Abstract:
An ultrasound transducer cover ( 100 ) includes a base ( 202 ), including an acoustically transmissive membrane ( 110 ) with first and second opposing sides. The cover further includes walls ( 204, 206 ) protruding from the base in a same direction away from the first side of the base, forming a cavity about the acoustically transmissive membrane with a geometry that conforms to a geometry of a probe head of an ultrasound apparatus housing a transducer array and a corresponding acoustic window. The cover further includes an acoustically transmissive adhesive ( 108 ) disposed on the membrane in the cavity, wherein the acoustically transmissive adhesive maintains the cover on the ultrasound apparatus in response to installing the cover on the ultrasound apparatus.

Description:
TECHNICAL FIELD 
       [0001]    The following generally relates to ultrasound imaging and more particularly to a medical ultrasound transducer array cover. 
       BACKGROUND 
       [0002]    Ultrasound scanners provide useful information about the interior characteristics of an object under examination. In medical applications, clinicians have used ultrasound scanners to examine human subjects in settings such as hospitals, physician&#39;s offices, and other locations. Ultrasound scanners have been used in the emergency room, operating room, radiology department, patient room, and/or other environments. In use, an acoustic coupling agent, typically a lubricious gel largely composed of water and propylene glycol, is placed on the acoustic window/lens of the ultrasound transducer array and/or an area of the patient in connection with the region of interest to be scanned. The user then positions the transducer array with respect to the area of the patient. The gel between the acoustic window and the area provides an acoustic medium that facilitates transferring ultrasound signals there between. The ultrasound scanner can then be used to scan the region of interest. 
         [0003]    In some environments (e.g., sterile environments), transducer covers are used. Transducer covers conventionally have included a rubber or thin plastic bag or sheath that physically surrounds and encloses the entire or a sub-portion of the probe. When a cover is used an acoustic coupling agent is required both between the transducer and cover and between the cover and the patient. Such covers are supplied sterilized in sterile packaging (e.g., U.S. Pat. No. 3,754,700) and may come prefilled with a coupling gel and/or other coupling agent. Other covers are not pre-filled, and the user adds gel into the bag prior installing on the transducer. The user also applies the gel on the outside of the cover and/or on the area of the patient. Other covers have included cup-shaped covers that snap on the probe (e.g., U.S. Pat. No. 6,132,378) and self-adhesive thin pliable film dressings that are wrapped around and adhere to the probe (e.g., U.S. 2006/0264751 A1). Unfortunately, such covers can be cumbersome to install and use. 
         [0004]    Procedures such as biopsies, peripheral intravenous insertions (PIVs), and/or other procedures which involve use of a needle entail employing a separate needle guide apparatus with the probe or a needle guide accessory that attaches to the probe. Generally, such needle guides have been configured to constrain a needle in a fixed path (plane and/or insertion angle), for example, that is in the middle of elevation of the acoustic beam (traditional single plane transducer) represented by a guide line on the ultrasound system. A typical needle guide has two main components: a reusable bracket that snaps on the probe and is placed under the cover (where a cover is used), and a disposable guide that attaches from outside the cover. Unfortunately, such assembly may not be easy to install and may require more than one person to maintain sterility during cover and/or needle guide installation in a sterile environment, and may be too restrictive for PIV. Furthermore, for certain procedures such as peripheral intravenous insertions, the size of the sterile field is limited to a small area directly around the insertion site and a cover that encloses the entire transducer may provide more coverage than is required. Moreover, traditional ultrasound gel is not well-suited for ultrasound guided peripheral intravenous insertions, for example, because of post needle insertion cleanup in preparation for application of dressings over the catheter. 
       SUMMARY 
       [0005]    Aspects of the application address the above matters, and others. 
         [0006]    In one aspect, an ultrasound transducer cover includes a base, including an acoustically transmissive membrane with first and second opposing sides. The cover further includes walls protruding from the base in a same direction away from the first side of the base, forming a cavity about the acoustically transmissive membrane with a geometry that conforms to a geometry of a probe head an ultrasound apparatus housing a transducer array and a corresponding acoustic window. The cover further includes an acoustically transmissive adhesive disposed on the base in the cavity. The acoustically transmissive adhesive maintains the cover on the ultrasound apparatus in response to installing the cover on the ultrasound apparatus. 
         [0007]    In another aspect, a method includes obtaining an ultrasound transducer cover. The cover includes a base with an acoustically transmissive membrane with first and second opposing sides. The cover further includes walls protruding from the base in a same direction away from the first side of the base, forming a cavity about the acoustically transmissive membrane with a geometry that conforms to a geometry of a probe head an ultrasound apparatus housing a transducer array and a corresponding acoustic window. The cover further includes an acoustically transmissive adhesive disposed on the base in the cavity. The cover further includes an adhesive liner removeably affixed to the acoustically transmissive adhesive. The method further includes removing the adhesive liner from the acoustically transmissive adhesive. The method further includes installing the cover on the probe head by physically contacting the acoustically transmissive adhesive with the acoustically transmissive window of the ultrasound apparatus. The acoustically transmissive adhesive maintains the cover on the ultrasound apparatus in response to installing the cover on the ultrasound apparatus. 
         [0008]    In another aspect, a method includes obtaining an ultrasound transducer cover. The cover includes a base with an acoustically transmissive membrane with first and second opposing sides. The cover further includes walls protruding from the base in a same direction away from the first side of the base, forming a cavity about the acoustically transmissive membrane with a geometry that conforms to a geometry of a probe head an ultrasound apparatus housing a transducer array and a corresponding acoustic window. The cover further includes an acoustically transmissive adhesive disposed on the base in the cavity. The method further includes installing a removable adhesive liner to cover the acoustically transmissive adhesive. The method further includes packaging the cover with the liner in a container. 
         [0009]    Those skilled in the art will recognize still other aspects of the present application upon reading and understanding the attached description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The application is illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which: 
           [0011]      FIG. 1  schematically illustrates an example cover for an ultrasound apparatus; 
           [0012]      FIGS. 2 and 3  illustrate an example cover for a hand held single enclosure ultrasound scanner; 
           [0013]      FIGS. 4 and 5  illustrate an example needle guide of the cover; 
           [0014]      FIG. 6  illustrates an example in which the cover includes an acoustically transmissive adhesive with a removable liner; 
           [0015]      FIGS. 7 and 8  illustrate a variation of the cover of  FIGS. 2 and 3  in which the cover includes a strap for holding the transducer in place on a patient; 
           [0016]      FIGS. 9 and 10  illustrate an example cover for a probe configured to be connected to an ultrasound scanner console via a cable; 
           [0017]      FIG. 11  illustrates an example method for the cover; and 
           [0018]      FIG. 12  illustrates an optional integrated gel dispense and an optional liner for covering the outside of the acoustically transmissive membrane. 
       
    
    
     DETAILED DESCRIPTION 
       [0019]      FIG. 1  schematically illustrates an ultrasound apparatus cover  100  in connection with an ultrasound apparatus  102 . In this example, the ultrasound apparatus  102  includes at least a transducer array  104  and an acoustic window/lens  106  located at a region of the ultrasound apparatus  102  configured to be placed in contact with an object or structure to scan a portion of the object or structure. As described in greater detail below, the ultrasound apparatus  102  may be part of a single enclosure hand held ultrasound scanner, a transducer probe configured to connect to a separate ultrasound console via a cable or the like, and/or other ultrasound apparatus  102 . 
         [0020]    The ultrasound apparatus cover  100  includes an acoustically transmissive membrane  110  and an acoustically transmissive adhesive  108 , which is affixed thereto. The acoustically transmissive membrane  110  can include a plastic, a rubber and/or other material, including, but not limited to, a water based or an alcohol based liquid or gel, and/or a semi-rigid pad. In one embodiment, the acoustically transmissive membrane  110  provides a barrier that inhibits pathogens from migrating from one side of the membrane to the other side. The acoustically transmissive adhesive  108  is located in connection with a first side  112  of the ultrasound apparatus cover  100 , and the acoustically transmissive membrane  110  is located adjacent thereto and in connection with a second opposing side  114  of the ultrasound apparatus cover  100 , which opposes the first side  112 . The acoustically transmissive adhesive  108  can be any type of adhesive with suitable acoustic coupling characteristics such as alcohol, water, oil, etc. based and/or other acoustically transmissive adhesive in the form of a liquid, a gel, a semi-rigid gel pad, a tape, a rigid material, and/or other form. The acoustically transmissive adhesive  108  and the acoustically transmissive membrane  110  are arranged with respect to each other in the ultrasound apparatus cover  100  such that the acoustically transmissive adhesive  108  and the acoustically transmissive membrane  110  are in mechanical contact and acoustically coupled. 
         [0021]    The ultrasound apparatus cover  100  is generally rigid and pre-formed (e.g., thermo, injection mold, or otherwise formed) so that the first side geometrically conforms to a shape of at least a portion of the ultrasound apparatus  102  that includes the acoustic window/lens  106 , before and after installing the cover  100  on the apparatus  102 . In one instance, this includes configuring at least the shape of the ultrasound apparatus cover  100  so that the acoustically transmissive adhesive  108  and acoustically transmissive membrane  110  are positioned to align with the acoustic window  106  and hence the transducer array  104  when the cover  100  is installed on the apparatus  102 . Suitable cover materials include plastic, cardboard, paper, metal, and/or other materials. In one instance, the material has a thickness in a range of about five thousandth of an inch to about forty thousandths of an inch such as twenty thousandths of an inch. Where the cover material includes a cardboard, paper or the like, the cover  100  can be laminated, coated and/or otherwise protected with a water resistant material. Optionally, the base, walls and acoustically transmissive membrane are monolithic and made of a thermoplastic material. 
         [0022]    The acoustically transmissive adhesive  108 , when placed in physical contact with the ultrasound apparatus  102 , adheres to the acoustic window/lens  106  of the ultrasound apparatus  102 , maintaining installation of the cover  100  with the apparatus  102 . The acoustically transmissive adhesive  108  and the acoustically transmissive membrane  110  are arranged in the ultrasound apparatus cover  100  so that acoustically transmissive membrane  110  aligns with the acoustic window/lens  106  when the cover  100  is installed on the apparatus  102 . In such a configuration, the acoustically transmissive adhesive  108  and the acoustically transmissive membrane  110  provide an acoustic medium between the transducer array  104  and the portion of the object or subject being scanned. In one instance, the acoustically transmissive adhesive  108  can be any suitable adhesive strength that allows the cover  100  to stay in place during use for scanning, but for purposes of disposal of the cover, is reasonably easily to release without damage to the ultrasound apparatus  102  or acoustic window/lens  106 . 
         [0023]    The ultrasound apparatus cover  100  may be disposable, cleanable, disinfectable, re-usable, and/or sterilizeable. Where the ultrasound apparatus cover  100  is disinfected and/or sterilized, the ultrasound apparatus cover  100  may provide a sonographer or other user of the ultrasound apparatus  102  a quick way of rendering the side  106  of the ultrasound apparatus  102  sterile. In this instance, the ultrasound apparatus cover  100  may also be packaged in a sterile package. 
         [0024]    Optionally, the ultrasound apparatus cover  100  includes physical features for various functions such as to guide a needle for needle access procedures such as biopsies or peripheral IV line placements, to secure the ultrasound apparatus  102  in a desired position without human intervention, to apply an acoustic couplant between the cover  100  and the patient for scanning, and/or other physical features. 
         [0025]      FIGS. 2 and 3  illustrate a non-limiting example of the ultrasound apparatus cover  100  where the ultrasound apparatus  102  includes an ultrasound scanner  200  configured as a hand held single enclosure. In  FIG. 2 , the cover  100  is not installed on the ultrasound scanner  200 , and in  FIG. 3  the cover  100  is installed on the ultrasound scanner  200 . 
         [0026]    Initially referring to  FIG. 2 , the cover  100  includes a base  202 , first and second opposing side walls  204 , and a front wall  206 . The walls  204  and  206  protrude from the base  202  in a same direction, thereby forming an open cavity  210  defined by the base  202  and the walls  204  and  206 , with an open side, which opposes the front wall  206 , and an open side, which opposes the base  202 . 
         [0027]    A first portion  212  of the base  202  is located adjacent to the front wall  206  and a second portion  214  of the base  202  extends from the first portion  212  in a direction away from the front wall  206 . The first portion  212  is recessed with respect to the second portion  212  and includes the acoustically transmissive membrane  110 . 
         [0028]    The first portion  212  has a geometrical shape that conforms substantially to a shape of a probe head  216  of the ultrasound scanner  200 , which houses the transducer array  104  and acoustic window  106  ( FIG. 1 ). The second portion  214  has a geometrical shape that conforms substantially to a shape of a handle portion  218  of the ultrasound scanner  200 . In this embodiment, a length of the second portion  214  is less than a length of the handle portion  218 . In other embodiments, the length of the second portion  214  can be larger or smaller, or the second portion  214  can be omitted. 
         [0029]    A removable liner  230  is located in the cavity  210  and is used to cover the acoustically transmissive adhesive  108 . The liner  230  is removed before installing the ultrasound apparatus cover  100  on the ultrasound scanner  200 . In  FIG. 2 , the removable liner  230  is shown extending past the front wall  206  to enable easy grasping by the user. In this embodiment the liner  230  is completely removed from the cover  100 . In other embodiments the liner could be folded to a position where it does not interfere with scanning with the ultrasound scanner  200 . 
         [0030]      FIG. 3  shows the cover  100  from a backside  302  of the base  202 , which faces away from the cavity  210 . As shown in  FIG. 3 , the walls  204  cover side walls  304  of the ultrasound scanner  200 , the front wall  206  covers a front wall  306  of the ultrasound scanner  200 , the first portion  212  of the base  202  rests against the probe head  216 , the second portion  214  of the base  202  rests against the handle portion  218 , and the acoustically transmissive membrane  110  adheres to the window portion  106  of the probe head  216  of the ultrasound scanner  200  via the acoustically transmissive adhesive 108 . 
         [0031]    In  FIGS. 2 and 3 , the cover  100  also includes a needle guide  224 , which is located in connection with the walls  204 . For sake of clarity, the needle guide  224  is discussed in connection with  FIGS. 4 and 5 , which respectively show a block diagram representation of the ultrasound apparatus cover  100  looking into the front wall  206  ( FIG. 4 ) and looking into one of the side walls  204  ( FIG. 5 ). 
         [0032]    In  FIGS. 4 and 5 , the needle guide  224  includes a channel  402  which is configured to guide (e.g., provide a centerline), but not constrain, a needle  404  along a path for freehand or other insertion. The channel  402  is configured so that a tip region  406  of the needle  404  can be readily positioned in an imaging region  408  of the transducer array  104  between the transducer array  104  and a region  410  of a subject  412  where the needle is inserted. With a conventional single plane transducer, this may include guiding the needle  404  in the middle of elevation of the imaging region  408 . 
         [0033]      FIG. 4  shows a configuration with two needle guides  224 , one on each of the two side walls  204 . Other embodiments may include no, one, or more than two needle guides  224 . In yet another embodiment, a needle guide  224  is additionally or alternatively located with respect to the front wall  206  and/or other location. Note that the size, shape and relative position of the components in  FIGS. 4 and 5  are for explanatory purposes and are not limiting. 
         [0034]    With continuing reference to  FIGS. 2 and 3  and with reference to  FIG. 6 , a block diagram looking into the front wall  206  of the cover  100  and showing the acoustically transmissive adhesive  108  in the first portion  212  is illustrated. In this embodiment, the acoustically transmissive adhesive  108  is a pre-applied liquid or gel acoustic adhesive. In another instance, the acoustically transmissive adhesive  108  is a semi-rigid double-sided adhesive gel pad. In yet another instance, the acoustically transmissive adhesive  108  includes a plurality of sheets material. The liner  230  is shown removeably affixed over the acoustically transmissive adhesive  108  and is removed before installing the cover  100  on the ultrasounds scanner  200 . 
         [0035]    In  FIGS. 2 and 3 , the ultrasound scanner  200  is a hand held ultrasound scanner housed in a single enclosure. As such, the scanner  200  includes, in addition to the transducer array  104 , a transducer array controller (not visible), an image processor (not visible), a display  232 , and a user interface  234 . The transducer array  104  includes a one-dimensional and/or a two-dimensional array of transducer elements arranged in a linear, curved, circular, or other manner, and is configured to acquire data for A-mode, B-mode, C-mode, etc. acquisitions, individually and in combination with color flow, Doppler flow, and/or other information. 
         [0036]    The transducer array controller includes transmit and receive circuitry and a switch that switches between transmit and receive circuitry. Generally, the transmit circuitry controls actuation of the transducer elements, which allows for steering and/or focusing the transmitted beam from predetermined origins along the array and at predetermined angles, and the receive circuitry&#39;s various processes receive echoes and generates and outputs a processed signal. In one non-limiting instance, the receive circuitry delays and sums received echoes, generating a focused signal for a single line through a scanned region of interest. Other suitable processing includes, but is not limited to, spatial compounding, filtering (e.g., FIR, IIR, etc.), and/or other processing. 
         [0037]    The image processor includes one or more processors that convert the signal from the transducer controller to generate data for display, for example, by converting the data to the coordinate system of the display. The display  232  can be used to present the converted data. By way of non-limiting example, in one mode, the display can present a plane of a vessel that is parallel to a bottom or transducer array and that shows the interior of the vessel along the long axis of the vessel, including a portion of the needle  404  within the displayed interior of the vessel, when the needle  404  is inserted into the vessel. 
         [0038]    The user interface  234  includes various input and/or output devices for interacting with the transducer controller, for example, to select a data processing and presentation mode, a data acquisition mode, initiate scanning, etc. The user interface  234  may include various controls such as buttons, knobs, a keypad, a touch screen, etc. The user interface  234  may also include various types of visual (e.g., LCD, LED, etc.) and/or audible feedback. 
         [0039]    Variations and/or other embodiments are contemplated. 
         [0040]      FIG. 12  shows an embodiment in which the ultrasound apparatus cover  100  also includes a support region  1200  where a packet  1202  of acoustic coupling material can be removeably affixed. Various approaches can be used to affix the packet  1202  to the support region  1200 . For example, an adhesive may be applied to the region  1200  and/or the packet  1202 , and this adhesive can be used to affix the packet  1202  to the region  1200 . In another example, the region  1200  may include a pocket in which the packet  1202  can be inserted into. Other approaches are also contemplated herein. In the illustrated embodiment, a removable tab  1204  is torn off and removed prior to the packet  1202  being squeezed to apply an acoustic coupling material to the exterior of acoustic membrane  110 . In another embodiment, the support  1200  and packet  1202  are omitted, and an acoustic couplant such as a hydrogel pad is integrated with the membrane  110 . 
         [0041]    In another embodiment, the removable tab  1204  additionally comprises a removable sterile liner  1204  that covers surfaces that are intended to remain sterile such as the acoustic membrane  110  of the side that contacts the patient. The liner  1204  can be removed before, during or after installing the ultrasound apparatus cover  100  on the ultrasound scanner  200 , but before scanning. In  FIG. 12 , the removable liner  1204  is shown partially folded back and partially removed. The liner  1204  can be completely removed from the cover  100  or folded to a position where it does not interfere with scanning with the ultrasound scanner  200 . In another embodiment this sterile liner  1204  may be a separate feature from the packet  1202  and/or there may be no packet. 
         [0042]      FIGS. 7 and 8  show a variation in which the ultrasound apparatus cover  100  further includes a strap  702 . In this example, the strap  702  is affixed at the front wall  206  of the cover  100 . In other embodiments, the strap  702  can be elsewhere affixed to the cover  100 . The strap  702  can include various materials such as rubber, plastic, leather, etc. The strap  702  can be used for various reasons. For example, in one instance the strap  702  is used to secure the ultrasound scanner  200  in position with respect to the region of the subject or object being scanned. This may include wrapping or tying the strap around a fixture or device in the examination room. In this manner, the user of the ultrasound scanner  200  does not have to hold the ultrasound scanner  200  in position. This allows, for example, the user of the ultrasound scanner  200  to free up his hands, for example, so that the user can use both hands to insert a needle into the subject or object. 
         [0043]      FIGS. 9 and 10  illustrate a non-limiting example in which the ultrasound apparatus  102  is a conventional ultrasound probe  902  that connects to a separate ultrasound console via an electrical cable interface  904 . This cable interface may or may be detachable from the console via an electrical connector. In this instance, the console includes the transducer array controller, the image processor, the display and a user interface. With the illustrated probe  902 , the transducer array  104  is located at an end  906  of the probe head  908 . 
         [0044]    In this embodiment, the second portion  214  of the base  202  extends in the same direction as the walls  204  and  206 , and the open cavity  210  is defined by the first and second portions  214  and  214  of the base  202  and the walls  204  and  206 , with only the open side that opposes the base  202 . Likewise, the cover  100  is rigid and the cavity  210  is pre-formed and geometrically configured based on the geometry of the probe head  908 . Furthermore, the acoustically transmissive adhesive  108  (not visible) is in the cavity  210  next to the acoustically transmissive membrane  110  and adheres to the acoustic window  104  when the cover  100  is installed on the probe  902 , maintaining installation. 
         [0045]    In this embodiment, the cover  100  also includes the packet of acoustic material  1202  affixed thereto which is discussed at least in connection with  FIGS. 2 and 3 . In another instance, the packet  1204  is omitted. Unlike cover  100  in  FIGS. 2 and 3 , the cover  100  in this embodiment does not include the needle guide  224  or the strap  702 . However, in other embodiments, the cover  100  for the probe  902  also includes at least one of needle guide  224  or the strap  702 . Additionally or alternatively, a separate needle guide can be employed with the probe  902 . 
         [0046]    Although two types of ultrasound apparatuses  102  are shown ( FIGS. 2 and 3  and  FIGS. 9 and 10 ), it is to be understood that other types of ultrasound apparatuses  102  are also contemplated herein. In such other instance, the apparatus cover  100  can be configured based on the geometry of the particular ultrasound apparatus  102 , in accordance to the description herein and/or variants thereof. Moreover, in such instances one or more of the features (e.g., needle guide, strap, acoustic couplant dispenser, etc.) described herein can be included. 
         [0047]    It is to be appreciated that the cover  100  can be sterilized and packaged for use in sterile environments and used in such an environment.  FIG. 11  illustrates an example method of this. 
         [0048]    It is to be understood that the following acts are provided for explanatory purposes and are not limiting. As such, one or more of the acts may be omitted, one or more acts may be added, one or more acts may occur in a different order (including simultaneously with another act), etc. 
         [0049]    At  1102 , the cover  100  is sterilized and placed in sterilizeable package, which is sealed and sterilized. This can be achieved by a manufacturer and/or any appropriate sterilization method (e.g., EtO, Gamma Ray, etc.). 
         [0050]    At  1104 , the package is acquired by a health care facility and stored in a location that won&#39;t compromise the sterility of the cover  100 . 
         [0051]    At  1106 , the package is retrieved and opened in a sterile environment. 
         [0052]    At  1108 , the cover  100  is removed from the sterile package. This can be done via authorized personnel wearing sterile clothes, where the cover  100  is handled so as not to breach its sterility. 
         [0053]    At  1110 , the inside adhesive liner  230  is removed. In instances where the cover  100  does not include the liner  230 , this act is omitted. 
         [0054]    At  1112 , the cover  100  is installed on the ultrasound apparatus  102 . As described herein, this includes physically contacting the acoustically transmissive adhesive  108  with the acoustic window  106  of the ultrasound apparatus  102 , where the acoustically transmissive adhesive  108  holds the cover  100  in place. 
         [0055]    At  1114 , the outside acoustically transmissive membrane liner  1204  is removed. In instances where the cover  100  does not include the liner  1204 , this act is omitted. 
         [0056]    At  1116 , the packet  1202  is used to apply a sterile acoustic couplant on the acoustically transmissive membrane  110 . In instances where the cover  100  does not include the packet  1202 , the sterile acoustic couplant can be manually applied from a separate bottle/packet to the acoustically transmissive membrane  110  and/or object or subject. 
         [0057]    At  1118 , the ultrasound apparatus  102  with the cover  100  installed thereon is used to perform an ultrasound procedure. 
         [0058]    At  1120 , subsequent to imaging with the apparatus  102 , the cover  100  is removed from the ultrasound apparatus  102  and discarded or alternatively cleaned, disinfected, sterilized, etc. 
         [0059]    The application has been described with reference to various embodiments. Modifications and alterations will occur to others upon reading the application. It is intended that the invention be construed as including all such modifications and alterations, including insofar as they come within the scope of the appended claims and the equivalents thereof.