Compliance packaging and method of using same

Abstract

A package for encouraging compliance with a protocol includes a first compartment housing a first component and a second compartment housing a second component. The first component and the second component are used in sequence when following the protocol. The first compartment is attached to the second compartment. The first and second compartments are configured so that access to the second compartment is possible only after the first compartment has been accessed.

Description

COMPLIANCE PACKAGING AND METHOD OF USING SAMEField of the Invention

[0001] The present application claims priority from and the benefit of Indian Patent Application No. 202341061291, filed September 12, 2023, the disclosure of which is hereby incorporated herein by reference in full.

[0002] The present invention is directed generally to medical catheter accessories, and more specifically to devices for aiding in the securing of catheters.Background

[0003] Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic procedures. In most uses, a catheter is a thin, flexible tube (soft catheter) though catheters are available in varying levels of stiffness depending on the application. Catheters can be inserted into a body cavity, duct, or vessel, brain, skin, or adipose tissue. Functionally, they allow drainage, administration of fluids or gases, access by surgical instruments, and perform a wide variety of other tasks depending on the type of catheter.

[0004] When a catheter is left in place in a patient long-term, often a securement technique is employed to secure the catheter in its location. This is particularly true for central venous catheters (CVCs) and peripherally inserted central catheters (PICCs), which are often inserted into the superior vena cava via the patient’s neck / chest and upper arm, respectively. Solutions include sutures (FIG. 1) and catheter securement devices (an exemplary catheter securement device is the STATLOCK™ device, available from Becton, Dickinson and Co. (Franklin Lakes, New Jersey) - see FIG. 3). With either of these techniques, typically a dressing associated with the catheter insertion site requires changing. As can be seen in FIGS. 2A-2C, cleaning around a catheter that is secured by sutures results in incomplete (and thereforeinadequate) cleaning, which in turn can increase the risk of central line-associated bloodstream infection (CLABSI).

[0005] When the catheter is secured with a securement device, typically the securement device is changed at the same time as the dressing. During changing of the dressing, replacement of the securement device, and cleaning around the insertion site, the caretaker should avoid undue movement of the catheter (for example, tip migration or dislodgement the catheter in the insertion site may occur, which may result in the catheter shifting sufficiently that it is no longer correctly positioned within the vein or intended anatomical site. This is particularly important for certain catheters and sites, such as CVCs and PICCs.

[0006] Different techniques for are currently used for temporarily securing the catheter during dressing change of adhesive-based securement devices (e.g., STATLOCK™)-secured catheters. In one technique, caretakers may attempt to use a finger to hold the catheter in place (FIG. 4A); however, this may require a second caretaker to clean the site while the first caretaker maintains the catheter in position with one hand while lifting extension lines with the other after removing the securement device. Also, this technique is not aligned with Antiseptic Non-Touch Technique (ANTT) protocol. Alternatively, a rolled-up dressing method may be used to temporarily hold the catheter as the securement device is being replaced (FIG. 4B). However, the use of the rolled-up dressing may present inconsistency (e.g., how much dressing to roll up use). As a third technique, a secondary securement component, such as an adhesive strip, may be used to temporarily hold the catheter in position during securement removal and replacement (FIG. 4C). This requires that the caretaker have the awareness to do this and the adherence to protocol to use the adhesive strip during dressing change. Experience has shown that this protocol is often ignored due to a few limitations e.g., removal of the adhesive strip may be difficult and / or may cause movement to the catheter, and in some instances the adhesive strip leaves a residue on the catheter lumen after removal that can attract contaminants / microbes.

[0007] It may be desirable to provide techniques for improving adherence to protocols, which may in turn improve patient outcomes.Summary

[0008] As a first aspect, embodiments of the invention are directed to a package for encouraging compliance with a protocol. The package comprises a first compartment housing a first component and a second compartment housing a second component. The first componentand the second component are used when following the protocol. The first compartment is attached to the second compartment. The first and second compartments are configured so that the second compartment is accessible after the first compartment has been accessed.

[0009] As a second aspect, embodiments of the invention are directed to a method of accessing first and second components from a compliance-encouraging package comprising the steps of:(a) providing a package comprising a first compartment housing a first component and a second compartment housing a second component, the second compartment being attached to the first compartment;(b) opening the first compartment to access the first component; then(c) opening the second compartment to access the second component; wherein the first and second compartments are configured such that access to the second compartment is possible only after the first compartment is accessed.

[0010] As a third aspect, embodiments of the invention are directed to a method of forming a package for encouraging compliance with a protocol, the method comprising: forming a first compartment; positioning a first component in the first compartment; forming a second compartment attached to the first compartment; positioning a second component in the second compartment; and enclosing the first and second compartments; wherein the first and second compartments are configured so that the second compartment is accessible via the first compartment and after the first compartment has been accessed.

[0011] As a fourth aspect, embodiments of the invention are directed to a package for encouraging compliance with a protocol comprising a first compartment housing a first component and a second compartment housing a second component and attached to the first compartment. A barrier is present between the first and second compartments. The first component and the second component are used when following the protocol. The second compartment is accessible via the first compartment after the first compartment has been accessed and after the barrier has been breached.Brief Description of the Figures

[0012] FIG. l is a top view of a catheter secured in place with sutures.

[0013] FIGS. 2A-2C illustrate an attempt to clean around the insertion site of a CVC that is sutured in place (FIG. 2A), with the result shown after cleaning with the CVC still present (FIG. 2B) and after cleaning with the CVC removed (FIG. 2C) to show the skin around the site that was net incompletely cleaned.

[0014] FIG. 3 is a top view of an exemplary catheter securement device.

[0015] FIG. 4A is a top view illustrating a caretaker manually holding a catheter with a gloved finger in place during dressing change and replacement of the catheter securing device.

[0016] FIG. 4B is a top view illustrating a caretaker inserting a rolled-up dressing to temporarily secure a catheter in place during dressing change and replacement of the catheter securing device.

[0017] FIG. 4C is a top view illustrating the use of an adhesive strip as a secondary securement component during dressing chance and replacement of the catheter securing device.

[0018] FIG. 5 is an exploded view of an assembly including a primary catheter securement device, a secondary catheter securement device, and a catheter at a catheter insertion site.

[0019] FIG. 6 is a top perspective view of the secondary catheter securement device shown in FIG. 5

[0020] FIG. 7 is a bottom perspective view of the secondary catheter securement deice of FIG. 6.

[0021] FIG. 8 is a top partial perspective view of the assembly of FIG. 5 in place at a catheter insertion site on a patient.

[0022] FIGS. 9A-9F are sequential perspective views showing the process of cleaning a catheter insertion site and replacing dressings and the primary catheter securement device.

[0023] FIG. 10 is a perspective view illustrating a compliance-encouragement package that can be used with the assembly of FIG. 5 to encourage the user to follow proper dressingchanging protocol.

[0024] FIGS. 11 A-l ID are sequential perspective views illustrating the use of the compliance-encouragement package of FIG. 10.

[0025] FIG. 12 is a perspective view of a compliance-encouragement package according to alternative embodiments of the invention.Detailed Description

[0026] The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0027] In the figures, certain layers, components or features may be exaggerated for clarity, and broken lines illustrate optional features or operations unless specified otherwise.

[0028] It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0029] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and / or clarity.

[0030] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises"and / or "comprising", when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0031] As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y." As used herein, phrases such as "from about X to Y" mean "from about X to about Y."

[0032] Referring now to the figures, an assembly for catheter securement and replacement is designated broadly at 10 and shown in FIG. 5. The components of the assembly 10 include a primary catheter securement device 12 and a secondary catheter securement device 20. The secondary catheter securement device 20 is used to secure a catheter C (for example, a CVC) at an insertion site (proximally) or distally on extension lines posterior to a catheter hub as the dressing is changed and the primary catheter securement device 12 replaces an existing primary catheter securement device.

[0033] The primary catheter securement device 12 can be any catheter securement device known to be suitable for securing a catheter. One example is shown in FIG. 5. More specifically, the primary catheter securement device 12 has a main body 13, pins 14 or other fastening features for fastening a catheter thereto, and a lower adhesive surface that is designed to adhere to the patient’s skin. Exemplary embodiments of the primary securing device 12 are discussed in U.S. Patent Nos. 7,223,256; 9,561,348; 8,743,400; and 11,020,565, the disclosures of which are hereby incorporated herein by reference in full.

[0034] The secondary catheter securement device 20 is shown in FIGS. 6 and 7. The secondary catheter securement device 20 includes a main strip 22. A lumen anchor 24 with clips 25 is attached to a central region of the underside of the main strip 22. The clips 25 are sized and configured to receive and retain a lumen therebetween. Adhesive surfaces 26 are located on the underside of the main strip 22 on either side of the lumen anchor 24. In some embodiments, the adhesive surfaces 26 may be covered with a backing layer in order to prevent unwanted adhesion of the device 20 prior to use. FIG. 8 illustrates a catheter C captured between the clips 25 as the secondary catheter securement device 20 is adhered to a patient’s skin.

[0035] The use of the assembly 10 is illustrated in FIGS. 9A-9G. FIG. 9A shows a catheter C in place on a patient’s skin. The catheter C is secured in place with the wings W of the catheter C being held by pins 14 inserted into holes H in the catheter C. The insertion site for the lumen L of the catheter C is covered with a small dressing D that is adapted for catheter insertion sites (an exemplary small dressing is the GuardIVa™ dressing, available from Becton, Dickinson and Co.). A transparent dressing 50 covers the insertion site, the catheter C, the dressing D, and the primary securement device 12.

[0036] When the dressing D is to be changed, the transparent dressing 50 is removed and the dressing D is also removed (FIG. 9B). The catheter C is then secured in place with the secondary catheter securement device 20 (FIG. 9C and 9D) being applied between the primary securement device 12 and the insertion site. The lumen L of the catheter C is received in the clips 25 and the adhesive surfaces 26 are adhered to the skin. The primary securement device 12 is then separated from the catheter C, and the area previously covered by the transparent dressing 50 is cleaned (FIG. 9E).

[0037] Once cleaning is complete, a new primary securement device 12’ is applied to the skin, and the catheter C is remounted onto the new primary securement device 12’. The secondary catheter securement device 20 is then removed (FIG. 9F). A new dressing D’ is applied to the insertion site, and a new transparent dressing 50’ is applied over the new dressing D’ and the catheter C as it is held in place by the new primary securement device 12 (FIG. 9G).

[0038] As described above, one of the realities of the process of changing the dressings and the primary securement device is that caretakers, who are often pressed for time, may not follow a full protocol (e.g., they may not bother with using an adhesive strip to anchor the securement device due to some of the shortcomings discussed above. As such, it may be beneficial to provide the components of the assembly 10 in a package that encourages compliance with a protocol (and / or discourages failing to follow proper protocol). One such package is shown in FIG. 10 and designated broadly at 100. As can be seen in FIG. 10, the package 100 includes an upper compartment 101 and a lower compartment 102. The upper compartment 101 is generally box-shaped, and is covered by a peelable cover 110. The peelable cover 110 may be transparent or partially transparent to show the item stored in the upper compartment 101. In some implementations, the peelable cover 110 may include a feature to indicate whether the peelable cover 110 has been breached or tampered with. Examples of such afeature include: color changing sealant, holographic or other image based indicators, electronic circuit (e.g., RFID antenna), physical seal, or similar devices. As shown in the example of FIG. 10, a secondary securement device 20 is stored in the upper compartment 101. The lower compartment 102 is attached to the upper compartment 101 such that they share at least part of a common wall 104 (e.g., the floor of the upper compartment 101 serves as part of the ceiling of the lower compartment 102). The lower compartment 102 is also box-shaped. A barrier 120 is present in the common wall 104 that can be removed (e.g., by tearing along one or more score lines) to provide access to the lower compartment 102. A primary securement device 12 is stored in the lower compartment 102. The barrier 120 may be transparent or partially transparent to show the item stored in the lower compartment 102. In some implementations, the barrier 120 may include a feature to indicate whether the barrier 120 has been breached or tampered with. Examples of such a feature include: color changing sealant, holographic or other image based indicators, electronic circuit (e.g., RFID antenna), physical seal, or similar devices. In some implementations, the barrier 120 may be formed from the same material as the peelable cover 110. In some implementations, the barrier 120 may be formed from a different material as the peelable cover 110. For example, the barrier 120 may be formed from a material that can support, at least, the weight of the item stored in the upper compartment. Furthermore, if the item in the upper compartment includes edges or friction elements, the barrier 120 should be formed from a material having sufficient strength to withstand tearing during normal transportation of the package 100. The barrier material can be, but not limited to, paper including recycled paper, mono or multi-layer polymeric film comprised of polypropylene, polyethylene, nylon, polyethylene terephthalate, and tie layer(s) or metallic thin film / foil etc. As packaging material is directly coming in contact of medical device, it is preferably composed of biocompatible, nontoxic, inert material not leaching out any harmful trace materials on storage, transportation, or usage.

[0039] It should be apparent to those of skill in this art that a user accesses the components within the package 100 by first removing the peelable cover 110 to open the upper compartment 101, which action provides access to the secondary securement device 20 located in the upper compartment 101. At that point, the lower compartment remains inaccessible. The user can then remove the barrier 120 from the lower compartment 102 to access the primary securement device 12 within the lower compartment 102. Because the lower compartment 102is inaccessible until after the removal (or at least partial removal) of the barrier 120, the user cannot access the primary securement device 12 without first accessing the secondary securement device 20 in the upper compartment 101.

[0040] As can be gleaned from the discussion above, the configuration of the package 100 encourages the user to follow the steps illustrated in FIGS. 9A-9G. Because of the design of the package 10, the user can only access the primary securement device 12 by first removing the secondary securement device 20. This reminds to the user to both (a) use the secondary securement device 20 to anchor the catheter prior to removing the old primary securement device 12 and (b) to do in the proper sequence (i.e., the user should attach the secondary securement device 20 to the catheter prior to replacing the primary securement device 12).

[0041] Because the primary securement device 12 and the secondary securement device 20 are typically in a health care environment, the package 100 should be constructed so that the upper and lower compartments 101, 102 are free of contamination (e.g., are aseptically packaged). The package 100 also permits a first phase of a protocol to be performed using the first item while keeping the second item for a subsequent protocol phase within a sealed container. This ensures that if something goes wrong during the first phase, the second item maintains sterility, potentially for later use.

[0042] Also, those of skill in this art will appreciate that other “forced-sequence” packaging configurations are also possible. For example, rather than the barrier 120 being a tearaway panel, in some embodiments the barrier 120 may essentially be the floor of the upper compartment 101, and an open window is present in the ceiling of the lower compartment 102. In such an instance, the entire upper compartment 101 (including its floor) may need to be detached (by tearing, sliding, peeling or the like) from the lower compartment 102 to allow the user to access the lower compartment 102.

[0043] As another example, the primary and secondary securement devices may be positioned in compartments that are positioned in side-by-side relationship (see FIG. 12). In such arrangements, the compartment 140 that houses the primary securement device is sealed from the compartment 130 that houses the secondary securement device, with access to the primary securement device compartment being prevented by a barrier 135 between the compartments (e.g., on a common side wall of the compartments). As an alternative, the primary securement device compartment may be covered by a peelable web, and both the primary andsecondary securement compartments may be covered by a second peelable web that overlies the first peelable web. In this arrangement, removal of the second peelable web allows access to the secondary securement device, but the first web remains in place and must be separately peeled off to allow access to the first securement device.

[0044] Those of skill in this art will appreciate that, although first and second compartments are shown in the figures and discussed herein, a package in accordance with embodiments of the invention may include more than two compartments that are configured to be opened in a specific sequence and / or to follow a particular protocol. Moreover, such a package may include both compartments with sequence-specific components and compartments that are not sequence-specific. Further, the compartments need not take the rectangular boxshaped configuration shown herein, but may alternatively be spherical, hemispherical, ovoid, triangular, hexagonal, or the like.

[0045] It is also contemplated that the upper compartment 101 may include markings or other indicia, either on its exterior or its interior, that guide or instruct the user how to access the lower compartment 102. Such indicia may be visible before the upper compartment is accessed (e g., printed on the cover 110), or may be visible only after the upper compartment 101 is accessed. In some implementations, the compartments of the package 100 (or substantial portion of the package 100) may include an indicator to identify the protocol associated with the materials stored in the package 100. The indicator may be a machine-readable indicator such as a quick read code, barcode, or other scannable element to identify the protocol. The indicator may be human perceivable such as a shape or color. Use of a human perceivable indicator may be beneficial in a care setting where urgent action may be needed. In such instances, a distinctive color may be associated with a specific emergency protocol to allow faster identification by either a machine or a human of the appropriate emergency supplies.

[0046] Those of skill in this art will appreciate that the package 100 may be used with other varieties of components. As one example, in some instances the secondary securement device 20 shown above may be replaced with an adhesive strip. As another example, in some instances the protocol may require that the primary securement be applied first, and the secondary component applied subsequent to the application of the primary securement. In such instances the package would be configured to so that access to the secondary component is available only after the primary component is accessed and removed. A number of differentsecondary securement devices are discussed in Indian Provisional Patent Application Nos. 202441028018 (filed April 4, 2024) and 202441028019 (filed April 4, 2024), the disclosures of which are hereby incorporated herein by reference in full.

[0047] In any of the described embodiments, the compartments of the package 100 may be formed of a recyclable material such as a plastic-based or paper-based material.

[0048] Those of skill in this art will appreciate that the package 100 and other packages described herein may be employed to house other components, whether they be other medical components or non-medical items, in which the user may be encouraged to follow a certain protocol or series of steps in order to employ the components correctly. Examples include, but are not limited to, skin or device disinfecting products such as wipes or disinfectant applicators, adhesive removal devices for easy removal of IV catheter dressings and / or securement devices, skin emollients, and tissue adhesives to seal the IV catheter entrance location into the skin.

[0049] Packages according to embodiments of the invention are typically formed by forming a first compartment; positioning a first component in the first compartment; forming a second compartment attached to the first compartment; positioning a second component in the second compartment; and enclosing the first and second compartments. The first and second compartments are configured so that the second compartment is accessible via the first compartment and after the first compartment has been accessed. In some instances the first and second compartments (or portions thereof) may be formed and / or enclosed at the same time, or may be formed at different times. In some instances the formation of the first compartment may be completed (i.e., it may be enclosed) with partial formation of the second compartment (e.g., if a barrier layer is applied to enclose the first compartment). Other variations are also possible.

[0050] The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention.

Claims

That Which is Claimed is:

1. A package for encouraging compliance with a protocol, the package comprising: a first compartment housing a first component; a second compartment housing a second component; wherein the first component and the second component are used when following the protocol; wherein the first compartment is attached to the second compartment; and wherein the first and second compartments are configured so that the second compartment is accessible via the first compartment and after the first compartment has been accessed.

2. The package defined in Claim 1, wherein a barrier is present between the first compartment and the second compartment, and wherein access to the second compartment requires at least partial removal of the barrier.

3. The package defined in Claim 2, wherein the first component must be removed from the first compartment to access the barrier.

4. The package defined in Claim 2, wherein the barrier is configured to be tom or peeled away from the second compartment to access the second compartment.

5. The package defined in Claim 1, wherein the first and second compartments comprise aseptic compartments.

6. The package defined in Claim 1, wherein the first component is a secondary catheter securement device, and the second component is a new primary catheter securement device.

7. The package defined in Claim 6, wherein the secondary catheter securement device is configured to secure a position of an inserted catheter as a used primary catheter securement device is replaced with the new primary catheter securement device.

8. The packaged defined in Claim 1, wherein the first compartment is positioned above the second compartment.

9. The package defined in Claim 1, wherein the first compartment includes indicia instructing a user how to access the second component from the second compartment.

10. A method of accessing first and second components from a complianceencouraging package, the method comprising the steps of(a) providing a package comprising a first compartment housing a first component and a second compartment housing a second component, the second compartment being attached to the first compartment;(b) opening the first compartment to access the first component; then(c) opening the second compartment to access the second component; wherein the first and second compartments are configured such that the second compartment is accessible and after the first compartment is accessed.

11. The method defined in Claim 10, wherein a barrier is present between the first compartment and the second compartment, and wherein step (c) comprises removing at least part of the barrier.

12. The method defined in Claim 11, wherein step (b) further comprises removing the first component from the first compartment prior to performing step (c).

13. The method defined in Claim 11, wherein step (c) comprising tearing or peeling the barrier away from the second compartment to access the second compartment.

14. The method defined in Claim 10, wherein the first and second compartments comprise aseptic compartments.

15. The method defined in Claim 10, wherein the first component is a secondary catheter securement device, and the second component is a new primary catheter securement device.

16. The method defined in Claim 15, further comprising the steps of: applying the secondary catheter securement device to secure a position of an inserted catheter on a patient; removing a used primary catheter securement device from the patient; and applying the new primary catheter securement device to the patient.

17. The method defined in Claim 10, wherein the first compartment is positioned above the second compartment.

18. The method defined in Claim 10, wherein the first compartment includes indicia instructing a user how to access the second component from the second compartment.

19. A method of forming a package for encouraging compliance with a protocol, the method comprising: forming a first compartment; positioning a first component in the first compartment; forming a second compartment attached to the first compartment; positioning a second component in the second compartment; and enclosing the first and second compartments; wherein the first and second compartments are configured so that the second compartment is accessible via the first compartment and after the first compartment has been accessed.

20. The method defined in Claim 19, further comprising forming a barrier between the first compartment and the second compartment, and wherein access to the second compartment requires at least partial removal of the barrier.

21. The method defined in Claim 20, wherein the first component must be removed from the first compartment to access the barrier.

22. The method defined in Claim 19, wherein the step of forming the second compartment encloses the first compartment.

23. The method defined in Claim 22, wherein the step of forming a barrier encloses the first compartment.

24. The method defined in Claim 19, wherein the enclosing step renders the first and second compartments aseptic.

25. The method defined in Claim 19, wherein the first component is a secondary catheter securement device, and the second component is a new primary catheter securement device.

26. The method defined in Claim 25, wherein the secondary catheter securement device is configured to secure a position of an inserted catheter as a used primary catheter securement device is replaced with the new primary catheter securement device.

27. The method defined in Claim 19, further comprising affixing indicia instructing a user how to access the second component from the second compartment.

28. A package for encouraging compliance with a protocol, the package comprising: a first compartment housing a first component; a second compartment housing a second component and attached to the first compartment; wherein a barrier is present between the first and second compartments; wherein the first component and the second component are used when following the protocol; wherein the second compartment is accessible via the first compartment after the first compartment has been accessed and after the barrier has been breached.

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