WO2010014699A1

WO2010014699A1 - Medicament package of the strip-type comprising pre-filled unit-dose bladders to be used with a power injector

Info

Publication number: WO2010014699A1
Application number: PCT/US2009/052092
Authority: WO
Inventors: Frank M. Fago; James R. Small; Gary S. Wagner; Joseph Blair Tyson
Original assignee: Mallinckrodt Inc.
Priority date: 2008-07-29
Filing date: 2009-07-29
Publication date: 2010-02-04

Abstract

A power injector (42) includes a bulk fluid member (10). The bulk fluid member (10) may include a plurality of bladders (16), each of which may be fluidly isolated from every other bladder of the plurality of bladders (16) when in a sealed state. The plurality of bladders (16) may be disposed along a length of the bulk fluid member (10). The power injector (42) may be operable to fluidly isolate a portion of the plurality of bladders (16) corresponding to a selected volume of fluid to be dispensed, and then dispense fluid from the isolated bladders (16). The dispensing of fluid may include selectively rupturing seals (24) between the isolated bladders (16) and a first channel (20) to fluidly interconnect the isolated bladders (16) to the first channel (20). Once fluidly interconnected, fluid may be dispensed from the isolated bladders (16), through the first channel (20), through a fluid outlet (26c) and tube set (54), and into a patient.

Description

MEDICAMENT PACKAGE OF THE STRIP-TYPE COMPRISING PRE-FILLED UNIT-DOSE BLADDERS TO BE USED WITH A POWER INJECTOR

CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims priority under 35 U.S.C. §119(e) to pending U.S. Provisional Patent

Application Serial No. 61/084,540 entitled "POWER INJECTOR STRIP PACKAGED INJECTION BLADDERS¹¹ filed on July 29, 2008.

FIELD QF THE INVENTION The present invention generally relates to injection systems and, more particularly, to injection systems with bulk fluid members that include a plurality of fl uidly isolated fluid bladders.

BACKGROUND

Various medical procedures require that one or more medical fluids be injected into the patient. Medical imaging procedures oftentimes involve the injection of contrast media into the patient, possibly along with saline or other fluids. Other medical procedures involve injecting one or more fluids into a patient for therapeutic purposes. Power injectors may be used for these types of applications.

One example of a medical procedure involving the injection of fluids is an imaging procedure such as a radiological procedure used to image the internal structure of a patient (e.g., computed tomography or CT imaging; magnetic resonance imaging or MRI; SPECT imaging; PET imaging; X-ray imaging; angiographic imaging; optical imaging; ultrasound imaging). To aid in the imaging, contrast media may be injected into the patient. Typically, this contrast media is administered to the patient from a syringe of a predetermined volume.

SUMMARY A first aspect of the present invention is embodied by an injection system that includes an injection device and an associated bulk fluid member. The bulk fluid member includes first and second sheets that are bonded together to define a plurality of biadders. These bladders are fluidly isolated from each other (e.g., when loaded into the injection system), and include an appropriate fluid (e.g., a medical fluid).

A number of feature refinements and additional features are applicable to the first aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. As such, each of the following features that will be discussed may be, but is not required to be, used with any other feature or combination of features of the first aspect. The following discussion is applicable to the first aspect, up to the start of the discussion of a second aspect of the present invention.

The first and second sheets utilized by the bulk fluid member may be formed from any appropriate material or combination of materials (e.g., a polymer material such as polyvinyichloride (PVC)). These sheets may be characterized as being flexible, pliable, deformable, or the like. Any appropriate way of bonding the first and second sheets together may be utilized, including (but not limited to) heat sealing, one or more adhesives, RF welding, pressure sealing, ultrasonic bonding, or any combination thereof. Those portions of the first and second sheets that are bonded together may provide a joint between the first and second sheets such that they no longer separate at the joint (e.g., absent exposure to an elevated pressure).

The bulk fluid member may include an outlet chamber or channel (e.g., a common header) that may be fluidiy interconnectable with each of the plurality of bladders. A separate seal of any appropriate type and defined in any appropriate manner (e.g., rupturable by exposure to at least a certain pressure) may be provided between each bladder and the outlet channel. The above-noted first and second sheets may be further bonded together to define the outlet channel, along with the plurality of bladders. In one embodiment, each of the bladders includes a pair of ends that are spaced in a first dimension (e.g., that defines a length dimension of the bladders, and which may be the largest dimension of the bladders). The outlet channel may extend along the bulk fluid member in a second dimension (e.g., orthogonally to the noted first dimension), for instance so that the outlet channel is located adjacent to an end of each of the bladders. The length dimension of the bladders may correspond with a width dimension of the bulk fluid member, while a length dimension of the outlet channel may extend in the length dimension of the bulk fluid member. The bulk fluid member may be movable relative to the injection device (e.g., to provide for sequential discharges from the bulk fluid member, where each discharge includes fluid from at least one bladder, and where no bladder is used for any two of such sequential discharges) along or parallel to the length dimension of the outlet channel.

The bulk fluid member may include at least one outlet, and thereby encompassing having a plurality of outlets. The above-noted outlet channel may be located between the plurality of bladders and each outlet. For instance, fluid from each of the bladders may be directed into the outlet channel, and then into at least one outlet. In any case, a separate rupturable seal of any appropriate type and defined in any appropriate manner (e.g., rupturable by exposure to at least a certain pressure) may be provided between each outlet and the outlet channel. The above-noted first and second sheets may be further bonded together to define each such outlet (e.g., along with the plurality of bladders, and possibly the outlet channel as noted above). However, each such outlet could also be in the form of a separate tube or the like (e.g., having an end portion that is secured between the first and second sheets). At least one outlet may always be disposed exteriorly of the injection device (e.g., to allow an external device (e.g., a tubing set) to be readily fluidiy connected with such an outlet).

The bulk fluid member may be moved relative to the injection device (e.g., where the injection device remains in a stationary position during this movement of the bulk fluid member). The bulk fluid member may include a plurality of indexing members that are engageable by the injection device to advance the bulk fluid member. These indexing members may be in the form of a plurality of holes that are disposed along opposing edges of the bulk fluid member (e.g., parallel to the outlet channel).

The injection device may be of any appropriate size, shape, configuration, and/or type. In one embodiment, the injection device is in the form of a power injector. In any case, the injection device may include a fluid transfer member that is movable relative to and engageable with the bulk fluid member. For instance, the fluid transfer member may be in the form of one or more rollers that compress at least one bladder at a time, and that moves along the length dimension of each such bladder (e.g., to discharge fluid out of an end of the bladder and into the noted outlet channel). The fluid transfer member could also be in the form of a movable plate or the like.

The injection device may include at least one sealing member that is used to define a further seal in the bulk fluid member (e.g., a heat seal; a pressure seal). One or more sealing members may be used to isolate one or more of the bladders from the remainder of the bladders of the bulk fluid member. A first seal may be formed by the injection device between one adjacent pair of bladders, and a second sea! may be formed by the injection device between another adjacent pair of bladders. Fluid in the bladder(s) between the first and second seals may be simultaneously discharged (e.g., into the above-noted outlet channel), such as by the noted fluid transfer member. In one embodiment, one or more sealing members of the injection device are movable relative to the bulk fluid member so as to be able to vary the number of bladders that exists between the first and second seals (e.g., to thereby vary the amount of fluid discharged),

A second aspect of the present invention is embodied by an injection system that includes an injection device and an associated bulk fluid member. The bulk fluid member includes a plurality of bladders, fluid in each of the bladders, a common outlet channel that is fiuidly interconnectable with each of the bladders, and a plurality of outlets that are each fiuidly interconnectable with the outlet channel. Fluid dispensed from any given bladder would initially be directed into the outlet channel, and then into at least one of the plurality of outlets.

The various features addressed above in relation to the first aspect may be utilized by the second aspect. The bulk fluid member described in relation to the first and second aspects may itself be an independent aspect of the present invention (e.g., so as to not be required to be used in combination with an injection device, but instead simply being adapted for use with such an injection device).

A third aspect of the present invention is provided by an imaging system. The imaging system includes a medical imaging device (e.g., radiological) and an injection device (e.g., a power injector). The medical imaging device may be of any appropriate modality, including, for example, X-ray, CT, MRI, SPECT₁ PET, ultrasound, and optical. The injection device includes a first bulk fluid member and a fluid transfer member. The first bulk fluid member includes a plurality of bladders. Each of the plurality of bladders is fiuidly isolated from every other one of the plurality of bladders when in a sealed state. Each of the plurality of bladders is disposed along a length of the bulk fluid member. The fluid transfer member is operable to transfer fluid out of at least one of the plurality of bladders.

A number of feature refinements and additional features are applicable to third aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. As such, each of the following features that will be discussed may be, but is not required to be, used with any other feature or combination of features of the third aspect. The following discussion is applicable to the third aspect, up to the start of the discussion of a fourth aspect of the present invention.

The first bulk fluid member may include a channel extending along the length of the bulk fluid member. Each one of the plurality of bladders may include a first perimeter seal portion. The first perimeter seal portion may be disposed between the bladder and the channel. Each of the plurality of bladders may include a second perimeter seal portion. A burst strength of the first perimeter seal portion may be less than a burst strength of the second perimeter seal portion, in this regard, pressure applied to a bladder may result in the first perimeter seal portion bursting without bursting the second perimeter seal portion. Therefore, the flow may be purposefully directed through the first perimeter seal portion of a given bladder upon the application of pressure (e.g., a squeezing the bladder to the point where the first perimeter seal portion bursts) to such a bladder. The injection device associated with the imaging system of the third aspect may further include a feed member operable to index the first bulk fluid member relative to the fluid transfer member. The feed member may be operable to index the first bulk fluid member in any appropriate manner. The first bulk fluid member may include a plurality of through holes aiigned along or parallel to a iongitudinal axis of the first bulk fluid member. The feed member may include a rotatable sprocket with protrusions corresponding to the through holes. Such a configuration may be used by the first and second aspects addressed above as well.

The imaging system may further include a seal member operable to fluidly isolate a first group of one or more of the plurality of bladders from the remainder of the plurality of bladders. The seal member may be operable to seal off the first group of bladders in any appropriate manner such as, for example, using a heat sealing element or ultrasonic energy applied to the first bulk fluid member to create one or more sealed regions, using one or more pressure-sealing members, or a combination thereof.

Each bladder of the plurality of bladders may contain any appropriate fluid and be of any appropriate size. For example, each of the plurality of bladders may contain contrast and be of an equal volume. For example, each of the plurality of bladders may contain saline and be of an equal volume. For example, some of the plurality of bladders may contain contrast and some of the plurality of bladders may contain saline. For example, the bladders may be of varying volume. Any appropriate total volume of fluid contained may be contained in the first bulk fluid member. For example, the aggregate fluid contained by the first bulk fluid member may be about one to ten liters or more.

The system may further include a second buik fluid member. Any of the permutations of the first bulk fluid member discussed above may also apply to the second bulk fluid member. The second bulk fluid member may be configured the same as the first bulk fluid member or the second bulk fluid member may be configured differently than the first bulk fluid member (e.g., may contain bladders that contain a different type of fluid and/or may include bladders of a different volume).

!n an embodiment, the system may further include a tube set that includes a bulk fluid member fluid interface, a patient fluid interface, and a tube fluidly connected to the bulk fluid member fluid interface and the patient fluid interface. The bulk fluid member fluid interface may be fluidly interconnected to the bulk fluid member. The patient fluid interface may be fluidly connected to a catheter inserted into a patient. The patient fluid interface may include a Luer connector.

The fluid transfer member may be operable to transfer fluid out of a single bladder. However, the fluid transfer member may be operable to simultaneously transfer fluid out of at least two of the plurality of bladders. The fluid transfer member may include members operable to squeeze the first bulk fluid member. The fluid transfer member may include two squeezing members oppositely disposed on each side of the first bulk fluid member. The squeezing members may include rollers operable to be translated along a lateral axis of a portion of the first bulk fluid member to force fluid out of at least one of the bladders. The fluid transfer member may include a syringe and plunger operable to draw fluid from one or more of the plurality of bladders and then dispense the drawn fluid (e.g., inject the drawn fluid into a patient). The fluid transfer member of this third aspect may be in accordance with the fluid transfer member addressed above in relation to the first aspect, and vice versa. 5 A fourth aspect of the present invention is provided by a method of dispensing fluid through an outlet port.

The method includes the steps of loading a bulk fluid member into an injection device {e.g., power injector) and then sealing off a portion of the bulk fluid member from a remaining portion of the bulk fluid member. The bulk fluid member includes a plurality of interconnected and fluidly isolated bladders and a fluid channel disposed along a longitudinal edge of the bulk fluid member. The sealing fluidly isolates a first portion of the bladders from a i o remaining portion of the bladders. Also, the sealing fluidly isolates a first portion of the fluid channel from a remaining portion of the fluid channel. The method further includes the steps of fluidly interconnecting the fluid outlet port to the first portion of the fluid channel. The method further includes squeezing or compressing the first portion of bladders to cause fluid to flow from each bladder of the first portion of bladders into the first portion of the fluid channel and through the fluid outlet port.

15 A number of feature refinements and additional features are applicable to the fourth aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. As such, each of the following features that will be discussed may be, but is not required to be, used with any other feature or combination of features of the fourth aspect. The following discussion is applicable to fourth aspect, up to the start of the discussion of fifth and sixth aspects of the present invention. 0 The method of dispensing fluid may further include bursting, during the squeezing step, seals disposed between each bladder of the first portion of bladders and the first portion of the fluid channel. The sealing off step may include applying heat and/or pressure to a portion of the bulk fluid member. The first portion of the bladders may include a plurality of bladders. The fluid outlet port may be fluidly interconnected to a patient {e.g., via tubing and an appropriate IV catheter). 5 Fifth and sixth aspects of the present invention are each provided by a method of dispensing fluid that includes loading a bulk fluid member into an injection device (e.g., a power injector), where the bulk fluid member includes a plurality of interconnected and fluidly isolated bladders.

In the case of the fifth aspect, the method further includes fluidly interconnecting a first group of the plurality of bladders to a first fluid outlet, and dispensing fluid from the first group of the plurality of bladders through0 the first fluid outlet. The first group of the plurality of bladders includes one or more of the plurality of bladders. The method further includes advancing the bulk fluid member relative to the injection device, then fluidly interconnecting a second group of the plurality of bladders to a second fluid outlet, and dispensing fluid from the second group of the plurality of bladders through the second fluid outlet. The second group of the plurality of bladders includes one or more of the plurality of bladders, and no bladder of the first group is part of the second5 group. in the case of the sixth aspect, each bladder contains a volume of fluid (the volume of fluid for any particular bladder may be of a different volume than the volume of fluid for another bladder; or all of the bladders may contain the same-sized volume of fluid), and the method further includes: selecting a first volume of fluid to be dispensed; selecting a first group of the plurality of bladders; fluidly interconnecting a first tube set to the first group of the plurality of bladders; and dispensing the first volume of fluid from the first group of the plurality of bladders into the first tube set. The first volume of fluid is greater than any volume contained in any single bladder of the plurality of bladders. The method further includes: selecting a second volume of fluid to be dispensed; selecting a second group of the plurality of bladders; fluidly interconnecting a second tube set to the second group of the plurality of bladders; and dispensing the second volume of fluid from the second group of the plurality of bladders into the second tube set. The second volume of fluid is greater than any volume contained in any single bladder of the plurality of bladders and is of a different size than the first volume of fluid. Furthermore, no bladder of the first group is part of the second group.

A number of feature refinements and additional features are applicable to the fifth and sixth aspects of the present invention. These feature refinements and additional features may be used individually or in any combination. As such, each of the following features that will be discussed may be, but is not required to be, used with any other feature or combination of features of the fifth and sixth aspects. The following discussion is applicable to the fifth and sixth aspects, up to the start of the discussion of a seventh aspect of the present invention.

The first group of the plurality of bladders may include two or more of the plurality of bladders. Similarly, the second group may include two or more of the plurality of bladders. The first group may include a different number of bladders than the second group. The loading of the bulk fluid member into the injection device may include feeding a strip of the plurality of interconnected and fluidly isolated bladders into the injection device. The method may further include sealing off a portion of the bulk fluid member from a remaining portion of the bulk fluid member such that the first group of the plurality of bladders is isolated from a remaining portion of the bladders. The dispensing of fluid may include squeezing a group (e.g., the first group) of the plurality of bladders, and causing fluid to flow from each bladder of the group of the plurality of bladders (e.g., into the first tube set; through the first fluid outlet). The dispensing of fluid (e.g., from the first group) may include sequentially flowing fluid from each bladder of a group of bladders or simultaneously flowing fluid from each bladder of a group of bladders. The dispensing of fluid may result in fluid from one or more of the plurality of bladders being injected into a patient (e.g., where the fluid outlets or tube sets are fluidly interconnected to a catheter inserted into a patient).

A seventh aspect of the present invention is embodied by a method of dispensing fluid. A buik fluid member is loaded into an injection device. This bulk fluid member includes a plurality of bladders that are fiuidly isolated from each other prior to the bulk fluid member being loaded into the injection device. First and second fluid quantities are sequentially dispensed from at least one of the bladders, with the bulk fluid member being advanced between these dispensings. No bladder that is used to dispense the first fluid quantity is used to dispense the second fluid quantity, and vice versa. A number of feature refinements and additional features are applicable to the seventh aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. As such, each of the following features that will be discussed may be, but is not required to be, used with any other feature or combination of features of the seventh aspect.

5 The fluid volume of the first and second fluid quantities may be the same or different. Consider the case where each bladder of the fluid transfer member is of the same fluid volume. The first and second fluid quantities may be provided by using the same number of bladders (e.g., such that the fluid volume of the first and second quantities are equal). The first and second fluid quantities may also be provided by using different numbers of bladders (e.g., such that the fluid volumes of the first and second quantities are different). The various bladders i o used by the bulk fluid member need not be of the same voiume. In this case, the first and second fluid quantities may be of the same fluid volume or may be of different fluid volumes.

Fluid may be dispensed from each of the bladders in any appropriate manner. Jn one embodiment, fluid is dispensed from one or more of the bladders by a compression of the corresponding bulk fluid member (e.g., using the above-noted fluid transfer member). A progressive compression of one or more of the bladders may be

15 used to discharge fluid from the bulk fluid member. Fluid may be dispensed from a single bladder for one or both of the first and second fluid quantities, fluid may be simultaneously dispensed from multiple bladders for one or both of the first and second fluid quantities, or a combination thereof.

Fluid directed out of any of the bladders may be directed into a common outlet channel. Fluid from a single bladder could be directed into such a common outlet channel, or fluid from two or more bladders could be 0 directed into such a common outlet channel. A seal between a given bladder and the common outlet channel may be ruptured prior to directing fluid from such a bladder into the common outlet channel.

This bulk fluid member may further include a plurality of outlets that may be fluidly interconnected with the above-noted common outlet channel. Each of these outlets may be fluidly isolated from the common outlet channel by an appropriate seal. At least one of these outlets may also be exposed on an interior of the injection5 device (e.g., to allow establishing a fluid connection with such an outlet, such as by piercing or rupturing a seal in the outlet when making the fluid connection).

A first portion of the plurality of bladders may be sealed off from the remainder of the bulk fluid member (e.g., by the injection device). This first portion of the plurality of bladders may include any appropriate number of bladders, and may provide the first fluid quantity. Similarly, a second portion of the plurality of bladders may be0 sealed off from the remainder of the bulk fluid member (e.g., by the injection device). This second portion of the plurality of bladders may include any appropriate number of bladders, and may provide the second fluid quantity. Any appropriate way of sealing off a desired number of bladders from one or more other bladders of the bulk fluid member may be utilized (e.g., heat sealing; pressure sealing).

As used herein, the term "fluidly interconnected" refers to two or more components or entities being5 connected (directly or indirectly) in a manner such that fluid can flow (e.g., unidirectionally or bidtrectionally) in a predetermined flow path therebetween. For example, "an injection device fluidly interconnected to a patient" describes a configuration where fluid can flow from the injection device through any interconnecting devices (e.g., tubing, connectors) and into the patient (e.g., into the vasculature of the patient).

A number of feature refinements and additional features are separately applicable to each of above-noted first, second, third, fourth, fifth, sixth, and seventh aspects of the present invention. These feature refinements and additional features may be used individually or in any combination in relation to each of the above-noted first, second, third, fourth, fifth, sixth, and seventh aspects. Any feature of any other various aspects of the present invention that is intended to be limited to a "singular" context or the like will be clearly set forth herein by terms such as "only," "single," "limited to," or the like. Merely introducing a feature in accordance with commonly accepted antecedent basis practice does not limit the corresponding feature to the singular (e.g., indicating that a power injector includes "a syringe" alone does not mean that the power injector includes only a single syringe). Moreover, any failure to use phrases such as "at least one" also does not limit the corresponding feature to the singular (e.g., indicating that a power injector includes "a syringe" alone does not mean that the power injector includes only a single syringe). Use of the phrase "at least generally" or the like in relation to a particular feature encompasses the corresponding characteristic and insubstantial variations thereof (e.g., indicating that a syringe barrel is at least generally cylindrical encompasses the syringe barrel being cylindrical). Finally, a reference of a feature in conjunction with the phrase "in one embodiment" does limit the use of the feature to a single embodiment.

Any power injector that may be utilized to provide a fluid discharge may be of any appropriate size, shape, configuration, and/or type. Any such power injector may be used for any appropriate application where the delivery of one or more medical fluids is desired, including without limitation any appropriate medical application (e.g., computed tomography or CT imaging; magnetic resonance imaging or MRI; SPECT imaging; PET imaging; X-ray imaging; angiographic imaging; optical imaging; ultrasound imaging). Any such power injector may be used in conjunction with any component or combination of components, such as an appropriate imaging system (e.g., a CT scanner). For instance, information could be conveyed between any such power injector and one or more other components (e.g., scan delay information, injection start signal, injection rate).

BRIEF DESCRIPTION OF THE FIGURES Figure 1 A is a schematic diagram of a bulk fluid member. Figure 1 B is a side view of the bulk fluid member of Figure 1 A and a seal member. Figure 1 C is a schematic diagram of a portion of the bulk fluid member of Figure 1 A and a representative fluid transfer member.

Figures 2A through 2C are perspective views of a power injector and related components operable to use the bulk fluid member of Figure 1.

Figure 3 is a perspective view of a power injector.

Figure 4 is a perspective view of bulk fluid members for use in the power injector of Figure 3. Figure 5 is a perspective view of a CT imaging scanner that includes the power injector of Figure 3.

Figures 6A through 8C are perspective views of alternate configurations of power injectors. Figure 9 is a flowchart of a method of dispensing fluid from a power injector. DETAILED DESCRIPTION

Figure 1A is a schematic diagram of a bulk fluid member 10. The bulk fluid member 10 may be used in procedures, such as medical imaging procedures, where fluid (e.g., contrast and/or saline) is to be delivered to a patient (e.g., injected into the venous structure of the patient). The bulk fluid member 10 may include a longitudinal axis 12 and a lateral axis 14. Disposed in series along the longitudinal axis 12 may be a plurality of fluid bladders 16. The volume of each of the individual bladders 16 may be selected based on the particular type of medical procedure being formed. For example, CT imaging may typically require an injection of contrast on the order of about 100 ml_. When configured to dispense {e.g., inject) contrast for such a procedure, the bladders 16 may each contain, for example, 20 mL of contrast. The bladders 16 may be configured to hold different volumes for CT imaging as appropriate. In another example, MRI may typically require an injection of contrast on the order of about 15 to 20 mL of contrast. Accordingly, when configured to dispense contrast for an MRI procedure, the bladders 16 may each contain, for example, 1 mL of contrast each. Other medical imaging procedures may require different volumes for the bladders 16. Hereinafter, the systems and methods described will generally be with reference to CT imaging and the delivery of contrast. It will be appreciated that the systems and methods are also applicable to other modes of imaging and the delivery of other types of fluids with adjustments to features (e.g., the volume of the bladders 16) where appropriate.

The bulk fluid member 10 may be defined by a pair of flexible, pliable, and/or deformable sheets or the like. In one embodiment, the individual bladders 16 are formed by bonding these two sheets together. Any appropriate bond may be used to define the various bladders 16 (e.g., a heat seal; RF welding; one or more adhesives; any appropriate combination thereof). However, these bladders 16 do exist for the bulk fluid member 10 prior to loading the bulk fluid member 10 into an appropriate injection device.

The bulk fluid member 10 with the plurality of individual bladders 16 may allow for variable volumes of contrast to be delivered to a patient while reducing contrast waste. For example, a typical known system may utilize 10O mL syringes of contrast. In a case where a particular patient may require, for example, 120 mL of contrast, the operator may need to use two 100 mL syringes of contrast, thereby wasting (e.g., not injecting into a patient and having to be discarded) 80 mL of contrast. In contrast, the systems and methods described herein may use a selectable number of pre-filled bladders to deliver contrast to the patient. In the current example, where the bladders are each 20 mL, the systems and methods described herein may allow the user to access six of the 20 mL bladders for delivery of 120 mL of contrast to a patient, thereby resulting in little or no waste of contrast. Returning to the bulk fluid member 10 of Figure 1A, the bulk fluid member 10 may include a plurality of sealed areas 18 disposed between each bladder 16 (e.g., each sealed area 18 may be a bonded region). These sealed areas 18 may prevent fluid communication between any of the bladders 16. Disposed along one side of the bulk fluid member 10 along the longitudinal axis 12 may be a first channel 20. Furthermore, the bulk fluid member 10 may include a second channel 22 disposed along and an edge opposite of the edge where the first channel 20 is located. The first and second channels 20, 22 may run along the entire length (or a portion thereof) of the bulk fluid member 10 Sn the longitudinal direction 12, The channels 20, 22 may also be formed by bonding together a pair of sheets that define at least part of the bulk fluid member 10. At the end of each bladder 16, proximate to the first channel 20, may be a seal 24 that fluidly isolates each bladder 16 from the first channel 20. Each seal 24 may be configured {e.g., the thickness of the seal 24 may be selected) such that an increase in pressure in a corresponding bladder 16 may cause the seal 24 to rupture (or burst), thereby placing the bladder 16 in fluid communication with the first channel 20. The seals 24 may be configured to burst before any other portion of the bladders 16 (e.g., the front or back layer of the bladders 16, the sealed area 18).

The bulk fluid member 10 may include a plurality of outlets 26, where each outlet 26 is in fluid communication with the first channel 20. Each outlet 26 may be provided without a seal such that an end of each outlet 26 is unsealed and in fluid communication with the first channel 20. Alternatively, each outlet 26 may be provided with an end seal and such an end seal may be broken when the outlet 26 is fluidly interconnected to a tube set 54 (Figure 2C) or otherwise. Each outlet 26 may also be formed by bonding together a pair of sheets that define at least part of the bulk fluid member 10. Another option would be for each outlet 26 to be in the form of a tube that is disposed between the above-noted pair of sheets that may be used to define at least part of the bulk fluid member 10 (e.g., where such sheets may be sealed about the perimeter of an end portion of each such tube). Continuing the above example where a CT imaging procedure requires the delivery of 120 mL of contrast a portion of the bulk fluid member 10 containing 120 mL of contrast may be sealed so that it is fluidly separated from the remaining portion of the bulk fluid member 10. This may be accomplished by, for example, creating isolation seals 28 where, in between the two isolation seals 28 are disposed six individual bladders - bladders 16b through 16g. The isolation seals 28 may be created in any appropriate manner. For example, the isolation seals 28 may be created by applying heat to the bulk fluid member 10 along the areas where the isolation seals 28 are to be created. In another example, the isolation seals 28 may be created through an ultrasonic welding process. In another example, the isolation seals 28 may be temporarily created (e.g., for the duration of the contrast injection procedure) by applying pressure along the length of the isolation seals 28, Once created, the isolation seals 28 may isolate the bladders 16b through 16g from adjacent bladders 16a, 16h and the remainder of the bulk fluid member 10. The isolation seals 28 may also isolate a section of the first channel 20 corresponding to the isolated bladders 16b through 16g.

Figure 1 B schematically shows a side view of the bulk fluid member 10 along with sealing members 34a, 34b of an appropriate injection device. The sealing members 34a, 34b may be operable to move relative to the bulk fluid member 10 (e.g., perpendicular to the longitudinal axis 12 as indicated by the double-headed arrows) such that the sealing members 34a, 34b may come into operative contact with the bulk fluid member 10 to create the isolation seals 28 described above. The sealing members 34a, 34b may use any appropriate technology that is operable to create the isolation seals 28. In a particular implementation, one or both of the sealing members 34a, 34b may be present and one or both of the sealing members 34a, 34b may be active (e.g., energized). For example, where the isolation seal 28 is a heat seal, one or both of the sealing members 34a, 34b may be heated. In such a configuration, when an isolation seal 28 is desired at a particular location, the bulk fluid member 10 may be indexed such that the region where the isolation seal 28 is desired is aligned with the sealing members 34a, 34b of the injection device with which the bulk fluid member 10 is being used. The sealing members 34a, 34b (which may be pre-heated to an appropriate temperature or heated on demand) may then be moved proximate to the bulk fluid member 10 in order to create the isolation seal 28. After the isolation seal 28 has been created, the sealing members 34a, 34b may be moved away from the bulk fluid member 10. In another example, the isolation seals 28 may be created by ultrasonic welding. In such a configuration, one of the sealing members 34a, 34b may be a horn and the other one of the sealing members 34a, 34b may be an anvil.

The sealing members 34a, 34b may also be operable to selectively cut the bulk fluid member 10. Cutting the bulk fluid member 10 may allow for separation of the used portions of the bulk fluid member 10 from unused portions of the bulk fluid member 10. Alternatively, a separate cutting member (not shown) may be provided. In configurations where the outlets 26 of the bulk fluid member 10 are not pre-sealed, a portion of the outlets 26 corresponding to the portion of the bulk fluid member 10 between the isolation seals 28 may be sealed in a process similar to the one that creates the isolation seals 28. For example, as illustrated in Figure 1 A, outlet seals 30 may be created on outlets 26a and 26b. Outlet 26c may remain unsealed for reasons described below.

After the appropriate isolation seals 28 and outlet seals 30 have been created, pressure applied to the isolated bladders 16b through 16g may result in the bursting of the seals 24 between the isolated bladders 16b through 16g, resulting in the isolated bladders 16b through 16g being in fluid communication with each other via the isolated portion of the first channel 20. As will be appreciated, pressure applied to the isolated bladders 16b through 16g (e.g., by squeezing or compressing the isolated bladders 16b through 16g) may result in the contrast flowing from the isolated bladders 16b through 16g into the isolated portion of the first channel 20 and out of the bulk fluid member 10 through the unsealed outlet 26c. In configurations of the bulk fluid member 10 where the outlets 26 are presealed, prior to the application of pressure to the isolated bladders 16b through 16g one of the outlets 26 (e.g., outlet 26c) may be unsealed to allow for the flow of contrast therethrough. For example, a fluid connector (e.g., a bulk fluid member fluid interface 38 (Figure 2C)) with a piercing cannula may be attached to outlet 26c such that the cannula pierces the seal of the outlet 26c, thereby creating an outlet for contrast once pressure is applied to the isolated bladders 16b through 16g and the corresponding seals 24 are ruptured.

Optionally, when one or both of the isolation seals 28 are created, the bulk fluid member 10 may also be cut along the isolation seals 28, For example, when creating the isolation seals 28 between bladders 16a and 16b, the bulk fluid member 10 may also be cut along the isolation seal 28. In this regard that portion of the bulk fluid member 10 containing bladder 16a may be severed from the remaining portion of the bulk fluid member 10. The bladder 16a may be an empty, used bladder 16 from a previous administration of contrast. The severed portion of the bulk fluid member 10 may be directed toward a receptacle for subsequent disposal.

The above example was described in terms of delivering a 120 mL dose of contrast from a bulk fluid member 10 containing 20 mL bladders 16. It will be appreciated that other volumes of contrast may be achieved by aggregating different numbers of bladders 16 (e.g., a 60 mL dose of contrast may be achieved by aggregating three 2O mL bladders 16). It will also be appreciated that other bladder 16 volumes may be used. Forexample 15 mL bladders 16 may be used in a particular bulk fluid member 10. Furthermore, as noted in other imaging procedures (e.g., MRI) different typical contrast doses may be required and the volume of the bladders 16 may be selected accordingiy. For example, bladders 16 used in an MRI procedure may contain 1 mL of contrast each. The bulk fluid member 10 may, for example, be made from two opposing sheets of polymer selectively bonded (e.g., welded) together in certain areas (e.g. sealed area 18) with the selected volume of contrast captured between the sheets of polymer or later injected between sheets of polymer. The bulk fluid member 10 may contain a plurality of index holes 32 arranged along the edges of the bulk fluid member 10 along the longitudinal axis 12. These index holes 32 may be used to manipulate the position of the bulk fluid member 10 relative to other components of an injection device with which the bulk fluid member 10 is being used. For example, wheels with posts corresponding to the size and pitch of the index holes 32 may be used to feed the bulk fluid member 10 into/through/relative to a power injector. The positions of the index hoies 32 relative to the bladders 16 may be fixed. Accordingly, the index holes 32 may enable the power injector to know the relative location of the outlet 26c to be accessed and the relative location of the bladders 16 for sealing operations. Other methods of determining the position of the individual bladders 16 may be incorporated. Such methods may include vision systems and/or sensors. The squeezing or compression of the isolated bladders 16b through 16g may be achieved in any appropriate manner. Figure 1C illustrates one method of squeezing fluid from bladders 16 of the bulk fluid member 10. Figure 1 C is an edge view of the bulk fluid member 10 of Figure 1 A taken along section lines 1 C and further illustrates squeezing members 36a, 36b, the bulk fluid member fluid interface 38, and a portion of the tube set 54. In Figure 1C, bladder 16g is illustrated being squeezed by squeezing members 36a, 36b. The other bladders 16b- 16f of the isolated portion of the bulk fluid member 10 may also be squeezed by the squeezing members 36a, 36b. In this regard, the squeezing members 36a, 36b may be operable to simultaneously or sequentially squeeze fluid from the bladders 16b-16g. Accordingly, the squeezing members 36a, 36b may be of a variable width to accommodate different quantities of isolated bladders 16, or the squeezing members 36a, 36b may include multiple individual members disposed along each bladder 16 to be squeezed, or the squeezing members 36a, 36b may be of any other appropriate configuration operable to selectively squeeze fluid from one or more bladders 16. In general, the squeezing members 36a, 36b may be selectably configurable to squeeze fluid from a selectable number of bladders 16 to deliver selectable volumes of fluid from the bulk fluid member 10.

Figure 1C illustrates the squeezing members 36a, 36b in the form of rollers operable to travel along the lateral axis 14 of bladder 16g of the bulk fluid member 10, The squeezing members 36a, 36b may be configured such that little or no fluid may pass between the squeezing members 36a, 36b. Consequently, as the squeezing members 36a, 36b move (e.g., roll) along the length of the bladder 16g, fluid within the bladder 16g is forced along the lateral axis 14 in the direction toward the outlet 26c. Fluid is thus pushed through the outlet 26c, through the bulk fluid member fluid interface 38, and into the fluidty connected tube set 54. Accordingly, where the tube set 54 is fluidly connected to a patient (e.g., through a catheter), fluid may be transferred from the bladder 16g and injected into the patient.

Figures 2A through 2C are perspective views of a power injector 42 and related components operable to use the bulk fluid member 10 of Figure 1A. The bulk fluid member 10 may be interconnected to the mounting axis 40 as shown in Figure 2A. The bulk fluid member 10 may be rolled onto the mounting axis 40. The mounting axis 40 may be disposed in a power injector 42 as shown in Figure 2B. The power injector 42 may internally include sealing devices (not shown in Figure 2B) to achieve the isolation seals 28 and the outlet seals 30 (if required) as described above with reference to Figure 1A. The power injector 42 may include one or more graphical user interfaces (GUI) 44. Each GUI 44: 1) may be of any appropriate size, shape, configuration, and/or type; 2) may be operatively interconnected with the power injector 42 in any appropriate manner; 3) may be disposed at any appropriate location; 4) may be configured to provide one or any combination of the following functions: controlling one or more aspects of the operation of the power injector 42; inputting/editing one or more parameters associated with the operation of the power injector 42; and displaying appropriate information (e.g., associated with the operation of the power injector 42); or 5) any combination of the foregoing. Any appropriate number of GUIs 44 may be utilized. In one embodiment, the power injector 42 includes a GUI 44 that is incorporated by a console that is separate from but which communicates with the power injector 42. In another embodiment, the power injector 42 includes a GUI 44 that is part of the power injector 42. In yet another embodiment, the power injector 42 utilizes one GUI 44 on a separate console that communicates with the power injector 42, and also utilizes another GUI 44 that is on the power injector 42. Each GUI 44 could provide the same functionality or set of functionalities, or the GUIs 44 may differ in at least some respect in relation to their respective functionalities.

The power injector 42 may further include a window 46 through which operation of the power injector 42, particularly with respect to the handling of the bulk fluid member 10, may be observed. The power injector 42 may further include a base 48. The base 48 may contain a plurality of wheels or casters to allow the power injector 42 to be readily repositioned. It should be appreciated that the power injector 42 couid be supported in any appropriate manner for providing fluid.

The power injector 42 may further include an outlet access area 50 shown in detail in Figure 2C. The outlet access area 50 may provide an area where selected outlets 26 of the bulk fluid member 10, such as the outlet 26c, may be accessible by a user. Such access may allow for the fluid interconnection of the tube set 54 to the outlet 26c. The interconnection between the tube set 54 and the outlet 26c may be made in any appropriate manner. The end of the tube set 54 opposite of the end fluidly connected to the outlet 26c may contain a fluid outlet port 56. The fluid outlet port 56 may be configured to fluidly interconnect (e.g., via a Luer connector) to a patient or a device (e.g., a catheter) fluidly interconnected to the patient. The power injector 42 may be operable to create the above-described isolation seals 28 and outlet seals

30 and perform the above described squeezing of the selected bladders 16. In this regard, the power injector 42 may be operable to dispense a selected volume of contrast from a corresponding number of bladders 16 while maintaining isolation between the remaining bladders 16 of the bulk fluid member 10 and a patient fluidly interconnected to the power injector 42. The power injector 42 may include a door 52 that provides access to an internal portion of the power injector 42 where used bladders 16 may be temporarily stored. The door 52 may include an integral storage area (e.g. used bladder 16 receptacle) such that the door 52 may be removed from the power injector 42 and used bladders 16 contained therein may then be transported to a trash receptacle.

Figure 3 is a perspective view of another embodiment of a power injector 60. The power injector 60 includes a housing 62 and a GUI 64. The GUI 64 may perform similar functions and be similarly configured as the GUI 44 discussed above with reference to Figure 2B. The power injector 60 may further include a door 66. The door 66 may allow access to bulk fluid members, such as a first bulk fluid member 68 and a second bulk fluid member 70. The power injector 60 may be operable to transfer fluids from individual bladders or groups of bladders of the first bulk fluid member 68 and the second bulk fluid member 70 to a patient through a tube set 72 and a fluid outlet port 74. The tube set 72 may be operable to be used for a plurality of fluid delivery procedures to a plurality of different patients. In this regard, the tube set 72 may interconnect to a patient-specific tube set (not shown) and in turn to the fluid outlet port 74. For example, the fluid outlet support 74 may be a Luer connector and during an imaging procedure it may connect to a patient-specific tube set that fluidly connects between a catheter inserted into the patient and the fluid outlet port 74. The patient-specific tube set may include one-way valves or other appropriate mechanisms to prevent contamination of the tube set 72 with any fluids or materials from the patient. The tube set 72 may be periodically replaced. For example, the tube set 72 may be replaced when the bulk fluid members 68 and/or 70 are installed/replaced into the power injector 60.

Figure 4 is a perspective view of bulk fluid members 68, 70 for use in the power injector 60 of Figure 3. As illustrated, the first bulk fluid member 68 may contain a plurality of serially disposed 20 mL bladders 80. Similarly, the second bulk fluid member 70 may contain a plurality of serially disposed 5 mL bladders 84. These particular volumes (20 mL and 5 mL) are used for explanatory purposes; other volumes may be used where appropriate. As illustrated, the bladders 80, 84 may be disposed along the longitudinal axes of the first and second bulk fluid members 68, 70, respectively. Each bladder 80, 84 may include a bladder neck 82. The power injector 60 may be operable to access the fluid within the bladders 80, 84 through the bladder neck 82. The bladder neck 82 may contain a rigid portion or other feature that permits access therethrough. For example, the power injector 60 may include a piercing cannula operable to pierce the individual bladders 80, 84 in the region of the bladder neck 82.

The bulk fluid members 68, 70 may further include a plurality of index holes 86 that serve the same function as the index holes 32 described with reference to Figure 1 A. The illustration of Figure 4 includes depleted bladders 88 from which the fluid formally contained therein has been removed.

As illustrated, the power injector 60 includes the first bulk fluid member 68 and the second bulk fluid member 70 and each contains bladders 80, 84 of different volumes. In an embodiment where each bulk fluid member 68, 70 contains the same fluid (e.g. contrast), the power injector 60 may be operable to transfer fluids to a patient from one or more of the bladders 80, 84 from one or both of the bulk fluid members 68, 70. For example, in a situation where a patient is to receive 75 mL of contrast, the power injector 60 may dispense fluids from three 20 mL bladders 80 of the first bulk fluid member 68 and from three 5 mL bladders 84 from the second bulk fluid member 70 to dispense a total of 75 mL of contrast to the patient. Such a configuration may further reduce contrast waste.

In an embodiment where each bulk fluid member 68, 70 contains a different type of fluid, the power injector 60 may be operable to serially (or combinatively) dispense preselected volumes of each fluid. For example, in a procedure it may be desired for the patient to receive 20 mL of contrast followed by 40 mL of saline. Accordingly, the first bulk fluid member 68 may contain a plurality of 20 mL bladders 80 that each contain saline and the second bulk fluid member 70 may contain a plurality of 20 mL bladders 84 that each contain contrast. Therefore, to dispense the desired dosages to the patient, the power injector 60 may dispense contrast from a single bladder 80 of the first bulk fluid member 68 to dispense the desired 20 mL of contrast followed by saline from two bladders 84 of the second bulk fluid member 70 to dispense the desired 40 mL of saline.

Although the power injector 60 is illustrated with two bulk fluid members 68, 70, other quantities of bulk fluid members (e.g., one, three or more) may be installed within and/or used by the power injector 60.

To inject fluid into the patient, the power injector 60 may squeeze fluid from the bladders 80 and/or 84 in a manner similar to as described above with reference to the bladders 16. Alternatively, the power injector 60 may transfer fluid from the bladders 80, 84 in any appropriate manner. For example, the power injector 60 may include a powered syringe (not shown). In such a configuration, the power injector 60 may fluidly connect the syringe to one or more of the bladders 8O₁ 84 and then retract a plunger of the syringe to draw fluid from the bladders 80, 84 into the syringe. The plunger of the syringe may then be extended to force fluid out of the syringe and into the tube set 72 and subsequently into the patient. The redirection of fluid may be achieved in any appropriate manner such as through the use of actuatable valves or one-way valves. In the latter circumstance, one-way valves may be positioned about the syringe such that a retraction of the plunger of the syringe draws fluid from any interconnected bladders 80, 84 and not from the tube set 72; and an extension of the plunger of the syringe forces fluid through the tube set 72 and not back into any interconnected bladders 80, 84. The syringe, any valves and any associated tubing with such a system may replaced on a regular basis similar to as described above with reference to the tube set 72.

Figure 5 is a perspective view of a CT scanner 98 that includes the power injector 60 of Figure 3. A user 92 may fluidly interconnect a patient 94 lying on a movable patient support 96 to the power injector 60 via the tube set 72 (Figure 3). The user 92 may then set any parameters of fluid delivery that may be required using the GUI 64 (Figure 3} of the power injector 60 and initiate the fluid delivery sequence. During and/or after the delivery of fluid, the patient 94 may be transported into the CT scanner 98 for imaging.

Figures 6A through 8C illustrate alternative configurations of the power injector 42 (Figure 2B). These alternative configurations each include user interface panels, bulk fluid member feeding mechanisms, used bulk fluid member collection mechanisms, GUIs and support structures.

Figures 6A through 6D illustrate a power injector 100 that includes a user interface panel 102 and a fluid outlet 106. The user interface panel 102 may be angled for use by a medical technician 116 as illustrated in Figure 6D. A tube set 114 (shown being discarded after use in Figure 6C) may be fluidly interconnected to the fluid outlet 106, and the power injector 100 may be used to deliver fluid to a patient 118. After fluid has been dispensed from a group of bladders, a bulk fluid member 112 {shown being loaded into the power injector in Figure 6B) may be advanced such that a plurality of filled bladders may be disposed for fluid dispensing. Accordingly, when the bulk fluid member 112 is advanced, the used bladders of the bulk fluid member 112 may be advanced into a used bulk fluid member collection mechanism 108. Additionally, used tube sets 114 may be discarded into the used bulk fluid member collection mechanism 108. The bulk fluid member 112 may be installed into the power injector 100 by opening an access door 110 and loading the bulk fluid member 112 into the top of the power injector 100.

Figures 7A and 7B illustrate an alternately configured power injector 130 that includes a user interface panel 132 and a fluid outlet 136. A tube set (not shown) may be fluidly interconnected to the fluid outlet 136, and the power injector 130 may be used to deliver fluid to a patient. After fluid has been dispensed from a group of bladders, a bulk fluid member (not visible, as it is contained within the power injector 130) may be advanced such that used bladders of the bulk fluid member are advanced into a used bulk fluid member collection mechanism 138. The used bulk fluid member collection mechanism 138 may subsequently be emptied into an appropriate container 140 for disposal (Figure 7B).

Figures 8A through 8C illustrate a power injector 150 that includes a user interface panel 152 and a fluid outlet 156. A tube set (not shown) may be fluidly interconnected to the fluid outlet 156, and the power injector 150 may be used to deliver fluid to a patient. The power injector 150 may include a mounting member 154 for adjustably suspending the power injector 150 from an overhead structure (e.g., ceiling). After fluid has been dispensed from a group of bladders, a bulk fluid member (not visible, as it is contained within the power injector 150) may be advanced such that used bladders of the bulk fluid member are advanced into a used bulk fluid member collection mechanism 158. The used bulk fluid member collection mechanism 158 may subsequently be emptied into an appropriate container 164 for disposal (Figure 8B). The power injector 150 may include a hinged cover 160 (illustrated in the closed position with the open position 161 shown in phantom) that may be swung open to provide access to the interior of the power injector 150 for replacement of the bulk fluid member. In an alternate configuration illustrated in Figure 8C, a wire rack 166 may replace the used bulk fluid member collection mechanism 158. Used portions of the bulk fluid member may collect in the wire rack 166. The used portions may be occasionally removed from the wire rack 166 and properly discarded.

Figure 9 is a flowchart of a method of dispensing fluid of any appropriate type (e.g., contrast, saline) from a power injector. The method will be described with reference to the power injector 42 of Figure 2B where fluid from the bladders 16b through 16g is to be dispensed into a tube set. Where appropriate, the steps described herein may be applicable to methods using other power injectors, such as those in Figures 5 through 8C. The first step 182 may be for a user (e.g. radiology technician, physician, nurse) to load the bulk fluid member 10 into the power injector 42. Such loading may be in the form of feeding the bulk fluid member 10 (in the form of a strip a plurality of interconnected and fluidly isolated bladders 16) into the power injector 10. Such loading may include positioning the bulk fluid member 10 such that sprockets of the power injector 10 align with corresponding index holes 32 of the bulk fluid member 10. The next step 184 may be for the user to select a volume of fluid to be delivered. The selection may be accomplished by interacting with the GUI 44. The next step 186 may be to seal off a portion of the bladders 16 that corresponds to the selected volume from step 184. The sealing off step 186 may include feeding a strip of the plurality of interconnected and fluidly isolated bladders 16 of the bulk fluid member 10 into a working area of the power injector 42. The power injector 42 may position sealing devices and subsequently seal off a portion of the bladders 16 from the remaining bladders of the bulk fluid member 10, where the sealed off portion corresponds to the selected volume. For purposes of the description of the present method, the sealing off step 186 isolates bladders 16b through 16g. The sealing may be accomplished through the application of heat to create the isolation seals 28 and (where appropriate) the outlet seals 30. Alternatively, any other appropriate method of sealing may be used (e.g., ultrasonic welding). The sealing operation may also isolate a corresponding portion of the first channel 20 from the remainder of the first channel 20 of the bulk fluid member 10. The next step 188 may be to fluidly interconnect a tube set 54 to the isolated bladders 16b through 16g of the bulk fluid member 10. This may include interconnecting the bulk fluid member fluid interface 38 of the tube set 54 to the outlet 26c of the isolated bladders 16b through 16g. This may be followed by interconnecting the tube set 54 to a catheter installed in the patient. The next step 190 may be to transfer fluid from the bladders 16b through 16g to the tube set 54. The transferring fluid step 190 may include the power injector 42 squeezing the isolated bladders 16b through 16g. This squeezing may result in the bursting of the seals 24 between the isolated bladders 16b through 16g and the corresponding portion of the first channei 20. Once the seals 24 have burst, fluid may flow from the isolated bladders 16b through 16g into the corresponding portion of the first channel 20 and out of the bulk fluid member 10 through the outlet 26c. Subsequently, the fluid may flow through the tube set 54 and be injected into the patient. The flowing of fluid from the isolated bladders 16b through 16g may occur sequentially or simultaneously.

For example, the power injector 42 may sequentially squeeze fluid out of each of the isolated bladders 16b through 16g by first squeezing fluid from bladder 16b, then, once fluid has been dispensed from bladder 16b, the power injector may squeeze fluid from bladder 16c. Then fluid may be squeezed from bladder 16d, and so on until fluid has been squeezed from each of the isolated bladders 16b through 16g. In another example, the fluid may be squeezed from the isolated bladders 16b through 16g simultaneously. This may be accomplished by, for example, advancing rollers along each of the isolated bladders 16b through 16g simultaneously. A combination of sequential and simultaneous dispensing may also be used. For example, fluid may be simultaneously squeezed from the bladders 16b through 16d, then, once fluid has been dispensed from bladders 16b through 16d, the power injector may squeeze fluid from bladders 16e through 16g. After fluid has been dispensed, the next step 192 may be to disconnect the tube set 54 from the bulk fluid member 10 and return to step 184 for subsequent delivery of fluid to another patient.

The bulk fluid members 10, 68, 70, 112 described herein have been generally described to have bladders 16, 80, 84 of generally the same volume containing the same type of fluid for a particular bulk fluid member 10, 80, 84. in other embodiments, a bulk fluid member may include bladders of varying volumes that may also contain variable fluids therein. For example, a bulk fluid member may be configured to alternate between bladders filled with contrast and saline, in another example, a bulk fluid member may be configured with variable volume bladders such as a bulk fluid member that contains a repeating sequence of 20 mL, 10 mL, and 5 mL bladders of contrast. In such systems, the related power injectors may be operable to non-linearly select and access various bladders. For example, such a power injector may be operable to bypass a particular bladder ff it is not filled with the currently needed fluid or does not contain a currently needed volume of fluid and access a subsequent bladder. The power injector may then later (e.g., either later in the current administration of fluid or in a subsequent administration of fluid) return to the bypassed bladder and access it to deliver fluids from ft to a patient. Also in such a system, and also in any power injector described herein, the bladders may include indicia of the contents therein (e.g., type of fluid, volume of fluid). For example, each bladder in a particular bulk fluid member may contain a barcode or a radio frequency identification (RFID) tag and the corresponding power injector may include components to read the barcode or RFID tag. In this regard, the power injector may determine the contents of a particular bladder and this may be used for administrative, verification, and or record-keeping purposes.

The power injectors 42, 60 of Figures 1 through 5 and the power injectors of Figures 6A through 8C each may be used for any appropriate application, including without limitation for medical imaging applications where fluid is injected into a subject (e.g., a patient). Representative medical imaging applications for the power injectors 42, 60 of Figures 1 through 5 and the power injectors of Figures 6A through 8C include without limitation CT imaging, MR!, SPECT imaging, PET imaging, X-ray imaging, angiographic imaging, optical imaging, and ultrasound imaging. The power injectors 42, 60 of Figures 1 through 5 and the power injectors of Figures 6A through 8C each could be used alone or in combination with one or more other components. The power injectors 42, 60 of Figures 1 through 5 and the power injectors of Figures 6A through 8C each may be operatively interconnected with one or more components, for instance so that information may be conveyed between the power injector 42, 60 of Figures 1 through 5 or the power injectors of Figures 6A through 8C and one or more other components (e.g., scan delay information, injection start signal, injection rate).

The foregoing description of the present invention has been presented for purposes of illustration and description. Furthermore, the description is not intended to limit the invention to the form disclosed herein. Consequently, variations and modifications commensurate with the above teachings, and skill and knowledge of the relevant art, are within the scope of the present invention. The embodiments described hereinabove are further intended to explain best modes known of practicing the invention and to enable others skilled in the art to utilize the invention in such, or other embodiments and with various modifications required by the particular application(s) or use(s) of the present invention. It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the prior art.

Claims

What is claimed:

1. An injection system, comprising: an injection device; and a bulk fluid member loaded in said injection device, wherein said bulk fluid member comprises first and 5 second sheets that are bonded together to define a plurality of bladders, wherein each of said plurality of bladders comprises a fluid, and wherein said plurality of bladders are fluidly isolated from each other.

2. The injection system of claim 1 , wherein bulk fluid member further comprises an outiet channel that is fluidly interconnectable with each of said plurality of bladders.

3. The injection system of claim 2, wherein said first and second sheets are bonded together to l o further define said outlet channel.

4. The injection system of any of claims 2-3, wherein each of said plurality of bladders comprises first and second ends that are spaced in a first dimension, and wherein said outlet channel extends in a second dimension along said second ends of said plurality of bladders.

5. The injection system of claim 4, wherein said bulk fluid member is movable relative to said 15 injection device along said second dimension.

6. The injection system of any of claims 2-5, further comprising a rupturable seai between each of said plurality of bladders and said outlet channel.

7. The injection system of any of claims 2-6, wherein said bulk fluid member further comprises a first outlet fluidly interconnectable with said outlet channel. 0

8. The injection system of claim 7, further comprising a rupturable seai between said first outlet and said outlet channel.

9. The injection system of any of claims 7-8, wherein said first and second sheets are bonded together to further define said first outlet.

10. The injection system of claim 7, further comprising a plurality of said first outlets fluidly 5 interconnectable with said outlet channel.

11. The injection system of claim 10, further comprising a separate rupturable seal between each of said plurality of first outlets and said outlet channel.

12. The injection system of any of claims 10-11, wherein said first and second sheets are further bonded together to further define said plurality of first outlets. 0

13. The injection system of any of claims 10-12, wherein at least one of said plurality of said first outlets is always disposed exteriorly of said injection device.

14. The injection system of any of claims 1-13, wherein said bulk fluid memberfurther comprises a plurality of indexing members engageable by said injection device to advance said bulk fluid member relative to said injection device. 5

15. The injection system of any of claims 1-14, wherein said injection device comprises a power injector.

16. The injection system of any of claims 1-15, wherein said injection device comprises a fluid transfer member movable relative to and engageable with at least one of said plurality of bladders,

17. The injection system of any of claims 1-15, wherein said injection device comprises at least one sealing member movable relative to said bulk fluid member and each of its said plurality of bladders.

18. The injection system of claim 17, wherein said at least one sealing member is operable to create first and second seals to isolate a first portion of said plurality of bladders.

19. The injection system of claim 18, wherein said at least one sealing member is movable relative to said bulk fluid member to vary a number of said plurality of bladders included in said first portion.

20. The injection system of any of claims 18-19, wherein said injection device further comprises a fluid transfer member movable relative to and engageable with said first portion of said plurality of bladders.

21. An injection system, comprising: an injection device; and a bulk fluid member loaded in said injection device, wherein said bulk fluid member comprises a plurality of bladders, fluid in each of said plurality of bladders, an outlet channel fluidly iπterconnectable with each of said plurality of bladders, and a plurality of outlets that are each fluidly interconnectable with said outlet channel, wherein a fluid exiting any of said plurality of bladders is directed into said outlet channel and then into at least one of said plurality of outlets.

22. The injection system of claim 21, wherein said bulk fluid member further comprises first and second sheets that are bonded together to define said plurality of bladders.

23. The injection system of claim 22, wherein said first and second sheets are bonded together to further define said outlet channel.

24. The injection system of any of claims 22-23, wherein said first and second sheets are further bonded together to further define said plurality of outlets.

25. The injection system of any of claims 21-24, wherein each of said plurality of bladders comprises first and second ends that are spaced in a first dimension, and wherein said outlet channel extends in a second dimension along said second ends of said plurality of bladders.

26. The injection system of claim 25, wherein said bulk fluid member is movable relative to said injection device along said second dimension.

27. The injection system of any of claims 21 -26, further comprising a rupturabte seai between each of said plurality of bladders and said outlet channel.

28. The injection system of any of any of claims 21-27, further comprising a separate rupturable seal between each of said plurality of outlets and said outlet channel.

29. The injection system of any of claims 21 -28, wherein at least one of said plurality of outlets is always disposed exteriorly of said injection device,

30. The injection system of any of claims 21-29, wherein said bulk fluid member comprises a plurality of indexing members engageable by said injection device to advance said bulk fluid member relative to said injection device.

31. The injection system of any of claims 21-30, wherein said injection device comprises a power injector.

32. The injection system of any of claims 21-31, wherein said injection device comprises a fluid transfer member movable relative to and engageable with at least one of said plurality of bladders.

33. The injection system of any of claims 21-31 , wherein said injection device comprises at least one sealing member movable relative to said bulk fluid member and each of its said plurality of bladders.

34. The injection system of claim 33, wherein said at least one sealing member is operable to create first and second seals to isolate a first portion of said plurality of bladders.

35. The injection system of claim 34, wherein said at least one sealing member is movable relative to said bulk fluid member to vary a number of said plurality of bladders included in said first portion.

36. The injection system of any of claims 34-35, wherein said injection device further comprises a fluid transfer member movable relative to and engageabie with said first portion of said plurality of bladders.

37. An imaging system comprising: a. a medical imaging device; and b. an injection device comprising: a first bulk fluid member comprising a plurality of bladders, wherein each of said plurality of bladders is fluidly isolated from every other bladder of said plurality of bladders when in a sealed state, wherein each of said plurality of bladders is disposed along a length of said bulk fluid member; and a fluid transfer member operable to transfer fluid out of at least one of said plurality of bladders.

38. The system of claim 37, wherein said first bulk fluid member comprises a channel extending along said length of said bulk fluid member, wherein each one of said plurality of bladders comprises a first perimeter seal portion disposed between said one of said plurality of bladders and said channel.

39. The system of any of claims 37-38, wherein each of said plurality of bladders comprises a first perimeter seal portion and a second perimeter seal portion, wherein a burst strength of said first perimeter seal portion is less than a burst strength of said second perimeter seal portion.

40. The system of claim 37, wherein said first bulk fluid member comprises a channel extending along said length of said bulk fluid member, wherein each one of said plurality of bladders comprises a first perimeter seal portion disposed between said one of said plurality of bladders and said channel, wherein each of said plurality of bladders comprises a second perimeter seal portion, wherein a burst strength of said first perimeter seal portion is less than a burst strength of said second perimeter seal portion.

41. The system of any of claims 37-40, wherein said fluid transfer member is operable to simultaneously transfer fluid out of at least two of said plurality of bladders to said fluid outlet port.

42. The system of any of claims 37-41 , further comprising a feed member operable to index said first bulk fluid member relative to said fluid transfer member.

43. The system of claim 42, wherein said first bulk fluid member comprises a plurality of through holes aligned along a longitudinal axis of said first bulk fluid member, wherein said feed member comprises a rotatable sprocket with protrusions corresponding to said through holes.

44. The system of any of claims 37-43, further comprising a seal member operable to fluidly isolate a first group of one or more of said plurality of bladders from the remainder of the plurality of bladders.

45. The system of claim 44, wherein said seal member includes a heat-sealing element.

46. The system of any of claims 37-45, wherein at least a portion of said plurality of bladders contains contrast.

47. The system of any of claims 37-46, wherein at least a portion of said plurality of bladders contains saline.

48. The system of any of claims 37-47, further comprising a second bulk fluid member comprising a plurality of bladders, wherein each of said plurality of bladders of said second bulk fluid member is fluidly isolated from every other of said plurality of bladders of said second bulk fluid member when in a sealed state, wherein each of said plurality of bladders of said second bulk fluid member is disposed along a length of said second bulk fluid member.

49. The system of claim 48, wherein each bladder of said first bulk fluid member contains a different volume of fluid than each bladder of said second bulk fluid member.

50. The system of any of claims 48-49, wherein each bladder of said first bulk fluid member contains a different type of fluid than each bladder of said second bulk fluid member.

51. The system of any of claims 37-50, further comprising a tube set comprising: a bulk fluid member fluid interface operable to fluidly connect to said first bulk fluid member; a patient fluid interface operable to fluidly connect to a catheter inserted into a patient; and a tube fluidly connected to said bulk fluid member fluid interface and said patient fluid interface.

52. The system of claim 51, wherein said patient fluid interface comprises a Luer connector.

53. The system of any of claims 37-52, wherein said fluid transfer member comprises two squeezing members oppositely disposed on each side of the first bulk fluid member.

54. The system of claim 53, wherein said squeezing members comprise rollers operable to be translated along a lateral axis of a portion of said first bulk fluid member to force fluid out of said at least one of said plurality of bladders.

55. The system of any of claims 37-54, wherein said fluid transfer member comprises a syringe and plunger operable to draw fluid from one or more of said plurality of bladders and then dispense fluid into a patient.

56. The system of any of claims 37-55, wherein said injection device comprises a power injector.

57. A method of dispensing fluid through a fluid outlet port, said method comprising: a. loading a bulk fluid member into an injection device, wherein said bulk fluid member comprises a plurality of interconnected and fluidly isolated bladders, wherein said bulk fluid member comprises a fluid channel disposed along a longitudinal edge of said bulk fluid member; b. sealing off, after step a, a first portion of said bulk fluid member from a remaining portion of said bulk fluid member, wherein said sealing off fluidly isolates a first portion of said bladders from a remaining portion of said bladders, wherein said sealing off fluidly isolates a first portion of said fluid channel from a remaining portion of said fluid channel; c. fluidly interconnecting said fluid outlet port to said first portion of said fluid channel; and d, squeezing, after steps b and c, said first portion of bladders, wherein said squeezing causes fluid to flow from each bladder of said first portion of bladders into said first portion of said fluid channel and through said fluid outlet port.

58. The method of claim 57, further comprising bursting, during said squeezing step, seals disposed between each bladder of said first portion of bladders and said first portion of said fluid channel,

59. The method of any of claims 57-58, wherein said sealing off step comprises applying heat to a portion of said bulk fluid member.

60. The method of any of claims 57-59, wherein said first portion of said bladders comprises a plurality of bladders.

61. The method of any of claims 57-60, wherein said fluid outlet port is fluidly interconnected to a patient.

62. A method of dispensing fluid, said method comprising; loading a bulk fluid member into an injection device, wherein said bulk fluid member comprises a plurality of interconnected and fluidly isolated bladders; fluidly interconnecting a first group of said plurality of bladders to a first fluid outlet, wherein said first group of said plurality of bladders comprises one or more of said plurality of bladders; dispensing fluid from said first group of said plurality of bladders through said first fluid outlet; advancing said bulk fluid member relative to said injection device; fluidly interconnecting a second group of said plurality of bladders to a second fluid outlet, wherein said second group of said plurality of bladders comprises one or more of said plurality of bladders, wherein no bladder of said first group is part of said second group; and dispensing fluid from said second group of said plurality of bladders through said second fluid outlet.

63. A method of dispensing fluid, said method comprising: a. loading a bulk fluid member into an injection device, wherein said bulk fluid member comprises a plurality of interconnected and fluidly isolated bladders, wherein each bladder contains a volume of fluid; b. selecting a first volume of fluid to be dispensed, wherein said first volume of fluid is greater than any volume of fluid contained in any single bladder of said plurality of bladders; c. selecting a first group of said plurality of bladders; d. fluidly interconnecting a first tube set to said first group of said plurality of bladders; e. dispensing said first volume of fluid from said first group of said plurality of bladders into said first tube set; f. selecting a second volume of fluid to be dispensed, wherein said second volume of fluid is greater than any volume of fluid contained in any single bladder of the plurality of bladders, wherein said second volume of fluid is of a different size than said first volume of fluid; g. selecting a second group of said plurality of bladders, wherein no bladder of said first group is part of said second group; h. fluidiy interconnecting a second tube set to said second group of said plurality of bladders; and i. dispensing said second volume of fluid from said second group of said plurality of bladders into said second tube set.

64. The method of claim 63, wherein said selecting said first group of said plurality of bladders step comprises sealing off a portion of said bulk fluid member from a remaining portion of said bulk fluid member, wherein said sealing fluidiy isolates said first group of said bladders from a remaining portion of said bladders.

65. The method of any of claims 63-64, wherein said dispensing said first volume step comprises squeezing said first group of said plurality of bladders, wherein said squeezing causes fluid to flow from each bladder of said first group of said plurality of bladders into said first tube set.

66. The method of any of claims 63-65, wherein said dispensing said first volume step comprises sequentially dispensing fluid from each bladder of said first group of said plurality of bladders.

67. The method of any of claims 63-65, wherein said dispensing said first volume step comprises simultaneously dispensing fluid from each bladder of said first group of said plurality of bladders.

68. The method of any of claims 63-67, wherein said first group comprises two or more of said plurality of bladders, and wherein said second group comprises two or more of said plurality of bladders.

69. The method of any of ciaims 63-68, wherein said first group comprises a different number of bladders than said second group.

70. The method of any of claims 63-69, wherein said first group comprises two or more of said plurality of bladders, and wherein said dispensing fluid from said first group comprises sequentially flowing fluid from each bladder of said first group.

71. The method of any of claims 63-69, wherein said first group comprises two or more of said plurality of bladders, and wherein said dispensing fluid from said first group comprises simultaneously flowing fluid from each bladder of said first group.

72. The method of any of claims 63-71 , wherein said loading a bulk fluid member into a power injector step comprises feeding a strip of said plurality of interconnected and fluidiy isolated bladders into said power injector.

73. A method of dispensing fluid, comprising: loading a bulk fluid member into an injection device, said bulk fluid member comprising a plurality of bladders that are fluidly isolated from each other prior to said loading step; dispensing a first fluid quantity from at least one of said plurality of bladders; advancing said bulk fluid member relative to said injection device; and dispensing a second fluid quantity from at least one of said plurality of bladders, wherein no bladder used by said dispensing a first fluid quantity step is used by said dispensing a second fluid quantity step.

74. The method of claim 73, wherein said first and second fluid quantities are selected from the group consisting of a common quantity and a different quantity.

75. The method of any of claims 73-74, wherein each of said dispensing steps comprises compressing said bulk fluid member.

76. The method of any of claims 73-75, wherein each of said plurality of bladders comprises a separate seal, and wherein each of said dispensing steps comprises rupturing said seal associated with at least one of said plurality of bladders.

77. The method of any of claims 73-76, wherein each of said dispensing steps comprises directing fluid into a common outlet channel associated with each of said plurality of bladders.

78. The method of claim 77, wherein said bulk fluid member further comprises a plurality of outlets fluidly interconnectable with said common outlet channel, and a separate seal between each of said plurality of outlets and said common outlet channel, wherein each said dispensing step further comprises rupturing at least one said seal between said plurality of outlets and said common outlet channel.

79. The method of any of claims 73-78, further comprising the steps of: sealing off a first portion of said plurality of bladders for and prior to said dispensing a first fluid quantity step; and sealing off a second portion of said plurality of bladders for and prior to said dispensing a second fluid quantity step.

80. The method of claim 79, wherein each of said sealing steps comprises creating first and second seals that are spaced from each so as to retain at least one of said plurality of bladders between said first and second seals.