WO2022113127A1 - Device and method for detection and control of the gaseous flow in a medical instrument for collection/injection - Google Patents
Device and method for detection and control of the gaseous flow in a medical instrument for collection/injection Download PDFInfo
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- WO2022113127A1 WO2022113127A1 PCT/IT2021/050056 IT2021050056W WO2022113127A1 WO 2022113127 A1 WO2022113127 A1 WO 2022113127A1 IT 2021050056 W IT2021050056 W IT 2021050056W WO 2022113127 A1 WO2022113127 A1 WO 2022113127A1
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- Prior art keywords
- medical instrument
- sampling
- control
- gas
- injection
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- 238000002347 injection Methods 0.000 title claims abstract description 31
- 239000007924 injection Substances 0.000 title claims abstract description 31
- 238000000034 method Methods 0.000 title claims abstract description 13
- 238000001514 detection method Methods 0.000 title description 5
- 238000005070 sampling Methods 0.000 claims abstract description 20
- 238000012545 processing Methods 0.000 claims abstract description 10
- 230000033228 biological regulation Effects 0.000 claims description 7
- 238000012544 monitoring process Methods 0.000 claims description 5
- 230000002401 inhibitory effect Effects 0.000 claims description 4
- 230000011664 signaling Effects 0.000 claims description 4
- 230000000903 blocking effect Effects 0.000 claims description 2
- 230000036961 partial effect Effects 0.000 claims description 2
- 238000000926 separation method Methods 0.000 claims description 2
- 230000001105 regulatory effect Effects 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 14
- 239000002245 particle Substances 0.000 description 8
- 229940079593 drug Drugs 0.000 description 5
- 230000006835 compression Effects 0.000 description 4
- 238000007906 compression Methods 0.000 description 4
- 238000001802 infusion Methods 0.000 description 4
- 238000007918 intramuscular administration Methods 0.000 description 4
- 238000001990 intravenous administration Methods 0.000 description 4
- 238000007920 subcutaneous administration Methods 0.000 description 4
- 208000005189 Embolism Diseases 0.000 description 2
- 208000006440 Open Bite Diseases 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 238000010253 intravenous injection Methods 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 230000009897 systematic effect Effects 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 206010010121 compartment syndrome Diseases 0.000 description 1
- 230000006837 decompression Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000011847 diagnostic investigation Methods 0.000 description 1
- 238000012854 evaluation process Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000004118 muscle contraction Effects 0.000 description 1
- 210000001087 myotubule Anatomy 0.000 description 1
- 230000000474 nursing effect Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000019432 tissue death Effects 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
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
- A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
-
- 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
- A61M5/16877—Adjusting flow; Devices for setting a flow rate
- A61M5/16881—Regulating valves
-
- 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
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0244—Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
Definitions
- the present invention refers to a device and a method for detecting and controlling the gaseous flow in a medical instrument for sampling/injection .
- the invention refers to a device and a method for detecting and controlling the air inside syringes.
- Numerous valve systems for the control of gaseous flows are known, in particular miniaturized valve systems are known, for example micro-valves with even very small openings, with dimensions of the order of millimeters.
- These known valve systems allow a control of viscous flows, in vacuum and non-vacuum conditions.
- flow in viscous regime we mean a gaseous flow in which the mean free path of a particle (“Mean Free Path" X) is much lower than the dimensions D of the channel or container in which it is located, therefore they have continuous collisions and there is a continuous transfer of moment and energy between different particles.
- flow in molecular regime we mean a gaseous flow in which the mean free path l of a particle is comparable or greater than the dimensions of the channel or container in which it is located, so the path of each particle is almost free and independent compared to that of other particles.
- viscous flow is defined as a flow in which the parameter D/l is greater than 100
- molecular flow is defined as a flow in which the parameter D/l is comparable or less than 1.
- flow in predominantly molecular regime we mean a flow in which the parameter D/l is of the order of magnitude of a few units, up to 10: in these conditions, although collisions between particles are not strictly zeroed, most part of the particles most of the time is in molecular regime conditions.
- the mean free path l of a particle naturally also depends on the conditions of pressure and temperature; in particular it is directly proportional to the temperature measured in Kelvin and inversely proportional to the pressure. Assuming that the significant uses of valve systems are in ambient temperature conditions (for example in a range between 273 °K and 313 °K), or at a different temperature as long as it is substantially constant, the essential parameter is pressure.
- This can be advantageous, for example, to measure the flow of air present inside medical instruments used for the withdrawal/injection of medicaments, in particular syringes: to manage a fluid communication between an environment at atmospheric pressure (internal pressure syringe barrel under normal or resting conditions), a vacuum pressure environment (when you push the syringe plunger down and force air out of the syringe before putting it into a medicine bottle), and a higher pressure environment (when you pull the plunger back to the level corresponding to the prescribed amount of medicine to enter the syringe barrel).
- Some of the known micro-valve systems are able to manage and control valve openings such as to guarantee micro-flows in a molecular or predominantly molecular regime, even at atmospheric or higher pressure.
- Object of the present invention is providing a device and a method for detecting and controlling the gaseous flow in a medical instrument for sampling/injection comprising openings configured to prevent the passage of air (at the entrance, during the aspiration of the medicine and/or at the outlet, during injection) , even at atmospheric pressure or higher and to ensure their operability and non-occlusion; this device allows the systematic control and monitoring of the administration (infusion) of medicines or drugs via the intravenous intramuscular or subcutaneous route.
- the present invention relates to the medical/nursing sector and relates to a clinical evaluation process of a patient undergoing intravenous, intramuscular or subcutaneous therapy.
- the gas could be retained inside the muscle, causing a dangerous increase in pressure that can reduce the flow of blood, triggering the so-called compartment syndrome, which can be followed by tissue death and other dangerous complications; alternatively, the gas could make its way along the hole opened by the needle, until it enters the circulation (see below the paragraph dedicated to intravenous injection of air).
- Another object of the present invention is to provide a device and a method for detecting and controlling the gaseous flow in a medical instrument for sampling/injection as well as related systems and methods using this device, which are improved so as to meet the above- mentioned requirements, and capable of at least partially obviating the drawbacks described above with reference to the known art, including gaseous embolisms.
- Figure 1 shows a schematic view of a gaseous flow detection and control device in a medical instrument for sampling/injection according to the present invention.
- gaseous flow control device 10 in a medical instrument for collection/injection, for example in a syringe, is illustrated and described, which comprises:
- a regulation interface 2 comprising a plurality of openings, preferably a plurality of nano-holes with sub-micro-metric dimensions, which can be closed again so as to inhibit the gaseous flow FT, in particular air, in transit through the device 10, i.e. the inlet flow FI from the external environment A1 to the internal environment A2 of the tank/container of the medical instrument during the aspiration of the medicine and/or at the outlet, during the injection; the interface allows the passage of fluids other than air, preferably a medicine;
- control means 3, 4, of the adjustment interface 2 comprising: actuation means, for example a solenoid valve, configured to control the openings so as to open/close them selectively - individually or collectively - blocking the escape of gas, in particular air, (before injection) or avoiding the aspiration of gas bubbles (when aspirating the medicine); said control means 3, 4 further comprise electronic processing means configured to control the actuation means, preferably integrated in the actuation means;
- actuation means for example a solenoid valve
- an input/output interface for example comprising signaling means, connected to the electronic processing means and configured to send 10 control and/or monitoring and/or calibration and/or diagnostic signals outside the device ;
- the signaling means are LEDs which provide, for example on the basis of their color, information on the presence of gas or a display; at least one sensor, for example a flow meter for detecting the quantity of gas, in particular air, present in the syringe tank, said sensor being connected to the control means 3, 4.
- the electronic processing means are configured to control the actuation means so that they determine/control the individual and autonomous opening/closing (with respect to the others) of each opening (nano-hole).
- the electronic processing means control the actuation means so that they determine/control the selective opening/closing of one or more groups of openings (nano-holes).
- each nano-hole has a substantially cylindrical geometry and has a diameter of the order of tens/hundreds of nm and a height of the order of hundreds of nm.
- the nano-holes have a frusto-conical geometry.
- the nano-holes are arranged according to a two-dimensional geometry (array) with rows and columns.
- the actuation means control each opening (nano-hole) making it assume a condition of complete or partial opening/closing, the characteristics of which vary in relation to the size of the gas molecules (air) whose flow must be controlled.
- the adjustment interface 2 and the control means 3, 4 are integrated in a miniaturized chip.
- the device 10 is configured to be housed in a separation structure between the aforementioned external environment A1 and internal environment A2 of the syringe tank/container, to control the gaseous flow (air) in transit FT between the external environment A1 and the indoor environment A2.
- the device 10 is configured both to extract air (outgoing gaseous flow FU) from the internal environment A2 (after any signaling of the LEDs) by means of a first and small compression of the plunger (technique currently known for extracting the air before injection) or to block/inhibit it during injection to the patient (second compression phase), thanks to the operation of the electronic processing means configured to control the actuation means so that they determine/control the opening/closing of each opening (nano-hole ), to keep the internal environment A2 free of air (and avoiding the infusion of air into the patient's body).
- the control means 3, 4 of the device 10 are configured to control the gaseous flow through the regulation interface 2 on the basis of the pressure values, respectively referred to the external environment A1 (piston rest area or sampling decompression area of the medicine) and to the internal environment A2 (compression of the plunger for the extraction of air or phase of injection of the medicine to the patient).
- the method of detecting and controlling the gaseous flow in a medical instrument for sampling/injection according to the present invention comprises the step of inhibiting or allowing in a controlled way a flow of gas through a regulation interface 2 of gaseous flow comprising a plurality of nano-holes of sub-micro-metric dimensions, in which each of the nano-holes can be opened or closed, so as to inhibit or allow the passage of a respective micro-flow.
- the aforementioned inhibiting or permitting step includes the step of controlling the opening or closing of each of the nano-holes, individually or collectively, so that the overall flow of gas passing through the regulation interface is the sum of the micro-holes, flows passing through the open nano-holes.
- the gaseous flow detection and control device 10 in a medical instrument for sampling/injection allows the systematic control and monitoring of the administration (infusion) of drugs or drugs by the intravenous, intramuscular or subcutaneous route, including openings configured to avoid passage of air (inlet, during drug aspiration and/or outlet, during injection), even at atmospheric pressure or higher and to ensure operability and non-occlusion of the same.
Landscapes
- 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)
- Physics & Mathematics (AREA)
- Fluid Mechanics (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Sampling And Sample Adjustment (AREA)
Abstract
A gaseous flow control device (10) is disclosed in a medical instrument for sampling/injection which comprises a regulating interface (2) with reclosable openings to inhibit the gaseous flow (FT) through the device (10), means control (3, 4) of the adjustment interface (2), an input/output interface connected to the electronic processing means and at least one sensor for detecting the quantity of gas present in the syringe barrel; a medical instrument for sampling/injection and a gaseous flow control method are also described.
Description
DEVICE AND METHOD FOR DETECTION AND CONTROL OF THE GASEOUS FLOW IN A MEDICAL INSTRUMENT FOR
COLLECTION/INJECTION
The present invention refers to a device and a method for detecting and controlling the gaseous flow in a medical instrument for sampling/injection .
In particular, the invention refers to a device and a method for detecting and controlling the air inside syringes. Numerous valve systems for the control of gaseous flows are known, in particular miniaturized valve systems are known, for example micro-valves with even very small openings, with dimensions of the order of millimeters. These known valve systems allow a control of viscous flows, in vacuum and non-vacuum conditions. By "flow in viscous regime" we mean a gaseous flow in which the mean free path of a particle ("Mean Free Path" X) is much lower than the dimensions D of the channel or container in which it is located,
therefore they have continuous collisions and there is a continuous transfer of moment and energy between different particles.
By "flow in molecular regime" we mean a gaseous flow in which the mean free path l of a particle is comparable or greater than the dimensions of the channel or container in which it is located, so the path of each particle is almost free and independent compared to that of other particles.
With regard to the classification of flows, "viscous flow" is defined as a flow in which the parameter D/l is greater than 100, and "molecular flow" is defined as a flow in which the parameter D/l is comparable or less than 1.
By "flow in predominantly molecular regime" we mean a flow in which the parameter D/l is of the order of magnitude of a few units, up to 10: in these conditions, although collisions between particles are not strictly zeroed, most part of the particles most of the time is in molecular regime conditions.
The mean free path l of a particle naturally also depends on the conditions of pressure and temperature; in particular it is directly
proportional to the temperature measured in Kelvin and inversely proportional to the pressure. Assuming that the significant uses of valve systems are in ambient temperature conditions (for example in a range between 273 °K and 313 °K), or at a different temperature as long as it is substantially constant, the essential parameter is pressure.
In an increasing number of important applications, the need emerges to be able to control micro-flows in a molecular or predominantly molecular regime, at vacuum and not vacuum pressures.
It is also desirable to be able to control and/or measure a flow with granularity and/or resolution of micro-flows in a molecular or predominantly molecular regime for most industrial applications that operate at pressures equal to or higher than atmospheric, or not vacuum. This can be advantageous, for example, to measure the flow of air present inside medical instruments used for the withdrawal/injection of medicaments, in particular syringes: to manage a fluid communication between an environment at atmospheric pressure (internal pressure syringe
barrel under normal or resting conditions), a vacuum pressure environment (when you push the syringe plunger down and force air out of the syringe before putting it into a medicine bottle), and a higher pressure environment (when you pull the plunger back to the level corresponding to the prescribed amount of medicine to enter the syringe barrel).
Some of the known micro-valve systems are able to manage and control valve openings such as to guarantee micro-flows in a molecular or predominantly molecular regime, even at atmospheric or higher pressure.
Object of the present invention is providing a device and a method for detecting and controlling the gaseous flow in a medical instrument for sampling/injection comprising openings configured to prevent the passage of air (at the entrance, during the aspiration of the medicine and/or at the outlet, during injection) , even at atmospheric pressure or higher and to ensure their operability and non-occlusion; this device allows the systematic control and monitoring of the administration (infusion) of medicines or drugs via the intravenous intramuscular or subcutaneous
route.
In particular, the present invention relates to the medical/nursing sector and relates to a clinical evaluation process of a patient undergoing intravenous, intramuscular or subcutaneous therapy.
The use of therapeutic tools/means that include biomedical/health detection equipment/means and/or generalized diagnostic investigations in the health sector is also known: the use of such therapeutic tools/means presents the problem of being inefficient.
In particular, it is not possible to perform or identify an intravenous, intramuscular or subcutaneous flow screening/control test without resorting to a prevention and monitoring model/protocol for detecting the presence of air inside the syringe barrel, which is be very wasteful and ineffective.
In particular, in the case of intramuscular injections, mistakenly injecting small amounts of air into the muscle does not generally expose the patient to particular health risks; by injecting a few milliliters of air, it will be located mainly between the muscle fibers, causing a sensation of small pops due to the compression of the bubbles
during muscle contraction.
In the case of larger quantities, the risks are greater: the gas could be retained inside the muscle, causing a dangerous increase in pressure that can reduce the flow of blood, triggering the so-called compartment syndrome, which can be followed by tissue death and other dangerous complications; alternatively, the gas could make its way along the hole opened by the needle, until it enters the circulation (see below the paragraph dedicated to intravenous injection of air).
For intravenous injections, injecting large amounts of air into a vein can expose the patient to serious, sometimes even life-threatening, health risks.
If small quantities of air are not able to cause damage by obstructing the circulation (such as micro-bubbles that can form in the infusion line), the risks increase when the quantity of injected air and the speed of injection increase, to develop venous embolism, a potentially fatal condition characterized by obstruction of a blood vessel caused by the presence of an air bubble; in the case of patients with cardiac problems
(congenital or acquired) the tolerated dose may decrease significantly.
Another object of the present invention is to provide a device and a method for detecting and controlling the gaseous flow in a medical instrument for sampling/injection as well as related systems and methods using this device, which are improved so as to meet the above- mentioned requirements, and capable of at least partially obviating the drawbacks described above with reference to the known art, including gaseous embolisms.
The aforementioned and other purposes and advantages of the invention, as will emerge from the following description, are achieved with a device and a method of detecting and controlling the gaseous flow in a medical instrument for sampling/injection such as those described in the main claims. Preferred embodiments and non-trivial variants of the present invention form the subject of the dependent claims.
It is understood that the attached claims form an integral part of the present description.
It will be immediately obvious that innumerable variations and modifications (for
example relating to shape, dimensions, arrangements and parts with equivalent functionality) can be made to what is described without departing from the scope of the invention as appears from the attached claims.
The present invention will be better described by a preferred embodiment, given by way of non limiting example, with reference to the attached drawings, in which: Figure 1 shows a schematic view of a gaseous flow detection and control device in a medical instrument for sampling/injection according to the present invention.
With reference to the Figure, a preferred embodiment of the gaseous flow control device 10 in a medical instrument for collection/injection, for example in a syringe, is illustrated and described, which comprises:
- a regulation interface 2 comprising a plurality of openings, preferably a plurality of nano-holes with sub-micro-metric dimensions, which can be closed again so as to inhibit the gaseous flow FT, in particular air, in transit through the device 10, i.e. the inlet flow FI from the external environment A1 to the internal environment A2 of
the tank/container of the medical instrument during the aspiration of the medicine and/or at the outlet, during the injection; the interface allows the passage of fluids other than air, preferably a medicine;
- control means 3, 4, of the adjustment interface 2 comprising: actuation means, for example a solenoid valve, configured to control the openings so as to open/close them selectively - individually or collectively - blocking the escape of gas, in particular air, (before injection) or avoiding the aspiration of gas bubbles (when aspirating the medicine); said control means 3, 4 further comprise electronic processing means configured to control the actuation means, preferably integrated in the actuation means;
- an input/output interface, for example comprising signaling means, connected to the electronic processing means and configured to send 10 control and/or monitoring and/or calibration and/or diagnostic signals outside the device ; preferably the signaling means are LEDs which provide, for example on the basis of their color, information on the presence of gas or a display; at least one sensor, for example a flow meter
for detecting the quantity of gas, in particular air, present in the syringe tank, said sensor being connected to the control means 3, 4.
Preferably, the electronic processing means are configured to control the actuation means so that they determine/control the individual and autonomous opening/closing (with respect to the others) of each opening (nano-hole). In a preferred embodiment of the device 10 of the invention, the electronic processing means control the actuation means so that they determine/control the selective opening/closing of one or more groups of openings (nano-holes).
Preferably, each nano-hole has a substantially cylindrical geometry and has a diameter of the order of tens/hundreds of nm and a height of the order of hundreds of nm.
In a preferred embodiment of the device 10, the nano-holes have a frusto-conical geometry. Preferably, the nano-holes are arranged according to a two-dimensional geometry (array) with rows and columns.
Preferably, the actuation means control each opening (nano-hole) making it assume a condition of complete or partial opening/closing, the
characteristics of which vary in relation to the size of the gas molecules (air) whose flow must be controlled.
In an embodiment of the control device 10 according to the invention, the adjustment interface 2 and the control means 3, 4 are integrated in a miniaturized chip.
The device 10 is configured to be housed in a separation structure between the aforementioned external environment A1 and internal environment A2 of the syringe tank/container, to control the gaseous flow (air) in transit FT between the external environment A1 and the indoor environment A2. The device 10 is configured both to extract air (outgoing gaseous flow FU) from the internal environment A2 (after any signaling of the LEDs) by means of a first and small compression of the plunger (technique currently known for extracting the air before injection) or to block/inhibit it during injection to the patient (second compression phase), thanks to the operation of the electronic processing means configured to control the actuation means so that they determine/control the opening/closing of each opening (nano-hole ), to
keep the internal environment A2 free of air (and avoiding the infusion of air into the patient's body). The control means 3, 4 of the device 10 are configured to control the gaseous flow through the regulation interface 2 on the basis of the pressure values, respectively referred to the external environment A1 (piston rest area or sampling decompression area of the medicine) and to the internal environment A2 (compression of the plunger for the extraction of air or phase of injection of the medicine to the patient).
The method of detecting and controlling the gaseous flow in a medical instrument for sampling/injection according to the present invention, having resolution corresponding to micro-flows, comprises the step of inhibiting or allowing in a controlled way a flow of gas through a regulation interface 2 of gaseous flow comprising a plurality of nano-holes of sub-micro-metric dimensions, in which each of the nano-holes can be opened or closed, so as to inhibit or allow the passage of a respective micro-flow.
The aforementioned inhibiting or permitting step includes the step of controlling the opening or closing of each of the nano-holes, individually
or collectively, so that the overall flow of gas passing through the regulation interface is the sum of the micro-holes, flows passing through the open nano-holes. Advantageously, the gaseous flow detection and control device 10 in a medical instrument for sampling/injection allows the systematic control and monitoring of the administration (infusion) of drugs or drugs by the intravenous, intramuscular or subcutaneous route, including openings configured to avoid passage of air (inlet, during drug aspiration and/or outlet, during injection), even at atmospheric pressure or higher and to ensure operability and non-occlusion of the same.
Claims
1. Gas flow control device (10) in a sampling/injection medical instrument, which includes: - a regulation interface (2) comprising a plurality of re-closable openings in order to inhibit the gaseous flow (FT) in transit through the device (10);
- control means (3, 4) of the adjustment interface (2) including: actuation means configured to control the openings in order to open/close them selectively by blocking the escape of gas or avoiding the aspiration of gas bubbles; electronic processing means configured to control the actuation means;
- an input/output interface connected to the electronic processing means and configured to send control and/or monitoring and/or calibration and/or diagnostic signals outside the device (10);
- at least one sensor for detecting the quantity of gas present in the syringe tank, said sensor being connected to the control means (3, 4).
2. Gas flow control device (10) in a medical instrument for sampling/injection according to
claim 1, characterized in that said openings are nano-holes with sub-micro-metric dimensions.
3. Gas flow control device (10) in a medical instrument for sampling/injection according to claim 2, characterized in that the nano-holes have a diameter of the order of tens/hundreds of nm and a height of order of hundreds of margin nos.
4. Gas flow control device (10) in a medical instrument for sampling/injection according to any one of claims 2 to 3, characterized in that each nano-hole has a substantially cylindrical or frusto-conical geometry.
5. Gaseous flow control device (10) in a medical instrument for sampling/injection according to any one of the preceding claims, characterized in that the electronic processing means are configured to control the actuation means so that they determine/control the individual and autonomous opening/closing of each opening and/or the selective opening/closing of one or more groups of openings.
6. Gas flow control device (10) in a medical instrument for sampling/injection according to any one of the preceding claims, characterized in that the actuation means control each opening causing it
to assume a complete or partial open/close condition.
7. Gas flow control device (10) in a medical instrument for sampling/injection according to any one of the preceding claims, characterized in that the electronic processing means are integrated in the actuation means.
8. Gas flow control device (10) in a medical instrument for sampling/injection according to any of the preceding claims, characterized in that the input/output interface includes signaling means that provide information on the presence of gas.
9. Medical instrument for sampling/injection, characterized in that it comprises a device (10) according to any one of the preceding claims housed in a separation structure between an external environment (Al) and an internal environment (A2) of the tank/container of the medical instrument, to control the gas flow in transit (FT) between the external environment (Al) and the internal environment (A2).
10. Method of detecting and controlling the gaseous flow in the medical instrument for sampling/injection according to claim 9, said method comprising the step of inhibiting or
allowing a flow of gas in a controlled manner through the gaseous flow regulation interface (2) comprising a plurality of nano-holes of sub-micro- metric dimensions, in which each of the nano-holes can be opened or closed, so as to inhibit or allow the passage of a respective micro-flow, said step of inhibiting or allowing including the step of controlling the opening or closing of each of the nano-holes, individually or collectively, so that the overall flow of gas passing through the regulation interface is the sum of the micro-flows passing through the open nano-holes.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102020000028598A IT202000028598A1 (en) | 2020-11-27 | 2020-11-27 | DEVICE AND METHOD OF DETECTING AND CONTROLLING THE GAS FLOW IN A SAMPLING/INJECTION MEDICAL INSTRUMENT |
| IT102020000028598 | 2020-11-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2022113127A1 true WO2022113127A1 (en) | 2022-06-02 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IT2021/050056 WO2022113127A1 (en) | 2020-11-27 | 2021-03-12 | Device and method for detection and control of the gaseous flow in a medical instrument for collection/injection |
Country Status (2)
| Country | Link |
|---|---|
| IT (1) | IT202000028598A1 (en) |
| WO (1) | WO2022113127A1 (en) |
Citations (4)
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| US20100051843A1 (en) * | 2008-08-29 | 2010-03-04 | Pushparaj Victor L | Carbon nanotube-based gas valve |
| US20120138180A1 (en) * | 2009-06-03 | 2012-06-07 | Justin Rorke Buckland | Valve |
| US20170168030A1 (en) * | 2014-07-07 | 2017-06-15 | Nanotech Analysis S.R.L.S. | Portable electronic system for the analysis of time-variable gaseous flows |
| WO2020154477A1 (en) * | 2019-01-25 | 2020-07-30 | Board Of Regents, The University Of Texas System | Apparatus and methods for cleaning and/or exchanging medical devices |
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2020
- 2020-11-27 IT IT102020000028598A patent/IT202000028598A1/en unknown
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2021
- 2021-03-12 WO PCT/IT2021/050056 patent/WO2022113127A1/en active Application Filing
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100051843A1 (en) * | 2008-08-29 | 2010-03-04 | Pushparaj Victor L | Carbon nanotube-based gas valve |
| US20120138180A1 (en) * | 2009-06-03 | 2012-06-07 | Justin Rorke Buckland | Valve |
| US20170168030A1 (en) * | 2014-07-07 | 2017-06-15 | Nanotech Analysis S.R.L.S. | Portable electronic system for the analysis of time-variable gaseous flows |
| WO2020154477A1 (en) * | 2019-01-25 | 2020-07-30 | Board Of Regents, The University Of Texas System | Apparatus and methods for cleaning and/or exchanging medical devices |
Also Published As
| Publication number | Publication date |
|---|---|
| IT202000028598A1 (en) | 2022-05-27 |
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