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

• US 6,929,637 B2
• Filed: 12/11/2002
• Issued: 08/16/2005
• Est. Priority Date: 02/21/2002
• Status: Expired due to Term

• 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.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/317,667
• Publication Number:
  US 20030158515A1
• Time in Patent Office: 979 Days
• Field of Search: 604 30- 34, 604/96.01, 604/246, 604/247, 604 10- 18, 604/890.1, 604/891.1, 606/108, 606/200, 606/213, 606/217, 606/119, 623/1.24, 623/1.26, 623/23.68, 623/1.25, 623/23.7, 623/2.26, 623/2.1, 600/16, 600/37, 607/2, 601/153
• US Class Current: 604/890.1
• 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 configured to be implanted in an air passageway of a lung;

a therapeutic agent overlying, embedded in, absorbed in, co-mixed with, or combinations thereof, at least a portion of the member and arranged for provision to a patient; and

at least one anchor that retains the intra-bronchial device within the air passageway when the anchor is deployed.

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

3. The intra-bronchialdevice of claim 1, wherein said member has a generally conical configuration with a base portion, said base portion being generally circular and having a periphery for contacting the walls of the air passageway.

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. The intra-bronchialdevice of claim 1, wherein the member comprises means for limiting air flow and/or mucociliary transport when said device is implanted in said air passageway.

6. The intra-bronchial device of claim 1, wherein the member comprises a one-way valve configured to allow fluid flow in one direction and to prohibit fluid flow in an opposite direction.

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

8. The intra-bronchial device of claim 1, wherein the membrane is supported by a metallic frame.

9. The intra-bronchial device of claim 1, wherein the member comprises a semi-permeable membrane configured to prevent the therapeutic agent from passing therethrough while permitting air and water molecules to pass therethrough.

10. The intra-bronchial device of claim 1, wherein the member further comprises an absorptive portion and the therapeutic agent is absorbed by said absorptive portion.

11. The intra-bronchial device of claim 1, wherein said member comprises a cavity, and the therapeutic agent is carried in the cavity.

12. The intra-bronchial device of claim 11, wherein the cavity includes a cover having an orifice.

13. The intra-bronchial device of claim 2, wherein said member has a generally conical configuration with a base portion, said base portion being generally circular and having a periphery for contacting the walls of the air passageway.

14. The intra-bronchial device of claim 1, wherein said member has a generally cylindrical configuration formed by a sidewall configured to contact the walls of the air passageway.

15. The intra-bronchial device of claim 1, wherein said member is secured to a central support structure, and said member is supported by support members attached to said support structure.

16. The intra-bronchial device of claim 1, wherein the therapeutic agent comprises at least one of an antimicrobial agent, antibiotic agent or antibacterial agent, antiviral agent, anthelmintic agent, anti-inflammatory agent, antineoplastic agent, antioxidant agent, biological reaction inhibitor, botulinum toxin agent, chemotherapy agent, diagnostic agent, gene therapy agent, hormonal agent, mucolytic agent, radioprotective agent, radioactive agent, tissue growth inhibitor, tissue growth enhancer, and vasoactive agent.