WO2024023508A1 - A wearable transdermal-drug-delivery-patch housing assembly - Google Patents

A wearable transdermal-drug-delivery-patch housing assembly Download PDF

Info

Publication number
WO2024023508A1
WO2024023508A1 PCT/GB2023/051968 GB2023051968W WO2024023508A1 WO 2024023508 A1 WO2024023508 A1 WO 2024023508A1 GB 2023051968 W GB2023051968 W GB 2023051968W WO 2024023508 A1 WO2024023508 A1 WO 2024023508A1
Authority
WO
WIPO (PCT)
Prior art keywords
drug
transdermal
patch
delivery
housing assembly
Prior art date
Application number
PCT/GB2023/051968
Other languages
French (fr)
Inventor
Emily Shae WARWICK
Original Assignee
Warwick Emily Shae
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Warwick Emily Shae filed Critical Warwick Emily Shae
Publication of WO2024023508A1 publication Critical patent/WO2024023508A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • A61M35/10—Wearable devices, e.g. garments, glasses or masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • G—PHYSICS
    • G04—HOROLOGY
    • G04B—MECHANICALLY-DRIVEN CLOCKS OR WATCHES; MECHANICAL PARTS OF CLOCKS OR WATCHES IN GENERAL; TIME PIECES USING THE POSITION OF THE SUN, MOON OR STARS
    • G04B47/00—Time-pieces combined with other articles which do not interfere with the running or the time-keeping of the time-piece
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061—Methods for using microneedles

Definitions

  • the present invention relates to a wearable transdermal-drug-delivery-patch housing assembly.
  • the invention further relates to a method of concealing a transdermal-drug patch using said wearable transdermal-drug-delivery-patch housing assembly and a wearable apparatus for concealing a transdermal medical device.
  • a holder for a transdermal-drug patch is also disclosed.
  • Transdermal drug delivery systems where active ingredients are delivered across the skin are increasingly popular as a route of drug administration.
  • Transdermal drug delivery systems are yet to fully achieve their potential as an alternative to oral delivery systems or hypodermic injections.
  • Transdermal systems are available for treating numerous conditions and illnesses from hypertension to pregnancy, and dementia.
  • Common transdermal systems include nicotine patches and scopolamine motion sickness patches.
  • T ransdermal systems are also of interest for the delivery of vaccines.
  • One of the main advantages of transdermal delivery is it can avoid premature metabolization by the liver, a common issue with oral delivery. As transdermal systems are non-invasive and can be self-administered, the use of painful hypodermic needles and the potentially harmful medical waste associated with them may be avoided. Therefore, patient compliance may be improved.
  • Transdermal patches can however be unsightly. The presence of a patch may also inform others that a patient is undergoing treatment, as they are not very discrete. In order for a transdermal patch to be efficient, appropriate contact with the skin needs to be maintained. Otherwise, the intended dose may not be supplied. Contact with the skin may be hard to sustain with some conditions or illnesses, or for certain patients, such as children or the elderly. Adherence to the skin may also be a problem over prolonged periods of time, or with the use of skin moisturisers or sun creams or water.
  • a wearable transdermal-drug-delivery- patch housing assembly comprising: a housing for receiving a transdermal-drug patch; a strap which extends from the housing to in use secure the housing to a user; the housing including: a receiver in which the said transdermal-drug patch is receivable; and a contact portion associated with the receiverwhich in use abuts against a received said transdermal-drug patch for holding the transdermal-drug patch against a user’s skin.
  • the present invention provides a discrete manner in which a user can wear a transdermal-drug patch.
  • a user may choose and customise the appearance the wearable transdermal-drug-delivery- patch housing assembly to suit their mood and style.
  • the present invention helps to ensure the transdermal-drug patch is in contact with the skin for the intended amount of time.
  • the contact portion helps to alleviate issues with the adherence of adhesive based transdermal- drug patches.
  • the invention also allows for non-adhesive transdermal-drug patches to be utilised.
  • drug is referred to in general terms, and may be interchangeably used with any sort of medicament or therapeutic agent, either pharmaceutical or non-pharmaceutical, which is brought into contact with the user’s skin.
  • the housing may comprise a housing body with an exterior-facing surface and a user-facing surface which opposes the exterior-facing surface, a first access opening at the exterior-facing surface for insertion of the said transdermal drug patch, and a second access opening at the user-facing surface to enable the said transdermal-drug patch to interface with a user; and further comprising a cover element which openably covers the first access opening.
  • the housing here forms a rigid casing around the transdermal-drug patch, and the cover element allows for access to be provided without the user needing to remove the entire wearable transdermal-drug-delivery-patch housing assembly.
  • the contact portion is preferably formed on the cover element.
  • the cover element may have a main body and a projecting portion from the main body, the contact portion being on the projecting portion.
  • Having the contact portion formed on the cover element reduces the number of separate parts needed. Thus, ease of manufacture may be increased. Additionally, it may alleviate concerns about engagement between the cover element and contact portion.
  • the main body may have a flange engageable with the exterior-facing surface of the housing body.
  • a flange may prevent over insertion of the contact portion into the chamber. Over insertion may cause damage to the transdermal-drug patch. Conversely, it may also function as a gauge to ensure the user places the contact portion further enough into the chamber.
  • the cover element may be sized to be entirely receivable within the receiver.
  • This alternative embodiment may permit different pressures to be applied via the cover element, compared with the arrangement in which a flange limits the extension of the cover element into the chamber.
  • the cover element may be hingeably engageable with the housing body.
  • a hingeable connection between the cover element and housing body is an easy, reliable way of allowing access to the chamber of the housing body without complete removal of the cover element. This may be beneficial as it reduces the risk of the cover element being misplaced, or damaged when the cover element is opened to expose the first access opening.
  • the cover element may be releasably connectable to the housing body.
  • a releasable connectable cover element allows for access to the receiver. Additionally, a releasably connectable cover element allows for interchangeability. A user may therefore have more control over the appearance of the cover element, and as such the wearable transdermal- drug-delivery-patch housing assembly. The user may swap between multiple cover elements around with ease. For example, one cover element may have a watch face, whilst another cover element has a pictural design. The user may therefore choose if they desired a functional and/or aesthetic cover element.
  • the cover element may be connectable to the housing body by at least one magnetic connection.
  • a magnetic connection is a simplistic way to provide for a releasable connection.
  • a magnetic connection may be used with ease.
  • the housing may include a seal element engageable at or adjacent to the second access opening.
  • a seal element on the user-facing surface aids the creation of a seal between the user and the housing of the wearable transdermal-drug-delivery-patch housing assembly. This may be beneficial for waterproofing purposes.
  • the efficiency of the transdermal-drug patch may be compromised if it comes into contact with water.
  • a seal may also prevent dust and debris from coming into contact with the transdermal-drug patch.
  • the seal element is integrally formed with the housing body.
  • An integrally formed seal element may be beneficial for manufacturing. Additionally, having an integrally formed seal element may ensure the alignment between the seal element and the second access opening is consistent. This may be beneficial in reducing the risk of the seal element overlapping with the receiver, and thus blocking engagement between the contact portion and the transdermal-drug patch.
  • the housing preferably includes a cover-seal element engageable at or adjacent to the first access opening for sealing between the housing body and the cover element.
  • a cover seal may be beneficial for creating a seal between the housing body and cover element. This may be particularly beneficial for waterproofing the housing.
  • the cover-seal element may be integrally formed with either the housing body or cover element.
  • An integrally formed cover-seal element reduces the risk of the cover-seal element being misaligned. It also reduces the risk of the cover-seal element being lost or misplaced upon loading a transdermal-drug patch.
  • the cover element preferably further comprises a display device.
  • a display device provides for a useful way to obscure the view of an associated transdermal-drug patch.
  • the display device may be informative, and provide additional functionality to the wearable transdermal-drug-delivery-patch housing assembly.
  • the display device is a watch.
  • the display device may be a smart device
  • the display device may be constructed to appear akin to a device which a user might ordinarily wear. Jewellery could also be considered.
  • the cover element may further comprise at least one sensor.
  • the provision of a sensor increases the functionality of the wearable transdermal-drug-delivery- patch housing assembly.
  • the provision of a sensor related to the condition, illness, or disease the transdermal-drug patch may be treating may be particularly beneficial.
  • the wearable transdermal-drug-delivery-patch housing assembly may further comprise an insertable holder receivably engagable with the housing body, the contact portion being formed on the insertable holder.
  • an insertable holder may make positioning of the relevant patch or drug-delivery substrate more straightforward within the housing.
  • the insertable holder may comprise a perimeter seal.
  • a perimetric seal associated with the insertable holder provides a means of creating watertightness around the transdermal-drug patch in a simple manner.
  • the wearable transdermal-drug-delivery-patch housing assembly may further comprise a holder receivably engagable with the strap, the contact portion being formed on the holder.
  • the holder may be receivable onto an existing watch strap or similar, to allow the functionality of the present invention to be retrofitted.
  • the contact portion may have a planar contact surface.
  • a planar contact surface helps to ensure even distribution of pressure against an associated transdermal-drug patch.
  • the contact portion may have a convex contact surface.
  • a convex surface may act to naturally urge the active portion of the patch against the user’s skin, particularly if the ends of the patch are otherwise held in place.
  • the strap and housing body may be integrally formed with one another.
  • a singular strap and housing body unit may increase the ease of manufacturing.
  • the strap ad housing body may be manufactured from one material to reduce waste. Additionally, the provision of a singular strap and housing body reduces the risk of the housing body becoming detached from the strap.
  • the strap and housing body may be formed as separate components.
  • Having a separate strap and housing body may increase the ease of manufacturing. It may also allow for straps of different sizes, with a singular housing body. Therefore, a user may select a strap of an appropriate size for the area they wish to attach the wearable transdermal-drug- delivery-patch housing assembly to. Therefore, the versatility of the wearable transdermal-drug- delivery-patch housing assembly is increased. Additionally, it may allow for user customisation. A user may be able to select straps with different designs that suit the style or type of coverage they desire. Different designs of the housing body may also be available and so a user may mix and match the straps and housing body to achieve a desired appearance and/or style.
  • the receiver may have a uniform width.
  • Uniformity of receiver width has the advantage of not inhibiting access, making introduction of the transdermal-drug patch more straightforward for a user.
  • a method of concealing a transdermal-drug patch using a wearable transdermal-drug-delivery-patch housing assembly comprising the steps of: a] providing a wearable transdermal-drug-delivery-patch housing assembly according to the first aspect of the invention; b] providing a transdermal-drug patch, coverable in use by the wearable transdermal-drug-delivery-patch housing assembly; and c] applying pressure using the contact portion of the wearable transdermal-drug-delivery-patch housing assembly when the first access opening is in a covered condition.
  • the method provides for an uncomplicated way for a user to apply pressure to a transdermal-drug patch. It also provides for a way in which to obscure and/or cover the appearance of the transdermal-drug patch.
  • a transdermal-device holder for receivably engaging with a wearable strap
  • the transdermal-device holder comprising: a housing for receiving a transdermal medical device; and a strap connector which extends from the housing to in use secure the housing to a wearable strap; the housing including a receiver in which the said transdermal-drug patch is receivable, the receiver having a contact portion for in use applying pressure towards the said transdermal-drug patch.
  • a retrofittable device holder which can engage with an existing watch strap allows a user to engage the patch with their existing watch or wearable device without needing to purchase a complete replacement.
  • a wearable apparatus for concealing a transdermal medical device comprising: a housing for receiving a transdermal medical device; a strap which extends from the housing to in use secure the housing to a user; the housing including: a housing body having an access port therethrough; and a cover element which openably covers the access port.
  • Figure 1 A shows a side perspective view of a first embodiment of a wearable transdermal- drug-delivery-patch housing assembly in accordance with the first aspect of the invention
  • Figure 1 B shows an exploded view of the wearable transdermal-drug-delivery-patch housing assembly of Figure 1 ;
  • Figure 1C shows an exploded view of the wearable transdermal-drug-delivery-patch housing assembly Figure 1 , inclusive of a transdermal-drug patch;
  • Figure 1 D shows a diagrammatic cross-sectional representation of the wearable transdermal-drug-delivery-patch housing assembly of Figure 2A in an in-use closed condition
  • Figure 2 shows a diagrammatic cross-sectional representation of a second embodiment of a wearable transdermal-drug-delivery-patch housing assembly in accordance with the first aspect of the invention
  • Figure 3A shows a side perspective view of a housing body of a third embodiment of a wearable transdermal-drug-delivery-patch housing assembly in accordance with the first aspect of the invention
  • Figure 3B shows a side perspective view of an insertable patch holder, suitable for insertion into the housing body of Figure 3A
  • Figure 3C shows a side perspective view of the housing body of Figure 3A and the insertable patch holder of Figure 3B in an assembled condition to form a wearable transdermal- drug-delivery-patch housing assembly
  • Figure 3D shows a diagrammatic cross-sectional representation of the wearable transdermal-drug-delivery-patch housing assembly of Figure 3C in an in-use closed condition
  • Figure 4A shows: in sub-figure (i), a plan view of a patch holder in accordance with the third aspect of the invention; in sub-figure (ii), an end view of the patch holder of sub-figure (i); in sub-figure (iii) a side view of the patch holder of sub-figure (i); in sub-figure (iv) a cross-section through the patch holder of sub-figure (i) taken along line B-B; and in sub-figure (v) a cross-section through the patch holder of sub-figure (i) taken along line A-A;
  • Figure 4B shows a cross-sectional representation of a wearable transdermal-drug- delivery-patch housing assembly in accordance with the first aspect of the invention, using the patch holder of Figure 4A;
  • Figure 5A shows a plan representation of a further wearable transdermal-drug-delivery- patch housing assembly in accordance with the first aspect of the invention.
  • Figure 5B shows a perspective representation of the wearable transdermal-drug-delivery- patch housing assembly of Figure 5B.
  • a wearable transdermal- drug-delivery-patch housing assembly referenced globally at 10, which is suitable for a user to secure to themselves.
  • the wearable transdermal-drug-delivery-patch housing assembly 10 may be worn on a wrist, ankle, arm or leg.
  • the wearable transdermal-drug-delivery-patch housing assembly 10 comprises a strap 12 and a housing 14.
  • the strap 12 is preferably formed from a deformable, flexible material, such as a fabric strap. More preferably, the strap 12 may be formed from an elastic material that may be deformed when under stress to allow a user to secure the wearable transdermal-drug-delivery-patch housing assembly 10 on their body, but that will revert towards its original shape when not under stress. The bias to its original shape will ensure the wearable transdermal-drug-delivery-patch housing assembly 10 fits snugly to the user. Any suitably flexible material is envisaged as suitable for the strap 12. Examples of suitable materials include plastics or silicone. However, it is envisaged that a link or mesh based strap would work with the present invention, as links may be removed to adjust the length of the strap 12.
  • the housing 14 preferably has a set of two or more strap connectors 16 for attaching the housing 14 to the strap 12.
  • the two or more strap connectors 16, which may be in the form of lugs, are preferably opposed from one another on either side of a housing body 18 of the housing 14.
  • Complementary connectors 16’ are provided on the strap 12.
  • Other means of attachment, such as a slot for the strap 12 to slot or clip into may also be envisaged.
  • the housing 14 and strap 12 may be integrally formed with one another.
  • the housing 14 comprises the housing body 18, having a first access opening 20a, a second access opening 20b, and a receiver 22 collectively forming an access port through the housing body 18.
  • the housing 14 further comprises a cover element 24 which is configured to cover the first access opening 20a and thereby close the receiver 22.
  • the housing body 18 has an exterior-facing surface and a user-facing surface which oppose one another.
  • the first access opening 20a is here defined on the exterior-facing surface, whilst the second access opening is defined on the user-facing surface, and this reference frame will be maintained hereafter.
  • the receiver 22 is preferably shaped to receive a standard size of a transdermal-drug patch 26, such as a nicotine patch, as illustrated in Figure 1C.
  • the receiver 22 has a circular crosssection, which may assist with receiving the cover element 24, whilst also being suitable for receiving a circular patch.
  • the size and shape of the transdermal-drug patch 26 may differ depending on the manufacturer, and no requirement for a specific size or shape is intended within the scope of the present disclosure. Circular, rectangular, or other geometric shapes are feasible.
  • the receiver 22 preferably has a uniform width, to ease insertion of the transdermal-drug patch 26, the first and second access openings 20a, 20b having identical or similar dimensions.
  • the cover element 24 is complementarily dimensioned to cover the first access opening 20a, and is configured to be releasable, at least in part, to permit access to the receiver 22.
  • the cover element 24 may engage via a bayonet connection with the housing body 18, though a screw-threaded engagement mechanism could easily be considered, as could snap- fit type connection. Permanent magnets may also provide a releasable engagement means.
  • a hinge type connection, in which the cover element 24 is openably connected to the housing body 18, may also be viable.
  • the cover element 24 may include a display device, for example, functioning as a watch. Watch hands may be present on an outer surface 28 thereof, though a digital watch is equally feasible, and other functions, such as a stopwatch, or alarm, may be integrated therein.
  • the cover element 24 may be a provided inclusive of a smart device, which may include GPS functionality, for example.
  • the cover element 24 may, in such an arrangement, additionally comprise at least one sensor. Examples of sensors include, heart rate sensors, glucose sensors, barometers, accelerometers, proximity sensors or ambient light sensors.
  • the cover element 24 is preferably opaque or semi-transparent to obscure or substantially obscure the view of a transdermal-drug patch present in the receiver 22.
  • a lower seal element 30 may be provided at or adjacent to the second access opening 20b.
  • the lower seal element 30 preferably has a width larger than the width of the receiver 22, and a width a similar or substantially similar to the housing body 18.
  • the lower seal 30 has a housing body contacting surface and a user contacting surface.
  • the lower seal 30 is here formed as an o-ring or similar type of seal, and may be provided as a separate component, or, more preferably, may be connected or otherwise fixed to the housing body 18.
  • the exterior-facing surface and user-facing surfaces of the housing body 18 are preferably smooth; however, they be non-smooth such as dimpled, ridged, chequered and the like, which may accomplish sealing against the user’s skin more effectively.
  • the cover element 24 may have a main body 32 and a projecting portion 34 therefrom, the main body 32 having diameter larger than the diameter of the receiver 22 and the projecting portion 34 to thereby define a flange 36 abuttably engagable with the housing body 18.
  • the projecting portion 34 is dimensioned to be receivable into the receiver 22, and thus may provide a contact portion 38 which in uses contacts the transdermal-drug patch 26.
  • a cover-seal element may be provided which provides a sealing effect between the cover element 24 and the housing body 18. This may take the form of an o-ring on the flange 36 of the main body 32 or on the exterior-facing surface of the housing body 18.
  • the contact portion 38 preferably extends from a lower surface of the cover element 24, and may be planar or substantially planar so as to make positive and uniform contact with the transdermal- drug patch 26 in use. This ensures that there is a uniform application of pressure from the transdermal-drug patch 26, encouraging good therapeutic activity.
  • the contact portion 38 and/or projecting portion 34 may be made of a different material to the main body 32.
  • the contact portion 38 and/or projecting portion 34 may be made of a rubber, elastics or plastic materials that forms a seal with the walls of the receiver 22 without the need for a separate insert-seal element. A firm material is preferred, however, so as to provide good pressure application capabilities.
  • the user attaches the strap 12 to their arm or other limb, which secures the housing body 18 in place.
  • the cover element 24 removed or opened, access to the receiver 22 is possible, and a transdermal-drug patch 26 can be inserted therein.
  • the cover element 24 is replaced, covering the first access opening 20a of the receiver 22, for example, by engaging the cover element 24 with the housing body 18 via a bayonet connection, the contact portion 38 will come into contact with the transdermal-drug patch 26, and thus apply a pressure thereto.
  • the user need only remove the cover element 24, withdraw the depleted transdermal-drug patch 26, and replace it with a new one, before re-covering the transdermal-drug patch 26 using the cover element 24.
  • the wearable transdermal-drug-delivery-patch housing assembly 10 thus mimics the appearance of a watch, or similar wearable device, disguising the underlying transdermal-drug patch 26, and the user can easily replace the transdermal-drug patch 26 without alerting others to the presence thereof.
  • FIG. 2 A second embodiment of a wearable transdermal-drug-delivery-patch housing assembly 110 is shown in Figure 2. Identical or similar features of the assembly are described using identical or similar reference numerals, and further detailed description is omitted for brevity.
  • the cover element 124 has a complementary diameter to the receiver 122.
  • the height of the cover element 124 may be larger than or less than the height of the housing body 118, so that the cover element 124 sits proud of the exterior-facing surface thereof.
  • a screw-threaded engagement between the cover element 124 and the housing body 1 18 may allow for a variable pressure to be applied by the contact portion 138 of the cover element 124 via the transdermal-drug patch 26.
  • FIGS 3A to 3D depict a third embodiment of a wearable transdermal-drug-delivery-patch housing assembly, referenced globally at 210.
  • identical or similar reference numerals will be utilised. Further detailed description is omitted for brevity.
  • the wearable transdermal-drug-delivery-patch housing assembly 210 comprises a strap 212 and a housing 214, though here the strap 212 and housing 214 are integrally formed with one another.
  • the strap 212 is preferably wholly or partially formed or manufactured from a flexible material.
  • the material can preferably undergo stress and/or tension, and revert back to its original shape.
  • the material may be deformable and/or elastic.
  • a preferred material is silicone.
  • the cover element 224 is here formed as a strap-like member hingeably engaged with the strap 212 at one end 240 thereof, so as to be receivable over the access port of the housing 214 to occlude the receiver 222.
  • the strap 212 is curved so as to fit around a user’s limb in use, such as a wrist, forearm or ankle. This may allow the strap 212 to be placed on a user via a push fit mechanism due to the flexion inherent therein.
  • the receiver 222 is formed as a rectangular access port through the housing 214, having a similar aspect to commercially available wearable fitness tracking devices.
  • the receiver 222 is approximately centrally located on the wearable transdermal-drug-delivery-patch housing assembly 210.
  • a longitudinal extent of the cover element 224 of is thus such that it extends across the first access opening of the receiver 222, and indeed, extends longitudinally beyond the receiver 222, thereby forming an overhang portion 242 of the cover element 224. In practice, this may assist with retention of the cover element 224 in position, as one or more connectors, such as a stud connector or a magnetic connector, may be provided in the overhang portion 242 and which is engagable with a complementary connector of the strap 212.
  • Many possible strap connection arrangements are known within the art, and will be apparent to the skilled person, and thus the above examples are non-limiting. In particular, the strap could be formed as a complete bangle, or similar.
  • the lateral extent of the cover element 224 is the same or substantially the same as the lateral extent of the housing body 218 to provide occlusion of the underlying housing body 218.
  • a recess 246 is provided, in which the transdermal-drug patch 226 is received, formed here as a cut-out in a major surface of the patch holder 244. An internal surface of the recess 246 thus becomes a contact portion 238 via which pressure can be applied to the transdermal-drug patch 226 in use, as the rear of the transdermal-drug patch 226 will be in contact with the contact portion 238 once received into the recess 246.
  • the patch holder 244 has a perimeter seal 248 engageable with an outer perimeter 250 of the receiver 222.
  • the perimeter seal 248 may be arranged such that lips of the perimeter seal 248 are respectively positioned on each of the exterior-facing surface and the user-facing surface of the housing body 218 to create a tight seal.
  • the seal is preferably waterproof.
  • the perimeter seal 248 may be integrally formed with the contact portion.
  • the patch holder may be slidably inserted into the receiver.
  • the patch holder, and as such the contact element may be inserted into the receiver 222 via a push- to-open mechanism.
  • the receiver 222 may contain a corresponding push to open latch. This may include a sprung mechanism for ease of insertion and removal of the patch holder in this arrangement.
  • the user inserts the transdermal-drug patch 226 into the patch holder 244. This is then inserted into the receiver 222 or access port of the housing 214, with the transdermal-drug patch 226 being in a user-facing condition. This could be before or after the user has attached the strap 212 to their limb.
  • the cover element 224 is then closed, covering the receiver 222, and applying a pressure to a rear surface 252 of the patch holder 244, thereby urging the transdermal-drug patch 226 towards the user’s skin and applying a relatively uniform pressure.
  • the cover element 224 applies an indirect pressure via the contact portion 238; the contact portion 238 need not necessarily be integrally formed with the cover element 224.
  • the tension applied by the cover element 224 when secured to the strap 212, for example, by a stud or magnetic connector, generates the necessary force towards the patch holder 244.
  • the perimeter seal 248 thus forms a seal between the user’s skin and the housing body 218, maintaining water-tightness under the application of pressure to the patch holder 244.
  • the transdermal-drug patch 226 may comprise an adhesive fixing and the patch holder 244 is not necessarily the only means of holding the patch in place.
  • Figure 4A shows a dedicated holder for a transdermal-drug-delivery device, such as a patch, and is indicated globally at 344.
  • a transdermal-drug-delivery device such as a patch
  • the holder 344 has a body 354 having a slot 356 therethrough, which allows a watch orwearable device strap to be engaged with the holder 344, typically by sliding onto the strap.
  • the body 354 has a perimetric lip 358 thereon which defines a receiver 322 on one side of the body 354.
  • a transdermal-drug patch 326 shown in Figure 4B, can be introduced into the receiver 322, in a similar manner to that described in respect of the third embodiment above.
  • the holder 344 is slid onto a strap 312 to form the housing 314, which may be a traditional watch strap connected to a watch orwearable device 360.
  • a strap 312 may be a traditional watch strap connected to a watch orwearable device 360.
  • This allows the functionality of the present invention to be retrofitted to existing straps. Indeed, this will work with bracelets or wristbands, irrespective of whether a watch is present.
  • the contact portion 328 of the receiver 322 is urged against the transdermal-drug patch 326 under the tension of the strap 312.
  • FIG. 5A and 5B show a further wearable transdermal-drug-delivery-device , referenced globally at 410. For identical or similar features to those described in respect of the preceding embodiments of the invention, identical or similar reference numerals will be utilised. Further detailed description is omitted for brevity.
  • the receiver 422 for a transdermal-drug patch is formed by a recessed portion of a body 418 of the housing 414, which has first and second receiver portions 462 for receiving ends of a flexible transdermal-drug patch therein.
  • the arrangement of Figure 5A is shown from an inside direction, that is, the receiver 422 illustrated would be in-use positioned against the user’s skin.
  • a contact portion 438 of the receiver 422 is formed so as to be convex in shape, stretching the flexible transdermal-drug patch towards the user’s skin, and thereby retaining an active-ingredient- containing portion in a position which is in constant or near-constant contact with the skin.
  • This contact portion 438 may not necessarily cause a specific force to be applied to the flexible transdermal-drug patch, but the shape assists with general retention.
  • the strap 412 has a plurality of apertures 464 and corresponding nub connectors 466 which enable easy and adjustable interconnection.
  • the strap may be formed so as to have an interconnecting buckle or similar interlinking device, which enables the disconnection of the strap by pulling in a longitudinal direction.
  • the strap may be akin to a standard watch strap.
  • the strap may be formed in two parts.
  • the strap may have a plurality of apertures spaced along the longitudinal extent of a first part of the strap.
  • the other, second part of the strap may have an engagement means for releasable engagement with one or more of the plurality of apertures.
  • the user may then select an aperture to engage with the engagement means such that the strap is tightened to the user’s preference.
  • a buckle, claw clasp or a pin may be used as suitable engagement means.
  • the first part of the strap and second part of the strap may have complementary sections of Velcro, or hook fasteners to allow the user to adjust the tightness of the strap.
  • the strap may take a variety of forms, and the term strap is used to describe a holding means for attaching the housing to a user.
  • the strap may be formed as an open-bangle where the first and second parts do not meet with one another and instead the first and second parts are moulded to the user’s appendage for engagement.
  • the emphasis of the invention has been on the ability to apply a pressure to maintain contact between a transdermal-drug patch and a user’s skin.
  • another core function of the invention is to perform concealment, and thus there may be many more use cases.
  • the present invention could be used as a concealment device for a glucose monitor for diabetes, in which case, the receiver of the assembly would need to have a much greater depth to accommodate the height of the monitor.
  • the application of pressure by the cover element in this scenario would be actively avoided.
  • a patch may be the traditional means of providing nicotine relief
  • other structures of transdermal-drug-delivery devices may be provided, such as non-flexible units which are held against the skin.
  • a generic wearable apparatus for concealing a transdermal medical device which comprises a housing for receiving a transdermal medical device, and a strap or similar user mounting means which extends from the housing to in use secure the housing to a user.
  • the housing includes an access port therethrough, and a cover element which openably covers the access port. In the scenario, concealment of a medical device is achievable.

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Abstract

A wearable transdermal-drug-delivery-patch housing assembly (10) is provided which comprises a housing (14) for receiving a transdermal-drug patch (26) and a strap (12). The housing (14) includes a housing body (18) having a receiver (22) therein in which the said transdermal-drug patch (26) is receivable. There is also a contact portion for in use applying pressure towards the said transdermal-drug patch (26).

Description

A Wearable Transdermal-Drug-Delivery-Patch Housing Assembly
The present invention relates to a wearable transdermal-drug-delivery-patch housing assembly. The invention further relates to a method of concealing a transdermal-drug patch using said wearable transdermal-drug-delivery-patch housing assembly and a wearable apparatus for concealing a transdermal medical device. A holder for a transdermal-drug patch is also disclosed.
Research into delivery systems for drugs is ever-growing. Transdermal drug delivery systems, where active ingredients are delivered across the skin are increasingly popular as a route of drug administration. Transdermal drug delivery systems are yet to fully achieve their potential as an alternative to oral delivery systems or hypodermic injections. Transdermal systems are available for treating numerous conditions and illnesses from hypertension to pregnancy, and dementia. Common transdermal systems include nicotine patches and scopolamine motion sickness patches. T ransdermal systems are also of interest for the delivery of vaccines. One of the main advantages of transdermal delivery is it can avoid premature metabolization by the liver, a common issue with oral delivery. As transdermal systems are non-invasive and can be self-administered, the use of painful hypodermic needles and the potentially harmful medical waste associated with them may be avoided. Therefore, patient compliance may be improved.
Transdermal patches can however be unsightly. The presence of a patch may also inform others that a patient is undergoing treatment, as they are not very discrete. In order for a transdermal patch to be efficient, appropriate contact with the skin needs to be maintained. Otherwise, the intended dose may not be supplied. Contact with the skin may be hard to sustain with some conditions or illnesses, or for certain patients, such as children or the elderly. Adherence to the skin may also be a problem over prolonged periods of time, or with the use of skin moisturisers or sun creams or water.
It is an object of the present invention to obviate or overcome the above-referenced difficulties.
According to a first aspect of the invention, there is provided a wearable transdermal-drug-delivery- patch housing assembly comprising: a housing for receiving a transdermal-drug patch; a strap which extends from the housing to in use secure the housing to a user; the housing including: a receiver in which the said transdermal-drug patch is receivable; and a contact portion associated with the receiverwhich in use abuts against a received said transdermal-drug patch for holding the transdermal-drug patch against a user’s skin.
The present invention provides a discrete manner in which a user can wear a transdermal-drug patch. A user may choose and customise the appearance the wearable transdermal-drug-delivery- patch housing assembly to suit their mood and style. Advantageously, the present invention helps to ensure the transdermal-drug patch is in contact with the skin for the intended amount of time. The contact portion helps to alleviate issues with the adherence of adhesive based transdermal- drug patches. The invention also allows for non-adhesive transdermal-drug patches to be utilised.
The term drug is referred to in general terms, and may be interchangeably used with any sort of medicament or therapeutic agent, either pharmaceutical or non-pharmaceutical, which is brought into contact with the user’s skin.
In a first optional embodiment, the housing may comprise a housing body with an exterior-facing surface and a user-facing surface which opposes the exterior-facing surface, a first access opening at the exterior-facing surface for insertion of the said transdermal drug patch, and a second access opening at the user-facing surface to enable the said transdermal-drug patch to interface with a user; and further comprising a cover element which openably covers the first access opening.
The housing here forms a rigid casing around the transdermal-drug patch, and the cover element allows for access to be provided without the user needing to remove the entire wearable transdermal-drug-delivery-patch housing assembly.
The contact portion is preferably formed on the cover element. In a preferred embodiment, the cover element may have a main body and a projecting portion from the main body, the contact portion being on the projecting portion.
Having the contact portion formed on the cover element reduces the number of separate parts needed. Thus, ease of manufacture may be increased. Additionally, it may alleviate concerns about engagement between the cover element and contact portion.
Optionally, the main body may have a flange engageable with the exterior-facing surface of the housing body.
The provision of a flange may prevent over insertion of the contact portion into the chamber. Over insertion may cause damage to the transdermal-drug patch. Conversely, it may also function as a gauge to ensure the user places the contact portion further enough into the chamber.
The cover element may be sized to be entirely receivable within the receiver.
This alternative embodiment may permit different pressures to be applied via the cover element, compared with the arrangement in which a flange limits the extension of the cover element into the chamber.
In one embodiment, the cover element may be hingeably engageable with the housing body.
A hingeable connection between the cover element and housing body is an easy, reliable way of allowing access to the chamber of the housing body without complete removal of the cover element. This may be beneficial as it reduces the risk of the cover element being misplaced, or damaged when the cover element is opened to expose the first access opening.
Optionally, the cover element may be releasably connectable to the housing body.
A releasable connectable cover element allows for access to the receiver. Additionally, a releasably connectable cover element allows for interchangeability. A user may therefore have more control over the appearance of the cover element, and as such the wearable transdermal- drug-delivery-patch housing assembly. The user may swap between multiple cover elements around with ease. For example, one cover element may have a watch face, whilst another cover element has a pictural design. The user may therefore choose if they desired a functional and/or aesthetic cover element.
The cover element may be connectable to the housing body by at least one magnetic connection.
A magnetic connection is a simplistic way to provide for a releasable connection. A magnetic connection may be used with ease.
Beneficially, the housing may include a seal element engageable at or adjacent to the second access opening.
The provision of a seal element on the user-facing surface aids the creation of a seal between the user and the housing of the wearable transdermal-drug-delivery-patch housing assembly. This may be beneficial for waterproofing purposes. The efficiency of the transdermal-drug patch may be compromised if it comes into contact with water. A seal may also prevent dust and debris from coming into contact with the transdermal-drug patch.
Preferably, the seal element is integrally formed with the housing body.
An integrally formed seal element may be beneficial for manufacturing. Additionally, having an integrally formed seal element may ensure the alignment between the seal element and the second access opening is consistent. This may be beneficial in reducing the risk of the seal element overlapping with the receiver, and thus blocking engagement between the contact portion and the transdermal-drug patch.
The housing preferably includes a cover-seal element engageable at or adjacent to the first access opening for sealing between the housing body and the cover element.
A cover seal may be beneficial for creating a seal between the housing body and cover element. This may be particularly beneficial for waterproofing the housing.
The cover-seal element may be integrally formed with either the housing body or cover element. An integrally formed cover-seal element reduces the risk of the cover-seal element being misaligned. It also reduces the risk of the cover-seal element being lost or misplaced upon loading a transdermal-drug patch.
The cover element preferably further comprises a display device.
A display device provides for a useful way to obscure the view of an associated transdermal-drug patch. The display device may be informative, and provide additional functionality to the wearable transdermal-drug-delivery-patch housing assembly.
Optionally, the display device is a watch. The display device may be a smart device
Given the desire to conceal the transdermal-drug patch, the display device may be constructed to appear akin to a device which a user might ordinarily wear. Jewellery could also be considered.
The cover element may further comprise at least one sensor.
The provision of a sensor increases the functionality of the wearable transdermal-drug-delivery- patch housing assembly. The provision of a sensor related to the condition, illness, or disease the transdermal-drug patch may be treating may be particularly beneficial.
In an alternative optional embodiment, the wearable transdermal-drug-delivery-patch housing assembly may further comprise an insertable holder receivably engagable with the housing body, the contact portion being formed on the insertable holder.
The provision of an insertable holder may make positioning of the relevant patch or drug-delivery substrate more straightforward within the housing.
Preferably, the insertable holder may comprise a perimeter seal.
A perimetric seal associated with the insertable holder provides a means of creating watertightness around the transdermal-drug patch in a simple manner.
In a yet further optional embodiment, the wearable transdermal-drug-delivery-patch housing assembly may further comprise a holder receivably engagable with the strap, the contact portion being formed on the holder.
In such an embodiment, the holder may be receivable onto an existing watch strap or similar, to allow the functionality of the present invention to be retrofitted.
Preferably, the contact portion may have a planar contact surface.
A planar contact surface helps to ensure even distribution of pressure against an associated transdermal-drug patch. Alternatively, the contact portion may have a convex contact surface.
A convex surface may act to naturally urge the active portion of the patch against the user’s skin, particularly if the ends of the patch are otherwise held in place.
The strap and housing body may be integrally formed with one another.
A singular strap and housing body unit may increase the ease of manufacturing. The strap ad housing body may be manufactured from one material to reduce waste. Additionally, the provision of a singular strap and housing body reduces the risk of the housing body becoming detached from the strap.
Alternatively, the strap and housing body may be formed as separate components.
Having a separate strap and housing body may increase the ease of manufacturing. It may also allow for straps of different sizes, with a singular housing body. Therefore, a user may select a strap of an appropriate size for the area they wish to attach the wearable transdermal-drug- delivery-patch housing assembly to. Therefore, the versatility of the wearable transdermal-drug- delivery-patch housing assembly is increased. Additionally, it may allow for user customisation. A user may be able to select straps with different designs that suit the style or type of coverage they desire. Different designs of the housing body may also be available and so a user may mix and match the straps and housing body to achieve a desired appearance and/or style.
Preferably, the receiver may have a uniform width.
Uniformity of receiver width has the advantage of not inhibiting access, making introduction of the transdermal-drug patch more straightforward for a user.
According to a second aspect of the invention, there is a provided a method of concealing a transdermal-drug patch using a wearable transdermal-drug-delivery-patch housing assembly, the method comprising the steps of: a] providing a wearable transdermal-drug-delivery-patch housing assembly according to the first aspect of the invention; b] providing a transdermal-drug patch, coverable in use by the wearable transdermal-drug-delivery-patch housing assembly; and c] applying pressure using the contact portion of the wearable transdermal-drug-delivery-patch housing assembly when the first access opening is in a covered condition.
The method provides for an uncomplicated way for a user to apply pressure to a transdermal-drug patch. It also provides for a way in which to obscure and/or cover the appearance of the transdermal-drug patch.
According to a third aspect of the invention, there is provided a transdermal-device holder for receivably engaging with a wearable strap, the transdermal-device holder comprising: a housing for receiving a transdermal medical device; and a strap connector which extends from the housing to in use secure the housing to a wearable strap; the housing including a receiver in which the said transdermal-drug patch is receivable, the receiver having a contact portion for in use applying pressure towards the said transdermal-drug patch.
The provision of a retrofittable device holder which can engage with an existing watch strap allows a user to engage the patch with their existing watch or wearable device without needing to purchase a complete replacement.
According to a fourth aspect of the invention, there is provided a wearable apparatus for concealing a transdermal medical device comprising: a housing for receiving a transdermal medical device; a strap which extends from the housing to in use secure the housing to a user; the housing including: a housing body having an access port therethrough; and a cover element which openably covers the access port.
There are many reasons why a user would want to conceal a transdermal medical device, and therefore a suitable wearable device for the purpose purely of concealment may be of great benefit.
The invention will now be more particularly described, by way of example only, with reference to the accompanying drawings, in which:
Figure 1 A shows a side perspective view of a first embodiment of a wearable transdermal- drug-delivery-patch housing assembly in accordance with the first aspect of the invention;
Figure 1 B shows an exploded view of the wearable transdermal-drug-delivery-patch housing assembly of Figure 1 ;
Figure 1C shows an exploded view of the wearable transdermal-drug-delivery-patch housing assembly Figure 1 , inclusive of a transdermal-drug patch;
Figure 1 D shows a diagrammatic cross-sectional representation of the wearable transdermal-drug-delivery-patch housing assembly of Figure 2A in an in-use closed condition;
Figure 2 shows a diagrammatic cross-sectional representation of a second embodiment of a wearable transdermal-drug-delivery-patch housing assembly in accordance with the first aspect of the invention;
Figure 3A shows a side perspective view of a housing body of a third embodiment of a wearable transdermal-drug-delivery-patch housing assembly in accordance with the first aspect of the invention;
Figure 3B shows a side perspective view of an insertable patch holder, suitable for insertion into the housing body of Figure 3A; Figure 3C shows a side perspective view of the housing body of Figure 3A and the insertable patch holder of Figure 3B in an assembled condition to form a wearable transdermal- drug-delivery-patch housing assembly;
Figure 3D shows a diagrammatic cross-sectional representation of the wearable transdermal-drug-delivery-patch housing assembly of Figure 3C in an in-use closed condition;
Figure 4A shows: in sub-figure (i), a plan view of a patch holder in accordance with the third aspect of the invention; in sub-figure (ii), an end view of the patch holder of sub-figure (i); in sub-figure (iii) a side view of the patch holder of sub-figure (i); in sub-figure (iv) a cross-section through the patch holder of sub-figure (i) taken along line B-B; and in sub-figure (v) a cross-section through the patch holder of sub-figure (i) taken along line A-A;
Figure 4B shows a cross-sectional representation of a wearable transdermal-drug- delivery-patch housing assembly in accordance with the first aspect of the invention, using the patch holder of Figure 4A;
Figure 5A shows a plan representation of a further wearable transdermal-drug-delivery- patch housing assembly in accordance with the first aspect of the invention; and
Figure 5B shows a perspective representation of the wearable transdermal-drug-delivery- patch housing assembly of Figure 5B.
Referring to Figures 1 A and 1 B, there is indicated a first embodiment of a wearable transdermal- drug-delivery-patch housing assembly, referenced globally at 10, which is suitable for a user to secure to themselves. For example, the wearable transdermal-drug-delivery-patch housing assembly 10 may be worn on a wrist, ankle, arm or leg.
The wearable transdermal-drug-delivery-patch housing assembly 10 comprises a strap 12 and a housing 14. The strap 12 is preferably formed from a deformable, flexible material, such as a fabric strap. More preferably, the strap 12 may be formed from an elastic material that may be deformed when under stress to allow a user to secure the wearable transdermal-drug-delivery-patch housing assembly 10 on their body, but that will revert towards its original shape when not under stress. The bias to its original shape will ensure the wearable transdermal-drug-delivery-patch housing assembly 10 fits snugly to the user. Any suitably flexible material is envisaged as suitable for the strap 12. Examples of suitable materials include plastics or silicone. However, it is envisaged that a link or mesh based strap would work with the present invention, as links may be removed to adjust the length of the strap 12.
The housing 14 preferably has a set of two or more strap connectors 16 for attaching the housing 14 to the strap 12. The two or more strap connectors 16, which may be in the form of lugs, are preferably opposed from one another on either side of a housing body 18 of the housing 14. Complementary connectors 16’ are provided on the strap 12. Other means of attachment, such as a slot for the strap 12 to slot or clip into may also be envisaged. Alternatively, instead of the housing 14 and strap 12 being formed as separate components, the housing 14 and strap 12 may be integrally formed with one another.
As illustrated in Figure 1 C in particular, the housing 14 comprises the housing body 18, having a first access opening 20a, a second access opening 20b, and a receiver 22 collectively forming an access port through the housing body 18. The housing 14 further comprises a cover element 24 which is configured to cover the first access opening 20a and thereby close the receiver 22.
The housing body 18 has an exterior-facing surface and a user-facing surface which oppose one another. The first access opening 20a is here defined on the exterior-facing surface, whilst the second access opening is defined on the user-facing surface, and this reference frame will be maintained hereafter.
The receiver 22 is preferably shaped to receive a standard size of a transdermal-drug patch 26, such as a nicotine patch, as illustrated in Figure 1C. Here, the receiver 22 has a circular crosssection, which may assist with receiving the cover element 24, whilst also being suitable for receiving a circular patch. It will, of course, be appreciated that the size and shape of the transdermal-drug patch 26 may differ depending on the manufacturer, and no requirement for a specific size or shape is intended within the scope of the present disclosure. Circular, rectangular, or other geometric shapes are feasible.
The receiver 22 preferably has a uniform width, to ease insertion of the transdermal-drug patch 26, the first and second access openings 20a, 20b having identical or similar dimensions.
The cover element 24 is complementarily dimensioned to cover the first access opening 20a, and is configured to be releasable, at least in part, to permit access to the receiver 22. In a preferred embodiment, the cover element 24 may engage via a bayonet connection with the housing body 18, though a screw-threaded engagement mechanism could easily be considered, as could snap- fit type connection. Permanent magnets may also provide a releasable engagement means. A hinge type connection, in which the cover element 24 is openably connected to the housing body 18, may also be viable.
The cover element 24 may include a display device, for example, functioning as a watch. Watch hands may be present on an outer surface 28 thereof, though a digital watch is equally feasible, and other functions, such as a stopwatch, or alarm, may be integrated therein. Alternatively, the cover element 24 may be a provided inclusive of a smart device, which may include GPS functionality, for example. The cover element 24 may, in such an arrangement, additionally comprise at least one sensor. Examples of sensors include, heart rate sensors, glucose sensors, barometers, accelerometers, proximity sensors or ambient light sensors. The cover element 24 is preferably opaque or semi-transparent to obscure or substantially obscure the view of a transdermal-drug patch present in the receiver 22.
A lower seal element 30 may be provided at or adjacent to the second access opening 20b. The lower seal element 30 preferably has a width larger than the width of the receiver 22, and a width a similar or substantially similar to the housing body 18. The lower seal 30 has a housing body contacting surface and a user contacting surface. The lower seal 30 is here formed as an o-ring or similar type of seal, and may be provided as a separate component, or, more preferably, may be connected or otherwise fixed to the housing body 18.
The exterior-facing surface and user-facing surfaces of the housing body 18 are preferably smooth; however, they be non-smooth such as dimpled, ridged, chequered and the like, which may accomplish sealing against the user’s skin more effectively.
As best shown in Figure 1 D, the cover element 24 may have a main body 32 and a projecting portion 34 therefrom, the main body 32 having diameter larger than the diameter of the receiver 22 and the projecting portion 34 to thereby define a flange 36 abuttably engagable with the housing body 18. The projecting portion 34 is dimensioned to be receivable into the receiver 22, and thus may provide a contact portion 38 which in uses contacts the transdermal-drug patch 26.
Whilst not illustrated, a cover-seal element may be provided which provides a sealing effect between the cover element 24 and the housing body 18. This may take the form of an o-ring on the flange 36 of the main body 32 or on the exterior-facing surface of the housing body 18.
The contact portion 38 preferably extends from a lower surface of the cover element 24, and may be planar or substantially planar so as to make positive and uniform contact with the transdermal- drug patch 26 in use. This ensures that there is a uniform application of pressure from the transdermal-drug patch 26, encouraging good therapeutic activity.
The contact portion 38 and/or projecting portion 34 may be made of a different material to the main body 32. For example, the contact portion 38 and/or projecting portion 34 may be made of a rubber, elastics or plastic materials that forms a seal with the walls of the receiver 22 without the need for a separate insert-seal element. A firm material is preferred, however, so as to provide good pressure application capabilities.
To use the wearable transdermal-drug-delivery-patch housing assembly 10, the user attaches the strap 12 to their arm or other limb, which secures the housing body 18 in place. With the cover element 24 removed or opened, access to the receiver 22 is possible, and a transdermal-drug patch 26 can be inserted therein. Once the cover element 24 is replaced, covering the first access opening 20a of the receiver 22, for example, by engaging the cover element 24 with the housing body 18 via a bayonet connection, the contact portion 38 will come into contact with the transdermal-drug patch 26, and thus apply a pressure thereto. To replace the transdermal-drug patch 26, the user need only remove the cover element 24, withdraw the depleted transdermal-drug patch 26, and replace it with a new one, before re-covering the transdermal-drug patch 26 using the cover element 24.
The wearable transdermal-drug-delivery-patch housing assembly 10 thus mimics the appearance of a watch, or similar wearable device, disguising the underlying transdermal-drug patch 26, and the user can easily replace the transdermal-drug patch 26 without alerting others to the presence thereof.
A second embodiment of a wearable transdermal-drug-delivery-patch housing assembly 110 is shown in Figure 2. Identical or similar features of the assembly are described using identical or similar reference numerals, and further detailed description is omitted for brevity. In this arrangement, the cover element 124 has a complementary diameter to the receiver 122. The height of the cover element 124 may be larger than or less than the height of the housing body 118, so that the cover element 124 sits proud of the exterior-facing surface thereof.
In this embodiment, there is no distinction between a main body and a projecting portion of the cover element 124. A screw-threaded engagement between the cover element 124 and the housing body 1 18 may allow for a variable pressure to be applied by the contact portion 138 of the cover element 124 via the transdermal-drug patch 26.
Figures 3A to 3D depict a third embodiment of a wearable transdermal-drug-delivery-patch housing assembly, referenced globally at 210. For identical or similar features to those described in respect of the first and second embodiments of the invention, identical or similar reference numerals will be utilised. Further detailed description is omitted for brevity.
As with the first embodiment, the wearable transdermal-drug-delivery-patch housing assembly 210 comprises a strap 212 and a housing 214, though here the strap 212 and housing 214 are integrally formed with one another.
The strap 212 is preferably wholly or partially formed or manufactured from a flexible material. The material can preferably undergo stress and/or tension, and revert back to its original shape. The material may be deformable and/or elastic. A preferred material is silicone.
The cover element 224 is here formed as a strap-like member hingeably engaged with the strap 212 at one end 240 thereof, so as to be receivable over the access port of the housing 214 to occlude the receiver 222. The strap 212 is curved so as to fit around a user’s limb in use, such as a wrist, forearm or ankle. This may allow the strap 212 to be placed on a user via a push fit mechanism due to the flexion inherent therein.
The receiver 222 is formed as a rectangular access port through the housing 214, having a similar aspect to commercially available wearable fitness tracking devices. The receiver 222 is approximately centrally located on the wearable transdermal-drug-delivery-patch housing assembly 210. A longitudinal extent of the cover element 224 of is thus such that it extends across the first access opening of the receiver 222, and indeed, extends longitudinally beyond the receiver 222, thereby forming an overhang portion 242 of the cover element 224. In practice, this may assist with retention of the cover element 224 in position, as one or more connectors, such as a stud connector or a magnetic connector, may be provided in the overhang portion 242 and which is engagable with a complementary connector of the strap 212. Many possible strap connection arrangements are known within the art, and will be apparent to the skilled person, and thus the above examples are non-limiting. In particular, the strap could be formed as a complete bangle, or similar.
The lateral extent of the cover element 224 is the same or substantially the same as the lateral extent of the housing body 218 to provide occlusion of the underlying housing body 218.
A removeable patch holder 244, referred to more generally as a holder since non-patch drug delivery substrates may be viable, as shown in Figure 3B, is then provided, which is dimensioned to receive a transdermal-drug patch 226. A recess 246 is provided, in which the transdermal-drug patch 226 is received, formed here as a cut-out in a major surface of the patch holder 244. An internal surface of the recess 246 thus becomes a contact portion 238 via which pressure can be applied to the transdermal-drug patch 226 in use, as the rear of the transdermal-drug patch 226 will be in contact with the contact portion 238 once received into the recess 246.
The patch holder 244 has a perimeter seal 248 engageable with an outer perimeter 250 of the receiver 222. The perimeter seal 248 may be arranged such that lips of the perimeter seal 248 are respectively positioned on each of the exterior-facing surface and the user-facing surface of the housing body 218 to create a tight seal. The seal is preferably waterproof. The perimeter seal 248 may be integrally formed with the contact portion.
It may be possible to provide an integrally formed patch holder, or similar, though this may make replacement of the transdermal-drug patch 226 more complicated. However, a hinged arrangement could be conceived.
In an alternative embodiment, the patch holder may be slidably inserted into the receiver. The patch holder, and as such the contact element may be inserted into the receiver 222 via a push- to-open mechanism. As such, the receiver 222 may contain a corresponding push to open latch. This may include a sprung mechanism for ease of insertion and removal of the patch holder in this arrangement.
To use the wearable transdermal-drug-delivery-patch housing assembly 210, the user inserts the transdermal-drug patch 226 into the patch holder 244. This is then inserted into the receiver 222 or access port of the housing 214, with the transdermal-drug patch 226 being in a user-facing condition. This could be before or after the user has attached the strap 212 to their limb.
The cover element 224 is then closed, covering the receiver 222, and applying a pressure to a rear surface 252 of the patch holder 244, thereby urging the transdermal-drug patch 226 towards the user’s skin and applying a relatively uniform pressure. Contrasting with the previous embodiments, the cover element 224 applies an indirect pressure via the contact portion 238; the contact portion 238 need not necessarily be integrally formed with the cover element 224. The tension applied by the cover element 224 when secured to the strap 212, for example, by a stud or magnetic connector, generates the necessary force towards the patch holder 244.
The perimeter seal 248 thus forms a seal between the user’s skin and the housing body 218, maintaining water-tightness under the application of pressure to the patch holder 244.
It will be appreciated that, even in the third described embodiment of the wearable transdermal- drug-delivery-patch housing assembly 210, the transdermal-drug patch 226 may comprise an adhesive fixing and the patch holder 244 is not necessarily the only means of holding the patch in place.
Figure 4A shows a dedicated holder for a transdermal-drug-delivery device, such as a patch, and is indicated globally at 344. For identical or similar features to those described in respect of the preceding embodiments of the invention, identical or similar reference numerals will be utilised. Further detailed description is omitted for brevity.
The holder 344 has a body 354 having a slot 356 therethrough, which allows a watch orwearable device strap to be engaged with the holder 344, typically by sliding onto the strap. The body 354 has a perimetric lip 358 thereon which defines a receiver 322 on one side of the body 354. A transdermal-drug patch 326, shown in Figure 4B, can be introduced into the receiver 322, in a similar manner to that described in respect of the third embodiment above.
In use, as shown in Figure 4B the holder 344 is slid onto a strap 312 to form the housing 314, which may be a traditional watch strap connected to a watch orwearable device 360. This allows the functionality of the present invention to be retrofitted to existing straps. Indeed, this will work with bracelets or wristbands, irrespective of whether a watch is present. In all events, the contact portion 328 of the receiver 322 is urged against the transdermal-drug patch 326 under the tension of the strap 312.
It will be apparent that the central slot as shown in the holder 344 is only one method of mounting to a strap 312. There could be smaller slotted receivers on a receiver-distal surface of the holder, which slide onto the strap 312, or there could be hooks on the holder which engage with the strap 312. Additionally, there could be studded connectors which engage with the buckle apertures of an existing strap 312, which might make assembly more straightforward. Figures 5A and 5B show a further wearable transdermal-drug-delivery-device , referenced globally at 410. For identical or similar features to those described in respect of the preceding embodiments of the invention, identical or similar reference numerals will be utilised. Further detailed description is omitted for brevity.
The receiver 422 for a transdermal-drug patch is formed by a recessed portion of a body 418 of the housing 414, which has first and second receiver portions 462 for receiving ends of a flexible transdermal-drug patch therein. The arrangement of Figure 5A is shown from an inside direction, that is, the receiver 422 illustrated would be in-use positioned against the user’s skin.
A contact portion 438 of the receiver 422 is formed so as to be convex in shape, stretching the flexible transdermal-drug patch towards the user’s skin, and thereby retaining an active-ingredient- containing portion in a position which is in constant or near-constant contact with the skin.
This contact portion 438 may not necessarily cause a specific force to be applied to the flexible transdermal-drug patch, but the shape assists with general retention.
The strap 412 has a plurality of apertures 464 and corresponding nub connectors 466 which enable easy and adjustable interconnection. However, it may be possible that the strap be formed so as to have an interconnecting buckle or similar interlinking device, which enables the disconnection of the strap by pulling in a longitudinal direction.
Whilst the design of the arrangement of Figures 5A and 5B shows an enlarged housing 414 relative to the strap, it will be appreciated that the width of the whole wearable transdermal-drug-delivery- device 410 have a uniform width, more akin to a bracelet in configuration than a watch.
Although a full strap has been described and is depicted, it is envisaged that the strap may be akin to a standard watch strap. The strap may be formed in two parts. The strap may have a plurality of apertures spaced along the longitudinal extent of a first part of the strap. The other, second part of the strap may have an engagement means for releasable engagement with one or more of the plurality of apertures. The user may then select an aperture to engage with the engagement means such that the strap is tightened to the user’s preference. A buckle, claw clasp or a pin may be used as suitable engagement means. Alternatively, the first part of the strap and second part of the strap may have complementary sections of Velcro, or hook fasteners to allow the user to adjust the tightness of the strap.
The strap may take a variety of forms, and the term strap is used to describe a holding means for attaching the housing to a user. Thus, any form of strap fulfilling the purpose would seem suitable. For example, the strap may be formed as an open-bangle where the first and second parts do not meet with one another and instead the first and second parts are moulded to the user’s appendage for engagement. Thus far, the emphasis of the invention has been on the ability to apply a pressure to maintain contact between a transdermal-drug patch and a user’s skin. However, it will be apparent that another core function of the invention is to perform concealment, and thus there may be many more use cases.
For example, the present invention could be used as a concealment device for a glucose monitor for diabetes, in which case, the receiver of the assembly would need to have a much greater depth to accommodate the height of the monitor. However, the application of pressure by the cover element in this scenario would be actively avoided. In general terms, whilst a patch may be the traditional means of providing nicotine relief, other structures of transdermal-drug-delivery devices may be provided, such as non-flexible units which are held against the skin.
It thus becomes possible to define a generic wearable apparatus for concealing a transdermal medical device which comprises a housing for receiving a transdermal medical device, and a strap or similar user mounting means which extends from the housing to in use secure the housing to a user. The housing includes an access port therethrough, and a cover element which openably covers the access port. In the scenario, concealment of a medical device is achievable.
The advantages herebefore defined, however, in terms of the application of a pressure to said medical device, where the medical device is a transdermal-drug patch, provide additional therapeutic benefits.
The words ‘comprises/comprising’ and the words ‘having/including’ when used herein with reference to the present invention are used to specify the presence of stated features, integers, steps or components, but do not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.
The embodiments described above are provided by way of examples only, and various other modifications will be apparent to persons skilled in the field without departing from the scope of the invention as defined herein.

Claims

Claims
1. A wearable transdermal-drug-delivery-patch housing assembly (10; 1 10; 210; 310; 410) comprising: a housing (14; 1 14; 214; 314; 414) for receiving a transdermal-drug patch (26); a strap (12; 212; 312; 412) which extends from the housing (14; 1 14; 214; 344; 414) to in use secure the housing to a user; the housing (14; 1 14; 214; 344; 414) including: a receiver (22; 122; 222; 322; 422) in which the said transdermal-drug patch (26) is receivable; and a contact portion (38; 138; 238; 338; 438) associated with the receiver (22; 122; 222; 322; 422) which in use abuts against a received said transdermal-drug patch for holding the transdermal-drug patch against a user’s skin.
2. A wearable transdermal-drug-delivery-patch housing assembly (10; 1 10) as claimed in claim 1 . wherein the housing (14; 1 14) comprises a housing body (18; 1 18) with an exteriorfacing surface and a user-facing surface which opposes the exterior-facing surface, a first access opening (20a) at the exterior-facing surface for insertion of the said transdermal drug patch (26), and a second access opening (20b) at the user-facing surface to enable the said transdermal-drug patch (26) to interface with a user; and further comprising a cover element (24; 124) which openably covers the first access opening (20a).
3. A wearable transdermal-drug-delivery-patch housing assembly (10; 1 10) as claimed in claim 2, wherein the contact portion (38; 138) is formed on the cover element (24; 124).
4. A wearable transdermal-drug-delivery-patch housing assembly (10; 1 10) as claimed in claim 2 or claim 3, wherein the cover element (24; 124) has a main body and a projecting portion from the main body, the contact portion (24; 124) being on the projecting portion.
5. A wearable transdermal-drug-delivery-patch housing assembly (10; 1 10) as claimed in claim 4, wherein the main body has a flange engageable with the exterior-facing surface of the housing body (18; 118).
6. A wearable transdermal-drug-delivery-patch housing assembly (10; 1 10) as claimed in claim 2 or claim 3, wherein the cover element (24; 124) is sized to be entirely receivable within the receiver.
7. Awearable transdermal-drug-delivery-patch housing assembly (10; 110) as claimed in any one of claims 2 to 6, wherein the cover element (24; 124) is hingeably engageable with the housing body (18; 1 18).
8. Awearable transdermal-drug-delivery-patch housing assembly (10; 110) as claimed in any one of claims 2 to 6, wherein the cover element (24; 124) is releasably connectable to the housing body (18; 1 18).
9. Awearable transdermal-drug-delivery-patch housing assembly (10; 110) as claimed in any one of claims 2 to 8, wherein the cover element (24; 124) is connectable to the housing body (18; 1 18) by at least one magnetic connection.
10. Awearable transdermal-drug-delivery-patch housing assembly (10; 110) as claimed in any one of claims 2 to 9, wherein the housing (14; 114) includes a seal element engageable at or adjacent to the second access opening (20b).
1 1 . Awearable transdermal-drug-delivery-patch housing assembly (10; 110) as claimed in any one of claims 2 to 10, wherein the housing (14; 1 14) includes a cover-seal element engageable at or adjacent to the first access opening (20a) for sealing between the housing body (18; 1 18) and the cover element (24; 124).
12. Awearable transdermal-drug-delivery-patch housing assembly (10; 110) as claimed in any one of claims 2 to 1 1 , wherein the cover element (24; 124) further comprises a display device.
13. A wearable transdermal-drug-delivery-patch housing assembly (10; 1 10) as claimed in claim 12, wherein the display device includes a watch.
14. A wearable transdermal-drug-delivery-patch housing assembly (10; 1 10) as claimed in claim 12 or claim 13, wherein the display device includes a smart device.
15. Awearable transdermal-drug-delivery-patch housing assembly (10; 110) as claimed in any one of claims 2 to 14, wherein the cover element (24; 124) further comprises at least one sensor.
16. A wearable transdermal-drug-delivery-patch housing assembly (210) as claimed in claim 1 , further comprising an insertable holder (244) receivably engagable with the housing body (218), the contact portion (238) being formed on the insertable holder (244).
17. A wearable transdermal-drug-delivery-patch housing assembly (210) as claimed in claim 8, wherein the insertable holder (244) comprises a perimeter seal.
18. A wearable transdermal-drug-delivery-patch housing assembly (310) as claimed in claim 1 , further comprising a holder (344) receivably engagable with the strap (312), the contact portion (338) being formed on the holder (344).
19. A wearable transdermal-drug-delivery-patch housing assembly (10; 110; 210; 310) as claimed in any one of the preceding claims, wherein the contact portion (38; 138; 238; 338) has a planar contact surface.
20. A wearable transdermal-drug-delivery-patch housing assembly (410) as claimed in any one of claims 1 to 18, wherein the contact portion (438) has a convex contact surface.
21 . Awearable transdermal-drug-delivery-patch housing assembly (10; 110; 210; 310; 410) as claimed in any one of the preceding claims, wherein the strap (12; 212; 312; 412) and housing body (22; 122; 222; 322; 422) are integrally formed with one another.
22. Awearable transdermal-drug-delivery-patch housing assembly (10; 110; 210; 310; 410) as claimed in any one of claims 1 to 20, wherein the strap (12; 212; 312; 412) and housing body (22; 122; 222; 322; 422) are formed as separate components to one another.
23. Awearable transdermal-drug-delivery-patch housing assembly (10; 110; 210; 310; 410) as claimed in any one of the preceding claims, wherein the receiver (22; 122; 222; 322; 422) has a uniform width.
24. A method of concealing a transdermal-drug patch using a wearable transdermal-drug- delivery-patch housing assembly, the method comprising the steps of: a] providing a wearable transdermal-drug-delivery-patch housing assembly (10; 110; 210; 310; 410) as claimed in any one of claims 1 to 23; b] providing a transdermal-drug patch, coverable in use by the wearable transdermal-drug-delivery-patch housing assembly (10; 1 10; 210; 310; 410); and c] applying pressure to the transdermal-drug patch (26) using the contact portion of the wearable transdermal-drug-delivery-patch housing assembly (10; 110; 210; 310; 410).
PCT/GB2023/051968 2022-07-27 2023-07-26 A wearable transdermal-drug-delivery-patch housing assembly WO2024023508A1 (en)

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GB2210978.9A GB2620957A (en) 2022-07-27 2022-07-27 A wearable transdermal-drug-delivery-device housing assembly
GB2210978.9 2022-07-27

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