Patent Publication Number: US-9427207-B2

Title: Motorized systems and methods for accessing the lumen of a vessel

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 13/080,348, filed on Apr. 5, 2011, and issued as U.S. Pat. No. 8,951,195 on Feb. 10, 2015, which is incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to imaging assisted insertion of access of the lumen of vessels. More particularly, systems and methods discussed herein are related to the placement of a sheath, needle, and/or guidewire in a vessel. 
     BACKGROUND 
     Medical treatment may require the placement of catheters or the like into a person&#39;s body. For example, central venous catheters (also referred to herein as “CVC”) are placed in a large vein for a variety of medical purposes. A series of manually performed steps that have remained largely unchanged to date. First, a hollow introducer needle is manually inserted through the skin and placed in the vein. Second, a guide wire is manually inserted through the hollow of the needle into the lumen of the vein. The guide wire is inserted until a portion of the guide wire extends past the end of the needle. In this position, the distal end of the wire is in the central vein and the proximal end is outside the patient&#39;s body. The introducer needle, which at this point has the guide wire running through its length, is then removed from the patient by pulling the needle out and over the wire. During removal of the needle, the distal end of the guide wire is undisturbed inside the lumen of vein. Third, the hollow CVC is placed over the proximal end of the guide wire, and the CVC advanced along the wire, through the skin, the subcutaneous tissues, and into the vein. At its final position, the catheter will have one end in the vein and the other end outside of the body. The guide wire can now be retrieved by pulling the guide wire through the catheter and out of the body, without disturbing the position of the catheter. The catheter can now be used to access to the central venous circulation. This process relies on the medical practitioner to locate the vein and may require several attempts before the CVC is properly placed. Similarly, other medical procedures may require placement of a sheath, needle, and/or guidewire into the lumen of a vessel. Medical practitioners may encounter similar problems when attempting to place a sheath, needle, and/or guidewire into the lumen of a vessel. 
     More recently, ultrasound has been used to assist in the placement of a CVC in a vein. Ultrasound can used to locate the venous lumen and provide a visual target. The CVC may be placed manually or a robotic device may be used to place the CVC. Even with ultrasound guidance, a medical practitioner may fail to properly place the CVC. Further, current robotic devices are significantly large, cumbersome, and costly and their use in the placement of CVC is impractical. 
     SUMMARY 
     In one implementation, an apparatus for accessing the lumen of a vessel is provided. The apparatus includes a main body and a disposable cartridge. The main body includes a imaging device attachment, wherein the imaging device attachment is utilized to secure an image capturing instrument to the main body; a cartridge carrier coupled to the imaging device attachment, wherein the cartridge carrier is adjustable to achieve a target insertion depth; and a first motor coupled to the cartridge carrier, wherein the first motor adjust the cartridge carrier to achieve the target insertion depth. The disposable cartridge is attached to the cartridge carrier and houses a sheath, needle, or guidewire to be inserted into the vessel to the target insertion depth. 
     In another implementation, a method for accessing the lumen of a vessel is provided. The method includes the steps of attaching an image capturing instrument to an imaging device attachment of a main body, and attaching a disposable cartridge to the main body. The main body includes a imaging device attachment, wherein the imaging device attachment is utilized to secure an image capturing instrument to the main body; a cartridge carrier coupled to the imaging device attachment, wherein the cartridge carrier is adjustable to achieve a target insertion depth; and a depth motor coupled to the cartridge carrier, wherein the depth motor adjust the cartridge carrier to achieve the target insertion depth. The method also includes determining a depth of the vessel with an imaging device, wherein the depth of the vessel is the target insertion depth; adjusting the main body to achieve the target insertion depth; and actuating a controller, wherein the controller causes a sheath, needle, or guidewire in the disposable cartridge to advance a first predetermined distance. 
     In yet another implementation, an apparatus for accessing the lumen of a vessel is provided. The apparatus includes a main body and a disposable cartridge. The main body includes a body providing an image device attachment and a cartridge carrier pivotally attached to the body, wherein the cartridge carrier provides at least one motor. The main body also includes a controller coupled to the motor, wherein actuating the controller inserts a sheath, needle, or guidewire to a target depth. The disposable cartridge includes a sheath slidably coupled to the disposable cartridge, wherein the sheath is advanced and retracted by the motor, and a needle slidably coupled to the disposable cartridge, wherein the needle is advanced and retracted by the motor, and the needle extends to a target insertion depth when fully advanced. The disposable cartridge also includes a guidewire coupled to the disposable cartridge, wherein the guidewire is advanced by the motor. 
     The foregoing has outlined rather broadly various features of the present disclosure in order that the detailed description that follows may be better understood. Additional features and advantages of the disclosure will be described hereinafter, which form the subject of the claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a more complete understanding of the present disclosure, and the advantages thereof, reference is now made to the following descriptions to be taken in conjunction with the accompanying drawings describing specific embodiments of the disclosure, wherein: 
         FIGS. 1A and 1B  are an illustrative implementation of a motorized insertion system; 
         FIGS. 2A and 2B  are illustrative implementations of a main body; 
         FIGS. 3A and 3B  are illustrative implementations of a disposable cartridge; 
         FIG. 4  is an illustrative implementation of a main body with a disposable cartridge attached; 
         FIG. 5  is an illustrative implementation of a main body and imaging device; 
         FIG. 6  is an illustrative implementation of a method for inserting a sheath into a vessel with a motorized sheath insertion device; 
         FIG. 7  is an illustrative implementation of an alignment cube; 
         FIG. 8  is an illustrative implementation of a reusable handheld device placed on top of an alignment cube; 
         FIG. 9  is an illustrative implementation of a image displayed on an imaging device when a reusable handheld device is placed on top of an alignment cube; 
         FIG. 10  is an illustrative implementation of an alignment cartridge; 
         FIGS. 11A and 11B  are illustrative implementations of a second arrangement for an insertion system; 
         FIGS. 12A and 12B  are illustrative implementations of a third arrangement for an insertion system; 
         FIGS. 13A and 13B  are illustrative implementations of a fourth arrangement for an insertion system; 
         FIGS. 14A and 14B  are illustrative implementations of a fifth arrangement for an insertion system; and 
         FIGS. 15A and 15B  are illustrative implementations of a sixth arrangement for an insertion system. 
     
    
    
     DETAILED DESCRIPTION 
     In the following description, certain details are set forth such as specific quantities, concentrations, sizes, etc. so as to provide a thorough understanding of the various embodiments disclosed herein. However, it will be apparent to those of ordinary skill in the art that the present disclosure may be practiced without such specific details. In many cases, details concerning such considerations and the like have been omitted inasmuch as such details are not necessary to obtain a complete understanding of the present disclosure and are within the skills of persons of ordinary skill in the relevant art. 
     Referring to the drawings in general, it will be understood that the illustrations are for the purpose of describing particular embodiments of the disclosure and are not intended to be limiting thereto. While most of the terms used herein will be recognizable to those of ordinary skill in the art, it should be understood that when not explicitly defined, terms should be interpreted as adopting a meaning presently accepted by those of ordinary skill in the art. 
     The systems and methods discussed herein are designed to integrate with a commercially available imaging system (e.g. ultrasound system) to provide a medical practitioner with the capability to accurately and reliably accessing the lumen of a vessel located at a depth of 5 mm to 60 mm below the skin surface. For example, the systems and methods discussed herein may be utilized to place a central venous catheter (CVC). While the implementations discussed herein may discuss usage of the systems and methods for starting a CVC, it will be recognized by one of ordinary skill in the art that the scope of the invention is in no way limited to starting a CVC. For example, in other implementations, the system may be utilized to place needle in a vessel; to place a guidewire via a needle placed in a vessel; or to place a sheath via a guidewire that is placed in a vessel via a needle. The systems and methods discussed herein may be utilized in a variety of medical procedures, including, but not limited to: CVC placement, peripherally inserted central catheters, phlebotomy, dialysis access, cardiac catheterization, amniocentesis, cholecystotomy, thoracentesis, paracentesis, and tracheostomy. The insertion system is portable, reusable, robotic, and easily operated. 
       FIGS. 1A and 1B  are an illustrative implementation of a motorized insertion system  10 . Motorized insertion system  10  may include a main body  15 , disposable cartridge  20 , cover  25 , alignment cube  30 , and alignment cartridge  35 . Motorized insertion system  10  is suitable for use with an imaging device  40  that may include an image capturing instrument  45  and image display  50 . For example, imaging device  40  may be an ultrasound imaging device with a transducer utilized to capture images and a display presenting the captured images. Imaging device  40  is independent and separate from motorized insertion system  10 . Because motorized insertion system  10  is separate from the imaging device, any suitable imaging device may be utilized with motorized insertion system. This may allow a pre-existing imaging device that a medical practitioner may already own to be utilized with motorized insertion system  10 . 
     Main body  15  provides a platform that receives several components that are utilized during the sheath insertion process. For example, disposable cartridge  20 , alignment cube  30 , alignment cartridge  35 , and/or image capturing instrument  45  may be attached or coupled to main body  15  during various steps in the sheath, needle, and/or guidewire insertion process. Main body  15  utilized several motors to move, adjust, and control components of motorized insertion system  10  during the insertion process as discussed herein. 
     Disposable cartridge  20  can be coupled to main body  15  and may include a needle, guidewire, catheter, and other components utilized to place a CVC or the like. Cover  25  is sterile and may be place on main body  15  to prevent contamination or the like. Cover  25  may be placed on or around main body  15  and disposed of after usage. Alignment cube  30  is utilized to properly align image capturing instrument  45  when it is coupled to main body  15 . Alignment cartridge  35  can be coupled to main body  15  and is utilized to perform a check on the alignment of main body  15 . 
       FIGS. 2A and 2B  are illustrative implementations of a main body  15 . For the purposes of illustration and clarity, main body  15  is shown without an imaging device and cover. An imaging device, such as an ultrasound, can be coupled to main body  15 , but it should be noted that the imaging device is not part of main body  15 . This arrangement allows any suitable brand or type of imaging device to be utilized with handheld device  15 . For example, an ultrasound transducer may be secured to main body  15  in preparation for use of the insertion system, and removed when desired. 
     Main body  15  may include an imaging device attachment  105 , cartridge carrier  110 , arc arm  115 , cartridge  120 , attachment points  125 , guidewire motor  130 , angle motor  135 , needle motor  140 , sheath motor  145 , guidewire actuator  150 , needle actuator  155 , and sheath actuator  160 . Imaging device attachment  105  is utilized to secure image capturing instrument  45  of imaging device  40  to main body  15 . For example, an ultrasound transducer may be placed in imaging device attachment  105  and secured to main body  15 . Main body  15  may provide attachment points  125  to hold and support cartridge  120  on cartridge carrier  110 . For example, cartridge  120  may be an alignment cartridge or disposable cartridge. A first end of cartridge carrier  110  is pivotally attached to main body  15  near image device attachment  105 . The opposite end of cartridge carrier  110  is coupled to arc arm  115 . A stop bar  147  is provided by main body  15 . Stop bar  147  is an arc-like bar positioned on main body  15  between imaging device attachment  105  and arc arm  115 . An extension  149  extends from needle actuator  155 . As shown, stop bar  147  is positioned along the pathway of needle actuator  155  so that extension  149  will contact stop bar  147  when the needle actuator  155  is advanced forward. Angle motor  135  on cartridge carrier  110  may be coupled to arc arm  115  as well to adjust the angle of cartridge carrier  110 . For example, angle motor  135  may be coupled to a gear or wheel that rotates to adjust the angle of arc arm  115 . Further, arc arm  115  may include gear teeth that mate with the teeth on the gear or wheel coupled to angle motor  135 . Arc arm  115  may provide depth scale indicating the depth of insertion for a particular angle of cartridge carrier  110 . 
     Guidewire motor  130  is coupled to guidewire actuator  150  on cartridge carrier  110 . When a cartridge  130  with a guidewire is properly attached to cartridge carrier  110 , guidewire motor  130  may actuate guidewire actuator  150  to advance or retract the guidewire. Needle motor  140  is coupled to needle actuator  155  on cartridge carrier  110 . When a cartridge  130  with a needle is properly attached to cartridge carrier  110 , needle motor  140  may actuate needle actuator  155  to advance or retract the needle. Sheath motor  145  is coupled to sheath actuator  160  on cartridge carrier  110 . When a cartridge  130  with a sheath is properly attached to cartridge carrier  110 , sheath motor  145  may actuate needle actuator  160  to advance or retract the sheath. Guidewire motor  130 , angle motor  135 , needle motor  140 , and sheath motor  145  may be coupled to a power source. For example, main body  15  may attach to a power cable that may be plugged into a power outlet or main body  15  may include a rechargeable battery pack. 
     In order to control the operation of guidewire motor  130 , angle motor  135 , needle motor  140 , and sheath motor  145 , main body  15  may provide a plurality of controllers. The controllers may be buttons, switches, joysticks, thumbsticks, a keypad, a combination thereof, or any other suitable controls. For example, each individual motor may be controlled by a separate controller or by a combined controller that allows an operator to advance and/or retract a guidewire, needle, or sheath. Further, a motor may be utilized to adjust the angle of cartridge carrier  110 . Guidewire motor  130  may have a corresponding guidewire controller. Angle motor  135  may have a corresponding angle/depth controller. Needle motor  140  may have a corresponding needle controller. Sheath motor  145  may have a corresponding sheath controller. Guidewire, needle, and sheath controllers may allow an operator to advance or retract the component, whereas angle/depth controller may allow the operator to adjust the angle of cartridge carrier  110  to adjust for a targeted insertion depth. In some implementations, an operator may operate the controller to adjust the angle of cartridge carrier  110  to a desired target depth shown on a depth scale. In other implementations, an operator simply enters a desired target depth into the controller, which causes main body to automatically adjust to the targeted depth. In another implementation, a single motor is utilized to provide the functionality of guidewire motor  130 , angle motor  135 , needle motor  140 , and sheath motor  145 . The single motor may be connected to a gear case that is capable of switching between modes that allow the motor to control the guidewire, needle, sheath, and the angle of cartridge carrier  110 . 
       FIGS. 3A and 3B  are illustrative implementations of a disposable cartridge  20 . Disposable cartridge  20  is sterile to prevent the spread of bacteria, disease, etc. Disposable cartridge  20  is disposed after a single use. However, in other implementations, a cartridge may be subject to a cleaning and disinfection process after each use. Disposable cartridge  20  may include an attachment bracket  205 , attachment slot  210 , needle interface  215 , sheath interface  220 , guidewire interface  225 , guidewire track  230 , guidewire  235 , guidewire wheel  240 , needle hub  245 , sliding truck  250 , sheath hub  255 , and sheath  260 . Attachment bracket  205  and attachment slot  210  are utilized to secured disposable cartridge  20  to cartridge carrier  110 . Needle interface  215  and sheath interface  220  of disposable cartridge  20  mate with needle actuator  155  and sheath actuator  160  of cartridge carrier  110 . This allows needle actuator  155  in cartridge carrier  110  to move a needle in disposable cartridge  20  and sheath actuator  160  in cartridge carrier  110  to move sheath  260  in disposable cartridge  20 . Guidewire interface  225  mates with guidewire actuator  150 , thereby allowing guidewire motor  130  to advance and retract guidewire  235 . 
     Guidewire  235  passes through guidewire track  230  to guidewire wheel  240 , which advances or retracts guidewire  235 . Guidewire  235  passes through the center of needle hub  245  down through the center of sheath  260  and the needle  262 . Needle  262  is positioned in the center of sheath  260  and may slide into and out of sheath  260 . In some implementations, a dilator may be provide in between needle  262  and sheath  260  to minimize or prevent bending of needle  262 . Needle hub  245  is attached to needle interface  215 , sliding truck  250 , and the needle. When needle interface  215  is advanced or retracted by needle motor  140 , it causes the needle, needle interface  215 , and sliding truck  250  to advance or retract as well. Sheath hub  255  is connected to sheath  260  and sheath interface  220 . When sheath motor  140  advances or retracts sheath interface  220 , it causes the sheath hub  255  and sheath  260  to advance or retract as well. Note, sliding truck  250  and sheath hub  255  are not connected. Because sliding truck  250  and sheath hub  255  travel along the same path, advancing sliding truck  250  into sheath hub  255  also causes the sheath hub to advance. However, retracting sliding truck  250  does not cause sheath hub  255  to retract. 
       FIG. 4  is an illustrative implementation of a disposable cartridge  20  placed in main body  15 . Lock bar  265  is designed to secure sheath  260 , needle, and/or associated medical components in a desired position to prevent undesired movement before the lock bar is removed. Lock bar  265  prevents sliding truck  250  and sheath hub  255  from advancing in disposable cartridge  20 . For example, during shipping, before attachment to the reusable handheld device, and/or prior to use it is desirable to prevent a sharp needle and sheath from protruding from disposable cartridge  20 . However, when disposable cartridge  20  is attached to main body  20  that is ready for use, lock bar  265  may be removed to allow sliding truck  250 , sheath hub  255 , and associated medical components to be freely advanced and retracted. Attachment clip  270  secures disposable cartridge  20  to main body  15 . Attachment clip  270  fits into attachment slot  210  on disposable cartridge  20  when properly attached. 
       FIG. 5  is an illustrative implementation of a main body  15  and imaging device  40 . Imaging device  40  may include an image capturing instrument  45  that may be secured in imaging device attachment  105  of main body  15 . Image capturing instrument  45  may send and/or received signals utilized to generate images. Imaging device  40  receives data from image capturing instrument  45  and shows the generated images on display  50 . For example, a commercially available ultrasound imaging device may be utilized and the ultrasound transducer may be secured in imaging device attachment  105  of the main body  15 . Screen overlay  275  is a transparent adhesive film that may include a vertical dashed line in the center and may provide tick marks (not shown) on each side. Screen overlay  275  is designed to fit on and adhere to a display  50  of imaging device  40 . Screen overlay  275  provides an operational reference for use of motorized insertion system  10 . 
     Screen overlay  275  may be a clear, thin, plastic sheet with low tack adhesive that can be affixed to a display  182  of imaging device  40 . Screen overlay  275  may provide a vertical dashed center line. In some implementations, screen overlay  275  may also provide tick marks on each side that provides a visual reference aid to the user. Screen overlay  275  and imaging device  40  allow the medical practitioner to accurately locate a vessel and determine the depth of the vessel. The medical practitioner may then set motorized insertion system  10  to the measured depth by actuating a depth controller that controls angle motor  135 . It should be noted that an image capturing instrument  45  of the imaging device  40  connects to main body  15 , but imaging device  40  is not part of the motorized insertion system  10 . Since medical facilities may already have a suitable imaging device, utilizing an existing imaging device, rather than incorporating the imaging device, reduces cost. This also allows the sheath insertion methods and systems discussed herein to easily be adapted for use with a variety of different types and/or brands of imaging devices. Imaging devices that are suitable for use with the insertion systems discussed herein will preferably be capable of imaging and measuring depths of approximately 5 mm to 60 mm. 
       FIG. 6  is an illustrative implementation of a method for inserting a sheath into a vessel with a motorized insertion system. Many of the steps for the method discussed herein may be performed in a different sequence than shown or may be omitted. The scope of methods for inserting a sheath into a vessel is in no way limited to the particular methods illustrated herein. One of ordinary skill in the art will recognize a variety of potential variations in the sequence and particular steps performed. While the following provides a description of inserting a sheath into a vessel, it will be recognized by one of ordinary skill in the art that the device is suitable for a variety of medical procedures involving the insertion of a sheath, needle, and/or guidewire into the lumen of a vessel. The scope of the claims is in no way limited to inserting a sheath into a vessel, except where expressly stated in the claims. For example, in other implementations, the insertion system may simply be utilized to place a needle in the lumen of a vessel or to place a guidewire in the lumen of a vessel with the aid of a needle. 
     To prepare motorized insertion system  10  for use, the operator may integrate the main body  15  with imaging device  40  in step S 100  by placing image capturing instrument  45  in imaging device attachment  60  and securing it with the thumb screws or the like. In step S 105  the alignment of the main body  15  may be checked using an alignment cartridge. In step S 110  the alignment of the imaging device can be check using an alignment cube. In other implementations of a sheath insertion method, screen overlay  275  may be placed on the display of the imaging device during these alignment checks rather than in step S 125 . Aligning the reusable handheld device and imaging device with an alignment cartridge and cube are discussed in further detail below. Note that the alignment steps S 105  and S 110  are optional steps that are performed for best results. However, in the case that alignment checks have been previously performed in the same day or recently, it may not be necessary to perform the alignment checks. 
     Disposable cartridge  100  can be attached to cartridge carrier  110  of main body  15  in step S 115 . Next, main body  15  can be placed on a desired vessel location to find a target vessel in step S 120 . The display of the imaging device will provide an image of a desired location. In step S 125 , the operator may adjust reusable handheld device so the target vessel is centered on the vertical dotted line of screen overlay  275 . The operator may then utilize the imaging device to determine the target depth of the vessel in step S 130 . The target depth indicates the distance from the top surface (or skin of the patient) to the center of the vessel. When the target depth of the vessel is determined, the operator can actuate an angle/depth controller to modify the insertion depth of the needle to a desired depth in step S 135 . The angle/depth controller may be an actuator or the like that controls the angle of cartridge carrier  110 . Depending on the particular type of actuator being utilized, the operator may actuate the angle/depth controller until the desired depth is reached on a depth scale provided on arc arm  115  or may simply input the desired depth to allow main body  15  to automatically adjust to achieve the desired depth. Once the operator has set the device to achieve the desired depth, the operator may actuate a needle controller to advance the needle into the patient in step S 140 . Note that advancing the needle also causes sheath  260  to advance, but does not cause sheath  260  to enter the patient. 
     Once the needle is fully advanced, the operator may actuate a guidewire controller to advance the guidewire  235  through the needle into the target vessel in step S 145 . Now that guidewire  235  is in the target vessel, the needle actuator can be actuated to retract the needle in step S 150 . Next, the operator may actuate a sheath controller to advanced sheath  260  along guidewire  235  into the patient and target vessel in step S 155 . Finally, in step S 160 , sheath  260  can be removed from main body  15 , thereby completing placement of the sheath in the target vessel. 
     Two alignment tasks may be performed to check the alignment of the insertion system. The first step in the alignment process is performed as part of the preparation procedure to ensure correct positioning of the image capturing instrument in the imaging device attachment. The second step in the alignment check is performed to ensure the mechanical structure and sliders on the reusable handheld device are in correct positions. Both alignment tasks can be performed in a non-sterile or sterile environment. 
       FIG. 7  is an illustrative implementation of an alignment cube  300 . Alignment cube  300  enables the user to perform alignment tasks. Top lid  305  of alignment cube  300  provides a needle insertion port  310 , alignment guides  315 , and image capturing window  320 . Needle insertion port  310  provides an entry point for the needle/stylet to enter alignment cube  300 . Alignment guides  315  receive the imaging device attachment  105  of the reusable handheld device and serve to properly align the reusable handheld device to alignment cube  300 . Image capturing window  320  provides an opening for the image capturing instrument  45  of the imaging device. Image capturing window  320  is directly above the target points of shallow vessel target (X-Axis)  325  and deep vessel target (X-Axis)  327  in alignment cube  300 . 
     The shallow vessel target  325  is positioned at a depth of 30 mm and the deep vessel target  327  is positioned at a depth of 60 mm. The shallow vessel target  325  and deep vessel target  327  are arranged perpendicular to the image capturing window  320  and horizontal to the top lid  305 , defining the x-axis of the alignment cube  300 . Both the shallow vessel target  325  and deep vessel target  327  in the alignment cube  300  includes a premeasured and marked target center point. In particular, the target center points are indicated by wire structures intersecting shallow vessel target  325  and deep vessel target  327 . Target wire (Y Axis)  330  is arranged vertically or along the y-axis in alignment cube  300 . Two target wires (Z-Axis)  335  are arranged perpendicular to the shallow vessel target  325  and deep vessel target  327  along the z-axis in alignment cube  300 . Target wire (Z-Axis)  335  are perpendicular to shallow vessel target  325 , deep vessel target  327  and target wire (Y-Axis)  330 . The shallow vessel target  325  at a depth of 30 mm may include a stylet window  340  that allows the stylet to pass through to the deep target vessel  327 . This stylet window  340  allows the needle/stylet to reach deep vessel target  327  at a depth of 60 mm. Alignment cube  300  may include several viewing windows  345 , or the sides of the cube may be made of a transparent material, to allow a user to view the alignment process of the main body  15 . Alignment cube  300  and the shallow vessel target  325  and deep vessel target  327  can be filled with water by the user to accommodate the imaging signal. 
       FIG. 8  is an illustrative implementation of a main body  15  placed on top of an alignment cube  300 . The first step in the alignment process is to attach the image capturing instrument  45  to the main body  15  and secure it in place with the thumbscrews  350 . Note that image capturing instrument  45  and main body  15  should be cleaned and disinfected prior to the first alignment check. With the image capturing instrument  45  attached, the user can power on the imaging device. After filling the alignment cube with water, the main body may be placed on top of the alignment cube. Image capturing instrument  45  is repositioned in the imaging device attachment  105  to make sure that it is positioned correctly and properly aligned. 
     In order to properly align image capturing instrument  45 , target vessels  325 ,  327  and target wires  330 ,  335  should be properly aligned on the display of the imaging device. Once target vessels  325 ,  327  and target wires  330 ,  335  are properly aligned on the display, screen overlay  275  should be positioned in alignment with target vessels  325 ,  327  and target wires  330 ,  335  displayed on imaging device  40 . For example, screen overlay  275  may be position on display  50  as shown in  FIG. 5 . When image capturing instrument  45  and screen overlay  275  are properly aligned, the vertical dashed centerline of screen overlay  275  corresponds to a plane of the needle and sheath. 
       FIG. 9  is an illustrative implementation of a image displayed on an imaging device when a main body  15  is placed on top of an alignment cube  300 . When image capturing instrument  45  is properly aligned, the image resulting from placing main body  15  on top of an alignment cube  300  should resemble  FIG. 9 . The ultrasound system display should show two circles  360 ,  365  aligned vertically in the center of the screen representing the shallow and deep target vessels  325 ,  327  at 30 mm and 60 mm in alignment cube  300 , respectively. Each of the circles  360 ,  365  will have a bright horizontal line  370  through the center. Vessel targets  325 ,  327  have target wires  335  travelling along the z-axis of alignment cube  300  passing through them. Target wires  335  are represented by horizontal lines  370  passing though the top circle  360  and bottom circle  365 . During the alignment check, the user can rotate the image capturing instrument  45  about the x-axis until horizontal lines  370  in the 30 mm and 60 mm vessel simulation are horizontal. Horizontal tick marks  380  may be provided by screen overlay  375  to help the operator determine a horizontal position. The user may then pitch the image capturing instrument  45  about the z-axis until the circles  360 ,  365  are clear and a small white circle  355  representing target wire  330  appears at the top center of the 30 mm vessel simulation image circle  360 . 
     Holding that position, the user or an assistant can hand tighten thumb screws  350  on the imaging device attachment  105 . Screen overlay  275  should be placed on the screen so that the center line dissects circles  360 , 365  through small white circle  355  at the top center and horizontal lines  370  looks horizontal when compared to the side tick marks. The final check of the alignment process is to use the depth measuring capability of the ultrasound system to measure the depth of the Z-axis vessel simulation wire at 60 mm. This is done by placing a mark  375  on the top of the display and another mark  375  (vertically aligned) on the image of the Z-axis of the 60 mm vessel simulation. Measured distance  385  computed by the imaging device  40  should match the known depth of the wire i.e. 60 mm. Similarly, a check may be performed on the vessel target at 30 mm. 
     The purpose of the second alignment check procedure is to ensure that the mechanical structure and sliders have not moved out of position due to misuse or damage.  FIG. 10  is an illustrative implementation of an alignment cartridge  390 . Alignment cartridge  390  can be used to perform the alignment check procedure. Alignment cartridge  390  has the same interfaces and attachment points as the disposable cartridge, but does not contain any medical components. Similar to the disposable cartridge, attachment tab  391  and locking pin  392  are utilized to attach alignment cartridge  390  to the reusable handheld device. Alignment cartridge  390  provides a stylet slider  394  attached to a stylet  396  that is the same length as the needle in the sterile disposable cartridge. Cartridge base  398  provides an opening that receives stylet slider  394  and allows stylet slider  394  to be advanced and retracted. 
     The user begins the procedure in a non-sterile or sterile environment by placing the image capturing instrument  45  in imaging device attachment  105  and securing it in place with the thumb screws  350 . With image capturing instrument  45  securely in place, the user attaches the alignment cartridge  390  to the main body  15 . After filling the alignment cube  300  with water, the user can follow the previously discussed alignment steps discussed above, if necessary, to align the position of the image capturing instrument if necessary. However, note that a screen overlay is not required to perform the alignment check procedure. 
     When the image capturing alignment or first alignment check is successfully completed, the user can set the main body  15  to a depth of 30 mm and actuate stylet slider  394  on alignment cartridge  390 . When the stylet slider  394  stops advancing, the distal end of stylet  396  should touch the intersection point at 30 mm between z-axis wire  335  and y-axis wire  330 . Visual confirmation of this is made by looking through the viewing windows on the sides of the alignment cube. The user can then repeat this procedure for the intersection point at 60 mm between the z-axis wire  335  and y-axis wire  330 . If visual confirmation indicates that the stylet does not touch the intersection points of the wires at 30 mm or 60 mm, the reusable handheld device is recalibrated and adjusted for proper alignment. 
     An example of a method for inserting a sheath into a vessel is discussed in detail below. In particular, the method discussed utilizes an ultrasound imaging device with motorized insertion system  10 . Initially, first and second alignment checks are performed with alignment cube  300  and alignment cartridge  390  as described previously. With the alignment checks complete, the insertion system is ready for use on the patient. Preparation may include, if necessary, positioning the patient, disinfecting the procedure site, draping the procedure site, administering anesthesia, and the like. The final patient preparation step is the application of sterile ultrasound gel to the procedure site. With patient preparation complete, the user applies the sterile ultrasound gel to the image capturing instrument  45  and attaches the sterile disposable cartridge  20  to main body  15 . With gel correctly applied to the image capturing instrument  45  and sterile disposable cartridge  20  attached, the user positions sterile cover  25  over main body  15  and image capturing instrument  45 . With the cover correctly positioned, the user can place main body  15  on the patient at the procedure site and begin to receive ultrasound images of the patient&#39;s vessel(s) displayed on the display. The ultrasound imaging display, with screen overlay  275 , allows the user to adjust main body  15  until the desired target vessel is centered on the vertical dotted line on screen overlay  275  or the target plane of needle and sheath  260 . The user can use the distance measuring capability of the ultrasound imaging device to measure the depth to the center of the target vessel. Additionally, the user can use the distance measuring capability of the ultrasound imaging device to measure the semi-major axis and semi-minor axis of the vessel image to determine the diameter of the target vessel. The depth of the vessel should be between 5 mm and 60 mm, and the diameter of the vessel should be at least 4 mm in diameter. If the depth or diameter is inappropriate, the user should select a different place along the vessel where the depth and diameter are satisfactory. To set main body  15  to the depth value obtained from the depth measurement, the user actuates a depth controller that causes angle motor  135  to adjust cartridge carrier  110  the targeted depth. With depth setting on the main body  15  achieved, the user may then actuate a needle controller that causes needle motor  140  to advance needle interface  215  in disposable cartridge  20 . This inserts needle into the patient and places the needle in the center of the target vessel. With needle fully advanced into the patient&#39;s vessel, the user can actuate a guidewire controller that causes guidewire motor  130  to actuate guidewire interface  225 , thereby causing guidewire  235  to advance through needle into the patient. The user can evaluate the placement of the guidewire via the ultrasound image display  50 . 
     With guidewire  235  fully advanced into the patient&#39;s vessel, the user can actuate the needle controller to fully retract the needle away from the patient. This will retract the needle completely back into disposable cartridge  20  and out of sheath  260 . The user can then actuate a sheath controller that causes sheath motor  145  to advance sheath interface  220 , thereby advancing sheath  260  along guidewire  235  into the target vessel. 
     With sheath insertion complete, the user can remove sheath  260  from disposable cartridge  20 . While holding sheath  260  and guidewire  235  in place, the user may remove main body  15  from the patient. As main body  15  is moved away from the patient, the proximal end of guidewire  235  slides through the needle and separates from disposable cartridge  20 . Disposable cartridge  20  is then removed from main body  15  and disposed. Image capturing instrument  45  and main body  15  may then be separated from each other, cleaned, disinfected, and stored. 
       FIGS. 11A and 11B  are illustrative implementations of a second arrangement for an insertion system  400 . In insertion system  400 , cartridge  405  is fixed at a predetermine angle. While cartridge  405  is shown independently attached to boom  410 , in other implementations, cartridge  405  may be secured to fixed arm in a similar manner as to the articulating arm  45  shown in  FIG. 4 . Cartridge  405  may be coupled to adjustable boom  410 , which may be adjusted vertically to achieve different target depths. Boom  410  is coupled to transducer arm  415 . Transducer arm  415  may provide a depth scale that indicates the needle depths of the range of heights for boom  410 . Transducer arm  415  provides an attachment for transducer  420 . Needle  425  extends to a fixed predetermined length. 
       FIGS. 12A and 12B  are illustrative implementations of a third arrangement for an insertion system  450 . In insertion system  450 , cartridge  455  has a variable angle in relation to boom  460 . While cartridge  455  is shown independently attached to boom  460 , in other implementations, cartridge  455  may be secured to fixed arm in a similar manner as to the articulating arm  45  shown in  FIG. 4 . In contrast to the previous implementation, boom  460  is a fixed height. Boom  460  is coupled to transducer arm  465 , which provides an attachment for transducer  470 . Needle  475  is a variable length needle. As the angle of cartridge  455  increase, the depth of insertion increases. The angle of cartridge  455  and length of needle  475  are adjusted to achieve a desired target depth. A depth scale (not shown) for insertion system  450  takes into account the angle of cartridge  455 . The depth scale may indicate the depth of needle  475  based on the angle of cartridge  455  and the amount needle  475  has been extended. 
       FIGS. 13A and 13B  are illustrative implementations of a fourth arrangement for an insertion system  500 . In insertion system  500 , cartridge  505  has a variable angle in relation to boom  510 . While cartridge  505  is shown independently attached to boom  510 , in other implementations, cartridge  505  may be secured to fixed arm in a similar manner as to the articulating arm  45  shown in  FIG. 4 . Boom  510  is fixed near the bottom of transducer arm  515 . Transducer arm  515  provides an attachment for transducer  520 . Needle  525  is a variable length needle. As in the previous implementation, the angle of cartridge  505  and length of needle  525  are adjusted to achieve a desired target depth. A depth scale (not shown) for insertion system  500  takes into account the angle of cartridge  505 . The depth scale may indicate the depth of needle  525  based on the angle of cartridge  505  and the amount needle  525  has been extended. 
       FIGS. 14A and 14B  are illustrative implementations of a fifth arrangement for an insertion system  550 . In insertion system  550 , cartridge  555  has a variable angle in relation to boom  560 . While cartridge  555  is shown independently attached to boom  560 , in other implementations, cartridge  555  may be secured to fixed arm in a similar manner as to the articulating arm  45  shown in  FIG. 4 . Boom  560  is fixed near the bottom of transducer arm  565 . Transducer arm  565  provides an attachment for transducer  570 . Needle  575  is a fixed length needle. In contrast to the previous implementations, cartridge  555  has a variable pivot point  580  that can be moved along boom  560 . The angle of cartridge  555  and variable pivot point  580  are adjusted to achieve a desired target depth. A depth scale (not shown) for insertion system  550  takes into account the angle of cartridge  555  and the variable pivot point  580 . 
       FIGS. 15A and 15B  are illustrative implementations of a sixth arrangement for an insertion system  600 . In insertion system  600 , cartridge  605  has a fixed angle in relation to boom  610 . While cartridge  605  is shown independently attached to boom  610 , in other implementations, cartridge  605  may be secured to fixed arm in a similar manner as to the articulating arm  45  shown in  FIG. 4 . Boom  610  is fixed near the bottom of transducer arm  615 . Transducer arm  615  provides an attachment for transducer  620 . Needle  625  is a variable length needle. Cartridge  605  has a variable pivot point  630  that can be moved along boom  610 . The variable pivot point  630  of cartridge  605  and length of needle  625  are adjusted to achieve a desired target depth. A depth scale (not shown) for insertion system  600  takes into account the a variable pivot point  630  and the amount needle  625  has been extended. 
     From the variety of arrangements discussed above, it should be noted that various arrangements may be also be suitable. For example, any suitable combination of a fixed/variable boom elevation, fixed/variable angle cartridge, fixed/variable needle length, and/or fixed/variable pivot point may be utilized. 
     Embodiments described herein are included to demonstrate particular aspects of the present disclosure. It should be appreciated by those of skill in the art that the embodiments described herein merely represent exemplary embodiments of the disclosure. Those of ordinary skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments described and still obtain a like or similar result without departing from the spirit and scope of the present disclosure. From the foregoing description, one of ordinary skill in the art can easily ascertain the essential characteristics of this disclosure, and without departing from the spirit and scope thereof, can make various changes and modifications to adapt the disclosure to various usages and conditions. The embodiments described hereinabove are meant to be illustrative only and should not be taken as limiting of the scope of the disclosure, which is defined in the following claims. 
     From the foregoing description, one of ordinary skill in the art can easily ascertain the essential characteristics of this disclosure, and without departing from the spirit and scope thereof, can make various changes and modifications to adapt the disclosure to various usages and conditions. The embodiments described hereinabove are meant to be illustrative only and should not be taken as limiting of the scope of the disclosure, which is defined in the following claims.