IMPLANTED BRONCHIAL ISOLATION DEVICES AND METHODS

• US 20110226238A1
• Filed: 09/17/2010
• Published: 09/22/2011
• Est. Priority Date: 03/04/2000
• Status: Active Grant

• Current Assignee: Pulmonx Corp.
• Original Assignee: Pulmonx Corp.
• Inventors: Dolin, Jeffrey J., French, Ronald, Gifford, Hanson S. III, Barrett, Michael, Deem, Mark E., Fields, Antony J., Hendricksen, Michael, Hundertmark, Ronald R., George, Robert M., Rapacki, Alan R., Sutton, Douglas
• Granted Patent: US 8,474,460 B2
• Time in Patent Office: Days
• US Class Current: 128/200.24
• 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: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2002/043 Bronchi

Abstract

Disclosed are methods and devices for regulating fluid flow to and from a region of a patient'"'"'s lung, such as to achieve a desired fluid flow dynamic to a lung region during respiration and/or to induce collapse in one or more lung regions. Pursuant to an exemplary procedure, an identified region of the lung is targeted for treatment. The targeted lung region is then bronchially isolated to regulate airflow into and/or out of the targeted lung region through one or more bronchial passageways that feed air to the targeted lung region.

Claims

1. A flow control device suitable for implanting in a bronchial passageway, comprising:

a valve element that transitions between an open configuration that permits air flow in an expiratory direction and a closed configuration that blocks air flow in the inspiratory direction, wherein a default state of the valve element is the open configuration wherein the valve transitions toward the closed configuration when exposed to air flow in the inspiratory direction.

2. The flow control device of claim 1, wherein the valve is in the default state when there is no pressure differential across the valve.

3. The flow control device of claim 1, wherein the valve is inclined to remain in the default state when not exposed to air flow through the bronchial passageway.

4. The flow control device of claim 1, wherein the valve progressively transitions toward the closed configuration as the level of air flow in the first direction increases.

5. A flow control device suitable for implanting in a bronchial passageway, comprising:

a valve defining a variable-sized mouth through which air can flow through the valve to regulate air flow when implanted in the bronchial passageway, wherein the mouth decreases in size in response to air flow in a second direction, and wherein the mouth is open when the valve is in a default state.

6. A flow control device as in claim 5, wherein the mouth can completely close to prevent air flow through the valve when the valve is exposed to a sufficient level of flow in the second direction.

7. The flow control device of claim 5, wherein the valve is inclined to remain in the default state when not exposed to air flow through the bronchial passageway.

8. The flow control device of claim 5, wherein the valve mouth progressively decreased in size as the level of air flow in the first direction increases.

9. The flow control device of claim 5, wherein the valve suddenly decreases in size when exposed to a level of air flow above a threshold level.

10. An flow control device as in claim 5, wherein the valve includes coaptation regions that define the mouth therebetween, the mouth being open when the coaptation regions are at least partially spaced apart from one another, wherein the coaptation regions move away from one another to increase the size of the mouth in response to air flow in the first direction and move toward one another to decrease the size of the mouth in response to air flow in the second direction, wherein the coaptation regions are at least partially spaced apart when exposed to no air flow.

11. An air flow control device as in claim 10, wherein valve comprises a duckbill valve and the coaptation regions comprise lips of the duckbill valve.

12. An air flow control device as in claim 10, wherein the coaptation regions are coated with a material that reduces sticking between the coaptation regions.

13. An air flow control device as in claim 5, wherein the mouth is oval when in the valve is in the default state.

14. An air flow control device as in claim 5, wherein the mouth is defined by a pair of parallel lips that are connected at opposed corners, the lips defining a relative angle in the range of approximately 1 to 10 degrees at the corners.

15. An air flow control device suitable for implanting in a bronchial passageway, comprising:

a frame configured to retain the flow control device within the bronchial passageway;

a seal coupled to the frame, the seal configured to seal against internal walls of the bronchial passageway; and

a valve coupled to the frame, the valve having lips that define a variable-sized mouth through which air can flow through the valve, wherein the lips move toward one another to decrease the size of the mouth in response to air flow in a second direction, and wherein the lips are at least partially spaced apart to define an open mouth when the valve is exposed to no air flow.

16. An air flow control device as in claim 15, further comprising a valve protector that at least partially surrounds the valve, the valve protector having sufficient rigidity to maintain the shape of the valve member against compression, wherein at least a portion of the valve is bonded to the valve protector to prevent the valve from inverting.

17. An air flow control device suitable for implanting in a bronchial passageway, comprising:

a frame configured to retain the flow control device within the bronchial passageway;

a seal coupled to the frame, the seal configured to seal against internal walls of the bronchial passageway; and

a valve configured to resist air flow in an inspiratory direction through the bronchial passageway, wherein the valve'"'"'s resistance to flow varies as a function of a pressure differential across the valve.

18. An air flow control device as in claim 17, wherein the pressure differential causes air to flow in an inspiratory direction through the bronchial passageway, and wherein the valve'"'"'s resistance to flow gradually increases as the pressure differential increases.

19. An air flow control device as in claim 17, wherein the pressure differential causes air to flow in an inspiratory direction through the bronchial passageway, and wherein the valve'"'"'s resistance to air flow suddenly increases when the pressure differential increases beyond a threshold.

20. An air flow control device as in claim 18, wherein the pressure differential is represented by a first pressure on a proximal side of the valve that is greater than a second pressure on a distal side of the valve, and wherein the valve'"'"'s resistance to air flow gradually increases as the pressure differential increases.

21. An air flow control device suitable for implanting in a bronchial passageway, comprising:

a frame configured to retain the flow control device within the bronchial passageway;

a seal coupled to the frame, the seal configured to seal against internal walls of the bronchial passageway; and

a valve configured to resist air flow in an inspiratory direction through the bronchial passageway, wherein the valve transitions to a state of increased resistance to air flow in response to an increase in a rate of air flow through the bronchial passageway.

22. An air flow control device as in claim 21, wherein the valve'"'"'s resistance to air flow gradually increases as the rate of air flow through the bronchial passageway increases.