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

• US 7,942,931 B2
• Filed: 08/15/2005
• Issued: 05/17/2011
• Est. Priority Date: 02/21/2002
• Status: Expired due to Fees

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Spiration, Inc. (Olympus Corporation)
• Inventors: Shea, Richard O., Springmeyer, Steven Chase, Wang, John H., DeVore, Lauri J., Gonzalez, Hugo X.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): FLICK, JASON E
• Application Number:
  US11/204,383
• Publication Number:
  US 20060074382A1
• Time in Patent Office: 2,101 Days
• Field of Search: 604/892.1
• US Class Current: 623/9
• 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 for maintaining a therapeutic agent within an air passageway, the device comprising:

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

at least one anchor associated with the flow control member, the at least one anchor having a linear elongate portion with a first end and second end, the first end of the linear elongate portion coupled to the flow control member, the second end of the linear elongate portion extending away from the flow control member, the linear elongate portion comprising more than one bend configured to allow the at least one anchor to be collapsed for positioning within a delivery catheter; and

the therapeutic agent associated with the flow control member.

2. The intra-bronchial device of claim 1 further comprising an introducer that introduces the therapeutic agent in a lung portion distal of the flow control member.

3. The intra-bronchial device of claim 1, wherein the flow control member inhibits movement of the therapeutic agent by limiting flow from the air passageway.

4. The intra-bronchial device of claim 1, wherein the flow control member inhibits the movement of the therapeutic agent by limiting mucociliary transport from the air passageway.

5. The intra-bronchial device of claim 1, wherein the flow control member includes a one-way valve.

6. The intra-bronchial device of claim 5, wherein the at least one anchor is positioned proximally relative to the one-way valve, and the one-way valve is positioned to permit inhalation of air into the air passageway, and the intra-bronchial device to prevent exhalation of air from the air passageway.

7. The intra-bronchial device of claim 5, wherein the at least one anchor is positioned distally relative to the one-way valve, and the one-way valve is positioned to permit exhalation of air from the air passageway.

8. The intra-bronchial device of claim 1, wherein the flow control member includes a flexible membrane impervious to air flow.

9. The intra-bronchial device of claim 8, 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.

10. The intra-bronchial device of claim 8, 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.

11. The intra-bronchial device of claim 1, wherein the flow control member includes a separator arranged to inhibit the movement of the therapeutic agent while allowing movement of air.

12. The intra-bronchial device of claim 11, 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.

13. The intra-bronchial device of claim 1, wherein the flow 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.

14. The intra-bronchial device of claim 1, wherein the flow control member allows airflow from the air passageway sufficiently to prevent over-inflation of a lung portion.

15. The intra-bronchial device of claim 1, wherein the flow control member is further arranged to automatically terminate the inhibiting of movement by the therapeutic agent.

16. The intra-bronchial device of claim 1, wherein the flow control member is further arranged to permit mucociliary transport from the air passageway.

17. The device of claim 1, 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.

18. The intra-bronchial device of claim 1, wherein the linear elongate portion comprises a first portion and a second portion, the second portion forming a substantially perpendicular angle relative to a central axis extending between distal and proximal ends of the device.

19. The intra-bronchial device of claim 1, wherein the flow control member further comprises at least one support member having a curved end for allowing removal of the device.

20. The intra-bronchial device of claim 1 further comprises a central support structure to carry the flow control member, the central support structure configured to extend proximally to allow a removal device to engage and remove the device.

21. The intra-bronchial device of claim 1, wherein the therapeutic agent is carried by the flow control member.

22. The intra-bronchial device of claim 1, wherein the therapeutic agent is absorbed into a portion of the flow control member.

23. The intra-bronchial device of claim 1, wherein the flow control member is configured to prevent exhalation airflow from a lung portion.

24. The intra-bronchial device of claim 1, wherein the flow control member further comprises at least one lip configured to open when air pressure in the lung portion exceeds a threshold level to allow exhalation airflow from the lung portion.