Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-06-22
2004-06-01
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S151000
Reexamination Certificate
active
06743202
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to apparatuses and methods for injecting fluid into a patient, and, more particularly, to apparatuses and methods for injecting fluid into a patient in which syringe information relevant to the injection procedure is encoded and shared with an injector.
The parameters of an injection procedure, such as the injection of contrast agents into a patient, include, for example, fluid volume available for delivery, flow rate, fluid pressure, and limits of piston travel. Injection parameters are determined by several variables, including, for example, syringe diameter, syringe length and fluid composition.
To program an injection procedure, some or all of the above injection parameters and variables, for example, must be input into the injector. In current injector systems, syringe size is input into an injector either (1) manually by an operator who enters the syringe size or syringe 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 barrel. Constraints on mechanical and electrical design, however, limit the number of such automatic detection switches. Indeed, only limited syringe configurations are automatically detected with present systems. (As used herein, the terms “syringe configuration” or “syringe information” encompasses all information about a particular syringe, including, but not limited to, information about the mechanical properties of a syringe (for example, length, diameter, available volume, pressure limitations, expiration date, prior use, and manufacturer) as well as information about the contents of the syringe (for example, fluid volume, expiration date, manufacturer and composition).
With the increasing variety of syringes and fluids contained therein, and especially prefilled syringes, a greater amount of syringe configuration information must be input into and accepted by injectors to program and control injection procedures. By providing an injector system having the capability to automatically obtain syringe configuration information from syringes with minimal or no operator intervention, injection procedures can be efficiently programmed and controlled, and/or recorded for billing or other purposes.
SUMMARY OF THE INVENTION
The present invention provides generally apparatuses and methods for sharing information on syringe configuration between syringes and injector systems. The syringe configuration information carried by syringes or other elements can be automatically accessed by or input into injectors to program and/or control injection procedures, such as angiographic, CT, MR and ultrasound injection procedures.
Further, the present invention may be used to generate and maintain data records associated with injection procedures. For example, to update inventory control records and to satisfy medical and insurance billing and cost information requirements, records 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, may be generated and maintained for use by, for example, external billing, inventory or control computer systems.
The present invention provides a syringe for use with a powered injector including a drive member and a having a detector or detection circuit in communication therewith. The detector may be incorporated within the injector. The syringe preferably comprises an elongated body and a plunger slidably disposed within the elongated body and operable to be driven by the drive member. The syringe also preferably comprises a means or mechanism adapted to convey syringe information to the detector or detection circuit.
The mechanism adapted to convey syringe information to the detection circuit may be included in an encoded element (for example, a cap that fits over the syringe plunger or a fluid path element that is connected to the syringe) that includes a store of syringe information and is separate from and connectable to the syringe. Alternatively, the attachable element incorporating the syringe information may be connectable or attachable to the injector or the detector.
In general, syringe information can be conveyed using various energy sources including, for example, electrical, magnetic, radio frequency, optical and ultrasound. Physical indicia can also be used. Combinations of one or more energy sources and/or physical indicia are also possible.
In the case that the information is encoded directly upon the syringe, areas of intimate contact between the syringe and another element are preferably used to convey the information. Because intimate contact is made between the plunger and the drive member, for example, the plunger/drive member interface provides a good place to transmit information regarding syringe configuration to the detection circuit. The present invention thus provides a syringe as described above in which the plunger includes information regarding the syringe encoded thereon. This information may be conveyed to the detector of the injector via one or more readout members or sensors in the drive member of the injector.
In the case of a number of syringes, a pressure jacket (typically, a robust cylindrical element) enables a relatively thin-walled syringe to be used at high pressures. In one embodiment of the present invention, information stored on the syringe (preferably, on the elongated body or barrel of the syringe) is communicated from the syringe to the pressure jacket.
Also, heaters are sometimes used to heat the contents of a syringe to, for example, body temperature (see, for example, U.S. Pat. No. 4,006,736). The interface between the syringe and such a heater also provides a useful interface for transfer of information.
In the case the information is encoded directly upon the syringe or upon an encoded element attached to or connected to the syringe, the syringe may comprise alignment elements that cooperate with associated alignment elements upon an injector, a pressure jacket or a heater element to align encoded elements on the syringe with cooperating readout elements of the detector.
According to one aspect of the present invention, a system is provided comprising a syringe for use with a powered injector to inject a fluid into a patient. The syringe includes an elongated body and a plunger slidably disposed therein as described above. The powered injector includes a drive member and is in communication with a detector or a detection circuit. The detector is communicative connection with or comprises at least one electrically conductive readout contact member.
The system further includes at least one electrically conductive code contact member adapted to contact and make an electrical connection with the readout contact member(s). The code contact member or members encode or are in communicative connection with encoded information relevant to the syringe configuration to transmit such encoded information to be read by the detection circuit when the code contact member(s) are in electrical connection with the readout contact member(s).
Preferably, the system comprises a plurality of electrically conductive code contact members. Each of the plurality of code contact members may be positioned to contact and make an electrical connection with only one of a plurality of electrically conductive readout contact members.
In one embodiment, the conductive code contact members are brought to a state of either digital high or digital low upon contact with corresponding readout contact members of the powered injector when the syringe and the powered injector are in operative connection. Preferably, one of the readout contact members is maintained at digital ground and the remainder of the readout contact members are maintained at a non-zero potential. Any code contact member in electrical connection with the digital ground readout
Hirschman Alan D.
Uber Arthur E.
Bradley Gregory L.
Casler Brian L.
Maynard Jennifer
Medrad Inc.
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