Abstract:
An ultrasound probe system for guiding introduction of an instrument into a patient includes a disk having a surface and an open channel passing axially through the disk and at least two ultrasound transducer elements disposed on the surface of the disk in a parallel arrangement. The open channel is configured to receive the instrument therethrough to permit alignment of the instrument with respect to the disk. Each of the ultrasound transducer elements is configured to transmit and receive ultrasonic waves for detecting an anatomical structure. A graphical representation of at least a portion of the anatomical structure can be provided for guiding the introduction or insertion of the instrument into the anatomical structure.

Description:
[0001]    This application claims priority under 35 U.S.C. §119 to U.S. Provisional Application No. 61/782,941, which was filed on Mar. 14, 2013, and is herein incorporated by reference in its entirety. 
     
    
     BACKGROUND 
       [0002]    Percutaneous introduction of the needles and catheters into the deep vessels (jugular, subclavian, femoral and other) requires detailed knowledge of the anatomy of the region and specialized training. 
         [0003]    The insertion can be associated with numerous potential complications including: bleeding, lacerations of the neighboring arteries or veins, injury to the nerves, pneumothorax and death. 
         [0004]    Recently, use of ultrasound for guiding the insertion has improved the safety of those procedures. However, presently available ultrasonic transducers and ultrasonic systems require triangulation of the needle insertion in relation to the ultrasonic image. Further, the quality of the image presented to the user during such procedure is poor (grainy and with poor resolution). Thus, additional ultrasonic image interpretation training is necessary for any user attempting to perform ultrasound guided insertion of the needle. 
       SUMMARY 
       [0005]    Various embodiments are directed to a disk-shaped probe having an ultrasonic transducer and a central channel or opening within the disk to accommodate a needle (including, for example, a penetration sensor-equipped needle) or other instrument, such as a catheter. The probe may be used for guided introduction or insertion of the instrument, via the central channel, into a vessel or other anatomical structure of a patient. Some embodiments provide a computer-enhanced graphic image of the vessels and other structures in the area covered by ultrasonic probe. The image may be used, for example, by a user for manually positioning and orienting the instrument, using the probe, with respect to the target structure so that the tip of the instrument can be introduced or inserted into the desired area. 
         [0006]    The size and location of the structures in the image can change as the user moves the probe around the area to determine the optimum needle insertion point and/or angle. Additionally, in some embodiments, a crosshair, or other suitable symbol, can be located in the center of the image indicating exact point of the penetration of the vessel or other structure when the needle is inserted through the channel in the center of the transducer. In some embodiments, data from the sensor-equipped needle can be transmitted during insertion of the needle and incorporated into the image on the screen, which gives a user indication that the tip of the needle has reached the lumen of the vessel. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings: 
           [0008]      FIG. 1  is a perspective view of an example of an ultrasonic transducer, in accordance with an embodiment. 
           [0009]      FIG. 2A  is a perspective view of the ultrasonic transducer of  FIG. 1 . 
           [0010]      FIG. 2B  depicts one example of a graphical image representing a structure detected by the ultrasonic transducer of  FIG. 1 , in accordance with an embodiment. 
           [0011]      FIG. 3A  is a perspective view of the ultrasonic transducer of  FIG. 1 . 
           [0012]      FIG. 3B  depicts another example of a graphical image representing a structure detected by the ultrasonic transducer of  FIG. 1 , in accordance with an embodiment. 
           [0013]      FIG. 4A  is a perspective view of the ultrasonic transducer of  FIG. 1 . 
           [0014]      FIG. 4B  depicts yet another example of a graphical image representing a structure detected by the ultrasonic transducer of  FIG. 1 , in accordance with an embodiment. 
           [0015]      FIGS. 5, 6 and 7  are different perspective views of an example of an ultrasonic transducer, in accordance with an embodiment. 
       
    
    
     DETAILED DESCRIPTION 
       [0016]      FIG. 1  depicts an example of a needle-accommodating ultrasonic probe, or transducer  100 , according to an embodiment. It will be appreciated that, according to various embodiments, various instruments, such as needles, catheters and the like, can be utilized, and the present disclosure is not intended to limit such instruments to needles. The transducer  100  may include, for example, a flat disk approximately 2 cm to 5 cm thick connected by the lateral power/data cord  102  to an external ultrasound unit  104 . The thickness of the disk can be varied to accommodate various needles or other instruments such that the needle or instrument is stably aligned when inserted through the disk for guiding the introduction of the needle or instrument into an anatomical structure of a patient, such as described below. 
         [0017]    The disk/transducer  100  can contain two or more linear arrays  106  of crystal (also referred to herein as transducer elements) that emit and then receive ultrasonic sound waves. For example, the ultrasonic transducer  100  may include a disk that contains two or three linear arrays  106  that are parallel to each other and located approximately 1 cm apart. The disk/transducer  100  includes an opening  108  or channel passing through the disk for accommodating the passage of a needle or other instrument, and a sterile channel, sleeve, sheet or other material (not shown in  FIG. 1 ) for separating the transducer disk  100  from the instrument and for providing a sterile environment for the portion of the instrument passing through the opening  108 . The opening  108  may, for example, be oriented substantially perpendicular to a surface  112  of the disk/transducer  100 . In some embodiments, the disk  100  includes a split  110  forming two portions or halves that can be separated from each other. The split  110  may pass through or adjacent to the opening  108 , as shown, for example, in  FIG. 5 . 
         [0018]      FIG. 2A  depicts another view of the transducer  100 , and  FIG. 2B  depicts an example of a graphical image  200  generated from signals received by the transducer. The arrays  106  can be configured to fire sequentially such that each array  106  transmits and receives ultrasonic signals independently of and without interference by the other arrays. The ultrasound image can be rendered as two or three images  202 ,  204 ,  206  of the area underneath the transducer  100 . Each image  202 ,  204 ,  206  may, for example, include a graphical representation of at least a portion of the vessel or other structure detected by the corresponding array  106 . The graphical representation may be, for example, an artificial or simplified representation of the actual vessel  120  or other structure being imaged (e.g., not a literal representation of the actual vessel). 
         [0019]    The images  202 ,  204 ,  206  can be summarized (e.g., in an overlay or additive manner) on a display  208  and presented in the form of graphic image of the target area (e.g., the vessel  120  or other structure) by a processor. If the arrays  106  are aligned at approximately 90 degrees to the longitudinal axis  122  of the vessel  120 , the images  202 ,  204 ,  206  will be almost identical. The images  202 ,  204 ,  206  can then be graphically summarized on the screen  208  showing a segment of the vessel  120  user is trying to access and a cross-hair  210  or other marker indicating an executable needle insertion site. The cross-hair  210  may, for example, indicate the point of penetration of the needle or instrument into the vessel or other structure if the needle is inserted through the opening  108 . If the transducer  100  is not aligned at 90 degrees to the longitudinal axis of the vessel, the graphic summary will not be displayed and there will be no executable needle insertion site, such as shown in  FIGS. 3A and 3B  (zero degrees), and  FIGS. 4A and 4B  (between zero and 90 degrees), where the disk/transducer  100  is oriented at an angle other than 90 degrees. In use, manual manipulation of the transducer  100  for adjusting the position and angle can ultimately align longitudinal axis of the vessel at 90 degrees to the transducer and that will create executable needle insertion site. 
         [0020]    In some embodiments, the disk/transducer  100  can be constructed to orient the needle at substantially perpendicular to (e.g., approximately 90 degrees) or at an angle other than 90 degrees (e.g., any angle between zero and 90 degrees) with respect to the longitudinal axis of the vessel  120  or other structure. For instance, the opening  108  may be formed at an angle other than 90 degrees with respect to the surface  112  of the disk/transducer  100 . 
         [0021]      FIGS. 5, 6 and 7  are perspective views of various examples of the transducer  100 . In some embodiments, the disk/transducer  100  has open channel  108  at the center able to accommodate sterile sheet or sterile tube  130  to allow insertion of a needle  140  or catheter in the sterile fashion. The channel  108  is at 90 degrees to the surface plane  112  of the disk/transducer  100 . The disk/transducer  100  can, in some embodiments, be divided into hinged halves, or other suitable portions of the circle allowing opening of the disk/transducer  100  to allow insertion of the sterile sheet or tube  130  into the center opening  108  of the disk/transducer  100 , after such insertion the disk/transducer  100  can be closed and ready to use. Such splitting of the disk/transducer  100  advantageously facilitates ease of access to the center opening  108  for inserting or removing the sterile tube  130  and for removing the disk/transducer  100  from the needle  140  after the needle has been inserted into the patient. 
         [0022]    In use, a user can take the disk/transducer  100  and place it at the surgically prepped desired region of the patient for the particular vascular or other access. Sterile ultrasonic coupling gel may be used between the disk/transducer  100  and the skin of the patient. The user can scan the area under the transducer  100  by manipulating the position, location and the angle of the disk/transducer  100  pressed against the skin. The image on the monitor can display the underlying structures with the cross-hair symbol  210  hovering in the center of the image if the disk/transducer  100  is properly aligned with the underlying vessel  120  or structure. Once the suitable insertion point is identified, the user can insert the needle  140  through the sterile channel  130  in the center of the disk/transducer  100  and advance it until the lumen of the vessel  120  or other desired structure is reached. The reaching can be confirmed by a sensor signal in the needle  140 , or by the withdrawal of blood or fluid through the needle. Once the insertion is confirmed, the disk/transducer  100  can be opened (i.e., the split portions separated from each other), decoupled from the needle  140  and removed from the field. 
         [0023]    Having thus described several exemplary embodiments of the disclosure, it is to be appreciated various alterations, modifications, and improvements will readily occur to those skilled in the art. For example, a computer-enhanced image of the target vessel, organ or other structure, such as the image in display  200  described above with respect to  FIGS. 2B, 3B and 4B , can simplify insertion decision making process for the user and reduce the amount of additional training required to perform the procedure. Two- or three-dimensional color or black and white graphic representations of the structures in the region can, in some embodiments, replace conventional black and white grainy ultrasonic images. In some embodiments, gender and weight specific databases of the structures for the particular region (e.g., femoral triangle, neck, subclavian region) can be pre-loaded to a memory of a logic unit or processor. After the user keys in the insertion region and inputs patient gender and weight, stored data can be preloaded as a base matrix. Real-time ultrasound generated data can be then incorporated into the matrix and imaged into the graphic on the screen. 
         [0024]    Accordingly, the foregoing description and drawings are by way of example only.