Tracheostoma spacer, tracheotomy method, and device for inserting a tracheostoma spacer

• US 8,985,099 B2
• Filed: 02/17/2012
• Issued: 03/24/2015
• Est. Priority Date: 05/18/2006
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Freitag, Lutz, Wondka, Anthony D.
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/399,309
• Publication Number:
  US 20120145147A1
• Time in Patent Office: 1,131 Days
• Field of Search: 128/207.29, 128/207.14, 128/200.26
• US Class Current: 128/200.26
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: 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
• CPC Class Codes: A61M 16/0472 Devices for performing a tracheostomy
• CPC Class Codes: A61M 16/0477 with incorporated means for delivering or removing fluids
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• CPC Class Codes: A61M 2202/0078 changed by chemical action
• CPC Class Codes: A61M 2202/20 Pathogenic agents
• CPC Class Codes: A61M 2205/0222 Materials for reducing friction
• CPC Class Codes: A61M 2205/0266 Shape memory materials

Abstract

The invention relates to a tracheostoma spacer with a tubular support framework. The support framework can be expand from an initial state to a supporting state of increased diameter and has a fixing element at the ends. The tracheostoma spacer is intended for use as a spacer in a tracheostoma (an opening in the trachea). The invention further relates to a device for inserting a tracheostoma spacer into a tracheostoma with a cutting instrument in the form of a trocar, the tracheostoma spacer being able to be positioned on the shaft of said trocar. A cover sleeve is also provided which can be moved on the shaft over a tracheostoma spacer positioned there.

Claims

1. Tracheostoma spacer with a support framework of a tubular shape having a first end and a second end, the support framework including at least one fixing element at the first end and at least one fixing element at the second end, wherein the support framework is able to expand from an initial state to a supporting state of increased diameter.

2. Tracheostoma spacer according to claim 1, wherein the support framework further includes:

an inner surface defining a passageway extending between the first and second ends; and

at least one guide element associated with the inner surface and configured to guide a medical device to be inserted through the passageway of the tracheostoma spacer.

3. Tracheotomy device for inserting a tracheostoma spacer according to claim 1 into a tracheostoma, wherein the tracheotomy device comprises:

a cutting instrument including a shaft, wherein at least a portion of the shaft is configured to be receivable within a passageway of the tracheostoma spacer; and

a cover sleeve slidably mounted on the shaft, wherein the cover sleeve is movable over the tracheostoma spacer when the tracheostoma spacer is positioned on the shaft.

4. Tracheotomy device according to claim 3, wherein the cutting instrument has a conical tip.

5. Tracheotomy device according to claim 3, wherein the cutting instrument has a channel for a guide wire.

6. Tracheotomy device according to claim 3, wherein the cutting instrument comprises a needle.

7. Tracheotomy device according to claim 3, wherein the cutting instrument is selected from the group consisting of a knife, a scalpel, and a trocar.

8. Tracheotomy device according to claim 3, wherein a cuff is arranged on the cover sleeve.

9. Tracheotomy device according to claim 3, wherein the shaft has a magazine section.

10. Tracheotomy device according to claim 3, wherein the shaft has a guide section.

11. Tracheotomy device according to claim 3, wherein the shaft and the cover sleeve are curved.

12. Tracheotomy device according to claim 3, wherein an outer shape is adapted in cross section to be capable of adapting to an opening of the trachea of a patient.

13. Tracheotomy device according to claim 3, wherein a grip surface is provided on the shaft.

14. Tracheotomy device according to claim 3, wherein a safety element is provided to protect from over-inserting the tracheotomy device into the trachea of a patient.

15. Tracheotomy device according to claim 14, wherein the safety element is a housing.

16. Tracheotomy device according to claim 14, wherein the safety element is an abutment.

17. Tracheotomy device according to claim 14, wherein the safety element is an arc shape formed along an axial length of the tracheostoma spacer to facilitate a curved entrance through the skin of a patient and into the trachea.

18. Tracheostoma spacer according to claim 2, wherein the medical device is selected from the group consisting of a catheter, a tracheotomy device, a tracheostoma spacer removal tool, and an instrument.

19. Tracheotomy device for inserting a tracheostoma spacer into a tracheostoma, the tracheotomy device comprising:

a cutting instrument, the cutting instrument including a shaft and a conical tip; and

a cover sleeve slidably mounted on the shaft, wherein the cover sleeve is movable over the tracheostoma spacer when the tracheostoma spacer is positioned on the shaft, the tracheostoma spacer including a support framework of a tubular shape having two ends with at least one fixing element at one of the two ends, wherein the support framework is able to expand from an initial state to a supporting state of increased diameter.

20. Tracheotomy device for inserting a tracheostoma spacer into a tracheostoma, the tracheotomy device comprising:

a cutting instrument, including;

a shaft; and

a channel for a guide wire; and

a cover sleeve slidably mounted on the shaft, wherein the cover sleeve is movable over the tracheostoma spacer when the tracheostoma spacer is positioned on the shaft, the tracheostoma spacer including a support framework of a tubular shape having two ends with at least one fixing element at one of the two ends, wherein the support framework is able to expand from an initial state to a supporting state of increased diameter.