Torque alleviating intra-airway lung volume reduction compressive implant structures

• US 9,402,633 B2
• Filed: 03/13/2014
• Issued: 08/02/2016
• Est. Priority Date: 03/13/2006
• Status: Active Grant

• Current Assignee: Ekos LLC (Boston Scientific Corporation)
• Original Assignee: PneumRx, Inc. (Boston Scientific Corporation)
• Inventors: Vasquez, Jaime, Mathis, Mark L., Machold, Timothy, Stein, Andrew
• Primary Examiner(s): Anderson, Gregory
• Application Number:
  US14/209,194
• Publication Number:
  US 20150051709A1
• Time in Patent Office: 873 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

A device for enhancing the breathing efficiency of a patient is provided. The implantable device may include a deployed configuration with one or more helical sections with proximal end in a stand-off proximal end configuration. The stand-off proximal end configuration may reduce migration of the deployed device and may preserve implant tissue compression. Alternative configurations may include two or more helical sections with a transition section disposed between the two or more helical sections. A device may include a right-handed helical section and a left-handed helical section and the transition section comprises a switchback transition section. The switchback section may provide greater control of the device during deployment by limiting recoiling forces of a device comprising a spring material. The deployed device may compress the lung to increase a gas filling resistance of the compressed portion of the lung, and/or increase tension and elastic recoil in other portions of the lung.

Claims

1. A lung volume reduction system for enhancing a breathing efficiency of a patient with an airway, the system comprising:

an implantable device configured to impart a compression force on lung tissue, the implantable device including a proximal end and a distal end and further having a first configuration and a second configuration, the second configuration of the implantable device corresponding to a configuration of the implantable device pre-implantation or post-implantation, the second configuration comprises at least two helical sections with a transition section disposed between the at least two helical sections;

wherein each of the at least two helical sections include a proximal portion and a distal portion, and wherein the proximal portion and the distal portion of each of the at least two helical sections are configured to compress lung tissue disposed between the proximal portion and the distal portion of each respective helical section.

2. The lung volume reduction system of claim 1, wherein the at least two helical sections comprise a right-handed helical section and a left-handed helical section and wherein the transition section disposed between the at least two helical sections comprises a switchback transition section when the implantable device is in the second configuration.

3. The lung volume reduction system of claim 1, wherein at least one of the at least two helical sections comprise a circular helical section when the implantable device is in the second configuration.

4. The lung volume reduction system of claim 1, wherein both of the at least two helical sections comprise circular helical sections when the implantable device is in the second configuration.

5. The lung volume reduction system of claim 1, wherein the implantable device further comprises a jacket which covers a portion of the implantable device, the jacket configured to reduce erosion into the airway by a deployed implantable device.

6. The lung volume reduction system of claim 5, wherein the jacket covers the at least two helical sections and the transition section disposed between the at least two helical sections.

7. The lung volume reduction system of claim 5, wherein the jacket covers the distal end of the implantable device.

8. The lung volume reduction system of claim 5, wherein the jacket comprises a polycarbonate urethane material.

9. The lung volume reduction system of claim 8, wherein the polycarbonate material has at least 55D hardness.

10. The lung volume reduction system of claim 1, wherein the distal end of the implantable device includes an anchor for coupling with the airway.

11. The lung volume reduction system of claim 1, wherein the proximal end of the implantable device is atraumatic.

12. The lung volume reduction system of claim 11, wherein the stand-off proximal tail extends away from each helical axis of the at least two helical sections when the implant is in the second configuration.

13. The lung volume reduction system of claim 1, wherein the at least two helical sections have a first and second helical axis, respectively, and wherein the first and second helical axes are different when the implantable device is in the second configuration.

14. The lung volume reduction system of claim 13, wherein the first and second helical axes form an angle ranging between 190°

and 230°

when the implantable device is in the second configuration.

15. The lung volume reduction system of claim 1, wherein the implantable device comprises a spring element.

16. The lung volume reduction system of claim 15, wherein the implantable device comprises a metal including nickel and titanium.

17. The lung volume reduction system of claim 1, wherein the distal helical section comprises more loops than the proximal helical section when the implantable device is in the second configuration.

18. The lung volume reduction system of claim 17, wherein the proximal helical section comprises less than one loop when the implantable device is in the second configuration.

19. The lung volume reduction system of claim 17, wherein the distal helical section comprises at least one loop when the implantable device is in the second configuration.

20. The lung volume reduction system of claim 19, wherein the distal helical section comprises at least four loops when the implantable device is in the second configuration.

21. A lung volume reduction device for enhancing a breathing efficiency of a patient with an airway, the device comprising:

a stand-off proximal end and a distal end; and

wherein the device includes a first configuration and a second configuration, the first configuration corresponding to a delivery configuration and the second configuration corresponding to a pre-implantation configuration or a post-implantation configuration;

the second configuration of the device comprising a first helical section with a helical axis, the first helical section disposed between the stand-off proximal end and the distal end of the device, and wherein a proximal portion of the first helical section transitions into the stand-off proximal end via a bend that is disposed between the proximal portion of the first helical section and the stand-off proximal end such that the stand-off proximal end bends away from and extends proximally relative to the first helical section and extends away from the helical axis of the first helical section when the device is in the second configuration.

22. The lung volume reduction device of claim 21, wherein the second configuration further comprises a second helical section with a helical axis, the second helical section coupled with the first helical section;

and wherein the first helical section and second helical section comprise a right-handed helical section and a left-handed helical section when the device is in the second configuration; and

wherein the proximal end extends away from the helical axis of the second helical section when the device is in the second configuration.

23. The lung volume reduction device of claim 22, wherein the more distal helical section comprises more loops than the more proximal helical section when the device is in the second configuration.

24. The lung volume reduction device of claim 22, wherein the helical axis of the second helical section is different than the helical axis of the first helical section when the device is in the second configuration.

25. The lung volume reduction device of claim 21, further comprising a jacket covering at least the distal end and the first helical section.

26. The lung volume reduction device of claim 25, wherein the jacket comprises polycarbonate urethane material having a hardness of at least 55D.

27. A method of enhancing a breathing efficiency of a patient with a lung having an airway, the method comprising:

advancing an implant distally through the airway to a portion of the lung of the patient while the implant is in a delivery configuration, the implant having a proximal end and a distal end;

deploying the implant in the portion of the lung by transitioning the implant from the delivery configuration to a deployed configuration, the deployed configuration of the implant comprising at least two helical sections with a transition section disposed between the at least two helical sections;

wherein each of the at least two helical sections include a proximal portion and a distal portion, and wherein the proximal portion and the distal portion of each of the at least two helical sections are configured to compress lung tissue disposed between the proximal portion and the distal portion of each respective helical section.

28. The method of claim 27, wherein the at least two helical sections comprise a right-handed helical section and a left-handed helical section and wherein the transition section disposed between the at least two helical sections comprises a switchback transition section when the implant is in the deployed configuration.

29. The method of claim 27, wherein at least one of the at least two helical sections comprise a circular helical section when the implantable device in the deployed configuration.

30. The method of claim 27, wherein both of the at least two helical sections comprise circular helical sections when the implant is in the deployed configuration.

31. The method of claim 27, wherein the implant further comprises a jacket which covers a portion of the implant, the jacket configured to reduce implant erosion into the airway after the implant is deployed within the lung.

32. The method of claim 31, wherein the jacket covers the at least two helical sections and the transition section disposed between the at least two helical sections.

33. The method of claim 31, wherein the jacket covers the distal end of the implant.

34. The method of claim 31, wherein the jacket comprises a polycarbonate urethane material.

35. The method of claim 34, wherein the polycarbonate material has at least 55D hardness.

36. The method of claim 27, wherein the distal end of the implant includes an anchor for coupling with the airway and wherein the step of deploying the implant in the portion of the lung comprises coupling the distal end of the implant to the lung tissue with the anchor before or during the transition of the implant from the delivery configuration to the deployed configuration.

37. The method of claim 27, wherein the proximal end of the implant is atraumatic.

38. The method of claim 37, wherein the proximal end of the implant comprises a stand-off proximal tail, the stand-off proximal tail extending away from each helical axis of the at least two helical sections when the implant is in the deployed configuration.

39. The method of claim 27, wherein the at least two helical sections have a first and second helical axis, respectively, and wherein the first and second helical axes are different when the implant is in the deployed configuration.

40. The method of claim 39, wherein the first and second helical axes form an angle ranging between 190°

and 230°

when the implant is in the deployed configuration.

41. The method of claim 27, wherein the implant comprises a spring element and wherein the implant is constrained to the delivery configuration during delivery and wherein the implant is configured to naturally recover from the constrained delivery configuration to the deployed configuration during deployment.

42. The method of claim 41, wherein the implant comprises a metal including nickel and titanium.

43. The method of claim 27, wherein the distal helical section comprises more loops than the proximal helical section when the in the deployed configuration.

44. The method of claim 43, wherein the proximal helical section comprises less than one loop when the implant is in the deployed configuration.

45. The method of claim 43, wherein the distal helical section comprises at least one loop when the implant is in the deployed configuration.

46. The method of claim 45, wherein the distal helical section comprises at least four loops when the implant is in the deployed configuration.

47. A method of enhancing a breathing efficiency of a patient with a lung having an airway, the method comprising:

advancing an implant distally through the airway to a portion of the lung of the patient while the implant is in a delivery configuration, the implant having a proximal end and a distal end;

deploying the implant in the portion of the lung by transitioning the implant from the delivery configuration to a deployed configuration, the deployed configuration of the implant comprising a first helical section with a helical axis, the first helical section disposed between the proximal end and the distal end of the device, and wherein a proximal portion of the first helical section transitions into the stand-off proximal end via a bend that is disposed between the proximal portion of the first helical section and the stand-off proximal end such that the stand-off proximal end bends away from and extends proximally relative to the first helical section and extends away from the helical axis of the first helical section when the device is in the deployed configuration.

48. The method of claim 47, wherein the deployed configuration further comprises a second helical section with a helical axis, the second helical section coupled with the first helical section;

and wherein the first helical section and second helical section comprise a right-handed helical section and a left-handed helical section when the implant in the deployed configuration; and

wherein the proximal end extends away from the helical axis of the second helical section when the implant is in the deployed configuration.

49. The method of claim 48, wherein the more distal helical section comprises more loops than the more proximal helical section when the implant is in the deployed configuration.

50. The method of claim 48, wherein the helical axis of the second helical section is different than the helical axis of the first helical section when the device is in the deployed configuration.

51. The method of claim 47, wherein the implant further comprises a jacket covering at least the distal end and the first helical section.

52. The method of claim 51, wherein the jacket comprises polycarbonate urethane material having a hardness of at least 55D.