Apparatus and method for guiding the insertion of a medical device into a subject - Patents.com

Abstract

An apparatus for guiding the movement of an insertable medical device is provided, the apparatus comprising a single-plane articulated arm adapted to be secured to an ultrasound transducer and configured to allow adjustment of the medical device in a single displacement plane, the displacement plane being coplanar with a scanning plane of the ultrasound transducer. A multi-plane ultrasound device comprises multiple transducers that simultaneously provide images of multiple planes.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 268,986, entitled "APPARATUS AND METHOD TO GUIDE MOVEMENT OF AN INSERTABLE MEDICAL DEVICE," filed in the U.S. Patent and Trademark Office on March 8, 2022, and U.S. Provisional Patent Application No. 63 / 375,134, entitled "APPARATUS AND METHOD TO GUIDE THE INSERTION OF MEDICAL DEVICE INTO A SUBJECT," filed in the U.S. Patent and Trademark Office on September 9, 2022, the contents of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present invention relates generally to apparatus and methods for guiding the operation of a medical device inserted into a patient or subject, and more particularly, to apparatus and methods that use ultrasound transducers to guide the insertion of a medical device into a patient. [Background technology]

[0003] In the field of in-plane needle alignment in medicine, a medical professional typically uses an ultrasound transducer to insert a needle into a patient's vein or artery. The medical professional typically aligns the needle in the scanning plane of the ultrasound transducer so that the output image of the ultrasound transducer shows the entire needle shaft and tip. In doing so, the medical professional typically operates the necessary equipment with their free hands, relying on their experience and intuition. As such, only a few medical professionals have sufficient skill and experience to properly position the needle in the required plane. In fact, due to the narrow ultrasound beam, the medical professional may easily lose sight of the needle in the output image by a small movement of the transducer. Of course, existing techniques require a high level of expertise and good hand-eye coordination, which can only be performed by highly trained professionals.

[0004] Existing guides are attached to the transducer, configured to align the needle with the scanning surface of the transducer. The transducer further includes a small hole that serves as a guide for the needle. However, these systems are generally only configured to receive a needle and are not capable of placing an intravenous catheter or other large medical device. Also, they are disposable, which adds to the cost. In other instances, such systems must be sterilized before each use.

[0005] Additionally, ultrasound is commonly used in anesthesiology to guide needle placement when injecting local anesthetic fluids near nerves identified in ultrasound images. Ultrasound is also used for vascular access such as cannulation of large central veins and difficult arterial cannulation. Prior art ultrasound transducers provide the medical practitioner with a single scanning plane, typically a cross-sectional or longitudinal view of the needle (as shown in Figures 1 and 2, respectively). However, none of these single scanning planes provide all the information necessary to perform such medical procedures. For example, ultrasound-guided application of anesthetic agents requires the needle to be placed in proximity to a nerve without penetrating the nerve. Thus, the use of a single scanning plane may provide the medical practitioner with information regarding needle placement or needle depth relative to the nerve's vicinity, but not both.

[0006] Thus, a need exists for an apparatus adapted to position and maintain a needle within the image plane of an ultrasound transducer while allowing the necessary range of motion. Further, a need exists for an ultrasound transducer or transducer mount that can selectively provide a field of view of multiple scan planes. Summary of the Invention [Means for solving the problem]

[0007] Summary of the Invention The shortcomings of the prior art are generally alleviated by an apparatus for guiding movement of a medical device. In one aspect of the present invention, an articulated arm is provided that is adapted to be attached to an ultrasonic transducer and configured to allow adjustment of the medical device in a single displacement plane. The displacement plane permitted by the arm is coplanar with the scanning plane of the ultrasonic transducer.

[0008] In another aspect of the invention, an ultrasound transducer mount is provided, the ultrasound transducer being configured to selectively rotate about its longitudinal axis to provide a range of longitudinal views of a desired vessel or nerve.

[0009] As used herein, a view of a vein may interchangeably refer to a view of a nerve, an artery, or any other target body part of a subject or patient. In another aspect of the present invention, a dual-plane ultrasound transducer comprising multiple transducers is provided.

[0010] In a further aspect of the invention, there is provided an apparatus for guiding movement of an insertable medical device within a body, the apparatus comprising: a mount assembly for receiving an ultrasound transducer, the ultrasound transducer mount being rotatable about the receiveable ultrasound transducer, and an articulated arm having a first end attachable to the mount assembly and a second end attachable to the insertable medical device, the articulated arm moving along a single plane to position a longitudinal axis of the medical device within the plane.

[0011] The articulated arm may be used to rotate the mount assembly. The mount assembly may include a pivoting base for receiving the ultrasound transducer and a rotation mechanism that engages the rotation of the pivoting base, which may have a shape that substantially matches the shape of the bottom of the ultrasound transducer. The pivoting base may include a suspension mechanism adapted to receive the bottom of the ultrasound transducer. The pivoting base may further include a liquid-fillable sealed chamber between the bottom of the ultrasound transducer and the subject's body part. The pivoting base may be shaped to lock with the bottom of the ultrasound transducer. The pivoting base may include a brake to maintain the pivoting base at a particular angle.

[0012] The second end of the articulated arm may be selectively detachable from the insertable medical device and may include a medical device mounting assembly for mounting and removing the insertable medical device using one hand. The medical device mounting assembly may include a non-contact cover removal mechanism for removing the cover of the insertable medical device. The non-contact cover removal mechanism may include a slideable member for moving the cover of the insertable medical device away from the insertable medical device. The slideable member may be attached to the medical device using an aseptic no touch technique (ANTT). The medical device mounting assembly may be a slideable chariot. The medical device mounting assembly may include a lateral force absorbing member. The lateral force absorbing member may be resilient along a longitudinal axis of the medical device. The second end of the articulated arm may also include a slideable member for moving the insertable medical device toward and away from the mounting assembly, which may conform to an outer surface of the medical device and may be integral with the ultrasound transducer.

[0013] In yet another aspect of the invention, a method of guiding movement of an insertable medical device is provided, the method including holding with a first hand a mount assembly adapted to receive an ultrasound transducer, mounting the insertable medical device to the mount assembly with a second hand, rotating with the second hand the mount assembly about an axis substantially perpendicular to the received ultrasound transducer, fixing the rotated mount assembly at a desired angle, and moving the mounted insertable medical device with the second hand to insert the medical device in a plane into a target area of ​​a patient.

[0014] The method may further include releasing the medical device with a second hand, removing a cover of the insertable medical device without touching the cover prior to inserting the medical device, and testing movement of the medical device by pulling and pushing the medical device.

[0015] In yet another aspect of the present invention, there is provided a gel dispenser for an ultrasound transducer, the gel dispenser comprising a top portion attachable to the ultrasound transducer and a bottom portion for contacting a body part of a user, the bottom portion comprising peripheral walls and a central recess therebetween for reducing pressure against tissue in a plane, the peripheral walls may comprise posts at corners of the bottom portion.

[0016] In yet another aspect of the invention, an assembly for single-handed attachment and detachment of a body-insertable medical device to an ultrasound transducer is provided, the assembly including a member for releasably mounting the medical device to the assembly in a planar manner, and a member for pivotally mounting the assembly to an extension arm of the ultrasound transducer.

[0017] The assembly may further include a non-contact cover removal mechanism for removing a cover of the insertable medical device. The non-contact cover removal mechanism may comprise a slidable member for moving the cover of the insertable medical device towards and away from the insertable medical device. The assembly may be a slidable carrier and may further comprise a lateral force absorbing member, and the medical device may be pre-attached to the assembly.

[0018] Other and further aspects and advantages of the present invention will be apparent upon understanding the exemplary embodiments described hereinafter or will be set forth in the appended claims, and various advantages not mentioned herein will become apparent to those skilled in the art upon practicing the invention.

[0019] The above and other aspects, features and advantages of the present invention will become more readily apparent with reference to the following description and accompanying drawings. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 is an exploded perspective view of one embodiment of an apparatus for guiding the insertion of a medical device into a subject according to the principles of the present invention.

[0021] [Diagram 2] FIG. 2 is a perspective view of the device of FIG.

[0022] [Diagram 3] FIG. 3 is a perspective view of a medical device attachment mechanism that can be attached to an extension arm of an apparatus for guiding the insertion of a medical device into a subject in accordance with the principles of the present invention, the medical device being shown unclipped;

[0023] [Figure 4]FIG. 4 is a perspective view of a medical device attachment mechanism that can be attached to an extension arm of a device that guides the insertion of a medical device into a subject, based on the principles of the present invention, with the medical device shown in a clipped state.

[0024] [Diagram 5] FIG. 5 is a bottom perspective view of one embodiment of a device for guiding insertion of a medical device into a subject, the bottom perspective view being shown with the base removed.

[0025] [Figure 6] FIG. 6 is a bottom perspective view of the articulated arm of the apparatus of FIG. 5 shown with the base attached.

[0026] [Figure 7] FIG. 7 is a perspective view of the apparatus of FIG. 5 with the medical device shown detached from the articulated arm.

[0027] [Figure 8] FIG. 8 is a perspective view of the apparatus of FIG. 7 with a medical device attached to the articulated arm.

[0028] [Figure 9] FIG. 9 is a rear perspective view of the apparatus of FIG. 8 shown with the attached medical device rotated.

[0029] [Figure 10] FIG. 10 is a front side perspective view of the device of FIG.

[0030] [Figure 11] FIG. 11 is a side perspective view of the apparatus of FIG. 10 shown with the medical device cover removed.

[0031] [Figure 12] FIG. 12 is a side perspective view of the apparatus of FIG. 11 shown with the medical device cap removed.

[0032] [Figure 13] FIG. 13 is a perspective view of the apparatus of FIG. 12 shown before the medical device is inserted into a body part of a subject.

[0033] [Figure 14] FIG. 14 is a perspective view of the apparatus of FIG. 13 when the medical device is inserted into a body part of a subject.

[0034] [Figure 15] FIG. 15 is a perspective view of the apparatus of FIG. 14 with the medical device removed from the attachment mechanism.

[0035] [Figure 16] FIG. 16 is a perspective view of the apparatus of FIG. 15 with the medical device removed from the extension arm.

[0036] [Figure 17] FIG. 17 is a perspective view of the catheter removed from the device of FIG. 16, shown removed from the needle.

[0037] [Figure 18] FIG. 18 is a perspective view of the catheter of FIG. 17 completely removed from the needle.

[0038] [Figure 19] FIG. 19 is a perspective view of another embodiment of an apparatus for guiding the insertion of a medical device into a subject according to the principles of the present invention.

[0039] [Figure 20] FIG. 20 is a perspective view of the apparatus of FIG. 19 shown with the transducer device removed from the pivot base.

[0040] [Figure 21]FIG. 21 is a perspective view of another embodiment of an apparatus for guiding the insertion of a medical device having a slidable member into a subject, the medical device being shown pushed toward the apparatus, according to the principles of the present invention.

[0041] [Figure 22] FIG. 22 is a perspective view of the apparatus shown with the medical device detached from the apparatus.

[0042] [Diagram 23] 23-25 ​​are side views of one embodiment of an apparatus for guiding the insertion of a medical device into a subject according to the principles of the present invention shown in different positions during positioning, prior to insertion, and during insertion, respectively. [Figure 24] 23-25 ​​are side views of one embodiment of an apparatus for guiding the insertion of a medical device into a subject according to the principles of the present invention shown in different positions during positioning, prior to insertion, and during insertion, respectively. [Diagram 25] 23-25 ​​are side views of one embodiment of an apparatus for guiding the insertion of a medical device into a subject according to the principles of the present invention shown in different positions during positioning, prior to insertion, and during insertion, respectively.

[0043] [Figure 26] FIG. 26 is a top perspective view of yet another embodiment of an ultrasound mount for holding an ultrasound device in accordance with the principles of the present invention.

[0044] [Figure 27] FIG. 27 is a side view of the ultrasound mount of FIG.

[0045] [Figure 28] FIG. 28 is a front perspective view of the ultrasound mount of FIG.

[0046] [Figure 29] 29 is a bottom perspective view of the ultrasound mount of FIG.

[0047] [Diagram 30] 30 is a rear perspective view of the ultrasound mount of FIG.

[0048] [Diagram 31] 31 is another bottom perspective view of the ultrasound mount of FIG.

[0049] [Diagram 32] FIG. 32 is a perspective view of one embodiment of a mounting assembly for a medical device according to the principles of the present invention.

[0050] [Diagram 33] 33 is a side view of the mounting assembly of FIG. 32. FIG.

[0051] [Diagram 34] 34 is a side view of the mounting assembly of FIG. 32 being pressed toward the cover.

[0052] [Diagram 35] 35 is a perspective view of the mounting assembly of FIG. 32 shown with the slidable member in a depressed position.

[0053] [Diagram 36] FIG. 36 is a perspective view of one embodiment of a rotating assembly of a transducer according to the principles of the present invention.

[0054] [Figure 37] FIG. 37 is a perspective view of another embodiment of a rotating assembly of a transducer in accordance with the principles of the present invention.

[0055] [Figure 38] FIG. 38 is a perspective view of yet another embodiment of a rotating assembly of a transducer according to the principles of the present invention, the rotating assembly including a first embodiment of a locking mechanism.

[0056] [Figure 39]FIG. 39 is a perspective view of yet another embodiment of a rotating assembly of a transducer according to the principles of the present invention, the rotating assembly including a second embodiment of a locking mechanism.

[0057] [Diagram 40] FIG. 40 is a perspective view of the locking mechanism of FIG. 39 shown with a handle.

[0058] [Diagram 41] FIG. 41 is a bottom perspective view of the locking mechanism of FIG. 39 shown with a handle.

[0059] [Diagram 42] FIG. 42 is a top view of the locking member of FIG. 39 shown in locked and unlocked positions.

[0060] [Diagram 43] FIG. 43 is a perspective view of one embodiment of a gel chamber of a transducer according to the principles of the present invention.

[0061] [Diagram 44] FIG. 44 is a perspective view of another embodiment of a gel chamber of a transducer according to the principles of the present invention.

[0062] [Diagram 45] FIG. 45 is a perspective view of one embodiment of a calibration device mounted on a transducer according to the principles of the present invention.

[0063] [Figure 46] FIG. 46 is a perspective view of another embodiment of a calibration device attached to a transducer in accordance with the principles of the present invention.

[0064] [Figure 47] FIG. 47 is a perspective view of one embodiment of an arm mounting assembly adapted to calibrate the arm of a transducer in accordance with the principles of the present invention, the perspective view being shown without the transducer.

[0065] [Figure 48] FIG. 48 is a perspective view of the arm mounting of FIG. 47 shown with a transducer.

[0066] [Figure 49] FIG. 49 is a top and side view of yet another embodiment of an ultrasound mount in accordance with the principles of the present invention.

[0067] [Figure 50] FIG. 50 is an illustration of one embodiment of a dual planar transducer according to the principles of the present invention.

[0068] [Figure 51] FIG. 51 is a top view of several embodiments of a multi-planar transducer according to the principles of the present invention.

[0069] [Figure 52] FIG. 52 is a side view of one embodiment of an ultrasound mount for holding an ultrasound device in accordance with the principles of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0070] Detailed Description of the Invention DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Apparatus and methods for guiding the movement of a medical device are described below. Although the present invention is described in terms of specific exemplary embodiments, it should be understood that the embodiments described herein are exemplary only and that the scope of the invention is not intended to be limited thereby.

[0071] 1-20, an embodiment of an ultrasound mount or apparatus for guiding movement of a medical device is shown. In such an embodiment, the apparatus comprises an articulated arm 100 for movement in a single plane. Generally speaking, the articulated arm 100 comprises a proximal end 102 adapted to be secured to an ultrasound transducer 200 and a distal end 104 configured to receive a medical device 300 for insertion into a patient. In particular, the articulated arm 100 is configured to guide the movement of the inserted medical device 300. In some embodiments, the apparatus may include a mounting assembly 640 for pivotally mounting the medical device 300. In some embodiments, the articulated arm 100 is adapted to position and maintain the longitudinal axis of the medical device 300 in a predetermined plane 210 (shown in FIG. 26 ) while allowing a desired range of motion within the plane 210. In a typical embodiment, the plane 210 is substantially perpendicular or normal / orthogonal to the bottom 220 of the ultrasound transducer 200 in contact with the patient or the patient's skin. Such a technique is known as in-plane insertion of the medical device. As will be appreciated, it is desirable for the articulated arm 100 to be rotated so as to be substantially aligned with respect to a scan plane or image detected by the ultrasound transducer 200, allowing the operator to maintain visibility of the medical device 300 throughout the procedure.

[0072] The present invention can be adapted for use by medical personnel or nurses in superficial vein injection or catheterization. Thus, the ultrasound transducer 200 can comprise high frequency continuous ultrasound. In such an embodiment, the ultrasound transducer can be used to detect veins less than 5 cm deep. The medical device 300 can be, but is not limited to, a needle, catheter, or other medical device that requires ultrasound guidance during the procedure or insertion.

[0073] In certain embodiments, as shown in FIG. 2, the articulated arm 100 may comprise multiple arms or sections 140 having any suitable length, longitudinal shape and / or cross-sectional shape. The articulated arm 100 may further comprise one or more joints 150 interconnecting two or more adjacent sections 140. The joints 150 may be bolted joints, prismatic joints, or any other joint suitable for allowing relative movement between two adjacent sections 140 in a single plane. In a preferred embodiment, the articulated arm 100 comprises an appropriate number of sections 140 and joints 150 to allow a desired range of motion of the medical device 300. In the illustrated embodiment, the combination of the joints 150 and sections 140 allows the medical device 300 to be lowered towards the patient while providing translational movement along a predetermined plane. In this manner, and by way of example, the medical device 300 may be inserted and removed longitudinally in a vein, an artery, or any other target or portion of a patient.

[0074] To avoid contamination, the articulated arm 100 may be manipulated entirely by manipulation of the arm 140 and / or joint 150 without the need for manipulation of the medical device 300 .

[0075] In some embodiments, the articulated arm 100 may be further configured to be manipulated by a robot or other automated system. In such embodiments, one or more of the sections 140 and / or joints 150 may include attachment points (not shown) configured to connect to one or more actuators of the robot. Alternatively, the joints 150 may be actuated or motorized to manipulate one or more of the sections 140. As will be appreciated, this may further facilitate sterilization of the procedure.

[0076] In certain embodiments, one or more of the sections 140 and / or joints 150 may be made of a sterilizable material to allow the components to be sterilized and reused for multiple medical procedures. In other embodiments, one or more of the sections 140 and / or joints 150 may be pre-sterilized and disposable for a single-use procedure. In yet other embodiments, the articulated arm 100 and ultrasonic transducer 200 may be configured to be encased in a protective sheath to be used in a medical or surgical procedure with greater surgical sterility.

[0077] As mentioned above, the articulated arm 100 is configured to be secured to the ultrasonic transducer 200 in a position that allows the articulated arm to be steered in a predetermined plane 210. In certain embodiments, the articulated arm 100 is removably secured to the ultrasonic transducer 200, thereby allowing an operator to selectively attach or remove the articulated arm 100 as desired. To that end, the proximal end 102 of the articulated arm 100 may comprise a fastening means 110 adapted to secure the articulated arm 100 to the ultrasonic transducer 200 while still allowing it to be removed. The fastening means 110 may be configured to secure the articulated arm 100 to the ultrasonic transducer 200 in a predetermined position, or alternatively, the ultrasonic transducer 200 may include a fastening point 230 adapted to receive the fastening means. In further embodiments, the articulated arm 100 may be attached to a handle 210 of the ultrasonic transducer 200. Therefore, the attachment of the articulated arm 100 to the handle 210 can allow for pivotal or rotational movement around the handle 210 to allow movement of the articulated arm 100 in different substantially perpendicular or orthogonal planes relative to the bottom 220 of the transducer 200.

[0078] In certain embodiments, the articulated arm 100 may further include a fastening joint 190 at its proximal end 102. The fastening joint 190 may be fastened to or may form part of a fastening means. The fastening joint 190 may be configured to allow a limited and / or predetermined range of motion of the articulated arm 100. As will be appreciated, in other embodiments, the fastening joint 190 may allow a different range of motion of the articulated arm 100. For example, the fastening joint 190 may define a circular or arcuate range of motion of the articulated arm 100 and medical device 300 along a single predetermined plane.

[0079] In yet another embodiment, the dimensions and arrangement of the sections 140 allow the articulated arm 100 to be folded into a stored configuration (see, e.g., FIGS. 2 and 23) when not in use. The ultrasonic transducer 200 may further comprise a recess 142 or compartment configured to receive the articulated arm 100 in the stored configuration such that the articulated arm 100 does not interfere with the procedure when not in use.

[0080] In certain embodiments, the installation of the articulated arm 100 on the ultrasonic transducer 200 may be performed by a specialized technician to ensure that the position of the medical device 300 is always within the scanning plane of the ultrasonic transducer 200. The installation of the articulated arm 100 may require a laser alignment tool to ensure that the medical device 300 is always displaced within the scanning plane of the ultrasonic transducer 200 with a possible deviation of up to 0.1 mm. It will be appreciated that by limiting the range of motion of the articulated arm 100 and the medical device 300, medical personnel can more easily identify the position of the medical device 300 within the scanning plane of the ultrasonic transducer 200.

[0081] In further embodiments, the distal end 104 of the articulated arm 100 may comprise an attachment means or connector (not shown) adapted to receive and be secured to the additional section 140. To that end, the articulated arm 100 may be extended to allow for additional range of motion of the medical device 300. In some embodiments, the articulated arm 100 may comprise multiple attachment points for receiving the medical device 300. Now referring to Figures 9 and 10, an exemplary attachment point or means 160 is illustrated. In some embodiments, the attachment point 160 comprises a support 162 configured to receive the medical device 300 and an actuator 164 adapted to manipulate the medical device 300. In certain embodiments, the support 162 may further comprise a groove (not shown) adapted to receive a portion of the medical device 300 and thereby limit its range of motion.

[0082] 5-17, a method for guiding the movement of an insertable medical device into a subject is shown. With reference to Figures 5 and 6, the device includes gel dispensers 422 and 424 that place a lubricant or gel on the skin of the subject during operation of the ultrasound transducer.

[0083] 7 and 8, the method further includes attaching the medical device to the extension arm 100 of the apparatus. In some embodiments, the apparatus may include a mounting assembly 640 that includes attachment means for attaching and detaching the medical device 300. The attachment means may be embodied as a locking mechanism 645 that allows an operator to secure the mounting assembly 640 to the articulated arm 100 with only one hand.

[0084] 9, once the medical device 300 is pivotally mounted to the articulated arm 100, the method further includes an operator holding the device or transducer with a first hand and rotating the mount around the transducer with a second hand (typically the operator's dominant hand). The rotation is stopped when the operator uses the transducer to detect a site of interest within the subject's body. The method may further include locking the articulated arm 100 at a set angle with the operator's first hand (holding the transducer or mount).

[0085] 10 and 11, the method may further include removing a cover or protective cap of the medical device using a second hand of the operator. In the illustrated embodiment, the operator presses a resilient button that releases the cover. The method may further include using the second hand to push the cap 315 away from the medical device. In the illustrated embodiment, the pushing is performed by sliding a carrier or member toward the cover using the second hand. The pushing separates the cover from the remainder of the medical device.

[0086] 12-13, the method may further include manipulating the extension arm to move the medical device in a single plane or planes corresponding to the plane detected by the transducer. The operator moves the medical device toward the skin of the subject to insert the medical device into the plane. As will be appreciated, the articulated arm 100 is constrained at the angle during manipulation of the medical device to ensure that the medical device is inserted into the plane.

[0087] 14 and 15, once the medical device is inserted into the skin of the subject, the method may further include removing a portion of the inserted medical device, such as a catheter, such that an operator may then manipulate the removed portion of the medical device without being restricted by the extension arm 100.

[0088] 16, the method may further include removing the medical device or attachment mechanism from the extension arm 100. In the illustrated embodiment, the attachment mechanism comprises a resilient member that pushes the joint pin inward to release the medical device or attachment mechanism from the end of the extension arm 100.

[0089] 17 and 18, the steps of removing the catheter from the medical device are shown. The method may further include using a member 317 to impart lateral movement to the medical device during manipulation.

[0090] With reference to Figs. 1-18, the device can be used, for example, to perform a procedure using sterile non-touch technique (ANTT). The user's first hand holds, manipulates, and maintains the ultrasonic transducer 200 throughout the procedure. The user's second hand, preferably the user's dominant hand, rotates the articulated arm 100, places the medical device 300, removes the protective cap 315 of the medical device 300, punctures the patient's skin, and releases the medical device 300 from the articulated arm 100. The dominant hand can then be used to remove the ultrasonic transducer 200. In this way, the device can perform the entire procedure with one hand on the ultrasonic transducer 200 and the other hand on the articulated arm 100 without directly touching the medical device 300, avoiding contamination. In a preferred embodiment, the operator manipulates the medical device 300 with the dominant hand and holds the transducer 200 with the other hand.

[0091] 19 and 20, another embodiment of an apparatus for guiding the insertion of a medical device is shown. The apparatus comprises a mount 400 attached to an ultrasound transducer. The apparatus further comprises a base that is pressed against the skin of a subject. The base comprises a rotating mount adapted to receive and rotate the bottom of the transducer. The base 430 comprises a sealed bottom that allows the passage of a light beam. Thus, the bottom 435 of the base 430 may be made of plastic or other material that allows the passage of a light beam. The bottom of the base may be partially filled with a liquid such as water. The liquid is generally intended to reduce or limit air bubbles that may affect the quality of the detection surface. FIG. 19 illustrates the transducer rotatably mounted on the base 430, and FIG. 20 illustrates the transducer removed from the rotating base 430.

[0092] 21 and 22, an embodiment of an attachment mechanism 640 is illustrated that includes a slidable member 115. The slidable member 115 generally allows the medical device to move toward or away from the subject or transducer. Thus, an operator can insert the medical device into the subject by sliding it. The slidable member 115 may include a longitudinal groove that receives a matching protrusion of the attachment mechanism 640 or medical device 300.

[0093] 23-25, another embodiment of an apparatus for guiding an insertable medical device into a subject is shown. In such an embodiment, the articulated arm 100 includes a slidable member or portion 115. The slidable member 115 may be adapted to receive a mounting assembly 640, thus providing the articulated arm 100 with an additional translational degree of freedom that may be used, for example, to move or insert the medical device 300 into a body part of a patient. FIG. 23 shows the slidable member 115 in an extended position and rotated such that the medical device 300 is positioned away from the mount 400. FIG. 24 shows the slidable member 115 in an extended position while the articulated arm 100 is rotated. FIG. 25 shows the slidable member 115 in a compressed or retracted position while the medical device 300 is inserted into the subject.

[0094] The present invention further relates to a method of guiding a medical device 300 in a medical procedure. The method may include fixing or attaching the articulated arm 100 to an ultrasonic transducer 200. Fixing the articulated arm 100 to the ultrasonic transducer 200 may include fixing a proximal end 102 of the articulated arm 100 to a handle 210 of the ultrasonic transducer 200. In certain embodiments, the method may further include aligning the articulated arm with respect to the ultrasonic transducer 200. In some embodiments, the alignment may be performed using a laser.

[0095] The method may further include displacing the medical device 300 along the predetermined plane 10 of the articulated arm 100 to maintain the medical device 300 in a scanning plane of the ultrasound transducer 200. Displacing the medical device 300 may include selectively pivoting one or more of the sections 140 of the articulated arm 100 about the joint 150. In certain embodiments, the method may further include attaching or detaching additional sections 140 to change the range of motion of the medical device 300. In certain embodiments, selectively pivoting one or more of the sections 140 may include engaging a robotic actuator.

[0096] The present invention further relates to an ultrasound transducer mount 400 configured to hold the ultrasound transducer 200 and allow rotation about an axis of rotation, preferably a longitudinal axis, such mounts being generally intended to vary the scanning plane of the ultrasound transducer 200 during operation in order to locate medical devices inserted within a patient.

[0097] 1 and 52, the mount 400 may comprise a transducer attachment mechanism 410, such as, but not limited to, a strap or matching portion. In such embodiments, a pivoting base 420 is configured to receive a conventional ultrasound transducer 200, a rotation mechanism 430 is configured to engage the rotation of the pivoting base 420, and one or more adjustment knobs 440 selectively control said rotation mechanism 430. The rotation mechanism 430 may comprise a gear system (such as a bevel gear) or any other suitable system.

[0098] In certain embodiments, mount 400 may further comprise a locking mechanism configured to lock rotation of pivot base 420 about its pivot axis after a desired pivot angle is achieved.

[0099] In some embodiments, the mount 400 comprises two mating portions that are attachable to one another such that each portion covers a side of the transducer and, when attached together, conforms to the contours of the exterior surface of the transducer (as shown in FIG. 1).

[0100] 5 and 6, in certain embodiments, the mount may further comprise ultrasound gel dispensers 422 and 424 fluidly connected to an ultrasound gel reservoir (not shown). The ultrasound gel dispensers 422 and 424 may be selectively or automatically activated to dispense ultrasound gel to the patient's skin surface under the ultrasound device. Because ultrasound waves travel poorly through air, ultrasound gel may be used to reduce the gap between the patient and the ultrasound transducer 200 to reduce acoustic impedance and reflections and allow for clearer images to be produced. However, ultrasound gel may impede or complicate the insertion of the medical device 300 in the vicinity of the ultrasound transducer 200. Thus, the mount 400 may further comprise a peripheral skirt 465 configured to scrape and collect excess ultrasound gel dispensed during operation of the ultrasound transducer 200. As will be appreciated, the peripheral skirt 465 may facilitate use of the articulated arm 100 and the medical device 300 by partially or completely removing excess ultrasound gel. The peripheral skirt 465 may include walls to form a container shape 466 that allows for collection and retention of the gel.

[0101] 5 and 6, in certain embodiments, the pivoting base 420 may comprise a silicone membrane base or gel dispenser 422, a gel base, or any other suitable material adapted to allow sound waves emitted by the ultrasound transducer 200 to pass through with little or no interference. The silicone membrane 424 or gel base may form a gap of about 2-7 mm between the ultrasound transducer 200 and the patient's skin surface. In certain embodiments, the silicone membrane or gel base may allow the ultrasound transducer 200 to provide better or clearer ultrasound images of internal body structures at depths of less than 1 cm. It may be appreciated that conventional ultrasound transducers provide blurry images of internal structures at shallow depths.

[0102] According to an exemplary use of the mount 400, a medical practitioner may detect a vein, artery, or any other target of a patient by displacing the pivoting base 420 and attached ultrasound transducer 200 across the surface of the patient's skin. Once a cross-sectional view of the desired vein, artery, or other target is detected (typically displayed as a circular element on a display), the medical practitioner may tighten the straps of the mount 400 around the patient's site and rotate the pivoting base 420 about its axis by means of the rotation mechanism 430 and one or more adjustment knobs. By rotating the pivoting base 420 about its fixed position relative to the target vein, the ultrasound transducer 200 may thus be automatically positioned to provide a longitudinal view of the target vein with little or no further adjustment by the medical practitioner.

[0103] In certain embodiments, the adjustment knobs may be manually actuated by one or more robotic actuators (not shown). In certain embodiments, the robotic actuators may be further actuated by an automated system. In certain embodiments, the one or more robotic actuators may be actuated and operated by an artificial intelligence system configured to identify the appropriate rotation of the rotation mechanism 430 and ultrasound device 200 to provide a desired longitudinal view of the selected vein.

[0104] During medical procedures involving the use of the ultrasound transducer 200, medical personnel and nurses may unintentionally apply excessive force to the ultrasound transducer 200. Excessive force may apply undesirable pressure to the patient's site, thereby reducing the cross-sectional area of ​​the target vein and making it less visible in the scan plane. Thus, with further reference to FIG. 1 , the mount 400 may comprise a suspension assembly 470 disposed between the mount 400 and the ultrasound transducer 200. The suspension assembly 470 is generally configured to maintain a desired level of pressure on the patient's site under examination. The suspension assembly 470 may comprise a spring, an air suspension assembly, a magnetic suspension assembly, or any other suitable system for storing mechanical energy. Thus, as will be appreciated, the suspension assembly 470 may prevent excessive pressure between the ultrasound transducer 200 and the surface of the patient's skin. In yet another embodiment, the bottom of the transducer 200 may have an elliptical shape that allows the device 200 to conform to the shape of the patient's skin rather than the subject's skin being pulled by the device 200. The bottom may also be concave to limit the pressure level directly beneath the transducer 200 .

[0105] In certain embodiments, the suspension assembly 470 may include vertical and horizontal suspension members. The vertical suspension members may reduce pressure caused by vertical forces applied to the mount 400. The horizontal suspension members may further reduce unintended horizontal vibrations of the ultrasonic transducer 200 during a scanning procedure.

[0106] It can be appreciated that in embodiments having a peripheral skirt 465, the peripheral skirt 465 can further assist in reducing undesirable pressure on the patient's area by providing a larger surface area for application of force to the patient's skin.

[0107] 49, an ultrasound transducer mount 1400 according to another embodiment is illustrated. The mount 1400 comprises a support 1405, a strap 1410, a pivot arm 1420 configured to receive an ultrasound transducer 1422, a rotation mechanism 1430 configured to engage the rotation of the ultrasound transducer 1422, one or more support arms 1425, and one or more adjustment knobs 1440 for selectively controlling the rotation mechanism 1430. The rotation mechanism 1430 may comprise a motor, a gear system, or any other suitable drive system. In certain embodiments, the mount 1400 may also comprise a suspension assembly 1460 disposed between the support 1405 and the pivot arm 1420 configured to maintain a desired level of pressure on the site of the patient under examination. The support arm 1425 may also assist in reducing undesired pressure on the site of the patient by providing a larger surface area for application of force to the skin of the patient.

[0108] During certain procedures, the patient's arm may not be large enough to be received within the strap 410, 1410. In such cases, the mount 400, 1400 may further include an arm support 480 configured to receive and hold the patient's arm while providing a larger surface for securing the strap 410, 1410.

[0109] The present invention further relates to a multi-planar ultrasonic device 1200 comprising multiple transducers. In the embodiment shown in Fig. 50, the multi-planar ultrasonic device 1200A comprises two transducers configured to provide two different scanning planes. Specifically, the dual-planar ultrasonic device 1200A comprises a primary transducer 1210 providing a first scanning plane 1212 and a secondary transducer 1220 providing a second scanning plane 1222. In a particular embodiment, the secondary transducer 1220 is substantially orthogonal to the primary transducer 1210 along their longitudinal axes.

[0110] With further reference to FIG. 50, the multi-planar ultrasonic device 1200A may include a casing or housing 1230 configured to protect and define a relative positional relationship between multiple transducers 1200, such as a primary transducer 1210 and a secondary transducer 1220.

[0111] As mentioned above, in anesthesiology, there is a need to ultrasonically guide an injection needle near a nerve. In particular, the multiplanar ultrasonic device 1200A may allow injections to be made in the desired vicinity of a nerve without injecting directly into the nerve. According to an exemplary use of the multiplanar ultrasonic device 1200A, the primary transducer 1210 and the secondary transducer 1220 may provide transverse and longitudinal cross-sectional views of the nerve, respectively.

[0112] In certain embodiments, the secondary transducer 1220 may have a narrower scanning surface than the primary transducer 1210. For example, the secondary transducer 1220 may provide a scanning surface having a lateral dimension of approximately 1 cm to 6 cm.

[0113] It can be appreciated that the multi-plane ultrasound device 1200A can provide a medical practitioner with a continuous view of the medical device 300 during insertion. For example, the secondary transducer 1220 can provide a first view of the medical device as it is being aimed at a target vein or nerve, while the primary transducer 1210 can provide a conventional cross-sectional view of the vein or nerve. In this manner, a simultaneous view can reduce risks associated with the insertion of a medical device and the positioning of the inserted medical device within the patient's body.

[0114] 51, another embodiment of a multi-planar ultrasound device is illustrated. More specifically, a multi-planar ultrasound device 1200B is illustrated. The multi-planar ultrasound device 1200B comprises a primary transducer 1210 providing a first scan plane 1212, and two secondary transducers 1220 arranged substantially parallel to and on either side of the primary transducer 1210. So arranged, the secondary transducers 1220 can provide a second scan plane 1222 parallel to the longitudinal axis of the target vein. As can be seen, the second scan plane 1222 thus indicates the needle when it is displaced beyond the first scan plane 1212, thereby prompting the medical practitioner to realign the needle.

[0115] 51, yet another embodiment of a multi-planar ultrasonic device is shown. More specifically, a multi-planar ultrasonic device 1200C is presented that includes a primary transducer 1210 that provides a first scan plane 1212 and a rotating secondary transducer 1220 positioned to rotate about a predetermined axis that is approximately perpendicular to the scan plane. The rotating secondary transducer 1220 can be rotated to provide a second scan plane 1222 at any desired angle relative to the first scan plane 1212.

[0116] As can be appreciated, the multi-planar ultrasonic device 1200 may include any desired number of transducers to detect a number of separate scan planes equal to the number of transducers. Preferably, the multi-planar ultrasonic device 1200 includes two transducers.

[0117] The multi-planar ultrasound device 1200 may further include a controller (not shown) configured to process signals generated by the multiple transducers 1200, such as the primary transducer 1210 and the secondary transducer 1220, and output a video feed to a monitor of the device 1200. In a preferred embodiment, the video feed generated by the controller displays the scan planes generated by all transducers, such as the primary transducer 1210 and the secondary transducer 1220, providing a simultaneous view of both scan planes to the medical practitioner. In this manner, the controller may be configured to combine the feeds of each transducer 1210, 1220 into a single image output.

[0118] In certain embodiments, the multi-planar ultrasound device 1200 may further comprise an audio generation device, such as a speaker (not shown), operable by the controller. In such embodiments, the controller may be further configured to activate a visual or audio alarm upon detection of a needle in a given scan plane. For example, an alarm may be activated upon detection of a needle in the second scan plane 1222, indicating that the needle has been displaced beyond the first scan plane 1212 and requires realignment.

[0119] 26-31, there is shown another embodiment of an ultrasound transducer device 600 that emits a scan plane 210. The device 600 includes a lower support 610 and a pivoting arm 620 configured to receive a medical device 300, such as a catheter.

[0120] In certain embodiments, the lower support 610 may include a cross-sectional shape adapted to distribute pressure over a larger surface area on the patient's skin surface to maintain a desired level of pressure at the patient's site under examination. In a preferred embodiment, the cross-sectional shape of the lower support 610 distributes pressure around the periphery of the area scanned by the device 600.

[0121] The illustrated embodiment of the ultrasonic transducer device 600 includes a pivot arm 620. The pivot arm 620 includes a first member 622 and a second member 624 that are similarly configured to restrict the movement of the medical device in a range of motion coplanar with the scanning plane 210. A first end of the first member 622 is pivotally attached to the upper support of the device 600 about a single first axis. A second end of the first member 622 is pivotally attached to a first end of the second member 624 about a single second axis, the second axis being substantially parallel to the first axis. In certain embodiments, the first member 622 and the second member 624 may be telescopic to allow extension along their longitudinal axes. The extension of the first member 622 and the second member 624 may provide a larger range of motion of the medical device 300 during a procedure. One or more of the first arm 622 and the second arm 624 may be angled to define an alternative and / or more desirable range of motion for the medical device 300. In the embodiment shown in Figures 18-23, the second arm 624 is angled in this manner.

[0122] The pivot arm 620 further comprises a third member 626 pivotally attached to the second member about a third axis, the third axis being substantially parallel to the first and second axes, the third member 626 adapted to receive a medical device to be inserted into a body part of a subject.

[0123] 32-35, one embodiment of a medical device attachment assembly 640 is illustrated. The medical device attachment assembly 640 generally allows for attachment and removal of a medical device while limiting movement of the medical device when inserted into a subject's body. The medical device attachment assembly may further allow for a cover 310 covering the medical device 300 to be attached and removed without touching the cover 310. Not touching the cover 310 is generally intended to maintain a sanitary environment and maintain positional stability of the device 600.

[0124] In the illustrated embodiment, the mounting assembly 640 comprises a slidable member 642 adapted to move toward and away from a portion of the cover 310. As such, when pressed against the cover, the slidable member 642 pushes the cover 310 away from the medical device 300. In some embodiments, the slidable member 642 is resiliently attached to the assembly 640 such that it returns to its initial position after being pressed.

[0125] In the illustrated embodiment, the mounting assembly 640 further comprises a carriage or push member 644 adapted to move toward and away from the medical device 300 .

[0126] In use, a user positions device 600 over the area where the medical device is to be inserted and uses pivot arm 620 to position medical device 300. Once positioned, the user first presses slidable member 642 to remove the cover without touching the cover. The user then moves or triggers the movement of carriage 644 to release medical device 300 from mounting assembly 640.

[0127] 26-31, the support 610 may further include a curved edge 612 that defines a curvature profile that is mirrored relative to the scan plane 210. To that end, the curved edge 612 may enable rotation of the ultrasound transducer mount 600 about an axis that is perpendicular to the scan plane 210. Rotation of the ultrasound transducer mount 600 may provide the medical practitioner with a desirable increase in the range of motion of the medical device 300 during a procedure, thereby providing a better view of the needle within the scan plane 210.

[0128] In certain embodiments, the ultrasonic transducer mount 600 may include one or more actuators (not shown) configured to pivot or rotate the ultrasonic transducer 200 within the ultrasonic transducer mount 600, also to provide a better view of the needle within the scan plane 210.

[0129] 36 and 37, an embodiment of a rotation assembly 650 is illustrated. The rotation assembly 650 is generally intended to rotate the support member 610 of the device 600. In use, a first hand of a user holds the rotation assembly 650 while the other hand of the user manipulates the device 600, such as via the body 610 or the articulated arm 620. The rotation assembly 650 allows for rotation of the device about a substantially vertical axis.

[0130] In the illustrated embodiment, the rotating assembly 650 comprises a mounting member 652 attached to the body 610 of the device 600. In such embodiments, the mounting member 652 surrounds the body 610. The rotating assembly 650 further comprises a disk or rotating member 654 adapted to rotate or slide on the mounting member 652. In this manner, the disk 654 can move freely around the body 610 of the device 600. In some embodiments, the rotating member 654 may further comprise a handle or manipulable portion 653. The handle 653 is typically designed to fit ergonomically in a user's hand.

[0131] 38, an embodiment of a rotating assembly 650 is shown that includes a brake or locking mechanism 656. The locking mechanism 656 is typically adapted to lock the rotating member 654 in place by default. When a user presses or activates the lock, the rotating member 654 is free to move on the mounting member 652. As will be appreciated, any known means or mechanism adapted to limit or lock the rotation of the rotating assembly relative to the body may be used within the scope of the present invention.

[0132] 39-42, another embodiment of a brake or lock mechanism 656 is illustrated. The brake mechanism 656 comprises a pivot point 657 attached to the rotating member 654. The brake mechanism 656 further comprises a disc 6562 attached to the body 610 of the device 600. The disc 6562 comprises teeth or engagement members 6563. The engagement members 6563 are typically located on the outer periphery or rim of the disc 6562. The brake mechanism 656 further comprises a lock member 6561 pivotally attached to the pivot point 657. The lock member 6561 typically comprises one or more engagement members 6564 adapted to interlock or mate with the engagement members 6563 when the lock member 6561 is pivoted to one side towards said disc 6562. In use, the user pushes the locking member 6561 to one side, locking the disc when the two engagement members 6563 and 6564 are locked together, and unlocking rotational movement when the locking member 6561 is returned to its initial position.

[0133] 40 and 41, in some embodiments, the brake mechanism 656 may further include a handle 6565 connected to the locking member 6561 to facilitate operation of the brake mechanism 656.

[0134] 42, one embodiment of a locking member 6561 is illustrated in a locked position (purple) and an unlocked position (blue).

[0135] 36 , in yet other embodiments, the mounting member 652 may be vertically slidable on the body 610 of the device 600. In this manner, the rotating assembly 650 may be positioned vertically to improve the ergonomics of the apparatus for different users. In such embodiments, the mounting member 652 may comprise a slider adapted to move vertically while surrounding the periphery of the body 610.

[0136] 43 and 44, there is shown a gel chamber 660 covering the lower portion of the body 610 of the device 600. The gel chamber 600 generally comprises an outer membrane 662 adapted to form an inner chamber (not shown) between the lower portion of the body 610 and an inner portion of the outer membrane 662. The membrane 662 comprises a slot or opening 663 for allowing the gel to exit the chamber during operation. The chamber 660 is typically clipped or removably attached to the body 610. Being removably attached to the body 610 allows the chamber or device 600 to be easily cleaned.

[0137] 44, in some embodiments, the chamber 660 comprises an outer wall 665 adapted to elevate a portion of the bottom of the device 600. Such height adjustment is generally intended to reduce the generation of air bubbles and allow the gel to flow between said walls. Additionally, the walls allow for pressure to be present around the body area scanned by the device 600.

[0138] 45 and 46, an embodiment of a mechanism for aligning or calibrating the device 600 is illustrated. In such an embodiment, the calibration device 700 comprises a number of holding points 710 for attaching the calibration device 700 to the body 610 of the transducer 600. The holding points 710 may be embodied as a screw with a rubber tip, as shown. With reference to FIG. 32, the calibration device 700 comprises an inner container 720. The inner container 720 may be filled with a liquid, such as water, to calibrate the orientation of a medical device 300, such as a catheter. The transducer 600 detects the liquid in the container, and then the user can calibrate or align the arm so that the transducer 600 scans the medical device 300 in the container.

[0139] 46, another embodiment of a calibration device 700 is shown. In such an embodiment, the calibration device 700 comprises one or more passages 730 adapted for the medical device 300 to pass through. The different passages ensure that the medical device 300 is adjusted to be inserted at a predetermined depth. As shown, the calibration device 700 may comprise multiple passages 730 disposed at predetermined depths within the container 720.

[0140] 47 and 48, the body 610 may include an arm attachment member 630. The attachment member 630 includes an arm connection member 632 attached to the arm attachment member 630 using any type of fastener, such as a fastener. In the illustrated embodiment, the arm attachment member 630 includes one or more openings 633 adapted to receive a fastener, and the arm connection member 632 further includes one or more openings 634 and 635 also adapted to receive a fastener. In such an embodiment, fasteners inserted into the openings 633, 634, 635 attach the arm 622 to the body 610. To calibrate the device, the user tightens or loosens the fasteners in the side openings 633 to move the arm correctly to the side. The user further tightens or loosens the upper fastener 634 to modify the height of the arm 620. The user can also tighten or loosen the other upper fastener 635 to modify the angle of the arm 620. It will be appreciated that calibration fasteners 633, 634, and 635 are illustrated as examples of methods for altering the calibration of arm 620. Other known methods of calibrating arm 620 may be used within the scope of the present invention.

[0141] In yet other embodiments, the arm 620 may be attached to the rotating member 654 and rotate about the device 600. In certain embodiments, the ultrasound transducer mount 600 may further comprise an orifice 660 adapted to receive a needle cap of the medical device 300. In particular, the orifice 660 may be configured to allow for insertion of the needle cap while subsequently retaining the needle cap therein. In this manner, the orifice 660 may allow a medical practitioner to position a needle or catheter for insertion without requiring manipulation of the needle, catheter and / or needle cap at any stage of the procedure.

[0142] The present invention further relates to an ultrasonic device 200 that includes a monitor (not shown). The monitor may be fixed to an upper end of the ultrasonic device 200 and configured to rotate about a lateral axis of the ultrasonic device 200 and tilt about a radial axis of the ultrasonic device 200. The monitor may provide a medical practitioner with a view of an ultrasound image captured during use of the ultrasonic diagnostic device 200.

[0143] While illustrative and presently preferred embodiments of the invention have been described in detail herein, it is to be understood that the inventive concepts may be variously embodied and employed in other ways, and that the appended claims are intended to be construed to include such modifications except insofar as limited by the prior art.

Claims

1. 1. An apparatus for guiding the operation of a body-insertable medical device, comprising: a mount assembly for receiving an ultrasonic transducer, the ultrasonic transducer mount being rotatable about the receivable ultrasonic transducer; and an articulated arm having a first end attachable to the mount assembly and a second end attachable to the insertable medical device, the articulated arm moving along a single plane to position a longitudinal axis of the medical device within the plane.

2. The apparatus of claim 1 , wherein the articulated arm is used to rotate the mount assembly.

3. The apparatus of claim 1 , wherein the mount assembly comprises a pivoting base for receiving the ultrasonic transducer and a rotation mechanism for engaging rotation of the pivoting base.

4. The apparatus of claim 3 , wherein the base has a shape that substantially matches a shape of a bottom portion of the ultrasonic transducer.

5. The apparatus of claim 3 , wherein the base includes a suspension mechanism adapted to receive a bottom of the ultrasonic transducer.

6. The apparatus of claim 3 , wherein the base includes a liquid-fillable sealed chamber between a bottom of the ultrasound transducer and a body part of a subject.

7. The device of claim 3 , wherein the base is shaped to lock with a bottom of the ultrasonic transducer.

8. The apparatus of claim 3 , wherein the pivoting base includes a brake to maintain the pivoted base at a particular angle.

9. The apparatus of claim 1 , wherein the second end of the articulated arm is selectively attachable to and detachable from the insertable medical device.

10. The apparatus of claim 1 , wherein the second end of the articulated arm comprises a medical device mounting assembly for single-handed mounting and removal of the insertable medical device.

11. The apparatus of claim 10 , wherein the medical device mounting assembly comprises a non-contact cover removal mechanism for removing a cover of the insertable medical instrument.

12. The apparatus of claim 11 , wherein the non-contact cover removal mechanism comprises a slidable member for moving a cover of the insertable medical device away from the insertable medical device.

13. The apparatus of claim 12 , wherein the slidable member is attached to the medical device using sterile non-contact techniques (ANTT).

14. The apparatus of claim 10 , wherein the medical device mounting assembly is a slidable carriage.

15. The apparatus of claim 10 , wherein the medical device mounting assembly comprises a lateral force absorbing member.

16. The apparatus of claim 15 , wherein the lateral force absorbing member is resilient along a longitudinal axis of the medical device.

17. The apparatus of claim 1 , wherein the second end of the articulated arm comprises a slidable member for moving the insertable medical device toward and away from the mounting assembly.

18. The apparatus of claim 10 , wherein the mounting assembly conforms to an exterior surface of the medical device.

19. The apparatus of claim 1 , wherein the mount assembly is integral with the ultrasonic transducer.

20. 1. A method for guiding movement of an insertable medical device, comprising: holding with a first hand a mount assembly adapted to receive an ultrasonic transducer; attaching the insertable medical device to the mount assembly with a second hand; rotating the mount assembly with the second hand about an axis substantially perpendicular to the received ultrasonic transducer; Fixing the rotated mount assembly at a desired angle; and moving the attached insertable medical device with the second hand to insert the medical device in a plane into a target area of ​​a patient.

21. 21. The method of claim 20, further comprising releasing the medical device with the second hand.

22. 21. The method of claim 20, further comprising non-contacting removal of a cover of the insertable medical device prior to inserting the medical device.

23. 21. The method of claim 20, further comprising testing the operation of the medical device by pulling and pushing the medical device.

24. 1. A gel dispenser for an ultrasonic transducer, the gel dispenser having a top portion attachable to the ultrasonic transducer and a bottom portion for contacting a body part of a user, the bottom portion having a peripheral wall and a central recess between the wall for reducing in-plane pressure on tissue.

25. 25. The gel dispenser of claim 24, wherein the peripheral wall includes posts at corners of the base.

26. 1. An assembly for one-handed attachment and detachment of a medical device insertable within a physical body to an ultrasound transducer, comprising: a member for releasably attaching the medical device to the assembly so as to lie in a plane; and a member for pivotally mounting the assembly to an extension arm of the ultrasonic transducer.

27. 27. The assembly of claim 26, further comprising a non-contact cover removal mechanism for removing a cover of the insertable medical device.

28. 30. The apparatus of claim 27, wherein the non-contact cover removal mechanism comprises a slidable member that moves the cover of the insertable medical device toward and away from the insertable medical device.

29. 27. The assembly of claim 26, wherein the assembly is a slidable carriage.

30. 27. The assembly of claim 26, wherein the assembly further comprises a lateral force absorbing member.

31. 27. The assembly of claim 26, wherein the medical device is pre-attached to the assembly.

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