Tuned strength chronic obstructive pulmonary disease treatment

• US 10,390,838 B1
• Filed: 08/20/2015
• Issued: 08/27/2019
• Est. Priority Date: 08/20/2014
• Status: Expired due to Fees

• Current Assignee: EKOS Corporation (Boston Scientific Corporation)
• Original Assignee: PneumRx, Inc. (Boston Scientific Corporation)
• Inventors: Mathis, Mark, Rodriguez, Verna
• Primary Examiner(s): Dang, Ahn T
• Application Number:
  US14/831,007
• Time in Patent Office: 1,468 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12104 in an air passage
• 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 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/4869 Determining body composition

Abstract

The present invention generally provides improved medical devices, systems, and methods, particularly for treating one or both lungs of a patient with an implant, such as a coil, having a strength tuned to a patient'"'"'s tissue treatment region. More particularly, embodiments of the present invention include a method for treating a lung of a patient with chronic obstructive pulmonary disease. The method comprises determining a regional tissue density of at least a portion of lung tissue of the patient and selecting between first and second coils based on the determined regional tissue density of the portion of lung tissue. In particular, the first coil has a first austenite final tuning and second coil has a second austenite final tuning different than the first tuning. Determining may comprise imaging at least the portion of lung tissue of the patient so as to identify a localized lung tissue density. Selecting may comprise matching the determined tissue density of the treatment region to a tuned strength of the first or second coil.

Claims

1. A method for treating a lung of a patient with chronic obstructive pulmonary disease, the method comprising:

determining a regional tissue characteristic of at least a portion of lung tissue of the patient; and

selecting between a first coil having a first austenite final tuning and a second coil having a second austenite final tuning different than the first austenite final tuning based on the determined regional tissue characteristic of the portion of lung tissue, wherein the first austenite final tuning is characterized by a first transition temperature that is higher than a second transition temperature of the second austenite final tuning.

2. The method of claim 1, wherein the determined regional tissue characteristic comprises a tissue density, strength, or compliance.

3. The method of claim 1, wherein the first and second coils comprise at least one alloy.

4. The method of claim 1, wherein the first transition temperature is just below a body temperature.

5. The method of claim 1, wherein the first transition temperature is in a range from about 30 degrees Celsius to about 35 degrees Celsius.

6. The method of claim 1, wherein the second transition temperature is in a range from about 5 degrees Celsius to about 15 degrees Celsius.

7. The method of claim 1, wherein the second transition temperature is in a range from about 15 degrees Celsius to about 30 degrees Celsius.

8. The method of claim 1, wherein the determining comprises imaging at least the portion of lung tissue of the patient so as to identify a localized lung tissue strength or density.

9. The method of claim 8, wherein imaging comprises taking a computed tomography (CT), magnetic resonance imaging (MRI), optical coherence tomography (OCT), ultrasound, bronchoscopic, or fluoroscopic image of at least the portion of lung tissue of the patient.

10. The method of claim 1, wherein the selecting comprises matching the determined regional tissue characteristic of the portion of lung tissue to a strength of the first or second coil.

11. The method of claim 1, further comprising deploying the selected first or second coil in at least a portion of the lung so as to locally compress lung tissue.

12. The method of claim 1, wherein the determining comprises identifying a first tissue region of lung tissue having a first regional tissue density, and wherein the selecting comprises selecting the first coil for deployment in the first tissue region in response to the first regional tissue density, the method further comprising:

identifying a second tissue region of the lung having a second regional tissue density different than the first regional tissue density; and

selecting the second coil for deployment in the second tissue region of the lung in response to the second regional tissue density.

13. The method of claim 12, wherein the first coil has a first coil strength and the second coil has a second coil strength, the first coil strength less than the second coil strength, wherein the determined regional tissue characteristic indicates the first tissue region has a first tissue strength and the second tissue region has a second tissue strength, the first tissue strength less than the second tissue strength, and wherein the second coil strength is sufficiently mismatched to the first tissue strength that deployment of the second coil in the first tissue region would be undesirable.

14. The method of claim 1, wherein the first and second coils are included in a group of candidate coils having differing strengths at body temperature and differing lengths, the method further comprising selecting a subset of the group of candidate coils for deployment in a first tissue region in response to a measurement of a length of the first tissue region, the subset of the group of candidate coils having similar lengths and including the first coil and the second coil.

15. The method of claim 1, wherein chronic obstructive pulmonary disease comprises a disease progression such that the at least a portion of the lung tissue has a first lax tissue volume associated with the determined regional tissue characteristic at a first time and an expected second lax tissue volume greater than the first lax tissue volume at a second time later than the first time, wherein the selecting is performed so that the selected first or second coil, when deployed in the at least a portion of the lung, is configured to compress the first lax tissue volume and to remain strained by the lung tissue at the first time, and is configured to compress the second lax tissue volume at the second time.

16. The method of claim 1, wherein the selecting comprises matching a weaker portion of lung tissue with the first coil having a higher austenite final tuning than the second coil so as to provide a lower tensioning load.

17. The method of claim 16, further comprising delivering the selected first coil having a higher austenite final tuning into the lung of the patient, wherein less force is required to deploy the selected first coil than the second coil.

18. The method of claim 17, wherein the selected first coil is configured to apply a chronic constant force over a longer period of time than the second coil.

19. The method of claim 1, wherein the selecting comprises matching a stronger portion of lung tissue with the second coil having a lower austenite final tuning than the first coil so as to provide a higher tensioning load.

20. The method of claim 1, wherein the selecting further comprises matching a strength of the first or second coil to an implantation location, anatomical characteristic, state of disease, or a state of disease progression.

21. The method of claim 1, wherein the first or second coils comprise at least a nitinol, nickel, or titanium alloy.

22. The method of claim 1, further comprising delivering the selected first or second coil into a portion of the lung of the patient, wherein the selected first or second coil is configured to compress a lung tissue volume.

23. The method of claim 22, further comprising cooling the selected first or second coil below an austenite final temperature prior to or during delivery into the lung of a patient so as to convert the selected first or second coil temporarily to a martensitic metallic phase.

24. A method for treating a lung of a patient with chronic obstructive pulmonary disease, the method comprising:

determining a regional tissue characteristic of at least a portion of lung tissue of the patient, wherein the determining comprises identifying a first tissue region of lung tissue having a first regional tissue density;

selecting between a first coil having a first austenite final tuning and a second coil having a second austenite final tuning different than the first austenite final tuning based on the determined regional tissue characteristic of the portion of lung tissue, wherein the first coil has a first coil strength and the second coil has a second coil strength, the first coil strength less than the second coil strength, and wherein the selecting comprises selecting the first coil for deployment in the first tissue region in response to the first regional tissue density;

identifying a second tissue region of the lung having a second regional tissue density different than the first regional tissue density, wherein the determined regional tissue characteristic indicates the first tissue region has a first tissue strength and the second tissue region has a second tissue strength, the first tissue strength less than the second tissue strength; and

selecting the second coil for deployment in the second tissue region of the lung in response to the second regional tissue density, wherein the second coil strength is sufficiently mismatched to the first tissue strength that deployment of the second coil in the first tissue region would be undesirable.

25. A method for treating a lung of a patient with chronic obstructive pulmonary disease, the method comprising:

determining a regional tissue characteristic of at least a portion of lung tissue of the patient;

selecting between a first coil having a first austenite final tuning and a second coil having a second austenite final tuning different than the first austenite final tuning based on the determined regional tissue characteristic of the portion of lung tissue, wherein the first and second coils are included in a group of candidate coils having differing strengths at body temperature and differing lengths; and

selecting a subset of the group of candidate coils for deployment in a first tissue region in response to a measurement of a length of the first tissue region, the subset of the group of candidate coils having similar lengths and including the first coil and the second coil.

26. The method of claim 25, wherein the first and second coils comprise at least one alloy, wherein the first austenite final tuning is characterized by a first transition temperature that is higher than a second transition temperature of the second austenite final tuning.

27. The method of claim 25, wherein the selecting comprises matching the determined regional tissue characteristic of the portion of lung tissue to a strength of the first or second coil.

28. A method for treating a lung of a patient with chronic obstructive pulmonary disease, the method comprising:

determining a regional tissue characteristic of at least a portion of lung tissue of the patient; and

selecting between a first coil having a first austenite final tuning and a second coil having a second austenite final tuning different than the first austenite final tuning based on the determined regional tissue characteristic of the portion of lung tissue, wherein the selecting comprises matching a weaker portion of lung tissue with the first coil having a higher austenite final tuning than the second coil so as to provide a lower tensioning load.

29. The method of claim 28, further comprising delivering the selected first coil having a higher austenite final tuning into the lung of the patient, wherein less force is required to deploy the selected first coil than the second coil.

30. The method of claim 29, wherein the selected first coil is configured to apply a chronic constant force over a longer period of time than the second coil.

31. The method of claim 28, wherein the first and second coils comprise at least one alloy, wherein the first austenite final tuning is characterized by a first transition temperature that is higher than a second transition temperature of the second austenite final tuning.

32. A method for treating a lung of a patient with chronic obstructive pulmonary disease, the method comprising:

determining a regional tissue characteristic of at least a portion of lung tissue of the patient; and

selecting between a first coil having a first austenite final tuning and a second coil having a second austenite final tuning different than the first austenite final tuning based on the determined regional tissue characteristic of the portion of lung tissue, wherein the selecting comprises matching a stronger portion of lung tissue with the second coil having a lower austenite final tuning than the first coil so as to provide a higher tensioning load.

33. The method of claim 32, wherein the first and second coils comprise at least one alloy, wherein the first austenite final tuning is characterized by a first transition temperature that is higher than a second transition temperature of the second austenite final tuning.