VALVE FOR INFLATABLE CHAMBER OF MEDICAL DEVICE

• US 20070010791A1
• Filed: 07/06/2006
• Published: 01/11/2007
• Est. Priority Date: 07/07/2005
• Status: Abandoned Application

• Current Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Johnsen, Kenneth, Cline, John, Blum, John, Veerapaneni, Bhavani, Drechsler, Steven, Lesko, Marc
• Application Number:
  US11/428,921
• Publication Number:
  US 20070010791A1
• Time in Patent Office: Days
• US Class Current: 604/327
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2433 Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
• CPC Class Codes: A61M 2039/244 Hinged closure member, e.g. flap valve
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

A medical device such as an ostomy appliance has an inflatable seal for sealing an opening in a patient'"'"'s body. A non-return valve is provided at an inlet port for admitting inflation fluid into the inflatable seal and for preventing escape of the inflation fluid.

Claims

1. A medical device comprising an inflatable chamber, an inlet port for inflation fluid, and a one-way valve located in the chamber and communicating with the inlet port for controlling the flow of inflation fluid through the inlet port, the valve comprising:

a. a wall portion having an opening therein communicating with the inlet port; and

b. a film panel comprising;

a first portion attached to the wall portion for anchoring the film panel; and

a second portion that

(i) overlaps the inlet port and at least a part of the wall portion,

(ii) is unattached to the wall portion so as to be displaceable relative to the wall portion in response to a differential fluid pressure between the pressure in the inflatable chamber and the pressure at the inlet port,

(iii) has a chamber facing surface that is exposed to fluid pressure in the inflatable chamber such that said fluid pressure in the inflatable chamber urges the second portion of the film panel into sealing contact with the wall portion to obstruct escape of inflation fluid from the inflatable chamber, and

(iv) has an inlet facing surface that is exposed to fluid pressure at the inlet port such that said fluid pressure at the inlet port urges the second portion of the film panel to lift away from the wall portion for admitting inflation fluid through the inlet port.

2. The medical device according to claim 1, wherein, in use, the valve adopts a position that is dependent on a pressure differential between the pressure at the inlet and the pressure in the internal chamber.

3. The medical device according to claim 1, wherein the device is an ostomy appliance.

4. The medical device according to claim 1, wherein the device comprises an inflatable seal for sealing an opening in a human body, the inflatable seal comprising the inflatable chamber.

5. The medical device according to claim 1, wherein the wall portion comprises a second film panel.

6. The medical device according to claim 5, wherein the second film panel is attached to a substrate more rigid than the second film panel.

7. The medical device according to claim 1, wherein the wall portion is substantially rigid.

8. The medical device according to claim 1, wherein the wall portion is flexible.

9. The medical device according to claim 1, wherein the film panel has a thickness in the range of from about 0.01 mm to about 2 mm.

10. The medical device according to claim 1, wherein the film panel and the wall portion define a direction of fluid flow through the valve that is generally parallel to the wall portion.

11. The medical device according to claim 1, wherein the film panel and the wall portion define a direction of fluid flow through the valve that is generally perpendicular to a direction of entry of fluid through the opening in the wall portion.

12. The medical device according to claim 1, wherein an area of the second portion of the film panel is at least twice the size of a cross-sectional area of the opening in the wall portion.

13. The medical device according to claim 1, wherein the first portion is shaped as one or more segments of a line.

14. The medical device according to claim 1, wherein first portion is attached to the wall portion by one or more selected from:

a weld;

an adhesive;

a solvent or chemical bond;

or an integral plastics molding.

15. The medical device according to claim 14, wherein the weld is selected from:

heat welding;

ultrasonic welding;

radio frequency welding;

a solvent or chemical bond;

or laser welding.

16. The medical device according to claim 14, wherein the integral plastics molding is selected from:

insert molding;

multi-shot injection molding; and

insert thermo-forming.

17. The medical device according to claim 1, wherein at least a portion of the film panel is substantially rigid or stiff.

18. The medical device according to claim 1, wherein at least a portion of the film panel is flexible.

19. The medical device according to claim 1, wherein the film panel comprises at least one relatively rigid or stiff portion and at least one flexible portion to allow localized valve movement.

20. The medical device according to claim 1, wherein at least one selected from the film panel and the wall portion has a first portion with a first thickness and a second portion with a second thickness.

21. The medical device according to claim 1, wherein the substrate comprises a plurality of materials or components attached together.

22. The medical device according to claim 21, wherein the plurality of materials or components are attached together by at least one selected from:

welding;

adhesive;

solvent or chemical bond;

integral plastics molding.

23. The medical device according to claim 22, wherein the welding is selected from:

heat welding;

ultrasonic welding;

laser welding;

or solvent or chemical bonding.

24. The medical device according to claim 22, wherein the integral plastics molding is selected from:

insert molding;

multi-shot injection molding; and

insert thermo-forming.

25. The medical device according to claim 1, wherein at least a portion of the film panel and/or a portion of the wall portion has a highly polished surface.

26. The medical device according to claim 1, wherein at least a portion of the film panel and/or a portion of the wall portion has a matte surface finish.

27. The medical device according to claim 1, wherein at least a portion of the film panel and/or a portion of the wall portion has a non-planar topographical surface characteristic.

28. The medical device according to claim 27, wherein the non-planar topographical surface characteristic comprises one or more selected from:

bumps;

dimples;

ridges;

grooves; and

corrugations.

29. The medical device according to claim 27, wherein the non-planar topographical surface characteristic is aligned generally randomly.

30. The medical device according to claim 27, wherein the non-planar topographical surface characteristic is aligned generally parallel to a direction of fluid flow through the valve.

31. The medical device according to claim 27, wherein the non-planar topographical surface characteristic is aligned perpendicular to a direction of fluid flow through the valve.

32. The medical device according to claim 1, wherein a substance is applied to one or more of the confronting surfaces of the film panel and the wall portion.

33. The medical device according to claim 32, wherein the substance is selected from:

oil;

water;

saline; and

wax.

34. The medical device according to claim 1, wherein at least a portion of a confronting surface of the film panel and/or the wall portion is modified to alter the surface characteristics.

35. The medical device according to claim 34, wherein said surface treatment is selected from:

corona treatment;

hydrophobic treatment; and

hydrophilic treatment.

36. The medical device according to claim 1, further comprising an opening element positioned removably between the film panel and the wall portion, so as to prevent full closing of the valve.

37. The medical device according to claim 36, wherein the opening element comprises a filament.

38. The medical device according to claim 36, wherein the opening element projects outwardly through the inlet port, and is removable by extracting the opening element through the inlet port.

39. The medical device according to claim 36, wherein the opening element is attached to a movable part of the medical device, such that in use, the opening element is removed from the valve when the inflatable chamber is inflated.

40. A one-way valve for an inflatable seal of a medical device, the one-way valve comprising:

a. an inlet port for inflation fluid;

b. a wall portion having an opening therein communicating with the inlet port; and

c. a film panel comprising;

a first portion attached to the wall portion for anchoring the film panel, and

a second portion that

(i) overlaps the inlet port and at least a part of the wall portion,

(ii) is unattached to the wall portion so as to be displaceable relative to the wall portion in response to a differential fluid pressure between the pressure in the inflatable seal and the pressure at the inlet port,

(iii) has a seal facing surface that is exposed to fluid pressure in the inflatable seal such that said fluid pressure in the inflatable seal urges the second portion of the film panel into sealing contact with the wall portion to obstruct escape of inflation fluid from the inflatable seal, and

(iv) has an inlet facing surface that is exposed to fluid pressure at the inlet port such that said fluid pressure at the inlet port urges the second portion of the film panel to lift away from the wall portion for admitting inflation fluid into the inflatable seal.

41. An inflatable seal for an ostomy appliance, the inflatable seal comprising:

a. a substrate;

b. an inflatable membrane supported by the substrate and defining an inflatable chamber, the inflatable membrane having a stoma engaging surface for engaging a stoma to obstruct stomal discharge when the inflatable membrane is inflated in use;

c. an inlet port in the substrate; and

d. a one-way valve located in the chamber and communicating with the inlet port for controlling the flow of inflation fluid through the inlet port, the valve comprising;

a wall portion having an opening therein communicating with the inlet port; and

a film panel comprising;

a first portion attached to the wall portion for anchoring the film panel, and

a second portion that

(i) overlaps the inlet port and at least a part of the wall portion,

(ii) is unattached to the wall portion so as to be displaceable relative to the wall portion in response to a differential fluid pressure between the pressure in the inflatable chamber and the pressure at the inlet port,

(iii) has a chamber facing surface that is exposed to fluid pressure in the inflatable chamber such that said fluid pressure in the inflatable chamber urges the second portion of the film panel into sealing contact with the wall portion to obstruct escape of inflation fluid from the inflatable chamber, and

(iv) has an inlet facing surface that is exposed to fluid pressure at the inlet port such that said fluid pressure at the inlet port urges the second portion of the film panel to lift away from the wall portion for admitting inflation fluid through the inlet port.

42. The seal according to claim 41, wherein the wall portion is a portion of the substrate.

43. The seal according to claim 41, wherein the wall portion comprises a second film panel attached to the substrate.