Body fluid flow control device

• US 7,033,387 B2
• Filed: 04/18/2003
• Issued: 04/25/2006
• Est. Priority Date: 09/16/1997
• Status: Expired due to Term

• Current Assignee: Pulmonx Corp.
• Original Assignee: Emphasys Medical, Inc. (Pulmonx Corp.)
• Inventors: Zadno-Azizi, Gholam-Reza, Marano-Ford, April, Ford, John S.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US10/419,653
• Publication Number:
  US 20030199972A1
• Time in Patent Office: 1,103 Days
• Field of Search: 623/1.1, 623/1.2, 623 111- 113, 623 123- 126, 623 118- 119, 623/2.14, 623/2.18, 623/2.17, 623/2.28, 623/900, 623/12, 623/11.11, 623/66.1, 623 132- 133, 623 2364- 2371, 623/9, 128/898, 606191-200, 600 29- 32, 600/36
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/0009 placed in or outside the body opening close to the surface of the body plugging an opening in the wall of a hollow or tubular organ A61B17/0057
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor

Abstract

A device to provide body fluid flow control in the form of a valve to be located within a duct or passageway. The device is controlled through pressure above a preselected threshold. Bulk resilience about a passageway in a valve body provides the mechanism for controlled flow. One-way valve operation may be provided through a flap or through a pressure differential on the valve body depending upon the direction of flow. A frame structure positioned within a resilient seal includes longitudinally elongate elements which may be of spring material, malleable material or heat recoverable material so as to accomplish an initial insertion state and an expanded anchoring state. A valve support transitions between the resilient seal portion and the valve body to insure that the states do not change the threshold opening pressure. Insertion devices may be employed to position and actuate a change of state of the frame in the body duct or passageway.

Claims

1. A body fluid flow control device for placement in a body lumen comprising:

a valve body having a passage and a first portion movable between an open configuration allowing fluid flow through the passage and a closed configuration restricting fluid flow through the passage, the first portion being biased into the closed configuration and movable into the open configuration in response to fluid flow;

an annular seal having a collapsed configuration suitable for insertion into the body lumen and an expanded configuration adapted to seal with a wall of the body lumen, wherein the seal is cylindrical; and

a valve support coupled to the valve body and to the seal, the valve support isolating the valve body from the seal to avoid distortion of the valve body when the seal is in the expanded configuration.

2. The body fluid flow control device of claim 1, further comprising a frame coupled to the seal and including a passageway extending longitudinally through the frame in communication with the passage in the valve body, the frame being movable between an insertion state and an anchoring state, the anchoring state having a transverse dimension larger than the insertion state, the seal being movable with the frame to seal with the wall of the body lumen in the anchoring state.

3. The body fluid control device of claim 2, wherein the valve body has a first outer diameter and the frame has a second outer diameter, the first outer diameter being less than the second outer diameter.

4. The body fluid control device of claim 2 wherein the valve body is axially displaced from the frame.

5. The body fluid control device of claim 2, wherein the valve body is outside the passageway in the frame.

6. The body fluid control device of claim 2, wherein the seal is disposed on an outer surface of the frame such that the seal is disposed between the frame and the wall of the body lumen in the anchoring state.

7. The body fluid control device of claim 2, wherein the frame compresses the seal against the wall of the body lumen in the anchoring state.

8. The body fluid flow control device of claim 2, wherein the frame is embedded within at least a portion of the seal.

9. The body fluid flow control device of claim 1, wherein the first portion of the valve body moves from the closed configuration to the open configuration at a threshold pressure, the valve support being adapted to maintain the threshold pressure generally constant during displacement of the seal.

10. The body fluid control device of claim 1, wherein the valve support is an elastomeric material.

11. The body fluid control device of claim 1, wherein the valve support is integrally formed with the valve body.

12. The body fluid control device of claim 1, wherein the valve support is integrally formed with the seal.

13. The body fluid control device of claim 1, wherein the valve support is disposed circumferentially around the valve body.

14. The body fluid control device of claim 1, wherein the valve body has an outer diameter less than an inner diameter of the seal, the valve support comprising an annular member between the valve body and the seal.

15. The body fluid control device of claim 1, wherein the valve body comprises a pair of walls separated by a slit, the walls being substantially parallel.

16. The body fluid flow control device of claim 1, wherein the valve support isolates the valve body from the seal to avoid distortion of the valve body as the seal moves between the collapsed configuration and the expanded configuration.

17. A body fluid flow control device for placement in a body lumen comprising:

a valve body having a passage and a first portion movable between an open configuration allowing fluid flow through the passage and a closed configuration restricting fluid flow through the passage, the first portion being biased into the closed configuration and movable into the open configuration in response to fluid flow;

an annular seal adapted to seal with a wall of the body lumen, wherein the seal is cylindrical;

a frame coupled to the seal and including a passageway extending longitudinally through the frame in communication with the passage in the valve body, the frame being movable between an insertion state and an anchoring state, the anchoring state having a transverse dimension larger than the insertion state, the seal being movable with the frame to seal with the wall of the body lumen in the anchoring state; and

a valve support coupled to the valve body and to the seal, the valve support isolating the valve body from the seal to avoid distortion of the valve body when the frame is in the anchoring state.

18. The body fluid flow control device of claim 17, wherein the valve support isolates the valve body from the seal to avoid distortion of the valve body as the frame moves between the insertion state and the anchoring state.