Urinary catheter

Patent metadata

Field	Value
Publication number	US-10857324-B2
Application number	US-201515506723-A
Country	US
Kind code	B2
Filing date	Aug 26, 2015
Priority date	Aug 26, 2014
Publication date	Dec 8, 2020
Grant date	Dec 8, 2020

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 glycol (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 packaged urinary catheter, comprising:
a catheter having a catheter shaft attached to a handle;
a first coating over the catheter shaft in a wet state, the first coating of a hydrogel, glycerin and/or water, and polyethylene glycol (PEG), wherein the hydrogel is glyceryl acrylate/acrylic acid copolymer together with glycerin and propylene glycol, and wherein the first coating exhibits hygroscopic and/or hydrophilic characteristics;
a second coating of PAA between the catheter shaft and the first coating; and
a container including the catheter, wherein the container does not include a moisture source for application to the catheter prior to insertion of the catheter into a urethra.

2. The packaged urinary catheter according to claim 1 , wherein the first coating is the hydrogel, the glycerin, and PEG 400, and wherein the hydrogel is in a range of 20 wt % to 30 wt %, the glycerin is in a range of 20 wt % to 30 wt %, and the PEG 400 is in a range of 40 wt % to 60 wt %.

3. The packaged urinary catheter according to claim 1 , wherein the first coating is the hydrogel, the glycerin, and PEG 300, and wherein the hydrogel is in a range of 20 wt % to 30 wt %, the glycerin is in a range of 40 wt % to 60 wt %, and the PEG 300 is in a range of 20 wt % to 30 wt %.

4. The packaged urinary catheter according to claim 1 , wherein the first coating is the hydrogel, the glycerin, PEG 300, and PEG 400, wherein the hydrogel is in a range of 10 wt % to 35 wt %, the glycerin is in a range of 25 wt % to 75 wt %, the PEG 300 is in a range of 25 wt % to 65 wt %, and the PEG 400 is in a range of 25 wt % to 50 wt %.

5. The packaged urinary catheter according to claim 1 , wherein the first coating is the hydrogel, the water, and PEG 400, wherein the hydrogel is in a range of 15 wt % to 35 wt %, the water is in a range of 10 wt % to 45 wt %, and the PEG 400 is in a range of 20 wt % to 75 wt %.

6. The packaged urinary catheter according to claim 5 , wherein the hydrogel is in a range of 22 wt % to 26 wt %, the water is 25 wt %, and the PEG 400 is in a range of 49 wt % to 53 wt %.

7. The packaged urinary catheter according to claim 1 , further comprising a catheter tip, the catheter shaft including two pairs of opposing eyelets proximal to the catheter tip, the pairs of eyelets circumferentially positioned 90 degrees apart and positioned in a non-overlapping configuration.

8. The packaged urinary catheter according to claim 7 , wherein a silicone film is over the first coating.

9. The packaged urinary catheter according to claim 1 , wherein the handle includes a funnel shaped proximal end and ridges configured to facilitate gripping.

10. The packaged urinary catheter according to claim 1 , wherein the container is of a gas impermeable foil material.

11. The packaged urinary catheter according to claim 10 , wherein the container includes an adhesive tab covering a perforated section of the foil material, the adhesive tab including a pull loop.

12. The packaged urinary catheter according to claim 10 , wherein the container does not include a water sachet as the moisture source or a gel package as the lubricant.

13. A method of making a packaged urinary catheter, comprising:
applying a first coating over a catheter shaft with a base coating of polyacrylic acid (PAA), the first coating of a hydrogel, glycerin and/or water, and polyethylene glycol (PEG) to form a coated catheter, wherein the hydrogel is glyceryl acrylate/acrylic acid copolymer together with glycerin and propylene glycol; and
placing the coated catheter into a container of a gas impermeable foil material, wherein the container does not include a moisture source for application to the catheter prior to insertion of the catheter into a urethra.

14. The method according to claim 13 , further comprising applying the base coating of PAA over the catheter shaft before the first coating is applied over the catheter shaft.

15. The method according to claim 14 , wherein applying the first coating includes dipping the catheter shaft with the base coating into a solution containing a formulation of the first coating, the formulation of the first coating having only the hydrogel, the water, and the PEG.

16. The method according to claim 15 , further comprising dipping the coated catheter into a silicone solution including ultraviolet (UV) curable agents to form a silicone film over the first coating.

17. The method according to claim 16 , further comprising exposing the silicone film to a UV light source for a period of time to cure the silicone solution.

18. A packaged urinary catheter, comprising:
a catheter, comprising:
a catheter shaft attached to a handle;
a base coating on an outer surface of the catheter shaft, the base coating comprising polyacrylic acid (PAA); and
an outer coating comprising a hydrogel, water, and polyethylene glycol (PEG), wherein the hydrogel is glyceryl acrylate/acrylic acid copolymer together with glycerin and propylene glycol, and wherein the catheter is lubricated and ready for use without the application of liquid or lubricant; and
a container surrounding the catheter, the container comprising:
a kiss cut section positioned over at least a portion of the handle; and
an adhesive tab covering the perforated section, the adhesive tab including a pull loop, wherein pulling the pull loop toward an end of the container opens the kiss cut section to expose the portion of the handle,
wherein the container does not include any source of liquid or lubricant.

19. The packaged urinary catheter according to claim 18 , wherein the hydrogel is in a range of 22 wt % to 26 wt %, the water is 25 wt %, and the PEG 400 is in a range of 49 wt % to 53 wt %.

Assignees

• Bard Inc C R

Inventors

• Yin Zhihui
• Fish David
• Roberts Tom

Classifications

• A61M2025/0048

  with an outer layer made from silicon · 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

• A61M25/0009

  Making of catheters or other medical or surgical tubes · CPC title

• A61L29/085 Primary

  Macromolecular materials · CPC title

• A61M2025/0046

  Coatings for improving slidability · CPC title