Medical device suitable for treating reflux from a stomach to an oesophagus

• US 9,308,077 B2
• Filed: 12/22/2006
• Issued: 04/12/2016
• Est. Priority Date: 12/23/2005
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Vysera Biomedical Limited
• Inventors: Behan, Niall, Devery, Donal, Finnegan, Sean, Lyons, Edwin, McLaughlin, Enda
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Lee, Morgan
• Application Number:
  US11/643,698
• Publication Number:
  US 20070198048A1
• Time in Patent Office: 3,399 Days
• Field of Search: 604/8, 604/9, 623/1.24, 623/1.26, 623 2364- 237
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A medical treatment device (200), for treating reflux from a stomach (201) to an esophagus (202) and for delivering a therapeutic agent to an inner surface of the esophagus (202), comprises a valve member (203), a lining member (204), and a support member (205). The valve member (203) is movable between a closed configuration and an open configuration, in which the valve member (203) facilitates passage of material between the esophagus (202) and the stomach (201). The valve member (203) is biased towards the closed configuration and gradually moves over a period of 4 to 10 secs from the open configuration to the closed configuration. The support member (205) supports the device (200) relative to the esophagus (202) and the stomach (201). The lining member (204) lines part of the inner surface of the esophagus (202) for delivery of a therapeutic agent to the esophagus (202).

Claims

1. A medical device suitable for treating reflux from a stomach to an oesophagus, the device comprising:

a valve member which is movable between an open configuration to facilitate passage of material between an oesophagus and a stomach, and a closed configuration; and

a generally tubular support member to support the valve member relative to an oesophagus and/or a stomach,

the valve member including valve leaflets extending substantially radially inwardly of the support member, the valve leaflets being movable between a contracted configuration and an expanded configuration,

the valve member being formed of a viscoelastic, biomimetic foam;

the valve member being a two-way leaflet valve,

the valve leaflets being compressed and moved from the expanded configuration to the contracted configuration when the valve member is both in the open configuration to allow antigrade flow from the oesophagus into the stomach and in the open configuration to allow retrograde flow from the stomach into the oesophagus and;

the valve leaflets gradually expanding to the expanded configuration from the contracted configuration when the valve member is in the closed configuration to resist retrograde flow from the stomach into the oesophagus.

2. The device as claimed in claim 1, wherein the valve member includes a polyurethane material.

3. The device as claimed in claim 1, wherein the device includes a lining member for lining a part of an inner surface of an oesophagus and/or a stomach.

4. The device as claimed in claim 1, wherein the support member extends distally of the valve member.

5. The device as claimed in claim 1, wherein the support member extends proximally of the valve member.

6. The device as claimed in claim 1, wherein the support member is tapered.

7. The device as claimed in claim 6, wherein the support member tapers distally radially outwardly.

8. The device as claimed in claim 1, wherein the support member includes two or more support elements.

9. The device as claimed in claim 6, wherein a first support element is coupled to a second support element.

10. The device as claimed in claim 9, wherein a region of coupling of the first support element to the second support element includes an articulation region.

11. The device as claimed in claim 7, wherein the support element includes at least one articulation region intermediate a first coupling region and a second coupling region.

12. The device as claimed in claim 6, wherein the support element extends circumferentially in a wave-pattern.

13. The device as claimed in claim 6, wherein the support element extends circumferentially in a zig-zag pattern.

14. The device as claimed in claim 1, wherein the support member includes a shape memory material.

15. The device as claimed in claim 14, wherein the support member includes Nitinol.

16. The device as claimed in claim 1, wherein the support member is a stent.

17. The device as claimed in claim 1, wherein the support member is engagable with a wall of an oesophagus and/or a stomach.

18. The device as claimed in claim 17, wherein the support member is extendable into a wall of an oesophagus and/or a stomach.

19. The device as claimed in claim 3, wherein the lining member is located radially outwardly of the valve member.

20. The device as claimed in claim 3, wherein the lining member is located radially inwardly of the support member.

21. The device as claimed in claim 3, wherein the support member is provided external of the lining member.

22. The device as claimed in claim 3, wherein the support member is engagable against an inner surface of the lining member.

23. The device as claimed in claim 3, wherein the support member is at least partially embedded within the lining member.

24. The device as claim in claim 3, wherein the support member extends through the lining member.

25. The device as claimed in claim 1, wherein the device is substantially tubular.

26. The device as claimed in claim 3, wherein the device defines a lumen therethrough.

27. The device as claimed in claim 1, wherein the device includes a distal support member and a proximal support member.

28. The device as claimed in claim 27, wherein the proximal support member is larger than the distal support member.

29. The device as claimed in claim 28, wherein a radial dimension of the proximal support member is larger than a radial dimension of the distal support member.

30. The device as claimed in claim 27, wherein the proximal support member is substantially of equal size to the distal support member.