US20030065287A1 - Encoding and sensing of syringe information - Google Patents

Abstract

A syringe for use with a powered injector to inject a fluid into a patient includes at least a first indicator positioned on the syringe at a predetermined axial position. The distance between a rearward surface of the first indicator and a predetermined position on the powered injector provides information about the syringe configuration. The first indicator can, for example, be a rear surface of the attachment flange. An injector system includes a powered injector having a drive member and at least one sensor for detecting energy. The injector system also includes a syringe having at least a first indicator positioned on the syringe at a predetermined axial position. The energy detected by the sensor is determined by the axial position of the indicator when the syringe is attached to the powered injector. The axial position of the indicator thereby provides information about the syringe configuration.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application claims the benefit of U.S. Provisional Patent Application Serial No. 60/281,169, filed on Apr. 3, 2001, the disclosure of which is incorporated herein by reference.[0001]
BACKGROUND OF THE INVENTION
• The present invention relates to encoding and sensing of information or configuration, and, especially, to encoded syringes, to injectors for reading encoded syringes, to injector systems including encoded syringes and to methods of encoding and sensing syringe information.[0002]
• Critical parameters of an injection procedure are determined by a number of variables, including, for example, syringe diameter, syringe length, syringe material and fluid composition/concentration. Among the affected injection procedure parameters are fluid volume delivered, flow rate, fluid pressure, and limits of injector piston travel. In current injector systems, syringe size/volume is generally determined either (1) manually by action of an operator who enters the syringe size/volume or type into the injector software, or (2) automatically by means of switches on the injector head which are mechanically coupled to raised or sunken elements on the syringe. See, for example, U.S. Pat. Nos. 5,741,232, 6,090,064 and 5,873,861, assigned to the assignee of the present application, the disclosures of which are incorporated herein by reference. In U.S. Pat. No. 5,873,861, the presence or absence of one or more of detents provides a code that is representative of syringe configuration.[0003]
• Constraints of current mechanical and electrical design, however, limit the number of such automatic detection switches. Indeed, only limited syringe configurations are automatically detected with present systems. Additionally, failure of certain moving mechanisms is also a problem. For example, spillage or leakage of contrast media can result in the failure of certain mechanisms. Moreover, certain electrical and mechanical encoding systems can significantly increase manufacturing costs of a syringe and/or injector. Other currently available methods of encoding and sensing syringe configuration include the placement of bar codes and corresponding sensors upon the syringe and injector, respectively, as disclosed in U.S. Pat. No. 5,997,502. Bar code systems, however, suffer from some of the same problems as the electromechanical systems discussed above.[0004]
• As used herein, the term “syringe configuration” is used to encompass all information about a particular syringe, including, but not limited to, information about the mechanical properties of a syringe (for example, material, length, diameter and/or volume) as well as information about the contents of the syringe (for example, fluid volume and/or composition). With the advent of new syringes, and especially prefilled syringes, the need to accurately encode and sense (or read) syringe configuration variables is heightened. A powered injector to control the injection procedure as a function of defined syringe configuration/injection parameters can use the information on syringe configuration. Moreover, a record of data associated with an injection procedure may be kept, for example, to track patient treatment history and/or to satisfy accurate billing and cost information requirements under managed health care. A record may be maintained of information such as the type of syringe used, the amount of contrast medium used, the type of contrast medium used, the sterilization date, the expiration date, lot codes, the properties of the contrast media, and/or other clinically relevant information. Such information can be recorded digitally for sharing with computerized hospital billing systems, inventory systems, control systems, etc.[0005]
SUMMARY OF THE INVENTION
• In one aspect, the present invention provides a syringe for use with a powered injector to inject a fluid into a patient. The syringe includes at least a first indicator positioned on the syringe at a predetermined position (for example, at a predetermined axial position). Preferably, the distance between a surface (for example, a rear surface) of the first indicator and a reference position (for example, a predetermined position on the syringe or on the powered injector when the syringe is in operative connection with the powered injector) provides information about the syringe configuration.[0006]
• In another aspect, the present invention provides a syringe including at least one indicator including a rearward-projecting member (for example, an attachment flange) on a rear portion of the syringe. The axial position of a rear surface of the rearward-projecting member, when the syringe is in operative connection with (for example, attached to) the powered injector, provides information about the syringe configuration.[0007]
• In a further aspect, the present invention provides a set of a plurality of syringes for use with a powered injector to inject a fluid into a patient. Each of the syringes includes at least a first indicator positioned on the syringe at a predetermined position. As described above, the distance between, for example, a rear surface of the first indicator and a reference position such as a predetermined position on the powered injector provides information about a configuration of each syringe. In one embodiment, the first indicator on each syringe is a rear surface of an attachment flange positioned on a rearward portion of the syringe. The axial position of the rear surface of the attachment flange of each syringe in this embodiment provides information about the syringe configuration of that syringe when the syringe is in operative connection with the powered injector.[0008]
• In general, the indicators of the present invention can be an integral part of a syringe or can be attachable thereto. For example, one or more indicators can be attachable to a syringe through use of an adapter as known in the art. A number of such adapters include a syringe attachment mechanism on a forward section thereof for attachment of a syringe thereto. The adapter also includes an injector attachment mechanism on a rearward section thereof to attach the adapter to an injector. An adapter can be used, for example, to attach a syringe not suitable for direct attachment to an injector to that injector. Adapters can also be used in the present invention to add an indicator as described above to a syringe that is otherwise suitable for attachment to an injector. For example, the adapter can include one or more attachment flanges having a rear surface positioned to provide information on syringe configuration. In general, as use herein, the term “syringe” includes syringe/adapter combinations.[0009]
• In another aspect, the present invention provides an injector system including a powered injector having a drive member and at least one sensor for detecting energy. The injector system also includes a syringe having at least a first indicator positioned on the syringe at a predetermined position (for example, a predetermined axial position). The sensor configuration detected by the sensor is determined by the position of the indicator when the syringe is in operative connection with the powered injector. The position of the indicator thus provides information about the syringe configuration.[0010]
• In one embodiment, a rear surface of the first indicator transmits energy to the sensor. For example, the rear surface of the first indicator can include an energy source to transmit energy to the sensor. The rear surface of the first indicator can also include a surface that transmits energy to the sensor by reflecting energy from an energy source to the sensor.[0011]
• In another embodiment, the powered injector includes at least one contact member movably (for example, slidably) disposed in the injector. A surface in operative connection with the contact member transmits energy to the sensor. For example, the transmitting surface can be the rear surface of the contact member. The contact member is positioned to come into contact with the first indicator when the syringe is in operative connection with the powered injector such that, for example, the axial position of the rear surface of the contact member is determined by the axial position of the first indicator. The rear surface of the contact member can, for example, transmit energy to the sensor. For example, the rear surface of the contact member can include an energy source to transmit energy to the sensor. In another embodiment, the rear surface of the contact member includes a surface to reflect or redirect energy from an energy source to the sensor.[0012]
• In several embodiments, the energy transmitted in the present invention is light energy. Reflective surfaces (for example, a mirrored surface) can be used on the contact member or on the indicator to transmit the light energy therefrom. The light can, for example, be transmitted to the mirrored surface by a transmitting fiber optic cable in communication with a light source. The mirrored surface can transmit the light to a receiving fiber optic cable in communication with a sensor. Sensors suitable for use with light energy include photodiodes.[0013]
• In several embodiments, the first indicator is a rear surface of a flange or projection on a rear portion of the syringe. The flange can, for example, also function as an attachment flange to attach the syringe to a powered injector.[0014]
• In another aspect, the present invention provides a powered injector for use with a syringe to inject a fluid into a patient. The syringe includes at least a first indicator at a predetermined position. The injector includes a powered drive member and at least one sensor to detect energy. The energy detected by the sensor is determined by the position of the indicator when the syringe is in operative connection with the powered injector. As discussed above, the position of the indicator thereby provides information about the syringe configuration.[0015]
• As also described above, the injector can, for example, include a contact member movably (for example, slidably) disposed in the injector in which the rear surface of the contact member transmits energy to the sensor. The contact member is positioned to come into contact with the first indicator when the syringe is attached to the powered injector such that the position of the contact member is determined by the position of the first indicator.[0016]
• In a further aspect, the present invention provides an injection system including at least one syringe having at least a first indicator positioned on the syringe at a predetermined position (for example, a rear surface of an attachment flange on the rear of the syringe). As described above, the position of the indicator is associated with information about the syringe configuration. The injector system further includes a powered injector including a drive member and at least a first contact member movably disposed in the injector. The first contact member is positioned to come into contact with the first indicator when the syringe is attached to the powered injector such that the position of the first contact member or the amount of change in the position of the first contact member is determined by the position of the first indicator and is thus associated with the syringe configuration.[0017]
• Preferably, at least three syringe configurations are associated with at least three corresponding positions of the first contact member. As clear to one skilled in the art, many more syringe configuration are associable with a corresponding number of positions of the first contact member. Each syringe configuration can, for example, be associated with a unique range of positions of the first contact member.[0018]
• In one embodiment, the powered injector includes at least one light reflective surface in operative connection with the first contact member and a sensor to detect light reflected from the light reflective surface as described above.[0019]
• In another embodiment, the powered injector includes a plurality of sensors and at least a first shutter mechanism in operative connection with the first contact member. Each of the sensors has an “on” state and an “off” state. The shutter mechanism includes at least one cooperating member to cooperate with at least one of the sensors to place the sensor in an on state or an off state. The state of each of the plurality of sensors can, for example, provide a digital code corresponding to information on syringe configuration.[0020]
• Preferably, the shutter mechanism includes a plurality of cooperating members. In one embodiment, the sensors are optical sensors and the cooperating members are spaced opaque members operable to block transmission of light to the sensors.[0021]
• The present invention provides, in a further aspect, an injector for use with a syringe including at least a first indicator positioned thereon. The position of the first indicator is associated with syringe configuration. The injector includes a powered drive member, and at least a first contact member movably disposed in the injector as described above.[0022]
• In one embodiment, the first indicator is positioned on the rear surface of an attachment flange of the syringe and causes the first contact member to move in an axial direction. The first contact member can, for example, be sidably positioned on a bushing that is rotatable about the axis of the syringe. In this embodiment, the shutter mechanism can be attached to the first contact member and is preferably rotated into cooperation with the plurality of sensors upon rotation of the bushing to attach the syringe to the injector.[0023]
• In another aspect, the present invention provides a method of reading syringe configuration information from a syringe for use with a powered injector. The method includes (1) positioning at least a first indicator at a predetermined position on the syringe, (2) transmitting energy from a position determined by the indicator to a sensor on the powered injector, and (3) measuring an output from the sensor and correlating the output to a state distance defined by a distance between the first indicator and a known position on the injector. The state distance provides information of the syringe configuration.[0024]
• In still a further aspect, the present invention provides a method of reading syringe configuration information from a syringe for use with a powered injector. The method includes (1) positioning at least a first indicator at a predetermined position on the syringe, (2) contacting the indicator with at least a first contact member movably disposed in the injector so that the position of the first contact member is determined by the position of the first indicator, and (3) associating the position of the contact member with syringe configuration. Preferably, at least three different syringe configurations are associated with at least three corresponding positions of the first contact member.[0025]
• In one embodiment, the method includes the step of transmitting light energy from a surface in operative connection with the first contact member to a sensor. The light energy measured by the sensor corresponds to the position of the first contact member.[0026]
• In another embodiment, a shutter mechanism in operative connection with the first contact member moves with motion of the contact member to a position that determines a state of each of a plurality sensors having an on state and an off state. The state of each of the plurality of sensors provides or corresponds to a digital code corresponding to information on syringe configuration.[0027]
• The encoded syringes, the injectors, the injectors systems, and the methods of the present invention are well suited for use in a magnetic resonance environment in which care must be taken to prevent failure of the encoding system or device and to prevent interference with the magnetic resonance imaging equipment.[0028]
• In that regard, the strong magnetic field in a magnetic resonance environment can adversely affect certain types of devices such as electromechanically activated devices. Furthermore, differences in magnetic permeability of materials within such devices and induced eddy currents therein can affect the homogeneity of the MRI magnetic field, generating image artifacts. Likewise, radio frequency energy generated by certain devices can induce unwanted artifacts upon the acquired MRI images. Such problems are easily avoided in the syringe encoding systems, devices and methods of the present invention. Any energy used in the encoding systems, devices and methods of the present invention is easily selected to prevent interference with magnetic resonance equipment as well as interference from the magnetic resonance equipment. For example, light energy in the infrared, visible or ultraviolet range of the spectrum can be used. Likewise, radio frequency energy outside of the frequency range of the MRI scanner can be used.[0029]
• Moreover, currently available syringes and injectors are readily retrofitted to incorporate the encoding systems of the present invention without substantial and/or expensive modifications thereto.[0030]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates a front perspective view of one embodiment of an injector system of the present invention.[0031]
• FIG. 2A illustrates a side, cross-sectional view of the injector system of FIG. 1.[0032]
• FIG. 2B illustrates a side, cross-sectional view of another embodiment of a syringe of the present invention attached to an injector.[0033]
• FIG. 2C illustrates a side, cross-sectional view of another embodiment of a syringe of the present invention attached to an injector. FIG. 2D illustrates a side, cross-sectional view of a further embodiment of a syringe of the present invention attached to an injector, in which the syringe includes indicators on the syringe barrel.[0034]
• FIG. 3 illustrates the output signal of a photodiode as a function of illuminance.[0035]
• FIG. 4 illustrates the output signal of a photodiode as a function of distance.[0036]
• FIG. 5 illustrates a side, cross-sectional view of another embodiment of an injector system of the present invention.[0037]
• FIG. 6A illustrates a rear perspective view of an embodiment of a syringe interface of the present invention in a disassembled or exploded state.[0038]
• FIG. 6B illustrates a rear perspective view of the syringe interface of FIG. 6A in a partially assembled state.[0039]
• FIG. 6C illustrates another rear perspective view of the syringe interface of FIG. 6A in another partially assembled state.[0040]
• FIG. 6D illustrates a rear perspective view of the syringe interface of FIG. 6A in a fully assembled state.[0041]
• FIG. 7A illustrates a rear perspective view of the syringe interface of FIG. 6A wherein the seating bushing is illustrated in a disengaged position (left) and rotated to an engaged position (right).[0042]
• FIG. 7B illustrates a front perspective view of the syringe interface of FIG. 6A wherein the seating bushing is illustrated in a disengaged position (left) and rotated to an engaged position (right).[0043]
• FIG. 7C illustrates a front view of the syringe interface of FIG. 6A wherein the seating bushing is illustrated in a disengaged position (left) and rotated to an engaged position (right).[0044]
• FIG. 7D illustrates a front perspective view of the syringe interface of FIG. 6A with a syringe aligned for engagement therewith and a front perspective view of an adapter for use with the syringe interface.[0045]
• FIG. 7E illustrates a rear view of the syringe interface of FIG. 6A with a syringe connected thereto.[0046]
• FIG. 7F illustrates a side, cross-sectional view of the syringe interface of FIG. 6A with a syringe connected thereto.[0047]
• FIG. 8A illustrates dimensions of one embodiment of a shutter of the present invention as well as several states corresponding to different shutter positions resulting from engagement of various syringe/adapter types.[0048]
• FIG. 8B illustrates engagement of the push pin or contact pin of the syringe interface of FIG. 6A by a syringe/adapter and tolerance analysis measurements associated with one embodiment of a shutter.[0049]
• FIG. 8C illustrates state changes associated with the shutter and sensor embodiments of FIGS. 8A and 8B.[0050]
DETAILED DESCRIPTION OF THE INVENTION
• The encoding devices, encoding systems and encoding methods of the present invention are particularly useful in encoding information of configuration for syringes and other pumping mechanisms used in medical injection procedures. Several representative embodiments of the present invention in which, for example, light energy is used in connection with syringe encoding are discussed below.[0051]
• An embodiment of a front-[0052]loading injector system5 of the present invention is illustrated in FIG. 1.Injector system5 includes a poweredinjector10 and asyringe20 for injection of, for example, a contrast medium. As best illustrated in FIG. 1,injector housing30 ofinjector10 preferably includes a first drive member orpiston40 therein which cooperates with a syringe plunger25 (see FIG. 2A) slideably disposed insyringe20 to inject a fluid from the interior ofsyringe20 into a patient.
• As used herein to describe[0053]injection system5 and other embodiments of the present invention, the terms “axial” or “axially” refer generally to, for example, an axis A around whichsyringe20 andpiston40 are preferably formed (although not necessarily symmetrically therearound) and to directions collinear with or parallel to axis A. The terms “proximal” or “rearward” refer generally to an axial or a longitudinal direction toward the end ofinjector housing30 opposite the end to whichsyringe20 is mounted. The terms “distal” or “forward” refer generally to an axial or a longitudinal direction toward asyringe tip26 of syringe20 (from which pressurized fluid exits syringe20). The term “radial” refers generally to a direction normal to an axis such as axis A.
• [0054]Syringe20 is preferably removably connected toinjector10 as described, for example, in U.S. Pat. No. 5,383,858, the disclosure of which is incorporated herein by reference. In that regard, front-loading injector10 can include a front portion orfaceplate60 having afirst interface62 formed therein.Piston40 is reciprocally mounted withininjector10 and is extendible throughinterface62 infaceplate60.Piston40 can, for example, include a piston flange orhead44 to assist in forming a connection withsyringe plunger25. In the embodiment of FIG. 1,faceplate60 includes receivingslots66aand66b, which are positioned opposite one another aroundinterface62. Receivingflanges68aand68bare positioned opposite one another and between receivingslots66aand66band extend inwardly intointerface62.
• In the embodiment of FIG. 1, the rearward end of[0055]syringe20 includes a releasable mounting mechanism such as a pair of mountingflanges22aand22bfor mountingsyringe20 in a desired position relative to the front wall ofinjector10. To attachsyringe20 toinjector10, the rearward end ofsyringe20 is inserted intoinjector interface62 such that mountingflanges22aand22bare inserted into receivingslots66aand66b, respectively.Piston flange44 can engage a capture mechanism on the rear of the syringe plunger (as, for example, described in U.S. Pat. No. 5,383,858).
• Once mounting[0056]flanges22aand22bare inserted into receivingslots66aand66b, respectively, andpiston40 is in position to be received by the plunger, the operator rotatessyringe20 approximately90 degrees such that mountingflanges22aand22bmove behind and are engaged by receivingflanges68aand68b, respectively.Injector10 may include a stop mechanism (not shown), for example, extending from at least one of the retainingslots68aand68b, to prevent rotation ofsyringe20 more than90 degrees. Aflange28 on the rear of thesyringe20 forward offlanges22aand22bsubstantially prevents injection fluid from the exterior ofsyringe20 from enteringinjector10.Flange28 also assists in ensuring secure connection ofsyringe20 toinjector10 and inpositioning syringe20 oninjector10 in a predetermined axial position relative toinjector10. Tactile, visual or audible feedback can be provided to the operator via, for example, cooperating members on syringe20 (for example, on sealing flange28) andinjector10 to inform the operator that a secure connection has been achieved. After securely attachingsyringe20 toinjector10, advancingpiston40 in a forward direction will apply a motive force to plunger25 to advance the plunger forward withinsyringe20, thereby forcing the contents ofsyringe20 out ofsyringe tip26 into the fluid path to the patient. Retractingpiston40 in a rearward direction will cause the plunger to move rearward withinsyringe20, thereby drawing fluid intosyringe20.
• In one embodiment of the present invention, the syringe is provided with at least one indicator element and the injector is provided with corresponding receiver(s)/sensor(s) to provide information on syringe configuration. A signal received by each receiver/sensor varies depending upon the position of the indicator element(s) upon the syringe or the distance between the indicator element(s) and the detection/reception point(s) on the injector. In the embodiment of FIGS. 1 and 2A, the indicator elements on[0057]syringe20 are the rear surfaces offlanges22aand22b.
• As illustrated, for example, in FIGS. 1 and 2A,[0058]syringe20 can be positioned relative toinjector10 andreceiver120aand120bin a known manner or position by abutment of the rear surface offlange28 with the forward surface ofinjector face60. A constant distance Y can be provided between the rear surface offlange28 and the forward surfaces offlanges22aand22b, for example, to provide for proper and secure seating offlanges22aand22bbehind retainingflanges68aand68b(see FIG. 1, not shown in FIG. 2A) ofinjector10 whensyringe20 is securely connected toinjector10. By varying the axial thickness (represented by X forflange22b) of one or both offlanges22aand22b, one can define various unique states that correspond to unique syringe configurations. As illustrated in FIG. 2A, the rear surface offlange22bextends beyond the rear surface of the syringe barrel by a predetermined or known amount, while the rear surface offlange22ais generally flush with the rear surface of the syringe barrel.
• In general, the syringes of the present invention can be attached to an injector in any manner suitable to position one or more indicators thereof (for example, the rear surfaces of[0059]flanges22aand22b) in a manner that will result in a correct reading of syringe configuration. In the embodiment of FIG. 2A,flange28 serves, in part, to reference the position ofsyringe20 toinjector10 and preventssyringe20 from traveling too far rearward during connection toinjector10. As clear to one skilled in the art, there are many alternative manners of attaching a syringe to an injector to properly position one or more indicators thereon.
• As shown in FIGS. 1 and 2A, the[0060]flange28 extends around the circumference of thesyringe20. However, the present invention contemplates that theflange28 may be segmented or otherwise formed by one or more flanges, tabs or shoulder members positioned on and extending radially from thesyringe20.
• FIG. 2B illustrates a[0061]syringe20aincluding two, generally opposed attachment flanges22aaand22ab(not shown in FIG. 2B) that cooperate with spaced flanges or surfaces such as flanges66aaand66abon aninjector10ato positionsyringe20aat a predetermined axial position with respect toinjector10a. Flange22aaincludes a connecting section23aathat seats between spaced flanges66aaand66aband a rearward extending section24aa. The axial position of therearward surface26aaof section24aacan be varied between different types of syringes to provide information on syringe configuration as described above. Flange22ab(not shown) can provide information on syringe configuration in a similar manner.
• As also clear to one skilled in the art, the indicators of the syringes of the present invention need not be part of or connected to an attachment flange or other attachment mechanism. For example, FIG. 2C illustrates a[0062]syringe20bincluding acircumferential attachment flange22bthat cooperates with anattachment mechanism66bof aninjector10bin a manner to removably attachsyringe20btoinjector10b. This system is described in PCT Publication No. WO 01/37903, the disclosure of which is incorporated herein by reference. In this embodiment, the axial position of the rear surface24baof the syringe wall (which can be varied among syringe types) can provide information on syringe configuration as described above. Additional or alternatively, on or more uniquely positioned indicators such as flange or projection24bbcan be provided on a rear portion ofsyringe20bto provide information on syringe configuration as described above.
• FIG. 2D illustrates a[0063]syringe20cattached to, for example,injector10cvia flanges22caand22cbin a manner described above forsyringe20. In the embodiment of FIG. 2D, indicators24caand24cbare positioned on the syringe barrel rather than on a rear section ofsyringe20c. Indicators24caand24cbcan, for example, transmit energy to receivers120caand120cbthrough atransmissive flange28consyringe20c.
• Returning now to the embodiment of FIGS. 1 and 2A,[0064]receivers120aand120bcan, for example, be fiber optic cables suitable to receive light signals transmitted from the rear surfaces ofsyringes22aand/or22b. Receivingfiber optic cables120aand120bcarry the received light to sensors such asphotodiodes130aand130b. The axial position of reception points offiber optic cables120aand120bare preferably known and fixed relative to flange28. In one embodiment, photodiodes available from Optek of Carrolton, Tex., under product number OPF422 were used.
• In the embodiment of FIGS. 1 and 2A,[0065]reflective surface23aand23b(for example, a mirrored surface in the case that light energy is used) are provided on the rear surfaces offlanges22aand22bto transmit/redirect light from the rear surfaces offlanges22aand22bto receivingfiber optic cables120aand120b. In one embodiment, protected aluminum mirrors available from Edmund Industrial Optics of Barrington, N.J., under product stock number J32-354 were used. Light is directed towardmirrors23aand23bsuch that light will be transmitted to receivingfiber optic cables120aand120b. In the embodiment of FIGS. 1 and 2, split fiber optic cabling was used. Transmittingfiber optic cables140aand140bwere arranged adjacent receivingfiber optic cables120aand120bto transmit light fromlight sources150aand150b(for example, laser diodes available from Sanyo Semiconductor Corporation of Allendale, N.J., under product number DL-3144-0) tomirrors23aand23b. Suitable fiber optic cabling is available, for example, from Omron of Santa Clara, Calif., under product number E32-DC200.
• In general, the electric signal produced by a photodiode is proportional to the illuminance (for example, in watts/cm[0066]²) of the radiant energy incident upon the photodiode. Indeed, the output signal of a photodiode is generally linear with respect to the illuminance applied to the photodiode junction as illustrated in FIG. 3.
• The illuminance of the incident radiant energy and thus the amplitude of the electric signal (for example, measured current and/or voltage) produced by a photodiode is indirectly proportional to the linear distance between the light source (mirrors[0067]23aand23bin FIG. 2A) and the point of reception (fiberoptic receivers120aand120b). Circuitry and/or software as known in the art can be used to translate the measured signal into a syringe configuration (using, for example, one or more comparison or lookup tables). The output signal of an Optek OPF422 photodiode used in one embodiment of the present invention is illustrated as a function of distance in FIG. 4.
• As clear to one skilled in the art, sensors such as[0068]photodiodes130aand130bcan be placed in direct communication with the light source (mirrors23aand23bin FIG. 2A) without intervening fiber optic cabling. However, use of fiber optic cabling can facilitate retrofitting of existing injectors with the encoding system of the present invention. Moreover (and as further discussed in connection with FIG. 5 below) use of fiber optic cabling and/or other transmitting media and the associated remote positioning of sensors and/or energy sources assists in preventing interference from extraneous energy sources (for example, ambient light) and in removing sensors from areas in which spilled or leaked injection media (for example, imaging contrast media) can have an adverse effect upon the sensors and/or energy sources. Moreover, fiber optic cabling can assist in positioning sensor/light source electronics away from the magnetic field (for example, within a shielded housing160) of MRI equipment to reduce interference with the MRI imaging equipment. Fiber optic cabling is a particularly efficient means of transmitting light. Indeed, measurements have shown that the reflection coefficient from a dielectric interface within, for example, a high quality optical fiber exceeds 0.9999. See, for example,Handbook of Optics, McGraw-Hill, p. 13-6. Furthermore, as also clear to one skilled in the art, a light or other energy source (for example, a laser or an LED) can be positioned on the rear surface offlanges22aand22brather than using reflected energy.
• The number of states or configurations detectable by the encoding systems of FIG. 2A depends, for example, upon the resolution of sensors such as[0069]photodiodes130aand130b. In general, photodiodes are relatively sensitive to even small changes in the distance between the transmittance point of the light and the reception point of the light, enabling the definition of a relatively large number of discreet states or configurations over a relatively short distance.
• The number of states or configurations detectable also depends upon the number of indicator/sensor parings. For example, if seven discreet states are detectable using a single indicator/sensor pairing, 49 states are detectable using two such pairings. Table 1 provides one embodiment of a state table for one Optek OPF422 photodiode used in the present invention. A disengage state and six additional states, corresponding to different lengths X as described above, are defined by associating or correlating discreet ranges of voltage output with those states.[0070]

  	TABLE 1
  	Distance (inches)	Min (V)	nom (V)	max (V)

  	Disengage	0.1	0.105	0.11
  	State 1	0.13	0.135	0.14
  	State 2	0.16	0.165	0.17
  	State 3	0.19	0.195	0.2
  	State 4	0.225	0.23	0.235
  	State 5	0.275	0.28	0.285
  	State 6	0.395	0.4	0.405

• In addition to providing additional detectable states or configuration, multiple indicators can be provided for calibration or to provide data integrity. Moreover, a single sensor can be used with multiple indicators. In certain situations, it can also be desirable to pulse the transmitted energy to improve detectability.[0071]
• In the embodiment of FIG. 5,[0072]injector10′ includes contact members such as push pins220aand220bthat are slideably disposed withininjector housing30′ such that they are contacted by the rear surfaces of at least one offlanges22aand22b, respectively. Push pins220aand220bare preferably biased in a forward position by, for example, springs230aand230b. In the embodiment of FIG. 5, the rear surfaces of push pins220aand220binclude reflective surfaces such asmirrors223aand223bas described above. Push pins223aand223bare suitably positioned to reflect light fromlight sources150aand150bexiting transmittingfiber optic cables140aand140bto receivingfiber optic cable120aand120band therethrough tophotodiodes130aand130b. The output signal ofphotodiodes130aand130bis proportional to the distance between the rear surface of push pins220aand220band receivingfiber optic cables130aand130b, respectively, as described above. The distance between the rear surface of push pins220aand220band receivingfiber optic cables130aand130bis directly proportional to the axial position of the rear surfaces offlanges22aand22b, respectively.
• Sealing members such as O-[0073]rings240aand240bcan be provided to further assist in preventing spilled or leaked injection fluid from coming into contact with the optics (or other transmission and/or sensing media) used in the injectors of the present invention.
• Although the indicators in the embodiment of FIGS. 1, 2A and[0074]5 of the present invention have been shown to be positioned onflanges22aand22bwithinhousing30 orhousing30′ ofinjector10 orinjector10′, respectively, whensyringe20 is attached toinjector10 orinjector10′, the indicators can be positioned anywhere on syringe20 (compare, for example, FIGS. 2A through 2D). Moreover, energy sources other than light sources can be used in the present invention. Any energy source/sensor or receiver pairing in which the output of the sensor is proportional to the distance the energy is transmitted from the indicator is suitable for use in the present invention. For example, any waveform type energy (for example, sonic energy or electromagnetic energy) can be used.
• In case fiber optic cable is used in the above embodiments to transmit light from an energy source to a sensor or receiver, preferably dynamic change or deformation (for example, bending or twisting) of the fiber optic cable is minimized. Because of the manner in which light propagates through fiber optic cable (that is, reflecting or bouncing between the sides of the cable as it passes therethrough), twisting and/or bending of the fiber optic cable changes the path of the fiber optic cable, thereby changing the path of the light. Light beams thus may exit the cable at different angles than for which the system was calibrated and can cause a different amount of light to reach a receiver. If the changes are substantial, an erroneous signal can result.[0075]
• FIGS. 6A through 8B illustrate another embodiment of the present invention in which a syringe (or, for example, a syringe adapter as known in the art) contacts and displaces a push pin or push pins to provide syringe configuration or information to an injector.[0076]
• As illustrated, for example, in FIGS.[0077]6A-6D, a syringe interface or mount400 (shown assembled, for example, in FIG. 6D) includes apush pin432 that is preferably part of or formed with ashutter mechanism430. Alternately, thepush pin432 may be a separate part that is connected or attached to theshutter mechanism430. A rubber boot or seal420 may be placed over thepush pin432 to prevent contrast fluid or other material from entering thesyringe interface400 or bushingseat450.
• When assembled, the push pin[0078]432 (and the shutter mechanism430) protrudes in a forward axial direction from a rear surface of arotatable bushing seat450. In the embodiment of FIGS.6A-8B, bushingseat450 is rotatable within an interface housing480 (see, for example, FIG. 6C).Interface housing480 includesslots482aand482bthrough which, for example,flanges822aand822b(not shown) ofsyringe adapter800, to whichsyringe700 is attached (illustrated, for example, in FIGS. 7D and 7F), can pass to be seated inslots452aand452b(see, for example, FIG. 7C) ofbushing seat450. After seatingsyringe adapter800,syringe700 andadapter800 are rotated approximately ¼ turn or 90° (thereby rotating bushing seat450) relative to interfacehousing480 so thatflanges822aand822bofsyringe adapter800 are rotated behind and into cooperation withretention flanges484aand484bofinterface housing480 to removably attachsyringe adapter800/syringe700 tosyringe mount400 as described above.Flange828 assists in forming a secure connection ofsyringe adapter800 to interface400 and in ensuring the proper axial position ofsyringe adapter800 relative to interface400 as discussed above. Rotation of bushingseat450 relative tohousing480 as a result of the connecting motion ofsyringe adapter800 also rotates ashutter434 of ashutter mechanism430 into operative connection with a sensor circuit board500 (see, for example, FIG. 7E) as described below.
• In general, a syringe such as a[0079]syringe700 that is not suitable for direct attachment tosyringe interface400 or that does not have one or more attachment flanges that are adapted/dimensioned to provide information on syringe configuration can be attached tosyringe interface400 through use ofintermediate adapter800 as described above.Flange822a, for example, is dimensioned to provide information on the syringe configuration ofsyringe700.Adapter800 can, for example, include asyringe attachment mechanism860 to attachsyringe700 thereto viaflanges722aand722b(not shown) ofsyringe700 in a manner described above. As known in the art, adapters have many types of syringe attachment mechanisms that can be used to adapt a wide variety of syringes for attachment tosyringe interface400. Examples of syringe adapters suitable for use in the present invention are disclosed, for example, in PCT Publication No. WO 01/08727, the contents of which are incorporated herein by reference.
• [0080]Syringe mount400 can provide tactile, visual or audible feedback to the operator and toinjector10 to inform the operator that a secure connection has been achieved. For example, bushingseat450 can include flexingextensions454 that cooperates with areceptacle486 oninterface housing480 to provide tactile and audible feedback. In that regard, rotation of flexingextensions454 into and out ofreceptacles486 requires radial inward flexing of flexingextensions454. The cooperation ofextensions454 andreceptacles486 can also provide resistance to rotation of, for example,syringe adapter800 orsyringe20 andbushing seat450 in a counterclockwise direction to releasesyringe adapter800 orsyringe20 from cooperation withretention flanges484aand484b(that is, toward the position of the left side of FIGS. 7A through 7C).
• As discussed above,[0081]push pin432 is moved rearward upon contact with syringe adapter800 a distance determined by the axial thickness of at least one ofsyringe adapter flanges822aor822b.Push pin432 is in operative connection withshutter assembly430 such that axial motion ofpush pin432 is translated to axial motion ofshutter assembly430. In the embodiment to FIGS. 6A through 8B, as discussed above,push pin432 preferably includes a cap or sealingmember420 seated thereon. The assembly ofpush pin432 andshutter assembly430 are seated in a rearward extending well454 formed on the rear of bushingseat450. Shutter434 ofshutter assembly430 moves axially throughslot458 ofwell456.Push pin432 andshutter assembly430 are preferably biased in a forward or reference position (corresponding, for example, to a state in which no syringe is connected to syringe interface400) by, for example, aspring436.Spring436 is biased against ashutter plate438 that operates to securepush pin432 andshutter assembly430 within well454.
• As discussed above,[0082]shutter434 is linearly translated a distance determined by the flange length of the engaged syringe/adapter (see, for example, FIG. 7F, showingsyringe adapter800 oftype 4 from Table 2 below attached to syringe interface400). The movement ofshutter434causes blocking extensions435 ofshutter434 to block or unblock a light source/receiver pair in each of a plurality ofsensors510a,510band510cpositioned oncircuit board500. The digital output ofsensors510a-cprovides the configuration of the syringe or adapter that is engaged on the injector.
• [0083]Syringe interface400 provides the ability to accurately detect (1) whether a syringe/adapter is engaged thereto as well as (2) multiple different syringes having different flange sizes as described above. In the embodiment of FIGS. 6A through 8B, threesensors510a-care preferably used to provide a maximum of eight combinations (2³=8) of sensor on/off states to associate with syringe or adapter configurations. As described above,shutter434 is rotated into communication withsensors510a-cupon engagement of a syringe or adapter. Thus, a disengaged state corresponds to the state when all three sensors are on. All ofsensors510a-care preferably placed on the same side ofshutter434 to provide for such rotation. Preferably, the state corresponding to all sensors being off is not used to determine a syringe state because of difficulties in testability. In that regard, it would be difficult to determine ifsensors510a-cwere blocked or malfunctioning in that state. Blockingextensions435 and the openings therebetween are preferably sufficiently wide to ensure total activation or deactivation ofsensors510a-c.
• Table 2 provides a representative list of syringe/adapters, corresponding flange lengths and sensor states for one embodiment of the present invention.[0084]

  TABLE 2
  Sensor State List

  Syringe/	Flange
  Adapter	Length	Displacement	Sensor	Sensor	Sensor
  Type	(in.)	(in.)	510aState	510bState	510c State

  1	0.25	0.032	Off	On	Off
  2	0.318	0.096	Off	Off	On
  3	0.386	0.162	On	Off	On
  4	0.455	0.229	On	On	Off
  5	0.515	0.288	Off	On	On

• FIG. 8A illustrates the dimensions of one embodiment of[0085]shutter434 and the states for each of the sensors/adapters of Table 2 for a given sensor spacing.
• The[0086]shutter mechanism430 andsensors510, in a preferred embodiment, reliably read multiple syringe and/or adapters of similar geometry within a given range of desired operation. A tolerance analysis was performed on the sensing mechanism to minimize or substantially prevent misreads. Misreads can occur, for example, if the entire “sweet spot” of a sensor is not blocked or unblocked with respect to a specific syringe state. In several embodiments of the present invention, Omron EE-SX1103 photomicrosensors available from Omron Electronics, Inc. of Schaumburg, Ill., were used assensors510a-c. Further information on these sensors is provided in the Omron Electronics, Inc. specification sheet for the EE-SX1103 photomicrosensor, the disclosure of which is incorporated herein by reference. For those sensors, the distance between the fully open and fully closed state is 0.020 in. Circuit board500 (upon whichsensors510a-care mounted) is adjustable in position in the direction of the movement axis ofpush pin432 to facilitate alignment.
• Preferably, a mechanical calibration is performed upon installation of[0087]sensor circuit board500. In the embodiment of FIGS. 8A and 8B, for example, a calibration was performed using a slug corresponding to syringe/adapter type 1 (see Table 2) engaged on syringe interface400 (see FIG. 7D). During the calibration, the top surface oftop-most sensor510ais aligned with the top ofshutter434 as illustrated by the arrow in FIG. 8A. This position biases the push pin/shutter assembly slightly and removed tolerances from the system. (Several remaining tolerances correspond to the flange thickness on the syringes or adapters, the sensor placement and the notch/blocking extension dimensions of shutter434 (see FIGS.8A and8B)). These tolerances can contribute to the “sweet spot” of the sensor(s) moving relative to the notches/blocking extensions onshutter434.
• FIG. 8B illustrates representative misread plays (that is, the distance between a sensor sweet spot and the edge of an adjacent blocking extension[0088]435) for a machined steel shutter assembly having the dimensions set forth in FIG. 8A. In FIG. 8B, the shutter displacement corresponds to a syringe/adapter oftype 3 engaged withinsyringe interface400. Distinct states are readily obtained and associated tolerances indicate that misreads should not occur. FIG. 8C illustrates test results obtained. The hatched regions between states in FIG. 8C represent transition zones in whichsensors510a-cwere in the process of changing states.
• The foregoing description and accompanying drawings set forth the preferred embodiments of the invention at the present time. Various modifications, additions and alternative designs will, of course, become apparent to those skilled in the art in light of the foregoing teachings without departing from the scope of the disclosed 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.[0089]

Claims (51)

What is claimed is:

1. A syringe for use with a powered injector, the syringe comprising:

at least a first indicator positioned on the syringe at a predetermined position, the at least a first indicator defining a surface, the distance between the surface of the at least a first indicator and a predetermined position on the powered injector when the syringe is in operative connection with the powered injector providing information about the syringe configuration.

2. A syringe for use with a powered injector, the syringe comprising:

a rearward projecting member on a rear portion of the syringe, an axial position of a rear surface of the rearward projecting member providing information about a syringe configuration when the syringe is attached to the powered injector; and

a positioning member operable to cooperate with the injector when the syringe is attached to the injector to position the rearward surface of the rearward projecting member at the axial position.

3. The syringe ofclaim 2 wherein the axial position is within a unique range of axial positions defined for the syringe configuration of the syringe.

4. The syringe ofclaim 3 wherein the rear surface comprises the rear surface of an attachment flange operable to attach the syringe to the injector.

5. The syringe ofclaim 4 wherein the positioning member comprises a flange on the syringe positioned forward of the attachment flange.

6. A set of a plurality of syringes for use with a powered injector to inject a fluid into a patient, each of the syringes comprising at least a first indicator positioned on the syringe at a predetermined position, the distance between a surface of the first indicator and a position on the powered injector when the syringe is in operative connection with the powered injector providing information about a configuration of each syringe.

7. A set ofclaim 6 wherein the indicator is a rearward surface of a rearward projecting member on a rear portion of each of the syringes.

8. A set ofclaim 7 wherein each of the syringes further comprises a positioning member operable to cooperate with the injector when the syringe is attached to the injector to position the rearward surface of the rearward projecting member at the predetermined position.

9. The set ofclaim 8 wherein the predetermined position of the rear surface of each syringe is within a unique range of axial positions defined for the syringe configuration of that syringe.

10. The set ofclaim 9 wherein the rear surface is the rear surface of an attachment flange operable to attach the syringe to the injector.

11. The set ofclaim 10 wherein the positioning member comprises one or more flanges on the syringe positioned forward of the attachment flange.

12. An injector system comprising:

a powered injector comprising a drive member and at least one sensor for detecting energy; and

a syringe comprising at least a first indicator positioned on the syringe at a predetermined position, the syringe configuration that is detected by the sensor is determined by the position of the at least a first indicator when the syringe is attached to the powered injector, the position of the at least a first indicator thereby providing information about the syringe configuration.

13. The injector system ofclaim 12 wherein a rear surface of the first indicator transmits energy to the sensor.

14. The injector system ofclaim 13 wherein the rear surface of the first indicator comprises an energy source to transmit energy to the sensor.

15. The injector system ofclaim 13 wherein the rear surface of the first indicator comprises a surface that transmits energy to the sensor by reflecting energy from an energy source to the sensor.

16. The injector system ofclaim 12 wherein the powered injector further comprises a contact member movably disposed in the injector, a surface in operative connection with the contact member transmitting energy to the sensor, the contact member being positioned to come into contact with the first indicator when the syringe is in operative connection with the powered injector such that the position of the surface is determined by the axial position of the first indicator.

17. The injector system ofclaim 16 wherein the surface is a rear surface of the contact member.

18. The injector system ofclaim 17 wherein the rear surface of the contact member comprises an energy source to transmit energy to the sensor.

19. The injector system ofclaim 17 wherein the rear surface of the contact member comprises a surface to reflect energy from an energy source to the sensor.

20. The injector system ofclaim 17 wherein the energy is light energy.

21. The injector system ofclaim 19 wherein the energy is light energy.

22. The injector system ofclaim 21 wherein the reflective surface of the contact member is a mirrored surface.

23. The injector system ofclaim 22 wherein the first indicator is a rear surface of an attachment flange on a rear portion of the syringe.

24. An injector system comprising:

at least one syringe comprising at least a first indicator positioned on the syringe at a predetermined position, the position of the at least a first indicator being associated with information about the syringe configuration; and

a powered injector comprising a drive member and at least a first contact member movably disposed in the injector, the at least a first contact member is positioned to come into contact with the at least a first indicator when the syringe is attached to the powered injector such that the position of the at least a first contact member is determined by the position of the at least a first indicator, the amount of change in the position of the at least a first contact member as a result of contact with the at least a first indicator being associated with syringe configuration.

25. The injector system ofclaim 24 wherein at least three syringe configurations are associated with at least three corresponding positions of the first contact member.

26. The injector system ofclaim 24 wherein each syringe configuration is associated with a range of positions of the first contact member.

27. The injector system ofclaim 24 wherein the powered injector further comprises at least one light reflective surface in operative connection with the first contact member, the injector system further comprising a sensor to detect light reflected from the light reflective surface.

28. The injector system ofclaim 27 wherein the first indicator is positioned on the rear surface of an attachment flange of the syringe.

29. The injector system ofclaim 24 wherein the powered injector further comprises a plurality of sensors and at least a first shutter mechanism in operative connection with the first contact member, each of the sensors having an on state and an off state, the shutter mechanism comprising at least one cooperating member to cooperate with at least one of the sensors to place the sensor in an on state or an off state, the state of each of the plurality of sensors providing a digital code corresponding to information on syringe configuration.

30. The injector system ofclaim 29 wherein the first indicator is positioned on the rear surface of an attachment flange of the syringe.

31. The injector system ofclaim 29 wherein the shutter mechanism comprises a plurality of cooperating members.

32. The injector system ofclaim 31 wherein the sensors are optical sensors and the cooperating members are spaced opaque members operable to block transmission of light to the sensors.

33. An injector for use with a syringe comprising at least a first indicator positioned thereon, the position of the at least a first indicator being associated with syringe configuration, the injector comprising:

a drive member; and

at least a first contact member movably disposed in the injector, the at least a first contact member is positioned to come into contact with the at least a first indicator when the syringe is in operative connection with the injector such that the position of the at least a first contact member is determined by the position of the at least a first indicator, the amount of change in the position of the at least a first contact member as a result of contact with the at least a first indicator being associated with syringe configuration.

34. The injector ofclaim 33 wherein at least three syringe configurations are associated with at least three corresponding positions of the first contact member.

35. The injector system ofclaim 33 wherein each syringe configuration is associated with a range of positions of the first contact member.

36. The injector ofclaim 35, further comprising at least one light reflective surface in operative connection with the first contact member, the injector system further comprising a sensor to detect light reflected from the light reflective surface, the light detected by the sensor being dependent upon the position of the first contact member.

37. The injector ofclaim 36 wherein the first indicator is positioned on the rear surface of an attachment flange of the syringe.

38. The injector ofclaim 33, further comprising a plurality of sensors and at least a first shutter mechanism in operative connection with the first contact member, each of the sensors having an on state and an off state, the shutter mechanism comprising at least one cooperating member to cooperate with at least one of the sensors to place the sensor in an on state or an off state, the state of each of the plurality of sensors providing a digital code corresponding to information on syringe configuration.

39. The injector ofclaim 38 wherein the first indicator is positioned on the rear surface of an attachment flange of the syringe.

40. The injector ofclaim 38 wherein the shutter mechanism comprises a plurality of cooperating members.

41. The injector ofclaim 40 wherein the sensors are optical sensors and the cooperating members are spaced opaque members operable to block transmission of light to the sensors.

42. The injector ofclaim 41 wherein the first indicator is positioned on the rear surface of an attachment flange of the syringe and causes the first contact member to move in an axial direction.

43. The injector ofclaim 42 wherein the first contact member is slidably positioned on a bushing that is rotatable about the axis of the syringe.

44. The injector ofclaim 43 wherein the shutter mechanism is attached to the first contact member and is rotated into cooperation with the plurality of sensor upon rotation of the bushing to attach the syringe to the injector.

45. A method of reading information of syringe configuration from a syringe for use with a powered injector, the method comprising:

positioning at least a first indicator at a predetermined position on the syringe;

transmitting energy from a position determined by the indicator to a sensor on the powered injector; and

measuring an output from the sensor and correlating the output to a state distance defined by a distance between the first indicator and a known position on the injector, the state distance providing information of the syringe configuration.

46. A method of reading information of syringe configuration from a syringe for use with a powered injector, the method comprising:

positioning at least a first indicator at a predetermined position on the syringe;

contacting the indicator with at least a first contact member movably disposed in the injector so that the position of the first contact member is determined by the position of the first indicator; and

associating the position of the contact member with syringe configuration.

47. The method ofclaim 46 wherein at least three different syringe configurations are associated with at least three corresponding positions of the first contact member.

48. The method ofclaim 47, further comprising the step of transmitting light energy from a surface in operative connection with the first contact member to a sensor, the light energy measured by the sensor corresponding to the position of the first contact member.

49. The method ofclaim 47 wherein a shutter mechanism in operative connection with the first contact member moves with motion of the contact member to a position that determines a state of each of a plurality sensors having an on state and an off state, the state of each of the plurality of sensors providing a digital code corresponding to information on syringe configuration.

50. A syringe adapter for use with a powered injector, the syringe adapter comprising:

an injector attachment;

a syringe attachment; and

at least a first indicator positioned on the syringe adapter at a predetermined position, the distance between a surface of the at least a first indicator and a predetermined position on the powered injector when the syringe adapter is in operative connection with the powered injector providing information about the syringe configuration of a syringe attachable to the syringe attachment.

51. An injector system comprising:

at least one syringe comprising at least a first indicator positioned on the syringe at a predetermined position, the position of the at least a first indicator being associated with information about the syringe configuration; and

an injector comprising:

a drive member;

a plurality of sensors;

at least a first contact member movably disposed in the injector, the at least a first contact member is positioned to come into contact with the at least a first indicator when the syringe is attached to the injector such that the position of the at least a first contact member is determined by the position of the at least a first indicator; and

at least a first shutter mechanism in operative connection with the at least a first contact member, each of the sensors having an on state and an off state, the shutter mechanism comprising at least one cooperating member to cooperate with at least one of the sensors to place the sensor in an on state or an off state, the state of each of the plurality of sensors providing a digital code corresponding to information on syringe configuration.

Images