System and method for infusing toxins using safety set, connect set and cyto admin set

• US 20070282278A1
• Filed: 06/01/2006
• Published: 12/06/2007
• Est. Priority Date: 06/01/2006
• Status: Active Grant

• Current Assignee: Codan US Corporation (Codan Holding GmbH)
• Original Assignee: Codan US Corporation (Codan Holding GmbH)
• Inventors: Knight, Thomas F.
• Granted Patent: US 7,862,539 B2
• Time in Patent Office: Days
• US Class Current: 604/236
• CPC Class Codes: A61M 2039/1066 having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 2202/049 Toxic
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14

Abstract

The present invention provides a method for safely infusing a toxic fluid into a patient using a safety set, a connect set and a cyto admin set, the safety set comprising a first male locking connector having a proximal end and a distal end attached to a toxic fluid container, an interlocking slide having a proximal end and a distal end that is releasably attached to the proximal end of the first male locking connector, a needle shroud assembly containing a needle and having a proximal end and a distal end slidably attached to the proximal end of the interlocking slide, and a withdrawing syringe having a distal tip releasably attached to the proximal end of the needle shroud assembly, the connect set comprising a connect set line in fluid communication with an infusion bag, wherein the connect set includes a port for connection with the safety set such that the withdrawing syringe is in fluid communication with the infusion bag, the cyto admin set comprising one or more check valves for connection with the connect set such that the infusion bag is in fluid communication with the cyto admin set, the method comprising the steps of drawing the toxic fluid from the toxic fluid container into the withdrawing syringe, disconnecting the safety set from the toxic fluid container at a junction of the first male locking connector and the interlocking slide, pushing the interlocking slide into the needle shroud assembly such that a sharpened distal tip of the needle is positioned within a resilient septum carried by the interlocking slide, connecting a second male locking connector to the interlocking slide, connecting the second male locking connector to the connect set, dispensing the toxic fluid from the syringe into the infusion bag, withdrawing the needle to position its sharpened distal tip within the resilient septum, attaching the connect set to the cyto admin set and infusing the toxic fluid into the patient.

Claims

1. A method for safely infusing a toxic fluid into a patient using a safety set, a connect set and a cyto admin set, the safety set comprising a first male locking connector having a proximal end and a distal end attached to a toxic fluid container, an interlocking slide having a proximal end and a distal end that is releasably attached to the proximal end of the first male locking connector, a needle shroud assembly containing a needle and having a proximal end and a distal end slidably attached to the proximal end of the interlocking slide, and a withdrawing syringe having a distal tip releasably attached to the proximal end of the needle shroud assembly, the connect set comprising a connect set line in fluid communication with an infusion bag, wherein the connect set includes a port for connection with the safety set such that the withdrawing syringe is in fluid communication with the infusion bag, the cyto admin set comprising one or more check valves for connection with the connect set such that the infusion bag is in fluid communication with the cyto admin set, the method comprising the steps of:

drawing the toxic fluid from the toxic fluid container into the withdrawing syringe;

disconnecting the safety set from the toxic fluid container at a junction of the first male locking connector and the interlocking slide;

pushing the interlocking slide into the needle shroud assembly such that a sharpened distal tip of the needle is positioned within a resilient septum carried by the interlocking slide;

connecting a second male locking connector to the interlocking slide;

connecting the second male locking connector to the connect set;

dispensing the toxic fluid from the syringe into the infusion bag;

withdrawing the needle to position its sharpened distal tip within the resilient septum;

attaching the connect set to the cyto admin set; and

infusing the toxic fluid into the patient.

2. The method of claim 1, wherein after disconnecting the safety set from the toxic fluid container at a junction of the first male locking connector and the interlocking slide, the first male locking connector remains attached to the toxic fluid container such that first male locking connector functions as a seal for the toxic fluid container.

3. The method of claim 1, wherein the step of pushing the interlocking slide into the needle shroud assembly involves the step of guiding the interlocking slide within the needle shroud assembly such that one or more outwardly projecting pins of the interlocking slide are received within corresponding slots of the needle shroud assembly.

4. The method of claim 3, wherein the slots include longitudinal portions and cross-slot portions.

5. The method of claim 1, wherein the step of connecting the second male locking connector to the interlocking slide involves threadably attaching a threaded proximal end of the second male locking connector to a distal end of the interlocking slide.

6. The method of claim 1, wherein the step of connecting the second male locking connector to the connect set comprises attaching a distal end of the second male locking connector to a vial spike of the connect set by way of a drug entry port.

7. The method of claim 6, wherein the step of connecting the second male locking connector to the connect set further comprises rotating the interlocking slide relative to, and pushing the interlocking slide into, the needle shroud assembly, thereby forcing the needle through a resilient septum carried by the second male locking connector.

8. The method of claim 1, wherein the step of attaching the connect set to the cyto admin set comprises attaching the connect set to a check valve of the cyto admin set to permit fluid communication between the connect set and the cyto admin set.

9. The method of claim 1, wherein a primary line of the cyto admin set is clamped off while the toxic fluid is being infused into the patient.

10. The method of claim 1, wherein the cyto admin set includes a dedicated universal spike adapter configured to be connected with a conventional spike on a conventional pump set.

11. The method of claim 10, wherein the conventional pump set comprises a spike, a pump key, a length of tubing, a needleless y-site, a roller clamp, or a luer lock for attachment with an IV catheter that connects to the patient'"'"'s blood vessel.

19. The system of claim 1, wherein the cyto admin set includes a dedicated universal spike adapter configured to be connected with a conventional spike on a conventional pump set.

20. The system of claim 19, wherein the conventional pump set comprises a spike, a pump key, a length of tubing, a needleless y-site, a roller clamp, or a luer lock for attachment with an IV catheter that connects to the patient'"'"'s blood vessel.

12. A system for safely infusing a toxic fluid into a patient, comprising:

a safety set comprising a first male locking connector having a proximal end and a distal end attached to a toxic fluid container, an interlocking slide having a proximal end and a distal end that is releasably attached to the proximal end of the first male locking connector, a needle shroud assembly containing a needle and having a proximal end and a distal end slidably attached to the proximal end of the interlocking slide, and a withdrawing syringe having a distal tip releasably attached to the proximal end of the needle shroud assembly;

a connect set comprising a connect set line in fluid communication with an infusion bag, wherein the connect set includes a port for connection with the safety set such that the withdrawing syringe is in fluid communication with the infusion bag; and

a cyto admin set comprising one or more check valves for connection with the connect set such that the infusion bag is in fluid communication with the cyto admin set;

wherein the toxic fluid is drawn from the toxic fluid container into the withdrawing syringe;

wherein the safety set is disconnected from the toxic fluid container at a junction of the first male locking connector and the interlocking slide;

wherein the interlocking slide is pushed into the needle shroud assembly such that a sharpened distal tip of the needle is positioned within a resilient septum carried by the interlocking slide;

wherein a second male locking connector is connected to the interlocking slide;

wherein the second male locking connector is connected to the connect set;

wherein the toxic fluid is dispensed from the syringe into the infusion bag;

wherein the needle is withdrawn to position its sharpened distal tip within the resilient septum;

wherein the connect set is attached to the cyto admin set the toxic fluid is infused into the patient.

13. The system of claim 12, wherein after disconnecting the safety set from the toxic fluid container at a junction of the first male locking connector and the interlocking slide, the first male locking connector remains attached to the toxic fluid container such that first male locking connector functions as a seal for the toxic fluid container.

14. The system of claim 12, wherein pushing the interlocking slide into the needle shroud assembly involves guiding the interlocking slide within the needle shroud assembly such that one or more outwardly projecting pins of the interlocking slide are received within corresponding slots of the needle shroud assembly.

15. The system of claim 12, wherein connecting the second male locking connector to the interlocking slide involves threadably attaching a threaded proximal end of the second male locking connector to a distal end of the interlocking slide.

16. The system of claim 12, wherein the step of connecting the second male locking connector to the connect set comprises attaching a distal end of the second male locking connector to a vial spike of the connect set by way of a drug entry port.

17. The system of claim 16, wherein connecting the second male locking connector to the connect set further comprises rotating the interlocking slide relative to, and pushing the interlocking slide into, the needle shroud assembly, thereby forcing the needle through a resilient septum carried by the second male locking connector.

18. The system of claim 12, wherein attaching the connect set to the cyto admin set comprises attaching the connect set to a check valve of the cyto admin set to permit fluid communication between the connect set and the cyto admin set.