BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of an extension set of a system for safely infusing a toxic fluid into a patient, in accordance with the principles of the present invention;
FIG. 2 is a schematic view of a the extension set of FIG. 1 attached to a connect set of the system for safely infusing a toxic fluid into a patient, in accordance with the principles of the present invention; and
FIG. 3 is a schematic view of the connect set of FIG. 2 attached to a cyto admin set of the system for enabling toxic solutions to be safely infused into a patient, in accordance with the principles of the present invention.
DETAILED DESCRIPTION
In the following paragraphs, the present invention will be described in detail by way of example with reference to the attached drawings. Throughout this description, the preferred embodiment and examples shown should be considered as exemplars, rather than as limitations on the present invention. As used herein, the “present invention” refers to any one of the embodiments of the invention described herein, and any equivalents. Furthermore, reference to various feature(s) of the “present invention” throughout this document does not mean that all claimed embodiments or methods must include the referenced feature(s).
The present invention provides a system and method for enabling toxic solutions such as used in chemotherapy to be safely infused into a patient with a considerably lower risk of contacting the patient or the handler(s) performing the infusion. In particular, an infusion and flushing system is used to transfer, mix and deliver hazardous fluid such as drugs or toxins from a supplied drug container to an intravenous bag or delivery system, wherein the drugs or toxins are then infused into the patient.
Referring to FIG. 1-3, a preferred system for enabling toxic solutions such as used in chemotherapy to be safely infused with a significantly reduced risk of contacting the patient or the handler(s) performing the infusion will now be described. Specifically, the system comprises an extension set 30 (depicted in FIGS. 1 and 2), a connect set 70 (depicted in FIGS. 2 and 3), and a cyto admin set 120 (depicted in FIG. 3). As illustrated in FIG. 1, the extension set 30 comprises a vial spike 15 for penetrating a drug container 20 in order to withdraw the fluid therefrom, an extension set line 25 (including a stopcock 35) for connecting the vial spike 15 to a pair of extension set syringes 50, 60. The extension set syringes 50, 60 may comprise standard luer locking syringes including a first syringe 50, which is initially empty, and a second syringe 60, which is initially filled with a flush solution. The extension set 30 is attached to the vial spike 15 via a male luer lock 55, which is generally disposed at a distal end of the line 25. The vial spike 15 preferably includes an inline filtration membrane that allows the drug to be filtered as it is withdrawn from the drug container 20.
The stopcock 35 includes three distinct positions comprising a first position which allows fluid flow of the toxic drug from the drug container 20 to the first syringe 50, a second position which allows fluid flow between the second syringe 60 and the drug container 20, and a third position in which all fluid flow is prevented. In accordance with the principles of the invention, the stopcock 35 includes an engineered controlled safety feature in that the stop post on the stopcock 35 prevents the flush syringe 60 and the drug syringe 50 from being opened at the same time, which would otherwise compromise the flushing and the fluid barrier protection afforded the handler. Additionally, the stopcock 35 permits the extension set line 25 to be flushed after drug delivery to rinse out any hazardous drug residue to prevent undue exposure of the toxic drug to the surrounding environment. After withdrawing the toxic fluid from the drug container into the first syringe 50, the stopcock 35 is turned to the second position, whereby the extension set line 25 is flushed by injecting a flush solution from the second syringe 60 through the extension set line 25 and into the drug container 20. At this time, the extension set 30 may be safely detached from the drug container 20.
Turning now to FIG. 2, the connect set 70 comprises a one-way valve port 78 for connecting the connect set line 82 at one end to an infusion bag 86 or other delivery system. The connect set 70 further comprises a connect set line 82, a clamp 88, and a spin lock 84 attached to the other end of the connect set line 82. As illustrated in FIG. 2, the extension set 30 is configured to be attached to the connect set 70 by way of the male luer lock 55, which is attached in a conventional manner to a side port 85 of the one-way valve port 78 to allow the fluids in the syringes 50, 60 to be moved into the infusion bag 86. During this process, the clamp 88 is used to prevent any fluids from entering the connect set line 82. In operation, the toxic fluid located in the first syringe 50 is injected through the extension set line 25 and one-way valve port 78 into the infusion bag 86. Then, the remaining flush solution within the second syringe 60 is injected into the infusion bag 86 in order to flush the extension set line 25 after drug delivery to rinse out any hazardous drug residue and prevent undue exposure of the toxic drug to the surrounding environment. The handler may manually knead the infusion bag 86 to mix the toxic drug and flush solution. At this point, the male luer lock 55 optionally may be disconnected from the side port 85 such that the extension set 30 may be disposed.
Referring to FIG. 3, the cyto admin set 120 comprises a one-way valve port 90 in fluid communication with an intravenous bag 100, a clamp 110, and a primary line 125 for the passage of saline or neutral fluids into the patient. The clamp 110 is used to obstruct the primary line 125 while the toxic fluid is being infused into the patient. The cyto admin set 120 further comprises a plurality of check valves 130 and a dedicated universal spike adapter 135. In the illustrated embodiment, the cyto admin set 120 contains four check valves 130. However, as would be appreciated by those of skill in the art, the cyto admin set 120 may include any number of check valves 130 without departing from the scope of the present invention. The connect set 70 is attached to one of the check valves 130 via the spin lock 84 to permit fluid communication between the connect set 70 and the cyto admin set 120. By way of example, the other check valves 130 may be employed to selectively infuse other solutions into the patient on an as needed basis.
Once fluid communication is established, the toxic fluids within the infusion bag are infused into the patient by way of the connect set line 82, the check valve 130 and the dedicated universal spike adapter 135, which is configured to be connected with virtually any conventional spike on any pump set. The pump set, for example, may comprise a spike, a pump key, a length of tubing, a needleless y-site, a roller clamp, and a luer lock for attachment with an IV catheter that connects to the patient's blood vessel. Since the dedicated universal spike adapter 135 is compatible with existing pump equipment, the connect set 70 may be attached to the existing pump sets without affecting the overall function of the device.
With further reference to FIGS. 1-3, a method of safely infusing toxins into a patient according to the principles of the present invention will now be described. Referring to FIG. 1, the method initially involves puncturing the drug container 20 with the vial spike 15 of the extension set 30 and turning the stopcock 35 to the first position to allow fluid flow of the toxic drug from the drug container 20 to the first syringe 50. In particular, the first syringe 50 is employed to draw fluid from the drug container 20 through the extension set line 25 and into the first syringe 50. The next step involves turning the stopcock 35 to the second position to allow fluid flow between the second syringe 60 and the drug container 20, whereby the second syringe 60 empties approximately one half of the flush solution through the extension set line 25 and into the drug container 20. The subsequent steps entail turning the stopcock 35 to the third, closed position and then disconnecting and capping the male luer lock 55 such the extension set 30 may be handled without fear of exposure to toxic fluid.
Referring to FIG. 2, the next steps involve attaching the male luer lock 55 of the extension set 30 to the side port 85 of the one-way valve port 78 of the connect set 70 to allow the fluids in the syringes 50, 60 to be moved into the infusion bag 86. Another step involves using the clamp 88 to prevent any fluids from entering the connect set line 82. The subsequent step comprises injecting the toxic fluid located in the first syringe 50 into the infusion bag 86 by way of the extension set line 25 and one-way valve port 78. In the next step, the remaining flush solution within the second syringe 60 is injected into the infusion bag 86 in order to flush the extension set line 25 and one-way valve port 78 after drug delivery. Optionally, the male luer lock 55 may be disconnected from the side port 85 and the extension set 30 disposed. In the next step, the handler may manually knead the infusion bag 86 to mix the toxic drug and flush solution.
Referring to FIG. 3, the next steps involve moving the connect set 70 to the vicinity of the patient and then attaching the connect set to the cyto admin set 120. In particular, the connect set 70 is attached to one of the check valves 130 of the cyto admin set 120 via the spin lock 84 to permit fluid communication between the connect set 70 and the cyto admin set 120. The primary line 125 of the cyto admin set 120 for the passage of saline or neutral fluids into the patient may be clamped off (using clamp 110) while the toxic fluid is being infused into the patient. The subsequent steps entail removing the clamp 88 from the connect set line 82 to allow fluid flow from the infusion bag 86 to the patient and infusing the toxic fluid into the patient. After infusion of the toxic fluid, the clamp 110 may be removed from the primary line 125 which that the infusion of fluids from the intravenous bag 100 may be resumed.
Thus, it is seen that a system and method for safely infusing toxins is provided. One skilled in the art will appreciate that the present invention can be practiced by other than the various embodiments and preferred embodiments, which are presented in this description for purposes of illustration and not of limitation, and the present invention is limited only by the claims that follow. It is noted that equivalents for the particular embodiments discussed in this description may practice the invention as well.
Patent Application
20070282297
