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Title:
UNTETHERED CATHETER CONTAINMENT SYSTEM
Document Type and Number:
WIPO Patent Application WO/2023/183263
Kind Code:
A4
Abstract:
A catheter containment system configured for securing a proximal portion of a catheter placement system (100) within a sterile field. This relieves the clinician from holding the proximal portion to prevent them for falling outside of the sterile field. Further, the proximal portion can be secured out of the way from the insertion site providing a clear field of view. Embodiments include a body (210), having a channel (214) configured to releasably engage an extension leg (162) or guidewire, and a securement feature (220) to secure the body to a portion of a drape or similar item of the sterile field. Exemplary securement features can include clips, clasps, pins, magnetic elements, adhesives, twist ties, zip ties, snap fasteners, hook and loop attachments, mechanical grasping devices or adhesive pads. The system can further include anchor tabs that can be adhered to the drape to provide an anchor point.

Inventors:
VINCENT CHRISTOPHER (GB)
ROBBINS LUKE (GB)
INOUE NORIHIKO (GB)
ROBERTS JIM (GB)
THORNLEY KYLE (US)
SPATARO JOE (US)
STOKES JOHN (US)
HOWELL GLADE (US)
BAILEY LISA (US)
RUTLEDGE JONATHAN (US)
BRASHARES DAVID (US)
O'NEILL HANNAH (US)
Application Number:
PCT/US2023/015696
Publication Date:
November 23, 2023
Filing Date:
March 20, 2023
Export Citation:
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Assignee:
BARD ACCESS SYSTEMS INC (US)
International Classes:
A61M25/00; A61M25/06
Attorney, Agent or Firm:
WIGHT, Todd, W. (US)
Download PDF:
Claims:
AMENDED CLAIMS received by the International Bureau on 11 October 2023 (11.10.2023)

1. A catheter containment system for retaining a portion of a catheter placement system within a sterile field, comprising: an anchor including an adhesive layer disposed on first side thereof and having a “U”-shape cutline defining a tab and a foot plate, the tab coupled to the foot plate of along a first fold line, folded in a first direction, the tab including a second fold line folded in a second direction, opposite the first direction, the foot plate configured to adhere to a portion of the sterile field proximate an insertion site; and a containment device comprising: a body defining a channel extending longitudinally along a first axis, the channel configured to retain the portion of the catheter placement system, and having an opening extending longitudinally and configured to allow ingress or egress along a second axis extending at an angle to the first axis of the channel; and a securement feature coupled to the body and configured to releasably engage the anchor.

2. The catheter containment system according to claim 1, wherein the portion of the catheter placement system includes one of a catheter body, catheter hub, extension leg, luer lock, or guidewire.

3. The catheter containment system according to claim 2, wherein the body includes a first channel configured to retain a first extension leg and a second channel configured to retain a second extension leg.

4. The catheter containment system according to claim 2, wherein the body includes a first channel configured to retain a first extension leg and a second extension leg.

5. The catheter containment system according to any of the preceding claims, wherein the catheter placement system includes a RICC catheter placement system for placing a rapidly insertable central catheter.

6. The catheter containment system according to any of the preceding claims, wherein the body is rotatably, hingedly or pivotably coupled to the securement feature.

31

AMENDED SHEET (ARTICLE 19)

7. The catheter containment system according to any of the preceding claims, wherein the securement feature includes one of a spring clip, butterfly clip, beret clip, alligator clip, clothes pin, safety pin, or suction cup.

8. The catheter containment system according to any of the preceding claims, wherein the tab, folded along the second fold line, defines a first tab portion and a second tab portion, the second tab portion supporting the first tab portion along an axis extending at an angle to the foot plate.

9. The catheter containment system according to any of the preceding claims, wherein the securement feature includes a first clip member hingedly coupled to a second clip member, the first clip member including a first gripping feature configured to engage a second gripping feature of the second clip member to secure the containment device to the portion of the sterile field.

10. The catheter containment system according to any of the preceding claims, wherein the securement feature further includes a biasing member configured to bias the securement feature to a closed position, the biasing member including one of a spring, compression spring, leaf spring, O-ring, rubber grommet, or magnetic element.

11.-12. (Canceled)

13. The catheter containment system according to claim 1, wherein the securement feature includes a tie selected from a group consisting of a string, cord, wire, twist tie, or zip tie.

14. The catheter containment system according to claim 1, wherein the securement feature includes a hook slidably engaged with a sleeve, the hook having an arm with a finger plate disposed at a first end of the arm and a J-hook disposed at a second end of the arm, opposite the finger plate, the arm configured to receive a portion of the anchor between the J- hook and the sleeve.

15. The catheter containment system according to claim 1, wherein the securement feature includes a sleeve and two or more hooks slidably engaged therewith, each of the two or more hooks slidable between a retracted position, open position, and a closed position.

32

AMENDED SHEET (ARTICLE 19)

16. A catheter placement and containment system for placing a catheter within a vasculature of a patient, comprising: a catheter placement device, comprising: a needle; a catheter including an extension leg; and a guidewire; a sterile drape configured to define a sterile field around the insertion site; and a catheter containment system, comprising: an anchor including an adhesive layer disposed on first side thereof, and having a “U”-shape cutline defining a tab and a foot plate, the tab coupled to the foot plate of along a first fold line, folded in a first direction, the tab including a second fold line folded in a second direction, opposite the first direction, the foot plate configured to adhere to a portion of the sterile drape proximate the insertion site; and a catheter containment device, comprising: a body defining a channel and configured to engage a portion of the catheter placement device; and a securement feature coupled to the body and configured to secure the catheter containment device to the anchor.

17. The system according to claim 16, wherein the securement feature includes one of a spring clip, butterfly clip, beret clip, alligator clip, clothes pin, safety pin, or suction cup.

18. The system according to either claim 16 or claim 17, wherein the tab, folded along the second fold line, defines a first tab portion and a second tab portion, the second tab portion supporting the first tab portion along an axis extending at an angle to the foot plate.

19.-20. (Canceled)

21. A method of placing a catheter, comprising: providing a catheter placement system including a needle, a catheter, and a guidewire; releasably engaging a portion of the catheter placement system with a catheter containment device;

33

AMENDED SHEET (ARTICLE 19) releasably engaging the catheter containment device to an anchor adhered to a portion of a sterile field; and placing the catheter within a vasculature through an insertion site within the sterile field.

22. (Canceled)

23. The method according to claim 21, wherein the catheter containment device includes one of a spring clip, butterfly clip, beret clip, alligator clip, clothes pin, safety pin, suction cup, string, cord, wire, twist tie, or zip tie.

24. A catheter containment device for retaining a portion of a catheter placement system, comprising: a body defining a channel extending along a longitudinal axis, the channel configured to permanently retain the portion of the catheter placement system; and a handle coupled to the body and configured to releasably engage an anchor coupled to a portion of a sterile field proximate an insertion site, the anchor including an adhesive layer disposed on first side thereof, and having a “U”- shape cutline defining a tab and a foot plate, the tab coupled to the foot plate of along a first fold line, folded in a first direction, the tab including a second fold line folded in a second direction, opposite the first direction, the foot plate configured to adhere to the portion of the sterile drape.

25. The catheter containment device according to claim 24, wherein the portion of the catheter placement system includes a proximal end of a guidewire permanently affixed to the body.

26. The catheter containment device according to claim 24, wherein the portion of the catheter placement system includes a proximal portion of a guidewire slidably engaged with the body.

34

AMENDED SHEET (ARTICLE 19)