Cross-Sectional Modification During Deployment of an Elongate Lung Volume Reduction Device

• US 20100305715A1
• Filed: 05/18/2010
• Published: 12/02/2010
• Est. Priority Date: 05/18/2009
• Status: Active Grant

• Current Assignee: Ekos LLC (Boston Scientific Corporation)
• Original Assignee: PneumRx, Inc. (Boston Scientific Corporation)
• Inventors: Dieck, Ronald, Stein, Andrew, McGurk, Erin, Mathis, Mark L., Wu, Patrick, Vasquez, Jaime, Lehrberg, David
• Granted Patent: US 8,721,734 B2
• Time in Patent Office: Days
• 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
• 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 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 with a lateral profile having a lateral bearing surface transverse to the axis;

deploying the implant within the airway such that the implant expands laterally from the axis of the implant so as to increase the lateral bearing surface;

locally compressing lung tissue along the implant by bearing laterally against a luminal surface of the airways with the expanded bearing surface of the implant so that the expansion inhibits penetration of the implant through the airway, and so that tension in other lung tissue of the patient is increased sufficiently to enhance lung function.

2. The method of claim 1, wherein deploying the implant within the implant system comprising bending the implant within the airways so that the implant bends 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 lateral expanding of the implant comprises resilient lateral expansion, the implant 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 deploying of the implant.

4. The method of claim 3, 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.

5. The method of claim 3, wherein the implant comprises a laterally bent or rolled sheet material when the implant is in the delivery configuration and wherein lateral expanding of the implant comprises laterally flattening or unrolling of the sheet material, the flattened or unrolled sheet material having first and second opposed major surfaces and the bearing surface comprising at least a portion of the first major surface.

6. The method of claim 3, wherein the lateral expanding of the implant comprises radial expansion of a radially expandable structure, the implant comprising the radially expandable structure and a shaft extending axially along the radially expandable structure, the radially expandable structure defining the bearing surface and being urged laterally by the shaft so as to effect compression of the lung tissue.

7. The method of claim 6, wherein the radial expansion of the implant body comprises lateral separation of struts defined between cuts or slots along a tube, the tube defining the radially expandable body.

8. The method of claim 6, wherein the radial expansion of the implant body comprises radial expansion of a braided sleeve, the braided sleeve defining the radially expandable body and shortening axially during radial expansion.

9. The method of claim 3, wherein the lateral expanding of the implant comprises bending of at least one wire or filament from an axial configuration extending along a shaft of the implant in the delivery configuration, the at least one wire or filament defining the bearing surface and being urged laterally by the shaft so as to effect compression of the lung tissue.

10. 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 axially bending the implant so that the lateral bearing surface of 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, wherein an interface between the bearing surface of the deployed implant and the airway is hydrophilic and/or locally enhanced along the axis of the implant so as to inhibit damage to the airway during long-term implantation so that tension in other lung tissue of the patient is increased sufficiently to enhance lung function.

11. The method of claim 10, wherein deploying the implant within the implant system comprises introducing adhesive around the implant so that the adhesive inhibits penetration of the implant through an airway wall.

12. The method of claim 10, wherein the implant comprises an axial series of plugs or lateral protrusions, wherein the implant bends between the plugs or protrusions and wherein the plugs or protrusions locally inhibit penetration of the implant through an airway wall.

13. The method of claim 10, wherein the 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 10, wherein the implant comprises a resilient metal shaft disposed within a sleeve of the polymer material, the sleeve comprising a polycarbonate-polyurethane copolymer.

15. An implant for treating a lung of a patient, the lung including an airway system having a plurality of branching airways, the implant comprising:

an elongate body having a proximal end and a distal end defining an axis therebetween;

the elongate body having a delivery configuration and a deployed configuration, the elongate body in the delivery configuration having a lateral profile and a lateral bearing surface transverse to the axis, the axis of the elongate body in the delivery configuration being sufficiently straight for advancement distally into the airway system;

the elongate body being deployable from the delivery configuration to the deployed configuration within the airway system such that the implant expands laterally from the axis of the implant to increase the lateral bearing surface, deployment of the elongate body within the airway effecting bending of the elongate body so that the bearing surface bears laterally against a luminal surface of the airways from within the airway system sufficiently to bend the airway while the expanded bearing surface of the implant inhibits penetration of the implant through the airway, and sufficient that local compression of lung tissue enhances tension in other lung tissue of the patient sufficiently to enhance lung function of the patient.

16. The implant of claim 15, wherein deploying the implant within the implant system comprising bending the implant within the airways so that the implant bends 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 when the first and second axial airway regions surround a first axial portion of the implant and a second axial portion of the implant offset along the axis, respectively.

17. The implant of claim 15, wherein the lateral expanding of the implant comprises resilient lateral expansion, further comprising a delivery catheter having a lumen sized for receiving the implant so that the implant is laterally constrained within the lumen of the delivery catheter during to facilitate advancing of the implant into the airway system, and so that withdrawing the catheter proximally from around the implant deploys the implant within the airway system.

18. The implant of claim 17, wherein the implant comprises an axially resilient body so that 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.

19. The implant of claim 17, wherein the implant comprises a laterally bent or rolled sheet material when the implant is in the delivery configuration and wherein lateral expanding of the implant comprises laterally flattening or unrolling of the sheet material, the flattened or unrolled sheet material having first and second opposed major surfaces and the bearing surface comprising at least a portion of the first major surface.

20. The implant of claim 17, wherein the lateral expanding of the implant comprises radial expansion of a radially expandable structure, the implant comprising the radially expandable structure and a shaft extending axially along the radially expandable structure, the radially expandable structure defining the bearing surface and being urged laterally by the shaft during deployment so as to effect compression of the lung tissue.

21. The implant of claim 20, wherein the radial expansion of the implant body comprises lateral separation of struts defined between cuts or slots along a tube, the tube defining the radially expandable body.

22. The implant of claim 20, wherein the radial expansion of the implant body comprises radial expansion of a braided sleeve, the braided sleeve defining the radially expandable body and shortening axially during radial expansion.

23. The implant of claim 17, wherein the lateral expanding of the implant comprises bending of at least one wire or filament from an axial configuration extending along a shaft of the implant in the delivery configuration, the at least one wire or filament defining the bearing surface and being urgable laterally by the shaft so as to effect compression of the lung tissue when the implant is released in the airway system.

24. An implant for treating a lung of a patient, the lung including an airway system having a plurality of branching airways, the implant comprising:

an implant body having a proximal end, a distal end, and an elongate length defining an axis therebetween, the implant body having a lateral bearing surface transverse to the axis, the implant body having a delivery configuration in which the axis of the implant body is sufficiently straight for axial advancement distally into the airway system; and

the implant body deployable from the delivery configuration to a deployed configuration within the airway system by axially bending the implant sufficiently that the lateral bearing surface of the implant bends a first axial airway region toward a second axial airway region and compresses lung tissues between the first and second axial airway regions, wherein an interface between the bearing surface of the deployed implant and the airway is hydrophilic and/or locally expanded along the axis of the implant so as to inhibit damage to the airway during long-term implantation.

25. The implant of claim 24, further comprising an adhesive delivery device in fluid communication with the implant so that the adhesive is deliverable with the implant such that the adhesive inhibits penetration of the implant through an airway wall.

26. The implant of claim 24, wherein the implant comprises an axial series of plugs or lateral protrusions, wherein the implant bends between the plugs or protrusions and wherein the plugs or protrusions locally inhibit penetration of the implant through an airway wall.

27. The implant of claim 24, wherein the 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.

28. The implant of claim 27, wherein the implant comprises a resilient metal shaft disposed within a sleeve of the polymer material, the sleeve comprising a poly carbonate urethane (PCU).

29. A lung volume reduction system comprising an implantable device that imparts a compression force on lung tissue, wherein the implant comprises an elongate implantable spring element having a first configuration and a second configuration, the elongate spring element in the first configuration extending along an axis of the elongate spring sufficiently for axial insertion into an airway system of the lung tissue, the inserted elongate spring element deployable to the second configuration where a first implant portion of the implant engages a first airway axial region of the airway system and a second implant portion of the implant engages a second airway axial region of the airway system, the implant urging the first airway axial region and the second airway axial region toward each other thereby compressing a volume of lung tissue disposed between the first airway axial region and the second airway axial region when the inserted elongate spring element is deployed to the second configuration.

30. The lung volume reduction system of claim 29, wherein the implant further comprises a proximal end extending from the elongate implantable spring element, and wherein the proximal end is not driven into the lung tissue upon implantation of the elongate implantable spring element, so as to facilitate recapture of the implanted elongate implantable spring element.

31. The lung volume reduction system of claim 29, wherein the implant further comprises a covering disposed over at least a portion of the elongate implantable spring element.