IP Library › Granted Patent US 12,290,645
Granted Patent B2
US 12,290,645 · App. 18/536,972 · Granted May 6, 2025

Catheter insertion-tray systems and methods thereof

Inventor: John Gohde (Decatur, GA)
Assignee: C. R. Bard, Inc.
A61M25/0111A61B42/10A61B46/23A61B46/30A61M25/0017A61M25/002A61B2046/234A61M2207/00A61M2210/1085
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Quick Facts
Patent No.
US 12,290,645
App. No.
18/536,972
Granted
May 6, 2025
Kind
B2
Abstract

A catheterization package including a catheterization tray and contents for a catheterization procedure. The catheterization tray can include a structural configuration for maintaining a sterile field about a patient throughout the catheterization procedure, the sterile field including at least a portion of the tray. The structural configuration of the tray can provide a sterile side of the tray designated for a first person performing sterile steps of the catheterization procedure in the sterile field. The structural configuration of the tray can also provide a non-sterile side of the tray designated for either the first person or a second person performing non-sterile steps of the catheterization procedure outside the sterile field. The contents for the catheterization procedure can include a perineal care kit, two or more pairs of gloves, and a drainage system including a catheter.

Claims (40)

1. A catheterization tray, comprising:

a first side structured as a sterile side of the catheterization tray for a first person performing sterile steps of a catheterization procedure in a sterile field, the first side including first contents in accordance with a sterile work path;

a second side structured as a non-sterile side of the catheterization tray for either the first person or a second person performing non-sterile steps of the catheterization procedure outside the sterile field, the second side of the catheterization tray including second contents in accordance with a non-sterile work path; and

a partition separating the first side of the catheterization tray from the second side of the catheterization tray, the partition extending lengthwise from one end of the catheterization tray to an opposite end of the catheterization tray, the partition configured to maintain sterility of the first side of the catheterization tray.

2. The catheterization tray according to claim 1 , further comprising a sterile wrap and a belly band configured to hold the sterile wrap around the catheterization tray, wherein a perineal care kit is located outside the sterile wrap with a package of hand sanitizer.

3. The catheterization tray according to claim 2 , wherein at least a first pair of gloves is located outside the sterile wrap.

4. The catheterization tray according to claim 2 , wherein at least a first pair of gloves is located inside the sterile wrap.

5. The catheterization tray according to claim 1 , wherein the first contents include a drainage system including a catheter.

6. The catheterization tray according to claim 5 , wherein the first contents further include a syringe of sterile saline, a container containing lubricant, and a sterile sample container.

7. The catheterization tray according to claim 1 , wherein the second contents include a waterproof underpad configured for placement under a patient and a fenestrated drape configured for placement over the patient.

8. The catheterization tray according to claim 7 , wherein the second contents further include a skin-preparation kit including a package of an antiseptic and one or more swabs configured for preparing the patient for inserting a urinary catheter.

9. The catheterization tray according to claim 1 , further comprising instructions for the catheterization procedure imprinted directly on a surface of the catheterization tray, the instructions revealed in accordance with the sterile steps and the non-sterile steps of the catheterization procedure as the first contents and the second contents are removed.

10. A method of using a catheterization package, comprising:

unwrapping the catheterization package to reveal a catheterization tray, the catheterization tray comprising:

a first side structured as a sterile side of the catheterization tray for a first person performing sterile steps of a catheterization procedure in a sterile field, the first side including first contents in accordance with a sterile work path;

a second side structured as a non-sterile side of the catheterization tray for either the first person or a second person performing non-sterile steps of the catheterization procedure outside the sterile field, the second side of the catheterization tray including second contents in accordance with a non-sterile work path; and

a partition separating the first side of the catheterization tray from the second side of the catheterization tray, the partition extending lengthwise from one end of the catheterization tray to an opposite end of the catheterization tray, the partition configured to maintain sterility of the first side of the catheterization tray;

removing an underpad and a fenestrated drape from the second side of the catheterization tray; and

removing a drainage system including a urinary catheter, drainage tubing, and a drainage bag from the first side of the catheterization tray.

11. The method according to claim 10 , further comprising:

removing a perineal care kit and a package of hand sanitizer from outside a sterile wrap of the catheterization package; and

cleaning a peri-urethral area of a patient with the perineal care kit.

12. The method according to claim 10 , further comprising:

placing the underpad under a patient; and

placing the fenestrated drape over the patient while maintaining the sterile field.

13. The method according to claim 10 , further comprising:

preparing a patient and the urinary catheter for catheterization; and

catheterizing the patient while maintaining the sterile field.

14. A method for manufacturing a catheterization package, comprising:

molding a catheterization tray for the catheterization package, the catheterization tray comprising:

a first side structured as a sterile side of the catheterization tray for a first person performing sterile steps of a catheterization procedure in a sterile field, the first side including first contents in accordance with a sterile work path;

a second side structured as a non-sterile side of the catheterization tray for either the first person or a second person performing non-sterile steps of the catheterization procedure outside the sterile field, the second side of the catheterization tray including second contents in accordance with a non-sterile work path; and

a partition separating the first side of the catheterization tray from the second side of the catheterization tray, the partition extending lengthwise from one end of the catheterization tray to an opposite end of the catheterization tray, the partition configured to maintain sterility of the first side of the catheterization tray;

disposing contents for the catheterization procedure in the catheterization tray for removal therefrom by one or two clinicians during the catheterization procedure in accordance with the sterile work path and the non-sterile work path; and

sterilizing the catheterization package.

15. The method for manufacturing according to claim 14 , wherein disposing contents in the catheterization tray includes placing an underpad and a fenestrated drape in the second side of the catheterization tray.

16. The method for manufacturing according to claim 14 , further comprising:

placing a drainage system including a urinary catheter, drainage tubing, and a drainage bag in the first side of the catheterization tray when disposing the contents in the catheterization tray; and

wrapping a sterile wrap around the catheterization tray.

17. The method for manufacturing according to claim 16 , further comprising placing a perineal care kit and a package of hand sanitizer outside the sterile wrap.

Continuity (3)
Continuation 16497770
Provisional Application 62479687 · Mar 31, 2017
Related Publication 20240108857A1 · Apr 4, 2024
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