Sealing film having separable support structure for tamper-evident protection - Patents.com

Abstract

Disclosed is a sealing film for surrounding a device for tamper-evident protection of a contained device. The sealing film has a backing having a periphery surrounding a central region and an adhesive on the backing at least at the periphery of the backing. A tamper-evident layer is separably connected to the backing along a substantial portion of the periphery of the backing. Thus, any attempt to peel, pull or open the sealing film will remove the tamper-evident layer from the backing indicating tampering.

Description

[Technical field]

[0001] The present disclosure relates to a sealing film having a separable tamper-evident layer for indicating tampering. In particular, the present disclosure relates to a sealing film for enclosing a device having a separable tamper-evident layer such that upon an attempt to peel, pull or open the sealing film, the separable tamper-evident layer separates to indicate tampering. [Background technology]

[0002] Patients receiving medical care typically have a medical access device, such as a vascular access device, inserted to assist the health care provider in delivering medications to the patient. Some medical access devices are for allowing fluids to be removed from the patient, such as a urinary catheter or a surgical drain line. When a person is under the care of a health care provider, it is important to control the medications delivered to the patient. Patients with psychiatric conditions, mentally retarded patients, pediatric patients, or intravenous drug users may tamper with intravenous access points or intentionally deliver drugs or medications to the vascular access device. If unprescribed medications enter the vascular access device, they may cause medical problems, drug interactions, and bloodstream infections. Summary of the Invention

[0003] The tamper-evident device can be used to encase a device, such as a medical access device, and any attempt to access the encased device will have a destructive effect on the tamper-evident device. For example, PCT Publication WO 2021 / 024139 describes various tamper-evident closures and adhesive coating films. There is still a need for better visual indication when attempting to separate the adhesive coating film. The disclosed sealing film includes a backing layer and a separable tamper-evident layer, and when the sealing film surrounds the device, any attempt to peel, pull, or open the sealing film will cause the tamper-evident layer to separate from the backing to indicate tampering.

[0004] In one embodiment, a sealing film for enclosing a device comprises a backing having a first major surface and a second major surface opposite the first major surface and having a periphery surrounding a central region, the backing forming a first backing portion and a second backing portion. The sealing film has an adhesive on at least the periphery on the first major surface of the backing. The sealing film further has a tamper-evident layer detachably connected to the second major surface of the backing and extending along a substantial portion of the periphery. In one embodiment, the adhesive of the first backing portion contacts the second backing portion to form an adhesive bond, the force breaking the adhesive bond being greater than the force separating the tamper-evident layer from the backing.

[0005] To use the sealing film, the device is placed in the central region of the backing, and then the sealing film is wrapped around the device such that the adhesive on the first backing portion contacts the second backing portion, which may also have adhesive. The tamper-evident layer forms the outermost layer of the sealing film. The force to break the adhesive bond is greater than the force to separate the tamper-evident layer from the backing layer. As the tamper-evident layer is removed from the underlying backing, tampering becomes evident. Typically, the tamper-evident layer is a different color or transparency than the underlying backing to enhance the visual impact of the removed tamper-evident layer. [Brief description of the drawings]

[0006] [Figure 1] FIG. 2 is a perspective view of one embodiment of a sealing film for tamper-evident protection of the device. [Diagram 2] FIG. 2 is a perspective view of the sealing film of FIG. 1 closed around a device. [Diagram 3] 3 is a cross-sectional side view of the encapsulation film of FIG. 2 surrounding the device. [Figure 4] FIG. 2 is a diagram of a second embodiment of a sealing film for tamper-evident protection of the device. [Diagram 5] FIG.

[0007] The above-identified drawings and figures illustrate embodiments of the invention; however, as noted in the discussion, other embodiments are also contemplated. In all cases, this disclosure presents the invention by way of representation and not limitation. Numerous other variations and embodiments can be devised by those skilled in the art that are within the scope and spirit of the invention. The drawings may not be drawn to scale. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Various designs of sealing films 100 for use around a device 200, such as a medical device 200 having fluid access lines to a patient, are disclosed. The disclosed sealing films 100 have a backing 110 and a tamper-evident layer 180. An adhesive 130 is on the backing 110 and enables the sealing film 100 to seal around the periphery of the device 200 in use. The tamper-evident layer 180 is separable from the backing 110 of the sealing film 100 such that in use, a force that breaks the adhesive bond formed by the adhesive 130 is greater than a force that separates the tamper-evident layer 180 from the backing 110 at the periphery 112. Once the tamper-evident layer 180 is separated from the backing 100, tampering becomes evident.

[0009] Figure 1 shows one embodiment of a sealing film 100 for tamper-evident protection of a device 200. Figure 2 shows the sealing film 100 of Figure 1 closed around a device 200. Figure 3 shows a cross-section of the sealing film 100 around the device 200 of Figure 2.

[0010] The backing 110 has a perimeter 112 surrounding a central region 114. The backing 110 has a first major surface 116 and a second major surface 118 opposite the first surface 116. The backing 110 generally has a first backing portion 120 and a second backing portion 122. Typically, the backing 110 is symmetric across the first backing portion 120 and the second backing portion 122 such that when the backing 110 is folded onto the device 200, as shown in FIG. 2, the perimeter 112 can be substantially aligned at the first backing portion 120 and the second backing portion 122.

[0011] In some embodiments, and similar to those described in PCT Publication WO 2021 / 024139, the disclosure of which is incorporated herein by reference, the backing can include a tear strip 170. The tear strip 170 is a portion of the sealing label 100 that is used to internally tear the sealing film 100 after the sealing film 100 is wrapped around the device 200. In this embodiment, there is a perforation between the tear strip 170 and the backing 110 so that the tear strip 170 can be easily separated from the backing 110. To use the tear strip 170, when the sealing film 100 is wrapped around the device 200 as in FIG. 2 to gain access to the device 200, the tear strip 170 is irreversibly removed from the backing 110 and the sealing film 100 cannot be closed again on the device 200. In some embodiments, if the backing 110 is a very thin flexible material, the tear strip 170 can include a reinforcing layer to allow the tear strip 170 to protrude and be more easily gripped upon removal.

[0012] The backing 110 is generally thin, flexible, conformable, and drapeable. The backing 110 may be formed from many different materials. Typically, the backing 110 is not easily punctured or, if punctured, the puncture is obvious. Typically, the backing 110 has structural integrity so that it does not easily tear or rip. The backing 110 may be made from polymeric films, foams, papers, nonwoven and woven fibrous webs, knits. In some embodiments, the backing 110 is hydrophobic and water resistant, which prevents liquids and other contaminants from being absorbed into the backing 110. In some embodiments, the backing 110 is transparent to allow viewing of the device 200.

[0013] The polymeric film backing 110 is well suited for the backing due to its toughness and elasticity. For example, the polymeric backing can be formed from polyurethane, polyester, polyether block amide, polyethylene, LDPE, metallocene polyolefin, and SBS and SIS block copolymer materials.

[0014] Having the backing 110 relatively thin and elastomeric allows the backing 110 to be wrapped around the device 200 with the backing 110 fitting snugly around the various shapes of the device 200, as seen in Figure 2. If the backing 110 is slightly elastomeric, the backing 110 can stretch, pull, and expand to fit snugly while surrounding the device 200 without tearing, tearing, or puncturing the backing 110. The snug fit prevents the inserted device 200 from falling out or being pulled out of the surrounding sealing film 100.

[0015] Elasticity can be measured by any number of means commonly used to evaluate the elongation and recovery of a material. In one embodiment, the backing 110 has an elongation to break of at least 200%. In one embodiment, the backing 110 has an elongation to break of less than 500%. In one embodiment, the backing 110 has an elongation to break of greater than 20% and less than 100%. Elasticity can be measured by the initial modulus, which is the force required to apply a specific amount of extension. In one embodiment, the backing layer 110 has a modulus of less than 5 Newtons at 10% elongation. In one embodiment, the backing layer 110 has a modulus of greater than 2 Newtons at 10% elongation.

[0016] Thinner materials tend to be more conformable. In one embodiment, the backing 110 has a thickness of less than 100 micrometers. In one embodiment, the backing 110 has a thickness of less than 10 micrometers. In one embodiment, the backing 110 has a thickness of less than 1 micrometer.

[0017] The adhesive 130 is on the first major surface 116 of the backing 110. In use, the backing 110 is folded around the device 200 and the adhesive 130 on the first major surface 116 of the first backing portion 120 contacts the second backing portion 122. The second backing portion 122 on the first major surface may also optionally have the adhesive 130. When the sealing film 100 is wrapped around the device 200, the adhesive 130 bonds the first backing portion 120 to the second backing portion 122.

[0018] The adhesive 130 is typically a permanent adhesive. Permanent adhesives are strong and do not easily break the bond when the adhesive touches the contacting surfaces. In this embodiment, the integrity of the underlying material breaks down before the adhesive bond breaks down.

[0019] In one embodiment, the adhesive 130 may be a pressure sensitive adhesive, where the adhesive 130 feels wet or sticky to the touch and can be secured to a target surface upon contact. 3M VHB™ Tape, available from 3M Company, has a permanent pressure sensitive adhesive. If a pressure sensitive adhesive is used, the central region 114 of the first major surface 116 is free of adhesive 130, has adhesive 130 detackified, or is covered with adhesive 130 to prevent the adhesive 130 from strongly adhering to the wrapped device 200. FIG. 5 shows the central region 114 without adhesive 130.

[0020] In one embodiment, the adhesive 130 is a contact adhesive. Contact adhesives are particularly suitable for use with sealing films because they are adhesives that adhere strongly to themselves but typically do not adhere well to other materials. Sometimes contact adhesives are called tackifiers when the bond is stronger than the integrity of the underlying material. Contact adhesives work well because they do not adhere strongly to the device 200, the user's hand, the doctor's glove, or tubing. Contact adhesives typically set quickly upon contact and form an instant bond. Furthermore, in embodiments where a contact adhesive is used, the entire first major surface 116 can be covered with the adhesive 130 because the adhesive 130 does not adhere strongly to the device 200. Completely coating the first major surface 116 with the adhesive 130 simplifies the manufacture of the sealing film 100.

[0021] Materials suitable for providing adhesive properties may be either elastomeric or non-elastomeric polymer binders. Elastomeric polymer binders typically provide long term flexibility, extensibility and / or elasticity. Suitable elastomeric polymer binders may include natural rubber latex, synthetic latexes such as acrylic, butadiene, styrene / butadiene rubber, chloroprene, ethylene (e.g., vinyl acetate / ethylene), isoprene, nitrile and urethane homopolymer and copolymer latexes, or mixtures thereof. Examples of suitable polymeric elastomer binders are disclosed in, for example, U.S. Patents 3,575,782, 4,984,585 and 6,156,424, as well as in textbooks such as Neoprene Latex: Principles of Compounding and Processing, JC Carl, 1962, Delaware, EI: DuPont de Nemours (e.g., page 100 in the chapter entitled Contact Bond Adhesives) and Handbook of Adhesives 3rd Edition, Ed. I. Skeist, 1990, New York, Van Nostrand Reinhold (e.g., page 305). It may be desirable for the outer dressing to be free of natural rubber latex. 3M Scotchflex & Seal Packing Rolls available from 3M Company is an example of a suitable contact adhesive.

[0022] 5 is a cross-sectional side view of the seal film 100 in an embodiment in which the central region 114 does not include adhesive 130. In this embodiment, the backing 110 has adhesive 130 on a first backing portion on the first major surface 116 and on a second backing portion on the first major surface 116, and the central region 114 is free of adhesive.

[0023] In use, the device 200 is placed in the central region 114 of the backing 110. The adhesive 130 on the first major surface 116 of the first backing portion 120 is then contacted with the adhesive 130 on the first major surface 116 of the second backing portion 122. The backing 110 substantially surrounds the device 200, as shown in Figures 2 and 3. Also, as shown, when folded, the perimeter 112 of the first backing portion 120 and the perimeter 112 of the second backing portion 122 typically align. When the perimeter 112 is aligned in the folded position, the adhesive 130 is not exposed for contact with the surroundings.

[0024] The backing 110 may be tightly wrapped around the device 200, as shown in Figure 2. It is particularly useful for the backing 110 to wrap as closed as possible around the device 200 without allowing gaps or openings through which the device 200 may be removed. For example, in Figure 2, the encapsulation film 100 completely closes on all sides of the device 200, with the closure narrowing around the portions of the device 200 that extend out from the encapsulation film 100.

[0025] The device 200 contained within the sealing film 100 may be any device where a tamper attempt to gain access to the device 200 is desirable. For example, if the device 200 is a device for vascular access to a patient, it may be desirable to restrict the patient from accessing the device 200 to introduce undesirable drugs into the patient's vascular system. In some cases, a user may wish to access the device. The user attempts to break or tear the backing 110 to gain access to the device 200. If the backing 110 is completely torn, it is visually evident that the user has gained access to the device 200. If a torn tear strip 170 is present, it is visually evident that the user has gained access to the device 200. Another possibility is when the user attempts to separate the backing 110 with the adhesive 130 encasing the medical device 200. In such an example, it may be possible for the user to separate the adhesive 130 between the first backing portion 120 and the second backing portion 122 to open the sealing film 100, gain access to the device 200, and then reclose the adhesive 130.

[0026] To address the issue of attempting to separate the adhesive 130 between the first backing portion 120 and the second backing portion 122 to open the sealing film 100, gain access to the device 200, and then reseal the adhesive 130, the sealing film 100 further includes a tamper-evident layer 180. The tamper-evident layer 180 has a first major surface 186 at the second major surface 118 of the backing 110. It is understood that there may be an intervening layer between the backing 110 and the tamper-evident layer 180. The tamper-evident layer 180 is typically adjacent to and along a substantial portion of the perimeter 112 in both the first backing portion 120 and the second backing portion 122. The adhesive 130 in the first backing portion 120 contacts the second backing portion 122 to form an adhesive bond. The force to break the adhesive bond is greater than the force to separate the tamper-evident layer 180 from the backing 110. Thus, if a user attempts to remove the adhesive 130 at the periphery 112 by pinching, pulling, or otherwise pulling the backing 110 away from the adhesive 130, the tamper-evident layer 180 will separate from the backing 110 before the adhesive 130 separates from the backing 110. Partial or complete removal of the tamper-evident layer 180 will reveal that the user has attempted tampering.

[0027] The tamper-evident layer 180 is held to the backing 110 by relatively weak bonding forces. The tamper-evident layer 180 may be secured to the backing 110 by adhesive, thermal, electrostatic, or other bonding mechanisms. This fastening typically does not allow the tamper-evident layer 180 to be re-secured to the backing 110 if the tamper-evident layer 180 becomes separated; that is, once removed, it is difficult to reapply the tamper-evident layer 180.

[0028] Also, typically there is a visual contrast between the tamper-evident layer 180 and the underlying backing layer 100. For example, one may be transparent and one may be opaque. One may be a first color and one may be a second color. One may have a first texture and one may have a second texture. The tamper-evident layer 180 is generally thin, flexible, conformable, and drapeable. The tamper-evident layer 180 can be formed from a number of different materials similar to those that can be used for the backing 110. Typically, the tamper-evident layer 180 is not easily punctured or if punctured, the puncture is obvious. Typically, the tamper-evident layer 180 has structural integrity such that it is not easily torn or ripped. The tamper-evident layer 180 may be made from polymeric films, foams, papers, nonwoven and woven fiber webs, knits. In some embodiments, a transparent substrate is desirable to allow viewing of the device 200.

[0029] Optionally, the sealing film 100 further includes a weakened area 150. The weakened area 150 is adjacent to and along a substantial portion of the perimeter 112 in both the first backing portion 120 and the second backing portion 122. The adhesive 130 in the first backing portion 120 contacts the second backing portion 122 to form an adhesive bond. The force to break the adhesive bond is greater than the force to break the backing 110 at the weakened area 150 of the backing 110. Thus, when a user attempts to peel the adhesive 130, in addition to the tamper-evident layer 180 separating from the backing 110 and pinching, pulling, or pulling the backing 110 away from the adhesive 130, the weakened area 150 causes a tear, tear, or break in the backing 110 before the adhesive 130 separates from the backing 110. A tear, rip, or break in the backing 110 would reveal that a user has attempted tampering.

[0030] The embodiment shown in Figures 1-3 shows a backing 110 and a tamper-evident layer 180. (Figure 2 shows optional areas of weakness 150 that are multiple slits 150 in the backing 110.) In this embodiment, the tamper-evident layer 180 extends across the entire backing 110. Thus, as shown in Figures 2 and 3, if the first backing portion 120 overlaps the second backing portion 122 in use, an attempt to separate the first backing portion 120 from the second portion 122 of the backing will result in the tamper-evident layer 180 separating from the backing 110 before the adhesive 120 separates from either the first backing portion 120 or the second backing portion 122.

[0031] Figure 4 is a second embodiment of a sealing film 100 for tamper evident protection of a device (device not shown). This embodiment is substantially similar to the embodiment described in Figures 1-3, except that in this embodiment, the tamper evident layer 180 is only disposed adjacent the periphery 112 of the sealing film 100 and does not overlie the central region 114. The advantage of this structure, where the tamper evident layer 180 is not over the central region 114, is that the overall sealing film 100 is more flexible and conformable.

[0032] Typically, the encapsulant film 100 may further include a release liner 190 that covers the adhesive 130 prior to application of the encapsulant film 100 to a device. The release liner 190 protects the adhesive 130 from contaminants.

[0033] The sealing film 100 may be colored, clear, or opaque. The sealing film 100 may include a filler such that upon stretching or tensioning, the film changes from clear to opaque to further aid in tamper indicating. The sealing film 100 may include indicia printed on the first major surface 116 to indicate proper location or placement of the inserted device 100.

[0034] Although specific embodiments have been shown and described herein, it is understood that these embodiments are merely illustrative of the many possible specific configurations that can be devised in application of the principles of the present invention. Numerous and varied other configurations can be devised in accordance with these principles by those skilled in the art without departing from the spirit and scope of the present 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.

Claims

1. An encapsulation film for surrounding a device, a backing having a first major surface, a second major surface opposite the first major surface, a periphery surrounding a central region, a first backing portion, and a second backing portion; an adhesive on the first major surface of the backing at least at the periphery; a tamper-evident layer detachably connected to the second major surface of the backing and extending along a substantial portion of the perimeter; A sealing film comprising:

2. The adhesive is located on the first backing portion and contacts the second backing portion to form an adhesive bond; 10. The sealing film of claim 1, wherein the amount of force required to break the adhesive bond is greater than the amount of force required to separate the tamper-evident layer from the backing.

3. A sealing film as described in claim 1, further comprising an opening strip separating the first backing portion from the second backing portion, the opening strip being detachably connected to the first backing portion and the second backing portion.

4. The seal film of claim 1 , wherein the first backing portion and the second backing portion are symmetrical.

5. The seal film of claim 1 , wherein the adhesive is a permanent pressure-sensitive adhesive.

6. The seal film of claim 1 , wherein the adhesive is a contact adhesive.

7. The seal film of claim 1 , wherein the adhesive is on substantially the entire first major surface of the backing.

8. A sealing film as described in claim 1, wherein the adhesive does not extend onto the central region.

9. 10. The sealing film of claim 1, wherein the tamper-evident layer is adjacent to and extends along the entire perimeter of the backing.

10. The sealing film of claim 1 , wherein the tamper-evident layer comprises a continuous film over the backing.

11. 10. The sealing film of claim 1, wherein the tamper-evident layer is a frame adjacent the periphery and does not cover the central region.

12. 10. The seal film of claim 1, wherein the tamper-evident layer is located on the second major surface of the backing.

13. 10. The sealing film of claim 1, wherein the tamper-evident layer is releasably secured to the backing by the adhesive.

14. 10. The seal film of claim 1, wherein the tamper-evident layer is visually distinct from the backing.

15. The sealing film of claim 1, wherein the tamper-evident layer is visually distinguishable from the backing by a difference in at least one of color or opacity.

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