Enhanced efficacy lung volume reduction devices, methods, and systems

• US 10,285,707 B2
• Filed: 10/01/2015
• Issued: 05/14/2019
• Est. Priority Date: 09/12/2008
• Status: Expired due to Fees

• Current Assignee: Ekos LLC (Boston Scientific Corporation)
• Original Assignee: PneumRx, Inc. (Boston Scientific Corporation)
• Inventors: Mathis, Mark L., Thompson, David, Wu, Patrick
• Primary Examiner(s): Iwamaye, Andrew M
• Application Number:
  US14/872,416
• Publication Number:
  US 20160113657A1
• Time in Patent Office: 1,321 Days
• 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 comprising a first airway and a second airway, the method comprising:

evaluating a pretreatment localized density of the lung and/or a pretreatment density distribution map of the lung prior to applying a treatment procedure to the lung of the patient;

compressing a first portion of the lung during the treatment procedure with a first implantable coil deployed within the first airway so as to generate an increased tension in an uncompressed portion of the lung while permitting airflow in opposing directions past the first implantable coil, the first implantable coil having a distal end, a proximal end, and an elongate body extending between the distal end and the proximal end;

the first implantable coil being deployed from a constrained delivery configuration to an unconstrained delivery configuration so that the first portion of the lung is laterally compressed between the proximal end and the distal end in the unconstrained delivery configuration;

subsequent to the compression of the first portion of the lung with the first implantable coil, evaluating, using an imaging device, a resulting localized density of the lung and/or a resulting density distribution map of the lung to measure an effectiveness of the treatment procedure; and

if the measured effectiveness of the treatment procedure is less than an improvement threshold for the treatment procedure, continuing the treatment procedure by compressing a second portion of the lung with a second implantable coil deployed within the second airway of the lung.

2. The method of claim 1, further comprising, subsequent to the compression of the second portion of the lung, continuing the treatment procedure by deploying one or more additional implantable coils within the lung and until the effectiveness of the treatment procedure, as evaluated via the imaging device, is equal to or exceeds the improvement threshold for the treatment procedure.

3. The method of claim 1, further comprising imaging a diaphragm of the patient and evaluating a shape, curvature, orientation, and/or position of the diaphragm of the patient.

4. The method of claim 1, wherein the first implantable coil is configured to increase a gas filling resistance in the first airway.

5. The method of claim 1, wherein the evaluation of the resulting localized density of the lung and/or the resulting density distribution map of the lung comprises imaging the lung using computed tomography (CT) imaging.

6. The method of claim 1, further comprising:

monitoring, via the imaging device, the effectiveness of the treatment procedure during the compression of the first portion of the lung.

7. The method of claim 1, further comprising measuring a change in a volume of the lung during the compression of the first portion of the lung to evaluate the effectiveness of the treatment procedure.

8. The method of claim 1, further comprising measuring a change of lung pressure during the compression of the first portion of the lung to evaluate the effectiveness of the treatment procedure.

9. The method of claim 1, further comprising measuring a change of air flow of the lung during the compression of the first portion of the lung to evaluate the effectiveness of the treatment procedure.

10. The method of claim 1, further comprising measuring a change of lung pressure versus lung volume during compression of the first portion of the lung to evaluate the effectiveness of the treatment procedure.

11. The method of claim 10, wherein a ventilator is coupled with the patient to measure the change in lung pressure versus lung volume during the compression of the first portion of the lung.

12. The method of claim 11, wherein the ventilator is operated in a pressure controlled mode.

13. The method of claim 11, wherein the ventilator is operated in a volume controlled mode.

14. The method of claim 11, wherein the ventilator generates an output indicative of airway resistance.

15. The method of claim 1, further comprising measuring a change of blood oxygen saturation during and/or after compression of the first portion of the lung to evaluate the effectiveness of the treatment procedure.

16. The method of claim 1, wherein the second implantable coil is configured to increase a gas filling resistance in the second airway.

17. The method of claim 1, further comprising maintaining the location of the patient throughout the treatment procedure.

18. A method for treating a lung of a patient, the lung including an airway system comprising a first airway and a second airway, the method comprising:

evaluating a pretreatment residual volume of the lung of the patient prior to applying a treatment procedure to the lung of the patient;

deploying a first coil within the first airway so as to compress a first portion of the lung to generate an increased tension in an uncompressed portion of the lung while permitting airflow in opposing directions past the first coil, the first coil having a distal end, a proximal end, and an elongate body extending between the distal end and the proximal end;

the first coil being deployed from a constrained delivery configuration to an unconstrained delivery configuration so that the first portion of the lung is laterally compressed between the proximal end and the distal end in the unconstrained delivery configuration;

subsequent to the deployment of the first coil within the first airway, evaluating, using an imaging device, a resulting residual volume of the lung; and

continuing treatment of the lung of the patient at the second airway of the lung if the resulting residual volume after compression of the first portion of the lung is less than 6% from the residual volume evaluated prior to the treatment of the lung of the patient by compressing a second portion of the lung from within the second airway with a second coil so as to generate an increased tension in the uncompressed portion of the lung.

19. A method for treating a lung of a patient, the lung including an airway system comprising a first airway and a second airway, the method comprising:

compressing a first portion of the lung during a treatment procedure by deploying a first implantable coil within the first airway so as to generate an increased tension in an uncompressed portion of the lung while permitting airflow through the first airway in opposing directions past the first implantable coil, the first implantable coil having a distal end, a proximal end, and an elongate body extending between the distal end and the proximal end;

the first implantable coil being deployed from a constrained delivery configuration to an unconstrained delivery configuration so that the first portion of the lung is laterally compressed between the proximal end and the distal end in the unconstrained delivery configuration;

measuring, using an imaging device, a localized density of the lung and/or a density distribution of the lung during the compression of the first portion of the lung to measure a change in the localized density of the lung and/or a density distribution of the lung during the compression of the first portion of the lung;

evaluating the measured change in the localized density of the lung and/or a density distribution of the lung during the compression of the first portion of the lung to determine an effectiveness of the treatment procedure; and

if the determined effectiveness of the treatment procedure is less than an improvement threshold for the treatment procedure, continuing the treatment procedure by compressing a second portion of the lung with a second implantable coil deployed within the second airway of the lung.

20. The method of claim 19, wherein the imaging device comprises a computed tomography (CT) imaging device.

21. The method of claim 19, further comprising imaging a diaphragm of the patient and evaluating a shape, curvature, position, and/or orientation of the diaphragm.