Body fluid flow control device

• US 20020095209A1
• Filed: 02/08/2002
• Published: 07/18/2002
• Est. Priority Date: 09/16/1997
• Status: Active Application

• Current Assignee: Pulmonx Pulmonx
• Original Assignee: Pulmonx Pulmonx
• Inventors: Zadno-Azizi, Gholam-Reza, Marano-Ford, April, Ford, John S.
• Application Number:
  US10/071,620
• Publication Number:
  US 20020095209A1
• Time in Patent Office: Days
• 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 comprising

a resilient seal of substantially annular configuration;

a frame extending within at least a portion of the resilient seal and including a passageway extending longitudinally through the frame and at least one longitudinally extending element having an insertion state and an anchoring state, the anchoring state being with the at least one longitudinally extending element outwardly of the insertion state, thereby expanding the portion of the resilient seal within which the frame extends, the passageway being inwardly of the at least one longitudinally extending element;

a valve body having bulk resilience and a passage therethrough resiliently biased closed by the bulk resilience and communicating with the passageway;

a valve support about the valve body and attached to the valve body and to the resilient seal, the passage being in communication with the passageway extending longitudinally through the frame.

2. The body fluid flow control device of claim 1, the resilient seal further including a skirt extending at least partially over the at least one longitudinally extending element to form a peripheral seal.

3. The body fluid flow control device of claim 1, the resilient seal further including a skirt extending within the at least one longitudinally extending element and having a cuff over one end of each of the at least one longitudinally extending element to form a peripheral seal.

4. The body fluid flow control device of claim 1, the resilient seal further including a skirt extending fully over the frame.

5. The body fluid flow control device of claim 1, the passage having a predetermined fluid opening pressure.

6. The body fluid flow control device of claim 5, the fluid opening pressure being about 0.2 psi to 3.0 psi for urinary incontinence.

7. The body fluid flow control device of claim 5, the fluid opening pressure being about 0.005 psi to 1.0 psi for intervasoular placement.

8. The body fluid flow control device of claim 1, the passage being a single slit.

9. The body fluid flow control device of claim 1, the resilient seal, the valve body and the valve support being one piece.

10. The body fluid flow control device of claim 1, the at least one longitudinally extending element being heat recoverable with a transition temperature range below a reasonable range of human body temperatures.

11. The body fluid flow control device of claim 1, the at least one longitudinally extending element being spring biased toward the anchoring state and being held in the insertion state by a release wire separable from the frame.

12. The body fluid flow control device of claim 1 further comprising

a flap attached to the valve body adjacent the passage and extending over the passage to restrict flow to one direction through the passage.

13. The body fluid flow control device of claim 1 further comprising

an elongate expander means for expanding the at least one longitudinally extending element from the insertion state to the anchoring state, the at least one longitudinally extending element defining a concavity receiving at least a portion of the elongate expander means.

14. The body fluid flow control device of claim 13, the elongate expander means including a balloon at a distal end thereof with a passage extending substantially the length of the elongate expander means.

15. The body fluid flow control device of claim 13, the elongate expander means including an outer sheath into which the resilient seal and the frame are positionable in the insertion state and a ram extending within the sheath to engage the frame in the passageway extending longitudinally through the frame.