Tracheostomy device holder and method of adapting the holder to the anatomy of a patient

Abstract

A tracheostomy device holder (10) for holding a tracheostomy device is provided, which is overlapped with a person's tracheostomy. The tracheostomy device holder (10) comprises: a plate (30) for being attached to the tracheostomy via its proximal side, the plate (30) being provided with a through hole (39); a tracheostomy device fitting (20) being provided with a channel (23) arranged to overlap with the through hole (39), the tracheostomy device fitting (20) extending distally from the plate (30). The plate (30) comprises a disk (50) of thermoplastic material surrounded by a plate material portion (40), wherein the melting point of the plate material portion (40) is different from the melting point of the disk (50).

Description

Technical Field

[0001] The present invention generally relates to a tracheostomy device holder. More specifically, the present invention relates to a tracheostomy device holder comprising a plate for attachment to a tracheostoma via a proximal side of the plate, the plate being provided with a through hole with a tracheostomy device fitting extending distally from the plate in a circumferential direction of the through hole. In addition, the present invention relates to a method for adapting such a tracheostomy device holder to its intended user. Background Art

[0002] A tracheostomy is a surgical procedure that creates an opening through the front surface of the neck and into the windpipe. The opening is called a tracheostomy. A tracheostomy tube may be arranged to extend between the tracheostomy and the windpipe. A tracheostomy is performed, for example, when there is a malfunction in the nervous system or airway that results in an inability to get enough air, such as due to injury or disorder. A tracheostomy may also be necessary if the lungs are poorly functioning or if respiratory therapy is required.

[0003] Laryngectomy is a surgical procedure, for example, for the treatment of cancer, which involves removing the larynx or larynx and forming a tracheostomy. The result of this operation is that the trachea is no longer connected to the pharynx, but is transferred to a tracheostomy. After this operation, it will be impossible to have normal nasal function. In subjects with normal respiratory function, the nose and the mucosal lining of the nasal cavity play an important role in regulating the air inhaled. Complex passages and abundant blood supply help to increase both the temperature and humidity of the inhaled air, so that the difference between these parameters and the lung surface is minimal. Before the exhaled gas is released to the atmosphere, some heat and humidity are usually captured from the exhaled gas. The mucosal lining of the nasal passage is also used to remove particulate matter, such as fine dust particles, pollutants and microorganisms from the inhaled air, and the action of cilia sends mucus and any particles from the lungs.

[0004] When a person has had a laryngectomy, virtually all inhaled air enters the lungs via the tracheostomy, and the nose is virtually not involved in the inhalation process. Exhaled air can pass through the tracheostomy, or, where a voice prosthesis has been fitted, the stoma can be blocked so that the exhaled air is diverted via the voice prosthesis into the pharynx and mouth, thereby enabling the person to speak. It is desirable to control the exhaled airflow by means of a tracheostomy valve. In these situations, the valve can be arranged to remain open during breathing, but can be closed to divert the airflow by a small additional increase in the exhaled airflow.

[0005] In this regard, tracheostomy devices such as filter devices, heat and moisture exchangers (HMEs), respirators, and speech valves have been developed to moisten the inhaled air, remove small particles and bacterial matter in the inhaled air, and provide speech capabilities to people by closing the airway through the tracheostomy by manual operation. As an alternative, some people use a "hands-free" HME (automatic speaking valve) activated by speaking. The hands-free HME enables laryngectomy patients to speak without having to cover their fingers. The device consists of a combination of an HME and an automatic speaking valve, which automatically closes when exhaling to speak, allowing lung air to enter the esophagus through a voice prosthesis. When exhalation decreases, it automatically reopens.

[0006] These tracheostomy devices are kept in place by the tracheostomy device holder arranged on the people's tracheostomy. The tracheostomy device holder is usually attached to the skin of the people by a plaster, and the plaster has an adhesive surface on a side thereof for pointing to the people using the plaster. Alternatively, the tracheostomy device holder is bonded to the plaster, or the tracheostomy device holder is arranged on the sticky surface of the plaster on the side intended to point outwards from the people using the plaster. A cover sheet can be applied on the skin adhesive surface, which is removed before the tracheostomy device holder is about to be applied. The cover sheet helps to transport, and keeps the skin adhesive ability of the skin adhesive surface.

[0007] However, since the neck of the people who receive the tracheostomy device holder is by no means flat, there is a problem associated with applying the tracheostomy device holder after removing the cover sheet. For people with a sunken stoma, that is, people whose stoma has been slightly sunken into the neck of the people, it is difficult to adhere the tracheostomy device holder to the pit between the sternocleidomastoid muscles, because the adhesive surface of the tracheostomy device holder will inevitably adhere to the wall of the pit before the central part of the system arrives at the bottom of the pit. During laryngectomy, in patients who do not have two vertical sternocleidomastoid muscles, the sunken stoma on the neck incision is very common. In addition, the poor fit between the non-flat surface of the neck and the adhesive surface of the tracheostomy device holder may cause leakage between the neck and the adhesive surface, because the distribution of the force on the plate will be uneven, wherein, the local area is exposed more than other areas, thereby causing the loss of speech pressure. Especially during the use of the automatic speaking valve, when the user does not block the tracheostomy device from moving forward by finger closure, the force from the speech pressure usually causes premature leakage.

[0008] Furthermore, in many hospitals, the surgical procedure during laryngectomy is adapted to form a stoma of a substantially flat nature to conform to the tracheostomy device holder system currently on the market. This adaptation includes cutting the two vertical sternocleidomastoid muscles on the neck.

[0009] Therefore, an improved tracheostomy device holder would be advantageous, particularly one that allows convenient application of the tracheostomy device holder with improved positioning capabilities while reducing the risk of loosening of the skin adhesion near the tracheostomy, even in people with a sunken tracheostomy, thereby maintaining speech sound pressure at a convenient level and compensating for irregularities in the shape of the skin near the stoma. Summary of the invention

[0010] Therefore, the present invention preferably attempts to mitigate, alleviate or eliminate one or more of the above-mentioned defects and disadvantages, either individually or in any combination, and at least solves the above-mentioned problems by providing a tracheostomy device holder for holding a tracheostomy device superimposed on a person's tracheostomy, the tracheostomy device holder comprising: a plate for being attached to the tracheostomy via its proximal side, the plate being provided with a through hole; a tracheostomy device fitting arranged to overlap with the through hole, the tracheostomy device fitting extending distally from the distal side of the plate: wherein the plate comprises a disc of thermoplastic material surrounded by a surrounding plate material portion.

[0011] For the same reasons, a method of adapting such a tracheostomy holding device is also provided.

[0012] Hereby, a tracheostomy device holder is provided which can be adapted to a wider range of stoma shapes and which can more closely follow the shape of the patient's stoma. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] These and other aspects, features and advantages of the present invention will become apparent and elucidated from the following description of embodiments of the present invention with reference to the accompanying drawings, in which:

[0014] Figure 1a is a cross-sectional view of a tracheostomy device holder according to an embodiment of the present invention;

[0015] Figure 1b is a cross-sectional view of a tracheostomy device holder according to an embodiment of the present invention;

[0016] Figure 2 is a cross-sectional view of a tracheostomy device holder according to an embodiment of the present invention;

[0017] Figure 3 is a perspective view of a tracheostomy device holder according to an embodiment of the present invention;

[0018] Figure 4 is a cross-sectional view of a tracheostomy device holder according to an embodiment of the present invention;

[0019] Figure 5 is a cross-sectional view of a tracheostomy device holder according to an embodiment of the present invention;

[0020] Figure 6 is a cross-sectional view of a tracheostomy device holder according to an embodiment of the present invention; and

[0021] Figure 7 is a cross-sectional view of a tracheostomy device holder according to an embodiment of the present invention. DETAILED DESCRIPTION

[0022] The following description focuses on an embodiment of the present invention suitable for a tracheostomy device holder, which is used to hold a tracheostomy device such as a tracheostomy valve on a person's stoma. In this case, the tracheostomy device can be a HME, a speech valve, or the like.

[0023] Figure 1a A cross-sectional view of a tracheostomy device holder 10 for holding a tracheostomy device superimposed on a person's tracheostomy is disclosed, the tracheostomy device holder 10 comprising a plate 30 for attachment to the tracheostomy via its proximal side, the plate 30 being provided with through holes 39 .

[0024] The tracheostomy device holder 10 further comprises a tracheostomy device fitting 20 extending distally from the distal side of the plate 30. The tracheostomy device fitting is preferably a tubular tracheostomy device fitting 20. The tracheostomy device fitting 20 comprises a passage 23 extending through the tracheostomy device holder 10. The passage 23 of the tracheostomy device fitting 20 is superimposed on the through hole 39 of the plate 30, thereby forming a distal opening 11 communicating with the proximal opening 12 in the tracheostomy device holder 10. Preferably, the orifice formed by the tubular tracheostomy device fitting 20 and the through hole 39 provided in the plate 30 coincide with respect to the axis 100 of the through hole 39.

[0025] Thus, the tracheostomy device holder 10 comprises a proximal end and a distal end. In this context, the proximal end refers to a position or direction towards the stoma, i.e. towards a user of the tracheostomy device holder 10, and the distal end refers to a position or direction away from the stoma, i.e. away from a user of the tracheostomy device holder 10. Lateral refers to a position or direction radially away from an axis 100, and central refers to a position or direction towards a central axis 100. The axis 100 extends through the tracheostomy device holder 10 in a proximal-distal direction. Advantageously, the axis 100 may coincide with a central axis of the tracheostomy device holder 10.

[0026] The tubular tracheostomy device fitting 20 is provided in the form of, for example, a cylindrical sleeve along the circumference of the through hole 39. Therefore, the tracheostomy device fitting 20 extends distally from the plate 30 in the circumference of the through hole 39. The plate 30 will extend mainly laterally from the tubular tracheostomy device fitting 20 as a flange relative to the axis 100 of the through hole 39. Similarly, the tubular tracheostomy device fitting 20 extends axially and distally from the plate 30 in accordance with the above.

[0027] Refer again Figure 1a , the plate 30 may be substantially circular in shape, with the through hole 39 extending through the center of the plate. The plate 30 may also be in other shapes, such as a polygon or a flower shape.

[0028] According to one embodiment, Figure 2 As shown in , the plate 30 comprises a disc 50 of thermoplastic material, which is at least laterally surrounded by a plate material portion 40. Thus, the plate 30 comprises at least two different materials. The melting point of the plate material portion 40 is different from the melting point of the disc 50 of thermoplastic material. The disc 50 of thermoplastic material adjoins the tracheostomy device fitting 20 at the center.

[0029] When the disc 50 is heated to its melting point, the disc 50 can be shaped so that the surface of the material is adapted to the shape of the anatomical aspects of the person wearing the tracheostomy device holder 100. Shaping the disc 50 allows the plate 30 to be shaped to more closely follow the shape of the patient's stoma. By providing a plate 30 comprising at least two materials with different melting points, only a portion of the plate 30 can be allowed to be shaped when the plate 30 is heated to a certain temperature. When the disc 50 has been heated to its melting point, the portion of the plate 30 with the lowest melting point will be allowed to be shaped accordingly. At the same time, another portion with a higher melting point will not melt. Therefore, some restrictions can be set on the shaped portion, because the portion of the plate 30 with a higher melting temperature can limit the various possibilities of the shaped material of the plate 30, and can also prevent it from flowing back and forth freely. Therefore, the application of the tracheostomy device holder 10 can be more accurately controlled, and a tracheostomy device holder 10 with improved positioning capabilities is achieved.

[0030] According to one embodiment, Figure 1a As shown, the plate 30 comprises a disk 50 made of thermoplastic material, which is surrounded at least centrally and laterally by a surrounding plate material portion 40. Thus, the plate 30 comprises at least two different materials, wherein the disk 50 of thermoplastic material is surrounded both centrally and laterally by the surrounding plate material portion 40. The melting point of the plate material portion 40 is different from the melting point of the disk 50 of thermoplastic material.

[0031] In an advantageous embodiment, the melting point of the plate material portion 40 is higher than the melting point of the disc 50. Therefore, when the disc 50 is in a formable state, the surrounding plate material portion 40 will maintain its basic spatial shape. Thus, the surrounding plate material portion 40 can constitute a barrier to the disc 50, which will prevent the disc 50 from flowing over the barrier, thereby also compromising the thickness of the disc, which in turn may cause the force distribution on the disc 50 to change.

[0032] The disc 50 may have a melting / softening temperature that allows shaping according to a person's local anatomy by direct contact between the plate 30 and the person's skin. Such a 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 60°C. Once softened, polycaprolactone can be formed into a suitable shape by hand. With the temperature of the outer layer lowered, it becomes non-sticky, but still flexible and shapeable.

[0033] refer to Figure 1a , the disc 50 of thermoplastic material can be surrounded by the surrounding plate material portion 40 in the center and laterally. Therefore, the disc 50 of thermoplastic material can be enclosed inwardly and outwardly by the surrounding plate material portion 40, preventing the thermoplastic material from flowing beyond the surrounding plate material portion 40 and flowing too far in any lateral or central direction. Therefore, the disc 50 of thermoplastic material can be prevented from freely flowing, potentially flowing into the inner cavity of the adhesive when in a formable state. The disc 50 of thermoplastic material can be prevented from flowing into areas that should be avoided and areas where the disc 50 of thermoplastic material should not be placed. Therefore, a safer tracheostomy device holder 10 is provided, which holder 10 more closely follows the shape of the patient's stoma.

[0034] In one embodiment, the disc of thermoplastic material 50 is further surrounded by a surrounding plate material portion 40 at the distal end. This can prevent the disc of thermoplastic material 50 from "escaping" out of the plate 30 in the distal direction and can ensure that the disc 50 remains within the plate 30. Therefore, a tracheostomy device holder 10 with improved positioning capabilities while maintaining the disc 50 in place is provided. By surrounding the disc of thermoplastic material 50 at the distal end, placement of the device can be facilitated because the sticky thermoplastic material 50 can be prevented from being exposed, which can facilitate the application of the tracheostomy device holder 10. In addition, because the surface of the plate 30 is a continuous material, the tracheostomy device holder 10 can be more aesthetically attractive when it is placed on the stoma. The plate material portion 40 at the distal end can also prevent unsightly fingerprints on the thermoplastic material.

[0035] The surrounding plate material portion 40 of the plate 30 may be made of a flexible and elastic material. Such a flexible and elastic material may be one that cannot be thermoformed at a comfortable low temperature. Examples of such materials are, for example, thermoplastic materials, such as thermoplastic elastomers (TPE). By providing the surrounding plate material portion 40 of the plate 30 with a flexible and elastic material, the entire plate 30 is enabled to follow the shape of the stoma more closely. In particular, the material may be so flexible that it may be implemented independently of the shape of the patient's stoma, thereby achieving a tracheostomy device holder 10 that is suitable for a wide range of stoma shapes. The flexible material also reduces the risk of leakage and / or discomfort felt by the patient by allowing the use of a softer material that closely follows the stoma.

[0036] According to one embodiment, the plate material portion 40 may be an injection molded component. Figure 1a , Figure 1b , Figure 2 and Figure 4 0. The tracheostomy device holder 10 according to this embodiment is illustrated in . These tracheostomy device holders 10 are advantageous in situations where it is desired that the shape and form of the plate material portion 40 is the same and consistent in each tracheostomy device holder 10. Furthermore, the plate material portion 40 may be cost-effective to manufacture.

[0037] According to another embodiment, the plate material portion 40 may be a thin film material. Figure 5 As shown, the film material may be arranged to be disposed at the distal end of the disc 50. As previously described, this may prevent the disc 50 of thermoplastic material from "escaping" the plate 30 in the distal direction and may ensure that the disc 50 remains within the plate 30. Thus, a tracheostomy device holder 10 having improved positioning capabilities while retaining the disc 50 in place is provided. By enclosing the disc 50 of thermoplastic material at the distal end, placement of the device may be facilitated because exposure of the sticky thermoplastic material 50 may be prevented, which may facilitate application of the tracheostomy device holder 10. Furthermore, since the surface of the plate 30 is a continuous material, the tracheostomy device holder 10 may be more aesthetically appealing when placed on the stoma. The distal plate material portion 40 may also prevent unsightly fingerprints on the thermoplastic material.

[0038] Alternatively, if Figure 6 As shown, the film material 40 can be arranged to be disposed at both the distal end and the proximal end of the disc 50, so that the disc 50 is disposed between the two-layer film plate material portion 40. According to this embodiment, the disc 50 of thermoplastic material is further prevented from "escaping" the plate 30 in the proximal direction, and the disc 50 can be ensured to remain in the plate 30.

[0039] In yet another alternative embodiment, the film material 40 may be disposed at the proximal end of the disk 50, such as Figure 7 Manufacturing of this embodiment may be advantageous because a disc 50 of thermoplastic material may be provided on top of the portion of sheet material 40 .

[0040] The tracheostomy device holder 10 according to those embodiments in which the plate material portion 40 is a thin film material may be easily adjustable and flexible in situations where requirements for the tracheostomy device holder 10 may change.

[0041] Since the plate material part 40 can be an injection molded plate or a film material plate, the tracheostomy device holder 100 can be adapted to the current situation. Since the two different embodiments have different requirements for eg manufacturing, the most suitable embodiment can be selected.

[0042] When adapting the tracheostomy device holder 100 to correspond to the anatomy of the neck near the tracheostomy of a person who intends to use the tracheostomy device holder 100, the plate 30 is heated at least to a temperature slightly above the melting temperature of its disc 50, i.e., approximately 65°C in the case of a PCL-based thermoplastic. This is done by heating the plate 30 for about 2 minutes to 5 minutes. However, the surrounding plate material portion 40, which has a different melting point, will not reach its melting point and, therefore, will not be affected and will maintain the disc 50 in an acceptable area. Therefore, the disc of thermoplastic material will be manually shaped, but will not be able to flow too far in any undesirable direction, such as into the lumen of the adhesive.

[0043] After the disc 50 reaches its melting temperature, the disc 50 becomes compliant and can therefore be manually shaped. Moreover, when the thermoplastic material used is a PCL-based thermoplastic, the transparency of the disc 50 changes from opaque to transparent. In this state, the disc 50 and therefore the plate 30 are shaped / shaped according to the anatomical structure of the neck of the person so that the through hole 39 is superimposed above the tracheostomy. The available shaping time is generally about 2 minutes, after which the disc 50 becomes non-shapeable, but still flexible. After about 10 minutes, the disc 50 hardens again and can then be used. In this way, the disc 50 can be shaped to correspond to the anatomical structure of the user's neck, so that the disc 50, for example, fits with two vertical sternocleidomastoid muscles and is still close to the sunken stoma.

[0044] Furthermore, due to the change in transparency at the melting temperature of the PCL-based material, it is not only easy to know when to start the shaping process, but also easy to adapt the plate 30 after the neck is dissected, because it is possible to see through the plate 30 and detect and compensate for changes in the contour of the neck. The surrounding plate material portion 40 is preferably transparent in its normal state, and will therefore remain transparent throughout the process. Furthermore, in the event that anatomical changes occur or should be shaped for another user, the disc 50 can be simply reshaped by reheating the plate 30 and reshaping it.

[0045] As in e.g. Figure 1b As shown in the figure, the proximal side of the plate 30 can be provided with a coating 60 having adhesive on both sides and a skin adhesive on one of the two sides. Such coating 60 can be sized according to the proximal side of the plate 30 so that the interaction surface between the plate 30 and the skin can be high. By providing high formability and uniform force distribution, it can allow the use of less viscous adhesives, which is beneficial to the user by reducing mechanical stress on the skin when removing the device. The adhesive can be a tape or foam tape, spray or coated with a skin adhesive.

[0046] The plate 30 may then be attached to the neck of the user such that the through hole 39 overlies the tracheostoma and a tracheostoma device such as a speech valve connected to the tracheostoma device fitting 20 in a known manner.

[0047] In an exemplary embodiment, the adhesive coating 60 may further enclose the disk of thermoplastic material in the proximal direction.

[0048] According to one embodiment, at least the proximal side of the disc 50 may be provided with a lining 70. This allows easier handling during shaping due to its reduced stickiness to the skin. Once the plate 30 has been shaped to the contours around the stoma (and perhaps after cooling to restore its rigidity), the lining is removed and the plate is attached to the patient's neck.

[0049] Refer again Figure 1a The tubular tracheostomy device fitting 20 may include a retaining lip 21 extending circumferentially from a distal region of the fitting 20. The retaining lip 21 includes a curved portion 22 extending proximally and laterally toward the axis 100 of the through hole of the plate. The retaining lip 21 is adapted to receive and retain a tracheostomy device.

[0050] The reception and retention of the tracheostomy device is provided by elastic deformation of the curved portion 22 of the retaining lip 21 and the more rigid material of the tracheostomy device fitting 20. When the tracheostomy device is inserted into the fitting 20 in a distal to proximal direction along the axis 100 of the through hole 39 of the plate 30, the curved portion 22 will deform laterally towards the inner portion of the tubular tracheostomy device fitting 20. This leaves room for the tracheostomy device to pass through the retaining lip 21 and be fully inserted into the tubular tracheostomy device fitting 20.

[0051] The curved portion 22 of the retaining lip 21 then retains the tracheostomy device within the tracheostomy device fitting 20. Due to the inwardly curved structure, any distal movement of the tracheostomy device beyond the retaining lip will be hindered. This is because any load on the retaining lip 21 caused by the movement will only cause the retaining lip 21 to deform by elastically bending the retaining lip 21, thereby causing the retaining lip 21 to exert a normal force directed proximally to hold the tracheostomy device in place.

[0052] The retaining lip 21 thus enables the tracheostomy device holder 10 to mitigate the risk of the tracheostomy device accidentally falling out of the tubular tracheostomy device fitting 20 when the tracheostomy device holder 10 is being used by a patient.

[0053] In order to provide the tracheostomy device fitting 20 with a retaining lip 21 having a desired retention characteristic, the fitting 20 can be provided with a more rigid material. Therefore, the tracheostomy device fitting 20 is preferably made of a more rigid material due to its required retention characteristics for holding the tracheostomy device 100 in place. Therefore, by elastic deformation of the fitting 20 of the more rigid material, the more rigid material can provide a press fit or snap fit between the tracheostomy device fitting 20 and the inserted tracheostomy device. However, in order to provide such a desired retention characteristic while still providing a tracheostomy device retainer 100 that is comfortable for the patient to wear, the tracheostomy device fitting 20 can be made of a more rigid material than the surrounding plate material portion 40 of the plate 30. Therefore, the material of the surrounding plate material portion 40 is more flexible than the material of the tracheostomy device fitting 20.

[0054] The tracheostomy device holder 100 with retaining lip solves the problem of achieving the following: reducing the risk of the tracheostomy device accidentally falling out of the tracheostomy device fitting 20 during wear without reducing the patient's sensory comfort or introducing additional bonding or connecting steps in the manufacturing process.

[0055] Reference Figure 3, the plate 30 further comprises a plurality of fins 33 extending laterally from the laterally outer portions of the plate 30. The fins 33 are preferably separated by a plurality of cut-ins 67 extending centrally from the lateral circumferential edges of the plate 30 towards the axis 100. The fins 33 further increase the adaptability of the plate 30, as each fin 33 can be bonded to a surface without affecting the orientation of the other fins of the plate 30.

[0056] In conventional plates, (partial) folding of sections of the outermost part of the plate 30 may cause strains to propagate through the material of the plate 30, which may force other sections of the plate 30 to release from their intended position on the patient's stoma. Thus, the flaps 33 provide an additional means for the plate 30 to conform more closely to the shape of the patient's stoma, and furthermore, they provide an improvement in the adhesive properties of the plate 30. Thus, the flaps 33 provide a means to enhance the ability of the plate to conform more closely to the shape of the patient's stoma.

[0057] Refer again Figure 1a , the thickness of the plate 30 varies in the lateral direction, i.e., in a direction moving radially outward substantially orthogonal to the axis 100. The central portion 32 of the plate 30 is preferably thicker than the lateral portions 31 of the plate 30. This is particularly advantageous because the thicker material of the central portion 32 allows for a stronger bond between the fitting 20 and the plate 30 due to the relatively larger contact area between the fitting 20 and the plate 30, while the thinner material at the side portions 31 makes the remainder of the plate 30 more flexible and easier to form. In addition, the thicker central portion 32 allows for increased forces distributed around the fitting 20 when subjected to axial or lateral forces during use. However, the lateral portions 31 are not so thin that they become difficult to apply or may wrinkle when the patient wears the tracheostomy device holder 10.

[0058] like Figure 1a As further depicted in FIG, the joint 34 between the plate 30 and the tubular tracheostomy device fitting 20 may be formed by the proximal-distal face portion 61 of the plate 30 and the tubular tracheostomy device fitting 20. The proximal-distal face portion 61 extends along the axis 100, i.e., in the proximal-distal direction, and abuts against the side of the tubular tracheostomy device fitting 20 that also extends along the axis 100, i.e., in the proximal-distal direction. Thus, the joint 34 is a proximal-distal joint 34 formed by a generally annular-shaped boundary that extends around the tubular tracheostomy device fitting 20 and generally orthogonal to the user's skin.

[0059] Since the tracheostomy device holder 10 is susceptible to forces parallel to the axis 100, which may be converted into shear forces in the joint between the tracheostomy device fitting 20 and the plate 30, the large proximal-distal joint can absorb such forces well.

[0060] However, such a proximal-distal joint is difficult to achieve using conventional adhesion operations. Instead, the fitting is typically adhered to the distal surface of the plate. In such a solution, there is little resistance to shear forces between the proximal surface of the fitting and the distal surface of the plate, and the adhesion is easily peeled. Such shear loads can cause cracks between the components, which can lead to leakage. Therefore, the orientation of the joint allows the joint between the plate and the fitting to maintain structural integrity even during relatively large proximal-distal loads and shear forces.

[0061] According to an alternative embodiment, Figure 4 As shown, the surrounding plate material portion 40 and the tracheostomy device fitting 20 are manufactured as an integral single body. Due to this embodiment, the manufacturing process is simplified because the two parts can be manufactured together in one process. Because the two parts do not need to be connected together, and only one material needs to be selected for both the tracheostomy device fitting 20 and the surrounding plate material portion 40, the number of production steps is reduced. In addition, by eliminating the joint between the tracheostomy device fitting 20 and the surrounding plate material portion 40, there is less risk of the joint between the two parts being separated because there will be no joint.

[0062] Although the present invention has been described above with reference to specific embodiments, it is not intended to limit the present invention to the specific form set forth herein. On the contrary, the present invention is limited only by the appended claims, and other embodiments except the above-mentioned specific embodiments may also fall within the scope of these appended claims.

[0063] In the claims, the term "comprises / comprising" does not exclude the presence of other elements or steps. In addition, although listed separately, multiple devices, elements or method steps may be implemented by, for example, a single unit or process. In addition, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not mean that the combination of features is not feasible and / or disadvantageous. In addition, singular references do not exclude plural cases. The terms "one", "a", "first", "second", etc. do not exclude the majority. The figure marks in the claims are provided only as illustrative examples and should not be interpreted as limiting the scope of the claims in any way.

Claims

1. A tracheostomy device holder (10), the tracheostomy device holder being used to hold a tracheostomy device superimposed on a person's tracheostomy, the tracheostomy device holder (10) comprising: a plate (30) for attachment to the tracheostomy via a proximal side of the plate, the plate (30) being provided with through holes (39); A tracheostomy device fitting (20) provided with a channel (23) arranged to overlap the through hole (39), the tracheostomy device fitting (20) extending distally from the plate (30); wherein The plate (30) comprises a disk (50) of thermoplastic material which is surrounded at least centrally and laterally by a surrounding plate material portion (40), wherein the melting point of the plate material portion (40) is different from the melting point of the disk (50).

2. The tracheostomy device holder (10) according to claim 1, wherein: The plate material portion (40) has a melting point higher than that of the disk (50).

3. The tracheostomy device holder (10) according to claim 1 or 2, wherein: The plate material portion (40) is disposed at a distal end of the disk (50).

4. The tracheostomy device holder (10) according to claim 1 or 2, wherein: The thermoplastic material is a polyester based thermoplastic.

5. The tracheostomy device holder (10) according to claim 1 or 2, wherein: The thermoplastic material is a polycaprolactone based thermoplastic material.

6. The tracheostomy device holder (10) according to claim 1 or 2, wherein: The plate material portion (40) is made of a flexible and elastic material.

7. The tracheostomy device holder (10) according to claim 6, wherein: The plate material portion (40) includes a thermoplastic elastomer.

8. The tracheostomy device holder (10) according to claim 1 or 2, wherein: At least the proximal side of the plate (30) is provided with a skin adhesive (60).

9. The tracheostomy device holder (10) according to claim 8, wherein: The adhesive (60) is a tape or a sprayed or coated skin adhesive having adhesive properties on both sides and a skin adhesive is provided on at least one of the two sides so that the proximal side of the plate (30) has adhesive properties to the skin.

10. The tracheostomy device holder (10) according to claim 9, wherein: The tape is a foam tape.

11. The tracheostomy device holder (10) according to claim 1 or 2, wherein: The material of the plate material portion (40) is more flexible than that of the tracheostomy device fitting (20).

12. The tracheostomy device holder (10) according to claim 1 or 2, wherein: The plate material portion (40) and the tracheostomy device fitting (20) are manufactured as an integral unitary body.

13. The tracheostomy device holder (10) according to claim 1 or 2, wherein: The thickness of the plate (30) decreases in a direction from the center to the lateral direction.

14. The tracheostomy device holder (10) according to claim 1 or 2, wherein: The lateral portion (31) of the plate (30) comprises a plurality of fins (33).

15. A method of adapting a tracheostomy device holder (10) according to any one of claims 1 to 14 to correspond to a human cervical anatomy, the method comprising the following steps: heating the sheet (30) to above the melting temperature of the thermoplastic disk (50) of the sheet so that the disk (50) becomes conformable and manually formable; applying the proximal side of the plate (30) to the neck of the person so that the through hole (39) overlaps the tracheostomy; shaping the disc (50) according to the person's cervical anatomy; and The sheet (30) is actively or passively cooled to below the melting temperature of the disk (50) of the sheet.

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