Puncture device guide

Abstract

The puncture device guide has a guide body member configured to be fixedly attached to an ultrasonic probe, and a lock assembly coupled to the guide body to fix the guide body to the ultrasonic probe. The guide body member has a guide tube with a central opening extending therein for receiving a puncture device, a front fixing member for engaging a front portion of the ultrasonic probe, and a rear fixing member for engaging a rear portion of the ultrasonic probe. The lock assembly is configured to be movably coupled to the guide body member between a locked configuration and an unlocked configuration.

Description

Technical Field

[0001] The present invention relates to a guidance device for a puncture device used together with a medical imaging device, and more particularly to a device for guiding a puncture device to a reproducible position with respect to a probe of a medical imaging device.

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 examine and evaluate the condition of human tissues and organs. As a result, diagnostic and treatment protocols have been developed that enable many very successful and safe procedures to be performed while minimizing the impact on the patient. For example, ultrasonic probes have become a generally accepted modality for examining the lumens of the gastrointestinal and reproductive tracts of humans and animals for performing routine examinations and for identifying evidence of areas of interest in tumors and other tissues.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0004] In the following detailed description, reference is made to the accompanying drawings. The same reference numbers in different drawings can identify the same or similar elements. Also, the following detailed description does not limit the present invention.

[0005] The implementations described herein relate to a guidance device that facilitates placement of a piercing device (e.g., a needle) at a defined position relative to an ultrasonic probe. In particular, the guidance device described below includes components configured to be releasably fixed to the ultrasonic probe in a defined configuration relative to the ultrasonic probe.

[0006] For example, in one implementation, the ultrasonic probe can be an intracavitary ultrasonic probe, and the guidance device can be configured to facilitate guidance of a needle, such as a biopsy needle, at a predefined orientation or angle with respect to the ultrasonic probe. Consistent with the examples described herein, the needle guidance device can be releasably locked to the ultrasonic probe prior to use.

[0007] Figures 1A and 1B are a top view and a left side view, respectively, showing an example of a needle guidance device 110 for use with an ultrasonic probe 100 in an assembled configuration, i.e., a locked configuration, consistent with the examples described herein. Figures 1C and 1D are a left side view and a right rear isometric view, respectively, showing the needle guidance device 110 and the ultrasonic probe 100 in an open configuration, i.e., a configuration prior to assembly.

[0008] Consistent with the embodiments described herein, the ultrasonic probe 100 and the needle guidance device 110 are configured to be lockably coupled to each other such that the needle guidance device 110 is fixed to the ultrasonic probe 100 during use. As shown in FIGS. 1A - 1D, the ultrasonic probe 100 includes one or more features that facilitate cooperative engagement with the needle guidance device 110. Specifically, the ultrasonic probe 100 includes a generally tubular body 101 having a front end 102, an intermediate portion 103, and a rear end 104. As shown, the front end 102 includes a generally spherical portion having a diameter greater than or similar to the diameter of the intermediate portion 103. The rear end 104 includes a handle portion 105 and a transition portion 106 where the shape of the body 101 transitions between the handle portion 105 and the intermediate portion 103. As shown, the transition portion 106 includes a portion having a diameter greater than at least the diameters of the intermediate portion 103 and the handle portion 105. The intermediate portion may be the same size as the handle portion.

[0009] Consistent with the implementations described herein, the transition portion 106 includes a pair of positioning pockets 107 disposed on both sides of the probe 100 and a positioning rib 108 protruding from the upper surface of the probe 100. The positioning pockets 107 include forward-facing cavities having a rear wall that effectively functions as a stop to prevent further axial advancement of the ultrasonic probe 100 relative to the needle guidance device 110. As will be described in additional detail below, the positioning pockets 107 and the positioning rib 108 jointly facilitate the placement and fixation of the needle guidance device 110 to the ultrasonic probe 100 during assembly.

[0010] The needle guidance device 110 includes a guide body 112 and a lock assembly 114. The guide body 112 includes a guide tube 116, a front fixing member 118, and a rear fixing member 120. FIGS. 1E-1G are a left side view, a top view, and a cross-sectional view of the guide body 112, respectively. The cross-sectional view of FIG. 1G is taken along line A-A of FIG. 1F.

[0011] As shown in FIGS. 1E-1G, the guide tube 116 has a generally cylindrical configuration with a central opening 122. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementations, guide tubes 116 with different sized openings 122 may be provided for different gauge piercing devices. In some embodiments, instead of a closed central opening 122, the guide tube 116 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0012] An intermediate portion of the guide tube 116 includes a cutout 124, as shown in FIG. 1G. The cutout 124 includes a lateral opening 126 that extends therein and is disposed below the central opening 122 of the guide tube 116. As described below, the lateral opening 126 is sized to receive a pivot pin when assembled with the lock assembly 114. In addition, the cutout 124 includes a planar upper portion 128 that forms a stop for engaging a portion of the lock assembly 114, as also described below.

[0013] The front fixing member 118 includes opposing curved arms 130 that project downward from the front portion of the guide tube 116 and are configured to correspond to the shape of the front end 102 of the ultrasonic probe 100. During assembly, the curved arms 130 are configured to engage the front end 102 of the ultrasonic probe 100 to securely center the guide tube 116 longitudinally with respect to the ultrasonic probe 100. Consistent with the embodiments of FIGS. 1A-1G, the curved arms 130 may be configured to extend beyond 180°. In this way, by inserting the front end 102 of the ultrasonic probe 100 into the curved arms 130, the axial position of the front end of the guide tube 116 with respect to the ultrasonic probe 100 is effectively captured. That is, when the front end 102 of the ultrasonic probe 100 is positioned by the curved arms 130, the front end of the guide tube 116 is not radially outwardly pulled from the ultrasonic probe 100.

[0014] Further, the rear fixing member 120 includes a curved arm 132 that projects downward from the guide tube 116 and is configured to engage the outer surface of the transition portion 106 of the ultrasonic probe 100. Consistent with some of the implementations described herein, unlike the curved arm 130 of the front fixing member 118, the curved arm 132 of the rear fixing member 120 includes a positioning element 134 that projects inwardly at the end of the curved arm 132. As shown in FIG. 1A, when assembled, the positioning element 134 slides into and is disposed within the positioning pocket 107 of the transition portion 106 of the ultrasonic probe 100.

[0015] Consistent with the implementations described herein, FIGS. 1H-1K are, respectively, a left side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 114. As shown, the lock assembly 114 includes a lever component 136 and a latch component 138, which together cooperate with the guide tube 116 and the ultrasonic probe 100 to fix the needle guidance device 100 to the ultrasonic probe 100 in the manner described below.

[0016] As shown in FIGS. 1I to 1K, the lever component 136 includes a main body portion 140 having a pair of opposing arms 142 and a guide tube alignment portion 144. The arms 142 are sized to receive at least a portion of the guide tube 116 therebetween, as shown in FIG. 1F. At the front end of each arm 142, an engaging portion 146 for engaging with the cutout portion 124 of the guide tube 116 is included. As shown in FIGS. 1H and 1K, an opening 148 for aligning with the lateral opening 126 of the cutout portion 124 passes through each engaging portion 146. During assembly, the openings 148 and 126 receive the pivot pin 150 therein.

[0017] Consistent with the embodiments described herein, the arm 142 also includes a pivot limiting element 152 configured to limit the range within which the lever component 136 can pivot (swivel) with respect to the guide tube 116. In one implementation, the pivot limiting element 152 includes a downwardly projecting portion 154 through which an opening 156 passes within the arm 142. A limiting pin 158 can be received in the opening 156. The pivot limitation of the lock assembly 114 is determined by the position of the opening 156 relative to the opening 148. In other implementations, the pivot limiting element 152 may include different structures, such as a fixed bar that joins the arm 142 at a position similar to the limiting pin 158.

[0018] As shown in FIGS. 1H and 1K, the arm 142 of the lever component 136 may also include a downwardly projecting rib engaging element 160. As shown in FIG. 1A, when locked to the ultrasonic probe 100, the rib engaging element 160 engages the rear side of the positioning rib 108. When the rib engaging element 160 engages the positioning rib 108 and the positioning element 134 of the rear fixing member 120 engages the positioning pocket 107, the needle guidance device is fixed to the ultrasonic probe 100.

[0019] As shown, the rear end of the lever component 136 includes a guide tube alignment portion 144 for joining the arm 142. As shown in FIG. 1K, the guide tube alignment portion 144 includes an upper guide tube engagement feature 164 and a central opening 166 that are longitudinally arranged to align with the central opening 122 of the guide tube 116 when the latch component 138 engages the lever component 136 and the guide tube 116, as described below. As shown in FIG. 1B, the upper guide tube engagement feature 164 includes a portion that protrudes forward relative to the remainder of the guide tube alignment portion 144. When the lock assembly 114 is latched to the guide tube 116, the upper guide tube engagement feature 164 is configured to engage the upper rear end of the guide tube 116 at a position where the opening 166 is aligned with the opening 122.

[0020] As shown in FIGS. 1B, 1H, and 1K, the guide tube alignment portion 144 further includes downwardly protruding tabs 168a and 168b. The tabs 168a and 168b include openings 170a and 170b formed therein, which function to engage a biasing element of the latch component 138, as described below.

[0021] As shown in FIGS. 1I-1K and FIGS. 1A-1B, the latch component 138 has a generally frame-shaped member 172 configured to engage both the rear portion of the guide tube 116 and the lever component 136. Specifically, as shown, the latch component 138 includes a latch engagement portion 173 and a lower guide tube engagement feature 174. The latch engagement portion 173 projects upward from the frame-shaped member 172 and provides an engagement surface. As described below, a user can operate (i.e., open and close) the latch component 138 using the engagement surface. The frame-shaped member 172 has a cavity 175 for receiving at least a portion of the guide tube alignment portion 144 as shown in FIG. 1A. The frame-shaped member 172 includes a pair of tab engagement elements 176a and 176b in which alignment openings 178a and 178b are formed. The lower guide tube engagement feature 174 projects forward from the front tab engagement element 176a and engages the lower surface of the guide tube 116 when the latch component 138 is in the latched position with respect to the guide tube 116.

[0022] During assembly, the guide tube alignment portion 144 of the lever component 136 is inserted into the cavity 175 such that the tab engagement elements 176a and 176b abut the respective rear surfaces of the tabs 168a and 168b. As shown in FIG. 1J, a rod 180 with a biasing element 182 such as a spring disposed thereon is inserted and fixed within the openings 170a / 170b and 178a / 178b such that the biasing element 182 is disposed between the rear side of the front tab engagement element 176a and the front side of the rear tab 168b.

[0023] To fix the needle guidance device 110 to the ultrasonic probe 100, the surgeon positions the guide tube 116 relative to the ultrasonic probe 100 such that the front fixing member 118 and the rear fixing member of the guide tube 116 engage with the front end 102 and the transition portion 106 of the ultrasonic probe 100, respectively. Then, the guide tube 116 is fixed to the ultrasonic probe 100 by fitting the positioning element 134 into the positioning pocket 107.

[0024] Next, the latch component 138 pulls the latch engagement portion 173 rearward, thereby compressing the biasing element 182 and opening it such that the lower guide tube engagement feature 174 moves rearward relative to the lever component 136. Next, the lever component 136 is pivoted about the pivot pin 150, whereby the rib engagement element 168 engages with the rear side of the positioning rib 108. Next, the latch engagement portion 173 is released, and the biasing element 182 moves the lower guide tube engagement feature 174 forward relative to the lever component 136. In its forward position, the lower guide tube engagement feature 174 engages with the lower surface of the guide tube 116, and the upper guide tube engagement feature 164 engages with the upper surface of the guide tube 116, effectively fixing the guide tube 116 to the ultrasonic probe 100.

[0025] Consistent with the embodiments described herein, the central opening 166 of the guide tube alignment portion 144 aligns with the central opening 122 of the guide tube 116 only when the guide tube 116 is firmly latched to the ultrasonic probe, preventing premature or unsafe use of the needle guidance device 110.

[0026] Once the procedure is complete, the needle guidance device 110 can be removed from the ultrasonic probe 100 by reversing the above steps. That is, the latch engagement portion 173 can be moved rearward again to release the guide tube 116 from the lower guide tube engagement feature 174. Next, the lever component 136 can be pivoted about the pivot pin 150, whereby the rib engagement element 168 can be disengaged from the positioning rib 108. At this point, the positioning element 134 can be removed from the positioning pocket 107 to remove the needle guidance device 110 from the ultrasonic probe 100.

[0027] Figures 2A and 2B are top and left side views, respectively, showing an example of a needle guidance device 210 for use with an ultrasonic probe 200 in an assembled configuration, i.e., a locked configuration, consistent with the embodiments described herein. Figures 2C and 2D are left side and right rear isometric views, respectively, showing the needle guidance device 210 and the ultrasonic probe 200 in an open configuration, i.e., the configuration before assembly.

[0028] Consistent with the embodiments described herein, the ultrasonic probe 200 and the needle guidance device 210 are configured to be lockably coupled to each other such that the needle guidance device 210 is fixed relative to the ultrasonic probe 200 during use. As shown in FIGS. 2A-2D, the ultrasonic probe 200 includes one or more features that facilitate cooperative engagement with the needle guidance device 210. Specifically, the ultrasonic probe 200 includes a generally tubular body 201 having a front end 202, an intermediate portion 203, and a rear end 204. As shown, the front end 202 includes a generally spherical portion having a diameter larger than the diameter of the intermediate portion 203. The rear end 204 includes a handle portion 205 and a transition portion 206 where the shape of the body 201 transitions between the handle portion 205 and the intermediate portion 203. As shown, the transition portion 206 includes a portion having a diameter at least larger than the diameters of the intermediate portion 203 and the handle portion 205.

[0029] In accordance with the implementation forms described in this specification, the transition part 206 includes a pair of positioning pockets 208 disposed on the upper surface of the probe 200 in front of the portion of the probe 200 having the maximum diameter. The positioning pocket 208 includes a forward-facing cavity having a rear wall inside. As will be described in the following additional details, the positioning pocket 208 facilitates the placement and fixation of the needle guidance device 210 to the ultrasonic probe 200 during assembly.

[0030] The needle guidance device 210 includes a guide body 212 and a lock assembly 214. The guide body 212 includes a guide tube 216, a front fixing member 218, and a rear fixing member 220. FIGS. 2E to 2G are respectively a left side view, a top view, and a cross-sectional view of the guide body 212. The cross-sectional view of FIG. 2G is taken along the line A-A of FIG. 2F.

[0031] As shown in FIGS. 2E to 2G, the guide tube 216 has a generally cylindrical configuration with a central opening 222. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementation forms, guide tubes 216 having different-sized openings 222 may be provided for different gauges of piercing devices. In some embodiments, instead of a closed central opening 222, the guide tube 216 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0032] In an intermediate portion of the guide tube 216, as shown in FIG. 2G, a cutout portion 224 is included. The cutout portion 224 includes a lateral opening 226 that extends therein and is disposed below a central opening 222 of the guide tube 216. As will be described below, the lateral opening 226 is sized to receive a pivot pin when assembled with the lock assembly 214. In addition, the cutout portion 224 includes a planar upper portion 228 that forms a stopper for engaging a part of the lock assembly 214, as will also be described below.

[0033] The front fixing member 218 includes opposing curved arms 230 that project downward from a front portion of the guide tube 216 and include a shape configured to correspond to a shape of a front end 202 of the ultrasonic probe 200. During assembly, the curved arms 230 are configured to engage with the front end 202 of the ultrasonic probe 200 to effectively center the guide tube 216 longitudinally with respect to the ultrasonic probe 200. Consistent with the embodiments of FIGS. 2A-2G, the curved arms 230 may be configured to extend more than 180°. In this way, by inserting the front end 202 of the ultrasonic probe 200 into the curved arms 230, the axial position of the front end of the guide tube 216 with respect to the ultrasonic probe 200 is effectively captured. That is, when the front end 202 of the ultrasonic probe 200 is disposed by the curved arms 230, the front end of the guide tube 216 is not radially outwardly pulled from the ultrasonic probe 200.

[0034] In addition, the rear fixing member 220 includes a curved arm 232 that protrudes downward from the guide tube 216 and is configured to engage with the outer surface of the transition portion 206 of the ultrasonic probe 200. Consistent with the embodiments of FIGS. 2A-2G, the curved arm 232 may be configured to extend more than 180°. In this way, by inserting the rear end 202 of the ultrasonic probe 200 into the curved arm 232, the axial position of the front end of the guide tube 216 with respect to the ultrasonic probe 200 is effectively captured. That is, when the transition portion 206 of the ultrasonic probe 200 is disposed by the curved arm 232, the rear end of the guide tube 216 is not radially outwardly pulled from the ultrasonic probe 200. In addition, as shown in FIG. 2G, after the curved arm 232 engages with the transition portion 206, the curved arm 232 of the rear fixing member 220 can be formed to conform to the surface configuration of the transition portion 206 in order to prevent the guide body 212 from moving longitudinally forward with respect to the ultrasonic probe 200.

[0035] Consistent with the implementations described herein, FIGS. 2H-2K are, respectively, a left side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 214. As shown, the lock assembly 214 includes a lever component 236 and a latch component 238, which together cooperate with the guide tube 216 and the ultrasonic probe 200 to fix the needle guidance device 200 to the ultrasonic probe 200 in the manner described below.

[0036] As shown in FIGS. 2I-2K, the lever component 236 includes a body portion 240 having a pair of opposing arms 242 and a guide tube alignment portion 244. The arms 242 are sized to receive at least a portion of the guide tube 216 therebetween, as shown in FIG. 2F. At the front end of each arm 242, an engagement portion 246 for engaging the cutout portion 224 of the guide tube 216 is included. As shown in FIGS. 2H and 2K, an opening 248 for aligning with the lateral opening 226 of the cutout portion 224 passes through each engagement portion 246. During assembly, the openings 248 and 226 receive the pivot pin 250 therein.

[0037] In accordance with the embodiments described herein, the arm 242 also includes a pivot limiting element 252 configured to limit the range within which the lever component 236 can pivot with respect to the guide tube 216. In one implementation, the pivot limiting element 252 includes a downwardly projecting portion 254 through which an opening 256 passes within the arm 242. A limiting pin 258 can be received in the opening 256. The pivot limitation of the lock assembly 214 is determined by the position of the opening 256 relative to the opening 248. In other implementations, the pivot limiting element 252 may include a different structure, such as a fixed bar that joins the arm 242 at a position similar to the limiting pin 258.

[0038] As shown in FIGS. 2H and 2K, the arm 242 of the lever component 236 may also include a downwardly projecting pocket engagement element 260. When locked to the ultrasonic probe 200, as shown in FIG. 2A, the pocket engagement element 260 fits into the pocket 208. When the pocket engagement element 260 engages the positioning pocket 208 and the rear fixing member 220 securely engages the transition portion 206 of the ultrasonic probe 200, the needle guidance device is fixed relative to the ultrasonic probe 200.

[0039] As shown in the illustration, the rear end of the lever component 236 includes a guide tube alignment portion 244 for joining the arm 242. As shown in FIG. 2K, the guide tube alignment portion 244 includes an upper guide tube engagement feature 264 and a central opening 266 that are longitudinally arranged so as to align with the central opening 222 of the guide tube 216 when the latch component 238 engages with the lever component 236 and the guide tube 216 as described below. As shown in FIG. 2B, the upper guide tube engagement feature 264 includes a portion that protrudes forward with respect to the remaining portion of the guide tube alignment portion 244. When the lock assembly 214 is latched to the guide tube 216, the upper guide tube engagement feature 264 is configured to engage with the upper rear end of the guide tube 216 at a position where the opening 266 is aligned with the opening 222.

[0040] As shown in FIGS. 2B, 2H, and 2K, the guide tube alignment portion 244 further includes downwardly protruding tabs 268a and 268b. The tabs 268a and 268b include openings 270a and 270b formed therein, which function to engage with the biasing elements of the latch component 238 as described below.

[0041] As shown in FIGS. 2I-2K and FIGS. 2A-2B, the latch component 238 has a generally frame-shaped member 272 configured to engage both the rear portion guide tube 216 and the lever component 236. Specifically, as shown, the latch component 238 includes a latch engagement portion 273 and a lower guide tube engagement feature 274. The latch engagement portion 273 projects upward from the frame-shaped member 272 and provides an engagement surface. As described below, a user can operate (i.e., open and close) the latch component 238 using the engagement surface. The frame-shaped member 272 has a cavity 275 for receiving at least a portion of the guide tube alignment portion 244 as shown in FIG. 2A. The frame-shaped member 272 includes a pair of tab engagement elements 276a and 276b in which alignment openings 278a and 278b are formed. The lower guide tube engagement feature 274 projects forward from the front tab engagement element 276a and engages the lower surface of the guide tube 216 when the latch component 238 is in the latched position with respect to the guide tube 216.

[0042] During assembly, the guide tube alignment portion 244 of the lever component 236 is inserted into the cavity 275 such that the tab engagement elements 276a and 276b abut the respective rear surfaces of the tabs 268a and 268b. As shown in FIG. 2J, a rod 280 having a biasing element 282, such as a spring, disposed thereon is inserted and secured within the openings 270a / 270b and 278a / 278b such that the biasing element 282 is disposed between the rear side of the front tab engagement element 276 and the front side of the rear tab 268b.

[0043] To fix the needle guidance device 210 to the ultrasonic probe 200, the surgeon positions the guide tube 216 relative to the ultrasonic probe 200 such that the front fixing member 218 and the rear fixing member of the guide tube 216 engage with the front end 202 and the transition portion 206 of the ultrasonic probe 200, respectively. Then, the guide tube 216 is fixed to the ultrasonic probe 200 by fitting the transition portion 206 into the curved arm 232 of the rear fixing member 220.

[0044] Next, the latch component 238 pulls the latch engagement portion 273 rearward, thereby compressing the biasing element 282 and opening it such that the lower guide tube engagement feature 274 moves rearward relative to the lever component 236. Next, the lever component 236 is pivoted about the pivot pin 250, whereby the pocket engagement element 268 fits into the positioning pocket 208. Next, the latch engagement portion 273 is released, and the biasing element 282 moves the lower guide tube engagement feature 274 forward relative to the lever component 236. In its forward position, the lower guide tube engagement feature 274 engages the lower surface of the guide tube 216, and the upper guide tube engagement feature 264 engages the lower surface of the guide tube 216, effectively fixing the guide tube 216 to the ultrasonic probe 200.

[0045] Consistent with the embodiments described herein, the central opening 266 of the guide tube alignment portion 244 aligns with the central opening 222 of the guide tube 216 only when the guide tube 216 is securely latched to the ultrasonic probe, preventing premature or unsafe use of the needle guidance device 210.

[0046] Once the procedure is complete, the needle guidance device 210 can be removed from the ultrasonic probe 200 by reversing the above steps. That is, the latch engagement portion 273 can be moved rearward again to release the guide tube 216 from the lower guide tube engagement feature 274. Next, the lever component 236 can be pivoted about the pivot pin 250, whereby the pocket engagement element 268 can be disengaged from the positioning pocket 208. At this point, the needle guidance device 210 can be removed from the ultrasonic probe 200 by sliding the guide body 212 forward relative to the ultrasonic probe 200.

[0047] Figures 3A and 3B are a top view and a left side view, respectively, showing an embodiment of a needle guidance device 310 for use with an ultrasonic probe 300 in an assembled configuration, i.e., a locked configuration, consistent with the embodiments described herein. Figures 3C and 3D are a left side view and a right rear isometric view, respectively, showing the needle guidance device 310 and the ultrasonic probe 300 in an open configuration, i.e., a configuration before assembly.

[0048] Consistent with the embodiments described herein, the ultrasonic probe 300 and the needle guidance device 310 are configured to be lockably coupled to each other such that the needle guidance device 310 is fixed relative to the ultrasonic probe 300 during use. As shown in FIGS. 3A-3D, the ultrasonic probe 300 includes one or more features that facilitate cooperative engagement with the needle guidance device 310. Specifically, the ultrasonic probe 300 includes a generally tubular body 301 having a front end 302 and a rear end 304.

[0049] As shown, the front end 302 includes a generally spherical portion having a diameter larger than the diameter of the middle portion between the front end and the rear end. Consistent with the embodiments described herein, the rear portion of the front end 302 includes a pair of front positioning pockets 303 disposed on both sides of the probe 300. The front positioning pockets 303 include rearward-facing cavities having a front wall therein. As will be described in the following additional details, the front positioning pockets 303 facilitate the placement and fixation of the needle guidance device 310 onto the ultrasonic probe 300 during assembly.

[0050] The rear end 304 includes a handle portion 305 and a transition portion 306 where the shape of the body 301 transitions between the handle portion 305 and the middle portion. As shown, the transition portion 306 includes a portion having a diameter at least larger than the diameters of the middle portion and the handle portion 305.

[0051] Consistent with the implementations described herein, the transition portion 306 includes a pair of rear positioning pockets 307 disposed on both sides of the probe 300 and an upper positioning slot 308 formed on the upper surface of the probe 300. The rear positioning pockets 307 include rearward-facing cavities having a front wall therein that effectively functions as a stopper to prevent further axial advancement of the ultrasonic probe 100 relative to the needle guidance device 310. The upper positioning slot 308 is configured to receive a slot engagement member. As will be described in the following additional details, the rear positioning pockets 307 cooperate with the front positioning pockets 303 and the upper positioning slot 308 to facilitate the placement and fixation of the needle guidance device 310 onto the ultrasonic probe 300 during assembly.

[0052] The needle guidance device 310 includes a guide body 312 and a lock assembly 314. The guide body 312 includes a guide tube 316, a front fixing member 318, and a rear fixing member 320. FIGS. 3E-3G are a left side view, a top view, and a cross-sectional view of the guide body 312, respectively. The cross-sectional view of FIG. 3G is taken along line A-A of FIG. 3F.

[0053] As shown in FIGS. 3E-3G, the guide tube 316 has a generally cylindrical configuration with a central opening 322. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementations, guide tubes 316 with different sized openings 322 may be provided for different gauge piercing devices. In some embodiments, rather than a closed central opening 322, the guide tube 316 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0054] An intermediate portion of the guide tube 316 includes a cutout 324, as shown in FIG. 3G. The cutout 324 includes a lateral opening 326 that extends therein and is disposed below the central opening 322 of the guide tube 316. As will be described below, the lateral opening 326 is sized to receive a pivot pin when assembled with the lock assembly 314. In addition, the cutout 324 includes a planar upper portion 328 that forms a stop for engaging a portion of the lock assembly 314, as also described below.

[0055] The front fixing member 318 includes opposing curved arms 330 that project downward from the front portion of the guide tube 316 and are configured to correspond to the shape of the front end 302 of the ultrasonic probe 300. During assembly, the curved arms 330 are configured to engage with the front end 302 of the ultrasonic probe 300 to securely center the guide tube 316 longitudinally with respect to the ultrasonic probe 300. Consistent with the embodiments of FIGS. 3A - 3G, the curved arms 330 end with a front pocket engaging member 331 for engaging the front positioning pocket 303 of the ultrasonic probe 300. In one implementation, the front pocket engaging member 331 has a pair of arms that project forward and substantially perpendicular from the curved arms 330. As shown, the front pocket engaging member 331 is sized to be received in the front positioning pocket 303.

[0056] In this way, by inserting the front end 302 of the ultrasonic probe 300 into the curved arms 330, the axial position of the front end of the guide tube 316 with respect to the ultrasonic probe 300 is effectively captured. That is, when the front end 302 of the ultrasonic probe 300 is positioned by the curved arms 330, the front end of the guide tube 316 is not radially outwardly pulled from the ultrasonic probe 300.

[0057] The rear fixing member 320 also includes a curved arm 332 that projects downward from the guide tube 316 and is configured to engage the outer surface of the transition portion 306 of the ultrasonic probe 300. Consistent with some of the implementations described herein, unlike the curved arm 330 of the front fixing member 318, the curved arm 332 of the rear fixing member 320 includes a positioning element 334 that projects inwardly at the end of the curved arm 332. As shown in FIG. 3A, when assembled, the positioning element 334 slides into and is disposed within the positioning pocket 307 of the transition portion 306 of the ultrasonic probe 300.

[0058] Consistent with the implementations described herein, FIGS. 3H - 3K are, respectively, a left side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 314. As shown, the lock assembly 314 includes a lever component 336 and a latch component 338, which together cooperate with the guide tube 316 and the ultrasonic probe 300 to fix the needle guidance device 300 to the ultrasonic probe 300 in the manner described below.

[0059] As shown in FIGS. 3I - 3K, the lever component 336 includes a body portion 340 having a pair of opposing arms 342 and a guide tube alignment portion 344. The arms 342 are sized to receive at least a portion of the guide tube 316 therebetween, as shown in FIG. 3F. At the front end of each arm 342, an engagement portion 346 for engaging the cutout portion 324 of the guide tube 316 is included. As shown in FIGS. 3H and 3K, an opening 348 for aligning with the lateral opening 326 of the cutout portion 324 passes through each engagement portion 346. During assembly, the openings 348 and 326 receive a pivot pin 350 therein.

[0060] Consistent with the embodiments described herein, the arm 342 also includes a pivot limiting element 352 configured to limit the range within which the lever component 336 can pivot with respect to the guide tube 316. In one implementation, the pivot limiting element 352 includes a downwardly projecting portion 354 through which an opening 356 passes within the arm 342. A limiting pin 358 can be received in the opening 356. The pivot limitation of the lock assembly 314 is determined by the position of the opening 356 relative to the opening 348. In other implementations, the pivot limiting element 352 may include different structures, such as a fixed bar that joins the arm 342 at a position similar to the limiting pin 358.

[0061] As shown in FIGS. 3H and 3K, the arm 342 of the lever component 336 may also include a downwardly projecting slot engagement element 360. As shown in FIG. 3A, when locked to the ultrasonic probe 300, the slot engagement element 360 fits into the positioning slot 308. When the slot engagement element 360 engages the positioning slot 308 and the positioning element 334 of the rear fixing member 320 engages the positioning pocket 307, the needle guidance device is fixed relative to the ultrasonic probe 300.

[0062] As shown, the rear end of the lever component 336 includes a guide tube alignment portion 344 that joins the arm 342. As shown in FIG. 3K, the guide tube alignment portion 344 includes an upper guide tube engagement feature 364 and a central opening 366 that are longitudinally arranged to align with the central opening 322 of the guide tube 316 when the latch component 338 engages the lever component 336 and the guide tube 316, as described below. As shown in FIG. 3B, the upper guide tube engagement feature 364 includes a portion that projects forward relative to the remainder of the guide tube alignment portion 344. When the lock assembly 314 is latched to the guide tube 316, the upper guide tube engagement feature 364 is configured to engage the upper rear end of the guide tube 316 at a position where the opening 366 is aligned with the opening 322.

[0063] As shown in FIGS. 3B, 3H, and 3K, the guide tube alignment portion 344 further includes downwardly projecting tabs 368a and 368b. The tabs 368a and 368b include openings 370a and 370b formed therein, which function to engage the biasing elements of the latch component 338, as described below.

[0064] As shown in FIGS. 3I - 3K and FIGS. 3A - 3B, the latch component 338 has a generally frame - shaped member 372 configured to engage both the rear - portion guide tube 316 and the lever component 336. Specifically, as shown, the latch component 338 includes a latch engagement portion 373 and a lower - guide - tube engagement feature 374. The latch engagement portion 373 projects upward from the frame - shaped member 372 and provides an engagement surface. As will be described below, a user can operate (i.e., open and close) the latch component 338 using the engagement surface. The frame - shaped member 372 has a cavity 375 for receiving at least a portion of the guide - tube alignment portion 344, as shown in FIG. 3A. The frame - shaped member 372 includes a pair of tab - engagement elements 376a and 376b in which alignment openings 378a and 378b are formed. The lower - guide - tube engagement feature 374 projects forward from the front - tab engagement element 376a and engages the lower surface of the guide tube 316 when the latch component 338 is in the latched position with respect to the guide tube 316.

[0065] During assembly, the guide - tube alignment portion 344 of the lever component 336 is inserted into the cavity 375 such that the tab - engagement elements 376a and 376b abut against the respective rear - surfaces of the tabs 368a and 368b. As shown in FIG. 3J, a rod 380 with a biasing element 382, such as a spring, disposed thereon is inserted and fixed within the openings 370a / 370b and 378a / 378b, whereby the biasing element 382 is disposed between the rear - side of the front - tab engagement element 376 and the front - side of the rear - tab 368b.

[0066] To fix the needle guidance device 310 to the ultrasonic probe 300, the surgeon positions the guide tube 316 relative to the ultrasonic probe 300 such that the front fixing member 318 and the rear fixing member of the guide tube 316 engage the front end 302 and the transition portion 306 of the ultrasonic probe 300, respectively. Then, the guide tube 316 is fixed to the ultrasonic probe 300 by fitting the transition portion 306 into the curved arm 332 of the rear fixing member 320.

[0067] Next, the latch component 338 pulls the latch engagement portion 373 rearward, thereby compressing the biasing element 382 and opening it such that the lower guide tube engagement feature 374 moves rearward relative to the lever component 336. Next, the lever component 336 is pivoted about the pivot pin 350, whereby the slot engagement element 368 fits into the positioning slot 308. Next, the latch engagement portion 373 is released, and the biasing element 382 moves the lower guide tube engagement feature 374 forward relative to the lever component 336. In its forward position, the lower guide tube engagement feature 374 engages the lower surface of the guide tube 316, and the upper guide tube engagement feature 364 engages the lower surface of the guide tube 316, effectively fixing the guide tube 316 to the ultrasonic probe 300.

[0068] In accordance with the embodiments described herein, the central opening 366 of the guide tube alignment portion 344 aligns with the central opening 322 of the guide tube 316 only when the guide tube 316 is securely latched to the ultrasonic probe, preventing premature or unsafe use of the needle guidance device 310.

[0069] Once the procedure is complete, the needle guidance device 310 can be removed from the ultrasonic probe 300 by reversing the above steps. That is, the latch engaging portion 373 can be moved rearward again to release the guide tube 316 from the lower guide tube engaging feature 374. Next, the lever component 336 can be pivoted about the pivot pin 350, whereby the slot engaging element 368 can be disengaged from the positioning slot 308. At this point, the needle guidance device 310 can be removed from the ultrasonic probe 300 by sliding the guide body 312 forward relative to the ultrasonic probe 300.

[0070] Figures 4A and 4B are top and left side views, respectively, showing an embodiment of a needle guidance device 410 for use with an ultrasonic probe 400 in an assembled configuration, i.e., a locked configuration, consistent with the embodiments described herein. Figures 4C and 4D are left side and right rear isometric views, respectively, showing the needle guidance device 410 and the ultrasonic probe 400 in an open configuration, i.e., the configuration before assembly.

[0071] Consistent with the embodiments described herein, the ultrasonic probe 400 and the needle guidance device 410 are configured to be lockably coupled to each other such that the needle guidance device 410 is fixed relative to the ultrasonic probe 400 during use. As shown in FIGS. 4A-4D, the ultrasonic probe 400 includes one or more features that facilitate cooperative engagement with the needle guidance device 410. Specifically, the ultrasonic probe 400 includes a generally tubular body 401 having a front end 402, an intermediate portion, and a rear end 404.

[0072] As shown in the figure, the front end 402 includes a substantially spherical portion having a diameter larger than the diameter of the middle portion between the front end and the rear end. The rear end 404 includes a handle portion 405 and a transition portion 406 where the shape of the main body 401 transitions between the handle portion 405 and the middle portion 403. As shown in the figure, the transition portion 406 includes a portion having a diameter at least larger than the diameters of the middle portion 403 and the handle portion 405.

[0073] In accordance with the implementation forms described in this specification, the transition portion 406 includes a pair of positioning pockets 407 disposed on both sides of the probe 400 and a positioning rib 408 formed on the upper surface of the probe 400. The positioning pocket 407 includes a cavity facing rearward with a front wall inside. The positioning rib 408 is configured to engage a part of the needle guidance device 410 during use, as will be described below. However, as shown in FIG. 4A, in contrast to the embodiments of FIGS. 4A - 4K, the positioning rib 408 is disposed on a part of the transition portion 406 behind the positioning pocket 407. As will be described below, the positioning pocket 407 facilitates the placement and fixation of the needle guidance device 410 on the ultrasonic probe 400 in cooperation with the positioning rib 408 during assembly.

[0074] The needle guidance device 410 includes a guide body 412 and a lock assembly 414. The guide body 412 includes a guide tube 416, a front fixing member 418, and a rear fixing member 420. FIGS. 4E - 4G are respectively a left side view, a top view, and a cross - sectional view of the guide body 412. The cross - sectional view of FIG. 4G is taken along line A - A of FIG. 4F.

[0075] As shown in FIGS. 4E - 4G, the guide tube 416 has a generally cylindrical configuration with a central opening 422. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementations, guide tubes 416 with different sized openings 422 may be provided for different gauge piercing devices. In some embodiments, rather than a closed central opening 422, the guide tube 416 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0076] An intermediate portion of the guide tube 416 includes a cutout 424, as shown in FIG. 4G. The cutout 424 includes a lateral opening 426 that extends therein and is disposed below the central opening 422 of the guide tube 416. As will be described below, the lateral opening 426 is sized to receive a pivot pin when assembled with the lock assembly 414. Additionally, the cutout 424 includes a planar upper portion 428 that forms a stop for engaging a portion of the lock assembly 414, as will also be described below.

[0077] The front fixing member 418 includes opposing curved arms 430 that project downwardly from the front portion of the guide tube 416 and are configured to correspond to the shape of the front end 402 of the ultrasonic probe 400. As shown in FIG. 4B, the curved arms 430 may include a forwardly directed prong 431 formed to correspond to the shape on the rear side of the front end 402 to securely position the needle guidance device 410 longitudinally relative to the ultrasonic probe during use, as will be described below.

[0078] In this way, by inserting the front end 402 of the ultrasonic probe 400 into the curved arm 430, the axial position of the front end of the guide tube 416 with respect to the ultrasonic probe 400 is effectively captured. That is, when the front end 402 of the ultrasonic probe 400 is arranged by the curved arm 430, the front end of the guide tube 416 is not pulled radially outward from the ultrasonic probe 400.

[0079] Further, the rear fixing member 420 includes a curved arm 432 that protrudes downward from the guide tube 416 and is configured to engage with the outer surface of the transition portion 406 of the ultrasonic probe 400. Consistent with some implementations described herein, unlike the curved arm 430 of the front fixing member 418, the curved arm 432 of the rear fixing member 420 includes a positioning element 434 that protrudes inward at the end of the curved arm 432. As shown in FIG. 4A, when assembled, the positioning element 434 is slidably disposed within the positioning pocket 407 of the transition portion 406 of the ultrasonic probe 400.

[0080] Consistent with the implementations described herein, FIGS. 4H-4K are, respectively, a left side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 414. As shown, the lock assembly 414 includes a lever component 436 and a latch component 438, which together cooperate with the guide tube 416 and the ultrasonic probe 400 to fix the needle guidance device 400 to the ultrasonic probe 400 in the manner described below.

[0081] As shown in FIGS. 4I - 4K, the lever component 436 includes a body portion 440 having a pair of opposing arms 442 and a guide tube alignment portion 444. The arms 442 are sized to receive at least a portion of the guide tube 416 therebetween, as shown in FIG. 4F. At the forward end of each arm 442, an engagement portion 446 for engaging the cutout portion 424 of the guide tube 416 is included. As shown in FIGS. 4H and 4K, an opening 448 for aligning with the lateral opening 426 of the cutout portion 424 passes through each engagement portion 446. During assembly, the openings 448 and 426 receive a pivot pin 450 therein.

[0082] In accordance with the embodiments described herein, the arm 442 also includes a pivot limiting element 452 configured to limit the range within which the lever component 436 can pivot with respect to the guide tube 416. In one implementation, the pivot limiting element 452 includes a downwardly projecting portion 454 through which an opening 456 passes within the arm 442. A limiting pin 458 can be received in the opening 456. The pivot limitation of the lock assembly 414 is determined by the position of the opening 456 relative to the opening 448. In other implementations, the pivot limiting element 452 may include a different structure, such as a fixed bar joining the arm 442 at a position similar to the limiting pin 458.

[0083] As shown in FIGS. 4H and 4K, the arm 442 of the lever component 436 may also include a downwardly projecting rib engagement element 460. As shown in FIG. 4A, when locked to the ultrasonic probe 400, the rib engagement element 460 engages the front side of the positioning rib 408. When the rib engagement element 460 engages the positioning rib 408 and the positioning element 434 of the rear fixing member 420 engages the positioning pocket 407, the needle guidance device is fixed relative to the ultrasonic probe 400.

[0084] As shown, the rear end of the lever component 436 includes a guide tube alignment portion 444 for joining the arm 442. As shown in FIG. 4K, the guide tube alignment portion 444 includes an upper guide tube engagement feature 464 and a central opening 466 that are longitudinally arranged to align with the central opening 422 of the guide tube 416 when the latch component 438 engages the lever component 436 and the guide tube 416, as described below. As shown in FIG. 4B, the upper guide tube engagement feature 464 includes a portion that projects forward with respect to the remaining portion of the guide tube alignment portion 444. When the lock assembly 414 is latched to the guide tube 416, the upper guide tube engagement feature 464 is configured to engage the upper rear end of the guide tube 416 at a position where the opening 466 is aligned with the opening 422.

[0085] As shown in FIGS. 4B, 4H, and 4K, the guide tube alignment portion 444 further includes downwardly projecting tabs 468a and 468b. The tabs 468a and 468b include openings 470a and 470b formed therein, which function to engage the biasing elements of the latch component 438, as described below.

[0086] As shown in FIGS. 4I-4K and FIGS. 4A-4B, the latch component 438 has a generally frame-shaped member 472 configured to engage both the rear portion guide tube 416 and the lever component 436. Specifically, as shown, the latch component 438 includes a latch engagement portion 473 and a lower guide tube engagement feature 474. The latch engagement portion 473 projects upward from the frame-shaped member 472 and provides an engagement surface. As will be described below, the user can operate (i.e., open and close) the latch component 438 using the engagement surface. The frame-shaped member 472 has a cavity 475 for receiving at least a portion of the guide tube alignment portion 444, as shown in FIG. 4A. The frame-shaped member 472 includes a pair of tab engagement elements 476a and 476b in which alignment openings 478a and 478b are formed. The lower guide tube engagement feature 474 projects forward from the front tab engagement element 476a and engages the lower surface of the guide tube 416 when the latch component 438 is in the latched position with respect to the guide tube 416.

[0087] During assembly, the guide tube alignment portion 444 of the lever component 436 is inserted into the cavity 475 such that the tab engagement elements 476a and 476b abut the respective rear surfaces of the tabs 468a and 468b. As shown in FIG. 4J, a rod 480 with a biasing element 482, such as a spring, disposed thereon is inserted and secured within the openings 470a / 470b and 478a / 478b such that the biasing element 482 is disposed between the rear side of the front tab engagement element 476 and the front side of the rear tab 468b.

[0088] To secure the needle guidance device 410 to the ultrasonic probe 400, the surgeon positions the guide tube 416 relative to the ultrasonic probe 400 such that the front fixing member 418 and the rear fixing member of the guide tube 416 engage the front end 402 and the transition portion 406 of the ultrasonic probe 400, respectively. Then, the guide tube 416 is fixed to the ultrasonic probe 400 by fitting the transition portion 406 into the curved arm 432 of the rear fixing member 420.

[0089] Next, the latch component 438 pulls the latch engagement portion 473 rearward, thereby compressing the biasing element 482 and opening it such that the lower guide tube engagement feature 474 moves rearward relative to the lever component 436. Next, the lever component 436 is pivoted about the pivot pin 450, whereby the slot engagement element 468 fits into the positioning slot 408. Next, the latch engagement portion 473 is released, and the biasing element 482 moves the lower guide tube engagement feature 474 forward relative to the lever component 436. In its forward position, the lower guide tube engagement feature 474 engages the lower surface of the guide tube 416, and the upper guide tube engagement feature 464 engages the lower surface of the guide tube 416, effectively securing the guide tube 416 to the ultrasonic probe 400.

[0090] In accordance with the embodiments described herein, the central opening 466 of the guide tube alignment portion 444 aligns with the central opening 422 of the guide tube 416 only when the guide tube 416 is firmly latched to the ultrasonic probe, preventing premature or unsafe use of the needle guidance device 410.

[0091] Once the procedure is complete, the needle guidance device 410 can be removed from the ultrasonic probe 400 by reversing the above steps. That is, the latch engaging portion 473 can be moved rearward again to release the guide tube 416 from the lower guide tube engaging feature 474. Next, the lever component 436 can be pivoted about the pivot pin 450, whereby the slot engaging element 468 can be disengaged from the positioning slot 408. At this point, the needle guidance device 410 can be removed from the ultrasonic probe 400 by sliding the guide body 412 forward relative to the ultrasonic probe 400.

[0092] Figures 5A and 5B are a top view and a left side view, respectively, showing an embodiment of a needle guidance device 510 for use with an ultrasonic probe 500 in an assembled configuration, i.e., a locked configuration, consistent with the embodiments described herein. Figures 5C and 5D are a left side view and a right rear isometric view, respectively, showing the needle guidance device 510 and the ultrasonic probe 500 in an open configuration, i.e., the configuration before assembly.

[0093] Consistent with the embodiments described herein, the ultrasonic probe 500 and the needle guidance device 510 are configured to be lockably coupled to each other such that the needle guidance device 510 is fixed relative to the ultrasonic probe 500 during use. As shown in FIGS. 5A-5D, the ultrasonic probe 500 includes one or more features that facilitate cooperative engagement with the needle guidance device 510. Specifically, the ultrasonic probe 500 includes a generally tubular body 501 having a front end 502, an intermediate portion, and a rear end 504.

[0094] As shown, the front end 502 includes a generally spherical portion having a diameter larger than the diameter of the middle portion between the front end and the rear end. The rear end 504 includes a handle portion 505 and a transition portion 506 where the shape of the main body 501 transitions between the handle portion 505 and the middle portion 503. As shown, the transition portion 506 includes a portion having a diameter at least larger than the diameters of the middle portion 503 and the handle portion 505.

[0095] In accordance with the implementations described herein, the transition portion 506 includes a pair of positioning pockets 508 disposed on the upper surface of the probe 500 behind the portion of the probe 500 having the maximum diameter. The positioning pockets 508 include cavities facing rearward having a front wall therein. As will be described below, the positioning pockets 508 facilitate the placement and fixation of the needle - guidance device 510 onto the ultrasonic probe 500 during assembly.

[0096] The needle - guidance device 510 includes a guide body 512 and a lock assembly 514. The guide body 512 includes a guide tube 516, a front fixing member 518, and a rear fixing member 520. FIGS. 5E - 5G are, respectively, a left - side view, a top view, and a cross - sectional view of the guide body 512. The cross - sectional view of FIG. 5G is taken along line A - A of FIG. 5F.

[0097] As shown in FIGS. 5E - 5G, the guide tube 516 has a generally cylindrical configuration with a central opening 522. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementations, guide tubes 516 having different - sized openings 522 may be provided for different - gauge piercing devices. In some embodiments, instead of a closed central opening 522, the guide tube 516 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0098] As shown in FIG. 5G, an intermediate portion of the guide tube 516 includes a cutout portion 524. The cutout portion 524 includes a lateral opening 526 that extends therein and is disposed below the central opening 522 of the guide tube 516. As will be described below, the lateral opening 526 is sized to receive a pivot pin when assembled with the lock assembly 514. In addition, the cutout portion 524 includes a planar upper portion 528 that forms a stop for engaging a portion of the lock assembly 514, as will also be described below.

[0099] In accordance with the implementation described herein, the front fixing member 518 includes a ring configuration portion 530 that protrudes downward from the front portion of the guide tube 516 and is configured to correspond to the shape of the front end 502 of the ultrasonic probe 500 to capture the front end 502 of the ultrasonic probe 500 within the front fixing member 518 during use.

[0100] In this embodiment, the rear fixing member 520 also includes a ring configuration portion 532 that protrudes downward from the guide tube 516 and is configured to engage a portion of the transition portion 506 of the ultrasonic probe 500 having the maximum diameter. In addition, as shown in FIG. 5G, after the rear fixing member 520 engages the transition portion 506, the rear fixing member 520 can be formed to conform to the surface configuration of the transition portion 506 to prevent the guide body 512 from moving longitudinally forward with respect to the ultrasonic probe 500.

[0101] In accordance with the implementation described herein, FIGS. 5H-5K are, respectively, a left side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 514. As shown, the lock assembly 514 includes a lever component 536 and a latch component 538, which together cooperate with the guide tube 516 and the ultrasonic probe 500 to fix the needle guidance device 500 to the ultrasonic probe 500 in the manner described below.

[0102] As shown in FIGS. 5I - 5K, the lever component 536 includes a body portion 540 having a pair of opposing arms 542 and a guide tube alignment portion 544. As shown in FIG. 5F, the arms 542 are sized to receive at least a portion of the guide tube 516 therebetween. At the forward end of each arm 542, an engagement portion 546 for engaging the cutout portion 524 of the guide tube 516 is included. As shown in FIGS. 5H and 5K, an opening 548 for aligning with the lateral opening 526 of the cutout portion 524 passes through each engagement portion 546. During assembly, the openings 548 and 526 receive the pivot pin 550 therein.

[0103] Consistent with the embodiments described herein, the arm 542 also includes a pivot limiting element 552 configured to limit the range within which the lever component 536 can pivot with respect to the guide tube 516. In one implementation, the pivot limiting element 552 includes a downwardly projecting portion 554 through which an opening 556 passes within the arm 542. A limiting pin 558 can be received in the opening 556. The pivot limitation of the lock assembly 514 is determined by the position of the opening 556 relative to the opening 548. In other implementations, the pivot limiting element 552 may include different structures, such as a fixed bar joining the arm 542 at a position similar to the limiting pin 558.

[0104] As shown in FIGS. 5H and 5K, the arm 542 of the lever component 536 may also include a downwardly projecting pocket engagement element 560. As shown in FIG. 5A, when locked to the ultrasonic probe 500, the pocket engagement element 560 fits into the positioning pocket 508. When the pocket engagement element 560 engages the positioning pocket 508 and the rear fixing member 520 securely engages the transition portion 506 of the ultrasonic probe 500, the needle guidance device is fixed relative to the ultrasonic probe 200.

[0105] As shown, the rear end of the lever component 536 includes a guide tube alignment portion 544 for joining the arm 542. As shown in FIG. 5K, the guide tube alignment portion 544 includes an upper guide tube engagement feature 564 and a central opening 566 that are longitudinally arranged to align with the central opening 522 of the guide tube 516 when the latch component 538 engages the lever component 536 and the guide tube 516, as described below. As shown in FIG. 5B, the upper guide tube engagement feature 564 includes a portion that protrudes forward relative to the remaining portion of the guide tube alignment portion 544. When the lock assembly 514 is latched to the guide tube 516, the upper guide tube engagement feature 564 is configured to engage the upper rear end of the guide tube 516 at a position where the opening 566 is aligned with the opening 522.

[0106] As shown in FIGS. 5B, 5H, and 5K, the guide tube alignment portion 544 further includes downwardly protruding tabs 568a and 568b. The tabs 568a and 568b include openings 570a and 570b formed therein, which function to engage the biasing elements of the latch component 538, as described below.

[0107] As shown in FIGS. 5I-5K and FIGS. 5A-5B, the latch component 538 has a generally frame-shaped member 572 configured to engage both the rear portion guide tube 516 and the lever component 536. Specifically, as shown, the latch component 538 includes a latch engagement portion 573 and a lower guide tube engagement feature 574. The latch engagement portion 573 projects upward from the frame-shaped member 572 and provides an engagement surface. As will be described below, the user can operate (i.e., open and close) the latch component 538 using the engagement surface. The frame-shaped member 572 has a cavity 575 for receiving at least a portion of the guide tube alignment portion 544, as shown in FIG. 5A. The frame-shaped member 572 includes a pair of tab engagement elements 576a and 576b in which alignment openings 578a and 578b are formed. The lower guide tube engagement feature 574 projects forward from the front tab engagement element 576a and engages the lower surface of the guide tube 516 when the latch component 538 is in the latched position with respect to the guide tube 516.

[0108] During assembly, the guide tube alignment portion 544 of the lever component 536 is inserted into the cavity 575 such that the tab engagement elements 576a and 576b abut the respective rear surfaces of the tabs 568a and 568b. As shown in FIG. 5J, a rod 580 with a biasing element 582, such as a spring, disposed thereon is inserted and fixed within the openings 570a / 570b and 578a / 578b such that the biasing element 582 is disposed between the rear side of the front tab engagement element 576 and the front side of the rear tab 568b.

[0109] To secure the needle guidance device 510 to the ultrasonic probe 500, the surgeon positions the guide tube 516 relative to the ultrasonic probe 500 such that the front fixing member 518 and the rear fixing member of the guide tube 516 engage the front end 502 and the transition portion 506 of the ultrasonic probe 500, respectively. Thereby, the guide tube 516 is fixed to the ultrasonic probe 500 by fitting the transition portion 506 into the curved ring 532 of the rear fixing member 520.

[0110] Next, the latch component 538 pulls the latch engagement portion 573 rearward, thereby compressing the biasing element 582 and opening it such that the lower guide tube engagement feature 574 moves rearward relative to the lever component 536. Next, the lever component 536 is pivoted about the pivot pin 550, whereby the pocket engagement element 560 fits into the positioning pocket 508. Next, the latch engagement portion 573 is released, and the biasing element 582 moves the lower guide tube engagement feature 574 forward relative to the lever component 536. In its forward position, the lower guide tube engagement feature 574 engages the lower surface of the guide tube 516, and the upper guide tube engagement feature 564 engages the lower surface of the guide tube 516, effectively securing the guide tube 516 to the ultrasonic probe 500.

[0111] Consistent with the embodiments described herein, the central opening 566 of the guide tube alignment portion 544 aligns with the central opening 522 of the guide tube 516 only when the guide tube 516 is securely latched to the ultrasonic probe, preventing premature or unsafe use of the needle guidance device 510.

[0112] Once the procedure is complete, the needle guidance device 510 can be removed from the ultrasonic probe 500 by reversing the above steps. That is, the latch engagement portion 573 can be moved rearward again to release the guide tube 516 from the lower guide tube engagement feature 574. Next, the lever component 536 can be pivoted about the pivot pin 550, whereby the pocket engagement element 560 can be disengaged from the positioning pocket 508. At this point, the needle guidance device 510 can be removed from the ultrasonic probe 500 by sliding the guide body 512 forward relative to the ultrasonic probe 500.

[0113] Figures 6A and 6B are a top view and a left side view, respectively, showing an embodiment of a needle guidance device 610 for use with an ultrasonic probe 600 in an assembled configuration, i.e., a locked configuration, consistent with the embodiments described herein. Figures 6C and 6D are a left side view and a right rear isometric view, respectively, showing the needle guidance device 610 and the ultrasonic probe 600 in an open configuration, i.e., the configuration before assembly.

[0114] Consistent with the embodiments described herein, the ultrasonic probe 600 and the needle guidance device 610 are configured to be lockably coupled to each other such that the needle guidance device 610 is fixed relative to the ultrasonic probe 600 during use. As shown in FIGS. 6A-6D, the ultrasonic probe 600 includes one or more features that facilitate cooperative engagement with the needle guidance device 610. Specifically, the ultrasonic probe 600 includes a generally tubular body 601 having a front end 602, an intermediate portion, and a rear end 604.

[0115] As shown, the front end 602 includes a substantially spherical portion having a diameter larger than the diameter of the middle portion between the front end and the rear end. The rear end 604 includes a handle portion 605 and a transition portion 606 where the shape of the main body 601 transitions between the handle portion 605 and the middle portion 603. As shown, the transition portion 606 includes a portion having a diameter at least larger than the diameters of the middle portion 603 and the handle portion 605.

[0116] In line with the implementation forms described in this specification, the transition portion 606 includes an upper positioning slot 608 formed on the upper surface of the probe 300 in front of the portion of the probe 600 having the maximum diameter. The upper positioning slot 308 is configured to receive the slot engaging member of the lock assembly, as will be described below.

[0117] The needle guidance device 610 includes a guide body 612 and a lock assembly 614. The guide body 612 includes a guide tube 616, a front fixing member 618, and a rear fixing member 620. FIGS. 6E - 6G are respectively a left side view, a top view, and a cross-sectional view of the guide body 612. The cross-sectional view of FIG. 6G is taken along line A - A of FIG. 6F.

[0118] As shown in FIGS. 6E - 6G, the guide tube 616 has a substantially cylindrical configuration with a central opening 622. The central opening extends into the guide tube and has a size for receiving a needle or other piercing device. In some implementation forms, guide tubes 616 with different sized openings 622 may be provided for different gauge piercing devices. In some embodiments, instead of a closed central opening 622, the guide tube 616 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0119] As shown in FIG. 6G, an intermediate portion of the guide tube 616 includes a cutout portion 624. The cutout portion 624 includes a lateral opening 626 that extends therein and is disposed below the central opening 622 of the guide tube 616. As will be described below, the lateral opening 626 is sized to receive a pivot pin when assembled with the lock assembly 614. In addition, the cutout portion 624 includes a planar upper portion 628 that forms a stopper for engaging a portion of the lock assembly 614, as will also be described below.

[0120] In accordance with the implementation forms described herein, the front fixing member 618 includes a ring configuration portion 630 that protrudes downward from the front portion of the guide tube 616 and is configured to correspond to the shape of the front end 602 of the ultrasonic probe 600 to capture the front end 602 of the ultrasonic probe 600 within the front fixing member 618 during use.

[0121] In this embodiment, the rear fixing member 620 also includes a ring configuration portion 632 that protrudes downward from the guide tube 616 and is configured to engage a portion of the transition portion 606 of the ultrasonic probe 600 having the maximum diameter. In addition, as shown in FIG. 6G, after the rear fixing member 620 engages the transition portion 606, the rear fixing member 620 can be formed to conform to the surface configuration of the transition portion 606 to prevent the guide body 612 from moving longitudinally forward with respect to the ultrasonic probe 600.

[0122] In accordance with the implementation forms described herein, FIGS. 6H to 6K are respectively a left side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 614. As shown, the lock assembly 614 includes a lever component 636 and a latch component 638, which together cooperate with the guide tube 616 and the ultrasonic probe 600 to fix the needle guidance device 600 to the ultrasonic probe 600 in the manner described below.

[0123] As shown in FIGS. 6I - 6K, the lever component 636 includes a body portion 640 having a pair of opposing arms 642 and a guide tube alignment portion 644. The arms 642 are sized to receive at least a portion of the guide tube 616 therebetween, as shown in FIG. 6F. Each front end of the arms 642 includes an engagement portion 646 for engaging with the cutout portion 444 of the guide tube 616. As shown in FIGS. 6H and 6K, an opening 648 for aligning with the lateral opening 446 of the cutout portion 444 passes through each engagement portion 646. During assembly, the openings 648 and 446 receive a pivot pin 650 therein.

[0124] Consistent with the embodiments described herein, the arms 642 also include a pivot limiting element 652 configured to limit the range within which the lever component 636 can pivot with respect to the guide tube 616. In one implementation, the pivot limiting element 652 includes a downwardly projecting portion 654 within the arm 642 through which an opening 656 passes. A limiting pin 658 can be received in the opening 656. The pivot limitation of the lock assembly 614 is determined by the position of the opening 656 relative to the opening 648. In other implementations, the pivot limiting element 652 may include a different structure, such as a fixed bar that joins the arms 642 at a position similar to the limiting pin 658.

[0125] As shown in FIGS. 6H and 6K, the arms 642 of the lever component 636 may also include a downwardly projecting slot engagement element 660. As shown in FIG. 6A, when locked to the ultrasonic probe 600, the slot engagement element 660 fits into the positioning slot 608. When the pocket engagement element 660 engages with the positioning pocket 608 and the rear fixing member 620 securely engages with the transition portion 606 of the ultrasonic probe 600, the needle guidance device is fixed relative to the ultrasonic probe 200.

[0126] As shown, the rear end of the lever component 636 includes a guide tube alignment portion 644 for joining the arm 642. As shown in FIG. 6K, the guide tube alignment portion 644 includes an upper guide tube engagement feature 664 and a central opening 666 that are longitudinally arranged to align with the central opening 442 of the guide tube 616 when the latch component 638 engages the lever component 636 and the guide tube 616, as described below. As shown in FIG. 6B, the upper guide tube engagement feature 664 includes a portion that protrudes forward with respect to the remaining portion of the guide tube alignment portion 644. When the lock assembly 614 is latched to the guide tube 616, the upper guide tube engagement feature 664 is configured to engage the upper rear end of the guide tube 616 at a position where the opening 666 is aligned with the opening 442.

[0127] As shown in FIGS. 6B, 6H, and 6K, the guide tube alignment portion 644 further includes downwardly protruding tabs 668a and 668b. The tabs 668a and 668b include openings 670a and 670b formed therein, which function to engage a biasing element of the latch component 638, as described below.

[0128] As shown in FIGS. 6I - 6K and FIGS. 6A - 6B, the latch component 638 has a generally frame - shaped member 672 configured to engage both the rear - portion guide tube 616 and the lever component 636. Specifically, as shown, the latch component 638 includes a latch engagement portion 673 and a lower - guide - tube engagement feature 674. The latch engagement portion 673 projects upward from the frame - shaped member 672 and provides an engagement surface. As will be described below, a user can operate (i.e., open and close) the latch component 638 using the engagement surface. The frame - shaped member 672 has a cavity 675 for receiving at least a portion of the guide - tube alignment portion 644, as shown in FIG. 6A. The frame - shaped member 672 includes a pair of tab - engagement elements 676a and 676b formed with alignment openings 678a and 678b. The lower - guide - tube engagement feature 674 projects forward from the front - tab engagement element 676a and engages the lower surface of the guide tube 616 when the latch component 638 is in the latched position with respect to the guide tube 616.

[0129] During assembly, the guide - tube alignment portion 644 of the lever component 636 is inserted into the cavity 675 such that the tab - engagement elements 676a and 676b abut against the respective rear surfaces of the tabs 668a and 668b. As shown in FIG. 6J, a rod 680 with a biasing element 682, such as a spring, disposed thereon is inserted and fixed within the openings 670a / 670b and 678a / 678b, whereby the biasing element 682 is disposed between the rear side of the front - tab engagement element 676 and the front side of the rear - tab 668b.

[0130] To fix the needle guidance device 610 to the ultrasonic probe 600, the surgeon positions the guide tube 616 relative to the ultrasonic probe 600 such that the front fixing member 618 and the rear fixing member of the guide tube 616 engage with the front end 602 and the transition portion 606 of the ultrasonic probe 600, respectively. Then, the guide tube 616 is fixed to the ultrasonic probe 600 by fitting the transition portion 606 into the curved arm 632 of the rear fixing member 620.

[0131] Next, the latch component 638 pulls the latch engagement portion 673 rearward, thereby compressing the biasing element 682 and opening it so that the lower guide tube engagement feature 674 moves rearward relative to the lever component 636. Next, the lever component 636 is pivoted about the pivot pin 650, whereby the slot engagement element 660 fits into the positioning slot 608. Next, the latch engagement portion 673 is released, and the biasing element 682 moves the lower guide tube engagement feature 674 forward relative to the lever component 636. In its forward position, the lower guide tube engagement feature 674 engages the lower surface of the guide tube 616, and the upper guide tube engagement feature 664 engages the lower surface of the guide tube 616, effectively fixing the guide tube 616 to the ultrasonic probe 600.

[0132] Consistent with the embodiments described herein, the central opening 666 of the guide tube alignment portion 644 aligns with the central opening 442 of the guide tube 616 only when the guide tube 616 is securely latched to the ultrasonic probe, preventing premature or unsafe use of the needle guidance device 610.

[0133] Once the procedure is complete, the needle guidance device 610 can be removed from the ultrasonic probe 600 by reversing the above steps. That is, the latch engagement portion 673 can be moved rearward again to release the guide tube 616 from the lower guide tube engagement feature 674. Next, the lever component 636 can be pivoted about the pivot pin 650, whereby the slot engagement element 660 can be disengaged from the positioning slot 608. At this point, the needle guidance device 610 can be removed from the ultrasonic probe 600 by sliding the guide body 612 forward relative to the ultrasonic probe 600.

[0134] Figures 7A and 7B are a top view and a left side view, respectively, showing an embodiment of a needle guidance device 710 for use with an ultrasonic probe 700 in an assembled configuration, i.e., a locked configuration, consistent with the embodiments described herein. Figures 7C and 7D are a left side view and a right rear isometric view, respectively, showing the needle guidance device 710 and the ultrasonic probe 700 in an open configuration, i.e., a configuration before assembly.

[0135] Consistent with the embodiments described herein, the ultrasonic probe 700 and the needle guidance device 710 are configured to be lockably coupled to each other such that the needle guidance device 710 is fixed relative to the ultrasonic probe 700 during use. As shown in FIGS. 7A-7D, the ultrasonic probe 700 includes one or more features that facilitate cooperative engagement with the needle guidance device 710. Specifically, the ultrasonic probe 700 includes a generally tubular body 701 having a front end 702, an intermediate portion, and a rear end 704.

[0136] As shown, the front end 702 includes a generally spherical portion having a diameter larger than the diameter of the middle portion between the front end and the rear end. The rear end 704 includes a handle portion 705 and a transition portion 706 where the shape of the main body 701 transitions between the handle portion 705 and the middle portion 703. As shown, the transition portion 706 includes a portion having a diameter at least larger than the diameters of the middle portion 703 and the handle portion 705.

[0137] Consistent with the implementations described herein and, in contrast to the foregoing examples, neither the front end 702 nor the transition portion 706 includes specific positioning features for cooperating with the needle guidance device 710. Rather, as will be described below, features of the needle guidance device 710 enable the needle guidance device 710 to be securely fixed to the ultrasonic probe 700 using existing aspects or features of the probe design to prevent rotation and forward and backward movement.

[0138] The needle guidance device 710 includes a guide body 712 and a lock assembly 714. The guide body 712 includes a guide tube 716, a front fixing member 718, and a rear fixing member 720. FIGS. 7E - 7G are, respectively, a left side view, a top view, and a cross-sectional view of the guide body 712. The cross-sectional view of FIG. 7G is taken along line A - A of FIG. 7F.

[0139] As shown in FIGS. 7E - 7G, the guide tube 716 has a generally cylindrical configuration with a central opening 722. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementations, guide tubes 716 having different sized openings 722 may be provided for different gauge piercing devices. In some examples, rather than a closed central opening 722, the guide tube 716 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0140] As shown in FIG. 7G, the middle part of the guide tube 716 includes a cutout portion 724. The cutout portion 724 includes a lateral opening 726 that extends therein and is disposed below the central opening 722 of the guide tube 716. As will be described below, the lateral opening 726 is sized to receive a pivot pin when assembled with the lock assembly 714. In addition, the cutout portion 724 includes a planar upper portion 728 that forms a stopper for engaging a part of the lock assembly 714, as will also be described below.

[0141] In accordance with the implementation form described in this specification, the front fixing member 718 includes a ring configuration portion 730 that protrudes downward from the front portion of the guide tube 716 and is configured to correspond to the shape of the front end 702 of the ultrasonic probe 700 to capture the front end 702 of the ultrasonic probe 700 within the front fixing member 718 during use.

[0142] In this embodiment, the rear fixing member 720 also includes a ring configuration portion 732 that protrudes downward from the guide tube 716 and is configured to engage a part of the transition portion 706 of the ultrasonic probe 700 having the maximum diameter. In addition, as shown in FIG. 7G, after the rear fixing member 720 engages with the transition portion 706, the rear fixing member 720 can be formed to conform to the surface configuration of the transition portion 706 to prevent the guide body 712 from moving longitudinally forward with respect to the ultrasonic probe 700.

[0143] In accordance with the implementation form described in this specification, FIGS. 7H to 7K are respectively a left side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 714. As shown, the lock assembly 714 includes a lever component 736 and a latch component 738, which together cooperate with the guide tube 716 and the ultrasonic probe 700 to fix the needle guidance device 700 to the ultrasonic probe 700 in the manner described below.

[0144] As shown in FIGS. 7I to 7K, the lever component 736 includes a main body portion 740 having a pair of opposing arms 742 and a guide tube alignment portion 744. The arms 742 are sized to receive at least a portion of the guide tube 716 therebetween, as shown in FIG. 7F. At the front end of each arm 742, an engaging portion 746 for engaging with the cutout portion 724 of the guide tube 716 is included. As shown in FIGS. 7H and 7K, an opening 748 for aligning with the lateral opening 726 of the cutout portion 724 passes through each engaging portion 746. During assembly, the openings 748 and 726 receive a pivot pin 750 therein.

[0145] In accordance with the embodiments described herein, the arm 742 also includes a pivot limiting element 752 configured to limit the range within which the lever component 736 can pivot with respect to the guide tube 716. In one implementation, the pivot limiting element 752 includes a downwardly projecting portion 754 through which an opening 756 passes within the arm 742. A limiting pin 758 can be received in the opening 756. The pivot limitation of the lock assembly 714 is determined by the position of the opening 756 relative to the opening 748. In other implementations, the pivot limiting element 752 may include a different structure, such as a fixed bar that joins the arm 742 at a position similar to the limiting pin 758.

[0146] As shown in FIGS. 7H and 7K, the arm 742 on the lever component 736 may also include a pair of front positioning elements 760 and a pair of rear positioning elements 761 that project downward therefrom. As shown in FIGS. 7A-7D, the front positioning elements 760 and the rear positioning elements 761 are arranged on the lever component 736 so as to straddle or engage the upper part of the rear fixing member 720 when in the locked or closed position. As shown in FIGS. 7C and 7K, the lower ends of the front positioning elements 760 and the rear positioning elements 761 can be formed to cooperate with the upper surface of the ultrasonic probe 700. Such a configuration, in combination with the front fixing member 718 and the rear fixing member 720, prevents the movement of the needle guidance device 710 relative to the ultrasonic probe 700 during use.

[0147] As shown, the rear end of the lever component 736 includes a guide tube alignment portion 744 that joins the arm 742. As shown in FIG. 7K, the guide tube alignment portion 744 includes an upper guide tube engagement feature 764 and a central opening 766 that are longitudinally arranged to align with the central opening 722 of the guide tube 716 when the latch component 738 is engaged with the lever component 736 and the guide tube 716, as described below. As shown in FIG. 7B, the upper guide tube engagement feature 764 includes a portion that projects forward relative to the rest of the guide tube alignment portion 744. When the lock assembly 714 is latched to the guide tube 716, the upper guide tube engagement feature 764 is configured to engage the upper rear end of the guide tube 716 at a position where the opening 766 is aligned with the opening 722.

[0148] As shown in FIGS. 7B, 7H, and 7K, the guide tube alignment portion 744 further includes downwardly projecting tabs 768a and 768b. The tabs 768a and 768b include openings 770a and 770b formed therein, which function to engage the biasing element of the latch component 738 as described below.

[0149] As shown in FIGS. 7I-7K and 7A-7B, the latch component 738 has a generally frame-shaped member 772 configured to engage both the rear portion guide tube 716 and the lever component 736. Specifically, as shown, the latch component 738 includes a latch engagement portion 773 and a lower guide tube engagement feature 774. The latch engagement portion 773 projects upward from the frame-shaped member 772 and provides an engagement surface. As described below, the user can operate (i.e., open and close) the latch component 738 using the engagement surface. The frame-shaped member 772 has a cavity 775 for receiving at least a portion of the guide tube alignment portion 744, as shown in FIG. 7A. The frame-shaped member 772 includes a pair of tab engagement elements 776a and 776b in which alignment openings 778a and 778b are formed. The lower guide tube engagement feature 774 projects forward from the front tab engagement element 776a and engages the lower surface of the guide tube 716 when the latch component 738 is in the latched position with respect to the guide tube 716.

[0150] During assembly, the guide tube alignment portion 744 of the lever component 736 is inserted into the cavity 775 such that the tab engagement elements 776a and 776b abut the respective rear surfaces of the tabs 768a and 768b. As shown in FIG. 7J, a rod 780 with a biasing element 782, such as a spring, is inserted and fixed within the openings 770a / 770b and 778a / 778b, whereby the biasing element 782 is disposed between the rear side of the front tab engagement element 776 and the front side of the rear tab 768b.

[0151] To fix the needle guidance device 710 to the ultrasonic probe 700, the surgeon positions the guide tube 716 relative to the ultrasonic probe 700 such that the front fixing member 718 and the rear fixing member 720 of the guide tube 716 engage with the front end 702 and the transition portion 706 of the ultrasonic probe 700, respectively. Then, the guide tube 716 is fixed to the ultrasonic probe 700 by fitting the transition portion 706 into the rear fixing member 720.

[0152] Next, the latch component 738 pulls the latch engagement portion 773 rearward, thereby compressing the biasing element 782 and opening by causing the lower guide tube engagement feature 774 to move rearward relative to the lever component 736. Next, the lever component 736 is pivoted about the pivot pin 750, whereby the front positioning element 760 and the rear positioning element 761 engage with the rear fixing member 720 as described above. Next, the latch engagement portion 773 is released, and the biasing element 782 moves the lower guide tube engagement feature 774 forward relative to the lever component 736. In its forward position, the lower guide tube engagement feature 774 engages the lower surface of the guide tube 716, and the upper guide tube engagement feature 764 engages the lower surface of the guide tube 716, effectively fixing the guide tube 716 to the ultrasonic probe 700.

[0153] Consistent with the embodiments described herein, the central opening 766 of the guide tube alignment portion 744 aligns with the central opening 722 of the guide tube 716 only when the guide tube 716 is securely latched to the ultrasonic probe, preventing premature or unsafe use of the needle guidance device 710.

[0154] Once the procedure is complete, the needle guidance device 710 can be removed from the ultrasonic probe 700 by reversing the above steps. That is, the latch engagement portion 773 can be moved rearward again to release the guide tube 716 from the lower guide tube engagement feature 774. Next, the lever component 736 can be pivoted about the pivot pin 750, thereby disengaging the front positioning element 760 and the rear positioning element 761 from the rear fixing member 720. At this point, the needle guidance device 710 can be removed from the ultrasonic probe 700 by sliding the guide body 712 forward relative to the ultrasonic probe 700.

[0155] Figures 8A and 8B are respectively a top view and a left side view showing an embodiment of a needle guidance device 810 for use with an ultrasonic probe 800 in an assembled configuration, i.e., a locked configuration, consistent with the embodiments described herein. Figures 8C and 8D are respectively a left side view and a right rear isometric view showing the needle guidance device 810 and the ultrasonic probe 800 in an open configuration, i.e., the configuration before assembly.

[0156] In accordance with the embodiments described herein, the ultrasonic probe 800 and the needle guidance device 810 are configured to be lockably coupled to each other such that the needle guidance device 810 is fixed to the ultrasonic probe 800 during use. As shown in FIGS. 8A-8D, the ultrasonic probe 800 includes one or more features that facilitate cooperative engagement with the needle guidance device 810. Specifically, the ultrasonic probe 800 includes a generally tubular body 801 having a front end 802, a middle portion 803, and a rear end 804. As shown, the front end 802 includes a generally spherical portion having a diameter larger than the diameter of the middle portion 803. The rear end 804 includes a handle portion 805 and a transition portion 806 where the shape of the body 801 transitions between the handle portion 805 and the middle portion 803. As shown, the transition portion 806 includes a portion having a diameter at least larger than the diameters of the middle portion 803 and the handle portion 805.

[0157] In accordance with the implementation forms described herein, the transition portion 806 includes a pair of positioning pockets 808 disposed on the upper surface of the probe 800 in front of the portion of the probe 800 having the maximum diameter. The positioning pockets 808 include forward-facing cavities having a rear wall on the inside. As will be described in further detail below, the positioning pockets 808 facilitate positioning and fixing the needle guidance device 810 to the ultrasonic probe 800 during assembly.

[0158] The needle guidance device 810 includes a guide body 812 and a lock assembly 814. The guide body 812 includes a guide tube 816, a front fixing member 818, and a rear fixing member 820. FIGS. 8E-8G are a left side view, a top view, and a cross-sectional view, respectively, of the guide body 812. The cross-sectional view of FIG. 8G is taken along line A-A of FIG. 8F.

[0159] As shown in FIGS. 8E - 8G, the guide tube 816 has a generally cylindrical configuration with a central opening 822. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementations, guide tubes 816 with different sized openings 822 may be provided for different gauge piercing devices. In some embodiments, rather than a closed central opening 822, the guide tube 816 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0160] In an intermediate portion of the guide tube 816, as shown in FIG. 8G, a cut - out portion 824 is included. The cut - out portion 824 includes a lateral opening 826 that extends therein and is disposed below the central opening 822 of the guide tube 816. As will be described below, the lateral opening 826 is sized to receive a pivot pin when assembled with the lock assembly 814. Additionally, the cut - out portion 824 includes a planar upper portion 828 that forms a stop for engaging a part of the lock assembly 814, as will also be described below.

[0161] The front fixing member 818 includes opposing curved arms 830 that project downward from the front portion of the guide tube 816 and are configured to correspond to the shape of the front end 802 of the ultrasonic probe 800. As shown in FIG. 8B, the curved arms 830 may include a forward - facing prong 831 formed to correspond to the shape on the rear side of the front end 802 to securely position the needle - guidance device 810 longitudinally with respect to the ultrasonic probe during use, as will be described below.

[0162] In this way, by inserting the front end 802 of the ultrasonic probe 800 into the curved arm 830, the axial position of the front end of the guide tube 816 with respect to the ultrasonic probe 800 is effectively captured. That is, when the front end 802 of the ultrasonic probe 800 is arranged by the curved arm 830, the front end of the guide tube 816 is not radially outwardly pulled from the ultrasonic probe 800.

[0163] Further, the rear fixing member 820 includes a curved arm 832 that protrudes downward from the guide tube 816 and is configured to engage with the outer surface of the transition portion 806 of the ultrasonic probe 800. Consistent with the embodiments of FIGS. 8A-8G, the curved arm 832 may be configured to extend beyond 180°. In this way, by inserting the rear end 802 of the ultrasonic probe 800 into the curved arm 832, the axial position of the rear end of the guide tube 816 with respect to the ultrasonic probe 800 is effectively captured. That is, when the transition portion 806 of the ultrasonic probe 800 is arranged by the curved arm 832, the rear end of the guide tube 816 is not radially outwardly pulled from the ultrasonic probe 800. In addition, as shown in FIG. 8G, after the curved arm 832 engages with the transition portion 806, the curved arm 832 of the rear fixing member 820 can be formed to conform to the surface configuration of the transition portion 806 in order to prevent the guide body 812 from moving longitudinally forward with respect to the ultrasonic probe 800.

[0164] Consistent with the implementation forms described in this specification, FIGS. 8H-8K are respectively a left side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 814. As shown, the lock assembly 814 includes a lever component 836 and a latch component 838, which cooperate with the guide tube 816 and the ultrasonic probe 800 to fix the needle guidance device 800 to the ultrasonic probe 800 in the manner described below.

[0165] As shown in FIGS. 8I to 8K, the lever component 836 includes a body portion 840 having a pair of opposing arms 842 and a guide tube alignment portion 844. As shown in FIG. 8F, the arms 842 are sized to receive at least a portion of the guide tube 816 therebetween. At the front end of each arm 842, an engaging portion 846 for engaging with the cutout portion 824 of the guide tube 816 is included. As shown in FIGS. 8H and 8K, an opening 848 for aligning with the lateral opening 826 of the cutout portion 824 passes through each engaging portion 846. During assembly, the openings 848 and 826 receive a pivot pin 850 therein.

[0166] Consistent with the embodiments described herein, the arm 842 also includes a pivot limiting element 852 configured to limit the range within which the lever component 836 can pivot with respect to the guide tube 816. In one implementation, the pivot limiting element 852 includes a downwardly projecting portion 854 through which an opening 856 passes within the arm 842. A limiting pin 858 can be received in the opening 856. The pivot limitation of the lock assembly 814 is determined by the position of the opening 856 relative to the opening 848. In other implementations, the pivot limiting element 852 may include different structures, such as a fixed bar that joins the arm 842 at a position similar to the limiting pin 858.

[0167] As shown in FIGS. 8H and 8K, the arm 842 of the lever component 836 may also include a downwardly projecting pocket engaging element 860. As shown in FIG. 8A, when locked to the ultrasonic probe 800, the pocket engaging element 860 fits into the pocket 808. When the pocket engaging element 860 engages the positioning pocket 808 and the rear fixing member 820 securely engages the transition portion 806 of the ultrasonic probe 800, the needle guidance device is fixed relative to the ultrasonic probe 800.

[0168] As shown, the rear end of the lever component 836 includes a guide tube alignment portion 844 for joining the arm 842. As shown in FIG. 8K, the guide tube alignment portion 844 includes an upper guide tube engagement feature 864 and a central opening 866 that are longitudinally arranged to align with the central opening 822 of the guide tube 816 when the latch component 838 engages the lever component 836 and the guide tube 816, as described below. As shown in FIG. 8B, the upper guide tube engagement feature 864 includes a portion that protrudes forward relative to the rest of the guide tube alignment portion 844. When the lock assembly 814 is latched to the guide tube 816, the upper guide tube engagement feature 864 is configured to engage the upper rear end of the guide tube 816 at a position where the opening 866 is aligned with the opening 822.

[0169] As shown in FIGS. 8B, 8H, and 8K, the guide tube alignment portion 844 further includes downwardly protruding tabs 868a and 868b. The tabs 868a and 868b include openings 870a and 870b formed therein, which function to engage the latch component 838, as described below. In one exemplary implementation, one or both of the openings 870a / 870b may include a threading configuration for engaging the threaded portion of the latch component 838.

[0170] As shown in FIGS. 8H - 8K and FIGS. 8A - 8B, the latch component 838 has a rod 872 and a latch knob 874. As shown, the rod 872 is configured to engage both the rear - portion guide tube 816 and the lever component 836 during use. Specifically, as shown, the rod 872 is sized to fit within the openings 870a / 870b and may include a threaded portion 875 for engaging the correspondingly threaded portions of the openings 870a / 870b. As shown in FIG. 8A, when fully inserted or threaded into the openings 870a / 870b, the front portion of the rod 872 engages the lower surface of the guide tube 816 to prevent the guide tube 816 from pivoting relative to the ultrasonic probe 800.

[0171] To fix the needle - guidance device 810 to the ultrasonic probe 800, the surgeon positions the guide tube 816 relative to the ultrasonic probe 800 such that the front - fixing member 818 and the rear - fixing member of the guide tube 816 engage the front end 802 and the transition portion 806 of the ultrasonic probe 800, respectively. Then, the guide tube 816 is fixed relative to the ultrasonic probe 800 by fitting the transition portion 806 within the curved arm 832 of the rear - fixing member 820.

[0172] Next, the lever component 836 is pivoted about the pivot pin 850, whereby the pocket - engaging element 860 fits into the positioning pocket 808. The rod 872 is inserted through the openings 870a / 870b, such as by turning the knob 874. In this way, the front end of the rod 872 engages the lower surface of the guide tube 816, and the upper - guide - tube - engaging feature 864 engages the lower surface of the guide tube 816, effectively fixing the guide tube 816 to the ultrasonic probe 800.

[0173] Consistent with the embodiments described herein, the central opening 866 of the guide tube alignment portion 844 aligns with the central opening 822 of the guide tube 816 only when the guide tube 816 is securely latched to the ultrasonic probe, thereby preventing premature or unsafe use of the needle guidance device 810.

[0174] Once the procedure is complete, the needle guidance device 810 can be removed from the ultrasonic probe 800 by reversing the above steps. That is, the rod 872 can be moved rearward (e.g., by threading) to release the guide tube 816 from the front end of the rod 872. Next, the lever component 836 can be pivoted about the pivot pin 850, thereby disengaging the pocket engagement element 860 from the positioning pocket 808. At this point, the needle guidance device 810 can be removed from the ultrasonic probe 800 by sliding the guide body 812 forward relative to the ultrasonic probe 800.

[0175] Figures 9A and 9B are a top view and a left side view, respectively, showing an embodiment of a needle guidance device 910 for use with an ultrasonic probe 900 in an assembled configuration, i.e., a locked configuration, consistent with the embodiments described herein. Figures 9C and 9D are a left side view and a right rear isometric view, respectively, showing the needle guidance device 910 and the ultrasonic probe 900 in an open configuration, i.e., the configuration before assembly.

[0176] In accordance with the embodiments described herein, the ultrasonic probe 900 and the needle guidance device 910 are configured to be lockably coupled to each other such that the needle guidance device 910 is fixed to the ultrasonic probe 900 during use. As shown in FIGS. 9A - 9D, the ultrasonic probe 900 includes one or more features that facilitate cooperative engagement with the needle guidance device 910. Specifically, the ultrasonic probe 900 includes a generally tubular body 901 having a front end 902, an intermediate portion 903, and a rear end 904. As shown, the front end 902 includes a generally spherical portion having a diameter larger than the diameter of the intermediate portion 903. The rear end 904 includes a handle portion 905 and a transition portion 906 where the shape of the body 901 transitions between the handle portion 905 and the intermediate portion 903. As shown, the transition portion 906 includes a portion having a diameter at least larger than the diameters of the intermediate portion 903 and the handle portion 905.

[0177] In accordance with the implementation forms described herein, the transition portion 906 includes a positioning rib 908 that protrudes from the upper surface of the probe 900 for engaging a corresponding feature in the needle guidance device 910, as described below.

[0178] The needle guidance device 910 includes a guide body 912 and a lock assembly 914. The guide body 912 includes a guide tube 916, a front fixing member 918, and a rear fixing member 920. FIGS. 9E - 9G are, respectively, a left side view, a top view, and a cross-sectional view of the guide body 912. The cross-sectional view of FIG. 9G is taken along line A - A of FIG. 9F.

[0179] As shown in FIGS. 9E - 9G, the guide tube 916 has a generally cylindrical configuration with a central opening 922. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementations, guide tubes 916 with different sized openings 922 may be provided for different gauge piercing devices. In some embodiments, rather than a closed central opening 922, the guide tube 916 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0180] In accordance with the implementations described herein, the front fixing member 918 includes a ring structure 930 that projects downward from the front portion of the guide tube 916 and is configured to correspond to the shape of the front end 902 of the ultrasonic probe 900 to capture the front end 902 of the ultrasonic probe 900 within the front fixing member 918 during use.

[0181] In this way, by inserting the front end 902 of the ultrasonic probe 900 into the front fixing member 918, the axial position of the front end of the guide tube 916 relative to the ultrasonic probe 900 is effectively captured. That is, when the front end 902 of the ultrasonic probe 900 is disposed within the front fixing member 918, the front end of the guide tube 916 is not radially outwardly pulled from the ultrasonic probe 900.

[0182] The rear fixing member 920 also includes a ring structure 930 that projects downward from the guide tube 916 and is configured to engage a portion of the transition portion 906 of the ultrasonic probe 900 having the maximum diameter. In addition, as shown in FIG. 9G, after the rear fixing member 920 engages the transition portion 906, the rear fixing member 920 can be formed to conform to the surface configuration of the transition portion 906 to prevent the guide body 912 from longitudinally moving forward relative to the ultrasonic probe 900.

[0183] As shown in FIGS. 9E - 9G, a portion of the rear fixing member 920 includes a lock - assembly engagement feature 921 for pivotally connecting to the lock assembly 914, as will be described below. In one exemplary implementation, the lock - assembly engagement feature 921 projects upward from the upper portion of the rear fixing member 920 at a position laterally offset from the guide tube 916. As shown, the lock - assembly engagement feature 921 includes a hinge pin 923 for engagement with the lock assembly 914.

[0184] In accordance with the implementations described herein, FIGS. 9H - 9K are, respectively, a left - side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 914. As shown, the lock assembly 914 includes a lever component 936 and a latch component 938, which together cooperate with the guide tube 916 and the ultrasonic probe 900 to engage the needle - guidance device 900 to the ultrasonic probe 900 in the manner described below.

[0185] As shown in FIGS. 9I - 9K, the lever component 936 includes a body portion 940 having a pair of opposing arms 942a and 942b and a guide - tube alignment portion 944. The arms 942a and 942b are sized to receive at least a portion of the guide tube 916 therebetween, as shown in FIG. 9A. In one implementation, an intermediate portion of the arm 942a includes an engagement portion 946 for pivotally coupling to the lock - assembly engagement feature 921. As shown in FIGS. 9H and 9K, the engagement portion 946 projects outwardly from the arm 942a and one or more openings 948 for alignment with the hinge pin 923 are passed therethrough. During assembly, the opening 948 is coupled to the hinge pin 923, whereby the lever component 936 can pivot to engage or disengage from the guide tube 916.

[0186] As shown in FIGS. 9H and 9K, the front portions of arm 942, arm 942a, and arm 942b include positioning rib engagement elements 960 that project downward therefrom. As shown in FIG. 9A, when locked to ultrasonic probe 900, rib engagement elements 960 engage the rear side of positioning rib 908. When rib engagement elements 960 engage positioning rib 908 and rear fixing member 920 securely engages transition portion 906 of ultrasonic probe 900, the needle guidance device is fixed relative to ultrasonic probe 900.

[0187] As shown, the rear end of lever component 936 includes a guide tube alignment portion 944 that joins arm 942. As shown in FIG. 9K, guide tube alignment portion 944 includes upper guide tube engagement features 964 and central opening 966 that are longitudinally disposed to align with central opening 922 of guide tube 916 when latch component 938 engages lever component 936 and guide tube 916, as described below. As shown in FIG. 9B, upper guide tube engagement features 964 include a portion that projects forward relative to the remainder of guide tube alignment portion 1. When lock assembly 914 is latched to guide tube 916, upper guide tube engagement features 964 are configured to engage the upper rear end of guide tube 916 at a position where opening 966 is aligned with opening 922.

[0188] As shown in FIGS. 9B, 9H, and 9K, guide tube alignment portion 944 further includes tabs 968a and 968b that project downward. Tabs 968a and 968b include openings 970a and 970b formed therein that function to engage latch component 938, as described below. In one exemplary implementation, one or both of openings 970a / 970b may include a threading configuration for engaging the threaded portion of latch component 938.

[0189] As shown in FIGS. 9H-9K and FIGS. 9A-9B, the latch component 938 has a rod 972 and a latch knob 974. As shown, the rod 972 is configured to engage both the rear portion guide tube 916 and the lever component 936 during use. Specifically, as shown, the rod 972 is sized to fit within the openings 970a / 970b and may include a threaded (i.e., screw-threaded) portion for engaging corresponding threaded portions of the openings 970a / 970b. As shown in FIG. 9A, when fully inserted or screwed into the openings 970a / 970b, the front portion of the rod 972 engages the lower surface of the guide tube 916 to prevent the guide tube 916 from pivoting relative to the ultrasonic probe 900.

[0190] To secure the needle guidance device 910 to the ultrasonic probe 900, the operator positions the guide tube 916 relative to the ultrasonic probe 900 such that the front fixing member 918 and the rear fixing member 920 of the guide tube 916 engage the front end 902 and the transition portion 906 of the ultrasonic probe 900, respectively. Thereupon, the guide tube 916 is secured to the ultrasonic probe 900 by fitting the transition portion 906 within the curved arm 932 of the rear fixing member 920.

[0191] Next, the lever component 936 is pivoted about the hinge pin 923, whereby the rib engaging element 960 fits behind the positioning rib 908. The rod 972 is inserted through the openings 970a / 970b, such as by turning the knob 974. In this way, the front end of the rod 972 engages the lower surface of the guide tube 916, and the upper guide tube engaging feature 964 engages the lower surface of the guide tube 916, effectively securing the guide tube 916 to the ultrasonic probe 900.

[0192] In accordance with the embodiments described herein, the central opening 966 of the guide tube alignment portion 944 aligns with the central opening 922 of the guide tube 916 only when the guide tube 916 is latched firmly to the ultrasonic probe, thereby preventing premature or unsafe use of the needle guidance device 910.

[0193] Once the procedure is complete, the needle guidance device 910 can be removed from the ultrasonic probe 900 by reversing the above steps. That is, the rod 972 can be moved rearward (e.g., by threading) to release the guide tube 916 from the front end of the rod 972. Next, the lever component 936 can be pivoted about the hinge pin 923, thereby disengaging the rib engagement element 960 from the positioning rib 908. At this point, the needle guidance device 910 can be removed from the ultrasonic probe 900 by sliding the guide body 1 forward relative to the ultrasonic probe 900.

[0194] Figures 10A and 10B are, respectively, a top view and a left side view showing an embodiment of the needle guidance device 1010 for use with an ultrasonic probe 1000 in an assembled configuration, i.e., a locked configuration, in accordance with the embodiments described herein. Figures 10C and 10D are, respectively, a left side view and a right rear isometric view showing the needle guidance device 1010 and the ultrasonic probe 1000 in an open configuration, i.e., the configuration before assembly.

[0195] In accordance with the embodiments described herein, the ultrasonic probe 1000 and the needle guidance device 1010 are configured to be lockably coupled to each other such that the needle guidance device 1010 is fixed to the ultrasonic probe 1000 during use. As shown in FIGS. 10A-10D, the ultrasonic probe 1000 includes one or more features that facilitate cooperative engagement with the needle guidance device 1010. Specifically, the ultrasonic probe 1000 includes a generally tubular body 1001 having a front end 1002, an intermediate portion 1003, and a rear end 1004. As shown, the front end 1002 includes a generally spherical portion having a diameter larger than the diameter of the intermediate portion 1003. The rear end 1004 includes a handle portion 1005 and a transition portion 1006 where the shape of the body 1001 transitions between the handle portion 1005 and the intermediate portion 1003. As shown, the transition portion 1006 includes a portion having a diameter at least larger than the diameters of the intermediate portion 1003 and the handle portion 1005.

[0196] In accordance with the implementation forms described herein, the transition portion 1006 includes a pair of positioning pockets 1007 disposed on both sides of the probe 1000 and a positioning rib 1008 protruding from the upper surface of the probe 1000. The positioning pocket 1007 includes a forward-facing cavity having a rear wall therein. As will be described in additional detail below, the positioning pocket 1007 and the positioning rib 1008 jointly facilitate the placement and fixation of the needle guidance device 1010 to the ultrasonic probe 1000 during assembly.

[0197] The needle guidance device 1010 includes a guide body 1012 and a lock assembly 1014. The guide body 1012 includes a guide tube 1016, a front fixing member 1018, and a rear fixing member 1020. FIGS. 10E-10G are, respectively, a left side view, a top view, and a cross-sectional view of the guide body 1012. The cross-sectional view of FIG. 10G is taken along line A-A of FIG. 10F.

[0198] As shown in FIGS. 10E - 10G, the guide tube 1016 has a generally cylindrical configuration with a central opening 1022. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementations, guide tubes 1016 with different - sized openings 1022 may be provided for different - gauge piercing devices. In some embodiments, rather than a closed central opening 1022, the guide tube 1016 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0199] In accordance with the implementations described herein, the front fixing member 1018 includes a ring configuration 1030 that projects downwardly from the front portion of the guide tube 1016 and is configured to correspond to the shape of the front end 1002 of the ultrasonic probe 1000 to capture the front end 1002 of the ultrasonic probe 1000 within the front fixing member 1018 during use.

[0200] In this way, by inserting the front end 1002 of the ultrasonic probe 1000 into the front fixing member 1018, the axial position of the front end of the guide tube 1016 with respect to the ultrasonic probe 1000 is effectively captured. That is, when the front end 1002 of the ultrasonic probe 1000 is disposed within the front fixing member 1018, the front end of the guide tube 1016 is not radially outwardly pulled from the ultrasonic probe 1000.

[0201] The rear fixing member 1020 includes a curved arm 1032 that projects downwardly from the guide tube 1016 and is configured to engage the outer surface of the transition portion 1006 of the ultrasonic probe 1000. In accordance with some implementations described herein, the curved arm 1032 of the rear fixing member 1020 includes a positioning element 1034 that projects inwardly at the end of the curved arm 1032. As shown in FIG. 10A, when assembled, the positioning element 1034 slides into and is disposed within the positioning pocket 1007 of the transition portion 1006 of the ultrasonic probe 1000.

[0202] As shown in FIGS. 10E - 10G, a portion of the rear fixing member 1020 includes a lock - assembly engagement feature 1021 for pivotally connecting to the lock assembly 1014, as described below. In one exemplary implementation, the lock - assembly engagement feature 1021 projects upward from the upper portion of the rear fixing member 1020 at a position laterally offset from the guide tube 1016. As shown, the lock - assembly engagement feature 1021 includes a hinge pin 1023 for engagement with the lock assembly 1014.

[0203] Consistent with the implementations described herein, FIGS. 10H - 10K are, respectively, a left - side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 1014. As shown, the lock assembly 1014 includes a lever component 1036 and a latch component 1038, which together cooperate with the guide tube 1016 and the ultrasonic probe 1000 to engage the needle - guidance device 1000 to the ultrasonic probe 1000 in the manner described below.

[0204] As shown in FIGS. 10I-10K, the lever component 1036 includes a body portion 1040 having a pair of opposing arms 1042a and 1042b and a guide tube alignment portion 1044. The arms 1042a and 1042b are sized to receive at least a portion of the guide tube 1016 therebetween, as shown in FIG. 10A. In one implementation, an intermediate portion of the arm 1042a includes an engagement portion 1046 for pivotally coupling to the lock assembly engagement feature 1021. As shown in FIGS. 10H and 10K, the engagement portion 1046 projects outwardly relative to the arm 1042a, and one or more openings 1048 for aligning with the hinge pin 1023 are passed therethrough. During assembly, the opening 1048 is coupled to the hinge pin 1023, whereby the lever component 1036 can pivot to engage or disengage from the guide tube 1016.

[0205] As shown in FIGS. 10H and 10K, a front portion of the arms 1042, arm 1042a and arm 1042b includes a positioning rib engagement element 1060 projecting downwardly therefrom. As shown in FIG. 10A, when locked to the ultrasonic probe 1000, the rib engagement element 1060 engages the rear side of the positioning rib 1008. When the rib engagement element 1060 engages the positioning rib 1008 and the rear fixing member 1020 securely engages the transition portion 1006 of the ultrasonic probe 1000, the needle guidance device is fixed relative to the ultrasonic probe 1000.

[0206] As shown, the rear end of the lever component 1036 includes a guide tube alignment portion 1044 for joining the arm 1042. As shown in FIG. 10K, the guide tube alignment portion 1044 includes an upper guide tube engagement feature 1064 and a central opening 1066 that are longitudinally arranged to align with the central opening 1022 of the guide tube 1016 when the latch component 1038 engages the lever component 1036 and the guide tube 1016 as described below. As shown in FIG. 10B, the upper guide tube engagement feature 1064 includes a portion that protrudes forward relative to the remaining portion of the guide tube alignment portion 1044. When the lock assembly 1014 is latched to the guide tube 1016, the upper guide tube engagement feature 1064 is configured to engage the upper rear end of the guide tube 1016 at a position where the opening 1066 is aligned with the opening 1022.

[0207] As shown in FIGS. 10B, 10H, and 10K, the guide tube alignment portion 1044 further includes downwardly protruding tabs 1068a and 1068b. The tabs 1068a and 1068b include openings 1070a and 1070b formed therein, which function to engage the latch component 1038 as described below. In one exemplary implementation, one or both of the openings 1070a / 1070b may include a threading configuration for engaging the threaded portion of the latch component 1038.

[0208] As shown in FIGS. 10I - 10K and FIGS. 10A - 10B, the latch component 1038 has a generally frame - shaped member 1072 configured to engage both the rear portion of the guide tube 1016 and the lever component 1036. Specifically, as shown, the latch component 1038 includes a latch engagement portion 1073 and a lower guide tube engagement feature 1074. The latch engagement portion 1073 projects upward from the frame - shaped member 1072 and provides an engagement surface. As will be described below, the user can operate (i.e., open and close) the latch component 1038 using the engagement surface. The frame - shaped member 1072 has a cavity 1075 for receiving at least a portion of the guide tube alignment portion 1044 as shown in FIG. 10A. The frame - shaped member 1072 includes a pair of tab engagement elements 1076a and 1076b in which alignment openings 1078a and 1078b are formed. The lower guide tube engagement feature 1074 projects forward from the front tab engagement element 1076a and engages the lower surface of the guide tube 1016 when the latch component 1038 is in the latched position with respect to the guide tube 1016.

[0209] During assembly, the guide tube alignment portion 1044 of the lever component 1036 is inserted into the cavity 1075 such that the tab engagement elements 1076a and 1076b abut against the respective rear surfaces of the tabs 1068a and 1068b. A rod 1080 with a biasing element 1082 such as a spring disposed as shown in FIG. 10J is inserted and fixed within the openings 1070a / 1070b and 1078a / 1078b, whereby the biasing element 1082 is disposed between the rear side of the front tab engagement element 1076 and the front side of the rear tab 1068b.

[0210] To fix the needle guidance device 1010 to the ultrasonic probe 1000, the surgeon positions the guide tube 1016 relative to the ultrasonic probe 1000 such that the front fixing member 1018 and the rear fixing member 1020 of the guide tube 1016 engage with the front end 1002 and the transition part 1006 of the ultrasonic probe 1000 respectively. Then, the guide tube 1016 is fixed to the ultrasonic probe 1000 by fitting the positioning element 1034 into the positioning pocket 1007.

[0211] Next, the latch component 1038 pulls the latch engagement part 1073 rearward, thereby compressing the biasing element 1082 and opening it by causing the lower guide tube engagement feature 1074 to move rearward relative to the lever component 1036. Next, the latch component 1038 is pivoted downward about the hinge pin 1023, whereby the rib engagement element 1068 engages with the rear side of the positioning rib 1008. Next, the latch engagement part 1073 is released, and the biasing element 1082 moves the lower guide tube engagement feature 174 forward relative to the lever component 1036. In its forward position, the lower guide tube engagement feature 1074 engages with the lower surface of the guide tube 1016, and the upper guide tube engagement feature 1064 engages with the upper surface of the guide tube 1016, effectively fixing the guide tube 1016 to the ultrasonic probe 1000.

[0212] Consistent with the embodiments described herein, the central opening 1066 of the guide tube alignment part 1044 aligns with the central opening 1022 of the guide tube 1016 only when the guide tube 1016 is firmly latched to the ultrasonic probe, preventing premature or unsafe use of the needle guidance device 1010.

[0213] Once the procedure is completed, the needle guidance device 1010 can be removed from the ultrasonic probe 1000 by reversing the above steps. That is, the latch engagement portion 1073 can be moved rearward again to release the guide tube 1016 from the lower guide tube engagement feature 1074. Next, the lever component 1036 can be pivoted about the hinge pin 1023, whereby the rib engagement element 1068 can be disengaged from the positioning rib 1008. At this point, the needle guidance device 1010 can be removed from the ultrasonic probe 1000 by removing the positioning element 1034 from the positioning pocket 1007.

[0214] Figures 11A and 11B are top and left side views, respectively, showing an example of a needle guidance device 1110 for use with an ultrasonic probe 1100 in an assembled configuration, i.e., a locked configuration, consistent with the embodiments described herein. Figures 11C and 11D are left side and right rear isometric views, respectively, showing the needle guidance device 1110 and the ultrasonic probe 1100 in an open configuration, i.e., the configuration before assembly.

[0215] Consistent with the embodiments described herein, the ultrasonic probe 1100 and the needle guidance device 1110 are configured to be lockably coupled to each other such that the needle guidance device 1110 is fixed to the ultrasonic probe 1100 during use. As shown in FIGS. 11A - 11D, the ultrasonic probe 1100 includes one or more features that facilitate cooperative engagement with the needle guidance device 1110. Specifically, the ultrasonic probe 1100 includes a generally tubular body 1101 having a front end 1102, a middle portion 1103, and a rear end 1104. As shown, the front end 1102 includes a generally spherical portion having a diameter larger than that of the middle portion 1103. The rear end 1104 includes a handle portion 1105 and a transition portion 1106 where the shape of the body 1101 transitions between the handle portion 1105 and the middle portion 1103. As shown, the transition portion 1106 includes a portion having a diameter at least larger than the diameters of the middle portion 1103 and the handle portion 1105.

[0216] Consistent with the implementation forms described herein, the transition portion 1106 includes a pair of side positioning pockets 1107 disposed on both sides of the probe 1100 and a pair of upper positioning pockets 1108 formed on the upper surface of the probe 1100. Each of the side positioning pockets 1107 includes a rearward-facing cavity having a front wall on the inside. As will be described in the following additional details, the side positioning pockets 1107 and the upper positioning pockets 1108 jointly facilitate the placement and fixation of the needle guidance device 1110 to the ultrasonic probe 1100 during assembly.

[0217] The needle guidance device 1110 includes a guide body 1112 and a lock assembly 1114. The guide body 1112 includes a guide tube 1116, a front fixing member 1118, and a rear fixing member 1120. FIGS. 11E - 11H are, respectively, a left side view, a top view, a front isometric view, and a front view of the guide body 1112.

[0218] As shown in FIGS. 11E to 11H, the guide tube 1116 has a generally cylindrical configuration with a central opening 1122. The central opening extends into the guide tube and is sized to receive a needle or other piercing device. In some implementations, guide tubes 1116 with different sized openings 1122 may be provided for different gauge piercing devices. In some embodiments, rather than a closed central opening 1122, the guide tube 1116 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0219] In accordance with the implementations described herein, the front fixing member 1118 includes a ring configuration that projects downward from the front portion of the guide tube 1116 and is configured to correspond to the shape of the front end 1102 of the ultrasonic probe 1100 to capture the front end 1102 of the ultrasonic probe 1100 within the front fixing member 1118 during use.

[0220] In this way, by inserting the front end 1102 of the ultrasonic probe 1100 into the front fixing member 1118, the axial position of the front end of the guide tube 1116 relative to the ultrasonic probe 1100 is effectively captured. That is, when the front end 1102 of the ultrasonic probe 1100 is disposed within the front fixing member 1118, the front end of the guide tube 1116 is not radially outwardly pulled from the ultrasonic probe 1100.

[0221] The rear fixing member 1120 includes a curved arm 1132 that projects downward from the guide tube 1116 and is configured to engage the outer surface of the transition portion 1106 of the ultrasonic probe 1100. In accordance with some implementations described herein, the curved arm 1132 of the rear fixing member 1120 includes a positioning element 1134 that projects inwardly at the end of the curved arm 1132. As shown in FIG. 11A, when assembled, the positioning element 1134 is slidably disposed within the side positioning pocket 1107 of the transition portion 1106 of the ultrasonic probe 1100.

[0222] As shown in FIGS. 11E to 11H, the rear fixing member 1120 includes a lock assembly hinge 1121 for pivotally connecting to the lock assembly 1114 and a latch engagement feature 1123 for releasably engaging the latch component 1138, as will be described below. In one exemplary implementation, the lock assembly hinge 1121 projects upward from the upper part of one side of the rear fixing member 1120 at a position laterally offset from the guide tube 1116. As shown, the lock assembly hinge 1121 includes a hinge pin 1125 for engagement with the lock assembly 1114. Similarly, the latch engagement feature 1123 also projects upward from the upper part of one side of the rear fixing member 1120 at a position laterally offset from the guide tube 1116 on the side opposite the lock assembly hinge 1121. As shown in FIG. 11H, the latch engagement feature 1123 includes an opening 1127 for engaging the latch component 1138, as will be described below.

[0223] Consistent with the implementations described herein, FIGS. 11I to 11L are, respectively, a top view, a left side view, a bottom view, and an exploded isometric view of the lock assembly 1114. As shown, the lock assembly 1114 includes a lever component 1136 and a latch component 1138, which together cooperate with the guide tube 1116 and the ultrasonic probe 1100 to fix the needle guidance device 1100 to the ultrasonic probe 1100 in the manner described below.

[0224] As shown in FIGS. 11I to 11K, the lever component 1136 includes a main body portion 1140 having a pair of opposing arms 1142a and 1142b and a guide tube alignment portion 1144. The arms 1142a and 1142b are sized to receive at least a portion of the guide tube 1116 therebetween, as shown in FIG. 11A. In one implementation, an intermediate portion of the arm 1142a includes an engagement portion 1146 for pivotally coupling to the lock assembly hinge 1121. As shown in FIGS. 11I and 11K, the engagement portion 1146 projects outwardly with respect to the arm 1142a, and one or more openings 1148 for aligning with the hinge pin 1125 are passed therethrough. During assembly, the opening 1148 is coupled to the hinge pin 1125, whereby the lever component 1136 can pivot to engage or disengage from the guide tube 1116.

[0225] As shown in FIGS. 11I and 11K, an intermediate portion of the arm 1142a and the arm 1142b includes a positioning pocket engagement element 1160 projecting downward therefrom. As shown in FIG. 11A, when locked to the ultrasonic probe 1100, the pocket engagement element 1160 engages the upper positioning pocket 1108 of the transition portion 1106 of the ultrasonic probe 1100. When the pocket engagement element 1160 engages the upper positioning pocket 1108 and the positioning element 1134 is slidably disposed within the side positioning pocket 1107, the needle guidance device is fixed to the ultrasonic probe 1100.

[0226] As shown in the illustration, the rear end of the lever component 1136 includes a guide tube alignment portion 1144 for joining the arm 1142. As shown in FIG. 11K, the guide tube alignment portion 1144 includes an upper guide tube engagement feature 1164 and a central opening 1166 that are longitudinally arranged so as to align with the central opening 1122 of the guide tube 1116 when the latch component 1138 engages with the lever component 1136 and the guide tube 1116, as described below. As shown in FIG. 11B, the upper guide tube engagement feature 1164 includes a portion that protrudes forward with respect to the remaining portion of the guide tube alignment portion 1144. When the lock assembly 1114 is latched to the guide tube 1116, the upper guide tube engagement feature 1164 is configured to engage with the upper rear end of the guide tube 1116 at a position where the opening 1166 is aligned with the opening 1122.

[0227] As shown in FIGS. 11A and 11I - 11K, the guide tube alignment portion 1144 further includes a latched tab 1168 that protrudes outward. As shown in the illustration, the latched tab 1168 has an opening 1170 formed therein for engaging with the latch component 1138, as described below. In one exemplary implementation, the opening 1170 may include a threading configuration for engaging with the threaded portion of the latch component 1138.

[0228] As shown in FIGS. 11I - 11L and FIGS. 11A - 11B, the latch component 1138 has a rod 1172 and a latch knob 1174. As shown, in use, the rod 1172 is configured to engage both the latch tab 1168 and the latch engagement feature 1123 of the rear fixing member 1120 by threading. Specifically, as shown, the rod 1172 is sized to fit within openings 1170 and 1127 and may include a threaded portion for engaging the correspondingly threaded portion of the opening 1170. As shown in FIG. 11A, when fully inserted or threaded into the opening 1170, the front portion of the rod 1172 engages the opening 1127 of the latch engagement feature 1123 to fix the latch component 1138 to the guide tube 1116.

[0229] To fix the needle guidance device 1110 to the ultrasonic probe 1100, the operator positions the guide tube 1116 relative to the ultrasonic probe 1100 such that the front fixing member 1118 and the rear fixing member 1120 of the guide tube 1116 engage the front end 1102 and the transition portion 1106 of the ultrasonic probe 1100, respectively. Then, the guide tube 1116 is fixed to the ultrasonic probe 1100 by fitting the positioning element 1134 into the side positioning pocket 1107.

[0230] Next, the lever component 1136 is pivoted about the hinge pin 1125, whereby the upper pocket engagement element 1160 fits into the upper positioning pocket 1108. The rod 1172 is inserted through the opening 1170, such as by turning the knob 1174. In this way, the front end of the rod 1172 engages the opening 1127 of the latch engagement feature 1123, effectively fixing the guide tube 1116 to the ultrasonic probe 1100.

[0231] In accordance with the embodiments described herein, the central opening 1166 of the guide - tube alignment portion 1144 aligns with the central opening 1122 of the guide - tube 1116 only when the guide - tube 1116 is securely latched to the ultrasonic probe, thereby preventing premature or unsafe use of the needle - guidance device 1110.

[0232] Once the procedure is complete, the needle - guidance device 1110 can be removed from the ultrasonic probe 1100 by reversing the above steps. That is, the rod 1172 can be moved rearward (e.g., by threading) to release the latch - engagement feature 1123 from the front end of the rod 1172. Next, the lever component 1136 can be pivoted about the hinge pin 1125, thereby disengaging the upper - pocket engagement element 1160 from the upper - positioning pocket 1108. At this point, the needle - guidance device 1110 can be removed from the ultrasonic probe 1100 by sliding the guide body 1112 forward relative to the ultrasonic probe 1100.

[0233] Figures 12A and 12B are, respectively, a top view and a left - side view showing an embodiment of a needle - guidance device 1210 for use with an ultrasonic probe 1200 in an assembled configuration, i.e., a locked configuration, in accordance with the embodiments described herein. Figures 12C and 12D are, respectively, a left - side view and a right - rear isometric view showing the needle - guidance device 1210 and the ultrasonic probe 1200 in an open configuration, i.e., the configuration before assembly.

[0234] In accordance with the embodiments described herein, the ultrasonic probe 1200 and the needle guidance device 1210 are configured to be lockably coupled to each other such that the needle guidance device 1210 is fixed to the ultrasonic probe 1200 during use. As shown in FIGS. 12A-12D, the ultrasonic probe 1200 includes one or more features that facilitate cooperative engagement with the needle guidance device 1210. Specifically, the ultrasonic probe 1200 includes a generally tubular body 1201 having a front end 1202 and a rear end 1204.

[0235] As shown, the front end 1202 includes a generally spherical portion having a diameter larger than the diameter of the middle portion between the front end and the rear end. In accordance with the embodiments described herein, the rear portion of the front end 1202 includes a pair of front positioning pockets 1203 disposed on both sides of the probe 1200. The front positioning pockets 1203 include rearwardly facing cavities having a front wall therein. As will be described in additional detail below, the front positioning pockets 1203 facilitate the placement and fixation of the needle guidance device 1210 to the ultrasonic probe 1200 during assembly.

[0236] The rear end 1204 includes a handle portion 1205 and a transition portion 1206 where the shape of the body 1201 transitions between the handle portion 1205 and the middle portion. As shown, the transition portion 1206 includes a portion having a diameter at least larger than the diameters of the middle portion and the handle portion 1205.

[0237] In accordance with the implementation forms described in this specification, the transition part 1206 includes a pair of positioning pockets 1207 disposed on both sides of the probe 1200 and a positioning slot 1208 formed on the upper surface of the probe 1200. The positioning pocket 1207 includes a cavity facing rearward with a front wall inside. As will be described in the following additional details, the positioning pocket 1207 and the positioning slot 1208 jointly facilitate the placement and fixation of the needle - guidance device 1210 on the ultrasonic probe 1200 during assembly.

[0238] The needle - guidance device 1210 includes a guide body 1212 and a lock assembly 1214. The guide body 1212 includes a guide tube 1216, a front fixing member 1218, and a rear fixing member 1220. FIGS. 12E - 12H are respectively a left - side view, a top view, a bottom view, and a front view of the guide body 1212.

[0239] As shown in FIGS. 12E - 12H, the guide tube 1216 has a generally cylindrical configuration with a central opening 1222. The central opening extends into the guide tube and has a size for receiving a needle or other piercing device. In some implementation forms, guide tubes 1216 with different - sized openings 1222 may be provided for different - gauge piercing devices. In some embodiments, instead of a closed central opening 1222, the guide tube 1216 may include a channel or slot formed vertically therein, into which the piercing device is received.

[0240] The front fixing member 1218 includes opposing curved arms 1230 that project downward from the front portion of the guide tube 1216 and include a shape configured to correspond to the shape of the front end 1202 of the ultrasonic probe 1200. During assembly, the curved arms 1230 are configured to engage the front end 1202 of the ultrasonic probe 1200 to securely center the guide tube 1216 longitudinally with respect to the ultrasonic probe 1200. Consistent with the embodiments of FIGS. 12A-12H, the curved arms 1230 terminate in a front pocket engagement member 1231 for engaging the front positioning pocket 1203 of the ultrasonic probe 1200. In one implementation, the front pocket engagement member 1231 has a pair of arms that project forward and substantially perpendicular from the curved arm 1230. As shown, the front pocket engagement member 1231 is sized to be received in the front positioning pocket 1203.

[0241] In this way, by inserting the front end 1202 of the ultrasonic probe 1200 into the curved arms 1230, the axial position of the front end of the guide tube 1216 relative to the ultrasonic probe 1200 is effectively captured. That is, when the front end 1202 of the ultrasonic probe 1200 is positioned by the curved arms 1230, the front end of the guide tube 1216 is not radially outwardly pulled from the ultrasonic probe 1200.

[0242] The rear fixing member 1220 includes a curved arm 1232 that projects downward from the guide tube 1216 and is configured to engage the outer surface of the transition portion 1206 of the ultrasonic probe 1200. Consistent with some implementations described herein, the curved arm 1232 of the rear fixing member 1220 includes a positioning element 1234 that projects inwardly at the end of the curved arm 1232. As shown in FIG. 12A, when assembled, the positioning element 1234 is slidably disposed within the positioning pocket 1207 of the transition portion 1206 of the ultrasonic probe 1200.

[0243] As shown in FIGS. 12E - 12H, the rear fixing member 1220 includes a lock - assembly hinge 1221 for pivotally connecting to the lock assembly 1214, and a latch - engaging feature 1223 for releasably engaging the latch component 1238, as will be described below. In one exemplary implementation, the lock - assembly hinge 1221 projects upwardly from the upper portion of one side of the rear fixing member 1220 at a position laterally offset from the guide tube 1216. As shown, the lock - assembly hinge 1221 includes a hinge pin 1225 for engagement with the lock assembly 1214. Similarly, the latch - engaging feature 1223 also projects upwardly from the upper portion of one side of the rear fixing member 1220 at a position laterally offset from the guide tube 1216 on the side opposite the lock - assembly hinge 1221. As shown in FIG. 12H, the latch - engaging feature 1223 includes a shoulder portion 1227 for engaging the latch component 1238 when in the lock position, i.e., the closed position, as will be described below.

[0244] Consistent with the implementations described herein, FIGS. 12H - 12K are, respectively, a left - side view, a top view, a bottom view, and an exploded isometric view of the lock assembly 1214. As shown, the lock assembly 1214 includes a lever component 1236 and a latch component 1238, which together cooperate with the guide tube 1216 and the ultrasonic probe 1200 to fixedly secure the needle - guidance device 1200 to the ultrasonic probe 1200 in the manner described below.

[0245] As shown in FIGS. 12I to 12K, the lever component 1236 includes a main body portion 1240 having a pair of opposing arms 1242a and 1242b and a guide tube alignment portion 1244. The arms 1242a and 1242b are sized to receive at least a portion of the guide tube 1216 therebetween, as shown in FIG. 12A. In one implementation, an intermediate portion of the arm 1242a includes an engaging portion 1246 for pivotally coupling to the lock assembly engaging feature 1221. As shown in FIGS. 12H and 12K, the engaging portion 1246 projects outwardly with respect to the arm 1242a, and one or more openings 1248 for aligning with the hinge pin 1223 are passed therethrough. During assembly, the opening 1248 is coupled to the hinge pin 1223, whereby the lever component 1236 can pivot to engage or disengage from the guide tube 1216.

[0246] As shown in FIGS. 12I and 12K, a front portion of the arm 1242, the arm 1242a, and the arm 1242b includes an upper pocket engaging element 1260 projecting downward therefrom. When locked to the ultrasonic probe 1200, as shown in FIG. 12A, the upper pocket engaging element 1260 engages the upper positioning pocket 1208. When the upper pocket engaging element 1260 engages the upper pocket 1208 and the positioning element 1234 is slidably disposed within the side positioning pocket 1207, the needle guidance device is fixed with respect to the ultrasonic probe 1200. In some implementations, as shown in FIG. 12D, at least a portion of the guide tube 1216 can be cut out to accommodate the arm 1242b and the associated upper pocket engaging element 1260.

[0247] As shown in the figure, the rear end of the lever component 1236 includes a guide tube alignment portion 1244 for joining the arms 1242a / 1242b. As shown in FIG. 12K, the guide tube alignment portion 1244 includes an upper guide tube engagement feature 1264 and a central opening 1266 that are longitudinally arranged to align with the central opening 1222 of the guide tube 1216 when the latch component 1238 engages with the lever component 1236 and the guide tube 1216 as described below. As shown in FIG. 12B, the upper guide tube engagement feature 1264 includes a portion that protrudes forward with respect to the remaining portion of the guide tube alignment portion 1244. When the lock assembly 1214 is latched to the guide tube 1216, the upper guide tube engagement feature 1264 is configured to engage with the upper rear end of the guide tube 1216 at a position where the opening 1266 is aligned with the opening 1222.

[0248] As shown in FIGS. 12A and 12I - 12K, the guide tube alignment portion 1244 further includes a pair of laterally protruding latch tabs 1268a and 1268b. The latch tabs 1268a and 1268b include openings 1270a and 1270b formed therein, which function to engage with the latch component 1238 as described below.

[0249] As shown in FIGS. 12I - 12L and 12A - 12B, the latch component 1238 has a substantially frame - shaped member 1272 configured to engage with the shoulder portion 1227 of the latch engagement feature 1223. Specifically, as shown in the figure, the latch component 1238 includes a latch engagement portion 1273 and a pair of latch tab engagement elements 1276a and 1276b in which alignment openings 1278a and 1278b are formed. The latch engagement portion 1273 protrudes forward with respect to the front tab engagement element 1276a and engages with the shoulder portion 1227 when the latch component 1238 is in the latch position with respect to the guide tube 1216.

[0250] During assembly, latch tabs 1268a and 1268b are inserted into latch component 1238, whereby tab engagement elements 1276a and 1276b abut against the respective rear faces of latch tabs 1268a and 1268b. A rod 1280, in which a biasing element 1282 such as a spring is disposed as shown in FIG. 12I, is inserted and fixed in openings 1270a / 1270b and 1278a / 1278b, whereby the biasing element 1282 is disposed between the rear side of the front tab engagement element 1276 and the front side of the rear tab 1268b.

[0251] To fix the needle guidance device 1210 to the ultrasonic probe 1200, the surgeon positions the guide tube 1216 relative to the ultrasonic probe 1200 such that the front fixing member 1218 and the rear fixing member 1220 of the guide tube 1216 engage with the front end 1202 and the transition portion 1206 of the ultrasonic probe 1200, respectively. Then, the guide tube 1216 is fixed to the ultrasonic probe 1200 by fitting the front pocket engagement member 1231 into the front positioning pocket 1203 and fitting the positioning element 1234 into the positioning pocket 1207.

[0252] Next, the latch component 1238 is opened by pulling the frame member 1272 rearward, thereby compressing the biasing element 1282 and causing the latch engagement portion 1273 to move rearward relative to the latch tabs 1268a and 1268b. Next, the latch component 1238 is pivoted downward about the hinge pin 1225, whereby the slot engagement element 1268 engages with the positioning slot 1208. Next, the frame member 1272 is released and the biasing element 1282 moves the latch engagement portion 1273 forward relative to the latch engagement feature 1223. At the forward position, the latch engagement portion 1273 engages with the shoulder portion 1227, effectively fixing the guide tube 1216 to the ultrasonic probe 1200.

[0253] Consistent with the embodiments described herein, the central opening 1266 of the guide tube alignment portion 1244 aligns with the central opening 1222 of the guide tube 1216 only when the guide tube 1216 is securely latched to the ultrasonic probe, thereby preventing premature or unsafe use of the needle guidance device 1210.

[0254] Once the procedure is complete, the needle guidance device 1210 can be removed from the ultrasonic probe 1200 by reversing the above steps. That is, the latch engagement portion 1273 can be moved rearward again to release the guide tube 1216 from the lower guide tube engagement feature 1274. Next, the lever component 1236 can be pivoted about the hinge pin 1225, whereby the slot engagement element 1268 can be disengaged from the positioning slot 1208. At this point, the positioning element 1234 can be removed from the positioning pocket 1207 to remove the needle guidance device 1210 from the ultrasonic probe 1200.

[0255] The foregoing description of the exemplary implementation provides illustration and description, but is not intended to be exhaustive or to limit the embodiments described herein to the exact forms disclosed. Modifications and variations are possible in light of the above teachings, or can be obtained from practice of the embodiments.

[0256] Although the present invention has been described in detail above, it should be clearly understood by those skilled in the art that the present invention can be modified without departing from the spirit of the present invention. Various forms, designs, or arrangements of the present invention can be changed without departing from the spirit and scope of the present invention. Therefore, the above description should be considered illustrative rather than limiting, and the true scope of the present invention is defined by the following claims.

[0257] No element, act, or instruction used in the description of this application should be construed as important or essential to the present invention unless explicitly described. 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 otherwise specified.

[0258] In a claim, the use of ordinal numbers such as "first", "second", "third", etc. to modify an element in the claim does not, in itself, mean a priority, superiority, or order of the element in the claim over other elements, or a temporal order in which acts of a method are performed, or a temporal order in which instructions are executed by a device, etc. Instead, it is merely used as a label to distinguish one element in a claim having a particular name from another element having the same name (but using an ordinal number) in the claim for the purpose of distinguishing the elements in the claim.

Claims

1. A guide body member configured to be fixedly attached to an ultrasonic probe, and a lock assembly coupled to the guide body to fix the guide body to the ultrasonic probe A puncture device guide having, wherein the guide body member, A guide tube having a central opening for receiving a puncture device extending therethrough, A front fixing member for engaging a front portion of the ultrasonic probe, And a rear fixing member for engaging a rear portion of the ultrasonic probe Having, The lock assembly is configured to be movably coupled to the guide body member between a locked configuration and an unlocked configuration. A puncture device guide.

2. At least one of the front fixing member and the rear fixing member is configured to axially receive the ultrasonic probe in one direction, At least one of the ultrasonic probe or the rear fixing member includes a structure for preventing the ultrasonic probe from continuously advancing axially beyond a predefined position. The puncture device guide according to claim 1.

3. The rear fixing member has a pair of curved arms protruding downward from the guide tube, The pair of curved arms is configured to engage a transition portion of the ultrasonic probe. The puncture device guide according to claim 2.

4. Each of the pair of curved arms has a pocket engagement element for engaging a respective positioning pocket in the transition portion of the ultrasonic probe. The puncture device according to claim 3.

5. The rear fixing member has a ring structure protruding downward from the guide tube. The puncture device guide according to claim 2.

6. The lock assembly, A lever component pivotally coupled to the guide body, And a latch component movably coupled to the lever component Having. The puncture device guide according to claim 1.

7. The lever portion, A pair of opposing arms configured to receive the guide tube therebetween, And an upper guide tube engagement feature for engaging an upper portion of the guide tube when in the locked configuration Having, The opposing arms are pivotally coupled to the guide tube via a pivot pin. The puncture device according to claim 6.

8. The puncture device guide according to claim 7, further comprising an upper positioning engagement feature for engaging an upper positioning feature of the ultrasonic probe when the lever portion is in the locked configuration.

9. The puncture device guide according to claim 8, wherein the ultrasonic probe has a positioning rib on an upper surface of the transition portion, and the upper positioning engagement feature has a rib engagement element for engaging the positioning rib of the ultrasonic probe when the lever portion is in the locked configuration.

10. The puncture device guide according to claim 9, wherein the rib engagement element and the positioning rib are disposed in front of a rear fixing member.

11. The puncture device guide according to claim 9, wherein the rib engagement element and the positioning rib are disposed behind a rear fixing member.

12. The puncture device guide according to claim 7, further comprising a pair of upper positioning engagement features for engaging the rear fixing member when the lever portion is in the locked configuration.

13. The rear fixing member has a lock assembly engagement feature protruding upward, The lever component has an engagement portion protruding outward, The engagement portion of the lever component is configured to be pivotally coupled to the lock assembly engagement feature of the rear fixing member so that the lever component can move between the locked configuration and the unlocked configuration. The puncture device guide according to claim 7.

14. A latch component has a lower guide tube engagement feature for engaging a lower portion of the guide tube when the lever portion is in the locked configuration, The lower guide tube engagement feature is movable to engage and disengage from the lower portion of the guide tube to enable movement between the locked configuration and the unlocked configuration. The puncture device guide according to claim 7.

15. The puncture device guide according to claim 14, wherein the latch component has a biasing element for biasing the lower guide tube engagement feature to engage the lower portion of the guide tube.

16. The puncture device guide according to claim 14, wherein the lower guide tube engagement feature has a threaded rod.

17. The rear fixing member has a latch engagement feature, The latch component has a latch engagement portion for engaging a latch engagement feature of the rear fixing member when in the locked configuration, the puncture device guide according to claim 7, wherein the latch engagement portion is movable to engage and disengage from the latch engagement feature of the rear fixing member to enable movement between the locked configuration and the unlocked configuration. **Claim 18** The puncture device guide according to claim 17, wherein the latch component has a biasing element that biases the latch engagement portion to engage the latch engagement feature of the rear fixing member. **Claim 19** The puncture device guide according to claim 17, wherein the latch engagement portion of the latch component has a threaded rod.

Images