Adhesive patch

The adhesive patch with separable sections and varying adhesive strengths addresses the issues of edge peeling and replacement complexity, ensuring secure and comfortable use of infusion devices.

JP7894389B2Active Publication Date: 2026-07-23UNOMEDICAL AS
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
UNOMEDICAL AS
Filing Date
2022-04-22
Publication Date
2026-07-23

AI Technical Summary

Technical Problem

Conventional adhesive patches for infusion devices often peel around the edges, require additional adhesive application to stay in place, cannot be replaced without reinserting the needle, and cover the injection site, hindering inspection.

Method used

The adhesive patch is designed with separable sections, allowing for easy replacement while maintaining the position of the infusion device, featuring different adhesive strengths and mechanical fasteners to secure the patch to the skin and base portion.

Benefits of technology

Enables secure, replaceable adhesive patches that maintain the infusion device's position during replacement, reducing patient discomfort by avoiding needle reinsertion and allowing visual inspection of the injection site.

✦ Generated by Eureka AI based on patent content.

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Abstract

An exemplary device generally includes a medical device and an adhesive patch. The medical device is configured to be placed on a patient and includes a base portion including a patient-facing surface configured to face the patient's skin during use of the medical device. The adhesive patch is configured to adhere the base portion to the patient's skin. The adhesive patch includes a first section and a second section. The first section and the second section are separable from one another, and the first section is operable to be removed for replacement while the second section maintains the medical device in a specific position relative to the patient's skin.
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Description

Technical Field

[0001] The present disclosure relates to adhesive patches, and more specifically, but not limited thereto, to medical-grade adhesive patches configured to be used with infusion devices.

Background Art

[0002] Infusion devices are often used to provide therapeutic agents to a patient over a long period, typically 1 to 3 days. Such infusion devices are usually attached to the skin via an adhesive patch. Many conventional adhesive patches have one or more drawbacks or limitations. For example, many conventional adhesive patches peel around their edges, so the user may need to apply additional adhesive to keep the infusion device from coming off the application site. Further, many conventional adhesive patches cannot be replaced while maintaining the position of the infusion device and require the needle to be removed and reinserted, which can cause further discomfort to the patient. Additionally, many conventional adhesive patches cover the injection site, preventing the user from inspecting the condition of the injection site. For these reasons in particular, there is still a need for further improvement in this technical field.

Disclosure of the Invention

[0003] An exemplary apparatus typically comprises a medical device and an adhesive patch. The medical device is configured to be placed on a patient and includes a base portion which includes a patient-facing side configured to face the patient's skin during use of the medical device. The adhesive patch is configured to adhere the base portion to the patient's skin. The adhesive patch includes a first section and a second section. The first and second sections are separable from each other, and the first section is operable to be removed for replacement while the second section maintains the medical device in a specific position relative to the patient's skin. Further embodiments, forms, features, and aspects of the present application will become apparent from the description and drawings provided herein. [Brief explanation of the drawing]

[0004] [Figure 1] Figure 1 is an exploded view of the device according to a specific embodiment.

[0005] [Figure 2] Figure 2 is a cross-sectional view of an adhesive patch according to a specific embodiment, which may be used in the apparatus shown in Figure 1.

[0006] [Figure 3] Figure 3 is an exploded view of the device according to a specific embodiment.

[0007] [Figure 4] Figure 4 is a cross-sectional view of an adhesive patch according to a specific embodiment, which may be used in the apparatus shown in Figure 3.

[0008] [Figure 5] Figure 5 is a perspective view of an adhesive patch according to a specific embodiment.

[0009] [Figure 6] Figure 6 is a cross-sectional view of the adhesive patch shown in Figure 5.

[0010] [Figure 7] Figure 7 is an exploded view of the device according to a specific embodiment.

[0011] [Figure 8] Figure 8 is a cross-sectional view of an adhesive patch according to a specific embodiment, which may be used in the apparatus shown in Figure 7.

[0012] [Figure 9] Figure 9 is a schematic diagram of a hook-and-loop fastener that may be used in a particular embodiment.

[0013] [Figure 10] Figure 10 is a schematic diagram of a hook-to-hook fastener that may be used in a particular embodiment.

[0014] [Figure 11] Figure 11 is a schematic diagram of a snap fastener that may be used in a particular embodiment.

[0015] [Figure 12] Figure 12 is a schematic diagram of a synthetic bristle fastener that may be used in a particular embodiment. [Modes for carrying out the invention]

[0016] While the concepts of this disclosure can take on various modifications and alternative forms, specific embodiments are shown in the drawings as examples and are described in detail herein. However, it should be understood that the concepts of this disclosure are not intended to be limited to the specific forms disclosed, but rather to encompass all modifications, equivalents, and alternatives that are consistent with the invention described in this disclosure and claims.

[0017] As used herein, terms such as "one embodiment", "an embodiment", "exemplary embodiment", etc. indicate that the embodiment may include certain features, structures, or characteristics, but not all embodiments necessarily include them, and such expressions do not necessarily refer to the same embodiment. Further, when referring to "preferred" components or features, it may indicate the desirability of a particular component or feature in one embodiment, but it should be understood that the present disclosure is not so limiting with respect to other embodiments in which such components or features may be omitted. Further, when a particular feature, structure, or characteristic, trait is described in relation to an embodiment, implementing such feature, structure, or characteristic, trait in relation to other embodiments is within the knowledge of those skilled in the art, whether explicitly described or not.

[0018] Further, it should be understood that items included in a list in the form of "at least one of A, B, and C" may mean (A), (B), (C), (A and B), (B and C), (A and C), or (A and B and C). Similarly, items listed in the form of "at least one of A, B, or C" may mean (A), (B), (C), (A and B), (B and C), (A and C), or (A and B and C), and in some cases may mean (A). Items listed in the form of "A, B, and / or C" may mean (A), (B), (C), (A and B), (B and C), (A and C), or (A and B and C). Further, with respect to the claims, the use of phrases such as "a", "an", "at least one of", and / or "at least one part of" should not be construed as limited to only one such element, unless otherwise stated. Also, the use of phrases such as "at least a part of" and / or "a part of" should be construed to include both embodiments that include only a part of such an element and embodiments that include the whole of such an element, unless otherwise stated.

[0019] In the drawings, some structural or methodological features may be shown in a particular arrangement and / or order. However, it should be understood that such a particular arrangement and / or order is not necessarily required. Rather, in some embodiments, such features may be arranged in a different way and / or order than that shown in the exemplary figures, unless otherwise stated to the contrary. Further, the inclusion of a structural or methodological feature in a particular figure does not mean that such a feature is required in all embodiments, and in some embodiments, it may be omitted or combined with other features.

[0020] Referring to FIG. 1, an apparatus 80 according to a particular embodiment is shown. The apparatus 80 generally includes a medical device 100 configured to be disposed on a patient, an adhesive patch 200 configured to attach the medical device 100 to the patient's skin, and an attachment device 90 for attaching the medical device 100 and the adhesive patch 200.

[0021] As described herein, the attachment device 90 generally includes a first attachment member 92 provided on the adhesive patch 200 and a second attachment member 94 provided on the medical device 100, and the second attachment member 94 is configured to be removably attached to the first attachment member 92. In one embodiment, the first attachment member 92 includes an adhesive layer 93 including an attachment member adhesive composition 93'. In a particular such form, the attachment member adhesive composition 93' is different from the adhesive composition 205' that can adhere the first region 203 of the adhesive patch 200 to the patient's skin. In addition to or instead of the second adhesive composition 93' that is different from the first adhesive composition 205', the attachment device 90 may include a mechanical fastener. Further details regarding additional exemplary forms of the attachment device 90 are provided herein with reference to FIGS. 9 - 12.

[0022] The medical device 100 generally includes a base 110 and a housing 120 that accommodates the operating components of the medical device 100. Although the illustrated medical device 100 is provided in the form of an infusion device, the adhesive patch described herein may also be used to secure other forms of medical devices to the patient's skin.

[0023] The base portion 110 generally includes a patient-facing side 111 configured to face the patient's skin during use of the device 100, and a second side 112 opposite to the patient-facing side 111. In the illustrated embodiment, the second side 112 includes a second mounting member 94 of the mounting device 90. For example, the second side 112 may form the second mounting member 94, or the second mounting member 94 may be fixed (e.g., adhesively attached) to the second side 112.

[0024] The housing 120 is positioned on the second surface 112 of the base portion 110 and houses the operating components of the medical device 100. As described above, the illustrated medical device 100 is an infusion device. Therefore, the housing 120 can house a reservoir for the therapeutic drug and a needle that can be operated to deliver the therapeutic drug subcutaneously to the patient. In embodiments in which the medical device 100 is provided in a form other than an infusion device, the housing 120 may also house additional or alternative components.

[0025] Referring further to Figure 2, the adhesive patch 200 generally includes a first surface, i.e., the patient-facing side 201, and a second surface 202 on the opposite side. The adhesive patch 200 also includes a first region 203 configured to contact the patient's skin and a second region 204 attached to the base portion 110 via an attachment device 90. More specifically, the second region 204 includes a first attachment member 92 of the attachment device 90. In the illustrated embodiment, the first region 203 and the second region 204 are located on the patient-facing side, and the first region 203 at least partially surrounds the second region 204. As described herein, the first region 203 and the second region 204 may be located on mutually opposing sides of the adhesive patch 200, and the first region 203 may not necessarily surround the second region 204.

[0026] The first region 203 comprises a first region adhesive layer 205 containing a first region adhesive composition 205' configured to adhere to the patient's skin. The second region 204 comprises a first mounting member 92 of the mounting device 90. In certain embodiments, the second region 204 may be more rigid than the first region 203. Such differences in the rigidity of the substrate 208 facilitate more uniform mounting of the second region 208 while allowing the first region 203 to bend in response to the patient's movement.

[0027] As described above, a particular embodiment of the first mounting member 92 includes an adhesive layer 93 comprising an adhesive composition 93'. In such a particular embodiment, the first region adhesive composition 205' may have greater adhesive strength than the first mounting member adhesive composition 93'. Such differences in adhesive properties can allow the first region adhesive layer 205 to adhere firmly to the skin while facilitating the removal of the adhesive patch 200 from the medical device 100 during replacement of the adhesive patch 200. In a particular embodiment, the outer periphery of the first adhesive layer 205 may include a second adhesive composition 205'' having greater adhesive strength than the first adhesive composition 205' to prevent (make less likely to peel off) the edges from the patient's skin after application.

[0028] The illustrated adhesive patch 200 comprises a first section 206 and a second section 206', each comprising corresponding portions of a first region 203 and corresponding portions of a second region 204. The adhesive patch 200 may include one or more perforations 207 that facilitate the separation of the first section 206 and the second section 206'. In the illustrated embodiment, the perforations 207 divide the adhesive patch 200 into two substantially identical sections 206, 206'. The sections 206, 206' do not necessarily have to be identical, and the perforations 207 may divide the adhesive patch 200 into three or more sections.

[0029] The adhesive patch 200 also includes a base material 208 that defines an opening 209 that functions to receive the housing 120. The patient-facing side 201 and the second side 202 are defined on the opposing sides of the base material 208. In certain embodiments, the adhesive patch 200 further includes a protective film that covers the adhesive layer 205 and / or the first mounting member 92 before use.

[0030] In the use of the device 80, the medical device 100 can be positioned appropriately on the patient's skin. Before, during, or after needle insertion into the patient's skin, the medical device 100 can be secured to the patient's skin using the adhesive patch 200. In embodiments including a protective film, the protective film can be removed to expose the adhesive layer 205 and / or the first mounting member 92. The adhesive patch 200 can then be positioned such that the housing 120 extends through the opening 209, with a first region 203 in contact with the patient's skin and a second region 204 in contact with the second surface 112 of the base portion 110. In this position, the first adhesive layer 205 adheres the adhesive patch 200 to the skin, while the mounting device 90 secures the adhesive patch 200 to the base portion 110. As a result, the position of the medical device 100 relative to the patient's skin is maintained by the adhesive patch.

[0031] During use, while the medical device 100 remains useful in its installation location, some performance characteristics of the adhesive patch 200 may begin to deteriorate. For example, the edge of the first adhesive layer 205 may begin to peel away from the patient's skin. Such peeling can be prevented by providing a stronger adhesive composition 205'' around the adhesive layer 205, as described above, but it may still be desirable to replace the patch 200 while maintaining the position of the medical device 100. In such situations, the features of the illustrated patch 200 may help maintain the position of the medical device 100 during patch replacement. For example, the user may be provided with a replacement adhesive patch 200 and separate the replacement adhesive patch 200 into a first section 206 and a second section 206' by tearing it, for example, along its perforations 207. Next, the user removes the first section 206 of the attached adhesive patch 200 for replacement, while maintaining the second section 206' in its attached state so that the second section 206' holds the medical device 100 in place. After applying the first section 206 of the replacement adhesive patch 200, the user removes the second section 206' of the original adhesive patch 200 for replacement, while maintaining the first section 206 of the new adhesive patch 200 in its attached state. This keeps the medical device 100 in place while the second section 206' is being replaced.

[0032] As is clear from the above, the illustrated adhesive patch 200 is configured to facilitate its own replacement while maintaining the medical device 100 in place during replacement. As a result, the needle of the infusion device 100 remains embedded during patch 200 replacement, eliminating the need to reinsert the needle and thus reducing patient discomfort.

[0033] Referring further to Figure 3, a device 80' according to a particular embodiment is shown. Similar to the device 80 described above, device 80' includes a medical device 100. Device 80' also includes an adhesive patch 300 according to a particular embodiment, and the attachment device 90 attaches the adhesive patch 300 to the medical device.

[0034] Referring further to Figure 4, the adhesive patch 300 generally includes a first surface 301 facing the patient and a second surface 302 on the opposite side, which are formed on opposite sides of the substrate 308. The adhesive patch 300 includes a first section 303 and a second section 304, and may further include perforations 307 to facilitate separation of the first section 303 and the second section 304. In the illustrated embodiment, the perforations 307 divide the adhesive patch 300 into two substantially identical sections 303, 304. The sections 303, 304 do not necessarily have to be identical, and the perforations 207 may divide the patch 300 into three or more sections.

[0035] A first adhesive layer 305 containing a first adhesive composition 305' is formed on the first surface 301 of the first section 303. A second adhesive layer 306 containing a second adhesive composition 306' is formed on the first surface 301 of the second section 304. The second surface 302 comprises a first mounting member 92. The first mounting member 92 is partially formed in the first section 303 and partially formed in the second section 304, such that the first section 303 and the second section 304 each comprise the corresponding portions of the first mounting member 92. In certain embodiments, the mounting device 90 may include an adhesive composition different from the first adhesive composition 305' and / or the second adhesive composition 306'. In addition, or as an alternative, the mounting device 90 may include mechanical fasteners. Further details regarding additional exemplary embodiments of the mounting device 90 are provided herein with reference to Figures 9-12.

[0036] In the illustrated configuration, the patient-facing side 111 of the base portion 110 is provided with a second mounting member 94. Therefore, in this embodiment, the mounting device 90 works to attach the first surface 111, which is the patient-facing side of the base portion 110, to the second surface 302 of the adhesive patch 300. In the illustrated configuration, substantially the entire adhesive patch 200 is positioned between the base portion 110 and the patient's skin such that the base portion 110 covers substantially the entire adhesive patch 200. It is also conceivable that a portion of one or both of sections 303, 304 (e.g., a tab) may protrude beyond the outer circumference of the base portion 110.

[0037] It should be understood that an adhesive patch 300 containing multiple sections 303, 304 can be easily replaced in a similar manner to that described above with respect to an adhesive patch 200 containing multiple sections 206, 206'. For example, a user may be provided with a replacement adhesive patch 300 and separate the replacement adhesive patch 300 into its first and second sections 303, 304, for example, by tearing the patch 300 along its perforations 307. Then, the first section 303 of the applied adhesive patch 300 can be removed for replacement while maintaining the second section 304 in its adhered state, so as to maintain the medical device 100 in place. After applying the first section 303 of the replacement adhesive patch 300, the user may remove the second section 304 of the original adhesive patch 300 for replacement while maintaining the first section 303 of the new adhesive patch 303 in its adhered state, thereby maintaining the medical device 100 in place while the second section 304 is replaced.

[0038] Referring further to Figures 5 and 6, an adhesive patch 310 according to a specific embodiment is shown. The adhesive patch 310 may be used, for example, in the apparatus 80' instead of the adhesive patch 300 described above. Patch 310 is somewhat similar to patch 300, and similar reference numerals are used to indicate similar elements and features. For example, patch 310 includes a substrate 318, a first surface 311 and a second surface 312 on the opposite side, a first section 313, a second section 314, and perforations 317 to facilitate separation of the first section 313 and the second section 314. The first surface 311 of the first section 313 includes a first adhesive layer 315 containing a first adhesive composition 315', and the first surface 311 of the second section 314 includes a second adhesive layer 316 containing a second adhesive composition 316'. For brevity, the following description of patch 310 will mainly focus on features that differ from those described above with respect to patch 300.

[0039] In the illustrated configuration, the first section 313 at least partially encloses the second section 314, and a set of main perforations 317 are formed at the boundary between the first section 313 and the second section 314. In certain embodiments, additional perforations 317' extend from the main perforations 317 toward the outer edge of the adhesive patch 310 to facilitate the removal of the first section 313. In certain embodiments, further perforations 317'' extend along the additional perforations 317', such that the second section 314 includes an extension 314' formed between the additional perforations 317' and the further perforations 317''.

[0040] In certain embodiments, the first adhesive composition 315' and the second adhesive composition 316' are different from each other. For example, the first adhesive composition 315' may have a stronger adhesive strength than the second adhesive composition 316'. Such an arrangement allows the stronger adhesive composition 315' to prevent peeling around the edges of the patch 310, while the weaker adhesive composition 316' allows for additional movement against the skin. In certain embodiments, the first adhesive composition 315' may be a non-silicone adhesive composition selected for durability. In certain embodiments, the second adhesive composition 316' may be a silicone-like adhesive whose strength increases over time.

[0041] In certain embodiments, the substrate 318 may exhibit different properties in the first section 313 compared to the second section 314. For example, the substrate 318 of the first section 313 may be formed of a first material and / or have a first weave pattern. The substrate of the second section 314 may be formed of a second material and / or have a second weave pattern. For example, the substrate 318 of the first section 313 may be formed of a more rigid material and / or have a denser weave pattern to prevent delamination, while the substrate 318 of the second section 314 may be formed of a less rigid material and / or have a looser weave pattern to provide better flexibility and / or breathability for the patient's skin.

[0042] The second surface 312 of the patch 310 includes a first mounting member 92 that is at least partially located within the first section 313. For example, the first mounting member 92 may extend around the outer edge of the first section 313 to prevent peeling from the base portion 110. In certain embodiments, the mounting member 92 is partially located within the second section 314, for example, to enhance attachment to the base portion 110. In other embodiments, the mounting member 92 is omitted from the second section 314 to increase breathability to the patient's skin.

[0043] It should be understood that the adhesive patch 310, which includes multiple sections 313, 314, can be easily replaced in a similar manner to that described above with respect to the adhesive patch 200, which includes multiple sections 206, 206'. For example, a user may be provided with a replacement adhesive patch 310 and separate the replacement adhesive patch 310 into its first and second sections 313, 314, for example, by tearing the patch 310 along its perforations 317, 317', 317''. The user may then remove the first section 313 of the applied adhesive patch 310 for replacement, while maintaining the second section 314 in its adhered state so that the second section 314 holds the medical device 100 in place.

[0044] Referring further to Figure 7, a device 80” according to a particular embodiment is shown. Similar to the device 80 described above, the device 80” includes a medical device 100. The device 80” also includes an adhesive patch 400 according to a particular embodiment, and an attachment device 90 attaches the adhesive patch 400 to the medical device.

[0045] Referring further to Figure 8, the adhesive patch 400 generally includes a substrate 410 having a first surface 412 facing the patient and a second surface 414 on the opposite side. A first adhesive layer 420 is provided on the first surface 412, and a first mounting member 92 is provided on the second surface 414. The first adhesive layer 420 includes a first adhesive composition 422. The first mounting member 92 includes at least a portion of a mechanical fastener and / or a second adhesive composition different from the first adhesive composition 422. Further details regarding exemplary embodiments of the mounting device 90 are provided below with reference to Figures 9 to 12.

[0046] The illustrated adhesive patch 400 further comprises a color-changing composition 440 configured to change color upon exposure to a specific fluid. In the illustrated embodiment, the color-changing composition 440 is provided within the substrate 410. The color-changing composition 440 may also be provided in the first adhesive layer 420, or elsewhere on and / or within the adhesive patch 400. While the adhesive patch 400 shown in Figures 7 and 8 is provided as a single, unperforated patch, it should be understood that the color-changing composition 440 may also be provided in a multi-section patch, for example, as described above with reference to Figures 1 to 6.

[0047] As described above, the color-changing composition 440 is configured to change color when exposed to a specific fluid. In a particular embodiment, the specific fluid is air, and the color-changing composition 440 is configured to change color when exposed to air for a predetermined period of time. In a particular embodiment, the predetermined period corresponds to the effective lifespan of the medical device 100. For example, if the infusion device 100 holds enough therapeutic agent to last for three days, the color-changing composition 440 may change color after being exposed to air for more than three days, thereby indicating to the patient that the infusion device 100 needs to be reloaded or replaced. As can be understood, the patch 400 may be stored in a vacuum-sealed package before use so that the three-day period does not begin until the package is opened for application of the patch 400.

[0048] In certain embodiments, the specific fluid that causes the color-changing composition 440 to change color is a therapeutic agent dispersed by the infusion device 100. For example, if the infusion device 100 contains an insulin product, the color-changing composition 440 changes color when exposed to the insulin product, indicating to the user that a leak has occurred. In another example, if the infusion device 100 contains a chemotherapy product, the color-changing composition 440 can change color when exposed to the chemotherapy product, thereby indicating to the user that a leak has occurred.

[0049] Referring further to Figures 9-12, various embodiments of the mechanical fastener 50 that may be used in conjunction with the mounting device 90 described herein are shown. More specifically, Figure 9 shows a mechanical fastener 500 in the form of a hook-and-loop fastener 510, Figure 10 shows a mechanical fastener 500 in the form of a hook-and-loop fastener 520, Figure 11 shows a mechanical fastener 500 in the form of a snap fastener 530, and Figure 12 shows a mechanical fastener 500 in the form of a synthetic bristle fastener 540.

[0050] Figure 9 shows a mechanical fastener 500 in the form of a hook-and-loop fastener 510. A first surface 511 (defined, for example, by a base portion 110 or an adhesive patch) has a plurality of hooks 512 protruding therefrom, and a second surface 513 (defined, for example, by the other of a base portion 110 or an adhesive patch) has a plurality of loops 514 protruding therefrom. When the surfaces 511 and 513 are pressed together, the hooks 512 engage with the loops 514, fixing the surfaces 511 and 513 to each other in a releasable manner.

[0051] Figure 10 shows a mechanical fastener 500 in the form of a hook-to-hook fastener 520. A first object 521 (e.g., one of the base portion 110 or the adhesive patch) has a plurality of first hooks 522 protruding therefrom, and a second object 523 (e.g., the other of the base portion 110 or the adhesive patch) has a plurality of second hooks 524 protruding therefrom. When objects 521 and 523 are pressed together, the first hooks 522 engage with the second hooks 524, fixing objects 521 and 523 to each other in a releasable manner.

[0052] Figure 11 shows a mechanical fastener 500 in the form of a snap fastener 530. A female snap member 532 is attached to a first object 531 (for example, one of the base portion 110 or the adhesive patch), and a male snap member 534 is attached to a second object 533 (for example, the other of the base portion 110 or the adhesive patch). When objects 531 and 533 are pressed together, the snap members 532 and 534 engage with each other in a releasable manner, thereby releasably fastening objects 531 and 533 to each other.

[0053] Figure 12 shows a mechanical fastener 500 in the form of a synthetic setae fastener 540. A first object 541 (for example, one of a base portion 110 or an adhesive patch) has a plurality of synthetic setae 542 attached thereon, and a second object (for example, the other of the base portion 110 or the adhesive patch) has an engagement surface 544. The synthetic setae 542 may be, for example, a biomimetic structure that mimics the structure and performance of a gecko's foot. When objects 541 and 543 are pressed together, the synthetic setae 542 engage with the engagement surface 544, fixing objects 541 and 543 in a releasable manner.

[0054] In certain existing methods for attaching an infusion device to a patient's skin, the patch is applied after the needle is inserted into the patient's skin. A particular embodiment of this application involves attaching the infusion device 100 to the patient's skin before needle insertion, which may facilitate needle insertion at a predetermined angle.

[0055] In certain embodiments, the adhesive layer facing the skin can be replaced with a mechanical fastener such as an array of microneedles. In certain embodiments, the adhesive layer facing the skin may contain a therapeutic substance so that the therapeutic substance begins to be released into the patient's skin once the patch is applied. For example, the therapeutic substance may be a local anesthetic, a sedative, or an anti-inflammatory agent.

[0056] A particular embodiment of this application comprises a medical device (100) and adhesive patches (200, 300, 310), The medical device (100) is configured to be placed on a patient, and the medical device (100) comprises a base portion (110) having a patient-facing surface (111) configured to face the patient's skin during use of the medical device (100), The adhesive patches (200, 300, 310) are configured to adhere the base portion (110) to the patient's skin, and the adhesive patches (200, 300, 310) comprise a first section (206, 303, 313) and a second section (206', 304, 314). The present invention relates to an apparatus (80, 80') characterized in that the first section (206, 303, 313) and the second section (206', 304, 314) are separable from each other, and the first section (206, 303, 313) is operable to be removed for replacement while the second section (206', 304, 314) maintains the medical device (100) in a specific position relative to the patient's skin.

[0057] In a particular embodiment, the first section (313) at least partially encloses the second section (314).

[0058] In a particular embodiment, the adhesive patch (310) comprises a skin-facing surface (311) and an equipment-facing surface (312). Here, the skin-facing surface (311) of the first section (313) comprises a first adhesive composition (315'), and the skin-facing surface (311) of the second section (314) comprises a second adhesive composition (316') different from the first adhesive composition (315').

[0059] In a particular embodiment, the first adhesive composition (315') has greater adhesive strength than the second adhesive composition (316').

[0060] In a particular embodiment, the base portion (110) further comprises a second surface (112) opposite to the patient-facing surface (111). The medical device further comprises a housing (120) positioned on the second surface (112) of the base portion, and the adhesive patch (200) at least partially surrounds the housing (120).

[0061] In a particular embodiment, the adhesive patches (200, 300, 310) further include perforations (207, 307, 317) to facilitate the separation of the first section (206, 303, 313) and the second section (206', 304, 314).

[0062] A particular embodiment of the present invention relates to an adhesive patch (400) configured to attach a medical device (100) to a patient's skin, the adhesive patch (400) comprising: a substrate (410) having a first surface (412) and a second surface opposite to the first surface; a first adhesive layer (420) comprising a first adhesive composition (422) disposed on the first surface (412) of the substrate (410) and configured to adhere to the patient's skin; and a color-changing composition (440) configured to change color when exposed to a particular fluid.

[0063] In a particular embodiment, the adhesive patch (400) further comprises an attachment device (90) configured to attach a substrate (410) to a medical device (100).

[0064] In a particular embodiment, the mounting device (90) includes a second adhesive composition (552) that is different from the first adhesive composition (422).

[0065] In a particular embodiment, the mounting device (90) comprises at least a portion of a mechanical fastener (500), the at least portion of the mechanical fastener (500) comprising at least one of a plurality of hooks (512, 522, 524), a plurality of loops (514), a snap mechanism (532, 534), or synthetic bristles ((542)).

[0066] In a particular embodiment, the particular fluid is air, and the color-changing composition (440) is configured to change color when exposed to air for a predetermined period of time.

[0067] In a particular embodiment, the predetermined period is three days or more.

[0068] In a particular embodiment, the particular fluid is a particular therapeutic agent.

[0069] A particular embodiment of the present application relates to an apparatus (80") including an adhesive patch (400), the apparatus (80") further comprising a medical device (100), the medical device (100) configured to administer a specific therapeutic agent.

[0070] A particular embodiment of this application is A medical device (100) comprising a base portion (110) having a first base portion surface (111) and a second base portion surface (112) opposite to the first base portion surface (111), An adhesive patch (300, 310) configured to be placed between the first surface (111) of the base portion and the patient's skin, comprising an adhesive patch first surface (301, 311) configured to face the patient's skin and an adhesive patch second surface (302, 312) facing the first surface (111) of the base portion, wherein the adhesive patch (301, 311) comprises an adhesive layer (305, 315) containing a first adhesive composition (305', 315'), A mounting device (90) for attaching the first surface (111) of the base to the second surface (302, 312) of the adhesive patch, Equipped with, The mounting device (90) relates to an apparatus (80') comprising (a) a mechanical fastener (500) or (b) a second adhesive composition different from the first adhesive composition (305', 315').

[0071] In a particular embodiment, the mounting device (90) includes a mechanical fastener (500).

[0072] In a particular embodiment, the mechanical fastener (500) includes at least one of hook-and-loop fasteners (510), hook-and-loop fasteners (520), snaps (530), or synthetic bristles (542).

[0073] In a particular embodiment, the mounting device (90) includes a second adhesive composition different from the first adhesive composition (305', 315').

[0074] A particular embodiment of this application is A medical device (100) configured to be placed on a patient, comprising a base portion (110) having a patient-facing surface (111) configured to face the patient during use, An adhesive patch (200, 300, 310) configured to adhere the base portion (110) to the patient's skin, comprising a first region (203, 303, 313) configured to contact the patient's skin, and a second region (204, 302, 312) attached to the base portion (110) via an attachment device (90), wherein the first region (203, 303, 313) contains a first adhesive composition (205', 305', 315'), and Equipped with, The mounting device (90) relates to an apparatus (80, 80') comprising at least one of (a) a mechanical fastener (500) or (b) a second adhesive composition different from the first adhesive composition (205', 305', 315').

[0075] In a particular embodiment, the mounting device (90) includes a mechanical fastener (500).

[0076] In a particular embodiment, the mechanical fastener (500) includes synthetic bristles (542).

[0077] In a particular embodiment, the mechanical fastener (500) comprises at least one of a hook-and-loop fastener (510), a hook-and-loop fastener (520), or a snap (530).

[0078] In certain embodiments, the mounting device (90) includes a second adhesive composition different from the first adhesive composition (205', 305', 315').

[0079] In a particular embodiment, the adhesive patch (200) further includes a first surface (201) and an opposite second surface (202), and each of the first region (203) and the second region (204) is located on the first surface (201) of the adhesive patch (200).

[0080] In a particular embodiment, the first region (203) at least partially surrounds the second region (204).

[0081] In a particular embodiment, the adhesive patch (300, 310) comprises a first surface (301, 311) and an opposite second surface (302, 312). Here, the first surface (301, 311) of the adhesive patch (300, 310) includes a first region (305, 315), and the second surface (302, 312) of the adhesive patch (300, 310) includes a second region (302, 312).

[0082] In a particular embodiment, the adhesive patch (300, 310) further includes a third region (304, 314) located on the first surface (301, 311) of the adhesive patch (300, 310), and the third region (303, 313) includes a third region adhesive composition (306', 316') different from the first adhesive composition (205', 305', 315').

[0083] In a particular embodiment, the third region (314) is at least partially surrounded by the first region (313), and the third region adhesive composition (316') has a lower adhesive strength than the first region adhesive composition (315').

[0084] In a particular embodiment, the first region (313) has higher rigidity than the third region (314).

[0085] In a particular embodiment, the second region (204) has higher rigidity than the first region (203).

[0086] Although the present invention has been illustrated and described in detail in the drawings and the foregoing description, it should be considered that these are illustrative and not limiting in nature, and only preferred embodiments have been illustrated and described, but it will be understood that all changes and modifications that are part of the spirit of the invention should be protected.

[0087] The use of terms such as “desirable,” “preferred,” “preferred,” or “more preferred” in the above description indicates that the features described in this way may be more desirable, but nevertheless they are not necessary, and embodiments lacking them may be considered within the scope of the invention, and that scope is defined by the subsequent claims. When reading the claims, where words such as “a,” “an,” “at least one,” or “at least one part” are used, there is no intention to limit the claim to only one item unless specifically stated in the claim. Where the terms “at least a part” and / or “a part” are used, unless specifically stated to the contrary, that item may include part and / or all of that item.

Claims

1. The device comprises a medical device (100) and adhesive patches (200, 300, 310), The medical device (100) is configured to be placed on a patient, and the medical device (100) comprises a base portion (110) having a patient-facing surface (111) configured to face the patient's skin during use of the medical device (100), The adhesive patches (200, 300, 310) are configured to adhere the base portion (110) to the patient's skin, and the adhesive patches (200, 300, 310) comprise a first section (206, 303, 313) and a second section (206', 304, 314). The first section (206, 303, 313) and the second section (206', 304, 314) are separable from each other, and the first section (206, 303, 313) is operable to be removed for replacement while the second section (206', 304, 314) holds the medical device (100) in a specific position relative to the patient's skin. The apparatus (80, 80') is characterized in that the first section (313) at least partially surrounds the second section (314).

2. The apparatus (80') according to claim 1, wherein the adhesive patch (310) comprises a skin-facing surface (311) and an apparatus-facing surface (312), the skin-facing surface (311) of the first section (313) comprises a first adhesive composition (315'), and the skin-facing surface (311) of the second section (314) comprises a second adhesive composition (316') different from the first adhesive composition (315').

3. The apparatus (80') according to claim 2, wherein the first adhesive composition (315') has greater adhesive strength than the second adhesive composition (316').

4. The apparatus (80') according to claim 1, wherein the base portion (110) further includes a second surface (112) opposite to the patient-facing surface (111), the medical device further comprises a housing (120) disposed on the second surface (112) of the base portion, and the adhesive patch (200) at least partially surrounds the housing (120).

5. The apparatus (80, 80') according to claim 1, wherein the adhesive patches (200, 300, 310) further include perforations (207, 307, 317) to facilitate separation of the first section (206, 303, 313) and the second section (206', 304, 314).