阅读说明：本技术 管固定装置 (Pipe fixing device ) 是由 阿曼达·C·恩格勒 丹尼斯·J·齐曼 理查德·L·雅各布森 金伯利·A·朔默 伊丽莎白·A· 于 2020-03-06 设计创作，主要内容包括：本发明公开了一种管固定装置(100),该管固定装置附接到患者的身体(200)和管(300),同时允许管的节段与管固定装置分离。管固定装置包括具有被粘合剂涂覆的节段(120,130)的背衬(110)。背衬包括第一端部节段(120)、第二端部节段(130)和将第一端部节段与第二端部节段分开的中间节段(140)。管固定装置还包括在第一端部节段(120)的第一主表面(112)的至少一部分上的第一粘合剂(122)、在第二端部节段(130)的第一主表面(112)的至少一部分上的第二粘合剂(132),并且其中中间节段(140)的第一主表面(112)不含粘性粘合剂。(A tube fixation device (100) attaches to a patient's body (200) and a tube (300) while allowing a segment of the tube to be separated from the tube fixation device. The tube securing device includes a backing (110) having adhesive coated segments (120, 130). The backing includes a first end segment (120), a second end segment (130), and an intermediate segment (140) separating the first end segment from the second end segment. The tube fixation device further includes a first adhesive (122) on at least a portion of the first major surface (112) of the first end segment (120), a second adhesive (132) on at least a portion of the first major surface (112) of the second end segment (130), and wherein the first major surface (112) of the intermediate segment (140) is free of tacky adhesive.)

1. A tube fixture device, the tube fixture device comprising:

a backing having a first major surface and a second major surface opposite the first major surface, wherein the backing comprises a first end segment, a second end segment, and an intermediate segment separating the first end segment from the second end segment;

wherein the first end section, the second end section, and the intermediate section extend in a longitudinal direction;

wherein the first end section is wider in a lateral direction perpendicular to the longitudinal direction than the middle section;

a first adhesive on at least a portion of the first major surface of the first end segment;

a second adhesive on at least a portion of the first major surface of the second end section;

wherein the first major surface of the intermediate section is free of tacky adhesive.

2. The tube securement device of claim 1, wherein the backing comprises a plurality of layers.

3. The tube securing device according to any of the preceding claims, wherein the backing is selected from paper, film, woven, knitted, nonwoven, or combinations thereof.

4. The pipe fixation device of any one of the preceding claims, wherein the second end section is wider in a lateral direction perpendicular to the longitudinal direction than the intermediate section.

5. The pipe fixation device according to any one of the preceding claims, wherein the first end section is symmetrically wider than the intermediate section in a first lateral direction perpendicular to the longitudinal direction and wider than the intermediate section in a second lateral direction opposite the first lateral direction.

6. The pipe fixation device of any one of the preceding claims, wherein first end portion is symmetrical in the first lateral direction and the second lateral direction.

7. The pipe fixation device of any one of the preceding claims, wherein the second end section is wider in a lateral direction perpendicular to the longitudinal direction than the intermediate section.

8. The tube securement device of any one of the preceding claims, wherein the first adhesive and the second adhesive are pressure sensitive adhesives.

9. The tube securement device of any one of the preceding claims, wherein the first adhesive and the second adhesive are selected from an acrylate adhesive or a silicone adhesive.

10. The tube securement device of any one of the preceding claims, wherein the first adhesive is a silicone adhesive and the second adhesive is an acrylate adhesive.

11. The tube fixation device according to any one of the preceding claims, wherein the first major surface of the intermediate section that is free of tacky adhesive comprises one of: (i) a debonded intermediate section adhesive composition to form the first major surface free of tacky adhesive; (ii) a coated intermediate section adhesive composition to form the first major surface free of tacky adhesive; or (iii) without an adhesive composition to form the first major surface free of tacky adhesive.

12. A system for securing a tube to skin, the system comprising:

a tube fixture, the tube fixture comprising:

a backing having a first major surface and a second major surface opposite the first major surface, wherein the backing comprises a first end segment, a second end segment, and an intermediate segment separating the first end segment from the second end segment;

wherein the first end section, the second end section, and the intermediate section extend in a longitudinal direction;

wherein the first end section is wider in a lateral direction perpendicular to the longitudinal direction than the middle section;

a first adhesive on at least a portion of the first major surface of the first end segment;

a second adhesive on at least a portion of the first major surface of the second end section;

wherein the first major surface of the intermediate section is free of tacky adhesive;

wherein the first adhesive of the first end section is secured to the skin;

wherein the second adhesive of the second end section is secured to the tube;

wherein the intermediate section is separate from the tube.

Technical Field

The present disclosure relates to a tube fixation device and a method of using a tube fixation device.

Background

Sometimes, it may be desirable to insert the tube into the patient for different purposes, such as feeding, air supply, and/or liquid removal. It is often necessary to attach such tubes to the skin of a patient in order to maintain the correct position of the tubes.

Tubes inserted through the nose are known as Nasogastric (NG) tubes and can be used for a variety of applications, including feeding, drug administration, and/or gastric drainage. Tubes inserted through the mouth are known as Endotracheal Tubes (ET) tubes. Tubes entering or exiting the body need to be securely attached to the patient's skin in order to maintain the correct position of the tube inside, such as inside the stomach, mouth or airways. These cannulas in the patient may cause discomfort to the patient.

Disclosure of Invention

The disclosed tube securement device is securely attached to the body of a patient and to the tube while allowing the segments of the tube to be separated from the tube securement device. When the tube is fixed to the body using an adhesive tape completely coated with an adhesive, all movement of the tube is converted into movement of the tube, which may cause pain and irritation. In the disclosed tube holding device, the separate section of the tube from the tube holding device will allow for a small amount of tube movement.

The tube securing device includes a backing having adhesive coated segments. The backing has a first major surface and a second major surface opposite the first major surface. The backing includes a first end segment, a second end segment, and an intermediate segment separating the first end segment from the second end segment. The first end section, the second end section and the intermediate section extend in a longitudinal direction. The first end section is wider in a lateral direction perpendicular to the longitudinal direction than the middle section. The tube fixation device also includes 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 intermediate section 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 in a lateral direction perpendicular to the longitudinal direction than the middle section. In one embodiment, the second end section is wider in a lateral direction perpendicular to the longitudinal direction than the middle section.

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

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

In one embodiment, the first major surface of the intermediate section that is free of tacky adhesive comprises one of: (i) debonding the intermediate section adhesive composition to form a first major surface free of tacky adhesive; (ii) a coated intermediate section adhesive composition to form a first major surface free of tacky adhesive; or (iii) without an adhesive composition to form a first major surface free of tacky adhesive.

In one embodiment, a system for securing a tube to skin or a body, such as a nose, lip, cheek, includes a tube securement device. The tube securing device includes a backing having a first major surface and a second major surface opposite the first major surface, wherein the backing includes a first end segment, a second end segment, and a middle segment separating the first end segment from the second end segment. The first end section, the second end section and the intermediate section extend in a longitudinal direction. The first end section is wider in a lateral direction perpendicular to the longitudinal direction than the middle section. A first adhesive is located on at least a portion of the first major surface of the first end segment. A second adhesive is located on at least a portion of the first major surface of the second end section. The first major surface of the intermediate section 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 intermediate section is separate from the tube.

Drawings

FIG. 1 is a plan view of one embodiment of a tube fixation device;

FIG. 2 is a side cross-sectional view of the tube retaining device of FIG. 1;

FIG. 3 is a front view of the tube securement device of FIG. 1 secured to a tube and a person;

FIG. 4 is a plan view of a second embodiment of a tube fixation device;

FIG. 5 is a plan view of a third embodiment of a tube fixation device;

FIG. 6 is a front view of a fourth embodiment of a tube securement device secured to a tube and a person.

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 the principles of this invention. The figures may not be drawn to scale.

Detailed Description

Typically, a strip of tape is wrapped around the tube and secures the tube to the patient. This may provide a firm attachment of the tube to the skin, but it is also a very rigid and inflexible connection of the tube to the patient. Tubes like NG tubes or ET tubes cause discomfort inside sensitive tissues of the nose and mouth, respectively. Because the tube has a very secure connection with the adhesive tape, any movement from the face or tube will cause actuation of the tube within the sensitive tissue of the patient.

The disclosed tube securement devices are secured to the body of a patient, such as the nose, mouth, lips, cheeks, etc., and to the tube, but include an intermediate section that is separate from the tube. Thus, this separate section of tubing from the tubing fixture will allow for a small amount of tubing movement relative to the tape fixture. This small amount of movement prevents each movement of the face or tube from actuating the tube against the interior of the patient's body. In other words, the tube hangs somewhat more freely on the tube fixture to allow very slight movement of the tube.

Fig. 1 is a plan view of one embodiment of a tube fixation device 100 showing a first major surface comprising an adhesive surface. FIG. 2 is a side cross-sectional view of the tube retaining device 100 of FIG. 1 through line 2-2 with the addition of a release liner 150. FIG. 3 is a front view of the tube securement device 100 of FIG. 1 secured to the tube 300 and nose 200.

The tube fixation device 100 has a first major surface 112 and a second major surface 114 opposite the first major surface 112. The first major surface 112 is shown in fig. 1 and is an adhesive-containing surface, as described below.

The tube fixture 100 includes a backing 110. The backing 110 is made of a flexible material that will form the contours of the nose 200 and tube 300. Common materials for backing 110 include paper, film, woven, knitted, nonwoven. The backing 110 may be of single layer or multi-layer construction. The backing 110 may be formed of a material that absorbs or allows the transmission of moisture generated from the skin at the nose 200.

Tube fixation device 100 includes a first end segment 120, a second end segment 130, and an intermediate segment 140 separating first end segment 120 from second end segment 130. Typically, a single unitary backing material 110 material extends continuously from the first end segment 120, the second end segment 130, and the intermediate segment 140, such as shown in the embodiments of fig. 1-2. It should be understood that the backing may include integral segments forming the first end segment 120, the second end segment 130, and the intermediate segment 140 such that the material forming each segment is different from the other segments.

As shown in fig. 1, first end segment 120, second end segment 130, and intermediate segment 140 extend in longitudinal direction 116. In this embodiment, first end segment 120, second end segment 130, and intermediate segment 140 are linearly arranged along longitudinal direction 116. It should be understood that first end segment 120, second end segment 130, and intermediate segment 140 need not be linearly arranged, but may be offset or extend, for example, at a diagonal.

First end segment 120 is wider in lateral direction 117, perpendicular to longitudinal direction 116, than middle segment 140, and is wider in lateral direction 118 than middle segment 140. In the embodiment shown in fig. 1-3, first end segment 120 contacts nose 200. Thus, the wider portion of first end segment 120 allows for secure attachment to nose 200 without having a majority of the material overlying tube 300 at middle segment 140. In some embodiments, referring to, for example, fig. 5, the wider first end segment 120 is the portion that contacts the tube 300. Thus, the wider portion of first end segment 120 allows for secure attachment to tube 300, and may be wrapped around tube 300 one or more times.

In some embodiments, as shown in fig. 1 and 4, the second end segment 130 is wider than the middle segment 140 in a lateral direction 117 perpendicular to the longitudinal direction 116. When first end segment 120 is used to secure to the nose, the wider portion of second end segment 130 secures to tube 300 and allows for secure attachment to tube 300 and possibly wrapping around tube 300 one or more times.

In some embodiments, as shown in fig. 1 and 4, first end segment 120 is symmetrical in first lateral direction 117 and second lateral direction 118 such that first end segment 120 may be placed centrally on the nose. It should be understood that this is not required and first end segment 120 may have any of a variety of shapes and sizes for securement to the body. For example, if secured to the nose, the first end segment 120 may fit to only one side of the nose 200 and not be centrally located on the nose 200.

Similarly, the second end segment 130 may extend only in the first lateral direction 117, as shown in fig. 1, or may extend symmetrically in the first and second lateral directions 117, 118, as shown in the embodiment of fig. 4.

Various shapes of tube securement devices suitable for use with tube securement device 100 are shown in PCT publications WO2017/034907, WO 2017/034909, WO 2017/034911, WO 2017/034912, WO 2017/034913, and WO 2018/160649, the disclosures of which are incorporated herein by reference.

The first major surface 112 comprises an adhesive on the tube fixture 100. The adhesive is any suitable adhesive that will secure to the skin or to the tube upon contact. Such adhesives may be referred to as tacky. For example, pressure sensitive adhesives, hydrogels, or hydrocolloids may be used.

First adhesive 122 is located on at least a portion of first major surface 112 of first end segment 120. A second adhesive 132 is located on at least a portion of the first major surface 112 of the second end segment 130. As can be seen in the embodiment of fig. 3, first adhesive 122 at first end segment 120 is secured to nose 200 and second adhesive 132 at second end segment 130 is secured to tube 300.

Fig. 2 shows an optional release liner 150 covering all or a portion of the adhesives 122, 132 to prevent contamination of the adhesives 122, 132 prior to use. In one embodiment, the release liner 150 may be a package containing the tube securing device 100. Suitable release liners may be made from paper or film such as, for example, kraft paper, polyethylene, polypropylene, polyester, or composites of any of these materials. In one embodiment, the liner is coated with a release agent such as a fluorochemical or silicone.

Having the first adhesive 122 and the second adhesive 132 on the first major surface 112 provides at least three benefits. First, it is more efficient to apply the first adhesive 122 and the second adhesive 132 to a single side of the tube fixation device 100 during manufacturing. Second, for a packaging tube fixture 100, a single release liner 150 may be used to cover both the first adhesive 122 and the second adhesive 132 prior to use, thereby minimizing the total amount and cost of material in the tube fixture 100. Third, once the tube fixation device 100 is applied, such as shown in fig. 3, both the first adhesive surface 122 and the second adhesive surface 132 face the patient and are therefore less likely to interfere with the hands of a nurse or physician during application.

In some embodiments, the second end segment 130 is completely covered by the second adhesive 132, such as shown in fig. 1. In some embodiments, a portion of the second end segment 130 (typically at the peripheral edge) is free of the second adhesive 132 to act as a tab, allowing the second end segment 130 to be easily removed from the tubing.

The first adhesive 122 or the second adhesive 132 can comprise any adhesive that provides acceptable adhesion to the skin and is acceptable for use on the skin (e.g., the adhesive should preferably be non-irritating and non-sensitive). Suitable adhesives are pressure sensitive and in certain embodiments have a relatively high moisture vapor transmission rate to allow moisture vapor to evaporate. Suitable adhesives include those based on acrylates, urethanes, hydrogels, hydrocolloids, block copolymers, silicones, rubber-based adhesives (including natural rubber, polyisoprene, polyisobutylene, butyl rubber, and the like), and combinations of these adhesives. The adhesive component may comprise tackifiers, plasticizers, rheology modifiers, absorbent particulates or fibers, and active components including, for example, antimicrobials.

The first adhesive 122 and the second adhesive 132 may be the same adhesive in composition. For example, both the first adhesive 122 and the second adhesive 132 may be an acrylate pressure sensitive adhesive or a silicone pressure sensitive adhesive. In other embodiments, the first adhesive 122 and the second adhesive 132 are different from each other. It may be desirable to use one adhesive that is well suited for securing to skin and another adhesive that is well suited for securing to tubing.

The first major surface 112 of the intermediate section 140 is free of tacky adhesive. This means that the first major surface 112 of the intermediate section 140 will not be fixed when in contact with the skin or tubing. There are various ways of providing the tack adhesive free first major surface 112 of the intermediate section 140. In one embodiment, such as shown in fig. 2, at the intermediate section 140, no adhesive composition is applied at the first major surface 112 of the intermediate section, and thus the first major surface 112 is free of tacky adhesive.

In another embodiment, if the intermediate section 140 is covered with an adhesive composition, the adhesive may be debonded such that the first major surface 112 is free of tacky adhesive. The adhesive may be debonded by using commonly known techniques such as, for example, radiation curing or applying a coating.

In another example, if the intermediate section 140 is covered with an adhesive composition, the adhesive composition may be covered to form the first major surface 112 free of tacky adhesive. The cover may be a film, paper, or other non-stick material. Regardless of how the intermediate section is formed, the intermediate section includes a first major surface 112 that is free of tacky adhesive.

In use, the first adhesive 122 of the first end section 120 is secured to a body, such as the nose 200, the second adhesive 132 of the second end section 130 is secured to the tube 300 and the intermediate section 140 is free of tacky adhesive. As can be seen in fig. 3, the intermediate section 140 is not in direct contact with the tube 300. In use, the tube securement device 100 is secured to a patient's body, such as the nose 200, and to the tube 300, as shown in fig. 3. Because the intermediate section 140 does not contain a tacky adhesive, the intermediate section 140 is separated from the tube. The result is tube securement device 100 allows tube 300 to hang from first end segment 120. Accordingly, this separate section of tube 300 from tube fixture 100 will allow for a small amount of movement of tube 300 relative to tape fixture 100.

To use the tube fixture 100, the release liner 150 (if provided) is removed to expose the first adhesive 122 and the second adhesive 132. The first adhesive 122 is then secured to the body, such as the nose 300. The second adhesive 132 is then secured to the tube 300. During application, the first major surface 112 comprising the first adhesive 122 and the second adhesive 132 faces the body.

As shown in fig. 3, first end segment 120 having first adhesive 122 is secured to nose 200. The second end segment 130 with the second adhesive 132 is secured to the tube 300 and can be wrapped around the tube. Intermediate section 140 is adjacent to tube 300, but is not directly secured to tube 300. The tube fixation device 100 securely attaches the tube 300 to the body, but not all movement of the tube 300 forces such rigid fixation of the tube 300 against the inner surface of the nose.

Fig. 4 is a plan view of a second embodiment of the tube fixation device 100 showing the first major surface 112 comprising an adhesive. Reference numerals in fig. 4 identify corresponding features as shown in fig. 1. In this embodiment of fig. 4, the first adhesive 122 and the second adhesive 132 are applied in a pattern on the first major surface 112. Thus, there are portions of first end segment 120 and second end segment 130 that are free of tacky adhesive. Limiting adhesive coverage can increase moisture permeability through the backing.

Additionally, in this embodiment of fig. 4, the second end segment 130 extends wider than the middle segment 140 in both the first lateral direction 117 and the second lateral direction 118, providing greater coverage for securing to the tube 300.

Fig. 5 is a plan view of a third embodiment of the tube securement device 100, showing a release liner 150 to which the first major surface 112 comprising adhesive is secured. Thus, the tube fixture 100 is shown slightly peeled away from the release liner 150. The dashed lines are intended to show breaks in the areas with adhesive and the areas of the intermediate section without tacky adhesive. Reference numerals in fig. 5 identify corresponding features as shown in fig. 1. In this embodiment, only first end segment 120 is wider in lateral direction 117 than middle segment 140, while second end segment 130 has the same width as middle segment 140. Additionally, in this embodiment of fig. 5, the first adhesive 122 and the second adhesive 132 are applied in a pattern on the first major surface 112. First end segment 120 or second end segment 130 may be for application to a body, such as the nose.

Fig. 6 is a front view of a third embodiment of a tube retaining device 100 secured to a lip 200 and a tube 300. In this embodiment, tube 200 is an endotracheal tube. Reference numerals in fig. 6 identify corresponding features as shown in fig. 1. In this embodiment of fig. 6, tube securement device 100 includes a first end segment 120 having a first adhesive (not visible in this figure) secured to body 200 at the upper lip and a second end segment 130 having a second adhesive (not visible in this figure) secured to tube 300. Between first end segment 120 and second end segment 130 is an intermediate segment 140 that is free of tacky adhesive. First end segment 120 includes a depression for improving fit in the narrow segment between the nose and lip so that a larger segment of first end segment 120 may provide more contact area at the face. In this embodiment, the intermediate section 140 is relatively shorter than the intermediate section 140 shown in fig. 1-5 to achieve less flexibility and less translation of the ET tube. To use the tube securement device 100, the first end segment 120 is secured to the body, such as the upper lip and cheek, and the second end segment 130 is secured to the tube 300.

The tube fixture 100 disclosed herein may be manufactured using conventional film converting, coating, cutting, and packaging techniques. For example, in one embodiment, the backing 110 is coated with a first adhesive 122 and a second adhesive. The coated backing is then cut into the shape of the tube fixture 100. The release liner 150 may be applied to the entire first major surface 112 of the tube fixture.

In some embodiments, as shown in fig. 5, the release liner 150 is generally larger in size than the tube securing device 100. The excess release liner 150 facilitates the release of the tube retaining device 100 from the release liner 150. Additional components such as a strip of tape 160 may also be secured to the excess release liner 150.

Although specific embodiments have been illustrated and described herein, it is to be understood that these embodiments are merely illustrative of the many possible specific arrangements that can be devised in applying the principles of the present invention. Numerous and varied other arrangements can be devised in accordance with these principles by those skilled in the art without departing from the spirit and scope of the invention. Thus, 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.