A voice prosthesis

Abstract

Voice prostheses (100) having a reservoir (140) including a growth inhibiting substance are disclosed. Release of a growth inhibiting substance in the vicinity of the voice prosthesis is considered to lower the ingrowth of fungi, such as Candida albicans, into the voice prosthesis. The reservoir may be positioned in various positions in the voice prosthesis.

Description

[0001] A Voice Prosthesis

[0002] The invention relates to a voice prosthesis and more particular to a voice prosthesis with a reservoir configured for containing and slowly releasing a growth inhibiting substance.

[0003] Brief Description of the Drawing

[0004] The accompanying drawings are included to provide a further understanding of embodiments and are incorporated into and are part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.

[0005] Figures 1 and 2 illustrate an example of a voice prosthesis as disclosed herein. Figure 1 illustrates a perspective view and figure 2 illustrates a cross-sectional view.

[0006] Figure 3 illustrates a cross-sectional view of an example of a voice prosthesis as disclosed herein.

[0007] Figures 4A to 7B illustrate views of valve flaps including reservoirs, which can be used in voice prostheses of this disclosure. Figures 4A, 5A, 6A, 7A illustrate cross-sectional views of valve flaps and figures 4B, 5B, 6B, 7B illustrate top views of valve flaps.

[0008] Figures 8 and 9 illustrate cross-sectional views of other examples of voice prostheses disclosed herein.

[0009] Figures 10 and 11 illustrate cut-off side views of portions of voice prostheses disclosed herein, illustrating examples of reservoirs and apertures into the reservoirs.

[0010] Figures 12A-12C illustrate ingrowth of fungi into a prior art voice prosthesis.

[0011] Detailed Description

[0012] Examples of this disclosure relate to a voice prosthesis configured for being inserted into a tracheoesophageal wall opening comprising - an exterior housing comprising a proximal flange and a distal flange and a tubular portion connecting the proximal flange and the distal flange, the flanges being configured for retaining the voice prosthesis in position at the tracheoesophageal wall opening, and

[0013] - a valve configured for opening in one direction and for closing in an opposite direction, wherein the voice prosthesis further comprises at least one reservoir configured for containing a growth inhibiting substance, and wherein the voice prosthesis comprises at least one aperture communicating with the reservoir for releasing the growth inhibiting substance from the reservoir.

[0014] When users have gone through a laryngectomy surgical procedure, they have had their natural voice box removed and are no longer able to speak normally. To alleviate this, a voice prosthesis can be inserted into an opening created in the tracheoesophageal wall between the windpipe (also called trachea) and the oesophagus. The voice prosthesis is generally speaking a valve, which allows inflow of air from the windpipe to the oesophagus, but which prevents flow from the oesophagus to the windpipe. Flow from the oesophagus to the windpipe may lead to matter travelling from the mouth into the oesophagus and from there through the windpipe into the lungs, which may eventually cause coughing in a first step, and in a later step, pneumonia. Therefore, flow in the direction from the oesophagus to the windpipe is to be prevented.

[0015] Voice prostheses are inserted and replaced regularly and are normally to be replaced every 3 to 6 months. The most common reason to replace a voice prosthesis prematurely is central leakage related to biofilm formation on the sealing surfaces of the valve. When fungus grows into the material of the voice prosthesis, it may not be possible to remove by brush-cleaning and therefore the valve may stop working prematurely, because it is no longer able to close properly. This means that the user will have to have the voice prosthesis replaced much sooner than would otherwise be necessary. Furthermore, exchange of a voice prosthesis is a somewhat cumbersome process for the user, and ingrowth of fungus may make it difficult, if not impossible, to foresee the service life of the voice prosthesis.

[0016] The biofilm formation can lead to the ingrowth of fungus such as Candida albicans, which is commonly present in the mouth-throat region of human beings. A voice prosthesis as disclosed herein has the advantage that it allows for slow release of a growth inhibiting substance, which is able to influence the ingrowth of fungus, such as Candida albicans. One example of this influence is due to lowering or increasing the pH- value. Lowering and increasing the pH value is contemplated to have a good influence on preventing the ingrowth of fungus such as Candida albicans, because fungi typically react negatively to being in a pH environment out of the normal range.

[0017] The growth inhibiting substance is provided in a reservoir. This allows for a more controlled or focused release of the growth inhibiting substance, at least due to the position of the reservoir and apertures influencing the direction of release of the growth inhibiting substance. Furthermore, potentially the reservoir provides an even release over time, in contrast to a decaying effect that often is the result of a coating, an impregnation onto or a mechanical dispersion of growth inhibiting substance into the material of the voice prosthesis.

[0018] In the following, whenever referring to a proximal end of an element of the voice prosthesis, a referral is made to the innermost portion of the voice prosthesis, when in situ in a user. Whenever referring to a distal end of an element of the voice prosthesis, a referral is made to the outermost portion of the voice prosthesis, when in situ. This means that the proximal portion of the voice prosthesis is positioned in the oesophagus and the distal portion of the voice prosthesis is positioned in the trachea, when in situ. The longitudinal direction of the voice prosthesis is defined as the direction extending from the distal end towards the proximal end.

[0019] A voice prosthesis includes a tubular portion extending from a distal end to a proximal end and is provided with flanges to keep the voice prosthesis positioned in the tracheoesophageal wall. The voice prosthesis is provided with two flanges, a proximal flange in the proximal portion of the voice prosthesis, which is adapted for being placed at an interior surface of the oesophagus, and a distal flange in the distal portion of the voice prosthesis, which is adapted for being placed at an interior surface of the trachea. The portion of the tubular portion of the voice prosthesis spanning the two flanges is adapted for traversing the tracheoesophageal wall. The proximal portion of the tubular portion is adapted to extend slightly into the oesophagus and the distal portion of the tubular portion is adapted to extend slightly into the windpipe. The voice prosthesis includes a valve element in the tubular portion. The valve-element is a one-way valve configured for opening in the proximal direction allowing air to pass in the proximal direction, and configured for closing when air and matter flows towards the valveelement in a distal direction, such that the valve-element has an open configuration and a closed configuration.

[0020] In the following, the referral to a reservoir is meant as a referral to a minor portion or volume of the voice prostheses, which functions as a reservoir for retaining and guiding a growth inhibiting substance towards the exterior of the voice prostheses in a controlled manner. The reservoir is at least partly delimited by interior walls, such as to provide an enclosure for the growth inhibiting substance. The reservoir is able to fluidly communicate with the exterior of the reservoir through one or more aperture(s) connecting the reservoir with the exterior of the reservoir. This allows for slowly release of the growth inhibiting substance to the surroundings of the voice prosthesis, for example through dissipation or dissolving the growth inhibiting substance.

[0021] Advantageously, the growth inhibiting substance in the reservoir should be able to be released in the proximity of the proximal portion of the voice prosthesis. The voice prosthesis will be most prone to fungus-attack at the proximal portion of it, because the proximal portion is located in the oesophagus and thus closer to the mouth-throat region of the user, when the voice prosthesis is in use. Therefore, it is an advantage if the effect of the release of the material is higher towards the proximal portion of the voice prosthesis than towards the distal portion of the voice prosthesis. One of the drawbacks with voice prosthesis without any protection against fungal ingrowth is that the flap, in case of a flapvalve, will be prone to ingrowth at its sealing surfaces and then leakage through the flapvalve may occur.

[0022] In the context of this disclosure, growth inhibiting substance refers to substances, which are able to influence the ability of the fungi to grow into the voice prosthesis. The substance may be in the form of a solid piece or in the form of a powder, which, through interaction with moisture, will dissolve and thus be released to the surrounding environment. The substance may also be in the form of liquid, which will slowly dissipate and thus be released to the surrounding environment.

[0023] The growth inhibiting substance may be a sacrificial substance, which is configured for dissolving within a predetermined period of time. Making the growth inhibiting substance as a sacrificial material allows a user, or rather a health care personnel, to determine when the substance is used up, and thus when the voice prosthesis is no longer protected for ingrowth. Alternatively, or additionally, the growth inhibiting substance may include an indicator (e.g. in the form of a colour-indicator), which indicates that the substance has reached the end of its functionality.

[0024] The predetermined period of time may be at least 1 month. The predetermined period of time may be about 45 days or 60 days or 90 days.

[0025] In examples, the reservoir is in the form of a cavity.

[0026] The cavity may be positioned in the valve.

[0027] In examples, the cavity is positioned in the flap of a flap-valve. Positioning the cavity in the flap of the flap-valve will ensure that the material in the cavity can be released in proximity to the proximal portion of the voice prosthesis, as mentioned above.

[0028] The cavity may be placed in a central portion of the flap. The cavity may be placed annularly inside the flap. The flap may include a top surface, a bottom surface and a rim between the bottom surface and the top surface. The cavity may be placed inside the flap between the top surface and the bottom surface and interior of the rim. The cavity may be subdivided into two, three or four sub-cavities.

[0029] The flap may include at least one aperture, providing opening(s) to the reservoir. The flap may include two, three, four, five, six, seven, eight, nine, ten or more, such as multiple small apertures. The aperture(s) may be in a top surface of the flap. The aperture(s) may be in a rim of the flap. These aperture(s) allow the growth inhibiting substance to slowly release from the reservoir.

[0030] In examples, the voice prosthesis further includes an interior lining at an interior surface of the tubular portion of the housing. This lining may function as a support ring. In these examples, the reservoir may be positioned in the interior lining. The reservoir may be positioned at a proximal end of the interior lining. The interior lining may include at least one aperture facing proximally and / or the interior lining may include at least one radially facing aperture. The interior lining may include multiple apertures facing radially inwards and / or facing proximally. The reservoir may be annular and include an exterior edge and an interior edge and wherein the interior lining includes a radial and / or proximal aperture into the reservoir. In this case, the aperture may be in the form of an open edge portion of the reservoir. This allows the growth inhibiting substance in the reservoir to slowly release from the reservoir. The reservoir may be positioned in a proximal portion of the interior lining and the interior lining may include one or more apertures facing radially inwards.

[0031] In examples, the voice prosthesis includes a medically acceptable thermoplastic material and / or rubber material such as silicone or Polyvinylidene Flouride (PVDF). In examples, the interior lining includes a medically acceptable thermoplastic material and / or rubber material, such as silicone or Polyvinylidene Flouride (PVDF). PVDF provides a good stability to the voice prosthesis and also provides for a durable voice prosthesis.

[0032] In examples, when the growth inhibiting substance influences the pH value, the substance is configured to lower the pH level to a pH level which prevents ingrowth of Candida.

[0033] The growth inhibiting substance may be selected from the group of citric acid, ascorbic acid (vitamin C), sodium bisulfate and tartaric acid and combinations thereof, which are substances configured to lower the level of pH in the surroundings of the voice prosthesis.

[0034] The growth inhibiting substance may be selected from the group of sodium bicarbonate, potassium bicarbonate, calcium carbonate and magnesium hydroxide and combinations thereof, which are substances configured to increase the level of pH in the surroundings of the voice prosthesis.

[0035] Detailed Description of the Drawing

[0036] Figures 1 and 2 illustrate an example of a voice prosthesis as disclosed herein. Figure 1 shows a perspective view of the voice prosthesis 100 and figure 2 shows a cross- sectional view of the voice prosthesis 100. The voice prosthesis 100 includes a proximal flange 102 in a proximal portion 104 of the voice prosthesis, and a distal flange 106 in a distal portion 108 of the voice prosthesis. The voice prosthesis further has a tubular portion 110 with a central tubular portion 112 extending between the proximal flange 102 and the distal flange 106 and a proximal tubular portion 114 extending proximally beyond the proximal flange and a distal tubular portion 116 extending distally beyond the distal flange 106. A valve 120 is positioned inside the central tubular portion 112 and is in the illustrated example shown as a flap-valve with a flap 122 attached to an interior surface 118 of the tubular portion via a hinge-element 124. The hinge-element 124 allows the flap 122 to pivot from a first position, in which the flap 122 is generally perpendicular to the longitudinal direction of the tubular portion 110 and thereby closing off the tubular portion, and a second position in which the flap 122 is pivoted and at angle with respect to the longitudinal direction of the tubular portion 110 when subjected to an opening pressure (the longitudinal direction is indicated as a dash-dotted line in the figures).

[0037] In the example illustrated in figures 1 and 2, the flap 122 includes a reservoir in the form of a cavity 140 configured for containing a growth inhibiting substance. The flap 122 is generally shaped as a (partly) circular disc and has a top surface 126 facing in the opening direction and a bottom surface 128 oppositely of the top surface, such that when the flap 122 closes off the tubular portion, the top surface faces in the proximal direction and the bottom surface faces in the distal direction. The flap 122 being shaped as a partly circular disc allows the flap to move freely inside the tubular portion 110. The flap 122 has a rim 130, which may taper slightly from the bottom surface 128 to the top surface 126, such that the bottom surface 128 is slightly larger than the top surface 126. The cavity 140 is illustrated as being encapsulated inside the flap 122 meaning that the cavity 140 is positioned between the top surface 126 and the bottom surface 128 and interior of the rim 130. Various examples of flaps with interior cavities are illustrated in figures 4 to 7 and will be explained further in relation to these figures.

[0038] A seat 132 for cooperating with the valve flap 122 is provided at the interior surface 112 of the tubular portion. The seat 132 is in figure 2 illustrated as being an annular element, however, other configurations of the seat are possible, such as an inwardly extending flange extending partly across the interior surface, or steps or the like. In the illustrated example in figure 2, the hinge-element 124 is integrated in the seat 132. The flap 122 includes a sealing surface 134 at the bottom surface 128 of the flap configured for cooperating with the seat 132 so as to create a sealed closure of the valve.

[0039] In figure 3, an example of a voice prosthesis 200 is shown. The voice prosthesis 200 of figure 3 is similar to the voice prosthesis of figures 1-2 and similar reference numbers are used, however with the numbers starting from 200 instead of 100. One difference is that in the voice prosthesis of figure 3, an interior lining 250 of the tubular portion 210 is present. As illustrated, the interior lining 250 makes it possible to integrate the hinge-element 224 in the interior lining. The hinge-element 224 is illustrated as completely integrated, however, it is also possible to integrate the hinge-element partly as illustrated in figures 8 and 9. The interior lining 250 only covers the central tubular portion 212, leaving the proximal tubular portion 214 and the distal tubular portion 216 uncovered. The flap 222, the valve seat 232, and the cavity constituting the reservoir 240 are all as explained in relation to figures 1-2.

[0040] Figures 4 to 7 illustrate various examples of valve-flaps including cavities. Figures 4A, 4B illustrate a valve flap 322 with a centrally positioned reservoir in the form of a cavity 340. Figure 4A illustrates the flap 322 in a cross-sectional view and figure 4B illustrate the flap 322 seen from above, i.e. seen facing the top surface 326 of the flap. In the illustrated example, the cavity 340 is positioned centrally in the flap both such that it is positioned in the middle of the disc constituting the flap and between the top surface 326 and the bottom surface 328. Furthermore, it is positioned interior of the rim 330. The cavity 340 is in communication with the exterior of the flap through a number of apertures 342, allowing for the growth inhibiting substance 360 in the cavity to be released to the exterior of the flap.

[0041] Figures 5A, 5B illustrate a flap 422 with a centrally positioned reservoir in the form of a cavity 440 as in figures 4A, 4B. The difference between the flap 322 of figures 4A, 4B and the flap 422 of figures 5A, 5B is that the number of small apertures 342 is replaced by one large aperture 442. The remaining features are similar, such as the top surface 426 including the one large aperture 442. Furthermore, the cavity 440 is positioned between the top surface 426 and the bottom surface 428 and interior of the rim 430.

[0042] Figures 6A, 6B illustrate a flap 522 with a reservoir in the form of an annular cavity 540. The cavity 540 is positioned between the top surface 526 and the bottom surface 528 and interior of the rim 530. The growth inhibiting substance 560 in the cavity 540 communicates with the exterior of the flap through a number of apertures 542. In the illustrated example, eight apertures 542 are shown, however, any number of apertures can be used, and the eight apertures can be replaced by a single aperture, or by two apertures or three, four, five, six, seven or more apertures, such as 10, 15, 20 apertures.

[0043] Figures 7A, 7B illustrate a flap 622 with a reservoir in the form of an annular cavity 640. The annular cavity 640 is, in this case, positioned such that it is open at the rim 630 of the flap. It is illustrated as being open towards the rim 630 as well as towards the top surface 626. In other examples, the annular cavity 640 is open only towards the rim 630 or only towards the top surface 626 and not both. The cavity 640 is positioned at a distance from the bottom surface 628. In this case, the growth inhibiting substance is released from the annular cavity 640 at the open rim or open top surface as will apply. Thus, this open rim and or open top surface of the reservoir will, in this context, be considered one large aperture.

[0044] In the examples illustrated in figures 4 to 7, all flaps 322, 422, 522, 622 are illustrated as including a single cavity 340, 440, 540, 640. However, this need not be the case, as the cavity could be divided into two, three or four sub-cavities instead of being just a single cavity. For example, in the case of an annular cavity 530, 630 as illustrated in figures 6 and 7, the annular cavity 530, 630 could be subdivided into two c-shaped cavities, which face each other, and in the case of the centrally positioned cavity 340, 440 as illustrated in figures 4, 5, this centrally positioned cavity could be subdivided into two halves.

[0045] Figure 8 illustrates a voice prosthesis 700 with a proximal flange 702 and a distal flange 706 and a tubular portion 710 with a central tubular portion 712 extending between the proximal flange 702 and the distal flange 706. The tubular portion 710 has a proximal tubular portion 714 extending proximally beyond the proximal flange and a distal tubular portion 716 extending distally beyond the distal flange 706. At an interior surface of the tubular portion, an interior lining 750 is provided. In the voice prosthesis of figure 8, the reservoir 740 is positioned at a proximal end of the interior lining 750. Arrows indicate how the pH-influencing material is able to slowly release from the reservoir in a proximal as well as in a radial direction. Similar to the voice prosthesis shown in the figures 1 to 3, the voice prosthesis of figure 8 also includes a valve with a valve flap 722. The valve flap 722 is hingedly attached to the interior lining 750 through a hinge-element 724. The hingeelement 724 may be moulded together with the interior lining 750, as also mentioned in relation to figure 3.

[0046] Figures 9-11 illustrate a voice prosthesis 800 with many similarities to the voice prosthesis shown in figure 8. The difference is that in the voice prosthesis in figures 9-11, the reservoir 840 is positioned in a proximal portion of the interior lining 850, but not in the proximal end. This means that the cavity has aperture(s) 842 facing radially inwards as shown in figures 10-11 , which will allow for the growth inhibiting substance to slowly release from the reservoir in a radially inwards direction as illustrated by the arrows in figure 9. The aperture(s) 842 may be either one or two larger apertures 842 as illustrated in figure 11 or a plurality of smaller apertures 842 as illustrated in figure 10 - or a combination, which is not illustrated. The valve flap 822 is hingedly attached to the interior lining 850 through a hinge-element 824. In the voice prosthesis illustrated in figure 9, the hinge-element 824 is partly integrated into the interior lining 850. It may be fully integrated, such that it is completely embedded in the interior lining. This hinge-construction, i.e. partly integrated or fully integrated, may also be implemented in the voice prostheses shown in figures 3 and 8. Figure 12A-C illustrate ingrowth of fungi 80 in a prior art voice prosthesis 1 without means for release of any growth inhibiting substance. Figure 12A illustrate a view seen from the top, where the ingrowth of fungi is visible at the valve-flap 22 and the proximal flange 14 of the voice prosthesis. Figure 12B illustrates a perspective view, where the valve flap is lifted so as to allow a view to the extent of the ingrowth of fungi 80 at the valve flap. Figure 12C illustrates a side view of the valve flap 22. The ingrowth of fungi 80 is clearly shown. It is also readily visible that the fungi 80 creates a deformation of the valve-flap, which may prevent the valve from closing properly.

[0047] Embodiments, and features of the various exemplary embodiments described in this application may be combined with each other (“mixed and matched”), unless specifically noted otherwise.

Claims

Claims1. A voice prosthesis configured for being inserted into a tracheoesophageal wall opening comprising- an exterior housing comprising a proximal flange and a distal flange and a tubular portion connecting the proximal flange and the distal flange, the flanges being configured for retaining the voice prosthesis in position at the tracheoesophageal wall opening, and- a valve configured for opening in response to air passing through it and for being closed, when not subjected to air pressure, wherein the voice prosthesis further comprises a reservoir configured for containing a growth inhibiting substance, and wherein the voice prosthesis comprises at least one aperture communicating with the reservoir for releasing the growth inhibiting substance from the reservoir.

2. The voice prosthesis as claimed in claim 1, wherein the growth inhibiting substance is a sacrificial substance, which is configured for dissolving or dissipating within a predetermined period of time.

3. The voice prosthesis as claimed in claim 2, wherein the predetermined period of time is at least 1 month.

4. The voice prosthesis as claimed in any of claims 2 or 3, wherein the predetermined period of time is about 45 days or 60 days or 90 days.

5. The voice prosthesis as claimed in any of the preceding claims, wherein the growth inhibiting substance is a pH-influencing material adapted to increase the pH value.

6. The voice prosthesis as claimed in any of the preceding claims, wherein the growth inhibiting substance is a pH-influencing material adapted to lower the pH value.

7. The voice prosthesis as claimed in any of the preceding claims, wherein the reservoir is in the form of a cavity.

8. The voice prosthesis as claimed in claim 7, wherein the cavity is positioned in the valve.

9. The voice prosthesis as claimed in any of claims 7-8, wherein the cavity is positioned in the flap of a flap-valve.

10. The voice prosthesis as claimed in claim 9, wherein the cavity is placed in a central portion of the flap.

11. The voice prosthesis as claimed in claim 9, wherein the cavity is placed annularly inside the flap.

12. The voice prosthesis as claimed in claim 9, wherein the flap comprises a top surface, a bottom surface and a rim between the bottom surface and the top surface and wherein the cavity is placed inside the flap between the top surface and the bottom surface and interior of the rim.

13. The voice prosthesis as claimed in claim 12, wherein the flap comprises at least one aperture in the top surface and / or the rim of the flap communicating with the cavity.

14. The voice prosthesis as claimed in claim 12, wherein the flap comprises multiple apertures in the top surface and / or the rim of the flap communicating with the cavity.

15. The voice prosthesis as claimed in any of claims 7 to 14, wherein the cavity is subdivided into two, three or four sub-cavities.

16. The voice prosthesis as claimed in any of the preceding claims, wherein the voice prosthesis further comprises an interior lining at an interior surface of the tubular portion of the housing.

17. The voice prosthesis as claimed in claim 16 when dependent on claims 1-6, wherein the reservoir is positioned in the interior lining.

18. The voice prosthesis as claimed in any of claims 16-17, wherein the reservoir is positioned at a proximal end of the interior lining.

19. The voice prosthesis as claimed in claim 18, wherein the interior lining comprises a proximally facing aperture communicating with the reservoir.

20. The voice prosthesis as claimed in claim 18, wherein the interior lining comprises a radially facing aperture communicating with the reservoir.

21. The voice prosthesis as claimed in claim 18, wherein the interior lining comprises multiple apertures facing radially inwards and / or facing proximally.

22. The voice prosthesis as claimed in any of the preceding claims, wherein the voice prosthesis comprises a medically acceptable thermoplastic material and / or rubber material such as silicone or Polyvinylidene flouride.

23. The voice prosthesis as claimed in any of the preceding claims, wherein the reservoir is annular comprising an exterior edge and an interior edge, and wherein the reservoir comprises a radial and / or proximal opening into the reservoir.

24. The voice prosthesis as claimed in any of the preceding claims, wherein the growth inhibiting substance is configured to lower the pH-level to a level which prevents ingrowth of Candida.

25. The voice prosthesis as claimed in any of the preceding claims, wherein the growth inhibiting substance is selected from the group of citric acid, ascorbic acid (vitamin C), sodium bisulfate and tartaric acid and combinations thereof.

26. The voice prosthesis as claimed in any of the preceding claims, wherein the growth inhibiting substance is selected from the group of sodium bicarbonate, potassium bicarbonate, calcium carbonate and magnesium hydroxide and combinations thereof.

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