|Publication number||US7632245 B1|
|Application number||US 10/921,083|
|Publication date||Dec 15, 2009|
|Priority date||Aug 18, 2003|
|Publication number||10921083, 921083, US 7632245 B1, US 7632245B1, US-B1-7632245, US7632245 B1, US7632245B1|
|Inventors||Kevin P. Cowan, Frederick W. Trombley, III, David M. Reilly, David M. Griffiths, George J. Misic, Keith Callan|
|Original Assignee||Medrad, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (37), Non-Patent Citations (4), Referenced by (12), Classifications (10), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of U.S. Provisional Application Ser. No. 60/495,972, filed on Aug. 18, 2003, the contents of which are incorporated herein by reference. This application is also related to U.S. application Ser. No. 10/916,946, filed on Aug. 12, 2004, titled “Actuators And Fluid Delivery Systems Using Such Actuators.”
The present invention relates generally to devices, systems and methods for delivery of a fluid, and, particularly, for infusion or injection of a fluid into a patient.
A number of injector-actuated syringes and powered injectors for use in medical procedures such as angiography, computed tomography (CT), ultrasound and NMR/MRI have been developed. U.S. Pat. No. 4,006,736, for example, discloses an injector and syringe for injecting fluid into the vascular system of a human being or an animal. Typically, such injectors comprise drive members such as pistons that connect to a syringe plunger. For example, U.S. Pat. No. 4,677,980, the disclosure of which is incorporated herein by reference, discloses an angiographic injector and syringe wherein the drive member of the injector can be connected to, or disconnected from, the syringe plunger at any point along the travel path of the plunger via a releasable mechanism. A front-loading syringe and injector system is also disclosed in U.S. Pat. No. 5,383,858, the disclosure of which is incorporated herein by reference.
Although significant advances have been made in the design and operation of powered injectors, a number of problems persist which can limit their use. For example, each year in the United States several million MRI procedures are performed. However, powered injectors are used in only a relatively small percentage of such procedures. In MRI procedures in which there is no need to accurately control the timing of contrast injection or the flow rate of injection, powered injectors are almost never used. In that regard, MRI procedures are relatively expensive and patient throughput is a primary concern. It is perceived that use of powered injectors in such procedures will require additional time, while providing little benefit. Thus, in contrast-enhanced procedure in which timing and flow rate control are not important, contrast is currently injected manually. Typically, the patient is placed in the MRI bore and a baseline scan is performed. The patient is then removed from the bore of the imaging device and the contrast is injected. The patient is then once again placed in the bore and the contrast-enhanced imaging is performed.
A number of problems often arise with the manual injection of contrast in an MRI procedure. For example, after injection it is often difficult to reposition the patient in the same position in which the baseline measurement was made. Even if repositioning can be achieved with success, removal of the patient from the bore to manually inject contrast and subsequent repositioning require a substantial amount of time. Moreover, in some instances, particularly with claustrophobic patients, the patient refuses to reenter the bore. Furthermore, it is sometimes difficult with some patients to properly inject the contrast manually. In such cases, it may become necessary to call for the services of an IV specialist team, greatly increasing the amount of time required for the scan.
Even in imaging procedures other than MRI procedures (such as CT, angiography and ultrasound), there may be reluctance to use powered injectors in certain procedures because of perceived or actual burdens with such use.
For the above reasons and others, it is desirable to develop improved devices, systems and methods for the injection of fluids into patients.
In one aspect, the present invention provides a device for injection of a fluid into a patient, including: a container to hold fluid, the container comprising an outlet through which fluid can exit the container, a pressurizing mechanism in connection with the container for pressurizing the fluid, and an actuator in fluid connection with the outlet. The actuator has a first state in which pressurized fluid is prevented from flowing through the outlet and a second state in which pressurized fluid can flow through the outlet. The injection device further includes a flow regulator to control the flow rate of fluid in fluid connection with the outlet.
In one embodiment, the container is a syringe with a plunger slidably disposed therein, and the pressurizing mechanism is in operative connection with the plunger.
The pressurizing mechanism can, for example, be powered by a vacuum drive, a chemical reaction, electrical power, expansion of a compressed gas, spring force or gravity. The mechanism of the actuator can, for example, include a rotory valve, a pinch valve with tubing, a ratchet valve, a fusible link, a trumpet valve, a port closing valve, a pump system or a drive system. The mechanism can, for example, be powered by a vacuum drive, a piezoelectric drive, an electric motor drive, a solenoid drive, an electro resistive pump, a charged ion pump, a magneto restrictive material, a thermochemically activated motion (TCAM®) device, a shape memory alloy (SMA) such as nitenol (a nickel-titanium alloy), a state transition, a bi-metallic material, an electro-active polymeric material or gravity. A number of non-magnetic, electroactive actuators (and fluid delivery systems) suitable for use in the present invention are described in U.S. Provisional Patent Application No. 60/495,386, entitled Actuators and Fluid Delivery Systems Using such Actuators, filed Aug. 15, 2003, assigned the assignee of the present invention, the disclosure of which is incorporated herein by reference.
The injection device can also include a controller to control the state of the actuator. The controller can be remote from the actuator. The controller can, for example, be untethered from the actuator. The controller can, for example, control the state of the actuator via ultrasound, via a protocol of an imaging scanner, via microwave energy, via a mechanical link, via infrared light, via fiber optic cable, via pneumatic power, via hydraulic power, via voice activation, via movement of a scanner table, via time delay, via an RF gradient trigger from a scanner, via a photo cell, via optical light, an RF signal, or via line power.
In one embodiment, the container, the pressurizing mechanism, the actuator and the flow regulator are MR compatible, thereby making the device suitable for use in or near the bore of an MR scanner.
The regulator can, for example, include a fluid path element of a known diameter. For example, the regulator can be an orifice or a catheter. Multiple orifices or an adjustable orifice can be provided for multiple flow rates. As used herein, the term “orifice” refers to an opening through which a fluid can pass and is typically a stricture or narrowing in the flow path providing a restriction to flow. A restriction to flow can also be created by adjustment (for example, lengthening) of the fluid path. Flow rate can also be controlled by controlling the pressure generated by the pressurizing mechanism.
The injection device can also include an attachment mechanism for attaching the device to the patient.
In one embodiment, the pressurizing mechanism includes a vacuum drive in operative connection with syringe plunger. The vacuum drive can include at least one chamber with a sealing member slidably disposed therein, wherein at least a partial vacuum is created by drawing the sealing member through the chamber. The pressurizing mechanism can also include a pressurized gas in operative connection with the syringe plunger. In one embodiment, the gas is a product of a chemical reaction. In another embodiment, the gas is supplied from a storage tank.
In another aspect, the present invention provides a system for use in magnetic resonance imaging, including: a magnetic resonance scanner comprising a bore in which a patient is positioned for a scan and a device for injection of a fluid in a patient. As described above, the device includes a container to hold fluid. The container includes an outlet through which fluid can exit the container. The injection device further includes a pressurizing mechanism in connection with the container for pressurizing the fluid. An actuator is in fluid connection with the outlet. The actuator has a first state in which pressurized fluid is prevented from flowing through the outlet and a second state in which pressurized fluid can flow through the outlet. The injection device further includes a flow regulator to control the flow rate of fluid in fluid connection with the outlet.
Preferably, the container, the pressurizing mechanism, the actuator and the flow regulator are MR compatible, thereby making the device suitable for use in or near the bore of an MR scanner.
In another aspect, the present invention provides a method of injection of a fluid into a patient including the steps: (i) attaching a container to hold fluid to the patient, the container including an outlet through which fluid can exit the container; a pressurizing mechanism being in connection with the container for pressurizing the fluid, and (ii) controlling an actuator in fluid connection with the outlet to be in a second state, the actuator having a first state in which pressurized fluid is prevented from flowing through the outlet and the second state in which pressurized fluid can flow through the outlet.
The step of controlling an actuator can occur remote from the patient. The patient can, for example, be inside the bore of an MR scanner and the controller for controlling the actuator can be remote from the patient.
In another aspect, the present invention provides a method of injecting a fluid into a patient during an MR procedure including the steps: (i) placing a container to hold fluid in close vicinity of the patient, the container including an outlet through which a fluid can exit the container, a pressurizing mechanism being in connection with the container to pressurize the fluid, and (ii) remotely controlling an actuator in fluid connection with the outlet to be in a second state, the actuator having a first state in which pressurized fluid is prevented from flowing through the outlet and the second state in which pressurized fluid can flow through the outlet.
The container can be MR compatible and be within the bore of the MR scanner. The container can, for example, be attached to the patient within the bore of the MR scanner.
In another aspect, the present invention provides a method performing an MR scan, including the steps: (i) placing an MR compatible container to hold contrast fluid in close vicinity or proximity to the patient, the container including an outlet through which contrast fluid can exit the container, a pressurizing mechanism being in connection with the container for pressurizing the fluid, (ii) performing a baseline scan, and injecting a contrast fluid into the patient without removing the patient from the bore of the MR scanner by controlling an actuator in fluid connection with the outlet to be in a second state, the actuator having a first state in which pressurized fluid is prevented from flowing through the outlet and the second state in which pressurized fluid can flow through the outlet. The container can be within the bore of the MR scanner. The container can also be attached to the patient within the bore of the MR scanner.
In a further aspect, the present invention provides an injection device for use in connection with a syringe having a plunger slidably disposed therein. The injection device includes a plurality of chambers that are closed on one end. Each chamber has a sealing member slidably disposed therein. At least a partial vacuum is created by drawing the sealing members through the chambers. The sealing members are in operative connection with the force transfer member to transfer force to the plunger of the syringe. The device can further include a cradle for the syringe into which the syringe is removably placed to place the force transfer member in operative connection with the plunger of the syringe.
In one embodiment, the force transfer member includes a connection member in operative connection with the sealing member of the chambers. The connection member includes an attachment member to which a plunger extension, which extends rearward from the plunger of the syringe, is attachable.
In still a further aspect, the present invention provides an injection device including a syringe barrel. The syringe barrel includes a first plunger slideably disposed therein and a second plunger slidably disposed therein. The first plunger is spaced forward from the second plunger in the syringe to create an intermediate volume therebetween. The intermediate volume includes therein a pressurizing mechanism for increasing the pressure in the intermediate volume upon activation of the pressurizing mechanism. The intermediate volume further includes a fluid therein. The pressurizing mechanism can, for example, generate a gas upon activation thereof to increase the pressure in the intermediate volume.
The injection device can further include a plunger extension operatively connected to the second plunger. In one embodiment, the injection device includes a stop mechanism to fix the position of the second plunger. The stop mechanism can, for example, include tabs on the plunger extension that abut with a stop member of the injection device to prevent movement of the injection device. In another embodiment, the plunger extension can be removable from connection with the second plunger and the injection device further includes a seal to close the rearward end of the syringe barrel after the plunger extension has been removed. It is not necessary, however, to seal the rearward end of the syringe barrel. As long as the second plunger is prevented from exiting the rear of the syringe, the injection device will be operable. Thus the injection device can alternatively include an abutment member that prevents the second plunger from exiting the rearward end of the syringe.
In a further embodiment, the plunger extension is axially movable relative to the second plunger to expel a material contained within a chamber of the plunger so that the material contacts a fluid in the intermediate volume with which the material reacts to generate a gas. The plunger can, for example, include threading, and the forward end of the plunger extension can include cooperating threading. In this embodiment, the plunger extension is rotated relative to the plunger to cause the plunger extension to move axially forward relative to the plunger. The axial forward motion of the plunger extension can, for example, force the material through a membrane separating the chamber of the plunger from the fluid within the intermediate volume. In one embodiment, rotation of the plunger extension also fixes the axial position of the second plunger within the syringe by bringing at least one contact member on the plunger into abutting engagement with at least one abutment member on the syringe.
In still a further aspect, the present invention provides an actuator for remote initiation of an injection procedure as described above. The actuator includes a fluid-filled (as used herein, the term fluid refers generally to either a gas or a liquid) chamber in fluid connection with a controller via a length of tubing. The controller is operable to increase the pressure within the chamber upon actuation thereof. The chamber is in operative connection with a valve mechanism that is a normally close state. Increasing fluid pressure in the chamber (via the controller) acts to place the valve in an open state. In one embodiment, the valve mechanism is within the chamber and is separated from the fluid therein by an elastomeric material that moves upon increasing the pressure of the fluid in the chamber to place the valve mechanism in an open state.
Numerous advantages are afforded by the injection devices of the present invention. For example, the devices are readily made patient wearable and readily fabricated to be fully in-bore compatible for MR procedures. The devices of the present invention can, for example, be applied to a patient outside the scanning room, and there is no need to remove a patient from the scanner bore to perform an injection. Likewise, the amount of time required for set up of the devices of the present invention is minimal. The devices of the present invention are also readily adaptable for remote activation, for example, from a scan control room. These advantages and others result in less time required for MR and other procedures and increase patient throughput.
Given the proximity of placement of the devices of the present invention to the patient, no saline flush to remove expensive contrast medium from the fluid path is required as is often necessary with current powered injectors in which long lengths of connective tubing are required. Indeed, in many embodiments of the present invention, less than three inches of connective tubing is required. Preferably, no more than one foot of connective tubing is required between the injection devices of the present invention and the injection point on the patient. The devices of the present invention are inexpensively and readily manufactured from relatively inexpensive materials and can be disposed of on a per-patient and/or other periodic basis, potentially reducing the risk of cross-contamination and making sterilization unnecessary.
Injection fluid (for example, contrast medium, stress agents, saline, blood pool agents and/or organ specific agents) can be delivered to the patient through standard catheters (for example, a 24 gauge butterfly catheter) using the devices of the present invention. Moreover, many of the devices of the present invention are operable with commercially available syringes, which can be supplied empty or prefilled.
Other aspects of the invention and their advantages will be discerned from the following detailed description when read in connection with the accompanying drawings, in which:
In general, the present invention provides infusion or injection devices and systems that are relatively easy to operate. The injection devices are preferably readily portable and can even be patient wearable.
In the embodiment of the present invention illustrated in
Pressurizing mechanism 40 can provide the force to pressurize the fluid in container or chamber 20 via, for example, air displacement of a vacuum (a vacuum drive), a chemical reaction (for example, releasing an expanding gas), electrochemical reactions, electrical power (for example, from a battery, wall outlet or from the scanner), expansion of a compressed gas (for example, CO2 or air pressure); spring force or gravity.
Actuator 50 can, for example, include a rotory valve at a syringe tip, a pinch valve w/tubing, a ratchet valve, a fusible link, a trumpet valve, a port closing valve, a pump system or a drive system to allow fluid to flow through outlet 30. The mechanism for operating actuator 50 (or imparting motion thereto to change a state) can, for example, include a vacuum drive, a piezoelectric drive, an electric motor drive (for example, an inside-MRI bore air core motor in which the magnet of the bore forms part of the motor), a solenoid drive, an electric motor drive outside of the bore, an electro resistive pump, a charged ion pump (available, for example, from Exigent), a magneto restrictive material (to which a voltage is applied), a thermochemical activated motion (TCAM) material or device, a nitenol material, a state transition (liquid to gas), a bi-metallic material (with different rates of expansion for each metal), an electro-active polymeric material, and/or gravity. Power can be supplied via, for example, vacuum power, chemical power, electrical power (for example, battery power, wall outlet power), power from the scanner, human/manual power, compressed or pressurized gas (for example, CO2 or air) power; spring power, gravity power, or light/photoelectric power.
Controller 70 can for example, control the state of actuator 50 via ultrasound (for example, via a piezo tweeter operating through glass); via a scanner coil protocol (for example, GE/Siemens scanners comprise approximately 85% of the axial market and include two 15 volt connections); via microwave energy (for example, a glass smart link); via a mechanical or cable link (for example, via a simple string of via camera-type cable link using a plastic cable); via infrared light; via fiber optic cable; via pneumatic power; via hydraulic power; via patient operation; via voice activation; via movement of table 210; via time delay; via an RF gradient trigger from scanner (for example, 5th shim tune); via a photo cell; via optical light control; via line power (for example, via audio frequency through panel); via an RF link, or via operator manual control (that is, sending the operator into the MRI room to activate the device).
For use in an MR environment, the components of injection device 10 are preferably fabricated from materials that are non-magnetic and/or otherwise suitable or compatible for use in an MRI environment. A review of issues related to the compatibility of various equipment in an MRI environment is set forth in Keeler, E. K. et al., “Accessory Equipment Considerations with Respect to MRI Compatibility,” JMRI, 8, 1 (1998), the disclosure of which is incorporated herein by reference. See also, Lemieux, L. et al., “Recording of EEG During MRI Experiments: Patient Safety,” MRM, 38, 943 (1997); and “A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems,” U.S Food and Drug Administration—Center for Devices and Radiological Health (Feb. 7, 1997), the disclosures of which are incorporated herein by reference.
In general, many devices, including but not limited to many injectors and infusion pumps, that contain electric actuators such as DC brush motors, step motors, brushless DC motors or other wound coil motors and solenoids often fail in a strong magnetic field as a result of damage to internal permanent magnets. Moreover, currents induced within the field windings of such devices from electromagnetic fields can cause overheating and potential damage to the windings and any connected electronic circuitry. The MRI magnetic field can also interfere with the device created magnetic field and prevent accurate operation.
Furthermore, differences in magnetic permeability of materials within the actuator and eddy currents induced within actuator windings can affect the homogeneity or uniformity of the MRI magnetic field, generating image artifacts. Actuators that use mechanical commutation, such as DC brush motors, can also generate radio frequency energy during switching which can induce unwanted artifacts upon the acquired MRI images.
As illustrated in
Preferably, the injection devices of the present invention are suitable to be placed within one foot of the MRI bore. More preferably, the injection devices of the present invention are suitable to be placed within the bore, thereby providing close access to the injection site on the patient and eliminating lengthy connective tubing used with many currently available injection devices. In general, to be “MR compatible” as that phrase is used herein, the materials of device 110 should not interfere with the operation of MR scanner 200 in a substantial manner (for example, to cause image artifacts). Additionally, the MR environment (for example, the powerful magnetic field) should not substantially interfere with the operation of injection device 110. Examples of suitable MRI compatible materials for injection device 110 include, but are not limited to, polymeric materials, glass materials and aluminum.
Container or chamber 120 for the injection fluid (generally an MR contrast fluid) can, for example, be a polymeric or glass MR syringe available, for example, from Medrad, Inc. of Indianola, Pa. Such syringes can be purchased “prefilled” with injection fluid or can be purchased empty and filled at the MRI site. The fluid in such syringes is pressurized via a plunger 125, which is slidably disposed within the syringe barrel.
In the embodiment of
While actuator 150 is in an “off” state, fluid cannot be injected through syringe outlet 130 and sealing members 142 cannot move forward within syringe vacuum chambers 140 a and 140 b. In that regard, the fluid within syringe 120 is generally incompressible and extensions 144 are mechanically connected to plunger extension 128. Once actuator 150 is placed in an “on” state, fluid can flow through syringe outlet 130 and atmospheric pressure will force sealing members 142 (and thereby extensions 144) to move forward. The force created (which is proportion to atmospheric pressure multiplied by the area of the sealing members) is transferred from extensions 144 to plunger extension 128 and, thus, to plunger 126, thereby forcing pressurized fluid through syringe outlet 130 to be injected into the patient through catheter 160.
Injection device 110 can, for example, be worn by the patient via straps 148. Likewise, device 10 can be attached to scan table 210.
The pressure at which the fluid is injected and the flow rate of fluid to be injected can be controlled, in part, by the diameter of syringe 120 and the diameter of syringe vacuum chambers 140 a and 140 b. In a typical MR procedure, approximately 15 to 20 ml of MR contrast are injected. To inject approximately 1 mL/sec of the MR contrast MAGNEVIST® (gadopentetate dimeglumine) available from Berlex Laboratories, Inc. of Montville, N.J. through a 24 gauge butterfly catheter requires a pressure of about 30 psi. Vacuum drive pressure mechanism 140 is well suited to provide such pressures and greater pressures.
As set forth above, pressurized fluid flows through outlet 130 upon activation of actuator 150. In the embodiment of
Outlet 330 of syringe 320 is connected to an actuator 350. Actuator 350 can, for example, be a simple on/off type switching mechanism that either prevents flow or permits flow from syringe outlet 330 to tubing 352 (and therethrough to patient catheter 360). Even though activation button 344 of pressurizing mechanism 340 may have been previously activated, plunger 325 of syringe 320 will not move and no fluid will exit outlet 330 until actuator 350 is in the “on” state. As described above, actuator 350 can be a “wireless” actuator that is controlled from the MR control room via controller 370. Once actuator 350 is placed in the “on” state gas pressure from pressurizing mechanism 340 will cause plunger 325 to advance within syringe 320, thereby causing fluid to be injected into the patient through catheter 360. As described above, fluid flow rate/pressure can be controlled through a number of mechanisms. For example, the gas pressure created by pressurizing mechanism 340 can be adjusted (for example, via the size of pressurizing mechanism 340, via the type of reaction used and/or via the size/rating of pressure relief valve 346). As described above, an orifice of a predetermined size/diameter in the flow path can act to control flow rate/pressure. Moreover, the size/gauge of catheter 360 can be chosen to control flow rate/pressure.
Expansion of bladder 325 a forces fluid contained within syringe 320 a forward of bladder 325 a out of outlet 330 a of syringe 320 a and into a patient (not shown in
In the embodiment of
Plunger 320 b is thereby forced forward to force fluid contained within syringe 320 b forward of plunger 325 b out of outlet 330 b of syringe 320 b and into a patient (not shown in
Intermediate space or volume 440 can, for example, be filled with an incompressible fluid such as water. Intermediate volume 440 also preferably includes therein a mechanism 460 for applying force to first plunger 420 to inject fluid contained within syringe barrel 410 forward of first plunger 420. The pressurizing mechanism 460 can, for example, be a carbon dioxide generator (for example, a reactive mixture of an alkali metal carbonate and a weak organic acid).
During operation, second plunger 430 can be drawn rearward (which will cause first plunger 420 to also be drawn rearward) to draw an injection fluid into the volume of syringe barrel 410 forward of first plunger 420. Air can be expelled, from the volume of syringe barrel 410 forward of first plunger 420 by advancing plunger extension 450 forward, thereby advancing both second plunger 430 and first plunger 420 forward within syringe barrel 410. Device 400 is now primed and ready for use to inject fluid into a patient. At this point, the operator can lock the position of second plunger 430 within syringe barrel 410 by sliding abutment members 470 into abutting connection with flanges or tabs 452 formed on or attached to plunger extension 450. The pressurizing mechanism can be activated to, for example, create carbon dioxide and increase the pressure within intermediate volume 440. Once the controller (as described above) is activated, fluid will be forced from syringe barrel 410 in a controlled manner.
Activation of pressurizing mechanism 460 such as carbon dioxide generator can be accomplished in a wireless manner by, for example, using induction or magnetic energy applied across syringe barrel 410 via, for example, an actuating mechanism 480 placed in the vicinity of pressurizing mechanism 460 as illustrated in
Alternatively, as illustrated in
Intermediate space or volume 440″ can, for example, be filled with a fluid including an aqueous solution of acetic acid or citric acid. In this embodiment, plunger 430″ can include a chamber 431″ formed therein in which is positioned a pellet 460″ of a compound such as an sodium carbonate or calcium carbonate that forms carbon dioxide when it react with acetic acid of citric acid. Chamber 431″ is separated from intermediate volume 440″ by a relatively thin membrane 436″. A rearward end of chamber 431″ is separated from a plunger extension/piston 450 by an elastomeric membrane or diaphragm 434″. To activate syringe barrel 410″, the operator rotates plunger extension 450″ relative to syringe barrel 410. Threading 454″ on a forward end of plunger extension 450″ cooperates with threading 432″ formed in a rearward end of plunger 430″ to cause plunger extension 450″ to move forward relative to plunger 430″. A forward surface of plunger extension 450″ deforms membrane 434″, which forces pellet 460″ forward to break through thin membrane 436″ and come into contact with the fluid within intermediate volume 440″. A reaction which releases carbon dioxide and increases the pressure within intermediate volume 440″ is initiated, thereby applying force to first plunger 420″ to inject fluid contained within syringe barrel 410″ forward of first plunger 420″. When plunger extension 450 is rotated as described above, tabs 452″ can come into contact with a radially inward extending flange 470″ positioned on a rearward end of syringe barrel 410″ to prevent axial motion of plunger extension 450 relative to syringe barrel 410″ as described in connection with the embodiment of
As described above, intermediate space or volume 540 can, for example, be filled with an incompressible fluid such as water. Intermediate volume 440 also preferably includes therein a mechanism 560 for applying force to first plunger 520 to inject fluid contained within syringe barrel 510 forward of first plunger 520. Once again, pressurizing mechanism 560 can, for example, be a carbon dioxide generator.
During operation, second plunger 530 is drawn rearward, causing first plunger 520 to be drawn rearward, to draw injection fluid into the volume of syringe barrel 510 forward of first plunger 520 (see
It is not necessary to completely seal or cover the rearward end of syringe barrel 510. As long as second plunger 530″ is prevented from exiting the rear of syringe barrel 510, injection device 500 will be operable. An abutment member that does not completely seal or cover the rear opening of syringe barrel 510, but which prevents second plunger 530 from exiting the rearward end of syringe barrel 510 thus can be used. It may not be necessary to remove plunger extension 550 from operative connection with second plunger 430 when using such an abutment member.
Valve mechanism 720 is preferably in a normally closed state. Syringe 800 can, for example, be located outside of the bore of an MRI device while injection device 500 and actuator 600 are positioned within the bore of the MRI device. In one embodiment, syringe 800 is positioned within the control room of an MRI suite. In another embodiment, syringe 800 is positioned within the MRI room, but outside of the MRI bore. In this embodiment, a remote actuating device 1000 can be in communicative connection (via, for example, antenna 1100) with a control device 1200 located within the control room of the MRI suite. When an operator forces the plunger 810 of syringe 800 forward via plunger extension 820 either manually or through use of actuating device 1000, the resulting pressure increase within actuating syringe chamber 710 causes valve 720 to be in the “on” state and allow fluid to flow from injection device 500 (or other injection device) to a patient (not shown). Each of injection device 500 and actuator 600 can, for example, be placed in the bore of an MRI device (not shown in
In the embodiments described above, the injection devices are particularly useful in MR procedures in which a single injection at a single flow rate is desired. However, as clear to one skilled in the art, the injection devices of the present invention are readily adaptable to procedures other than MR procedures in which much higher pressures/flow rates are used and in which it often is desirable to have timed phases in which, for example, one or more flow rates might occur. Multiple phase can, for example, be provided using multiple containers, multiple actuators, multiple pressurizing units, multiple orifices and/or one or more adjustable orifices.
Although the present invention has been described in detail in connection with the above embodiments and/or examples, it should be understood that such detail is illustrative and not restrictive, and that those skilled in the art can make variations without departing from the invention. The scope of the invention is indicated by the following claims rather than by the foregoing description. All changes and variations that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
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|U.S. Classification||604/131, 600/420, 600/432, 600/431|
|Cooperative Classification||A61M5/14526, A61M2039/0009, A61M5/007, A61M2205/3362|
|Jan 10, 2005||AS||Assignment|
Owner name: MEDRAD, INC., PENNSYLVANIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:COWAN, KEVIN P.;TROMBLEY, FREDERICK W. III;MISIC, GEORGEJ.;AND OTHERS;REEL/FRAME:016156/0465;SIGNING DATES FROM 20041213 TO 20041216
|Aug 17, 2010||CC||Certificate of correction|
|Feb 22, 2013||FPAY||Fee payment|
Year of fee payment: 4
|Feb 11, 2014||AS||Assignment|
Owner name: BAYER MEDICAL CARE INC., PENNSYLVANIA
Free format text: CHANGE OF NAME;ASSIGNOR:MEDRAD, INC.;REEL/FRAME:032250/0165
Effective date: 20131107
|Oct 27, 2015||AS||Assignment|
Owner name: BAYER HEALTHCARE LLC, NEW JERSEY
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BAYER MEDICAL CARE, INC.;REEL/FRAME:036965/0244
Effective date: 20151019