Patent Description:
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. 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 need of respiratory treatment may also result in a tracheostomy.

A laryngectomy is a surgical procedure, used for example to treat a carcinoma, which involves removal of the larynx or voice box and the 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 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 is 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 person 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 person to speak. It is desirable that the flow of the exhaled air be controlled by means of a tracheostoma valve. In these situations, the valve can be arranged to remain open during breathing but can be closed to divert the airflow, through a small additional increase in exhaled air flow.

In this respect tracheostoma devices, such as filter devices, Heat and Moisture Exchange (HME), breathing protectors, and speech valves, have been developed to enable moisturizing of inhaled air, removal of small particles and bacteriological substances in said inhaled air, and providing the person with the ability to speak by closing the air passage through the tracheostoma by manual operation. As an alternative, some use a "hands free" HME (automatic speaking valve) that is activated by speaking. A hands-free HME enables laryngectomees to speak without requiring finger occlusion. The device consists of a combination of HME and an automatic speaking valve, which closes automatically, when exhaling air for speaking, enabling the pulmonary air to be diverted through the voice prosthesis into the esophagus. It reopens automatically, when exhalation decreases.

These tracheostoma devices are held in place by a tracheostoma device holder, arranged above the tracheostoma of the person. The tracheostoma device holder is normally attached to the skin of the person by a plaster, having an adhesive surface on the side of the plaster intended to be directed towards the person using it. Either, the tracheostoma device holder is welded to the plaster, or the tracheostoma device holder is arranged on an adhesive surface on the side of the plaster intended to be directed outwards from the person using it. On the skin adhesive surface a covering sheet may be applied, which is removed just before application of the tracheostoma device holder. The covering sheet facilitates transportation, and maintains skin adhesive ability of the skin adhesive surface.

There is however a problem associated with the application of the tracheostoma device holder after the removal of the covering sheet, since the neck of the person receiving the tracheostoma device holder by no means is planar. It is difficult to adhere the tracheostoma device holder in the pit in between the sternocleidomastoid muscles, at persons with sunken stomas, i.e. stomas that somewhat has sunken into the neck of the person, since the adhesive surface of the tracheostoma device holder inevitably will adhere to the walls of the pit before reaching the bottom of the pit with the central portion of the system. Sunken stomas are very frequent in the group of persons not having the two vertical sternocleidomastoid muscles on the neck cut during laryngectomy. Furthermore, a bad fit between the non-planar surface of the neck and the adhesive surface of the tracheostoma device holder may lead to leakages between the neck and said adhesive surface, since the force distribution over the plate will be uneven with local areas being more exposed than others, thereby causing a loss of speaking pressure. The force from the speaking pressure, especially during use of automatic speaking valves when the user does not hinder the tracheostoma device to move forward by finger occlusion, often leads to premature leakage.

<CIT> discloses a tracheostoma holder for holding a tracheostoma device superimposed over a tracheostoma of a person. <CIT> discloses another example of a tracheostoma holder device. <CIT> discloses yet a further example of a tracheostomy holder device.

Furthermore, in many hospitals the surgical steps during laryngectomy are adapted for creating stomas of substantially planar natures, to comply with the tracheostoma device holder system presently on the market. This adaptation includes the cutting of the two vertical sternocleidomastoid muscles on the neck.

Hence, an improved tracheostoma device holder would be advantageous, and in particular a tracheostoma device holder allowing for convenient application of the tracheostoma device holder with improved positioning ability, while simultaneously decreasing the risk of loosening of skin adhesion close to the tracheostoma, also in persons with sunken tracheostomas, thus keeping speech pressure at a convenient level, as well as making up for irregularities in skin shape adjacent the stoma.

Accordingly, the present invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies and disadvantages, singly or in any combination, and solves at least the above mentioned problems by providing a tracheostoma device holder for holding a tracheostoma device superimposed of a tracheostoma of a person according to the appended claims.

An exemplary method for adaptation of such tracheostoma holding device is also disclosed.

Thereby, a tracheostoma device holder which can become suitable for a wider range of stoma shapes, as well as able to follow the shape of stoma of a patient more closely, is provided.

These and other aspects, features and advantages of which the invention is capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which.

The following description focuses on an embodiment of the present invention applicable to a tracheostoma device holder, for holding a tracheostoma device, such as a tracheostoma valve, over the stoma of a person. A tracheostoma device may in this context be a HME, speech valve, etc..

<FIG> discloses a cross-section view of a tracheostoma device holder <NUM> for holding a tracheostoma device superimposed of a tracheostoma of a person, said tracheostoma device holder <NUM> comprising a plate <NUM> for attachment over the tracheostoma via a proximal side thereof, said plate <NUM> being provided with a through hole <NUM>.

The tracheostoma device holder <NUM> further comprises a tracheostoma device fitting <NUM> extending distally from a distal side of the plate <NUM>. The tracheostoma device fitting is preferably a tubular tracheostoma device fitting <NUM>. The tracheostoma device fitting <NUM> comprises a through passage <NUM>, extending through the tracheostoma device holder <NUM>. The through passage <NUM> of the tracheostoma device fitting <NUM> is superimposed the through hole <NUM> of the plate <NUM>, so as to form a distal opening <NUM> communicating with a proximal opening <NUM> in the tracheostoma device holder <NUM>. Preferably, the aperture formed by the tubular tracheostoma device fitting <NUM> and said through hole <NUM> being provided in the plate <NUM> coincide about an axis <NUM> of the through hole <NUM>.

The tracheostoma device holder <NUM> thus comprises a proximal end and a distal end. In this context proximal refers to a position or direction towards the stoma, i.e. towards the user of the tracheostoma device holder <NUM>, whilst distal refers to a position or direction away from the stoma, i.e. away from the user of the tracheostoma device holder <NUM>. Lateral refers to a position or direction radially away from the axis <NUM>, whilst central refers to a position or direction towards the central axis <NUM>. The axis <NUM> extends in a distal-proximal direction through the tracheostoma device holder <NUM>. With advantage said axis <NUM> may coincide with a central axis of said tracheostoma device holder <NUM>.

The tubular tracheostoma device fitting <NUM> is disposed circumferentially of the through hole <NUM>, in the form of for example a cylindrical sleeve. Thus, the tracheostoma device fitting <NUM> extends distally from the plate <NUM> circumferentially of said through hole <NUM>. The plate <NUM> will extend mainly laterally as a flange from the tubular tracheostoma device fitting <NUM>, in relation to the axis <NUM> of the through hole <NUM>. Similarly, the tubular tracheostoma device fitting <NUM> extends axially and distally from the plate <NUM>, in accordance with above.

Referring again to <FIG>, the plate <NUM> may be of a substantially circular shape, with the through hole <NUM> extending through the center of said plate. The plate <NUM> may also have other shapes, such as polygonal or flower-shape. As illustrated in <FIG>, the plate <NUM> comprises a disc of thermoplastic material <NUM> enclosed at least laterally by a surrounding plate material <NUM>. Accordingly, the plate <NUM> comprises at least two different materials. The plate material <NUM> has a melting point which is different from a melting point of the disc <NUM> of thermoplastic material. Centrally, the disc of thermoplastic material <NUM> adjoins the tracheostoma device fitting <NUM>.

When the disc <NUM> is heated to its melting point, it may be possible to mold the disc <NUM> and thereby adapting the surface of the material to an anatomic shape of a person wearing the tracheostoma device holder <NUM>. The molding of the disc <NUM> allows for forming of the plate <NUM> in shapes which more closely follow the shape of the stoma of a patient. By providing a plate <NUM> which comprises at least two materials with different melting points, it is possible to allow only a part of the plate <NUM> to be moldable when the plate <NUM> is heated to a certain temperature. The part of the plate <NUM> that has the lowest melting point will accordingly allow molding when the disc <NUM> has been heated to its melting point. At the same time, the other part, with the higher melting point, will not be melted. Thereby, it is possible to set some restriction for the moldable part, as the part of the plate <NUM> with the higher melting temperature may limit the possibilities of how the moldable material of the plate <NUM> may be formed and may also prevent it from flowing freely. Accordingly, it is possible to more accurately control the application of the tracheostoma device holder <NUM> and a tracheostoma device holder <NUM> with improved positioning ability is achieved.

As illustrated in <FIG>, the plate <NUM> comprises a disc <NUM> of a thermoplastic material enclosed at least centrally and laterally by a surrounding plate material <NUM>. Accordingly, the plate <NUM> comprises at least two different materials, wherein the disc <NUM> of thermoplastic material is enclosed in both central and lateral directions by the surrounding plate material <NUM>. The plate material <NUM> has a melting point which is different from a melting point of the disc <NUM> of thermoplastic material.

In an advantageous embodiment, the melting point of the plate material <NUM> is higher than the melting point of the disc <NUM>. Thus, the surrounding plate material <NUM> will maintain its substantial spatial shape when the disc <NUM> is in a moldable state. Thereby, the surrounding plate material <NUM> may constitute a barrier to the disc <NUM>, which will prevent the disc <NUM> from flowing beyond this barrier and then also jeopardizing the thickness of the disc, whereby force distribution again may vary over the disc <NUM>.

The disc <NUM> may have a melting/softening temperature allowing for molding according to the local anatomic shape of the person through direct contact between the plate <NUM> and the skin of the person. Such thermoplastic may suitably be a polyester based thermoplastic, such as a polycaprolactone (PCL) based thermoplastic. Polycaprolactone is a biodegradable polyester with a low melting point of about <NUM>. Once softened, it can be molded by hand in the proper shape. If the temperature of an outer layer decreases, it becomes non-sticky, but still pliable and moldable.

With reference to <FIG>, the disc of thermoplastic material <NUM> is enclosed centrally and laterally by the surrounding plate material <NUM>. Accordingly, the disc of thermoplastic material <NUM> may be encapsulated by the surrounding plate material <NUM> inwardly and outwardly, preventing it to flow beyond the surrounding plate material <NUM> and too far in any lateral or central direction. It is thereby made possible to prevent the disc of thermoplastic material <NUM> from flowing freely, potentially into the lumen of the adhesive, when in a moldable state. The disc of the thermoplastic material <NUM> may be prevented to flow into areas that should be avoided and where the disc of thermoplastic material <NUM> should not be located. Hence a more secure tracheostoma device holder <NUM> is provided, which follow the shape of a stoma of a patientmore closely is provided.

In one embodiment, the disc of thermoplastic material <NUM> is further enclosed distally by the surrounding plate material <NUM>. This may prevent the disc of thermoplastic material <NUM> to "escape" out of the plate <NUM> in a distal direction and may assure that the disc <NUM> stays within the plate <NUM>. Hence, a tracheostoma device holder <NUM> with improved positioning ability, while simultaneously keeping the disc <NUM> in place is provided. By enclosing the disc <NUM> of thermoplastic material distally, the placing of the device may be facilitated as the sticky thermoplastic material <NUM> will be prevented from being exposed, which may facilitate application of the tracheostoma device holder <NUM>. Furthermore, when the tracheostoma device holder <NUM> is placed over the stoma, the device may be more esthetically appealing as the surface of the plate <NUM> is of one coherent material. The distal plate material <NUM> may also prevent non-appealing fingerprints on the thermoplastic material.

The surrounding plate material <NUM> of the plate <NUM> may be made of a flexible and elastic material. The flexible and elastic material may not be heat formable at comfortably low temperatures. Example of such a material is e.g. thermoplastic materials, such as a thermoplastic elastomer (TPE). By providing the surrounding plate material <NUM> of the plate <NUM> in a flexible and elastic material, it allows for the whole plate <NUM> to more closely follow the shape of the stoma. Notably, the material may be so flexible that this can be achieved independently of the shape of the stoma of the patient, whereby a tracheostoma device holder <NUM> which is suitable for a wide range of shapes of stoma is achieved. The flexible material also reduces the risk for leakage and/or perceived discomfort of the patient by allowing for a softer material which closely follows the stoma.

According to one example, the plate material <NUM> may be an injection molded part. Tracheostoma device holders <NUM> according to this embodiment are illustrated in <FIG> and <FIG>. These tracheostoma device holders <NUM> may be advantageous when it is desired that the shape and the form of the plate material <NUM> is the same and consistent in the tracheostoma device holders <NUM>. Furthermore, this plate material <NUM> may be cost efficient to manufacture.

According to another example, the plate material <NUM> may be a film material. The film material may be arranged to be provided distally of the disc <NUM>, as illustrated in <FIG>. As previously described, this may prevent the disc of thermoplastic material <NUM> to "escape" out of the plate <NUM> in a distal direction and may assure that the disc <NUM> stays within the plate <NUM>. Hence, a tracheostoma device holder <NUM> with improved positioning ability, while simultaneously keeping the disc <NUM> in place is provided. By enclosing the disc <NUM> of thermoplastic material distally, the placing of the device may be facilitated as the sticky thermoplastic material <NUM> will be prevented from being exposed, which may facilitate application of the tracheostoma device holder <NUM>. Furthermore, when the tracheostoma device holder <NUM> is placed over the stoma, the device may be more esthetically appealing as the surface of the plate <NUM> is of one coherent material. The distal plate material <NUM> may also prevent non-appealing fingerprints on the thermoplastic material.

Alternatively, as illustrated in <FIG> the film material <NUM> may be arranged to be provided both distally and proximally of the disc <NUM>, such that the disc <NUM> is provided between two layers of film plate material <NUM>. According to this embodiment, it is further prevented that the disc of thermoplastic material <NUM> "escapes" out of the plate <NUM> in a proximal direction and it may be assured that the disc <NUM> stays within the plate <NUM>.

In a comparative example, the film material <NUM> can be arranged proximally of the disc <NUM>, as illustrated in <FIG>. The manufacturing of this example can be advantageous as the disc <NUM> of thermoplastic material can be provided on top of the plate material <NUM>.

Tracheostoma device holders <NUM> according to embodiments, where the plate material <NUM> is a film material, may be flexible and easily adjusted if the requirements for the tracheostoma device holder <NUM> may change.

As the plate material <NUM> may be either an injection molded plate or a film material plate, the tracheostoma device holder <NUM> may be adapted according to prevailing conditions. As the two different embodiments have different demands on, for example, manufacturing, the most suitable embodiment may be chosen.

When adapting the tracheostoma device holder <NUM> in correspondence with the anatomy of the neck portion in the vicinity of the tracheostoma of the person intended to use the tracheostoma device holder <NUM>, at least the plate <NUM> is heated to somewhat over the melting temperature of its disc <NUM>, i.e. approximately <NUM> in case of a PCL based thermoplastic. This is accomplished by heating the plate <NUM> approximately <NUM>-<NUM> minutes. However, the surrounding plate material <NUM> which has a different melting point, will not reach its melting point and accordingly, the surrounding plate material <NUM> will be unaffected and keep the disc <NUM> within the acceptable area. Accordingly, the disc of thermoplastic material will be hand moldable, but will not be able to flow away too far in any unwanted direction, such as into the lumen of the adhesive.

After the disc <NUM> has reached its melting temperature, the disc <NUM> becomes compliable, and thus hand moldable. Also, when the thermoplastic material used is a PCL based thermoplastic, the disc <NUM> changes in transparency from opaque to transparent. In this state, the disc <NUM> and thus the plate <NUM> is molded/shaped in accordance with the neck anatomy of the person, such that the through hole <NUM> is superimposed over the tracheostoma. The available molding time is normally about <NUM> minutes, thereafter the disc <NUM> turns unmoldable but still flexible. After approximately <NUM> minutes, the disc <NUM> again turns rigid, and is then ready for use. In this way, the disc <NUM> may be molded in correspondence with the anatomy of the neck of the user, such that it conforms with for example the two vertical sternocleidomastoid muscles, and still getting close also to sunken stomas.

Additionally, due to the change in transparency at the melting temperature of PCL based materials, not only will it be easy to know when to start the molding process, but also it will be easy to adapt the plate <NUM> after the anatomy of the neck, since it will be possible to see through the plate <NUM> and detect and make up for contour changes at the neck. The surrounding plate material <NUM> is preferably transparent in its normal state and will accordingly stay transparent during the whole process. Furthermore, the disc <NUM> may simply be remolded by reheating the plate <NUM> and reshaping it, if anatomy changes would occur or if it should be shaped in accordance with another user.

As illustrated in e.g. <FIG>, the proximal side of the plate <NUM> may be provided with a coating <NUM> being adhesive on both sides, and at least skin adhesive on one of these. Such a coating <NUM> may be dimensioned in accordance with the proximal side of the plate <NUM>, such that the interaction surface between the plate <NUM> and the skin may be high. By providing high formability and even force distribution a less tacky adhesive may be allowed, which may be beneficial to the user by decreasing the mechanical stress on the skin when removing the device. The adhesive may be a tape or foam tape, a sprayed or painted skin adhesive formulation.

The plate <NUM> may then be attached to the neck of the user, such that the through hole <NUM> is superimposed over the tracheostoma, and a tracheostoma device, such as a speech valve, is connected to the tracheostoma device fitting <NUM> in a known manner.

The adhesive coating <NUM> may in one exemplary embodiment further encapsulate the disc of thermoplastic material in a proximal direction.

According to one example, at least the proximal side of the disc <NUM> may be provided with a liner <NUM>. This allows for easier handling during molding, since it decreases the stickiness to skin. Once the plate <NUM> has been shaped in accordance with the contours around the stoma (and perhaps after the plate <NUM> has regained its rigidity after cooling) the liner is removed, and the plate attached to the neck of the patient.

Yet again referring to <FIG>, the tubular tracheostoma device fitting <NUM> may comprise a retaining lip <NUM> extending circumferentially from a distal zone of said fitting <NUM>. The retaining lip <NUM> comprises a bent portion <NUM> extending proximally and laterally towards the axis <NUM> of the through hole of the plate. Said retaining lip <NUM> being adapted to receive and retain the tracheostoma device.

The receiving and the retaining of the tracheostoma device is provided by the elastic deformation of the more rigid material of the tracheostoma device fitting <NUM> and the bent portion <NUM> of the retaining lip <NUM>. When the tracheostoma device is inserted into the fitting <NUM> in a distal to proximal direction along the axis <NUM> of the through hole <NUM> of the plate <NUM>, the bent portion <NUM> will deform laterally towards the inner portion of the tubular tracheostoma device fitting <NUM>. This leaves room for the tracheostoma device to pass through the retaining lip <NUM> and be fully inserted into the tubular tracheostoma device fitting <NUM>.

The bent portion <NUM> of the retaining lip <NUM> then retains the tracheostoma device inside the tracheostoma device fitting <NUM>. Due to the inwardly bent structure any distal movement of the tracheostoma device past the retaining lip will be hindered. This being due to any load on the retaining lip <NUM> caused by said movement will simply lead to the retaining lip <NUM> deforming by means of elastically bending the retaining lip <NUM> so as to urge the retaining lip <NUM> to exert a proximally directed normal force holding the tracheostoma device in place.

The retaining lip <NUM> thus allows for a tracheostoma device holder <NUM> mitigating the risk for a tracheostoma device to accidentally fall out of the tubular tracheostoma device fitting <NUM>, when the tracheostoma device holder <NUM> is used by a patient.

For the tracheostoma device fitting <NUM> to provide a retaining lip <NUM> with the desired retaining properties, the fitting <NUM> may be provided in a more rigid material. Accordingly, the tracheostoma device fitting <NUM> is preferably in a more rigid material due to its required retaining properties for holding the tracheostoma device <NUM> in place. Thus, the more rigid material allows for a press-fit or snap-fit between the tracheostoma device fitting <NUM> and the inserted tracheostoma device provided by the elastic deformation of the more rigid material of the fitting <NUM>. However, in order to provide such desired retaining properties while still providing a tracheostoma device holder <NUM> which is comfortable to wear for the patient, the tracheostoma device fitting <NUM> may be in a more rigid material than the surrounding plate material <NUM> of the plate <NUM>. Accordingly, the surrounding plate material <NUM> is in a more flexible material than the tracheostoma device fitting <NUM>.

A tracheostoma device holder <NUM> with a retaining lip solves the problem of achieving a tracheostoma device holder <NUM> which mitigates the risk for the tracheostoma device to accidentally fall out of the tracheostoma device fitting <NUM> during wearing without reducing the perceived comfort of the patient or introducing additional adhering or joining steps during manufacturing.

With reference to <FIG>, the plate <NUM> further comprises a plurality of flaps <NUM> extending laterally from a lateral outer portion of the plate <NUM>. The flaps <NUM> are preferably separated by a plurality of cut-ins <NUM> extending centrally towards the axis <NUM> from a lateral circumferential edge of the plate <NUM>. Said flaps <NUM> further increase the adaptability of the plate <NUM> since each flap <NUM> may be adhered to a surface without affecting the orientation of the other flaps of the plate <NUM>.

In a conventional plate the (partial) folding of a section of the outermost portion of the plate <NUM> may cause a strain propagating through the material of the plate <NUM> which may force other sections of said plate <NUM> to release from their intended position on the stoma of the patient. Said flaps <NUM> thus provides additional means for the plate <NUM> to more closely follow the shape of the stoma of a patient, furthermore they provide an improvement in the adhering properties of the plate <NUM>. Hence, the flaps33 provide a mean to increase the ability for the plate to follow the shape of the stoma of a patient more closely.

Again referring to <FIG>, the thickness of the plate <NUM> varies in a lateral direction, i.e. a direction substantially orthogonal to the axis <NUM> moving radially outwards. A central portion <NUM> of the plate <NUM> is preferably thicker than a lateral portion <NUM> of the plate <NUM>. This is particularly advantageous since the thicker material of the central portion <NUM> allows for a stronger bond between the fitting <NUM> and the plate <NUM> due to the relatively large contact area between said fitting <NUM> and plate <NUM>, while the thinner material at the lateral portion <NUM> makes the remaining portion of the plate <NUM> more flexible and formable. Additionally, a thicker central portion <NUM> allows for an increased force distribution around the fitting <NUM>, upon exposure to axial or transversal forces during use. However, the lateral portion <NUM> is not so thin that it becomes difficult to apply or may wrinkle when the tracheostoma device holder <NUM> is worn by a patient.

As further depicted in <FIG>, an interface <NUM> between the plate <NUM> and the tubular tracheostoma device fitting <NUM> may be formed by a proximodistal face <NUM> of the plate <NUM> and the tubular tracheostoma device fitting <NUM>. The proximodistalface <NUM> extends along the axis <NUM>, i.e. in a proximodistal direction and abuts to the lateral face of the tubular tracheostoma device fitting <NUM> also extending along said axis <NUM>, i.e. in a proximodistal direction. The interface <NUM> is thus a proximodistal interface <NUM> formed by a substantially annularly shaped boundary surrounding the tubular tracheostoma device fitting <NUM>, extending substantially orthogonal to the skin of the user.

Due to the tracheostoma device holder <NUM> being susceptible to forces parallel to the axis <NUM>, which may be transferred into a shear force in the interface between the tracheostoma device fitting <NUM> and the plate <NUM>, a large proximodistal interface may absorb such forces in a good way.

However, with conventional adhering operations such a proximodistal interface is difficult to achieve. Instead, the fitting is usually adhered on top of the distal surface of the plate. In such a solution little resistance is provided to shearing forces between the proximal surface of the fitting and the distal surface of the plate and the adhesion is prone to peel off. Such shearing load may induce cracks between said components which causes leakage. Thus, the orientation of the interface allows for an interface between plate and fitting which maintains structural integrity even during relatively large proximodistal loads, as well as shearing forces.

According to an alternative embodiment, as illustrated in <FIG>, the surrounding plate material <NUM> and the tracheostoma device fitting <NUM> is manufactured as one integral and monolithic body. Due to this embodiment, the production process is simplified as the two parts may be manufactured together in one process. The number of production steps is reduced, as the two parts do not have to be joined together and only one material for both the tracheostoma device fitting <NUM> and the surrounding plate material <NUM> has to be chosen. Furthermore, by eliminating the interface between the tracheostoma device fitting <NUM> and the surrounding plate material <NUM>, there may be less risk of the interface between the two parts to break, as there will not exist an interface.

Although the present invention has been described above with reference to specific embodiments, it is not intended to be limited to the specific form set forth herein. Rather, the invention is limited only by the accompanying claims and, other embodiments than the specific above are equally possible within the scope of these appended claims.

Claim 1:
A tracheostoma device holder (<NUM>) for holding a tracheostoma device superimposed of a tracheostoma of a person, said tracheostoma device holder (<NUM>) comprising:
a plate (<NUM>) for attachment over a tracheostoma via proximal side thereof, said plate (<NUM>) being provided with a through hole (<NUM>);
a tracheostoma device fitting (<NUM>) being provided with a through passage (<NUM>) arranged superimposed the through hole (<NUM>), said tracheostoma device fitting (<NUM>) extending distally from the plate (<NUM>); characterized in that
the plate (<NUM>) comprises a disc (<NUM>) of a thermoplastic material enclosed at least centrally and laterally by a surrounding plate material (<NUM>), wherein the plate material (<NUM>) has a melting point different from a melting point of the disc (<NUM>).