Lung volume reduction devices, methods, and systems

• US 10,226,257 B2
• Filed: 06/24/2016
• Issued: 03/12/2019
• Est. Priority Date: 03/13/2006
• Status: Expired due to Fees

• Current Assignee: Ekos LLC (Boston Scientific Corporation)
• Original Assignee: PneumRx, Inc. (Boston Scientific Corporation)
• Inventors: Mathis, Mark L., Thompson, David, Aronson, Nathan, Wu, Patrick
• Primary Examiner(s): Anderson, Gregory
• Application Number:
  US15/192,142
• Publication Number:
  US 20170027585A1
• Time in Patent Office: 991 Days
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• 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 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/043 Bronchi
• 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 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2205/0266 Shape memory materials

Abstract

The invention provides improved medical devices, therapeutic treatment systems, and treatment methods for treatment of the lung. A lung volume reduction system includes an implantable device having an elongate body that is sized and shaped for delivery via the airway system to a lung airway of a patient. The implant is inserted and positioned while the implant is in a delivery configuration, and is reconfigured to a deployed configuration so as to locally compress adjacent tissue of the lung, with portions of the elongate body generally moving laterally within the airway so as to laterally compress lung tissue. A plurality of such implants will often be used to treat a lung of a patient.

Claims

1. A method of treating a lung of a patient having a lung with an airway, the method comprising:

delivering a lung volume reduction implant through the airway of the lung in a delivery catheter, the lung volume reduction implant having an elongate body with a proximal portion defining a first local axis and a distal portion defining a second local axis, the lung volume reduction implant comprising a resilient material configured to naturally return the lung volume reduction implant to a desired configuration from a delivery configuration, wherein the lung volume reduction implant is elastically strained into the delivery configuration in the delivery catheter during delivery of the lung volume reduction implant through the airway of the lung;

deploying the lung volume reduction implant in the lung by advancing the proximal portion of the lung volume reduction implant distally relative to the delivery catheter and distal to a distal end of the delivery catheter; and

wherein the lung volume reduction implant naturally recoils from the delivery configuration toward the desired configuration during the deployment process such that the distal portion is urged laterally relative to the second local axis against a surrounding inner luminal surface of the airway and such that the proximal portion is urged laterally relative to the first local axis against a surrounding inner luminal surface of the airway; and

wherein the deployed lung volume reduction implant reduces a volume of the lung and compresses lung tissue between the proximal portion and the distal portion of the elongate body.

2. The method of claim 1, wherein the lung volume reduction implant comprises an elongate body, the body having a distal end and a proximal end, and wherein the elongate body comprises an atraumatic tip at the distal and proximal ends.

3. The method of claim 2, wherein a load bearing structure extends around the elongate body of the lung volume reduction implant to increase a bearing area of the implant that is applied to a tissue of the lung.

4. The method of claim 3, wherein the load bearing structure comprises any combination of a main wire, a wire frame, a covering, and/or a tube.

5. The method of claim 4, wherein the load bearing structure comprises a wire frame coiled about the elongate body.

6. The method of claim 5, wherein the lung volume reduction implant is configured to possess more than 0.000001 square inches of surface area per linear inch of the length of the implant.

7. The method of claim 5, wherein the wire frame is coated with urethane.

8. The method of claim 4, wherein the load bearing structure comprises a polymeric covering.

9. The method of claim 4, wherein the covering is chosen from the group consisting of biocompatible plastic, thermoplastic, fluoropolymer, Teflon®

, urethane, metal mesh, and silicone.

10. The method of claim 9, wherein the covering is urethane.

11. The method of claim 9, wherein the covering comprises a first end and a second end, and wherein each end is open so as to allow a user to flush antibiotics into and out of the covering.

12. The method of claim 4, wherein the load bearing structure comprises a tube, the tube having a plurality of slots separated by a distance so as to allow preferential bending of the tube where the slots are oriented.

13. The method of claim 12, wherein the location, depth, and/or orientation of the plurality of slots provide different operational effects and configurations of the lung volume reduction implant when deployed.

14. The method of claim 12, wherein the tube comprises a metallic substance or a polymeric substance.

15. The method of claim. 3, wherein the load bearing structure is joined to the atraumatic tips of the elongate body of the lung volume reduction implant.

16. The method of claim 3, wherein increasing the bearing area of the lung volume reduction implant reduces the pressure born by a tissue of the lung.

17. The method of claim 3, wherein increasing the bearing area of the lung volume reduction implant reduces the propensity for the lung volume reduction implant to pierce through the tissue of the lung.

18. The method of claim 3, wherein increasing the bearing area of the lung volume reduction implant reduces the potential for inflammation of the tissue of the lung.

19. A device for deployment in an airway of a lung to treat the lung, the airway having an airway axis, the device comprising:

an elongate body with a proximal portion and a distal portion;

the elongate body configured to be delivered in a delivery catheter in a substantially straight delivery configuration and configured to be deployed from the delivery catheter to a deployed configuration;

at least one anchor disposed along the elongate body and comprised of a shape memory material;

wherein the at least one anchor self-expands away from the elongate body when the delivery catheter is retracted about the anchor such that the at least one anchor engages the lung; and

wherein, when the elongate body is in the deployed configuration within the airway of the lung, the distal portion of the elongate body is urged laterally relative to the airway axis against a surrounding inner luminal surface of the airway and the proximal portion is urged laterally relative to the airway axis against a surrounding inner luminal surface of the airway; and

lung tissue disposed between the proximal portion and the distal portion of the elongate body is compressed.

20. The device of claim 19, wherein the at least one anchor is configured to extend away from the elongate body at a predetermined angle.

21. The device of claim 20, wherein the predetermined angle is 10 degrees.

22. The device of claim 19, wherein the at least one anchor engages the lung via friction.

23. The device of claim 19, wherein the at least one anchor is configured to extend through the airway.