Patent Description:
Tubes and catheters are inserted through a patient's skin to either introduce fluids to the patient or to remove fluids from the patient. The tubes must be secured to prevent the tube from slipping out of the patient. Commonly, surgical tape or sutures are used to hold tubing to the patient's skin.

One very common type of tube is an intravenous (IV) catheter. An IV catheter is inserted into the patient's bloodstream. Movement of an IV catheter while the catheter is inserted in a vein is a leading cause of catheter failure. When a catheter moves in a vein, it scrapes and pokes the inner wall of the vein, thereby irritating the vein. Repeated movement of the catheter can cause sufficient irritation of the vein to require that the catheter be removed and then a new catheter to be inserted in a different location along the same vein or in an entirely different vein. Therefore, a need exists for effective securement systems for tubes, such as catheters.

<CIT> discloses an assembly containing at least two adhesive tapes with a U or V shape notch, or a slit that enables them to be placed one opposite the other and the V or U shape or the slit can be placed around an object extruding from a skin exit site minimizing the distance from the base of the U or V or the bottom slit of each adhesive.

The disclosed tape system comprises a first tape and second tape each with an adhesive that interacts to secure a device such as tubing. The first tape and second tape each have a longitudinally extending midsection and laterally extending legs. The first tape overlaps the device, while the second tape is under the device, but with the legs of the second tape overlapping the legs of the first tape. This overlapping connection of the first tape and second tape strongly secures the tubing.

In one embodiment, the tape system includes first and second tapes, each tape having a first major surface comprising an adhesive, and a second major surface opposite the first major surface. The first and second tapes each have a midsection, and first and second legs extending from first and second ends of the midsection, the two legs extending in a direction lateral to the midsection. The first tape is applied over the second tape such that the first lateral direction of the first tape is opposed to the first lateral direction of the second tape. The midsections of the first and second tapes are aligned, but spaced apart from each other.

In a further embodiment, the second tape is applied over the first tape with the first leg of the second tape applied over the second leg of the first tape, and with the second leg of the second tape applied over the first leg of the first tape.

In one embodiment, the tape system includes a dressing overlying a device and a substrate. At least a portion of the tape system can be adhered to the dressing. At least a portion of the tape system can be adhered to the substrate. In some embodiments, the substrate is skin.

In one embodiment, a method for securing a device to a substrate includes applying the tape system to the device, the adhesive at the midsection of the first tape overlying a portion of the device with the first leg and second leg of the first tape adjacent to the device and overlying the substrate, and applying the midsection of the second tape of claim <NUM> under a portion of the device with the adhesive towards the substrate. The first leg of the second tape is overlying the second leg of the first tape, the second leg of the second tape is overlying the first leg of the first tape, and the device extends between the midsection of the first tape and the midsection of the second tape.

In a further embodiment, the method includes applying a dressing over the device, and under at least a portion of the tape system.

In some embodiments, the substrate is skin.

In one embodiment, a kit is provided that includes: <NUM>) a dressing system and a first tape, the entire first tape overlying the dressing film; and <NUM>) a second tape. The first and second tapes include features of the first and second tapes in embodiments of the tape system.

While the above-identified drawings and figures set forth embodiments of the invention, other embodiments are also contemplated, as noted in the discussion. In all cases, this disclosure presents the invention by way of representation and not limitation. Other modifications and embodiments can be devised by those skilled in the art, which fall within the scope of this invention. The figures may not be drawn to scale.

The disclosed tape system <NUM> comprises a first tape <NUM> and second tape <NUM> each with an adhesive that interact to secure a device such as tubing. The first tape and second tape each have a longitudinally extending midsection and laterally extending legs. The first tape overlaps the device, while the second tape is under the device, but with the legs of the second tape overlapping the legs of the first tape. This overlapping connection of the first tape and second tape strongly secures the tubing.

<FIG> is an embodiment of the first tape <NUM> having a backing <NUM>. Backing <NUM> has a first major surface and a second major surface opposite the first major surface. The first major surface of backing <NUM> has an adhesive. Tape <NUM> has midsection <NUM>, the midsection having a first end <NUM> and a second end <NUM>. A first leg <NUM> extends away from midsection <NUM> at first end <NUM> in a lateral direction <NUM>, and a second leg <NUM> extends away from midsection <NUM> at second end <NUM> in the lateral direction <NUM>. Midsection <NUM> extends in a longitudinal direction perpendicular to lateral direction <NUM>. In this embodiment, the midsection <NUM> is curved with the first leg <NUM> and second leg <NUM> extending along the same curved shape forming a "C" shaped tape <NUM>. In this embodiment, the tape <NUM> is symmetrical. Other shapes and configurations of the tape <NUM> can be used such as being asymmetrical, having wider and narrower portions, legs of differing lengths, straight, curved or a combination for the arrangements of the midsection and legs, so long as the legs extend in the same lateral direction.

Optionally, midsection <NUM> has tabs <NUM> and <NUM> extending away from midsection <NUM>. Midsection <NUM> optionally includes a perforation set <NUM> extending laterally across midsection <NUM>. Optional tabs <NUM> and <NUM>, and optional perforation set <NUM> can be beneficial in removal of the tape system.

<FIG> show a side sectional view of tape <NUM>, showing backing <NUM> as a layer having a first major surface <NUM> and a second major surface <NUM> opposed to first major surface <NUM>. First major surface <NUM> of backing <NUM> has a layer of adhesive <NUM>. In some embodiments, the adhesive is a skin-adhesive.

In some embodiments, backing <NUM> can include multiple layers, including, for example, a reinforcement layer <NUM> to provide stiffness and/or strength to tape <NUM> for securing a device, such as a tube, or more specifically a catheter. In some embodiments, reinforcement layer <NUM> is disposed at second major surface <NUM>. The reinforcement layer may be visually clear or have a color to indicate its presence.

<FIG> illustrates an alternate embodiment of a tape <NUM> having a backing <NUM>. In contrast the "C" shape of tape <NUM>, tape <NUM> has a more rectilinear shape. Backing <NUM> has a first major surface and a second major surface opposite the first major surface. The first major surface of backing <NUM> has an adhesive. Tape <NUM> has midsection <NUM> extending in a longitudinal direction along axis <NUM>, the midsection having a first end <NUM> and a second end <NUM>. A first leg <NUM> extends away from midsection <NUM> at first end <NUM> in a lateral direction <NUM>, and a second leg <NUM> extends away from midsection <NUM> at second end <NUM> in the lateral direction <NUM>. The longitudinal direction is perpendicular to the lateral direction <NUM>. In this embodiment, the tape <NUM> is symmetrical. Other shape and configurations of the tape <NUM> can be used such as being asymmetrical, having wider and narrower portions, legs of differing lengths, straight, curved or a combination for the arrangements of the midsection and legs, so long as the legs extend in the same lateral direction.

In some embodiments, backing <NUM> can include multiple layers, including, for example, a reinforcement layer <NUM> to provide stiffness and/or strength to tape <NUM> for securing a device, such as a tube, or more specifically a catheter. In some embodiments, reinforcement layer <NUM> is disposed at the second major surface of backing <NUM>.

<FIG> shows the tape system <NUM> with the first tape <NUM> and second tape <NUM>. Second tape <NUM> is substantially the same as first tape <NUM>. Second tape <NUM> includes a midsection and a first leg and a second leg.

As shown in <FIG>, first tape <NUM> is over tube <NUM> and overlies a substrate <NUM>. Second tape <NUM> is under the tube <NUM>, but with the first leg and the second leg of the second tape <NUM> placed over the first leg and the second leg of tape <NUM>. The midsections of tapes <NUM> and <NUM> are aligned, but spaced apart, to allow, for example, tube <NUM> to be situated between the midsections of tapes <NUM> and <NUM>. In this configuration, tape system <NUM> can advantageously secure tube <NUM> from being pulled away from the substrate.

In some embodiments, tapes <NUM> and <NUM> in tape system <NUM> are identical. A significant advantage of having tapes <NUM> and <NUM> be identical is simplification of applying the tape, in part by eliminating the need to select among two different types of tape during a catheterization process, where speed and ease of apply the tape system is highly valuable, to both the patient and the medical professional performing the catheterization. In some situations, only one type of the tape needs to be available to form the tape system, which can result in additional benefits in the areas of packaging, inventory, and cost.

In some other embodiments, tapes <NUM> and <NUM> in tape system <NUM> are not identical; for example, tapes <NUM> and <NUM> may differ from each other in shape, size, materials, in whether or not a perforation set is present, among other possible differences, or combinations of such differences. A tape system that uses non-identical tapes could be a useful, for example, in cases where the skin surface available for application of the tape system has restricted geometric requirements.

<FIG> shows a dressing system including the tape system <NUM> described above in <FIG> and an underlying dressing <NUM>. Dressing <NUM> has a body layer <NUM> defined by a perimeter <NUM>, body layer <NUM> having a first major surface opposite a second major surface. The second major surface has an adhesive. In the embodiment shown, a portion of body layer <NUM> includes a support layer <NUM>. Dressing <NUM> overlies tube <NUM> and substrate <NUM>. In embodiments where tube <NUM> is an IV catheter inserted into a vein, the dressing <NUM> can beneficially provide a physical protection of the insertion site from fluids, particulates, microorganisms, and the like. In the embodiment shown, a portion of tape system <NUM> is adhered to the first major surface of the dressing <NUM>, and a portion of tape system <NUM> is adhered to substrate <NUM>.

The backing layer <NUM> can be any material that provides mechanical stiffening of the tape while also allowing enough flexibility to allow for conformability and comfortable wear. Backing material can be a film, a paper, or a fabric layer material, such as a woven, knitted, or nonwoven fabric. Backing material can be elastic or stiff. In some embodiments, the backing layer material is a woven, knitted, or nonwoven material. One example of a nonwoven material is a high strength nonwoven fabric available from E. Dupont de Nemours & Company of Wilmington, Delaware, under the trademark SONTARA. Other suitable nonwoven webs include a hydroentangled polyester fabric available from Vertac, a division of International Paper of Walpole, MN. Another suitable nonwoven web is the nonwoven elastomeric web described in <CIT>. The backing can be a high moisture vapor permeable film backing. <CIT> describes methods of making such films and methods for testing their permeability.

The backing may be a single or multilayer construction. In some embodiments, an optional reinforcing layer material may be used with the backing. The reinforcing material may be as pliable as a thick adhesive or as stiff as a solid material (e.g., a paper or a film). For example, <CIT> discloses a permanent adhesive as a reinforcement material.

Any number of adhesives can be used with the tape and on the dressing, if included. Suitable adhesives are pressure sensitive and in certain embodiments have a relatively high moisture vapor transmission rate to allow for moisture evaporation. Suitable pressure sensitive adhesives include those based on acrylates, urethane, hydrogels, hydrocolloids, block copolymers, silicones, rubber-based adhesives (including natural rubber, polyisoprene, polyisobutylene, butyl rubber etc.) as well as combinations of these adhesives. The adhesive component may contain tackifiers, plasticizers, rheology modifiers as well as active components, for example an antimicrobial agent.

The pressure sensitive adhesive is usually reasonably skin compatible and "hypoallergenic", such as the acrylate copolymers described in <CIT>. Particularly useful is a <NUM>:<NUM> isooctyl acrylate: acrylamide copolymer, as is <NUM>:<NUM>:<NUM> isooctyl acrylate: ethyleneoxide acrylate: acrylic acid terpolymer described in <CIT>. Additional useful adhesives are described in <CIT>; <CIT>; <CIT>; and <CIT>. Inclusion of medicaments or antimicrobial agents in the adhesive is also contemplated, as described in <CIT> and <CIT>.

Silicone adhesives can also be used. Generally, silicone adhesives can provide suitable adhesion to skin while gently removing from skin. Suitable silicone adhesives are disclosed in <CIT> and <CIT>.

Adhesive layers of the present disclosure can be flood-coated, or pattern-coated. The adhesive layer is preferably pattern-coated to allow for better vapor transmission. An example of useful pattern coating is described in <CIT>.

In some embodiments, suitable dressings of the present disclosure include a thin, flexible and transparent polymeric film body layer. In some embodiments, the dressing further includes a support material. In general, the support layer materials can include, but are not limited to, an elastic film, a non-elastic film, non-woven fibrous web, woven fibrous web, knits, and polyethylene/vinyl acetate copolymer-coated papers and polyester films. Examples of suitable dressings can be found, for example, in <CIT>, U. Patent Application Publication No. <CIT>, and in <CIT>). One example of a commercially available medical dressing is TEGADERM IV ADVANCED DRESSING (<NUM> Co.

In some embodiments, tapes and dressings of the present disclosure include a release liner film disposed on the skin adhesive layer (for example, adhesive layer <NUM> in <FIG>). Release liners can be made of kraft papers, polyethylene, polypropylene, polyester or composites of any of these materials. The films are preferably coated with release agents such as fluorochemicals or silicones. For example, <CIT> describes low surface energy perfluorochemical liners. The liners are papers, polyolefin films, or polyester films coated with silicone release materials. Examples of commercially available silicone coated release papers are POLYSLIK™, silicone release papers available from Rexam Release (Bedford Park, Ill. ) and silicone release papers supplied by Loparex Group (Willowbrook, Ill.

In some embodiments, a kit is provided that includes: <NUM>) a dressing having a first major surface, a second major surface opposite the first major surface, defined by a perimeter around a body layer, the second major surface comprising a skin-compatible adhesive, with a first tape of the disclosure overlying the first major surface of the dressing; and <NUM>) a second tape of the disclosure. In some embodiments, the entire first surface of the first tape overlies first major surface of the dressing. In some embodiments, a portion of the body of the dressing includes a support layer, and the entire first surface of the first tape overlies the support layer.

The kit can facilitate applying the dressing and first tape together over a device inserted into a substrate, and applying the second tape under the device, with the first leg of the second tape applied over the second leg of the first tape, and with the second leg of the second tape applied over the first leg of the first tape, with the device extending between the midsection of the first tape and midsection of the second tape. In some embodiments, the first and second components of the kit can be disposed on a single release liner, to simplify application of the components to a patient.

Claim 1:
A dressing system comprising
a tape system (<NUM>) comprising
a first tape (<NUM>; <NUM>) comprising:
a first major surface (<NUM>) with a first tape adhesive (<NUM>) and a second major surface (<NUM>) opposite the first major surface;
a midsection (<NUM>; <NUM>) extending in a longitudinal direction (<NUM>), the midsection having a first end (<NUM>; <NUM>) and a second end (<NUM>; <NUM>);
a first leg (<NUM>; <NUM>) extending from the midsection at the first end in a first lateral direction (<NUM>; <NUM>);
a second leg (<NUM>; <NUM>) extending from the midsection at the second end in the first lateral direction; and
a second tape (<NUM>) comprising:
a first major surface with a second tape adhesive and a second major surface opposite the first major surface;
a midsection extending in a longitudinal direction, the midsection having a first end and a second end;
a first leg extending from the midsection at the first end in a first lateral direction;
a second leg extending from the midsection at the second end in the first lateral direction;
wherein the second tape is applied over the first tape with the first lateral direction of the first tape opposed to the first lateral direction of the second tape; and
wherein the midsection of the first tape is aligned with but spaced apart from the midsection of the second tape,
wherein the dressing system further comprises a dressing (<NUM>) comprising
a first major surface, a second major surface opposite the first major surface, defined by a perimeter (<NUM>) around a body layer (<NUM>), the second major surface comprising an adhesive; and
wherein at least a portion of the tape system overlies the first major surface of the dressing.