Device and method for intra-bronchial provision of a therapeutic agent

• US 20030158515A1
• Filed: 12/11/2002
• Published: 08/21/2003
• Est. Priority Date: 02/21/2002
• Status: Active Grant

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Spiration, Inc. (Olympus Corporation)
• Inventors: DeVore, Lauri J., Gonzalez, Hugo X., Shea, Richard O., Springmeyer, Steven Chase, Wang, John H.
• Granted Patent: US 6,929,637 B2
• Time in Patent Office: Days
• US Class Current: 604/93.01
• 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 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/242 for bronchial passages
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61M 1/79 Filters for solid matter specially adapted for dental use A61C17/065
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2210/1035 Bronchi
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 2005/1021 Radioactive fluid
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy

Abstract

The present invention includes an intra-bronchial device, system, and method for providing a therapeutic agent to a patient. A device includes a flow control member for placement in an air passageway communicating with a lung portion, and when deployed in the air passageway inhibits a therapeutic agent distal of the control member from moving proximal of the control member, and includes the therapeutic agent associated with the flow control member. The control member may inhibit movement of the therapeutic agent by limiting airflow, and may include a one-way valve limiting exhalation of air from the lung portion. The control member may include a flexible membrane impervious to air flow, or a separator arranged to inhibit the movement of the therapeutic agent. The control member may include at least one anchor, and the anchor may be releasable from the air passageway for removal of the intra-bronchial device.

Claims

1. An intra-bronchial device comprising:

a member arranged for placement in an air passageway; and

a therapeutic agent associated with the member and arranged for provision to a patient.

2. The intra-bronchial device of claim 1, wherein the member is further arranged for inhibiting the therapeutic agent from moving proximal of the control member.

3. The intra-bronchial device of claim 1, further including at least one anchor that retains the intra-bronchial device within the air passageway when the anchor is deployed.

4. The intra-bronchial device of claim 3, wherein at least one anchor is releasable from the air passageway for removal of the intra-bronchial device.

5. A assembly comprising:

a therapeutic agent arranged for intra-bronchial delivery into an air passageway of a patient; and

a flow control member arranged for placement in the air passageway and inhibiting the therapeutic agent from moving proximal of the control member.

6. The assembly of claim 5, wherein the flow control member is arranged to allow the therapeutic agent to be associated with the flow control member after the flow control member is placed in the air passageway.

7. The assembly of claim 5, wherein the flow control member is arranged to allow the therapeutic agent to be placed into the air passageway distal of the flow control member after the flow control member is placed in the air passageway.

8. An intra-bronchial device for maintaining a therapeutic agent within an air passageway, the device comprising:

a flow control member arranged for placement in the air passageway and inhibiting the therapeutic agent from moving proximal of the control member; and

the therapeutic agent.

9. The intra-bronchial device of claim 8, wherein the control member inhibits movement of the therapeutic agent by limiting flow from the air passageway.

10. The intra-bronchial device of claim 8, wherein the control member inhibits movement of the therapeutic agent by limiting flow into the air passageway.

11. The intra-bronchial device of claim 8, wherein the control member inhibits the movement of the therapeutic agent by limiting mucociliary transport from the air passageway.

12. The intra-bronchial device of claim 8, wherein the control member includes a one-way valve.

13. The intra-bronchial device of claim 12, wherein the one-way valve permits inhalation of air into the air passageway.

14. The intra-bronchial device of claim 12, wherein the one-way valve permits exhalation of air from the air passageway.

15. The intra-bronchial device of claim 8, wherein the control member includes a flexible membrane impervious to air flow.

16. The intra-bronchial device of claim 15, wherein the flexible membrane is arranged in cooperation with a wall of the air passageway to form a one-way valve permitting airflow from the air passageway.

17. The intra-bronchial device of claim 15, wherein the flexible membrane is arranged in cooperation with a wall of the air passageway to form a one-way valve permitting airflow into the air passageway.

18. The intra-bronchial device of claim 8, wherein the control member includes a separator arranged to inhibit the movement of the therapeutic agent while allowing movement of air.

19. The intra-bronchial device of claim 18, wherein molecules of the therapeutic agent are associated with molecules larger than air molecules, and the separator is arranged to inhibit movement of the associated molecules while allowing movement of air molecules.

20. The intra-bronchial device of claim 8, wherein the control member includes a semi-permeable membrane arranged to retain the therapeutic agent distal of the control member while permitting air and water molecules to be exhaled.

21. The intra-bronchial device of claim 8, wherein the control member limits airflow from the air passageway sufficiently to maintain inflation of a lung portion communicating with the air passageway.

22. The intra-bronchial device of claim 8, wherein the control member allows airflow from the air passageway sufficiently to prevent over-inflation of the lung portion.

23. The intra-bronchial device of claim 8, wherein the control member further includes at least one anchor that retains the intra-bronchial device within the air passageway when the anchor is deployed.

24. The intra-bronchial device of claim 23, wherein at least one anchor is releasable from the air passageway for removal of the intra-bronchial device.

25. The intra-bronchial device of claim 8, wherein the control member is further arranged to automatically terminate the inhibiting of movement by the therapeutic agent.

26. The intra-bronchial device of claim 25, wherein the automatic termination is provided by a deterioration of the control member.

27. The intra-bronchial device of claim 25, wherein the automatic termination is provided by a dissolution of the control member.

28. The intra-bronchial device of claim 8, wherein the control member is further arranged to permit mucociliary transport from the air passageway.

29. The intra-bronchial device of claim 8, wherein the therapeutic agent is associated with at least a portion of the control member.

30. The intra-bronchial device of claim 29, wherein the therapeutic agent overlies at least a portion of the airflow control member.

31. The device of claim 29, wherein the therapeutic agent is imbedded in at least a portion of the airflow control member.

32. The device of claim 29, wherein the therapeutic agent is absorbed in at least a portion of the airflow control member.

33. The device of claim 29, wherein the therapeutic agent is co-mixed with at least a portion of the airflow control member.

34. The device of claim 29, wherein the control member further includes an absorptive member and the therapeutic agent is absorbed by the absorptive member.

35. The device of claim 8, wherein control member includes a cavity, and the therapeutic agent is carried in the cavity.

36. The device of claim 35, wherein the cavity includes an absorptive member, and the therapeutic agent is absorbed by the absorptive member.

37. The device of claim 35, wherein the cavity includes a cover having an orifice.

38. The device of claim 8, wherein the therapeutic agent is one of antimicrobial agents such as adrenergic agents, antibiotic agents or antibacterial agents, antiviral agents, anthelmintic agents, anti-inflammatory agents, antineoplastic agents, antioxidant agents, biological reaction inhibitors, botulinum toxin agents, chemotherapy agents, diagnostic agents, gene therapy agents, hormonal agents, mucolytic agents, radioprotective agents, radioactive agents including brachytherapy materials, tissue growth inhibitors, tissue growth enhancers, and vasoactive agents.

39. A system for intra-bronchially providing a therapeutic agent to a patient, the system comprising:

an intra-bronchial device including a flow control device arranged for placement in an air passageway, and when deployed, limits flow from the air passageway sufficiently to inhibit a therapeutic agent distal of the control member from moving proximal; and

an introducer that introduces the therapeutic agent in the lung portion distal of the airflow control member.

40. A method for providing a therapeutic agent to a patient, the method including the steps of:

delivering a therapeutic agent to a lung portion; and

inhibiting movement of the therapeutic agent from the lung portion.

41. The method of claim 40, wherein the inhibiting step includes the further step of limiting airflow from the lung portion to inhibit therapeutic agent distal of the control member from moving proximal.

42. The method of claim 40, including the further step of maintaining an inflation of the lung portion.

43. The method of claim 40, including the further step of maintaining a collapse of the lung portion.

44. The method of claim 40, wherein the delivering step is performed with one intra-bronchial device and the inhibiting step is performed with another intra-bronchial device.

45. The method of claim 40, including the further step of performing the delivering step again.

46. The method of claim 40, wherein the inhibiting step includes the further step of implanting an intra-bronchial device in an air passageway in communication with the lung portion.

47. The method of claim 46, wherein the delivery step includes providing the therapeutic agent to the intra-bronchial device.

48. The method of claim 40, including the further step of terminating the inhibition of movement.

49. The method of claim 40, wherein the therapeutic agent is one of antimicrobial agents such as adrenergic agents, antibiotic agents or antibacterial agents, antiviral agents, anthelmintic agents, anti-inflammatory agents, antineoplastic agents, antioxidant agents, biological reaction inhibitors, botulinum toxin agents, chemotherapy agents, diagnostic agents, gene therapy agents, hormonal agents, mucolytic agents, radioprotective agents, radioactive agents including brachytherapy materials, tissue growth inhibitors, tissue growth enhancers, and vasoactive agents.

50. An intra-bronchial device for providing a therapeutic agent to a patient, the device comprising:

means for delivering a therapeutic agent into an air passageway of the patient; and

means for intra-bronchially inhibiting movement of the therapeutic agent from the air passageway.

51. The intra-bronchial device of claim 50, wherein the movement is inhibited by limiting exhalation from the air passageway.

52. The intra-bronchial device of claim 50, wherein the movement is inhibited by limiting inhalation into the air passageway.

53. The intra-bronchial device of claim 50, wherein the movement is inhibited by limiting movement of mucus from the air passageway.