Tube securement device

The disclosed tube securement device attaches to the patient's body and to the tube, while allowing for a section of the tube to be detached from the tube securement device. The tube securement device comprises a backing with adhesive coated sections. The backing comprises a first end section, a second end section, and a midsection, separating the first end section from the second end section. The tube securement device further comprises a first adhesive on at least a portion of the first major surface of the first end section, a second adhesive on at least a portion of the first major surface of the second end section, and wherein the first major surface of the midsection is free of tacky adhesive.

TECHNICAL FIELD

The present disclosure relates to a tube securement device and methods of using a tube securement device.

BACKGROUND

At times, it may be necessary to insert tubes into a patient for different purposes, such as, feeding, air supply, and/or liquid removal. Such tubes generally need to be attached to the patient's skin in order to maintain the correction position of the tube.

Tubes inserted through the nose are referred to as a nasogastric (NG) tube and can be used for various applications, including feeding, drug administration and/or stomach drainage. Tubes inserted through the mouth are referred to an endotracheal tubes (ET) tubes. Tubes entering or exiting a body need to be securely attached to the patient's skin in order to maintain the correct position of the tube internally, such as inside the stomach, mouth, or airway. These tubed inside of a patient can be uncomfortable to the patient.

SUMMARY

The disclosed tube securement device securely attaches to the patient's body and to the tube, while allowing for a section of the tube to be detached from the tube securement device. When fully adhesive coated tapes are used to secure a tube to the body, all movement of the tube translates to movement of the tube, which can cause pain an irritation. In the disclosed tube securement device, the detached section of the tube from the tube securement device will allow for a small amount of tube movement.

The tube securement device comprises a backing with adhesive coated sections. The backing has a first major surface and a second major surface, opposite the first major surface. The backing comprises a first end section, a second end section, and a midsection, separating the first end section from the second end section. The first end section, second end section, and midsection extend along a longitudinal direction. The first end section is wider than the midsection in a lateral direction that is perpendicular to the longitudinal direction. The tube securement device further comprises a first adhesive on at least a portion of the first major surface of the first end section, a second adhesive on at least a portion of the first major surface of the second end section, and wherein the first major surface of the midsection is free of tacky adhesive.

In one embodiment, the backing comprises a plurality of layers. In one embodiment, the backing is selected from paper, film, woven, knitted, nonwoven, or combinations thereof.

In one embodiment, the second end section is wider than the midsection in a lateral direction that is perpendicular to the longitudinal direction. In one embodiment, the second end section is wider than the midsection in the lateral direction that is perpendicular to the longitudinal direction.

In one embodiment, the first end section is wider than the midsection in a first lateral direction that is perpendicular to the longitudinal direction symmetrical and wider than the midsection in a second lateral direction that is opposite the first lateral direction. In one embodiment, the first end is symmetrical in the first lateral direction and second lateral direction.

In one embodiment, the first adhesive and second adhesive are pressure sensitive adhesives. In one embodiment, the first adhesive and second adhesive are selective from an acrylate or a silicone adhesive. In one embodiment, the first adhesive is a silicone adhesive and second adhesive is an acrylate adhesive.

In one embodiment, the first major surface of the midsection that is free of tacky adhesive comprises one of: (i) a midsection adhesive composition detackified to form the first major surface that is free of tacky adhesive; (ii) a midsection adhesive composition covered to form the first major surface that is free of tacky adhesive, or (iii) no adhesive composition to form the first major surface that is free of tacky adhesive.

In one embodiment, a system for securing a tube to a skin or a body, such as a nose, lip, cheek, comprises a tube securement device. The tube securement device comprises a backing having a first major surface and a second major surface, opposite the first major surface, wherein the backing comprises a first end section, a second end section, and a midsection, separating the first end section from the second end section. The first end section, second end section, and midsection extend along a longitudinal direction. The first end section is wider than the midsection in a lateral direction that is perpendicular to the longitudinal direction. A first adhesive on at least a portion of the first major surface of the first end section. A second adhesive on at least a portion of the first major surface of the second end section. The first major surface of the midsection is free of tacky adhesive. The first adhesive of the first end section is secured to the body. The second adhesive of the second end section is secured to the tube. The midsection is detached from the tube.

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. It should be understood that numerous other modifications and embodiments can be devised by those skilled in the art, which fall within the scope and spirit of this invention. The figures may not be drawn to scale.

DETAILED DESCRIPTION

Commonly, tape strips are used to wrap around a tube and secure the tubes to a patient. This can provide secure attachment of the tube to the skin, but this is also a very rigid and inflexible connection of the tube to the patient. Tubes, like NG tubes or ET tubes are uncomfortable inside the sensitive tissue of the nose and mouth, respectively. Because the very secure connection of the tube from the tape, any movements from the face or the tube will cause actuation of the tube inside the sensitive tissue of the patient.

The disclosed tube securement device secures to the patient's body, such as a nose, mouth, lip, cheek, etc., and to the tube, but includes a midsection that is detached from the tube. Therefore, this detached section of the tube from the tube securement device will allow for a small amount of tube movement relative to the tape securement device. This small amount of movement prevents every movement of the face or the tube from actuating tube against the inside of the patients body. In other words, the tube is slightly more free to suspend from the tube securement device to allow for very slight movements of the tube.

FIG.1is a plan view of one embodiment of a tube securement device100, showing the first major surface that contains the adhesive surfaces.FIG.2is a side sectional view of the tube securement device100ofFIG.1through line2-2, with the addition of a release liner150.FIG.3is a front view of the tube securement device100ofFIG.1secured to a tube300and to a nose200.

The tube securement device100has a first major surface112and a second major surface114, opposite the first major surface112. The first major surface112is shown inFIG.1and is the surface containing the adhesive, described below.

The tube securement device100comprises a backing110. The backing110is made from a flexible material that will contour to the nose200as well as the tube300. Common materials for the backing110include paper, film, woven, knitted, nonwoven materials. The backing110can be a single layer or a multilayer construction. The backing110can be formed from materials that absorb or allow for transmission of moisture vapor generated from the skin at the nose200.

The tube securement device100comprises a first end section120, a second end section130and a midsection140, separating the first end section120from the second end section130. Typically, the single, unitary backing material110material extends continuously from the first end section120, the second end section130and the midsection140, such as shown in the embodiment inFIGS.1-2. It is understood, that the backing may comprise integrated sections that form the first end section120, a second end section130and a midsection140such that the material forming each section is not identical to the other sections.

As shown inFIG.1, the first end section120, second end section130, and midsection140extend along a longitudinal direction116. In this embodiment, the first end section120, second end section130, and midsection140are linearly arranged along the longitudinal direction116. It is understood that it is not necessary the first end section120, second end section130, and midsection140be linearly arranged, but could be offset or extend at a diagonal, for example.

The first end section120is wider than the midsection140in a lateral direction117that is perpendicular to the longitudinal direction116, and much wider than the midsection140in a lateral direction118. In the embodiment shown inFIGS.1-3, the first end section120contacts the nose200. Therefore, a wider portion of the first end section120allows for secure attachment to the nose200, without the bulk of material overlying the tube300at the midsection140. In some embodiments, see for exampleFIG.5, the wider first end section120is the portion that contacts the tube300. Therefore, the wider portion of the first end section120allows for secure attachment to the tube300and possibly for wrapping around the tube300one or more times.

In some embodiments, like shown inFIGS.1and4, the second end section130is wider than the midsection140in a lateral direction117that is perpendicular to the longitudinal direction116. When the first end section120is used to secure to the nose, the wider portion of the second end section130is secured to the tube300and allows for secure attachment to the tube300and possibly for wrapping around the tube300one or more times.

In some embodiments, like shown inFIGS.1and4, the first end section120is symmetrical in a first lateral direction117and second lateral direction118so that the first end section120can be placed centrally on the nose. It is understood that this is not required and the first end section120can be of any variety of shapes and sizes to secure to a body. If securing to a nose, for example, the first end section120may be fitted to just a single side of the nose200and not centrally on the nose200.

Similarly, the second end section130may extend in only in a first lateral direction117, like shown inFIG.1or may extend symmetrically in a first lateral direction117and second lateral direction118, like shown in the embodiment ofFIG.4.

Various shapes of the tube securement device suitable for the tube securement device100are shown in PCT publications: WO 2017/034907, WO 2017/034909, WO 2017/034911, WO 2017/034912, WO 2017/034913, and WO 2018/160649, the disclosures of which are herein incorporated by reference.

The first major surface112contains the adhesive on the tube securement device100. The adhesive is any suitable adhesive that will secure on contact to skin or secure to a tube. Such an adhesive may be referred to as having tack. For example, pressure sensitive adhesives, hydrogels, or hydrocolloids can be used.

A first adhesive122is on at least a portion of the first major surface112of the first end section120. A second adhesive132is on at least a portion of the first major surface112of the second end section130. As can be seen in the embodiment inFIG.3, the first adhesive122at the first end section120secures to the nose200, and the second adhesive132at the second end section130secures to the tube300.

FIG.2shows an optional release liner150that covers all or a portion of the adhesives122,132to prevent contamination of the adhesives122,132prior to use. In one embodiment, the release liner150may be the package that contains the tube securement device100. Suitable release liners can be made of papers or films, such as, for example kraft papers, polyethylene, polypropylene, polyester or composites of any of these materials. In one embodiment, the liners are coated with release agents such as fluorochemicals or silicones.

Having the first adhesive122and second adhesive132on the first major surface112gives at least three benefits. First, it is more efficient to apply the first adhesive122and second adhesive132to a single side of the tube securement device100during manufacturing. Second, for packaging the tube securement device100, a single release liner150, can be used to cover both the first adhesive122and second adhesive132prior to use, minimizing the total amount and cost of material in the tube securement device100. Third, once the tube securement device100is applied, such as shown inFIG.3, the first adhesive surface122and second adhesive surface132are both facing the patient and therefore are less likely to interfere with the nurse or doctor's hands during application.

In some embodiments, second end section130is entirely covered with the second adhesive132, such as shown inFIG.1. In some embodiment, a portion of the second end section130, typically at the perimeter edge, is free of second adhesive132, to function as a tab to allow for easy removal of the second end section130from the tubing.

The first or second adhesive122,132can include any adhesive that provides acceptable adhesion to skin and is acceptable for use on skin (e.g., the adhesive should preferably be non-irritating and non-sensitizing). Suitable adhesives are pressure-sensitive and in certain embodiments have a relatively high moisture vapor transmission rate to allow for moisture evaporation. Suitable 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, absorbent particles or fibers as well as active components including for example an antimicrobial agent.

The first adhesive122and second adhesive132may be compositionally the same adhesive. For example, both the first adhesive122and second adhesive132may be acrylate pressure sensitive adhesives or silicone pressure sensitive adhesives. In other embodiments, the first adhesive122and second adhesive132are different from one another. It may be desirable to use one adhesive that is well suited for securing to skin, while a different adhesive is used that is suited for securing to tubing.

The first major surface112of the midsection140is free of tacky adhesive. This means that the first major surface112of the midsection140will not secure on contact with skin or tubing. There are various ways of providing the first major surface112of the midsection140that is free of tacky adhesive. In one embodiment, such as shown inFIG.2, at the midsection140no adhesive composition is applied at the first major surface112of the midsection and therefore the first major surface112is free of tacky adhesive.

In another embodiment, if the midsection140is covered with an adhesive composition, then the adhesive could be detackified so that the first major surface112is free of tacky adhesive. Adhesives can be detackified by using commonly know techniques, such as, for example, radiation curing or applying coatings.

In another example, if the midsection140is covered with an adhesive composition, then the adhesive composition could be covered to form the first major surface112that is free of tacky adhesive. The covering could be a film, paper, or other non-tacky material. Regardless of how it is formed, the midsection includes a first major surface112that is free of tacky adhesive.

In use, the first adhesive122of the first end section120secures to the body, such as the nose200, the second adhesive132of the second end section130secures to the tube300, and the midsection140, which is free of tacky adhesive. As can be seen inFIG.3, the midsection140is not in direct contact with the tube300. In use, the tube securement device100secures to the patient's body, such as a nose200, and to the tube300, like shown inFIG.3. Because the midsection140is free of tacky adhesive, the midsection140is detached from the tube. The result is that the tube securement device100allows the tube300to be suspended from first end section120. Therefore, this detached section of the tube300from the tube securement device100will allow for a small amount of tube300movement relative to the tape securement device100.

To use the tube securement device100, the release liner150(if provided) is removed to expose the first adhesive122and second adhesive132. Then, first adhesive122is secured to the body, such as the nose300. Then the second adhesive132is secured to the tube300. During application, the first major surface112, containing the first adhesive122and second adhesive132is facing the body.

As shown inFIG.3, the first end section120with the first adhesive122is secured to the nose200. The second end section130with the second adhesive132secures to the tube300and is able to wrap around the tube. The midsection140is adjacent to the tube300but is not directly secured to the tube300. The tube securement device100securely attached the tube300to the body, but not such a rigid securement that all movement of the tube300forces the tube300against the inner surface of the nose.

FIG.4is a plan view of a second embodiment of a tube securement device100showing the first major surface112containing the adhesive. Reference numbers inFIG.4identify the corresponding features as shown inFIG.1. In this embodiment inFIG.4, the first adhesive122and second adhesive132are applied in a pattern on the first major surface112. Therefore, there are portions of the first end section120and second end section130that are free of tacky adhesive. Limiting the adhesive coverage can increase the moisture vapor permeability through the backing.

Additionally, in this embodiment inFIG.4, the second end section130extend in both a first lateral direction117and second lateral direction118wider than the midsection140providing more coverage for securing to the tube300.

FIG.5is a plan view of a third embodiment of a tube securement device100showing a release liner150that the first major surface112containing the adhesive is secured to. Therefore, the tube securement device100is shown slightly peeled up from the release liner150. The dotted line is intended to show the break in the area with adhesive and the area of the midsection without the tacky adhesive. Reference numbers inFIG.5identify the corresponding features as shown inFIG.1. In this embodiment, only the first end section120is wider than the midsection140in a lateral direction117, while the second end section130is of the same width as the midsection140. Additionally, in this embodiment inFIG.5, the first adhesive122and second adhesive132are applied in a pattern on the first major surface112. First end section120or section end section130could be used to apply to the body, such as a nose.

FIG.6is a front view of a third embodiment of a tube securement device100secured to a lip200and to a tube300. In this embodiment the tube200is an endotracheal tube. Reference numbers inFIG.6identify the corresponding features as shown inFIG.1. In this embodiment inFIG.6, the tube securement device100include a first end section120with first adhesive (not apparent in this figure) secured to the body200at the upper lip and second end section130with second adhesive (not apparent in this figure) secured to the tube300. Between the first end section120and second end section130is the midsection140, that is free of tacky adhesive. The first end section120includes a recess for improving the fit in the narrow section between the nose and lip, so that larger sections of the first end section120can provide more contact area at the face. In this embodiment, the midsection140is relative short compared to the midsection140shown inFIGS.1-5for less flexibility and less translation of the ET tube. To use the tube securement device100, the first end section120is secured to the body, such as the upper lip and cheeks, and the second end section130is secured to the tube300.

The tube securement devices100disclosed herein can be manufactured using commonly used film converting, coating, cutting, and packaging techniques. For example, in one embodiment, the backing110is coated with the first adhesive122and second adhesive. Then, the coated backing is cut to the shape of the tube securement device100. A release liner150may be applied to entire first major surface112of the tube securement device.

In some embodiments, like shown inFIG.5, the release liner150is overall larger in size than the tube securement device100. The excess release liner150aids in peeling the tube securement device100from the release liner150. Additional components, such as an adhesive tape strip160, can also be secured to the excess release liner150.

Although specific embodiments have been shown and described herein, it is understood that these embodiments are merely illustrative of the many possible specific arrangements that can be devised in application of the principles of the invention. Numerous and varied other arrangements can be devised in accordance with these principles by those of skill in the art without departing from the spirit and scope of the invention. The scope of the present invention should not be limited to the structures described in this application, but only by the structures described by the language of the claims and the equivalents of those structures.