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

• US 7,708,712 B2
• Filed: 07/19/2004
• Issued: 05/04/2010
• 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): MARCETICH, ADAM M
• Application Number:
  US10/894,647
• Publication Number:
  US 20050043751A1
• Time in Patent Office: 2,115 Days
• Field of Search: 604/8, 128/898, 623/23.65, 623/23.64, 623/26.4, 623/23.7, 623/1.12, 623/1.15, 623/1.2, 623/1.3, 623/1.31, 623/1.32, 623/1.33, 623/1.34, 623/1.42, 623/1.43
• 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 for maintaining an opening in a wall of an airway in a lung, the implant having a delivery state and an expanded state, the implant comprising:

a support member, said support member comprising a first portion having an axial length, where at least the first portion of the support member comprises a plurality of control segments folded in a curvilinear shape, each control segment forming a portion of a circumference of said support member such that collectively, the plurality of control segments span the entire circumference of the first portion of the support member, and wherein each of the control segments are circumferentially adjacent to another control segment, and where upon in the expanded state the control segments each unfold and become substantially aligned about the circumference of the support member to limit radial expansion of the first portion of the support member, and where upon, the axial length of the first portion in the expanded state is less than the axial length of the first portion in the delivery state such that the axial length decreases when expanded, and where the support member has at least a second portion unconstrained to expand beyond the first portion such that upon expansion the support member is non-cylindrical, and the support member further comprises a third portion on an end of the support member opposite to that of the second portion, the third portion being unconstrained to expand beyond the first portion, such that upon expansion the support member forms a grommet shape adapted to apply pressure to opposite sides of the wall the airway, wherein the second portion and the third portion are configured to surround the wall of the airway to secure the implant in the opening in the wall of the airway; and

a composition located on the support member and comprising an antiproliferative agent, where the composition comprises an antiproliferative agent that maintains patency of an artificial opening located in the airway.

2. The implant of claim 1, where the curvilinear shape is selected from a group consisting of an s-shape, a v-shape, a u-shape, and a sinusoidal shape.

3. The implant of claim 1, where the composition further comprises a polymer.

4. The implant of claim 3, where the composition comprises both a release rate and an amount of the antiproliferative substance sufficient to modify a healing response of the wall of the lung resulting from creation of the opening.

5. The implant of claim 3, 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 implant of claim 3, where the composition fully covers an outer surface of the support member.

7. The implant of claim 1, where the support member has at least one pocket where the antiproliferative agent is located in the pocket, and further comprising a polymer at least covering the pocket to act as a barrier to release.

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

9. The implant of claim 1, where the support member comprises a plurality of members forming a mesh having a plurality of interstices.

10. The implant of claim 1, where the antiproliferative agent comprises a microtubule stabilizing agent.

11. The implant of claim 10, where the microtubule stabilizing agent is paclitaxel.

12. The implant of claim 1, where the antiproliferative agent comprises a microtubule destabilizing agent.

13. The implant of claim 12, where the microtubule destabilizing agent is selected from the group comprising vincristine, vinblastine, podophylotoxin, estramustine, noscapine, griseofulvine, dicoumarol, a vinca alkaloid, and a combination thereof.

14. The implant of claim 1, 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.

15. The implant of claim 1, where the antiproliferative agent comprises a cytostatic agent.

16. The implant of claim 15, where the cytostatic agent is selected from the group consisting of:

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

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

18. The implant of claim 17, where the mucus affecting substance is selected from a group consisting of mucolytics, pulmozyme, and a combination thereof.

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

20. The implant of claim 19, where the fibrin reducing substance is selected from a group consisting of streptokinase, urokinase, and tissue plasminogen activator.

21. The implant of claim 1, where in the expanded state the first portion has a length of between 0.5 mm to 2.5 mm.

22. The implant of claim 1, where the composition comprises a 9% ratio of antiproliferative agent.

23. The implant of claim 1, where composition comprises 400 micrograms of antiproliferative agent per implant.

24. The implant of claim 1, where the composition comprises an amount of the antiproliferative agent that does not exhibit substantial cytotoxicity but controls the healing response by suppressing hyperplasia of lung tissue, to maintain the patency of the artificial opening 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.

25. An implant for maintaining an opening in a wall of an airway in a lung, the implant having a delivery state and an expanded state, the implant comprising:

a support member where at least a first portion of the support member includes a plurality of pairs of control segments located circumferentially about the support member, each of the pair being folded in a curvilinear shape, each control segment being located circumferentially adjacent to another control segment so that the plurality of control segments are located about a circumference of the support member, and where upon expanding into the expanded state each pair of the plurality of control segments unfolds to a substantially straight shape and become substantially aligned about he circumference of the support member to limit radial expansion of the first portion of the support member such that an expanded size of the center section is limited by the plurality of unfolded control segments, where the support member has at least a second portion unconstrained to expand beyond the first portion such that in the expanded state the support member is non-cylindrical, and wherein said second portion comprises a plurality of deflecting petal members such that each of said control segments has a corresponding petal member, and the support member further comprises a third portion on an end of the support member opposite to that of the second portion, the third portion comprising a plurality of deflecting petal members and the third portion being unconstrained to expand beyond the first portion, such that upon expansion the support member applies pressure to opposite sides of the wall the airway, wherein the second portion and the third portion are configured to surround the wall of the airway to secure the implant in the opening in the wall of the airway; and

a composition located on the support member and comprising an antiproliferative agent.

26. An implant for maintaining an opening in a wall of an airway in a lung, the implant having a delivery state and an expanded state, the implant comprising:

a support member comprising a first portion, a second portion, and a radially expandable center portion, wherein said center portion comprise a plurality of diametrical control means for limiting the radial expansion of the center portion to an expanded diameter, where the plurality of diametrical control means are located circumferentially adjacent to each other so that the plurality of diametrical control means are located about a circumference of the support member; and

a composition located on the support member and comprising an antiproliferative agent, wherein said implant shrinks in axial length when expanded such that the expanded diameter of the center section is greater or equal to the axial length of the implant.

27. The implant of claim 26, where the plurality of diametrical control means is configured such that upon application of an expansion force at least one diametrical control means expands to a substantially straight configuration and causes the expansion force to be applied to another diametrical control means.