# US 11,896,778 B2 · Catheter insertion-tray systems and methods thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,896,778 B2 - Document ID: US11896778B2 - Status: Granted - Kind: B2 - Application number: 16/497,770 - Filed: 2018-03-29 - Published: 2021-04-08 - Granted: 2024-02-13 - Earliest claimed: 2017-03-31 - Assignees: C. R. Bard, Inc. - Applicants: C. R. Bard, Inc. - Inventors: John Gohde - Web page: https://patentgrep.com/patent/US11896778B2 ## CPC - A61B 46/20: specially adapted for patients - A61M 25/0111: {Aseptic insertion devices} - A61B 42/00: Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof - A61B 42/10: Surgical gloves - A61B 42/40: Packages or dispensers - A61B 46/00: Surgical drapes - A61B 46/23: with means to retain or hold surgical implements - A61B 46/30: {for surgery through the lower body openings, e.g. urology, gynaecology} - A61B 50/33: Trays - A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections} - 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)} - A61B 2046/234: {with means for retaining a catheter} - A61B 2050/3008: {having multiple compartments} - A61M 2207/00: Methods of manufacture, assembly or production - A61M 2210/1085: Bladder - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## 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 ### Claim 1 A catheterization package, comprising: sterile contents for a catheterization procedure, including: a perineal care kit; two or more pairs of gloves; and a drainage system including a catheter; and a sterile catheterization tray with a structural configuration for maintaining a sterile field including at least a portion of the catheterization tray throughout the catheterization procedure, the structural configuration of the catheterization tray including: a first side of the catheterization tray configured as a sterile side of the catheterization tray for a first person performing sterile steps of the catheterization procedure in the sterile field, a second side of the catheterization tray configured 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, and a partition separating the first side and the second side of the catheterization tray along a length of the catheterization tray from one end of the catheterization tray to an opposite end of the catheterization tray, wherein the contents for the catheterization procedure are disposed in the catheterization tray for removal therefrom by the first person or the first person and the second person during the catheterization procedure in accordance with sterile and non-sterile work paths respectively across the first and second sides of the catheterization tray. ### Claim 2 (depends on 1) The catheterization package according to claim 1, further comprising a sterile wrap and a belly band configured to hold the sterile wrap around the catheterization tray, wherein the perineal care kit is located outside the sterile wrap with a package of hand sanitizer. ### Claim 3 (depends on 2) The catheterization package according to claim 2, wherein at least a first pair of gloves of the two or more pairs of gloves is located outside the sterile wrap. ### Claim 4 (depends on 2) The catheterization package according to claim 2, wherein at least a first pair of gloves of the two or more pairs of gloves is located inside the sterile wrap. ### Claim 5 (depends on 1) The catheterization package according to claim 1, wherein the contents for the catheterization procedure further include: a syringe of sterile saline; a container containing lubricant; and a sample container, wherein the first side of the catheterization tray is configured to include the drainage system, the syringe of sterile saline, the container containing lubricant, and the sample container. ### Claim 6 (depends on 1) The catheterization package according to claim 1, wherein the contents for the catheterization procedure further include: an underpad; and a fenestrated drape, wherein the second side of the catheterization tray is configured to include the underpad and the fenestrated drape. ### Claim 7 A catheterization package, comprising: sterile contents for a catheterization procedure, including: a perineal care kit configured for cleaning a patient's peri-urethral area; two or more pairs of sterile gloves; and a drainage system configured for draining urine from a patient's bladder including a urinary catheter, drainage tubing, and a drainage bag; and a sterile catheterization tray with a structural configuration for maintaining a sterile field including at least a portion of the catheterization tray throughout the catheterization procedure, wherein the structural configuration of the catheterization tray includes: a first side of the catheterization tray configured as a sterile side of the catheterization tray for a first person performing sterile steps of the catheterization procedure in the sterile field; a second side of the catheterization tray configured 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; and a partition separating the first side and the second side of the catheterization tray along a length of the catheterization tray from one end of the catheterization tray to an opposite end of the catheterization tray, wherein the contents for the catheterization procedure are disposed in the catheterization tray for removal therefrom by the first person, or the first person, and the second person, during the catheterization procedure in accordance with sterile and non-sterile work paths respectively across the first and second sides of the catheterization tray. ### Claim 8 (depends on 7) The catheterization package according to claim 7, wherein the contents for the catheterization procedure further include: a syringe of sterile saline configured for inflating a balloon of the urinary catheter; a container containing lubricant configured for lubricating the urinary catheter; and a sterile sample container configured for holding a patient's urine sample, wherein the first side of the catheterization tray is configured to include the drainage system, the syringe of sterile saline, the container containing lubricant, and the sample container. ### Claim 9 (depends on 7) The catheterization package according to claim 7, wherein the contents for the catheterization procedure further include: a waterproof underpad configured for placement under a patient; and a fenestrated drape configured for placement over a patient, wherein the second side of the catheterization tray is configured to include the waterproof underpad and the fenestrated drape. ### Claim 10 (depends on 7) The catheterization package according to claim 7, wherein the contents for the catheterization procedure further include a skin-preparation kit including a package of an antiseptic and one or more swabs configured for preparing a patient for inserting the urinary catheter, wherein the second side of the catheterization tray is configured to include the skin-preparation kit. ### Claim 11 (depends on 7) The catheterization package according to claim 7, wherein the catheterization tray includes instructions for the catheterization procedure imprinted directly on the catheterization tray, at least some of which instructions are revealed in step with the sterile and the non-sterile steps of the catheterization procedure as the contents in the catheterization tray are removed. ### Claim 12 (depends on 7) The catheterization package according to claim 7, further comprising a sterile wrap and a belly band configured to hold the sterile wrap around the catheterization tray, wherein the perineal care kit is located outside the sterile wrap with a package of hand sanitizer. ### Claim 13 (depends on 12) The catheterization package according to claim 12, wherein at least a first pair of gloves of the two or more pairs of gloves is located outside the sterile wrap. ### Claim 14 (depends on 12) The catheterization package according to claim 12, wherein at least a first pair of gloves of the two or more pairs of gloves is located inside the sterile wrap. ### Claim 15 A method of using a catheterization package, comprising: unwrapping the catheterization package to reveal a sterile catheterization tray with a structural configuration for maintaining a sterile field about a patient including at least a portion of the catheterization tray throughout a catheterization procedure, wherein the structural configuration of the catheterization tray includes: a first side of the catheterization tray configured as a sterile side of the catheterization tray for a first person performing sterile steps of the catheterization procedure in the sterile field, a second side of the catheterization tray configured 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, and a partition separating the first side and the second side of the catheterization tray along a length of the catheterization tray from one end of the tray to an opposite end of the catheterization tray, wherein sterile contents for the catheterization procedure are disposed in the catheterization tray for removal therefrom by the first person or the first person and the second person during the catheterization procedure in accordance with sterile and non-sterile work paths respectively across the first side and the second 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. ### Claim 16 (depends on 15) The method of using the catheterization package according to claim 15, 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 the patient with the perineal care kit. ### Claim 17 (depends on 15) The method of using the catheterization package according to claim 15, further comprising: placing the underpad under the patient; and placing the fenestrated drape over the patient, wherein the structural configuration of the catheterization tray enables performance of the non-sterile steps of placing the underpad under the patient and placing the fenestrated drape over the patient by either the first person or the second person while maintaining the sterile field. ### Claim 18 (depends on 15) The method of using the catheterization package according to claim 15, further comprising: preparing the patient and the urinary catheter for catheterization; and catheterizing the patient, wherein the structural configuration of the catheterization tray enables performance of the sterile steps of removing the drainage system from the catheterization tray, preparing the patient and the urinary catheter for catheterization, and catheterizing the patient by the first person while maintaining the sterile field. ### Claim 19 A method for manufacturing a catheterization package, comprising: molding a catheterization tray for the catheterization package, wherein the catheterization tray includes a structural configuration for maintaining a sterile field about a patient including at least a portion of the catheterization tray throughout a catheterization procedure, wherein the structural configuration of the catheterization tray includes: a first side of the catheterization tray configured as a sterile side of the catheterization tray for a first person performing sterile steps of the catheterization procedure in the sterile field; a second side of the catheterization tray configured 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; and a partition separating the first side and the second side of the catheterization tray along a length of the catheterization tray from one end of the catheterization tray to an opposite end of the catheterization tray; disposing contents for the catheterization procedure in the catheterization tray for removal therefrom by the first person or the first person and the second person during the catheterization procedure in accordance with sterile and non-sterile work paths respectively across the first and second sides of the catheterization tray; and sterilizing the catheterization package. ### Claim 20 (depends on 19) The method for manufacturing the catheterization package according to claim 19, wherein disposing the contents for the catheterization procedure in the catheterization tray includes placing an underpad and a fenestrated drape in the second side of the catheterization tray. ### Claim 21 (depends on 19) The method for manufacturing the catheterization package according to claim 19, 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 for the catheterization procedure in the catheterization tray; and wrapping a sterile wrap around the catheterization tray. ### Claim 22 (depends on 21) The method for manufacturing the catheterization package according to claim 21, further comprising placing a perineal care kit and a package of hand sanitizer outside the sterile wrap of the catheterization package.