IMPLANTABLE DEVICE FOR DIRECTIONAL CONTROL OF FLOW WITHIN THE ANATOMIC TRACTS OF THE BODY

• US 20140039641A1
• Filed: 07/31/2013
• Published: 02/06/2014
• Est. Priority Date: 07/31/2012
• Status: Active Grant

• Current Assignee: Brigham and Women's Hospital Incorporated
• Original Assignee: Brigham and Women's Hospital Incorporated, Charles Stark Draper Laboratory Incorporated
• Inventors: Trainor, Christopher V., Tavakkoli, Ali, Ishizuka, Jeffrey, Traviglia, Daniel F., McFarland, William
• Granted Patent: US 9,566,145 B2
• Time in Patent Office: Days
• US Class Current: 623/23.68
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: B29C 33/424 Moulding surfaces provided with means for marking or patterning for injection moulding B29C45/372

Abstract

The systems and methods described herein related generally to a device that enables the directional control of flow through an anatomical tract of the body. More particularly, the device described herein includes a valve from a plurality of projections. In some implementations, the projections are configured as flaps, posts, or any combination thereof. In some implementations, the device is implanted into a patient'"'"'s esophagus to prevent gastroesophageal reflux disease. The plurality of projections allow flow into a patient'"'"'s stomach while substantially preventing a backflow of undesired fluids from the patient'"'"'s stomach to the patient'"'"'s esophagus.

Claims

1. An implantable device for the directional control of flow through an anatomic tract of a body, the device comprising:

a biocompatible valve with a substantially cylindrical housing sized to fit the anatomic tract, the valve further comprising;

a first set of projections disposed circumferentially around an interior wall of the housing, wherein a distal end of each of the projections in the first set of projections projects a first distance towards the center of the housing at a first angle relative to the wall of the housing.

2. The device of claim 1, wherein the first set of projections form flaps.

3. The device of claim 1, further comprising a second set of projections disposed circumferentially around the interior wall of the housing, wherein a distal end of the projections in the second set of projections projects a second distance towards the center of the housing at a second angle relative to the wall of the housing.

4. The device of claims 3, wherein the first set of projections and the second set of projections are flaps.

5. The device of claims 3, wherein the second set of projections is rotationally offset from the first set of projections.

6. The device of claims 3, wherein the second angle is equal to the first angle.

7. The device of claim 1, wherein the first set of projections form bristles.

8. The device of claim 1, wherein the housing is configured such that when implanted, the device includes a stomach-facing end and a mouth-facing end, and the first angle is less than 90 degrees with the distal ends of the projections directed towards the stomach-facing end of the housing.

9. The device of claim 1, wherein the first set of projections have a plurality of microstructures formed thereon.

10. The device of claim 9, wherein the microstructures are between about 100 μ

m and about 1 mm long.

11. The device of claim 9, wherein the microstructures are only formed on portions of the bottom surface of the first set of projections.

12. The device of claim 1, wherein the valve is configured to substantially impede the flow of fluid in a first direction but allows the flow of fluid in a second direction.

13. The device of claim 1, wherein the first set of projections are at least partially flexible, and are configured to, in response to a force that exceeds a threshold, deform towards the mouth-facing end of the housing to allow passage of fluid in the second direction.

14. The device of claim 1, further comprising an anchoring system to reversibly anchor the device to the anatomic tract.

15. The device of claim 1, wherein the anatomic tract is an esophagus.

16. The device of claim 1, wherein the height of the device is between about 1 cm and about 4 cm and the width of the device is between about 2 cm and about 3 cm.

17. A method for fabricating an implantable device for the directional control of flow through an anatomic tract of a body, the method comprising:

forming a mold for a valve, wherein the valve is sized to fit the anatomic tract and comprises a first set of projections disposed circumferentially around an interior wall of a housing, wherein a distal end of each of the projections in the first set of projections projects a first distance towards the center of the housing at a first angle relative to the wall of the housing;

injecting a biocompatible material into the mold; and

releasing a formed valve from the mold.

18. The method of claim 17, further comprising forming a microstructure pattern on at least one surface of the mold.

19. The method of claim 18, wherein forming the microstructure pattern comprises one of micromachining or chemically etching the microstructure into the mold.

20. The method of claim 17, further comprising coupling an anchoring system to the formed valve.

21. A method for preventing gastroesophageal reflux, the method comprising:

implanting a directional flow control device, wherein the control device comprises a valve with a housing sized to fit the anatomic tract, the valve further comprising;

a first set of projections disposed circumferentially around an interior wall of the housing, wherein a distal end of each of the projections in the first set of projections projects a first distance towards the center of the housing at a first angle relative to the wall of the housing.

22. The method of claim 21, wherein the valve further comprises a second set of projections disposed circumferentially around the interior wall of the housing, wherein a distal end of the projections in the second set of projections projects a second distance towards the center of the housing at a second angle relative to the wall of the housing.

23. The method of claim 21, wherein the first set of projections have a plurality of microstructures formed thereon.

24. The method of claim 23, wherein the bristles are between about 100 μ

m and about 1 mm long.

25. The method of claim 23, wherein the microstructures are only formed on portions of the bottom surface of the first set of projections.

26. The method of claim 21, wherein the anatomic tract is an esophagus.