Ultrasonic transducer mounting device

Abstract

The ultrasonic transducer mounting device (1;1') includes a substrate layer (2, 2') having a first surface (4, 4') and a second surface (6, 6'), the second surface (6, 6') being opposite to the first surface (4, 4'), and the first surface (4, 4') includes a first adhesive surface (5, 5') for adhesion to the skin of the neck of a human or animal patient. The ultrasonic transducer mounting device (1, 1') further includes an ultrasonic transducer (8, 8') fixed to a first surface (4, 4') of a substrate layer (2, 2') for positioning in close proximity to the patient's carotid artery, and a removable alignment layer (10, 10') detachably bonded to a second surface (6, 6') of the substrate layer (2, 2') and extending along a first axis (15) beyond the substrate layer (2, 2') in at least a first direction (15'), thereby facilitating the alignment of the ultrasonic transducer (8, 8') in close proximity to the patient's carotid artery.

Description

Technical Field

[0001] The present invention relates to an ultrasonic transducer mounting device.

Background Art

[0002] It is known to monitor the blood flow of a patient using an ultrasonic transducer, for example, using Doppler ultrasound technology. However, it is known to be difficult to accurately position an ultrasonic transducer on a specific blood vessel for diagnosis, particularly in locations where the patient's blood flow is weak or absent. Therefore, it is desirable to provide an improved device for attaching an ultrasonic transducer near a blood vessel.

Summary of the Invention

Problems to be Solved by the Invention

[0003] An object of the present invention is to provide an improved ultrasonic transducer mounting device.

Means for Solving the Problems

[0004] In a first aspect, the present invention provides an ultrasonic transducer mounting device, the ultrasonic transducer mounting device comprising: a substrate layer having a first surface and a second surface, the second surface being on the opposite side of the first surface, the first surface having a first adhesive surface for adhering to the skin of a human or animal neck; an ultrasonic transducer fixed to the first surface of the substrate layer for placement in proximity to a patient's carotid artery; a removable alignment layer removably adhered to the second surface of the substrate layer, extending along a first axis at least in a first direction beyond the substrate layer, and assisting in aligning the ultrasonic transducer in proximity to the patient's carotid artery.

[0005] In a second aspect, the present invention provides a method for attaching an ultrasonic transducer to the skin of the neck of a human or animal patient, in close proximity to and aligned with the patient's carotid artery. The ultrasonic transducer is fixed to the first surface of the substrate layer. The first surface has a first adhesive surface for adhering to the patient's skin, A removable alignment layer is detachably bonded to a second surface of the substrate layer opposite to the first surface, extending beyond the substrate layer along the first axis in at least the first direction, to assist in aligning the ultrasonic transducer to bring it close to the patient's carotid artery. This method is The steps include aligning the ultrasonic transducer on the patient's carotid artery using the alignment layer, The steps include applying pressure to the substrate layer to adhere the first adhesive surface to the patient's skin, The procedure includes the step of removing the alignment layer from the substrate layer, thereby exposing the neck region of the patient.

[0006] Accordingly, according to embodiments of the present invention, a removable alignment layer extends beyond the substrate layer, facilitating alignment of the ultrasonic transducer with the carotid artery. This allows the operator of the ultrasonic transducer mounting device to easily mount the ultrasonic transducer in the desired position, with the ultrasonic transducer close to the patient's carotid artery (i.e., positioned on the skin of the patient's neck, sufficiently close to the carotid artery and aligned with it to collect medically useful blood flow data from the carotid artery). Furthermore, since the alignment layer is removable from the substrate layer, it can be removed after mounting the ultrasonic transducer, thereby reducing the amount of obstruction the patient's neck by the device after the transducer has been mounted. In particular, in at least some embodiments, after the removable alignment layer is removed from the mounting device, only a portion of the patient's neck below the substrate layer is covered, rather than the entire area below the alignment layer (the area extending beyond the substrate layer). Because the alignment layer is larger than the substrate layer, the transducer can be positioned more easily and accurately. By removing the alignment layer, more of the patient's neck can be exposed while maintaining the convenience of alignment, which can improve patient comfort and facilitate additional medical interventions.

[0007] The first adhesive surface is suitable for adhering to the skin adjacent to the front of the neck (also known as the throat) of a human or animal.

[0008] The neck region exposed by removing the alignment layer from the substrate layer can be located, in part or not entirely, in the neck region opposite the ultrasonic transducer. This opposite region can be extended to include the patient's second carotid artery and / or other blood vessels in that region.

[0009] In some embodiments, the removable alignment layer has one or more alignment features. In some embodiments, these one or more alignment features include visible surface marks such as notches, notches and / or protrusions and / or printed lines. Such alignment features may be positioned on, over, or along the centerline of the removable alignment layer.

[0010] The first axis can be the axis of length. The second axis (for example, the axis of width) can be perpendicular to the first axis.

[0011] The procedure for positioning an ultrasonic transducer over a patient's carotid artery using the alignment layer includes positioning the alignment feature of the alignment layer to the center of the patient's neck (i.e., aligning it with the central vertical axis of the patient's body, i.e., the sagittal plane). In some embodiments, one or more of the alignment features indicate the center of the removable alignment layer on the first axis for alignment with the center of the patient's neck (i.e., covering and aligning with the center of the patient's neck). This can be achieved, for example, by positioning the alignment feature indicating the center of the removable alignment layer to the laryngeal prominence of the thyroid cartilage. Utilizing the symmetry of the alignment layer in this way allows for very simple and reliable positioning (both lateral and rotational) even by inexperienced operators.

[0012] In some embodiments, the substrate layer is positioned entirely on one side of the centerline of the removable alignment layer in the first axis. That is, the substrate layer is positioned entirely within the first half of the removable alignment layer in the first axis. In some embodiments, at least a portion of the substrate layer is positioned on one end of the removable alignment layer or in its vicinity in the first axis.

[0013] In some embodiments, the removable alignment layer has a length of twice or more than twice the length of the substrate layer in the first axis (e.g., the maximum length) in the first axis (e.g., the maximum range if there are multiple ranges). The removable alignment layer may extend beyond the substrate layer in the first direction by a distance equal to or greater than the length of the substrate layer in the first axis. The removable alignment layer may extend beyond the substrate layer in the opposite direction to the first direction (when the removable alignment layer is not folded) by a length shorter than the length of the substrate layer in the first axis.

[0014] In some embodiments, the removable alignment layer is elongated along the first axis. In some embodiments, the removable alignment layer is symmetrical with respect to the center line in the direction of the first axis. In some embodiments, the substrate is also elongated in the direction of the first axis.

[0015] The alignment layer has a pair of parallel edges parallel to the axis of the first axis. These edges may be joined by a pair of straight or curved edges. The substrate can be rectangular, and the length of the first axis can be longer than the length of the second axis.

[0016] In some embodiments, the removable alignment layer has the same length as the length of the substrate along the second axis perpendicular to the first axis. In such embodiments, the removable alignment layer may extend beyond the substrate layer along the first axis, but not along the second axis. That is, at least in the first direction, it extends laterally (or vertically) beyond the substrate layer, but hardly extends upward or downward relative to the substrate layer. Having the same length means being exactly the same, but it will be understood that an error margin of, for example, up to 10% or 5%, or up to 5 mm or 2 mm, can be tolerated.

[0017] However, in other embodiments, the substrate layer extends longer than the removable alignment layer in the second axis (i.e., the removable alignment layer is narrower than the substrate layer). In yet another embodiment, the removable alignment layer extends longer than the substrate layer in the second axis (i.e., the removable alignment layer is wider than the substrate layer and extends longer than the substrate layer in both the first and second axes).

[0018] In some embodiments, the removable alignment layer has a length of 200 mm or more, and optionally about 250 mm, in the first axis. In some embodiments, the removable alignment layer has a length of less than 300 mm in the first axis.

[0019] In some embodiments, the removable alignment layer extends beyond the substrate layer by 100 mm or more, and optionally about 125 mm, in the first direction. However, in some embodiments, the removable alignment layer does not extend beyond 200 mm from the substrate layer in the first direction.

[0020] In some embodiments, the length of the substrate layer along the first axis is 50 mm or more, or 100 mm, for example, about 100 mm. However, in some embodiments, the length of the substrate layer along the first axis is 125 mm or less (for example, limited to half the length of the removable alignment layer if the length is about 250 mm).

[0021] In some embodiments, the substrate layer and / or removable alignment layer have a length of about 50 mm in the second axis.

[0022] In some embodiments, the substrate layer includes a flexible sheet of plastic material. This flexible sheet of plastic material includes a layer of plastic foam in which one side is covered with polypropylene and the other side is covered with polyethylene.

[0023] In some embodiments, the substrate layer includes (or consists of) a hydrogel. The hydrogel can include (or consist of) an embedded mesh to facilitate manufacturing and handling. The hydrogels can be laminated and may have different hydrogel compositions on each side of the mesh. This can impart different properties, such as different adhesiveness, on both sides. The substrate layer can further include a layer of (e.g., flexible) plastic foam and / or one or more adhesive layers (i.e., forming a second adhesive surface).

[0024] In some embodiments, the first adhesive surface includes (e.g., is made of) a hydrogel, i.e., the substrate layer includes a hydrogel (layer) that constitutes the first adhesive surface.

[0025] In some embodiments, the substrate layer has a (first) slit that can be configured to accommodate the cable of the ultrasonic transducer within the slit and / or for the cable of the ultrasonic transducer to pass through (i.e., move forward) the slit. The (first) slit can extend along a first axis. The (first) slit can be located in the vicinity of the location where the ultrasonic transducer is attached to the substrate layer.

[0026] In some embodiments, the removable alignment layer has a (second) slit that can be configured to accommodate the cable of the ultrasonic transducer within the slit and / or for the cable of the ultrasonic transducer to pass through (i.e., move forward) the slit. The (second) slit can extend along a first axis. Also, the (second) slit can be aligned on top of the first slit.

[0027] In some embodiments, the ultrasonic transducer is offset in the first axial direction from the centerline of the removable alignment layer. When the removable alignment layer is not folded, the ultrasonic transducer may be offset from the centerline in the direction opposite to the first direction. In some embodiments, the ultrasonic transducer is offset along the first axis from the centerline of the removable alignment layer, and the center of the ultrasonic transducer is about 50 mm away from the centerline of the removable alignment layer along the first axis.

[0028] In some embodiments, the ultrasonic transducer mounting device further comprises a backing cover that covers the first bonding surface of the substrate layer. The method of this embodiment may include the step of removing the backing cover to expose the first bonding surface. The ultrasonic transducer may be positioned between the substrate layer and the backing cover. In some embodiments, the backing cover comprises tabs extending away from the substrate layer and / or the removable alignment layer, thereby facilitating removal of the backing cover from the substrate layer. The tabs may extend along a first axis. The tabs may also extend in the opposite direction to the first direction when the removable alignment layer is unfolded.

[0029] In some embodiments, the removable alignment layer comprises a first portion detachably bonded to a second surface of the substrate layer and a second portion extending beyond the substrate layer in the first direction. The second portion may be bonded (e.g., non-removably) to a backing cover. The removable alignment layer may have a folded shape such that the backing cover covers the first bonding surface of the substrate layer. Thus, in some embodiments, the method of this embodiment further includes removing the backing cover to expose the first bonding surface, thereby unfolding the removable alignment layer from its folded shape to, for example, a substantially flat (or planar) shape when the backing cover is removed. When used and fitted to a patient's neck, it will be understood that the removable alignment layer is not planar but curves around the neck. The second portion may also be made of a non-adhesive material and may include an adhesive bonding material positioned between the second portion and the backing cover to bond them together.

[0030] It will become clear that whether a component is "irremovably" bonded or "removably" bonded means whether it can be removed by the normal force applied by a handler, and does not refer to whether there are physical means to enable removal. For example, if the second portion is irremovably bonded to the backing cover, this simply requires that the second portion is bonded so strongly that it does not peel off the backing cover when the backing cover is peeled off the first bonding surface. Thus, in some embodiments, the second portion is bonded to the backing cover with an adhesive strength higher than the adhesive strength between the backing cover and the first bonding surface. Adhesion strength is tensile strength and / or shear strength and / or peel strength, and can be determined by any suitable method.

[0031] In other embodiments, the second portion may not be bonded to the backing cover (for example, as shown in Figure 2 (described in more detail below), the removable alignment layer may always be open). The second portion may be made of a non-adhesive material (such as paper) and / or may have a non-adhesive surface.

[0032] Alternatively, in another embodiment, the removable alignment layer comprises a first portion removablely bonded to a second surface of the substrate layer and a second portion extending beyond the substrate layer in the first direction and removablely bonded to the first bonding surface of the first surface of the substrate layer. Thus, a portion of the backing cover in contact with the first surface of the substrate layer (i.e., the surface to which the transducer is fixed) can function as a backing cover for the first bonding surface (i.e., if the removable layer is in a folded configuration). Therefore, the method of this embodiment may further include the step of removing the second portion from the first bonding surface to expose the first bonding surface. This has the advantage that a separate backing cover is not required because the second portion of the removable alignment layer functions as a backing cover.

[0033] In some embodiments, the ultrasonic transducer mounting device further comprises an acoustic coupling layer disposed between the ultrasonic transducer and the backing cover. For example, the acoustic coupling layer may be an ultrasonic coupling gel, a hydrogel, or a silicone compound.

[0034] In some embodiments, the removable alignment layer is bonded to the substrate layer. The removable alignment layer has a second bonding surface, which is bonded to the substrate layer. A first portion of the removable alignment layer may have the second bonding surface.

[0035] The first adhesive surface may extend over the entire length and / or width of the first surface of the substrate layer (e.g., over the entire first surface), or it may extend over only a portion of the length and / or width of the first surface. The first surface may comprise a plurality of first adhesive surfaces (i.e., adhesive regions separated by non-adhesive surfaces). In some embodiments, at least in typical use conditions, the adhesive strength between the removable alignment layer and the substrate layer is lower than the adhesive strength between the first adhesive surface and the patient's skin after the first adhesive surface of the substrate layer has been adhered to the skin. This allows the removable alignment layer to be removed from the substrate layer without removing the substrate layer (i.e., from the patient's skin) after the first adhesive surface has been adhered to the patient. In some embodiments, the first adhesive surface includes a first adhesive, and the second adhesive includes a second adhesive, the second adhesive being weaker than the first adhesive. However, it is not necessary to use two different adhesives to obtain different adhesive strengths for different bonding conditions. This can be achieved in any suitable way. For example, in addition to using two different adhesives, or instead, it is also possible to use an adhesive on the first bonding surface of the substrate layer with a smaller area (e.g., aggregate total area) compared to the total area (e.g., aggregate total area) of adhesive used between the alignment layer and the substrate layer (i.e., for bonding).

[0036] Similarly (i.e., using any of the methods described above), it will be understood that the substrate layer may be bonded more strongly to the alignment layer than to the backing cover, i.e., the substrate layer may remain bonded to the alignment layer even if the backing cover is removed.

[0037] In some embodiments, the removable alignment layer is flexible and can conform to the shape of the patient's neck. In some embodiments, the method of this embodiment includes the step of aligning the alignment layer such that the first direction is perpendicular to the patient's midline plane (i.e., the first direction extends around the patient's neck and is substantially parallel to the patient's cross-section). In some embodiments, the method of this embodiment includes the step of fitting the alignment layer to the patient's neck before removing the removable alignment layer.

[0038] As used herein, "approximately" means within + / - 10%, within + / - 5%, or other appropriate range.

[0039] Any characteristic features of any aspect or embodiment described herein may, where appropriate, be applied to other aspects or embodiments described herein. When different embodiments or sets of embodiments are referred to, it should be understood that these embodiments are not necessarily clearly distinguishable and may overlap. [Brief explanation of the drawing]

[0040] Hereinafter, specific preferred embodiments of the present invention will be described only as examples, with reference to the accompanying drawings described below. [Figure 1] This is an exploded view showing the components of an ultrasonic transducer mounting device according to one embodiment of the present invention. [Figure 2] Figure 1 is a front view of the removable alignment layer. [Figure 3] Figure 1 is a perspective view of the ultrasonic transducer attachment device before it is attached to the patient. [Figure 4] Figure 1 is a perspective view of the ultrasonic transducer mounting device in the process of being unfolded. [Figure 5] This is a flowchart illustrating the procedure for attaching an ultrasonic transducer to a patient according to one embodiment of the present invention. [Figure 6]This is an exploded view showing the components of an ultrasonic transducer mounting device according to a second embodiment of the present invention. [Modes for carrying out the invention]

[0041] Figure 1 shows an ultrasonic transducer mounting device 1. The ultrasonic transducer mounting device 1 includes a substrate layer 2 having a first inward-facing surface 4 and a second outward-facing surface 6. The outward-facing surface 6 is visible from the viewpoint in Figure 1 and is opposite to the inward-facing surface 4. The substrate layer 2 is mainly made of a flexible sheet of plastic material, and an adhesive coating layer 5 is provided on the inward-facing surface 4. The flexible sheet of plastic material is made of laminated layers of "plastic foam" (e.g., Foam 3M 1773), with one side (e.g., the outward-facing surface 6) covered with polypropylene (e.g., TC50 / RC10) and the other side covered with polyethylene. Alternatively, in other examples, instead of polyethylene, the other side of the flexible sheet of plastic material is covered with hydrogel. The adhesive used for the adhesive coating layer 5 can be a skin adhesive 3M 4075 or a hydrogel adhesive such as Axelgaard AG2530. The applicant recognized that the use of a hydrogel adhesive allows the attachment device 1 to be bonded particularly effectively to certain patients, such as those with moist and / or cold skin, as is often seen in patients in cardiac arrest. Thus, the inward-facing surface 4 includes a first bonding surface for bonding to the patient's skin.

[0042] The ultrasonic transducer mounting device 1 also includes an ultrasonic transducer 8, which is fixed to the inward-facing surface 4 of the substrate layer 2, as described below, in order to be positioned close to the patient's carotid artery. Figure 1 shows the back of the ultrasonic transducer 8, which, when attached to a patient, is configured to emit ultrasonic signals toward the patient from one or both of two inclined surfaces that extend diagonally from the substrate layer 2 toward the patient, and to receive reflected signals on one or both of the two inclined surfaces. A cable 9 extends from the ultrasonic transducer 8 and can be connected to another device. The other device transmits electrical signals to the ultrasonic transducer 8 and receives and processes electrical signals from the ultrasonic transducer 8. For example, the cable 9 (at the other end, not shown) is connected to a resuscitation device such as a defibrillator or a medical monitoring device.

[0043] The ultrasonic transducer mounting device 1 also includes a removable alignment layer 10. This alignment layer 10 is mainly made of a sheet of paper or plastic material, for example, a polyester sheet with a thickness of 50 μm. The removable alignment layer 10 has a first portion 12 that overlaps (i.e., covers) the outward-facing surface 6 of the substrate layer 2 and is removablely bonded to the outward-facing surface 6 of the substrate layer 2 by, for example, an adhesive coating to the removable alignment layer 10. The adhesive coating can be, for example, RP51. The removable alignment layer 10 also has a second portion 14 that extends beyond the substrate layer 2 in a first direction 15' parallel to a first "length" axis 15 to facilitate the alignment of the ultrasonic transducer 8 in close proximity to the patient's carotid artery. In this example, the removable alignment layer 10 also extends beyond the substrate layer 2 in the opposite direction to the first direction 15' (when the alignment layer 10 is unfolded), but by a very small amount.

[0044] The ultrasonic transducer mounting device 1 further includes an acoustic coupling layer 16. In this example, the acoustic coupling layer 16 is a hydrogel (e.g., hydrogel AG625) for acoustic impedance matching and is placed partially or entirely on one or more surfaces of the ultrasonic transducer (i.e., the sound-emitting surface and / or sound-receiving surface).

[0045] A backing cover 18 (for example, made of molded plastic material) is positioned as a removable cover over the acoustic coupling layer 16 and the ultrasonic transducer 8. The backing cover 18 also extends to removablely cover the adhesive surface of the inward-facing surface 4 of the substrate layer 2.

[0046] Figure 2 is a more detailed front view of the removable alignment layer 10, showing the outward-facing surface of this layer 10 (i.e., the surface not in contact with the outward-facing surface 6 of the substrate layer 2). Figure 2 shows various reference lines 7', 15, 15', 17, 20, 24, 26, and 28 that are not included in the removable alignment layer 10 itself. However, the outer surface of the removable alignment layer 10 is adorned with a printed design, including three letter elements 32, 34, and 36 and a picture 37, which will be described in more detail below.

[0047] As shown in Figure 2, in this example, the first direction 15' is oriented from right to left along the removable alignment layer 10.

[0048] The first part 12 is located to the right of the dashed line 20, and the second part 14 is located to the left of the dashed line 20, if not entirely. The dashed line 20 represents the center line at the midpoint of the length axis 15 of the removable alignment layer 10.

[0049] In this example, the removable alignment layer 10 has a maximum length 22, approximately 250 mm, along the length axis 15. The removable alignment layer 10 also has a maximum length 24, approximately 50 mm, along a second "width" axis 17 perpendicular to the length axis 15.

[0050] In this example, the substrate layer 6 (not shown in Figure 2) is rectangular and has a length of approximately 100 mm in the length axis direction 15 and a length of approximately 48 mm in the width axis direction 17.

[0051] Although the ultrasonic transducer 8 is not visible from the viewpoint in Figure 2, its position is indicated by a dashed rectangle 7' for reference. The length 26 of the ultrasonic transducer in the direction of the length axis 15 in this example is approximately 30 mm. The ultrasonic transducer 7' is offset to the right from the center line 20 of the removable alignment layer 10, and the center of the ultrasonic transducer 7' is located at a distance 28 of approximately 50 mm from the center line 20.

[0052] The centerline 20 of the removable alignment layer 10 is indicated by a pair of notches 30 on the centerline 20, and also by a centerline 37' printed on the outer surface of the alignment layer 10 that coincides with a virtual centerline 20. These provide alignment features that allow the ultrasonic transducer 8 to be easily positioned on the patient's carotid artery. In particular, a person using the ultrasonic transducer mounting device 1 (e.g., a paramedic) can properly position the ultrasonic transducer on the patient's carotid artery simply by aligning the vertical line 37' and the notches 30 with the centerline of the patient's neck and throat region (i.e., placing it in the patient's sagittal plane). This can be achieved, for example, by aligning the printed centerline 37' and / or notches 30 with the laryngeal prominence of the thyroid cartilage if the patient has one. The dimensions and lateral distance 28 of the transducer 8 are selected so that at least a portion of the transducer 8 covers the carotid artery of any patient, or at least a specific patient group (e.g., 90% of adults), regardless of sex, age, or build.

[0053] Figures 1 and 2 show the removable alignment layer 10 in a flat, "open" state. However, it will be understood that when fitted to a patient, the removable alignment layer 10 will curve to conform to the patient's neck.

[0054] Furthermore, in some embodiments, in order to make the ultrasonic transducer mounting device 1 more compact (for example, for transport before attachment to a patient) and to improve the convenience of the handler, the removable alignment layer 10 can be folded in half around the center line 20 for storage before use, so that the second portion 14 of the removable alignment layer 10 is close to the first portion 12. The second portion 14 can be bonded to the backing cover 18. This storage configuration is shown in Figures 3 and 4.

[0055] The pictorial elements 32, 34, and 36 of the lettering shown in Figure 2 are omitted in Figures 3 and 4 for simplification. As shown in Figures 3 and 4, in some embodiments, the removable alignment layer 10 starts in a folded configuration, with the first portion 12 bonded to the inward-facing surface 6 of the substrate layer 2 by a first adhesive strength (or adhesive force), and the second portion 14 bonded to the back surface of the backing cover 18 by a second adhesive strength (or adhesive force). Here, the second adhesive strength is stronger than the first adhesive strength (in this case, the back surface of the backing cover 18 faces away from the coupling layer 16). Bonding between the first portion 12 and the inward-facing surface 6, and / or between the second portion 14 and the back surface of the backing cover 18 can be achieved by adhesive RP51 (402-034-A). It will be understood that even when the same adhesive is used for both joints, different bonding strengths can be achieved by changing the configuration of the adhesive, such as providing a larger adhesive area for one joint than for the other.

[0056] Figure 5 is a flowchart showing the procedure for attaching the transducer element 8 to the carotid artery on the patient's skin using the ultrasonic transducer attachment device 1.

[0057] These steps are illustrated by pictorial elements 32, 34, and 36 printed on the removable alignment layer 10 (see Figure 2) to provide handlers of the ultrasonic transducer mounting device with clear guidance and instructions on the procedure for mounting ultrasonic transducers. These steps are outlined by the printed words “Peel” 32, “Position” 34, and “Peel” 36. In the illustrated example, these steps are also numbered to ensure that handlers perform them in the correct order.

[0058] In some embodiments, as shown in Figure 3, the mounting device 1 is initially folded for storage.

[0059] In the first step 40 of the installation procedure, as shown in Figure 4, the backing cover 18 is separated from the inward-facing surface 4 of the substrate layer 2 by pulling the protruding tab 19 of the backing cover 18. This exposes the adhesive coating 5 of the inward-facing surface 4 and also exposes the acoustic coupling layer 16. At this time, the second portion 14 of the removable alignment layer 10 is unfolded to the open position, and the removable alignment layer 10 takes on approximately the same shape as shown in Figures 1 and 2. This step is represented by the pictorial element "peel off" 32 in Figure 2, instructing the handler to first peel off the backing cover 18.

[0060] Next, in step 42, the operator aligns the printed center line 37' and the notch 30 with the center line of the patient's neck and applies sufficient pressure to the removable alignment layer 10 to fit it to the patient's neck. This aligns the ultrasonic transducer over the patient's carotid artery, allowing the ultrasonic transducer 8 to collect useful data about the patient's carotid artery (e.g., blood flow Doppler data). The angle of the active surface of the transducer 8 is set so that the ultrasonic signal is directed in a direction not perpendicular to the carotid artery, because only the velocity component perpendicular to the transducer surface can be accurately measured using Doppler ultrasound. This step is indicated by a pictographic element "positioning" 34 that instructs the operator to "position" the ultrasonic transducer mounting device 1 in place, and further, this pictographic element depicts an image 37 of a human head and neck representing the position where the device 1 will be positioned.

[0061] Next, in step 44, the operator applies even stronger pressure to the substrate layer 2, for example by firmly pressing down on the right-side portion 12 of the removable alignment layer 10, thereby bonding the adhesive coating 5 on the inward-facing surface 4 of the substrate layer 2 to the patient's neck skin. As a result, the ultrasonic transducer 8 is fixed in place by the tension between the adhesive 5 and the substrate layer 2, and will not easily shift position even if, for example, the cable 9 is pulled.

[0062] Finally, in step 46, the operator of the ultrasonic transducer mounting device 1 removes the removable alignment layer 10 from the substrate layer 2 by peeling it off from the end indicated by the third pictorial element “peel” 36. This exposes the area of ​​the patient’s neck that was covered by the removable alignment layer 10, specifically the area previously located beneath the second portion 14, and this area of ​​the patient’s neck opposite the ultrasonic transducer 8 becomes available and exposed for other medical interventions.

[0063] Since many animals, including humans, have carotid arteries on both sides of the neck, it will be understood that the ultrasonic transducer attachment device 1 can be used in either orientation, as shown in Figure 2, or rotated 180 degrees within the plane of Figure 2. Therefore, the ultrasonic transducer 8 can be positioned on the right or left side of the patient's neck, depending on the orientation of the ultrasonic transducer attachment device 1. Studies have shown that approximately 90% of people are right-handed, and therefore the diagram on the patch indicates that the ultrasonic transducer should be positioned on the left side of the patient (from the patient's perspective), and is primarily designed to assist with this positioning. This is because the diagram is easy to use for right-handed users. This configuration leaves the right side of the patient's neck free for venous access. Left-handed users can rotate the patch 180 degrees before application. Even upside down, useful information can be obtained from the diagram elements, assisting in this task.

[0064] By providing a positioning layer 10 that extends significantly beyond the substrate layer 2 (for example, more than twice the length of the substrate layer 2 in some embodiments), the positioning layer 10, equipped with the ultrasonic transducer 8, can be easily, accurately, and symmetrically positioned on (i.e., close to) the patient's carotid artery. Furthermore, since the positioning layer 10 is removable, after serving its function of assisting in the placement of the transducer to the patient's neck, it can be removed from the substrate layer 2, allowing for greater exposure of the patient's neck than if the positioning layer 10 were left on the patient's neck. After removal, only the area of ​​the patient's neck below the substrate layer 2 is covered, leaving the rest of the neck exposed and accessible for other medical interventions (for example, the internal jugular vein may be used for venous access in the event of cardiac arrest). Thus, this ultrasonic transducer mounting device 1 assists in the easy and accurate initial placement of the ultrasonic transducer 8, and after the position of the transducer 8 is fixed, it minimizes obstruction of the patient's neck.

[0065] Figure 6 shows a transducer mounting device 1' according to a second embodiment of the present invention. This device comprises all the same components as the embodiment in Figure 1. For convenience, these components are given the same reference numerals as those used in Figure 1, but in Figure 6, an apostrophe is added after these reference numerals.

[0066] In this embodiment, slits are formed in specific components of the transducer mounting device 1', allowing the cable 9' to be routed away from the ultrasonic transducer 8' to a location outside. These slits are shown by dashed lines in Figure 6.

[0067] A first slit 90' is formed in the substrate layer 2', extending inward along a first direction from the outer edge of the substrate layer 2' (the right edge in Figure 6). As a result, the cable 9' is housed within the slit 90', allowing it to move at least linearly relative to the substrate layer 2', thus enabling it to move further away from the ultrasonic transducer 8' when exiting the mounting device 1'.

[0068] In this example, a second slit 92' is formed in the removable alignment layer 10' and is aligned with the first slit 90'. The second slit 92' extends inward along the first direction from the outer edge of the removable alignment layer 10'. This allows the cable 9' to extend further away from the ultrasonic transducer 8' along its longitudinal direction and, if necessary, can also extend forward (i.e., approximately perpendicular to the plane of the ultrasonic transducer 8'). In other embodiments, this second slit 92' is not necessarily present, and instead the cable 9' may extend between the substrate layer 6' and the removable alignment layer 10'.

[0069] The applicant recognized that the presence of one or more slits improves the adhesion of the ultrasonic transducer 8' to the patient and / or reduces the risk of the ultrasonic transducer 8' detaching, as the force is transmitted to the mounting device 1' closer to the ultrasonic transducer 8' rather than to the outer edge of the substrate layer 2' if a pulling force is accidentally applied to the cable 9.

[0070] Although the present invention has been described with reference to one or more specific embodiments, it will be apparent to those skilled in the art that the present invention is not limited to these embodiments, and that many modifications and alterations are possible within the scope of the accompanying claims.

Claims

1. An ultrasonic transducer mounting device, A substrate layer having a first surface and a second surface, wherein the second surface is on the opposite side of the first surface, and the first surface has a first adhesive surface for adhering to the skin of the neck of a human or animal patient, An ultrasonic transducer fixed to the first surface of the substrate layer for placement in close proximity to the patient's carotid artery, The substrate layer includes a removable alignment layer that is removably bonded to the second surface of the substrate layer, extends beyond the substrate layer in at least a first direction along the first axis, and assists in aligning the ultrasonic transducer to bring it close to the patient's carotid artery. An ultrasonic transducer mounting device characterized by the following.

2. The removable alignment layer is provided with one or more alignment features. The ultrasonic transducer mounting device according to claim 1, characterized by the above.

3. One or more of the aforementioned alignment features include notches and / or protrusions and / or visible surface marks. The ultrasonic transducer mounting device according to claim 2, characterized by the above.

4. One or more of the alignment features indicate the center of the removable alignment layer on the first axis for alignment near the center of the patient's neck. The ultrasonic transducer mounting device according to claim 2 or 3, characterized by the above.

5. The entire substrate layer is positioned on one side of the centerline of the removable alignment layer in the first axis. An ultrasonic transducer mounting device according to any one of claims 1 to 4, characterized by the above.

6. The removable alignment layer has a maximum length in the first axis that is at least twice the maximum length of the substrate layer in the first axis. An ultrasonic transducer mounting device according to any one of claims 1 to 5, characterized by the above.

7. The removable alignment layer is elongated along the first axis. An ultrasonic transducer mounting device according to any one of claims 1 to 6, characterized by the above.

8. The removable alignment layer has a length in the second axis perpendicular to the first axis that is the same as the length of the substrate in the second axis. An ultrasonic transducer mounting device according to any one of claims 1 to 7, characterized by the above.

9. The removable alignment layer has a length of 200 mm or more in the first axis. An ultrasonic transducer mounting device according to any one of claims 1 to 4, characterized by the above.

10. The removable alignment layer extends 100 mm or more beyond the substrate layer in the first direction. An ultrasonic transducer mounting device according to any one of claims 1 to 9, characterized by the above.

11. The substrate layer has a length of 50 mm or more and a maximum of 125 mm in the first direction. An ultrasonic transducer mounting device according to any one of claims 1 to 10, characterized by the above.

12. The ultrasonic transducer is offset from the center line of the removable alignment layer in the direction opposite to the first direction. An ultrasonic transducer mounting device according to any one of claims 1 to 11, characterized by the above.

13. The ultrasonic transducer is offset from the center line of the removable alignment layer, and the center of the ultrasonic transducer is located approximately 50 mm away from the center line of the removable alignment layer along the first axis. The ultrasonic transducer mounting device according to claim 12, characterized by the above.

14. Furthermore, the substrate layer is provided with a backing cover that covers the first adhesive surface, and the ultrasonic transducer is positioned between the substrate layer and the backing cover. An ultrasonic transducer mounting device according to any one of claims 1 to 13, characterized by the above.

15. The removable alignment layer comprises a first portion bonded to the second surface of the substrate layer with a first adhesive strength, and a second portion extending beyond the substrate layer in the first direction and bonded to the backing cover with a second adhesive strength greater than the first adhesive strength. The ultrasonic transducer mounting device according to claim 14, characterized by the above.

16. The backing cover is provided with tabs that extend in a direction away from the substrate layer along the first axis in order to facilitate the removal of the backing cover from the substrate layer. An ultrasonic transducer mounting device according to claim 14 or 15, characterized by the above.

17. The device further comprises an acoustic coupling layer disposed between the ultrasonic transducer and the backing cover. An ultrasonic transducer mounting device according to any one of claims 14 to 16, characterized by the above.

18. The acoustic coupling layer is an ultrasonic coupling gel, hydrogel, or silicone compound. The ultrasonic transducer mounting device according to claim 17, characterized by the above.

19. The removable alignment layer is bonded to the substrate layer with an adhesive strength less than the adhesive strength between the first adhesive surface of the substrate layer and the patient's skin after the first adhesive surface is attached to the patient. An ultrasonic transducer mounting device according to any one of claims 1 to 18, characterized by the above.

20. In order to allow the removable alignment layer to conform to the patient's neck, the removable alignment layer must be flexible. An ultrasonic transducer mounting device according to any one of claims 1 to 19, characterized by the above.

21. The first adhesive surface contains hydrogel. An ultrasonic transducer mounting device according to any one of claims 1 to 20, characterized by the above.

22. The substrate layer has a slit that accommodates the cable of the ultrasonic transducer and / or is arranged so that the cable can pass through the slit. An ultrasonic transducer mounting device according to any one of claims 1 to 21, characterized by the above.

23. The removable alignment layer is provided with a slit, which houses the cable of the ultrasonic transducer and / or allows the cable to pass through the slit. An ultrasonic transducer mounting device according to any one of claims 1 to 22, characterized by the above.

24. A method for attaching an ultrasonic transducer to the skin of the neck of a human or animal patient, in close proximity to and alongside the patient's carotid artery, The ultrasonic transducer is fixed to the first surface of the substrate layer. The first surface has a first adhesive surface for adhering to the patient's skin, A removable alignment layer is detachably bonded to a second surface of the substrate layer opposite to the first surface, extending beyond the substrate layer at least in a first direction along the first axis, to assist in aligning the ultrasonic transducer to bring it close to the patient's carotid artery. The aforementioned method, The steps include aligning the ultrasonic transducer on the patient's carotid artery using the alignment layer, The steps include applying pressure to the substrate layer to adhere the first adhesive surface to the patient's skin, The step of removing the alignment layer from the substrate layer, thereby exposing the neck region of the patient. A method characterized by the following.

25. The ultrasonic transducer mounting device further comprises a backing cover that covers the first adhesive surface of the substrate layer, The method further includes the step of removing the backing cover to expose the first adhesive surface. The method according to claim 24, characterized by the above.

26. The removable alignment layer comprises a first portion that is removablely bonded to a second surface of the substrate layer, and a second portion that extends beyond the substrate layer in the first direction and is bonded to the backing cover. The method further includes the step of removing the backing cover to expose the first adhesive surface, and after removing the backing cover, the step of unfolding the removable alignment layer from a folded state. The method according to claim 24 or 25, characterized by the above.

27. The removable alignment layer, which is flexible in order to align the removable alignment layer with the patient's neck, The method further includes the step of aligning the removable alignment layer to the patient's neck before removing the removable alignment layer from the substrate layer. The method according to any one of claims 24 to 26, characterized by the above.

28. The method further includes the step of aligning the alignment layer such that the first direction is perpendicular to the midline plane of the patient. The method according to any one of claims 24 to 27, characterized by the following:

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