Granted Patent B2

US 12,697,467 · App. 18/536,063 · Granted Aug 4, 2026

Inventors: Zhihui Yin (Lilburn, GA); David Fish (Rutledge, GA); Tom Roberts (Bishop, GA)

Assignee: C. R. Bard, Inc.

A61M25/0017A61L29/085A61L29/14A61L29/145A61M25/002A61M25/0045A61M25/007A61M25/0136A61L29/08A61L29/141A61L2400/10A61L2420/08A61M25/0009A61M2025/0046

Abstract

Claims (41)

1 . A packaged urinary catheter, comprising:

a urinary catheter including:

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”); and

a container including the urinary catheter, wherein the container does not include an added moisture source or lubricant for application to the catheter shaft, the base coating and the outer coating in a wet state sufficient for insertion of the catheter shaft into a urethra without the added moisture source or lubricant.

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 is 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 . The urinary catheter of claim 1 , wherein the container further comprises:

a weakened area of sheet material positioned over at least a portion of the handle of the urinary catheter; and

an adhesive tab covering the weakened area of the sheet material, the adhesive tab including a pull loop configured to open the container about the weakened area of the sheet material when the pull loop is pulled toward an end of the container.

16 . A method of manufacturing a packaged urinary catheter, comprising:

folding a sheet material such that longitudinal edges of the sheet material meet;

forming a back seam from the longitudinal edges of the sheet material and, thereby, forming a cavity within the sheet material;

disposing a urinary catheter in the cavity of the sheet material, the urinary catheter including:

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”); and

sealing ends of the cavity of the sheet material to form a container including the urinary catheter, wherein the container does not include an added moisture source or lubricant for application to the catheter shaft, the base coating and the outer coating in a wet state sufficient for insertion of the catheter shaft into a urethra without the added moisture source or lubricant.

17 . The method of claim 16 , further comprising:

weakening the sheet material before folding the sheet material, thereby providing a weakened area of the sheet material positioned over at least a portion of the handle of the urinary catheter in the container.

18 . The method of claim 17 , further comprising:

covering the weakened area of the sheet material with an adhesive tab, the adhesive tab including a pull loop configured to open the container about the weakened area of the sheet material when the pull loop is pulled toward an end of the container.

19 . The method of claim 16 , wherein the base coating includes 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 %.

20 . The method of claim 19 , wherein the outer coating includes a combination of components selected from a hydrogel, PAA, glycerin, water, and PEG.

Continuity (4)

References Cited (400)