Tracheostoma device holder

Inventors: Maarten Jan Antony van Alphen (Amsterdam, NL); Maartje Leemans (Gouda, NL); Edsko Evert Geert Hekman (Enschede, NL); Richard Dirven (Nijmegen, NL)

Assignee: Coloplast A/S

A61M16/0468 A61M2205/0216

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Quick Facts

Patent No.: US 12702778
App. No.: 17/927,705
Granted: Aug 11, 2026
Kind: B2

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Abstract

A tracheostoma device holder ( 10 ) for holding a tracheostoma device to a tracheostoma of a person is provided. The tracheostoma device holder ( 10 ) comprises a head portion ( 50 ) for engaging with a tracheostoma device and a fixation portion ( 20 ) for fixating the tracheostoma device holder ( 10 ) to the tracheostoma of the person. At least a portion of the fixation portion ( 20 ) is provided with a deformable material ( 60 ).

Claims (32)

1 . A tracheostoma device holder comprising:

a head portion comprising a distal end of the tracheostoma device holder, with the head portion provided with a distal opening formed in the distal end of the tracheostoma device holder and sized to receive and retain a tracheostoma device insertable into the distal opening;

a fixation portion connected to and extending in a proximal direction from the head portion to a proximal end of the tracheostoma device holder, with a proximal end of the fixation portion provided with a proximal opening;

a lumen formed through the tracheostoma device holder extending from the distal opening of the head portion to the proximal opening of the fixation portion; and

a seal disposed on an exterior surface of the fixation portion, where the seal is a hydrophilic foam adapted to expand when exposed to moisture;

wherein the fixation portion and the seal are insertable together into a tracheostoma such that the seal is adapted to attract moisture present in exhaled air and mucus expand to fixate the tracheostoma device holder to tissue of the tracheostoma.

2 . The tracheostoma device holder of claim 1 , wherein the seal, when expanded, provides intratracheal fixation for the tracheostoma device holder inserted into the tracheostoma.

3 . The tracheostoma device holder of claim 1 , wherein the seal is an expandable foam comprising polyvinyl alcohol.

4 . The tracheostoma device holder of claim 1 , wherein the seal is disposed around an entire circumference of the exterior surface of the fixation portion.

5 . The tracheostoma device holder of claim 1 , wherein the fixation portion is a cylindrical tube that is connected to the head portion by a radially expanded portion located between the fixation portion and the head portion.

6 . The tracheostoma device holder of claim 5 , wherein the radially expanded portion tapers outwardly between the fixation portion to the head portion.

7 . The tracheostoma device holder of claim 1 , wherein the fixation portion has a first diameter and the head portion has a second diameter, and the second diameter is larger than the first diameter.

8 . The tracheostoma device holder of claim 1 , wherein the fixation portion is integrated with the head portion to provide the tracheostoma device holder as a single unit.

9 . The tracheostoma device holder of claim 1 , further comprising: a device fitting formed on an interior surface of the head portion, where the device fitting is adapted to secure the tracheostoma device within the head portion in alignment and concentric with a portion of the lumen extending through the fixation portion.

10 . The tracheostoma device holder of claim 1 , wherein the distal opening of the head portion is sized to receive an automatic speaking valve.

11 . The tracheostoma device holder of claim 1 , wherein the distal opening of the head portion is sized to receive a heat and moisture exchange unit.

12 . The tracheostoma device holder of claim 1 , wherein the fixation portion and the head portion of the tracheostoma device holder are formed of a silicone rubber having a first Young's modulus matching a Young's modulus of tracheal mucosa, and the seal has a second Young's modulus that is less than the first Young's modulus such that the seal is softer than the tracheostoma device holder.

13 . The tracheostoma device holder of claim 1 , wherein a length of the seal extends for less than a length of the tracheostoma device holder.

14 . The tracheostoma device holder of claim 13 , wherein the length of the seal terminates before a proximal end of the head portion.

15 . The tracheostoma device holder of claim 1 , wherein the fixation portion and the seal are insertable within the tracheostoma at the same time.

16 . A tracheostoma device holder comprising:

a head portion having an opening sized to retain a tracheostoma device;

a fixation portion integrated as a monolithic unit with the head portion, where the fixation portion has a first diameter and the head portion has a second diameter, and the second diameter is larger than the first diameter;

a radially expanded portion attached between the first diameter of the fixation portion and the second diameter of the head portion;

a lumen formed through the tracheostoma device holder from the head portion through the fixation portion; and

a seal disposed around an exterior surface of the fixation portion and around a portion of the radially expanded portion;

wherein the seal is formed of a hydrophilic foam such that when the fixation portion with the seal is inserted into the tracheostoma, the seal attracts moisture from air and mucus in a tracheostoma environment and expands to provide intratracheal fixation that fixates the tracheostoma device holder to tissue of a tracheostoma.

17 . The tracheostoma device holder of claim 16 , further comprising:

an adhesive baseplate attached relative to the fixation portion of the tracheostoma device holder.

18 . The tracheostoma device holder of claim 16 , wherein the seal is disposed around an entire exterior surface of the fixation portion.

19 . The tracheostoma device holder of claim 16 , wherein a length of the seal extends for less than a length of the tracheostoma device holder.

20 . The tracheostoma device holder of claim 16 , wherein the seal is adapted to expand to seal a space between a wall of the tissue of the tracheostoma and the fixation portion such that the seal is adapted to expand to conform to a shape of the tissue of the tracheostoma.