# US 11,298,490 B2 · Tracheostoma device holder

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- Number: US 11,298,490 B2
- Document ID: US11298490B2
- Status: Granted
- Kind: B2
- Application number: 17/280,838
- Filed: 2019-09-26
- Published: 2021-10-07
- Granted: 2022-04-12
- Earliest claimed: 2018-09-27
- Assignees: Atos Medical AB
- Applicants: Atos Medical AB
- Inventors: Richard Falkenberg
- Web page: https://patentgrep.com/patent/US11298490B2

## CPC

- A61M 16/0465: {Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters}
- A61M 16/047: {Masks, filters, surgical pads, devices for absorbing secretions, specially adapted therefor}
- A61M 16/0816: {Joints or connectors}
- A61M 16/0468: {with valves at the proximal end limiting exhalation, e.g. during speaking or coughing (air passages from trachea to oesophagus or to pharynx, artificial epiglottis A61F2/203)}
- A61M 16/0688: {by means of an adhesive}
- A61M 16/1045: {Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas}
- A61M 2016/0661: {with customised shape}
- A61M 2025/0266: {using pads, patches, tapes or the like}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/0238: the material being a coating or protective layer
- A61M 2205/36: related to heating or cooling
- A61M 2205/583: by visual feedback
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A tracheostoma device holder for holding a tracheostoma device superimposed of a tracheostoma of a person. The tracheostoma device holder may include a plate and a tracheostoma device fitting. The plate may be configured for attachment over a tracheostoma via a proximal side thereof. The plate may include a through hole. The tracheostoma device fitting may include a through passage arranged superimposed the through hole. The tracheostoma device fitting may extend distally from the plate. The plate may further include a disc of a thermoplastic material and a plate material arranged at least laterally of the disc. The plate material may have a melting point different from a melting point of the disc.

## Claims

### Claim 1

A tracheostoma device holder for holding a tracheostoma device superimposed of a tracheostoma of a person, the tracheostoma device holder comprising:
a plate for attachment over the tracheostoma via a proximal side thereof, the plate including a through hole;
a tracheostoma device fitting with a through passage arranged superimposed the through hole, the tracheostoma device fitting extending distally from the plate;
the plate further including a disc of a thermoplastic material and a plate material arranged laterally of the disc;
wherein the plate material has a melting point different from a melting point of the disc; and
wherein the plate material is also arranged centrally of the disc and laterally of the tracheostoma device fitting such that the plate material is disposed radially between the disc and the tracheostoma device fitting.

### Claim 2 (depends on 1)

The tracheostoma device holder according to claim 1, wherein the melting point of the plate material is higher than the melting point of the disc.

### Claim 3 (depends on 1)

The tracheostoma device holder according to claim 1, wherein the plate material is provided distally of the disc.

### Claim 4 (depends on 1)

The tracheostoma device holder according to claim 1, wherein the thermoplastic material is a polyester-based thermoplastic.

### Claim 5 (depends on 1)

The tracheostoma device holder according to claim 1, wherein the thermoplastic material is a polycaprolactone (PCL)-based thermoplastic.

### Claim 6 (depends on 1)

The tracheostoma device holder according to claim 1, wherein:
the plate material is composed of a flexible and elastic material; and
the plate material includes a thermoplastic elastomer.

### Claim 7 (depends on 1)

The tracheostoma device holder according to claim 1, wherein:
at least the proximal side of the plate includes a skin adhesive;
the skin adhesive is configured as at least one of a tape, a foam tape, a sprayed skin adhesive formulation, and a painted skin adhesive formulation; and
the at least one of the tape, the foam tape, the sprayed skin adhesive formulation, and the painted skin adhesive formulation is adhesive on both sides and at least one of the sides includes the skin adhesive such that the proximal side of the plate is skin adhesive.

### Claim 8 (depends on 1)

The tracheostoma device holder according to claim 1, wherein the plate material is a more flexible material than a material of the tracheostoma device fitting.

### Claim 9 (depends on 1)

The tracheostoma device holder according to claim 1, wherein the plate material and the tracheostoma device fitting are structured as one integral and monolithic body.

### Claim 10 (depends on 1)

The tracheostoma device holder according to claim 1, wherein a thickness of the plate decreases in a central to lateral direction.

### Claim 11 (depends on 1)

The tracheostoma device holder according to claim 1, wherein a lateral portion of the plate includes a plurality of flaps.

### Claim 12 (depends on 1)

The tracheostoma device holder according to claim 1, wherein a thickness of the plate continuously decreases in a radially outward direction.

### Claim 13 (depends on 1)

The tracheostoma device holder according to claim 1, wherein:
the plate material includes a groove disposed in a proximal side surface of the plate material; and
the disc is arranged in the groove.

### Claim 14 (depends on 13)

The tracheostoma device holder according to claim 13, further comprising a skin adhesive disposed on the proximal side surface of the plate material and a proximal side surface of the disc.

### Claim 15 (depends on 1)

The tracheostoma device holder according to claim 1, wherein the tracheostoma device fitting includes:
a main portion defining the through passage;
a retaining lip disposed at least partially within the through passage and extending toward the through hole; and
a bent portion connecting a distal end of the main portion and the retaining lip.

### Claim 16 (depends on 1)

The tracheostoma device holder according to claim 1, wherein the tracheostoma device fitting, the plate material, and the disc are structured as separate, independent components.

### Claim 17 (depends on 1)

The tracheostoma device holder according to claim 1, wherein the plate and the tracheostoma device fitting are coupled to one another along an interface defined by a radially inward facing surface of the plate and a radially outward facing surface of the tracheostoma device fitting.

### Claim 18 (depends on 1)

A method for adapting a tracheostoma device holder according to claim 1, the method comprising:
heating the plate over the melting temperature of the disc of the thermoplastic material such that the disc becomes compliable and hand moldable;
applying the proximal side of the plate onto a neck of a person such that the through hole is superimposed over the tracheostoma;
shaping the disc in accordance with a neck anatomy of the person; and
at least one of actively and passively cooling the plate below the melting temperature of the disc.

### Claim 19

A tracheostoma device holder for holding a tracheostoma device, comprising:
a plate for attachment over a tracheostoma, the plate including a through hole and a groove, the groove disposed in a surface of the plate and extending around the through hole;
a tracheostoma device fitting coupled to the plate and extending in an axial direction of the through hole, the tracheostoma device fitting including a through passage extending to the through hole;
a disc arranged in the groove of the plate; and
wherein the plate is composed of a plate material, the disc is composed of a disc material, and a melting point of the plate material is different than a melting point of the disc material.

### Claim 20

A tracheostoma device holder for holding a tracheostoma device, comprising:
a plate for attachment over a tracheostoma, the plate including a through hole;
a tracheostoma device fitting coupled to the plate and extending in an axial direction of the through hole, the tracheostoma device fitting including:
a main portion defining a through passage extending to the through hole;
a retaining lip disposed at least partially within the through passage and extending toward the through hole;
a bent portion connecting a distal end of the main portion and the retaining lip;
a disc connected to the plate;
wherein the plate is composed of a plate material, the disc is composed of a disc material, and a melting point of the plate material is different than a melting point of the disc material; and
further comprising a skin adhesive disposed on a proximal side surface of the plate material and a proximal side surface of the disc.
