Bubble Shaped Membrane and Use of Such Membrane in a Device

• US 20110036844A1
• Filed: 02/24/2009
• Published: 02/17/2011
• Est. Priority Date: 02/25/2008
• Status: Abandoned Application

• Current Assignee: Unomedical AS (ConvaTec Group Plc)
• Original Assignee: Unomedical AS (ConvaTec Group Plc)
• Inventors: Hasted, Søren Bo, Gyrn, Steffen
• Application Number:
  US12/918,663
• Publication Number:
  US 20110036844A1
• Time in Patent Office: Days
• US Class Current: 220/361
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001

Abstract

The invention relates to a membrane (17) completely covering an opening (13) giving access to a space in a device which membrane (17) is made of an elastic material penetrable by a needle, the membrane (17) is fastened around the opening (13) and the membrane (17) protrudes from the opening (13) and forms an air filled volume in front of the opening (13) which air filled volume can be reduced in size when a pressure is put on the membrane (17) from the outside, the inner surfaces of the membrane (17) define a passage (17a) at the first closed end of the membrane (17) through which a needle (19) can pass and the second end of the membrane (17) is adapted to attach the membrane (17) to a holding part (61). The walls of the membrane (17) have a thickness and shape of the chosen membrane material making it possible, to maintain the protruding shape in a use position without the outer surfaces of the membrane (17) are supported with walls of rigid material. Also the invention relates to a device in which the membrane is used, and a kit where this device is combined with a corresponding unit.

Claims

1. A membrane (17) completely covering an opening (13) giving access to a space in a device which membrane (17) is made of an elastic material penetrable by a needle, the membrane (17) is fastened around the opening (13) and the membrane (17) protrudes from the opening (13) and forms an air filled volume in front of the opening (13) which air filled volume can be reduced in size when a pressure is put on the membrane (17) from the outside, the inner surfaces of the membrane (17) define a passage (17a) at the first closed end of the membrane (17) through which a needle (19) can pass and the second end of the membrane (17) is adapted to attach the membrane (17) to a holding part (61), characterized in that the walls of the membrane (17) have a thickness and shape of the chosen membrane material making it possible, to maintain the protruding shape in a use position without the outer surfaces of the membrane (17) being supported with walls of rigid material.

2. A membrane according to claim 1, wherein the second end of the membrane (17) has an internal opening (17b) fitting around the outer contour of a protruding part (61a) on the holding part (61) and that the membrane (17) is fastened to the holding part (61) by interference fit.

3. A membrane according to claim 1 or 2, wherein the membrane (17) is supported with walls of a rigid material on the inner surfaces of the membrane (17) e.g. in the form of a penetrating needle.

4. A membrane according to claim 1, 2 or 3, wherein the cross-section of the air-filled volume in the passage (17a) is smaller than 2·

[max cross-section of the opening (13)].

5. A membrane according to any preceding claim, wherein the membrane (17) has a constant or decreasing outer cross-section from where the membrane (17) is attached to the device and to the proximal end, and the passage (17a) is formed by increasing the thickness of the walls of the membrane (17) at the proximal end of the membrane (17) thereby reducing the inner air-filled cross-section of the membrane (17).

6. A membrane according to any preceding claim, wherein the properties of the material forming the membrane (17) forming folding sections and making it possible to predict how the air filled volume is reduced when subjected to an external pressure.

7. A membrane according to any of the preceding claims, wherein the membrane (17) can be penetrated by a pointy needle.

8. A membrane according to any of the preceding claim, wherein the material of the membrane (17) positioned closest to the device has the thickness b₁ and has the form of a hollow truncated cone or a cylinder and the material positioned furthest away from the device has a thickness b₂ and has the form of a hollow cylinder which is closed at the end opposite the device, and b₂>

b₁.

9. A membrane according to claim 8, wherein a part of the membrane (17) positioned between the material closest to the device having the thickness b₁ and the material positioned furthest away from the device having a thickness b₂, has a thickness varying from b₁ to b₂.

10. A membrane according to claim 8 or 9, wherein b₂≧

1.5·

b₁.

11. A membrane according to any of the claims 3-7, wherein b₂<

b₁ and the distance between the rigid material supporting the inner surfaces of the membrane (17) and the inner surfaces of the membrane (17) is less than 0.5 mm.

12. A device comprising

a membrane (17) according to any of the claims 1-11,

a base part which base part comprise a surface plate (1), fastening means which fasten the base part to a subject, a fluid path (3) having at least two openings (12, 13):

an inlet and an outlet for fluid, where one opening (13) is protected by the membrane (17) and the second opening during use connects to a penetrating part (7) transferring fluid to and/or from the subject in which it is inserted.

13. A device according to claim 12, wherein the opening (13) is provided at the end of a needle (19) which needle (19) is fastened unreleasably to the device and the needle (19) is placed in the air filled volume inside the membrane (17) and during periods where no pressure is put on the membrane (17) the part of the needle (19) extending into the air filled volume is completely surrounded by air.

14. A device according to claim 13, wherein the needle (19) during periods where pressure is put on the membrane (17) extends through the membrane (17) and protrudes from the outer surface of the membrane (17).

15. A device according to claim 12, 13 or 14, wherein the needle (19) is a pointy needle.

16. A device according to claim 12, 13, 14 or 15, wherein the penetrating part (7) comprises a cannula (22).

17. A kit comprising a device comprising a membrane according to any of the claims 1-11 and a unit adapted to be joined to the device assuring a sterile transfer of fluid between the device and the joined unit.