Methods, systems, and kits for lung volume reduction

• US 6,287,290 B1
• Filed: 07/02/1999
• Issued: 09/11/2001
• Est. Priority Date: 07/02/1999
• Status: Expired due to Term

• Current Assignee: Pulmonx Corp.
• Original Assignee: Pulmonx Pulmonx
• Inventors: Kotmel, Robert, Soltesz, Peter P., Perkins, Rodney A.
• Primary Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US09/347,032
• Time in Patent Office: 802 Days
• Field of Search: 604/28, 604/35, 604/43, 604/516, 604/102.01, 604/102.02, 604/101.01, 604/101.04, 604/79, 128/207.15, 128/207.14
• US Class Current: 604/516
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0404 with means for selective or partial lung respiration
• CPC Class Codes: A61M 16/0418 with integrated means for changing the degree of curvature, e.g. for easy intubation
• CPC Class Codes: A61M 16/0459 : one cuff behind another
• CPC Class Codes: A61M 16/0486 : Multi-lumen tracheal tubes
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2016/0413 : with detectors of CO2 in exhaled gases
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/058 : with ultrasound therapy
• CPC Class Codes: A61M 2209/06 : Packaging for specific medical equipment
• CPC Class Codes: A61M 2210/1039 : Lungs

Abstract

Lung volume reduction is performed in a minimally invasive manner by isolating a lung tissue segment, optionally reducing gas flow obstructions within the segment, and aspirating the segment to cause the segment to at least partially collapse. Further optionally, external pressure may be applied on the segment to assist in complete collapse. Reduction of gas flow obstructions may be achieved in a variety of ways, including over inflation of the lung, introduction of mucolytic or dilation agents, application of vibrational energy, induction of absorption atelectasis, or the like. Optionally, diagnostic procedures on the isolated lung segment may be performed, typically using the same isolation/access catheter.

Claims

1. A method for lung volume reduction, said method comprising:

isolating a lung tissue segment;

reducing gas flow obstructions within the segment;

aspirating the segment to cause the segment to at least partially collapse; and

sealing the segment from the remainder of the lung to inhibit reinflation of the lung segment.

2. A method as in claim 1, wherein reducing gas flow obstructions comprises inflating the lung tissue segment to a pressure higher than its normal inflated pressure.

3. A method as in claim 2, further comprising deflating adjacent lung regions while the lung tissue segment is inflated.

4. A method as in claim 2, wherein inflating the lung tissue segment comprises positioning a catheter in an air passage leading into the segment, inflating a balloon on the catheter to seal the air passage, and introducing a gas through the catheter to inflate the segment.

5. A method as in claim 1, wherein reducing gas flow obstructions comprises introducing an agent to the lung tissue segment, wherein the agent clears or dilates air passages within the segment.

6. A method as in claim 5, wherein the agent is selected from the group consisting of mucolytic agents, bronchodilators, surfactants, desiccants, solvents, necrosing agents, and absorbents.

7. A method as in claim 5, wherein introducing the agent comprises positioning a catheter in an air passage leading to the segment and delivering the agent through the catheter to the segment.

8. A method as in claim 1, wherein reducing gas flow obstructions comprises delivering mechanical energy to the lung segment.

9. A method as in claim 8, wherein the mechanical energy is vibrational energy.

10. A method as in claim 9, wherein the vibrational energy is delivered by inflating the segment with a non-compressible fluid and ultrasonically exciting the fluid to distribute ultrasonic energy throughout the segment.

11. A method as in claim 1, wherein isolating the lung tissue segment comprises positioning a catheter in an air passage leading to the lung tissue segment and inflating a balloon on the catheter to occlude the air passage.

12. A method as in claim 11, wherein aspirating comprises drawing gas and liquids present from the isolated lung segment through a lumen in the catheter while the balloon remains inflated.

13. A method as in claim 11, wherein sealing comprises sealing the air passage which opens to the lung tissue segment to inhibit reinflation of the segment.

14. A method as in claim 1, wherein sealing comprises deploying a plug in an air passage leading to the isolated lung tissue segment.

15. A method as in claim 14, wherein the plug is swellable and absorbs water to swell within the air passage when deployed.

16. A method as in claim 15, wherein the plug comprises a collagen hydrogel which is not fully hydrated prior to deployment.

17. A method for lung volume reduction, said method comprising:

isolating a lung tissue segment;

aspirating the isolated segment to cause the segment to collapse, wherein the segment is collapsed to a volume which is no greater than 40% of the inflated size prior to aspiration; and

sealing the segment from the remainder of the lung to inhibit reinfliction of the lung segment.

18. A method as in claim 17, further comprising insufflating the isolated lung tissue segment with substantially pure oxygen to promote absorption atelectasis prior to aspirating.

19. A method as in claim 17, wherein isolating the lung tissue segment comprises positioning a catheter in an air passage leading to the lung tissue segment and inflating a balloon on the catheter to occlude the air passage.

20. A method as in claim 19, wherein aspirating comprises drawing gas from the isolated lung segment through a lumen in the catheter while the balloon remains inflated.

21. A method as in claim 19, wherein sealing the lung segment comprises sealing the air passage which opens to the lung tissue segment to inhibit reinflation of the segment.

22. A method as in claim 17, wherein sealing comprises deploying a plug in an air passage leading to the isolated lung tissue segment.

23. A method as in claim 22, wherein the plug is swellable and absorbs water to swell within the air passage when deployed.

24. A method as in claim 23, wherein the plug comprises a collagen hydrogel which is not fully hydrated prior to deployment.

25. A kit comprising:

an isolation/access catheter capable of being introduced transtracheally into the air passages of the lungs; and

instructions to introduce the isolation/access catheter to a target region of the lungs and to aspirate an isolated tissue segment as follows;

isolating a lung tissue segment;

reducing gas flow obstructions within the segment;

aspirating the segment to at least partially collapse; and

sealing the segment from the remainder of the lung to inhibit reinfection of the lung segment.

26. A kit as in claim 25, further comprising a sealing catheter, wherein said instructions further set forth that an air passage leading to the isolated tissue segment is to be sealed using the sealing catheter after the region has been aspirated.

27. A kit as in claim 25, further comprising means for applying external pressure to the lung at the same time the lung is being aspirated.

28. A kit as in claim 25, further comprising an agent which clears or widens air passages in the lungs when introduced into the lungs prior to aspiration.

29. A kit as in claim 28, wherein the agent is selected from the group consisting of mucolytic agents, bronchodilators, surfactants, desiccants, solvents, necrosing agents, and absorbents.

30. A kit comprising:

an isolation/access catheter capable of being introduced transtracheally into the air passages of the lungs; and

instructions to introduce the isolation/access catheter to a target region of the lungs and to aspirate an isolated tissue segment as follows;

isolating a lung tissue segment;

aspirating the isolated segment to cause the segment to collapse to a volume which is no greater than 40% of the inflated size prior to aspirating; and

sealing the segment from the remainder of the lung to inhibit reinfection of the lung segment.

31. A kit as in claim 30, further comprising a sealing catheter, wherein said instructions further set forth that an air passage leading to the isolated tissue segment is to be sealed using the sealing catheter after the region has been aspirated.

32. A kit as in claim 30, further comprising means for applying external pressure to the lung at the same time the lung is being aspirated.

33. A kit as in claim 30, further comprising an agent which clears or widens air passages in the lungs when introduced into the lungs prior to aspiration.

34. A kit as in claim 33, wherein the agent is selected from the group consisting of mucolytic agents, bronchodilators, surfactants, desiccants, and solvents.