Syringe fluid flow switching device

Abstract

A fluid flow switching device includes: a first fluid communication channel; a second fluid communication channel; a third fluid communication channel between a first fluid outlet and a second fluid inlet, and including a third fluid inlet, a syringe, and a third fluid outlet; and a valve device having first and second positions and being in communication with the first, second, and third communication channels, wherein the valve device being in the first position allows driving fluid to be received via the first fluid outlet and the third fluid inlet to a driving fluid volume of the syringe and drug to be administered from the drug volume of the syringe to a patient, wherein the valve device being in the second position allows driving fluid to be communicated, thereby permitting the driving fluid to flush the fluid switching device.

Description

SYRINGE FLUID FLOW SWITCHING DEVICETECHNICAL FIELD

[0001] The present disclosure relates to fluid flow switching devices for use in medical injection systems.BACKGROUND

[0002] Pharmaceutical products (including large and small molecule pharmaceuticals) are administered to patients using a variety of different drug delivery devices for the treatment of a variety of different medical indications. Drug delivery devices for delivering liquid drugs include, for example, syringes, manual injectors, pen injectors, auto injectors, on-body delivery devices, and off-body delivery devices. These delivery devices commonly include an actuator, a drug container, and a needle or cannula. The drug container contains the liquid drug and the actuator drives the liquid drug from the drug container, and through the needle or cannula to the patient.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] FIG. 1 depicts an example of a syringe fluid flow switching device according to one or more embodiments described herein.

[0004] FIG. 2 depicts an example plan view of a syringe fluid flow switching device according to one or more embodiments described herein.

[0005] FIGS. 3A and 3B depict an example of a valve device for a syringe fluid flow switching device according to one or more embodiments described herein.

[0006] FIG. 4 depicts dispensing a dose of a drug using the syringe flow switching device 100 according to one or more embodiments described herein.

[0007] FIGS. 5 A and 5B depict preparing a first syringe and a second syringe for use with a syringe flow switching device according to one or more embodiments described herein.

[0008] FIGS. 6A, 6B and 6C depict preparing a syringe flow switching device according to one or more embodiments described herein.

[0009] FIGS. 7A, 7B and 7C depict attaching a first syringe to the syringe flow switching device according to one or more embodiments described herein.

[0010] FIGS. 8 A, 8B and 8C depict priming a syringe flow switching device with driving fluid according to one or more embodiments described herein.

[0011] FIG. 9 depicts priming an injection apparatus attached to a syringe flow switching device according to one or more embodiments described herein.

[0012] FIGS. 10A and 10B depict delivering the drug to a patient using the syringe flow switching device according to one or more embodiments described herein.

[0013] FIG. 11 depicts flushing the syringe flow switching device according to one or more embodiments described herein.

[0014] FIG. 12A depicts an example of a syringe fluid flow switching device according to one or more embodiments described herein.

[0015] FIG. 12B depicts an example plan view of a syringe fluid flow switching device according to one or more embodiments described herein.

[0016] FIG. 13 depicts preparing a syringe flow switching device according to one or more embodiments described herein.

[0017] FIG. 14 depicts setting a valve device of a syringe flow switching device according to one or more embodiments described herein.

[0018] FIG. 15 depicts inserting a first syringe into a syringe flow switching device according to one or more embodiments described herein.

[0019] FIG. 16 depicts priming a syringe flow switching device with driving flulid according to one or more embodiments described herein.

[0020] FIG. 17 depicts completion of priming a syringe flow switching device with driving fluid according to one or more embodiments described herein.

[0021] FIG. 18 depicts setting a valve device to prime a syringe flow switching device with a drug according to one or more embodiments described herein.

[0022] FIG. 19 depicts positioning of an injection apparatus of a syringe flow switching device at a patient site according to one or more embodiments described herein.

[0023] FIG. 20 depicts delivering the drug of a syringe flow switching device according to one or more embodiments described herein.

[0024] FIG. 21 depicts setting a valve device of a syringe flow switching device according to one or more embodiments described herein.

[0025] FIG. 22 depicts flushing of remaining drug from a syringe flow switching device according to one or more embodiments described herein.

[0026] Various embodiments are described in detail below with reference to the accompanying drawings, wherein like reference numerals represent like elements. DESCRIPTION OF EMBODIMENTS

[0027] A drug delivery system may be used to provide injection of a drug over a relatively long distance between a patient and a supply of the pharmaceutical product. Such a drug delivery system may be referred to as a remote drug delivery system and may be in contrast to simply injecting a patient directly with a syringe. As recognized by the inventors, it may bedifficult to provide a stable force to inject the drug into the patient in a remote drug delivery system. Further, the drug may be expensive, and as such, it may be undesirable to leave leftover drug in the remote drug delivery system, and it may desirable to inject as much of the drug into the patient as possible.

[0028] As discovered by the inventors, a syringe fluid flow switching device may employ a remote hydraulic pushing force to inject a drug into a patient. To use a remote hydraulic pushing force, a mechanical separation may be used between a driver section of the syringe and an injection section of the syringe. Such a mechanical separation may prevent mixing of a driving fluid from the driver section and the drug in the injection section.

[0029] Moreover, as realized by the inventors, it may be desirable to maximize the utilization of the drug while preventing mixing of the driving fluid with the drug. Further, it may be desirable to allow the driving fluid to flush the system after the drug has been delivered to the patient. As discovered by the inventors, the syringe fluid flow switching device may further employ a valve device to prevent mixing of the driving fluid from the driver section and the drug in the injection section. The valve device may also be capable of flushing the syringe fluid flow switching device so that as much of the drug is injected into the patient as possible and so that as little of the drug remains in the syringe fluid flow switching device as possible.

[0030] In some embodiments, a fluid flow switching device may include a valve device having a first position and a second position and being in communication with a first fluid communication channel providing driving fluid (e.g., saline), a second fluid communication channel to expel a drug (e.g., a pharmaceutical product, a large molecule pharmaceutical, a small molecule pharmaceutical, a fluid medicant, etc.) for injecting the patient, and a third fluid communication channel having a syringe. The syringe may include an interior volume dividedinto a driving fluid volume for fluidly communicating with the first fluid communication channel and a drug volume for fluidly communicating with the second fluid communication channel. In the first position, the valve device may allow driving fluid to be received in the driving fluid volume from first fluid communication channel and drug to be administered from the drug volume into the second fluid communication channel, thereby administering the drug to a patient. In the second position, the valve device may allow driving fluid to be communicated from the first fluid communication channel to the second first fluid communication channel, thereby permitting the driving fluid to flush the fluid switching device. As an example, the valve device may include a pinchable internal shunt between the first fluid communication channel and the second communication channel. As an example, the valve device may include a first rotatable internal shunt and a second rotatable internal shunt.

[0031] In some embodiments, a fluid flow switching device may include a valve device having a first position and a second position and being in communication with a first fluid communication channel having a syringe and a second fluid communication channel for providing driving fluid (e.g., saline). The syringe may include an interior volume divided into a driving fluid volume for fluidly communicating with the second fluid communication channel and a drug volume for providing the drug (e.g., a pharmaceutical product, a large molecule pharmaceutical, a small molecule pharmaceutical, a fluid medicant, etc.) to a patient. In the first position, the valve device may allow flow through the first fluid communication channel and restrict flow through the second fluid communication channel, thereby administering the drug to a patient. In the second position, the valve device may flow through the second fluid communication channel and restrict flow through the first fluid communication channel, thereby permitting the driving fluid to flush the fluid switching device. As an example, in the firstposition and then in the second position, the valve device may alternately pinch the second fluid communication channel and then the first communication channel, respectively.

[0032] FIG. 1 depicts an example of a syringe fluid flow switching device 100 according to one or more embodiments described herein, and FIG. 2 depicts an example plan view of the syringe fluid flow switching device 100 according to one or more embodiments described herein. The syringe fluid flow switching device 100 may include a valve housing 10 and a third fluid communication channel 17. The valve housing 10 may include a first fluid communication channel 16, a second fluid communication channel 22, and a valve device 30. The first fluid communication channel 16 may have a first fluid inlet 12 and a first fluid outlet 14. The first fluid inlet 12 may receive fluid from a fluid inlet line 13. The second fluid communication channel 22 may have a second fluid inlet 18 and a second fluid outlet 20. The second fluid outlet 20 may lead to fluid outlet line 21. The valve device 30 may include a pinchable internal shunt 24, which by action of the valve device 30 may form a fourth fluid communication channel between the first fluid communication channel 16 and the second fluid communication channel 22. The valve device 30 may be a rotary device and may include a rotary knob 32 or other mechanism for manual or processor-controlled rotation.

[0033] The valve device 30 may be capable of being positioned in a first position or a second position. In the first position, the valve device 30 may pinch the pinchable internal shunt 24 so as to close the pinchable internal shunt 24 and not permit fluid flow in the fourth fluid communication channel between the first fluid communication channel 16 and the second fluid communication channel 22. The arrow 39 may indicate where the pinchable internal shunt 24 may be pinched. In the first position, the valve device 30 may maintain fluid separation between the first and second fluid communication channel 16, 22.

[0034] In the second position, the valve device 30 may allow the pinchable internal shunt 24 to be open and permit fluid flow in the fourth fluid communication channel between the first fluid communication channel 16 and the second fluid communication channel 22. In the second position, the valve device 30 may provide a direct fluid communication path between the first and second fluid communication channels 16, 22.

[0035] The valve device 30 may include a visual indicator 31 to display a status of the valve device 30. The visual indicator 31 may include a window in the valve housing 10 to display different indicia depending on a position of the valve device 30. As an example, for the valve device 30 in the first position, the visual indicator 31 may display “RX” for indicating pharmaceutical administration, and for the valve device 30 in the second position, the visual indicator 31 may display “flush” for indicating system flush.

[0036] The third fluid communication channel 17 may include a first syringe 40, a fluid line 15, and a closed system drug-transfer device (CSTD) 52. The first syringe 40 may include a barrel 41, an adapter 44, a syringe inlet port 45, and a syringe outlet port 50. The barrel 41 may define an internal volume of the first syringe 40 and may include a separating member 48 slidably translatable within the internal volume of the first syringe 40. The separating member 48 may separate the internal volume defined by barrel 41 of the first syringe 40 into a driving fluid volume 42 and a drug volume 43. The adapter 44 may include the syringe inlet port 45 and a syringe vent 46. The syringe inlet port 45 may be in fluid communication with the fluid line 15. The syringe outlet port 50 may be in fluid communication with the CSTD 43.

[0037] The fluid line 15 may be in fluid communication with the first fluid outlet 14 and the syringe inlet port 45. The driving volume 42 of the first syringe 40 may be in fluid communication with the first fluid outlet 14 via the fluid line 15.

[0038] The CSTD 54 may have an inlet 54 and an outlet 56. The inlet 54 of the CSTD 52 may be in fluid communication with the syringe outlet port 50 and the drug volume 43. The outlet 56 of CSTD 52 may be in fluid communication with the second fluid inlet 18. The outlet 56 of CSTD 52 may include a luer fitting.

[0039] In use, the syringe fluid flow switching device 100 may be in fluid communication with an injection apparatus 102, as depicted in FIG. 2. The injection apparatus 102 may be in fluid communication with fluid outlet line 21. The second fluid communication channel 22 may be in fluid communication with the injection apparatus 102 via the fluid outlet line 21.

[0040] In use, the driving fluid for the syringe fluid flow switching device 100 may be provided by a driving fluid providing device, such as a second syringe 110 as depicted in FIG. 2. The second syringe 110 may be a source of driving fluid for the syringe fluid flow switching device 100. The second syringe 110 may be in fluid communication with the first fluid inlet 12 through fluid inlet line 13. The second syringe 110 may include a plunger 112, a seal 116 slidably operating within a barrel 114, and an outlet 118. The second syringe 110 may be operated so as to eject driving fluid out of the outlet 118 of the second syringe 110 through the fluid inlet line 13 and into the first fluid communication channel 16. In some embodiments, the second syringe 110 may be operated using a syringe pump 300. In some embodiments, the second syringe 110 may be operated manually.

[0041] In operation, driving fluid may be injected from second syringe 110 to first fluid inlet 12 via fluid inlet line 13. In the first (or “RX”) position (e.g., blocking fluid flow through pinchable internal shunt 24), the valve device 30 may permit the driving fluid to be pushed through first fluid communication channel 16, out of first fluid outlet 14, and into third fluid communication channel 17. Once in the third fluid communication channel 17, the driving fluidmay be pushed into syringe inlet port 45 on adapter 44 of first syringe 40 and into driving fluid volume 42. The force of driving fluid moving into driving fluid volume 42 may, in turn, urge separating member 48 to move toward drug volume 43 and force the drug out of drug volume 43, through outlet port 50 of first syringe 40, into the inlet 54 of CSTD 52 and out of outlet 56 of CSTD 52. The drug may then flow into the second fluid inlet 18 and through second fluid communication channel 22 to be administered to a patient via fluid outlet line 21 and injection apparatus 102.

[0042] In the second (or “flush”) position (e.g., allowing fluid flow through pinchable internal shunt 24), the valve device 30 may permit the driving fluid to be pushed through first fluid inlet 13, through pinchable internal shunt 24, and out second fluid outlet 20, resulting in a remainder of the drug in fluid outlet line 21 and injection apparatus 102 to be flushed out and / or administered to the patient.

[0043] In some embodiments, instead of the pinchable internal shunt 24, the valve device 30 may use other mechanisms to switch fluid flow in the valve housing 10. For example, FIGS. 3 A and 3B depict an example of a valve device 30’ for a syringe fluid flow switching device 100 according to one or more embodiments described herein. Instead of the pinchable internal shunt 24, the valve device 30’ may include a first rotatable internal shunt 34A and a second rotatable internal shunt 34B. When the valve device 30’ is placed in a first position (e.g., by rotation), as shown in FIG. 3A, first internal shunt 34A may form a fluid communication channel between first fluid inlet 12 and first fluid outlet 14, and the second internal shunt 34B may form a fluid communication channel between second fluid inlet 18 and second fluid outlet 20. In this first position, as shown in FIG. 3A, first and second rotatable internal shunts 34A, 34B may be oriented so as to form part of the respective first and second fluid communication channels 16,22, and the fluid flow configuration may be essentially identical to the first position as discussed above. When the valve device 30’ is placed in a second position (e.g., by rotation), as shown in FIG. 3B, first internal shunt 34A may form a fluid communication channel between first fluid inlet 12 and second fluid outlet 20, and the second internal shunt 34B may form a fluid communication channel between first fluid outlet 14 and second fluid inlet 18.

[0044] Due to the partial rotational symmetry of valve device 30’ of this example, first and second internal shunts 34A, 34B may reverse positions while maintaining functionality of the syringe flow switching device 100. In other words, the reverse is also contemplated. In the reverse for FIG. 3A, valve device 30’ may be rotated so that first internal shunt 34A may form a fluid communication channel between second fluid inlet 18 and second fluid outlet 20, and the second internal shunt 34B may form a fluid communication channel between first fluid inlet 12 and first fluid outlet 14. Further, in the reverse for FIG. 3B, valve device 30’ may be rotated so that the first internal shunt 34A may form a fluid communication channel between first fluid outlet 14 and second fluid inlet 18, and the second internal shunt 34B may form a fluid communication channel between first fluid inlet 12 and second fluid outlet 20.

[0045] FIGS. 4-11 depict steps in an exemplary method for operating the syringe flow switching device 100 according to one or more embodiments described herein. Additional processes also may be included, and it should be understood that the method depicted in FIGS. 4- 11 represent illustrations, and that other processes may be added or existing processes may be removed, modified, or rearranged without departing from the scope of the present disclosure.

[0046] FIG. 4 depicts dispensing a dose of a drug using the syringe flow switching device 100 according to one or more embodiments described herein. A dose of the drug may be compounded and initially placed into pharmaceutical vial 104. The outlet 56 of CSTD 52 maybe attached to the vial 104. The inlet 54 of CSTD 52 may be attached to outlet port 50 of the first syringe 40 in fluid communication with drug volume 43. The drug within drug volume 43 of first syringe 40 may be divided into the dose 43A and the overage 43B. A plunger 49 may be slidably disposed within barrel 41 of first syringe 40 and may be used to draw the medicant from vial 104 to the first syringe 40 in a standard manner. The first syringe 40, the CSTD 52, and the medicant may be moved to a next step.

[0047] FIGS. 5 A and 5B depict preparing the first syringe 40 and the second syringe 110 for use with the syringe flow switching device 100 according to one or more embodiments described herein. In FIG. 5 A, the second syringe 110 may be provided with driving fluid. FIG. 5 A may depict a first step of an exemplary method for operating the syringe flow switching device 100. In FIG. 5B, plunger 49 is detached from the first syringe 40, such as by rotating plunger 49 out of separating member 48 or by disengaging an engagement mechanism between plunger 49 and separating member 48. FIG. 5B may depict a second step of an exemplary method for operating the syringe flow switching device 100.

[0048] FIGS. 6A, 6B and 6C depict preparing a syringe flow switching device 100 according to one or more embodiments described herein. FIGS. 6A, 6B and 6C may depict a third step of an exemplary method for operating the syringe flow switching device 100. In FIG. 6A, the packaging of the syringe flow switching device 100 may be opened. The valve device 30 may be in the second (“flush”) position. In FIG. 6B, following instructions on a removable instruction card 58, the valve device 30 may be moved from the second position to the first (“RX”) position. In FIG. 6C, once the valve device 30 is the first position, the removable instruction card 58 may be removed from the valve housing 10 and discarded. In someembodiments, the first syringe 40 and the CSTD 52 may or may not be provided in this packaging of the syringe flow switching device 100.

[0049] FIGS. 7A, 7B and 7C depict attaching the first syringe 40 to the syringe flow switching device 100 according to one or more embodiments described herein. FIGS. 7A, 7B, and 7C may depict a fourth step of an exemplary method for operating the syringe flow switching device 100. As shown in FIGS. 7A and 7B, the adapter 44 may be attached to the barrel 41 of first syringe 40. As shown in FIG. 7C, the CSTD 52 may be attached to second fluid inlet 18 by a luer fitting at outlet 56, and as such, the first syringe 40 may be in fluid communication with the CSTD 52.

[0050] FIGS. 8 A, 8B and 8C depict priming the syringe flow switching device 100 with driving fluid according to one or more embodiments described herein. FIGS. 8 A, 8B and 8C may depict a fifth step of an exemplary method for operating the syringe flow switching device 100. The second syringe 110 may be attached to the first fluid inlet 12 via fluid inlet line 13. The first syringe 40 may be filled with driving fluid from the second syringe 110 until the driving fluid overflows from the syringe vent 46, as shown in FIG. 8B. The first syringe 40 and syringe fluid flow switching device 100 should be maintained in the depicted upright position during the step of filling syringe 40 with driving fluid. As shown in FIG. 8C, the syringe vent 46 of adapter 44 may be closed with a cap or a seal.

[0051] FIG. 9 depicts priming an injection apparatus 102 attached to the syringe flow switching device 100 according to one or more embodiments described herein. FIG. 9 may depict a sixth step of an exemplary method for operating the syringe flow switching device 100. The second syringe 110 may be inserted into the syringe pump 300. With the valve device 30 in the first (“RX”) position, the syringe pump 300 may be activated to drive the drug out of firstsyringe 40 and into fluid outlet line 21 and injection apparatus 102 to prime injection apparatus 102. A needle of the injection apparatus 102 may be inserted in the vial 104 to catch any drug that may drip out during priming.

[0052] FIGS. 10A and 10B depict delivering the drug to a patient using the syringe flow switching device 100 according to one or more embodiments described herein. FIGS. 10A and 10B may depict a seventh step of an exemplary method for operating the syringe flow switching device 100. The injection apparatus 102 may be inserted into the patient to prepare for delivery of the drug to a patient site 1000. As an example, the patient site may be within a tumor, and the drug may be administered to treat the tumor. The syringe pump 300 may drive driving fluid from the second syringe 110 into the syringe flow switching device 100 thereby driving drug out of second fluid outlet 20 and through injection apparatus 102, thereby delivering the drug into the patient at patient site 1000. As shown in FIG. 10B, after all drug has been delivered out of drug volume 43 (dose 43 A), the valve device 30 may be moved to the second (“flush”) position in order to flush out any drug remaining in fluid outlet line 21 and injection apparatus 102 (overage 43B).

[0053] FIG. 11 depicts flushing the syringe flow switching device 100 according to one or more embodiments described herein. FIG. 11 may depict an eighth step of an exemplary method for operating the syringe flow switching device 100. With the valve device 30 being turned to the second (“flush”) position as shown in FIG. 10B, additional driving fluid may be driven from the second syringe 110, into first fluid inlet 12, through the pinchable internal shunt line 24 or one of rotatable internal shunts 34A, 34B, out second fluid outlet 20, through fluid outlet line 21, and through the injection apparatus 102. In some embodiments, this flushing may also continueto inject drug in the fluid path into the patient. In some embodiments, both the injection apparatus 102 and the fluid outlet line 21 may be flushed with driving fluid.

[0054] FIG. 12A depicts an example of a syringe fluid flow switching device 200 according to one or more embodiments described herein, and FIG. 12B depicts an example plan view of the syringe fluid flow switching device 200 according to one or more embodiments described herein. The syringe flow switching device 200 may include a housing 60, a first syringe 65, a CSTD 82, and a valve device 94. The housing 60 may maintain and hold the first syringe 65 in place. An adapter 73 may engage a top of the first syringe 65 and may include a fluid inlet 62 for receiving driving fluid from inlet line 64 and a fluid outlet 66 to tubing 68. The first syringe 65 may include a barrel 75 defining an internal volume. The internal volume of the first syringe 65 may be divided into a driving fluid volume 76 and a drug volume 78 as delineated by a separating member 77 which may be slidably translatable within the first syringe 65. The driving fluid volume 76 may be in communication with the fluid inlet 62, and the drug volume 78 may be in communication with the fluid outlet 66. The drug volume 78 may lead to an outlet 80 of the first syringe 65, which may lead to an inlet 84 of the CSTD 82 and the outlet 86 of CSTD 82 having a luer fitting.

[0055] Tubing segment 88 may lead from the outlet 86 of the CSTD 82 to the fluid outlet 74. A first fluid communication channel 71 may be formed from the fluid inlet 62, through the first syringe 65 and the CSTD 82, though the tubing segment 88, and to the fluid outlet 74. Tubing 68 may lead to fluid inlet 70 which may be in communication with a second or bypass fluid communication channel 72. The second fluid communication channel 72 may join with tubing segment 88 prior to fluid outlet 74.

[0056] The valve device 94 may be moved to pinch either the tubing segment 88 or the second fluid communication channel 72 near fluid outlet 74. The valve device 94 may be a rotatory valve device. The valve device 94 may be moved from a first (“RX”) position to a second (“flush”) position. The valve device 94 may be a rotary device and may include a rotary knob 92 or other mechanism for manual or processor-controlled rotation. The rotary knob 92 may include indicia to indicate a position of the valve device 94. As an example, when the housing 60 is viewed from a front view, for the valve device 94 in the first position, the rotary knob 92 may display “RX” for indicating pharmaceutical administration (e.g., the rotary knob in FIG. 18), and for the valve device 30 in the second position, the rotary knob 92 may display a fluid droplet icon or “flush” for indicating system flush (e.g., the rotary knob in FIG. 17).

[0057] In the first (“RX”) position, the valve device 94 may pinch the second fluid communication channel 72 shut, thereby preventing flow therethrough, while allowing flow through tubing segment 88 which forms a part of the first fluid communication channel 71. The arrow 95 may indicate where the second fluid communication channel 72 may be pinched. In the second (“flush”) position, the valve device 94 may pinch the tubing segment 88 shut, thereby preventing flow through the first fluid communication channel 71 and allowing flow through the second fluid communication channel 72. The arrow 97 may indicate where the tubing segment 88 may be pinched.

[0058] In use, the syringe fluid flow switching device 200 may be in fluid communication with an injection apparatus 102, as depicted in FIG. 12B. The injection apparatus 102 may be in fluid communication with the fluid outlet 74. Depending on the position of the valve device 94, the valve device 94 may be in fluid communication with the first communication channel 71 orthe second communication channel 72. The injection apparatus 102 may be include the features as discussed above and may be operated as discussed above.

[0059] In use, the driving fluid for the syringe fluid flow switching device 200 may be provided by a driving fluid providing device, such as a second syringe 110 as depicted in FIG. 12B. The second syringe 110 may be a source of driving fluid for the syringe fluid flow switching device 200. The second syringe 110 may be in fluid communication with the inlet line 64 and the fluid inlet 62. The second syringe 110 may be include the features as discussed above and may be operated as discussed above.

[0060] In operation, when the valve device 94 is in the first (“RX”) position, the supply of driving fluid to inlet line 64 may operate the first syringe 65 to force the drug out of the drug volume 78 and out fluid outlet 74 to the fluid outlet line 90, and no driving fluid may flow in the second fluid communication channel 72. On the other hand, when the valve device 94 is in the second (“flush”) position, the supply of driving fluid to inlet line 64 may be diverted through second fluid communication channel 72 to force driving fluid out the fluid outlet 74 to the fluid outlet line 90, and none of the drug may flow since the tubing segment 88 is pinched shut.

[0061] FIGS. 13-22 depict steps in an exemplary method for operating the syringe flow switching device 200 according to one or more embodiments described herein. Additional processes also may be included, and it should be understood that the method depicted in FIGS. 13-22 represent illustrations, and that other processes may be added or existing processes may be removed, modified, or rearranged without departing from the scope of the present disclosure.

[0062] FIG. 13 depicts preparing the syringe flow switching device 200 according to one or more embodiments described herein. FIG. 13 may depict a first step of an exemplary method for operating the syringe flow switching device 200. The first syringe 65 may be primed with thedrug in the drug volume 68, and the CSTD 82 may be attached to the first syringe 65. A CSTD 82 may be inserted in the housing 60 and attached by a luer fitting at outlet 86 to communicate with tubing segment 88. The housing 60 may include indicia to provide guidance on inserting the first syringe 65 and the CSTD 82.

[0063] FIG. 14 depicts setting the valve device 94 of the syringe flow switching device 200 according to one or more embodiments described herein. FIG. 14 may depict a second step of an exemplary method for operating the syringe flow switching device 200. The knob 92 may be rotated to switch the valve device 94 to the second (“flush”) position so as to pinch the tubing segment 88 shut, thereby preventing flow through the first fluid communication channel 71 and allowing flow of driving fluid through the second fluid communication channel 72.

[0064] FIG. 15 depicts inserting the first syringe 65 into the syringe flow switching device 200 according to one or more embodiments described herein. FIG. 15 may depict a third step of an exemplary method for operating the syringe flow switching device 200. The first syringe 65 and the CSTD 82 may be inserted into the syringe flow switching device 200. The adapter 73 may be attached to first syringe 65, and the CSTD 82 is connected within the housing 60 to complete the first fluid communication channel 71.

[0065] FIG. 16 depicts priming the syringe flow switching device 200 with driving fluid according to one or more embodiments described herein. FIG. 16 may depict a fourth step of an exemplary method for operating the syringe flow switching device 200. The syringe flow switching device 200 may be held upright during this step. As shown in FIG. 12B, the syringe flow switching device 200 may be attached to the second syringe 110 (for operation with a syringe pump 300 and / or for manual operation) and the injection apparatus 102. Driving fluid may be provided by action of the second syringe 110 through inlet line 64 to fill the driving fluidvolume 76 of first syringe 65. The adapter 73 may include a syringe vent (similar to syringe vent 46 discussed above).

[0066] FIG. 17 depicts the completion of priming the syringe flow switching device 200 with driving fluid according to one or more embodiments described herein. FIG. 17 may depict a fifth step of an exemplary method for operating the syringe flow switching device 200.Driving fluid may continue to be supplied through inlet line 64 (with the valve device 94 in the second (“flush”) position) and through fluid outlet line 90 until driving fluid appears at an outlet of injection apparatus 102.

[0067] FIG. 18 depicts setting the valve device 94 to prime the syringe flow switching device 200 with the drug according to one or more embodiments described herein. FIG. 18 may depict a sixth step of an exemplary method for operating the syringe flow switching device 200. The knob 92 may be rotated to switch the valve device 94 to the first (“RX”) position so as to pinch the second fluid communication channel 72 shut, thereby allowing flow of the drug through the first fluid communication channel 71. Through action of the second syringe 110, driving fluid instead advances separating member 77 to push drug out of drug volume 78 and through the fluid outlet line 90 to prime a needle or a cannula of the injection apparatus 102.During priming of the injection apparatus 102, the injection apparatus 102 may not be inserted in a patient to permit all driving fluid in fluid outlet line 90 and injection apparatus 102 to be flushed out and replaced with drug.

[0068] FIG. 19 depicts the positioning of the injection apparatus 102 of the syringe flow switching device 200 at a patient site 1000 according to one or more embodiments described herein. FIG. 19 may depict a seventh step of an exemplary method for operating the syringe flow switching device 200.

[0069] FIG. 20 depicts delivering the drug of the syringe flow switching device 200 according to one or more embodiments described herein. FIG. 20 may depict an eighth step of an exemplary method for operating the syringe flow switching device 200. Through action of the second syringe 110, the drug may be delivered. The drug may be delivered to the patient site 1000 through the needle or the cannula of the injection apparatus 102. The drug may be delivered until the first syringe 65 bottoms out.

[0070] FIG. 21 depicts setting the valve device 94 of the syringe flow switching device 200 according to one or more embodiments described herein. FIG. 21 may depict a ninth step of an exemplary method for operating the syringe flow switching device 200. The knob 92 may be rotated to switch the valve device 94 to the second (“flush”) position so as to release the pinch on second fluid communication channel 72 and to pinch the tubing segment 88 shut, thereby preventing flow through the first fluid communication channel 71 and allowing flow of driving fluid through the second fluid communication channel 72.

[0071] FIG. 22 depicts flushing of remaining drug from the syringe flow switching device 200 according to one or more embodiments described herein. FIG. 22 may depict a tenth step of an exemplary method for operating the syringe flow switching device 200. Driving fluid may continue to be provided through the second fluid communication channel 72 so as to flush any remaining drug from the fluid outlet line 90 and injection apparatus 102.

[0072] Embodiments illustrated under any heading or in any portion of the disclosure may be combined with embodiments illustrated under the same or any other heading or other portion of the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context. For example, and without limitation, embodiments described in dependent claim format for a given embodiment (e.g., the given embodiment described in independent claim format) may becombined with other embodiments (described in independent claim format or dependent claim format).

[0073] Numerous modifications, alterations, and changes to the described embodiments are possible without departing from the scope of the present invention defined in the claims. It is intended that the present invention need not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.

Claims

CLAIMSWhat is claimed is:

1. A fluid switching device comprising: a first fluid communication channel comprising a fluid inlet, a syringe, and a fluid outlet, the syringe comprising an interior volume divided into a driving fluid volume and a drug volume, the driving fluid volume being in communication with the fluid inlet and the drug volume being in communication with the fluid outlet; a second fluid communication channel being in fluid communication between the driving fluid volume and the fluid outlet; and a valve device with a first position for allowing flow through the first fluid communication channel and restricting flow through the second fluid communication channel and a second position for allowing flow through the second fluid communication channel and restricting flow through the first fluid communication channel.

2. The fluid flow switching device of claim 1, wherein the valve device being in the first position provides for the dispensing of drug through the fluid outlet for delivery to a patient and the valve device being in the second position provides for the dispensing of driving fluid through the fluid outlet, thereby flushing the fluid switching device.

3. The fluid flow switching device of claim 2, further comprising a closed system drug transfer device in the first communication channel between the syringe and the fluid outlet.

4. The fluid flow switching device of claim 3, further comprising a patient injection device in communication with the fluid outlet.

5. The fluid flow switching device of claim 1, wherein the valve device being in the first position pinches the second fluid communication channel thereby restricting flow therethrough, wherein the valve device being in the second position pinches the first fluid communication channel thereby restricting flow therethrough.

6. The fluid flow switching device of claim 1, further comprising a third fluid communication channel being in fluid communication with the first fluid communication channel and to provide driving fluid to the first fluid communication channel, wherein the first fluid communication channel comprises a bypass top at the fluid inlet, the bypass top being in fluid communication with the driving fluid volume of the syringe, the second fluid communication channel, and the third fluid communication channel.

7. The fluid flow switching device of claim 6, wherein the valve device being in the first position provides for the driving fluid to flow from the first fluid communication channel through the bypass top into the driving fluid volume of the syringe, thereby providing for the dispensing of drug through the fluid outlet for delivery to a patient, wherein the valve device being in the second position provides for the driving fluid to flow from the first fluid communication channel through the bypass top into the driving fluid volume of the syringe and from the driving fluid volume of the syringe through the bypass topinto the second fluid communication channel, thereby providing for the dispensing of driving fluid through the fluid outlet.

8. The fluid flow switching device of claim 1, wherein the syringe comprises a separating member slidably engaged within the interior volume, thereby dividing the interior volume into the driving fluid volume and the drug volume.

9. The fluid flow switching device of claim 8, wherein the separating member is movable by the driving fluid when the valve device is in the first position and is not movable by the driving fluid when the valve device is in the second position.

10. The fluid flow switching device of claim 1, wherein the valve device includes a user interface operatively communicating flow direction of the driving fluid.

11. The fluid flow switching device of claim 1, wherein the valve device includes a rotating knob with a visual indicator, wherein the visual indicator provides a first visual identifier when the rotating knob is in the first position and a second visual identifier when the rotating knob is in the second position.

12. The fluid switching device of any of claims 1 to 11, wherein the driving fluid is saline.

13. A method for providing drug to a patient via a fluid switching device, the fluid switching device comprising: a first fluid communication channel comprising a fluid inlet, a syringe and a fluid outlet; the syringe comprising an interior volume, divided into a driving fluid volume and a drug volume, the driving fluid volume being in communication with the fluid inlet and a fluid driving device and the drug volume being in communication with the fluid outlet; a second fluid communication channel being in fluid communication between the driving fluid volume and the fluid outlet; and a valve device with a first position for allowing flow through the first fluid communication channel and restricting flow through the second fluid communication channel and a second position for allowing flow through the second fluid communication channel and restricting flow through the first fluid communication channel, the method comprising: providing drug to the drug volume of the syringe; with the valve device in the first position, providing driving fluid through the fluid inlet to expand the driving fluid volume of the syringe and to expel drug from the drug volume of the syringe and out of the fluid outlet, thereby providing drug to the patient; and with the valve device in the second position, providing driving fluid through the first fluid inlet to the fluid outlet via the second fluid communication channel without expelling drug from the drug volume of the syringe, thereby flushing the fluid switching device.

14. The method of claim 13, further comprising placing the valve device in the first position, thereby preventing driving fluid from passing from the second fluid communication channel to the fluid outlet.

15. The method of claim 14, wherein placing the valve device in the first position pinches the second fluid communication channel thereby restricting flow therethrough.

16. The method of claim 14, further comprising placing the valve device in the second position, thereby preventing driving fluid from expanding the driving fluid volume of the syringe.

17. The method of claim 16, wherein placing the valve device in the second position pinches the first fluid communication channel thereby restricting flow therethrough.

18. The method of claim 13, wherein the fluid switching device further comprises a closed system drug transfer device in the first communication channel between the syringe and the fluid outlet.

19. The method of claim 18, wherein the fluid switching device further comprises a patient injection device in communication with the fluid outlet, and the method further comprises, with the valve device in the first position, providing drug to the patient via the patient injection device.

20. The method of claim 13, wherein the fluid switching device further comprises a third fluid communication channel being in fluid communication with the first fluid communication channel and to provide driving fluid to the first fluid communication channel,wherein the first fluid communication channel comprises a bypass top at the fluid inlet, the bypass top being in fluid communication with the driving fluid volume of the syringe, the second fluid communication channel, and the third fluid communication channel.

21. The method of claim 20, wherein, with the valve device in the first position, providing driving fluid through the fluid inlet comprises providing driving fluid through the bypass top into the driving fluid volume of the syringe, and wherein, with the valve device in the second position, providing driving fluid through the fluid inlet comprises providing driving fluid through the bypass top into the driving fluid volume of the syringe and from the driving fluid volume of the syringe through the bypass top into the second fluid communication channel.

22. The method of claim 13, wherein the syringe comprises a separating member slidably engaged within the interior volume, thereby dividing the interior volume into the driving fluid volume and the drug volume.

23. The method of claim 22, wherein, with the valve device in the first position, providing driving fluid moves the separating member to expand the driving fluid volume of the syringe.

24. The method of claim 23, wherein, with the valve device in the second position, providing driving fluid does not move the separating member.

25. The method of any of claims 13 to 24, wherein the driving fluid is saline.

26. A fluid flow switching device comprising: a first fluid communication channel comprising a first fluid inlet and a first fluid outlet; a second fluid communication channel comprising a second fluid inlet and a second fluid outlet; a third fluid communication channel between the first fluid outlet and the second fluid inlet, the third communication channel comprising a third fluid inlet, a syringe, and a third fluid outlet, the syringe comprising an interior volume divided into a driving fluid volume and a drug volume, the driving fluid volume being in communication with the third fluid inlet and the drug volume being in communication with the third fluid outlet; and a valve device having a first position and a second position and being in communication with the first fluid communication channel, the second fluid communication channel, and the third fluid communication channel, wherein the valve device being in the first position allows driving fluid to be received via the first fluid outlet and the third fluid inlet to the driving fluid volume and drug to be administered from the drug volume into the third fluid outlet, into the second fluid inlet, and out of the second fluid outlet to be administered to a patient, wherein the valve device being in the second position allows driving fluid to be communicated via the first fluid inlet to the second fluid outlet, thereby permitting the driving fluid to flush the fluid switching device.

27. The fluid flow switching device of claim 28, wherein the valve device comprises a pinchable internal shunt between the first fluid communication channel and the second communication channel.

28. The fluid flow switching device of claim 27, wherein in the first position, the valve device restricts fluid flow through the pinchable internal shunt, wherein in the second position, the valve device allows fluid flow through the pinchable internal shunt.

29. The fluid flow switching device of claim 27, wherein the valve device comprises a rotary device, wherein, in the first position, the rotary device pinches the pinchable internal shunt thereby restricting flow therethrough, wherein, in the second position, the rotary device allows flow through the pinchable internal shunt.

30. The fluid flow switching device of claim 26, wherein the valve device comprises a first rotatable internal shunt and a second rotatable internal shunt.

31. The fluid flow switching device of claim 30, wherein, in the first position, the first rotatable internal shunt is in fluid communication with the first fluid communication channel, and the second rotatable internal shunt is in fluid communication with the second fluid communication channel, wherein, in the second position, the first rotatable internal shunt is in fluid communication with the first fluid communication channel and the second fluid communication channel.

32. The fluid flow switching device of claim 30, wherein, in the first position, the first rotatable internal shunt in fluid communication with the first fluid outlet and the third fluid inlet, and the second rotatable internal shunt is in fluid communication with the third fluid outlet and the second fluid inlet, wherein, in the second position, the first rotatable internal shunt is in fluid communication with first fluid outlet, and the second fluid inlet and the second rotatable internal shunt is in fluid communication with the third fluid inlet and the third fluid outlet.

33. The fluid flow switching device of claim 26, wherein the valve device comprises a rotary element having two rotatable internal shunts.

34. The fluid flow switching device of claim 26, further comprising a closed system drug transfer device in the third communication channel between the syringe and the second fluid inlet.

35. The fluid flow switching device of claim 34, further comprising a patient injection device in communication with the second fluid outlet.

36. The fluid flow switching device of claim 26, wherein the syringe comprises a separating member slidably engaged within the interior volume, thereby dividing the interior volume into the driving fluid volume and the drug volume.

37. The fluid flow switching device of claim 36, wherein the separating member is movable by the driving fluid when the valve device is in the first position and is not movable by the driving fluid when the valve device is in the second position.

38. The fluid flow switching device of claim 26, wherein the valve device includes a user interface operatively communicating flow direction of the driving fluid.

39. The fluid flow switching device of claim 26, wherein the valve device includes a rotating knob with a visual indicator, wherein the visual indicator provides a first visual identifier when the rotating knob is in the first position and a second visual identifier when the rotating knob is in the second position.

40. The fluid switching device of any of claims 26 to 39, wherein the driving fluid is saline.

41. A method for providing drug to a patient via a fluid switching device, the fluid switching device comprising: a first fluid communication channel comprising a first fluid inlet and a first fluid outlet; a second fluid communication channel comprising a second fluid inlet and a second fluid outlet; a third fluid communication channel between the first fluid outlet and the second fluid inlet, the third communication channel comprising a third fluid inlet, a syringe, and a third fluid outlet, the syringe comprising an interior volume divided into a driving fluid volume and a drug volume, the driving fluid volume being in communication with the third fluid inlet and the drug volume being in communication with the third fluid outlet; and a valve device having a first position and a second position and being in communication with the first fluid communication channel, the second fluid communication channel, and the third fluid communication channel, the method comprising: providing drug to the drug volume of the syringe; with the valve device in the first position, providing driving fluid via the first fluid outlet and the third fluid inlet to expand the driving fluid volume of the syringe and to expel the drug from the drug volume of the syringe into the third fluid outlet, into the second fluid inlet, and out of the second fluid outlet, thereby providing the drug to the patient; and with the valve device in the second position, providing driving fluid via the first fluid inlet to the second fluid outlet without providing driving fluid to the driving fluid volume of the syringe, thereby flushing the fluid switching device.

42. The method of claim 41, wherein the valve device comprises a pinchable internal shunt between the first fluid communication channel and the second communication channel.

43. The method of claim 42, further comprising placing the valve device in the first position, thereby pinching the pinchable internal shunt and restricting flow therethrough.

44. The method of claim 42, further comprising placing the valve device in the second position, thereby allowing flow through the pinchable internal shunt.

45. The method of claim 41, wherein the valve device comprises a first rotatable internal shunt and a second rotatable internal shunt.

46. The method of claim 45, further comprising placing the valve device in the first position, wherein the first rotatable internal shunt is in fluid communication with the first fluid communication channel and the second rotatable internal shunt is in fluid communication with the second fluid communication channel.

47. The method of claim 46, further comprising placing the valve device in the second position, wherein the first rotatable internal shunt is in fluid communication with the first fluid communication channel and the second fluid communication channel.

48. The method of claim 45, further comprising placing the valve device in the first position, wherein the first rotatable internal shunt is in fluid communication with first fluid outlet and the third fluid inlet and the second rotatable internal shunt is in fluid communication with the third fluid outlet and the second fluid inlet.

49. The method of claim 48, further comprising placing the valve device in the second position, wherein the first rotatable internal shunt is in fluid communication with the first fluid outlet and the second fluid inlet and the second rotatable internal shunt is in fluid communication with the third fluid inlet and the third fluid outlet.

50. The method of claim 41, wherein the fluid switching device further comprises a closed system drug transfer device in the third communication channel between the syringe and the second fluid inlet.

51. The method of claim 50, further comprising a patient injection device in communication with the second fluid outlet, wherein the method further comprises, with the valve device in the first position, providing the drug to the patient via the patient injection device.

52. The method of claim 41, wherein the syringe comprises a separating member slidably engaged within the interior volume, thereby dividing the interior volume into the driving fluid volume and the drug volume.

53. The method of claim 51, wherein, with the valve device in the first position, providing driving fluid moves the separating member to expand the driving fluid volume of the syringe.

54. The method of claim 53, wherein, with the valve device in the second position, providing driving fluid does not move the separating member.

55. The method of any of claims 41 to 54, wherein the driving fluid is saline.

56. A method, machine, manufacture, and / or system substantially as shown and described.

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