Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/1407—Infusion of two or more substances
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
  • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
  • A61M5/16804—Flow controllers
  • A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
  • A61M2205/051—General characteristics of the apparatus combined with other kinds of therapy with radiation therapy
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/007—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media

Definitions

• the present invention relates to an appliance for the injection of fluids for applications in medicine, particularly radioactive diagnostic fluids in nuclear medicine.
• nuclear medicine is a method which, by means of radiology image diagnostics, allows detecting organic, anatomic or biological molecular alterations in the body of a patient.
• Such method requires, to start with, the peripheral injection of a radiopharmaceutical product into a patient.
• PET positron emission tomography
• tomography appliances are able to detect the radiation emitted by a radiopharmaceutical product and subsequently transform it into a digital signal for computerised analysis. It is known that the infusion of the radiopharmaceutical product into the patient is traditionally done manually by an operator, by means of specific pre-filled syringes that are screened against the radiations.
• the operator remains alongside the patient for all the time needed to make the infusion of the radiopharmaceutical product and during any subsequent operations, such as the post-hydration of the patient and, consequently, is exposed to the radioactive emissions produced by the injected radiopharmaceutical product.
• the known appliances have a housing suitable for accommodating a syringe pre-filled with the radiopharmaceutical product and have automatic injection means suitable for moving the syringe piston.
• the operator is in any case obliged to intervene manually before and after the injection of the radiopharmaceutical product, in particular to perform a preliminary cycle of pre-hydration of the patient by means of the injection of a physiological salt solution, to prepare the injection of the radiopharmaceutical product and, if necessary, to perform a cycle of post-hydration of the patient after the injection.
• the main aim of the present invention is to provide an appliance for the injection of fluids for applications in medicine, particularly radioactive diagnostic fluids in nuclear medicine, which provides the utmost protection of the appointed operators from radioactive emissions .
• Another object of the present invention is to provide an appliance for the injection of fluids that permits performing a complete infusion cycle on the patient: from the preparation of the hydraulic circuit for the injection, to the subsequent pre-hydration of the patient, to the injection of the radioactive diagnostic fluid, up to the washing of the hydraulic circuit and the post- hydration of the patient.
• Another object of the invention is to provide an appliance for the injection of fluids that ensures utmost safety for the patient. Another object of the invention is to provide an appliance for the injection of fluids that is simple to use.
• Another object of the invention is to provide an appliance for the injection of fluids that allows speeding up the overall injection cycle of the radioactive diagnostic fluid into a patient.
• the present appliance for the injection of fluids for applications in medicine comprising at least a hydraulic circuit associable with a patient and automatic injection means for injecting a fluid for applications in medicine through said hydraulic circuit and towards said patient, characterized in that said hydraulic circuit comprises an infusion line associable with said patient, first introduction means for introducing a physiological salt solution or the like associated with said infusion line and associable with said automatic injection means, and second introduction means for introducing a predetermined volume of said fluid associated with said infusion line and associable with said automatic injection means, said automatic injection means being electronically associated with at least a management and control unit for the controlled introduction of said physiological salt solution and said fluid towards said patient.
• the present method for the injection of fluids for applications in medicine comprising: a first introduction phase of a physiological salt solution or the like in an infusion line of a hydraulic circuit associated with a patient; a second introduction phase in said infusion line and towards said patient of a fluid for applications in medicine; a third introduction phase of said physiological salt solution in said infusion line, subsequently to said second introduction phase; characterized in that said first, second and third introduction phases are implemented in sequence by means of automatic injection means for the controlled introduction of said physiological salt solution and of said fluid towards said patient.
• Figure 2 is a schematic view of the hydraulic circuit of the appliance according to the invention.
• FIG. 3 is a block diagram showing the operation of the appliance according to the invention.
• an appliance for the injection of fluids for applications in medicine particularly radioactive diagnostic fluids in nuclear medicine has been globally indicated by 1.
• the appliance 1 comprises a frame 2 having a base 3 for resting on the ground and supporting a container 4 housing a hydraulic circuit 5 associable with a patient.
• the base 3 has wheels 6 resting on the ground and suitable for facilitating the movement of the entire appliance 1.
• the hydraulic circuit 5 comprises an infusion line 7 associable with the patient and with which are associated first introduction means 8 for introducing a physiological salt solution or the like and second introduction means 9 for introducing a predetermined volume of radioactive diagnostic fluid, of the type commonly used for diagnostic exams in nuclear medicine.
• the appliance 1 also comprises automatic injection means, generically indicated in figure 1 with the reference 10, which are operatively associated with the first and the second introduction means 8 and 9.
• the automatic injection means 10 are electronically connected to a management and control unit not shown in the illustrations, of the type of a microprocessor system or the like, suitable for performing the controlled introduction into the patient of the physiological salt solution and of the radioactive diagnostic fluid.
• the base 3 comprises an inner compartment for housing the management and control unit and supports on a swivel arm 11 interfacing means 12 of the visual and/or sound type, associated with the management and control unit and accessible by an operator to regulate the parameters of introduction of the physiological salt solution and of the radioactive diagnostic fluid during the patient infusion cycle.
• the interfacing means 12 are composed of a touch screen.
• the container 4 is supported by an upright 13, above the base 3, and has on the front an access opening to the hydraulic circuit 5 and a door 14 for hermetically closing such opening.
• the container 4 may have a sensor device, not shown in the illustration, suitable for detecting the correct closing of the door 14.
• the container 4 is made entirely of screening material so as to retain within it the radiations emitted by the radioactive diagnostic fluid contained inside the hydraulic circuit 5.
• the container 4 may have a lower slot, not shown in the figure 1, suitable for allowing the dispersed fluids to flow out in case of any damage to the hydraulic circuit 5.
• the base 3 has a tray 15, made of stainless steel, that is arranged underneath the container 4 and which may be used, not only to rest instruments such as syringes, needles, bottles, etc., but also to collect up any fluids that have flowed out of the hydraulic circuit 5 through the above lower slot.
• the frame 2 comprises a rod 16 that extends vertically above the container 4 and which is suitable for supporting a bottle 17 of a physiological salt solution or the like.
• the appliance 1 may have an electric switch, startable by an operator in the event of an anomalous situation occurring during the patient infusion cycle, and suitable for stopping the automatic injection means 10.
• the appliance 1 comprises a supply circuit that may be connected to the outside power supply and, advantageously, may comprise a power supply battery, of the rechargeable type, suitable for intervening in case of an interruption in the outside power supply.
• the appliance 1 may also have one or more light sources, not shown in the figure 1, suitable for lighting determinate operating areas in case of an interruption of the outside power supply.
• all the elements of the hydraulic circuit 5 are fixed to a support element 18, substantially plate-shaped and made of polymer material.
• the support element 18 has fastening/release means for the quick fastening to/release from one of the inner walls of the container 4, genetically indicated by the reference 19, which allow the quick installation and removal of the entire hydraulic circuit 5 on/from the appliance 1.
• the quick fastening/release means 19 may e.g. be of the trip type but alternative embodiments cannot however be ruled out.
• the presence of the support element 18 and of the quick fastening/release means 19 permits the quick removal of the entire hydraulic circuit 5 and facilitates the cleaning operations of the container 4, which is composed of smooth and easy-to-wash surfaces.
• the first introduction means 8 are composed of a first piston device, of the type of a conventional syringe for injections, fastened to the support element 18 by means of suitable first retention means 20, of the clip type or the like.
• the second introduction means 9 are composed of a second piston device, of the type of a syringe for injections conventionally used for the injection of the radioactive diagnostic fluid, fastened to the support element 18 by means of suitable second retention means 21, of the clip type or the like, and associated with the infusion line 7 downstream with respect to the first piston device 8.
• the second piston device 9 comprises a containment chamber having external screening from radiations and pre-filled with a predetennined volume of radioactive diagnostic fluid to be injected into a patient.
• the automatic injection means 10 comprise a first actuator 22 and a second actuator 23 operatively associated with the first piston device 8 and with the second piston device 9 respectively.
• the first and the second actuator 22 and 23 are of the electromechanical linear actuator type. Different embodiments cannot however be ruled out.
• the hydraulic circuit 5 comprises an inlet line 24 for the physiological salt solution which has, at one extremity, a first connector 25 associable with the bottle 17 and which is associated, at the opposite extremity, with a valve 26.
• the valve 26 is of the type of a three-way valve with an inlet mouth 26a associated with the inlet line 24, and inlet/outlet mouth 26b associated with the dispensing/suction mouth of the first piston device 8 and an outlet mouth 26c associated with the infusion line 7.
• the hydraulic circuit 5 comprises a pressure detector 28 suitable for detecting and signalling to the management and control unit any abnormal pressure values inside the infusion line 7, fixed to the support element 18 by means of suitable third retention means 29, of the clip type or the like.
• high pressure values may be caused by an out of vein injection potentially dangerous for the patient, while low pressure values may be caused by a breakage of the infusion line 7.
• the abnormal pressure is detected by the pressure detector 28, and the abnormality is then communicated to the management and control unit which stops the infusion cycle.
• a third connector 30, of the type of a T connector arranged downstream of the second connector 27 and having a connection mouth 30a associated with the pressure detector 28.
• a solenoid valve may be placed, schematised in figure 2 and indicated by the reference 31, suitable for isolating the pressure detector 28 from the rest of the hydraulic circuit 5 and usable, in particular, during the operations of preparation of the appliance 1, before the infusion cycle.
• the hydraulic circuit 5 also comprises a hydrophobic filter 32 suitable for expelling the air inside the infusion line 7 and fixed to the support element 18 by means of suitable fourth retention means 33, of the clip type or the like.
• a fourth connector 34 of the type of a T connector, arranged downstream of the third connector 30, having an air outlet mouth 34a, associated with the hydrophobic filter 32, and an outlet mouth 34b for the fluid introduced by the first or the second piston device 8 or 9, associated with an outlet line 35 towards the patient.
• the method for the injection of the radioactive diagnostic fluid into a patient is shown schematically in figure 3, and is indicated genetically by the reference A.
• the hydraulic circuit 5 is positioned by an operator inside the container 4, and the support element 18 is fixed to the inner wall of the container 4 by means of the quick fastening/release means 19.
• the door 14 is then closed, the inlet line 24 is connected to the bottle 17 and the outlet line 35 of the hydraulic circuit 5 is connected to a venous catheter on the patient.
• the method A comprises a first introduction phase B of the physiological salt solution into the infusion line 7 towards the patient, by means of the first piston device 8.
• the first piston device 8 aspirates the physiological salt solution from the bottle 17, through the inlet line 24 and through the mouth 26a and the mouth 26b of the valve 26 and, subsequently, introduces the physiological salt solution into the infusion line 7, through the mouth 26b and the mouth 26c of the valve 26.
• the first introduction phase B of the physiological salt solution comprises a phase B 1 for the elimination of the air inside the infusion line 7, with the patient connected to the circuit and, therefore, without any manual intervention being required on the part of the operator.
• the entire infusion line 7 is filled with the physiological salt solution and the air is expelled through the hydrophobic filter 32.
• the first introduction phase B of the physiological salt solution may also comprise a patient pre-hydration phase B2, in which the physiological salt solution is injected into the patient according to predefined volume and flow.
• the method A comprises a second introduction phase C of the radioactive diagnostic fluid into the infusion line 7 towards the patient by means of the second piston device 9.
• the second piston device 9 introduces the radioactive diagnostic fluid already present inside the containment chamber in the infusion line 7, through the mouth 27a of the second connector 27.
• the method A comprises a third introduction phase D of the physiological salt solution in the infusion line 7 towards the patient, by means of the first piston device 8 and subsequently at the second phase C.
• the first piston device 8 aspirates the physiological salt solution from the bottle 17, through the inlet line 24 and through the mouth 26a and the mouth 26b of the valve 26 and, subsequently, introduces the physiological salt solution into the infusion line 7, through the mouth 26b and the mouth 26c of the valve 26.
• the third introduction phase D of the physiological salt solution comprises an emptying phase Dl of the infusion line 7 of the radioactive diagnostic fluid residues.
• the third introduction phase D of the physiological salt solution may also comprise a patient post-hydration phase D2, in which the physiological salt solution is injected into the patient according to predefined volume and flow.
• the first phase B, the second phase C and the third phase D are performed in sequence by means of the first and the second actuator 22 and 23, which are moved by the management and control unit of the appliance 1 for the controlled introduction of the physiological salt solution and of the radioactive diagnostic fluid into the patient.
• the method A comprises a preliminary setting phase E for the preliminary setting of the infusion cycle to be carried out on the patient, performed by the operator with the aid of the touch screen 12.
• the preliminary setting phase E may envisage the selection of a standard infusion cycle, indicated by means of the reference F, which envisages the phase Bl for the elimination of the air from the infusion line, the phase C for the introduction of the radioactive diagnostic fluid and the phase Dl for the emptying of the infusion line of radioactive diagnostic fluid residues.
• the preliminary setting phase E may envisage the personalisation of the infusion cycle, in particular the following may be performed: a first definition phase Gl for the definition of the total volume and/or flow parameters of the physiological salt solution to be introduced into the patient during the pre-hydration phase B2; a second definition phase G2 for the definition of the flow and, if necessary, the volume parameters of the radioactive diagnostic fluid to be introduced during the second introduction phase C; a third definition phase G3 for the definition of the total volume and/or flow parameters of the physiological salt solution to be introduced during the post-hydration phase D2.
• the appliance does in fact allow automating a complete patient infusion cycle, both of the physiological salt solution and of the radioactive diagnostic fluid, thus reducing to the utmost the number of manual interventions on the part of the appointed operators.
• the described appliance also guarantees the utmost safety for the patient, in particular thanks to the presence of the pressure detector inside the hydraulic circuit.

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• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Priority Applications (1)

Applications Claiming Priority (2)

Publications (1)

Family

ID=40291764

Family Applications (1)

Country Status (3)

Cited By (2)

Citations (5)

• 2008
  • 2008-02-29 IT ITMO20080055 patent/ITMO20080055A1/it unknown
• 2009
  • 2009-02-26 EP EP09716089A patent/EP2254620A1/en not_active Withdrawn
  • 2009-02-26 WO PCT/IB2009/000399 patent/WO2009106977A1/en active Application Filing

Patent Citations (5)

Non-Patent Citations (1)

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