A heat and moisture exchange (HME) device having a paper-based housing and a method of manufacturing
The paper-based HME device addresses the challenges of size, moisture exchange, and environmental impact by using a foldable design with a paper-based housing, enhancing sustainability and usability for diverse user needs.
Patent Information
- Application Number
- PCT/DK2025/050138
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-08-20
- Filing Date
- 2025-08-19
- Publication Date
- 2026-02-26
AI Technical Summary
Existing HME devices for laryngectomized or tracheostomized users face challenges in balancing moisture exchange, filtration, and size, while also posing environmental concerns due to material usage and disposal.
A paper-based housing for HME devices with a foldable design using sheet-like sidings and tab elements, incorporating a paper-based material and moisture-resistant lining, providing a compact and efficient moisture exchange system.
The paper-based HME device offers improved environmental sustainability, reduced production costs, enhanced visibility for timely replacement, and effective moisture exchange, suitable for both laryngectomy and tracheostomy users.
Smart Images

Figure DK2025050138_26022026_PF_FP_ABST
Abstract
Description
[0001] A HEAT AND MOISTURE EXCHANGE (HME) DEVICE HAVING A PAPER-BASED HOUSING AND A METHOD OF MANUFACTURING
[0002] A heat and moisture exchange (HME) device for a laryngectomized or tracheostomized user is provided in the following disclosure. Also provided is a paperbased blank for a foldable housing for an HME device for a laryngectomized or tracheostomized user. Also provided is a method for manufacturing an HME device.
[0003] Background
[0004] A tracheostomy is a surgical procedure in which an opening is formed through the anterior surface of the neck into the trachea. The opening is referred to as a tracheostoma (or neck stoma). A tracheostomy tube can be provided to extend between the tracheostoma and the trachea. A tracheostomy is performed, for example, when there is a malfunction, such as a result from injury or disorder, in respect of the nervous system or the respiratory passages, which malfunction results in an incapacity to obtain enough air. An inferior lung capacity or a need for respiratory treatment may also result in a tracheostomy.
[0005] A laryngectomy is a surgical procedure, used for example to treat a carcinoma, which involves removal of the larynx or voice box and creation of a tracheostoma. A consequence of the procedure is that the trachea is no longer connected to the pharynx but is diverted to the tracheostoma. After this procedure, normal nasal function is not possible. In a subject whose breathing functions normally, the nose and the mucous membrane lining of the nasal cavity perform important functions in conditioning the inhaled air. The convoluted passages and rich blood supply serve to increase both the temperature and humidity of the inhaled air to minimise the differential in these parameters with those of the surface of the lungs. Normally, some heat and moisture are also captured from exhaled air prior to its release to the atmosphere. The mucous lining of the nasal passages also serves to remove particulate matter, such as fine dust particles, pollutants and microorganisms, from the inhaled air, and the action of cilia transports mucous and any particles away from the lungs. When a patient has received a laryngectomy, in effect all inhaled air enters the lungs via the tracheostoma, and the nose is effectively not involved in the inhalation process. Exhaled air may pass through the tracheostoma or, if a voice prosthesis has been fitted, the stoma can be occluded so that the exhaled air is diverted through the voice prosthesis into the pharynx and the mouth, enabling the patient to speak.
[0006] For such patients, filter devices and breathing protectors have been developed to enable conditioning including heat exchange and moisturizing of inhaled air and removal of small particles and bacteriological substances in said inhaled air. This is to resemble the functions of a nose. Such devices are generally known as Heat and Moisture Exchangers (HMEs). However, there are several contradictive criteria related to the provision of such devices. Firstly, the users of such devices need good moisturizing and removal effect while keeping the size, such as the surface area, of the device as small as possible. Secondly, for the moisturizing effect and the filtering effect a large surface area is preferable, while also seeking to not create a too large breathing resistance over the device. Also, a person with a laryngectomy typically must hold their finger or thumb over these devices when wishing to speak, to thereby obstruct the air flow through the device and the stoma through the tracheal wall, which will burden the filter with undue contamination, due to transfer of impurities from the finger of the user to the filter.
[0007] Moreover, pulmonary rehabilitation of airways has a significant impact on recovery of patients breathing through a neck stoma. Administrating HMEs during recovery after surgery helps maintain a good humidity level in the patients' lungs. Existing HMEs in hospitals typically consist of a thermoplastic body that houses some sort of medium or material helping to increase the heat moisture level of each breath.
[0008] During early stages of recovery, the patients experience an increase in mucus production that causes the patients to cough more frequently. Before the patient's body has gotten used to the new circumstances, users tend to use many HMEs, due to mucus blockage of the HME device caused by uncontrolled coughing.
[0009] Furthermore, the awareness of making sustainable products in combination of material choice of conventional HMEs, makes health care professionals as well as product users concerned about their own impact on the environment considering they use a lot of HMEs, particularly at the early stages of recovery as explained above. Users and health care professionals alike would therefore welcome improved as well as more environmentally friendly or sustainable HME devices.
[0010] Summary
[0011] In one aspect, the present disclosure relates to a heat and moisture exchange (HME) device for a laryngectomized or tracheostomized user. In another aspect, the disclosure relates to a paper-based blank for a foldable housing for an HME device for a laryngectomized or tracheostomized user as described herein. In yet another aspect, the disclosure relates to a method for manufacturing an HME device. The various aspects disclosed herein are further defined by the appended claims.
[0012] Brief Description of the Drawings
[0013] The accompanying drawings are included to provide a further understanding of implementations or embodiments and are incorporated in and constitute a part of this specification. The figures illustrate implementations and together with the description explain principles of implementations. Other implementations and many of the intended advantages of all implementations will be readily appreciated as they become better understood by reference to the following detailed description.
[0014] Various exemplary implementations and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale. It should also be noted that the figures are only intended to facilitate the description of the implementations. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated implementation or embodiment needs not have all the effects or advantages shown. An effect or an advantage described in conjunction with a particular implementation or embodiment is not necessarily limited to that implementation or embodiment and may be practiced in other implementations or embodiments even if not so illustrated, or if not so explicitly described. The figures can be listed as follows:
[0015] Figure 1 is a schematic, sectional view illustrating one implementation of an HME device including a housing including a paper-based material as disclosed herein.
[0016] Figure 2 is a schematic, perspective view illustrating one implementation of a foldable housing blank of a paper-based material for an HME device.
[0017] Figure 3A is a schematic, perspective view illustrating an HME device housing resulting from performing a folding action of the foldable housing blank of Fig. 2.
[0018] Figure 3B is a schematic, perspective view illustrating an HME device housing resulting from performing a folding action of the foldable housing blank of Fig. 2.
[0019] Figure 4 is a schematic, perspective view illustrating another implementation of a foldable housing blank of a paper-based material for an HME device.
[0020] Figure 5 is another schematic, perspective view similar to Fig. 4 illustrating an implementation of a foldable housing blank of a paper-based material for an HME device.
[0021] Figure 6 is a schematic, perspective view illustrating an HME device housing resulting from performing a folding action of the foldable housing blank of Figs. 4 and 5.
[0022] Figure 7 is a schematic, perspective view illustrating an implementation of the foldable housing of a paper-based material for an HME device in accordance with Figs. 3A-3B.
[0023] Figure 8 is a schematic, cross-sectional side view illustrating an implementation of the foldable housing in Fig. 7.
[0024] Figure 9A is a schematic, perspective view illustrating another implementation of a foldable housing blank of a paper-based material for an HME device.
[0025] Figure 9B is a schematic, enlarged sectional view of a portion of a siding of one implementation of a housing for an HME device as disclosed herein.
[0026] Figure 10 is a schematic, perspective view of one implementation of a housing for an HME device as disclosed herein.
[0027] Figure 11 is a schematic, perspective view illustrating one implementation of a housing for an HME device as disclosed herein.
[0028] Figure 12 is a perspective, cross-sectional view of one implementation of a foldable housing for an HME device as disclosed herein. Figure 13 is a cross-sectional view of one implementation of an HME device as disclosed herein further illustrating some of the functionalities of the device.
[0029] Figure 14 is a schematic, perspective illustration of a model of a laryngectomized user's throat portion below their chin showing an HME device including a paper-based foldable housing as disclosed herein.
[0030] Fig. 15 is a schematic, perspective illustration of a model of a tracheotomized user's throat portion below their chin showing an HME device including a paper-based foldable housing as disclosed herein.
[0031] Figs. 16A-16C are schematic, perspective views illustrating one implementation of a foldable housing blank of a paper-based material for an HME device.
[0032] Figs. 17A-17B are schematic, perspective views illustrating one implementation of a paper-based connector blank (Fig. 17A) foldable into a connector element (Fig. 17B) for an HME device as disclosed herein.
[0033] Figs. 18A-18C are schematic, perspective, side, and bottom views, respectively, illustrating one implementation of the paper-based connector element of Fig. 17B connected to a paper-based housing for an HME device as disclosed herein.
[0034] Figs. 19A-19B are schematic, perspective, views illustrating one implementation of the paper-based connector element of Fig. 17B connected to a paper-based housing for an HME device as disclosed herein.
[0035] Fig. 19C is a schematic, perspective, cross-sectional view illustrating the paperbased connector element of Figs. 19A-19B connected to a paper-based housing for an HME device as disclosed herein and further connected to an end portion of a tracheostomy tube.
[0036] Detailed Description
[0037] In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific implementations in which the invention may be practiced. In this regard, directional terminology, such as "top," "bottom," "front," "back," "leading," "trailing," etc., is used with reference to the orientation of the Figure(s) being described. Because components of implementations can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is not necessarily limiting. It is to be understood that other implementations may be utilized, and structural or logical changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims. In this application, the term "proximal" or "proximal direction" signals that something is towards the (center of) the user's body, and the term "distal" or "distal direction" signals that something is away from the (center of) the user's body.
[0038] It is to be understood that individual features of the various exemplary implementations described herein may be combined with each other, unless specifically noted otherwise.
[0039] In this disclosure, a person or subject using the HME may be referred to as "patient" or "user". However, in some cases, "user" can also relate or refer to a health care professional (HCP), such as a doctor / physician, nurse, or other person.
[0040] In this disclosure, 'axially' or 'axial direction' should generally be considered as being along or parallel to a described longitudinal axis of a thing. The radial direction should be understood as being at an angle to the axial direction. In some sentences, the words "inner" and "outer" can be used. These qualifiers should generally be perceived with reference to the radial direction, such that a reference to an "outer" element means that the element is generally farther away from a centre portion of a component than an element referenced as "inner". In addition, "innermost" should be interpreted as the portion of a component forming a centre of the component and / or being adjacent to the centre of the component. In analogy, "outermost" should be interpreted as a portion of a component forming an outer edge or outer contour of a component and / or being adjacent to that outer edge or outer contour. In further analogy this is also the case regarding the use of the words "upper" / "lower" and "uppermost" / "lowermost".
[0041] The use of phrases such as (but not limited to) "substantially" and "approximately" as qualifiers of certain features or effects in this disclosure, is intended to simply mean that any deviations are within tolerances that would normally be expected by the skilled person in the relevant field.
[0042] The use of the word "generally" as a qualifier to certain features or effects in this disclosure is intended to mean - for a structural feature: that a majority or major portion of such feature exhibits the characteristic in question, and - for a functional feature or an effect: that a majority of outcomes involving the characteristic provide the effect but that, exceptionally, some outcomes may not provide the effect.
[0043] In the present disclosure, the use of identifiers including "first", "second", "third", "fourth", "fifth", "sixth", "seventh", "eighth", "ninth", and "tenth" and higher counts, as well as identifiers including "primary", "secondary", "tertiary", "quaternary" and higher counts, should not necessarily be understood as implying a specific and / or required rank or order of described elements, but are primarily applied to be able to contextually distinguish the elements from each other (as these identifiers typically refer to elements of similar structure or functionality).
[0044] In the context of the present disclosure, a total laryngectomy means the surgical removal of the larynx and separation of the airway from the mouth, nose, and esophagus. A tracheostomy (or -stoma) is a hole (opening) made in the skin in the front of the neck to allow breathing. The stoma is made at the base of the neck. Air goes in and out of the trachea and lungs through this hole. It is also sometimes called a neck stoma.
[0045] In a first aspect, the present disclosure relates to a heat and moisture exchange (HME) device for a laryngectomized or tracheostomized user including a housing including two or more sheet-like sidings including a first sheet-like siding and a second sheet-like siding. Each of the sheet-like sidings, i.e., the first sheet-like siding and the second sheet-like siding includes a peripheral edge portion.
[0046] The housing further includes one or more tab elements extending from the peripheral edge portion of a siding. Each of the one or more tab elements is configured to engage with a different one of the two or more sidings to provide a connection between the sidings.
[0047] The two or more sheet-like sidings and the one or more tab elements are configured to be positioned in spatial relation to each other to combine and define an accommodation of the housing of the HME device. Furthermore, an HME material is provided in the accommodation of the housing.
[0048] The housing includes a paper-based material. Thereby, it is to be understood that the two or more sheet-like sidings include a paper-based material. It is further to be understood that the one or more tab elements include a paper-based material. In implementations, the housing consists of a paper-based material. Thereby, it is understood that in some cases the housing can consist entirely of a paper-based material.
[0049] In some implementations, one or more portions of an entirety of the housing can consist of a paper-based material. Thereby, it is to be understood that one or more portions of the housing can be made solely from the paper-based material and do not include other elements or materials, whereas one or more other portions of the housing can include one or more other materials in addition to the paper-based material.
[0050] In implementations, the housing includes a paperboard material. According to Wikipedia, paperboard is a thick paper-based material. While there is no rigid differentiation between paper and paperboard, paperboard is generally thicker (usually over 0.30 mm) than paper. In some definitions, paperboard is paper with a grammage above 250 g / m2, but there are exceptions. Paperboard can be single- or multi-ply. The definition of paperboard is intended to include materials commonly understood to be "cardboard", however "cardboard" may not be accepted as a clear or specific definition by all sources. Sometimes "paperboard" is identified as "thin cardboard". In implementations, the housing includes a paperboard material with a grammage of 290 g / m2.
[0051] In implementations, the housing includes a lining provided on the paper-based material.
[0052] In implementations, the lining is adapted to cover an entirety of the paperbased material. Thereby, it is understood that an entire surface area of the paperbased material included in the housing is covered by the lining. In implementations, the material for the housing is provided as a paper-based material covered by the lining before being processed further. In implementations, the material for the housing is provided as a paper-based material including a lining supplied as an intermediate material from a supplier before being further processed according to the present disclosure. In implementations, the housing includes a paper carton single-sidedly laminated with a lining material. In implementations, the housing includes a paper carton double-sidedly laminated with a lining material. In implementations, the housing includes a lining laminated to one side of the paper-based material. In implementations, the housing includes a lining laminated to both sides of the paper- based material. In implementations, the paper-based material of the housing includes a paper carton.
[0053] In implementations, the lining includes a moisture resistant lining. In implementations, the lining is a moisture resistant lining. In implementations, the lining includes a polyethylene (PE) film material. In implementations, the lining includes a polypropylene (PP) film material. In implementations, the lining includes a food-grade film material. In implementations, the lining is a food-grade PE film material or a foodgrade PP film material. In implementations, the lining is a food-grade PE film material having a thickness of 40p. In implementations, the lining includes a polypropylene film material. In implementations, the lining includes a bi-axially oriented polypropylene (BOPP) film material. BOPP film materials have excellent resistance characteristics towards various external effects (including moisture) and also good transparency. Moreover, it has surprisingly been found that a BOPP film material provides excellent bonding characteristics when two surfaces including BOPP film material or PE film material are welded together, such as by heat or ultrasonic welding. Using this material would therefore advantageously provide both good resistance and bonding characteristics, which is particularly useful when the components of the housing are to be locked together in their spatial relationship, forming the accommodation of the housing. In implementations, the lining material is a BOPP film material having a thickness of 16p. Other lining materials can be acceptable, subject to particular requirements for the resistance / protection that is desired from the lining.
[0054] In the present disclosure, the term "sheet-like siding" generally refers to an element forming a side portion of the housing and having a substantially smaller thickness than its length and width (smaller dimension along the z-axis than the dimensions along each of the x- and y-axes in an x,y,z-coordinate system) (three- dimensional)). That a siding forms a side portion should not be understood in any limiting sense with regard to a specific three-dimensional orientation of the housing. Thus, a side portion formed by a siding includes also the possibility of forming a top or uppermost portion and / or a bottom or lowermost portion of the housing.
[0055] In implementations, the housing of the HME device is formed with two sheetlike sidings, including a first sheet-like siding and a second sheet-like siding, wherein the first sheet-like siding and the second sheet-like siding are formed as separate entities. These separate first and second sheet-like sidings are configured to combine with each other and with one or more of the at least one tab element of the sidings, such as to be positioned in spatial relation to each other and define an accommodation of the housing of the HME device. In implementations, the first sheet-like siding and the second sheet-like siding of the housing formed as separate entities are stamped out from one (the same) sheet of paper-based material.
[0056] According to the disclosure, a sheet-like siding includes a peripheral edge portion. The peripheral edge portion can be understood to form an outer contour (seen in a plan view) and provide a general delimitation of a sheet-like siding towards its surroundings. In implementations, the peripheral edge portion of a sheet-like siding describes a generally closed shape. In implementations, the generally closed shape can include a round, circular, oval, square, rectangular, diamond, star, flower, or other suitable closed shape. Moreover, by the wording 'generally closed shape' the reference should be understood to be to a majority of the peripheral edge portion of a sheet-like siding, but disregarding any portion formed by the one or more tab elements. In implementations, the two or more sheet-like sidings each include peripheral edge portions of different closed shapes. In one particularly suitable implementation, each of the two or more sheet-like sidings includes a peripheral edge portion of round closed shape. In implementations, each of the two or more sheet-like sidings includes a peripheral edge portion of circular closed shape. In implementations, at least one of the at least two sheet-like sidings include a peripheral edge portion of generally circular shape and at least one other sheet-like siding includes a peripheral edge portion of generally rectangular shape. In implementations, one or more of the four side edges of a siding with a peripheral edge portion of generally rectangular shape can include a curved indentation along the edge to assist a user in gripping and handling the HME device, for example when attaching or detaching the HME device to / from a tracheal tube. Furthermore, making curved indentations in one or more edges can also provide for the HME device to give a "lighter" appearance, which is also advantageous as discretion is a factor to many users. In implementations, a maximum surface area of each of the two or more sheet-like sidings is identical for the sidings. In implementations, a total surface area (seen in a plan view) of each of the two or more sheet-like sidings is identical for the sidings. In implementations, a total length of the peripheral edge of each of the two or more sheet-like sidings is identical for the sidings. In implementations, the two or more sheet-like sidings include identically shaped and identically sized sheet-like sidings.
[0057] In the present disclosure, the term "tab element" generally refers to a small flap or strip of material. In the present context, a tab element can be understood as something which is suitable and useful for engaging with and holding "onto" something else and which is generally manipulable, including being manipulable in more than one manner and / or more than one dimension and / or more than one direction. According to the disclosure, a tab element extends from the peripheral edge portion of a siding. Each tab element is configured to engage with a different siding. Thereby, a tab element can be understood to be configured for providing a connection between two respective sidings. In implementations, wherein more than one tab element extends from one particular siding, the two or more tab elements can be configured for engagement with one other siding, or the two or more tab elements can be configured for engagement with two or more different, other sidings. An individual tab element of the one or more tab elements can be configured for engagement with more than two different sheet-like sidings. In implementations, a first tab element can be configured to provide an uninterrupted connection between a first sheet-like siding and a second sheet-like siding. This means that the first tab element extends from both the peripheral edge portion of the first sheet-like siding and from the peripheral edge portion of the second sheet-like siding without discontinuity. In the same implementation, a second tab element can be configured to be provided with an uninterrupted connection only to one of the first and the second sheet-like sidings (i.e., the first tab element extends uninterrupted between the first and the second sheet-like siding, but the second tab element extends uninterrupted only from one of the two sheet-like sidings). In implementations, a first tab element and a second tab element can be configured to each extend uninterrupted from the peripheral edge portion of the first sheet-like siding, while being configured to engage with the second sheet-like siding without extending uninterruptedly from the peripheral edge portion of the second sheet-like siding.
[0058] In implementations, at least one of the one or more tab elements of the housing is / are provided integrally with at least one of the two or more sheet-like sidings. Thereby, it is understood that a sheet-like siding and a tab element can be provided as a continuous entity, for example, the tab element can be understood as an extension portion projecting from the sheet-like siding, such as from the peripheral edge portion thereof.
[0059] In implementations, at least one of the one or more tab elements of the housing is / are provided integrally with and configured to form a connection between two sheet-like sidings. Thus, in implementations, a tab element can be provided integrally with two sheet-like sidings, thereby understood to be continuous with both sidings and provide a connection between the two sidings.
[0060] In implementations, more than one tab element can be provided integrally with one sheet-like siding, for example, the tab elements each provide an extension portion projecting from the sheet-like siding, such as from different positions along the peripheral edge portion thereof. In implementations, each of two tab elements can be provided integrally with each of two sheet-like sidings, thereby providing a housing including at least a first and a second sheet-like siding connected to each other by each of two tab elements provided integrally with each siding.
[0061] The two or more sheet-like sidings and the one or more tab elements are configured to be positioned in spatial relation to each other to combine and define an accommodation of the housing. Thereby, the two or more sheet-like sidings and the one or more tab elements can be provided in a spatial position relative to each other such that they unite (come together) and define the accommodation of the housing. In this context, 'accommodation' is generally to be understood as a holding space for something being located within its confines, in the present case within the housing.
[0062] Configurations include that the two or more sheet-like sidings are configured to be positioned in spatial relation to each other, e.g. by being provided in a first spatial relationship with each other. In one implementation, a first spatial relationship includes that a first sheet-like siding and a second sheet-like siding extend in a generally parallel relationship to each other and with some distance between them. In implementations, the two or more sheet-like sidings can be understood to be provided in parallel planes with some distance between the planes. In implementations, the two or more sheetlike sidings can be provided to have coinciding peripheral edge contours, wholly or partially (when seen in a plan view with one siding above the other).
[0063] Also, the one or more tab elements is / are configured to be positioned in spatial relation to the two or more sheet-like sidings and / or to each other. In implementations including more than one tab element, the tab elements can for example be provided in (at least) a second spatial relationship with each other. In implementations, the second spatial relationship includes that the at least two tab elements generally extend in the same direction and / or along parallel axes.
[0064] In implementations, a spatial relationship between one or more tab elements and the two or more sheet-like sidings includes that the first and second sheet-like sidings extend in a generally parallel relationship to each other and the one or more tab elements extend(s) in a direction which is generally perpendicular to the parallelly- extending first and second sheet-like sidings.
[0065] In general, it is to be understood that the two or more sheet-like sidings are configured to be positioned in spatial relation to each other and that one or more tab elements are configured to be positioned to form a spatial relationship with the two or more sheet-like sidings and / or with subsets thereof and / or with one or more other tab elements. Moreover, it is to be understood that the two or more sheet-like sidings and the one or more tab elements are spatially positioned so as in combination to define a holding space and thereby define the accommodation of the housing as discussed herein.
[0066] In particular implementations, the housing includes a first sheet-like siding with a peripheral edge of round closed shape and a second sheet-like siding with a peripheral edge of round closed shape and two tab elements configured to provide a connection between the first and second sidings. The first and the second sheet-like siding and the two tab elements are spatially positioned so as in combination to define the accommodation of the housing.
[0067] In particular implementations, the housing includes a first sheet-like siding with a peripheral edge of round closed shape and a second sheet-like siding with a peripheral edge of round closed shape and four tab elements configured to provide a connection between the first and second sidings. The first and the second sheet-like siding and the four tab elements are spatially positioned so as in combination to define the accommodation of the housing.
[0068] In implementations, the housing includes three sheet-like sidings.
[0069] In particular implementations, the housing includes a first sheet-like siding with a peripheral edge of round closed shape and a second sheet-like siding with a peripheral edge of round closed shape and a third sheet-like siding with a peripheral edge of round closed shape and two tab elements configured to provide a connection between at least the first and second sidings. The first and the second and the third sheet-like siding and the two tab elements are spatially positioned so as in combination to define the accommodation of the housing. In particular implementations, each of the two tab elements is configured to provide a connection between the first, second, and third sidings. In other implementations, a primary of the two tab elements is configured to provide a connection between the first and the second siding and a secondary of the two tab elements is configured to provide a connection between the first and the third siding or between the second and the third siding.
[0070] In particular implementations, the housing includes a first sheet-like siding with a peripheral edge of round closed shape and a second sheet-like siding with a peripheral edge of round closed shape and a third sheet-like siding with a peripheral edge of round closed shape and four tab elements configured to provide a connection between at least the first and second sidings. The first and the second and the third sheet-like siding and the four tab elements are spatially positioned so as in combination to define the accommodation of the housing. In particular implementations, the four tab elements are configured to provide a connection between the first, second, and third sidings. In other implementations, a primary of the four tab elements is configured to provide a connection between the first and the second siding and each of a secondary, a tertiary, and a quaternary of the four tab elements is configured to provide a connection between any two or more of the first, second, and third sidings.
[0071] In a particular implementation of a housing provided with three sheet-like sidings and four tab elements, a primary of the four tab elements is configured to provide a connection between the first sheet-like siding and the second sheet-like siding; and a secondary of the four tab elements is configured to provide a connection between the first sheet-like siding and the third sheet-like siding; and a tertiary and a quaternary of the four tab elements are configured to each provide a connection between the first sheet-like siding and one or both of the second and the third sheetlike siding.
[0072] In implementations, the housing includes four sheet-like sidings.
[0073] In particular implementations, the housing includes a first sheet-like siding with a peripheral edge of round closed shape and a second sheet-like siding with a peripheral edge of round closed shape and a third sheet-like siding with a peripheral edge of round closed shape and a fourth sheet-like siding with a peripheral edge of round closed shape, and two tab elements configured to provide a connection between at least the first and second sidings. The first, the second, the third and the fourth sheet-like siding and the two tab elements are spatially positioned so as in combination to define the accommodation of the housing. In particular implementations, each of the two tab elements is configured to provide a connection between any two or more of the first, second, third, and fourth sidings.
[0074] In particular implementations, the housing includes a first sheet-like siding with a peripheral edge of round closed shape and a second sheet-like siding with a peripheral edge of round closed shape and a third sheet-like siding with a peripheral edge of round closed shape and a fourth sheet-like siding with a peripheral edge of round closed shape, and four tab elements configured to provide a connection between at least the first and second sidings. The first, the second, the third, and the fourth sheet-like siding and the four tab elements are spatially positioned so as in combination to define the accommodation of the housing. In particular implementations, the four tab elements are configured to provide a connection between any two or more of the first, second, third, and fourth sidings.
[0075] In a particular implementation of the housing provided with four sheet-like sidings and four tab elements, a primary of the four tab elements is configured to provide a connection between two, or all three, of the first, second, and third sheet-like siding; and a secondary of the four tab elements is configured to provide a connection between the first sheet-like siding and the second sheet-like siding; and a tertiary of the four tab elements is configured to provide a connection between the first sheetlike siding and the third sheet-like siding; and a quaternary of the four tab elements is configured to provide a connection between the second sheet-like siding and the fourth sheet-like siding.
[0076] In implementations, the housing includes a plurality of sheet-like sidings. In implementations, the housing includes five sheet-like sidings. In implementations, the housing includes six sheet-like sidings. In implementations, the housing includes seven sheet-like sidings. In implementations, the housing includes eight sheet-like sidings. The number of sheet-like sidings for the housing of the HME device can be customized in accordance with various criteria, such as, but not limited to, desired hardness, stiffness, durability, temperature resistance, moisture resistance, any mechanical functionality, etc. of the housing, and in turn be customized by controlling and specifically selecting the quality and the dimensions of the paper-based material included in the housing. Particularly, but not exclusively, the number of sheet-like sidings can be understood to influence the structural integrity of the housing, including its tenacity and solidity, such that a higher number of sheet-like sidings can be seen to generally increase the structural integrity and thus provide a more robust housing.
[0077] In implementations, at least one of the sheet-like sidings includes one or more notches extending radially inward from the peripheral edge portion and configured to engage with a tab element of a different one of the sheet-like sidings. Herein, a "notch" can generally be understood as a cut or groove in the peripheral edge portion of the sheet-like siding. The one or more notches can be understood to provide a guiding slot that is adapted to receive and engage with a tab element extending from the of a different one (another one) of the sheet-like sidings. Additionally, the one or more notches can also help provide some tolerance in combining the two or more sheet-like sidings and the one or more tab elements in the spatial relation to each other that defines the accommodation of the paper-based housing.
[0078] In implementations, at least one of the sheet-like sidings includes one or more slits which extend(s) through the siding from one side thereof to the other (i.e., through a thickness of the siding) and located radially inward of the peripheral edge portion and configured to engage with a tab element of a different one of the sheet-like sidings. Thereby, it is understood that the one or more slits are to be considered a different type of element than the notches described above, in that the slits do not form parts (-segments) of the peripheral edge portion of a siding. Instead, the one or more slits are provided as a hole in the surface of the siding (the hole extending through the wall of the siding). The one or more slits can also be considered as elements surrounded entirely by the material of the siding, whereas a notch, as described above, extends radially inward from the peripheral edge portion of the siding and is therefore not surrounded entirely by material of the siding. In implementations, wherein at least one sheet-like siding includes a peripheral edge portion of generally rectangular shape, the one or more slits can suitably be formed near or adjacent to one or more of the corners of the rectangularly contoured siding.
[0079] It is to be understood that each of the tab elements of the first sheet-like siding are configured to engage with the second sheet-like siding through each of the respective slits to provide a connection between the two sidings. Such a configuration is particularly, but not exclusively, useful in implementations wherein the housing of the HME device is formed with two sheet-like sidings, including a first sheet-like siding and a second sheet-like siding, and wherein the first sheet-like siding and the second sheet-like siding are formed as entities separate from each other, because this configuration of the sidings facilitates both manufacture and helps to provide a secure and robust combining of the elements of the housing of the HME device.
[0080] In implementations, at least one of the one or more tab elements include(s) one or more creases. In implementations, all tab elements include at least one crease.
[0081] In implementations, a transition between a sheet-like siding and a tab element at the peripheral edge portion of the siding includes a crease.
[0082] A "crease" should generally be understood as either a fold or plication provided or introduced in the tab element prior to defining the accommodation of the housing.
[0083] A crease provided in a tab element can generally be considered a "collapse- crease". This is to be understood such that the primary functionality of the collapse- crease is to allow a tab element to collapse (undergo a sharp bending along an axis of the crease) in a controlled manner when subjected to a certain externally provided force. This will be further described and discussed below. In implementations, all tab elements include at least one crease.
[0084] A crease provided in a transition between a sheet-like siding and a tab element at the peripheral edge portion of the siding can generally be considered a "folding- crease". This is to be understood such that the primary functionality of the folding- crease is to facilitate easy and controllable folding between the tab element and the peripheral edge portion of the siding when combining the one or more tab elements and the two or more sheet-like sidings to define the accommodation of the housing.
[0085] An HME material is provided in the accommodation of the housing. The HME material should be of a nature which includes flow passages therein and can have an open structure in which the flow passages can be either randomly oriented or provided in a pattern of channels. The HME material can suitably include paper, foamed plastics, wadding made of different fibres, or combinations thereof. It can also be impregnated with a moisture absorbing substance. In advantageous implementations, pores or interstices in the HME material do not align with any specific direction, such that the breathing air can easily pass through the HME material in a variety of directions.
[0086] In implementations, the HME device can include a filtering material provided on and / or around at least a portion of the housing of the HME device. In implementations, at least one of the two or more sheet-like sidings is entirely surrounded and / or encapsulated by, or in, the filtering material. In implementations, an entirety of the housing is surrounded and / or encapsulated by, or in, the filtering material (or at least a major portion thereof is, except for a through-going coupling opening). The filtering material is suitably configured to have high breathability while capable of filtering micro particles. In implementations, the filtering material includes electrostatic filtering material. In implementations, the filtering material includes a spun-bond, non-woven material.
[0087] An HME device as disclosed herein presents with multiple general and more specific advantages in comparison with traditional HME devices currently available.
[0088] One advantage of the HME device presented herein is that the housing including a paper-based material is more environmentally friendly with regard to both production process and materials, because the use of traditional plastic (polymer) materials for providing the housing of the HME can be dispensed with or at least be significantly reduced. This is also advantageous in terms of disposal of used HMEs, in terms of both the total amount of waste generated and the options for better sorting the waste into potentially reuseable waste fractions.
[0089] Another advantage of the HME device presented herein is that it is likely less expensive with regard to production costs as all or a substantial portion of polymer materials needed for production are removed. This may in turn help provide the possibility for users in countries having no public reimbursement system to also have access to innovative HME devices or in that health authorities in countries with reimbursement may have a less expensive option to offer to users.
[0090] Another advantage of the HME device presented herein is that it is easily visually noticeable to users that the HME device is prone for substitution with a new device. Further, it is easy to notice when the HME has been in use (even if just for a short while) and therefore due for change. Making the HME device of the paper-based material may make it a bit more sensitive to use. So, a used HME device according to the disclosure may start showing signs of wear after being attached and removed a number of times. Also, if heavy mucus is secreted some of the moisture thereof may become visible on the edges of the paper-based material for the HME device. This may make it easier for a user or caretaker to see if it is time to change the HME. This is even more advantageous for newly operated users, who are not yet fully familiarized with the routines concerning HME devices and their use. It is therefore contemplated that the HME device disclosed herein is particularly well suited as a postoperative HME device. Providing an HME device that allows new users to more easily get some routine with their new condition and the manner in which the HME device can help them, in turn is likely to increase the general patient outcome / success rate and the speed of pulmonary rehabilitation of users to the benefit of both the user themselves and the health care system, not least financially.
[0091] A further advantage of the HME device presented herein is that it can provide a high level of humidification of the air being breathed in by the user, which is particularly useful for new users in a post-operative setting in the period following their surgery. This is supported by results from testing the HME device of the disclosure in a laboratory set-up.
[0092] Another advantage of the HME device presented herein is that it also has increased suitability for being used together with a tracheostomy tube compared to existing products available on the market. At present, it is found that it is not common for HME devices designed for laryngectomy users to also be suitable for tracheostomy tube users. It should be understood that use of laryngectomy products supports a chronic condition, whereas use of tracheostomy tubes is typically more in acute settings such as during hospitalization. Thus, with the present HME device, an offering is made which can be suitable both for users with laryngectomy and tracheostomy, unlike existing HME devices that are optimized for each of these particular conditions. Advantageous embodiments including a particularly suitable connector element for connection to a tracheostomy tube is described in more detail elsewhere in this disclosure.
[0093] In some implementations, the accommodation of the housing and / or the HME material can include one or more air filtering portions. The one or more air filtering portions can include different layers each including differently arranged and / or sized flow passages to cater for filtering particles of various type and size. In implementations, the filtering material (additionally described above) provided on and / or around at least a portion of the housing of the HME device is configured to combine with the one or more air conditioning portions of the accommodation and / or of the HME material to provide for example an enhanced filtering effect, and, generally, provide a more versatile HME device customizable to the various breathability requirements of users.
[0094] In advantageous implementations, the HME material provided in the accommodation of the housing includes an HME foam. In advantageous implementations, the HME material is an HME foam. In implementations, the HME foam includes a reticulated polyurethane (PU) foam. In implementations, the PU foam is impregnated with calcium chloride as a moisture absorbing / releasing substance.
[0095] In implementations, the HME material is configured as a ring-shaped element. Thereby, in implementations, the HME material is configured to only partially fill up space in the volume of the accommodation of the housing. In particular, in some implementations, a center portion (spatial volume) of the accommodation is free from HME material. This is advantageous in that there is no HME material in the center portion of the accommodation in the way of any mucus that may be expelled from the tracheostomy during coughing. This is because any mucus or slime is only received on an internal surface of one of the sheet-like sidings instead of being received immediately by HME material, this being useful in increasing the HME device lifetime as the HME material is not clogged. The mucus in movement (by the coughing) is heavier and has more difficulty in changing direction, thus the mucus ends up on the internal surface of the sheet-like siding. In alternative implementations, the HME material is donut-shaped.
[0096] The HME device according to the first aspect is advantageous in that it provides good filtering and moisturizing effect, while still providing a low-profile housing of an HME device with a satisfactory breathing resistance. One parameter that influences the characteristics of the HME device is the pore size of the HME material, such as the pore size of an HME foam. A smaller pore size increases the humidification capability; however, this goes hand in hand with an increased resistance to breathing. Smaller pores create a larger total area of the HME material and thus better humidification at the expense of higher breathing resistance. This can also be expressed as higher pore density yields higher breathing resistance. The present inventive HME device is found to advantageously provide a solution that can suitably be adapted to most user scenarios, because it provides a higher degree of freedom to adapt the various device parameters than conventional HME's. In one, non-limiting example, the parameters of the present HME device can be adapted to provide an HME device that is particularly well suited for new users having a relatively (compared to more experienced users) high consumption of HME devices.
[0097] The HME device can be additionally advantageous in that it can be configured to provide the user with the possibility of closing the HME device for allowing the user to speak, with a relatively low force. It can provide an HME device that is easily moved from an open to a closed state for speaking by pressing a finger onto an external surface of a top siding of the at least two sheet-like sidings and forcing the HME material in the accommodation to compress, and forcing the collapse of each of the one or more tab elements, to thereby achieve the engagement of an internal surface of the top siding with a skin attachment component for the HME device to form a seal closing off the airflow through the HME device to allow speech. As described above, the one or more tab elements can advantageously be provided with one or more collapse-creases to facilitate the collapse of the tab element during the finger-pressing closing action.
[0098] In implementations, the HME material, such as HME foam, can additionally function as a return spring for the closing functionality. Resiliency of the HME material allows the HME device to return to an open state when finger pressure thereupon ceases. Thus, the user can press the external surface of the top siding to turn the HME device into a speaking mode / state, when the user wishes to speak, and then simply release the finger-pressure on the top siding when the user wants to quit speaking and return the HME device into its breathing mode / state.
[0099] Providing the HME material in a configuration as a ring- or donut-shaped element, whereby a center portion (spatial volume) of the accommodation is kept free from HME material not only prevents or reduces risk of mucus or slime entering into the pores of the HME material during coughing, thus preventing or reducing any compromission of its heat- and moisture exchange capacity but further provides other and additional advantages including preventing increase in breathing resistance or even blockage of airflow through the HME. Moreover, providing the HME material as a ring- or donut-shaped element further ensures that the HME material stays clear of the seal to be created when attaching the HME device to a skin attachment component. Even further, one additional contemplated advantage includes that the performance of the HME device is increased because the ring-shape (or donut-shape) of the HME material element, leaving the center portion of the accommodation free from material, provides a hollow center of the device whereby the exhaled air can begin to cool down before the airflow enters the HME material (provided as a surrounding ring- or donut-shaped element) - and thus, condensation of moisture present in the exhaled air begins before flow reaches the HME material impregnated with hygroscopic material (e.g. calcium chloride as described elsewhere herein). Moreover, providing a ring- or donut-shaped HME material element reduces the breathing resistance of the HME device which can be particularly useful for users that are new to having to use HME devices and may help such new users to more quickly become accustomed to their new situation.
[0100] In implementations, one or more of the sheet-like sidings include(s) a through- going opening. The through-going opening is formed in the one or more sidings radially inward of the peripheral edge portion of the siding. The size of the through- going opening, i.e., the size of the area of the siding taken up by the through-going opening can be different for different of the sheet-like sidings. The size of the through- going opening can thus be chosen in accordance with different purposes or uses of the through-going opening. Alternatively, two or more sheet-like sidings are provided with through-going openings of identical size. In implementations, a through-going opening can be understood to provide a sheet-like siding with an opening therethrough exhibiting an inner peripheral edge portion of the siding. The inner peripheral edge portion can include a continuous rounded edge contour, or can alternatively include one or more indents or the like, thus breaking the continuous nature of the rounded edge contour. The one or more indents can help provide additional flexibility to the sheet-like siding of the paper-based housing. Additionally, one or more indents can be configured to provide a structure of the through-going opening that can help in attaching the HME device to a skin attachment component worn by the user.
[0101] In implementations, at least one of the sheet-like sidings includes a through- going coupling opening adapted to allow fitting engagement of the HME device with a skin attachment component or with a tracheostomy tube.
[0102] Thereby, at least one of the sidings can be configured with the through-going coupling opening to provide for an easy and intuitive engagement and coupling of the paper-based housing of the HME device to another component. The other component is typically either a skin attachment component, such as an adhesive base plate for a laryngectomized patient that can include a suitable adapter or coupling means, such as a ring-shaped flange of a relatively rigid nature extending from adhesive base plate, or a tracheostomy tube that also can include suitable coupling means for coupling with a siding of the present HME device having a through-going coupling opening.
[0103] In some implementations, the housing for the HME device further includes a paper-based connector element adapted to allow fitting engagement of the HME device with a tracheostomy tube.
[0104] In implementations, alternatively to attachment of the housing of the HME device to a skin attachment component, a through-going coupling opening in one of the sheet-like sidings provides a means of connection to a paper-based connector element, wherein an opposite end of the paper-based connector element is suitably configured for engagement with a standard 15mm tracheostomy tube.
[0105] In some aspects and implementations, the paper-based connector element can also be considered as providing a suitable adapter or coupling means as mentioned above.
[0106] In implementations, the paper-based connector element includes a connector blank formed from a paper-based material (such as a material similar to the paperbased material for the sheet-like sidings and tab elements described in this disclosure). In implementations, the connector blank is provided at least with a first plurality of folding lines and / or folding cuts and is adapted for folding of the blank to provide the paper-based connector element. In one implementation, the connector blank suitably includes a first end portion and a second end portion, the first and second end portions delimited (or distinguishable) from each other by a lateral folding line, wherein the first end portion is subdivided into a first plurality of folding leaves each of which extends generally orthogonally from the lateral folding line. The folding leaves are separated from each other by folding cuts provided between them, the folding cuts extending generally orthogonally from the lateral folding line. Thereby, each of the folding leaves can be moved (folded) about the lateral folding line independently of any one or more of the other folding leaves. In implementations, the connector blank includes eight folding leaves. In implementations, the second end portion of the connector blank is subdivided into a second plurality of parallelly extending folding panels delimited (or distinguishable) from each other by a number of vertical folding lines. Each of the parallelly extending folding panels, as well as each of the number of vertical folding lines, extend generally orthogonally from the lateral folding line (and to the opposite side of the lateral folding line than the folding leaves of the first plurality of folding leaves of the first end portion). It should be understood that contrary to the first plurality of folding leaves of the first end portion, the second plurality of folding panels of the second end portion are not physically separated from each other by folding cuts but are only delimited (or distinguishable) from each other by the folding lines. In implementations, the connector blank includes eight folding panels. In implementations, a lateral dimension (e.g. "width") of each of the folding leaves is substantially identical to a lateral dimension of each of the folding panels. In implementations, each of the folding cuts provided between the folding leaves of the first end portion coincides with and extends along a respective axis of each of the number of folding lines of the second end portion. In implementations, the second end portion of the connector blank can additionally include at least one folding-lock wing adapted to facilitate keeping the paper-based connector element locked in the correct shape and form after folding of the connector blank into the connector element. It should be understood that the elements of the connector blank described herein, including at least the folding leaves, folding cuts, folding panels, and folding lines, generally facilitate the provision of an intuitively foldable, robust, and relatively durable paper-based connector element for connecting the housing of the HME device described herein to a tracheostomy tube. It should further be understood that the first and second end portions described in relation to the connector blank ultimately (after folding) form corresponding end portions of the paper-based connector element. It is further understood that the paper-based connector blank and hence the connector element can include a lining provided on the paper-based material, corresponding to the manner and principles of the lining for the paper-based housing, as described above.
[0107] When the connector blank has been folded into the paper-based connector element, the resulting first end portion of the connector blank provides that the connector element is adapted for connection with a sheet-like siding at a through- going coupling opening of the siding. Conversely, the second end portion of the connector blank provides that the other end of the folded connector element is adapted for connection with a ('machine end' of a) tracheostomy tube. In implementations, when folded, the first end portion of the connector element including the folding leaves can be configured to extend into the accommodation of the housing through the through-going coupling opening and at least partially connect with an internal surface of the siding around the through-going coupling opening thereof, while simultaneously the second end portion including the folding panels locates externally of the accommodation of the housing. Alternatively, when folded, the first end portion of the connector element including the folding leaves is configured to connect with an external surface of a siding around a through-going coupling opening thereof, while the second end portion including the folding panels simultaneously extends internally (into) the accommodation of the housing. In implementations, when folded, the second end portion of the connector element is adapted to connect to an external surface of the tracheostomy tube. In implementations, when folded, the second end portion of the connector element is adapted to connect to an internal surface of the tracheostomy tube. In implementations, when folded, the second end portion of the connector element is adapted to connect to an (ISO) standard 15mm (outer diameter measure) tracheostomy tube. It is to be understood that the connector blank can be provided in various sizes for providing a paper-based connector element that, when folded, can be configured to connect to tracheostomy tubes or other relevant elements of diameters being of other than 15mm standard diameter.
[0108] In a particular implementation of a housing provided with three sheet-like sidings and four tab elements, a primary of the four tab elements is configured to provide a connection between the first sheet-like siding and the second sheet-like siding; and a secondary of the four tab elements is configured to provide a connection between the first sheet-like siding and the third sheet-like siding; and a tertiary and a quaternary of the four tab elements are configured to each provide a connection between the first sheet-like siding and one or both of the second and the third sheetlike siding. The first sheet-like siding can include a through-going coupling opening adapted to allow fitting engagement of the housing with a skin attachment component or with a tracheostomy tube.
[0109] In another particular implementation of the housing provided with four sheetlike sidings and four tab elements, a primary of the four tab elements is configured to provide a connection between two, or all three, of the first, second, and third sheet-like siding; and a secondary of the four tab elements is configured to provide a connection between the first sheet-like siding and the second sheet-like siding; and a tertiary of the four tab elements is configured to provide a connection between the first sheetlike siding and the third sheet-like siding; and a quaternary of the four tab elements is configured to provide a connection between the second sheet-like siding and the fourth sheet-like siding. In a further particular implementation, the first sheet-like siding can include a through-going coupling opening adapted to allow fitting engagement of the housing with a skin attachment component or with a tracheostomy tube. The second sheet-like siding does not include any through-going opening. The third sheetlike siding includes a through-going opening. The through-going opening in the third sheet-like siding can be of smaller size than the through-going coupling opening in the first sheet-like siding. The fourth sheet-like siding also includes yet another through- going opening. The through-going opening in the fourth sheet-like siding can be of larger size than the through-going coupling opening in the first sheet-like siding (and hence also of larger size than the through-going opening in the third sheet-like siding). An outer diameter of the third and the fourth sheet-like sidings can be slightly less than an outer diameter of the first and second sheet-like sidings. At least the second sheet-like siding can include at least one notch configured to engage with the primary tab element.
[0110] In implementations, one of the sheet-like sidings includes a surface-indentation configured to receive and guide a fingertip of a user. This is particularly advantageous in implementations incorporating a speaking functionality ("speech valve") in the HME device (as described elsewhere in this disclosure). The surface-indentation can include a recess or depression in the sheet-like siding. The recess or depression can preferably be provided with an ergonomically smooth profile such as to provide a pleasant, intuitive and easily locatable landing zone for the user's fingertip.
[0111] In implementations, one or more of the sheet-like sidings include(s) one or more portions formed with a surface contour including one or more three-dimensional portions adapted to increase the flexural modulus of the siding. Adding three- dimensional portions to a flat sheet-like siding, for example by adding embossed or recessed areas, increases the flexural modulus of the siding. The surface contour can include that the paper-based material of the housing of the HME device includes a stair-like pattern profile having a plurality of stepped portions, e.g., with a plurality of linear portions extending alternately perpendicular to each other. This configuration helps provide a reinforcing effect to the paper-based material and can thus increase the mechanical properties of the sheet-like siding. In particular implementations, a sheet-like siding with a surface contour adapted to increase the mechanical properties of the paper-based siding is provided in an implementation of a sheet-like siding including a through-going coupling opening. Thereby, the sheet-like siding can include a relatively large opening while retaining sufficient mechanical properties, such as, but not exclusively, the integral strength thereof, during the steps of attaching the HME device to a skin attachment component or tracheostomy tube. In some implementations, the paper-based material of a sheet-like siding of the housing can be pre-formed, e.g., including one or more embossments, to thereby increase the mechanical properties of the sheet-like siding.
[0112] In implementations, at least one surface portion of the housing includes an adhesive material. The at least one surface portion of the housing can include one or more of at least one surface portion of a sheet-like siding and / or one or more of at least one surface portion of a tab element. Generally, the adhesive material can be provided for maintaining the spatial relation between the two or more sheet-like sidings and the one or more tab elements of the housing when the accommodation of the housing including an HME material located therewithin is established. It is to be understood that the adhesive material helps provide a locking of the components in the desired relation to each other. Alternatively, or additionally, the optional one or more notches provided in a sheet-like siding can also help provide locking of the components in relation to each other.
[0113] In another aspect, the disclosure relates to a paper-based blank for a foldable housing for a heat and moisture exchange (HME) device for a laryngectomized or tracheostomized user. The paper-based blank includes two or more sheet-like sidings including a first sheet-like siding and a second sheet-like siding. Each of the sheet-like sidings includes a peripheral edge portion. The paper-based blank also includes one or more tab elements extending from the peripheral edge portion of a siding. The one or more tab elements are configured to engage with a different one of the two or more sidings to provide a connection between the sidings. The two or more sheet-like sidings and the one or more tab elements are configured to be folded in relation to each other such as to define an accommodation of the foldable housing for an HME material of the HME device.
[0114] It should be understood that the paper-based blank for the foldable housing for an HME device is generally made from a paper-based material. Thereby, it is to be understood that each of the two or more sheet-like sidings and the one or more tab elements are generally made from a paper-based material. In implementations, the paper-based blank consists of a paper-based material. Thereby, it is understood that in some cases the paper-based blank consists entirely of a paper-based material.
[0115] In implementations, the paper-based blank includes a paperboard material (as defined elsewhere in this disclosure).
[0116] In implementations, the paper-based blank includes a lining on one or more portions of its surface. In implementations, the lining is adapted to cover an entirety of the paper-based blank. Thereby, it is understood that an entire surface area of the paper-based blank can be covered by the lining. In implementations, the blank is made from the paper-based material covered with the lining before being processed further. The lining can suitably be of the same type(s) as described above under the description of the first aspect.
[0117] The two or more sheet-like sidings of the paper-blank each includes a peripheral edge portion. The two or more sheet-like sidings and their peripheral edge portion can suitably be the same or similar to those described and defined above under the first aspect. The peripheral edge portion can be understood to form an outer contour (seen in a plan view) and provide a general delimitation of a sheet-like siding towards its surroundings and can take any of the shapes defined above.
[0118] As above, the term "tab element" generally refers to a small flap or strip of material. In the present context, a tab element can be understood as something which is suitable and useful for engaging with and holding "onto" something else and which is generally manipulable, including being manipulable in more than one manner and / or more than one dimension and / or more than one direction. A tab element extends from the peripheral edge portion of a sheet-like siding of the paper-based blank. Each tab element is configured to engage with a different siding of the paper-based blank. Thereby, a tab element can be understood to provide a connection between two respective sidings of the paper-based blank. The one or more tab elements of the paper-based blank are suitably as described and defined above under the first aspect.
[0119] In implementations, at least one of the one or more tab elements is / are provided integrally with at least one of the two or more sheet-like sidings of the paperbased blank for the foldable housing for the HME device. Thereby, it is understood that a sheet-like siding and a tab element of the paper-based blank can be provided as a continuous entity, for example, the tab element can be understood as an extension portion projecting from the sheet-like siding, such as from the peripheral edge portion thereof. In implementations, at least one of the one or more tab elements is / are provided integrally with and configured to form a connection between two sheet-like sidings of the paper-based blank. Thus, in implementations, a tab element can be provided integrally with two sheet-like sidings, thereby understood to be continuous with both sidings and provide a connection between the two sidings of the paperbased blank.
[0120] In implementations of the paper-based blank, more than one tab element can be provided integrally with one sheet-like siding, for example, the tab elements each provide an extension portion projecting from the sheet-like siding, such as from different positions along the peripheral edge portion thereof. In implementations, each of two tab elements can be provided integrally with each of two sheet-like sidings, thereby presenting a paper-based blank including at least a first and a second sheetlike siding connected to each other by each of two tab elements provided integrally with each siding.
[0121] The two or more sheet-like sidings and the one or more tab elements of the paper-based blank are configured to be folded in relation to each other such as to define an accommodation of the foldable housing for an HME material of the HME device.
[0122] Thus, it is understood that when the paper-based blank is provided according to the desired characteristics selected from the various features in the implementations presented in this disclosure, the paper-based blank can be further processed by folding of the blank to provide the accommodation of the foldable housing of the HME device. Before locking the two or more sheet-like sidings and the one or more tab elements in position in relation to each other, for example by use of adhesive material or ultrasonic welding as described for the first aspect, an HME material is located in the accommodation of the foldable housing of the HME device created by the folding action. The folding action can be carried out either manually or mechanically. Alternatively, the HME material can be placed in the accommodation of the foldable housing of the HME device after the folding action.
[0123] The two or more sheet-like sidings and the one or more tab elements of the paper-based blank are configured to be folded in relation to each other to define an accommodation of the foldable housing for the HME material. Thereby, the two or more sheet-like sidings and the one or more tab elements of the paper-based blank can be provided in a spatial position relative to each other such that they unite (come together) and define the accommodation of the foldable housing for the HME device.
[0124] In implementations, a first sheet-like siding and a second sheet-like siding of the paper-based blank are folded to be positioned and extend in a generally parallel relationship to each other and with some distance between them. In implementations, the two or more sheet-like sidings can be understood to be provided in parallel planes with some distance between the planes. In implementations, the two or more sheetlike sidings can be folded to be positioned and have coinciding peripheral edge contours, wholly or partially (when seen in a plan view with one siding in a plane above the other).
[0125] Also, the one or more tab elements is / are configured to be folded and positioned in relation to the two or more sheet-like sidings and / or to each other. In implementations of a paper-based blank including more than one tab element, the tab elements can for example be positioned to each other such that the at least two tab elements generally extend in the same direction and / or along parallel axes.
[0126] In implementations, the paper-based blank for the foldable housing is folded such that one or more tab elements and the two or more sheet-like sidings include that the first and second sheet-like sidings extend in a generally parallel relationship to each other and the one or more tab elements extend(s) in a direction which is generally perpendicular to the parallelly-extending first and second sheet-like sidings.
[0127] In implementations, the paper-based blank for the foldable housing for the HME device includes three sheet-like sidings.
[0128] In implementations, the paper-based blank for the foldable housing for the HME device includes four sheet-like sidings. In particular implementations, the paper-based blank for the foldable housing for the HME device includes a first sheet-like siding with a peripheral edge of round closed shape and a second sheet-like siding with a peripheral edge of round closed shape and a third sheet-like siding with a peripheral edge of round closed shape and four tab elements configured to provide a connection between at least the first and second sidings. In implementations, the four tab elements are configured to provide a connection between the first, second, and third sidings. In other implementations, a primary of the four tab elements is configured to provide a connection between the first and the second siding and each of a secondary, a tertiary, and a quaternary of the four tab elements is configured to provide a connection between any two or more of the first, second, and third sidings.
[0129] In a particular implementation, the paper-based blank for the foldable housing for the HME device includes three sheet-like sidings and four tab elements, wherein a primary of the four tab elements is configured to provide a connection between the first sheet-like siding and the second sheet-like siding; and a secondary of the four tab elements is configured to provide a connection between the first sheet-like siding and the third sheet-like siding; and a tertiary and a quaternary of the four tab elements are configured to each provide a connection between the first sheet-like siding and one or both of the second and the third sheet-like siding.
[0130] In implementations, the paper-based blank for the foldable housing for the HME device includes four sheet-like sidings.
[0131] In implementations, each of the sheet-like sidings of the paper-based blank for the foldable housing of the HME device are adapted to have a substantially round closed shape.
[0132] In particular implementations, the paper-based blank for the foldable housing for the HME device includes a first sheet-like siding with a peripheral edge of round closed shape and a second sheet-like siding with a peripheral edge of round closed shape and a third sheet-like siding with a peripheral edge of round closed shape and a fourth sheet-like siding with a peripheral edge of round closed shape, and two tab elements configured to provide a connection between at least the first and second sidings. In implementations, each of the two tab elements is configured to provide a connection between any two or more of the first, second, third, and fourth sidings. In particular implementations, the paper-based blank for the foldable housing for the HME device includes a first sheet-like siding with a peripheral edge of round closed shape and a second sheet-like siding with a peripheral edge of round closed shape and a third sheet-like siding with a peripheral edge of round closed shape and a fourth sheet-like siding with a peripheral edge of round closed shape, and four tab elements configured to provide a connection between at least the first and second sidings. In implementations, the four tab elements are configured to provide a connection between any two or more of the first, second, third, and fourth sidings.
[0133] In a particular implementation, the paper-based blank for the foldable housing for the HME device includes four sheet-like sidings and four tab elements, wherein a primary of the four tab elements is configured to provide a connection between two, or all three, of the first, second, and third sheet-like siding; and a secondary of the four tab elements is configured to provide a connection between the first sheet-like siding and the second sheet-like siding; and a tertiary of the four tab elements is configured to provide a connection between the first sheet-like siding and the third sheet-like siding; and a quaternary of the four tab elements is configured to provide a connection between the second sheet-like siding and the fourth sheet-like siding.
[0134] In implementations, the paper-based blank for the foldable housing of the HME device includes three sheet-like sidings, the three sidings including a first siding including a through-going opening, a second generally continuous siding, and a third generally continuous siding. The first siding and the second siding are connected to each other by one primary tab element that is provided integrally with each of the first siding and the second siding and extends radially from a first position on the peripheral edge portion of the first siding. The first siding and the third siding are connected to each other by one secondary tab element that is provided integrally with each of the first siding and the third siding and extends radially from a second position on the peripheral edge portion of the first siding. The second position can be understood as being on an opposite side of the peripheral edge portion of the sheet-like first siding relative to the first position. The term "continuous siding" is to be understood such that the siding in question generally does not include openings or at least that a major portion of the siding is solid. A "continuous siding" can however include one or more notches provided in the peripheral edge portion. The term "opposite side" is to be understood such that if one tab element extends from the peripheral edge portion of a siding at a first position which is considered the 6 o'clock position, then the second tab element extends from the peripheral edge portion of the same siding at a second position which is then the 12 o'clock position.
[0135] In implementations, the paper-based blank for the foldable housing of the HME device includes a first sheet-like siding including a tertiary tab element provided integrally with the first siding and extending radially from a third position on the peripheral edge portion of the first siding, the third position being different from each of the first and second positions, respectively.
[0136] In implementations, the paper-based blank for the foldable housing of the HME device includes a first sheet-like siding including a quaternary tab element provided integrally with the first siding and extending radially from a fourth position on the peripheral edge portion of the first siding, the fourth position being different from each of the first, second, and third positions, respectively.
[0137] In implementations, the paper-based blank for the foldable housing of the HME device is configured such that the first, second, third, and fourth positions are distributed such that the primary, secondary, tertiary, and quaternary tab elements extend from the peripheral edge portion of the first siding in directions being at an angle of approximately 90 degrees to each other. Thus, by analogy to above, if one tab element for example extends from the peripheral edge portion of a siding at a first position which is considered the 6 o'clock position, then a second tab element extends from the 9 o'clock, a third tab element extends from the 12 o'clock position, and a fourth tab element extends from the 15 o'clock position.
[0138] In implementations, the first sheet-like siding of the paper-based blank for the foldable housing of the HME device includes a surface portion adapted to receive an HME material. The HME material can suitably include an HME foam. Thereby, the surface portion of the first sheet-like siding can be arranged to easily receive and engage with the HME material, such that the HME material can conveniently be placed in the accommodation of foldable housing of the HME device during the final steps of folding and positioning of the components of the foldable housing in relation to each other. In implementations, the surface portion of the first sheet-like siding can include a recess or similar in which the HME can be positioned and potentially secured in place, e.g., by a press-fit connection. More than one of the sheet-like sidings can include a surface portion adapted to receive the HME material if additional engagement of the HME material with the foldable housing is considered beneficial.
[0139] In implementations, one or more of the sheet-like sidings of the paper-based blank for the foldable housing of the HME device include(s) one or more portions formed with a surface contour including one or more three-dimensional portions adapted to increase the flexural modulus of the siding. One or more three-dimensional surface contour portions can help increase mechanical properties of the respective siding. The surface contour of the one or more sidings can generally be provided in accordance with the description of surface contour provided in relation to the first aspect above. In implementations, the surface contour includes one or more embossments in a respective siding. In implementations, the surface contour includes one or more recessed areas in a siding.
[0140] In implementations, at least one of the sheet-like sidings of the paper-based blank for the foldable housing of the HME device includes one or more notches extending radially inward from the peripheral edge portion and configured to engage with a tab element of a different siding. The one or more notches can generally be provided in accordance with the description of notches provided in relation to the first aspect above.
[0141] In implementations, one or more surface portions of the paper-based blank include(s) an adhesive material. The one or more surface portions including adhesive can generally be provided in accordance with the description provided in relation to the first aspect above.
[0142] In implementations, one or more of the sheet-like sidings of the paper-based blank for the foldable housing of the HME device include(s) a through-going opening. The through-going opening can generally be provided in accordance with the description provided in relation to the first aspect above.
[0143] In implementations, at least one of the sheet-like sidings of the paper-based blank for the foldable housing of the HME device includes a through-going coupling opening adapted to allow fitting engagement of the HME device with a skin attachment component or with a tracheostomy tube. The through-going coupling opening can generally be provided in accordance with the description provided in relation to the first aspect above. In implementations, at least one of the one or more tab elements of the paperbased blank for the foldable housing of the HME device include(s) one or more creases. A crease provided in a tab element can generally be considered a "collapse- crease". This is to be understood such that the primary functionality of the collapse- crease is to allow a tab element to collapse (undergo a sharp bending along an axis of the crease (axis generally parallel to planes of the one or more sheet-like sidings) in a controlled manner. It can be understood that one or more "collapse-" creases provided in a tab element can help provide for the tab element to form a "collapsible paper pillar" for the purpose of providing speech-functionality to the paper-based HME device. In implementations, all tab elements of the paper-based blank include at least one collapse-crease.
[0144] This "collapsibility" is particularly useful when the HME device is subjected to a certain externally provided force, such as finger-pressure provided on an external surface of a siding of the foldable housing of the HME device for occluding the passage of air through the HME device when the user wants to speak, as also described above. In accordance therewith, in implementations, one of the sheet-like sidings of the paper-based blank for the foldable housing of the HME device includes a surface-indentation configured to receive and guide a fingertip of a user.
[0145] In implementations, a transition between a sheet-like siding and a tab element at the peripheral edge portion of the siding of the paper-based blank for the foldable housing of the HME device includes a crease. A crease provided in a transition between a sheet-like siding and a tab element at the peripheral edge portion of the siding can generally be considered a "folding-crease". This is to be understood such that the primary functionality of the folding-crease is to facilitate easy and controllable folding of the paper-based blank between the tab element and the peripheral edge portion of the siding when combining the one or more tab elements and the two or more sheet-like sidings to define the accommodation of the foldable housing of the HME device.
[0146] In yet another aspect, the disclosure relates to a method for manufacturing a heat and moisture exchange (HME) device according to the first aspect. The method of manufacturing includes the following steps: - (a) providing a paper-based sheet material;
[0147] - (b) stamping at least one foldable housing blank for the HME device from the paper-based sheet material;
[0148] - (c) providing an HME material in engagement with at least one of the sheet-like sidings;
[0149] - (d) folding the at least one foldable housing blank to position the two or more sheet-like sidings and the one or more tab elements in spatial relation to each other to combine and define an accommodation of a housing of the HME device configured to hold the HME material therein;
[0150] - (e) securing the two or more sheet-like sidings and the one or more tab elements in one or more mutually locked relations such as to provide a structural integrity of the housing of the HME device.
[0151] Step (a) includes the provision of a paper-based sheet material. This can typically be supplied from paper manufacturers. Depending on the particular characteristics of the chosen paper-based material (see above under the first aspect) the sheet material can for example be provided on a roll and then unrolled to the appropriate format for manufacture. It is noted that in implementations, the paperbased sheet material can be provided including a lining as described elsewhere in this disclosure (e.g., the housing material includes a paper carton double-sidedly laminated with a lining material). Alternatively, in implementations, the method further includes providing a lining on the paper-based sheet material in a step immediately subsequent to step (a).
[0152] Step (b) includes stamping at least one foldable housing blank for the HME device from the paper-based sheet material. In this disclosure, "stamping" is intended to mean to press an appropriately shaped tool, e.g., formed of metal, into the sheet material to press and / or cut a foldable housing blank out of the (typically relatively large) paper-based sheet material. It is understood that step (b) can include stamping of a plurality of blanks simultaneously, in which case each of a plurality of identically shaped tools is made to work simultaneously on the paper-based sheet material. It is further understood that in implementations, the tool can be adapted to form (stamp out) a foldable housing blank in accordance with the desired configuration of the resulting housing for the HME device, i.e., the tool can be provided to stamp out a blank with two or more sidings, one or more tab elements, and any one or more of the optional other features described herein. In implementations, the tool can be adapted to stamp out the two or more sidings of the at least one foldable housing blank as two or more separate entities that can be folded into the housing of the HME device. For ease of production, two or more separate entity parts of the housing blank such as including the two or more sidings can be held cursory together by a thin strip of the paper material (comparable to flash or a fin in injection moulding technique) until the folding action takes place. The thin strip between the separate entity parts can easily be torn or removed when needed to prepare the separate entity parts for folding the housing of the HME device. In implementations, the tool can be adapted to form (stamp out or cut) a through-going opening in one or more of the two or more sheetlike sidings, meaning that in implementations incorporating one or more through-going openings the opening(s) can be provided (by the tool) in the sheet-like siding(s) simultaneously in the process of stamping the foldable housing blank from the paperbased sheet material. Alternatively, in implementations, the method further includes providing a through-going opening in one or more of the two or more sheet-like sidings in a step immediately subsequent to step (b).
[0153] In implementations, the step of providing a through-going opening includes providing a through-going coupling opening in a sheet-like siding. This can include providing a through-going coupling opening being adapted to allow fitting engagement of the HME device with a skin attachment component or with a tracheostomy tube. This can include providing the coupling opening with a particularly shaped and / or customized inner peripheral edge suitable for the fitting engagement. This can be done e.g. using a cutting or pressing tool and or by other suitable means.
[0154] Step (c) includes providing an HME material in engagement with at least one of the sheet-like sidings. A suitable nature and characteristics of the HME material is described elsewhere in this disclosure. In implementations, step (b) can further include a sub step of providing a surface portion adapted to receive the HME material in the first sheet-like siding of the paper-based blank. In implementations, the surface portion of the first sheet-like siding can include a recess or similar pressed or cut into the surface of the blank by the tool, in which recess or cut the HME can be positioned and potentially secured in place, e.g., by a press-fit connection. More than one of the sheet-like sidings can include a surface portion adapted to receive the HME material if additional engagement of the HME material with the housing is considered beneficial. Regardless of the provision of an adapted surface portion of the one or more sidings, the HME material can be placed in engagement with at least one of the two or more sheet-like sidings. In implementations, the HME material and / or the at least one siding can include an adhesive material to further secure engagement between the parts.
[0155] Step (d) includes folding the at least one foldable housing blank to position the two or more sheet-like sidings and the one or more tab elements in spatial relation to each other to combine and define an accommodation of a housing of the HME device configured to hold the HME material therein. Thereby, it is understood that the foldable housing blank is folded such that the components of the housing (incl. the sidings and the one or more tab elements) are positioned in relation to each other and combine to form the accommodation of the housing of the HME device suitable for holding (containing) the HME material positioned therein. During the folding, a three- dimensional holding space forming the accommodation is created around the HME material engaged with at least one of the sidings.
[0156] Step (e) includes securing the two or more sheet-like sidings and the one or more tab elements in one or more mutually locked relations such as to provide a structural integrity of the housing of the HME device.
[0157] In implementations, the method further includes providing an adhesive material on at least one surface portion of the foldable housing blank. This can include providing adhesive material on one or more of at least one surface portion of a sheetlike siding and / or on one or more of at least one surface portion of a tab element.
[0158] In implementations, the method further includes welding of the lining on two different surface portions of the housing in one or more discrete positions.
[0159] In implementations, the components are mutually locked using adhesive material provided on the surface of one or more of the components. In implementations, the components are mutually locked by configuring one or more of the sidings with one or more notches adapted to receive and engage with one or more tab elements of one or more different sidings. In implementations, the components are mutually locked using both adhesive material and interlocking using notches. In implementations incorporating three or more sidings, one or more tab elements can further be locked in mutual engagement between surfaces of two or more sidings.
[0160] In implementations, step (d) is carried out before step (c). Thus, in such implementations of the method of manufacturing, step (d) can alternatively be carried out before step (c) meaning that the folding action of the paper-based foldable housing blank can be carried out before the HME material is engaged with the one or more sidings. This is to be understood such that in accordance with step (d) the foldable housing blank is folded along the one or more folding-creases at the transition between sheet-like sidings and tab elements to basically form a three-dimensional holding space of the accommodation of the housing. Next, the HME material is provided in engagement with at least one of the sheet-like sidings, e.g., by simply placing the HME material on the surface of the siding or alternatively press-fitting the HME material into a recess provided in the surface of the siding, or other.
[0161] The formation of the housing is then finalized by carrying out step (e), i.e., securing the two or more sheet-like sidings and the one or more tab elements in one or more mutually locked relations such as to provide a structural integrity of the housing of the HME device. This means that the HME material is then securely located in the accommodation of the paper-based housing of the HME device.
[0162] Detailed description of the drawings
[0163] Figure 1 is a schematic, perspective view illustrating one implementation of an HME device 20 including housing 21 including a paper-based material as disclosed herein. The housing 21 includes two or more sheet-like sidings. The HME device 20 as illustrated in in the implementation of Fig. 1 includes a housing 21 having four sheetlike sidings including a first sheet-like siding 22, a second sheet-like siding 24, a third sheet-like siding 26 and a fourth sheet-like siding 27. Each of the sheet-like sidings 22, 24, 26, 27 includes a peripheral edge portion 28, 30, 32, 33.
[0164] The housing 21 of the HME device 20 further includes one or more tab elements extending from the peripheral edge portion of a siding. Each of the one or more tab elements is configured to engage with a different one of the two or more sidings to provide a connection between two or more sidings. In the implementation of the HME device 20 as illustrated in Fig. 1, three tab elements 38, 40, 42 are visible of a totality of four tab elements. In Fig. 1, the tab element 38 connects at least the second sheet-like 24 and the fourth sheet-like siding 7 and tab elements 40, 42 connect at least the first sheet-like siding 22 and the second sheet-like siding 24. The sheet-like sidings 22, 24, 26, 27 and the tab elements 38, 40, 42 are positioned in spatial relation to each other to combine and define an accommodation 58 of the housing 21 of the HME device 20. An HME material 60 is provided in the accommodation 58 of the housing 21.
[0165] Figure 2 is a schematic, perspective view illustrating one implementation of a foldable housing blank 100 of a paper-based material for an HME device 20 (Fig. 1) as disclosed herein. The foldable housing blank 100 shown includes four sheet-like sidings 102, 104, 106, 107. Each of the sheet-like sidings 102, 104, 106, 107 includes a peripheral edge portion 108, 110, 112, 113. The foldable housing blank 100 also includes four tab elements 114, 116, 118, 120 extending from respective peripheral edge portions of the sidings. Primary tab element 114 extends from the peripheral edge portion 108 of the first sheet-like siding 102. Secondary and tertiary tab elements 116 and 118 extend from mutually opposite sides (positions) on the peripheral edge portion 108 of the first sheet-like siding 102. Each of the secondary and tertiary tab elements 116, 118 extends from opposite sides of the first siding 102 at an angle of approximately 90 degrees in relation to the axial direction of the first tab element 114. In the view of Fig. 2, the foldable housing blank 100 includes sheetlike sidings each with a peripheral edge of generally round closed shape. Secondary tab element 116 engages with the second sheet-like siding 104 and is seen to provide a connection between the first sheet-like siding 102 and the second sheet-like siding 104. Tertiary tab element 118 engages with the third sheet-like siding 106 and is seen to provide a connection between the first sheet-like siding 102 and the third sheet-like siding 106. Quaternary tab element 120 engages with the secondary sheet-like siding 104 and is seen to provide a connection between the fourth sheet-like siding 107 and the second sheet-like siding 104.
[0166] The peripheral edge portions 108, 110, 112, 113 of each of the sidings 102, 104, 106, 107 can be seen to form an outer contour and provide a general delimitation of each of the sheet-like sidings towards their surroundings. In the view of Fig. 2, each of the tab elements 114, 116, 118 is provided integrally with the first sheet-like siding 102 meaning that each of the tab elements 114, 116, 118 is provided as a continuous entity with the first sheet-like siding 102. Each of the tab elements 114, 116, 118 can be seen to form an extension portion projecting from the first sheet-like siding 102, such as from the peripheral edge portion 108 thereof. In the view of Fig. 2, the third tab element 118 is provided integrally with and forms a connection between the first sheet-like siding 102 and the third sheet-like siding 106 and the secondary tab element 116 is provided integrally with and forms a connection between the first sheet-like siding 102 and the second sheet-like siding 104. In the view of Fig. 2, the quaternary tab element 120 is provided integrally with both the fourth sheet-like siding 107 and the second sheet-like siding 104 thus forming a continuous entity with both sidings and a connection between them.
[0167] In the view of Fig. 2, the first sheet-like siding 102 of the foldable housing blank 100 includes a through-going coupling opening 124, whereas the second sheet-like siding 104 is provided as a generally continuous siding. The third sheet-like siding 106 includes a through-going opening 125. In Fig. 2, the through-going opening 125 is shown to be of smaller diameter than the through-going coupling opening 124 in the first sheet-like siding 102. The through-going opening 125 is further described below. The fourth sheet-like siding 107 includes another through-going opening 127. In Fig. 2, the through-going opening 127 is shown to be of greater diameter than the through- going coupling opening 124 in the first sheet-like siding 102. The through-going opening 127 is further described below.
[0168] The through-going coupling opening 124 is adapted to allow fitting engagement of the HME device 20 with a skin attachment component (or with a tracheostomy tube). Thereby, the first sheet-like siding 102 with the through-going coupling opening 124 provides for easy and intuitive engagement and coupling of the HME device 20 to another component, such as a skin attachment component in the form of an adhesive base plate for a laryngectomized patient in itself including a suitable coupling or adapter element 70, such as a ring-shaped flange 75 extending distally from an adhesive base plate 80 shown in Fig. 8. Figure 2 further illustrates an implementation, wherein the through-going coupling opening 124 of the first sheetlike siding 102 includes an inner peripheral edge portion including two indents 131, 133, thereby breaking an otherwise continuous nature of the inner peripheral edge. The two indents 131, 133 help provide additional flexibility to the first sheet-like siding 102 and further helps a user attaching the HME device 20 to a coupling element 70 such as a ring-shaped flange 75 extending generally perpendicularly from the skin attachment component, such as the adhesive base plate 80 in Fig. 8.
[0169] Figure 2 further illustrates an implementation, wherein the second sheet-like siding 104 includes a notch 129 extending radially inward from the peripheral edge portion 110 of the second sheet-like siding 104 and is configured to engage with a tab element of a different one of the sheet-like sidings, in Fig. 1 this engagement is with the primary tab element 114 extending from the first sheet-like siding 102. The notch 129 provided in the second sheet-like siding 104 offers various benefits, of which one is to help provide locking of the components 102, 104, 106, 107, 114, 116, 118, 120 of the housing 21 in relation to each other.
[0170] Figures 3A and 3B are schematic, perspective views illustrating an HME device housing 21 resulting from performing the folding action of the foldable housing blank 100 of Fig. 2 (with the exception that Figs. 3A and 3B, for ease of illustration, do not show the HME material 60 located in the accommodation 58 of the housing 21). As can be seen from Figs. 3A and 3B, the four sheet-like sidings 102, 104, 106, 107 and the four tab elements 114, 116, 118, 120 have been folded and positioned in mutually locked relationship to each other so as to define the accommodation 58 of the housing 21 for the HME material (cf. Fig. 1) of the HME device 20. The described folding action can be carried out either manually or mechanically.
[0171] In the views of Figs. 1-3B, implementations include that the first sheet-like siding 102 and the second sheet-like siding 104 are positioned and extend in a generally parallel relationship to each other with a distance "d" between them, thereby defining one dimension of a holding space of the accommodation 58. The third and fourth sheet-like sidings 106, 107 also each extends generally parallel to each of the first and second sheet-like sidings 102, 104. In the views of Fig. 3A and 3B, each of the first and second sheet-like sidings 102, 104 is of greater diameter than each of the third and fourth sidings 106, 107. In the views of Figs. 3A and 3B, the tab elements 114, 116, 118, 120 extend in a direction which is generally perpendicular to the parallelly-extending first to fourth sheet-like sidings 102, 104, 106, 107 to thereby form the accommodation 58 of the housing 21. Fig. 3A further illustrates one implementation of a through-going opening 125 in the third sheet-like siding 106 being of smaller diameter than the through-going coupling opening 124 in the first sheet-like siding 102. As Fig. 3A shows the housing 21 in the folded (with components mutually locked) configuration, the third sheet-like siding 106 is provided on top of the second sheet-like siding 104 and it is therefore not possible to see through the opening 125 as the second siding 104 blocks the passage. The size of the through-going opening 125 is chosen in accordance with the specific purpose of receiving and guiding a fingertip of a user. This is particularly advantageous in implementations incorporating a speaking functionality ("speech valve") in the HME device. The inner peripheral edge of the through-going opening 125 in the third sheetlike siding 106 provides an intuitive and easily discernible tactile sensation on a user's fingertip when engaged, thereby offering guidance for a user to push and provide pressure approximately on the centre of the HME device for a speaking action.
[0172] Fig. 3B further illustrates one implementation of another through-going opening 127 in the fourth sheet-like siding 107 being of greater diameter than the through-going coupling opening 124 in the first sheet-like siding 102. As Fig. 3B shows the housing 21 in the folded (with components mutually locked) configuration, the fourth sheet-like siding 107 is provided 'underneath' the first sheet-like siding 102 and an entirety of the through-going coupling opening 124 in the first siding 104 overlaps with the through-going opening 127 in the fourth siding 107. The size of the through- going opening 127 is chosen such that an entirety of the solid portion of the fourth siding 107 is in engagement with the first siding 102, thereby providing a reinforcing effect to the first siding 102 and in turn the housing 21, which is particularly advantageous for strengthening the paper-based HME device during engagement and coupling of the HME device 20 to a skin attachment component (while maintaining the desired size of the through-going coupling opening 124).
[0173] In one possible implementation of a folding action of the foldable housing blank 100 illustrated in Figs. 2-3B, the second siding 104 is folded first. The folding action involves the secondary tab element 116 and suitably includes folding along folding- creases 134 and 136 provided at a transition between the secondary tab element 116 and the first and second sidings 102, 104, respectively. As a result of the first step of the folding action, a surface portion denoted as an internal surface portion 138 of the second siding 104 is located over an internal surface portion 139 of the first siding 102. Alternatively, an HME material has already been located on the internal surface portion 139 of the first siding 102, in which case the folding of the second siding 102 results in the internal surface portion 138 of the second siding 104 being brought into engagement with a top surface portion of the HME material (not shown). In a next (second) step of the folding action, the primary tab element 114 is folded along folding-crease 150 provided at a transition between the first tab element 114 and the first siding 102. Thereby, an end portion 154 of the primary tab element 114 is engaged with (on top of) an external surface portion 148 of the second siding 104. In the implementation illustrated in Fig. 2, the second siding 104 includes notch 129 in this case facilitating receipt of the primary tab element 114. In a next (third) step of the folding action the tertiary tab element 118 is along folding-creases 160 and 162 provided at transitions between the tertiary tab element 118 with the first and third sidings 102 and 106, respectively. Thereby, the third siding 106 is folded to be positioned in engagement with (on top of) the surface portion 148 of the second siding and further thereby locks the end portion 154 of the primary tab element 114 in position between the second and third sidings 104, 106. In a final (fourth) step of the folding action, the fourth sheet-like siding 107 is folded, which involves the quaternary tab element 120 and suitably includes folding along folding-creases 170 and 172 provided at transitions between the quaternary tab element 120 with the second and fourth sidings 104, 107, respectively. As a result of the fourth step of the folding action, an internal surface portion 147 of the fourth siding 107 is brought into engagement with the external surface portion 148 of the second siding 104, thereby locating the fourth siding 107 "underneath" the second siding 104. The end portion 154 of tab element 114 and / or any of the surface portions of any one or more of the first, second, third, and fourth sidings 102, 104, 106, 107, including, but not limited to, internal surface portions 138, 139 and 147, can be provided with an adhesive material to secure the sidings and the tab elements in mutually locked relation and provide a structural integrity of the foldable housing. In implementations wherein the housing includes a lining provided on the paper-based material and the lining includes a bi- axially oriented polypropylene (BOPP) film material or a polyethylene (PE) material, the film material provides excellent bonding characteristics when two surfaces including BOPP or PE film material are (heat) welded together. Using either of these materials for the lining can therefore advantageously be used as an alternative to using adhesive material to secure the sidings and the tab elements in mutually locked relation and provide a structural integrity of the foldable housing.
[0174] Figure 4 is a schematic, perspective view illustrating another implementation of a foldable housing blank 200 of a paper-based material for an HME device 20 as disclosed herein. The foldable housing blank 200 shown includes three sheet-like sidings 202, 204, 206. Each of the sheet-like sidings 202, 204, 206 includes a peripheral edge portion 208, 210, 212. The foldable housing blank 200 also includes four tab elements 214, 216, 218, 220 extending from the peripheral edge portion of a siding. Primary and secondary tab elements 214 and 216 extend from opposite sides of the first sheet-like siding 202. In Fig. 4, neither of the primary and the secondary tab element 214, 216 are shown connected to other sidings than the first siding 202. Tertiary and quaternary tab elements 218, 220 also extend from opposite sides of the first siding 202 at an angle of approximately 90 degrees in relation to the axial direction of the primary and secondary tab elements 214, 216. Tertiary tab element 218 engages with the second sheet-like siding 204 and is seen to provide a connection between the first sheet-like siding 202 and the second sheet-like siding 204. Quaternary tab element 220 engages with the third sheet-like siding 206 and is seen to provide a connection between the first sheet-like siding 202 and the third sheet-like siding 206.
[0175] Although not explicitly visible in Fig. 4, it should be understood that the foldable housing blank 200 can include a lining 222 on one or more portions of its surface, in Fig. 4 indicated by arrow A pointing towards a major surface of the third sheet-like siding 206.
[0176] The peripheral edge portions 208, 210, 212 of each of the sidings 202, 204, 206 can be seen to form an outer contour and provide a general delimitation of each of the sheet-like sidings towards their surroundings.
[0177] Each of the four tab elements 214, 216, 218, 220 illustrated in Fig. 4 extends from the peripheral edge portion of a respective sheet-like siding of the foldable housing blank 200. In the view of Fig. 4, each of the tab elements 214, 216, 218, 220 is provided integrally with the first sheet-like siding 202 meaning that each of the tab elements 214, 216, 218, 220 is provided as a continuous entity with the first sheet-like siding 202. Thus, each tab element can be understood to form an extension portion projecting from the first sheet-like siding 202, such as from the peripheral edge portion 208 thereof. In the view of Fig. 4, the tertiary tab element 218 is provided integrally with and forms a connection between the first sheet-like siding 202 and the second sheet-like siding 204 and the quaternary tab element 220 is provided integrally with and forms a connection between the first sheet-like siding 202 and the third sheet-like siding 206.
[0178] In the view of Fig. 4, the foldable housing blank 200 includes a first sheet-like siding 202 with a peripheral edge 209 of round closed shape; a second sheet-like siding 204 with a peripheral edge 211 of round closed shape, and; a third sheet-like siding 206 with a peripheral edge 213 of round closed shape and four tab elements 214, 216, 218, 220.
[0179] In the view of Fig. 4, the first sheet-like siding 202 of the foldable housing blank 200 includes a through-going coupling opening 224, whereas both the second sheetlike siding 204 and the third sheet-like siding 206 are provided as generally continuous sidings.
[0180] The through-going coupling opening 224 is adapted to allow fitting engagement of an HME device with a housing formed by blank 200 with a skin attachment component (or with a tracheostomy tube) similar to the manner in which the HME device with a housing 21 formed by blank 100 of Figs. 1-3B attached.
[0181] In the view of Fig. 4, the first sheet-like siding 202 includes a portion 226 around the through-going coupling opening 224 formed with a surface contour adapted to increase mechanical properties of the first sheet-like siding 202. In the view of Fig. 4, the surface contour includes that the paper-based material of the foldable housing blank 200 is provided with a stair-like pattern profile with a plurality of stepped portions, here shown as a plurality of linear portions alternatingly extending perpendicular to each other. This configuration helps provide a reinforcing effect to the paper-based material and thus increases the mechanical properties of the first sheet-like siding 202 of the foldable housing blank 200. The surface contour can also include one or more embossments provided in the paper-based material of a respective siding.
[0182] Figure 5 is another schematic, perspective view similar to Fig. 4 illustrating an implementation of a foldable housing blank 200 of a paper-based material for an HME device. The housing blank of Fig. 5 is similar to that of Fig. 4. The primary difference between Figs. 4 and 5 is that Fig. 5 further illustrates an HME material 260 provided as a ring-shaped element 230. Arrow B indicates that the ring-shaped element 230 of HME material 260 is configured to be engaged with the first sheet-like siding 202, such as on an (annular) surface portion 232 thereof. Arrows C indicate a direction of folding of the second sheet-like siding 204. Arrows D indicate a direction of folding of the primary and secondary tab elements 214, 216. Arrows E indicate a direction of folding of the third sheet-like siding 206.
[0183] In one possible implementation of a folding action of the foldable housing blank 200 illustrated in Figs. 4 and 5, the second siding 204 is folded first. The folding action involves the tertiary tab element 218 and suitably includes folding along folding- creases 234 and 236 provided at a transition between the tertiary tab element 218 and the first and second sidings 202, 204, respectively. As a result of the first step of the folding action, a surface portion denoted as an internal surface portion 238 of the second siding 204 is brought into engagement with a surface portion denoted a top surface portion 240 of the HME material 260. In a next (second) step of the folding action, each of the primary and secondary tab elements 214, 216 is folded in the direction of arrows D, the folding takes place along folding-creases 250 and 252 provided at a transition between the first siding 202 and respective primary and secondary tab elements 214 and 216. As a result of the second step of the folding action, end portions 254, 256 of each of the primary and secondary tab elements 214, 216 are engaged with (on top of) a surface portion denoted external surface portion 248 of the second siding 204. In a final (third) step of the folding action, the third sheet-like siding 206 is folded, which involves the quaternary tab element 220 and suitably includes folding along folding-creases 242 and 244 provided at a transition between the quaternary tab element 220 and the first and third sidings 202, 206, respectively. As a result of the third step of the folding action, a surface portion denoted as an internal surface portion 246 of the third siding 206 is brought into engagement with the external surface portion 248 of the second siding 204, thereby locating the third siding 206 "on top of" the second siding 204 and also on top of the end portions 254, 256 of the tab elements 214 and 216. The end portions 254, 256 of tab elements 214, 216 and / or the external surface portion 248 of the second siding 204 and / or the internal surface portion 246 of the third siding 206 can suitably be provided with an adhesive material to secure the sidings and the tab elements in mutually locked relation and provide structural integrity of the housing. In implementations, such as illustrated by the views of Figs. 4-6, the first sheetlike siding 202 includes a surface portion 232 adapted to receive and engage with an HME material 260. In Figs. 4-6, the surface portion 232 of the first sheet-like siding 202 is arranged to receive and engage with the HME material 260, such that the HME material 260 can conveniently be placed in the accommodation 258 (Fig. 6) of the housing 221 for the HME device during the final steps of folding and positioning of the components of the housing 221 in relation to each other. Alternatively, in the views of Figs. 4-6, the first sheet-like siding 202 includes a recess 275 in which the HME material 260 can be placed and potentially secured. In the view of Fig. 5 the HME material 260 is in the form of ring-shaped element 230, e.g., made from an HME foam material.
[0184] Figure 6 is a schematic, perspective view illustrating an HME device housing 221 resulting from performing the above-described folding action of the foldable housing blank 200 of Figs. 4 and 5. As can be seen from Fig. 6, the three sheet-like sidings 202, 204, 206 and the four tab elements 214, 216, 218, 220, of which only primary tab element 214 and tertiary tab element 218 are visible, have been folded and positioned in mutually locked relationship to each other so as to define the accommodation 258 of the housing 221 for the HME material of the HME device.
[0185] As can be seen from the views of Figs. 4-6, implementations include that the first sheet-like siding 202 and the second sheet-like siding 204 are positioned and extend in a generally parallel relationship to each other with a distance "d" between them. The third sheet-like siding 206 also extends generally parallel to the first and second sheet-like sidings 202, 204. In the view of the implementation in Fig. 6, the three sheet-like sidings 202, 204, 206 have coinciding outer peripheral edge contours (the three sidings have generally the same diameter in this implementation).
[0186] In the view of Fig. 6, the housing 221 is folded such that the sheet-like sidings 202, 204, 206 extend in a generally parallel relationship to each other and the tab elements 214, 216, 218, 220 extend in a direction which is generally perpendicular to the parallelly-extending first to third sheet-like sidings to thereby help provide the accommodation 258 of the housing 221.
[0187] In the implementations illustrated in the views of Figs. 4-6 of the foldable housing blank 200 the tertiary tab element 218 provides a connection between the first sheet-like siding 202 and the second sheet-like siding 204; and the quaternary tab element 220 provides a connection between the first sheet-like siding 202 and the third sheet-like siding 206; and the primary and secondary tab elements 214, 216 each provide a connection between the first sheet-like siding 202 and one or both of the second sheet-like siding 204 and the third sheet-like siding 206 (when the housing 221 is in the folded configuration as in Fig. 6).
[0188] Figure 7 is a schematic, perspective view illustrating an implementation of the foldable housing 21 of a paper-based material for an HME device in accordance with Figs. 3A-3B. The housing includes four sheet-like sidings and four tab elements. In Fig. 7, the housing 21 is shown including an HME material 60 located in the accommodation 58 of the housing. In Fig. 7, the HME material 60 is an HME foam, typically a reticulated polyurethane foam impregnated with calcium chloride and provided in a ring- or donut-shape (cf. also Fig. 5). Furthermore, Fig. 7 indicates a coupling or adapter element 70 suitable for engagement with the through-going coupling opening 124 (Figs. 3A-3B) to provide for an easy and intuitive engagement and coupling of the paper-based housing 21 of the HME device to another component worn by the user. The other component is typically either a skin attachment component or a tracheostomy tube located in the trachea of the user, which suitably includes complementary means for coupling with the housing 21 of the HME device.
[0189] Fig. 8 is a schematic, cross-sectional side view illustrating an implementation of the housing 21 as in Fig. 7. Fig. 8 further illustrates a skin attachment component such as an adhesive base plate 80 for a laryngectomized patient that include the adapter element 70 shown in Fig. 7. The adapter element 70 can include a ring-shaped flange 75 of a relatively rigid nature extending generally perpendicularly from the adhesive base plate 80.
[0190] Figure 9A is a schematic, perspective view illustrating another implementation of a foldable housing blank 300 of a paper-based material for an HME device as disclosed herein. The foldable housing blank 300 shown includes three sheet-like sidings 302, 304, 306 each including a peripheral edge portion. The siding 302 includes a through-going coupling opening 324. The foldable housing blank 300 also includes four tab elements 314, 316, 318, 320 extending from the peripheral edge portion of a siding. Primary and tertiary tab elements 314 and 318 extend from opposite sides of the first sheet-like siding 302. Secondary and quaternary tab elements 316 and 320 also extend from mutually opposite sides of the first sheet-like siding 302 at an angle of approximately 90 degrees in relation to the axial direction of the primary and tertiary tab elements 314, 316. Secondaey tab element 316 engages with the second sheet-like siding 304 and is seen to provide a connection between the first sheet-like siding 302 and the second sheet-like siding 304. Quaternary tab element 320 engages with the fourth sheet-like siding 306 and is seen to provide a connection between the first sheet-like siding 302 and the third sheet-like siding 306. In the implementation illustrated in Fig. 9A, primary and tertiary tab elements 314, 318 are longer (extend further radially from the peripheral edge of the first siding 302) than secondary and quaternary tab elements 316, 320. The view of Fig. 9A further in particular illustrates creases provided in each of the four tab elements.
[0191] In implementations, and as illustrated in the schematic view of Fig. 9A, a transition between a sheet-like siding 302, 304, 306 and a tab element 314, 316, 318, 320 at a peripheral edge portion of a respective siding includes a crease 334, 336, 342, 344, 350, 352. Creases 334, 336, 342, 344, 350, 352 provided in the transitions generally provide "folding-creases". The primary functionality of the folding-creases 334, 336, 342, 344, 350, 352 is to facilitate easy and controllable folding of the foldable housing blank 300 in the transition between the respective tab elements 314, 316, 318, 320 and the peripheral edge portion of each of the sidings 302, 304, 306 when performing a folding action to define the accommodation of the housing of the HME device.
[0192] In implementations also illustrated in the view of Fig. 9A, the first and the third tab elements 314, 318 each also includes another crease 370, 372. In Fig. 9A, each of the creases 370, 372 is provided approximately halfway between a peripheral edge 309 of the first siding 302 and a radially outermost end 374, 376 of each of the first and third tab elements 314, 318. Creases 370, 372 can be understood to provide "collapse-creases". The primary functionality of the collapse-creases 370, 372 is to allow the tab element 314, 318 to collapse (undergo a sharp bending along an axis of the crease 370, 372) in a controlled manner. Each of the collapse-creases 370, 372 can be understood to form a "collapsible paper pillar" inter alia for the purpose of providing speech-functionality to the paper-based HME device, as explained below in relation to Fig. 10.
[0193] In implementations as illustrated in the view of Fig. 9B, which is an enlarged sectional view (or close-up) of a portion of the housing including a lining provided on the paper-based material of a siding, e.g. siding 304 of Fig. 9A. In the implementations of Fig. 9B, the lining is adapted to cover an entirety of the paper-based material. In the implementations of Fig. 9B, the housing includes a paper-based material provided as a paper carton 380 double-sidedly laminated with lining material, such as a layer of BOPP-film lining 385 on a first side of the paper-based material of siding 304 and another layer of BOPP-film lining 390 on a second side of the paper-based material of siding 304.
[0194] With reference to Fig. 10, which is a schematic, perspective view of one implementation of a housing 421 for an HME device 20 as disclosed herein, the collapsibility of collapse-creases 470, 472 provided in tab elements 414 and 420 is illustrated. The HME device 20 is connected to an adhesive base plate 80 via an adapter element 70 including a ring-shaped flange of a relatively rigid nature extending generally perpendicularly from the adhesive base plate 80. The collapsibility of the collapse-creases 470, 472 is particularly useful when the HME device 20 is subjected to an externally provided finger-pressure force, such as provided on the top (or distalmost) external surface of a siding of the housing 421 (indicated by arrow 'F' in Fig. 10). In such implementations, a user can provide finger-pressure on the housing to occlude the passage of air through the HME device 20 when the user wants to speak, as described above. By exerting a finger-pressure on the housing 421, the collapse- creases 470, 472 (other tab elements / collapse-creases not visible in Fig. 10) give in and begin folding along an axis of the collapse-crease, while at the same time the HME material 60 is compressed to occlude air passage through the pores thereof. In implementations including the one illustrated in Fig. 10, the HME material 60, such as HME foam, functions as a return spring for the closing functionality. A resiliency of the HME material 60 allows the HME device to return to an open state when the finger pressure thereupon ceases. Thus, a user can press the external top surface of the housing 421 to set the HME device into a speaking mode / state, when the user wishes to speak, and then simply release the finger-pressure on the top surface of the housing when the user wants to quit speaking and return the HME device 20 into its breathing mode / state.
[0195] Fig. 11 is a schematic, perspective view illustrating one implementation of a housing 521 for an HME device 20 including a surface-indentation 82 configured to receive and guide a fingertip of a user for pressing the external top surface of the housing 521 to set the HME device 20 into a speaking mode / state, when the user wishes to speak. The surface-indentation 82 includes a recess or depression in the top (distalmost) sheet-like siding 506. In Fig. 11, the recess or depression is provided with an ergonomically smooth profile such as to provide a pleasant, intuitive and easily locatable landing zone for the user's fingertip. Fig. 11 further indicates a folding of the tab elements at the collapse-creases 570, 572, as discussed above in relation to Fig. 10.
[0196] Fig. 12 is a perspective, cross-sectional view of one implementation of a foldable housing 621, wherein the HME material 60, e.g. a reticulated PU foam, is configured as a ring-shaped element 630. Thereby, in implementations, the HME material 60 only partially fills up the accommodation 58 of the housing 621. In the view of Fig. 12, the configuration of the ring-shaped element 630 means that a spatial volume 84 in a center portion of the accommodation 58 is free from HME material. As there is no HME material in the center portion 84 of the accommodation 58, any mucus or slime that may be expelled from the tracheostomy when the user is coughing is received on an internal surface 638 of the second sheet-like siding 604 instead ending up in the HME material 60, this being useful in increasing the HME device lifetime as the pores of the HME material are not clogged. Mucus or slime in movement (by the coughing) is heavier than air and has more difficulty in changing direction, thus it ends up on the internal surface portion 638 of the second sheet-like siding 604 during coughing.
[0197] Fig. 13 is a cross-sectional view of one implementation of an HME device 20 as disclosed herein further illustrating some of the functionalities of the device. In Fig. 13, the HME device is shown engaged with, or coupled to, a coupling or adapter element 70 in engagement with the through-going coupling opening 724 in a siding of the housing 721. In the different implementations disclosed herein, the structure of the foldable housing, including, but not limited to, housing 721 in Fig. 13, provides for the HME device to exhibit good air filtering and moisturizing effects, while offering a low- profile housing (cf. y-axis direction indicated in Fig. 13) of the HME 20 device and a satisfactory breathing resistance. In Fig. 13, the HME material 60 is an HME foam material including pores 90. The size of the pores 90 of the HME influences the characteristics of the functionality of the HME device 20. The smaller the size of the pores 90, the better the humidification of inhaled air through the HME device 20, which humidification contributes to a better environment in the airways / lungs of the user and therefore reduces the potential for coughing. For example, this makes the HME device 20 disclosed herein particularly attractive to use when starting to use HME devices as this is known to a period of adaptation for the user, which usually involves a high frequency of coughing. Usually, providing a smaller pore size also increases the resistance to breathing. However, tests have shown that an HME device as disclosed herein has low moisture loss (and thus good humidification) compared to a standard reference HME while having low flow resistance (pressure drop).
[0198] As further indicated in Fig. 13, an additional advantage of the HME device 20 is that the ring- (or donut-) shaped HME material element 730 provides a hollow center portion 759 of the accommodation 758. Thereby, warm and moist air 92 being exhaled from the lungs of the user flowing out of the stoma and through the HME device 20 cools down before the airflow enters the HME material (flow paths of inhaled air 94 and exhaled air 92 indicated by curved lines in Fig. 13). This causes condensation of moisture in the exhaled air 92 to begin before flow reaches the reticulated or porous HME material, e.g., impregnated with hygroscopic material such as calcium chloride. This is believed to be advantageous over conventional laryngectomy HME's on the market, in which condensation starts and increases as the exhaled air passes through the HME material. With the HME device according to the disclosure, the exhaled air is cooled to a higher extent before entering the HME material media. Moreover, providing a ring- or donut-shaped HME material element providing a hollow center portion of the accommodation reduces the breathing resistance to air 94 being inhaled through the HME device 20, which effect can be particularly useful for users that are new to having to use HME devices.
[0199] Fig. 14 is a schematic, perspective illustration of a model of a user's throat portion below their chin showing an HME device 20 including a paper-based foldable housing 21 as disclosed herein. The HME device 20 is located over the opening of a neck stoma (not visible) of the user and is attached to the peristomal skin surface of the user with a skin attachment component in the form of an adhesive base plate 80 including an adapter element (or coupling) 70 extending from the adhesive base plate 80. The HME device 20 is coupled to the adapter element 70 at a through-going coupling opening provided in one of the sheet-like sidings, such as provided in the first sheet-like siding (not visible). By providing finger-pressure on the (distal) surface of the housing facing away from the skin, such as at the center of the HME device and guided by a through-going opening 125 in the second sheet-like siding, the user can occlude the passage of air (otherwise exhaled) through the HME device 20 when they want to speak, as described elsewhere in the disclosure.
[0200] Fig. 15 is a schematic, perspective illustration of a model of a user's throat portion below their chin showing an HME device 20 including a paper-based foldable housing 21 as disclosed herein. The HME device 20 is connected to a tracheal tube 96 provided in the trachea of the user and extending out through a neck stoma (not visible) of the user. The tracheal tube 96 can be attached to the user with a skin attachment component in the form of a neck flange 98 to which e.g. a neck tying band can be fitted. The HME device 20 is coupled to the tracheal tube 96 via an adapter element 70 engaging with a through-going coupling opening provided in one of the sheet-like sidings, such as provided in the first sheet-like siding (not visible). Speaking functionality can be obtained in a similar manner as explained above in relation to Fig. 14 by providing finger-pressure on the (distal) surface of the housing facing away from the skin, such as at the center of the HME device 20.
[0201] Figs. 16A-16C are schematic, perspective views of one implementation of an HME device 20 including a housing 821 including a paper-based material as disclosed herein. The housing 821 includes two sheet-like sidings including a first sheet-like siding 822 and a second sheet-like siding 825. The first sheet-like siding 822 includes a peripheral edge portion 808 of generally circular shape and the second sheet-like siding 825 includes a peripheral edge portion 810 of generally rectangular shape. In the implementation illustrated in the views of Figs. 16A-16C, the peripheral edge portion 810 of the second sheet-like siding 825 further includes a curved indentation 831 along each of the four major edges or sides. The curved indentation is useful for assisting a user in gripping and handling the housing 821.
[0202] The housing 821 further includes four tab elements 838 (three are visible in the perspective view of Fig. 16A) extending from the peripheral edge portion 808 of the first sheet-like siding 822 into engagement with the second sheet-like siding 825. Each of the four tab elements 838 engages with the second sheet-like siding 825 to provide a connection between the two sidings. The first and second sheet-like sidings 822, 825 and the tab elements 838 are folded and positioned in spatial relation to each other to combine and define an accommodation 858 (Fig. 16B) of the housing 821 of the HME device 20. An HME material 860 is provided in the accommodation 858 of the housing 821 in a ring-shape. In the implementations illustrated in Fig. 16A- 16C, the housing 821 of the HME device is formed with the first sheet-like siding 822 and the second sheet-like siding 825 provided as separate entities. In the implementations illustrated in Fig. 16A-16C, the second sheet-like siding 825 further includes four slits 840 (three visible) which extend through the second sheet-like siding 825. Each of the tab elements 838 of the first sheet-like siding 822 engages with a respective slit 840 of the second sheet-like siding 825. Each of the four slits 840 is located radially inward of the peripheral edge portion 810 of the second sheet-like siding 825 and engages with a respective one of the four tab elements 838 of the first sheet-like siding 822. This is particularly visible in Figs. 16B and 16C. As can be seen from these figures, each of the slits 840 is provided as a through-going hole extending through a wall of the second sheet-like siding 825. In the implementations illustrated in Fig. 16A-16C, wherein the second sheet-like siding 825 includes a peripheral edge portion 810 of generally rectangular shape, each of the slits 840 are formed near or adjacent a corner portion 842 of the rectangular siding 825. As can further be seen, particularly from Figs. 16A-16B, each of the four tab elements 838 suitably includes a foot portion 844 formed by bending a free-end portion of a tab element 838 approximately 90° when the free-end portion has been guided through the slit 840 in the folding process. The foot portion 844 provides a connection and a locking of the tab elements 838 of the first sheet-like siding 822 with the slits 840 of the second sheet-like siding 825 and hence provides a construction that suitably facilitates both ease of manufacture and which helps provide a secure and robust combination of the elements of the housing 821 of the HME device.
[0203] Figs. 17A-17B are schematic, perspective views of one implementation of a paper-based connector element 900 of the housing for the HME device. The paperbased connector element 900 is adapted to allow fitting engagement of the HME device 20 with a tracheostomy tube (see Fig. 19C).
[0204] In the implementation illustrated in Figs. 17A-17B, the paper-based connector element 900 includes a paper-based connector blank 902. In the implementation illustrated in Figs. 17A-17B, the connector blank 902 is provided with a first end portion 904 and a second end portion 906 delimited from each other by a lateral folding line 908. Moreover, the first end portion 904 is subdivided into a first plurality 910 of folding leaves 912 each of which extends generally orthogonally from the lateral folding line 908. The folding leaves 912 are separated from each other by folding cuts 913 provided between them, the folding cuts 913 extending generally orthogonally from the lateral folding line 908. Thereby, each of the folding leaves 912 can be moved (folded) about the lateral folding line 908 independently of the other folding leaves. In the implementation illustrated in Figs. 17A-17B, the connector blank 902 includes eight folding leaves 912. In the implementation illustrated in Figs. 17A- 17B, the second end portion 906 of the connector blank 902 is subdivided into a second plurality 914 of parallelly extending folding panels 916 delimited from each other by a number of vertical folding lines 918. Each of the folding panels 916, as well as each of the folding lines 918, extend generally orthogonally from the lateral folding line 908 (and to the opposite side of the lateral folding line 908 than the folding leaves 912 of the first plurality 910 of folding leaves of the first end portion 904). As can be seen from Figs. 17A-17B, the second plurality 914 of folding panels 916 of the second end portion 906 are not physically separated from each other but only delimited from each other by the folding lines 918. In the implementation illustrated in Figs. 17A-17B, the connector blank 902 also includes eight folding panels 916 each having a lateral dimension which is substantially identical to a lateral dimension of each of the folding leaves 912. In the implementation illustrated in Figs. 17A-17B, the second end portion 906 additionally includes a folding-lock wing 920 adapted to facilitate keeping the paper-based connector element 900 locked in the correct shape and form after folding of the connector blank 902 into the connector element (Fig. 17B). The foldinglock wing 920 can suitably be applied to form a lock by providing an engagement area for an adhesive or a welded connection between the wing 920 and one or more of the folding panels 916 (principles, materials, and methods of connection are in analogy with what is described above for the paper-based housing).
[0205] Fig. 17B illustrates one implementation of a paper-based connector element 900 which is suitably folded such that the second plurality 914 of folding panels 916 of the second end portion 906 provides a first end portion of the connector element 900 with an octagonal shape (cf. also the bottom view of Fig. 18C). The first plurality 910 of folding leaves 912 provides a first end portion 904 of the connector element 900 with a "crown"-shape, including a surface area suitable for engagement with one or more other elements of the housing of the HME device, such as at least one of the sheet-like sidings.
[0206] Figs. 18A-18C are schematic, perspective, side, and bottom views, respectively, of implementations of a housing 821 for a HME device 20 (cf. Figs. 16A-16C) including a paper-based connector element 900 adapted to allow fitting engagement of the HME device 20 with a tracheostomy tube (cf. Fig. 19C). Fig. 18A is a schematic, cross- sectional perspective view illustrating (in part) one example of how the first end portion 904 of the connector element 900 including the folding leaves 912 extends into the accommodation 858 of the housing 821 through the through-going coupling opening 824 therein (Fig. 18B) and at least partially connects with an internal surface of the second sheet-like siding 825 around the through-going coupling opening 824 thereof. Also, Figs. 18A and 18B illustrate how the second end portion 906 including the folding panels 916 locates externally of the accommodation 858 of the housing 821. Fig. 18B is a side view illustrating one implementation as in Figs. 18A and 18C, wherein the second end portion 906 including the folding panels 916 of the connector element 900 is seen extending externally of the accommodation of the housing 821 through the through-going coupling opening 824. Fig. 18C is a bottom view of the implementation of Figs. 18A and 18B illustrating the octagonal shape of the externally extending second end portion 906 of the connector element 900, and further illustrating a proximal surface 823 of the second sheet-like siding 825 with the tab elements 838 of the first sheet-like siding 822 extending through the slits 840 of the second sheet-like siding 825 and having been folded / bent into provide a foot portion 844 of the tab elements 838 to keep the first and second sheet-like sidings 822, 824 in secure and robust engagement with each other to provide the housing 821 of the HME device.
[0207] Figs. 19A-19C are schematic, perspective views of alternative implementations of the housing 821 for a HME device 20 (cf. Figs. 16A-16C) including a paper-based connector element 900 adapted to allow fitting engagement of the HME device 20 with a tracheostomy tube. In this alternative, when folded, the first end portion 904 of the connector element 900 including each of the folding leaves 912 (cf. Fig. 17A) is connected with an external (the proximal) surface 823 of the second sheet-like siding 825 around the through-going coupling opening 824 thereof, while the second end portion 906 including the folding panels 916 extends into the accommodation 858 of the housing 821, as is particularly visible in Fig. 19A. In one understanding, the paperbased connector element 900 of Figs. 19A-19C is turned upside down compared to the manner in which it is placed in Figs. 18A-18C.
[0208] In the implementation illustrated in Figs. 19A-19B, the second end portion 906 of the connector element 900 is adapted to connect to an external surface of the tracheostomy tube 950. In Fig. 19C, the second end portion 906 of the connector element 900 is shown to engage or connect to the external surface at the end portion of the tracheostomy tube 950 which may suitably be an (ISO) standard 15mm tracheostomy tube.
[0209] Thus, it is understood from Figs. 16A-19C, that when the connector blank 902 has been folded into the paper-based connector element 900, the resulting first end portion 904 of the connector blank 902 provides that the connector element 900 can be connected with (at least) the second sheet-like siding 825 at the through-going coupling opening 824 thereof. Conversely, the resulting second end portion 906 of the connector blank 902 provides that the other end of the folded connector element 900 can be connected with a ('machine end' of a) tracheostomy tube 950. This additionally and advantageously facilitates connection of the paper-based HME device with a tracheostomy tube. The folded connector element 900 can be connected to either an inner or an outer surface portion of the tracheostomy tube 950, depending on configuration.
[0210] Although particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be made obvious to those skilled in the art that various changes and modifications may be made without departing from the scope of the claimed invention. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The claimed invention is intended to cover all alternatives, modifications, and equivalents. Index of reference numbers
[0211] 20 HME device
[0212] 21, 221, 421, 521, 621, 721, 821 housing
[0213] 22, 102, 202, 302, 822 first sheet-like siding
[0214] 24, 104, 204, 304, 604, 825 second sheet-like siding
[0215] 26, 106, 206, 306 third sheet-like siding
[0216] 27, 107 fourth sheet-like siding
[0217] 28, 108, 208 peripheral edge portion of first sheet-like siding
[0218] 30, 110, 210 peripheral edge portion of second sheet-like siding
[0219] 32, 112, 212 peripheral edge portion of third sheet-like siding
[0220] 33, 113 peripheral edge portion of fourth sheet-like siding
[0221] 38, 838 tab element
[0222] 40 tab element
[0223] 42 tab element
[0224] 58, 258, 758, 858 accommodation
[0225] 60, 260, 860 HME material
[0226] 70 coupling / adapter element
[0227] 75 ring-shaped flange
[0228] 80 adhesive base plate
[0229] 82 surface-indentation
[0230] 84 spatial volume
[0231] 90 pores
[0232] 92 warm and moist air
[0233] 94 inhaled air
[0234] 96 tracheal tube
[0235] 98 neck flange
[0236] 100, 200, 300 foldable housing blank
[0237] 114, 214, 314, 414 primary tab element
[0238] 116, 216, 316 secondary tab element
[0239] 118, 218, 318 tertiary tab element
[0240] 120, 220, 320, 420 quaternary tab element
[0241] 124, 224, 324, 724, 824 through-going coupling opening 125 through-going opening
[0242] 127 through-going opening
[0243] 129 notch
[0244] 131, 133 indents
[0245] 134, 136 creases
[0246] 138 internal surface portion of second sheet-like siding 104
[0247] 139 internal surface portion of first sheet-like siding 102
[0248] 147 internal surface portion of fourth sheet-like siding 107
[0249] 148 external surface portion of second sheet-like siding 104
[0250] 150, 160, 162, 170, 172, 242, 244, 250, 252 folding creases
[0251] 154, 254, 256 end portion of respective tab element 114, 214, 216
[0252] 209 peripheral edge of first sheet-like siding 202
[0253] 211 peripheral edge of second sheet-like siding 204
[0254] 213 peripheral edge of third sheet-like siding 206
[0255] 222 lining
[0256] 226 portion of first sheet-like siding 202 with surface contour
[0257] 230, 630, 730 ring- (or donut-) shaped element
[0258] 232 surface portion of first sheet-like siding 202
[0259] 238 internal surface portion of second sheet-like siding 204
[0260] 240 top surface portion of HME material 260
[0261] 246 internal surface portion of third sheet-like siding 206
[0262] 248 external surface portion of second sheet-like siding 204
[0263] 275 recess in first sheet-like siding 202
[0264] 334, 336, 342, 344, 350, 352 folding creases
[0265] 370, 372, 470, 472, 570, 572 collapse creases
[0266] 506 top (distalmost) sheet-like siding
[0267] 638 internal surface portion of second sheet-like siding 604
[0268] 759 hollow center portion of accommodation 758
[0269] 823 proximal surface of second sheet-like siding
[0270] 831 curved indentation
[0271] 840 slits
[0272] 842 corner portion of rectangularly shaped siding
[0273] 844 foot portion of tab element 838 900 paper-based connector element
[0274] 902 connector blank
[0275] 904 first end portion
[0276] 906 second end portion 908 lateral folding line
[0277] 910 first plurality of folding leaves
[0278] 912 folding leaves
[0279] 914 second plurality of folding panels
[0280] 916 folding panels 918 vertical folding lines
[0281] 920 folding-lock wing
Claims
CLAIMS:
1. A heat and moisture exchange (HME) device for a laryngectomized or tracheostomized user, comprising:- a housing comprising two or more sheet-like sidings comprising a first sheetlike siding and a second sheet-like siding, each of the sheet-like sidings comprising a peripheral edge portion, the housing comprising one or more tab elements extending from the peripheral edge portion of a siding, the one or more tab elements being configured to engage with a different one of the two or more sidings to provide a connection between the sidings; wherein the two or more sheet-like sidings and the one or more tab elements are configured to be positioned in spatial relation to each other to combine and define an accommodation of the housing; an HME material provided in the accommodation of the housing; and wherein the housing comprises a paper-based material.
2. The HME device of claim 1, wherein the housing comprises three sheet-like sidings.
3. The HME device of claim 2, wherein the housing comprises four sheet-like sidings.
4. The HME device of any one of the preceding claims, wherein the housing comprises a plurality of sheet-like sidings, such as 5 sheet-like sidings, such as 6 sheetlike sidings, such as 7 sheet-like sidings, such as 8 sheet-like sidings.
5. The HME device of claim 1, wherein the housing of the HME device is formed with two sheet-like sidings, including the first sheet-like siding and the second sheet-like siding, wherein the first sheet-like siding and the second sheet-like siding are formed as separate entities.
6. The HME device of any one of the preceding claims, wherein one or more of the sheet-like sidings comprise(s) a through-going opening.
7. The HME device of any one of the preceding claims, wherein at least one of the sheet-like sidings comprises a through-going coupling opening adapted to allow fitting engagement of the HME device with a skin attachment component or with a tracheostomy tube.
8. The HME device of any one of the preceding claims, wherein at least one of the one or more tab elements of the housing is / are provided integrally with at least one of the two or more sheet-like sidings.
9. The HME device of any one of the preceding claims, wherein at least one of the one or more tab elements of the housing is / are provided integrally with and configured to form a connection between two sheet-like sidings.
10. The HME device of any one of the preceding claims, wherein at least one of the sheet-like sidings comprises one or more notches extending radially inward from the peripheral edge portion and configured to engage with a tab element of a different one of the sheet-like sidings.
11. The HME device of any one of claims 1-9, wherein at least one of the sheetlike sidings comprises one or more slits which extend(s) through the siding from one side thereof to the other and located radially inward of the peripheral edge portion and configured to engage with a tab element of a different one of the sheet-like sidings.
12. The HME device of any one of the preceding claims, wherein at least one of the one or more tab elements comprise(s) one or more creases.
13. The HME device of any one of the preceding claims, wherein a transition between a sheet-like siding and a tab element at the peripheral edge portion of the siding comprises a crease.
14. The HME device of any one of the preceding claims, wherein one of the sheetlike sidings comprises a surface-indentation configured to receive and guide a fingertip of a user.
15. The HME device of any one of the preceding claims, wherein one or more of the sheet-like sidings comprise(s) one or more portions formed with a surface contour comprising one or more three-dimensional portions adapted to increase the flexural modulus of the siding.
16. The HME device of any one of the preceding claims, wherein the housing consists of a paper-based material.
17. The HME device of any one of the preceding claims, wherein the housing comprises a lining provided on the paper-based material.
18. The HME device of claim 17, wherein the lining comprises a polyethylene film material or a polypropylene film material, such as a bi-axially oriented polypropylene film material.
19. The HME device of claim 17, wherein the lining is laminated to one side of the paper-based material.
20. The HME device of claim 17, wherein the lining is laminated to both sides of the paper-based material.
21. The HME device of any one the preceding claims, wherein the paper-based material of the housing comprises a paper carton.
22. The HME device of any one of the preceding claims, wherein at least one surface portion of the housing comprises an adhesive material.
23. The HME device of any one of the preceding claims, wherein the housing further comprises a paper-based connector element adapted to allow fitting engagement of the HME device with a tracheostomy tube.
24. The HME device of any one of the preceding claims, wherein the HME material is configured as a ring-shaped element.
25. The HME device of any one of the preceding claims, wherein at least one of the at least two sheet-like sidings comprises a peripheral edge portion of generally circular shape and at least one other sheet-like siding comprises a peripheral edge portion of generally rectangular shape.
26. A paper-based blank for a foldable housing for a heat and moisture exchange (HME) device for a laryngectomized or tracheostomized user, comprising:- two or more sheet-like sidings comprising a first sheet-like siding and a second sheet-like siding, each of the sheet-like sidings comprising a peripheral edge portion,- one or more tab elements extending from the peripheral edge portion of a siding, the one or more tab elements being configured to engage with a different one of the two or more sidings to provide a connection between the sidings; wherein the two or more sheet-like sidings and the one or more tab elements are configured to be folded in relation to each other such as to define an accommodation of the foldable housing for an HME material of the HME device.
27. The paper-based blank of claim 26, comprising three sheet-like sidings, the three sidings comprising a first siding comprising a through-going opening, a second generally continuous siding, and a third generally continuous siding, the first siding and the second siding being connected to each other by one primary tab element providedintegrally with each of the first siding and the second siding and extending radially from a first position on the peripheral edge portion of the first siding, and the first siding and the third siding being connected to each other by one secondary tab element provided integrally with each of the first siding and the third siding and extending radially from a second position on the peripheral edge portion of the first siding, the second position being on an opposite side of the peripheral edge portion of the sheet-like first siding relative to the first position.
28. The paper-based blank of claim 27, wherein the first sheet-like siding comprises a tertiary tab element provided integrally with the first siding and extending radially from a third position on the peripheral edge portion of the first siding, the third position being different from each of the first and second positions, respectively.
29. The paper-based blank of claim 28, wherein the first sheet-like siding comprises a quaternary tab element provided integrally with the first siding and extending radially from a fourth position on the peripheral edge portion of the first siding, the fourth position being different from each of the first, second, and third positions, respectively.
30. The paper-based blank of claim 29, wherein the first, second, third, and fourth positions are distributed such that the primary, secondary, tertiary, and quaternary tab elements extend from the peripheral edge portion of the first siding in directions being at an angle of approximately 90 degrees to each other.
31. The paper-based blank of any one of claims 26-30, wherein at least the first sheet-like siding and the second sheet-like siding are formed as separate entities.
32. The paper-based blank of any one of claims 26-30, wherein each of the sheetlike sidings are adapted to have a substantially round closed shape.
33. The paper-based blank of any one of claims 26-31, wherein at least one of the at least two sheet-like sidings comprises a peripheral edge portion of generally circularshape and at least one other sheet-like siding comprises a peripheral edge portion of generally rectangular shape.
34. The paper-based blank of any one of claims 26-33, wherein the first sheet-like siding comprises a surface portion adapted to receive an HME material.
35. The paper-based blank of any one of claims 26-34, wherein one or more of the sheet-like sidings comprise(s) one or more portions formed with a surface contour comprising one or more three-dimensional portions adapted to increase the flexural modulus of the siding.
36. The paper-based blank of claim 35, wherein the surface contour comprises one or more embossments in a respective siding.
37. The paper-based blank of any one of claims 26-36, wherein at least one of the sheet-like sidings comprises one or more notches extending radially inward from the peripheral edge portion and configured to engage with a tab element of a different siding.
38. The paper-based blank of any one of claims 26-36, wherein at least one of the sheet-like sidings comprises one or more slits which extend(s) through the siding from one side thereof to the other and located radially inward of the peripheral edge portion and configured to engage with a tab element of a different one of the sheetlike sidings.
39. The paper-based blank of any one of claims 26-38, comprising a lining on one or more portions of its surface.
40. The paper-based blank of any one of claims 26-39, wherein one or more surface portions of the paper-based blank comprise(s) an adhesive material.
41. The paper-based blank of any one of claims 26-40, wherein one or more of the sheet-like sidings comprise(s) a through-going opening.
42. The paper-based blank of any one of claims 26-41, wherein at least one of the sheet-like sidings comprises a through-going coupling opening adapted to allow fitting engagement of the HME device with a skin attachment component or with a tracheostomy tube.
43. The paper-based blank of any one of claims 26-42, wherein at least one of the one or more tab elements comprise(s) one or more creases.
44. The paper-based blank of any one of claims 26-43, wherein a transition between a sheet-like siding and a tab element at the peripheral edge portion of the siding comprises a crease.
45. The paper-based blank of any one of claims 26-44, wherein one of the sheetlike sidings comprises a surface-indentation configured to receive and guide a fingertip of a user.
46. A method for manufacturing a heat and moisture exchange (HME) device, comprising the steps of:- (a) providing a paper-based sheet material;- (b) stamping at least one foldable housing blank according to any one of claims 26-45 from the paper-based sheet material;- (c) providing an HME material in engagement with at least one of the sheet-like sidings;- (d) forming an accommodation of a housing of the HME device configured to hold the HME material therein by folding at least one foldable housing blank to position the two or more sheet-like sidings and the one or more tab elements in spatial relation to each other;- (e) securing the two or more sheet-like sidings and the one or more tab elements in one or more mutually locked relations such as to provide a structural integrity of the housing of the HME device.
47. The method according to claim 36, wherein step (d) is carried out before step (c).
48. The method according to claim 46 or 47, further comprising providing a through-going opening in one or more of the two or more sheet-like sidings in a step immediately subsequent to step (b).
49. The method according to any one of claims 46-48, further comprising providing a lining on the paper-based sheet material in a step immediately subsequent to step (a).
50. The method according to any one of claims 46-49, further comprising providing an adhesive material on at least one surface portion of the foldable housing blank.
51. The method according to claim 49, further comprising welding of the lining on two different surface portions of the housing in one or more discrete positions.
Citation Information
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