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

• US 20050060044A1
• Filed: 07/19/2004
• Published: 03/17/2005
• Est. Priority Date: 08/05/1999
• Status: Abandoned Application

• Current Assignee: Broncus Technologies, Inc
• Original Assignee: Broncus Technologies, Inc
• Inventors: Massetti, Patrick John, Roschak, Ed, Phan, Loc
• Application Number:
  US10/895,256
• Publication Number:
  US 20050060044A1
• Time in Patent Office: Days
• US Class Current: 623/23.650
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00106 ultrasonic
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00541 : Lung or bronchi
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1437 : whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/08021 : of the patient or his organs
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/395 : with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 5/489 : Blood vessels
• CPC Class Codes: A61B 8/06 : Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61F 2/02 : Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/20 : Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith tracheae, bronchi per se A61F2/04 ; tracheostomy tubes A61M16/0465
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 : Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 : made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/92 : Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2002/043 : Bronchi
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/8483 : Barbs
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61N 2007/0078 : with multiple treatment transducers

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 comprising:

a support member; and

an antiproliferative substance carried by the support member and having an amount that does not exhibit substantial cytotoxicity but controls the healing response by suppressing hyperplasia of lung tissue, to maintain patency of an artificial opening 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.

2. The implant of claim 1, comprising an amount of antiproliferative substance carried by the support member where the support member releases the antiproliferative substance at a pre-determined release rate, where the amount of antiproliferative substance and the release rate are sufficient to modify a healing response of the airway wall resulting from creation of the opening.

3. The implant of claim 1, where the support member is constructed from a polymer.

4. 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.

5. The implant of claim 1, where the antiproliferative substance is carried within a polymeric material.

6. The implant of claim 1, where support member further includes distal and proximal wall retaining members and where the distal and proximal wall retaining members are tapered and have a slope that increases towards the mid-portion.

7. The implant of claim 3, where the polymeric material comprises a bioabsorbable material

8. The implant of claim 1, where support member comprises a metallic frame having a polymer attached thereto.

9. The implant of claim 8, where the polymer fully encapsulates an interior surface of the frame.

10. The implant of claim 1, where the support member is non-expandable.

11. The implant of claim 1, where the distal portion and proximal portions are expandable to a greater diameter than the mid portion.

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

13. The implant of claim 12, where the distal portion and proximal portion have a greater diameter than the mid portion.

14. The implant of claim 1, where the distal and proximal portions have a distal and proximal end respectively, where the distal and proximal ends are blunt or rounded.

15. The implant of claim 1, where the support member 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 barrier to release.

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

17. The implant of claim 16, where the microtubule stabilizing agent is paclitaxel, taxotere, epothilone-B.

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

19. The implant of claim 18, 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.

20. The implant of claim 1, where the antiproliferative substance comprises a substance selected from the group consisting of steroids, non-steroidal anti-inflammatories, and d-actinomycin.

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

22. The implant of claim 21, where the cytostatic agent is selected from the group consisting of:

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

23. The implant of claim 1, further including a mucus affecting substance.

24. The implant of claim 23, where the mucus affecting substance is selected from a group consisting of mucolytics, pulmozyme, and a combination thereof.

25. The implant of claim 1, where the antiproliferative substance comprises a fibrinolytic.

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

27. The implant of claim 26, where the visualization mark comprises a stripe circumferentially disposed about at least a portion the support member.

28. The implant of claim 1, further comprising a valve in fluid communication with the passageway.

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

59. The implant of claim 1, where the support member comprises a sheet having an opening therein.

60. The implant of claim 59, where the support member further comprises a plurality of wall retention members each individually formed from sections of the sheet.

61. The implant of claim 60, where the wall retention members are elastic such that after deformation away from a plane of the sheet, the wall retention members return to the plane of the sheet.

30. An implant for maintaining an opening in an airway wall comprising:

a non-expandable conduit having a first and second ends and a body therebetween, the conduit also comprising a passageway extending between the first and second ends;

at least two wall retaining portions on an exterior surface of the conduit and separated by a first body section, where the wall retaining portions have a diameter greater than the first body section;

a first bio-active material carried by at least the first body section.

31. The implant of claim 30, further comprising a second body section extending away from a first end of the body, where at least one wall retaining portion is located between the first and second body sections.

32. The implant of claim 30, wherein at least one of the wall retaining portions is located near the first end and is tapered in an increasing direction away from the first end.

33. The implant of claim 30, wherein at least a second wall retaining portions is located near the second end and is tapered in an increasing direction away from the second end.

34. The implant of claim 30, further comprising a one way valve.

35. The implant of claim 30, where the non-expandable conduit is constructed from a polymer.

36. The implant of claim 35, 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.

37. The implant of claim 30, where the antiproliferative substance is carried within a polymeric material.

38. The implant of claim 37, where the polymeric material comprises a bioabsorbable material

39. The implant of claim 30, where the non-expandable conduit comprises a metallic frame having a polymer attached thereto.

40. The implant of claim 39, where the polymer fully encapsulates an interior surface of the frame.

41. The implant of claim 30, where the non-expandable conduit comprises a ceramic material.

42. The implant of claim 41, where the first and second body ends have a greater diameter than the mid portion.

43. The implant of claim 30, where the first and second body ends have a distal and proximal end respectively, where the distal and proximal ends are blunt or rounded.

44. The implant of claim 30, where the antiproliferative substance comprises a microtubule stabilizing agent.

45. The implant of claim 44, where the microtubule stabilizing agent is paclitaxel, taxotere, epothilone-B.

46. The implant of claim 30, where the antiproliferative substance comprises a microtubule destabilizing agent.

47. The implant of claim 46, 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.

48. The implant of claim 30, where the antiproliferative substance comprises a substance selected from the group consisting of steroids, non-steroidal anti-inflammatories, and d-actinomycin.

49. The implant of claim 30, where the antiproliferative substance comprises a cytostatic agent.

50. The implant of claim 49, where the cytostatic agent is selected from the group consisting of:

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

51. The implant of claim 30, further including a mucus affecting substance.

53. The implant of claim 30, where the antiproliferative substance comprises a fibrinolytic.

54. The implant of claim 30, further comprising at least one visualization mark disposed on a portion of the non-expandable conduit.

55. The implant of claim 30, where the visualization mark comprises a stripe circumferentially disposed about at least a portion the support member.

56. The implant of claim 30, further comprising a valve in fluid communication with the passageway.

57. The implant of claim 30, further comprising an antibiotic substance carried on or within the support member.

52. The implant of claim 52, where the mucus affecting substance is selected from a group consisting of mucolytics, pulmozyme, and a combination thereof.

58. An implant for maintaining an opening in a wall of an airway, the implant comprising

a support member having a proximal portion, a distal portion, a mid portion and an interior passage extending therethrough;

an amount of antiproliferative substance carried by the support member where the support member releases the antiproliferative substance at a pre-determined release rate, where the amount of antiproliferative substance and the release rate are sufficient to modify a healing response of the airway wall resulting from creation of the opening.