CN117715575A - Flexible stretchable cover for attaching a component to a patch - Google Patents

Flexible stretchable cover for attaching a component to a patch Download PDF

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Publication number
CN117715575A
CN117715575A CN202280045714.7A CN202280045714A CN117715575A CN 117715575 A CN117715575 A CN 117715575A CN 202280045714 A CN202280045714 A CN 202280045714A CN 117715575 A CN117715575 A CN 117715575A
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CN
China
Prior art keywords
cover
patch
flexible
stretchable
shore
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Pending
Application number
CN202280045714.7A
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Chinese (zh)
Inventor
T·兰布勒彻斯
M·贝法
R·奥特
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Datwyler Pharma Packaging Belgium NV
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Datwyler Pharma Packaging Belgium NV
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Application filed by Datwyler Pharma Packaging Belgium NV filed Critical Datwyler Pharma Packaging Belgium NV
Priority claimed from PCT/EP2022/068225 external-priority patent/WO2023275342A1/en
Publication of CN117715575A publication Critical patent/CN117715575A/en
Pending legal-status Critical Current

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Abstract

The present invention relates to the technical field of patches, more particularly to patches for attachment to the skin of a subject, for example in medical applications, living applications, health applications or sports applications, etc. In particular, it relates to the field of patch assemblies comprising elements such as sensors, electronic circuits, processors, data communication modules, batteries, etc., and/or any other suitable electronic element, also referred to as smart patches.

Description

Flexible stretchable cover for attaching a component to a patch
Technical Field
The present invention relates to the technical field of wearable patches, and more particularly to patches that are attached to the skin of a subject, e.g. a subject in medical applications, life applications, health applications or sports applications, etc. In particular, the present invention relates to the field of patch assemblies, also referred to as smart patches, comprising elements such as sensors, electronic circuits, processors, data communication modules, batteries, etc., and/or any other suitable electronic element.
Background
An adhesive patch device for monitoring impedance and electrocardiogram signals is known from WO2009/036313 A1. Such an adhesive patch device is applied, for example, to physiological monitoring of a patient. Particularly when it is desired to monitor the patient over a longer period of time, it is desirable that the patient be able to wear such patch devices in a comfortable manner.
WO2009/036313A1 discloses a cover that can be attached to an adhesive patch such that when the adhesive patch expands and/or contracts with the skin of a patient, the cover also expands and/or contracts. Between the stretchable material of the patch and the stretchable material of the cover, there are provided elements such as electronic components, printed circuit boards, housings for electronic devices, and the like, which are substantially inextensible, if any. As described in WO2009/036313A1, these elements are mounted on top of the electrodes, which may limit the stretch and/or shrink properties of the cover and/or the patch.
According to the embodiment described in WO2009/036313A1, the mounting of these elements, whose mounting position is determined by the position of the following electrodes, limits the flexibility and extensibility of the patch device, even in the case where the cover and the affixed patch are slidable with respect to these elements: the electrodes are fixedly mounted and mounted at a fixed location in the subject, and the electrodes generally have a high rigidity. According to such an embodiment, similar to that described in WO2009/036313A1, this obviously also brings the disadvantage of concentrating the majority of the holding force for these elements at these specific mounting positions determined by the electrodes. With embodiments such as described in WO2009/036313A1, in this way, these retention forces interact with the subject's skin in a concentrated manner at those specific mounting locations where the electrodes are attached to the subject's skin.
Another disadvantage of the embodiment described for example in WO2009/036313A1 is that: since the electrodes themselves are generally less flexible or more rigid structures than the patch, the retention force is transferred to the subject's skin at a location that is not able to accommodate any changes in the subject's skin. It is clear that another disadvantage of the embodiments described for example in WO2009/036313A1 relates to the transmission of the holding forces of these elements at specific locations of the electrode, so that all holding forces are concentrated at this limited contact surface, which also increases the risk of the electrode coming off and/or changing the level of attachment under varying holding forces during use of the patch device. It is also evident that in such prior art embodiments, this brings with it the following drawbacks: such variations may lead to a risk of electrode detachment or a risk of the measurements made by the electrodes being affected by any of these variations.
It is thus evident that in such prior art embodiments, this also has a negative impact on the comfort of the subject, since the retention forces of these elements, which are typically the heaviest components of the patch device, are concentrated at those specific locations and will thus exert stress on the skin of the patient in a concentrated manner, for example, at those locations. To reduce these problems, WO2009/036313A1 proposes adhering the upper surface of the electronic device housing to the cover with an adhesive in order to suspend the printed circuit module above the affixed patch by such connection with the cover. However, it is evident that in this prior art embodiment, this connection of these elements to the cover by means of an adhesive reduces the flexibility of the cover itself.
Furthermore, according to such prior art embodiments, the cover needs to have a sufficient level of rigidity in order to support the weight of these elements, otherwise the cover would collapse under the weight of these elements, thus failing to guarantee the desired suspension. Obviously, this increased level of stiffness of the cover will result in a reduction in the desired level of extensibility and flexibility of the cover. In addition, according to such prior art embodiments, a desired gap between the PCB module and the attached patch cannot be ensured in case, for example, the patch device is subjected to the following impacts or sudden movements: the shock or abrupt movement is caused, for example, by an abrupt movement or shock generated by the subject himself during the wearing of the patch device, or by an external event that causes the patch device to abruptly move or vibrate. This is the case, for example, when the subject is performing a physical action, for example, during exercise, physical therapy, etc., in which case monitoring by such a wearable patch device is particularly useful. Obviously, all of the above-described drawbacks of the prior art embodiments negatively impact patient comfort, robustness and safety of the patch device.
A patch device is also known from WO2011/081891A1, which describes the use of a bridge ring. These bridge rings are fixed to the patch and to the circuit carrier and form a structure that controls the movement of the circuit carrier relative to the patch, allowing relatively free rotation of the circuit carrier about the X-axis and Y-axis shown in fig. 4 of WO2011/081891A1 and constraining rotation of the circuit carrier about the Z-axis. However, it is clear that in this prior art embodiment, the desired gap between the PCB module and the patch is not guaranteed, in particular when subjected to e.g. an impact or sudden movement in a direction away from and/or towards the patch. It is further evident that also according to this prior art embodiment, the holding force for holding the elements of the patch device is concentrated at the attachment location where the bridge ring is attached to the patch. It is therefore evident that all of the above negatively affects patient comfort, robustness and safety of the patch device.
Furthermore, the use of adhesives, the need for connections at specific locations, and/or the use of additional mounting elements such as bridging rings adds complexity, which reduces the efficiency of manufacturing and/or assembling the patch device. In the context of such patch devices, it is often desirable to quickly, easily and robustly mount and dismount components such as batteries, electronic modules, etc., which limit the robustness of the patch device and reduce the efficiency of such mounting and dismounting operations due to their susceptibility to failure.
Thus, there is a need for an improved patch assembly and/or components thereof that allows for a more robust mounting of elements while still allowing for increased comfort levels when mounting elements with higher rigidity, lower flexibility and/or lower extensibility on such patches, for example, by improved extensibility, flexibility and/or compliance to the skin movements of the subject.
Disclosure of Invention
In order to provide a solution to the above-described problems in the art, the present disclosure describes a flexible and stretchable cover and/or cover assembly configured for attachment to a patch for attachment to the skin of a subject, for example in medical applications, living applications, health applications, or sports applications, etc. The cover of the present application defines a holding space for one or more elements, such as sensors, processors, data communication modules, batteries, electronic connectors, etc., and/or any other suitable electronic element, for the purpose of attaching the elements to the patch. Accordingly, the present disclosure also describes a patch assembly 1 comprising a cover and an element, also referred to as a smart patch.
One aspect of the present invention provides a flexible and stretchable cover configured for attachment to a patch and at least partially surrounding an element, the cover comprising at least one flexible and stretchable clamping member configured to:
-clamping the element with the clamping member in contact with the element mounted inside the cover; and
-applying a pressing force to the element, thereby attaching the element to the interior of the cover.
In some preferred embodiments, the clamping member is configured to: the element (70) is clamped in such a manner that the clamping member can be brought into sliding contact with the element, with the element being mounted inside the cover.
In some preferred embodiments, the cover is configured to attach to a patch at one or more attachment points, wherein the patch is configured to attach to the skin of a subject.
In some preferred embodiments, the cover is configured as a separate element and/or a different element from the patch.
In some preferred embodiments, the cover is not configured for attachment to the skin of a subject.
In some preferred embodiments, only the cover is configured to grip the element with the element mounted inside the cover.
In some preferred embodiments, only the cover is configured to apply a compressive force to the element.
In some preferred embodiments, the patch is configured to not clamp the element with the element mounted inside the cover.
In some preferred embodiments, the patch is configured to apply a compressive force to the element with the element mounted inside the cover.
In some preferred embodiments, the patch is configured not to contact the element if the element is mounted inside the cover.
In some preferred embodiments, at least one of the clamping members is configured to apply a compressive force to the element in at least one direction.
In some preferred embodiments, at least one of the clamping members is configured to apply a compressive force to the element in a plurality of directions.
In some preferred embodiments, at least one of the clamping members is configured to apply a compressive force inwardly along at least a portion of the outer surface of the element.
In some preferred embodiments, the cover is composed of a monolithic element.
In some preferred embodiments, the cover comprises at least two flexible and stretchable gripping members.
In some preferred embodiments, the cover comprises at least two flexible and stretchable gripping members arranged on opposite sides of the element (70) when the element is mounted.
In some preferred embodiments, the cover comprises at least two flexible and stretchable gripping members configured to: a compressive force is applied to the element with the element mounted between the at least two clamping members.
In some preferred embodiments, the cover comprises: at least two flexible and stretchable clamp members located on opposite sides of the element when the element is mounted, wherein the at least two flexible and stretchable clamp members are arranged such that the at least two flexible and stretchable clamp members cooperate to apply a compressive force to attach the element to an interior of the cover between the at least two flexible and stretchable clamp members.
In some preferred embodiments, the cover comprises, preferably consists of, a material defined by a hardness of: at least 10 shore a up to 90 shore a; preferably 20 shore a to 80 shore a; more preferably 30 shore a to 70 shore a; even more preferably 30 shore a to 60 shore a.
In some preferred embodiments, the cover comprises, preferably is constructed of, a material defined by the tensile strength described belowThe tensile strength is: at least 5.0N/mm 2 Up to 11.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Preferably 5.5N/mm 2 Up to 10.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the More preferably 6.0N/mm 2 Up to 10.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 6.5N/mm 2 Up to 9.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.0N/mm 2 Up to 9.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.5N/mm 2 Up to 8.5N/mm 2 。
In some preferred embodiments, the cover comprises, preferably consists of, a material defined by a maximum elongation of: at least 100% and at most 800%; preferably 200% to 800%; more preferably 300% to 750%; even more preferably 350% to 750%; even more preferably 400% to 700%; even more preferably 450% to 650%; even more preferably 500% to 600%.
In some preferred embodiments, the cover comprises, preferably consists of, a material defined by a tear resistance of: at least 20N/mm up to 30N/mm; preferably 21N/mm to 29N/mm; more preferably 21N/mm to 28N/mm; even more preferably 22N/mm to 27N/mm; even more preferably 23N/mm to 26N/mm.
In some preferred embodiments, the material of the cover comprises, preferably consists of: silicone Rubber (SR), more preferably Liquid Silicone Rubber (LSR); thermoplastic elastomers (TPE), more preferably Thermoplastic Polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic Polyamide (TPA); thermoplastic vulcanizates (TPV); crosslinkable elastomers, more preferably Isoprene Rubber (IR), nitrile rubber (NBR), styrene-butadiene rubber (SBR), ethylene-propylene-diene rubber (EPDM), fluorocarbon-based fluoroelastomer material (FKM), polybutadiene rubber (BR); and/or combinations of the above.
Another aspect of the invention provides a cover assembly configured for attachment to a patch, the cover assembly comprising a cover as described in the present disclosure, wherein the cover assembly further comprises an element mounted inside the cover by at least one flexible and stretchable clamping member.
In some preferred embodiments, the cover, preferably at least one flexible and stretchable gripping member of the cover, is in direct contact with the element on at least a portion of its inner surface, i.e. at least a portion of the inner surface of the cover is in direct contact with the outer surface of the element.
In some preferred embodiments, the cover, preferably at least one flexible and stretchable gripping member of the cover, is provided with one or more inward protrusions in direct contact with the element, wherein optionally the one or more inward protrusions are dimensioned such that the stretchability and/or flexibility is increased at the location of the direct contact with the gripping member. Preferably, the one or more inward protrusions comprise: a protrusion on an inner surface of the distal portion of the cover; a protrusion on an inner surface of the proximal portion of the cover; and/or a protrusion on an inner surface of a lateral portion of the cover.
In some preferred embodiments, the at least one flexible and stretchable gripping member is configured such that: the material of the gripping member in contact with the element is slidable relative to the element in the event of encountering a change caused by flexing and/or stretching of the cover.
Another aspect of the invention provides a patch assembly configured to be attached to the skin of a subject, the patch assembly comprising:
-at least one cover assembly as described in the present disclosure, and
-a patch configured to be removably attached to the skin of the subject, at least one of the cover assemblies being attached to the patch by the cover of the cover assembly.
In some preferred embodiments, the patch comprises, preferably consists of, a material defined by the following durometers: at least 10 shore a up to 90 shore a; preferably 20 shore a to 80 shore a; more preferably 30 shore a to 70 shore a; even more preferably 30 shore a to 60 shore a.
In some preferred embodiments, the patch comprises, preferably consists of, a material defined by the tensile strength: at least 5.0N/mm 2 Up to 11.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Preferably 5.5N/mm 2 Up to 10.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the More preferably 6.0N/mm 2 Up to 10.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 6.5N/mm 2 Up to 9.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.0N/mm 2 Up to 9.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.5N/mm 2 Up to 8.5N/mm 2 。
In some preferred embodiments, the patch comprises, preferably consists of, a material defined by a maximum elongation of: at least 100% and at most 800%; preferably 200% to 800%; more preferably 300% to 750%; even more preferably 350% to 750%; even more preferably 400% to 700%; even more preferably 450% to 650%; even more preferably 500% to 600%.
In some preferred embodiments, the patch comprises, preferably consists of, a material defined by a tear resistance of: at least 20N/mm up to 30N/mm; preferably 21N/mm to 29N/mm; more preferably 21N/mm to 28N/mm; even more preferably 22N/mm to 27N/mm; even more preferably 23N/mm to 26N/mm.
According to some preferred embodiments, the element comprises, and/or consists of, one or more of the following:
-an electronic component;
-a non-electronic component;
-a reservoir;
-a dispenser.
According to some preferred embodiments, the element comprises a reservoir and/or dispenser configured to store and/or hold one or more of the following:
-a liquid;
-a spray;
-a solid;
-a drug;
-a cosmetic product.
In some preferred embodiments, the patch assembly further comprises:
-at least one sensor configured for measuring a physiological state and in electronic communication with the element, wherein the element comprises at least one electronic circuit configured to process, store and/or transmit a measurement result of the sensor.
In some preferred embodiments, the patch assembly further comprises a membrane that is gas permeable and preferably liquid impermeable.
According to some preferred embodiments, there is provided a patch assembly, wherein the cover comprises a proximal or lower portion configured to at least partially cover a side of the element closest to the patch of the patch assembly, and wherein the lower portion of the cover defines a gap between the element and the patch,
and wherein preferably the cover comprises at least one pair of clamping members arranged on opposite sides of the element, whereby each of the pair of clamping members comprises the lower portion or a portion thereof arranged between the element and the patch.
According to a preferred embodiment, the gap is an air gap. According to alternative embodiments, the gap may comprise any other suitable medium, such as a compressible material configured to provide a cushioning function, such as a material comprising silicone rubber.
Another aspect of the invention provides a use of a cover and/or cover assembly as described in the present disclosure for attaching an element to a patch.
Another aspect of the invention provides a use of a patch assembly as described in the present disclosure for measuring a physiological state of a subject.
Drawings
The following description of the drawings of the invention is merely exemplary in nature and is not intended to limit the teachings, application, or uses of the invention.
Corresponding reference characters indicate the following parts and features throughout the several views: a patch assembly 1; a patch 10; a patch layer 11; a cover 40; a clamping member 41; a holding space 42; attachment points 44; a proximal portion 45; an extension member 46; a protruding portion 47; a distal protrusion 471; a proximal protrusion 472; a lateral protrusion 473; an orifice 48; a membrane 50; a member 70; a component package 71; a film element package 75; other elements 80; a wire 81; a clamping force CF; a distal direction D; a proximal direction P; a lateral direction L.
Fig. 1 is a cross section taken along line J-J of an embodiment of the patch assembly 1 as shown in the top view of fig. 2, the patch assembly 1 having clamping members 41 that apply a Compressive Force (CF) to the distal (D) side and the proximal (P) side of the element 70.
Fig. 2 is a top view of the embodiment of fig. 1.
Fig. 3 is a cross section of an alternative embodiment of the patch assembly 1 with clamping members 41 that apply a Compressive Force (CF) to all sides of the element 70.
Fig. 4 is a cross section of an alternative embodiment of the patch assembly 1 with a clamping member 41 that applies a Compressive Force (CF) on the lateral (L) side of the element 70.
Fig. 5 is a cross section of an embodiment of the patch assembly 1 with an extension member 46.
Fig. 6 is a cross section of an embodiment of the patch assembly 1 with a protrusion 47.
Fig. 7 is a cross section of an embodiment of the patch assembly 1 with a distal aperture 48.
Fig. 8 is a cross section of an embodiment of the patch assembly 1 with a lateral aperture 48.
Fig. 9 is a cross section of an embodiment of the patch assembly 1 with a plurality of apertures 48.
Fig. 10 is a cross-section of an embodiment of the patch assembly 1 with a membrane 50 disposed in the distal and proximal portions of the cover 40.
Fig. 11 is a cross-section of an embodiment of the patch assembly 1 with a membrane 50 disposed in the lateral aperture 48 and the proximal portion of the cover 40.
Fig. 12 is a cross-section of an embodiment of the patch assembly 1 with an integral membrane 50 located within the cover 40 completely surrounding the element 70.
Fig. 13 is a cross-section taken along line K-K of an embodiment of the patch assembly 1 as shown in the top view of fig. 14, the patch assembly 1 having other elements 80 integrally formed in the patch 10.
Fig. 14 is a top view of the embodiment of fig. 13. .
Fig. 15 is a cross section of an embodiment of the patch assembly 1 with a component package 71.
Fig. 16 is a cross section of an embodiment of the patch assembly 1 with a membrane element package 75.
Fig. 17 is a cross section taken along line L-L of an embodiment of the patch assembly 1 as shown in the top view of fig. 18, the patch assembly 1 having other elements 80 that are removable from the patch 10.
Fig. 18 is a top view of the embodiment of fig. 17.
Detailed Description
The present invention will be described with respect to particular embodiments, but the invention is not limited thereto but only by the claims. Any reference sign in a claim should not be construed as limiting the scope of the claim.
As used in this application, the singular forms "a," "an" and "the" include both the singular and the plural reference unless the context clearly dictates otherwise.
The terms "comprising," "including," and "comprised of" are used in this application synonymously with "comprising" … ("including," "included," or "containing," "containing"), and are inclusive or open-ended, and do not exclude additional, non-recited members, elements, or method steps. When referring to a recited member, element or method step, the term "comprising" also includes embodiments consisting of the recited member, element or method step.
The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within that range, and the recited endpoint.
Furthermore, the terms first, second, third and the like in the description and in the claims, unless otherwise specified, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.
Unless otherwise defined, all terms including technical and scientific terms used in the process of the invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Definitions of terms used in the specification are included by way of additional guidance to better understand the teachings of the present invention. The terms or definitions used in this application are provided only to aid in understanding the present invention. All documents cited in this specification are incorporated by reference in their entirety into this application.
The terms "left", "right", "front", "rear", "top", "bottom", "above", "in" the description and claims are used for descriptive purposes and not necessarily for describing permanent relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in other orientations than those illustrated or otherwise described herein. "distal" and "proximal" are typically the "distal" and "proximal" relative positions with respect to the patch and/or the skin to which the patch is applied. In the same context, "lower" and "upper" generally refer to "proximal" and "distal", respectively.
The term "coupled," as used herein, is defined as directly or indirectly connected, whether electrically or non-electrically (i.e., physically), and objects described herein as "adjacent" to each other may be in physical contact with each other, in close proximity to each other, or within the same general range or region of each other, depending on the context in which the phrase is used.
The term "about" is used to provide flexibility to the endpoints of a numerical range by specifying that a given value may be "slightly above" or "slightly below" the endpoint of the numerical range. The use of the term "about" in reference to a particular number or range of values is also to be understood as providing support for such number or range of values without the term "about" unless otherwise indicated. For example, when referring to measurable values such as parameters, amounts, durations, etc., for convenience and brevity, it is meant to encompass variations of +/-10% or less relative to the particular value, preferably +/-5% or less relative to the particular value, more preferably +/-1% or less relative to the particular value, and still more preferably +/-0.1% or less relative to the particular value, so long as such variations are suitable for execution in the disclosed invention. It should be understood that the value itself, to which the modifier "about" refers, is also specifically disclosed, and is preferably specifically disclosed.
The term "substantially" refers to a degree of completeness or nearly a degree of completeness or of a result of an action, feature, attribute, state, structure, item or result. For example, an object that is "substantially" enclosed means that the object is completely enclosed or nearly completely enclosed. In some cases, the exact allowable degree of deviation from absolute integrity may depend on the particular context. In general, however, near-complete will have the same overall result as achieving absolute complete integrity. The same applies when "substantially" is used in the negative sense to refer to the complete or nearly complete lack of action, features, attributes, states, structures, items or results. For example, a composition that is "substantially free" of particles is either completely devoid of particles or almost completely devoid of particles so that the same effect as completely devoid of particles. In other words, a composition that is "substantially free" of a certain component or element may actually still comprise such an article, so long as the article has no measurable effect.
Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrase "in one embodiment" or "in an embodiment" appearing in various places throughout the specification are not necessarily all referring to the same embodiment. The appearances of the phrase "in one embodiment" or "in one aspect" in this application are not necessarily all referring to the same embodiment or aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner as would be apparent to one of ordinary skill in the art in view of this disclosure in one or more embodiments. Furthermore, while some embodiments described herein include some features but not others included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention and form different embodiments, as will be appreciated by those of skill in the art. For example, in the claims and descriptions that follow, any of the claimed or described embodiments may be used in any combination.
In addition, it should be understood that embodiments of the present invention may include hardware, software, and electronic components or modules that, for purposes of discussion, may be shown and described as if most of the components were implemented solely in hardware or software. However, those skilled in the art will appreciate, based on a reading of this detailed description, that in at least one embodiment, the electronic-based aspects of the invention may be implemented in software (e.g., instructions stored on a non-transitory computer-readable medium) that is executable by one or more processing units, such as a microprocessor and/or an application specific integrated circuit.
Thus, the hardware described in the present application may comprise a processing unit configured to perform the methods presented in the present application as software. Embodiments of the method may be implemented in code and may be stored on a storage medium having stored thereon instructions which can be used to program a system to perform the instructions. For the purposes of this disclosure, the term "code" or "program" encompasses a wide range of components and constructs, including applications, drivers, processes, routines, methods, modules, and subroutines. Thus, the term "code" or "program" may be used to refer to any of the following instruction sets: when the set of instructions is executed by the processing system, the desired one or more operations are performed. Additionally, alternative embodiments may include: processes that use fewer than all of the disclosed operations, processes that use additional operations, processes that use the same operations in a different order, and processes in which the individual operations disclosed herein are combined, subdivided, or otherwise altered. Various modifications and changes thereto will be apparent to those skilled in the art.
In order to provide a solution to the above-described problems in the art, the present disclosure describes a flexible and stretchable cover 40 and/or cover assembly configured for attachment to a patch 10, the patch 10 being for attachment to the skin of a subject, for example in medical applications, life applications, health applications, beauty product applications, or sports applications, etc. The cover of the present application defines a holding space for one or more elements 70, such as sensors, processors, data communication modules, batteries, electrical connections, etc., and/or any other suitable electronic element, for the purpose of attaching the elements to the patch 10. Accordingly, the present disclosure also describes a patch assembly 1, also referred to as a smart patch, comprising a cover 40 and an element 70.
The mechanical terms "flexible" and "stretchable" as used herein mean that the element or material thereof in question is capable of bending and/or stretching without breaking when an external force is applied thereto, and is also capable of recovering its previous size or shape when said external force is relieved. However, those skilled in the art will appreciate that the flexibility and/or extensibility of any element is defined by the physical characteristics of its material and structure. Accordingly, to determine whether a given element may be considered flexible and/or stretchable in the context of the present disclosure, reference is made to exemplary embodiments of suitable materials and/or material properties discussed further below in the present disclosure. Those skilled in the art will be able to select appropriate materials and/or structures to produce elements having the desired physical characteristics, such as flexible and stretchable covers or any element thereof, in the light of these exemplary embodiments.
It will be apparent that, in the context of the present disclosure, when used in reference to patch 10, "flexible and stretchable" refers to materials and/or structural characteristics that bring about flexibility and/or extensibility similar or substantially similar to that of the skin to which the patch is configured to be attached. When referring to a more "rigid" element 70 in the context of the present disclosure, this refers to the following elements: the material properties of the element result in a flexibility and/or extensibility that is substantially different from the flexibility and/or extensibility of the patch 10 and similar to the flexibility and/or extensibility of the skin to which the patch 10 is configured to be attached. According to some embodiments, the elongation and/or bending angle produced by element 70 will be substantially lower than the elongation and/or bending angle of flexible and stretchable patch 10, such as 10% or less, 5% or less, or 1% or less, when subjected to similar forces, for example.
Similarly, when "flexible and stretchable" is used with reference to cover 40, this refers to the following flexibility and stretchability resulting from suitable materials and/or structural characteristics: which is substantially higher than the flexibility and extensibility of the more "rigid" element 70 and which is similar or at least more consistent with the flexibility and extensibility of the patch 10 and/or skin than the rigid component. According to some embodiments, the elongation and/or bending angle produced by element 70 will be substantially lower than the elongation and/or bending angle of flexible and stretchable cover 40, such as 50% or less, 25% or less, or 10% or less, when subjected to similar forces, for example. According to some embodiments, the elongation and/or bending angle produced by the flexible and stretchable cover 40, when subjected to similar forces, for example, is within one or more of the following ranges relative to the elongation and/or bending angle of the patch 10 and/or the skin to which the cover is attached: 10% to 300% (300% inclusive); 30% to 150% (150%); or 50% to 100% (100% inclusive).
The element 70 will be referred to hereinafter as a single unit, containing all the sub-elements capable of fulfilling the intended function of the patch assembly 1. However, those skilled in the art will appreciate that the element 70 may include various sub-units formed of different components that are optionally electrically connected to one another. Moreover, the elements may include hardware configured to improve the functionality of the electronic element, such as a cooler/heater, humidifier/dehumidifier, etc. For purposes of brevity and clarity, similar elements are therefore grouped together under a single name or noun. According to some embodiments, the elements may include, and/or consist of, electronic elements, non-electronic elements, reservoirs, dispensers, and the like. Such electronic components may, for example, comprise or consist of one or more electronic components. Such non-electrical components do not comprise any electronic components, for example. Such a reservoir or dispenser may, for example, be configured to store and hold suitable liquids, sprays, solids, pharmaceuticals, cosmetic products, and the like.
In an embodiment, the element 70 may comprise an outer housing that houses and advantageously protects the inner components at least partially disposed within the housing. The housing may be entirely rigid but may also be at least partially flexible. However, to adequately protect the element 70, the element housing is more rigid and less flexible than the cover 40.
Patches 10 for attachment to the skin of a subject are known in the art. For example, patch 10 may be self-adhesive, such as having a skin adhesive layer disposed on the proximal side (i.e., the side facing the skin), or may require an adhesive to be disposed on the subject's skin. Advantageously, patch 10 is constructed of a compliant material configured to conform to the shape of the skin and/or change to the shape of the skin during movement of the subject. Further advantageous embodiments of the patch 10 in relation to the cover 40 of the present invention will be set forth throughout this disclosure.
The subject may be a mammal, more particularly a human, e.g. a healthy person or a patient suffering from an abnormal health condition. The cover 40 and/or the patch assembly 1 may be allocated to a single subject, for example in a disposable and/or partially disposable embodiment, but may be reused for another subject or for use by a group of subjects if desired, for example in a partially or fully reusable embodiment for use by another subject or by a group of subjects, as will become apparent from the description below.
A preliminary overview of the elements of the cover is provided below, followed by a more detailed description of the specific embodiments. This preliminary overview is intended to aid the reader in understanding the technical concepts more quickly, but is not intended to identify key or essential features thereof, nor is it intended to limit the scope of the present subject matter.
In addition, those of ordinary skill in the art will understand, and upon reading this detailed description, that various aspects can be combined unless indicated otherwise. Thus, any particular embodiment of a particular aspect may be understood as constituting a particular embodiment of another aspect without explicit discussion. For example, embodiments of the construction of the cover also form embodiments for manufacturing the cover according to the construction, embodiments for using the cover according to the construction, and so on.
Cover 40 is constructed of a flexible and stretchable material that forms a barrier configured to at least partially enclose element 70. The interior of the cover defines a holding space for holding the element. For this purpose, the cover 40 may include: a lateral portion configured to at least partially cover a lateral side of element 70; a distal portion or upper portion configured to at least partially cover a distal side or upper portion of the member 70; and/or a proximal portion or lower portion 45 configured to at least partially cover a proximal side or lower portion of element 70.
In an embodiment, the cover 40 may include: a lateral portion configured to entirely cover a lateral side of the element 70; a distal portion configured to completely cover a distal side of the element 70; and/or proximal portion 45 configured to completely cover the proximal side of element 70. It will be appreciated that complete coverage of one side of element 70 also includes near complete coverage although apertures or holes are provided to allow gas/liquid to pass through.
The flexible and stretchable material of cover 40 may serve as a flexible stop member that provides resistance against displacement of element 70 in at least one direction; the element 70 may still move, but this movement requires more force to resist the resistance defined by the material properties of the cover 40. Thus, providing a material that is more flexible and stretchable may allow for greater displacement than a material that is less flexible and stretchable. However, it will be apparent from this disclosure that the purpose of the cover 40 is to prevent removal of the element 70 from the patch, thus implying a limit on maximum displacement.
Fig. 1 shows an embodiment of a cover 40 comprising a flexible and stretchable clamping member 41, the clamping member 41 being configured to clamp an element 70 with the element 70 mounted inside the cover 40 in the following manner: so that the clamping member 41 contacts the element 70 and applies a pressing force CF to the element attaching the element 70 to the inside of the cover 40. Thus, fig. 1 also shows a cover assembly comprising a cover 40 and an element 70, wherein said element 70 is mounted inside the cover 40 by means of at least one flexible and stretchable clamping member 41.
The element 70 may be mounted in the cover 40 before being clamped by the clamping member 41 to more easily mount/dismount the element 70 to/from the cover 40. In such embodiments, the cover 40 may be provided with a clamping mechanism to create a compressive force exerted by the clamping member 41 on the element 70. Thus, the clamping member 41 may be configured to apply a compressive force to the element, thereby attaching the element 70 to the interior of the cover 40.
As used herein, a compressive force or pressure refers to a physical force that presses inward on an object such as element 70 so that it is attached. In case the cover material is used as a flexible stop member, the pressing force may limit the movement of the element 70 in at least one direction, preferably in the distal (D) direction or above and/or in the proximal (P) direction or below, but still possibly allow a sliding movement of the component in the other direction, preferably in the lateral (L) direction.
As will become clear from the further described embodiments, the attachment of the element 70 may be temporary or permanent, depending on the embodiment of the clamping member 41. For example, the element 70 may need to be displaced to a specific position within the holding space 42, e.g. twisted, turned, bent to a specific position within the holding space 42, etc., which holding space 42 is used for the clamping means 41 to clamp said element 70. Alternatively, in an embodiment, the element 70 may be automatically clamped by the clamping member 41 during insertion or installation, thereby obtaining easier and faster attachment of the element 70. Furthermore, depending on the direction or position in which the compaction force is applied to the object, different results may be produced.
In an embodiment, the clamping member 41 may be configured such that: when encountering a change caused by flexing and/or stretching of the cover 40, the material of the clamping member 41 in contact with the element 70 is slidable relative to the element 70, i.e. the element 70 is capable of slidably moving within the holding space 42 of the cover 40. Preferably, the surface of the clamping member 41 has a coefficient of friction suitable to allow sliding movement of the element 70 in case a force is applied to the cover 40. It will be appreciated that the appropriate coefficient of friction depends on the contact surface material of the clamping member 41 and the contact surface material of the element 70. One skilled in the art can select suitable materials as directed by the exemplary embodiments discussed further below.
In another embodiment, the clamping member 41 may be configured such that: when subjected to changes caused by flexing and/or stretching of the cover 40, the material of the clamping member 41 in contact with the element 70 is adhesive with respect to the element 70; i.e. the element 70 is fixed in the holding space 42 of the cover 40. Preferably, the material of the clamping member 41 has a coefficient of friction suitable to prevent most, if not all, movement of the element 70. One skilled in the art can select suitable materials.
In another embodiment, the clamping member 41 may be configured such that: when subjected to changes caused by flexing and/or stretching of the cover 40, the material of the clamping member 41 in contact with the element 70 is slidable relative to the element 70 in one direction and adhesive relative to the element 70 in the other direction. For example, the element 70 may be slidably movable in a lateral direction but fixed in a distal/proximal direction, or the element 70 may be slidably movable in a distal/proximal direction but fixed in a lateral direction.
In spite of the above embodiments, in practice the material of the clamping member 41 may have a slidability/adhesiveness that depends on the force applied to the element 70. In other words, the clamping member 41 may provide the following embodiments: is adhesive with a relatively small force applied so that the element 70 remains fixed in position, and is slidable to some extent with a relatively large force applied so that the element 70 can move. In this way, the position of the element 70 within the holding space 42 may be adjusted as needed, for example by grasping or pushing, but not moved during normal movement of the subject. Thus, it should be appreciated that in preferred embodiments, no other means for attaching the element 70 to the cover 40 are provided, such as an adhesive substance applied between the element 70 and the cover 40, or a fastener disposed through the cover 40 or around the cover 40 to fasten the element 70 within the cover 40. Thus, the cover 40 may be considered as the primary means for attaching the element 70 to the patch 10 within the holding space of the cover 40, i.e. without the need to provide other means such as adhesives, fasteners, etc. It should be understood that the means for attaching does not include any components that are not used for the attachment element 70. For example, the element 70 may include various electrical elements, such as wires or cables that connect the element 70 to other elements 80 (e.g., one or more sensors) in the assembly 1. However, such electrical components are not typically configured to secure the component 70 and may therefore be damaged or destroyed when the component 70 is moved, or alternatively, such electrical components may be configured to automatically disconnect to prevent damage. Providing a "grip only" attachment may reduce design complexity and advantageously enable the element 70 to be displaced depending on the embodiment of the cover 40 and/or facilitate easier passage of gas/liquid from the subject's skin through the cover 40.
In an embodiment, the clamping member 41 may be configured to apply a compressive force to the element 70 in accordance with at least one of the following options:
along at least one direction, for example a distal direction or a proximal direction;
along a plurality of directions, for example distal and proximal and lateral;
inward along at least a portion of the outer surface of the element 70.
Referring to fig. 1, an embodiment of the cover 40 is shown, wherein the clamping member 41 applies a compressive force (shown by four CF arrows) to the distal D-side and the proximal P-side of the element, thereby limiting movement of the element 70 in the distal/proximal direction. The compression force shown may be achieved by simultaneously compressing the distal side of element 70 from the distal portion of cover 40 and the proximal side of element 70 with proximal portion 45 of cover 40. In the present embodiment, no pressing force is applied to the lateral L side of the element 70, so that the element 70 can potentially move in the lateral direction by sliding into the retaining space 42 of the cover to the lateral portion of the cover 40 forming the flexible stop member.
Referring to fig. 3, an alternative embodiment of the cover 40 is shown, wherein the clamping member 41 applies a compressive force (shown by six CF arrows) to the distal D-side and proximal P-side and lateral L-side of the member, thereby limiting movement of the element 70 in the distal, proximal and lateral directions. The compression force shown is achieved by simultaneously compressing the distal side of element 70 with the distal portion of cover 40, the proximal side of element 70 with the proximal portion 45 of cover 40, and the lateral side of element 70 with the lateral portion of cover 40. In the present embodiment, the clip member 41 is adhered to the element 70, so that the element 70 can be prevented from moving within the holding space 42 of the cover.
Referring to fig. 4, another alternative embodiment of the cover 40 is shown, wherein the clamping member 41 applies a compressive force (shown by two CF arrows) onto the lateral L-side of the element 70, thereby limiting movement of said element 70 in the lateral direction and advantageously also in the distal and/or proximal direction. The illustrated pressing force is achieved by simultaneously pressing the lateral sides of the element 70 with the lateral portions of the cover 40. In an embodiment, at least two opposing lateral portions of the cover 40 (i.e., two lateral portions located on opposing sides of the cover 40) may apply a compressive force. In another embodiment, at least four lateral portions of the cover 40 (i.e., four lateral portions on two opposite sides of the cover 40) may apply a compressive force. Those skilled in the art will appreciate that for embodiments in which the cover has a diverging shape (e.g., hexagonal or octagonal), multiple lateral portions may apply compressive forces to the element 70. Further, in the present embodiment, no pressing force is applied to the proximal side portion and the distal side portion of the element 70, and therefore, the element 70 can be moved in the proximal direction and/or the distal direction by sliding to the distal end portion of the cover 40 forming the flexible stopper member within the holding space.
Preferably, the applied compressive force may be applied at different locations along at least one side of the element 70 to improve clamping reliability. For example, referring to fig. 1, an embodiment is shown in which compressive forces are applied at opposite edges of the element 70, specifically, at the proximal and distal edges of the cover 40. Advantageously, the pressing force may be applied along at least a portion, preferably the entire side of the element 70. For example, referring to fig. 3, an embodiment is shown in which the compressive force is applied continuously along the lateral sides of the element 70, specifically along two opposing lateral sides of the element 70. Those skilled in the art will appreciate that the embodiment of fig. 3 is a cross-section (e.g., a cross-section along the length of the assembly), and that the lateral side of the cover 40, not shown, may similarly apply a compressive force to the element 70 such that the compressive force is applied along the entire lateral side of the element 70.
In an embodiment, the cover 40, and in particular the clamping member 41, may be configured to clamp at least a portion of the element 70. Advantageously, at least one clamping component 41 may be provided with a rigid member extending from the cover 40, which may clamp the element 70 with the element 70 inserted or mounted inside the cover 40. Clamping the element 70 may be particularly advantageous for embodiments in which the cover 40 has a more limited contact surface with the element 70 (e.g., embodiments including relatively large and/or multiple apertures) to prevent release of the element 70.
Referring back to fig. 1, an embodiment of a cover 40 is shown, the cover 40 including attachment points 44 configured for attachment to the patch 10, i.e., patch attachment points 44. In the present embodiment, the cover 40 is shown with two attachment points 44 arranged on opposite sides of the element 70. However, additional attachment points 44 may be provided at fixed locations along the attachment surface of patch 10. In an embodiment, the continuous attachment may extend continuously along the edge of the cover 40 to provide a continuous attachment surface with the patch 10. Thus, one skilled in the art will appreciate that providing more attachment points may enhance the attachment of the cover 40 to the patch 10.
In an embodiment, the attachment points 44 may be non-removably attached to the patch 10 to provide a secure attachment with the patch. For example, the attachment points 44 may be attached to the patch 10 by adhesive or by other suitable securing methods (e.g., welding, over-molding, etc.).
In an embodiment, the attachment points 44 may be removably attached to the patch 10 for easier mounting and dismounting of the element 70 to and from the patch 10. For example, the attachment points 44 may be provided with reusable mechanisms, such as hooks and loops. The removable attachment may provide a partially reusable embodiment of the patch assembly 1, for example, wherein the patch 10 may be disposable and the cover 40 is reusable, or the cover 40 may be disposable and the patch 10 is reusable. Advantageously, the patch 10 may be provided with the following attachment means: the attachment means are configured for mutual attachment with one or more corresponding attachment points 44 of the cover 40.
Referring back to fig. 1, an embodiment of the cover 40 is shown wherein the proximal portion 45 is disposed adjacent to the element 70, optionally with the element 70 spaced from the patch 10, thereby defining a gap between the element 70 and the patch 10. The gap may provide a space between the element 70 and the patch 10 to prevent the skin of the subject from squeezing the element 70, possibly resulting in separation of the patch 10 from the skin. In addition, the gap may allow the gas/liquid required for skin breathing to pass more easily, such as a "breathable" patch. In this way, the wearing comfort of the subject may be improved, which is particularly advantageous for applications requiring wearing the patch 10 for a long period of time.
In some preferred embodiments, the gap has a depth defined as the distance from the proximal skin-facing side of the element 70 to the distal element-facing side of the patch 10, the depth ranging from: at least 0.1mm up to 20.0mm; preferably 0.5mm to 15.0mm; more preferably 0.5mm to 10.0mm; even more preferably from 1.0mm to 5.0mm; even more preferably 1.5mm to 2.5mm; even more preferably 1.5mm to 2.5mm; even more preferably about 2.0mm. It will be appreciated that the optimal depth of the gap will depend on the size of the element 70, in particular the length of the element 70 along the patch 10, and the location of the patch 10 on the subject's skin. However, the ranges shown in the columns are considered suitable for the general patch assembly 1.
In an embodiment, the cover 40 may include breathing holes configured to allow gas and optionally liquid to pass therethrough, i.e., a "breathable" cover. In a preferred embodiment of the present invention,breathing holeMay be apertures or (micro) perforations provided on the surface of the cover 40. Typically, a plurality of such having the same size or different sizes are providedCalling a call Suction pipeThe holes, preferably breathing apertures, may be arranged in a specific shape or form to facilitate efficient passage of gas and/or liquid through specific areas or portions of the patch assembly 1. Advantageously, a hole (preferably an orifice) may be in fluid connection with the above-mentioned gap, such that a gas (optionally a liquid) may flow through the cover 40. In one example, this may enable gas exchange between the subject's skin and the exterior of the patch, so that moisture or condensation on the element 70 may be prevented. In another example, this may allow for the supply of a gas, such as air required for a battery housed within the patch assembly, such as on the element 70. Advantageously, the holes (preferably apertures) have a relatively small diameter so as not to substantially affect the material properties of the cover 40 or to form structural weak points that may cause the cover 40 to tear or wear more easily.
In a particular embodiment, a "breathable" cover may be formed by combining one or more apertures that cover the membrane 50 or include the membrane 50 disposed therein, the membrane 50 being selectively permeable to gas and/or impermeable to liquid. Optionally, such a membrane 50 may be composed of a material comprising one or more apertures. Embodiments of suitable membranes 50 are discussed further in this disclosure.
Fig. 5 illustrates an embodiment of a cover 40 including one or more extension members 46, the extension members 46 configured to determine the location of the holding space 42 in a distal direction from the one or more attachment points 44. The extension member may additionally ensure that the element 70 is maintained at a minimum distance from the subject's skin during movement of the subject. Advantageously, the extension member 46 is sufficiently rigid to resist the weight of the element 70 without undergoing complete deformation.
In certain embodiments, the extension member 46 also determines the depth of the gap between the element 70 and the patch 10. The provision of the extension member 46 thus provides a simple solution to ensure a minimum gap depth, according to the embodiments discussed in the present disclosure. In this way, the length of the extension member 46 may determine the three-dimensional dimensions of the gap, i.e., the depth, width, and length of the gap.
In some embodiments, the extension member 46 has a length defined as the distance from the attachment point 44 to the clamping component 41 or proximal portion 45 thereof, the length ranging from: at least 0.1mm up to 20.0mm; preferably 0.5mm to 15.0mm; more preferably 0.5mm to 10.0mm; even more preferably from 1.0mm to 5.0mm; even more preferably 1.5mm to 2.5mm; even more preferably 1.5mm to 2.5mm; even more preferably about 2.0mm. It will be appreciated that the optimal length of the extension member 46 will depend on the size of the element 70, in particular the length of the element 70 along the patch 10, and the location of the patch 10 on the subject's skin. However, the ranges shown in the columns are considered suitable for the general patch assembly 1.
Fig. 6 shows an embodiment of a cover 40 having an inner surface facing the element 70 and an opposite outer surface, wherein the inner surface is provided with a plurality of protrusions 47 extending from the inner surface, the protrusions 47 preferably forming a slidable contact with the element 70.
The protrusions 47 provide a space between the inner surface of the cover 40 and the element 70. In a general embodiment, the projection 47 may be configured to additionally limit/enable sliding movement of the element 70 within the cover 40, the element 70 being capable of sliding movement within the cover 40. The protrusions 47 may also reduce the size of the contact area between the adjacent surfaces of the cover 40 and the element 70, thereby reducing friction on the component surfaces when sliding in one direction within the holding space. Thus, the protrusions 47 may be configured to provide different flexibility and extensibility than the interior material of the cover 40. Further, the protruding portion 47 may serve as a "bumper" by absorbing an impact or preventing impact damage from the outside.
The projection 47 may have any geometry. The projection 47 shown in fig. 6 has a spherical shape, which, as will be appreciated, forms a preferred embodiment of the projection. However, other geometries are equally possible, such as cylinders, pyramids, spirals, etc.
With further reference to fig. 6, it is shown that protrusions may be provided on different portions of the cover 40; that is, the protrusion 47 on the inner surface of the distal end portion of the cover 40 is referred to as a distal protrusion 471; the protrusion 47 on the inner surface of the proximal portion of the cover 40 is referred to as a proximal protrusion 472; and a protrusion 47 on the inner surface of the lateral portion of the cover 40, referred to as a lateral protrusion 473. Each of these projections 47 has particular advantages in addition to those mentioned above, as will be discussed below. Although this embodiment exists, it should be understood that each of the mentioned protrusions 47 may be provided without the other mentioned protrusions 47 or may be provided in combination with the other mentioned protrusions 47. For example, only the proximal protruding portion 472, only the distal protruding portion 471, the proximal protruding portion 472, and the like are provided.
The distal tab 471 may also maintain a gap between the inner surface of the cover 40 and the element 70. This gap may ensure that oxygen flows to a cell (e.g., a zinc-air cell) that may otherwise be sealed by the cover 40.
The proximal protrusion 472 may also determine the depth of the gap between the element 70 and the patch 10. Thus, according to embodiments discussed in this disclosure, the provision of the extension member 46 provides a simple solution to ensure a minimum gap depth. In this way, the diameter of the proximal protrusion 472 may determine the three dimensional dimensions of the gap, i.e., the depth, width, and length of the gap. However, the proximal protrusion 472 may provide greater flexibility and extensibility, as opposed to the extension member 46 described above, and thus increase the depth of the gap with less impact on the deflection and extension of the cover 40.
The lateral protrusions 473 may additionally protect the element 70 against sudden impacts during use of the patch assembly 1 and/or allow easier handling of the patch, e.g. when inserting the element 70 or when adjusting the cover 40.
As will be further discussed in this disclosure, the element 70 may be provided with an element package 71, and in an embodiment, the element package 71 may be provided with at least one or more protrusions 47 according to the previously discussed embodiments. Accordingly, those skilled in the art will appreciate that similar advantages may be realized depending on the parameters and locations of the protrusions 47 that are provided. In another embodiment, a plurality of protrusions 47 may be provided on the cover 40 and the element 70, the plurality of protrusions 47 being configured to achieve a combined effect related to further limiting/achieving slidable movement of the element 70 within the cover 40.
In some embodiments, the protrusions 47 have a height, or in the case of a spherical embodiment, the protrusions 47 have a diameter, ranging from: at least 0.1mm up to 2.0mm; preferably 0.2mm to 1.9mm; more preferably 0.3mm to 1.8mm; even more preferably 0.4mm to 1.7mm; even more preferably 0.4mm to 1.6mm; even more preferably 0.5mm to 1.5mm; even more preferably 0.6mm to 1.4mm; even more preferably 0.7mm to 1.3mm; even more preferably 0.8mm to 1.2mm; even more preferably 0.9mm to 1.1mm; even more preferably about 1.0mm. It will be appreciated that the optimal height/diameter of the tab 47 depends on the size of the element 70, in particular the height, length and width of the element 70, and the location of the patch 10 on the skin of the subject. However, the ranges shown in the columns are considered suitable for the general patch assembly 1.
In particular embodiments, different protrusions 47 may have different material properties depending on the location in the cover 40. In an exemplary embodiment, the proximal protrusion 472 may be made more rigid to provide improved pressure resistance and better maintain the size of the gap, while the distal protrusion 471 or lateral protrusion 473 may be made more flexible to provide improved impact resistance.
In an embodiment, the cover 40 may include an aperture 48, the aperture 48 configured for accessing and/or inserting the element 70 or a portion of the element 70. The diameter of the aperture 48 may be adjustable, preferably extendable, to allow for easier access or insertion. Advantageously, apertures may be provided on the distal and/or proximal portions 45 of the cover 40 to avoid having structural weaknesses in the lateral portions of the cover 40. However, embodiments with apertures provided on the lateral portions of the cover 40 are conceivable, as long as the pressing force exerted by the clamping member 41 is not impaired, possibly resulting in an accidental release of the element 70.
Referring to fig. 7, an embodiment of the cover 40 is shown in which the aperture 48 is provided on a distal portion of the cover 40. The large diameter of the aperture 48 may allow for easier access to the element 70, such as insertion or access to a portion thereof, such as a screen or other user input device. The clip component 40 may include an extension member that retains a portion of the distal portion of the element 70 such that the element 70 may be grasped within the cover 40 to prevent accidental release. Advantageously, the clamping member 40 applies a proximal compressive force to the element 70.
Referring to fig. 8, an embodiment of the cover 40 is shown in which the aperture 48 is provided on a lateral portion of the cover 40. The lateral position of the aperture 48 may allow for easy lateral insertion of the element 70 without compromising the integrity of the cover 40. Advantageously, the attachment points 44 and optional extension members 46 adjacent the aperture 48 may be reinforced to ensure that the cover 40 does not deform during insertion of the element 70. For example, the material of the cover may be made stiffer around the orifice 48.
Referring to fig. 9, an embodiment of the cover 40 is shown in which a plurality of apertures 48 are provided on the distal portion of the cover 40. In the illustrated embodiment, two apertures 48 are provided on the distal portion, but it should be understood that the cover 40 may be readily adapted to be configured with more than two apertures 48, such as three, four, or more apertures 48. Advantageously, the plurality of apertures may be arranged in a particular shape or form, for example to allow easier access to particular portions of the element 70.
As also shown in fig. 9, the proximal portion of the cover 40 may be separated by additional support members including attachment points 44 and/or extension members 46. This allows the proximal portion of the cover 40 to be divided into two or more portions, so that the stability and/or rigidity of the cover 40 can be further improved. In the illustrated embodiment, one such support member is centrally disposed below the element 70, but it should be understood that the cover 40 may be readily adapted to be configured with more than one support member, such as three, four or more, which may be disposed at different locations on the proximal portion of the cover 40.
In an embodiment, the patch assembly 1 may comprise a membrane 50, the membrane 50 being at least partially breathable. The membrane 50 may be selectively permeable to air, for example, only to air, or specifically only to oxygen/carbon dioxide, or the membrane may be generally permeable to allow air to pass freely. Such a membrane may thus allow the passage of gases required for skin breathing, for example, as a "breathable" patch, to prevent condensation on patch 10 and/or element 70.
In general, the membrane 50 may comprise holes or (micro) perforations configured to allow gas and optionally liquid to pass therethrough, i.e. a "breathable" membrane. Typically, a plurality of holes are provided, which may be arranged in specific groups or shapes to facilitate efficient passage of gas and/or liquid through the patch assembly 1. In a preferred embodiment, the aperture is configured to allow air to pass freely or selectively therethrough, but to prevent liquid from passing therethrough.
In an embodiment, the membrane 50 may have one or more pores with a pore size of: at least 0.1 μm and at most 10.0 μm; preferably 0.1 μm to 9.0 μm; more preferably 0.1 μm to 8.0 μm; even more preferably 0.1 μm to 7.0 μm; even more preferably 0.1 μm to 6.0 μm; even more preferably 0.1 μm to 5.0 μm; even more preferably 0.1 μm to 4.0 μm; even more preferably 0.1 μm to 3.0 μm; even more preferably 0.2 μm to 3.0 μm; even more preferably 0.3 μm to 3.0 μm; for example 0.5 μm, 1.0 μm, 1.5 μm, 2.0 μm or 2.5 μm.
In one embodiment, the membrane 50 may have the following pore densities: at least 10 5 Individual holes/cm 2 Up to 10 9 Individual holes/cm 2 The method comprises the steps of carrying out a first treatment on the surface of the Preferably 10 6 Individual holes/cm 2 Up to 10 8 Individual holes/cm 2 . It will be appreciated that the optimum pore size and pore density will depend on the desired air flow rate, which in turn will depend on the application and location of the patch 10 on the skin of the subject. However, the ranges shown in the columns are considered to be suitable for the general patch assembly 1.
In one embodiment, the film 50 may have a thickness of: at least 1 μm and at most 500 μm; preferably from 2 μm to 400 μm; more preferably 5 μm to 300 μm; even more preferably from 10 μm to 200 μm.
The membrane 50 will typically be provided within the patch assembly 1 at a location where gas is required to pass through. Thus, a film may be provided between the patch 1 and the element 70 and partially cover the element 70. For example, the membrane 50 may be disposed within a gap as described above, or the membrane 50 may be disposed around the element 70 and at least partially surround the element 70. Exemplary embodiments of the membrane 50 will be discussed below. It should be appreciated that these embodiments can be readily extended or combined.
Referring to fig. 10, an embodiment of the cover 40 is shown wherein the membrane 50 is disposed within the space between the patch 10 and the element 70 and on the proximal portion of the cover 40. Such proximal membrane 50 may be connected to an edge of the cover 40, preferably such proximal membrane 50 may be connected to an edge of the cover 40 on the proximal portion 45 of the cover 40. Alternatively, the proximal membrane 50 may be connected to other portions of the cover 40, such as to the attachment points 44 and/or the extension members 46 of the cover 40. However, providing some space between patch 10 and membrane 50, and/or between element 70 and membrane 50, may allow gas and/or liquid to more easily pass through, thereby achieving adequate skin ventilation under element 70.
Fig. 10 also shows that another membrane 50 is provided in the aperture 48 provided on the distal end portion of the cover 40. Such distal membrane 50 may be attached to the edge of the cover 40, preferably on the distal portion of the cover 40 to the edge of the cover 40. The distal membrane 50 may enable gas exchange between the holding space 42 and the outside air while protecting the element 70 from, for example, outside liquid that may leak into the holding space 42. In a preferred embodiment, the distal membrane 50 may be provided with ventilation holes as discussed in the disclosure above. It should be appreciated that while the distal membrane 50 and the proximal membrane 50 are shown in a single preferred embodiment, the cover can be readily adapted to include the membrane on only one side, such as including only the distal membrane 50 or including only the proximal membrane 50. However, the illustrated embodiment having both distal and proximal membranes 50, 50 has additional benefits in that gas (e.g., air) is allowed to pass through the membrane 50 away from and/or to the sides of the cover 40 while protecting the element 70 from water or other liquids. This will for example allow a better flow of gas through the cover, for example as described above, thereby providing improved breathability relative to the skin and/or providing oxygen to allow operation of a suitable battery.
Referring to fig. 11, an embodiment of the cover 40 is shown in which the membrane 50 is disposed on a lateral portion of the cover 40. Such a lateral membrane 50 may be connected to an edge of the cover 40, preferably on a lateral portion of the cover 40 to an edge of the cover 40. Similar to the membranes described above, the lateral membranes 50 may enable gas exchange between the holding space 42 and the outside air. However, the lateral membrane 50 has the additional benefit that the lateral membrane 50 is not blocked from air when the subject covers the distal portion of the cover 40, for example when lying down, or another object covers the distal portion of the cover 40.
Referring to fig. 12, an embodiment of cover 40 is shown in which membrane 50 is disposed around element 70 to surround element 70. As shown, the membrane 50 may be connected to the cover 40 via a connecting member extending from the cover 40 towards the element 70. Alternatively, the membrane 50 may be directly connected to the cover 40 such that the membrane 50 is fully integrated within said cover 40. Such an embodiment is advantageous for completely protecting the element 70 from e.g. liquids or condensation. It should be appreciated that embodiments in which the membrane 50 only partially encloses the element 70 are also contemplated. For example, in the embodiment shown in fig. 7, the cover 40 is provided with a distal aperture 48, and the membrane 50 may be provided at a distal portion thereof.
In another embodiment, the patch assembly 1 may comprise a plurality of membranes 50, for example a first membrane disposed between the patch 10 and the element 70, the first membrane being partially permeable to liquid, and a second membrane disposed between the cover 40 and the element 70, the second membrane being impermeable to liquid. The overlapping of the films may allow gases and/or liquids (e.g., sweat) from the skin to selectively flow to the outside.
In a particular embodiment, the membrane 50 may be constituted by a modified section of the cover 40 or replaced by a modified section of the cover 40, preferably thinner than the average wall thickness of the cover and provided with a plurality of holes or micro-holes (micro-perforations) limited to said modified section. An advantage of this embodiment is that a continuous cover 40 may be provided to prevent the presence of structural weaknesses that may occur where the cover 40 transitions to the film 50. For example, in one embodiment, the cover may be constructed of silicone rubber having a thin section of notched silicone rubber that effectively forms a film on the cover 40. It should be understood that other cover materials are also considered suitable for such embodiments.
In one embodiment, the material of cover 40 has a hardness defined by a Shore A hardness value measured according to ISO 7619-1, the hardness being: at least 10 shore a up to 90 shore a; preferably 20 shore a to 80 shore a; more preferably 30 shore a to 70 shore a; even more preferably 30 shore a to 60 shore a; for example 40 shore a or 50 shore a. It will be appreciated that the optimum hardness will depend on the adhesion or slidability of the desired embodiment. In general, the lower the hardness value, the higher the adhesion of the material and the lower its slidability. One skilled in the art can select a material suitable for its intended purpose.
In one embodiment, the material of cover 40 has a tensile strength measured according to ISO 37 type 1, the tensile strengthThe strength is: at least 5.0N/mm 2 Up to 11.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Preferably 5.5N/mm 2 Up to 10.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the More preferably 6.0N/mm 2 Up to 10.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 6.5N/mm 2 Up to 9.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.0N/mm 2 Up to 9.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.5N/mm 2 Up to 8.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably about 8.0N/mm 2 For example 8.2N/mm 2 Or 8.5N/mm 2 . It will be appreciated that the optimal tensile strength depends on the rigidity or extensibility of the desired embodiment. One skilled in the art can select a material suitable for its intended purpose.
In one embodiment, the material of the cover layer 40 has an elongation defined by the maximum elongation at break measured according to ISO 37 type 1, the elongation being: at least 100% and at most 800%; preferably 200% to 800%; more preferably 300% to 750%; even more preferably 350% to 750%; even more preferably 400% to 700%; even more preferably 450% to 650%; even more preferably 500% to 600%, for example 550% or 590%. It will be appreciated that the optimal elongation depends on the rigidity or extensibility of the desired embodiment. One skilled in the art can select a material suitable for its intended purpose.
In one embodiment, the material of cover 40 has a tear strength measured according to ASTM D624 BN, which is: at least 20N/mm up to 30N/mm; preferably 21N/mm to 29N/mm; more preferably 21N/mm to 28N/mm; even more preferably 22N/mm to 27N/mm; even more preferably 23N/mm to 26N/mm; for example 24N/mm or 25N/mm. It will be appreciated that the optimum tear strength depends on the rigidity or extensibility of the desired embodiment. One skilled in the art can select a material suitable for its intended purpose.
In one embodiment, the material of the cover 40 comprises, preferably consists of: silicone Rubber (SR), more preferably Liquid Silicone Rubber (LSR); thermoplastic elastomers (TPE), more preferably Thermoplastic Polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic Polyamide (TPA); thermoplastic vulcanizates (TPV); crosslinkable elastomers, more preferably Isoprene Rubber (IR), nitrile rubber (NBR), styrene-butadiene rubber (SBR), ethylene-propylene-diene rubber (Ethlylene Propylene Diene Monomer) (EPDM), fluorocarbon-based fluoroelastomer materials (FKM), polybutadiene rubber (BR); and/or combinations of the above.
In an embodiment, the cover 40 may be transparent to allow for easier visual tracking of the position of the element 70. However, it is also contemplated that pigments may be provided to add color to the cover 40 depending on the intended application.
For convenience and clarity, the cover 40 is described in this disclosure as a single layer composed of a single material. While such a simple embodiment is presented, it is to be understood that the cover 40 may be multi-layered and/or may comprise a combination of materials, depending on the rigidity or extensibility of the desired embodiment. For example, for the aforementioned advantages, the multi-layer cover 40 may have an outer layer facing the exterior space that is stiffer to better resist external forces and an inner layer facing the element 70 that is more flexible or stretchable, or vice versa. In another example, the multi-layered cover 40 may be composed of different materials at specific portions of the cover 40. For example, the corners may be made stiffer, while the side walls in contact with the elements 70 may be more flexible or stretchable, and vice versa; for example, the lateral portions of the cover 40 may be made stiffer, while the distal and proximal portions may be more flexible or stretchable, and vice versa; for example, the clamping component 41, attachment points 44, extension members, and/or protrusions 47 may be made of the same or different materials depending on their desired characteristics. One skilled in the art can select a suitable combination of materials and/or a suitable combination of layers for their intended purpose.
In an embodiment, the patch assembly 1 may comprise a component package 71 at least partially surrounding the component 70. The component enclosure 71 may provide a protective barrier to protect and/or secure the component 70 or portions of the component 70 within the cover 40. In addition, the element package 71 may be composed of the following materials: the material provides a coefficient of friction suitable for achieving selected embodiments of the patch assembly 1. For example, the element package 71 may have a coefficient of friction that enables sliding movement of the element 70 that would otherwise be difficult or impossible with the outer material of the element 70. Alternatively, in another embodiment of the component package, the protective package 71 may have a coefficient of friction that adheres to the cover 40. Thus, it will be appreciated by those skilled in the art that the component package 71 may be rigid, flexible, or between the two, depending on the implementation. In addition, the element package 71 may be composed of a rigid portion (e.g., a corner portion) and a flexible portion (e.g., along a sidewall). It should be appreciated that these embodiments can be readily extended or combined.
Referring to fig. 15, an embodiment is shown in which a component enclosure 71 is disposed in the holding space 42 between the cover 40 and the component 70 to completely enclose the component 70. It should be understood that embodiments are also contemplated in which the membrane 50 only partially encloses the element 70, e.g. an element package 71 enclosing lateral portions of said element 70 may be sufficient in case the clamping member 41 exerts a compressive force only in a lateral direction. The same is true for the distal/proximal compressive force.
Referring to fig. 16, an embodiment is shown in which the film is integrated into the component package, thereby forming a film component package 75. It should be appreciated that the membrane element package 75 may be provided in the same embodiments as described above for the element package 75 with added membrane. For example, the membrane element package 75 may only partially surround the element 70 with a membrane, such as only a distal or proximal portion of the element 70, or completely surround the element 70 with a membrane.
In one embodiment, the material of the component package 71 has a hardness defined by a Shore A hardness value measured according to ISO 7619-1, the hardness being: at least 10 shore a up to 90 shore a; preferably 20 shore a to 80 shore a; more preferably 30 shore a to 70 shore a; even more preferably 30 shore a to 60 shore a; for example 40 shore a or 50 shore a.
In one embodiment, the material of the element package 71 has a tensile strength measured according to ISO 37 type 1, the tensile strength being: at least 5.0N/mm 2 Up to 11.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Preferably 5.5N/mm 2 Up to 10.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the More preferably 6.0N/mm 2 Up to 10.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 6.5N/mm 2 Up to 9.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.0N/mm 2 Up to 9.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.5N/mm 2 Up to 8.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably about 8.0N/mm 2 For example 8.2N/mm 2 Or 8.5N/mm 2 。
In one embodiment, the material of element package 71 has an elongation defined by the maximum elongation at break measured according to ISO 37 type 1, which is: at least 100% and at most 800%; preferably 200% to 800%; more preferably 300% to 750%; even more preferably 350% to 750%; even more preferably 400% to 700%; even more preferably 450% to 650%; even more preferably 500% to 600%, for example 550% or 590%.
In one embodiment, the material of the component package 71 has a tear strength measured according to ASTM D624 BN, which is: at least 20N/mm up to 30N/mm; preferably 21N/mm to 29N/mm; more preferably 21N/mm to 28N/mm; even more preferably 22N/mm to 27N/mm; even more preferably 23N/mm to 26N/mm; for example 24N/mm or 25N/mm.
In one embodiment, the component package 71 comprises, preferably consists of: silicone Rubber (SR), more preferably Liquid Silicone Rubber (LSR); thermoplastic elastomers (TPE), more preferably Thermoplastic Polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic Polyamide (TPA); thermoplastic vulcanizates (TPV); crosslinkable elastomers, more preferably Isoprene Rubber (IR), nitrile rubber (NBR), styrene-butadiene rubber (SBR), ethylene-propylene-diene rubber (EPDM), fluorocarbon-based fluoroelastomer material (FKM), polybutadiene rubber (BR); and/or combinations of the above.
According to alternative embodiments, the element package 71 may comprise higher hardness, stiffness, tensile strength, rigidity than the above mentioned values, e.g. an increase of 20% or more, 50% or more, 100% or more, at least 1-fold higher, at least 4-fold higher relative to the above mentioned material of the patch assembly 1 and/or the material of the cover 40 and/or the material of the patch 10. According to such embodiments, the material may comprise a thermoplastic material, a thermosetting material, a metal … …, and/or the material may be composed of a thermoplastic material, a thermosetting material, a metal … …. Similarly, the material of the element package 71 may include reduced elasticity and/or flexibility relative to the material of the cover 40 and/or the patch 10. For example, 20% or more, 50% or more, 100% or more, at least 1-fold, at least 4-fold less when compared to the flexibility and/or elasticity of the above-mentioned material of the patch assembly 1 and/or the material of the cover 40 and/or the material of the patch 10. Preferably, the material provides rigidity and strength that allows the protective element 70 to resist, for example, sudden impact forces. Preferably, the component package 71 is configured to protect the component 70 from moisture ingress. According to one embodiment, the component 70 includes a component package 71.
For convenience and clarity, patch 10 is referred to in this disclosure as a single layer composed of a single material. Despite these simple embodiments, patch 10 may in practice be generally multi-layered, i.e., comprising multiple layers of the same material or different materials. Thus, each layer may be defined by the same material properties or different material properties depending on its purpose.
In an embodiment, the closest positioning patch layer facing the skin of the subject may be configured to: adhering to the skin tissue of the subject, optionally in the presence of an adhesive, so that the patch 1 can remain adhered without detachment during physical movement. However, any additional distally-located patch layers may not require such skin adhesion properties and thus may be configured for other structural purposes. For example, one or more distally located patch layers may be configured to have a particular rigidity, flexibility, or extensibility, depending on the application and placement of the patch assembly on the subject's body. For example, medical applications may require different material parameters than sports applications. One skilled in the art can select a material suitable for its intended purpose. It should be appreciated that these embodiments can be readily extended or combined.
In an embodiment, the extension and flex traces may be provided in the patch, preferably between or across different layers of a multi-layer patch. As used herein, stretch and flex traces refer to patch segments having increased extensibility and flexibility as compared to other portions of the same patch 10. This may further improve wearing comfort and/or prevent the patch 10 from disengaging during movement.
In a preferred embodiment, the extension and flex traces may provide space for wired connections, such as electrical leads 81 described in this disclosure, for connecting two or more separate electronic components. Thus, the extension trace and the flex trace are preferably disposed between the electronic element (e.g., sensor) and its corresponding electrode or receiving element. A further advantage is that this allows the element 70 to be mounted away from its corresponding electrode such that the element 70 and the electrode do not substantially overlap. This may be advantageous for the extension and/or retraction properties of the cover 40 and/or patch 10, and for preventing release of the element 70. Similar advantages may be provided for embodiments including other elements 80, as discussed further below.
In one embodiment, the material of patch 10 has a hardness defined by a Shore A hardness value measured according to ISO 7619-1, the hardness being: at least 10 shore a up to 90 shore a; preferably 20 shore a to 80 shore a; more preferably 30 shore a to 70 shore a; even more preferably 30 shore a to 60 shore a; for example 40 shore a or 50 shore a.
In one embodiment, the material of patch 10 has a tensile strength measured according to ISO 37 type 1, the tensile strength being: at least 5.0N/mm 2 Up to 11.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Preferably 5.5N/mm 2 Up to 10.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the More preferably 6.0N/mm 2 Up to 10.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 6.5N/mm 2 Up to 9.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.0N/mm 2 Up to 9.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.5N/mm 2 Up to 8.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably about 8.0N/mm 2 For example 8.2N/mm 2 Or 8.5N/mm 2 。
In one embodiment, the material of patch 10 has an elongation defined by the maximum elongation at break measured according to ISO 37 type 1, which is: at least 100% and at most 800%; preferably 200% to 800%; more preferably 300% to 750%; even more preferably 350% to 750%; even more preferably 400% to 700%; even more preferably 450% to 650%; even more preferably 500% to 600%, for example 550% or 590%.
In one embodiment, the material of patch 10 has a tear strength measured according to ASTM D624 BN, which is: at least 20N/mm up to 30N/mm; preferably 21N/mm to 29N/mm; more preferably 21N/mm to 28N/mm; even more preferably 22N/mm to 27N/mm; even more preferably 23N/mm to 26N/mm; for example 24N/mm or 25N/mm.
In one embodiment, patch 10 comprises, preferably consists of, the following materials: silicone Rubber (SR), more preferably Liquid Silicone Rubber (LSR); thermoplastic elastomers (TPE), more preferably Thermoplastic Polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic Polyamide (TPA); thermoplastic vulcanizates (TPV); crosslinkable elastomers, more preferably Isoprene Rubber (IR), nitrile rubber (NBR), styrene-butadiene rubber (SBR), ethylene-propylene-diene rubber (EPDM), fluorocarbon-based fluoroelastomer material (FKM), polybutadiene rubber (BR); and/or combinations of the above.
In an embodiment, the cover 40, and extending to the patch assembly 1, may be configured to hold a plurality (i.e., more than one, such as two) of the elements 70, 80. These elements may be connected such that they can interact with each other. In such an embodiment, a wired connection, such as an electrical lead 81, may be provided to connect at least two of the elements 70, 80. Alternatively, the elements may be configured to interact in a wireless manner, such as via bluetooth, such that a wired connection is not required. It should be appreciated that the cover 40 may be readily adapted to hold more than two elements, such as three elements or four elements, but for brevity only embodiments comprising two elements 70, 80 will be discussed below.
Referring to fig. 14, an embodiment of the patch assembly 1 is shown, wherein a second element 80 is arranged between the patch 10 and the further layer 11 of the patch. It is also shown that the element 80 is electrically connected to the element 70 by electrical leads 81, and that the element 80 comprises 2 electrodes arranged at the proximal side of the patch facing the subject's skin. For example, element 80 may be a sensor configured to sense a physiological state of the subject, and optionally, after sensing, transmit raw sensor data or processed sensor data to element 70 for further processing via electrical leads 81. Advantageously, extension traces and flex traces may be provided between the electronic component and the electrodes.
Referring to fig. 13, fig. 13 shows the element 80 being integrated into the patch 10; the element 80 forms a non-removable element of the patch 10. Such an embodiment may be suitable for a disposable patch 10, particularly where the patch 10 and element 80 are discarded after use, while the element 70 may be removed and transferred into an unused patch for additional use, optionally provided with another element 80.
Referring to fig. 18, another embodiment of a patch assembly 1 is shown in which a second element 80 is provided in a separate cover assembly in a similar manner to element 70. The element 80 is shown as a removable component of the patch assembly 1 as well. In this embodiment, both the element 70 and the element 80 may be removable or replaceable from the patch 10 for additional use. As further shown, the element 70 may interact with the element 80 via electrical leads 81 embedded in the patch 10, for example, to exchange data.
It is further clear that according to some preferred embodiments, similar to the above-described embodiments, the cover 40 is configured as a separate and/or distinct element from the patch 10. It is thus clear that the cover 40 and the patch 10 are both structurally and functionally separate and distinct elements, although each may be implemented as a single-layer or multi-layer component. The patch 10 of the patch assembly 1 is configured to provide adhesion to the skin of a subject. The cover 40 of the patch assembly 1 is configured to at least partially enclose the element 70. Preferably, the cover 40 is not configured to be attached to the skin of the subject to which the patch 10 is attached. In other words, according to such an embodiment, when in use, the patch assembly 1 comprises a cover 40 and a patch adhered to the skin of a subject, the cover 40 being a different or separate element than the patch 10, the cover 40 at least partially surrounding the element 70, the cover 40 not adhering to the skin of the subject, which means that the cover does not directly adhere, adhere and/or contact the skin of the subject.
Preferably, similar to that shown in the above embodiments, only the cover 40 is configured to clamp the element 70 when the element 70 is mounted inside the cover 40. In other words, according to such an embodiment, the following patch assembly 1 is provided: in this patch assembly, only the cover 40 holds the element 70. Obviously, in such an embodiment, it is preferred that only the cover 40 is configured to apply a compressive force to the element 70. In other words, according to such an embodiment, the following patch assembly 1 is provided: in this patch assembly, only the cover 40 applies a compressive force to the element 70, thereby clamping the element 70 at least partially surrounded by the cover 40. This therefore means that according to this preferred embodiment the patch assembly does not comprise any other elements that function to clamp the component by: a compressive force is applied to the element 70 to attach the element 70 to the interior of the cover 40. More specifically, according to such embodiments, patch 10 does not clamp element 70 inside cover 40 or cooperate with cover 40 to clamp element 70 inside cover 40. Similarly, according to such an embodiment of the patch assembly 1, the patch 10 does not apply a compressive force to the element 70 or cooperate with the cover 40 to apply a compressive force to the element 70. The patch 10 is configured to not clamp the element 70 with the element 70 mounted inside the cover 40. In other words, according to this embodiment, the patch 10 is configured not to apply a pressing force to the element 70 in the case where the element 70 is mounted inside the cover 40.
Preferably, similar to the embodiment shown above, patch 10 is configured to: the element 70 is not contacted in case the element 70 is mounted inside the cover 40. In other words, the patch assembly 1 includes the following patches 10: the patch 10 does not contact the element 70 in the case where the element 70 is mounted inside the cover 40. Similar to the above-described embodiments, the cover 40 comprises, for example, a proximal or lower portion 45, which proximal or lower portion 45 is configured to at least partially cover the proximal or lower side of the element 70, or in other words, the side of the element 70 closest to the patch 10 of the patch assembly 1. It is therefore apparent that, in this way, the lower portion 45 of the cover 40 defines a gap between the element 70 and the patch 10, similar to that described above, according to a specific embodiment, preferably the lower portion 45 of the cover 40 ensures that a space or channel is created for easier passage of the skin-breathing gas or liquid, or that the element 70 does not contact the patch 10 or the skin. Similar to the above-described embodiments, preferably the cover 40 comprises at least one pair of clamping members 41 arranged on opposite sides of the element 70, whereby each of such pairs of clamping members 41 comprises a lower portion 45 of the cover 40, or a portion thereof, arranged between the element 70 and the patch 10.
It is further evident that according to an embodiment of the patch assembly 1, such as the embodiment shown in the drawings, the cover 40 comprises at least one pair of clamping members 41 at opposite sides of the element 70. It is further evident that according to this embodiment, each of such pairs of clamping members 41 preferably comprises a lower portion 45 arranged between the element 70 and the patch 10. It is further evident that according to this embodiment such pairs of clamping members 41 are arranged on opposite sides of the element 70, more specifically, that a pair of clamping members 41, for example a cover 40, is provided on opposite sides of the element 70 along the lateral direction L. In other words, the pair of clamping members 41 of the cover 40 are arranged on opposite sides of the element 70 in a direction parallel or substantially parallel to the planar patch 10 of the patch assembly 1. In other words, in the orientation shown in the figures, a pair of clamping members 41 are positioned laterally to the sides, or in other words, to the left and right opposite sides of the element 70. It is clear that according to such an embodiment, the cover 40 may comprise two pairs of such clamping members 41 located at opposite sides of the element 70, for example, for an element 70 having a rectangular or substantially rectangular shape, a first pair of clamping members 41 being located at a first pair of opposite sides of the perimeter of the rectangular shape and a second pair of clamping members 41 being located at the other pair of opposite sides of the perimeter of the rectangular shape, when seen from a top view. Obviously, according to this embodiment, the cover 40 comprises: at least two flexible and stretchable clamping members 41 located at opposite sides of the element 70 with the element 70 mounted, wherein the at least two flexible and stretchable clamping members 41 are arranged such that the at least two flexible and stretchable clamping members 41 cooperate to apply a compressive force to attach the element 70 to the interior of the cover 40 between the at least two flexible and stretchable clamping members 41. Obviously, there may be further alternative embodiments, wherein the cover 40 comprises at least two flexible and stretchable clamping members 41, preferably said at least two flexible and stretchable clamping members 41 being arranged at opposite sides of the element 70 in case the element 70 is mounted. Similarly, according to the above embodiment, it is evident that there may be further embodiments, wherein the cover 40 comprises at least two flexible and stretchable clamping members 41, the at least two flexible and stretchable clamping members 41 being configured to: a pressing force is applied to the element 70 with the element 70 mounted between the at least two clamping members 41.
Preferably, as illustrated by the above embodiments, the cover 40 and more specifically the clamping member 41 of the cover is constituted by a single piece element. While such an embodiment of the cover may be implemented, for example, as a single-layer or multi-layer element, it is clear that such a cover 40, and more particularly the clamping member 41 of the cover, is not constituted by different elements of the patch assembly 1 or part thereof. In other words, it is apparent that the cover 40 partially encloses the component 40, preferably as a monolithic element, at opposite sides of which the component 40 is partially enclosed with a pair of clamping members 41. According to such an embodiment, the cover, and more specifically the clamping member 41, does not comprise any other element or portion thereof, such as the patch 10 or portion thereof, or any other element of the patch assembly 10, such that the cover is capable of partially enclosing and clamping the element 70 within the cover 40 by applying a compressive force thereto. According to such an embodiment, it is thus preferred that only the cover 40 and more particularly only the clamping part 41 of the cover applies a pressing force to the element to attach the element to the interior of the cover 40.
It is further clear that in the context of the present description "clamping" or "gripping" shall be interpreted as fastening or holding with a clamping device, wherein the clamping device is a device preferably comprising at least two of the following clamping elements: the clamping members are configured to exert a compressive force on something when the two clamping members are pushed and pulled closer together.

Claims (15)

1. A flexible and stretchable cover, the cover (40) being configured for attachment to a patch (10) and at least partially surrounding an element (70), wherein the cover (40) comprises at least one flexible and stretchable clamping member (41), the clamping member (41) being configured to:
-clamping the element (70) with the clamping member (41) in contact with the element (70) mounted inside the cover (40); and
-applying a pressing force to the element (70) thereby attaching the element (70) to the interior of the cover (40).
2. Cover according to claim 1, wherein the clamping member (41) is configured to clamp the element (70) in such a way that the clamping member (41) can be in sliding contact with the element (70) mounted inside the cover (40).
3. The cover (40) according to any one of the preceding claims, wherein:
-the cover (40) is configured to be attached to a patch (10) at one or more attachment points (44); and
-the patch (10) is configured to be attached to the skin of a subject;
-and optionally, the cover (40) is configured as a separate and/or distinct element from the patch (10);
-and optionally, the cover (40) is not configured for attachment to the skin of a subject;
-and optionally, only the cover (40) is configured to clamp the element (70) with the element (70) mounted inside the cover (40);
-and optionally, only the cover (40) is configured to apply a pressing force to the element (70);
-and optionally, the patch (10) is configured to not clamp the element (70) with the element (70) mounted inside the cover (40);
-and optionally, the patch (10) is configured to not apply a compression force to the element (70) with the element (70) mounted inside the cover (40);
-and optionally, the patch (10) is configured not to contact the element (70) if the element (70) is mounted inside the cover (40).
4. The cover (40) according to any one of the preceding claims, wherein:
-at least one of the clamping members (41) is configured to apply a pressing force to the element (70) according to at least one of the following options:
-along at least one direction;
-along a plurality of directions;
-inwardly along at least a portion of the outer surface of the element (70);
-and optionally wherein the cover (40) is constituted by a monolithic element;
-and optionally wherein the cover (40) comprises at least two flexible and stretchable clamping members (41);
-and optionally wherein the cover (40) comprises at least two flexible and stretchable clamping members (41), said at least two flexible and stretchable clamping members (41) being arranged on opposite sides of the element (70) when the element (70) is mounted;
-and optionally wherein the cover (40) comprises at least two flexible and stretchable clamping members (41), the at least two flexible and stretchable clamping members (41) being configured to: applying a compressive force to the element (70) with the element (70) mounted between the at least two flexible and stretchable clamping members (41);
-and optionally wherein the cover (40) comprises: at least two flexible and stretchable clamping members (41) located at opposite sides of the element (70) with the element (70) mounted, wherein the at least two flexible and stretchable clamping members (41) are arranged such that the at least two flexible and stretchable clamping members (41) cooperate to apply a compressive force to attach the element (70) to an interior of the cover (40) between the at least two flexible and stretchable clamping members (41).
5. The cover (40) according to any one of the preceding claims, wherein the cover comprises a material defined by at least one of the following parameters:
-a hardness of: at least 10 shore a up to 90 shore a; preferably 20 shore a to 80 shore a; more preferably 30 shore a to 70 shore a; even more preferably 30 shore a to 60 shore a;
-a tensile strength of: at least 5.0N/mm 2 Up to 11.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Preferably 5.5N/mm 2 Up to 10.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the More preferably 6.0N/mm 2 Up to 10.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 6.5N/mm 2 Up to 9.5N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.0N/mm 2 Up to 9.0N/mm 2 The method comprises the steps of carrying out a first treatment on the surface of the Even more preferably 7.5N/mm 2 Up to 8.5N/mm 2 ；
-a maximum elongation of: at least 100% and at most 800%; preferably 200% to 800%; more preferably 300% to 750%; even more preferably 350% to 750%; even more preferably 400% to 700%; even more preferably 450% to 650%; even more preferably 500% to 600%; and/or
-tear resistance, said tear resistance being: at least 20N/mm up to 30N/mm; preferably 21N/mm to 29N/mm; more preferably 21N/mm to 28N/mm; even more preferably 22N/mm to 27N/mm; even more preferably 23N/mm to 26N/mm.
6. The cover (40) according to any one of the preceding claims, wherein the material of the cover comprises, preferably consists of: silicone Rubber (SR), more preferably Liquid Silicone Rubber (LSR); thermoplastic elastomers (TPE), more preferably Thermoplastic Polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic Polyamide (TPA); thermoplastic vulcanizates (TPV); crosslinkable elastomers, more preferably Isoprene Rubber (IR), nitrile rubber (NBR), styrene-butadiene rubber (SBR), ethylene-propylene-diene rubber (EPDM), fluorocarbon-based fluoroelastomer material (FKM), polybutadiene rubber (BR); and/or combinations of the above.
7. A cover assembly configured for attachment to a patch (10), the cover assembly comprising a cover (40) according to any one of the preceding claims, wherein the cover assembly further comprises an element (70) mounted inside the cover (40) by at least one flexible and stretchable clamping member (41).
8. The cover assembly according to claim 7, wherein the cover (40), preferably the at least one flexible and stretchable clamping member (41):
-in direct contact with said element (70) on at least a portion of its inner surface; and/or
-providing one or more inward protrusions (47) in direct contact with the element (70), wherein optionally the inward protrusions (47) are dimensioned to: the extensibility and/or flexibility at the location of direct contact with the clamping member (41) is increased.
9. The cover assembly according to claim 7 or 8, wherein the at least one flexible and stretchable clamping member (41) is configured such that: the material of the clamping member (41) in contact with the element (70) is slidable relative to the element (70) in the event of encountering a change caused by flexing and/or stretching of the cover (40).
10. A patch assembly (1) configured for attachment to the skin of a subject, the patch assembly (1) comprising:
-at least one cover assembly according to any one of claims 7 to 9, and
a patch (10) configured for removable attachment to the skin of the subject, at least one of the cover assemblies being attached to the patch (10) by the cover (40) of the cover assembly,
and optionally wherein the element (70) comprises and/or consists of one or more of:
-an electronic component;
-a non-electronic component;
-a reservoir;
-a dispenser.
11. The patch assembly of claim 10, wherein the cover (40) comprises a proximal or lower portion (45), the proximal or lower portion (45) being configured to at least partially cover a side of the element (70) closest to the patch (10) of the patch assembly (1), and wherein the lower portion (45) of the cover (40) defines a gap between the element (70) and the patch (10),
and wherein preferably the cover (40) comprises at least one pair of clamping members (41) arranged on opposite sides of the element (70), whereby each of the pair of clamping members (41) comprises the lower portion (45) or a portion thereof arranged between the element (70) and the patch (10).
12. The patch assembly of claim 10 or 11, wherein the patch assembly further comprises:
-a sensor configured for measuring a physiological state and in electronic communication with the element (70), wherein the element (70) comprises at least one electronic circuit configured to process, store and/or transmit a measurement result of the sensor.
13. The patch assembly according to any one of claims 10 to 12, comprising a membrane (50), the membrane (50) being gas permeable and preferably liquid impermeable.
14. Use of the cover (40) according to any one of claims 1 to 6 and/or the cover assembly according to any one of claims 7 to 9 for attaching an element (70) to a patch (10).
15. Use of a patch assembly according to any one of claims 10 to 13 for measuring a physiological state of a subject.
CN202280045714.7A 2021-07-01 2022-07-01 Flexible stretchable cover for attaching a component to a patch Pending CN117715575A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18033066 2021-07-01
EP211833066 2021-07-01
PCT/EP2022/068225 WO2023275342A1 (en) 2021-07-01 2022-07-01 A flexible and stretchable cover for attaching a component to a patch

Publications (1)

Publication Number Publication Date
CN117715575A true CN117715575A (en) 2024-03-15

Family

ID=90144784

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202280045714.7A Pending CN117715575A (en) 2021-07-01 2022-07-01 Flexible stretchable cover for attaching a component to a patch

Country Status (1)

Country Link
CN (1) CN117715575A (en)

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