Enhanced efficacy lung volume reduction devices, methods, and systems

• US 10,058,331 B2
• Filed: 09/14/2012
• Issued: 08/28/2018
• Est. Priority Date: 09/12/2008
• Status: Expired due to Fees

• Current Assignee: EKOS Corporation (Boston Scientific Corporation)
• Original Assignee: PneumRx, Inc. (Boston Scientific Corporation)
• Inventors: Mathis, Mark L., Thompson, David, Wu, Patrick
• Primary Examiner(s): Prone, Christopher D
• Assistant Examiner(s): Diop, Rokhaya
• Application Number:
  US13/618,902
• Publication Number:
  US 20130103059A1
• Time in Patent Office: 2,174 Days
• Field of Search: 623 2364, 623 2365, 606151, 606157, 600104, 600424
• 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 17/12104 in an air passage
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61M 16/04 : Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0406 : implanted flow modifiers
• CPC Class Codes: A61M 16/0833 : T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 2205/0266 : Shape memory materials

Abstract

A lung volume reduction system is disclosed having an implantable device adapted to be delivered to a lung airway of a patient in a delivery configuration and to change to a deployed configuration to bend the lung airway. The invention also discloses a method of bending a lung airway of a patient by inserting a device into the airway in a delivery configuration and bending the device into a deployed configuration, thereby bending the airway.

Claims

1. A method of treating a lung of a patient, the lung including an airway system having a plurality of branching airways and a damaged portion, the method comprising:

delivering a self-recovering implant through the airway system in a constrained delivery configuration, the implant having an atraumatic distal end and an atraumatic proximal end and an elongate body defining an implant axis therebetween;

deploying the implant in the airway system from the constrained delivery configuration to an unconstrained deployed configuration so as to locally enhance a gas-filling resistance of the damaged portion of the lung;

wherein the implant is deployed through a delivery catheter, wherein the atraumatic distal end and the atraumatic proximal end inhibit penetration of the implant through a luminal wall surface of the airway system, and wherein the proximal end of the implant is advanced distally relative to the airway system while the delivery catheter is retracted proximally relative to the airway system to enhance a volume of tissue compressed by the implant and to inhibit axial loading between the implant and the airway when the implant laterally compresses lung tissue along a length of the implant.

2. The method of claim 1, wherein the atraumatic distal end of the implant comprises a ball formed by melting back a portion of the distal end, welding the atraumatic ball onto the distal end, pressing the atraumatic ball onto the distal end, or gluing the atraumatic ball onto the distal end.

3. The method of claim 1, wherein the proximal end of the implant is coupled with a pusher grasper during implant deployment, and wherein the pusher grasper moves the proximal end of the implant distally relative to the airway system while the delivery catheter is retracted proximally relative to the airway system.

4. The method of claim 1, further comprising evaluating lung characteristics of the patient with a first portion of the airway system laterally compressed and deploying a second implant in a second portion of the airway system to laterally compress lung tissue in the second portion of the airway system in response to the evaluation of the lung characteristics.

5. The method of claim 1, further comprising measuring an airway length and selecting the implant from a plurality of implants of different lengths such that a length of the implant is longer than the measured airway length where the implant is to be deployed.

6. The method of claim 1, wherein the deployed implant uncollapses an airway in another portion of the lung.

7. The method of claim 6, wherein the deployed implant distorts a blood vessel.

8. The method of claim 1, wherein the implant is deployed during an operation, and wherein the deployed implant provides a near-term measurable increase in lung efficacy such that the increase in lung efficacy may be evaluated during the operation for deploying the implant.

9. The method of claim 1, wherein the deployed configuration of implant is configured to permit airflow through the airway system and past the deployed implant in either direction.

10. The method of claim 1, wherein the deployed implant locally compresses a portion of the lung tissue disposed between the atraumatic proximal end and the atraumatic distal end of the deployed implant such that tension in the damaged portion increases.

11. The method of claim 1, wherein the deployed implant moves a diaphragm up such that a lung cavity operates more effectively.

12. The method of claim 11, wherein the deployed implant flattens the diaphragm.

13. The method of claim 11 wherein the deployed implant curves the diaphragm more upwardly such that the lung is distorted to change from a convex shape to a concave shape.

14. The method of claim 1, wherein the deployed implant locally compresses a portion of the lung tissue disposed between the proximal end and the distal end of the deployed implant such that a local tissue density increases.

15. The method of claim 14, wherein the deployed implant locally compresses the portion of the lung tissue disposed between the atraumatic proximal end and the atraumatic distal end of the deployed implant such that an adjacent tissue density decreases.

16. The method of claim 1, wherein the implant is deployed within the damaged portion of the lung which provides limited or no exchange of gas to and from the blood stream.

17. The method of claim 16, wherein the deployed implant provides gas filling resistance to the damaged portion of the lung.

18. The method of claim 17, wherein the gas filling resistance provided to the damaged portion of the lung is more than a normal physiologic resistance in a viable portion of the lung so as to reduce preferential filling of the damaged portion of the lung.

19. A method of treating lungs of a patient, the lungs including an airway system having a plurality of branching airways, the method comprising:

providing a plurality of implants having different lengths;

sequentially delivering the plurality of implants through the airway system in a constrained delivery configuration, each implant of the plurality of implants having a distal end and a proximal end and an elongate body therebetween;

sequentially deploying the plurality of implants of different lengths in the airway system at a plurality of locations, each implant of the plurality of implants deployed from the constrained delivery configuration to an unconstrained deployed configuration so as to laterally compress a portion of a lung tissue disposed between the proximal end and the distal end of the deployed implants;

measuring airway lengths at the plurality of locations; and

selecting the plurality of implants of different lengths such that a selected length of each respective self-recovering implant is longer than the measured airway length where the implant is to be deployed and wherein the longer length of the implant relative to the length of the associated target airway limits axial loads between the implant and the lung tissue during deployment,

wherein the deployed implants provide a near-term measureable increase in lung efficacy such that the increase in lung efficacy may be evaluated during an operation for deploying the plurality of implants, and

wherein the distal ends and the proximal ends inhibit penetration of the implants through luminal wall surfaces of the airway system.

20. The method of claim 19, wherein each of the distal ends of the plurality of implants comprise atraumatic balls formed by melting back a portion of the distal end, welding the atraumatic ball onto the distal end, pressing the atraumatic ball onto the distal end, or gluing the atraumatic ball onto the distal end.

21. The method of claim 19, wherein each implant is deployed through a delivery catheter and wherein the proximal end of the implant is advanced distally relative to the airway system while the delivery catheter is retracted proximally relative to the airway system to enhance a volume of tissue compressed by the implant.

22. The method of claim 21, wherein the proximal end of the implant is coupled with a pusher grasper during implant deployment, and wherein the pusher grasper moves the proximal end of the implant distally relative to the airway system while the delivery catheter is retracted proximally relative to the airway system.

23. The method of claim 19, wherein the plurality of implants of different lengths comprise implants having a length of 125 mm, 150 mm, 175 mm, or 200 mm.

24. The method of claim 19, wherein the plurality of implants of different lengths comprise implants having a length in a range from 120 mm to 250 mm.

25. The method of claim 19, wherein the selected length of each respective implant is at least 10% longer than the measured airway length.

26. The method of claim 19, wherein the selected length of each respective implant is at least 20% longer than the measured airway length.

27. The method of claim 19, wherein the plurality of implants comprise a baseball-seam shape, a C-shape, a S-shape, or a spiral shape in the unconstrained deployed configuration.