Method for inserting a puncture device into a subject's skin using a skin cover unit.

Abstract

A method for inserting a puncture device through the skin of a subject includes the steps of: applying a skin cover unit to the skin of the subject at the puncture site; imaging the anatomical structures and / or the puncture device beneath the skin of the subject at or near the puncture site using an ultrasound probe on the upper side of the base in a distal direction; and inserting the puncture device at the puncture site.

Description

Technical Field

[0005]

[0001] Cross - Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 508,077, filed on June 14, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0002]

[0002] This disclosure relates to an ultrasonic - transmissive surgical skin cover unit for use when inserting a puncture device, such as a cannula, electrode, or probe, into the human body, for example, into a vein or artery. In particular, a procedure is provided that involves an ultrasonic device for visualization of the exact location for puncture using a puncture device.

Background Art

[0003] When a cannula is inserted into a part of the body, such as a blood vessel in an arm or leg, the insertion can be optimized by using ultrasonic visualization to visualize the blood vessel and the cannula.

[0004]

[0004] U.S. Patent No. 9,393,381 discloses a skin cover unit for this purpose. The skin cover unit includes an ultrasonic - transmissive window made of a polymer film, the ultrasonic - transmissive window is adhered onto the skin at the puncture site, and an ultrasonic probe is disposed on the ultrasonic - transmissive window to image the puncture site during insertion of the cannula. Typically, a gel is used between the probe and the film for better contact between the ultrasonic probe and the base polymer film. To properly separate the probe from the puncture site and to prevent the gel from flowing onto the puncture site, a vertical wall is provided within an extension of the base to separate the window from the puncture site. The film for the window is relatively rigid, allowing the vertical wall to be in a position perpendicular to the window. Optionally, the unit includes a gel - removal layer on top of the window for removing the gel - removal layer together with the gel from the window after ultrasonic visualization.

Summary of the Invention

[0005]

[0005] The present disclosure provides an improved skin cover unit for ultrasound-assisted control when inserting a cannula or other puncture device into a puncture site on the skin, for example, for injection or blood collection. This objective is achieved by the surgical skin cover unit and its use, as will be described in more detail below.

[0006]

[0006] In one embodiment, the skin cover unit includes a base and walls within the extension of the base, connected to the base by a bending region located at the proximal end of the base to bend the walls so as to be angled relative to the base. The base includes an ultrasound-transmitting flexible sheet extending to the distal end of the cover unit. The base includes a stabilizing but equally flexible frame. The frame, together with the ultrasound-transmitting flexible sheet, defines an ultrasound-transmitting window. The ultrasound-transmitting window extends all the way to the distal end of the cover unit; that is, the frame is open at the distal end of the cover unit.

[0007]

[0007] In one embodiment, a method for inserting a puncture device through the skin of a subject includes the steps of: applying a skin cover unit to the skin of the subject at the puncture site; imaging the anatomical structures and / or the puncture device beneath the skin of the subject at or near the puncture site using an ultrasound probe on the upper side of the base in a distal direction; and inserting the puncture device at the puncture site.

[0008]

[0008] In one embodiment, a method for inserting a puncture device through the skin of a subject includes the steps of: applying a skin cover unit to the skin of the subject at the puncture site; imaging the anatomical structures and / or the puncture device beneath the skin of the subject at or near the puncture site using an ultrasound probe on the upper side of the cover unit in a distal direction; inserting the puncture device at the puncture site; and imaging the anatomical structures and / or the puncture device beneath the skin of the subject beyond the distal end of the cover unit in a distal direction using an ultrasound probe. [Brief explanation of the drawing]

[0009] [Figure 1]

[0009] This is a top view of a conventional skin cover unit in a flexible configuration. [Figure 2A]

[0010] This is a top view of a skin cover unit according to an embodiment of the present disclosure. [Figure 2B]

[0011] This is a cross-sectional view of the skin cover unit in a bent configuration according to an embodiment of the disclosure. [Figure 3A]

[0012] This is a cross-sectional view of the skin cover unit before bending according to an embodiment of the present disclosure. [Figure 3B]

[0013] This is a cross-sectional view of the skin cover unit after the stabilizer according to the embodiment of the present disclosure has been bent. [Figure 3C]

[0014] This is a cross-sectional view of the skin cover unit after the wall has been bent relative to the base according to an embodiment of the present disclosure. [Figure 4A]

[0015] This is a perspective view of the skin cover unit in a flat configuration before removal of a predetermined portion of the cover sheet according to an embodiment of the present disclosure. [Figure 4B]

[0016] This is a perspective view of the skin cover unit in a flat configuration during the removal of a predetermined portion of the cover sheet according to an embodiment of the present disclosure. [Figure 4C]

[0017] This is a perspective view of the skin cover unit in the flexed configuration before final attachment of the stabilizer according to the embodiments of this disclosure. [Figure 5A]

[0018] This is a cross-sectional view of the cover unit in a flat configuration before being applied to the skin of a subject according to an embodiment of the present disclosure. [Figure 5B]

[0019] This is a cross-sectional view of the cover unit in a flat configuration after it has been applied to the skin of a subject according to an embodiment of the present disclosure. [Figure 6A]

[0020] This is a cross-sectional view of the skin cover unit in a flat configuration when the stabilizer according to the embodiment of this disclosure is bent. [Figure 6B]

[0021] This is a cross-sectional view of a skin cover unit after it has been applied to a subject's skin, with the wall in a bent configuration relative to the base according to an embodiment of the disclosure. [Figure 7]

[0022] This is a cross-sectional view of a further embodiment of a stabilizer according to the embodiments of the present disclosure. [Figure 8]

[0023] This is a cross-sectional view of a skin cover unit similar to Figure 6B, having an added gel removal strip, according to an embodiment of the present disclosure. [Figure 9]

[0024] Figure 9A is a cross-sectional view of a skin cover unit similar to Figure 8, according to an embodiment of the present disclosure, having a gel removal strip along with a gel removal strip extending beneath the stabilizer for the removal of the stabilizer.

[0025] Figure 9B is a cross-sectional view of the skin cover unit in a flat configuration after the removal of the gel removal strip and stabilizer. [Modes for carrying out the invention]

[0010]

[0026] Conventional skin cover units enable ultrasonic assistance control when inserting a cannula or other puncture device at a puncture site on the skin of a subject for, for example, blood sampling or injection. However, when the cannula or other puncture device is relatively long, appropriate ultrasonic assistance control may not be provided. Conventional skin cover units may provide ultrasonic assistance control laterally when a relatively long cannula or other puncture device is used. However, conventional skin cover units do not provide appropriate ultrasonic assistance control longitudinally when a relatively long cannula or other puncture device is used. This is because the distal end of the skin cover unit may block the ultrasonic scan. Even when a relatively short cannula or other puncture device is used, in order to avoid this ultrasonic scan block, it may be necessary for the user to place the conventional skin cover unit in a more precise location.

[0011]

[0027] FIG. 1 is a diagram of such a conventional skin cover unit 1. The skin cover unit 1 includes a base 2 and a wall 3 within an extension of the base 2. The skin cover unit 1 also includes a tab 31 at the distal end. The wall 3 is connected to the base 2 by a bending region 4 to orient the wall 3 in an angled orientation with respect to the base 2. The base 2 includes a stabilization frame 5 and an ultrasonic transmissive flexible sheet 6, typically a polymer film, on or within the frame 5 or at least partially within the frame 5 for ultrasonic exploration of an insertion site (not shown) by an ultrasonic probe (not shown). The flexible sheet 6 is attached to and supported by the frame 5. Further, the flexible sheet 6 includes an adhesive layer (not shown) on the bottom side of the flexible sheet 6 for adhering the base 2 to the skin of the subject (not shown). The frame 5 creates an ultrasonic transmissive window 30. The distal portion 5' of the frame 5 sets the boundary of the ultrasonic transmissive window 30 longitudinally.

[0012]

[0028] Here, when a relatively long cannula (e.g., a cannula longer than the vertical length of the ultrasonic transmissive window 30 of the skin cover unit 1) is used in combination with the skin cover unit 1, the distal portion of the frame 5 of the cover unit 1 is not ultrasonically transmissive, and thus may block the ultrasonic examination view of the relatively long cannula and the anatomical structures around the end of the relatively long cannula. Even when a shorter cannula is used, this prior art skin cover unit 1 requires a more precise application to the skin. This is because if the distal portion of the frame 5 of the cover unit 1 is placed too close to the puncture site, it may interfere with the ultrasonic scan.

[0013]

[0029] Therefore, there is a need to improve ultrasonic-assisted control when inserting a cannula or other puncture device at a puncture site on the skin.

[0014]

[0030] According to the present disclosure, using a skin cover unit having a configuration in which the tip is open at the distal end provides an ultrasonic examination view that is not blocked even in a relatively long cannula and the anatomical structures around the end of the cannula. Similarly, precise application of the skin cover unit is not emphasized by this configuration in which the tip is open.

[0015]

[0031] As used throughout the present disclosure, the term "proximal" refers to the direction toward the puncture site. Conversely, the term "distal" refers to the direction away from the puncture site. The distal direction typically corresponds to the direction of penetration of the cannula or puncture device into the skin.

[0016]

[0032] As used throughout the present disclosure, the term "lateral" refers to a direction perpendicular to the proximal-distal direction. The term "longitudinal" refers to the proximal-distal direction.

[0017]

[0033] As used throughout this disclosure, the term “puncture site” refers to the exact location where a cannula (typically having a diameter ranging from 0.6 to 2.1 mm) or another puncture device penetrates the skin of a subject or its vicinity. For example, a puncture site may include an area having a radius of 0.5 mm or less, 1 mm or less, 1.5 mm or less, 2 mm or less, 3 mm or less, 4 mm or less, 5 mm or less, 6 mm or less, 7 mm or less, 8 mm or less, 9 mm or less, 10 mm or less, 15 mm or less, or 20 mm or less, or any radius in between, relative to the exact location where the cannula or other puncture device penetrates the subject's skin. For the purposes of this disclosure, skin cover units are not penetrated by a cannula or any other puncture device. Therefore, a skin cover unit positioned “at a puncture site” does not mean that any part of the skin cover unit directly covers the exact location of skin penetration by the cannula or other puncture device. After penetration, a portion of the skin cover unit may cover and secure the cannula or other puncture device to prevent it from falling out. At the puncture site, the skin cover unit may or may not be in direct contact with the skin.

[0018]

[0034] While this disclosure exemplifies the insertion of a cannula or catheter as a puncture device, it also encompasses the insertion of different types of puncture devices, such as electrodes for nerve stimulation, transducers for recording electrical signals from nerves, or cannulas or catheters for injecting steroids or anesthetics for nerve blocks. A further use of the skin cover unit is the insertion of probes for the analysis of chemical agents, such as oxygen, metabolites, or drugs.

[0019]

[0035] Imaging of the subcutaneous anatomical structures and / or the puncture device at or near the puncture site in the distal direction using the ultrasound probe on the upper side of the base / cover unit; insertion of the puncture device at the puncture site; and imaging of the subcutaneous anatomical structures and / or the puncture device beyond the distal end of the cover unit in the distal direction using the ultrasound probe may be performed in any order and may be performed simultaneously at any given moment.

[0020]

[0036] In one embodiment, imaging of the subcutaneous anatomical structures and / or the puncture device at or near the puncture site in the distal direction using the ultrasound probe on the upper side of the base / cover unit may be performed in the first pass, insertion of the puncture device at the puncture site may be performed in the second pass (the first step does not need to be stopped when performing the second step), and imaging of the subcutaneous anatomical structures and / or the puncture device beyond the distal end of the cover unit in the distal direction using the ultrasound probe may be performed in the third pass (the first and / or second steps do not need to be stopped when performing the first and / or second steps).

[0021]

[0037] In one embodiment, insertion of the puncture device at the puncture site may be performed in the first pass, imaging of the subcutaneous anatomical structures and / or the puncture device at or near the puncture site using the ultrasound probe on the upper side of the base / cover unit in the distal direction may be performed in the second pass (the first step does not need to be stopped when performing the second step), and imaging of the subcutaneous anatomical structures and / or the puncture device beyond the distal end of the cover unit using the ultrasound probe in the distal direction may be performed in the third pass (the first and / or second steps do not need to be stopped when performing the first and / or second step).

[0022]

[0038] In one embodiment, insertion of the puncture device at the puncture site may be performed in the first pass, imaging of the subcutaneous anatomical structures of the subject beyond the distal end of the cover unit and / or the puncture device in the distal direction using the ultrasound probe may be performed in the second pass (the first step does not need to be stopped when performing the second step), and imaging of the subcutaneous anatomical structures of the subject at or near the puncture site and / or the puncture device in the distal direction using the ultrasound probe on the upper side of the base / cover unit may be performed in the third pass (the first and / or second steps do not need to be stopped when performing the first and / or second steps).

[0023]

[0039] Figure 2A is a diagram of a skin cover unit 101 according to an embodiment of the present disclosure. The skin cover unit 101 includes a base 102 and a wall 103 within an extension of the base 102. The base 102 and the wall 103 may be made of a single component or of different components. The skin cover unit 101 also includes a tab 131 on one side of the distal end. The wall 103 is connected to the base 102 by a bending region 104 to orient the wall 103 to be angled relative to the base 102. The base 102 includes a stabilizing frame 105 and an ultrasound-transparent flexible sheet 106, typically a polymer film, on or within the frame 105, or at least partially within the frame 105, for ultrasound exploration of the insertion site 120 by an ultrasound probe 119. The flexible sheet 106 is attached to and supported by the frame 105. Furthermore, the flexible sheet 106 includes an adhesive layer 107 on the first side of the flexible sheet 106 to adhere the base 102 to the subject's skin 108. The frame 105 creates an ultrasound-transparent window 130. The distal portion of the frame 105 is absent such that the longitudinal boundary of the ultrasound-transparent window 130 is the distal end of the flexible sheet 106. Advantageously, relatively long cannulas can be used by guidance of an unobstructed ultrasound view of the anatomical structures around the tip of the relatively long cannula, and thus the cannula is typically inserted into relatively larger and / or relatively deeper veins. Compared to a standard cannula or catheter length of 2–6 cm, relatively long cannulas or catheters may have non-limiting lengths of approximately 6–8 cm, approximately 8–15 cm, or approximately 15–25 cm, or any length in between.

[0024]

[0040] Typically, the wall 103 is made of polymer film, paper, or dressing textile, or a combination thereof. For transport, typically, the wall 103 is placed within the longitudinal extension of the base 102 so that the base 102 and wall 103 are packaged in a flat state. Alternatively, the base 102 and wall 103 may be folded over each other to form a compact double-layer structure that must be unfolded for use.

[0025]

[0041] When the skin cover unit 101 is unpacked from its packaging, the wall 103 folds relative to the base 102 to an angled, typically perpendicular, or nearly perpendicular orientation, providing the wall 103 in an upright orientation relative to the skin 108. This folding is performed before or after the base 102 is adhered to the skin 108.

[0026]

[0042] Frame 105 may be made of materials including, but not limited to, woven fabrics, knitted fabrics, non-woven fabrics, plastics, rubber, paper, silicone, or combinations thereof.

[0027]

[0043] The ultrasound-permeable flexible sheet 106 may be made of materials including, but not limited to, rubber, paper, silicone, plastic, or a combination thereof. Non-limiting examples of plastics include polyurethane or elastomer polyester (e.g., polyethylene (PE), polyethylene terephthalate (PET)). The ultrasound-permeable flexible sheet 106 is understood as a sheet having sufficient elasticity and resilience to follow the movement of the skin and remain attached. For example, the flexible sheet 106 has a thickness in the range of about 10 to about 45 microns.

[0028]

[0044] Wall 103 may be made of materials including, but not limited to, textiles, knitted fabrics, non-woven fabrics, plastics, rubber, paper, silicone, or combinations thereof.

[0029]

[0045] The skin cover unit 101 can have a width of approximately 1 to 20 cm, approximately 2 to 15 cm, approximately 3 to 12.5 cm, approximately 4 to 10 cm, approximately 5 to 8 cm, or any width in between. Preferably, the skin cover unit 101 has a width of approximately 4 to 10 cm. The skin cover unit 101 can have a length of approximately 1 to 30 cm, approximately 3 to 25 cm, approximately 5 to 20 cm, approximately 6 to 15 cm, approximately 7.5 to 12 cm, or any length in between. Preferably, the skin cover unit 101 has a length of approximately 6 to 15 cm. The skin cover unit 101 can have thicknesses for each layer ranging from approximately 1 to approximately 3000 microns, approximately 1 to approximately 2000 microns, approximately 1 to approximately 1000 microns, approximately 1 to approximately 500 microns, approximately 1 to approximately 250 microns, approximately 5 to approximately 100 microns, approximately 10 to approximately 45 microns, or any thickness in between. Preferably, the skin cover unit 101 has thicknesses for each layer ranging from approximately 10 to approximately 45 microns.

[0030]

[0046] In Figure 2B, the flexible sheet 106 is shown positioned on the frame side, away from the skin 108; however, the flexible sheet 106 may alternatively be positioned facing the skin 108, inside the frame 105, or between the frame 105 and the adhesive layer. When the flexible sheet 106 is positioned below the frame, an adhesive layer 107 may be provided to adhere the flexible sheet 106 to the skin 108. When the flexible sheet 106 is positioned on the frame 105, as shown in Figure 2B, the frame 105 may similarly be provided with an adhesive layer 107 to adhere the frame to the skin 108. At the start of the puncture procedure, the puncture site is localized, cleaned, or sterilized.

[0031]

[0047] A flexible sheet 106, typically made of a flexible polymer film, is attached to and supported by a frame 105. The flexible sheet 106 is ultrasonically transparent. For example, the material of the frame 105 is thicker, mechanically stable, and rigid compared to the flexible sheet 106. The stable frame 105 allows the thin, flexible flexible sheet 106 to easily bend with the skin and make close contact with the skin for good ultrasonic transmission. That is, the stable frame 105 supports the flexible sheet 106 so that it is positioned on the subject's skin 108 without forming wrinkles and without sticking to itself. The stable frame 105 may help maintain the wall 103 at a certain angle relative to the base 102; however, it is preferable to have a stabilizer 109 in the bending region 104 to maintain the angled orientation. Typically, the flexible sheet 106 is also light-transmitting to allow examination of the puncture site by the eye and / or a patient care camera.

[0032]

[0048] In one embodiment, an ultrasonically transparent flexible sheet 106, for example, a polymer film, is bonded to the skin 108 with an adhesive 107, the adhesive 107 providing good contact for ultrasonic transmission from the flexible sheet 106 and into the skin 108. However, this is not strictly necessary. For example, if the sheet 106 is made of a thin polymer film, the film itself may readily adhere to the skin 108 and conform to the contours of the skin 108 even without glue. The principle is similar to the adhesive properties of kitchen wrap film. However, in the case of such a thin and flexible film, a stable frame 105 is advantageous in that it provides the necessary stability to hold not only the film but also the wall 103, and the film can be made thin enough for good skin contact.

[0033]

[0049] As a further alternative, only the frame 105 has adhesive on the side adjacent to the skin, and the flexible sheet simply comes into contact with the skin 108. Some polymer films adhere easily to the skin even without glue and have sufficient ultrasonic transmission for exploration.

[0034]

[0050] An adhesive layer 107 is provided on the bottom side of the base 102 for adhering the base to the subject's skin 108. The opposing upper side of the base 102 is configured to contact / be in contact with the ultrasound probe 119 for visualization of the insertion area adjacent to (and distal to) the base 102 when the puncture device is inserted into the skin 108.

[0035]

[0051] To provide good contact between the ultrasonic probe 119 and the flexible sheet 106 of the base 102, it is often advantageous to use an ultrasonic fluid, typically a gel 114. This gel 114 is applied to the ultrasonically transparent flexible sheet 106 before ultrasonic exploration and then removed again. For example, the gel 114 is wiped off after use of the ultrasonic probe 119. Alternatively, a gel removal strip, which is also ultrasonically transparent, is provided on top of the flexible sheet 106 and forms part of the base 102. This gel removal strip is then removed from the ultrasonically transparent flexible sheet 106 along with the gel 114, thereby avoiding wiping the gel 114 from the base. For example, the gel removal strip extends under at least part of the stabilizer 109, or, for example, under the entire stabilizer 109, for manual removal of the gel removal strip from the flexible sheet 106, which also removes the stabilizer 109.

[0036]

[0052] Furthermore, the skin cover unit 101 may include a stabilizer 109 within or in the bending region 104. The stabilizer 109 is configured to maintain an angled orientation between the wall 103 and the base 102, such as a vertical orientation, simply by the stabilizing action of the stabilizer 109, for example, when the skin cover unit 101 is positioned on top of a flat, straight skin surface. In one embodiment, the stabilizer 109 is positioned outside the ultrasonic transparent window 130. Optionally, the stabilizer 109 or a portion of the stabilizer 109 is positioned along the periphery of the ultrasonic transparent window 130. In one embodiment, the stabilizer 109 is provided on the frame 105 and on the wall 103 to stabilize the orientation of the wall 103 relative to the frame 105.

[0037]

[0053] The stabilizer 109 may be made of materials including, but not limited to, polyester, polyethylene terephthalate (PET), polyethylene, polyamide (e.g., nylon), paper (typically coated), or a combination thereof.

[0038]

[0054] The stabilizer 109 is located in or near the bending region 104, which is typically the region where the wall 103 connects to the base 102. For example, the stabilizer 109 is bendable itself so that the base 102 and the wall 103 are bent manually around the bending region 104 so that they are bent from a planar or crushed configuration to a bent configuration in which the wall 103 is angled with respect to the base 102, for example, angled perpendicular to the base 102. However, once the wall 103 is bent to an angled orientation with respect to the base 102, for example, a perpendicular orientation, the stabilizer 109 maintains the angled orientation between the wall 103 and the base 102. Typically, the bend of the wall 103 with respect to the base 102 around the bending region 104 lies along the bend line.

[0039]

[0055] In one embodiment, the stabilizer 109 is inelastically flexible and configured to adopt and maintain a selectable flexed state when bent, thereby maintaining a selected orientation of the wall 103 relative to the base 102. Once bent to a selected flexed configuration, the inelastic stabilizer 109 maintains this configuration. For example, the stabilizer 109 includes a metal foil having inelastic flexibility properties. Optionally, the stabilizer 109 is provided as an inelastically flexible hinge, for example, an inelastically flexible polymer sheet or metal foil, which adopts and maintains a selectable flexed state when bent, thereby maintaining a selected orientation of the wall 103 relative to the base 102.

[0040]

[0056] In one embodiment, the stabilizer 109 is bent during manufacturing to form a crushed double-layer configuration and supplied in a crushed position where the base 102 abuts against the wall 103. The stabilizer 109 is then straightened at least partially for use. Alternatively, the stabilizer 109 is not bent during manufacturing and is supplied in a straight configuration, typically a flat configuration, and the stabilizer 109 is then bent for use.

[0041]

[0057] In Figures 2A and 2B, the stabilizer 109 is shown as an angled profile having two legs 111A and 111B, where one leg 111A is bonded to the wall 103 by a first stabilizer-adhesive 110A, and the other leg 111B is bonded to the base 102 by a second stabilizer-adhesive 110B, thus maintaining the angled orientation between the wall 103 and the base 102.

[0042]

[0058] If the flexible sheet 106 is provided on the upper side of the frame 105, on the side furthest from the side having the adhesive 107, the stabilizer 109 will be attached to the flexible sheet 106 by the portion of the flexible sheet that adheres to the frame itself. If the flexible sheet 106 is provided only within the frame 105, the stabilizer will instead be attached directly to the frame 105, since the frame at least partially surrounds the flexible sheet 106. If the flexible sheet 106 is provided between the frame 105 and the skin 108, the stabilizer 109 will be attached to the frame, because in this case the frame 105 is attached to the opposing upper side of the flexible sheet 106. In any case, the stabilizer is attached to the frame directly or through a film on the frame. Various embodiments and variations of the principle are possible.

[0043]

[0059] The upright wall 103 is provided with the wall adhesive layer 117 covered by a cover sheet 118, and the use of the upright wall 103 will be described in more detail below, particularly in reference to Figures 5A, 5B, 6A, and 6B.

[0044]

[0060] As shown in Figure 2A, the stabilizer 109 is provided as two separate flex strips, one flex strip on either side of the flexible sheet 106. Each strip has a first leg 111A attached to the wall around the sheet 106 and outside the sheet 106, and a second leg 111B attached to the frame 105, and the sheet 106 covers the ultrasonic transparent window 130.

[0045]

[0061] Alternatively, the stabilizer 109 has a second leg 111B attached to the frame 105 on either side of the frame 105. However, the leg 111A attached to the wall 103 extends across the wall 103 from one side edge of the wall to the opposite side edge of the wall 103. The configuration of the stabilizer in this embodiment resembles a C shape.

[0046]

[0062] As shown in Figures 2A and 2B, the flexible sheet 106 extends around the bending region 104 by a smaller portion 106' of the flexible sheet 106, so that the smaller portion 106' bends upward together with the wall 102.

[0047]

[0063] In an alternative embodiment, the sheet 106 is not bent upward together with the wall 102, but has a periphery of the stabilizer 109 in the bent region 104. In this case, the sheet 106 is simply provided in close contact with the skin.

[0048]

[0064] In a further alternative embodiment, the configuration of the base 102 having walls 103 and frame 105 can be combined with the stabilizer strip 109 shown in Figure 2A.

[0049]

[0065] In all cases, the stabilizer 109 is located outside the portion of the base 102 used for ultrasonic exploration.

[0050]

[0066] It should be noted that the stabilizer 109 is initially attached to the base 102 and wall 103, then bent to form an angled configuration, and that this angled configuration is then maintained by the non-elastic material of the stabilizer 109, such as metal.

[0051]

[0067] Alternatively, one leg 111A of the stabilizer 109 may be attached to the wall 103, while the other leg 111B is not yet attached to the base 102, or vice versa, but once the orientation between the wall and the base is adjusted, the legs may be attached to either the base or the wall, respectively. This option of principle will be described in more detail below.

[0052]

[0068] Figure 3A shows possible packaging and transport states of the cover unit 101. The wall 103 is oriented within the flat extension of the base 102. The adhesive layer 107 for adhesion to the skin is covered by a removable cover sheet 112, typically, paper. The two legs 111A and 111B of the stabilizer 109 are folded together and configured to unfold as shown in Figure 3B. The second stabilizer-adhesive 110B is covered by a further cover sheet 113, typically, further paper, and the further cover sheet 113 is removed from the second stabilizer-adhesive 110B as shown in Figure 3B. Once the cover unit 101 shown in Figure 2A is removed from its packaging (not shown) and the additional cover sheet 113 is removed from the second stabilizer-adhesive 110B, the wall 103 is bent around the bending region 104 so as to be angled relative to the base 102, and the second stabilizer-adhesive 110B is then adhered to the base 102, stabilizing the orientation of the wall 103 relative to the base 102, as shown in Figure 3C. In the case of adhesion to skin 108, the cover sheet 112 is removed and the adhesive layer 107 of the base 102 is adhered to the skin 108. This is preferably done before bending the wall 103 relative to the base 102, but can be done after bending the wall 103.

[0053]

[0069] In one embodiment, the cover unit 101 is removed from the subject after ultrasound exploration and insertion of a puncture device, particularly cannula insertion, or alternatively, insertion of another puncture device, such as an electrode or probe. In other situations, the cover unit 101 remains on the subject's skin 108 even after exploration and insertion of a puncture device, such as a cannula. In the latter case, the wall 103 can, in principle, be removed from the base 102, for example, by detaching the wall 103. Alternatively, the wall 103 is bent on the base 102 and remains there. In these situations, the wall 103 does not need to be fitted with adhesive 117, in contrast to the figures in Figures 2B, 5A, 5B, 6A, and 6B.

[0054]

[0070] However, as will be described in more detail below, the wall 103 is optionally bonded to the skin 108 after ultrasound exploration and insertion of a cannula or other puncture device into the skin 108. Thus, although the adhesive layer 107 is shown in Figure 2B as merely extending along the base 102, the adhesive layer 107 may also be provided beneath the wall 103. Such embodiments are shown in Figures 2B, 5A, 5B, 6A, and 6B and will be described in more detail below.

[0055]

[0071] Figures 4A, 4B, and 4C show the sequence of preparation steps from the just-unpacked state to the bent configuration. In Figure 4A, the cover unit 101 is in a flat, straight configuration immediately after unpacking. The wall 103 is within the straight extension of the base 102. The base 102 is not yet permeable as it is covered by a cover sheet (not shown) on its skin-adjacent side. However, once such a cover sheet is removed, the permeable flexible sheet 106 is clearly visible inside the frame 1015, as shown in Figure 4B. Further cover sheets 13 can be seen in Figure 4A and during the removal process in Figure 4B. After the removal of further cover sheets 113, two flaps 111B' corresponding to the second leg 111B in Figure 2B can be seen in Figure 4C. These two flaps 111B' are two parts of the stabilizer 109 and are provided on opposite edges 115A, 115B of the wall 103 to secure the two flaps 111B' to two opposing parts 105A, 105B of the frame 105 of the base 102. Once these flaps 111B' are bonded to the base 102, the wall 103 is fixed to the base 102 in a predetermined orientation, as shown in Figure 2A.

[0056]

[0072] In some embodiments, the wall 103 includes a slot 116 extending from the end of the wall 103 toward the base 102. As can be best seen in Figure 2A, the slot 116 has a bottom 116' that is close to the flexible sheet 106 near the bending region 104. In some embodiments, the slit may be provided within the wall material, and the slot 116 may then be provided by pushing apart two adjacent opposing edges of the slit.

[0057]

[0073] Alternatively, the slot 116 is provided with an appropriate width to facilitate the insertion of the puncture device. As shown in Figures 2B, 5A, 6A, and 6B, the wall 103 includes a first wall side 103A having adhesive 117 for adhering the wall 103 to the subject's skin 108 and for positioning the cannula inside the slot 116 while the wall 103 is adhering to the subject's skin 108. The adhesive 117 is covered by a wall cover sheet 118. Once the wall cover sheet 118 is removed, the first side 103A of the wall 103 can also be adhering to the subject's skin 108 by the adhesive 117.

[0058]

[0074] In one embodiment, the wall cover sheet 118 is maintained on the adhesive 117 of the first wall side 103A, while the wall cover sheet 118 is used as an upright wall 103 adjacent to the insertion site while the wall 103 is bent relative to the base 102. Selectively, the wall cover sheet 118 is then removed from the wall 103, which is adhered to the patient's skin 108 after the adhesive 117 and insertion of the puncture device, to accommodate the puncture device inside the slot after adhesion. Alternatively, the wall cover sheet 118 on the adhesive 117 on the wall 103 is removed along with the wall cover sheet 112 on the adhesive 107 of the base 102, and the wall 103 and base 102 are adhered to the patient's skin before ultrasound examination.

[0059]

[0075] In the initial configuration, the adhesive 117 of the first wall side 103A is covered by the wall cover sheet 118 for the user to maintain the wall cover sheet 118 on top of the adhesive 117 of the first wall side 103A, while the wall 103 is bent at the bending region 1014 relative to the base 102, as described above and as shown in Figures 2B and 6B, while the wall 103 is used in an upright configuration stabilized by the stabilizer 109 for safe ultrasonic exploration adjacent to the insertion site 119.

[0060]

[0076] The user may then choose to remove the wall cover sheet 118 from the adhesive 117 and, similarly after the insertion of a puncture device, particularly a cannula, into the skin 108, thereby adhering the wall 103 to the subject's skin 108, so that the puncture device 123, particularly a cannula, is positioned within the slot 116. In the latter case, the stabilizer 109 must be deactivated, for example, by cutting the stabilizer 109 or by partial detachment from the base 102 or the wall 103. In embodiments having stabilizing leg flaps 111B, these are detached from the base 102 or the frame 103 or both for deactivation. Alternatively, the stabilizer 109 is cut for deactivation.

[0061]

[0077] Alternatively, the user can selectively adhere the wall 103 and base 102 to the subject's skin 108 and insert a puncture device, particularly a cannula, into the skin 108 through the slot 118 while performing ultrasound exploration with a probe 119 through the base 102. In this case, the cover unit 101 is used in a straight position, and the wall 103 is not used in an upright configuration.

[0062]

[0078] The flat configuration of the cover unit 101 with both the wall 103 and the base 102 adhered to the skin is shown in Figure 5B. In this figure, the stabilizer 109 is not activated and remains in the transport state.

[0063]

[0079] As shown in Figure 5A, once the skin cover unit 101 is transported in an upright position, the user has several options. As a first option, the user can remove the cover sheets 112 and 118 while the skin cover unit 101 is upright, as shown in Figure 5B, and adhere the skin cover unit 101 to the user's skin 108. As a second option, the user can remove the cover sheet 113 from the stabilizer 109, bend the stabilizer 109 to an angled orientation, as shown in Figure 6A, and then raise the wall 103 to an upright configuration, as in Figures 2B and 6B. After ultrasound examination, the user may optionally place the wall 103 on the skin 108, as in the configuration of Figure 5B.

[0064]

[0080] In these methods, the cover unit 101 has multiple functions. On the one hand, the cover unit 101 maintains the functions of the prior art, while on the other hand, the cover unit 101 adds the function of an upright wall 103 that is stabilized by the stabilizer 109 when the skin surface 108 is relatively flat.

[0065]

[0081] Figure 7 shows a further embodiment of the stabilizer 109. The stabilizer 109 is attached to a first point or region 121A on the wall 103 and a second point or region 121B on the base 102, for example, on the frame 105, with both points or regions 121A, 121B being remote from the bent region 104. The stabilizer 109 connects these two remote points or regions 121A, 121B and thus forms a stable triangular configuration between the two points or regions 121A, 121B and the bent region 104.

[0066]

[0082] The upright wall 103 is shown as having a perpendicular orientation to the base 102, but this is not strictly necessary, because the angle between the wall 103 and the base 102 can be adjusted to other angles, for example, in the range of 45 to 135 degrees.

[0067]

[0083] Optionally, to facilitate gel removal, a gel removal strip 122 (see Figure 8) is provided on top of the flexible sheet 106. This gel removal strip 122 is also ultrasonically transparent and is removed from the ultrasonically transparent flexible sheet 106 along with the gel, thereby avoiding the need to wipe the gel from the flexible sheet 106.

[0068]

[0084] Figure 9A is similar to Figure 8A, but has a gel removal strip 122 extending beneath the second leg 111B of the stabilizer 109 so that the stabilizer 109 is removed together with the gel removal strip 122 when the user pulls the gel removal strip 122 away from the surface of the flexible sheet 106. Thus, the adhesive 110A of the first leg 111A of the stabilizer 109 is pulled away from the upright wall 103. Once the stabilizer 109 is removed, the upright wall 103 can be laid flat on the skin 108 and adhered to the skin 108 by the adhesive 117 once the wall cover sheet 118 covering the adhesive 117 is removed. This situation is shown in Figure 9B. The puncture device 123 then extends through the slot 116 and through the skin 108 into the underlying tissue.

[0069]

[0085] It is also possible that the gel removal strip 122 may extend under the adhesive 110A and first leg 111A of the stabilizer 109 to a certain distance above the upright wall 103. In this case, the gel removal strip 122 extends completely under the stabilizer 109, and the entire stabilizer can withstand being removed together with the gel removal strip 122.

[0070]

[0086] The stabilizer 109 may be made of materials including, but not limited to, polyester, polyethylene terephthalate (PET), polyethylene, polyamide (e.g., nylon), paper (typically coated), or a combination thereof.

[0071]

[0087] Examples

[0072]

[0088] Specific embodiments will be demonstrated herein by reference to the following examples. It should be understood that these examples are disclosed merely to illustrate the invention and should not be considered to limit the scope of the invention.

[0073]

[0089] (Example 1)

[0090] Skin cover devices according to embodiments of the present disclosure, such as those shown in Figures 2A-2B, are applied to a subject. The skin cover device is flat and unpacked from its packaging. The base is attached to the subject's skin. The wall, including the stabilizer, is then bent to maintain a certain angle to the base. The gel is applied to the gel removal strip at the top of the flexible sheet of the base. A cannula having a length of 6-10 cm is inserted into the subject's skin, while an ultrasound probe positioned in contact with the gel at the top of the gel removal strip is used to monitor the insertion of the cannula and the location of the vein. After insertion is complete, ultrasound monitoring is stopped and the gel removal strip is removed. The wall cover sheet covering the bottom side of the wall is removed, and the wall is then straightened to be attached to the subject's skin.

Claims

1. A method for inserting a puncture device through the skin of a subject, A step of applying a cover unit to the subject's skin at the puncture site, wherein the cover unit is It's the base, The first adhesive layer on the bottom side of the base, An ultrasonically transparent flexible sheet extending to the distal end of the cover unit, and Together with the ultrasonically transparent flexible sheet, a frame defining an ultrasonically transparent window, wherein the ultrasonically transparent window extends to the distal end of the cover unit, and the frame has an open tip at the distal end of the cover unit. A base equipped with, A wall connected to the base via a bent region located at the proximal end of the base. The steps to apply include, The steps include: using the upper ultrasound probe of the base to image the subcutaneous anatomical structures and / or the puncture device of the subject in a distal direction at or near the puncture site; The steps include inserting the puncture device at the puncture site and Methods that include...

2. A method according to claim 1, further comprising the step of using the ultrasound probe to image the anatomical structures and / or the puncture device beneath the skin of the subject beyond the distal end of the cover unit in the distal direction.

3. A method according to claim 1 or 2, further comprising the step of bending the bending region in order to orient the wall at an angle with respect to the base.

4. A method according to any one of claims 1 to 3, The steps include applying gel to the upper side of the base before imaging the anatomical structure, The step of removing the gel after the insertion of the puncture device. Methods that further include this.

5. A method according to claim 4, wherein the cover unit further comprises an ultrasonically transparent gel removal strip covering the ultrasonically transparent flexible sheet on the upper side of the base.

6. A method according to claim 5, further comprising the step of removing the ultrasonically permeable gel removal strip from the base.

7. A method according to any one of claims 1 to 6, further comprising the step of sterilizing the puncture site.

8. A method according to any one of claims 1 to 7, wherein in the bending step, the angle between the wall and the base is between 45 and 135 degrees.

9. A method according to any one of claims 1 to 8, wherein the cover unit further comprises a stabilizer located in or near the bending region, the stabilizer being capable of maintaining the angled orientation between the wall and the base.

10. A method according to claim 9, wherein the stabilizer is a flexible sheet comprising a first stabilizer portion fixed to the wall and a second stabilizer portion fixed to the base.

11. A method according to claim 9, wherein the cover unit comprises two stabilizers, each stabilizer located at or near each lateral end of the bendable region.

12. A method according to claim 9, wherein the cover unit further comprises an ultrasonically transparent gel removal strip covering the ultrasonically transparent flexible sheet on the upper side of the base, the ultrasonically transparent gel removal strip extending below at least a portion of the stabilizer.

13. The method according to claim 12, The steps include applying gel to the upper side of the ultrasound-transparent gel removal strip before imaging the anatomical structure, A step of removing the ultrasound-transparent gel removal strip from the base after insertion of the puncture device, thereby removing the gel and the stabilizer. Methods that further include this.

14. A method according to any one of claims 1 to 13, wherein the wall comprises a slot extending from the proximal end of the wall toward the base, the slot being capable of positioning the perforation device after insertion of the anatomical structure.

15. A method according to claim 14, wherein the wall further comprises a second contact layer on the bottom side of the wall.

16. The method according to claim 15, A step of straightening the bent region, wherein at least a portion of the second adhesive layer is in contact with the subject's skin and the puncture device is positioned within the slot. Methods that further include this.

17. A method according to claim 15, wherein the wall further comprises a wall cover sheet on the bottom side of the second adhesive layer.

18. The method according to claim 17, The step of removing the aforementioned wall cover sheet, A step of straightening the curved region, wherein at least a portion of the second adhesive layer is in contact with the subject's skin and the puncture device is positioned within the slot. Methods that further include this.

19. A method for inserting a puncture device through the skin of a subject, The steps include applying a cover unit to the subject's skin at the puncture site, The steps include: using the upper ultrasound probe of the cover unit to image the anatomical structures and / or the puncture device beneath the skin of the subject in a distal direction at or near the puncture site; The steps include inserting the puncture device at the puncture site, The steps include: using the ultrasound probe to image the anatomical structures and / or the puncture device beneath the subject's skin beyond the distal end of the cover unit in the distal direction; Includes, The method wherein the cover unit comprises an ultrasonically transparent window extending to the distal end of the cover unit.

20. It is a cover unit, It's the base, The first adhesive layer on the bottom side of the base, An ultrasonically transparent flexible sheet extending to the distal end of the cover unit, and Together with the ultrasonically transparent flexible sheet, a frame defining an ultrasonically transparent window, wherein the ultrasonically transparent window extends to the distal end of the cover unit, and the frame has an open tip at the distal end of the cover unit. It has a base and A wall connected to the base via a bent region located at the proximal end of the base, A cover unit equipped with the following features.

21. A cover unit according to claim 20, further comprising an ultrasonically transparent gel removal strip covering the ultrasonically transparent flexible sheet on the upper side of the base.

22. A cover unit according to claim 20 or 21, further comprising a stabilizer located in or near the bending region, wherein the stabilizer is capable of maintaining the angled orientation between the wall and the base.

23. A cover unit according to claim 22, wherein the stabilizer is a flexible sheet comprising a first stabilizer portion fixed to the wall and a second stabilizer portion fixed to the base.

24. A cover unit according to claim 22, comprising two stabilizers, each stabilizer located at or near each lateral end of the bendable region.

25. A cover unit according to claim 22, further comprising an ultrasonically transparent gel removal strip covering the ultrasonically transparent flexible sheet on the upper side of the base, wherein the ultrasonically transparent gel removal strip extends below at least a portion of the stabilizer.

26. A cover unit according to any one of claims 20 to 25, wherein the wall comprises a slot extending from the proximal end of the wall toward the base, the slot being capable of positioning the perforation device after the insertion of the anatomical structure.

27. A cover unit according to claim 26, wherein the wall further comprises a second adhesive layer on the bottom side of the wall.

28. A cover unit according to claim 27, wherein the wall further comprises a wall cover sheet on the bottom side of the second adhesive layer.

Images