamp sleeve 105 and the ultrasonic probe and engages (e.g., pierces) the patient at the selected location. The guide tower further advances until the tip of the piercing instrument 125 reaches a desired depth within the patient's body or until a stop 205 within the guide tower 110 abuts a stop engagement portion 135 within the clamp sleeve 105.

[0033] Consistent with the embodiments described herein, following the piercing of the patient, the alignment plate 115 can be returned to its first non-locking position. The needle holder device 120 can then pivot about the needle holder device receiving cup 158 or be removed from the needle holder device receiving cup 158 and moved to a new vertical position without the need for a second piercing.

[0034] Figures 3A and 3B are an isometric view and an exploded isometric view, respectively, showing another embodiment of a needle guidance device 300 for use with an ultrasonic probe that corresponds to the embodiments described herein. As shown, the 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, the guide platform 305 can be secured to an ultrasonic probe (not shown), and the guide tower 310 can be slidably coupled to the guide platform 305. As shown in FIGS. 3A and 3B, the needle holder device 320 can be inserted into one of a plurality of path positions within the guide tower 310. A trocar or other puncture instrument 325, such as a Luer lock trocar needle, can be received through the needle holder device 320 as described below. In other embodiments, the puncture instrument 325 can be formed as an integral unit with the needle holder device 320, such that the puncture instrument 325 cannot be removed independently of the needle holder device 320. The alignment plate 315 can be inserted into the guide tower 310, as described below, to provide a guidance path parallel to the longitudinal axis of the ultrasonic probe. During use, the guide tower 310 slides forward relative to the guide platform 305 and the ultrasonic probe and engages the patient at a selected position. When the procedure is complete, the guide tower 310 retracts relative to the guide platform 305 and the ultrasonic probe to remove the puncture instrument 325 from the patient.

[0035] As shown in FIG. 3B, the guide platform 305 includes a mounting portion 330, a strap portion 336, and a fixing portion 340. As described herein, the mounting portion 330 can include a longitudinally extruded shape having an upper surface 332 and a lower surface 334. The upper surface 332 of the mounting portion 330 can be configured to support the guide tower 310 in a longitudinally adjustable configuration. For example, as shown in FIG. 3B, the upper surface 332 includes a pair of side rails 333 that project upward from the upper surface 332. As will be described below, each of the side rails 333 is configured to be slidably received within a corresponding side rail 354 within the guide tower 310, as shown in FIG. 4A. During use, to prevent the guide tower 310 from moving too loosely relative to the mounting portion 330, the tolerance of each side rail 333 may be such that there is a frictional relationship between the mounting portion 330 and the guide tower 310 that resists unwanted movement. In other embodiments, other mechanisms for fixing the guide tower 310 to the guide platform 305 may be used. For example, by using a combination of protrusions and detents or openings, the guide tower 310 can be removably fixed to the mounting portion 330.

[0036] As shown in FIGS. 3A and 3B, the front end of the mounting surface 330 can include a stabilization mechanism 335 that projects vertically upward from the upper surface 332. The stabilization mechanism 335 can have a large central opening therein such that the puncture instrument 325 can move freely therethrough. During use, the front end of the stabilization mechanism 335 is configured to engage a patient (e.g., the perineum of the patient) to stabilize the relationship between the needle guidance device 300 and the patient. Further, the rear end of the stabilization mechanism 335 further provides a definite stop against longitudinal movement of the guide tower 310 relative to the guide platform 305.

[0037] The lower surface 334 of the attachment portion 330 includes a generally curved shape corresponding to the curved outer shape of at least a part of a transducer probe (not shown). The strap portion 336 of the guide platform 305 may include a generally elastic or flexible shape that optimally conforms to the outer surface of a part of the transducer probe to which the needle guidance device 300 is attached. In particular, the strap portion 336 may include a first lateral portion 337 extending from a first side of the attachment portion 330 and a second lateral portion 339 extending from a second side of the attachment portion 330 opposite the first lateral portion 337. The first and second lateral portions 337 / 339 may terminate together at a fixing portion 340. As shown in FIGS. 3A and 3B, in one embodiment, the fixing portion 340 may include a collar portion 341 formed at the end of the first lateral portion 337 and a screw portion 342 formed at the end of the second lateral portion 339. The collar portion 341 may include an opening adapted to receive the end of the screw portion 342 while attaching the guide platform 305 onto the ultrasonic probe.

[0038] To fix the guide platform 305 to the ultrasonic probe, the lower surface 334 of the attachment portion 330 and the inner surface of the first lateral portion 337 first contact the outer surface of the ultrasonic probe. Then, the second lateral portion 339 is bent so that its inner surface also contacts the outer surface of the ultrasonic probe, whereby the screw portion 342 enters the collar portion 341. A clamp nut 344 having a fitting collar portion 346 is screwed onto the screw portion 342 to clamp-engage the collar portion 346 on the clamp nut 344 with the collar portion 341 within the first lateral portion 337, thus fixing the guide platform 305 to the ultrasonic probe. When it is desired to remove the guide platform 305, the collar portion 341 can be removed by reversing the clamp nut 344.

[0039] Consistent with the embodiments described herein, one or more of the side portions 337 / 339 can be formed with a thickness sufficient to allow for flexure. In some embodiments, only the second side portion 339 is formed to allow for flexure, and the first side portion 337 has a substantially rigid configuration. In some examples, the entire guide platform 305, excluding the clamp nut 344, can be integrally formed by injection molding, 3D printing, or the like.

[0040] Figures 4A and 4B are rear views of a guide tower 310 having an alignment plate in the unlocked and locked positions, respectively. Figure 4C is a side view of the guide tower 310. As shown in Figures 3A, 3B, and 4A - 4C, the guide tower 310 has a substantially frame - like shape for providing a stable interface to the guide platform 305, as described herein, and a plurality of spaced - apart needle - guiding paths for engaging the needle - holder device 320 (relative to the longitudinal orientation of the ultrasonic probe, as shown by line A - A in Figure 3A). In particular, the guide tower 310 includes a platform - interface portion 350 and a guiding - path portion 352 projecting upward from the platform - interface portion 350. The lower surface of the platform - interface portion 350 includes opposing side rails 354 configured to project downward from the lower surface of the platform - interface portion 350 and interface - connect with side rails 333 within the guide platform 305. In some embodiments, the side rails 354 have an opposing C - shaped configuration that captures the side rails 333 and prevents relative radial movement between the guide platform 305 and the guide tower 310 while allowing longitudinal movement therebetween to slide when the side rails 333 within the attachment portion 330 are positioned within the side rails 354 within the guide tower 310.

[0041] In one embodiment consistent with the embodiments described herein, the guiding path portion 352 projects substantially vertically upward from the platform interface portion 350. As shown in FIGS. 3A, 3B, and 4B, the guiding path portion 352 includes a vertical guiding slot 356, a plurality of needle holder device receiving cups 358, a tower advancing handle 359, and an alignment plate receiving slot 360.

[0042] The vertical guiding slot 356 is centered within the guide tower 310 to be aligned with the longitudinal ultrasonic imaging crystal oscillator within the transducer and is designed to penetrate such that the puncturing instrument 325 (e.g., a trocar needle) is consistently visualized within the imaging plane under typical imaging conditions when the needle guiding device 300 is fixed. As shown in FIG. 4B, the vertical guiding slot 356 extends substantially throughout the height of the guide tower 310 such that the inserted puncturing instrument can move freely between the positions of the needle guiding device receiving cups.

[0043] As shown in FIG. 3B, the needle holder device receiving cup 358 includes a plurality of pairs of aligned recesses or openings disposed within the induction path portion 352 and on the opposite side of the vertical induction 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 mounting positions for the needle holder device 320, as will be described in further detail below. In the present embodiment, five pairs of needle holder device receiving cups 358 are provided, although other embodiments may include fewer needle holder device receiving cups 358 or additional needle holder device receiving cups 358 may be provided. Consistent with the embodiments described herein, each needle induction device receiving cup 358 includes a generally arcuate opening configured to receive a respective portion of the needle holder device 320, as described below. In some embodiments, the dimensions of each needle induction device receiving cup 358 are such that the needle holder device 320 is removably capturable therein. For example, each needle induction device receiving cup 358 may be sized to provide a tight friction fit to the needle holder device 320. In other embodiments, each needle induction device receiving cup 358 can have an opening with an arc slightly larger than 180°, such that the needle holder device 320 is snap-fitted into each pair of needle holder device receiving cups 358.

[0044] As shown in FIGS. 3A, 3B, and 4B, the tower forward handle 359 projects laterally outward from the guide tower 310 proximate the platform interface portion 350. In use, the operator can manually advance or retract the guide tower 310 longitudinally along the guide platform 305 by pushing or pulling on the tower forward handle 359, respectively.

[0045] As shown in FIG. 3B, the alignment plate receiving slot 360 is configured to extend laterally within the guide tower 310 at a position behind the needle holder device receiving cup 358. The alignment plate receiving slot 360 is sized to receive the alignment plate 315 therein. As will be described in more detail below, when the needle holder device 320 and the corresponding puncturing instrument 325 are received within a particular pair of needle holder device receiving cups 358, the alignment plate 315 can be advanced within the alignment plate receiving slot 360 to securely support the puncturing instrument 325 in a defined path relative to the ultrasonic probe. For example, in some embodiments, due to the shape of the alignment plate 315, the puncturing instrument 325 is pushed into a parallel path, although different shapes may be used to accommodate different path angles. In one embodiment, the alignment plate receiving slot 360 includes an outer rim portion configured to receive a portion of the alignment plate 315 at a defined depth within the alignment plate receiving slot 360. FIG. 4D is an isometric view of a needle holder device 320 consistent with the embodiments described herein. As shown in FIGS. 3A, 3B, and 4D, the needle holder device 320 includes an adapter for coupling to the guide tower 310 and for receiving the puncturing instrument 325. In some embodiments, the needle holder device 320 may be configured to receive the puncturing instrument through the needle holder device 320.

[0046] In one embodiment, the needle holder device 320 includes a body portion 362, an engagement shoulder 364, and a handle portion 366. As shown, the body portion 362 includes a generally tubular element having a through central opening 368. The body portion 362 is configured to receive the puncturing instrument 325 within the central opening 368. The front end of the body portion 362 terminates at the engagement shoulder 364, and the rear end of the body portion 362 terminates at the handle portion 366, which can be manipulated to effect proper placement of the needle holder device 320 during use. As shown in FIG. 4D, an intermediate portion of the body portion 362 can include an alignment plate engagement surface 370 for engaging a path retaining channel 380 within the alignment plate 315, as will be described below.

[0047] For example, the handle portion 366 can be used to insert the engagement shoulder portion 364 into the needle holder device receiving cup 358, remove it from the needle holder device receiving cup 358, rotate the needle guiding device to enable removal from the guide tower 310, move the needle holder device 320 up and down between the needle holder device receiving cups 358, or affect the manual angular deflection of the needle holder device 320.

[0048] The engagement shoulder portion 364 includes a pair of substantially cylindrical elements that project vertically outward from both sides of the front end of the main body portion 362. As shown in FIG. 3A and generally as described above, the engagement shoulder portion 364 is configured to be received within a selected pair of needle holder device receiving cups 358 during use. The cylindrical shape of the engagement shoulder portion 364 allows for rotation of the needle holder device 320 upward and downward within the receiving cup 358 by the handle portion 366, if desired, prior to advancing the alignment plate 315 within the needle holder alignment plate receiving slot 360, thereby fixing the angular orientation of the needle holder device 320.

[0049] As shown in FIGS. 3B, 4A, and 4B, the alignment plate 315 includes a main body portion 376, an abutting portion 378, a freely movable portion 379, and a plurality of path holding channels 380. Generally, the main body portion 376 includes a substantially flat element sized to be received within the alignment plate receiving slot 360. The abutting portion 378 includes a flange portion 382 that provides a surface for abutting against the outer rim portion of the alignment plate receiving slot 360 when the alignment plate 315 is fully inserted within the alignment plate receiving slot 360.

[0050] In accordance with the embodiments described herein, the free movement portion 379 includes a slotted opening that communicates with the path holding channel 380. The path holding channel 380 includes a plurality of arcuate recesses spaced apart to correspond to the needle holder device receiving cups 358. The combination of the free movement portion 379 and the path holding channel 380 provides two operating positions for the alignment plate 315.

[0051] In the first position, the alignment plate 315 is partially inserted into the alignment plate receiving slot 360 such that the free movement portion 379 is aligned with the vertical guide slot 356. This enables the needle holder device 320 to be inserted into the guide tower 310 via the handle portion 366. When the needle holder device 320 is inserted into the guide tower 310 and within a selected pair of needle holder device receiving cups 358, the alignment plate 315 advances within the alignment plate receiving slot 360 (until the flange portion 382 abuts against the outer rim portion of the alignment plate receiving slot 360). In this second position, the path holding channel 380 corresponding to a particular pair of needle holder device receiving cups 358 engages the alignment plate engagement surface 370 of the needle holder device 320 with the needle holder device 320 held in a path parallel to the ultrasonic probe.

[0052] The position of the path holding channel 380 in the alignment plate 315 of the embodiment of FIGS. 3A and 3B provides a parallel path for the needle holder device 320, but in other embodiments, the position of the path holding channel 380 may be offset relative to the needle holder device receiving cups 358 to provide other angular orientations.

[0053] As shown in FIGS. 3B, 4A, and 4B, the alignment plate 315 can include one or more spring clip portions 384 configured to engage the corresponding rim portion of the slot 360 to prevent the alignment plate 315 from inadvertently disengaging from the alignment plate receiving slot 360 when the alignment plate 315 is in the first position.

[0054] During assembly and use, the engagement shoulder 364 of the needle holder device 320 is initially oriented vertically, and the needle holder device 320 is inserted into the vertical guide slot 356 and forwardly through the alignment plate 315 when the alignment plate is in the first position. The needle holder device 320 is then rotated 90° and inserted into a selected pair of needle holder device receiving cups 358. The alignment plate 315 then advances to the second position, thereby capturing the needle holder device 320 within a selected parallel path.

[0055] After the puncturing instrument 325 is positioned (e.g., within a selected pair of needle holder device receiving cups 358, locked by the alignment plate 315) within a selected parallel path within the guide tower 310, the guide tower 310 slides forward relative to the guide platform 305 and the ultrasonic probe and engages (e.g., punctures) the patient at a selected location. The guide tower 310 further advances until the tip of the puncturing instrument 325 reaches a desired depth within the patient's body or until the guide tower 310 abuts against the stabilization mechanism 335 at the front of the guide platform 305.

[0056] Consistent with the embodiments described herein, following puncture of the patient, the alignment plate 315 can be returned to its first non-locking position. The needle holder device 320 can then pivot about the needle holder device receiving cup 358 or be removed from the needle holder device receiving cup 358 and moved to a new vertical position without the need for a second puncture.

[0057] FIG. 5A and FIG. 5B are an isometric view and an exploded isometric view, respectively, showing another embodiment of a needle guidance device 500 for use with an ultrasonic probe, which is consistent with the embodiments described herein. As shown, the 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, the guide platform 505 can be fixed to an ultrasonic probe (not shown), and the guide tower 510 can be slidably coupled to the guide platform 505. Prior to administration, a needle, such as a trocar needle, or other type of puncture instrument 525 may be coupled to the needle holder device 520 as described below. In some embodiments, the puncture instrument 525 can be formed as an integral unit with the needle holder device 520, such that the puncture instrument 525 cannot be removed independently of the needle holder device 520. The combined needle holder device 520 and puncture instrument 525 may be oriented within one of a plurality of path positions within the guide tower 510. During use, the guide tower 510 slides forward relative to the guide platform 505 and the ultrasonic probe and advances to engage the patient at a selected location. When the procedure is complete, the guide tower 510 retracts relative to the guide platform 505 and the ultrasonic probe to remove the puncture instrument 525 from the patient.

[0058] As shown in FIG. 5B, the guide platform 505 includes a mounting portion 530, a strap portion 535, and a fixing portion 540. As described herein, the mounting portion 530 can include a shape extruded in the longitudinal direction to support the guide tower 510 in an adjustable configuration in the longitudinal direction. For example, as shown in FIG. 5B, the side edges of the mounting portion can form a pair of side rails 533. As described below, the side rails 533 are configured to be slidably received within corresponding side rails 554 or channels within the guide tower 510 as shown in FIG. 5A. During use, to prevent the guide tower 510 from moving too loosely relative to the mounting portion 530, the tolerance of each side rail 533 may be such that there is a frictional relationship that resists unwanted movement between the mounting portion 530 and the guide tower 510. In some embodiments, the relative dimensions of the mounting portion 530 can be configured such that the frictional resistance increases at the rear end to prevent the guide tower 510 from being inadvertently removed from the mounting portion 530. In other embodiments, one or more stop portions, detents, or engagement portions may be provided on one or more of the rails 533 and 554 to limit relative movement between the guide tower 510 and the guide platform 505. For example, as shown in FIGS. 5A-5B, the rear end of the mounting portion 530 may include an elastic stop clip 534 that prevents removal of the guide tower 510 from the guide platform 505. If removal is necessary, the clip 534 can be manually deflected downward to slide the guide tower 510 out of the guide platform 505.

[0059] As shown in FIGS. 5A and 5B, the front end of the attachment portion 530 can include a stabilization mechanism 536 that projects vertically upward from the attachment portion 530. In the illustrated embodiment, the stabilization mechanism 536 includes a large central opening or window 537 therein so that the puncture instrument 525 can move freely therethrough. In other embodiments, the stabilization mechanism 536 may be provided on one side surface of the guide platform 505 with respect to the puncture instrument path such as the stabilization mechanism 636 and the opening 637 shown in FIG. 6C. The stabilization mechanism 636 shown in FIG. 6C includes a central opening 637, but in other embodiments, since the puncture instrument 525 does not project through the stabilization mechanism but rather proceeds laterally, the central opening may not be provided.

[0060] In use, the front end of the stabilization mechanism 536 is configured to engage a patient (e.g., the perineum of the patient) to stabilize the relationship between the needle guidance device 500 and the patient. Further, the rear end of the stabilization mechanism 536 further provides a clear stop against the longitudinal movement of the guide tower 510 relative to the guide platform 505. In some embodiments, the stabilization mechanism 536 can further include an indicator display (e.g., numbers, marks, etc.) that enables quick confirmation of the needle path at the penetration point. In some embodiments, such an indicator display may be provided in a glow-in-the-dark printing format to facilitate visibility during use.

[0061] As shown in FIGS. 5A and 5B, the strap portion 535 includes a pair of strap members 539 and 540, each of the strap members being configured to at least substantially correspond to the curved outer shape of at least a portion of a transducer probe (not shown). In one embodiment, the strap members 539 / 540 are integrally formed with the attachment portion 530 as shown in FIGS. 5A - 6B. In other embodiments, the side surface of the attachment portion 530 can include slots for receiving the upper surfaces of the strap members 539 / 540 and pivotally fixing them to the attachment portion 530.

[0062] Consistent with the embodiments described herein, the distance between the strap portion 535 and the front end / stabilization mechanism 536 of the attachment portion 530 is selected to optimize the operating length of the ultrasonic probe and needle guidance device 500. For example, in one embodiment, the distance between the front end of the strap portion 535 and the rear end of the stabilization mechanism 536 may range from about 1.27 to 2.54 cm (0.5 to 1 inch), and preferably may be a distance of 1.745 cm (0.687 inch).

[0063] As shown, the stop members 539 / 540 form a V-platform that can be securely attached to various ultrasonic probes having different diameters and shapes. The strap members 539 / 540 terminate together at the fixed portion 546. As shown in FIGS. 5A and 5B, in one embodiment, the fixed portion 546 can include a collar portion 547 formed at the end of the strap member 540 and a lock assembly 549 coupled to the end of the strap member 539. The collar portion 547 can include an opening 548 adapted to receive a portion of the lock assembly 549 while attaching the guide platform 505 onto the ultrasonic probe, as will be described in more detail below with respect to FIGS. 6A and 6B.

[0064] FIGS. 6A and 6B are an isometric view and a reverse isometric view, respectively, of the guide platform 505 in a configuration where the latch is released. As shown in FIGS. 5A, 5B, 6A, and 6B, the lock assembly 549 includes a lock attachment portion 600, a threaded rod 602, and a thumb screw element 604. As shown in FIG. 6A, the lock attachment portion 600 includes a portion of the end of the strap member 539 that forms a receiving channel or opening for receiving the first end 606 of the threaded rod 602 therein. In one embodiment, the lock attachment portion 600 includes a pair of opposing slotted openings 601 for receiving the corresponding portion of the threaded rod 602, as will be described below.

[0065] As shown in FIG. 6A, the threaded rod 602 includes a generally cylindrical threaded configuration having a first end 606 that engages the first strap member 539 and a second end 608 that engages the second strap member 540. A pair of pivot elements 610 project outwardly from both sides of the first end 606 of the threaded rod 602. The pivot elements 610 are configured to be received within the openings 601 of the lock attachment portions 600 of the first strap member 539.

[0066] As shown in FIG. 6B, the thumb screw element 604 includes a threaded receiving opening 612, a ball-type engagement interface 614, and a knob portion 616. The receiving channel 612 is configured to receive the second end 608 of the threaded rod 602. The ball-type engagement interface 614 is configured to engage the hemispherical engagement portion 615 within the collar portion 547 in a ball-and-socket manner. Such a ball-and-socket type clamp interface promotes a more uniform clamping force and feel over a plurality of clamping angles that need to be adapted to clamp various probe shaft sizes and shapes.

[0067] To secure the guide platform 505 to the ultrasonic probe, the threaded rod 602 rotates about the pivot elements 610 until the second end 606 of the threaded rod 602 enters the opening 548 within the collar portion 547. The knob portion 616 then advances along the threaded rod 602 such that the ball-type engagement interface 614 engages the hemispherical engagement portion 615 within the collar 547.

[0068] In accordance with the embodiments described herein, one or more of the strap members 539 / 540 may be formed with a thickness sufficient to allow for flexure. In some embodiments, only one of the strap members 539 / 540 is formed to allow for flexure and the other strap member 539 / 540 has a generally rigid configuration.

[0069] Figures 7A, 7B, and 7C are side, rear, and isometric views of the guide tower 510 that are consistent with the embodiments described herein. As shown in FIGS. 5A, 5B, and 7A-7C, as described herein, the guide tower 510 has a substantially frame-like shape for providing a stable interface to the guide platform 505 and a plurality of spaced-apart needle guide paths for engaging the needle holder device 520 (as shown by line A-A in FIG. 5A, relative to the longitudinal orientation of the ultrasonic probe). In particular, the guide tower 510 includes a platform interface portion 550 and a guide path portion 552 that projects upward from the platform interface portion 550. The lower surface of the platform interface portion 550 includes opposing side rails 554 that project downward from the lower surface of the platform interface portion 550 and are configured to interface and connect with side rails 533 within the guide platform 505. In some embodiments, the side rails 554 have an opposing C-shaped configuration that captures the side rails 533 and prevents relative radial movement between the guide platform 505 and the guide tower 510 while allowing longitudinal movement that slides therebetween when the side rails 533 within the attachment portion 530 are positioned within the side rails 554 within the guide tower 510.

[0070] In one embodiment consistent with the examples described herein, the guide path portion 552 projects substantially vertically upward from the platform interface portion 550. As shown in FIG. 7B, the guide path portion 552 includes a vertical guide slot 556, a plurality of needle holder device receiving cups 558, a plurality of spring element portions 560, a guide tower engagement and display portion 561, an alignment plate receiving slot 562, and an alignment plate adjustment assembly 563.

[0071] The vertical guidance slot 556 is centrally aligned within the guide tower 510 so as to be in line with the longitudinal ultrasonic imaging crystal oscillator within the transducer, and the needle guidance device 500 is fixed such that the puncture instrument 525 designed to penetrate is consistently visualized within the imaging plane under typical imaging conditions. As shown in FIG. 9B, the vertical guidance slot 556 extends substantially throughout the height of the guide tower 510 such that the inserted puncture instrument can move freely between the positions of the needle holder device receiving cups.

[0072] As shown in FIGS. 5B, 7B, and 7C, the needle holder device receiving cup 558 includes a plurality of pairs of aligned recesses or openings disposed within the guidance path portion 552 and on the opposite side of the vertical guidance slot 556. Consistent with the embodiments described herein, each needle holder device receiving cup 558 may include a generally arcuate or grooved opening configured to receive respective portions of the needle holder device, as described below. Consistent with the examples described herein, the spring element portion 560 includes a plurality of pairs of resilient mechanisms disposed adjacent to each needle holder receiving cup 558. As shown in FIG. 7C, the spring element portion 560 projects rearward and includes a narrow deflection portion 566 and a larger engagement end portion 568.

[0073] As described below, the spring element portion 560 is configured to engage a portion of the needle holder device 520 so as to removably capture the needle holder device within a selected pair of needle holder receiving cups 558. Each pair of needle holder device receiving cups 558 / spring element portions 560 are spaced vertically relative to the adjacent pair of needle holder device receiving cups 558 / spring element portions 560 to provide a plurality of mounting positions for the needle holder device 520, as described in further detail below. In this example, five pairs of needle holder device receiving cups 558 are provided, although other embodiments may include fewer needle holder device receiving cups 558 or additional needle holder device receiving cups 558 may be provided.

[0074] As shown in FIGS. 5B, 7B, and 7C, the guide tower engagement and display portion 561 may include a portion of the guide tower 510 that projects outwardly adjacent to the receiving cup 558 / spring element portion 560. The guide tower engagement and display portion 561 can form an engagement surface for use in advancing or retracting the guide tower 510 along the guide platform 505. Further, the guide tower engagement and display portion 561 may include a display and / or mark indicating the relative position of the inserted needle holder device 520.

[0075] As shown in FIG. 5B, the alignment plate receiving slot 562 is formed on one side of the guide tower 510 at a position behind the needle holder device receiving cup 558. The alignment plate receiving slot 562 is sized to receive the alignment plate 515 therein. The alignment plate adjustment assembly 563 is formed on the opposite side of the guide tower 510 from the alignment plate receiving slot 562 and includes a threaded opening 570 and an adjustment knob 590. The threaded opening 570 is laterally aligned with the alignment plate receiving slot 562 and is configured to receive a threaded bolt 592 that projects from the adjustment knob 590.

[0076] When the needle holder device 520 and the corresponding puncture instrument 525 are received within a particular pair of needle holder device receiving cups 558 / spring element portions 560, by rotating the adjustment knob 590, the alignment plate 515 can be advanced within the alignment plate receiving slot 562 to securely support the puncture instrument 525 at a selected position / orientation relative to the ultrasonic probe. Consistent with the embodiments of FIGS. 5A - 7E, the alignment plate 515 can securely hold the puncture instrument 525 along any selected path.

[0077] Figures 7D and 7E are, respectively, an isometric view and a top view of a needle holder device 520 that conforms to the embodiments described herein. As shown in FIGS. 5A, 5B, 62D, and 7E, the needle holder device 520 includes an adapter for coupling to the guide tower 510 and for receiving the puncturing instrument 525. In some embodiments, the needle holder device 520 can be configured to receive the puncturing instrument through the needle holder device 520. In one embodiment, the needle holder device 520 includes a body portion 700, an engagement shoulder 702, an alignment plate engagement portion 704, and a needle receiving portion 706. As shown, the body portion 700 includes a generally tubular element having a through central opening 708. The body portion 700 is configured to receive the puncturing instrument 525 within the central opening 708. In some embodiments, the body portion 700 can include engagement elements 707 (e.g., tabs, ears, etc.) to facilitate insertion into and operation within the guide tower 510.

[0078] The front end of the body portion 700 terminates at the engagement shoulder 702, and the rear end of the body portion 700 terminates at the needle receiving portion 706, which can be manipulated to effect proper placement of the needle holder device 520 during use. For example, the engagement elements 707 of the body portion 700 can be used to insert the engagement shoulder 702 into or remove it from the needle holder device receiving cup 558, to rotate the needle holder device 520 to enable removal from the guide tower 510, to move the needle holder device 520 up and down between the holder device receiving cups 558, or to affect manual angular deflection of the needle holder device 520. In some embodiments, the needle receiving portion 706 includes one or more rotational fixation elements, such as slots, keys, clips, screws, etc., for receiving corresponding structures within the puncturing instrument 525 to prevent axial rotation and / or longitudinal movement of the puncturing instrument 525 relative to the needle holder device 520.

[0079] The engagement shoulder 702 includes a pair of generally cylindrical elements that project perpendicularly outward from both ends of the front end of the main body 700. As shown in FIG. 5A and generally as described above, the engagement shoulder 702 is configured to be received within a selected pair of needle holder device receiving cups 558 during use. The cylindrical configuration of the engagement shoulder 702 allows for rotation of the needle holder device 520 above and below within the receiving cup 558 via the main body 700, if desired, prior to advancing the alignment plate 515 within the alignment plate receiving slot 562, thereby fixing the angular orientation of the needle holder device 520. In some embodiments, the engagement shoulder 702 includes an angle limiting portion 716 that projects rearwardly from the engagement shoulder 702 and is configured to engage a portion of the needle holder device receiving cup 558 to limit the rotational movement of the needle holder device 520 within the needle holder device receiving cup 558.

[0080] As shown in FIGS. 5A and 7E, the alignment plate engagement portion 704 is formed within the main body 700 and includes a generally rectangular configuration for engaging a portion of the alignment plate at a specific path location. The alignment plate engagement portion 704 can further include a parallel path alignment mechanism 718 provided longitudinally on one side thereof, as shown in FIG. 7D. As described below, the parallel path alignment mechanism 718 can be configured to securely engage one of a plurality of detents or notches 594 within the alignment plate corresponding to the needle holder device receiving cup 558 / spring element portion 560, as described below.

[0081] As shown in FIG. 5B, the alignment plate 515 includes a body portion 576, a freely movable portion 579, and a needle holder device engaging portion 580. Generally, the alignment plate body portion 576 includes a substantially flat element sized to be received within the alignment plate receiving slot 562. Consistent with the embodiments described herein, the freely movable portion 579 includes an opening through the alignment plate 515 that allows for free movement of the needle holder device 520. The needle holder device engaging portion 580 includes the inner surface of the freely movable portion 579 configured to clampingly engage the alignment plate engaging portion 704 of the needle holder device 520. As briefly described above, the needle holder device engaging portion 580 may include a plurality of notches or detents 594 corresponding to the needle holder device receiving cup 558 / spring element portion 560. The notches 594 are configured to engage the path alignment mechanism 718 within the alignment plate engaging portion 704 to maintain the needle holder device in a selected parallel path orientation. In some embodiments (not shown), the alignment plate body portion 576 may include a tab or other engaging means extending through the alignment plate slot 562 for use in moving the guide tower 510 longitudinally back and forth on the guide platform 505.

[0082] When the user desires to establish a parallel needle path, the user can rotate the needle holder device 520 so that the parallel path alignment mechanism 718 is aligned with a particular detent or notch 594 corresponding to the desired parallel path. When the knob 590 is tightened, the alignment plate 515 is biased toward the needle holder device 520 and can seat the parallel path alignment mechanism 718 within the particular detent or notch 594. By continuing to tighten the knob 592, the needle holder device 520 is effectively clamped in the desired position.

[0083] Conversely, when the user desires to establish a non-parallel needle path, the user can rotate the needle holder device 520 to a desired non-parallel orientation. In such an orientation, the parallel path alignment mechanism 718 is not aligned with any of the notches 594. When the knob 590 is tightened, the alignment plate 515 is biased toward the needle holder device 520, clamping the needle holder device engagement portion 580 to the path alignment mechanism 704 / 718. By continuing to tighten the knob 590, the needle holder device 520 is effectively clamped in the desired position.

[0084] FIG. 8 is an isometric view of an alternative embodiment of the guide tower 510 and alignment plate 515 that is consistent with the embodiments described herein. As shown in FIG. 8, in contrast to the embodiments of FIGS. 5A-7E, the guide tower 510 includes an alignment plate adjustment assembly 800 formed on the side of the guide tower 510 opposite the alignment plate receiving slot 562. As shown, the alignment plate adjustment assembly 800 includes an opening 802, an adjustment knob retaining channel 804, and an adjustment knob 806. The opening 802 is configured to receive a threaded bolt 808 that protrudes from the alignment plate 515. In this embodiment, the adjustment knob 806 includes a flange portion 810 and a threaded opening 812 for receiving the threaded bolt 808. The flange portion 810 is received within the adjustment knob retaining channel 804, holding the adjustment knob 806 in a fixed lateral relationship with respect to the guide tower 510 while allowing rotation of the adjustment knob 806 and moving the alignment plate 515 laterally within the alignment plate receiving slot 562.

[0085] When the needle holder device 520 and the corresponding puncture instrument 525 are received within a specific pair of needle holder device receiving cups 558 / spring element portions 560, the adjustment knob 806 can advance the alignment plate 515 within the alignment plate receiving slot 562 to securely support the puncture instrument 525 in a selected position / orientation relative to the ultrasonic probe. Consistent with the embodiments of FIGS. 5A-7E, the alignment plate 515 can securely hold the puncture instrument 525 in any selected path.

[0086] The puncturing device 525 is installed within a selected parallel path within the guide tower 510 (e.g., within a selected pair of needle holder device receiving cups 558 and locked by the alignment plate 515). After installation, the guide tower 510 slides forward relative to the guide platform 505 and the ultrasonic probe and advances to engage (e.g., puncture) the patient at the selected position. The guide tower 510 further advances until the tip of the puncturing device 525 reaches the desired depth within the patient's body or until the guide tower 510 abuts against the stabilization mechanism 536 at the front of the guide platform 305.

[0087] In accordance with the embodiments described herein, following the puncturing of the patient, the adjustment knob 590 can be rotated to return the alignment plate 515 to its first non-locking position. Subsequently, the needle holder device 520 can pivot about the needle holder device receiving cup 558 or be removed from the needle holder device receiving cup 558 and moved to a new vertical position without the need for a second puncture.

[0088] The foregoing description of the exemplary embodiments provides illustration and description, but is not intended to be exhaustive or to limit the embodiments described herein to the exact form disclosed. Modifications and variations are possible in light of the above teachings or may be obtained from practice of the examples.

[0089] Having described the present invention in detail, it is clearly understood by those skilled in the art that the present invention can be modified without departing from the spirit thereof. Various changes in form, design, or arrangement can be made to the present invention without departing from the spirit and scope thereof. Accordingly, the above description is to be regarded as illustrative rather than restrictive, and the true scope of the present invention is defined by the following claims.

[0090] Elements, acts, or instructions used in the description of this application should not be construed as important or essential to the present 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 "at least partially based on" unless otherwise specified.

[0091] In the claims, the use of ordinal numbers such as "first," "second," "third," etc. to modify claim elements does not itself include any particular priority, precedence, or order of one claim element over another claim element, the chronological order in which acts of a method are performed, the chronological order in which instructions executed by an apparatus are executed, etc., but is used only as a label for distinguishing one element having a particular name from another element having the same name (but for the use of the ordinal number).

Claims

1. A guide platform configured to be removably attached to an ultrasonic probe, A guide tower slidably coupled to the guide platform, A needle holder device removably coupled to the guide tower, A puncture instrument guiding device comprising: The guide tower projects upward from the guide platform, The guide tower includes a vertical guiding slot and a plurality of vertical mounting positions at a plurality of vertical positions spaced apart within the vertical guiding slot, each vertical mounting position of the plurality of vertical mounting positions engaging the needle holder device at a corresponding vertical position within the vertical guiding slot, The needle holder device, A body portion having a central opening extending therethrough, And a pair of engaging shoulders extending outward from the body portion, Further comprising, Each vertical mounting position within the guide tower includes a pair of needle holder device receiving cups located on opposite sides of the vertical guiding slot that define a vertical distance from the ultrasonic probe, Each of the pair of needle holder device receiving cups is configured to pivotally receive a corresponding engaging shoulder of the pair of engaging shoulders within the needle holder device, A puncture instrument guiding device.

2. The guide platform, An attachment portion for engaging the guide tower, And a strap portion coupled to the attachment portion, Comprising, The strap portion is removably attachable to the ultrasonic probe. The puncture instrument guiding device according to claim 1.

3. The attachment portion includes at least one side rail for slidably engaging at least one corresponding side rail on the guide tower. The puncture instrument guiding device according to claim 2.

4. The lower surface of the attachment portion is configured to engage the ultrasonic probe, The lower surface of the attachment portion includes a longitudinal channel for receiving an accessory device through the longitudinal channel. The puncture instrument guiding device according to claim 2.

5. The upper surface of the attachment portion includes a stabilizing element configured to engage at least one of a patient or the guide tower. The puncture instrument guiding device according to claim 2.

6. The puncture instrument guiding device according to claim 2, wherein an upper surface of the mounting portion includes a stop element for preventing relative movement between the guide tower and the guide platform.

7. The upper surface of the mounting portion includes a plurality of fixing elements protruding upward from the upper surface of the mounting portion, and each of the plurality of fixing elements is configured to engage a spring clip element at each of a plurality of positions of the guide tower as the guide tower advances through each of the plurality of positions relative to the mounting portion, so as to facilitate removable fixing of the guide tower to the guide platform at the lower surface of the guide tower. The puncture instrument guiding device according to claim 2.

8. The lower surface of the mounting portion is configured to engage with the ultrasonic probe. The puncture instrument guiding device according to claim 2, wherein the lower surface of the mounting portion includes a longitudinal channel for receiving an accessory device through the longitudinal channel.

9. The strap portion further includes a first lateral portion protruding from a first side of the mounting portion and a second lateral portion protruding from a second side of the mounting portion. and the first lateral portion includes a collar portion having an opening therein. The second lateral portion includes a threaded portion and a clamp nut threadedly coupled to the threaded portion. During assembly, the opening of the collar portion receives the threaded portion, and the clamp nut advances toward the threaded portion to engage the collar portion. The puncture instrument guiding device according to claim 2.

10. Each of the pair of needle holder device receiving cups includes an angle restraining portion, and at least one of the pair of engaging shoulders in the needle holder device is configured to engage an angle restraining portion for restricting pivotal rotation of the needle holder device relative to the pair of needle holder device receiving cups. The puncture instrument guiding device according to claim 1.

11. The puncture instrument guiding device according to claim 1, further comprising a pair of spring element portions disposed adjacent to the pair of needle holder device receiving cups, the pair of spring element portions including elastic elements configured to removably capture the needle holder device within adjacent pairs of needle holder device receiving cups.

12. The puncture instrument guiding device further includes an alignment plate, and the guide tower includes an alignment plate receiving slot extending therethrough in a lateral direction.

12. The puncture instrument guiding device further includes an alignment plate. The guide tower includes an alignment plate receiving slot extending therethrough in a lateral direction. The alignment plate includes a main body portion and a plurality of path holding elements. By inserting the alignment plate into the alignment plate receiving slot, one of the plurality of path holding elements corresponding to the pair of needle holder device receiving cups is aligned with the pair of needle holder device receiving cups, defining a corresponding path passing through the vertical guiding slot. The puncture instrument guiding device according to claim 1.

13. One of the plurality of path holding elements includes a path holding channel formed in the main body portion of the alignment plate. The path holding channel is aligned with the pair of needle holder device receiving cups. The puncture instrument guiding device according to claim 12.

14. It further includes an alignment plate comprising a main body portion, a freely movable portion, and a plurality of path holding elements protruding into the freely movable portion, wherein one of the plurality of path holding elements corresponds to the pair of needle holder device receiving cups. The guide tower includes an alignment plate receiving slot extending through laterally. An alignment plate adjustment knob. And comprises. By rotating the alignment plate adjustment knob, the alignment plate engages with the main body portion of the needle holder device and holds the needle holder device at a selected position. The puncture instrument guiding device according to claim 1.

15. The main body portion of the needle holder device further includes a parallel path alignment mechanism. One of the plurality of path holding elements is configured to selectively engage with the parallel path alignment mechanism and hold the needle holder device in the direction of parallel paths. The puncture instrument guiding device according to claim 14.

16. A guide platform having a surface and configured to be removably attached to an ultrasonic probe. A guide tower extending from the surface of the guide platform and configured to slide between a first position and a second position along at least a part of the length of the surface. A puncture instrument guiding device comprising. The guide tower is A single vertical guiding slot. A plurality of pairs of aligned needle holder device receiving cups spaced at a plurality of vertical positions on the guide tower, each pair of aligned needle holder device receiving cups of the plurality of pairs of aligned needle holder device receiving cups including a first needle holder device receiving cup disposed on a first lateral side of the vertical guide slot and a second needle holder device receiving cup disposed on a second lateral side of the vertical guide slot opposite the first lateral side, the plurality of pairs of aligned needle holder device receiving cups. A needle holder device removably coupled to the guide tower, the needle holder device including a body portion and a pair of engaging shoulders extending outwardly from the body portion. Comprising. Each pair of aligned needle holder device receiving cups is configured to receive the pair of engaging shoulders such that the needle holder device is pivotable between a first path angle relative to the ultrasonic probe and a second path angle different from the first path angle relative to the ultrasonic probe at a corresponding vertical position among the plurality of vertical positions, and to hold the needle holder device in the vertical guide slot at the corresponding vertical position, and each pair of aligned needle holder device receiving cups is arcuate. A puncture instrument guiding device.

Images