WO2016126257A1 - Ultrasound apparatus cover - Google Patents

Ultrasound apparatus cover Download PDF

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Publication number
WO2016126257A1
WO2016126257A1 PCT/US2015/014716 US2015014716W WO2016126257A1 WO 2016126257 A1 WO2016126257 A1 WO 2016126257A1 US 2015014716 W US2015014716 W US 2015014716W WO 2016126257 A1 WO2016126257 A1 WO 2016126257A1
Authority
WO
WIPO (PCT)
Prior art keywords
ultrasound apparatus
support
sub
cover
acoustically transmissive
Prior art date
Application number
PCT/US2015/014716
Other languages
French (fr)
Inventor
Bradley R. Nelson
Serge Savard
Original Assignee
Sound Technology Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sound Technology Inc. filed Critical Sound Technology Inc.
Priority to PCT/US2015/014716 priority Critical patent/WO2016126257A1/en
Publication of WO2016126257A1 publication Critical patent/WO2016126257A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4209Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • A61B8/4236Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames characterised by adhesive patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4272Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4411Device being modular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4422Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to hygiene or sterilisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/4455Features of the external shape of the probe, e.g. ergonomic aspects

Definitions

  • the following generally relates to ultrasound imaging and more particularly to a cover for an ultrasound apparatus.
  • Ultrasound scanners provide useful information about the interior characteristics of an object under examination.
  • clinicians have used ultrasound scanners to examine human subjects in settings such as hospitals, physician's offices, and other locations.
  • Ultrasound scanners have been used in the emergency room, operating room, radiology department, patient room, and/or other environments.
  • 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 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.
  • 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.
  • 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., US 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.
  • an ultrasound transducer cover for a single enclosure hand held ultrasound apparatus includes an acoustically transmissive membrane, a support affixed to the acoustically transmissive membrane, and an adhesive disposed on the acoustically transmissive membrane.
  • an ultrasound system in another aspect, includes a single enclosure hand held ultrasound apparatus and an acoustically transmissive membrane.
  • the apparatus includes a transducer array and an acoustic window.
  • the cover includes an acoustically transmissive membrane, a support affixed to the acoustically transmissive membrane, and an adhesive disposed on the acoustically transmissive membrane.
  • the ultrasound apparatus cover is affixed to the single enclosure hand held ultrasound apparatus with the acoustically transmissive membrane secured to the acoustic window through the adhesive.
  • a method in another aspect, includes obtaining an ultrasound transducer cover.
  • the cover includes an acoustically transmissive membrane, a support affixed to the acoustically transmissive membrane, and an adhesive disposed on the acoustically transmissive membrane.
  • the method further includes installing the ultrasound transducer cover on a single enclosure hand held ultrasound apparatus, wherein the installation includes adhering the acoustically transmissive membrane of the cover to an acoustic window of the single enclosure hand held ultrasound apparatus through the adhesive disposed on the acoustically transmissive membrane.
  • Figure 1 schematically illustrates an example ultrasound apparatus in connection with an ultrasound apparatus
  • Figure 2A schematically illustrates an example single enclosure elongate hand held ultrasound imaging apparatus from a back side
  • Figure 2B schematically illustrates the example apparatus of Figure 2A from a front side
  • Figure 3A schematically illustrates an example of the ultrasound apparatus cover from a back side
  • Figure 3B schematically illustrates the example cover of Figure 3 A from a front side
  • Figure 4 schematically illustrates the example cover of Figures 3A and 3B with a release liner installed on the front side;
  • Figures 5, 6, 7 and 8 show an example installation of the ultrasound apparatus cover of Figures 3 A and 3B on the ultrasound apparatus of Figures 2A and 2B;
  • Figure 9 illustrates another example of the ultrasound apparatus cover
  • Figures 10, 11 and 12 show example installation of the cover of Figure 9 on the ultrasound apparatus of Figures 2A and 2B ;
  • FIGS 13, 14, 15, 16 and 17 illustrate another example of the ultrasound apparatus cover
  • Figures 18, 19, 20 and 21 show example installation of the cover of Figures 13-17 on the ultrasound apparatus of Figures 2 A and 2B ;
  • Figures 22 and 23 illustrate another example of the ultrasound apparatus cover; and Figures 24, 25, 26 and 27 show example installation of the cover of Figures 22 and
  • Figure 1 schematically illustrates an ultrasound apparatus cover 100 in connection with an ultrasound apparatus 102. Together, the ultrasound apparatus cover 100 and the ultrasound apparatus 102 can be considered an ultrasound system 101. The ultrasound apparatus cover 100 removably affixes to the ultrasound apparatus 102.
  • the ultrasound apparatus 102 includes a transducer array 104 (i.e., an array of one or more transducing elements) and an acoustic window 106.
  • the transducer array 104 is oriented with respect to the acoustic window 106 so that a transducing surface of the transducer array 104 emits and/or receives ultrasound through the acoustic window 106.
  • the ultrasound apparatus 102 can be part of a single enclosure hand held ultrasound scanner, a transducer probe separate from an ultrasound console that connects thereto via a cable, wirelessly, etc., and/or other ultrasound apparatus.
  • the ultrasound apparatus cover 100 includes an acoustically transmissive membrane 110 and an adhesive 114.
  • the acoustically transmissive membrane 110 is generally planar and flexible and configured for installation on the acoustic window 106 and covers a subject or object contact surface of the ultrasound apparatus 102 when installed thereon.
  • the ultrasound apparatus cover 100 further includes at least one support 112.
  • the support 112 in one instance, is a part of the ultrasound apparatus cover 100. In another instance, the support 112 represents a temporary release liner. In this instance, the support 112 facilitates maintaining sterility and/or installing and/or removing the ultrasound apparatus cover 100.
  • the adhesive 114 is on a side of the acoustically transmissive membrane 110 that contacts the ultrasound apparatus 102 and facilitates transmission and reception of ultrasound between the acoustically transmissive membrane 110 and the acoustic window 106.
  • the adhesive 114 is permanently attached to the acoustically transmissive membrane 110 and is removable from the acoustic window 106.
  • the adhesive 114 is deposited on the acoustically transmissive membrane 110, a separate transfer adhesive, a single or two sided tape laminated to the acoustically transmissive membrane 110, etc.
  • the ultrasound apparatus cover 100 is one or more of disposable, cleanable, disinfectable, re -usable, and/or sterilizeable. Where sterilizeable, the ultrasound apparatus cover 100 can be sterilizeable by at least one of a radiation process, a chemical process, and/or other sterilization process. Furthermore, the ultrasound apparatus cover 100 may be sterilized and subsequently placed in a package that maintains sterility, or disposed in a package that allows for sterilization of the ultrasound apparatus cover 100 and maintains the sterility for a predetermined time such as until removed from the package.
  • a geometry (shape, size, etc.) of the ultrasound apparatus cover 100 is custom tailored to the housing of an individual ultrasound apparatus 102 so that at least the acoustic window 106 and a predetermined margin of the housing around the window 106 is covered (e.g., approximately 25 mm to 50 mm past an active sensor of the transducer array 104). As such, the primary patient contact surface(s) plus the predetermined margin of the housing is covered.
  • the ultrasound apparatus cover 100 may also cover a handle and/or other portion of the ultrasound apparatus 102.
  • FIGS 2A and 2B illustrate a non-limiting example in which the ultrasound apparatus 102 is a single enclosure elongate hand held ultrasound scanner 202.
  • the scanner 202 has a longitudinal axis 204 and includes a first end region 206 at one end of the longitudinal axis 204 and a second end region 208 (which opposes the first end region 206) at the opposing end of the longitudinal axis 204.
  • a single enclosure housing 210 supports and/or encloses electrical and mechanical components (e.g., the transducer array 104, etc.) of the scanner 202.
  • the housing 210 includes a plurality of sides, which are referred to herein as a front 212, a back 214, a top 216, a bottom 218, a left 220, and a right 222 for
  • the front and back sides 212 and 214 oppose each other; the top and bottom sides 216 and 218 oppose each other, and the left and right sides 220 and 222 oppose each other.
  • the left and right sides 220 and 222 respectively extend between the top and bottom sides 216 and 218, and the left, right, top and bottom sides 220, 222, 216 and 218 are between front and back sides 212 and 214.
  • Figure 2A illustrates a perspective view showing the back, right and bottom sides 214, 222 and 218.
  • the back 214 includes a display screen 224 configured to visually present ultrasound imaging and/or other data.
  • the display screen 224 is integrated in the back 214, e.g., in a cut out or recess therein, and is part of the back 214 and/or the single housing 210.
  • a control 226 is configured to control at least an ultrasound imaging function of the scanner 202.
  • the control 226 is integrated in the back 214, e.g., in another cut out or recess therein, and is part of the back 214 and/or the housing 210.
  • Figure 2B illustrates a perspective view showing the front, the top and the left sides
  • the front 212 includes the acoustic window 106, which is integrated in the front 212, e.g., in yet another cut out or recess, and is part of the front 212 and/or the housing 210.
  • the second end region 208 represents a handle portion of the scanner 202.
  • Another example of the ultrasound apparatus 102 is described in US 7,699,776 to Walker et al., entitled "Intuitive Ultrasonic Imaging System and Related
  • Figures 3A and 3B illustrate an example of the ultrasound apparatus cover 100.
  • the ultrasound apparatus cover 100 has an elongate shape (e.g., a shape that corresponds to a shape of the ultrasound apparatus 102 of Figures 2A and 2B) and is a flexible with flat surfaces.
  • Figure 3A illustrates a first major side 302
  • Figure 3B illustrates a second major side 304, which opposes the first side 302.
  • the first side 302 faces away from the ultrasound apparatus 102 and the second side 304 contacts at least the acoustic window 106 of the ultrasound apparatus 102.
  • the support 112 has a length 306 corresponding to the longitudinal axis 204, a width 308 corresponding to an axis extending between the sides 220 and 222 and transverse to the axis 204, and a thickness or depth 310.
  • the length 306 and the width 308 correspond to the dimensions of the ultrasound apparatus 102 and, in one instance, at least cover the first end region 206 ( Figure 2B) of the ultrasound apparatus 102 ( Figures 1, 2A and 2B). In another instance, the length 306 at least also covers at least a sub-portion of the second end region 208 ( Figure 2B) and/or the top 216, the bottom 218, the left 220 and/or the right 222.
  • the support 112 includes a material free region 312.
  • a geometry of the material free region 312 corresponds to at least a geometry of the transducer array 104. That is, the material free region 312 is such that at least the transducer array 104 is behind the material free region 312 and not the support 112, when the ultrasound apparatus cover 100 is installed on the ultrasound apparatus 102. In this configuration, the support 112 does not inhibit, block, attenuate, etc. ultrasound emitted and/or received by the transducer array 104.
  • a suitable material for the support 112 includes a polymeric film, a non-woven fabric, a paper or card stock, a coated paper, a synthetic paper, a metal foil and/or other material.
  • a suitable thickness 310 is in a range of approximately 0.1 mm to 0.4 mm thick (e.g., depending on the material stiffness).
  • the acoustically transmissive membrane 110 is affixed to the first side 302 of the support 112 ( Figure 3 A).
  • the support 112 provides structure to the acoustically transmissive membrane 110.
  • the support 112 prevents the acoustically transmissive membrane 110 from bunching up and sticking to itself, yet allowing the acoustically membrane 110 to be formed around the shape of the housing 210.
  • the acoustically transmissive membrane 110 extends over a range 314, which includes an entirety of the material free region 312 and a sub- portion 316 of the support 112 which entirely surrounds the material free region 312.
  • the acoustically transmissive membrane 110 includes a polymeric film such as a polyurethane, a low density polyethylene or the like.
  • the acoustically transmissive membrane 110 includes a translucent tape with non-adhesive side 111 and an adhesive side 113 with the adhesive 114.
  • the non-adhesive side 111 is on the first side 302.
  • the adhesive side 113 with the adhesive 114 is on the second side 304.
  • the adhesive side 113 faces the support 112 and a peripheral region of the adhesive side 113 adheres to the support 112.
  • the portion of the adhesive side 113 over the material free region 312 also includes the adhesive 114.
  • An example of the acoustically transmissive membrane 110 is the single coated polyurethane medical tape, product number 9833, which is a product of 3MTM. Such a tape is approximately 0.05 millimeters (mm) thick with an acrylate adhesive and is optically transparent.
  • An adhesive 318 is affixed to at least two (2) sub-regions 320 and 322 of the second side 304 of the support 112 (Figure 3B).
  • the first sub-region 320 is located adjacent to the material free region 312 and extends to a first end 324 of the support 112.
  • the second sub-region 322 is adjacent to an opposing side of the material free region 312 and extends, but not all the way, to an opposing end 325 of the support 112.
  • the adhesive 318 includes a double-sided tape, such as the double-sided tape, product number 9425, which is a product of 3MTM.
  • a non-adhesive region or third region 327 extends from the second sub-region 322 to the opposing end 325 of the support 112.
  • the third region 327 does not include an adhesive.
  • the third region 327 can be disposed along one or more of the edges of the ultrasound apparatus cover 100.
  • the third region 327 provides a non-sticky tab, which can be used to facilitate installation of the ultrasound apparatus cover 100 on the ultrasound apparatus 102 and/or removal of an installed ultrasound apparatus cover 100 from the ultrasound apparatus 102.
  • the support 112 includes a top middle tab
  • top side tabs 328 which extend from the support 112 but are separated from each other by material free regions or gaps 330.
  • the top side tabs 328 are connected to side portions 332 of the support 112 and move with the side portions 332. That is, folding the side portions 332 causes the top side tabs 328 to fold with the side portions 332.
  • the top side tabs 328 can also fold independently of the side portions 332, e.g., at their connection 334 to the side portions 332.
  • the top middle tab 326 folds independently from the top side tabs 328.
  • Figure 4 shows the ultrasound apparatus cover 100 of Figures 3A and 3B with a release liner 402.
  • the release liner 402 in this example, covers the second side 304 of the support 112, including the material free region 312 with the adhesive 114.
  • the release liner 402 is removably attached to the second side 304 of the support 112 and to the acoustically transmissive membrane 110, and is removeable therefrom, e.g., for installing the ultrasound apparatus cover 100 on the ultrasound apparatus 102.
  • Figures 5, 6, 7 and 8 show an example installation of the ultrasound apparatus cover 100 of Figures 3A and 3B on the ultrasound apparatus 102 of Figures 2A and 2B.
  • the release liner 402 if included, is already removed from the ultrasound apparatus cover 100.
  • the adhesive side 113 of the acoustically transmissive membrane 110 of the support 112 is installed on the acoustic window 106 of the ultrasound apparatus 102 via the adhesive 114, and the second side 304 of the support 112 is installed on a sub- portion of the front side 212 of the second end region 208 of the ultrasound apparatus 102 via the adhesive 318.
  • the acoustically transmissive membrane 110 is also of a material that is optically transparent or translucent and the material free region 312 of support 112 provides a visual alignment guide for proper placement on the acoustic window 106. A user can maneuver the ultrasound apparatus cover 100 into place with the adhesive free end region 327.
  • the side portions 332 are folded towards the ultrasound apparatus 102 and adhered thereto via the adhesive 318 at the region 322.
  • the top middle tab 326 is folded towards the top 216 of ultrasound apparatus 102 and adhered thereto via the adhesive 318 in the region 320.
  • the top side tabs 328 are folded onto the top middle tab 326 and adhered thereto via the adhesive 318 in the region 320.
  • Figure 7 shows a bottom up perspective view looking into the back side 214
  • Figure 8 shows a top down perspective view looking into the top side 216, after installation of the ultrasound apparatus cover 100 on the ultrasound apparatus 102.
  • the shape of transducer housing 210 may include some relatively sharp corners and edges.
  • the gaps 330 allow for independent installation of the tabs 326 and 328, which allows for installation over the acoustic window 106 first, followed by installation of the middle tab 326, followed by installation of the top side tab 328. In one instance, this mitigates bunching and pinching at the corners and results in a neater installed ultrasound apparatus cover 100 in the corners.
  • the ultrasound apparatus cover 100 is shaped generally like a cross where the intersection size and shape generally matches the active transducer surface and the extensions generally match the width of each side.
  • Figure 9 illustrates another example of the ultrasound apparatus cover 100 with a temporary support 112.
  • the support 112 includes first and second sub- supports 902 and 904, which are both removably affixed to the acoustically transmissive membrane 110.
  • the portion of the acoustically transmissive membrane 110 affixed to the first and second sub-supports 902 and 904 include an adhesive.
  • the first sub-support 902 includes a first section 906 removably affixed to a first sub-portion 907 of the acoustically transmissive membrane 110 and a second section 908 that is not affixed to the acoustically transmissive membrane 110.
  • the second section 908 is folded back at a fold 910 in a direction towards the first section 906.
  • the second section 908 is configured to flex or pivot about the fold 910.
  • the second sub-support 904 includes a first section 912 removably affixed to a second sub-portion 914 of the acoustically transmissive membrane 110 and a second section 916 not affixed to the acoustically transmissive membrane 110.
  • the second section 916 in this example, is layered over the second section 908 and a sub-portion of the first section 906. In another example, the second section 916 may be layered only over a sub-portion of the second section 908, the entire second section 908, or the entire second section 908 and the entire first section 906.
  • a shape of the acoustically transmissive membrane 110 in this example is the same shape as the shape of the combination of the shape of the acoustically transmissive membrane 110 and the shape of the support 112 of the embodiment in Figures 3-8.
  • the acoustically transmissive membrane 110 has the length 306, the width 308 and the depth 310, and the tabs 328 and 326 with the gaps 330 therebetween.
  • the shape of the acoustically transmissive membrane 110 can be different from the shape of the combination of the acoustically transmissive membrane 110 and the shape of the support 112 from the embodiment in Figures 3-8.
  • Figures 9, 10, 11 and 12 show example installation of the ultrasound apparatus cover 100 of Figure 9 on the ultrasound apparatus 102 of Figures 2 A and 2B.
  • the second sub-support 904 is removed from the acoustically transmissive membrane 110. This includes initially grasping the second section 916 and pulling it away from the acoustically transmissive membrane 110. Once at least a sub- portion of the first section 912 has been pulled away from the acoustically transmissive membrane 110, the first and/or second sections 912 and 916 can be used to remove the remaining portion of the first section 912 off the acoustically transmissive membrane 110.
  • the exposed adhesive side of the acoustically transmissive membrane 110 is installed on the top 216 of the ultrasound apparatus 102 and adhered via the adhesive 114.
  • the acoustically transmissive membrane 110 is also of a material that is optically transparent or translucent and includes a printed on visual alignment guide 1002.
  • the illustrated guide 1002 includes an outline 1004 of a sub-portion of the ultrasound apparatus 102 including an outline 1006 of the acoustic lens 106.
  • the guide 1002 may include a physical feature such as a protrusion, bump, a recess, texture, and/or other visible and/or tactile feature for aligning the acoustically transmissive membrane 110 and the ultrasound apparatus 102 to install the acoustically transmissive membrane 110 on the ultrasound apparatus 102.
  • the first sub-support 902 is being removed from the acoustically transmissive membrane 110. This includes initially grasping the second section 908 and pulling it away from the acoustically transmissive membrane 110. Concurrently with removing the first sub-support 902, the exposed adhesive side of the acoustically transmissive membrane 110 is installed on the acoustic window 106 and a sub-portion of the front side 212 of the second end region 208 of the ultrasound apparatus 102 via the adhesive 114.
  • An example of the acoustically transmissive membrane 110 installed on the ultrasound imaging apparatus 102 is shown in Figure 12.
  • Figures 13-17 illustrate another example of the ultrasound apparatus cover 100.
  • the support 112 includes a first sub-support 1302 ( Figures 13 and 14) and a second sub-support 1404 ( Figures 14-17).
  • the acoustically transmissive membrane 110 ( Figures 16 and 17) is disposed on the second sub-support 1404 with the adhesive 114 facing away from the second sub-support 1402 and towards the first sub- support 1302.
  • An adhesive release liner 1404 ( Figures 14, 15 and 16) is disposed over the adhesive 114.
  • the first sub-support 1302 is disposed over the second sub-support 1404 with the acoustically transmissive membrane 110 and the liner 1404 there between.
  • the first sub-support 1302 is removably attached to the second sub-support 1404 at a peripheral region 1406 outside of the acoustically transmissive membrane 110 and the liner 1404.
  • the acoustically transmissive membrane 110 includes a printed on visual alignment guide 1702 for installing the transmissive membrane 110 on the ultrasound apparatus 102.
  • the illustrated guide 1702 includes an outline 1704 of a sub- portion of the ultrasound apparatus 102 including an outline 1706 of the acoustic lens 106.
  • the guide 1702 may include a physical feature such as a protrusion, bump, a recess, texture, and/or other visible and/or tactile feature for aligning the acoustically transmissive membrane 110 and the ultrasound apparatus 102 to install the acoustically transmissive membrane 110 on the ultrasound apparatus 102.
  • the acoustically transmissive membrane 110 is rectangular in shape.
  • the acoustically transmissive membrane 110 may be some other shape such as the same shape as the shape of the combination of the shape of the acoustically transmissive membrane 110 and the shape of the support 112 of the embodiment in Figures 3-8.
  • Figures 18, 19, 20 and 21 show example installation of the ultrasound apparatus cover 100 of Figures 13-17 on the ultrasound apparatus 102.
  • sub-support 1404 has already been removed and the front side 222 of the ultrasound apparatus 102 is aligned with the illustrated guide 1702 ( Figure 18) and installed on the acoustically transmissive membrane 110 via the adhesive 114.
  • sides 1902 of the second sub-support 1404 are folded onto the sides 220 and 222 of the ultrasound apparatus 102, installing side portions of the acoustically transmissive membrane 110 to the sides 220 and 222 via the adhesive 114.
  • one of the sides 1902 is folded back, with the acoustically
  • Figure 21 shows the acoustically
  • transmissive membrane 110 installed on the ultrasound apparatus 102 from the front side 212.
  • Figures 22 and 23 illustrate another example of the ultrasound apparatus cover 100.
  • the support 112 includes first and second sub-supports 2202 and 2204.
  • the first sub-support 2202 ( Figure 22) includes a first middle section 2206 ( Figure 23) affixed to a first strip or sub-portion 2302 ( Figure 23) of the acoustically transmissive membrane 110 with the adhesive 114 and a second peripheral sections 2208 that are not affixed to the first sub-portion 2302.
  • the second sections 2208 at least partially overlays (Figure 23) over the second sub-support 2204.
  • the second sub-support 2204 includes first sections 2304 and 2306 respectively affixed to peripheral regions 2308 and 2310 of the acoustically transmissive membrane 110 and second sections 2312 and 2314 not affixed to the acoustically transmissive membrane 110.
  • the second sections 2312 and 2314 are folded back at folds 2316 and 2318 in a direction away from the strip 2302.
  • the second sections 2312 and 2314 can flex or pivot about the folds 2316 and 2318.
  • At least one side 2210 ( Figure 22) of the acoustically transmissive membrane 110 includes a protrusion 2212 ( Figure 22) which does not include any adhesive and is not covered by any liner.
  • Figures 24, 25, 26 and 27 show example installation of the ultrasound apparatus cover 100 of Figures 22 and 23 on the ultrasound apparatus 102.
  • the exposed adhesive 114 of the strip 2302 is installed over the acoustic lens 106 and at least part of the housing 210 on the front 212 of the ultrasound apparatus 102.
  • a geometry of the strip of adhesive corresponds to a width of the acoustic window 106.
  • a user can maneuver the ultrasound apparatus cover 100 into place by handling the sections 2304/2312 and 2306/2314.
  • the acoustically transmissive membrane 110 is also of a material that is optically transparent or translucent.
  • a layer having low tack, removable adhesive, or light mechanical attachment as in a film is cast on the side of the acoustically transmissive membrane 110 facing away from the ultrasound apparatus 102, which is the side that contacts the patients.
  • This layer acts as a barrier during installation allowing the user to rub and apply direct pressure to the ultrasound apparatus cover 100 to smooth out wrinkles and obtain optimal acoustic coupling without compromising the sterility of the first layer. In this example, this would be done in connection with Figures 24, 25 or 26. After initial installation on the transducer, this layer is removed prior to use.
  • the second sub-support 2204 is removed from the acoustically transmissive membrane 110. In one instance, this can be achieved through pulling on the second section 2312, which pulls the second sections 2304 off the peripheral region 2308 of the acoustically transmissive membrane 110. The same approach is used to remove the second sub-support 2206.
  • the exposed peripheral regions 2308 and 2310 of the acoustically transmissive membrane 110, as well as other portions of the acoustically transmissive membrane 110 not already installed on the ultrasound apparatus 102, are installed on the ultrasound apparatus 102.
  • the protrusion 2212 is not affixed to the ultrasound imaging apparatus 102 and extends or protrudes out therefrom.
  • the protrusion 2212 provides a tab that facilitates removing the installed acoustically transmissive membrane 110 from the ultrasound imaging apparatus 102.
  • first and/or second sub-supports 2202 and 2204 include alphanumeric and/or graphical indicia. It is to be understood that such indicia can be omitted and/or other indicia (in addition to or in alternative to the illustrated indicia) can be used.
  • a hydrogel may be disposed in the acoustic transmission area on either side (or both sides) of the acoustically transmissive membrane 110.
  • Such gel on the outside of the ultrasound apparatus cover 100 allows transmission of ultrasound between the patient and the acoustically
  • transmissive membrane 110 In one instance, this eliminates the mess of conventional ultrasound coupling gel and is well-suited for procedures such as PIV placements where typically the catheter is secured with tape or an adhesive film after placement, requiring all gel to be removed from the area.
  • Such gel on the inside of the ultrasound apparatus cover 100 can be a replacement for the adhesive 114 as the acoustic coupler between the transducer array 104 and the acoustically transmissive membrane 110. This may allow installation of the acoustically transmissive membrane 110 without the user touching the acoustically transmissive membrane 110 to obtain an acoustic coupling of interest.
  • one or more of the embodiments are also contemplated herein.
  • one or more of the embodiments are also contemplated herein can be combine with one or more of the embodiments in application serial number 14/234,063, entitled “Ultrasound Apparatus Cover,” filed January 21, 2014, the entirety of which is incorporated herein by reference. Still other embodiments are contemplated herein.

Abstract

An ultrasound apparatus cover (100) for a single enclosure hand held ultrasound apparatus (102) includes an acoustically transmissive membrane (110), a support (112) affixed to the acoustically transmissive membrane, and an adhesive (114) disposed on the acoustically transmissive membrane. An ultrasound system (101) includes a single enclosure hand held ultrasound apparatus (102) and an acoustically transmissive membrane (110). The apparatus includes a transducer array (104) and an acoustic window (106). The cover includes an acoustically transmissive membrane (110), a support (112) affixed to the acoustically transmissive membrane, and an adhesive (114) disposed on the acoustically transmissive membrane. The ultrasound apparatus cover is affixed to the single enclosure hand held ultrasound apparatus with the acoustically transmissive membrane secured to the acoustic window through the adhesive.

Description

ULTRASOUND APPARATUS COVER
TECHNICAL FIELD
The following generally relates to ultrasound imaging and more particularly to a cover for an ultrasound apparatus.
BACKGROUND
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'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.
In some medical applications (e.g., sterile procedures), 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., US 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., US 6,132,378) and self-adhesive thin pliable film dressings that are wrapped around and adhere to the probe (e.g., US 2006/0264751 Al). Unfortunately, such covers can be cumbersome to install and use. As such, there is an unresolved need for at least another ultrasound apparatus cover. SUMMARY
Aspects of the application address the above matters, and others.
In one aspect, an ultrasound transducer cover for a single enclosure hand held ultrasound apparatus includes an acoustically transmissive membrane, a support affixed to the acoustically transmissive membrane, and an adhesive disposed on the acoustically transmissive membrane.
In another aspect, an ultrasound system includes a single enclosure hand held ultrasound apparatus and an acoustically transmissive membrane. The apparatus includes a transducer array and an acoustic window. The cover includes an acoustically transmissive membrane, a support affixed to the acoustically transmissive membrane, and an adhesive disposed on the acoustically transmissive membrane. The ultrasound apparatus cover is affixed to the single enclosure hand held ultrasound apparatus with the acoustically transmissive membrane secured to the acoustic window through the adhesive.
In another aspect, a method includes obtaining an ultrasound transducer cover. The cover includes an acoustically transmissive membrane, a support affixed to the acoustically transmissive membrane, and an adhesive disposed on the acoustically transmissive membrane. The method further includes installing the ultrasound transducer cover on a single enclosure hand held ultrasound apparatus, wherein the installation includes adhering the acoustically transmissive membrane of the cover to an acoustic window of the single enclosure hand held ultrasound apparatus through the adhesive disposed on the acoustically transmissive membrane.
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
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:
Figure 1 schematically illustrates an example ultrasound apparatus in connection with an ultrasound apparatus;
Figure 2A schematically illustrates an example single enclosure elongate hand held ultrasound imaging apparatus from a back side; Figure 2B schematically illustrates the example apparatus of Figure 2A from a front side;
Figure 3A schematically illustrates an example of the ultrasound apparatus cover from a back side;
Figure 3B schematically illustrates the example cover of Figure 3 A from a front side;
Figure 4 schematically illustrates the example cover of Figures 3A and 3B with a release liner installed on the front side;
Figures 5, 6, 7 and 8 show an example installation of the ultrasound apparatus cover of Figures 3 A and 3B on the ultrasound apparatus of Figures 2A and 2B;
Figure 9 illustrates another example of the ultrasound apparatus cover;
Figures 10, 11 and 12 show example installation of the cover of Figure 9 on the ultrasound apparatus of Figures 2A and 2B ;
Figures 13, 14, 15, 16 and 17 illustrate another example of the ultrasound apparatus cover;
Figures 18, 19, 20 and 21 show example installation of the cover of Figures 13-17 on the ultrasound apparatus of Figures 2 A and 2B ;
Figures 22 and 23 illustrate another example of the ultrasound apparatus cover; and Figures 24, 25, 26 and 27 show example installation of the cover of Figures 22 and
23 on the ultrasound apparatus of Figures 2 A and 2B.
DETAILED DESCRIPTION
Figure 1 schematically illustrates an ultrasound apparatus cover 100 in connection with an ultrasound apparatus 102. Together, the ultrasound apparatus cover 100 and the ultrasound apparatus 102 can be considered an ultrasound system 101. The ultrasound apparatus cover 100 removably affixes to the ultrasound apparatus 102.
The ultrasound apparatus 102 includes a transducer array 104 (i.e., an array of one or more transducing elements) and an acoustic window 106. The transducer array 104 is oriented with respect to the acoustic window 106 so that a transducing surface of the transducer array 104 emits and/or receives ultrasound through the acoustic window 106. The ultrasound apparatus 102 can be part of a single enclosure hand held ultrasound scanner, a transducer probe separate from an ultrasound console that connects thereto via a cable, wirelessly, etc., and/or other ultrasound apparatus.
The ultrasound apparatus cover 100 includes an acoustically transmissive membrane 110 and an adhesive 114. As described in greater detail below, the acoustically transmissive membrane 110 is generally planar and flexible and configured for installation on the acoustic window 106 and covers a subject or object contact surface of the ultrasound apparatus 102 when installed thereon. The ultrasound apparatus cover 100 further includes at least one support 112. The support 112, in one instance, is a part of the ultrasound apparatus cover 100. In another instance, the support 112 represents a temporary release liner. In this instance, the support 112 facilitates maintaining sterility and/or installing and/or removing the ultrasound apparatus cover 100.
The adhesive 114 is on a side of the acoustically transmissive membrane 110 that contacts the ultrasound apparatus 102 and facilitates transmission and reception of ultrasound between the acoustically transmissive membrane 110 and the acoustic window 106. In one instance, the adhesive 114 is permanently attached to the acoustically transmissive membrane 110 and is removable from the acoustic window 106. In another instance, the adhesive 114 is deposited on the acoustically transmissive membrane 110, a separate transfer adhesive, a single or two sided tape laminated to the acoustically transmissive membrane 110, etc.
The ultrasound apparatus cover 100 is one or more of disposable, cleanable, disinfectable, re -usable, and/or sterilizeable. Where sterilizeable, the ultrasound apparatus cover 100 can be sterilizeable by at least one of a radiation process, a chemical process, and/or other sterilization process. Furthermore, the ultrasound apparatus cover 100 may be sterilized and subsequently placed in a package that maintains sterility, or disposed in a package that allows for sterilization of the ultrasound apparatus cover 100 and maintains the sterility for a predetermined time such as until removed from the package.
Generally, a geometry (shape, size, etc.) of the ultrasound apparatus cover 100 is custom tailored to the housing of an individual ultrasound apparatus 102 so that at least the acoustic window 106 and a predetermined margin of the housing around the window 106 is covered (e.g., approximately 25 mm to 50 mm past an active sensor of the transducer array 104). As such, the primary patient contact surface(s) plus the predetermined margin of the housing is covered. However, the ultrasound apparatus cover 100 may also cover a handle and/or other portion of the ultrasound apparatus 102.
Figures 2A and 2B illustrate a non-limiting example in which the ultrasound apparatus 102 is a single enclosure elongate hand held ultrasound scanner 202. The scanner 202 has a longitudinal axis 204 and includes a first end region 206 at one end of the longitudinal axis 204 and a second end region 208 (which opposes the first end region 206) at the opposing end of the longitudinal axis 204. A single enclosure housing 210 supports and/or encloses electrical and mechanical components (e.g., the transducer array 104, etc.) of the scanner 202.
The housing 210 includes a plurality of sides, which are referred to herein as a front 212, a back 214, a top 216, a bottom 218, a left 220, and a right 222 for
distinguishing the sides from each other, but can be referred to otherwise. The front and back sides 212 and 214 oppose each other; the top and bottom sides 216 and 218 oppose each other, and the left and right sides 220 and 222 oppose each other. The left and right sides 220 and 222 respectively extend between the top and bottom sides 216 and 218, and the left, right, top and bottom sides 220, 222, 216 and 218 are between front and back sides 212 and 214.
Figure 2A illustrates a perspective view showing the back, right and bottom sides 214, 222 and 218. The back 214 includes a display screen 224 configured to visually present ultrasound imaging and/or other data. The display screen 224 is integrated in the back 214, e.g., in a cut out or recess therein, and is part of the back 214 and/or the single housing 210. A control 226 is configured to control at least an ultrasound imaging function of the scanner 202. Likewise, the control 226 is integrated in the back 214, e.g., in another cut out or recess therein, and is part of the back 214 and/or the housing 210.
Figure 2B illustrates a perspective view showing the front, the top and the left sides
212, 216 and 220. The front 212 includes the acoustic window 106, which is integrated in the front 212, e.g., in yet another cut out or recess, and is part of the front 212 and/or the housing 210. In Figures 2 A and 2B, the second end region 208 represents a handle portion of the scanner 202. Another example of the ultrasound apparatus 102 is described in US 7,699,776 to Walker et al., entitled "Intuitive Ultrasonic Imaging System and Related
Method Thereof," and filed on March 6, 2003, which is incorporated herein in its entirety by reference. Figures 3A and 3B illustrate an example of the ultrasound apparatus cover 100.
In this example, the ultrasound apparatus cover 100 has an elongate shape (e.g., a shape that corresponds to a shape of the ultrasound apparatus 102 of Figures 2A and 2B) and is a flexible with flat surfaces. Figure 3A illustrates a first major side 302, and Figure 3B illustrates a second major side 304, which opposes the first side 302. With Figures 3A and 3B, when installed on the ultrasound apparatus 102, the first side 302 faces away from the ultrasound apparatus 102 and the second side 304 contacts at least the acoustic window 106 of the ultrasound apparatus 102.
The support 112 has a length 306 corresponding to the longitudinal axis 204, a width 308 corresponding to an axis extending between the sides 220 and 222 and transverse to the axis 204, and a thickness or depth 310. The length 306 and the width 308 correspond to the dimensions of the ultrasound apparatus 102 and, in one instance, at least cover the first end region 206 (Figure 2B) of the ultrasound apparatus 102 (Figures 1, 2A and 2B). In another instance, the length 306 at least also covers at least a sub-portion of the second end region 208 (Figure 2B) and/or the top 216, the bottom 218, the left 220 and/or the right 222.
The support 112 includes a material free region 312. In one instance, a geometry of the material free region 312 corresponds to at least a geometry of the transducer array 104. That is, the material free region 312 is such that at least the transducer array 104 is behind the material free region 312 and not the support 112, when the ultrasound apparatus cover 100 is installed on the ultrasound apparatus 102. In this configuration, the support 112 does not inhibit, block, attenuate, etc. ultrasound emitted and/or received by the transducer array 104.
A suitable material for the support 112 includes a polymeric film, a non-woven fabric, a paper or card stock, a coated paper, a synthetic paper, a metal foil and/or other material. A suitable thickness 310 is in a range of approximately 0.1 mm to 0.4 mm thick (e.g., depending on the material stiffness). The acoustically transmissive membrane 110 is affixed to the first side 302 of the support 112 (Figure 3 A). The support 112 provides structure to the acoustically transmissive membrane 110. For example, the support 112 prevents the acoustically transmissive membrane 110 from bunching up and sticking to itself, yet allowing the acoustically membrane 110 to be formed around the shape of the housing 210. In the illustrated embodiment, the acoustically transmissive membrane 110 extends over a range 314, which includes an entirety of the material free region 312 and a sub- portion 316 of the support 112 which entirely surrounds the material free region 312. In this example, the acoustically transmissive membrane 110 includes a polymeric film such as a polyurethane, a low density polyethylene or the like. In one non- limiting instance, the acoustically transmissive membrane 110 includes a translucent tape with non-adhesive side 111 and an adhesive side 113 with the adhesive 114.
The non-adhesive side 111 is on the first side 302. The adhesive side 113 with the adhesive 114 is on the second side 304. In this instance, the adhesive side 113 faces the support 112 and a peripheral region of the adhesive side 113 adheres to the support 112. The portion of the adhesive side 113 over the material free region 312 also includes the adhesive 114. An example of the acoustically transmissive membrane 110 is the single coated polyurethane medical tape, product number 9833, which is a product of 3M™. Such a tape is approximately 0.05 millimeters (mm) thick with an acrylate adhesive and is optically transparent.
An adhesive 318 is affixed to at least two (2) sub-regions 320 and 322 of the second side 304 of the support 112 (Figure 3B). The first sub-region 320 is located adjacent to the material free region 312 and extends to a first end 324 of the support 112. The second sub-region 322 is adjacent to an opposing side of the material free region 312 and extends, but not all the way, to an opposing end 325 of the support 112. In one instance, the adhesive 318 includes a double-sided tape, such as the double-sided tape, product number 9425, which is a product of 3M™.
A non-adhesive region or third region 327 extends from the second sub-region 322 to the opposing end 325 of the support 112. The third region 327 does not include an adhesive. Generally, the third region 327 can be disposed along one or more of the edges of the ultrasound apparatus cover 100. The third region 327 provides a non-sticky tab, which can be used to facilitate installation of the ultrasound apparatus cover 100 on the ultrasound apparatus 102 and/or removal of an installed ultrasound apparatus cover 100 from the ultrasound apparatus 102.
At the first end 324 of the support 112, the support 112 includes a top middle tab
326 and top side tabs 328, which extend from the support 112 but are separated from each other by material free regions or gaps 330. The top side tabs 328 are connected to side portions 332 of the support 112 and move with the side portions 332. That is, folding the side portions 332 causes the top side tabs 328 to fold with the side portions 332. The top side tabs 328 can also fold independently of the side portions 332, e.g., at their connection 334 to the side portions 332. The top middle tab 326 folds independently from the top side tabs 328.
The arrangement of all materials in Figures 3A, 3B and 4 is such that they extend across the entire width 308. Those skilled in the art will recognize that this enables production by means of rotary conversion and rotary die cutting thereby minimizing manufacturing cost.
Figure 4 shows the ultrasound apparatus cover 100 of Figures 3A and 3B with a release liner 402. The release liner 402, in this example, covers the second side 304 of the support 112, including the material free region 312 with the adhesive 114. The release liner 402 is removably attached to the second side 304 of the support 112 and to the acoustically transmissive membrane 110, and is removeable therefrom, e.g., for installing the ultrasound apparatus cover 100 on the ultrasound apparatus 102.
Figures 5, 6, 7 and 8 show an example installation of the ultrasound apparatus cover 100 of Figures 3A and 3B on the ultrasound apparatus 102 of Figures 2A and 2B. For this example, the release liner 402, if included, is already removed from the ultrasound apparatus cover 100.
In Figure 5, the adhesive side 113 of the acoustically transmissive membrane 110 of the support 112 is installed on the acoustic window 106 of the ultrasound apparatus 102 via the adhesive 114, and the second side 304 of the support 112 is installed on a sub- portion of the front side 212 of the second end region 208 of the ultrasound apparatus 102 via the adhesive 318. In this example the acoustically transmissive membrane 110 is also of a material that is optically transparent or translucent and the material free region 312 of support 112 provides a visual alignment guide for proper placement on the acoustic window 106. A user can maneuver the ultrasound apparatus cover 100 into place with the adhesive free end region 327.
In Figure 6, the side portions 332 are folded towards the ultrasound apparatus 102 and adhered thereto via the adhesive 318 at the region 322. The top middle tab 326 is folded towards the top 216 of ultrasound apparatus 102 and adhered thereto via the adhesive 318 in the region 320. In Figures 7 and 8, the top side tabs 328 are folded onto the top middle tab 326 and adhered thereto via the adhesive 318 in the region 320. Figure 7 shows a bottom up perspective view looking into the back side 214, and Figure 8 shows a top down perspective view looking into the top side 216, after installation of the ultrasound apparatus cover 100 on the ultrasound apparatus 102.
The shape of transducer housing 210 may include some relatively sharp corners and edges. The gaps 330 allow for independent installation of the tabs 326 and 328, which allows for installation over the acoustic window 106 first, followed by installation of the middle tab 326, followed by installation of the top side tab 328. In one instance, this mitigates bunching and pinching at the corners and results in a neater installed ultrasound apparatus cover 100 in the corners. In a variation, the ultrasound apparatus cover 100 is shaped generally like a cross where the intersection size and shape generally matches the active transducer surface and the extensions generally match the width of each side.
Figure 9 illustrates another example of the ultrasound apparatus cover 100 with a temporary support 112. In Figure 9, the support 112 includes first and second sub- supports 902 and 904, which are both removably affixed to the acoustically transmissive membrane 110. The portion of the acoustically transmissive membrane 110 affixed to the first and second sub-supports 902 and 904 include an adhesive.
The first sub-support 902 includes a first section 906 removably affixed to a first sub-portion 907 of the acoustically transmissive membrane 110 and a second section 908 that is not affixed to the acoustically transmissive membrane 110. In the illustrated example, the second section 908 is folded back at a fold 910 in a direction towards the first section 906. The second section 908 is configured to flex or pivot about the fold 910.
The second sub-support 904 includes a first section 912 removably affixed to a second sub-portion 914 of the acoustically transmissive membrane 110 and a second section 916 not affixed to the acoustically transmissive membrane 110. The second section 916, in this example, is layered over the second section 908 and a sub-portion of the first section 906. In another example, the second section 916 may be layered only over a sub-portion of the second section 908, the entire second section 908, or the entire second section 908 and the entire first section 906.
A shape of the acoustically transmissive membrane 110 in this example is the same shape as the shape of the combination of the shape of the acoustically transmissive membrane 110 and the shape of the support 112 of the embodiment in Figures 3-8. As such, the acoustically transmissive membrane 110 has the length 306, the width 308 and the depth 310, and the tabs 328 and 326 with the gaps 330 therebetween. In a variation, the shape of the acoustically transmissive membrane 110 can be different from the shape of the combination of the acoustically transmissive membrane 110 and the shape of the support 112 from the embodiment in Figures 3-8.
Figures 9, 10, 11 and 12 show example installation of the ultrasound apparatus cover 100 of Figure 9 on the ultrasound apparatus 102 of Figures 2 A and 2B.
In Figure 9, the second sub-support 904 is removed from the acoustically transmissive membrane 110. This includes initially grasping the second section 916 and pulling it away from the acoustically transmissive membrane 110. Once at least a sub- portion of the first section 912 has been pulled away from the acoustically transmissive membrane 110, the first and/or second sections 912 and 916 can be used to remove the remaining portion of the first section 912 off the acoustically transmissive membrane 110. In Figure 10, the exposed adhesive side of the acoustically transmissive membrane 110 is installed on the top 216 of the ultrasound apparatus 102 and adhered via the adhesive 114.
In this example the acoustically transmissive membrane 110 is also of a material that is optically transparent or translucent and includes a printed on visual alignment guide 1002. The illustrated guide 1002 includes an outline 1004 of a sub-portion of the ultrasound apparatus 102 including an outline 1006 of the acoustic lens 106. In another example, the guide 1002 may include a physical feature such as a protrusion, bump, a recess, texture, and/or other visible and/or tactile feature for aligning the acoustically transmissive membrane 110 and the ultrasound apparatus 102 to install the acoustically transmissive membrane 110 on the ultrasound apparatus 102.
In Figure 11, the first sub-support 902 is being removed from the acoustically transmissive membrane 110. This includes initially grasping the second section 908 and pulling it away from the acoustically transmissive membrane 110. Concurrently with removing the first sub-support 902, the exposed adhesive side of the acoustically transmissive membrane 110 is installed on the acoustic window 106 and a sub-portion of the front side 212 of the second end region 208 of the ultrasound apparatus 102 via the adhesive 114. An example of the acoustically transmissive membrane 110 installed on the ultrasound imaging apparatus 102 is shown in Figure 12.
Figures 13-17 illustrate another example of the ultrasound apparatus cover 100. In Figures 13-17, the support 112 includes a first sub-support 1302 (Figures 13 and 14) and a second sub-support 1404 (Figures 14-17). The acoustically transmissive membrane 110 (Figures 16 and 17) is disposed on the second sub-support 1404 with the adhesive 114 facing away from the second sub-support 1402 and towards the first sub- support 1302. An adhesive release liner 1404 (Figures 14, 15 and 16) is disposed over the adhesive 114. The first sub-support 1302 is disposed over the second sub-support 1404 with the acoustically transmissive membrane 110 and the liner 1404 there between. The first sub-support 1302 is removably attached to the second sub-support 1404 at a peripheral region 1406 outside of the acoustically transmissive membrane 110 and the liner 1404.
In Figure 17, the acoustically transmissive membrane 110 includes a printed on visual alignment guide 1702 for installing the transmissive membrane 110 on the ultrasound apparatus 102. The illustrated guide 1702 includes an outline 1704 of a sub- portion of the ultrasound apparatus 102 including an outline 1706 of the acoustic lens 106. In another example, the guide 1702 may include a physical feature such as a protrusion, bump, a recess, texture, and/or other visible and/or tactile feature for aligning the acoustically transmissive membrane 110 and the ultrasound apparatus 102 to install the acoustically transmissive membrane 110 on the ultrasound apparatus 102.
In this example the acoustically transmissive membrane 110 is rectangular in shape. In another example, the acoustically transmissive membrane 110 may be some other shape such as the same shape as the shape of the combination of the shape of the acoustically transmissive membrane 110 and the shape of the support 112 of the embodiment in Figures 3-8.
Figures 18, 19, 20 and 21 show example installation of the ultrasound apparatus cover 100 of Figures 13-17 on the ultrasound apparatus 102. In Figure 18, sub-support 1404 has already been removed and the front side 222 of the ultrasound apparatus 102 is aligned with the illustrated guide 1702 (Figure 18) and installed on the acoustically transmissive membrane 110 via the adhesive 114. In Figure 19, sides 1902 of the second sub-support 1404 are folded onto the sides 220 and 222 of the ultrasound apparatus 102, installing side portions of the acoustically transmissive membrane 110 to the sides 220 and 222 via the adhesive 114. In Figure 20, one of the sides 1902 is folded back, with the acoustically
transmissive membrane 110 remaining affixed to the side 220. This is repeated for the other side. The remaining portion of the second sub-support 1402 is also removed from the acoustically transmissive membrane 110. Figure 21 shows the acoustically
transmissive membrane 110 installed on the ultrasound apparatus 102 from the front side 212.
Figures 22 and 23 illustrate another example of the ultrasound apparatus cover 100. In Figures 22 and 23, the support 112 includes first and second sub-supports 2202 and 2204. The first sub-support 2202 (Figure 22) includes a first middle section 2206 (Figure 23) affixed to a first strip or sub-portion 2302 (Figure 23) of the acoustically transmissive membrane 110 with the adhesive 114 and a second peripheral sections 2208 that are not affixed to the first sub-portion 2302. The second sections 2208 at least partially overlays (Figure 23) over the second sub-support 2204.
The second sub-support 2204 includes first sections 2304 and 2306 respectively affixed to peripheral regions 2308 and 2310 of the acoustically transmissive membrane 110 and second sections 2312 and 2314 not affixed to the acoustically transmissive membrane 110. The second sections 2312 and 2314 are folded back at folds 2316 and 2318 in a direction away from the strip 2302. The second sections 2312 and 2314 can flex or pivot about the folds 2316 and 2318. At least one side 2210 (Figure 22) of the acoustically transmissive membrane 110 includes a protrusion 2212 (Figure 22) which does not include any adhesive and is not covered by any liner.
Figures 24, 25, 26 and 27 show example installation of the ultrasound apparatus cover 100 of Figures 22 and 23 on the ultrasound apparatus 102. In Figure 24, the exposed adhesive 114 of the strip 2302 is installed over the acoustic lens 106 and at least part of the housing 210 on the front 212 of the ultrasound apparatus 102. Generally, a geometry of the strip of adhesive corresponds to a width of the acoustic window 106. A user can maneuver the ultrasound apparatus cover 100 into place by handling the sections 2304/2312 and 2306/2314. In this example the acoustically transmissive membrane 110 is also of a material that is optically transparent or translucent.
In a variation, a layer having low tack, removable adhesive, or light mechanical attachment as in a film, is cast on the side of the acoustically transmissive membrane 110 facing away from the ultrasound apparatus 102, which is the side that contacts the patients. This layer acts as a barrier during installation allowing the user to rub and apply direct pressure to the ultrasound apparatus cover 100 to smooth out wrinkles and obtain optimal acoustic coupling without compromising the sterility of the first layer. In this example, this would be done in connection with Figures 24, 25 or 26. After initial installation on the transducer, this layer is removed prior to use.
In Figure 25, the second sub-support 2204 is removed from the acoustically transmissive membrane 110. In one instance, this can be achieved through pulling on the second section 2312, which pulls the second sections 2304 off the peripheral region 2308 of the acoustically transmissive membrane 110. The same approach is used to remove the second sub-support 2206.
In Figures 26 and 27, the exposed peripheral regions 2308 and 2310 of the acoustically transmissive membrane 110, as well as other portions of the acoustically transmissive membrane 110 not already installed on the ultrasound apparatus 102, are installed on the ultrasound apparatus 102. The protrusion 2212 is not affixed to the ultrasound imaging apparatus 102 and extends or protrudes out therefrom. The protrusion 2212 provides a tab that facilitates removing the installed acoustically transmissive membrane 110 from the ultrasound imaging apparatus 102.
In Figures 22-24 and 27, the first and/or second sub-supports 2202 and 2204 include alphanumeric and/or graphical indicia. It is to be understood that such indicia can be omitted and/or other indicia (in addition to or in alternative to the illustrated indicia) can be used.
With one or more of the embodiments discloses herein, a hydrogel may be disposed in the acoustic transmission area on either side (or both sides) of the acoustically transmissive membrane 110. Such gel on the outside of the ultrasound apparatus cover 100 allows transmission of ultrasound between the patient and the acoustically
transmissive membrane 110. In one instance, this eliminates the mess of conventional ultrasound coupling gel and is well-suited for procedures such as PIV placements where typically the catheter is secured with tape or an adhesive film after placement, requiring all gel to be removed from the area. Such gel on the inside of the ultrasound apparatus cover 100 can be a replacement for the adhesive 114 as the acoustic coupler between the transducer array 104 and the acoustically transmissive membrane 110. This may allow installation of the acoustically transmissive membrane 110 without the user touching the acoustically transmissive membrane 110 to obtain an acoustic coupling of interest.
Other embodiments are also contemplated herein. For example, in another instance, one or more of the embodiments are also contemplated herein can be combine with one or more of the embodiments in application serial number 14/234,063, entitled "Ultrasound Apparatus Cover," filed January 21, 2014, the entirety of which is incorporated herein by reference. Still other embodiments are contemplated herein.
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.

Claims

CLAIMS What is claimed is:
1. An ultrasound apparatus cover (100) for a single enclosure hand held ultrasound apparatus (102), comprising:
an acoustically transmissive membrane (110);
a support (112) affixed to the acoustically transmissive membrane; and
an adhesive (114) disposed on the acoustically transmissive membrane.
2. The ultrasound apparatus cover of claim 1, wherein the support has a length (306), a width (308) and a depth (310), and further includes:
a first major side (302) and a second major side (304), which opposes the first major side;
a support (112) containing at least one material free region (312) extending through the depth, wherein the material free region is surrounded by a sub-portion (316) of the support,
wherein the acoustically transmissive membrane is permanently affixed to a sub- region of the sub-portion on the first major side and extends over the material free region along the length and the width;
wherein the second major side includes:
a first region (320) disposed at a first end region (324) of the support, wherein the first region includes an adhesive (114); and
a second region (322) disposed on a second end region (325) of the support, wherein the second region includes the adhesive, and the first and second regions are on opposing sides of the material free region.
3. The ultrasound apparatus cover of claim 2, wherein the second major side at least extending over the material free region includes: an adhesive (114).
4. The ultrasound apparatus cover of any of claims 2 to 3, wherein the adhesive extends the entirety of the width at the first region and at the second region.
5. The ultrasound apparatus cover of any of claims 2 to 4, where the second major side further includes a third region (327) of the second end region, wherein the second region is between the material free region and the third region, and the third region does not include an adhesive.
6. The ultrasound apparatus cover of any of claims 2 to 5, where the first end region includes:
two top side tabs (328); and
a top middle tab (326) disposed there between, wherein the two top side tabs and the top middle tab are physically connected to the support adjacent to the material free region and are separated from each other by gaps (330).
7. The ultrasound apparatus cover of claim 6, wherein each of the top two side tabs and the top middle tab are independently foldable regions.
8. The ultrasound apparatus cover of any of claims 2 to 7, further comprising:
an adhesive release liner (402) temporarily affixed to the second major side.
9. The ultrasound apparatus cover of claim 8, wherein the adhesive release liner includes a portion that extends out beyond the support.
10. The ultrasound apparatus cover of claim 1, wherein the adhesive release liner includes a portion that extends out beyond the support.
11. The ultrasound apparatus cover of claim 1, wherein the acoustically transmissive membrane has a length, a width and a depth, and further includes:
a first major side and
a second major side, which opposes the first major side, wherein the second major side includes an adhesive; and
wherein the support includes:
a first sub-support (902); and a second sub-support (904), which are both removably affixed to the second major side.
12. The ultrasound apparatus cover of claim 11, wherein the first sub-support (902) comprises:
a first section (906) affixed to a first sub-portion (904) of the acoustically transmissive membrane; and
a second section (908) not affixed to the acoustically transmissive membrane, wherein the second section is folded back at a first fold (910) in a direction towards the first section, and the second section is configured to flex about the first fold.
13. The ultrasound apparatus cover of claim 12, wherein the second sub-support (904) comprises:
a first section (912) affixed to a second first sub-portion (914) of the acoustically transmissive membrane; and
a second section (916) not affixed to the acoustically transmissive membrane 110, wherein the second section (916) of the second sub-support (904) is layered over at least a sub-portion of the second section (908) of the first sub-support (902), with the sub-portion of the second section (908) of the first sub-support (902) between the second section (916) of the second sub-support (904) and the acoustically transmissive membrane.
14. The ultrasound apparatus cover of any of claims 11 to 13, wherein the acoustically transmissive membrane includes an ultrasound apparatus installation guide.
15. The ultrasound apparatus cover of claim 14, wherein the ultrasound apparatus installation guide provides visual alignment.
16. The ultrasound apparatus cover of claim 14, wherein the ultrasound apparatus installation guide includes an outline of a sub-portion of an ultrasound apparatus.
17. The ultrasound apparatus cover of claim 16, wherein the sub-portion includes an outline of an acoustic lens of the ultrasound apparatus.
18. The ultrasound apparatus cover of claim 14, wherein the ultrasound apparatus installation guide includes at least one of a physical feature or tactile feature.
19. The ultrasound apparatus cover of claim 1, wherein the support comprises:
a first sub-support (1302), wherein the adhesive is disposed on a side of the acoustically transmissive membrane, and wherein the acoustically transmissive membrane is disposed on the first sub-support with the adhesive facing away from the first sub- support;
an adhesive liner (1404) disposed over the acoustically transmissive membrane disposed on the first sub-support; and
a second sub-support (1404) affixed to the first sub-support with the liner and the acoustically transmissive membrane disposed there between.
20. The ultrasound apparatus cover of claim 19, wherein the first sub-support is removably attached to the second sub-support at a peripheral region (1406) outside of the transmissive membrane and the liner.
21. The ultrasound apparatus cover of any of claims 19 to 20, wherein the acoustically transmissive membrane includes an ultrasound apparatus installation guide.
22. The ultrasound apparatus cover of claim 20, wherein the guide includes a graphic.
23. The ultrasound apparatus cover of any of claims 20 to 21, wherein the guide includes at least one of a protrusion or a recess.
24. The ultrasound apparatus cover of claim 1, wherein the support comprises:
a first sub- support (2202), including:
a first middle section (2206) affixed to a strip (2302) of the acoustically transmissive membrane; and
second peripheral sections (2208) that are not affixed to the first sub- portion; and a second sub-support (2204), including:
first sections (2304 and 2306) respectively affixed to peripheral regions (2308 and 2310) of the acoustically transmissive membrane 110; and
second sections (2312 and 2314) not affixed to the acoustically transmissive membrane, wherein the second sections are folded back at folds (2316 and 2318) in a direction away from the strip and flex about the folds,
wherein the second peripheral sections of the first sub-support at least partially overlay over the second sub- support.
25. The ultrasound apparatus cover of claim 24, wherein at least one side (2210) of the acoustically transmissive membrane includes a protrusion (2212), which does not include any adhesive and is not covered by any liner.
26. The ultrasound apparatus cover of any of claims 1 to 25, wherein the ultrasound apparatus cover is sterilize and included in a removable package.
27. The ultrasound apparatus cover of claim 26, wherein the removable package maintains a sterility of the ultrasound apparatus cover as long as the ultrasound apparatus cover is in the package.
28. The ultrasound apparatus cover of claim 26, wherein the ultrasound apparatus cover is sterilized and subsequently disposed in the package.
29. The ultrasound apparatus cover of claim 26, wherein the ultrasound apparatus cover is sterilized after being disposed in the package.
30. The ultrasound apparatus cover of claim 26, wherein the ultrasound apparatus cover is sterilized via one of a radiation process or a chemical process.
31. An ultrasound system (101), comprising:
a single enclosure hand held ultrasound apparatus (102), including:
a transducer array (104); and an acoustic window (106); and
an ultrasound apparatus cover (100) for a single enclosure hand held ultrasound apparatus (102), comprising:
an acoustically transmissive membrane (110);
a support (112) affixed to the acoustically transmissive membrane; and an adhesive (114) disposed on the acoustically transmissive membrane, wherein the ultrasound apparatus cover is affixed to the single enclosure hand held ultrasound apparatus with the acoustically transmissive membrane secured to the acoustic window through the adhesive.
32. A method, comprising:
obtaining an ultrasound transducer cover, the cover including:
an acoustically transmissive membrane (110);
a support (112) affixed to the acoustically transmissive membrane; and an adhesive (114) disposed on the acoustically transmissive membrane; and installing the ultrasound transducer cover on a single enclosure hand held ultrasound apparatus, wherein the installation includes adhering the acoustically transmissive membrane of the cover to an acoustic window of the single enclosure hand held ultrasound apparatus through the adhesive disposed on the acoustically transmissive membrane.
33. The method of claim 32, further comprising:
receiving a package that includes the ultrasound transducer cover, wherein the ultrasound transducer cover is sterilized, and wherein obtaining the ultrasound transducer cover includes obtaining the ultrasound transducer cover from the package.
PCT/US2015/014716 2015-02-06 2015-02-06 Ultrasound apparatus cover WO2016126257A1 (en)

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EP4144300A1 (en) * 2021-09-02 2023-03-08 Compremium AG Replaceable head for an ultrasonic probe

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EP4144300A1 (en) * 2021-09-02 2023-03-08 Compremium AG Replaceable head for an ultrasonic probe

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