Cross-sectional modification during deployment of an elongate lung volume reduction device

• US 8,721,734 B2
• Filed: 05/18/2010
• Issued: 05/13/2014
• Est. Priority Date: 05/18/2009
• Status: Expired due to Fees

• Current Assignee: EKOS Corporation (Boston Scientific Corporation)
• Original Assignee: PneumRx, Inc. (Boston Scientific Corporation)
• Inventors: Mathis, Mark L., Wu, Patrick, Lehrberg, David, Vasquez, Jaime, McGurk, Erin, Dieck, Ronald, Stein, Andrew
• Primary Examiner(s): McEvoy, Thomas
• Assistant Examiner(s): SZPIRA, JULIE ANN
• Application Number:
  US12/782,515
• Publication Number:
  US 20100305715A1
• Time in Patent Office: 1,456 Days
• Field of Search: 623/23.65, 128/898, 128/207.15, 606/139, 606/213, 604/508, 604/509
• US Class Current: 623/23.65
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• 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 17/1214 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 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• 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

Abstract

Elongate implant structures can be introduced into an airway system to a target airway axial region, often to apply lateral bending and/or compression forces against the lung tissue from within the airways for an extended period of time. Structures or features of the implants may inhibit tissue reactions that might otherwise allow portions of the device to eventually traverse through the wall of the airway. The devices may enhance the area bearing laterally on the tissue of a surrounding airway lumen wall. Embodiments may have features which increase the device friction with the airway to allow the device to grip the surrounding airway as the device is deployed. An appropriate adhesive may be introduced around the device in the lung. Hydrophilic material may inhibit biofilm formation, or features which induce some tissue ingrowth (stimulation of tissue growth) may enhance implanted device supported.

Claims

1. A method for treating a lung of a patient, the lung including an airway system having an airway axis and a plurality of branching airways, the method comprising:

advancing an implant distally into the airway system while the implant is in a delivery configuration, the implant having an elongate length defining an axis and a lateral bearing surface transverse to the axis, the lateral bearing surface of the implant having a bearing surface area when the implant is in the delivery configuration; and

deploying the implant within the airway by;

expanding the lateral bearing surface laterally from the axis of the implant and within the airway so as to increase the bearing surface area of the lateral bearing surface; and

bending the implant within the airway such that the implant bends the airway axis and locally compresses lung tissue along the implant by bearing laterally against a luminal surface of the airway so that tension in other lung tissue of the patient is increased to enhance lung function, and

limiting penetration of the implant through the luminal surface of the airway using the increased airway bearing surface area by performing the bending of the airway axis using engagement of the expanded lateral bearing surface against the luminal surface;

wherein the expanding of the lateral bearing surface further comprises resilient lateral expansion, the lateral bearing surface being laterally constrained within a lumen of a delivery catheter during advancing of the implant into the airway system and the catheter being withdrawn proximally during expanding of the lateral bearing surface.

2. The method of claim 1, wherein bending the implant within the airways further comprises bending a first axial airway region toward a second axial airway region so as to compress the lung tissues between the first and second axial airway regions, the first and second axial airway regions surrounding a first axial portion of the implant and a second axial portion of the implant offset along the axis.

3. The method of claim 1, wherein the compressing of the lung tissue is effected by resilient bending of the implant toward a relaxed configuration, the delivery catheter constraining the axis of the implant toward a sufficiently straight configuration to facilitate advancing the implant into the airway system.

4. The method of claim 1, wherein the lateral bearing surface comprises a laterally bent or rolled sheet material when the implant is in the delivery configuration and wherein lateral expanding of the lateral bearing surface comprises laterally flattening or unrolling of the sheet material, the flattened or unrolled sheet material having first and second opposed major surfaces.

5. The method of claim 1, wherein the lateral bearing surface comprises a radially expandable structure, the implant extending axially along the radially expandable structure and wherein expanding of the expandable lateral bearing surface comprises radial expansion of the radially expandable structure while allowing airflow distal to the deployed implant.

6. The method of claim 5, wherein the radially expandable structure comprises struts defined between cuts or slots along a tube, the struts laterally separating during radial expansion.

7. The method of claim 5, wherein the radially expandable structure comprises a braided sleeve, the braided sleeve shortening axially during radial expansion.

8. The method of claim 1, wherein the lateral bearing surface comprises at least one wire or filament extending along a shaft of the implant when the implant is in the delivery configuration, and wherein the lateral expanding of the expandable lateral bearing surface comprises bending the at least one wire or filament from the axis of the implant.

9. The method of claim 1, wherein the expanding of the lateral bearing surface further comprises laterally expanding a plurality of protrusions separated along the axis, with narrowed regions between the protrusions, the narrowed regions facilitating the axial bending.

10. The method of claim 9, wherein the plurality of protrusions axially grab tissues during deployment while permitting airflow past the deployed implant.

11. A method for treating a lung of a patient, the lung including an airway system having a plurality of branching airways, the method comprising:

advancing an implant distally into the airway system while the implant is in a delivery configuration, the implant having a proximal end, a distal end, and an elongate length defining an axis therebetween, the implant having a lateral bearing surface transverse to the axis;

deploying the implant within the airway system by;

expanding the lateral bearing surface from the axis within the airway system to increase an airway bearing surface area of the lateral bearing surface, wherein an interface between the expanded bearing surface of the deployed implant and the airway is hydrophilic and/or locally enhanced along the axis of the implant so as to limit damage to the airway during long-term implantation; and

axially bending the implant so that the implant bends a first axial airway region toward a second axial airway region and locally compresses lung tissues between the first and second axial airway regions so that tension in other lung tissue of the patient is increased sufficiently to enhance lung function;

wherein the expanding of the lateral bearing surface further comprises resilient lateral expansion, the lateral bearing surface being laterally constrained within a lumen of a delivery catheter during advancing of the implant into the airway system and the catheter being withdrawn proximally during expanding of the lateral bearing surface.

12. The method of claim 11, wherein deploying the implant within the implant system further comprises introducing adhesive around the implant so that the adhesive inhibits penetration of the implant through an airway wall.

13. The method of claim 11, wherein the expandable lateral bearing surface of the implant comprises a polymer material, the polymer material sufficiently hydrophilic for biofilm formation inhibition when the implant is disposed in the lung.

14. The method of claim 11, wherein the implant comprises a resilient metal shaft disposed within a sleeve of the polymer material, the sleeve comprising a polycarbonate-polyurethane copolymer.

15. The method of claim 11, wherein the expanding of the lateral bearing surface further comprises laterally expanding a plurality of protrusions separated along the axis, with narrowed regions between the protrusions, the narrowed regions facilitating the axial bending.

16. The method of claim 15, wherein the plurality of protrusions axially grab tissues during deployment while permitting airflow past the deployed implant.