Enhanced efficacy lung volume reduction devices, methods, and systems

• US 9,173,669 B2
• Filed: 09/11/2009
• Issued: 11/03/2015
• 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): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US12/558,206
• Publication Number:
  US 20100070050A1
• Time in Patent Office: 2,244 Days
• Field of Search: 623 2364- 2365, 623 2367- 237, 606/151, 606/157, 128/898
• US Class Current: 1/1
• 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 comprising 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 comprising 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 for treating a lung of a patient, the lung including an airway system with a plurality of branching airways, the method comprising:

coupling a ventilator to the patient prior to treatment of the patient for measuring lung characteristics;

obtaining a pre-treatment forced expiratory volume in one second (FEV1) lung measurement of the patient;

while the ventilator is coupled with the patient and measuring lung characteristics of the patient, compressing a first portion of the lung from within a first airway so as to generate an increased tension in a first uncompressed portion of the lung while permitting airflow through the first airway into the compressed first portion of the lung from the first uncompressed portion of the lung;

evaluating a change in the ventilator measured lung characteristics of the patient with the first portion of the lung compressed, wherein the evaluation comprises measurement of FEV1 with the first portion of the lung compressed; and

while the ventilator is coupled with the patient and measuring lung characteristics of the patient, compressing a second portion of the lung from within a second airway in response to the evaluation indicating an increase of less than an FEV1 improvement threshold from the pre-treatment FEV1 to the FEV1 after compression of the first portion of the lung, the FEV1 improvement threshold being at least 8% or more, wherein the compressing of the second portion of the lung is performed so as to generate an increased tension in a second uncompressed portion of the lung while permitting airflow through the second airway into the compressed second portion of the lung from the second uncompressed portion of the lung, the second compressed portion of the lung being different from the first compressed portion of the lung.

2. The method of claim 1, wherein the evaluation and the compression of the second portion of the lung both occur within 6 hours of the compressing of the first portion of the lung.

3. The method of claim 2, wherein the compression of the second portion of the lung is completed in the same procedure as the compression of the first portion of the lung so that the patient is not relocated therebetween.

4. The method of claim 2, wherein evaluation is initiated within a few breathing cycles of completion of the compressing of the first portion of the lung, the evaluation indicating enhanced lung function induced at least in part by mechanical compression within the lung and without requiring other tissue response-induced delay for effective determination of efficacy.

5. The method of claim 1, wherein the evaluation further comprises evaluating a change in density of lung tissue by remotely imaging the lung tissue in situ.

6. The method of claim 1, wherein the evaluation further comprises identifying a change in shape of a diaphragm along a lower surface of the lung from an overall convex shape bulging outwardly away from the lung before treatment to a surface which is not yet curving sufficiently inwardly into the lung after compression of the first portion of the lung by remotely imaging the lung tissue in situ.

7. The method of claim 1, wherein the evaluation indicates an improvement of less than 6% from a pre-treatment residual volume to a residual volume after compression of the first portion of the lung.

8. The method of claim 1, wherein the evaluation indicates an improvement of less than 10% from a pre-treatment six minute walk distance to a six minute walk distance after compression of the first portion of the lung.

9. The method of claim 1, wherein the evaluation comprises an increase of less than 1% from a pre-treatment measurement of blood oxygen to a measurement of blood oxygen after compression of the first portion of the lung.

10. The method of claim 1, wherein the evaluation indicates that airways of the lung outside the first portion of the lung remain subject to collapse due to lack of tension in adjacent lung tissue.

11. The method of claim 1, wherein the evaluation comprises imaging of an uncompressed region of distributed disease after compression of the first portion of the lung, the uncompressed region of distributed disease being separated from the first portion of the lung and the compression of the first portion of the lung increasing pre- expiration tension in distributed tissue of the lung that is healthier than the imaged uncompressed region of distributed disease.

12. The method of claim 1, wherein the increased tension in the first uncompressed portion of the lung is generated regardless of collateral flow between the compressed first portion of the lung and the first uncompressed portion of the lung.

13. The method of claim 12, wherein the increased tension in the second uncompressed portion of the lung is generated regardless of collateral flow between the compressed second portion of the lung and the second uncompressed portion of the lung.

14. The method of claim 1, wherein the increased tension in the second uncompressed portion of the lung is generated regardless of collateral flow between the compressed second portion of the lung and the second uncompressed portion of the lung.

15. The method of claim 1, wherein the FEV1 improvement threshold is within a range from 8% to 15%.

16. The method of claim 1, wherein the FEV1 improvement threshold is within a range from 8% to 20%.

17. The method of claim 1, wherein the FEV1 improvement threshold is within a range from 8% to 50%.

18. The method of claim 1, wherein the FEV1 improvement threshold is within a range from 8% to 75%.