A method for Preparing an Insertion Site for a Cannula on a Skin of a Patient, a Skin Cover Unit Therefore and Its Use
20210038249 ยท 2021-02-11
Inventors
- Thomas Fichtner Bendtsen (Aarhus C, DK)
- Erik Sloth (Risskov, DK)
- Lars Knudsen (Risskov, DK)
- Neal Joseph Buchalter (Short Hills, NJ, US)
Cpc classification
A61B8/4281
HUMAN NECESSITIES
A61B90/04
HUMAN NECESSITIES
A61F13/023
HUMAN NECESSITIES
International classification
Abstract
An insertion site for a cannula (23) on a skin (8) of a patient is prepared by applying a skin cover unit (1) of the type comprising a window (2) and a wall (3) in extension of the window (2) and connected to the window (2) by a bending region (4) for bending the wall (3) into an angled orientation relatively to the window (2); wherein the win-dow (2) comprises a stabilizing frame (5) and an ultrasonic-transparent flexible sheet (6) within the frame (5). The flexible sheet (6) is glued onto the skin (8) of the patient for ultrasonic investigation of the insertion site through the flexible sheet (6). By bending the bending region (4), the angular orientation of the wall (3) is adjusted into an approximately perpendicular orientation relatively to the window (2) for separating the insertion site from the flexible sheet (6) by the wall (3). The cover unit (1) in or at the bending region (4) comprises a stabilizer (9) that is configured for maintaining the angled orientation between the wall (3) and the window (2) by a stabilizing action of the stabilizer (9).
Claims
1-20. (canceled)
21. A surgical skin cover unit (1) for use when inserting a cannula or other puncture device (23) through the skin of a patient, wherein said skin cover unit (1) comprises a window (2) and a wall (3), the wall (3) being provided in extension of the window (2) and connected to the window (2) by a bending region (4) for bending the bending region so that the wall (3) gets into an angled orientation relatively to the window (2); wherein the window (2) comprises an adhesive layer (7) on a first side of the window (2) for gluing the window (2) onto the skin (8) of the patient; wherein the window (2) comprises an ultrasonic-transparent flexible sheet (6) for ultrasonic investigation of the patient through the flexible sheet from a second side of the window (2), which is opposite the first side of the window (2); wherein the skin cover unit (1) in addition to the flexible sheet (6) comprises a stabilizer (9), wherein the stabilizer (9) is provided in or at the bending region (4) and is configured for maintaining the angled orientation between the wall (3) and the window (2) by a stabilizing action of the stabilizer (9), wherein the stabilizer (9) is a bendable sheet comprising a first stabilizer part (11A, 21A) that is fastened to the wall (3) and, in extension of the first stabilizer part (11A, 21A) a second stabilizer part (11B, 21B) that is bendable relatively to the first stabilizer part (11A, 21A) and fastened to the window (2).
22. A surgical skin cover unit according to claim 21, wherein the stabilizer (9) is non-resiliently bendable and configured for adopting and maintaining a selectable bending condition when being bent for thereby maintaining a selected orientation of the wall (3) relatively to the window (2).
23. A surgical skin cover unit according to claim 21, wherein the window (2) comprises a stabilizing frame (5), wherein the flexible sheet (6) is provided within the frame (5) and attached to and supported by the frame (5).
24. A surgical skin cover unit according to claim 23, wherein the first stabilizer part (11A, 21A) is fastened to the wall (3) and the second stabilizer part (11B, 21B) comprises a portion (11B) at each of two opposite edges (15A, 15B) of the wall (3) wherein the two portions (11B) are fastened to two opposite parts (5A, 5B) of the frame (5) of the window (2).
25. A surgical skin cover unit according to claim 21, wherein the wall (3) comprises a slot (16) extending from an edge of the wall (3) towards the window (2); and wherein the wall (3) comprises a first wall side (3A) with an adhesive (17) for also gluing the wall (3) to the skin (8) of the patient and for locating the cannula or other puncture device inside the slot (16) while the wall (3) is glued to the skin of the patient; wherein the adhesive (17) of the first wall side (3A) is covered by a wall cover sheet (18) for keeping the wall cover sheet (18) on the adhesive (17) of the first wall side (3A) while using the wall (3) as an upstanding wall (3) adjacent to the insertion site (20), while the wall (3) is in bent orientation relatively to the window (2), and for selectively removing the wall cover sheet (18) from the adhesive (17) and gluing the wall (3) to the patient's skin (8) for locating the cannula or other puncture device within the slot (16) while the cannula or other puncture device is inserted in the skin (8).
26. A surgical skin cover unit according to claim 21, wherein the skin cover comprises a gel-removal strip (22) covering the flexible sheet (6) on the second side of the window (2) for by removal of the gel-removal strip also removing potential gel (14) from the second side; wherein the gel-removal strip (22) extends under at least part of the stabilizer (9) for by manual removal of the gel-removal strip (22) from the flexible sheet (6) also removing the stabilizer (9).
27. A method for preparing an insertion site for a cannula or other puncture device (23) on a skin (8) of a patient, the method comprising providing a skin cover unit (1) of the type comprising a window (2) and a wall (3), the wall (3) being provided in extension of the window (2) and connected to the window (2) by a bending region (4) for bending the bending region so that the wall (3) gets into an angled orientation relatively to the window (2); wherein the window (2) comprises an adhesive layer (7) on a first side of the window (2) for gluing the window (2) onto the skin (8) of the patient; wherein the window (2) comprises an ultrasonic-transparent flexible sheet (6) for ultrasonic investigation of the patient through the flexible sheet; wherein the method comprises gluing the first side of the window (2) onto the skin (8) of the patient and, before or after the gluing, bending the bending region (4) for changing the angular orientation of the wall (3) into an angle in the range of 45-135 degrees relatively to the window (2) and applying an ultrasonic probe (19) to the second side of the window (2) and ultrasonic-imaging the insertion site (20) for controlled insertion of the cannula or other puncture device (23) into the patient; wherein the skin cover unit (1) in addition to the flexible sheet (6) comprises a stabilizer (9), wherein the stabilizer (9) is provided in or at the bending region (4) and is configured for maintaining the angled orientation between the wall (3) and the window (2) by a stabilizing action of the stabilizer (9), wherein the method comprising, by the stabilizer (9) maintaining the angled orientation of the wall (3) relatively to the window (2) in order for the wall (3) separating the insertion site (20) from the window (2), wherein the stabilizer (9) is a bendable sheet comprising a first stabilizer part (11A, 21A) that is fastened to one of the wall (3) or the window (2) and, in extension of the first stabilizer part (11A, 21A) a second stabilizer part (11B, 21B) that is bendable relatively to the first stabilizer part (11A, 21A), and wherein the second stabilizer part (11B, 21B) is fastened to the other of the wall (3) or the window (2), wherein the method comprises bending the wall (3) relatively to the window (2) at the bending region (4) into an angled orientation between the wall (3) and the window (2).
28. A method according to claim 27, wherein the stabilizer (9) is non-resiliently bendable and configured for adopting and maintaining a selectable bending condition when being bent for thereby maintaining a selected orientation of the wall (3) relatively to the window (2), wherein the method comprises non-resiliently bending the stabilizer (9) into a selected bent configuration and by the stabilizer (9) maintaining this bent configuration.
29. A method according to claim 27, wherein the window (2) comprises a stabilizing frame (5) and the ultrasonic-transparent flexible sheet (6) is provided within the frame (5), the flexible sheet (6) being attached to and supported by the frame (5).
30. A method according to claim 29, wherein the first stabilizer part (11A, 21A) is fastened to the wall (3) and the second stabilizer part (11B, 21B) comprises a portion (11B) at each of two opposite edges (15A, 15B) of the wall (3) and the method comprises fastening the two portions (11B) to two opposite parts (5A, 5B) of the frame (5) of the window (2).
31. A method according to claim 27, wherein the wall (3) comprises a slot (16) extending from an edge of the wall (3) towards the window (2); and wherein the wall (3) comprises a first wall side (3A) with an adhesive (17) for also gluing the wall (3) to the skin (8) of the patient and for locating the cannula or other puncture device inside the slot (16) while the wall (3) is glued to the skin of the patient; wherein the adhesive (17) of the first wall side (3A) is covered by a wall cover sheet (18), and the method comprises keeping the wall cover sheet (18) on the adhesive (17) of the first wall side (3A) while using the wall (3) as an upstanding wall (3) adjacent to the insertion site (20), while the wall (3) is in bent orientation relatively to the window (2), and selectively removing the wall cover sheet (18) from the adhesive (17) and gluing the wall (3) to the patient's skin (8) for locating the cannula or other puncture device within the slot (16) while the cannula or other puncture device is inserted in the skin (8)
32. A method according to claim 27, wherein the surgical skin cover unit comprises a gel-removal strip (22) covering the flexible sheet (6) on the second side of the window (2) for by removal of the gel-removal strip also removing potential gel (14) from the second side; wherein the gel-removal strip (22) extends under at least part of the stabilizer (9) and the method comprises manually removing of the gel-removal strip (22) from the flexible sheet (6) and by the removal action also removing the stabilizer (9).
33. Use of a skin cover unit according to claim 21 for separating an insertion site (20) of a cannula or other puncture device from an ultrasonic probe (19) on the skin of a patient.
Description
SHORT DESCRIPTION OF THE DRAWINGS
[0038] The invention will be explained in more detail with reference to the drawing, where
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
DETAILED DESCRIPTION/PREFERRED EMBODIMENT
[0047]
[0048] In
[0049] As a further alternative, only the frame 5 is provided with adhesive on the skin-adjacent side, and the flexible sheet is merely resting against the skin 8. Some polymer films are readily attaching to the skin even without glue and have sufficient ultrasonic transmission for the investigation.
[0050] The adhesive layer 7 as well as an ultrasonic-transmission fluid, typically gel 14, on top of the flexible sheet 6 provides a good contact for ultrasonic transmission from the probe 19 through the gel 14, through the flexible sheet 6, through the adhesive layer 7 and into the skin 8. This gel 14 is applied onto the flexible sheet 6 prior to the ultrasonic investigation and then removed again.
[0051] Furthermore, the skin cover 1 unit comprises a stabilizer 9, in or at the bending region 4. The stabilizer 9 is configured for maintaining the angled orientation between the wall 3 and the window 2 only by a stabilizing action of the stabilizer 9, for example when the skin cover unit 1 is positioned on top of a flat straight skin surface. In
[0052] In case that the flexible sheet 6 is provided on the upper side of the frame 5, which is the side remote from the side with the adhesive 7, the stabilizer 9 would be attached to the flexible sheet 6 on that portion of the flexible sheets that is itself attached to the frame. If the flexible sheet 6 is only provided within the frame 5, the stabilizer would be attached to the frame 5 directly, instead, as the frame at least partially surrounds the flexible sheet 6. The stabilizer 9 would be attached to the frame if the flexible sheet 6 is provided between the frame 5 and the skin 8, as the frame 8 in this case is attached to the opposite, upper side of the flexible sheet 6. In either case, the stabilizer is attached to the frame, either directly or through the film on the frame. Various embodiments and variations of the principle are possible.
[0053] The upstanding wall 3 is provided with a wall adhesive layer 17 covered by a cover sheet 18, the use of which is explained in more detail in the following, especially in connection with
[0054] The stabilizer 9, as illustrated in
[0055] As illustrated in
[0056] In the case of
[0057] Alternatively, as illustrated in in
[0058] However, this configuration of the bent sheet 6 is not necessary, and the flexible sheet 6 is illustrated in the following sketches as not extending around the bending region 4.
[0059] In an alternative embodiment of
[0060] As a further alternative, the configuration of the wall 3 and window 2 with a frame 5 of
[0061] In all cases of, the stabilizer 9 is outside that part of the window 2 that is used for ultrasonic investigation.
[0062] It should be mentioned that the stabilizer 9 can be attached to the window 2 and the wall 3 from the onset and then bent into an angled configuration, which is then maintained due to the non-resilient material of the stabilizer 9, for example metal.
[0063] Alternatively, one leg 11A of the stabilizer 9 is fastened to the wall 3 and the other leg 11B is not yet fastened to the window 2, or vice versa, but is only fastened to the window, or respectively the wall, once the orientation between the wall and the window has been adjusted. Options of this principle are explained in greater detail below.
[0064]
[0065] In some events, the cover unit 1 is removed from the patient after the ultrasonic investigation and insertion of a puncture device, especially a cannula insertion or, alternatively, insertion of other puncture device, for example electrode or probe. In other situations, the cover unit 1 remains on the skin 8 of the patient even after the investigation and insertion of the puncture device, for example cannula. In the latter case, the wall 3 can, in principle, be removed from the window 2, for example by cutting it off. Alternatively, the wall 3 is bent onto the window 2 and remains there. For these situations, the wall 3 does not need to be provided with adhesive 17 in contrast to the illustrations in
[0066] However as explained in more detail in the following, the wall 3 is optionally glued onto the skin 8 after the ultrasonic investigation and insertion of the cannula or other puncture device into the skin 8. Thus, although, the adhesive layer 7 is shown in
[0067]
[0068] In order to provide multiple functions, the wall 3 is provided with a slot 16 that extends from an edge of the wall 3 towards the window 2. As best seen in
[0069] As illustrated in the sketch of
[0070] In the initial form, the adhesive 17 of the first wall side 3a is covered by a wall cover sheet 18 in order for the user to keep the wall cover sheet 18 on the adhesive 17 of the first wall side 3A while using the wall 3 in upstanding configuration, stabilized by the stabilizer 9, for safe ultrasonic investigation adjacent to the insertion site 19, as explained above and as illustrated in the
[0071] The user can then select removing the wall cover sheet 18 from the adhesive 17 and gluing also the wall 3 to the patient's skin 8 after insertion of the puncture device, especially a cannula, into the skin 8, such that the puncture device 23, especially a cannula, is located inside the slot 16. For the latter case, the stabilizer 9 has to be deactivated, for example by cutting it or by partial detachment from the window 2 or the wall 3. In the embodiment with the stabilizer legs flaps 11B, these are decoupled from the window 2 or frame 3 or both for the de-activation. Alternatively, the stabilizer 9 is cut for de-activation.
[0072] As an alternative, the user can selectively glue the wall 3 as well as the window 2 to the skin 8 of the patient and insert the puncture device, especially a cannula, into the skin 8 through the slot 18 while performing the ultrasonic investigation with the probe 19 through the window 2. In this case, the cover unit 1 is used in straight condition and the wall 3 is not used in upstanding configuration.
[0073] The flat configuration of the cover unit 1 with both the wall 3 and the window 2 being glued to the skin is illustrated in
[0074] When starting with the straight transport condition of the skin cover unit 1, as illustrated in
[0075] In these ways, the cover unit 1 is has multiple functions. On the one hand, it preserves the function of the prior art and, on the other hand, it adds the function of the upstanding wall 3 which is stabilized by the stabilizer 9 in case that the skin 8 surface is flat.
[0076]
[0077] Although, the upstanding wall 3 is illustrated as having a perpendicular orientation relatively to the window 2, this is not strictly necessary, as the angle between the wall 3 and the window 2 can be adjusted to other angles, for example in the range of 45-135 degrees.
[0078] Optionally, in order to ease removal of the gel, a gel-removal strip 22, see
[0079] In
[0080] It is pointed out that the gel-removal strip 22 could also extend underneath the adhesive 10A and first leg 11A of the stabilizer 9 a distance up the upstanding wall 3. In this case the gel-removal strip 22 extends entirely under the stabilizer 9 and endures that the entire stabilizer is removed together with the gel-removal strip 22.
REFERENCE NUMBERS
[0081] 1 cover unit [0082] 2 window [0083] 3 wall [0084] 3A first wall side [0085] 4 bending region [0086] 5 stabilizing frame [0087] 5A, 5B opposite parts of frame [0088] 6 ultrasonic-transparent flexible sheet, typically polymer film, within the frame 5 [0089] 7 adhesive layer [0090] 8 skin [0091] 9 stabilizer [0092] 10A, 10B first and second stabilizer-adhesive [0093] 11A, 11B first and second legs of bent profile as example of stabilizer 9 [0094] 11B flaps as two portions of the stabilizer 9 [0095] 12 removable cover sheet, typically a paper sheet, covering adhesive layer 7 [0096] 13 further cover sheet covering second stabilizer-adhesive 11B [0097] 14 gel [0098] 15A, 15B opposite edges of the wall 3 [0099] 16 slot in wall 3 [0100] 17 adhesive on first side 3A of the wall 3 [0101] 18 wall cover sheet for covering adhesive 17 [0102] 19 ultrasonic probe [0103] 20 insertion site [0104] 21 attachment regions of stabilizer 9 [0105] 22 gel-removal strip [0106] 23 cannula or, optionally, other puncture device