METHODS OF PRODUCING AN INTERMITTENT URINARY CATHETER

• US 20180161539A1
• Filed: 12/04/2017
• Published: 06/14/2018
• Est. Priority Date: 12/13/2016
• Status: Active Grant

• Current Assignee: Cure Medical LLC (ConvaTec Group Plc)
• Original Assignee: Cure Medical LLC (ConvaTec Group Plc)
• Inventors: Palmer, Timothy A.
• Granted Patent: US 10,639,449 B2
• Time in Patent Office: Days
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: B65D 81/22 in moist conditions or immersed in liquids

Abstract

A package or container for a catheter having a catheter tube with a proximal end provided with a catheter outlet and a distal opening at a distal end thereof. A gel receptacle is provided with a cavity for holding an amount of a lubricating agent, and the catheter tube extends therethrough. The gel receptacle is configured such that as the catheter is withdrawn from a stored position therein, a leading tip of the catheter is immersed in the lubricating agent, thus automatically coating the leading tip. The gel receptacle may be held within a rigid body or may be a standalone item packaged in a sterile bag solely with the catheter. A side wall of the gel receptacle is deformable so that as the catheter is withdrawn proximally the side wall is collapsed inward to displace the lubricating agent gel and coat an exterior surface of the catheter tube.

Claims

1. A method of producing an intermittent urinary catheter package, comprising:

a) providing an intermittent urinary catheter having a flexible catheter tube with a distal tip and at least one discharge opening proximate the distal tip, and a catheter outlet provided at a proximal end of the catheter tube,

b) providing a gel receptacle defining a cavity therein and having a distal opening at a distal end with an inner diameter corresponding to a catheter tube diameter, and a proximal opening at a proximal end with an inner diameter larger than the catheter tube diameter, wherein a side wall of the gel receptacle is made of a deformable material and configured to collapse inward in a relaxed state to a collapsed shape,

c) inserting the catheter distal tip through the proximal opening, cavity and out of the distal opening of the gel receptacle to a stored position so as to deform the side wall outward from its collapsed shape to an enlarged shape, in the process enlarging the cavity,

d) filling the enlarged cavity of the gel receptacle with a lubricating agent gel so that the gel surrounds a portion of the catheter tube within the cavity, wherein withdrawing the catheter distal tip proximally from its stored position in the gel receptacle permits the side wall of the gel receptacle to collapse inward to its collapsed shape so as to coat the distal tip of the catheter tube with the lubricating agent gel, and

e) sealing the gel-filled gel receptacle and catheter within an inner space of an outer container.

2. The method of claim 1, wherein the deformable material is silicone rubber.

3. The method of claim 1, wherein the outer container has a rigid main body and the gel receptacle is held in an inner space of the main body, wherein the main body has diametrically-opposed apertures that expose the side wall of the gel receptacle such that a user may manually depress the side wall inward.

4. The method of claim 1, wherein the side wall has at least one inward projection which extends inward into contact with the catheter tube in its stored position.

5. The method of claim 4, wherein there are at least two opposed inward projections which extend inward into contact with opposite side of the catheter tube in its stored position and hold the side wall away from the catheter tube to create a volume within the gel receptacle for receiving the lubricating agent gel.

6. The method of claim 5, wherein the side wall and inward projections extend substantially the entire length of the gel receptacle.

7. The method of claim 5, wherein the side wall and inward projections extend along less than half of the length of the gel receptacle.

8. The method of claim 5, wherein the side wall and inward projections are formed adjacent the distal end of the gel receptacle and the side wall comprises a series of circumferentially spaced concave portions and the inward projections comprise radial fins attached thereto.

9. The method of claim 1, wherein the gel receptacle is shaped so as to have at least one inward bulge on one side which extends into a straight line path for the catheter tube extending between the distal and proximal openings.

10. The method of claim 1, wherein the outer container comprises a flexible, sterile bag and the catheter and gel receptacle are the only items within the bag.

11. The method of claim 1, wherein the gel receptacle has a cylindrical proximal end and a cylindrical distal end flanking an indented section formed by opposed flat walls that extend along a proximal-to-distal axis substantially the whole length of the gel receptacle.

12. The method of claim 11, wherein the inward projections extend inward from the opposed flat walls and projections from one wall are offset from projections from the opposed wall.

13. The method of claim 12, wherein the distal and proximal openings of the gel receptacle are aligned along a central axis thereof, and the inward projections extend inward in their relaxed states across the central axis.

14. The method of claim 1, wherein the gel receptacle has a cylindrical proximal end and a cylindrical distal end flanking an indented section formed by opposed flat walls that extend along a proximal-to-distal axis approximately one-half of the length of the gel receptacle.

15. The method of claim 14, wherein the inward projections extend inward from the opposed flat walls and projections from one wall are offset from projections from the opposed wall.

16. The method of claim 15, wherein the distal and proximal openings of the gel receptacle are aligned along a central axis thereof, and the inward projections extend inward in their relaxed states across the central axis.

17. The method of claim 1, wherein the catheter outlet comprises a funnel secured to a proximal end of the catheter tube, and the gel receptacle proximal opening is defined by a protruding conical wall having a smaller diameter than a distal end of the funnel.