Methods and systems for tracheal access and ventilation

• US 7,556,042 B2
• Filed: 05/18/2005
• Issued: 07/07/2009
• Est. Priority Date: 05/18/2005
• Status: Expired due to Fees

• Current Assignee: Apmed Solutions Incorporated
• Original Assignee: Apmed Solutions Incorporated
• Inventors: Lolachi, Christopher, Abolfathi, Amir, West, Scott H.
• Primary Examiner(s): Yu; Justine R
• Assistant Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US11/132,603
• Publication Number:
  US 20060260616A1
• Time in Patent Office: 1,511 Days
• Field of Search: 128/200.26, 128/207.14, 128/207.15, 128/207.16, 128/207.29, 606/108, 604/264, 604/506, 604/174
• US Class Current: 128/207.16
• CPC Class Codes: A61M 16/0429 with non-integrated distal obturators
• CPC Class Codes: A61M 16/044 External cuff pressure control or supply, e.g. synchronisation with respiration
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• 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

Abstract

A tracheostomy is performed using an access device and a separate ventilation device. The access device is introduced through a surgical opening in the tracheal wall and has an anchor which is expanded in situ to hold the access device in place. The ventilation device is introduced through a passage in the access device and has an expandable cuff which is oriented above the access point through the tracheal wall. A concavity in the expandable cuff collects body secretions, and other materials from the oral and nasal cavities and/or gastro-intestinal reflux into the trachea, and the collected secretions are removed by aspiration through a lumen provided in the ventilation device. A one-way valve may be provided in the expandable cuff in order to permit exhalation through the larynx to assist in speech.

Claims

1. A percutaneous access device, said device comprising:

a base having a posterior surface adapted to cover a percutaneous tissue penetration;

a conduit having an access lumen disposed through the base and adapted to pass through the penetration; and

an anchor on a posterior portion of the conduit, said anchor shiftable between an expanded anchoring configuration and an unexpanded deployment configuration, wherein the anchor comprises;

an anchor element which radially expands upon axial compression;

a compliant mount securing the anchor element to the base; and

a pulling assembly connected between the anchor element and the base to draw the anchor element toward the base and to both (1) axially compress the anchor element to cause radial expansion and (2) pull the radially expanded anchor element against a posterior tissue surface.

2. A percutaneous access device as in claim 1, wherein the anchor element comprises a malecot or a deformable braid.

3. A percutaneous access device as in claim 1, wherein the compliant mount comprises a coil spring.

4. A percutaneous access device as in claim 1, wherein the pulling assembly comprises a reel on the base, and one or more tethers between the reel and anchor.

5. A percutaneous access device as in claim 1, wherein the pulling assembly comprises coaxial tubes.

6. A percutaneous access device as in claim 1, wherein the pulling assembly comprises a locking clip and a pull tool.

7. A method for providing percutaneous access through skin, said method comprising:

penetrating the skin to provide an access hole;

passing a conduit through the hole so that a posterior surface of a base on the conduit covers the access hole;

expanding an anchor on the conduit over a posterior surface of the skin; and

adjusting the distance between the expanded anchor and the posterior surface of the base to accommodate the thickness of the wall,

wherein adjusting comprises compressing a compliant member between the expanded anchor and the base, and compressing comprises reeling tethers connected between the anchor and the base.

8. A tracheal ventilation device comprising:

a tube having a distal end, a proximal end, and an aspiration lumen therethrough; and

an expandable cuff at a distal end of the tube, said cuff having when expanded a periphery which seals against a tracheal wall and an upper surface adapted to collect and pool nasal secretions, wherein the aspiration lumen is coupled to aspirate the pooled secretions;

wherein a portion of the tube is upwardly bent or bendable so that the cuff is above an axis of the tube when deployed in the trachea,

wherein the tube has at least a second lumen for ventilation, the second lumen connected to a one-way valve on the cuff that permits air flow to the larynx.

9. A tracheal ventilation device as in claim 8, wherein the tube has at least a third lumen for inflating an inflatable expandable cuff.

10. A tracheal ventilation device as in claim 8, wherein the tube is hinged to allow axial alignment of the cuff during deployment and upward orientation of the cuff after entry to the trachea.

11. A tracheal ventilation device as in claim 8, wherein the upper surface of the expandable cuff has a concave region for collecting and pooling the nasal secretions.

12. A tracheal ventilation device as in claim 11, wherein the upper surface of the cuff has a conical concavity.

13. A tracheal ventilation device as in claim 8, wherein the expandable cuff is inflatable.

14. A tracheal ventilation device as in claim 8, wherein the expandable cuff is self-expanding.

15. A tracheal ventilation device comprising:

a tube having a distal end, a proximal end, and an aspiration lumen therethrough;

an expandable cuff at the distal end of the tube, said cuff having when expanded a periphery which seals against a tracheal wall and an upper surface adapted to collect and pool nasal secretions, wherein the aspiration lumen is coupled to aspirate the pooled secretions; and

a one-way valve in the cuff to permit air from the lungs to pass upwardly into the larynx when the cuff is expanded in the trachea.

16. A tracheal ventilation device as in claim 15, wherein the tube has at least a second lumen for ventilation.

17. A tracheal ventilation device as in claim 16, wherein the tube has at least a third lumen for inflating an inflatable expandable cuff.

18. A tracheal ventilation device as in claim 16, wherein the second lumen is connected to a one-way valve in the cuff that permits air flow to the larynx.

19. A tracheal ventilation device as in claim 15, wherein the tube is hinged to allow axial alignment of the cuff during deployment and upward orientation of the cuff after entry to the trachea.

20. A tracheal ventilation device as in claim 15, wherein the upper surface has a concave region for collecting and pooling the nasal secretions.

21. A tracheal ventilation device as in claim 20, wherein the upper surface of the cuff has a conical concavity.

22. A tracheal ventilation device as in claim 15, wherein the expandable cuff is self-expanding.

23. A tracheal ventilation device comprising:

a tube having a distal end, a proximal end, and an aspiration lumen therethrough, wherein the tube includes at least a first lumen to permit air flow to the larynx when deployed in the trachea, at least a second lumen connected to a one-way valve in the cuff that permits air flow to the larynx for ventilation, and at least a third lumen for inflating an inflatable expandable cuff;

an expandable cuff at a distal end of the tube, said cuff having when expanded a periphery which seals against a tracheal wall and an upper surface adapted to collect and pool nasal secretions, wherein the aspiration lumen is coupled to aspirate the pooled secretions; and

a ventilator fitting having a first end adapted to removably mount in a tracheal access device, a second end proximal to the first end and adapted to removably connect to a ventilator, and a passage therethrough to receive the tube.

24. A tracheal ventilation device as in claim 23, wherein the tube is hinged to allow axial alignment of the cuff during deployment and upward orientation of the cuff after entry to the trachea.

25. A tracheal ventilation device as in claim 23, wherein an upper surface of the expandable cuff has a concave region for collecting and pooling the nasal secretions.

26. A tracheal device as in claim 25, wherein the upper surface of the cuff has a conical concavity.

27. A tracheal ventilation device as in claim 23, wherein the expandable cuff is inflatable.

28. A tracheal ventilation device as in claim 23, wherein the expandable cuff is self-expanding.

29. A method for providing tracheal ventilation, said method comprising:

forming a percutaneous hole into a patient'"'"'s trachea;

introducing a tracheal ventilation device through the hole;

expanding a cuff on the ventilation device to isolate the trachea below the cuff, wherein the trachea below the cuff is otherwise unblocked to permit air exchange through the cuff on the ventilation device and air flow up to the larynx; and

aspirating collected nasal secretions from a collection location on an upper surface of the cuff.

30. A method as in claim 29, wherein the cuff is expanded within the trachea at a position above the percutaneous hole.

31. A method as in claim 29, wherein the nasal secretions pool in a concavity in an upper surface of the cuff from where they are aspirated.

32. A method as in claim 31, wherein the nasal secretions are aspirated through a vertical passage through the expanded cuff.

33. A method as in claim 29, further comprising anchoring an access device through the percutaneous hole, wherein the tracheal ventilation device is removably introduced through an access passage of the access device.

34. A method for providing tracheal ventilation, said method comprising:

forming a percutaneous hole into a patient'"'"'s trachea;

anchoring an access device in the percutaneous hole, wherein the access device comprises a base and an anchor;

removably introducing a tracheal ventilation device through an access passage of the access device;

expanding a cuff on the tracheal ventilation device; and

aspirating nasal secretions from a collection location on an upper surface of the cuff;

wherein the anchored access device is adapted to anchor in a hole in the trachea by the base of the anchored access device being secured against the skin and by the anchor of the anchored access device being secured against the inner tracheal wall circumscribing the hole and wherein the trachea below the cuff remains otherwise unblocked to permit air exchange through the ventilation device.

35. A method as in claim 34, further comprising removably introducing a ventilation fitting in the access passage of the access device, wherein the tracheal ventilation device is positioned through.

36. A tracheal ventilation device comprising:

a tube having a distal end, a proximal end, and an aspiration lumen therethrough;

an expandable cuff at a distal end of the tube, said cuff having when expanded a periphery which seals against a tracheal wall and an upper surface adapted to collect and pool nasal secretions, wherein the aspiration lumen is coupled to aspirate the pooled secretions; and

a ventilator fitting having a first end adapted to removably mount in a tracheal access device, a second end proximal to the first end and adapted to removably connect to a ventilator, and a passage therethrough to receive the tube,

wherein the tube has at least a second lumen for ventilation, and

wherein the second lumen is connected to a one-way valve in the cuff that permits air flow to the larynx.