Fluid supply adaptor to a tracheostoma device arrangement

Abstract

A fluid supply adaptor (100) for a tracheostoma device arrangement (200, 300) superimposed of a tracheostoma of a person is provided. The fluid supply adaptor (100) comprises a tubular body (101) with a proximal end zone (102) and a distal end zone (103), said tubular body having a central axis (A), wherein the proximal end zone (102) is configured to be connected to a holder (200) attached to user skin, and the distal end zone (103) is configured to be connected to a tracheostoma device (300). The fluid supply connector (100) comprises a tube connector (104), extending laterally outwards from periphery of the tubular body (101), said tube connector (104) comprising an inlet (105) and an outlet (106), fluidly connecting the exterior of the tubular body (101) with the interior of the tubular body (101). The outlet (106) is directed distally.

Description

[0001] FLUID SUPPLY ADAPTOR TO A TRACHEOSTOMA DEVICE ARRANGEMENT

[0002] Field of the Invention

[0003] This invention pertains in general to a fluid supply adaptor. More particularly, the present invention pertains to a fluid supply adaptor to be placed between a tracheostoma device and a tracheostoma device holder.

[0004] Background of the Invention

[0005] 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.

[0006] 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.

[0007] 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, by manually closing the valve or in the case of an automatic tracheostoma valve through a small additional increase in exhaled air flow.

[0008] In this respect tracheostoma aid devices, such as filter devices, 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 speech by closing the air passage through the tracheostoma by manual operation.

[0009] These tracheostoma aid 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 in use. 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 in use. On the skin adhesive surface a covering sheet / foil 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.

[0010] Due to the nature of the surgeries and people in need of these, sometimes the user of tracheostoma aid devices need an extra supply of fluid, such as oxygen. The gas stream of oxygen supply is very dry. Oxygen is then normally supplied proximally of the tracheostoma aid devices, and this gas stream therefore does not pass through the tracheostoma aid device, whereby the function and intention of the tracheostoma aid device is lost for this part of the inhaled fluid - especially due to the dry nature of the oxygen supply. As the oxygen supply passes through the tracheostoma aid device and is conditioned, it collides with the air inhaled through the tracheostoma aid device. The stream collision affects the stream pattern through the tracheostoma aid device. Simulations have shown that the relative flow rates of the inhaled air and supplied oxygen affect to what degree the oxygen penetrates the tracheostoma aid device, as the flows of inhaled air and oxygen supply counteract each other because of their opposite directions. Hence, an improved tracheostoma device holder would be advantageous, and in particular a tracheostoma device holder allowing for extra supply of fluid, wherein the extra supply of fluid is directed through the tracheostoma aid device, while maintaining a robust configuration of parts.

[0011] Summary of the Invention

[0012] Accordingly, the present invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination and solves at least the above mentioned problems by providing a fluid supply adaptor for a tracheostoma device arrangement superimposed of a tracheostoma of a person, wherein said fluid supply adaptor comprises: a tubular body with a proximal end zone and a distal end zone, said tubular body having a central axis, wherein the proximal end zone is configured to be connected to a holder attached to user skin, and the distal end zone is configured to be connected to a tracheostoma device; a tube connector, extending laterally outwards from a periphery of the tubular body, said tube connector comprising an inlet and an outlet, fluidly connecting the exterior of the tubular body with the interior of the tubular body; wherein the outlet is directed distally.

[0013] Advantageous features of the invention are defined in the dependent claims.

[0014] Brief Description of the Drawings

[0015] 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

[0016] Fig. 1 is an exploded view of a tracheostoma assembly according to an embodiment of the invention;

[0017] Fig. 2 is a cross-sectional view of a tracheostoma assembly according to an embodiment of the invention;

[0018] Fig. 3 is a perspective view of a fluid supply adaptor according to one embodiment of the present invention; and Fig. 4 is a perspective view of a fluid supply adaptor according to one embodiment of the present invention.

[0019] Figs. 5 and 6 are graphical representations of the test results listed in Table 1.

[0020] Description of embodiments

[0021] The following description concerns embodiments of the present invention applicable to a fluid supply adaptor 100 for a tracheostoma device arrangement, such as a tracheostoma device arrangement comprising a tracheostoma device holder 200 and a tracheostoma aid device 300. A tracheostoma aid device 300 may in this context be a tracheostoma valve, HME, speech valve, etc., or combinations thereof. The fluid supply adaptor 100 is configured to be arranged between the tracheostoma device holder 200 and the tracheostoma aid device 300, such that the fluid supply adaptor 100 is arranged distally of the tracheostoma device holder 200 and proximally of the tracheostoma aid device 300. The fluid supply adaptor is arranged on the tracheostoma device holder 200 such that a proximal end of the fluid supply adaptor 100 connects to a distal end of the tracheostoma device holder 200, and that a distal end of the fluid supply adaptor 100 connects to a proximal end of the tracheostoma aid device 300. The fluid supply adaptor 100 for a tracheostoma device arrangement 200, 300 is configured to be superimposed of a tracheostoma of a person.

[0022] In embodiments disclosed in Figs. 1 to 4, the fluid supply adaptor 100 comprises a tubular body 101. The tubular body 101 has a proximal end zone 102 and a distal end zone 103. The tubular body 101 has a central axis A. The proximal end zone 102 is configured to be connected to the holder 200 attached to user skin, and the distal end zone 103 is configured to be connected to a tracheostoma aid device 300. The fluid supply adaptor 100 further comprises a tube connector 104. The tube connector 104 extends laterally outwards from a periphery of the tubular body 101. In embodiments, the tube connector 104 is arranged at the external side of the tubular body 101 and extends radially outwards. The tube connector 104 comprises an inlet 105 and an outlet 106. The inlet 105 is configured to be connected to a supply tube (not shown), which may supply a fluid to the patient via the fluid supply adaptor 100 and the tracheostoma device arrangement 200, 300. The fluid supplied to the fluid supply adaptor 100 and the tracheostoma device arrangement 200, 300 may for example be oxygen, in case the user has trouble oxygenating his / her blood to an ample degree. In embodiments, the tube connector 104 is provided with a lumen that connects an exterior of the tubular body 101 with an interior of the tubular body 101. The outlet 106 is arranged on the interior side of the tubular body, such that the outlet 106 communicates with a lumen of the tubular body 101. On the interior side of the tubular body 101 the outlet 106 is directed distally, such that fluid supplied to the fluid supply adaptor 100 and the tracheostoma device arrangement 200, 300 is directed distally inside the interior of the tubular body 101, into the tracheostoma aid device 300, arranged distally of the fluid supply adaptor 100. In this way, the fluid supplied to the user can pass through the tracheostoma aid device 300, such that also the inhaled supplied oxygen will pass the tracheostoma aid device 300 before entering the user.

[0023] In embodiments, the outlet 106 is provided with a deflector 107. The deflector 107 is arranged internally of the tubular body 101. The deflector 107 may be in the form of a screen, screening supplied fluid from central movement, and directing it distally inside the interior of the tubular body 101. In embodiments, the deflector 107 can be cup-shaped and connected to the interior side of the tubular body 101, wherein an opening of the cup-shape is directed distally.

[0024] In embodiments, the outlet 106 can be furcated, such as bifurcated, which is shown in Fig. 4. In this way, the fluid supplied to the fluid supply adaptor 100 and the tracheostoma device arrangement 200, 300 can be spread over a larger area of the tracheostoma aid device 300, such that the supplied fluid can be more affected by the tracheostoma aid device 300. Very often tracheostoma aid devices, such as HME’s, have a spoke configuration on the proximal side, to suspend for example a foam. The furcated outlet may then be adapted to the spoke configuration, such that supplied fluid hits the foam and not spokes. In embodiments, the furcation of the outlet 106 is provided in the deflector 107.

[0025] Measurements, using standardized test methods and equipment for measuring performance of tracheostoma aid devices, show that the distally directed flow of the outlet 106, such as the oxygen deflector 107, reduces the negative effect of the added dry oxygen to the inhaled gas mixture by up to about 60% at half of the maximum flow (3 1 / min) to be used with tracheostoma aid devices. Slightly lower levels of reduction of the negative effect of the added dry oxygen at the maximum specified oxygen flow rate (6 1 / min) to be used with tracheostoma aid devices have been obtained. From the above, it is understood that when a person needs a supplementary supply of oxygen, a drawback of adding oxygen to the inhalation flow is that the inhaled air contains less moisture, which is suboptimal as drier air can cause irritation and coughing. Table 1 below shows the relative differences in percent between the baseline moisture loss (ML) where no oxygen is added and the ML when oxygen is added to the inhalation air. The values are averaged results from tests, illustrating in particular the measured relative difference in moisture loss when using the fluid supply adaptor 100 according to the invention with and without deflector 107 directing oxygen flow distally in the tubular body 101, and in arrangement with two different, commercially available HMEs from Atos Medical, the Provox Life series ‘Home’ and ‘GO’ HMEs, at two different oxygen flow rates, respectively.

[0026] Table 1

[0027] As can be seen in Table 1, the use of deflector 107, directing the oxygen flow distally in the tubular body 101, significantly reduces the moisture loss in the inhalation air to the benefit of the user. For example, for the ‘GO’ HME at half the maximum oxygen flow (3 l / min), the average moisture loss increase without the deflector 107 is 13.3%, whereas the moisture loss increase including the deflector 107 is reduced to 5.0%, corresponding to a reduction of about 60%. Figs. 5 & 6 show graphical representations of the results of Table 1 (wherein the identified ‘HME A’ corresponds to the Provox Life ‘Home’ HME and the ‘HME B’ corresponds to the Provox Life ‘Go’ HME).

[0028] In embodiments, the fluid supply adaptor 100 is provided with a holder ridge 108 at the proximal end zone 102 for cooperation with the tracheostoma device holder 200. The holder ridge 108 extends circumferentially on the external side of the tubular body 101. The holder ridge 108 can be continuous, as in the figures, but it can also be a plurality of ribs, collectively constituting a holder ridge 108. The holder ridge 108 is arranged externally of the tubular body 101 and extending laterally. Thus, it extends radially outwards from the tubular body 101. Thus, the fluid supply adaptor 100 may be retained in the tracheostoma device holder 200 may be retained by friction inside the tracheostoma device holder 200, wherein the holder ridge 108 cooperates with a corresponding groove or ledge (not shown) at the tracheostoma device holder 200. The tubular body 101 is provided with an internal socket 109 for supporting the tracheostoma device 300. The socket 109 extends in a plane transversally of the central axis A. The socket 109 extends circumferentially on the internal side of the tubular body 101. The socket may be continuous, as in the figures, but it may also be a plurality of socket sections, collectively constituting socket 109.

[0029] The socket 109 and the outlet 106 are at same proximodistal level. Hence, the socket 109 and the outlet 106 may be arranged at the same transversal plane, in relation to the central axis A. In this way the socket 109 and the outlet 106 are arranged between the proximal end zone 102 and the distal end zone 103.

[0030] In embodiments, a tracheostoma device fitting 110 extends distally from the socket 109. The tracheostoma device fitting 110 can be in the form of a skirt 110 arranged circumferentially and peripherally of the socket 109. This means that the tracheostoma device fitting 110 is arranged laterally and distally of the socket 109. The tracheostoma device fitting 110 can comprise a tracheostoma device ledge 111 at the distal end zone 103 for cooperation with the tracheostoma aid device 300. In this way the fluid supply adaptor 100 may fit with a range of different tracheostoma aid devices 300, such that a nurse or a carrying person may select the tracheostoma aid device 300 most suitable for a specific situation. For example, the fluid supply adaptor 100 may be used with tracheostoma aid devices with different breathing resistances, depending on where in a rehabilitation process a patient is - also taking into account that the supply of oxygen increases flow resistance through the tracheostoma aid device 300. In summary, one holder may fit with a range of tracheostoma aid devices 300 with purposefully effect, instead of adapting each tracheostoma aid device 300 individually; with or without tube connectors 104 and specific adaptations of the tube connectors 104. Thus, the tracheostoma aid device 300 may be retained by friction inside the tracheostoma device fitting 110, wherein the tracheostoma device ledge 111 cooperates with a corresponding groove or ledge (not shown) at the tracheostoma aid device 300. The tracheostoma device ledge 111 is arranged internally of the tubular body 101 and extending centrally. Hence, the tracheostoma device ledge 111 extends radially inwards towards the central axis A of the tubular body 101.

[0031] In embodiments, a flange 112 is arranged circumferentially of the tubular body 101. The flange 112 extends laterally, i.e. radially outwards from the tubular body 101. The flange 112 extends laterally beyond the tracheostoma device fitting 110 and the holder ridge 108. The flange 112 acts as a socket in relation to the tracheostoma device holder 200, such that the flange 112 may sit distally of the tracheostoma device holder 200 upon connection between the tracheostoma device holder 200 and the fluid supply adaptor 100. The flange 112 is arranged between the proximal end zone 102 and the distal end zone 103. The flange 112 is arranged proximally of the socket 109 and the tube connector 105.

[0032] In embodiments, the tube connector 104 is provided with external friction ribs 113. In embodiments, the tube connector 104 extends distolateral from the tubular body 101. The tube connector 104 extends laterally and outwardly from the user, i.e. distally, which is the meaning of the term distolateral within the ambit of this disclosure. This means that the tube connector 104 is angled in relation to a transversal plane of the tubular body 101, to realize the distal component of the distolateral direction. The tube connector 104 is also angled in relation to the central axis A, to realize the lateral component of the distolateral direction. In this way, attachment of a supply tube may be facilitated.

[0033] In embodiments, the fluid supply adaptor 100 is monolithic. The fluid supply adaptor 100 can suitably be made of plastic.

[0034] 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.

[0035] In the claims, the term “comprises / comprising” does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e.g. a single unit or processor. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. In addition, singular references do not exclude a plurality. The terms “a”, “an”, “first”, “second” etc do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

Claims

CLAIMS1. A fluid supply adaptor (100) for a tracheostoma device arrangement (200, 300) superimposed of a tracheostoma of a person, wherein said fluid supply adaptor (100) comprises: a tubular body (101) with a proximal end zone (102) and a distal end zone (103), said tubular body having a central axis (A), wherein the proximal end zone (102) is configured to be connected to a holder (200) attached to user skin, and the distal end zone (103) is configured to be connected to a tracheostoma device (300); a tube connector (104), extending laterally outwards from a periphery of the tubular body (101), said tube connector (104) comprising an inlet (105) and an outlet (106), fluidly connecting the exterior of the tubular body (101) with the interior of the tubular body (101); wherein the outlet (106) is directed distally.

2. The fluid supply adaptor (100) according to claim 1, wherein the outlet (106) is provided with a deflector (107), arranged internally on the tubular body (101).

3. The fluid supply adaptor (100) according to claim 1 or 2, comprising a holder ridge (108) at the proximal end zone (102) for cooperation with a tracheostoma device holder (200).

4. The fluid supply adaptor (100) according to claim 3, wherein the holder ridge (108) is arranged externally of the tubular body (101) and extending laterally.

5. The fluid supply adaptor (100) according to any of the preceding claims, wherein the tubular body (101) is provided with an internal socket (109) for supporting a tracheostoma device (300), said socket (109) extending in a plane transversally of the central axis (A).

6. The fluid supply adaptor (100) according to claim 5, wherein the socket (109) and the outlet (106) are at same proximodistal level.

7. The fluid supply adaptor (100) according to claim 5 or 6, comprising a tracheostoma device fitting (110) extending distally from the socket (109).

8. The fluid supply adaptor (100) according to claim 7, wherein the tracheostoma device fitting (110) comprises a tracheostoma device ledge (111) at the distal end zone (103) for cooperation with a tracheostoma device (300).

9. The fluid supply adaptor (100) according to claim 8, wherein the tracheostoma device ledge (111) is arranged internally of the tubular body (101) and extending centrally.

10. The fluid supply adaptor (100) according to any of the preceding claims, wherein the outlet (106) is furcated.

11. The fluid supply adaptor (100) according to claim 7, wherein the outlet (106) is bifurcated.

12. The fluid supply adaptor (100) according to claim 10 or 11 in combination with claim 2, wherein the outlet (106) is furcated in the deflector (107).

13. The fluid supply adaptor (100) according to any of the preceding claims, wherein a flange (112) is arranged circumferentially of the tubular body (101), said flange extending laterally.

14. The fluid supply adaptor (100) according to claim 13, wherein the flange (112) is arranged between the proximal end zone (102) and the distal end zone (103).

15. The fluid supply adaptor (100) according to claims 13 or 14, wherein the flange (112) is arranged proximally of the tube connector (104).

16. The fluid supply adaptor (100) according to any of the preceding claims, wherein the tube connector (104) is provided with external friction ribs (113).

17. The fluid supply adaptor (100) according to any of the preceding claims, wherein the tube connector (104) extends distolateral from the tubular body (101).

18. The fluid supply adaptor (100) according to any of the preceding claims, wherein the fluid supply adaptor (100) is monolithic.

19. The fluid supply adaptor (100) according to any of the preceding claims, wherein the fluid supply adaptor (100) is made of plastic.

20. A kit of parts comprising at least the fluid supply adaptor (100) according to any one of the preceding claims and a tracheostoma aid device selected from a group comprising a tracheostoma valve, a HME (300), a speech valve, or combinations thereof.

21. The kit of parts of claim 20, further comprising a tracheostoma device holder (200).

Images