Methods and devices to induce controlled atelectasis and hypoxic pulmonary vasoconstriction

• US 8,136,526 B2
• Filed: 03/07/2007
• Issued: 03/20/2012
• Est. Priority Date: 03/08/2006
• Status: Active Grant

• Current Assignee: Pulmonx Corp.
• Original Assignee: Pulmonx Corp.
• Inventors: Perkins, Rodney C., Aljuri, Nikolai, Nair, Ajit
• Primary Examiner(s): Yu, Justine
• Assistant Examiner(s): Louis, Latoya M
• Application Number:
  US11/682,986
• Publication Number:
  US 20070225747A1
• Time in Patent Office: 1,840 Days
• Field of Search: 128/207.15, 128/200.24, 128/207.16, 128/899, 623/23.68, 623/23.65, 623/23.7, 623/1.15, 623/1.24, 623/1.14, 623/1.35
• US Class Current: 128/207.15
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector

Abstract

Lung conditions are treated by implanting a flow restrictor in a passageway upstream from a diseased lung segment. The restrictor will create an orifice at the implantation site which inhibits air exchange with the segment to induce controlled atelectasis and/or hypoxia. Controlled atelectasis can induce collapse of the diseased segment with a reduced risk of pneumothorax. Hypoxia can promote gas exchange with non-isolated, healthy regions of the lung even in the absence of lung collapse.

Claims

1. A method for treating a lung condition, said method comprising:

implanting an air flow restrictor in an airway of the lung, wherein said restrictor allows a reduced bidirectional volumetric rate of air flow exchange between upstream of the restrictor and downstream of the restrictor through a tube that is integral to the restrictor, wherein the bidirectional volumetric rate of air flow is equal in both directions and wherein such air flow rate reduction induces at least one of controlled atelectasis and localized hypoxia in a treated region of the lung downstream of the restrictor.

2. A method as in claim 1, wherein controlled atelectasis is induced which causes collapse of the treated region downstream of the air flow restrictor.

3. A method as in claim 2, wherein the treated region collapses over a period in the range from 12 hours to 30 days.

4. A method as in claim 1, wherein localized hypoxia is induced without collapse of the treated region, wherein the hypoxia shifts blood flow away from the treated region to other regions of the lung.

5. A method as in claim 4, wherein the treated region has collateral flow channels with adjacent lung regions, wherein collateral flow channels inhibit atelectasis and collapse.

6. A method as in claim 1, wherein the volumetric rate of air flow exchange is reduced by a percentage from 10% to 99.99% relative to an unrestricted volumetric rate of air flow exchange.

7. A method as in claim 6, wherein the percentage is from 99% to 99.9%.

8. A method as in claim 1, wherein the passage permits air flow exchange.

9. A method as in claim 8, wherein the passage consists of a single orifice.

10. A method as in claim 8, wherein the restrictor includes a plurality of passages.

11. A method as in claim 8, wherein the open passage area is in the range from 0.01% to 90% of the area of the airway where the restrictor is implanted.

12. A method as in claim 8, wherein the open passage area is in the range from 0.01 mm squared to 50 mm squared.

13. A method as in claim 1, wherein implanting comprises releasing a self-expanding restrictor from a constraint so that the restrictor opens and anchors in the airway.

14. A method as in claim 13, wherein the restrictor is released from a tubular introducer.

15. A method as in claim 1, wherein the restrictor is expanded by an expansion member.

16. A bronchial flow restrictor comprising a body having a continuously and constantly open tube that is integral to the body to permit equal bidirectional volumetric rate of air flow therethrough, wherein the body is adapted to be expanded and anchored within a lung airway for the control of air exchange with a downstream region of the lung, wherein the passage has dimensions selected to provide a reduced bidirectional volumetric flow rate which induces at least one of controlled atelectasis and localized hypoxia in a treated region beyond an anchored location in the airway.

17. A bronchial flow restrictor as in claim 16, wherein the passage consists of a single orifice.

18. A bronchial flow restrictor as in claim 16, wherein the restrictor includes a plurality of passages.

19. A bronchial flow restrictor as in claim 16, wherein the open passage area is in the range from 0.01% to 90% of the cross-sectional area of the body when expanded.

20. A bronchial flow restrictor as in claim 16, wherein the open passage area is in the range from 0.01 mm squared to 50 mm squared.

21. A bronchial flow restrictor as in claim 16, wherein the at least one passage comprises a plurality of channels on the outside of the body.

22. A bronchial flow restrictor as in claim 16, wherein the body is elastic so that it can be constrained to a smaller width for introduction to the lung airway and released to self-expand and anchor at a designated location.

23. A bronchial flow restrictor as in claim 16, wherein the body is malleable and expandable by application of an expansion force.

24. A bronchial flow restrictor as in claim 16, wherein the body comprises a plurality of woven elements adapted to radially self-expand and form a generally contiguous surface having a plurality of openings which provide a resistance to the bi-directional flow of air when deployed in an airway of a lung.

25. A system comprising:

a bronchial flow restrictor having a body having a continuously and constantly open tube that is integral to the body to permit equal, reduced, bidirectional volumetric rate of air flow therethrough, wherein the body is adapted to be expanded and anchored within a lung airway for the control of air exchange with a downstream region of the lung; and

a delivery catheter adapted to deliver the bronchial flow restrictor in an airway of the lung.

26. A system as in claim 25, wherein the delivery catheter comprises an outer catheter tube and an inner pusher member, wherein the bronchial flow restrictor is receivable in a distal end of the outer catheter tube and the inner pusher member is adapted to advance and release the bronchial flow restrictor from the tube.