Intra-bronchial apparatus for aspiration and insufflation of lung regions distal to placement or cross communication and deployment and placement system therefor

• US 20060102186A1
• Filed: 07/01/2005
• Published: 05/18/2006
• Est. Priority Date: 11/18/2004
• Status: Active Grant

• Current Assignee: Mark Adler
• Original Assignee: Mark Adler
• Inventors: Adler, Mark
• Granted Patent: US 7,451,765 B2
• Time in Patent Office: Days
• US Class Current: 128/207.140
• 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 17/12104 in an air passage
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/242 for bronchial passages
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0447 Bell, canopy or umbrella shaped

Abstract

An anchored intra-bronchial apparatus for placement and deployment into selected airways and a method for using the same. When deployed, the apparatus creates a restriction of air flow to one or more targeted lung regions and achieves total lung volume reduction through a collapse or partial collapse of the targeted regions. The air flow valve of the apparatus includes a through lumen that permits drug delivery concurrent with lung volume reduction procedure

Claims

1. An intra-bronchial apparatus for deployment in a body cavity, duct, vessel, or air passageway to effect drug delivery concurrent with anchored placement of the intra-bronchial apparatus, said apparatus comprising:

an air flow control valve having a center tube with a central lumen, a plurality of spaced apart strut arms distributed around said center tube and having tips for anchoring said valve on the interior wall of a body cavity, duct, vessel, or passageway;

an air restriction membrane having a portion attached to said strut arms and to said center tube to form a tubular portion; and

an inner membrane disposed within the central lumen of said center tube, said inner membrane preventing the passage of gasses while also permitting the selective delivery of drugs to lung tissue distal to the deployment site of said apparatus.

2. The apparatus of claim 1, wherein each of said spaced-apart strut arms is resilient and includes a lower end, and an upper arcuate portion having a lower end and a tip adapted for anchoring said valve on the interior lumen wall of a body cavity, duct, vessel, or passageway.

3. The apparatus of claim 2, wherein said center tube has a lower portion, and wherein said lower ends of said strut arms are disposed in an evenly spaced arrangement around said lower portion of said center tube.

4. The apparatus of claim 3, wherein said air restriction membrane is a woven or polymeric material molded, adhesively bonded, woven, or fused to said strut arms and to saod center tube to form a columnar or tubular portion around said lower portion of said center tube and said lower ends of said strut arms.

5. The apparatus of claim 4, wherein said air restriction membrane has a lower border and an upper border, said upper border encircling the strut arms immediately under the lower ends of said upper arcuate portions of said strut arms.

6. The apparatus of claim 5, wherein said air restriction membrance, said center tube, and said strut members form an assembly having a tubular lower portion.

7. The apparatus of claim 6, further including a collet, wherein when said valve is in a collapsed configuration, said collet is disposed over said tubular portion of said membrane/center tube/strut arm assembly.

8. The apparatus of claim 7, wherein said collet includes at least one longitudinal slit to facilitate a firm press-fit placement.

9. The apparatus of claim 1, wherein said inner membrane is a solid disc that permits no passage of gases when deployed.

10. The apparatus of claim 1, wherein said inner membrane is a disc having valve elements that permit one-way or bi-directional passage of gases.

11. The apparatus of claim 1, further including a deployment and placement catheter, said deployment and placement catheter having a length from a distal end to a proximal end, and an outside diameter, and comprising:

body portion encasing and defining a center lumen extending the entire length of said catheter;

at least four control wire lumen disposed between the center lumen and said outside diameter of the catheter, including at least two steering wires each slidingly disposed in a lumen, and at least two release ring wires each slidingly disposed in a lumen;

a steering tip disposed at said distal end of said catheter operatively connected to steering wires, said steering tip including a center lumen coaxial with the center lumen of said catheter, and having two throughholes through which the ends of said release ring wires are disposed;

and a release ring attached to said release ring wires.

12. The apparatus of claim 11, further including a steering and release handle assembly connected to said apparatus through said deployment and placement catheter.

13. The apparatus of claim 12, wherein said steering and release handle assembly comprises:

a housing having a steering knob connected to said steering wires and said release ring wires.

14. The apparatus of claim 13, further including a release ring lock handle opeartively connected to said release ring wires.

15. A method of delivering drugs for the treatment of pulmonary ailments concurrently with lung reduction therapy, said method comprising the steps of:

providing an intra-bronchial air flow restriction apparatus having a valve member with a central lumen;

providing a deployment and placement apparatus for the intra-bronchial air flow restriction apparatus;

using the deployment and placement apparatus to deploy the intra-bronchial air flow restriction apparatus in an air passageway in fluid communication with a lung region to be collapsed and pharmaceutically treated;

anchoring the intra-bronchial air flow restriction apparatus in an air passageway wall; and

delivering therapeutic drugs to lung regions distal to the valve member through the central lumen of the valve member.

16. The method of claim 15, wherein the intra-bronchial air flow restriction apparatus includes a center tube, a plurality of strut arms, and an air flow restriction membrane connected to the center tube and the strut arms;

urging the strut arms inwardly toward the center tube and gathering the strut arms at their respective upper ends to place the air flow restriction appartus in a collapsed configuration;

placing a release ring around the upper ends of the strut arms to retain and restrain them from moving outwardly;

using a steering and release mechanism to direct the intra-bronchial air flow restriction apparatus to a target site;

releasing the release ring to pull it off from the strut arm upper ends, thereby allowing the strut arms to move outwardly and urge the strut arms outwardly and the air restriction membrane into an open configuration.