Methods of evaluating individuals having reversible obstructive pulmonary disease

• US 7,992,572 B2
• Filed: 11/07/2006
• Issued: 08/09/2011
• Est. Priority Date: 06/10/1998
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Asthmatx, Inc. (Boston Scientific Corporation)
• Inventors: Shriner, Kelly M., Kaplan, Gary, Biggs, Michael, Laufer, Michael D., Loomas, Bryan, Danek, Christopher James, Wizeman, William J.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US11/557,309
• Publication Number:
  US 20070102011A1
• Time in Patent Office: 1,736 Days
• Field of Search: 128/898, 607 96-102, 607/42
• US Class Current: 128/898
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00803 : with temperature prediction
• CPC Class Codes: A61B 2018/044 : the surgical action being effected by a circulating hot fluid
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/1807 : using light other than laser radiation
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2210/1039 : Lungs
• CPC Class Codes: A61M 25/0043 : characterised by structural features
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body

Abstract

This relates to treating an asthmatic lung and more particularly, relates to advancing a treatment device into the lung and treating the lung with the device. This also includes additional steps of treating the airway wall, applying energy or heat to the airway wall in an asthmatic lung.

Claims

1. A method of evaluating to eliminate or treat an individual having been previously diagnosed with a reversible obstructive pulmonary disease as a candidate for a treatment procedure to reduce the ability of a lung of the individual to produce a reversible obstructive pulmonary disease symptom by delivering energy to an airway wall within the lung of the individual, the method comprising:

performing a pulmonary function test on the individual to obtain a measured total lung pulmonary function value;

comparing the measured total lung pulmonary function value to a corresponding predetermined efficacy pulmonary function value that defines an efficacy threshold for the procedure in patients that have been diagnosed with the reversible obstructive pulmonary disease; and

treating the individual with the treatment procedure only if the measured total lung pulmonary function value meets the efficacy pulmonary function value, wherein treating the individual includes (a) inserting an energy delivery device into an airway of the lung of the individual and (b) actuating the energy delivery device multiple times as the energy delivery device is moved along the airway to deliver energy along the length of the airway wall at a plurality of treatment sites to form a repeating pattern of treated segments extending along the length of the airway such that the ability of the airway to contract is reduced.

2. The method of claim 1, further comprising assessing a total lung pulmonary function value of the individual, wherein the total lung pulmonary function value comprises a forced expiratory volume, forced vital capacity, forced expiratory flow, maximum flow, peak expiratory flow rate, functional residual capacity, residual volume, total lung capacity, or a combination thereof.

3. The method of claim 1, further comprising assessing a total lung pulmonary condition of the individual, wherein the assessing comprises determining a subtype of asthma.

4. The method of claim 3, wherein determining further comprises assessing a trigger that induces the asthma in the individual.

5. The method of claim 3, wherein determining further comprises assessing a characteristic feature of an immune system response in the individual having asthma.

6. The method of claim 3, wherein determining further comprises assessing an expression of genes controlling an interleukin in the individual.

7. The method of claim 1, further comprising assessing a total lung pulmonary condition of the individual and stimulating the lung to produce an artificially induced symptom of reversible obstructive pulmonary disease prior to the assessing the total lung pulmonary condition.

8. A method of evaluating an effectiveness of a procedure to reduce the ability of a lung to produce a symptom of reversible obstructive pulmonary disease previously performed on an individual having reversible obstructive pulmonary disease, the method comprising:

assessing a total lung pulmonary condition of the individual;

treating the lung by inserting an energy delivery device into an airway of the lung and actuating the energy delivery device multiple times as the energy deliver device is moved along the airway to deliver energy along the length of the airway wall at a plurality of treatment sites to form a repeating pattern of treated segments extending along the length of the airway such that the ability of the airway to contract is reduced;

assessing a total lung post-procedure pulmonary condition of the individual;

comparing the total lung pulmonary condition to the total lung post-procedure pulmonary condition after treating the lung; and

evaluating the effectiveness of the procedure based upon the act of comparing.

9. The method of claim 8, further comprising:

performing a total lung pulmonary function test on the individual to obtain a pulmonary function value;

performing a total lung post-procedure pulmonary function test on the individual to obtain a post-procedure total lung pulmonary function value; and

comparing the total lung pulmonary function value with the post-procedure total lung pulmonary function value to determine an effect of the treatment.

10. The method of claim 9, further comprising stimulating the lung to produce an artificially induced symptom of reversible obstructive pulmonary disease prior to performing the total lung pulmonary function test and the post-procedure total lung pulmonary function test.

11. The method of claim 8, further comprising obtaining clinical information from the individual, wherein evaluating further comprises accounting for the clinical information to assess the effectiveness of the procedure.