Patent Application
20220296427
The disclosure relates to a securement device for mounting an article to a conformable surface, such as a medical device on skin and to a method for securing an article to a conformable surface, such as a medical device on the skin surface of the patient.
Various medical devices are attached to a patient. For example, tubing, monitors, sensors, or catheters are secured to skin. To limit irritation, dislodgement, and potential exposure to infection the medical devices should be securely attached to the patient. Adhesives and adhesive tapes are commonly used to secure devices to skin. Very strong adhesives can cause trauma to skin upon removal. A very gentle adhesive will remove from the skin easily, but might not have sufficient strength to secure the medical device.
One common medical device that is secured to a patient's skin is an intravenous venous catheter. Few types of intravenous catheter include central line catheter and peripheral line catheter. A peripheral venous catheter often referred to as an intravenous cannula is a flexible hollow plastic tube that is inserted in a peripheral vein most commonly the metacarpal vein of the hand or cephalic or basilic vein of the upper limb forearm. The peripheral venous catheterization involves piercing of a vein or artery of a patient with needle carrying cannula called as catheter and the cannula is slowly slid over the needle and into the punctured blood vessel. Subsequently, the needle should be removed from the cannula and the cannula is closed with a cap. The cannula would be then secured by means of an additional form of securement by tapping or with adhesive patches and is connected to a connector for supplying an intravenous fluid to the patient. Most frequent complications in catheterization procedures are due to repeated movements of the cannula inside the vein resulting in friction of the cannula against the entry site, dislodgement of the cannula and accidental removal. This may result in repeated microtrauma and laceration of skin edges leading to phlebitis, infection and pain for the patients.
Improper securement of peripheral venous catheter to the skin allows the catheter to move within the vein, which increases the incidence of peripheral venous catheter dislodgement, mechanical phlebitis, infiltration, leakage and infection. This movement results in peripheral venous catheter failure, an interruption to intravenous therapy and the need to re-site the peripheral venous catheter. Repeated re-siting of peripheral venous catheter can lead to venous access difficulties, including the need for more frequent peripheral venous catheter re-sites or for a central venous catheter, and causing interruption to the delivery of IV therapy and a potential increase in the duration of hospital stay and healthcare costs.
U.S. Pat. No. 8,591,471: A catheter assembly having a catheter with a longitudinal body having a transverse attachable detachable fastening member thereunder comprising a pliable polymeric element having a top side and a bottom side with the top side having a longitudinal groove fixedly attached to the catheter's longitudinal body with the bottom side having an adhesive layer covered by a removable cover so that when removed the catheter assembly can be adhesively attached to a recipient's skin and when desirous of removal can be peelably removed from said recipient's skin.
U.S. Pat. No. 8,157,770: A stabilizing device (and method of use) for insertion and maintenance of a catheter or cannula maintains a sterile insertion site and is simple and easy to construct and use, yet optimally maintains the catheter or cannula in place. A first stabilizing element includes a pair of bilateral wings and a catheter or cannula receiving element generally between the wings. A proximal stabilizing element—desirably two distinct and spaced pieces of tape—is operatively connected to the wings and has a sterile adhesive for affixing the wings to a patient to provide stability during needle removal and substantially for the duration that the catheter or cannula is inserted into a patient. A lateral stabilizing element—desirably two pieces of tape—is distinct and spaced from the proximal stabilizing element, to provide primarily lateral and medial stability to a catheter or cannula in a patient. A release sheet may cover the tape adhesive, or the tape may have a pattern of adhesive and non-adhesive sections cooperating with each other. Butterfly catheter, or angiocatheter, embodiments are particularly desirable.
EP2814552: The application relates to a two-part overlapping dressing for securing a cannula during intravenous catheterization on the skin surface of a patient. The dressing comprises a first flexible adhesive sheet (10) provided with an opening (16) spaced from all its peripheral edges; and a second flexible adhesive sheet (12). The opening (16) in the first sheet comprises a slit (18), one end of which terminates in an enlarged aperture (20). The second sheet (12) is dimensioned such that, when it is aligned with and adhered against the first sheet (10) in use, it is capable of overlapping the full length of the slit (18) so as to reduce the opening (16) to the size of the enlarged aperture (20). The apparatus allows for a more secure fitting of the cannula whilst minimising the risk of infection.
U.S. Pat. No. 5,087,248: An adhesive patch for anchoring an intravenous needle to the skin of a patient at the transcutaneous insertion site is disclosed in which a patch of continuous flexible asymmetrically elastic sheet material having one side covered with a layer of biocompatible adhesive is provided substantially shaped as large and small abutting parallel rectangles integrally joined parallel to the easy axis of elasticity and adapted to engage an intravenous needle. The small rectangle is configured such that a portion can disengage from the larger rectangle and fold on itself as a tab and adhesively engage the periphery of the hub of the needle and wherein the larger rectangle has a central shaped cut out facing the small rectangle and is adapted to fold over the tab and adhesively attach to the skin thereby attaching the entire assembly to the skin. A layer of peel able release paper adhering to said adhesive is provided for packaging.
EP1307253: An anchoring system for securing a dialysis catheter to a patient comprises an anchor pad and a retainer. The anchor pad is attached to the skin of the patient by an adhesive layer on one side of the pad. The retainer is disposed upon the surface of the anchor pad opposite the adhesive layer and includes a base and a cover and a adhesive spot. A groove upon the base is arranged to receive a Y-site portion of a dialysis catheter where the lumens merge distal to the insertion site. A post also protrudes from the base to the cover at a position which will be disposed between the two distal branches of the dialysis catheter. The cover closes over the base, securing the Y-site between the groove and the post. Closing the cover also places at least a portion of the catheter in contact with the adhesive spot. This contact between the retainer, adhesive spot and catheter thereby inhibits inadvertent motion of the catheter upon the patient. A latch mechanism is disposed upon the retainer to maintain the cover in a closed position over the Y-site of the catheter on the base.
U.S. Pat. No. 3,910,272: A cannula for the introduction of a flexible catheter comprises a cannula having a wing of a foil material joined to each side and it includes a cannula protective cap at a spaced location from a guard cap for the catheter. An intermediate bacteria-proof shell encloses the cannula between the protective cap and the guard cap, and it has two separable portions which are arranged in juxtaposition over the wings. The protective shell includes projecting portions to permit it to be spread open to cause a corresponding movement of the wings and the breaking open of the cannula. The protective shell is made preferably of a single moulded part which is joined together at a hinge, but which includes a separate foil hinge and which include inwardly projecting dogging elements which engage against the wings after the lower portion of the housing is engaged around the cannula. The half shell portions are each provided with inter-engageable projections and recesses so that the shell portions are locked together to form a bacteria-proof joint.
U.S. Pat. No. 3,910,272 describes the design with bacteria-poof closure ensuring perfectly sterile manipulation.
According to the conventional methodology, the vein would be initially identified and the patient's skin should be cleaned with alcohol wipe and allowed to dry. Subsequently, the cannula is taken from its sterile packaging and then the needle cover is removed without touching the needle. As a next step the cannula with needle, the bevel looking upwards at 30 degree, is advanced into the peripheral vein until a flashback of blood is seen in the hub at the back of the cannula. Finally, the clinician opens a sterile pack containing the securement patch which may have a hypoallergenic plastic tape and such like parts which would be applied over the cannula in a crisscross configuration for securement. According to this existing technology, dressing requires the engagement of both hands of the clinician to apply and sometimes more than one clinician to apply depending upon the patient. Moreover, the rate of dislodging of the cannula secured by this existing methodology is a higher.
The disclosed securement device has an extensible substrate with an adhesive surface and two opposing tabs on the extensible substrate that are stretched in opposing directions to easily remove the adhesive surface from the underlying substrate. This securement device is well suited for use on underlying substrates that are conformable, such as skin. Conformable substrates may be any suitable non-rigid surface that will slide, compress, or stretch, and stretching the extensible substrate in opposing provides stability when releasing the adhesive surface from the underlying conformable substrate. This stretching to release the adhesive surface from the underlying substrate allows for a strong adhesive to be used on the securement device.
In one embodiment, the securement device secures an existing medical device, such as a venous catheter, firmly onto the skin to limit movement in all axis.
In one embodiment, the securement device further includes cross tapes that enable the clinician to secure existing peripheral venous catheter firmly to the skin to limit movement in all axis.
In one embodiment, the securement device is secured to the peripheral venous catheter which enables the clinician to secure the assembly firmly to the skin to limit movement in all axis.
The following drawings illustrate the various embodiments and parts of the claimed devices.
The one of the objectives of the device (1) is to secure an article (A) onto the surface of the underlying substrates. The underlying substrate may be conformable surface that is any suitable non-rigid surface that will slide, compress, or stretch, such as skin, foam, hydrogel, etc or can flex and not interfere with the stretch removable characteristics of the device (1), although it can be stretchable or not. However, underlying substrate may be in any form. For example, the underlying substrate may be a surface of an article that may not be linear e.g., a curved surface. The article may be, but it is not limited to medical devices such as IV catheter (such as article (A) shown in
In one embodiment, the first tab (9a) and second tab (9b) are free of exposed adhesive. The first tab (9a) and the second tab (9b) are used for removing the securement device (1) from the underlying substrate in detail later with respect to
Considering the example of the article (A) being an intravenous catheter, as per standard clinical protocols, the article (A) is inserted through the underlying substrate such as skin, and once it is in a vein: the liner/needle is removed and the article is pressed onto the skin. The article (A) is placed exactly at the position where it entered, such as the vein. The adhesive between the extensible substrate (2) and the underlying substrate hold the article (A) in place.
The complete underside portion of the article (A) may be in contact with the underlying substrate (2). Subsequently in an embodiment, the two cross tapes having cover/liner (6a, 6b) on the long tail of the device (1) can be placed over the needle entry point in a crossed manner and pressed them onto the underlying substrate so as to secure the article (A) on the skin. This completes the securement of the article (A). No additional patches or tapes are required to hold the article (A). In one embodiment, the above configuration allows to collect flash back blood, change to IV lines or infuse drugs into the article (A) without the fear of dislodging it. Further, even though the article (A) in this example is an intravenous catheter, the device (1) can be used to position other medical devices (e.g. wearable medical devices) or articles or electronic devices on a conformable surface (such as, skin or clothing) in various other embodiments. Thus, the device (1)(broadly explained here) can be customized for any number of applications including medical, industrial, and consumer products.
The device (1) has multiple parts as shown in
In one aspect, the top side of the extensible substrate (2) has first adhesive (3) with superior adhesive properties. A substrate with plurality of optional cross tapes (4) or at least a pair of cross tapes is bonded on the adhesive layer (3) at the top side of the extensible substrate (2). In one embodiment, a third adhesive layer (5) secures any type of material used to make article (A), and this layer (5) is available at the top side of the substrate with cross tapes (4). An adhesive layer/fourth adhesive layer (5a) is on the top portion of the cross tapes (4). The adhesive layers (5, 5a) at the top side of the substrate with cross tapes (4) are protected with plurality of protective cover/liner (6a, 6b) at the top.
For example, the first protective cover (6a) at the top side of the substrate with cross tapes (4), where the article (A) shall be fixed, have a tab (6c) on one end so that the tab (6c) can be pulled out easily before installing the article (A) in case of retrofit application. After securement of the article (A) to the adhesive layer (5) at the top side of the substrate with cross tapes (4), the bonding ensures no movement of the article (A). Any slight difference in size between the extensible substrate (2), the substrate with the cross plates (4) and the bottom side of the article (A) will not have any impact on the movement as the adhesives used are strong enough to adhere article (A) larger in size than the extensible substrate (2). Similarly, the adhesives used are not limited to the weight of the article (A) as the adhesives used can hold all types of existing articles, such as medical devices or other articles based on different applications or need. The adhesive on these tapes have antimicrobial properties that protect and secure the cannulated site in case of intravenous application.
In another embodiment, if the device (1) is retrofit the protective cover (6a) is peeled to expose the adhesive layer (5) at the top side of the substrate with cross tapes (4). Then, the bottom side of the article (A) is placed onto the adhesive layer (5) at the top side of the substrate with cross tapes (4) and it is pressed gently. Now, the securement device (1) is a part of the article (A).
The bottom side of the extensible substrate (2) has a second adhesive layer (7) which is a stretch release adhesive layer. The adhesive layer (7) used in the bottom side of the extensible substrate (2) may be a skin friendly adhesive. The said adhesive layer (7) has stretching property i.e., it retains its tack and adhesion property as long as its initial shape is intact. The two tabs (9a, 9b) of the extensible substrate (2) provided at opposite ends helps in stretching the adhesive layer (7) thereby releasing the securement device (1) and article (A) from the underlying substrate. Explaining in another way, pulling on the extensible substrate (2) using the tabs (9a and 9b) causes the extensible substrate (2) to elongate or stretch. Stretching reduces the volume of the extensible substrate (2) in the region touching the underlying substrate such as, the conformable surface and facilitates release of the extensible substrate (2) from the underlying substrate. Pulling the tabs (9a and 9b) can release the adhesive layers from the substrate (2) if the adhesive layer has sufficient cohesive strength. The adhesive layer has sufficient shear strength and adhesive holding power for the specific applications, its adhesive holding power to any substrate preferably being less than its cohesive strength, such that the adhesive layer will not be separate from the backing when the backing is subjected to stretching. The adhesive layer is also preferably highly extensible. In an embodiment, the extensible substrate (2) typically can be stretched in a first direction (often the first direction is length-wise) without breaking or snapping under the stretch releasing conditions. After the extensible substrate (2) is stretched along a major axis and is released from the substrate, substantially no adhesive residue may remain on the underlying substrate.
A protective cover (8) protects the adhesive layer (7) at the bottom side of the extensible substrate (2) while not in use. The protective cover (8) at the bottom side has a tab (8a) that extends like a long arm. The tab (8a) capable of being folded back to one side of the cover at the bottom. After, the article (A) fitted with the securement device (1) is placed over the underlying substrate, the tab (8a) is pulled to remove the protective cover (8). Since the tab (8a) is designed in such a way that it folds back during the pull operation it delaminates from the adhesive layer (7) in face down position making it simpler for one-handed operation. Finally, a simple manual press on the article (A) or the securement device (1) will firmly secure the article (A) and the securement device (1) to the underlying substrate.
Subsequent to the completion of securing the article (A) and the securement device (1) to the underlying substrate, such as skin, the tab (6d) present in second protective cover (6b) of each cross tape is pulled to expose the fourth adhesive layer (5a). The cross tapes are then crossed over the article (A) entry point by the adhesive layer on the top of the plurality of cross tapes/fourth adhesive layer. On applying simple manual pressure across the cross tapes, the cross tapes will seal the article (A) entry point and provide additional restriction to the movement of the securement device (1) and the article (A) in all directions/axis such as, vertical axis, horizontal axis and lateral axis as shown in
The fourth adhesive layer used at the cross tapes does not leave any residue on the cannula entry point when the securement device (1) along with the article (A) is removed. The shape of the adhesive layer can be deformed by extending/stretching/expanding.
In one embodiment, colour changing cross tapes can be used as a different alternative to the normal cross tapes to detect microbial activity. For example, if microbes start to grow in the cannulation site, the colour of tapes may change indicating microbe growth thereby providing warning to the patient or user.
In another aspect, the article (A) is directly bonded over the adhesive available on the top side of the extensible substrate (2) of the device (1). Moreover, this aspect may not comprise the substrate with cross tapes, the adhesive layer over the substrate with the cross tapes and other parts related to the cross tapes.
In yet another aspect, an embodiment herein provides a method of securing a device to a substrate with the securement device (1). The method comprises the steps of: i) applying the article (A) to the first adhesive (3); and ii) applying the second adhesive (7) to the underlying substrate (as shown in
Moving on to
The tabs 9(a) and 9(b) are shown in
In an embodiment, the extensible substrate (2) can be provided in any useful form including, e.g., tape, strip, sheet (e.g., perforated sheet), label, roll, web, disc, and kit (e.g., an object for mounting and the extensible substrate used to mount the object). Likewise, multiple extensible substrate can be provided in any suitable form including, e.g., tape, strip, sheet (e.g., perforated sheet), label, roll, web, disc, kit, stack, tablet, and combinations thereof in any suitable package including, for example, dispenser, bag, box, and carton.
| Number | Date | Country | Kind |
|---|---|---|---|
| 201941039958 | Oct 2019 | IN | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2020/059247 | 10/2/2020 | WO |
