Methods and devices for use in performing pulmonary procedures

• US 6,904,909 B2
• Filed: 11/22/2002
• Issued: 06/14/2005
• Est. Priority Date: 03/04/2000
• Status: Expired due to Term

• Current Assignee: Pulmonx Corp.
• Original Assignee: Emphasys Medical, Inc. (Pulmonx Corp.)
• Inventors: Fields, Anton J., Andreas, Bernard H., Chew, Sunmi, Hundertmark, Ronald R., Rapacki, Alan R., Wilson, Peter M.
• Primary Examiner(s): BENNETT, HENRY A
• Assistant Examiner(s): Dagostino, Sabrina
• Application Number:
  US10/303,318
• Publication Number:
  US 20030075170A1
• Time in Patent Office: 935 Days
• Field of Search: 604/27, 128/200.24, 128/200, 600/407
• US Class Current: 128/200.24
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: F16K 15/147 the closure elements having specially formed slits or being of an elongated easily collapsible form

Abstract

An implantable flow control element is provided which prevents air from entering an isolated portion of a patient'"'"'s lung. The element may permit air to escape from the isolated portion so that the element acts like a valve. Systems for implanting pulmonary devices are also provided.

Claims

1. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve having first and second lips which engage one another when the valve is in a closed position;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an expiratory direction.

2. The method of claim 1, wherein:

the providing step is carried out with the first lip being stiffer than the second lip, the first lip biasing the second lip toward the closed position.

3. The method of claim 1, wherein:

the providing step is carried out with the first and second lips being curved when viewed from an end of the lips.

4. The method of claim 1, wherein:

the providing step is carried out with the first and second lips forming a duckbill valve.

5.The method of claim 1, wherein;

the providing step is carried out with the first and second lips forming a heimlich valve.

5. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the flow control element having a valve body with a sealing portion which seals against the wall of the pulmonary passageway;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

6. The method of claim 6, wherein:

the releasing step is carried out with the sealing portion sealing against the wall of the pulmonary passageway until an opening pressure differential is achieved wherein the sealing portion opens to permit air to pass in the same direction as the valve.

7. A The method of claim 6, wherein:

the providing step is carried out with the sealing portion being made of a resilient material.

8. The method of claim 6, wherein:

the providing step is carried out with the sealing portion being a ring.

11. The method of claim 6, wherein:

the providing step is carried out with the ring having a helical shape.

9. The method of claim 9, wherein:

the providing step is carried out with at least two rings.

10. The method of claim 10, wherein:

the rings have different sizes to seal different size locations.

12. The method of claim 12, further comprising the step of:

rotating the valve so that the ring anchors the device.

13. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the flow control element having a body mounted to an expandable support structure;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

14. The method of claim 14, wherein:

the providing step is carried out with the support structure having an exposed portion not covered by the body.

15. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the flow control element having a plurality of flexible bristles extending from the outer surface;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction, the bristles engaging the wall of the pulmonary passageway.

16. The method of claim 16, wherein:

the releasing step is carried out with the bristles being angled to preferentially anchor the valve relative to forces exerted in an expiratory direction.

17. The method of claim 16, wherein:

the providing step is carried out with at least 10 bristles.

18. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve being a valve selected from the group consisting of poppet, ball, duckbill, heimlich, flap and leaflet;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

19. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve having a valve structure;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction, the releasing step being carried out so that the valve structure cooperates with a portion of the wall of the passageway, the valve structure being positioned against the portion of the wall in a closed position and being spaced apart from the wall when in an open position.

36. The method of claim 19, wherein the providing step is carried out with the flow control element having a sealing portion which seals against the wall of the pulmonary passageway.

20. The method of claim 20, wherein:

the providing step is carried out with the valve structure being a resilient portion positioned against the wall.

21. The method of claim 20, wherein:

the providing step is carried out with the valve structure being a ring.

22. The method of claim 20, wherein:

the providing step is carried out with the valve structure being formed by a number of independent sections which each have an open position and a closed position.

23. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve being generally conical;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

24. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the flow control element having a body, the body being integrally formed with the valve;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

25. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve having a support structure with the valve mounted to the support structure;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

26. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the flow control element having a large end and a small end;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

27. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve being a slit valve;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

28. The method of claim 28, wherein:

the providing step is carried out with the valve being generally conical.

29. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve with a sealant on an exterior surface of the flow control element;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

30. The method of claim 30, wherein:

the providing step is carried out with the sealant being an adhesive which seals a space between the flow control element and pulmonary wall.

31. The method of claim 30, wherein:

the providing step is carried out with the sealant being a flowable substance which conforms to the shape of the pulmonary site.

32. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve having first and second lips and reinforcing elements extending along lateral edges of the lips;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

33. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve opening upon a pressure differential of no more than 10 inches of water;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

34. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve opening upon a pressure differential of no more than 5 inches water;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

35. A method of controlling air flow in a pulmonary passageway, comprising the steps of:

providing a flow control element having a valve, the valve opening upon a pressure differential of no more than 1 inch water;

advancing the flow control element through a patient'"'"'s pulmonary system;

releasing the flow control element at a pulmonary site to isolate a portion of the patient'"'"'s lung, the valve permitting air flow in an expiratory direction and preventing air flow in an inspiratory direction.

37. The method of claim 37, wherein the releasing step is carried out with the sealing portion sealing against the wall of the pulmonary passageway until an opening pressure differential is achieved wherein the sealing portion opens to permit air to pass in the same direction as the valve.