Antiproliferative devices for maintaining patency of surgically created channels in a body organ

• US 7,462,162 B2
• Filed: 07/19/2004
• Issued: 12/09/2008
• Est. Priority Date: 09/04/2001
• Status: Expired due to Fees

• Current Assignee: Broncus Medical Incorporated
• Original Assignee: Broncus Technologies, Inc
• Inventors: Roschak, Ed, Phan, Loc
• Primary Examiner(s): Deak; Leslie R
• Assistant Examiner(s): WIEST, PHILIP R
• Application Number:
  US10/895,010
• Publication Number:
  US 20050043752A1
• Time in Patent Office: 1,604 Days
• Field of Search: 604 8- 10, 604 401- 616, 623 11- 242, 623/11.11, 623 2364- 2371, 606/153, 606/109, 606/185, 606/195, 606/155
• US Class Current: 604/8
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• 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 17/12104 in an air passage
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector

Abstract

This is directed to methods and devices suited for maintaining an opening in a wall of a body organ for an extended period. More particularly devices and methods are directed maintaining patency of channels that alter gaseous flow within a lung to improve the expiration cycle of, for instance, an individual having chronic obstructive pulmonary disease.

Claims

1. An implant configured for maintaining an artificial opening in a wall of an airway, the implant comprising:

a support member having a proximal portion, a mid portion, a distal portion, and an interior passage extending therethrough, where the proximal, and distal portions are all expandable and the proximal and distal portions are expandable to a greater size than the mid portion, where the mid portion includes a plurality of members forming a mesh having a plurality of interstices and wherein the proximal and distal portions are expandable such that the support member forms a grommet shape and secures the support member about a perimeter of the artificial opening in the airway wall; and

a means for maintaining patency of the artificial opening in the airway wall at 12 weeks following deployment of the implant in the artificial opening in the airway wall.

2. The implant of claim 1. where said means for maintaining patency of the artificial opening in the airway wall includes a composition. and where said composition comprises an antiproliferative agent and a polymer.

3. The implant of claim 2, where the composition comprises an amount of antiproliferative agent that does not exhibit substantial cytotoxicity but controls the healing response by suppressing hyperplasia of lung tissue, to maintain patency of an artificial opening located in the airway which allows for maintaining air passage between the opening and parenchyma for a sufficient time until the healing response of the lung tissue subsides such that the opening essentially becomes a natural airway passage.

4. The implant of claim 2, where the composition comprises both a release rate and an amount of antiproliferative substance sufficient to modify a healing response of the airway wall resulting from creation of the opening.

5. The implant of claim 2, where the polymer is selected from a group consisting of thermoplastic polymers, thermoset polymers, acrylate polymers, a blend of acrylate-methacrylate polymers, silicone elastomers, urethane elastomers, ethylene vinyl acetate polymers, polyethylene, polypropylene, PLA-PGA, PLA, PGA. polyortho-ester, polycapralactone, polyester, hydrogels, polystyrene, co-polymers of styrene-isobutylene-styrene, and combinations or blends thereof.

6. The conduit of claim 2, further comprising a dye located in the polymer to aid in identification of the implant during placement.

7. The implant of claim 2, where the composition fully covers an outer surface of the support member.

8. The implant of claim 7, where the polymer fully encapsulates an interior surface of the support member.

9. The implant of claim 2, where the support member comprises a second polymeric material.

10. The implant of claim 9, where the polymer and second polymeric material are bioabsorbable.

11. The implant of claim 1, where the support structure has at least one pocket where the antiproliferative substance is located in the pocket, and further comprising a polymer at least covering the pocket to act as a baffler to release.

12. The implant of claim 1. where the support member comprises a metallic material.

13. The implant of claim 1, further comprising folded control members disposed within said interstices of the mid portion, and where the folded control members form a shape selected from a group consisting of an s-shape, a u-shape, and a sinusoidal shape.

14. The implant of claim 2, where the antiproliferative agent comprises a microtubule stabilizing agent.

15. The implant of claim 14, where the microtubule stabilizing agent is paclitaxel.

16. The implant of claim 2, where the antiproliferative agent comprises a microtubule destabilizing agent.

17. The implant of claim 16, where the microtubule destabilizing agent is selected from the group comprising vincristine, vinblastine, podophylotoxin, estramustine, noscapine, griseofulvin, dicoumarol, a vinca alkaloid, and a combination thereof.

18. The implant of claim 2, where the antiproliferative agent comprises a substance selected from the group consisting of steroids, non-steroidal anti-inflammatories, and d-actinomycin, and a combination thereof.

19. The implant of claim 2, where the antiproliferative agent comprises a cytostatic agent.

20. The implant of claim 19, where the cytostatic agent is selected from the group consisting of:

sirolimus, everolimus, ABT-578, biolimus, tacrolimus, and a combination thereof.

21. The implant of claim 1, further comprising a mucus affecting substance.

22. The implant of claim 21, where the mucus affecting substance is selected from a group consisting of mucolytics, rhDnase. and a combination thereof.

23. The implant of claim 1, further comprising at least one visualization mark disposed on a portion of the support member.

24. The implant of claim 23, where the visualization mark comprises a stripe circumferentially disposed about at least a portion the support member.

25. The implant of claim 1, further comprising a one-way valve in fluid communication with the interior passage.

26. The implant of claim 1, further comprising an antibiotic substance carried on or within the support member.

27. The implant of claim 1, further comprising a barrier located within the support member.

28. The implant of claim 1, further comprising a fibrin reducing substance.

29. The implant of claim 28, where the fibrin reducing substance is selected from a group consisting of streptokinase, urokinase, and tissue plasminogen activator.

30. An implant configured for maintaining an artificial opening in a wall of an airway, the implant comprising:

a support member having a proximal portion, a mid portion, a distal portion, and an interior passage extending therethrough, where the proximal, and distal portions are all expandable and the proximal and distal portions are expandable to a greater size than the mid portion, such that the support member forms a grommet shape and secures the support member about a perimeter of the artificial opening in the airway wall; and

a composition located on the support member, where the composition comprises approximately 400 micrograms of paclitaxel.

31. The implant of claim 30, where said composition comprises a polymer, and said composition has a ratio of paclitaxel to polymer of about 9%.

32. The implant of claim 30, where the implant comprises a size and amount of composition to maintain patency of the artificial opening in the airway wall at about 18 weeks following deployment of the implant in the artificial opening in the airway wall.