Patent ID: 12207839

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to the various figures of the drawing wherein like reference characters refer to like parts, there is shown inFIG.1one exemplary preferred embodiment of a reusable needle guide device20constructed in accordance with this invention. Another preferred exemplary embodiment of a reusable needle guide device20′ constructed in accordance with this invention is shown inFIG.18. Still another reusable needle guide device20″ constructed in accordance with this invention is shown inFIG.21. Those three exemplary embodiments are configured to be releasably mounted directly on an imaging instrument, e.g., an ultrasound transducer or probe10, or indirectly mounted on an adaptor bracket200constructed in accordance with this invention and shown inFIGS.13and25, to guide a needle12or any other elongated instrument through a desired path or trajectory into the body of a patient (human or animal) for a tissue biopsy procedure or any number of other medical procedures.

As will be seen and described in detail later the needle guide device20is adjustable, so that it can establish a trajectory path enabling the needle or instrument to reach an internal site in the patient's body that is close to or far away from the distal or working end of the transducer. In particular, the needle guide device20is configured to enable the user to adjust the needle angle trajectory through a wide range, e.g., a range of approximately 40 degrees. The needle guide device20′ ofFIG.18and the needle guide device20″ ofFIG.21are not adjustable. Rather, each establishes a fixed, different respective, trajectory angle for the needle or other instrument. In accordance with one preferred aspect of this invention a plurality of fixed angle needle guide devices, like guides20′ and20″ can be provided in the form of a kit of several fixed needle guide devices, each establishing its own, and different, angled trajectory path. Thus, by the appropriate selection of the fixed angle needle guide the user can establish the desired angular path for the needle or other instrument.

Irrespective of whether the needle guide device is an adjustable angle or fixed angle device, all of the needle guide devices of this invention make use of a mounting feature to enable them to be readily and quickly mounted on an imaging transducer10, with a conventional cover14interposed therebetween. That cover is typically formed of a thin, flexible sheath of any suitable material, e.g., latex, into a suitable shape, e.g., condom-shaped sheath, to be placed over the imaging transducer before the needle guide device is mounted thereon to keep the transducer sanitary. In the interest of drawing simplicity the cover has been omitted from many of the figures of the drawing, it being understood that the cover is, in fact, interposed between the needle guide device and the imaging transducer on which the needle guide device is mounted or interposed between the needle guide device and the adaptor bracket on which the needle guide is mounted.

The releasably mounting feature of this invention will be described in detail later. Suffice it for now to state that the exemplary needle guide devices20,20′ and20″ include a locking member that is configured to be slidably releasably secured to a locating feature or coupling member that is provided on a specially constructed imaging transducer housing or is provided on a bracket or adapter for use on a conventional imaging transducer. Moreover, the adjustable needle guide device20and the fixed needle guide device20″ (and all other needle guides constructed in accordance with subject invention), enable the user to establish a very shallow depth of penetration for a needle, with a minimal blind spot, since the needle guides do not include any portion which projects far out from the transducer to block the view of the user, i.e., all of the needle guide devices of this invention have a compact form factor.

Turning now toFIGS.1and2it can be seen that the needle guide device20basically comprises a needle guide assembly22and a lockable mounting member24. The lockable mounting member is configured to be releasably secured to a universal or common locating feature or coupling member16that is located on the housing of the transducer adjacent the distal or working end of the transducer. The coupling member16is preferably mounted at the location of the typical “#1 array indicator” of a conventional ultrasonic transducer. As best seen inFIGS.3-5the coupling member16is in the form of a projection of somewhat rectangular profile and having an enlarged top portion16A and a pair of undercut recesses16B on the opposed long sides of the projection.

The lockable mounting member24is best seen inFIGS.6and7and basically comprises a rectangularly shaped frame, e.g., an integrally molded plastic component, having one side section in the form of a thickened handle26, a pair of intermediate sections28and30extending from respective ends of the handle section and an opposite side section32connected between the intermediate sections. A cross-piece section34extends parallel and closely adjacent the handle section. The cross piece includes a projection, e.g., a flange,36extending along the length thereof. As best seen inFIG.6, the sections26,28,30and32define a window38therebetween. The window38is configured to receive the transducer's coupling member16and the portion of the cover14overlying the top16A of the coupling member when the guide device20is to be mounted on the transducer. In particular, as will be described in detail later, the lockable mounting member24is configured to be slidably received within a slot or channel62(to be described later) forming a portion of the needle guide assembly22so that it can be slid by a user pushing on the handle from an open position wherein the coupling member is located within the window38, to a locked position, and vice versa. When the lockable mounting member is in the locked position the coupling member is still located within the window38, but the flanged projection36is disposed within the confronting undercut recess16B of the coupling member16. This action releasable secures the lockable mounting member24to the transducer coupling member.

In order to ensure that the lockable mounting member is held in the locked position so that it is resistant to accidental displacement, it includes a pair of extending fingers40projecting outward from the respective ends of its side section32. Each finger40is connected to its respective end of the side section32by a short flexible bridge section42, which engages a respective portion in the slot or channel62of the needle guide assembly to securely hold the lockable mounting member in the locked position. The bridge sections42, being resilient, are effectively spring-biased so that they are configured to be flexed inward when the fingers40are squeezed together by a user. This brings the bridge sections42towards each other to thereby release the lockable mounting member24from its locked position. That action enables the lockable mounting member to be slid to its open position, wherein the flanged projection36is outside of (beyond) the undercut recess16B of the coupling member and with the coupling member being within the window38to effectively free the coupling member, thereby disconnecting the needle guide device from the imaging transducer. If desired, the lockable mounting member can be removed from the needle guide by squeezing the fingers40together after the transducer's coupling member16is out of the window38and then pulling on the handle36to pull the lockable mounting member out of the slot or channel62.

Referring now toFIGS.2,10and11the details of the needle guide assembly22will now be described. To that end, it basically comprises a body or base member44, a needle holder subassembly46and a slide member48. Each is molded of a suitable plastic material. The body member44comprises a generally flat panel having a pair of long sides50A and50B. A pair of triangularly shaped flanged ears52A and52B project rearwardly from the bottom portions of the sides50A and50B, respectively. Each ear includes a short slot terminating in a circular hole54for accommodating a respective pivot pin of a cylindrically shaped barrel member56(to be described shortly) forming a portion of the needle holder subassembly46. The holes54are axially aligned. A generally planar back wall58extends between the marginal edges of the triangular ears as best seen inFIG.9. The front portion of the body member44includes an arcuate recess or cavity60, as best seen inFIG.8, which is configured to accommodate the barrel member56. The back wall58includes a slot or channel62extending from one side of the back wall to the other and is open to the back surface of the back wall from the ear52A to a point adjacent the ear52B. A central opening64is located in the front surface of the back wall and is shaped to accommodate the top portion16A of the transducer coupling member16to releasably secure the needle guide device to the transducer.

The barrel member56is an elongated generally tubular member having a centrally located front slot66extending parallel to the central longitudinal axis78of the barrel member. A pair of triangular ears68project outward from the barrel member56on opposite sides of the slot66. Each ear includes a linear slot or track70(only one of which can be seen in the figures) which extends at an acute angle, e.g., 15°, from the longitudinal axis of the barrel member, and oriented upward and outward as shown inFIGS.2and8-12. The bottom edge portion of the barrel member includes a pair of pivot pins72projecting outward therefrom. The pins72are diametrically opposed and axially aligned, and each pin is configured to be disposed within a respective hole54in the body member44. When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown inFIG.8) to 40° (as shown inFIG.9). The means for effecting the pivoting of the barrel member with respect to the base member is the heretofore identified slide member48.

Before describing the slide member, a description of the member for holding the needle12in the needle guide device20is in order. That member is best seen inFIGS.10and11. It is in the form of an elongated cylindrical needle holder or insert74. The insert is molded of any suitable plastic material and is configured to be disposed within the barrel member46to directly hold the needle12therein. Moreover, as will be seen and described later, the insert74is configured to be rotated about the central axis78of the barrel member between an open position, such as shown inFIG.12, and a closed position, such as shown inFIG.2, and vice versa. The insert74has a slot76extending parallel to the central longitudinal axis78of the insert from one end of the insert to the other. The width of the slot76is just slightly larger than the diameter of the particular diameter needle12to be used with the needle guide device. The inner end80of the slot76extends parallel to the central longitudinal axis78and is circular in shape to accommodate the needle12therein. The depth of the slot, i.e., the distance from the outer surface of the insert (and the inner surface of the barrel member) to the inner end of the slot is just slightly larger than the diameter of the needle. Thus, when the needle is inserted in the slot76a portion of the periphery of the slot at the inner end80engages the needle, while a portion of the inner surface of the barrel member contiguous with the slot engages another portion of the periphery of the needle, thereby holding the needle in place along a path that is parallel to the longitudinal central axis78of the needle holder. That path establishes the trajectory for the needle.

It should be pointed out at this juncture that different inserts with different size slots76can be provided in lieu of the insert76shown herein to accommodate different diameter needles.

As best seen inFIG.11the upper or entrance end of the slot76is chamfered or tapered to facilitate the axial introduction of the needle therein, i.e., the tapered or chamfered surface directs the distal end of the needle towards the slot when the needle is introduced axially.

A tab82projects radially outward from the top end of the insert to enable the user to rotate the insert76about central longitudinal axis78within the barrel member between the open and closed positions. In order to accommodate the tab82the upper end of the barrel member has a pair of notches84immediately adjacent each side of the slot66. The ends of the notches establish a pair of stops enabling the insert to be rotated through an angle of 180 degrees and no more.

When the needle holder or insert74is in the open position, like that shown inFIG.12, the needle12can be inserted laterally therein, instead of axially through the chamfered upper end of the insert as discussed above. To that end, the tab82is grasped by the user to rotate the insert74180° about central longitudinal axis78(which is also the longitudinal central axis of the barrel member) from the position shown inFIGS.1and2to the position like shown inFIG.12. At that time the slot76of the insert will be aligned with the slot66of the barrel member, whereupon the needle can be inserted laterally through the aligned slots. Once the needle is in the slot76and parallel to the longitudinal central axis78, the tab82can be rotated 180° back to the closed position shown inFIGS.1and2, thereby holding the needle in place.

As will be appreciated by one skilled in the art, after the needle has been deployed, i.e., inserted into the patient's body along the desired trajectory, the imaging transducer10and needle guide device20can be freed (removed) from the needle leaving the needle12in place by merely rotating the insert74to its open position, like shown inFIG.12, whereupon the imaging transducer10and needle guide device20mounted thereon can be moved as a unit laterally with respect to the needle12so that the needle passes through the aligned slots66and77.

Turning now toFIGS.10and11the details of the construction and operation of the slide member48will be described. The slide member basically comprises a generally planar body section86having a thickened pair of side flanges88, each of which includes a longitudinally extending slot or channel for receipt of a respective side edge50A or50B of the base member44to slidably mount the slide member thereon. The central portion of the body section includes a recess or cavity90to accommodate the barrel member46when it is in its 0° orientation, i.e., when the slot76of the needle holder mounted within the barrel member extends parallel to the plane of the slot62of the base member. That orientation is shown inFIGS.1and8. A pair of ears92project outward perpendicularly from the bottom of the body section86on each side of the slot90. Each ear terminates in a free end from which a pivot pin94projects. The pivot pins94are axially aligned and each is configured to be disposed within a respective one of the angularly extending tracks70of the barrel member.

When the slide member48is its upper-most position with respect to the base member46, the pivot pins94of the slide member will be at the upper ends of the tracks70of the barrel member, whereupon the barrel member will be pivoted about its pivot pins70to the 0° angular orientation shown inFIG.8. Conversely, when the slide member48is its lower-most position with respect to the base member46, the pivot pins94of the slide member will be at the lower ends of the tracks70of the barrel member, whereupon the barrel member will be pivoted about its pivot pins70to the 40° angular orientation shown inFIG.9.

The exemplary embodiment of the variable angle needle guide device20shown herein includes a detent mechanism to hold the barrel member in any one of a number, e.g., seven, discrete distinct predetermined angular orientations with respect to the base member, so that the slide member can be readily and repeatedly slid to any one of those positions and to be held therein against accidental displacement therefrom. The detent mechanism basically comprises a plurality of pairs of notches96(FIGS.10and11) extending along the sides50A and50B of the base member at various predetermined spaced locations therealong and which are configured to be engaged by pair of fingers on the slide member to releasably hold the slide member at the position established by the pair of notches into which the fingers have been disposed. Thus, as can be seen, the slide member48includes a pair of pivotable arms98mounted on the side flanges88. The upper end of each arm98is in the form of a handle and a lower portion in the form of an inwardly directed free end finger100. Each arm is mounted on a respective one of the side flanges by a flexible bridge section102, whereupon when the handles98are squeezed together the flexible bridge sections102flex to cause the two opposed fingers100to move apart from each other. That action frees the pair of fingers100from whatever pair of notches96they had been located in so that the slide member48can then be slid to any other position with respect to the base member44, whereupon the pair of fingers are aligned with the pair of notches at that new position. The handles98can then be released, causing them to snap back to bring the fingers into those notches to releasably secure the slide in that position.

In order to facilitate usage of the needle guide device20to establish a desired angular trajectory for the needle, the device20includes indicia to provide an indication of the angle to which the needle guide has been set. In particular, the needle guide includes a plurality of letters, in this exemplary case the letters A through G, located on the front surface of the base member44. The notches associated with the letters A-G, establish the angles of 45°, 35°, 25°, 20°, 15°, 10°, and 5°, respectively.

It should be pointed out at this juncture that the use of letters to indicate a desired angular orientation for the needle is merely exemplary. Thus, the indicia may be in the form of numerical indicia directly identifying the angle, e.g., indicia stating “40°”, or numerical indicia representing a particular angle. Alternatively, the indicia may be in the form of different colors representing different angles or some other indicia representing different angles.

In any case, the top edge portion of the body section86includes a pair of windows104(FIG.10) which are configured to expose the particular indicia, e.g., in this example the letters A-G, associated with the pair of notches96in which the pair of fingers100are located. Thus, the user of the device can press on the handles98of the slide member to free its fingers from the base member so that the slide member can be slid with respect to the base member until one of windows104exposes the letter (or other indicia) associated with the desired angle for the needle. The handles can then be released to enable the arms to spring back, whereupon the fingers enter the associated notches, thereby releasably locking the slide in that desired position.

It should be noted that while the needle guide device20as described above is configured so that the slide can be moved to any of the seven discrete positions established by the pairs of notches96to establish the angled needle trajectory associated with that pair of notches, the spring bias provided by the flexible bridge sections102will hold the free end of the fingers in sufficient frictional engagement with the side edges50A and5B of the base member between the notches96. Thus, the slide member can be slid and held at a “free hand” position in between any of the notches. This feature is important to enable the user to establish a precise desired needle trajectory angle even if it isn't one of the pre-established angles defined by the pairs of notches.

As discussed above, the needle guide20is configured to be directly mounted on an imaging transducer10which has been specially constructed or modified to include the heretofore described locating feature (e.g., coupling member16). The needle guide devices of this invention are also suitable for use on conventional imaging transducers, i.e., imaging transducers without the locating feature or coupling member. To that end, the heretofore mentioned adaptor bracket, constituting another aspect of this invention, is provided. The adaptor bracket200is best seen inFIGS.13-17and enables a needle guide of this invention to be indirectly mounted on the prior art imaging transducer10. The adaptor bracket200basically comprises a hollow housing202made of any suitable material, e.g., a plastic. The housing is hollow and shaped to accommodate the lower portion of whatever prior art imaging transducer it is to be used on. The housing202includes a front portion204and a rear portion206disposed opposite to the front portion. The bottom of the housing is open to expose the working end of the imaging transducer10. In order to facilitate the disposition of the adaptor bracket200on the bottom portion of the conventional imaging transducer, the housing is split to enable the housing to be opened like a clamshell. In particular the housing202includes a vertically oriented channel208extending from the top edge of the housing at the back portion to approximately the mid-height of the housing. The portion210of the housing202between the bottom of the channel208and the bottom edge of the housing (i.e., the open bottom of the housing) forms the “hinge” of the clamshell arrangement. The front portion204of the housing is split in half from its top edge to its bottom edge by means of a top channel212and a bottom channel214. The top channel merges with the bottom channel and is slightly wider than the top channel.

In order to enable a needle guide device constructed in accordance with this invention on the adaptor bracket200, the front portion of the housing202includes a coupling member216. The coupling member216is constructed like the coupling member16described heretofore, except that it is split by the channel214into two halves. In particular, the coupling member216includes one half on one side of the channel214and the other half on the other side of that channel. Taken together the two half sections of the coupling member form of a projection of somewhat rectangular profile and having an enlarged top portion116A and a pair of undercut recesses116B on the opposed long sides of the projection, i.e., on one side of one half section and on the corresponding side of the other half section.

The mounting of the adaptor bracket200can be readily accomplished by grasping portions of the front portion of the housing on opposite sides of the channel212to open that channel, whereupon the two portions of the housing on opposite sides of the channel can pivot open about hinge210so that the bottom portion of the conventional imaging transducer10can be placed between the two open halves of the housing, with the working end of the imaging transducer within the open bottom of the housing. The housing can then be released so that it snaps back into its normally closed state on the imaging transducer like shown inFIG.14. A cover14can then be placed over the adaptor bracket and the transducer. A needle guide device constructed in accordance with this invention can then be releasably mounted on the coupling member as described above with reference to the needle guide20.

Thus, any existing prior art imaging transducer can be readily retrofit by means of the adaptor200to accommodate the needle guide device20(or any other needle guide device making use of the lockable mounting member).

Turning now toFIGS.18-20and22-24the details of the fixed angle needle guide device20′ will now be described. That device makes use of the same lockable mounting member24for releasable mounting on the same coupling member16or216as described heretofore. Thus, in the interest of brevity the common features of those components will be given the same reference numbers and the details of their construction and operation will not be reiterated.

As best seen inFIGS.12-14and16-18, the needle guide device20′ basically comprises a needle guide assembly122and the lockable mounting member24. Those components are each preferably molded of any suitable plastic material. The needle guide assembly122basically comprises a base member126having a slot or channel128extending through it from one side of the base member to the other side. The channel128is configured to slidably receive the lockable mounting member24in a manner similar to the slot or channel62in the adjustable needle guide device20. The back surface of the base member126includes a recess130.

With the lockable mounting member24in place within the slot or channel128in its open position, the coupling member16of the transducer, with a portion of the cover14overlying the top16A of the coupling16, can be extended through the recess130and through the window38in the lockable mounting member. Then the handle26of the lockable mounting member can be pushed inward to move the lockable mounting member to the locked position, whereupon the flanged projection36is located within the undercut recess12B of the coupling member16or216to thereby releasably mounting the needle guide device20′ onto the imaging transducer or on the adaptor bracket with the cover14interposed therebetween.

The needle guide assembly also includes a barrel member132and a needle holder134. The barrel member132is an elongated generally tubular member having a slot136extending parallel to the central longitudinal axis138of the barrel member from the top of the barrel member to the bottom thereof. The barrel member is fixedly mounted on the base member126so that the longitudinal central axis138of the barrel member, which defines the needle trajectory, extends at a predetermined angle to the base member126. In the exemplary embodiment20′ shown inFIGS.18-20,22and24the predetermined angle is 5° in relation to its mounting member126. In the exemplary embodiment20″ shown inFIGS.21and25the predetermined angle is 45° in relation to its mounting member126. The means for mounting the barrel member132in its particular angular orientation comprises a pair of arcuate struts140projecting outward from the base member126.

The needle holder134is in the form of an elongated cylindrical insert that is configured to be disposed within the barrel member132to directly hold the needle12therein. Moreover, the insert is configured to be rotated about the longitudinal central axis138of the barrel member between an open position, such as shown inFIG.24, and a closed position, such as shown inFIGS.18and20, and vice versa. The elongated cylindrical insert has a slot142extending parallel to the central longitudinal axis of the insert from one end of the insert to the other. The width of the slot142is just slightly larger than the diameter of the particular diameter needle12to be used with the needle guide device20′. The inner end of the slot142is circular in shape to accommodate the needle12therein. The depth of the slot, i.e., the distance from the outer surface of the insert134(and the inner surface of the barrel member132) to the inner end of the slot is just slightly greater than the diameter of the needle. Thus, when the needle is inserted in the slot142and the insert is in the closed position a portion of the periphery of the slot142engages a portion of the periphery of the needle12, while a portion of the inner surface of the barrel member contiguous with the slot engages another portion of the periphery of the needle, thereby holding the needle in place along a path that is parallel to the longitudinal central axis138of the needle holder. That path establishes the trajectory for the needle.

As is the case of the adjustable needle guide device20, different inserts or needle holders can be provided with different size slots142to accommodate different diameter needles for use with a fixed angle needle guide device, like device20′. Moreover, like the needle holder74of device20, the needle holder of device20′ makes use of a slot142whose upper end is chamfered to facilitate the axial introduction of the needle therein.

A tab144projects radially outward from the top end of the insert132to enable the user to rotate the insert about central longitudinal axis138within the barrel member134between the open and closed positions, and vice versa. In order to accommodate the tab144the upper end of the barrel member has an internal T-shaped slot having an elongated portion146extending about a portion of the periphery of the barrel member just below the top edge thereof and an entry portion148extending from the top edge to the elongated portion146. The tab144includes a narrow section where the tab merges with the tubular insert and which is configured to be introduced through the entry portion148of the T-shaped slot and then into the elongated portion of that slot. The elongated portion of the T-shaped slot is of a sufficient length to enable the insert132to be rotated about an angle of approximately 180° between the closed position and the open position, and vice versa, when the tab144is within the elongated portion146of the slot.

It should be pointed out at this juncture that when the needle holder or insert132is in the open position, like that shown inFIG.24, the needle12can be inserted therein laterally instead of axially through the chamfered upper end of the insert as discussed above. In particular, the tab is grasped by the user to rotate the insert 180° about central longitudinal axis138(which is also the longitudinal central axis of the barrel member) from the position like shown inFIGS.18and19to the position like shown inFIG.24. At that time the slot142of the insert will be aligned with the slot136of the barrel member, whereupon the needle12can be inserted laterally through the aligned slots. Once the needle is in the slot142the tab144can be rotated 180 degrees back to the closed position shown inFIGS.18and19, thereby holding the needle in place.

After the needle has been deployed, i.e., inserted into the patient's body along the desired trajectory, the imaging transducer10and needle guide device20′ that is mounted thereon can be freed (removed) from the needle leaving the needle in place by merely rotating the insert74to its open position, like shown inFIG.18, whereupon the transducer and needle guide device can be moved as unit laterally with respect to the needle so that the needle passes through the aligned slots136and142.

InFIG.21there is shown an alternative embodiment of a fixed angle needle guide device20″ constructed in accordance with this invention. The needle guide device20″ is virtually identical in construction to the needle guide device20′, except that it establishes a greater angled trajectory for the needle, i.e., a 40° angle with respect to the body member126. To that end, the struts140are of a longer length, e.g., establish an angle of 40°. In the interest of brevity the common features of the embodiments of the devices20′ and20″ will be given the same reference numbers and the details of their construction and operation will not be reiterated.

As mentioned above the subject invention contemplates providing a kit of plural fixed angle needle guide devices, like device20′ and20″ as well as others establishing other fixed angles desired for use.

Like the adjustable needle guide device20, the fixed angle devices20′,20′ and any other fixed angle device, are configured to be directly mounted on an imaging transducer which has been specially constructed or modified to include the heretofore described locating feature, e.g., the coupling member16, and with a cover interposed therebetween. For applications making use of a conventional imaging transducer, the bracket or adaptor200, like shown inFIG.14, can be used with the fixed angle needle guide device. For example,FIG.25shows a conventional imaging transducer10on which an adaptor200, like that described above, has been mounted and over which a conventional cover14has been disposed. In that embodiment the fixed needle guide device20″ is releasably mounted to the coupling member16of the adaptor, with the cover interposed therebetween.

It should be pointed out at this juncture that various modifications can be made to the structure of the needle guide devices, the coupling members and the adaptor brackets within the scope of this invention. By way of example, and not limitation, the slidable connection between the coupling member of the imaging transducer or the adaptor bracket and the lockable mounting member can be reversed from the exemplary embodiment described above. Thus, instead of the lockable mounting member of the needle guide device having a projection which is configured to be received within a recess in the coupling member of the imaging transducer or the adaptor bracket, the lockable mounting member can make use of a recess, e.g., an undercut recess, while the coupling member can make use of a projection for slidable receipt in the recess of the lockable mounting member. Moreover, the recess on the coupling member or the recess on the lockable mounting member (if the components are reversed) need not be located as shown in the exemplary embodiment, e.g., on the sides of the coupling member, but can be in any suitable location to effect the slidable, releasably locking engagement between the coupling member and the lockable mounting member. Furthermore, the pivotable connection between the slide member and the barrel member can be reversed from the exemplary embodiment described above, i.e., the adjustable angle needle guide can make use of a barrel having at least one projecting fingers and a slide member having an ear with at least one angularly extending track or slot for receipt of the at least one finger. Similarly, the pivotable connection between the slide member and the body member can be reversed from the exemplary embodiment described above, i.e., the barrel member can include a pair of aligned holes and the body member can include a pair of pins for receipt in the aligned holes to enable the barrel member to pivot thereabout.

In view of the foregoing it should be appreciated by those skilled in the art that the common locating feature, e.g., the coupling member, of this invention can be applied to most general purpose ultrasound transducers. That common locating feature can be easily cleaned. Moreover, it is shaped similar to a #1 array indicator, so users of the invention should feel familiar with it. Moreover, the structure and arrangement of the common locating feature causes minimal interference or discomfort during scanning, yet provides stable support of for the needle guide device. Further still, the locating feature allows attachment without damaging an ultrasound cover. Insofar as the needle guide device is concerned, it enables one to fix the trajectory angle of the device and also allows for user selection of multiple trajectories. The device incorporates functionality where the user can change the needle trajectory angle before or after assembly to a transducer, bracket and/or insertion of the needle therein. Further yet, the needle guide device provides visible indicia in the form of a character/number/identification element for each needle path trajectory, allowing the user to identify the trajectory and manually select the corresponding guidelines overlay on the ultrasound system. In accordance with one preferred aspect of the invention the needle guide devices enable the establishment of an angular range of at least 40° and can maintain a close proximity to the transducer to achieve a minimal “blind zone”. The needle guide devices of this invention accept multiple versions of inserts sized for differing needle diameters. Whether a fixed angle needle guide device or a variable need guide device, a needle guide device constructed in accordance with this invention exhibits a form factor that is minimal near the transducer lens so as not to interfere with scanning and has a sufficiently low profile without any fixed features that extend past the needle path.

Referring now toFIG.26another, and more preferred, exemplary embodiment of a reusable needle guide device320constructed in accordance with this invention is shown. The needle guide device320is configured to be releasably mounted directly on an imaging instrument, e.g., an ultrasound transducer or probe10like shown inFIGS.26and27, or mounted on an adapter bracket400constructed in accordance with this invention and shown inFIGS.43and44. In any case the device320when mounted on a transducer10or on an adaptor400which in turn is mounted on a transducer serves to mount and guide a needle12or any other elongated instrument through a desired path or trajectory into the body of a patient (human or animal) for a tissue biopsy procedure or any number of other medical procedures.

As will be seen and described in detail later the needle guide device320is adjustable, so that it can establish a trajectory path enabling the needle or instrument to reach an internal site in the patient's body that is close to or far away from the distal or working end of the transducer. In particular, the needle guide device320is configured to enable the user to adjust the needle angle trajectory through a wide range.

The exemplary needle guide device320(and any other needle guide device constructed in accordance with this invention) makes use of a mounting feature to enable it to be readily and quickly mounted on an imaging transducer10either with or without a conventional cover14interposed therebetween. If a cover is used it will typically be formed of a thin, flexible sheath of any suitable material, e.g., latex, into a suitable shape, e.g., a condom-shaped sheath, to be placed over the imaging transducer before the needle guide device is mounted thereon to keep the transducer sanitary. In the interest of drawing simplicity the cover has been omitted from figures of the drawing of the embodiment320, it being understood that the cover can be interposed between the needle guide device and the imaging transducer on which the needle guide device is mounted. Alternatively the cover can be interposed between the needle guide device and the adapter bracket on. In either such case the needle device can be releasably mounted without breaching the cover.

The releasably mounting feature of this invention will be described in detail later. Suffice it for now to state that the exemplary needle guide device320includes a lockable mounting assembly arranged to be releasably secured to a universal or common locating feature or coupling member that is provided on the housing of a specially constructed imaging transducer or on an adapter bracket for use on a conventional imaging transducer. The lockable mounting assembly includes a slidable member (e.g., a lock slide to be described later) that is configured to be slid from an unlocked position to enable the needle guide device to be mounted on the coupling member, to a locked position wherein the needle guide is releasably locked or secured to the coupling member and hence to the transducer.

As will also be described later the needle guide device320(and all other needle guides constructed in accordance with subject invention) is configured to enable the user to adjust the angle of penetration for the needle between a minimum angle and a maximum angle. When adjusted to the maximum angle the needle guide device enables a very shallow depth of penetration for the needle, with a minimal blind spot, without any portion of the needle guide device projecting far out from the transducer to block the view of the user. Thus, the needle guide device320, like other needle guide devices of this invention, has a compact form factor.

Turning now toFIGS.26,27and31it can be seen that the exemplary needle guide device320basically comprises a needle guide assembly322and a lockable mounting assembly324. The lockable mounting assembly324is configured to be releasably secured to a universal or common locating coupling member316that is located on the housing of the transducer adjacent the distal or working end of the transducer. The coupling member316is preferably mounted at the location of the typical “#1 array indicator” of a conventional ultrasonic transducer. In the case where the common locating coupling member316is used on an adapter bracket400, it will be located on that bracket at a position corresponding to the position that the coupling member is mounted on the transducer itself.

As best seen inFIGS.28-31the coupling member16is in the form of a projection of somewhat rectangular profile and having an enlarged generally planar front surface portion316A, an undercut recesses316B on the left side of the projection, an undercut recess316C on the right side of the projection, and an undercut recess316D on the top side of the projection. As best seen inFIG.30, the undercut recess316D slants downward symmetrically from the center of the top side towards the left side of the projection and also toward the right side of the projection.

The lockable mounting assembly324is best seen inFIGS.32-36Band basically comprises a slidable member or lock slide310and a lock lever312. Each is molded of a suitable plastic material. The lock slide310is a generally planar frame-like member having a generally linear side surface310A and a pair of projecting ears310B and310C (FIG.34) located on opposite sides of the surface310A. The surface310A constitutes an engagement surface configured to mate with (be received within) the left side undercut recess316C of the projection316when the lockable mounting assembly is in the locked position. The lock slide includes an opening310D for receipt of portions of the lock lever312(to be described later). The lock slide is arranged for slidable receipt within an undercut slot302in a body or base member304of the needle guide device to enable the lock slide to be slid between the unlocked position (not shown) and the locked position (FIG.33), and vice versa. The body or base member304of the needle guide device forms a portion of the needle guide assembly322. As best seen inFIG.34the undercut slot302includes short front edge surface302A and an opposed pair of linear surfaces302B and302C which between them define the entryway to the undercut slot. The end of the slot opposite the slot's entryway is in the form of a generally planar, linear projection306overlying the slot. The ears310B and310C of the lock slide are configured to be introduced into the undercut slot by locating them within the portions of the slot contiguous with the surfaces302B and303C, respectively, and then sliding the lock slide towards projection306. The projection306forms a stop surface which is configured to mate with (be received within) the right side undercut recess316C of the coupling member (projection)316when the lockable mounting assembly is in the locked position, whereupon the projection316is tightly sandwiched between the engagement surface310A and the stop surface306.

The means for sliding the lock slide310between the unlocked position and the locked position, and vice versa, is the heretofore identified lock lever312. As can be seen inFIGS.35,36A and36Bthe lock lever312basically comprises a finger grip portion312A, a pivot pin portion312B (FIG.36B), and a cam portion312C. The pivot pin312B is a split member of circular profile having an enlarged head312D at the free end thereof. A small tab312E projects outward from the head312D. As best seen inFIG.36Athe cam312C is laterally offset from the central axis of the pivot pin312B. The cam312C is configured to be located within the opening310D of the lock slide310, with the pivot pin312B being located within a hole304A in a projecting portion304B of the body member304adjacent the slot302and with the head312D of the pivot pin located on the opposite side of the projection304B as the slot302. The hole includes a recess304C (FIGS.32and34) which is provided for the purpose of providing an opening to allow tab312E to fit through. The tab312E is configured to fit through the recess304C.

The pivot pin312B is arranged to be pivoted within the hole304A about its central axis by the finger grip312A to cause the cam31C to engage portions of the lock slide to move it to either the locked or unlocked positions, depending upon the direction of notation of the pivot pin312B. In particular, since the cam312C is laterally offset from the central axis of the pivot pin312B, and since the cam is located within the opening310D of the lock slide310, the pressing downward on the finger grip312A effects the clockwise rotation of the pivot pin, whereupon a portion of the surface of the cam pushes on a portion of the slide lock contiguous with the opening310D towards the stop surface306to the locked position. Conversely, pressing upward on the finger grip effects the counter-clockwise rotation of the pivot pin, whereupon a portion of the surface of the cam pushes on a diametrically opposed portion of the slide lock contiguous with the opening310D away from the stop surface306to move the slide lock to the unlocked position.

The releasable mounting of the needle guide device320onto a transducer having a coupling member316or onto an adapter bracket400including a similarly constructed coupling member is achieved as follows. The finger grip312A of the lock lever312is pressed upward to move the slide lock to the unlocked or open position (if the slide lock is not already in that position). The needle guide device320and the transducer or adapter bracket400are then moved relative to each other so that the coupling member or projection316is located within the undercut slot302between the engagement surface310A and the stop surface306. Once that has been accomplished the finger grip312A of the lock lever is pressed downward, to cause the cam312C to engage a portion of the slide lock310contiguous with the opening310D to slide the slide lock towards the stop surface306, whereupon the stop surface is located within the right side recess316C of the projection and the engagement surface310of the slide lock is located in the left side recess316B of the projection whereupon the coupling member316is tightly sandwiched between the engagement surface310A and the stop surface306. This action effectively releasably secures the needle guide device onto the transducer or adapter bracket so that it is ready for use. To remove the needle guide device from the transducer or adapter bracket, when such is desired, all that is required is to press upward on the finger grip312A of the lock lever to cause the cam312B to engage a diametrically opposed portion of the slide lock contiguous with the opening310D to slide the slide lock away from the stop surface306, thereby freeing the coupling member316so that it can be removed from the undercut slot302.

Referring now toFIGS.31,37-42the details of the needle guide assembly322will now be described. To that end, it basically comprises the heretofore identified body or base member304, a needle holder subassembly346and a slide member348. Each is molded of a suitable plastic material. The body member304comprises a generally flat panel having a pair of long sides350A and350B. A pair of triangularly shaped flanges352A and52B project rearwardly from the bottom portions of the sides350A and350B, respectively. The inner surface of each flange includes a short slot terminating in a circular hole354for accommodating a respective pivot pin of a cylindrically shaped barrel member356(to be described shortly) forming a portion of the needle holder subassembly346. The holes354are axially aligned. The front portion of the body member304includes an arcuate recess or cavity360, as best seen inFIGS.32and40, which is configured to accommodate the barrel member356.

The barrel member356forms a portion of the needle holder subassembly346and is an elongated generally tubular member having a centrally located linear front slot366(FIG.41) extending parallel to the central longitudinal axis of the barrel member. A pair of triangular ears368project outward from the barrel member356on opposite sides of the slot366. Each ear368includes a linear slot or track370which extends at an acute angle, e.g., 15°, from the longitudinal axis of the barrel member, and oriented upward and outward as shown inFIGS.31,39and141. As best seen inFIG.41, the bottom edge portion of the barrel member includes a pair of axially aligned pivot pins372projecting outward therefrom (although only one the pins can be seen). The pins372are configured to be disposed within respective holes354in the body member304. When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown inFIGS.26and27) to 40° (as shown inFIGS.27and38). The means for effecting the pivoting of the barrel member with respect to the base member is the heretofore identified slide member248.

Before describing the slide member248, a description of the member for holding the needle12in the needle guide device320is in order. That member forms a portion of the needle holder subassembly346and is best seen inFIG.41. It is in the form of an elongated cylindrical needle holder or insert374. The insert is molded of any suitable plastic material and is configured to be disposed within the barrel member346to directly hold the needle12therein. Moreover, as will be seen and described later, the insert374is configured to be rotated about the central longitudinal axis378of the barrel member between an open position, such as shown inFIG.41, and a closed position, such as shown inFIGS.33and39, and vice versa. The insert374has a slot376extending parallel to the central longitudinal axis of the insert from one end of the insert to the other. The width of the slot376is just slightly larger than the diameter of the particular diameter needle12to be used with the needle guide device. The inner end of the slot376extends parallel to the central longitudinal axis of the insert and is circular in shape to accommodate the needle12therein. The depth of the slot, i.e., the distance from the outer surface of the insert (and the inner surface of the barrel member) to the inner end of the slot is just slightly larger than the diameter of the needle. Thus, when the needle is inserted in the slot376a portion of the periphery of the slot at the inner end engages the needle, while a portion of the inner surface of the barrel member contiguous with the slot engages another portion of the periphery of the needle, thereby holding the needle in place along a path whose longitudinal axis378is parallel to but slightly laterally offset from the central longitudinal axis of the needle holder. That path establishes the trajectory for the needle. The upper or entrance end of the slot376is chamfered or tapered to facilitate the axial introduction of the needle therein, i.e., the tapered or chamfered surface directs the distal end of the needle towards the slot when the needle is introduced axially.

It should be pointed out at this juncture that different inserts with different size slots376can be provided in lieu of the insert shown herein to accommodate different diameter needles.

A tab82projects radially outward from the top end of the insert to enable the user to rotate the insert376about central longitudinal axis of the barrel member within the barrel member between the open and closed positions. In order to accommodate the tab382the upper end of the barrel member has a pair of notches384immediately adjacent each side of the slot366. The ends of the notches establish a pair of stops enabling the insert to be rotated through an angle of 180 degrees and no more.

When the needle holder or insert374is in the open position the slot376of the needle holder is aligned with the slot266of the barrel member the needle12can be inserted laterally through the aligned slots, instead of axially through the chamfered upper end of the needle holder as discussed above. To that end, the tab382is grasped by the user to rotate the needle holder 180° about central longitudinal axis378(which is also the longitudinal central axis of the barrel member) from the closed position shown inFIGS.31and39to a position like shown inFIG.41where the slots376and366are aligned, whereupon the needle can be inserted laterally through the aligned slots. Once the needle is in the slot376along axis378, the tab382can be rotated 180° back to the closed position shown inFIGS.6and14, thereby holding the needle in place.

As will be appreciated by one skilled in the art, after the needle has been deployed, i.e., inserted into the patient's body along the desired path or trajectory, the imaging transducer10and needle guide device20can be freed (removed) from the needle leaving the needle12in place by merely rotating the insert374to its open position, whereupon the imaging transducer10and needle guide device320mounted thereon can be moved as a unit laterally with respect to the needle12so that the needle passes through the aligned slots376and366.

Turning now toFIGS.6,15and16the details of the construction and operation of the slide member348to pivot the needle holder assembly to the desired angle will be described. The slide member basically comprises a generally planar body section386having a pair of side flanges388projecting backward from respective side edges of the body section386. Each flange388includes a longitudinally extending slot or channel388A (FIG.31) for receipt of a respective side edge350A or350B of the base member304to slidably mount the slide member on the base member. The central portion of the body section386includes a recess or cavity390to accommodate the barrel member346when it is in its 0° orientation, i.e., when the slot376of the needle holder mounted within the barrel member extends parallel to the plane of the undercut slot302of the base member304. A pair of ears392project outward perpendicularly from the lower portion of the body section386on each side of the slot390. Each ear terminates in a free end from which a pivot pin394projects. The pivot pins394are axially aligned and each is configured to be disposed within a respective one of the angularly extending tracks370of the barrel member.

When the slide member348is its upper-most position with respect to the base member304, the pivot pins394of the slide member will be at the upper ends of the tracks370of the barrel member, whereupon the barrel member will be pivoted about its pivot pins372to the 0° angular orientation shown inFIGS.26and37. Conversely, when the slide member348is its lower-most position with respect to the base member304, the pivot pins394of the slide member will be at the lower ends of the tracks370of the barrel member, whereupon the barrel member will be pivoted about its pivot pins372to the 40° angular orientation shown inFIGS.27and38.

The exemplary embodiment of the variable angle needle guide device320shown herein includes a locking mechanism to hold the barrel member in any one of a number, e.g., five, discrete distinct predetermined angular orientations with respect to the base member, so that the slide member can be readily and repeatedly slid to any one of those positions and to be held against accidental displacement therefrom. The locking mechanism basically comprises a plurality of notches396(FIGS.39and40) and a slide lock398. The notches396extend along the side350B of the base member304at various predetermined spaced locations therealong. Each notch is configured to be engaged by the slide lock398to hold the slide member at the position established by the selected notch. The slide lock is slidably mounted on the slide member via a flanged rail330(FIGS.40and41) extending along the ear392adjacent the right side of the slide member. The flanged rail is configured for slidable receipt in the slide lock. The slide lock is best seen inFIGS.41and42and basically comprises a member having a somewhat hollow body including a T-shaped slot398A in the bottom portion thereof and a L-shaped flange398B projecting outward from the inner end of the slide lock. The T-shaped slot is arranged to receive the flanged rail330(FIG.40) of the slide member to enable the slide lock to be slid therealong from an unlocked or retracted position to a locked or extended position, and vice versa. A slot386A is located adjacent the flanged rail330and extends through the channel388A. When the slide lock is in the extended or locked position the upper section of the L-shaped flange398B will extend through the slot386A for disposition in any one of the notches396to thereby hold the slide member348in place with respect to the body member304. When the slide member is in the retracted or unlocked position, the upper section of the L-shaped flange398B will be located outside all of the notches so that the slide member can be slid up or down the body member to any desired position therealong. The slide lock includes a detent mechanism to ensure that the slide lock does not become disconnected from the flanged rail when it is in the retracted position.

In order to facilitate usage of the needle guide device320to establish a desired angular trajectory for the needle, the device320includes indicia to provide an indication of the angle to which the needle guide has been set. In particular, the needle guide includes a plurality of letters, in this exemplary case the letters A through E, located on the front surface of the base member304. The notches associated with the letters A-E, establish the angles of 40°, 28°, 18°, 9°, and 3°, respectively.

It should be pointed out at this juncture that the use of letters to indicate a desired angular orientation for the needle is merely exemplary. Thus, the indicia may be in the form of numerical indicia directly identifying the angle, e.g., indicia stating “28°”, or numerical indicia representing a particular angle. Alternatively, the indicia may be in the form of different colors representing different angles or some other indicia representing different angles.

In any case, the body section386includes a window332(FIGS.39-41) which is configured to expose the particular indicia, e.g., in this example the letters A-E, associated with the notches396in which slide lock's L-shaped flange is located. Thus, the user of the device can press on the top surface of the slide lock to slide it to the retracted or unlocked position to free it from the base member so that the slide member can be slid with respect to the base member until the window332exposes the letter (or other indicia) associated with the desired angle for the needle. The slide lock can then be slid back to the extended or locked position, whereupon the upper section of the L-shaped flange398B enters the associated notch396, thereby releasably locking the slide member in that desired position.

It should be pointed out at this juncture that the needle guide device320can be used to establish an angular orientation for the needle that is different than the predetermined angles established by the notches396, since the construction of the slide member is such that it is continuously slidable with respect to the base member to any position between discrete positions established by those notches. In such a case, all that the user has to do is slide the slide member to the desired position along the base member to establish a desired angle for the needle while keeping the slide lock398in its retracted or unlocked position. When the slide lock is in the unlocked position, the upper section of the L-shaped flange398B will be located outside all of the notches so that the slide member will effectively be floating and can be slid up or down the body member to any desired position therealong to establish any desired angle for the needle. Thus, the needle guide device320, and other needle guide devices constructed in accordance with this invention, can be used to guide needles or other elongated instruments within the center elevation plane of the transducer allowing free angle movement in relation to the center azimuth plane of the transducer by leaving the slide lock in the unlocked position.

As discussed above, the needle guide320is configured to be directly mounted on an imaging transducer10which has been specially constructed or modified to include the heretofore described locating feature (e.g., the coupling member316). The needle guide devices of this invention are also suitable for use on conventional imaging transducers, i.e., imaging transducers without the locating feature or coupling member. To that end, the heretofore mentioned adaptor bracket400, constituting another aspect of this invention, is provided. The adaptor bracket400is best seen inFIGS.43and44and enables a needle guide device of this invention to be indirectly mounted on any prior art imaging transducer. To that end, the adaptor bracket400basically comprises a hollow housing402made of any suitable material, e.g., a plastic. The housing is hollow shaped to accommodate the lower portion of whatever prior art imaging transducer it is to be used on. The housing402includes a front portion404(FIG.43) and a rear portion406(FIG.44) disposed opposite to the front portion. The bottom of the housing is open at408to expose the working end of a conventional imaging transducer10. In order to facilitate the disposition of the adaptor bracket400on the bottom portion of the imaging transducer, the housing is split to enable it to be opened like a clamshell. In particular, the housing402includes a vertically oriented channel410extending from the top edge of the housing at the back portion to approximately the mid-height of the housing. The portion of the housing between the bottom of the channel410and the bottom edge of the housing (i.e., the open bottom408) forms the “hinge” of the clamshell arrangement. The front portion404of the housing is split in half from its top edge to its bottom edge by means of a top channel412A and a contiguous bottom channel412B. The top channel is aligned with and merges with the bottom channel and is slightly wider than the bottom channel.

In order to enable a needle guide device constructed in accordance with this invention to be releasably mounted on the adaptor bracket400, the front portion404of the housing402includes a locating feature of coupling member like that described previously. In particular the coupling member of the adaptor bracket410is constructed like the coupling member316described heretofore, except that it is split by the lower channel412B into two halves, i.e., a left half and a right half. In particular, the coupling member316includes one half on one side of the channel412B and the other half on the other side of that channel. Taken together the two half sections of the coupling member316form of a projection of the same shape as described earlier with respect to the coupling member forming a part of the transducer housing.

The mounting of the adaptor bracket400on a conventional transducer10can be readily accomplished by grasping portions of the front portion404of the housing402on opposite sides of the channels412A and412B to open those channels, whereupon the two portions of the housing402on opposite sides of the channel can pivot open like the opening of a clamshell so that the bottom portion of the conventional imaging transducer10can be placed between the two open halves of the housing, with the working end of the imaging transducer within the open bottom of the housing. The housing can then be released so that it snaps back into its normally closed state on the imaging transducer like shown inFIG.43. If desired a cover (not shown) can then be placed over the adaptor bracket and the transducer. A needle guide device constructed in accordance with this invention can then be releasably mounted on the coupling member as described above.

It should thus be apparent to those skilled in the art that any existing prior art imaging transducer can be readily retrofit by means of the adaptor400to accommodate the needle guide device320(or any other needle guide device in accordance with this invention).

Various modifications can be made to the structure of the needle guide devices, the coupling members and the adaptor brackets within the scope of this invention. By way of example, and not limitation, the slidable connection between the coupling member of the imaging transducer or the adaptor bracket and the lockable mounting member can be reversed from the exemplary embodiment described above. Thus, instead of the slide lock member310of the needle guide device having a projection which is configured to be received within a recess in the left side of the coupling member of the imaging transducer or the adaptor bracket, the slide lock can make use of a recess, e.g., an undercut recess, while the left side of coupling member can make use of a projection for slidable receipt in the recess of the slide lock. So too, the projection or stop306can be in the form of a recess at its free end, while the right side of coupling member includes a projection for receipt in the stop306, so long as the coupling member is tightly sandwiched between opposing surfaces to releasably secure the needle guide device onto the coupling member. Furthermore, the pivotable connection between the slide member and the barrel member can be reversed from the exemplary embodiment described above, i.e., the adjustable angle needle guide can make use of a barrel having at least one projecting fingers and a slide member having an ear with at least one angularly extending track or slot for receipt of the at least one finger. Similarly, the pivotable connection between the slide member and the body member can be reversed from the exemplary embodiment described above, i.e., the barrel member can include a pair of aligned holes and the body member can include a pair of pins for receipt in the aligned holes to enable the barrel member to pivot thereabout.

In view of the foregoing it should be appreciated by those skilled in the art that the common locating feature, e.g., the coupling member, of this invention can be applied to most general purpose ultrasound transducers. That common locating feature can be easily cleaned. Moreover, it is shaped similar to a #1 array indicator, so users of the invention should feel familiar with it. Moreover, the structure and arrangement of the common locating feature causes minimal interference or discomfort during scanning, yet provides stable support of for the needle guide device. Further still, the locating feature allows attachment without damaging an ultrasound cover, if such is used.

Insofar as the needle guide device is concerned, it enables one to fix the trajectory angle of the device and also allows for user selection of multiple trajectories. The device incorporates functionality where the user can change the needle trajectory angle before or after assembly to a transducer, bracket and/or insertion of the needle therein.

Further yet, the needle guide device provides visible indicia in the form of a character/number/identification element for each needle path trajectory, allowing the user to identify the trajectory and manually select the corresponding guidelines overlay on the ultrasound system. In accordance with one preferred aspect of the invention the needle guide devices enable the establishment of an angular range of at least 40° and can maintain a close proximity to the transducer to achieve a minimal “blind zone”. The needle guide devices of this invention accept multiple versions of inserts sized for differing needle diameters. Further still, needle guide devices constructed in accordance with this invention exhibit a form factor that is minimal near the transducer lens so as not to interfere with scanning and has a sufficiently low profile without any fixed features that extend past the needle path.

Without further elaboration the foregoing will so fully illustrate my invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.