Needle Guidance System

Abstract

A guidance system for guiding an interventional device, such as a needle, to a target site, such as a blood vessel, while remaining within the field of view of an imaging device, such as an ultrasound. The guidance system may include an attachment mechanism for detachably attaching to a particular ultrasound probe or adaptable to multiple different probes. The guidance mechanism extends outward from the attachment mechanism to guide the angle and depth of the interventional device. The guidance mechanism may include multiple openings through which the interventional device can be selectively inserted, each configured for a different angle and / or depth. Alternatively, the guidance mechanism may include a single opening that is adjustable along an arcuate path. The guidance system may include a release mechanism for safely removing the interventional device from the guidance mechanism without excessive movement.

Description

[Background technology]

[0001] A wide range of medical procedures may require precise needle insertion to access various parts of a patient's body for treatment or diagnosis, such as accessing the femoral or subclavian arteries, or for tissue biopsies.

[0002] If the needle is not accurately guided and placed at the intended target site, various complications can occur. While such procedures are typically performed by trained medical professionals, without guidance, multiple attempts may be required to reach the target site. Failure to reach the target site on the first attempt can lead to delays in the procedure, patient discomfort, and / or various medical complications.

[0003] Although ultrasound imaging is sometimes used to improve the accuracy of such needle insertion procedures, it can be difficult to maintain the needle's position within the ultrasound field of view (e.g., within the ultrasound beam) and maintain clear visibility of the needle as it moves through the patient's body to reach the target site. In many cases, the ultrasound field of view is very narrow (e.g., approximately 1 mm), making it very difficult to maintain the needle's position within the field of view during insertion. Summary of the Invention [Problem to be solved by the invention]

[0004] (Means for solving the problem) A guidance system is described for guiding an interventional device, such as a needle, to a target location, such as a blood vessel, while remaining within the field of view of an imaging device, such as an ultrasound.

[0005] One embodiment may include an attachment mechanism for removably attaching to an imaging device such as an ultrasound probe.

[0006] One embodiment may include a guidance mechanism that guides the interventional device along an optimal angle and to an optimal depth while remaining within the field of view of the imaging device.

[0007] In one embodiment, the guidance mechanism may be fixed in place.

[0008] In another embodiment, the guide mechanism may be movable along an arcuate path.

[0009] In one embodiment, the guidance mechanism comprises multiple openings, each extending through the guidance mechanism at a different angle, and the interventional device is removably inserted through these openings and guided to a target location at a desired depth while remaining within the field of view of the interventional device.

[0010] In another embodiment, the guide mechanism includes a single opening, and the guide mechanism itself is movable along an arcuate path between different angles to accommodate different depths.

[0011] In one embodiment, the guidance mechanism may include visual, auditory, and / or tactile feedback to distinguish between different angles and / or depths.

[0012] One embodiment of such visual feedback may include multiple indicia, such as markings or grooves representing different angles and / or depths.

[0013] In one embodiment, the guidance system may include a release mechanism that allows the interventional device to be safely detached from the guidance mechanism without movement after the interventional device reaches the target location.

[0014] In one embodiment, the release mechanism may comprise a hinged member that latches closed to retain the interventional device and pivots open to release the interventional device.

[0015] In another embodiment, the release mechanism may comprise a magnetic element that magnetically engages the interventional device during use but allows the interventional device to release once the target location is reached. The magnetic element can assist in orienting the interventional device.

[0016] In another embodiment, the release mechanism may comprise one or more resilient flaps that adjust outward to release the interventional device and then resiliently return to their original position. [Brief explanation of the drawings]

[0017] These and other aspects, features and advantages by which embodiments of the present invention may be realized will become apparent and will be explained from the following description of embodiments of the invention, which proceeds with reference to the accompanying drawings.

[0018] [Figure 1] FIG. 1 is a front view of a needle guidance system according to one embodiment of the present invention when in use.

[0019] [Figure 2A] FIG. 2A is a side view of a needle guidance system utilizing short access guidance according to one embodiment.

[0020] [Figure 2B] FIG. 2B is a front view of a needle guidance system utilizing long access guidance according to one embodiment.

[0021] [Figure 3] FIG. 3 is a front view illustrating exemplary depth and angle measurements of a needle guidance system according to one embodiment.

[0022] [Figure 4] FIG. 4 is a front view of a needle guidance system according to one embodiment.

[0023] [Figure 5] FIG. 5 is a front view of a needle guidance system showing multiple needle positions according to one embodiment.

[0024] [Figure 6A] FIG. 6A is a first perspective view of a needle guidance system according to one embodiment.

[0025] [Figure 6B] FIG. 6B is a second perspective view of a needle guidance system according to one embodiment.

[0026] [Figure 7A] FIG. 7A is a top view of a needle guidance system according to one embodiment.

[0027] [Figure 7B] FIG. 7B is a second bottom view of a needle guidance system according to one embodiment.

[0028] [Figure 8] FIG. 8 is a front view of an adjustment mechanism of a needle guidance system according to one embodiment.

[0029] [Figure 9] FIG. 9 is a top view of a needle guidance system according to one embodiment.

[0030] [Figure 10] FIG. 10 is a front view of a needle guidance system according to one embodiment.

[0031] [Figure 11A] FIG. 11A is a front view of a needle guidance system showing multiple needle positions at minimum depth according to one embodiment.

[0032] [Figure 11B] FIG. 11B is a front view of a needle guidance system showing multiple needle positions at maximum depth according to one embodiment.

[0033] [Figure 12A] FIG. 12A is a first perspective view of a needle guidance system according to one embodiment.

[0034] [Figure 12B] FIG. 12B is a second perspective view of a needle guidance system according to one embodiment.

[0035] [Figure 13] FIG. 13 is a perspective view of a needle guidance system showing a needle release mechanism according to one embodiment.

[0036] [Figure 14A] FIG. 14A is a top view of a needle guidance system according to one embodiment.

[0037] [Figure 14B] FIG. 14B is a bottom view of a needle guidance system according to one embodiment.

[0038] [Figure 15] FIG. 15 is a top view of a needle guidance system according to one embodiment.

[0039] [Figure 16] FIG. 16 is a front view of a needle guidance system according to one embodiment.

[0040] [Figure 17] FIG. 17 is a front view of a needle guidance system showing multiple needle positions according to one embodiment.

[0041] [Figure 18A] FIG. 18A is a first perspective view of a needle guidance system according to one embodiment.

[0042] [Figure 18B] FIG. 18B is a second perspective view of a needle guidance system according to one embodiment.

[0043] [Figure 19A] FIG. 19A is a perspective view of a needle guidance system showing a needle release mechanism according to one embodiment.

[0044] [Figure 19B] FIG. 19B is a perspective view of a needle guidance system showing a needle release mechanism according to one embodiment.

[0045] [Figure 20A]FIG. 20A is a top view of a needle guidance system according to one embodiment.

[0046] [Figure 20B] FIG. 20B is a bottom view of a needle guidance system according to one embodiment.

[0047] [Figure 21] FIG. 21 is a bottom view of a needle guidance system according to one embodiment.

[0048] [Figure 22] FIG. 22 is a perspective view of a needle guidance system according to one embodiment.

[0049] [Figure 23A] FIG. 23A is a perspective view of a needle guidance system in a first position according to one embodiment.

[0050] [Figure 23B] FIG. 23B is a perspective view of a needle guidance system in a second position according to one embodiment.

[0051] [Figure 23C] FIG. 23C is a perspective view of a needle guidance system in a third position according to one embodiment.

[0052] [Figure 24A] FIG. 24A is a front view of a release mechanism of a needle guidance system in a first position according to one embodiment.

[0053] [Figure 24B] FIG. 24B is a front view of a release mechanism of a needle guidance system in a second position according to one embodiment.

[0054] [Figure 25] FIG. 25 is a perspective view of a release mechanism of a needle guidance system according to one embodiment.

[0055] [Figure 26A]FIG. 26A is a perspective view of a release mechanism of a needle guidance system in a released position according to one embodiment.

[0056] [Figure 26B] FIG. 26B is a perspective view of a release mechanism of a needle guidance system in a locked position according to one embodiment.

[0057] [Figure 26C] FIG. 26C is a perspective view of a needle inserted into a needle guidance system with the release mechanism in a locked position, according to one embodiment.

[0058] [Figure 26D] FIG. 26D is a perspective view of a needle released from a needle guidance system with the release mechanism in an unlocked position, according to one embodiment.

[0059] [Figure 27A] FIG. 27A is a first perspective view of a needle guidance system according to one embodiment.

[0060] [Figure 27B] FIG. 27B is a second perspective view of a needle guidance system according to one embodiment.

[0061] [Figure 28A] FIG. 28A is a front view of a needle guidance system according to one embodiment.

[0062] [Figure 28B] FIG. 28B is a rear perspective view of a needle guidance system according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0063] Specific embodiments of the present invention will be described with reference to the accompanying drawings. The present invention may be embodied in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the accompanying drawings is not intended to be limiting. In the drawings, like reference numerals refer to like elements.

[0064] Described herein are various embodiments of needle guidance systems that can be used to guide the position and angle of an interventional device so that the interventional device is within the field of view of an imaging device. Generally, the methods and systems described and / or illustrated herein can be used to guide any interventional device having an elongated body so that the interventional device is maintained within the field of view of an imaging device while the interventional device is delivered to a target site. The methods and systems described and / or illustrated herein can be used on human or animal patients for a variety of purposes, including, but not limited to, vascular access, tissue biopsy, etc.

[0065] By way of non-limiting example, the interventional device may include a needle, such as a syringe, and the imaging device may include ultrasound. A guidance mechanism may be utilized to guide the interventional device to a target site, such as a blood vessel. The guidance mechanism may be fixedly attached, removably attached, or integral with the imaging device.

[0066] Generally, the guidance mechanism can be located at or near the distal end of the imaging device. For example, the guidance mechanism can be located at or near the probe of the imaging device. However, it should be understood that in some embodiments, the guidance mechanism can be located further from the probe of the imaging device than shown, for example, near the handle, as long as the angle is adjusted appropriately.

[0067] In embodiments in which the guidance mechanism is removably attached to the imaging device, the attachment mechanism can be removably attached in various ways to various locations on the imaging device body, such as at or near its distal end. The attachment mechanism can be sized to fit a particular imaging device, in which case multiple attachment mechanisms can be designed for different imaging devices. Alternatively, the attachment mechanism can function as an adapter to fit multiple different imaging devices, such as different types of imaging devices or imaging devices from different manufacturers.

[0068] A guidance mechanism can be utilized to guide the interventional device to remain within the field of view of the ultrasound device both during delivery to the target site and once at the target site. For example, a guidance mechanism can be utilized to guide a needle to remain within the field of view of the ultrasound both during advancement and once inserted into a blood vessel to puncture the needle into the blood vessel.

[0069] In some exemplary embodiments, the guidance mechanism may include multiple openings, slots, notches, grooves, etc. that can selectively route the interventional device at an optimal angle so that it remains within the field of view of the imaging device during delivery and upon arrival at the target location. In such embodiments, adjustment of the guidance mechanism may function to pivot the position of the interventional device about a single pivot point (e.g., the intersection between the interventional devices shown in FIGS. 5 and 17).

[0070] In some embodiments, the guidance mechanism may include a single opening, slot, notch, groove, etc. that is movable along an arcuate path. Figures 3-9 and 16-23C show exemplary embodiments of guidance mechanisms having a single opening, slot, notch, groove, etc. that is movable along an arcuate path to guide an interventional device to a desired depth at a desired angle and remain within the field of view of the imaging device.

[0071] In other embodiments, the guidance mechanism may include multiple (e.g., two or more) openings, slots, notches, grooves, etc., which may be individually selected to guide the interventional device to a desired depth at a desired angle while remaining within the field of view of the imaging device. Figures 10-15 show an example of such an embodiment.

[0072] In some embodiments, the guide mechanism may include a release mechanism to allow the interventional device to be safely and efficiently removed from the guide mechanism without moving the interventional device from its position and angle. Figures 12A-15 illustrate an embodiment in which the guide mechanism opens, such as by a hinge, allowing the guide mechanism to be removed from around the interventional device without moving the interventional device. Figures 24A, 24B and 26A, 26B illustrate an embodiment in which the guide mechanism can be pivotally adjusted. Figures 19A, 19B illustrate an embodiment in which the guide mechanism includes a release slot, allowing the guide mechanism to be pulled away from the interventional device without moving the interventional device.

[0073] In embodiments in which the guidance mechanism is adjustable along an arcuate path, such as those shown in FIGS. 3-9 and 16-23C, the arcuate path has preset intervals, which may be indicated by various types of feedback, such as visual, auditory, and / or tactile feedback. For example, the guidance mechanism may emit clicking sounds when it reaches different preset angular intervals. Additionally, markings or other indicators may indicate the current different angular intervals. However, in some embodiments, the arcuate path may not have preset intervals (e.g., no feedback of any kind is provided).

[0074] 10-15 illustrate an exemplary embodiment of a guidance mechanism 150 that utilizes multiple selectable openings to guide the position and angle of an interventional device, such as a needle, toward a target location while remaining within the field of view of an imaging device, such as an ultrasound probe.

[0075] In the exemplary embodiment shown in Figures 1-4B, four openings are available that allow access to the blood vessel to depths ranging from 1.5 cm to 4.0 cm. In such an embodiment, the imaging device 100 can be placed inside the patient and the blood vessel aligned within its field of view. At a given opening, a standard 7 cm long needle can be inserted to various depths while remaining within the field of view of the imaging device 100. The angle and position of the openings allows continuous access to any depth (e.g., from 1.5 cm to 4.0 cm or more).

[0076] Generally, the needle guidance system can include a scale indicating the appropriate depth (measured from the bottom of the imaging device's probe) at which the interventional device should cross the centerline of the imaging device 100. The center point and radius of the arc can be selected to meet several design requirements. As a non-limiting example, the needle length from the guidance mechanism to the centerline of the probe can be 67 mm or less to accommodate a standard 7 cm needle. As another non-limiting example, the needle length from the guidance mechanism to the centerline of the probe can be 87 mm or less to accommodate a 9 cm needle. Various other values ​​can be utilized in different embodiments to accommodate different needle types.

[0077] The gap between the centerline of the needle path and the probe 100A preferably exceeds a minimum value to ensure clearance between the needle and the probe 100A (or its sterile cover) and prevent the sterile cover from being punctured during use. For a standard 18-gauge needle with a diameter of approximately 1.3 mm, this gap is preferably at least 1-2 mm. The angle of the needle relative to the base of the imaging probe is preferably less than its maximum value to facilitate access to the target site. The arc boundary preferably leaves sufficient space for the guidance mechanism when the needle is at its maximum and minimum depths. The guidance mechanism is preferably long enough to stabilize the needle at its opening, but does not interfere with the patient's skin at one boundary or the probe at the other.

[0078] It should be noted that the angle and depth measurements used to maintain the interventional device within the field of view of the imaging device during delivery to the target site can be calculated in a variety of ways. As a first example, the Pythagorean theorem (a 2 +b 2 =c 2 ) can be used, where a represents the sum of the distance from the puncture site to the body surface (measured by the imaging device) and the distance from the body surface to the needle holder, b represents the distance from the needle holder to the needle position on the needle holder, and c represents the distance the needle must travel from the needle position on the needle holder to the puncture site. As a second example, a similar function can be performed using the equation Sinθ=b / c=n. However, various other methods can be used to perform the calculations necessary to determine the optimal angle and depth measurements to ensure the needle remains within the field of view of the imaging device during delivery and arrival at the target site (puncture site).

[0079] Specific embodiments are described in more detail below, but it should be understood that any feature of each embodiment can be combined in any combination, and therefore the present invention is not limited to these embodiments but also encompasses a broader range of combinations.

[0080] 1 illustrates an exemplary embodiment of an imaging device 100 positioned on a patient's skin. An attachment mechanism 110 is utilized to removably attach a guidance mechanism 120 to the imaging device 100. The guidance mechanism 120 is utilized to guide an interventional device 200 to puncture a blood vessel while remaining within the field of view of the imaging device 100.

[0081] FIG. 1 illustrates an exemplary embodiment in which an interventional device 200 punctures a common femoral artery 300A near the bifurcation of the superficial femoral artery 300B and the internal femoral artery 300C. Note that FIG. 1 illustrates only one example use. The systems and methods shown and / or described herein can be utilized in connection with delivering an interventional device 100 to various blood vessels or other internal regions of the body. Thus, the scope of the present invention should not be construed as limited to the particular placement of the imaging device 100 shown in the exemplary embodiment of FIG. 1.

[0082] It should be understood that the systems and methods shown and / or described herein can be used for both short-access guidance and long-access guidance, depending on the placement of the imaging device 100. Figure 2A illustrates the placement of the imaging device 100 for short-access guidance of a blood vessel 300 according to one embodiment. Figure 2B illustrates the placement of the imaging device 100 for long-access guidance of a blood vessel 300 according to one embodiment.

[0083] 3 illustrates example depth settings in an embodiment in which the guidance mechanism 120 is attached to the imaging device 100 using the attachment mechanism 110. In the embodiment illustrated in FIG. 3, six needle depth settings are shown. It should be understood that the systems and methods shown and / or described herein may support more or less than six needle depth settings, depending on the embodiment. It should also be understood that more depth settings can be achieved by positioning the interventional device 200 between the marked depth settings.

[0084] 3, it can be seen that depths are shown ranging from 15 mm to 40 mm from the surface of the imaging device 100, and needle lengths are shown ranging from 49.8 mm to 66.5 mm. It should be understood that such settings, including depth and length settings, may vary between embodiments and therefore should not be construed as limited to the exemplary embodiment shown in the diagram of FIG.

[0085] 4, 5, 10-11B, 16-17, 22-23C, and 28A-28B, attachment mechanism 110 may be removably attached to imaging device 100. Attachment mechanism 110 may include an opening 110C into which imaging device 100, for example, probe 100A of imaging device 100, may be removably inserted. Imaging device 100 may be frictionally engaged within opening 110C, thereby securing attachment mechanism 110 to imaging device 100.

[0086] In some embodiments, attachment mechanism 110 may include one or more tabs 110A, 110B that releasably engage one or more outer edges of imaging device 100. The exemplary embodiment of FIG. 1 shows attachment mechanism 110 having a pair of tabs 110A, 110B, with a first tab 110A for engaging a first side of imaging device 100 and a second tab 110B for engaging a second side of imaging device 100. When imaging device 100 is inserted into opening 110C of attachment mechanism 110, tabs 110A, 110B "click" into place.

[0087] 4 and 10, each tab 110A, 110B may have a curved inner edge that closely matches the contours of the curved outer edge of the imaging device 100. Each tab 110A, 110B may also include a release means, such as a handle, that can be adjusted outwardly away from the imaging device 100 to disengage the tabs 110A, 110B and slide the attachment mechanism 110 off the end of the imaging device 100. In this manner, the attachment mechanism 110 can be removed from the imaging device 100 when not needed and stored for future use in embodiments in which the guidance mechanism 150 is removably attached to the imaging device 100 rather than fixedly attached.

[0088] 11A and 11B illustrate the attachment mechanism 110 fixed to the imaging device 100, with the interventional device 200 shown in various guide openings 120A, 120B, 120C, 120D of the guidance mechanism 120. FIG. 11A illustrates the interventional device 200 inserted to a minimum specified depth, while FIG. 11B illustrates the interventional device 200 inserted to a maximum specified depth while remaining within the field of view of the imaging device 100. While FIGS. 11A and 11B illustrate these concepts in the context of an exemplary embodiment of the guidance mechanism 120 having fixed openings, it should be understood that these concepts apply equally to any of the other embodiments shown and / or described herein.

[0089] 11A and 11B, it can be seen that the field of view of imaging device 100 can be divided into two regions: a puncture region 130 and a non-puncture region 135. A guidance mechanism 150 can be utilized to prevent punctures from occurring in the non-puncture region 135 shown in FIGS. 11A and 11B. In the illustrated illustration, the puncture region 130 is approximately 1 cm wide. Typically, during use, imaging device 100 is positioned such that a target site, such as a blood vessel, is located within the non-puncture region 135, allowing the interventional device 100 to be viewed both during delivery to and upon arrival at the target site.

[0090] However, it should be understood that the regions 130, 135 shown in Figures 11A and 11B are merely exemplary and are not intended to limit the scope of the present invention. For example, there may be situations in which a physician desires or needs to puncture a blood vessel with a needle at the non-puncture region 135. Furthermore, the size of each region 130, 135, as well as the ratio between those sizes, may vary in different embodiments and should not be construed as being limited to the example embodiment shown in Figures 11A and 11B.

[0091] The manner in which guidance mechanisms 120, 150 are secured to imaging device 100 may vary depending on the embodiment and, therefore, should not be construed as limited to the illustrated example embodiment. It will be appreciated that in the embodiments shown in Figures 4, 10, and 16, guidance mechanisms 120, 150 may be removably attached to imaging device 100 by attachment mechanism 110. However, as previously mentioned, guidance mechanisms 120, 150 may be fixedly attached to or integral with imaging device 100 in other embodiments. In embodiments in which guidance mechanism 150 is integrally formed with imaging device 100, guidance mechanisms 120, 150 may extend outwardly from a distal portion of imaging device 100.

[0092] 6A-7B, 12A-15, 18A-18B, and 20A-21 illustrate exemplary embodiments of the attachment mechanism 110 and the guidance mechanisms 120, 150. As shown, the attachment mechanism 110 can include an opening 110C through which the imaging device 100 can be removably inserted and used. The shape of the opening 110C can vary depending on the embodiment and should therefore not be construed as limited by the exemplary embodiment shown in the figures. Generally, the opening 110C is substantially rectangular, although other shapes may be utilized depending on the type of imaging device 100.

[0093] The size of opening 110C also varies depending on the embodiment and similarly should not be construed as limited to the illustrated embodiment. Generally, opening 110C is sized to snugly fit imaging device 100. In some embodiments, imaging device 100 frictionally engages within opening 110C, eliminating the need for tabs 110A, 110B. In such embodiments, opening 110C is sized slightly smaller than the circumference or width of imaging device 100, and the frictional engagement holds attachment mechanism 110 on imaging device 100 during use.

[0094] The attachment mechanism 110 may include one or more tabs 110A, 110B to assist in removably attaching the attachment mechanism 110 to the imaging device 100. In the illustrated embodiment, it can be seen that a first tab 110A extends upward from a first side of the attachment mechanism 110, and a second tab 110B extends upward from a second side of the attachment mechanism 110. However, it can be seen that the number of tabs 110A, 110B can vary from embodiment to embodiment (e.g., the number of tabs 110A, 110B can be more or less than two). It should also be noted that the arrangement of the tabs 110A, 110B on the attachment mechanism 110 can vary from embodiment to embodiment.

[0095] 6A-7B, each tab 110A, 110B may include a curved inner surface that can engage with a curved outer surface of imaging device 100, as shown in Figure 4. A protrusion, such as a handle, extends at an angle from the curved surface such that pressing the protrusion outward disengages tab 110A, 110B from imaging device 100, thereby allowing attachment mechanism 110 to be slid off imaging device 100 after use.

[0096] As shown throughout the figures, at least one guide mechanism 120 can extend outward from the attachment mechanism 110. The placement and orientation of the guide mechanism 120 relative to the body of the attachment mechanism 110 may vary depending on the embodiment. For example, in the embodiment shown in Figure 6A, one guide mechanism 120 is provided on the side of the attachment mechanism 110. Figure 9 shows one guide mechanism 120 provided on the end of the attachment mechanism 110 at a 90 degree angle relative to the embodiment shown in Figure 6A.

[0097] 22-23C show an embodiment with a pair of guide mechanisms 120 (one on a side and the other on an end). While not shown, it should be understood that in some embodiments, more guide mechanisms 120 may extend from the attachment mechanism 110. For example, using three or more guide mechanisms 120 can increase versatility for use with a wide range of imaging devices 100 and applications.

[0098] Although described separately, it should be understood that attachment mechanism 110 and guidance mechanism 120 may be formed from a unitary structure. However, in other embodiments, guidance mechanism 120 may be fixedly or removably attached to attachment mechanism 110.

[0099] Generally, the guidance mechanism 120 can extend outward from a side or end of the attachment mechanism 110, although other attachment locations than those shown in the exemplary embodiment can be utilized. The guidance mechanism 120 can generally include one or more openings 120A, 120B, 120C, 120D for optimally guiding an interventional device 200, such as a needle, at an angle to maintain the interventional device 200 within the field of view of the imaging device 100 during delivery and arrival at a target site, such as a blood vessel.

[0100] 4-9 illustrate an example of a needle guidance system for guiding an interventional device 200 to a target site while remaining within the field of view of the imaging device 100. In the illustrated embodiment, it can be seen that the guidance mechanism 150 includes a pair of parallel adjustment members 155A, 155B, each extending outward from a side of the attachment mechanism 110. Thus, a first arm 150A extends from a side of the attachment mechanism 110 near the front end, and a second arm 150B extends parallel to the first arm 150A from the same side of the attachment mechanism 110 near the rear end. The arms 150A, 150B are positioned parallel to and spaced apart from each other, defining a space between them, as shown in FIG. 11A.

[0101] 6A-7B, arms 150A and 150B have tracks 151A and 151B, respectively, with first arm 150A having first track 151A and second arm 150B having second track 151B. Tracks 151A and 151B each have an arcuately oriented slot that functions as a guide and track for a pair of adjustment members 155A and 155B, described below.

[0102] 6A-7B, it can be seen that a pair of adjustment members 155A, 155B are movably connected to arms 150A, 150B, with first adjustment member 155A movably connected to first arm 150A and second adjustment member 155B movably connected to second arm 150B. Adjustment members 155A, 155B may be coupled to each other for coordinated movement, such as by receiver 160 described herein.

[0103] As best shown in Figures 6A and 6B, first adjustment member 155A includes a first pin 152A that passes through first track 151A, and second adjustment member 155B includes a second pin 152B that passes through second track 151B. As best shown in Figure 5, a third pin 152C also passes through both tracks 151A and 151B but does not extend beyond the outer edges of tracks 151A and 151B. Pins 152A, 152B, and 152C movably connect adjustment members 155A, 155B to arms 150A, 150B, allowing adjustment members 155A, 155B to move along an arcuate path defined by tracks 151A, 151B.

[0104] 7A, each arm 150A, 150B is provided with an index 153A, 153B to identify different points on the arcuate path traveled by the arm 150A, 150B during adjustment, with the first arm 150A being provided with a plurality of first indexes 153A and the second arm 150B being provided with a plurality of second indexes 153B. Each index 153A, 153B can indicate the depth to which the interventional device 200 crosses the centerline of the imaging device 100, as measured from the bottom surface of the probe 100A.

[0105] Each of the adjustment members 155A, 155B may include a window 156A, 156B for visually identifying the indicia 153A, 153B, with the first adjustment member 155A having a first window 156A and the second adjustment member 155B having a second window 156B. While the windows 156A, 156B are shown as rectangular, it should be understood that other shapes are possible.

[0106] 7A-9, receiver 160 may be connected between adjustment members 155A and 155B in the gap or space between arms 150A and 150B. Receiver 160 may include a receiver opening 160A for receiving an interventional device 200, such as a needle. Receiver opening 160A may include an elongated opening, such as a slot, through which interventional device 200 can be inserted into and removed from receiver opening 160A.

[0107] 8-9, the receiver opening 160A may include a flap that defines an elongated opening for inserting or removing the interventional device 200. The flap may be constructed of a flexible or semi-flexible elastic material such that the flap adjusts outward to allow the interventional device 200 to be removed from the receiver opening 160A.

[0108] In use, imaging device 100 can be placed over a target site on a patient's skin. The target site is located within the field of view of imaging device 100. Adjustment members 155A, 155B can be adjusted along the arcuate path of tracks 151A, 151B until a desired depth is reached, indicated by indicia 153A, 153B visible through windows 156A, 156B. Before or after adjusting adjustment members 155A, 155B, interventional device 200 can be inserted into receiver 160 through receiver opening 160A.

[0109] The interventional device 200 can then be advanced to the target site, maintaining it within the field of view of the imaging device both during delivery and after reaching the target site. After the interventional device 200 reaches the target site, such as after puncturing a blood vessel, it can be detached from the guidance mechanism 150 without moving the interventional device 200. Releasing the guidance mechanism 150 adjusts the flap of the receiver opening 160A outward, allowing the interventional device 200 to be detached from the receiver 160, after which the flap elastically returns to its original position.

[0110] 10-12B illustrate an example of a needle guidance system for guiding an interventional device 200 to a target site while remaining within the field of view of an imaging device 100. As best shown in FIGS. 10-11B, multiple openings 120A, 120B, 120C, and 120D extend through the guidance mechanism 120 at different angles. However, in some embodiments, only one opening 120A, 120B, 120C, and 120D may be utilized. While the figures show four openings 120A, 120B, 120C, and 120D, consisting of a first opening 120A, a second opening 120B, a third opening 120C, and a fourth opening 120D, it should be understood that different embodiments may utilize more (e.g., five or more) or fewer (e.g., three or fewer) openings 120A, 120B, 120C, and 120D.

[0111] The angle of each opening 120A, 120B, 120C, 120D varies depending on the embodiment and should not be construed as limiting by the figures. As best shown in Figures 11A and 11B, each opening 120A, 120B, 120C, 120D can correspond to a different depth of the interventional device 200. An operator of the present invention can select an appropriate opening 120A, 120B, 120C, 120D depending on the location (e.g., depth and angle) of the target site relative to the imaging device 100.

[0112] Generally, each of openings 120A, 120B, 120C, and 120D can be sized to accommodate an interventional device 200, such as a needle, as shown in Figures 11A and 11B. The size of openings 120A, 120B, 120C, and 120D can be different in different embodiments to accommodate different gauges of interventional device 200. For example, for an 18-gauge needle with a diameter of approximately 1.3 mm, each of openings 120A, 120B, 120C, and 120D can have a diameter of 1.3 mm to 1.4 mm to prevent the needle from bobbing within openings 120A, 120B, 120C, and 120D.

[0113] 13 , the guidance mechanism 120 may include a release mechanism so that the interventional device 200 can be easily removed from the guidance mechanism 120 without moving the interventional device 200 after it reaches the target location. In one embodiment, the guidance mechanism 120 may include a first fixed portion 121A and a second adjustable portion 121B. The second portion 121B is adjustable toward or away from the first portion 121A, thereby opening the guidance mechanism 120 and releasing the interventional device 200.

[0114] 13, the first and second portions 121A, 121B of the guide mechanism 120 may be hingedly connected, such as by a pivot pin 121C. In the illustrated embodiment, the second portion 121B is hingedly or pivotally connected to the first portion 121A by the pivot pin 121C, allowing the second portion 121B to pivot toward or away from the first portion 121A. However, it should be noted that various adjustment methods other than pivoting may be used in some embodiments.

[0115] 12A and 12B, the guide mechanism 120 may include indicia 125 to indicate the different angles of each of the openings 120A, 120B, 120C, and 120D. The indicia 125 may comprise markings, grooves, etc. that visually indicate the corresponding angles of each of the openings 120A, 120B, 120C, and 120D. The indicia 125 may be located on the exterior surface of the guide mechanism 120 so that they are easily visible during use.

[0116] First portion 121A and second portion 121B each have a semicircular opening that, when fitted together, form openings 120A, 120B, 120C, and 120D for guiding interventional device 200. A locking member, such as a fastener, removably secures two portions 121A and 121B together, and squeezing locking member 121D separates portions 121A and 121B from each other, allowing removal of interventional device 200. Releasing the locking member causes second portion 121B to pivot away from first portion 121A, releasing interventional device 200.

[0117] During use, first, the attachment mechanism 110 is attached to the imaging device 100. For example, the probe 100A of the imaging device 100 is inserted into the opening 110C of the attachment mechanism 110 until the tabs 110A and 110B of the attachment mechanism 110 engage with the outer edge of the imaging device 100. Next, the imaging device 100 is placed on the patient's skin so that a target site, such as a blood vessel, is within the field of view of the imaging device 100.

[0118] The operator can select one of the openings 120A, 120B, 120C, and 120D in the guidance mechanism 120 based on the depth of the target site. The optimal opening 120A, 120B, 120C, and 120D ensures that the interventional device 200 remains within the puncture region shown in Figures 2A and 2B both during delivery and upon reaching the target site. Once an opening 120A, 120B, 120C, and 120D is selected, the interventional device 200 is inserted through that opening and delivered to the target site, guided by the images generated by the imaging device 100.

[0119] Once the interventional device 200 reaches the target site, such as puncturing a blood vessel, the operator can release the locking member 121D and separate the second portion 121B of the guidance mechanism 120 from the first portion 121A of the guidance mechanism 120. With the release member thus engaged, the guidance mechanism 120 can be removed from around the interventional device 200 without moving the interventional device 200.

[0120] 16-18B show another embodiment of a needle guidance system. In the embodiment shown in Figures 16-18B, rather than multiple openings, a single opening 140A is used, and the angular position of this single opening 140A is adjustable using an adjustment mechanism 140 movably connected to the guidance mechanism 120.

[0121] As best shown in FIG. 18A , the guide mechanism 120 can include a track 141 along which the adjustment mechanism 140 can move between different arcuate positions and angular orientations. The track 141 can include a slot formed in the guide mechanism 120. In the illustrated embodiment, it can be seen that the slot is movable along an arcuate path. The adjustment mechanism 140 is slidably disposed within the track 141 so as to be adjustable relative to the guide mechanism 120 along the arcuate path.

[0122] 18A, it can be seen that the adjustment mechanism 140 includes an opening 140A for receiving the interventional device 200, and the position and orientation of the opening 140A can be adjusted by moving the adjustment mechanism 140 along a track 141. The opening 140A can comprise a slot, as shown, or a sealed opening. In the embodiment shown in FIG. 7A, the opening 140A is shown as comprising a V-shaped slot that can frictionally secure the interventional device 200.

[0123] The guidance mechanism 120 may include indicia 125 at various intervals to represent different depths and angles of the interventional device 200. Thus, the indicia 125 may indicate the depth at which the interventional device 200 crosses the centerline of the imaging device 100, measured from the bottom surface of the probe 100A.

[0124] It should be appreciated that while the indicia 125 provide a visual indication of depth and angle, audible or tactile indications may also be provided. For example, the guidance mechanism 120 may emit a "click" sound upon passing each predetermined interval along the arcuate path of the guidance mechanism 120 as it traverses the track 141.

[0125] In some embodiments, adjustment mechanism 140 may be locked at different positions along track 141. Various methods known in the art for temporarily locking adjustment mechanism 140 at a predetermined arcuate position along track 141 may be used, such as protrusions, apertures, clamps, etc.

[0126] A release means, such as a button, can be used to release the adjustment mechanism 140 and allow it to move along the track 141. In some embodiments, the adjustment mechanism 140 defaults to a locked position and is only allowed to move along the track 141 when the release means is engaged (e.g., by pressing a button). In other embodiments, the adjustment mechanism 140 defaults to an unlocked position and is only locked (e.g., unlocked) when the locking mechanism is engaged, for example, by pressing a button.

[0127] 19A and 19B illustrate an exemplary method for releasing the interventional device 200 from the adjustment mechanism 140 without excessively moving the interventional device 200. Depending on the shape and configuration of the opening 140A, the interventional device 200 can simply be slid out of the opening 140A, or the guidance mechanism 120 can be moved to release the interventional device 200 from the adjustment mechanism 140.

[0128] In one embodiment, the opening 140A may have a slot through which the interventional device 200 can pass as the guidance mechanism 150 moves away from the interventional device 200. In other embodiments, the opening 140A may include a flexible, elastic member that deforms to allow the interventional device 200 to pass through the opening 140A and then returns to its original shape. For example, a pair of elastic flaps may be adjusted outward to allow the interventional device 200 to pass through, and then adjusted inward to resiliently move back to their original position.

[0129] In another embodiment, opening 140A may comprise a V-shaped slot, as best shown in Figures 18A-21. In such an embodiment, a magnetic element 145, such as a magnet, is positioned within or near opening 140A and magnetically engages interventional device 200 when interventional device 200 is positioned within opening 140A, as best shown in Figures 18A, 18B, and 20A.

[0130] In the illustrated embodiment, the magnetic element 145 is attached to the adjustment mechanism 140 behind the opening 140A. The magnetic element 145 is preferably strong enough to maintain the positioning of the interventional device 200 within the opening 140A during use of the interventional device 200. At the same time, after delivery of the interventional device 200 to the target site, the interventional device 200 can be magnetically released when the guidance mechanism 120 is moved. The magnetic element 145 can also serve to assist in maintaining the interventional device 200 within the field of view of the imaging device 100.

[0131] In use, the imaging device 100 can be placed over a target site on the patient's skin. The target site is located within the field of view of the imaging device 100. The adjustment mechanism 140 can be adjusted along the trajectory 141 until a desired position corresponding to the appropriate depth is reached. The interventional device 200 is inserted into the opening 140A and advanced to the target site. Once the target site is reached, the interventional device 200 can be released by moving the guidance mechanism 120 away from the interventional device 200, thereby releasing the interventional device 200 from the opening 140A.

[0132] As previously mentioned, the position and orientation of the guidance mechanism 120 relative to the body of the attachment mechanism 110 may vary depending on the embodiment. Additionally, the number of guidance mechanisms 120 may also vary. Varying the position, orientation, and number of guidance mechanisms 120 provides additional versatility with respect to the position and orientation of the imaging device 100. For example, certain configurations may be suitable for short-range access, while other configurations may be suitable for long-range access. As described below, in some configurations, the same device may provide both short-range and long-range access.

[0133] Figures 7A, 7B, 14A, 14B, 20A and 20B show a single guide mechanism 120 attached to or extending from one side of attachment mechanism 110. Figures 9, 15 and 21 show a single guide mechanism 120 attached to or extending from one end of attachment mechanism 110 at a 90 degree angle relative to one side of attachment mechanism 110.

[0134] 23A-23C and 27A-27B show multiple guide mechanisms 120 attached to or extending from attachment mechanism 110, including a first guide mechanism 120 on the side of attachment mechanism 110 and a second guide mechanism 120 on the end of attachment mechanism 110 at a 90 degree angle relative to first guide mechanism 120. It should also be understood that in some embodiments, more than two guide mechanisms 120 may be utilized for further versatility.

[0135] It should be noted that in all embodiments shown or described herein, the placement, orientation, and number of guide mechanisms 120, 150 may vary. For example, the embodiments shown in Figures 4-9 may use more guide mechanisms 150 than shown, or may have different placements / orientations of the guide mechanisms 150. Similarly, the embodiments shown in Figures 10-15 and 16-21 may use more guide mechanisms 150 than shown, or may have different placements / orientations of the guide mechanisms 120.

[0136] 22-23C illustrate an embodiment in which multiple guidance mechanisms 150 extend from a single attachment mechanism 110. In such an embodiment, two sets of arms 150A, 150B are used, with the first set of arms 150A, 150B oriented perpendicular to the second set of arms 150A, 150B. This configuration allows for lateral access perpendicular to the field of view of the imaging device 100. Lateral access can be used to accommodate depths as shallow as 0.5 cm to 2 cm. However, it should be understood that the methods and systems described and / or illustrated herein can accommodate depths less than 0.5 cm or greater than 2 cm.

[0137] 22-23C, instead of using pins 152A, 152B to connect guide members 155A, 155B to arms 150A, 150B, elongated bosses protruding from a single integrated guide member 155C within tracks 151A, 151B can be used. This configuration eliminates the need for through-holes in arms 150A, 150B, improving the strength of arms 150A, 150B and guide mechanism 150 as a whole. As shown, a single integrated guide member 155C can be connected across a pair of arms 150A, 150B.

[0138] 22-23C, it can be seen that such exemplary embodiments can include a locking mechanism 170 for locking guide member 155C at various positions along arms 150A, 150B and a hinged needle release mechanism 180 for allowing radial release of interventional device 200. In some embodiments, the locking of needle release mechanism 180 can also function to lock locking mechanism 170. In this manner, when interventional device 200 is locked within guide mechanism 150, guide member 155C is also locked in place and prevented from moving along tracks 151A, 151B. Thus, translational movement of guide mechanism 150 relative to attachment mechanism 110 can be prevented.

[0139] Figures 23A-23C show different operational states of such an embodiment. Figure 23A shows the unlocked operational state. Figure 23B shows the unlocked state with both guide mechanisms 150 set to their shallowest depth. Figure 23C shows the unlocked state with both guide mechanisms 150 set to their deepest depth.

[0140] 24A and 24B show close-up views of a single, integral guide member 155C that traverses the pair of arms 150A, 150B at a right angle. As shown, the guide member 155C can include a locking mechanism 170 that is linear, pivotal, or otherwise adjustable between an open and a closed (locked) position. The locking mechanism 170 is fitted with a release mechanism 180 that can be used to selectively lock or unlock the radial position of the interventional device 200 within the receiver 160, e.g., within the receiver opening 160A. In the embodiment shown in FIGS. 24A, 24B, and 26A-26D, the release mechanism 180 is hinged or pivotally adjustable between the open and locked positions. Note, however, that even when the release mechanism 180 is in the locked position, the interventional device 200 is still free to move axially, and the receiver opening 160A functions as a hole to guide the axial movement of the interventional device 200.

[0141] 24A shows guide member 155C in an open position, allowing interventional device 200 to pass freely through receiver opening 160A, such as a slot. In this open position, guide member 155C is free to move along tracks 151A, 151B.

[0142] 24B shows guide member 155C in a closed position. In this position, interventional device 200 cannot pass freely through receiver opening 160A. Also, guide member 155C is fixed in place and cannot move freely along tracks 151A, 151B. This configuration may improve safety during handling of the device.

[0143] 25 shows the bottom of a hinged door that includes both a locking mechanism 170 and a release mechanism 180. As shown, the bottom of the release mechanism 170 is provided with one or more teeth 170A (e.g., an array of teeth 170A). The teeth 170A can be configured to engage with a rack on the guide mechanism 150.

[0144] 26A-26D illustrate the guide member 155C and release mechanism 180 in use. FIG. 26A illustrates the guide member 155C positioned at the desired radial position with the release mechanism 180 in an open position. FIG. 26B illustrates the guide member 155C positioned at the desired radial position with the release mechanism in a closed position. FIG. 26C illustrates the interventional device 200 locked at the desired radial position (but still axially movable) with the locking mechanism 170 similarly engaged to prevent movement of the guide mechanism 150. FIG. 26B illustrates the interventional device 200 released with the locking mechanism 170 disengaged and the release mechanism 180 in an open position.

[0145] In use, the imaging device 100, such as an ultrasound device, is first used to measure the depth of the target vessel or target site. The guide member 155C can be configured and adjusted to the appropriate depth setting with the release mechanism 180 in an open position, as shown in FIG. 26A. Next, the guide member 155C can be configured to lock at the desired depth by adjusting the release mechanism 180 to a locked position, as shown in FIG. 26B. Next, the interventional device 200 is passed through the receiver opening 160A to reach the target site, as shown in FIG. 26C. Finally, the release mechanism 180 is released, and the interventional device 200 can be threaded through the receiver 160 (e.g., slot) as shown in FIG. 26D, allowing the imaging device 100 and guide member 155C to be lifted and removed from the interventional device 200 and the patient without disturbing the position and / or angle of the interventional device 200.

[0146] As described above, the attachment mechanism 110 can be configured to be adaptable to various types of imaging devices 100. For example, imaging devices 100 may vary in size, and it is desirable for the attachment mechanism 110 to be easily adjustable to various sizes. Therefore, if there were a universal attachment mechanism 110 that could be securely attached to various imaging devices 100 from various manufacturers, an operator would not need to purchase and store many different types of attachment mechanisms 110.

[0147] 27A and 27B show a first embodiment of an attachment mechanism 110 that can be attached to different imaging devices 100 of different sizes. Such an embodiment includes a strap 190 configured to be attached to the head of the imaging device 100. The strap 190 includes a plurality of openings 190A configured to releasably engage with protrusions 195 on the end or side of the attachment mechanism 110. By selecting which openings 190A secure to the protrusions 195, the effective length of the strap 190 can be adjusted to fit different imaging devices 100.

[0148] 27A and 27B, it can be seen that strap 190 can be secured to attachment mechanism 110. More specifically, one end of strap 190 is fixed and the other end is free to move, allowing strap 190 to be secured to protrusion 195 via opening 190A.

[0149] 27A and 27B, it can be seen that the shaded areas represent flexible or semi-flexible material. Strap 190 is shown as being flexible or semi-flexible so that it can be wrapped around imaging device 100. Sides 191 of attachment mechanism 110 can also be constructed of a flexible or semi-flexible material, allowing attachment mechanism 110 to flex itself to accommodate imaging devices 100 of various sizes. In some embodiments, sides 191 can be perforated to provide greater flexibility.

[0150] The type of flexible or semi-compliant material varies depending on the embodiment and may include, for example, rubber or various polymeric materials. Additionally, the configuration of the flexible or semi-compliant material may differ from that shown in Figures 27A and 27B. Any portion of the attachment mechanism 110 may be constructed from such materials to allow for bending. In some embodiments, the entire attachment mechanism 110 may be constructed from such materials, although having rigid portions may improve the structural integrity of the device during operation.

[0151] 28A and 28B show another embodiment that can be adapted to fit a variety of imaging devices 100. In this embodiment, one or more bands 194 are used instead of the strap 190 of the previous embodiment. Protrusions 196A, 196B may be provided on either or both ends of the attachment mechanism 110. The one or more bands 194 are selected to pass over or around the imaging device 200 between the protrusions 196A, 196B and help secure the attachment mechanism 110 to the imaging device 200.

[0152] As shown in FIG. 28A, a first end of the attachment mechanism 110 is provided with a first protrusion 196A consisting of an L-shaped or U-shaped bracket, to which the first ends of one or more bands 194 are secured. The first protrusion 196A can be attached at different angles as shown. As shown in FIG. 28B, a second end of the attachment mechanism 110 is provided with a second protrusion 196B consisting of a round flange-like protrusion, to which the second ends of one or more bands 194 are secured.

[0153] The type, number, size, orientation, and shape of the protrusions 196A, 196B may vary depending on the embodiment. Accordingly, the number of protrusions 196A, 196B on each portion of the attachment mechanism 110 may differ from the number shown. This is because different embodiments may use more or fewer protrusions 196A, 196B. Similarly, the placement of the protrusions 196A, 196B, such as on the end of the attachment mechanism 110, the side of the attachment mechanism 110, or a combination thereof, may also vary.

[0154] While the present invention has been described with respect to particular embodiments and applications, those skilled in the art, in view of this teaching, can devise further embodiments and modifications without departing from the spirit or beyond the scope of the present invention. It is therefore to be understood that the drawings and descriptions herein are presented by way of example to facilitate understanding of the invention and should not be construed as limiting the scope of the invention.

Claims

1. an attachment mechanism configured to be detachably attached to the imaging device; a guidance mechanism for guiding the interventional device; the guide mechanism comprises at least one opening; The guidance mechanism includes a release mechanism for releasing the interventional device from the guidance mechanism.

2. the at least one opening comprises a plurality of openings; The guidance system of claim 1 , wherein each of the plurality of openings extends through the guidance mechanism at a different angle.

3. The guidance system of claim 1 , wherein the release mechanism comprises a hinge member.

4. the guide mechanism includes a first member and a second member; The guidance system of claim 1 , wherein the second member is hingedly connected to the first member to form the release mechanism.

5. The guidance system of claim 4 , wherein the at least one opening is defined between the first member and the second member.

6. The guidance system of claim 5 , wherein the second member includes a release tab for releasing the second member from the first member.

7. The guidance system of claim 1 , wherein the attachment mechanism comprises at least one tab for releasably engaging the imaging device.

8. The guidance system of claim 7 , wherein the at least one tab comprises a curved inner surface for engaging a curved outer surface of the imaging device.

9. The guidance system of claim 1 , wherein the attachment mechanism is configured to accommodate different types of imaging devices.

10. The guidance system of claim 1 , wherein the attachment mechanism comprises a strap configured to wrap around a portion of the imaging device.

11. The guidance system of claim 1 , wherein the attachment mechanism comprises a portion constructed of a flexible material such that the attachment mechanism can bend to accommodate different types of imaging devices.

12. 2. The guidance system of claim 1, wherein the attachment mechanism comprises a plurality of protrusions and further comprises one or more bands, each of the one or more bands removably attached to the plurality of protrusions of the attachment mechanism to accommodate different types of imaging devices.

13. an attachment mechanism configured to be detachably attached to the imaging device; a guidance mechanism for guiding the interventional device; the guidance mechanism includes an adjustment mechanism adjustable along an arcuate path between a plurality of angular positions; the adjustment mechanism comprises an opening for receiving the interventional device; The adjustment mechanism includes a release mechanism for releasing the interventional device from the opening.

14. The guidance system of claim 13 , wherein the guidance mechanism comprises a track along which the adjustment mechanism is adjusted between the plurality of angular positions.

15. The guidance system of claim 13 , wherein the release mechanism comprises a magnetic element.

16. further comprising a locking mechanism attached to the release mechanism; The guidance system of claim 13 , wherein the locking mechanism is configured to adjust the release mechanism between an open state and a closed state.

17. The guidance system of claim 16 , wherein the release mechanism is configured to pivot between the open and closed states.

18. 17. The guidance system of claim 16, wherein the locking mechanism is configured to releasably lock the adjustment mechanism in one of the plurality of angular positions.

19. the release mechanism is disposed across the opening when in a locked state; The guidance system of claim 13 , wherein the release mechanism does not lie across the opening when in an open position.

20. an attachment mechanism configured to be detachably attached to the imaging device; a first guidance mechanism for guiding the interventional device along a desired angle to a desired depth; a second guidance mechanism for guiding the interventional device along a desired angle to a desired depth; the first guide mechanism extends from a side surface of the attachment mechanism, The second guidance mechanism extends from an end of the attachment mechanism and is perpendicular to the first guidance mechanism.

Images