DEVICE AND METHOD FOR CREATING A LOCALIZED PLEURODESIS AND TREATING A LUNG THROUGH THE LOCALIZED PLEURODESIS

• US 20080188809A1
• Filed: 04/07/2008
• Published: 08/07/2008
• Est. Priority Date: 05/07/2003
• Status: Active Grant

• Current Assignee: Portaero, Inc
• Original Assignee: Portaero, Inc
• Inventors: Tanaka, Don, Russell, Scott M.
• Granted Patent: US 7,828,789 B2
• Time in Patent Office: Days
• US Class Current: 604/122
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/02 Gases
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/03 Gases in liquid phase, e.g. cryogenic liquids
• CPC Class Codes: A61M 2210/101 Pleural cavity
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04

Abstract

The invention provides methods and devices for creating a localized pleurodesis between the thoracic wall and the lung such that a ventilation bypass conduit may be introduced into the lung through the thoracic wall and visceral membrane without causing a pneumothorax. A medical device such as a catheter is used to enter the pleural cavity and deliver a pleurodesis agent to a localized area between the visceral and parietal membranes.

Claims

1. A method to introduce a conduit through a parietal membrane and a visceral membrane and into a lung of a subject without allowing air to enter an intrapleural space around the lung, the method comprising:

(a) introducing a delivery device into the intrapleural space;

(b) releasing a chemical agent from the delivery device into a localized area of the intrapleural space;

(c) substantially retaining the chemical agent within the localized area of the intrapleural space such that the chemical agent creates a localized adhesion between the parietal membrane and visceral membrane within the localized area; and

(d) subsequent to steps (a), (b) and (c) introducing the conduit from a position external to the lung into tissue of the lung through the parietal membrane and the visceral membrane within the localized adhesion.

2. The method of claim 1, further comprising removing the delivery device before step (d).

3. The method of claim 1, wherein the delivery device comprises a radiopaque marker and wherein step (a) comprises:

(a1) introducing the delivery device into the intrapleural space;

(a2) scanning the subject to determine information about a location of the radiopaque marker; and

(a3) positioning the delivery device using the information about the location of the radiopaque marker.

4. The method of claim 1, wherein the delivery device comprises a distal tip of a catheter, the distal tip having one or more openings therein, and wherein:

step (a) comprises introducing the distal tip of the catheter into the intrapleural space through the parietal membrane;

step (b) comprises providing a pleurodesis agent through the catheter to the distal tip of the catheter and releasing the pleurodesis agent through the one or more openings in the distal tip of the catheter into a localized area of the intrapleural space.

5. The method of claim 4, wherein the pleurodesis agent comprises a radiopaque constituent and wherein step (b) comprises:

(b1) providing a pleurodesis agent through the catheter to the distal tip of the catheter and releasing the pleurodesis agent through one or more openings in the distal tip of the catheter into a localized area of the intrapleural space;

(b2) scanning the subject to determine information about a location of the radiopaque constituent; and

(b3) using the information about the location of the radiopaque constituent to confirm the location of the pleurodesis agent.

6. The method of claim 1, wherein the delivery device comprises a distal tip of a catheter, the distal tip having one or more openings therein and a radiopaque marker, and wherein:

step (a) comprises (a1) introducing the delivery device through the parietal membrane into the intrapleural space, (a2) scanning the subject to determine information about the location of the radiopaque marker, and (a3) positioning the delivery device using the information about the location of the radiopaque marker; and

step (b) comprises providing a pleurodesis agent through the catheter to the distal tip of the catheter and releasing the pleurodesis agent through the one or more openings in the distal tip of the catheter into a localized area of the intrapleural space.

7. The method of claim 1, wherein the delivery device comprises a distal tip of a catheter, the distal tip being configured to substantially encircle an area and having one or more openings therein oriented towards the center of the area, and wherein:

step (a) comprises introducing the distal tip of the catheter into the intrapleural space through the parietal membrane so that the distal tip of the catheter encircles the localized area of the intrapleural space;

step (b) comprises providing a pleurodesis agent through the catheter to the distal tip of the catheter and releasing the pleurodesis agent through the one or more openings in the distal tip of the catheter into the localized area of the intrapleural space; and

step (c) comprises substantially retaining the chemical agent within the localized area of the intrapleural space substantially encircled by the distal tip of the catheter such that the chemical agent creates a localized adhesion between the parietal membrane and visceral membrane within the localized area.

8. A method to introduce a conduit through a parietal membrane and a visceral membrane and into a lung of a subject without allowing air to enter an intrapleural space around the lung, the method comprising:

(a) introducing a distal tip of a catheter through the parietal membrane into the intrapleural space;

(b) providing a pleurodesis agent through the catheter to the distal tip of the catheter

(c) releasing the pleurodesis agent through one or more openings in the distal tip of the catheter into a localized area of the intrapleural space;

(d) substantially retaining the pleurodesis agent within the localized area of the intrapleural space such that a pleurodesis creates a localized adhesion between the parietal membrane and visceral membrane within the localized area; and

(e) subsequent to steps (a), (b), (c) and (d) introducing the conduit from a position external to the lung into tissue of the lung through the parietal membrane and the visceral membrane within the localized adhesion.

9. The method of claim 8, wherein the pleurodesis agent comprises a radiopaque constituent and wherein step (c) comprises:

(c1) releasing the pleurodesis agent through one or more openings in the distal tip of the catheter into a localized area of the intrapleural space;

(c2) scanning the subject to determine information about the location of the radiopaque constituent; and

(c3) using the information about the location of the radiopaque constituent to confirm the location of the pleurodesis agent.

10. The method of claim 8, wherein the distal tip of the catheter comprises a radiopaque marker, and wherein step (a) comprises:

(a1) introducing the distal tip of the catheter through the parietal membrane into the intrapleural space;

(a2) scanning the subject to determine information about the location of the radiopaque marker; and

(a3) positioning the delivery device using the information about the location of the radiopaque marker.

11. The method of claim 8, wherein the catheter is used to facilitate introducing the conduit in step (e).

12. The method of claim 8, further comprising removing the distal tip of the catheter before step (e).

13. The method of claim 8, wherein the distal tip of the catheter is configured to substantially encircle an area and having one or more openings therein oriented towards the center of the area, and wherein:

step (a) comprises introducing the distal tip of the catheter into the intrapleural space through the parietal membrane so that the distal tip of the catheter encircles the localized area of the intrapleural space;

step (b) comprises providing a pleurodesis agent through the catheter to the distal tip of the catheter and releasing the pleurodesis agent through the one or more openings in the distal tip of the catheter into the localized area of the intrapleural space; and

step (d) comprises substantially retaining the chemical agent within the localized area of the intrapleural space substantially encircled by the distal tip of the catheter such that the chemical agent creates a localized adhesion between the parietal membrane and visceral membrane within the localized area.

14. A device to localize the delivery of a pleurodesis agent to an intrapleural space of a patient, the device comprising:

a catheter; and

a distal tip, having one or more openings, attached to and in fluid communication with the catheter;

wherein the distal tip is sized and configured so as to discharge a pleurodesis agent through the one or more openings into a localized area of the intrapleural space of a patient; and

wherein the distal tip is sized and configured to obstruct movement of the pleurodesis agent out from the localized area of the intrapleural space.

15. The device of claim 14, wherein the distal tip is configured to substantially surround a defined area of the intrapleural space.

16. The device of claim 15, wherein the one or more openings are oriented so as to discharge the pleurodesis agent towards the interior of the defined area of the intrapleural space substantially surrounded by the distal tip.

17. The device of claim 14, wherein the distal tip is configured to substantially surround a substantially circular area of the intrapleural space.

18. The device of claim 17, wherein the one or more openings are oriented so as to discharge the pleurodesis agent towards the interior of the substantially circular area of the intrapleural space.

19. The device of claim 14, wherein the distal tip is configured so as to substantially confine the pleurodesis agent to a predefined area of the intrapleural space.

20. The device of claim 14, wherein the distal tip has a first configuration adapted to allow insertion of the distal tip through the parietal membrane into the intrapleural space and a second configuration adapted to control the location of delivery of the agent and wherein the distal tip is adapted to reconfigure from the first configuration to the second configuration after insertion into the intrapleural space.

21. The device of claim 14, wherein the distal tip has a first configuration adapted to allow insertion of the distal tip through the parietal membrane into the intrapleural space and a second configuration adapted to control the location of delivery of the agent and wherein the distal tip comprises a shape memory metal component which causes the distal tip to reconfigure from the first configuration to the second configuration after insertion into the intrapleural space.

22. The device of claim 14, wherein the distal tip comprises a radiopaque marker to facilitate positioning the distal tip in the intrapleural space.