Minimally invasive lung volume reduction devices, methods, and systems

• US 8,282,660 B2
• Filed: 07/02/2008
• Issued: 10/09/2012
• Est. Priority Date: 03/13/2006
• Status: Active Grant

• Current Assignee: EKOS Corporation (Boston Scientific Corporation)
• Original Assignee: PneumRx, Inc. (Boston Scientific Corporation)
• Inventors: Thompson, David, Aronson, Nathan, Wu, Patrick, Lehrberg, David, Mathis, Mark L., Boutillette, Michael, Vasquez, Jaime
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US12/167,167
• Publication Number:
  US 20090012626A1
• Time in Patent Office: 1,560 Days
• Field of Search: 623/23.65, 623/23.64, 606/151, 606/157
• US Class Current: 606/157
• 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 system for treating a patient having a lung with an airway, the airway having an airway path prior to treatment, the system comprising:

a bronchoscope having an elongate bronchoscope insertion tube, the insertion tube extending from a proximal working head to a distal end with a working channel therebetween, the distal end of the insertion tube configured to be inserted distally into an airway and having a scope oriented distally so as to acquire an image from within the airway distally of the distal end of the insertion tube;

an airway delivery catheter having a proximal end and a distal end with a delivery lumen therebetween, the delivery catheter receivable within the working channel of the bronchoscope, the distal end of the delivery catheter configured for advancement distally of the distal end of the insertion tube along the path of the airway; and

an implant including an elongate body extending between a proximal end and a distal end, the elongate body having a relatively straight configuration and a bent configuration, the elongate body in the straight configuration extending along an axis and advanceable within the delivery lumen into the airway so as to extend along the path of the airway, the elongate body of the implant configured to deploy from the straight configuration to the bent configuration within the airway so as to move the elongate body adjacent the distal end laterally from the axis and impart bending force on the airway such that the path of the airway bends.

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

3. An implant for use in a system and for treating a patient, the patient having a lung with an airway, the airway having an airway path prior to treatment, the system including a bronchoscope having a working channel and a distally oriented viewing scope, the system also including a delivery catheter having a delivery lumen and advanceable from the working channel of the bronchoscope along the path of the airway, the implant comprising:

an elongate implantable spring element having a proximal end and a distal end, the spring element configured to be constrained into a relatively straight shape by the delivery catheter when disposed in the delivery lumen so as to extend along an axis, the spring element in the straight shape configured for advancement axially from the bronchoscope for delivery to the lung airway so as to extend axially along the path of the airway, the spring element biased to bend the spring element adjacent the distal end away from the axis when disposed in the airway unconstrained by the delivery catheter so as to impart bending force on the airway to cause the airway to be bent from the path.

4. The implant 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%.

5. The implant of claim 3 wherein the implant comprises a metal, the metal including Nickel and Titanium.

6. The implant of claim 5 wherein the implant wherein the spring element is temperature activated during deployment.

7. A system for use with a bronchoscope and for treating a patient, the patient having a lung with lung tissue including an airway, the airway having an airway path prior to treatment, the bronchoscope having a working channel and a viewing scope for viewing distally within the airway, the system comprising:

a lung airway delivery catheter having a proximal end and a distal end with a delivery lumen therebetween, the distal end of the delivery catheter configured to be advanced distally from the working channel of the bronchoscope along the path of the airway;

an implantable device having an elongate body receivable within the delivery lumen and that is configured to be deployed from the delivery lumen into the airway of the lung of the patient, the elongate body configured to extend along an axis in a first configuration when disposed within the delivery catheter for axial insertion along the path of the airway, the elongate body of the implantable device configured to be reshaped from the first configuration to a second configuration within the airway, the elongate body in the second configuration configured to bend laterally away from the axis so as bend the path of the airway.

8. The system of claim 7 wherein the device is reshaped by releasing the device from the delivery catheter, wherein the device has first and second ends separated by a first length when in the first configuration, the first end being blunt so as to inhibit penetration of the lung airway, and wherein the elongate body is configured such that 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.

9. The system of claim 7 wherein the device is configured to be reshaped to a permanent second configuration.

10. The system of claim 7 wherein the device has a first shape and is configured to be strained elastically to a deliverable shape of the first configuration.

11. The system of claim 7 wherein the implant has a first shape and is adapted to be elastically constrained by the delivery catheter to the first configuration whereby removal of the delivery catheter allows the implant to recoil and be reshaped closer to its first shape.

12. The system of claim 11, further comprising a plurality of implants, each implant being configured to be delivered to and reshaped within an associated airway region so as to reduce lung volume.

13. The system of claim 12 wherein the implants are configured to be coupled to other implants when deployed.

14. The system of claim 7 wherein the implant in the second configuration is shorter in length than the implant in the first configuration.

15. The system of claim 7 wherein the distance between the two ends of the implant is reduced when the implant is reshaped.

16. The system of claim 7 wherein the implant is configured to reduce lung volume when the implant occupies less than the entire lumen cross sectional area of a lung airway.

17. The system of claim 7 wherein the implant in the first configuration fits within a cylindrical space that is 18 mm in diameter or smaller.

18. The system of claim 7 wherein a surface area of the implant that is oriented for contact with tissue of the lung is larger than 1.0E-6 square inches per linear inch of length of the implant.

19. The lung volume reduction system of claim 7, wherein the elongate body has an axial length, wherein the elongate body is configured so that reshaping of the implant moves a bearing area extending along the length of the elongate body against the airway sufficiently to bend the airway.

20. The system of claim 7 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.

21. The system of claim 7 wherein the reshaped implant is configured to lie within a single plane.

22. The system of claim 7 wherein the reshaped implant is configured to not lie within a single plane.

23. The system of claim 22 wherein the reshaped implant is generally in the shape of a baseball seam or a coil.

24. The system of claim 23 wherein the reshaped implant is generally in the shape of a C or an S.

25. The system of claim 7 wherein the implantable device is made of a resiliently bendable material.

26. The system of claim 7 wherein the system further comprises an actuator adapted to be operated from outside the patient to reshape the implant.

27. The system of claim 7 wherein the system further comprises a pusher adapted to deliver the implant from the catheter into the patient'"'"'s lung.

28. The system of claim 27 wherein the pusher is releaseably coupled to the implant device so as to allow the implant to be retrieved into the delivery lumen of the catheter so as to allow retrieval of the implant after the implant has been pushed out of the delivery lumen and into the airway.

29. The system of claim 7 wherein the system further comprises a recapture device to remove the implant from a patient'"'"'s lung.

30. The system of claim 29 wherein the recapture device can be coupled to the proximal end of the implant and is configured to operate within the retrieval catheter or bronchoscope working channel.

31. The system of claim 7 wherein the system further comprises:

a resilient wire receivable within the delivery catheter, wherein the resilient wire is configured to guide the catheter distally of the bronchoscope within the airway.

32. The system of claim 7 wherein an arc length of the implant remains constant as the implant is reshaped.

33. The system of claim 7 wherein the implant further comprising rounded structures at the proximal end and at the distal end of the elongate body so as to inhibit trauma to the airway at the distal and proximal ends of the implant.

34. The system of claim 7 wherein the implant comprises a central wire that spans the length of the implant.

35. The system of claim 34 wherein the central wire is wrapped by a wire frame or covering that is configured to contact lung tissue.

36. A device for use in a system and for treating a patient having a lung with an airway lumen, the airway lumen having an airway path prior to treatment, the system including a bronchoscope having a working channel and a scope for viewing within the airway, the device comprising:

an elongate body having a proximal end and a distal end, the elongate body having a delivery configuration and a deployed configuration, the elongate body in the delivery configuration extending relatively straight along an axis and being adapted to be inserted within the working channel of the bronchoscope and advanced into the airway a lumen adjacent a region of lung tissue targeted for compression so as to extend along the airway path, the device configured for deployment from the delivery configuration to the deployed configuration within the airway lumen, the deployed configuration being more curved than the delivery configuration so that the elongate body, after deployment, bends the airway lumen away from the axis between the proximal and distal ends and locally compresses the region of lung tissue.

37. The device of claim 36, wherein the device is configured to reshape the region of lung tissue while allowing fluid to flow along the airway lumen in both directions past the device.

38. The device of claim 36, wherein the device is configured to be reshaped to a shape that is not axi-symmetric to bend the region of lung tissue.