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

• US 7,631,642 B2
• Filed: 05/18/2007
• Issued: 12/15/2009
• 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: Wondka, Anthony, Freitag, Lutz
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US11/798,965
• Publication Number:
  US 20080029088A1
• Time in Patent Office: 942 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. A tracheostoma spacer comprising a tubular support framework, wherein the tubular support framework is able to expand from an initial state to a supporting state of increased diameter and comprises at least one fixing element at least one end;

and wherein the tubular support framework comprises at least one tubular guide element to guide a tracheotomy device or a catheter to be inserted through the tracheostoma spacer.

2. The tracheostoma spacer according to claim 1, wherein the tubular support framework is able to self-expand from the initial state to the supporting state of increased diameter.

3. The tracheostoma spacer according to claim 1, wherein a length of the tubular support framework is adjustable.

4. The tracheostoma spacer according to claim 1, wherein at least on of the at least one the fixing element has atraumatic edges.

5. The tracheostoma spacer according to claim 1, wherein, when the tubular support framework is in the supporting state, at least one of the at least one fixing element protrudes beyond an outer circumference of the tubular support framework, transversely with respect to a central longitudinal axis of the tubular support framework.

6. The tracheostoma spacer according to claim 1, wherein wherein at least one end of the tubular support framework comprises at least two fixing elements.

7. The tracheostoma spacer according to claim 6, wherein the at least two fixing elements are arranged opposite one another.

8. The tracheostoma spacer according to claim 1 wherein the tubular support framework comprises at least two ends, wherein each of the at least two ends of the support framework comprises a pair of fixing elements.

9. The tracheostoma spacer according to claim 8, wherein the pair of fixing elements of one end of the tubular support framework are offset relative to the pair of fixing elements of the other end of the tubular support framework by a right angle about a central longitudinal axis of the support framework.

10. The tracheostoma spacer according to claim 1, wherein the fixing element has an aperture.

11. The tracheostoma spacer according to claim 1, wherein at least one of the at least one tubular guide element extends beyond an end of the support framework.

12. The tracheostoma spacer according to claim 1, wherein at least one of the at least one tubular guide element is curved.

13. The tracheostoma spacer according to claim 1, wherein the support framework comprises at least one valve unit.

15. The tracheostoma spacer according to claim 1, wherein the support framework comprises a jacket.

16. The tracheostoma spacer according to claim 15, wherein the jacket comprises a polymer.

17. The tracheostoma spacer according to claim 15, wherein the jacket contains pharmaceutical active substances.

19. The tracheostoma spacer according to claim 1, wherein the support framework has a circular cross section.

20. The tracheostoma spacer according to claim 1, wherein the support framework has an oval cross section.

22. The tracheostoma spacer according to claim 1, wherein the support framework comprises a bulge in its cross section.

23. The tracheostoma spacer according to claim 1, wherein the support framework comprises struts made of filaments.

24. The tracheostoma spacer according to claim 23, wherein the filaments are made of metal.

25. The tracheostoma spacer according to claim 23, wherein the filaments are made of a shape-memory alloy.

26. The tracheostoma spacer according to claim 1, wherein the support framework comprises woven synthetic filaments.

27. The tracheostoma spacer according to claim 23, wherein the filaments are coated with an elastomer.

28. The tracheostoma spacer according to claim 1, wherein a wall thickness of the support framework is smaller than one fifth (⅕

) of an external diameter in the supporting state.

29. The tracheostoma spacer according to claim 1, wherein a wall thickness of the support framework is less than one tenth ( 1/10) of an external diameter in a supporting state.

35. The tracheostoma spacer according to claim 1, wherein at least one of the at least one tubular guide element has a shoulder.

36. The tracheostoma spacer according to claim 1, wherein the catheter is a ventilation catheter.

37. The tracheostoma spacer according to claim 6, wherein the at least two fixing elements protrude beyond an outer circumference of the support framework.

38. The tracheostoma spacer according to claim 6, wherein the at least two fixing elements comprise two fixing elements that are rotationally spaced approximately 180 degrees apart from one another.

39. The tracheostoma spacer according to claim 8, wherein, in each pair of fixing elements, the two fixing elements are rotationally spaced approximately 180 degrees apart from one another.

40. The tracheostoma spacer according to claim 1, wherein the tracheotomy device is adapted to insert the tracheostoma spacer into a stoma.

41. The tracheostoma spacer according to claim 1, wherein the tracheotomy device comprises a cutting instrument.

42. The tracheostoma spacer according to claim 41, wherein the cutting instrument is selected from the group consisting a conical tip, a trocar, a needle, a scalpel, and a knife.

43. The tracheostoma spacer according to claim 41, wherein the cutting instrument comprises a channel for a guidewire.

44. The tracheostoma spacer according to claim 1, wherein the tracheotomy device comprises a cover sleeve.

45. The tracheostoma spacer according to claim 44, wherein the tracheotomy device comprises a cuff arranged on the cover sleeve.

46. The tracheostoma spacer according to claim 1, wherein the tracheotomy device comprises a safety element adapted to prevent over-insertion of the instrument into a trachea.

47. The tracheostoma spacer according to claim 1, wherein the tracheotomy device comprises a dilator.

48. The tracheostoma spacer according to claim 1, wherein the tracheostoma spacer is adapted to be placed over a shaft of the tracheotomy device.

49. The tracheostoma spacer according to claim 13, wherein at least one of the at least one valve unit is adapted to open to allow a flow of gas in at least one direction.

50. The tracheostoma spacer according to claim 13, wherein at least one of the at least one valve unit is adapted to open to allow the passage of a catheter through the opening.

51. The tracheostoma spacer according to claim 26, wherein the filaments are coated with an elastomer.

52. The tracheostoma spacer according to claim 1, wherein at least one of the at least one fixing element is ring-shaped and has at least one flat face, and wherein one of the at least one flat face is adapted to lie against tissue of a patient when the tracheostoma spacer is inserted into a stoma of a patient and the support framework is in the supporting state.

53. The tracheostoma spacer according to claim 1, wherein at least one of the at least one fixing element is collapsible to facilitate insertion into a stoma, and is expandable into a protruded state.

14. A tracheostoma spacer comprising a tubular support framework, wherein the tubular support framework is able to expand from an initial state to a supporting state of increased diameter and comprises at least one fixing element at least one end;

and further comprising a coupling element for fixing articles passed through or inserted into the support framework.

18. A tracheostoma spacer comprising a tubular support framework, wherein the tubular support framework is able to expand from an initial state to a supporting state of increased diameter and comprises at least one fixing element at least one end;

and further comprising a channel which has one end on a circumferential face of the support framework.

21. A tracheostoma spacer comprising a tubular support framework, wherein the tubular support framework is able to expand from an initial state to a supporting state of increased diameter and comprises at least one fixing element at least one end;

and wherein the support framework comprises an indentation in its cross section.

30. A tracheotomy method comprising the following steps:

forming an opening in the trachea; and

placing a tracheostoma spacer in the opening of the trachea;

where in the tracheostoma spacer comprises a tubular support framework, wherein the tubular support framework is able to expand from an initial state to a supporting state of increased diameter and comprises at least one fixing element at least one end; and

wherein the tubular support framework comprises at least one guide element to guide a tracheotomy device or catheter to be inserted through the tracheostoma spacer.

31. The tracheotomy method according to claim 30, wherein the opening of the trachea is punctured using a needle or a trocar.

32. The tracheotomy method according to claim 30, wherein the opening of the trachea is cut with a knife or a scalpel.

33. The tracheotomy method according to claim 32, wherein an incision for forming the opening of the trachea is made transversely with respect to the trachea.

34. The tracheotomy method according to claim 30, wherein, before the tracheostoma spacer is placed in the opening in the trachea, the opening in the trachea is widened using an instrument which is rigid.

54. The tracheotomy method according to claim 30, wherein, before the tracheostoma spacer is placed in the opening in the trachea, the opening in the trachea is widened using an instrument whose diameter can be widened.