MINIMALLY INVASIVE LUNG VOLUME REDUCTION DEVICES, METHODS, AND SYSTEMS

• US 20090012626A1
• Filed: 07/02/2008
• Published: 01/08/2009
• Est. Priority Date: 03/13/2006
• Status: Active Grant

• Current Assignee: EKOS Corporation (Boston Scientific Corporation)
• Original Assignee: PneumRx, Inc. (Boston Scientific Corporation)
• Inventors: WU, Patrick, MATHIS, Mark L., VASQUEZ, Jaime, ARONSON, Nathan, BOUTILLETTE, Michael, LEHRBERG, David, THOMPSON, David
• Granted Patent: US 8,282,660 B2
• Time in Patent Office: Days
• US Class Current: 623/23.650
• CPC Class Codes: A61B 1/044 for absorption imaging
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/12031 complete occlusion
• 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 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• 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 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/485 involving fluorescence X-ray imaging
• 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: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2002/043 : Bronchi
• CPC Class Codes: A61F 2002/046 : Tracheae
• 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 16/208 : Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 2205/32 : with radio-opaque indicia
• CPC Class Codes: A61M 37/0069 : Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

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 lung volume reduction system comprising an implantable device that imparts bending force on lung tissue.

2. The lung volume reduction system of claim 1, wherein the implant comprises an elongate implantable spring element having a straight configuration and an axially bent configuration, the elongate spring element in the straight configuration extending along an axis of the elongate spring sufficiently for axial insertion into an airway of the lung tissue, the inserted elongate spring element deployable to the bent configuration, an end of the elongate spring element moving laterally from the axis so as to impart the bending force on the lung tissue when deployed within the airway, the bending force being sufficient to laterally bend the airway.

3. A lung volume reduction system comprising an implantable spring element that can be constrained into a shape that can be delivered to a lung airway and unconstrained to allow the element to impart bending force on the airway to cause the airway to be bent.

4. The lung volume reduction system of claim 3 wherein the implant is constrained to a more straight delivery configuration and allowed to recover to a less straight deployed configuration in the lung.

5. The lung volume reduction system of claim 3 wherein the implant is made, at least partially, of spring material that will fully recover after having been strained at least 1%.

6. The lung volume reduction system of claim 3 wherein the implant comprises a metal, the metal including Nickel and Titanium.

7. The lung volume reduction system of claim 6 wherein the implant wherein the spring element is temperature activated during deployment.

8. A lung volume reduction system comprising an implantable device that is configured to be deliverable into a patient'"'"'s lung and configured to be reshaped to make the lung tissue that is in contact with the device more curved.

9. The lung volume reduction system of claim 8 wherein the device has a first configuration and a second configuration, the device in the first configuration extending along an axis and insertable through the airway system so that the device extends along an elongate axial region of an airway, the device being deployable in the airway to the second configuration by reshaping the device so that the device bends the airway away from the axis.

10. The lung volume reduction system of claim 8 wherein the device is reshaped by releasing the device from a delivery catheter system, wherein the device has first and second ends separated by a first length when in a deliverable configuration, the first end being blunt so as to inhibit penetration of the lung airway, and wherein reshaping of the device within the airway bends the airway so that the airway between the ends curves laterally away from between the ends, so that the distance between the ends is less than the first length, and so that lung tissue adjacent the airway and between the ends of the deployed device is compressed.

11. The lung volume reduction system of claim 8 wherein the device is configured to be reshaped to a permanent second configuration.

12. The lung volume reduction system of claim 8 wherein the device has a first shape and is configured to be strained elastically to a deliverable shape.

13. The lung volume reduction system of claim 8 wherein the implantable device has a first shape and is adapted to be elastically constrained by a delivery device to a deliverable configuration whereby removal of the delivery device allows the implant to recoil and be reshaped closer to its first shape.

14. The lung volume reduction system of claim 8 wherein the tissue that is in contact with the device is that of blood vessel, airway, lung dissection fissure or a combination of these.

15. The lung volume reduction system of claim 8 wherein the reshaped implant shape is shorter in length than the deliverable implant configuration.

16. The lung volume reduction system of claim 8 wherein the implant has a distal end and a proximal end and the distance between the two ends is reduced when the implant is reshaped.

17. The lung volume reduction system of claim 8 wherein the implant is configured to reduce lung volume when the implant occupies less than the entire lumen cross section area of a lung airway.

18. The lung volume reduction system of claim 8 wherein the deliverable shape fits within a cylindrical space that is 18 mm in diameter or smaller.

19. The lung volume reduction system of claim 8 wherein the surface area of the implant that can come in contact with tissue is larger than 1.0E-6 square inches per linear inch of length of the implant.

20. The lung volume reduction system of claim 8, wherein the implant comprises an elongate body having an axial length, the body being axially insertable into an airway of the lung, wherein the reshaping of the implant moves a bearing area extending along the length of the elongate body against the airway sufficiently to bend the airway.

21. The lung volume reduction system of claim 8 wherein the implant is coated with material that reduces the rate of wound healing, tissue remodeling, inflammation, generation of granular tissue or a combination of these.

22. The lung volume reduction system of claim 8 wherein the reshaped implant can lie within a single plane.

23. The lung volume reduction system of claim 25 wherein the reshaped implant is generally in the shape of a C or an S.

24. The lung volume reduction system of claim 8 wherein the reshaped implant cannot lie within a single plane.

25. The lung volume reduction system of claim 24 wherein the reshaped implant is generally in the shape of a baseball seam or a coil.

26. The lung volume reduction system of claim 13, further comprising a plurality of implants, each implant being deliverable and reshapable within an associated airway region so as to reduce lung volume.

27. The lung volume reduction system of claim 26 wherein the implants are configured to be coupled to other implants when deployed.

28. The lung volume reduction system of claim 8 wherein the implantable device is made of a resiliently bendable material.

29. The lung volume reduction system of claim 8 wherein the system further comprises an actuator adapted to be operated from outside the patient to reshape the implant.

30. The lung volume reduction system of claim 8 wherein the system further comprises a lung airway catheter releasably receiving the implant so as to constrain the implant in a deliverable configuration.

31. The lung volume reduction system of claim 30 wherein the system further comprises a pusher adapted to deliver the implant from the catheter into a patients lung.

33. The lung volume reduction system of claim 8 wherein the system further comprises a recapture device to remove the implant from a patient'"'"'s lung.

35. The lung volume reduction system of claim 30 wherein the system further comprises:

a resilient wire receivable within the catheter to guide the catheter distally, the catheter comprising a delivery catheter; and

a resilient dilator device that fits in the catheter lumen, wherein the dilator device has a lumen that accommodates the resilient wire.

36. The lung volume reduction system of claim 8 wherein an arc length of the implant remains as the implant is reshaped constant.

60. The lung volume reduction system of claim 8 wherein the implant comprises an elongate body and further comprising rounded structures at a proximal end and at a distal end of the elongate body so as to inhibit trauma to the airway at the distal and proximal ends of the implant.

61. The lung volume reduction system of claim 8 wherein the device comprises a central wire that spans the length of the device.

62. The lung volume reduction system of claim 61 wherein the central wire is wrapped by a wire frame or covering that contacts lung tissue.

37. A lung volume reduction device comprising an elongate body adapted to be inserted into a lumen adjacent lung tissue, the device having a delivery configuration and a deployed configuration more curved than the delivery configuration.

38. A lung volume reduction system comprising an implantable device that is configured to be deliverable into a patient'"'"'s lung and configured to reshape lung tissue while allowing fluid to flow both directions past the implant.

39. A lung volume reduction system comprising an implantable device that is configured to be deliverable into a patient'"'"'s lung configured to be reshaped to a shape that is not axi-symmetric to bend lung tissue.

40. A method of reducing a patient'"'"'s lung volume comprising:

inserting a lung volume reduction device into a patient lumen adjacent lung tissue in a delivery configuration, the device comprising an elongate body; and

moving the elongate body from the delivery configuration to a deployment configuration more curved than the delivery configuration.

32. The lung volume reduction system of claim 40 wherein the pusher is releaseably coupled to the implant device so as to allow the implant to be retrieved into a lumen of the catheter so as to allow retrieval of the implant after the implant has been pushed out of the lumen and into an airway.

34. The lung volume reduction system of claim 42 wherein the recapture device can be coupled to the proximal end of the implant and is configured to operate within a catheter or bronchoscope working channel lumen.

41. The method of claim 40 wherein the moving step comprises forming an arc along the elongate body while the elongate body extends along and within an airway so that the elongate body bends the airway surrounding the elongate body and the bending of the airway compresses adjacent lung tissue.

42. The method of claim 40 wherein the moving step comprises forming a rigid arc in the elongate body, the rigid arc having a rigidity greater than that of the lung tissue.

43. The method of claim 41 wherein the moving step further comprises forming a plurality of arcs in the elongate body.

45. 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 to reduce the radius of curvature of at least a portion the airway.

46. A method of bending a lung airway of a patient comprising inserting an implantable device into the airway in a delivery configuration and bending the device into a deployed configuration to reduce the radius of curvature of at least a portion the airway.

44. The method of claim 57 wherein the lumen comprises a lung airway.

47. The method of claim 46 wherein the step of bending comprises operating an actuator outside the patient, the actuator being operatively connected to the device.

48. The method of claim 46 wherein the step of bending further comprising locking the device into the deployed configuration.

49. The method of claim 46 wherein the device comprises an axial series of asymmetric segments, inserting comprises delivering the plurality of asymmetric segments to the airway, and wherein the step of bending comprises rotating at least one of the asymmetric segments with respect to another of the asymmetric segments so as to move at a portion of the device away from the axis.

50. The method of claim 46 wherein the device comprises shape memory material and bending the device comprises thermally activating the device so that device is biased toward an airway bending shape.

51. The method of claim 46 wherein the device bends into a substantially C shape, a substantially S shape, a substantially spiral shape, a coil of varying radius, and/or a shape that can lie within a single plane.

52. The method of claim 46 wherein the device bends into a shape that cannot lie within a single plane.

53. The method of claim 46 further comprising retrieving the device from the airway after bending the device.

54. The method of claim 46 further comprising relieving strain adjacent an end of the device with a tip of the device, the tip extending from an elongate body of the device at the end, the extension being more flexible than the elongate body.

57. The method of claim 46 further comprising inserting a second device into a second airway of the lung;

wherein the first device is bent to a deployed condition to bend the airway; and

wherein the second device is bent to a deployed condition to bend the second airway.

58. The method of claim 57 wherein the devices are connected in a common airway adjacent the airway and the second airway.

59. The method of claim 46 wherein the device conforms the airway to the shape of the implant in the deployed condition.

55. A method of reducing lung volume by bending a lung airway of a patient comprising inserting an implantable device into the airway in a delivery configuration and bending the device into a deployed configuration to change the radius of curvature of at least a portion of the airway.

56. A method of reducing lung volume in a patient comprising inserting a device into an airway and causing bending of the airway with the device so that the bending of the airway compresses lung tissue.