Urinary catheter

Patent metadata

Field	Value
Publication number	US-11850370-B2
Application number	US-202017114275-A
Country	US
Kind code	B2
Filing date	Dec 7, 2020
Priority date	Aug 26, 2014
Publication date	Dec 26, 2023
Grant date	Dec 26, 2023

Abstract

A urinary catheter and container are described. The urinary catheter may have a catheter shaft attached to a handle, and a coating disposed on an outer surface of the catheter shaft. The coating may include a hydrogel, water and/or glycerin, and a polyethylene gylcol (PEG). The PEG may have a molecular weight equal to or less than 600, for example one or more of polyethylene glycol (PEG) 300 and PEG 400. The coating may be applied in a wet state and remain wet for an extended period of time in the container, thereby obviating the need for a lubricant, such as a water sachet or gel package, to accompany the catheter in the container. The container may include a gas impermeable foil material. The container may include an adhesive tab covering a perforated section, the adhesive tab including a pull loop.

First claim

What is claimed is:

1. A urinary catheter, comprising:
a handle;
a catheter shaft attached to the handle;
a base coating over the catheter shaft; and
an outer coating over the base coating, each coating of the base coating and the outer coating including a combination of components selected from a hydrogel, polyacrylic acid (“PAA”), glycerin, water, and polyethylene glycol (“PEG”) such that the base coating and the outer coating are in a wet state sufficient for insertion of the catheter shaft into a urethra without applying an additional moisture source or lubricant to the base coating or the outer coating.

2. The urinary catheter of claim 1 , wherein the base coating includes PAA in a range of 0.2 wt % to 3 wt %, glycerin in a range of 15 wt % to 25 wt %, water in a range of 20 wt % to 30 wt %, and PEG 400 in a range of 40 wt % to 60 wt %.

3. The urinary catheter of claim 1 , wherein the base coating includes PAA in a range of 0.1 wt % to 2.5 wt %, water in a range of 10 wt % to 45 wt %, and PEG in a range of 20 wt % to 65 wt %.

4. The urinary catheter of claim 1 , wherein the hydrogel is glyceryl acrylate/acrylic acid copolymer together with glycerin and propylene glycol.

5. The urinary catheter of claim 4 , wherein the outer coating includes hydrogel in a range of 20 wt % to 30 wt %, glycerin in a range of 20 wt % to 30 wt %, and PEG 400 in a range of 40 wt % to 60 wt %.

6. The urinary catheter of claim 4 , wherein the outer coating includes hydrogel in a range of 20 wt % to 30 wt %, glycerin in a range of 40 wt % to 60 wt %, and PEG 300 in a range of 20 wt % to 30 wt %.

7. The urinary catheter of claim 4 , wherein the outer coating includes hydrogel in a range of 10 wt % to 35 wt %, glycerin in a range of 25 wt % to 75 wt %, PEG 300 in a range of 25 wt % to 65 wt %, and PEG 400 in a range of 25 wt % to 50 wt %.

8. The urinary catheter of claim 4 , wherein the outer coating includes hydrogel in a range of 15 wt % to 35 wt %, water in a range of 10 wt % to 45 wt %, and PEG 400 in a range of 20 wt % to 75 wt %.

9. The urinary catheter of claim 4 , wherein the outer coating includes hydrogel in a range of 22 wt % to 26 wt %, water at approximately 25 wt %, and PEG 400 in a range of 49 wt % to 53 wt %.

10. The urinary catheter of claim 1 , further comprising:
a silicone film over the outer coating, the silicone film configured to be moved toward the handle of the urinary catheter to expose the outer coating before the insertion of the catheter shaft into the urethra.

11. The urinary catheter of claim 10 , wherein the silicone film includes ultraviolet (“UV”) light-cured UV agents.

12. The urinary catheter of claim 1 , wherein the handle includes a plurality of ridges designed for gripping the handle.

13. The urinary catheter of claim 1 , wherein the catheter shaft includes a plurality of eyelets proximate a catheter tip in fluid communication with an opening in a proximal end of the handle by way of a lumen through the urinary catheter.

14. The urinary catheter of claim 13 , wherein the plurality of eyelets include two pairs of eyelets circumferentially positioned 90 degrees apart from each other in a non-overlapping configuration.

15. A urinary catheter, comprising:
a handle;
a catheter shaft attached to the handle;
a base coating over the catheter shaft including either:
i) polyacrylic acid (“PAA”) in a range of 0.2 wt % to 3 wt %, glycerin in a range of 15 wt % to 25 wt %, water in a range of 20 wt % to 30 wt %, and polyethylene glycol (“PEG”) 400 in a range of 40 wt % to 60 wt %; or
ii) PAA in a range of 0.1 wt % to 2.5 wt %, water in a range of 10 wt % to 45 wt %, and PEG in a range of 20 wt % to 65 wt %; and

an outer coating over the base coating including a combination of components selected from a hydrogel, PAA, glycerin, water, and PEG such that the base coating and the outer coating are in a wet state sufficient for insertion of the catheter shaft into a urethra without applying an additional moisture source or lubricant to the base coating or the outer coating.

16. The urinary catheter of claim 15 , wherein the outer coating includes hydrogel in a range of 20 wt % to 30 wt %, glycerin in a range of 20 wt % to 30 wt %, and PEG 400 in a range of 40 wt % to 60 wt %.

17. The urinary catheter of claim 15 , wherein the outer coating includes hydrogel in a range of 20 wt % to 30 wt %, glycerin in a range of 40 wt % to 60 wt %, and PEG 300 in a range of 20 wt % to 30 wt %.

18. The urinary catheter of claim 15 , wherein the outer coating includes hydrogel in a range of 10 wt % to 35 wt %, glycerin in a range of 25 wt % to 75 wt %, PEG 300 in a range of 25 wt % to 65 wt %, and PEG 400 in a range of 25 wt % to 50 wt %.

19. The urinary catheter of claim 15 , wherein the outer coating includes hydrogel in a range of 15 wt % to 35 wt %, water in a range of 10 wt % to 45 wt %, and PEG 400 in a range of 20 wt % to 75 wt %.

20. The urinary catheter of claim 15 , wherein the outer coating includes hydrogel in a range of 22 wt % to 26 wt %, water at approximately 25 wt %, and PEG 400 in a range of 49 wt % to 53 wt %.

Assignees

• Bard Inc C R

Inventors

• Yin Zhihui
• Fish David
• Roberts Tom

Classifications

• A61M25/0017 Primary

  specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections · CPC title

• A61L29/085 Primary

  Macromolecular materials · CPC title

• A61L29/14

  Materials characterised by their function or physical properties {, e.g. lubricating compositions} · CPC title

• A61L29/145

  Hydrogels or hydrocolloids · CPC title

• A61M25/002

  Packages specially adapted therefor (combined with means for introducing catheters, e.g. dispensers, A61M25/0113); catheter kit packages (for surgical articles A61B50/30) · CPC title