WO2022201036A1

WO2022201036A1 - Medical patch removal

Info

Publication number: WO2022201036A1
Application number: PCT/IB2022/052622
Authority: WO
Inventors: Gera Strommer; Moshe YTZHAIK; Avraham BRODER
Original assignee: Newpace Ltd.
Priority date: 2021-03-23
Filing date: 2022-03-22
Publication date: 2022-09-29

Abstract

A rapid removal mechanism for removing a medical patch when attached to the skin of a subject, the patch having an inner active area and an outer adhesive area, and including an opening on the exterior of the patch leading into a conduit fluidly connecting an exterior of the patch with an area under the patch adjacent to the skin. The conduit is for transferring an adhesive removal material from the opening on the exterior of the patch to the area under the patch adjacent to the skin

Description

MEDICAL PATCH REMOVAL

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from US Provisional Patent Application No. 63/164,612 fried March 23, 2021, which is expressly incorporated herein by reference in its entirety.

FIELD

The subject matter disclosed herein relates in general to medical patches and in particular to rapid removal of medical patches.

BACKGROUND

Medical patches are commonly used for various medical applications and devices such as ECG patches, glucose monitoring patches, cardiac monitoring devices automated cardiac defibrillators (AED) as well as wearable defibrillators. As shown in FIG. 1, such patches 100 include in many cases an inner active area 102 coated by a conductive gel 105 or other conductive material attached to a patient’s skin 103 by an outer adhesive area 104. While the inner active area 102 supports the medical applications/device (such as ECG electrode contact, glucose monitor needle, shocking area for defibrillators, etc.), the outer adhesive area 104 usually comprises a bio-compatible adhesive 106 which keeps patch 100 in place on patient's skin 103. Such bio-compatible adhesive 106 is adhered to patient's skin 103 enabling a patch 100 to hold in place, and in many cases outer adhesive area 104 also creates a hermetical sealing of inner active area 102, preventing moisture or water from penetrating the active area. To remove patch 100, an edge of outer adhesive area 104 is pulled upwards, as indicated by zone 107. SUMMARY

In various embodiments there is provided a rapid removal mechanism for removing a medical patch when attached to the skin of a subject, the patch having an inner active area and an outer adhesive area and including a conduit fluidly connecting an exterior of the patch with an area under the patch adjacent to the skin. The conduit serves for transferring an adhesive removal material from the exterior of the patch to the area under the patch adjacent to the skin. An opening on the exterior of the patch leads into the conduit.

In some embodiments, the area under the patch includes an area bordering between the inner active area and the outer adhesive area.

In some embodiments, the conduit includes a plurality of conduits connecting the exterior of the patch with the area under the patch adjacent to the skin.

In some embodiments, the plurality of conduits connects to the opening on the exterior of the patch.

In some embodiments, each conduit of the plurality of conduits includes an opening on the exterior of the patch.

In some embodiments, a cover seals the opening on the exterior of the patch.

In some embodiments, the cover is removable.

In some embodiment, the exterior of the patch includes an external surface of a cover layer of the patch.

In some embodiments, the exterior of the patch includes an external surface of an electrical device attached to the patch.

In some embodiments, the conduit includes a circular cross-section.

In various embodiments there is provided a method of removing the medical patch attached to the skin of the subject, the patch having the inner active area and the outer adhesive area, the method including accessing the opening on the exterior of the patch with an introducer device and introducing an adhesive removal material into the opening; transferring the adhesive removal material through the conduit from the opening on the exterior of the patch to the area under the patch adjacent to the skin; allowing the adhesive removal material to interact with an adhesive on the outer adhesive area; and removing the patch.

In some embodiments, the method includes applying the adhesive removal material along the outer edge of the outer adhesive area.

In some embodiments, the introducer device includes a syringe. In some embodiments, the method includes transferring the adhesive removal material through the plurality of conduits connecting the exterior of the patch with the area under the patch adjacent to the skin.

In some embodiments, the method includes removing the cover sealing the opening on the exterior of the patch.

In some embodiments, the method includes forming the conduit.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting examples of embodiments disclosed herein are described below with reference to figures attached hereto that are listed following this paragraph. The drawings and descriptions are meant to illuminate and clarify embodiments disclosed herein and should not be considered limiting in any way. Like elements in different drawings may be indicated by like numerals. Elements in the drawings are not necessarily drawn to scale. In the drawings:

FIG. 1 illustrates schematically a top view and a side view of a medical patch including an adhesive material covering a typical patch area and a typical method of removal;

FIG. 2 illustrates schematically an embodiment of a medical patch rapid removal mechanism for use in medical patches;

FIG. 3A illustrates schematically a detailed view of a section of a medical patch with an attached relatively small electrical device and another embodiment of the medical patch rapid removal mechanism including an injection opening on the cover layer;

FIG. 3B illustrates schematically a detailed view of a section of a medical patch with an attached relatively large, integrally connected, electrical device and another embodiment of the medical patch rapid removal mechanism including an injection opening on the electrical device;

FIG. 4 illustrates schematically another embodiment of the medical patch rapid removal mechanism including a plurality of conduits with a single injection opening;

FIG. 5A illustrates schematically another embodiment of the medical patch rapid removal mechanism including multiple injection openings; and

FIG. 5B illustrates schematically another embodiment of the medical patch rapid removal mechanism including multiple conduits and a single injection opening. DETAILED DESCRIPTION

A widespread problem associated with the use of medical patches, for example such as that shown in FIG. 1, is their removal. Occasionally, the patches are adhered to the skin using a substantially strong bio-compatible adhesive. In many cases, their removal may inflict pain and lack of comfort to the patient due to the strong adherence created by the bio-compatible adhesive which also provides a hermetic sealing between the exterior and the active area. In cases where the patient's skin is thin or damaged, the removal of the patch may also cause injury to the skin.

To reduce pain or possible skin damage, adhesive removal materials are used to facilitate removal of the patch by pulling and peeling. The adhesive removal material is applied in general around and/or externally to the patch by wiping and/or spraying around the border of the outer adhesive area, and does not penetrate under the outer adhesive area. Consequently, the patch must be peeled slowly, as the adhesive removal material is applied repeatedly around the border of the adhered area, the process frequently being slow and sometimes painful.

There is therefore provided, according to some embodiments, a means to allow rapid removal of medical patches by providing on the patch one or more conduits into which an adhesive removal material may be introduced to allow the adhesive removal material to penetrate the outer adhesive area from the direction of the inner active area. Optionally, the adhesive removal material may also be applied from a direction exterior to the outer adhesive area. The adhesive removal material may include a liquid, a gel, or other materials (such as, for example, Alcohol, Benzoate Alcohol, and Alcohol free materials, among others).

In some embodiments, the one or more conduits in the patch are connected to an injection opening through which the adhesive removal material is introduced into the one or more conduits. In a plurality of conduits, the conduits may share a single injection opening, or may share several openings, and the adhesive removal material is introduced into the plurality of conduits through the shared opening or openings. Alternatively, each conduit may have its own opening. Optionally, a syringe may be used to introduce the adhesive removal material into the conduit. Introducing the adhesive removal material via the injection hole enables the adhesive removal material to flow through the conduit into the area below the patch and adjacent to skin of a user, and access the inner edges of the outer adhesive area bordering the active area to interact with the adhesive.

In some embodiments, the injection opening may be covered by a cover that may be removed, or alternatively may be sealed with a material that may be removed or may be punctured by a sharp penetration object such as, for example, the syringe, to allow introducing the adhesive removal material into the conduit. The cover, which maintains hermeticity in the area of the inner active area and the conducting gel until the time to introduce the adhesive removal material for removing the patch, may include a sealed heat cover, an ultrasonic welded cap, a silicone cap, other polyurethane or vinyl materials, or other suitable means for sealing the injection opening.

In some embodiments, the conduits may be formed through the active area of the patch and/or the perimeter of the active area along the border with the inner edges of the outer adhesive area. Additionally, or alternatively, the conduits may be formed through the outer adhesive area. The conduits may have a circular cross-section, may be channel-shaped, or may include grooves and/or slots, or any other suitable shape that may allow smooth flow of the adhesive removal material through the conduit, or any combination thereof. The conduits may be made from the same material of the patch, optionally as an integral part of the patch surface, and may include plastic, silicon or any other polymer. Alternatively, the conduits may be metal conduits. The conduits may be elastic or stiff. The conduits may be formed at the time of manufacture of the patch and may be integral to the patch, or alternatively, may be formed later following manufacture of the patch (i.e., retrofit).

In some embodiments, the patch may be used with an electrical device that may be removably attached to the patch, or alternatively, integrally attached. For example, the electrical device may include a connector that transfers electrical signals from the patch to a medical device, a rigid PCB, a flexible PCB, or other means. In integrally connected electrical devices of a relatively large dimension that do not allow the injection opening on the patch to be exposed, the conduit may be extended into the electrical device and the opening included in the electrical device.

FIG. 2 illustrates schematically an embodiment of a medical patch rapid removal mechanism numbered 201 for use in medical patches, for example, a medical patch 200. Shown therein is a top view and a sectional view of medical patch 200 including an outer adhesive zone 204 with an adhesive 206, an inner active area 202 coated on an underside with a conductive gel 207 (or other suitable conductive material) and including a cover layer (not shown), and two conduits 208 each with an opening 210 (injection hole) that leads from the cover layer of the patch to inner edges 212 of the outer adhesive area. To remove patch 201, an adhesive removal material is introduced through the two openings 210, optionally injected with a syringe or other suitable instrument, to enable its flow through the two conduits 208 to inner edges 212 of outer adhesive zone 204 bordering active area 202, where the adhesive removal material may interact with adhesive 206. Prior to introducing the adhesive removal material through the two openings 210, covers (not shown) over the openings are removed to expose the openings. An adhesive removal material, optionally the same as that injected into conduits 208, may also be applied to outer edges 214 of outer adhesive area 204, thereby allowing the adhesive removal material to penetrate under the outer adhesive area from both its inner and outer edges and interact with adhesive 205.

FIG. 3A illustrates schematically a detailed view of a section of a medical patch numbered 300A with an attached relatively small electrical device 309A, as well as anan embodiment of a medical patch rapid removal mechanism 301A including an injection opening 310A on a cover layer 307 of the medical patch. Shown in the figure is patch 300A including an adhesive 306 on an outer adhesive area 304 to adhere the patch to skin 303, an active inner area 302 with cover layer 307 and a conductive gel 305 (or other suitable conducting material) between the skin and the inner active area, and electrical device 309A (e.g. an electric wire with a connector) attached to the patch, optionally removably attached, which interfaces with electronic circuitry in the inner active area to allow processing of electrical signals received from the inner active area.

Also shown is a conduit 308A extending through cover layer 305 including opening 310A on an upper side of cover layer 307, and an exit opening 316 on an underside of the cover layer. Opening 310A is located on cover layer 307 so that electrical device 309 does not cover the opening when attached to patch 300. An adhesive removal material may be introduced through opening 310A and may flow through conduit 308 and out exit opening 316 into an air gap 320 formed between inner active area 302 and conductive gel 305, and outer adhesive area 304 and adhesive 306. From within air gap 320, the adhesive removal material may seep under outer adhesive area 304 to interact with adhesive 306 and to produce a peeling action in an outward direction from inside the patch. A cover 314 seals opening 310A to preserve hermeticity in the area of inner active area 302 and conductive gel 305. Cover 314 is removed to introduce the adhesive removal material into the conduit 308.

FIG. 3B illustrates schematically a detailed view of a section of a medical patch numbered 300B with an attached relatively large, integrally connected, electrical device 309B as well as another embodiment of a medical patch rapid removal mechanism 301B including an injection opening 310B on the electrical device. Patch 300B resembles patch 300A in FIG. 3A with the exception that electrical device 309B is integrally attached to the cover layer 307 and is of a size which covers the opening 310A in patch 300A. As a result, patch 300B includes a conduit 308B which extends both through cover layer 307 and electrical device 309B so that injection opening 310B in the conduit is located on the electrical device. Cover 314 seals opening 310B on electrical device 309B.

FIG. 4 illustrates schematically another embodiment of a medical patch rapid removal mechanism 401 including a plurality of conduits 408 with a single injection opening 410. Shown therein is a top view and a sectional view of medical patch 400 including an outer adhesive zone 404 with an adhesive 406, an inner active area 402 coated on an underside with a conductive gel 407 and including a cover layer (not shown), and a plurality of conduits 408 connecting to single injection opening 410 which lead from the cover layer of the patch to inner edges 412 of the outer adhesive area. A cover 414 seals the opening 410.

FIG. 5 A illustrates schematically another embodiment of a medical patch rapid removal mechanism numbered 501A that includes multiple injection openings 510A. Shown in the figure is a medical patch 500A including an inner active area 502A, an outer adhesive area 504A, an air gap 520A peripherally surrounding the edge of the inner active area bordering the inner edge of the outer adhesive area, and injection openings 510A distributed along the area of the air gap. Each opening 510A leads to a conduit (not shown) through which an adhesive removal material may be introduced into air gap 520A to interact with the adhesive under the outer adhesive area.

FIG. 5B illustrates schematically another embodiment of the medical patch rapid removal mechanism numbered 501 B that includes multiple conduits 508B and a single injection opening 510B. Shown in the figure is the medical patch 500B including an inner active area 502B, an outer adhesive area 504B, an air gap 520B peripherally surrounding the edge of the inner active area bordering the inner edge of the outer adhesive area, and the plurality of conduits 508B extending from the central opening 510B towards the area of the air gap. An adhesive removal material may be introduced through central opening 510B into the plurality of conduits 508B and therefrom into the air gap 520 to interact with the adhesive under the outer adhesive area.

While this disclosure has been described in terms of certain embodiments and generally associated methods, alterations and permutations of the embodiments and methods will be apparent to those skilled in the art. The disclosure is to be understood as not limited by the specific embodiments described herein, but only by the scope of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A mechanism for removing a medical patch when attached to the skin of a subject, the patch having an inner active area and an outer adhesive area, comprising: a conduit fluidly connecting an exterior of the patch with an area under the patch adjacent to the skin, said conduit used for transferring an adhesive removal material from said exterior of the patch to said area under the patch adjacent to the skin; and an opening on said exterior of the patch leading into said conduit.

2. A mechanism according to claim 1, wherein said area under the patch comprises an area bordering between the inner active area and the outer adhesive area.

3. A mechanism according to claim 1, further comprising a plurality of conduits connecting said exterior of the patch with said area under the patch adjacent to the skin.

4. A mechanism according to claim 3, wherein said plurality of conduits connect to said opening on said exterior of the patch.

5. A mechanism according to claim 3, wherein each conduit of said plurality of conduits comprises an opening on said exterior of the patch.

6. A mechanism according to claim 1, further comprising a cover to seal said opening.

7. A mechanism according to claim 6, wherein said cover is removable.

8. A mechanism according to claim 1, wherein said exterior of the patch comprises an external surface of a cover layer of the patch.

9. A mechanism according to claim 1, wherein said exterior of the patch comprises an external surface of an electrical device attached to the patch.

10. A mechanism according to claim 1, wherein said conduit comprises a circular cross- section.

11. A method of removing a medical patch attached to the skin of a subject, the patch having an inner active area and an outer adhesive area, the method comprising: accessing an opening on an exterior of the patch with an introducer device and introducing an adhesive removal material into said opening; transferring said adhesive removal material through a conduit from said opening on said exterior of the patch to an area under the patch adjacent to the skin; allowing said adhesive removal material to interact with an adhesive on the outer adhesive area; and removing the patch.

12. A method of claim 11, further comprising applying an adhesive removal material along the outer edge of the outer adhesive area.

13. A method of claim 11, wherein said introducer device comprises a syringe.

14. A method of claim 11, wherein said area under the patch comprises an area bordering between the inner active area and the outer adhesive area.

15. A method according to claim 11 , further comprising transferring said adhesive removal material through a plurality of conduits connecting said exterior of the patch with said area under the patch adjacent to the skin.

16. A method according to claim 15, wherein said plurality of conduits connect to said opening on said exterior of the patch.

17. A method according to claim 15, wherein each conduit of said plurality of conduits comprises an opening on said exterior of the patch.

18. A method according to claim 11, further comprising removing a cover sealing said opening on said exterior of the patch.

19. A method according to claim 11, wherein said exterior of the patch comprises an external surface of a cover layer of the patch.

20. A method according to claim 11, further comprising forming said conduit.