Abstract:
A device that assists surgical procedures by maintaining a specific percutaneous access location and orientation of needles, wires, trocars, dilators, catheters, etc., and which secures the tip of said access device(s) relative to said location and orientation during a percutaneous procedure. There are three main parts: (1) a base that conforms to the skin of the patient at various locations; (2) an adjustment mechanism mounted in ball-and-socket fashion inside the base and moving about at least one, and preferably multiple, axes of rotation relative to the base; and (3) a securement mechanism capable of being affixed to the adjustment mechanism for securely holding an access device at an angle to allow it to pass through the adjustment mechanism and enter the patient&#39;s skin at the desired angle and location. The device can be removed following the procedure without affecting the inserted access device(s).

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
       [0001]    The present application derives priority from U.S. Provisional Application Ser. No. 62/182,221 filed 19 Jun. 2015. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention generally relates to assistive procedural devices and, more particularly, to procedures that are performed percutaneously with one or more procedural tools or devices that can benefit from maintaining a specific percutaneous access location, orientation of said procedural tools or devices, and securement of said procedural tools or devices. 
         [0004]    2. Description of Prior Art 
         [0005]    In placing a medical device or instrument into a patient it is best to use precision. However, correct device placement and preservation of device position are made difficult by various patient, disease, environmental, and user factors. Moreover, there is often a need for slight adjustment of the device in one or more dimensions (e.g., depth, angle with skin). Various systems, assemblies, devices, and methods for guiding and positioning, medical tools or devices are known in the medical field. The following are examples. 
         [0006]    U.S. Pat. No. 4,265,561 to Heckele (herein, “Heckele &#39;561”) discloses a device for holding a medical instrument wherein the device holder is mounted to a headband worn by the user. The device includes a base mounted to the headband with a recess therein, into which a rotatable member with a through-hole fits in a ball-and-socket fashion. The through-hole in the rotatable member accommodates an arm of the medial instrument. 
         [0007]    U.S. Pat. No. 4,693,240 to Evans (herein, “Evans &#39;240”) discloses a bone pin clamp as depicted in Evans ‘240.’ The bone pin clamp is secured in a ball-in-socket joint wherein the ball comprises a through-hole for receiving the pin ( 100 ). The through-hole may be axially grooved for securing the pin therein. 
         [0008]    U.S. Pat. No. 6,328,748 to Henning (herein, “Henning &#39;748”) also discloses a device for adjusting stereotactically and endoscopically located equipment where the holder comprises a lower ring ( 1 ) for receiving a ball ( 2 ) which will form a ball joint, and an upper ring ( 3 ) for locking the ball in a specific position, where the ball ( 2 ) has a channel for insertion of medical instruments, and where the lower ring ( 1 ) has an external threaded surface ( 8 ) for direct screwing to an area of a patient&#39;s skull. The device is characterized by the fact that the ball&#39;s ( 2 ) central point, and thereby the ball joint&#39;s fulcrum is arranged for positioning on a level with the patient&#39;s cranium by way of a groove-like or curved surface ( 21 ) on the holder which forms an abutment for the ball ( 2 ), wherein the groove-like surface ( 21 ) may be screwed directly into the patient&#39;s skull. 
         [0009]    U.S. Pat. No. 7,204,840 to Skakoon et al. discloses (herein, “Skakoon &#39;840”) discloses devices and methods to provide accurate targeting, placement, and/or stabilization of an electrode or other instrument(s) into the brain or other body organ. In an example an embodiment of Skakoon &#39;840, a base  104  is secured to the skull using bone screws. A pedestal or tower  3002  is secured to base  104  as illustrated or, alternatively, is secured directly to the skull. Tower  3002  includes a socket  3004  housing a ball  3006 . Ball  3006  includes a center opening that receives a rotating inner barrel sleeve  3008 . In this example, sleeve  3008  includes one or more lumens  3010 A-C extending there through for passing and guiding instruments, sheaths, stylets, etc. An affixation device, such as thumbscrew  3012 , fixes the position of ball  3006  when the desired trajectory alignment has been obtained, such as by using the MRI, CT, PET, or frameless navigational guidance techniques discussed above. Proximal portions of lumens  3010 A-C include recesses for snapping into place lips on devices inserted therein, such as alignment stem (or frameless adapter)  3014  and/or Luer stem  3016 . 
         [0010]    U.S. Pat. No. 7,824,417 to Magnusson et al. (herein, “Magnusson &#39;417”) discloses a skin-mounted gimbal-like device for guiding a puncturing needle or other medical device to a treatment site. The device comprises a series of adhesive pads ( 6 ) that are releasably secured to the patient&#39;s skin and mounted with a base ( 5 ) and ball joint ( 7 ) to allow rotatable positioning of a needle guiding member ( 3 ) over the patient&#39;s skin. 
         [0011]    U.S. Pat. No. 8,425,404 to Wilson et al. (herein, “Wilson &#39;404”) discloses a laparoscopic surgical tool positioning device comprising a plurality of arms connected by ball-and-socket joints and able to be increased and decreased in length to provide the proper position and angle of skin entry for the laparoscopic tool. Wilson &#39;404 discloses a clamp for holding the tool, comprising a spring-loaded clamping jaw ( 122 ) for gripping medical devices of different diameters. The clamping jaw is open on one side to allow releasable attachment to the device being positioned for skin entry, 
         [0012]    U.S. Pat. No. 5,354,283 to Bark et al. (herein, “Bark &#39;283”) describes a trocar retention device for attachment to the skin of the patient. The device comprises a trocar-receivable rotatable spheroid frictionally retained in a stabilizing member. The base, or stabilizing member ( 10 ) is preferably a frusto-conical member molded from a material such as silicone elastomer, rubber, plastic or the like and comprising a socket ( 14 ) into which the rotatable spheroid ( 22 ) sits and is frictionally engaged. The spheroid ( 22 ) has a cylindrical bore  24  that is adapted to slidably receive a trocar  22 . In one disclosed embodiment, the stabilizing member ( 10 ) and the spheroid both have a slit ( 34 ) that allows the flexible material of the stabilizing member and the spheroid to be fitted over the trocar at the surface of the patient&#39;s skin after the has been placed in the proper position. The stabilizing member comprises a groove ( 28 ) around a “neck” portion thereof which may be secured by a clamp or other means to close the slit ( 34 ) and secure the stabilizing member and spheroid around the placed trocar. Bark &#39;283 also describes bow the interior walls  26  of the stabilizing member  10  are inclined, preferably at a 45° angle to the skin of the patient, to prevent the trocar  22  from becoming dislodged during the surgical procedure by limiting the angle of inclination of the trocar  22 . The spheroid is engaged and secured to the trocar ( 22 ) by the frictional force of the clamp or tie acting on the stabilizing member and spheroid. In some embodiments, the Bark &#39;283 device is secured to the patient by means of a plurality of suction cups  40  positioned about the bottom of the base disc  18  of the trocar retaining apparatus. The suction cups  40  secure the stabilizing member  10  to the patient. The suction cups  40  provide for short term attachment of the stabilizing member  10  during surgery, rather than long term therapy. Alternatively, double sided. medical tape or a contact medical adhesive may be used to secure the stabilizing member  10  to the skin of the patient. 
         [0013]    U.S. Pat. No. 4,841,967 to Chang et al. (herein, “Chang &#39;967”) discloses a device for accurate positioning of needles for percutaneous insertion comprising a base having a circular angle indicator similar to a protractor for indicating the angle of needle insertion by reference to markings thereon. As seen in Chang &#39;967, a needle holding device may comprise a needle holder  40  having a longitudinal grooved housing adapted to receive a needle  70  (or other elongated medical instrument intended for percutaneous insertion into a body cavity) in a longitudinal groove  45  defined in the front face  43  of housing  40 . The needle  70  can be removably affixed to housing  40  by means of a removable clasp  50  which can be fabricated from a material and of a size such that the inner sides  65  of clasp  50  securely grip the sides  41  of housing  40  to hold needle  70  within groove  45  and to prevent needle  70  from moving. 
       SUMMARY OF THE INVENTION 
       [0014]    In accordance with the foregoing objects, the purpose of the present invention is to facilitate the performance of percutaneous procedures by stabilizing various access devices, thereby reducing trauma to the tissues (especially when the access devices have sharp tips) and enabling the user to take one hand off of the access device to perform other steps with two hands. Hence, the present invention is a device to maintain a specific percutaneous access location and orientation of access devices once said location and orientation have been identified by the user, and to secure the distal tip of said access device(s) relative to said location and orientation during said percutaneous procedure. Access devices include but are not limited to a needle, wire, trocar, dilator, and catheter (together referred to as “access devices”). 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    Other objects, features, and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiments and certain modifications thereof when taken together with the accompanying drawings in which: 
           [0016]      FIG. 1  is a top-front perspective view of a procedural assist device  1  according to a preferred embodiment of the present invention showing how a needle (e.g., access device)  100  interacts with it. 
           [0017]      FIG. 2  is a back perspective view of the procedural assist device  1  of  FIG. 1 . 
           [0018]      FIG. 3  is a bottom-front view of the procedural assist device  1  of  FIGS. 1-2 . 
           [0019]      FIG. 4  shows a top perspective view of the preferred embodiment of base  10  and adjustment mechanism  40  of  FIGS. 1-3 . 
           [0020]      FIG. 5  shows a back view of the base  10  and adjustment mechanism  40  of  FIGS. 1-4 , wherein said adjustment mechanism is rotated nearly parallel to said base. 
           [0021]      FIG. 6  is a back view of base  10  and adjustment mechanism  40  of  FIGS. 1-5 , wherein said adjustment mechanism is rotated nearly vertical and then leftward with respect to said base. 
           [0022]      FIG. 7  is a top view of the base  10  of  FIGS. 1-6 . 
           [0023]      FIG. 8  is a back perspective view of the base  10  of  FIGS. 1-7 . 
           [0024]      FIG. 9  is a back view of the base  10  of  FIGS. 1-8 . 
           [0025]      FIG. 10  is a bottom perspective view of the base  10  of  FIGS. 1-9 . 
           [0026]      FIG. 11  is a sequential operating illustration of the securement components  70  (shell  71  and detent plug  72 ). 
           [0027]      FIG. 12A  is a side cross-sectional view of the securement mechanism in a fully closed position. 
           [0028]      FIG. 12B  is a side cross-sectional view of the securement mechanism in a fully open position. 
           [0029]      FIG. 13  is a front perspective view of the isolated plug  72 . 
           [0030]      FIG. 14  is a rear perspective view of the isolated plug  72 . 
           [0031]      FIG. 15  is a front perspective view of securement mechanism  70  with an optional door feature  82 , wherein said door is closed. 
           [0032]      FIG. 16  is a front perspective view of securement mechanism  70  with optional door feature  82  as in  FIG. 15 , wherein said door is open. 
           [0033]      FIG. 17  is a bottom view of the procedural assist device  1  of the present invention housed around the hub of a needle  101 . 
           [0034]      FIG. 18  is a side view of the procedural assist device of the present invention housed around the hub of a needle as per  FIG. 17 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0035]    For purpose of the present disclosure, the term “percutaneous” means via needle-puncture of the skin, and “percutaneous access device” means any medical device that employs a percutaneous access modality for a medical procedure. Percutaneous access and procedures frequently refer to catheter procedures such as cardiac catheterization, percutaneous transluminal angioplasty (PTA) ballooning, stent delivery, filter delivery, cardiac ablation, and peripheral vascular or neurovascular catheter procedures. Also included are procedures for percutaneous access of other body cavities such as parts of the gastrointestinal track, peritoneal cavity, pleural cavity, airway, abscesses, and other fluid- or air-containing cavities. Moreover, procedures that employ the Seldinger approach to access a space in the body generally fit into the category of percutaneous procedures. Other percutaneous procedures serve to access bone including intraosseous vascular access, vertebroplasty, and bone marrow biopsy. Still other percutaneous procedures are used to biopsy tissues. The procedures listed above are meant to serve as examples and are not an exhaustive list. The core functions of the device of the present invention are to provide the following: 
         [0036]    (1) a securement mechanism for percutaneous access devices, wherein a component of the subject invention holds the access devices in place relative to the base and adjustment components, accommodates access devices of different sizes and diameters, maintains at least three positions (fully open, partially open, fully closed), enables the user&#39;s hand to come off of the access device, skin and/or procedural location, and does not materially limit amount of access device available for the procedure; 
         [0037]    (2) an adjustment mechanism to maintain the location and orientation of the access device(s), wherein a component of the subject invention moves about at least one axis relative to the base, may lock to hold the position identified by the user, and may be rotated to align with the base so as to easily remove the device from the patient; and 
         [0038]    (3) a base component designed to conform to the skin at varying locations (e.g., on flat, curved, indented or otherwise irregular surfaces), which may include adhesive, may serve as part of a sterile and/or antimicrobial dressing, may be easily replaceable, is easily removable from the skin (e.g., at the end of the procedure), has a small footprint, and accommodates the concurrent use of other procedural tools, including but not limited to scalpel, hook or retractor, ultrasound probe. Multiple techniques and/or approaches may be used to accomplish each of the functions. The detailed discussion and figures below describe limited embodiments of the device. 
         [0039]      FIGS. 1-3  show three perspective views of a preferred embodiment 1 of the present invention and a needle  100 . As shown and mentioned above, the device  1  is generally composed of a base  10 , an adjustment mechanism  40 , and a securement mechanism  70 . 
         [0040]    The device  1  features at least one axis of orientation adjustment relative to the identified procedure location on the patient, though the device preferably accommodates multiple axes of adjustment. This is herein accomplished by the adjustment mechanism  40  which articulates relative to base  10 .  FIGS. 4-6  show three perspective views of the preferred embodiment of base  10  and adjustment mechanism  40  of  FIGS. 1-3 , wherein adjustment mechanism  40  is shown in three different positions relative to base  10 . The preferred adjustment mechanism  40  comprises a spherical, universal, or ball joint  30  providing free adjustment in all three rotational axes (roll, pitch, yaw). The joint  30  is preferably formed by providing adjustment mechanism  40  with a partial-spherical shaped body  41  seated within a conforming cavity  11  of base  10 . The adjustment mechanism  40  can be angularly rotated within cavity  11  within a defined range of motion. It should be noted that other methods of adjustment other than a universal joint are possible without changing the scope or spirit of the present invention, including but not limited to at least one single axis pivot joint, any plurality of pivot joints, living hinge formed of gusseted semi-rigid material, or a flexible material. Fixation (setting or holding) of the desired angles is accomplished with a locking device  12 . In the preferred embodiment, locking device  12  is a single, easily accessible thumb screw that is threaded through the base  10  and can be tightened against the spherical body  41  to maintain its orientation angles, though other methods of mechanical locking are obviously possible without changing the scope or spirit of the invention. Some of these include friction locks, clamps, clasps, etc. Note also that the locking device  12  (whether thumb screw or other locking mechanism) can preferably be attached to either side of the base  10  to better accommodate different handedness of the user. In the preferred embodiment with the locking device  12  being a thumb screw, this is accomplished by placing a threaded hole  19  on both sides of the spherical cavity  11  of base component  10 . 
         [0041]    The base  10  of the device  1  is configured to facilitate percutaneous access at acute angles of the access device(s) relative to the patient&#39;s skin (e.g., insertion angle approaching parallel to skin). The acute angles may range from nearly perpendicular as shown in  FIGS. 4 and 6  to nearly parallel as shown in  FIGS. 1-3 and 5 . 
         [0042]    A passageway  43  traverses the spherical shaped body  41  of adjustment mechanism  40 , and exits through a collar  42  that protrudes from the spherical body  41  on one side. The percutaneous access device(s) are inserted through passageway  43  and collar  42 , and so the orientation of the access device is intended to be substantially coaxial to the collar  42  and passageway  43  through adjustment mechanism  40 . 
         [0043]      FIGS. 7-10  show four perspective views of the preferred embodiment of the base  10 , which is preferably an annular member that includes a receptacle  13  for seating the spherical body  41  of adjustment mechanism  40 , and feet  18  for elevating the receptacle  13 . The percutaneous access device(s) are intended to pass freely through base  10  when they are in nearly all angles other than those corresponding to the feet  18 , and if these angles are needed, base  10  can simply be re-positioned. As pictured in  FIGS. 7-10  this is accomplished by making the receptacle  13  a discontinuous annulus, open on one side (at the back) and narrowing a portion of the receptacle  13  on the other side (at the front) so that it defines a notch  14 . Notch  14  provides clearance for the access devices to pass. The under-side of the base  10  preferably defines a partial ring of enlarged diameter that is joined to the receptacle  13 , the under-side of the ring providing angled feet  18  to increase stability and conformity to local skin topography at the procedure site. Note that feet  18  may be somewhat flexible to facilitate conformability. The notch  14  opens to a space  17  between the feet  18 . The under-foot surfaces  15  are also preferably coated with an adhesive layer (e.g., peel-adhesive) to adhere the device to the patient&#39;s skin during the procedure for added stability, but the adhesive is preferably intended to create only a temporary bond and be easily removable, so as not to interfere with the inserted access device(s) when procedural assist device is removed. This bottom surface  15  may also provide and/or be part of a sterile and/or antimicrobial dressing at the procedure site and may be easily replaceable or exchangeable. Similarly, the base  10  and adjustment mechanism  40  are preferably configured to enable easy removal of the device  1  from the procedure site following completion of the procedure without interfering with the inserted access device(s). It can he seen in  FIGS. 4-5  that the base  10  and adjustment mechanism  40  can be rotated to align their respective openings  16  and  44 , so that the device  1  can be freely and unimpededly extricated from an access device passing therethrough. That is, neither the base  10  nor adjustment mechanism  40  form a complete circle or ring in at least one plane. Such an opening on the back side  17  of the base component  10  also allows use of other tools, such as a scalpel. These openings  16  and  17  in base  10  effectively form two feet  18   a,    18   b  as seen in  FIG. 7 , the under-side of which contain surfaces  15 . Note that securement of the access device(s) within the procedural assist device  1  is accomplished by the securement mechanism  70 , as is described below. 
         [0044]    The adjustment mechanism  40  of the procedural assist device  1  is additionally fitted with securement mechanism  70  for holding the access device(s) in place relative to the base  10  and adjustment mechanism  40 , as was shown in  FIG. 1 .  FIG. 11 (A-C collectively) shows the two primary securement components which are a shell  71  and detent plug  72 , alone in three different positions: (A) fully open, (B) partially open, and (C) fully closed. These two components, shell  71  and detent plug  72 , function essentially like a cord lock, where the detent plug  72  is pre-biased against the shell  71  to clamp access device(s) in jaws, but the plug  72  can be finger-pressed to open the jaws to remove the access devices. A spring (not pictured, but housed within shell  71 ) keeps an upward (relative to the figure orientation) force on detent plug  72  at all times such that the neutral position for this assembly is the fully closed position (C). The jaws are defined by conforming open C-shaped notches  74 ,  75  in both the detent plug  72  and shell  71 . Small tabs  73  extend outward from the bottom of the C-shape  74  of the plug  72  to prevent the spring from pushing it completely out of the shell  71 . It is this continual upward force that provides the securing function of the securement mechanism  70  about the access devices. If the top of the plug  72  (e.g., the button) is depressed any intermediate amount (anything less than all the way down), it will move back upward and hold the access device(s) when let go. Note that the spring stiffness is selected such that the reaction force does not crush, kink, or otherwise damage the access devices, and the partially open adjustability enables passage and securement of access devices of different diameters. That is, the size of the C-shaped jaws  74 ,  75  in the plug  72  and shell  71 , respectively, can be chosen to allow passage of the largest access device. When the plug  72  is depressed completely, it will lock open. This is effectively a second neutral position. Then from this fully open position (A), when the plug is depressed that small amount farther and released, the plug  72  will return to the fully closed (C) or partially closed (B), yet securing an access device position. While three positions of these components are shown, there are essentially only two functional states: fully open, where the user need not maintain involvement with the procedural assist device  1  and access devices can freely pass through the aligned jaw openings ( 75 ,  74 ) and the passageway  43  through spherical body  41 , and engaged (fully/partially closed), where the user need not maintain involvement with the procedural assist device  1  and access devices passing therethrough are securely held in place by interference from shell  71  and plug  72 . It should be noted that other such methods of securement devices are included within the scope and spirit of the present invention, including but not limited to clothespin-like spring-loaded jaws and wire-winding/wrapping devices. 
         [0045]      FIGS. 12A and 12B  show two side cross-sectional views of the securement mechanism  70  to facilitate explanation of the fully open locking capability, in fully closed and fully open positions, respectively. As can be seen, opposing inner side faces of the shell  71  feature an inverted heart-like shaped track  76 , through which pegs  77  on the plug  72  travel. These pegs  77  are more readily visible in  FIGS. 13-14 . 
         [0046]      FIGS. 13 and 14  show front and rear perspective views of the isolated plug  72 . When the plug  72  starts from the fully closed position and is pressed downward, the pegs  77  extending laterally from legs  78  follow the left side ( FIGS. 12A and 12B ) of the track  76  to the bottom, which moves the peg slightly to the right. When the plug  72  is released from here, the peg  77  moves upward slightly and to the right slightly along the track  76 , locking the plug  72  in the fully open position. When the plug  72  is depressed from the fully open position, the peg  77  moves slightly down and slightly to the right again before following the right side of the track  76  back up to the starting position. Note that in the preferred embodiment, the pegs  77  are biased toward the right side of the plug  72 , so when they start down the left side of the track, bending stiffness in their legs  78  will provide a continual rightward force to assist with the pegs  77  following the track  76  correctly until reaching their neutral (straight down) position, after which (toward the right), the track  76  is designed to guide the pegs  77  to their starting position. Note that the plug  72  component also has a spring centering feature  79  between the two peg legs  78 . 
         [0047]    Note that the back side of the plug  72  component also contains a slot-following feature  80 , here being of a dovetail tongue-in-groove design, though this is not meant to be limiting. In a standard cord lock device, the shell component and plug component both make complete circles for other complete constraining shapes) such that the object passing therethrough can only pass through in that direction, e.g. O-shaped. The similar components of the present invention feature C-shaped jaws  74  and  75 , as described, with the specific purpose of allowing the objects passing there through to exit the side unimpeded. This being the case, there is a tendency for the bottom of the C-shaped jaw  74  of plug  72  to protrude from the  75  of shell  71 . To prevent this occurrence, the back side of the plug  72  has a guide feature  80  that interfaces with a companion guide feature  81  on the same side of the shell  71  to constrain the plug  72  motion to remain only up and down within the shell  71 . 
         [0048]      FIGS. 15 and 16  show front and rear perspective views of the isolated shell  71  with an optional door feature  82 . To prevent the access devices from exiting the procedural assist device  1  through these C-shaped jaw openings  74  and  75 , the shell  71  may be provided with a feature  82  that acts effectively as a door (e.g., transitioning between C-shape and D-shape) that remains closed until the user opens it at the time when ready to remove the procedural assist device  1  from the inserted access device. One embodiment of this door feature is visible in  FIG. 1 , but was removed from the subsequent figures for clarity. It is shown again more closely in  FIGS. 15-16 , where it can be seen that the door  82  preferably has a material or living hinge  83  on the top, connecting it to the shell  71 , and a hole on the bottom, through which the locking tab  85  on the shell  71  holds it in place. Though a hinge design is shown here, an alternate embodiment may use a similar sliding dovetail design as on the back of the plug  80 , where the door  82  is slid downward to open the side of the C-shaped jaw  75 . Other hinged type connections are also possible within the scope and spirit of the invention. 
         [0049]    In the preferred embodiment, the adjustment mechanism  40  can be rotated a certain way to fit in the opening  16  of base  10  for assembly. As pictured in  FIG. 6 , the upper collar  42  extending from the adjustment mechanism  40  is fitted with a lip  45  that interfaces with a matching slot  86  of shell  71  (see  FIGS. 12A-12B ) to facilitate assembly. Other attachment or assembly methods may likewise be employed without changing the invention, including but not limited to bonding, threading, and clamping. 
         [0050]      FIGS. 17 and 18  are a bottom and side view, respectively, of the procedural assist device  1  of the present invention housed around the huh of a needle  101 . The procedural assist device  1  of the present invention is of minimal height, where the assembled device components have an axial length that is similar to the hub  101  of a needle  100  ( FIG. 17 ). Note that a needle  100  is the first access device used in many percutaneous procedures, such as those that employ the Seldinger technique. As such, the passage way diameter of the procedural assist device  1  components is large enough to allow the needle hub  101  to pass there through. Further, the percutaneous procedure may be maximally facilitated with the present device by beginning the procedure with the device  1  positioned around the needle hub  101 , where it can then be passed downward onto the patient at the correct location and orientation and secured in place with the features described above. The overall footprint of the device  1  is also small to enable concurrent use of other procedural tools, including but not limited to scalpels and ultrasound probes. 
         [0051]    Having now fully set forth the preferred embodiment and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concept. It is to be understood, therefore, that the invention may be practiced otherwise than as specifically set forth in the appended claims.