Systems and methods for providing a closed venting hazardous drug IV set

• US 8,870,846 B2
• Filed: 01/10/2013
• Issued: 10/28/2014
• Est. Priority Date: 05/06/2010
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Davis, Bryan G., Hoang, Minh Quang
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US13/738,889
• Publication Number:
  US 20130102974A1
• Time in Patent Office: 656 Days
• Field of Search: 604 80- 87, 604/122, 604/126, 604/247, 604/251, 60428801-28804, 604/246, 604/257, 604/506
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2202/049 Toxic
• CPC Class Codes: A61M 39/20 Closure caps or plugs for connectors or open ends of tubes
• CPC Class Codes: A61M 5/1411 Drip chambers A61M5/162, A61M5/1689, A61M5/40 take 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
• CPC Class Codes: A61M 5/165 Filtering accessories, e.g. blood filters, filters for infusion liquids A61M1/14 , A61M1/34, A61M1/3627, A61M1/3679, A61M1/3687 take precedence; needle sets with incorporated air inlet filters A61M5/162
• CPC Class Codes: A61M 5/38 using hydrophilic or hydrophobic filters

Abstract

A device for priming and venting a hazardous drug within an intravenous administration set. The device includes various access ports and fluid channels to permit direct injection of a hazardous drug into the fluid reservoir, while eliminating the possibility of undesirable exposure to the hazardous drug. The device further includes priming and flushing ports to enable flushing of a hazardous drug from the system following an infusion procedure.

Claims

1. A device for storing and administering a hazardous solution to a patient via an intravenous needle, the device comprising:

a spike comprising a first fluid pathway having an input and an output and a second fluid pathway having an input and an output, the spike being configured to insert within a primary fluid reservoir such that the input of the first fluid pathway and the output of the second fluid pathway are in fluid communication with a fluid within the primary fluid reservoir;

an access port coupled to the spike, the access port forming the input to the second fluid pathway, wherein the access port is configured to receive a syringe for injecting a hazardous drug into the primary fluid reservoir and to irreversibly lock the syringe within the access port to prevent removal of the syringe from the access port thereby minimizing the risk of exposure to the hazardous drug;

a drip chamber fluidly coupled to the spike and comprising an input and an output positioned at a bottom of the drip chamber, the drip chamber input being fluidly coupled to the output of the first fluid pathway, the output of the drip chamber being configured to receive a patient conduit; and

a flushing port coupled to the drip chamber to thereby enable a flushing fluid to be injected directly into the drip chamber through the flushing port.

2. The device of claim 1, wherein the flushing port also comprises a priming port for injecting a priming solution into the drip chamber.

3. The device of claim 1, further comprising:

a membrane covering the output of the drip chamber, wherein the membrane comprises a hydrophilic material that traps fluid to thereby prevent passage of air from the drip chamber to the output of the drip chamber.

4. The device of claim 3, wherein the membrane limits the flow rate of fluid from the drip chamber.

5. The device of claim 4, wherein the output of the drip chamber is connected to a patient conduit having a vent membrane attached thereto, and wherein the membrane is configured to provide a flow rate that matches a flow rate of the vent membrane.

6. The device of claim 1, wherein the flushing port extends from a sidewall of the drip chamber.

7. The device of claim 1, wherein the flushing port comprises a septum which seals the flushing port from an external environment.

8. The device of claim 1, wherein a hazardous drug is injected through the access port and into the primary fluid reservoir to mix with the fluid within the primary fluid reservoir and then pass into a patient via the drip chamber and the patient conduit, and wherein the fluid containing the hazardous drug is flushed from the drip chamber and patient conduit by injecting a flushing fluid through the flushing port.

9. A device for storing and administering a hazardous solution to a patient via an intravenous needle, the device comprising:

a spike comprising a first fluid pathway having an input and an output and a second fluid pathway having an input and an output, the spike being configured to insert within a primary fluid reservoir such that the input of the first fluid pathway and the output of the second fluid pathway are in fluid communication with a fluid within the primary fluid reservoir;

an access port forming the input of the second fluid pathway, the access port enabling a fluid containing a hazardous drug to be injected into the primary fluid reservoir;

a drip chamber fluidly coupled to the spike and comprising an input and an output, the drip chamber input being fluidly coupled to the output of the first fluid pathway, and the output of the drip chamber being configured to receive a patient conduit;

a priming port being positioned on a sidewall of the drip chamber, the priming port comprising a sealed second input to the drip chamber, wherein the priming port is configured to receive a syringe containing a second fluid such that the second fluid can be injected into the drip chamber via the priming port; and

a vent, separate from the priming port, that is positioned on a sidewall of the drip chamber, the vent including a filter that is configured to filter hazardous gas that is generated as the hazardous drug passes through the drip chamber.

10. The device of claim 9, wherein the priming port is sealed via a septum.

11. The device of claim 10, wherein the syringe is inserted through the septum to inject the second fluid into the drip chamber.

12. The device of claim 9, wherein the second fluid comprises a non-hazardous drug.

13. The device of claim 9, wherein the second fluid comprises a flushing fluid for flushing a hazardous drug from the drip chamber.

14. The device of claim 9, wherein the access port is configured to receive a syringe for injecting a hazardous drug into the primary fluid reservoir and to lock the syringe within the access port to prevent removal of the syringe from the access port thereby minimizing the risk of exposure to the hazardous drug.

15. The device of claim 14, wherein a hazardous drug is injected through the access port and into the primary fluid reservoir to mix with the fluid within the primary fluid reservoir and then pass into a patient via the drip chamber and the patient conduit, and wherein the fluid containing the hazardous drug is flushed from the drip chamber and patient conduit by injecting a flushing fluid through the priming port.

16. The device of claim 9, wherein the second fluid is a priming fluid.

17. A method for administering a hazardous drug to a patient, the method comprising:

priming an IV system in preparation for administering a hazardous drug to a patient, the IV system comprising;

a spike comprising a first fluid pathway having an input and an output and a second fluid pathway having an input and an output, the spike being configured to insert within a primary fluid reservoir such that the input of the first fluid pathway and the output of the second fluid pathway are in fluid communication with a fluid within the primary fluid reservoir;

an access port coupled to the spike, the access port forming the input to the second fluid pathway;

a drip chamber fluidly coupled to the spike and comprising an input and an output positioned at a bottom of the drip chamber, the drip chamber input being fluidly coupled to the output of the first fluid pathway, the output of the drip chamber being configured to receive a patient conduit; and

a priming/flushing port coupled to the drip chamber thereby providing direct fluid access to the drip chamber, the priming/flushing port including a septum that forms an airtight seal which maintains pressure within the drip chamber;

wherein the IV system is primed by inserting a device containing a priming fluid into the priming/flushing port to bypass the septum and injecting the priming fluid into the drip chamber;

inserting the spike of the IV system into a primary fluid reservoir containing an intravenous fluid;

inserting a device containing a hazardous drug into the access port and injecting the hazardous drug into the primary fluid reservoir to be mixed with the intravenous fluid for delivery through the IV system into the vasculature of a patient; and

after the intravenous fluid containing the hazardous drug has passed through the IV system, inserting a device containing a flushing fluid into the priming/flushing port to bypass the septum and injecting the flushing fluid into the drip chamber such that the flushing fluid washes residual intravenous fluid containing the hazardous drug through the IV system and into the vasculature of the patient.

18. The method of claim 17, wherein the access port locks the device containing the hazardous drug within the access port to minimize the risk of exposure to any hazardous drug that remains on the device after the hazardous drug is injected into the primary fluid reservoir.