WO2017195226A1 - Injective administration system by using a syringe without needle - Google Patents

Injective administration system by using a syringe without needle Download PDF

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Publication number
WO2017195226A1
WO2017195226A1 PCT/IT2016/000123 IT2016000123W WO2017195226A1 WO 2017195226 A1 WO2017195226 A1 WO 2017195226A1 IT 2016000123 W IT2016000123 W IT 2016000123W WO 2017195226 A1 WO2017195226 A1 WO 2017195226A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal
needle
pressure
medicine
ampule
Prior art date
Application number
PCT/IT2016/000123
Other languages
French (fr)
Inventor
Mario Mancini
Giovanni TRAINA
Original Assignee
MEDIFORM ITALIA S.r.l.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by MEDIFORM ITALIA S.r.l. filed Critical MEDIFORM ITALIA S.r.l.
Priority to PCT/IT2016/000123 priority Critical patent/WO2017195226A1/en
Publication of WO2017195226A1 publication Critical patent/WO2017195226A1/en

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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
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/332—Force measuring means
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3327—Measuring
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/65—Impedance, e.g. conductivity, capacity

Definitions

  • the present invention essentially regards a device for medical use comprising an injector without needle, said device being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue.
  • the injector without needle includes an electronic and mechanic control system monitoring the cutaneous tissue to which the same device is applied.
  • injector devices without needle are widely used, and they are used especially to overcome the drawbacks of the syringe with needle.
  • the penetration of skin with a needle is not without risk, especially in case that the person providing the injection is not an expert.
  • the side effects in the person receiving the injection, can be of different type, like in example: pain, hematoma, formation of scar tissue, infection or abscess, transmission of infective diseases (in case the used needles are not of the single use type). All these problems are independent in respect to the type of medicine injected and are related exclusively to the effect of an injection with a needle.
  • Penjel® represents a type of syringe without needle for the underskin injections of medicines and for some interventions of aesthetic surgery. It works in a simple way, similar to the mechanism of the air pressure toy guns. Once it has been loaded, the syringe is placed perpendicular to the skin, and then the device is activated. The high pressure vaporizes the medicine making it to pass through the skin, reaching the underskin layer in a short time, without any pain for the patient. This type of injection allows a uniform diffusion of the medicine, without causing local inflammations that sometimes happen by using standard syringes, and especially it avoids totally the risk of infections.
  • Penjet® belongs to the class of prefilled syringes without needle, for liquid and lyophilized medicines. It is a single use injector that is prefilled of a prefixed quantity of medicine. It can be injected quickly by a medical doctor or by the same patient.
  • Injex® represents a syringe without needle that, first avoids the diffuse fear of the injection, and then avoids the risk of transmission of infective diseases that can happen after an accidental contamination by injection. In fact, each year millions of accidental injuries by needles are reported.
  • This injector belongs to the latest generation, and can be applied in a safe and almost not painful way, increasing therefore the treatment of chronic patients.
  • Injex® ejects a thin high pressure jet of liquid going through the surface layers of skin.
  • the pressure is generated by the energy of a spring, and it is sufficient to make the medicine to pass through reaching a depth that is comparable to that reached by a standard needle, providing therefore a good level of absorption.
  • this device it should be remarked the avoided risk of injuries caused by failure of the needle, the impossibility of transmission of infections or virus arising from a mixed use, the decrease of the cost involved in the disposal process of the used materials, and the simplicity of use.
  • PowderJect® is composed of a combination of an injection device without needle and a medicine in the form of a powder, using therefore substance that is not liquid.
  • the system uses the energy given by a jet of helium gas in order to accelerate a fixed quantity of medicine powder at a very high speed, in order to pass through the cutaneous skin.
  • the medicine should be prepared in a powder of dehydrated particles being in a specific range of sizes, or in an advanced formulation with inactive components that are necessary to dilute or stabilize the medicine for an optimal absorption. Therefore, this device defines precise characteristics of the substance to be injected.
  • the PowderJect® injection device is powered by a micro-cylinder filled of gas that has been properly designed, and uses a small container in order to supply the powder of medicine in the jet of gas.
  • a capsule made of aluminium is filled of helium at a specific pressure and it is soldered by using a laser.
  • the container of medicine and the housing parts are made of a plastic compatible with a medical use, using standard production processes.
  • the user places the device on the application site and pushes it on the skin so that a safety mechanism, that prevents a non-intentional or wrong activation of the device, is bypassed.
  • a safety mechanism that prevents a non-intentional or wrong activation of the device.
  • the user pushes the activation button that breaks the capsule of gas.
  • the compressed gas that is ejected breaks the container of medicine and injects immediately the medicine inside the tissue. After its use, the device is disposed away.
  • a device for medical use comprising an injector without needle, said device being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue.
  • the injector without needle includes an electronic and mechanic control system monitoring the cutaneous tissue to which the same device is applied.
  • said electronic and mechanic control system is able to detect the exact value of pressure at the end of the device placed on the cutaneous tissue where it is applied, and can send a signal that informs the operator when the value of pressure is correct or not.
  • said electronic and mechanic control system is able to detect the exact value of electrical conductivity of the cutaneous tissue placed in touch with the end of the device, and can send a signal that informs the operator when the value of electrical conductivity is correct or not.
  • the electrical conductivity is associated to the type of tissue, for example of muscular type or adipose type.
  • said electronic and mechanic control system is able to detect, at the exact point of touch between the end of device and the cutaneous tissue where it is applied, other characteristic physical parameters, like in example humidity, temperature, pH, etc., that can inform the operator when the detected conditions are correct or not.
  • system with rear spring can compensate any noise or any vibration caused from the switch of the spring or gas in the propulsor element, going to delete any noise.
  • the signal informing the operator that the detected conditions are correct or not can be expressed as: a light of a LED element emitting green or red light; a continuous or intermittent sound of beep type; a message on a display of a word like 'GO' or 'STOP'; etc.
  • a device for medical use comprising an injector body without needle, at the distal or distal and rear end of which an ampule is connected, containing a medicine to be injected, said device being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue, and being characterized in that comprising:
  • a propulsor element in example composed of a container in which a compressed gas is contained; said container being connected to a opening/closing mechanism of electric and/or mechanic type, activated by an operator, and able to eject said gas with high pressure towards said ampule, so that said medicine to be injected is ejected with high pressure inside the underskin tissue;
  • a pressure detector composed of: a primary container, with said ampule contained inside, where the distal end of said primary container is protruding at its front part, and having a spring connected at its rear part; a secondary container with said primary container and said spring are contained inside, so that the pressure at the end of the primary container causes a compression of the spring, and its displacement is detected by a position of a cursor on a measuring scale that is connected to a first electronic circuit;
  • an electrical conductivity detector composed of: a first terminal, placed at the right border in the distal end of said primary container, and a second terminal, placed at the left border in the distal end of said primary container, so that applying a voltage between said first and second terminals a weak electric current is generated, the intensity of which is proportional to the type of tissue that is in touch with the device, and said intensity is detected by a second electronic circuit.
  • Figure 1 is a lateral perspective view of a device for medical use, according to the prior art, comprising an injector body without needle;
  • Figure 2 is a schematic view of a device, according to the present invention, comprising a pressure detector and a detector of electrical conductivity, with respective LED element emitting green or red light, that informs the operator when the conditions for injection are correct or not;
  • Figure 3 is a lateral view of an injector body without needle, belonging to a device for medical used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue;
  • Figure 4 is a lateral view of an ampule to be connected at the front part of the injector body without needle of Figure 3, according to the prior art;
  • Figure 5 is a lateral view of an ampule to be connected at the front part of the injector body without needle of Figure 3, according to the present invention, comprising a pressure detector and a detector of electrical conductivity, with respective LED element emitting green or red light, that informs the operator when the conditions for injection are correct or not;
  • Figure 6 is a view of a block diagram that represents an electronic circuit for detection of pressure and electrical conductivity, and control of a respective LED element emitting green or red light;
  • Figure 7 is a view of a flow diagram describing how the electronic circuit of Figure 6 works, by enabling or not the injection, according to the measures of pressure and electrical conductivity being in the range of the proper values or not;
  • Figure 8 is a schematic view of the components of a device, according to an alternative embodiment of the present invention, comprising a pressure detector and a detector of electrical conductivity, where the pressure detector is place in the rear part of the injector body;
  • Figure 9 is a lateral view of a device, having the components according to the alternative embodiment of Figure 8, where the pressure detector is place in the rear part of the injector body.
  • Figure 1 shows a device for medical use 100, according to the prior art, comprising an injector body without needle 104, at the distal or distal and rear end of which an ampule 101 is connected, containing a medicine to be injected.
  • Said device 100 being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue, and comprising a propulsor element, in example composed of a container in which a compressed gas is contained.
  • Said container is connected to a opening/closing mechanism of electric and/or mechanic type, activated by an operator, and able to eject said gas with high pressure towards said ampule 101.
  • said medicine to be injected is ejected with high pressure inside the underskin tissue.
  • the present invention compared to the devices of the prior art, includes two innovative components, represented in Figure 2, that together permit to increase significantly the precision, safety and effectiveness of the injection of medicines using injectors without needle.
  • the first component is represented by a pressure detector, composed of: a primary container 204, with said ampule 104 contained inside, and a secondary container 206.
  • the primary container 204 has a protruding front part and a spring 205 connected at its rear part. Said primary container 204 and said spring 205 are contained inside the secondary container 206.
  • the pressure at the end of the primary container 204 causes a compression of the spring 205, and its displacement is detected by a position of a cursor on a measuring scale that is connected to a first electronic circuit.
  • the second component is represented by an electrical conductivity detector, composed of: a first terminal, placed at the right border in the distal end of said primary container 204, and a second terminal, placed at the left border in the distal end of said primary container 204.
  • an electrical conductivity detector composed of: a first terminal, placed at the right border in the distal end of said primary container 204, and a second terminal, placed at the left border in the distal end of said primary container 204.
  • Figures 3 and 4 show an injector body without needle 210, belonging to a device for medical use, according to the prior art, being used to apply a desensitization and immunostimulant therapy to an underskin tissue, and an ampule 220 to be connected to the front part of the same injector body without needle 210.
  • FIG. 5 it is represented an ampule 230 to be connected to the front part of injector body without needle 210, according to the present invention, comprising a pressure detector 201 , 202 and a detector of electrical conductivity 203, with respective LED element 209 emitting green 207 or red light 208, that informs the operator when the conditions for injection are correct or not.
  • said first and second electronic circuit are integrated in a single electronic board 70 comprising: sensors of pressure and sensors of electrical conductivity 71 , internal communication lines 80, a local memory 72, a control software 75, a LED element 77 emitting green or red light, a microprocessor 74, external communication lines 78, 79 from/to external peripherals.
  • the microprocessor 74 can provide the acquisition of pressure and electrical conductivity, and can generate a first signal that informs the operator when the value of pressure is correct or not, and a second signal that informs the operator when the value of electrical conductivity is correct or not.
  • the electrical conductivity is associated to the type of tissue, for example of muscular type or adipose type.
  • Said first and second signal that inform the operator when the value of pressure and electrical conductivity are correct or not, are electric signals directed from said microprocessor 74 to said LED element 77.
  • Said signals activate the green light when both the measures of pressure and electrical conductivity are within a specific range of values, instead they activate the red light when at least among the measures of pressure and electric conductivity are outside said specific range of values.
  • the device for injection of medicines without needle can comprise, in addition or as an alternative, a detector of other physical parameters, composed in example of: a detector of humidity, of temperature, of pH, etc., that can acquire respective measures and generates signals that inform the operator when the detected values of the physical parameters are correct or not.
  • a detector of other physical parameters composed in example of: a detector of humidity, of temperature, of pH, etc., that can acquire respective measures and generates signals that inform the operator when the detected values of the physical parameters are correct or not.
  • the device for injection of medicines without needle can comprise, as an alternative to said LED 77 element emitting a green or a red light, an element that generates a continuous or intermittent sound of beep type; or an element that generates a message on a display of a word like 'GO' or 'STOP'; etc.
  • said signals that inform the operator when the values of the physical parameters are correct or not are electric signals directed from said microprocessor 74 to a generator of sound or a visual display.
  • Said signals activate respectively a continuous beep or a 'GO' message when all the measures of the physical parameters are within a specific range of values, instead they activate an intermittent beep or a 'STOP' message when at least one among the detected measures is outside said specific range of values.
  • a process 140 to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue uses a device for medical use 100, according to the present invention, comprising an injector body without needle 104, at the distal or distal and rear end of which an ampule 101 is connected, containing a medicine to be injected.
  • the process 140 comprises the following steps:
  • the present invention reaches all the expected objectives.
  • it permits to achieve a device for medical use, comprising an injector without needle, said device being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue.
  • the injector without needle includes an electronic and mechanic control system monitoring the cutaneous tissue to which the same device is applied.
  • said electronic and mechanic control system is able to detect the exact value of pressure at the end of the device placed on the cutaneous tissue where it is applied, and can send a signal that informs the operator when the value of pressure is correct or not.
  • said electronic and mechanic control system is able to detect the exact value of electrical conductivity of the cutaneous tissue placed in touch with the end of the device, and can send a signal that informs the operator when the value of electrical conductivity is correct or not.
  • the electrical conductivity is associated to the type of tissue, for example of muscular type or adipose type.
  • said electronic and mechanic control system is able to detect, at the exact point of touch between the end of device and the cutaneous tissue where it is applied, other characteristic physical parameters, like in example humidity, temperature, glycemic index, pH, etc., that can inform the operator when the detected conditions are correct or not.
  • the signal informing the operator that the detected conditions are correct or not can be expressed as: a light of a LED element emitting green or red light; a continuous or intermittent sound of beep type; a message on a display of a word like 'GO' or 'STOP'; etc.
  • FIG 8 the components of a device are represented, according to an alternative embodiment of the present invention, comprising a pressure detector and a detector of electrical conductivity, where the pressure detector is place in the rear part of the injector body.
  • the same components are shown in Figure 9, being placed in their position on an injector body without needle and related ampule.

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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)

Abstract

Device for medical use (100) comprising an injector body without needle (104), at the distal or distal and rear end of which an ampule (101) is connected, containing a medicine to be injected, said device (100) being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue, and being characterized in that comprising: - a propulsor element, in example composed of a container in which a compressed gas is contained; said container being connected to a opening/closing mechanism of electric and/or mechanic type, activated by an operator, and able to eject said gas with high pressure towards said ampule (101), so that said medicine to be injected is ejected with high pressure inside the underskin tissue; - a pressure detector, composed of: a primary container (204), with said ampule (104) contained inside, where the distal end of said primary container (204) is protruding at its front part, and having a spring (205) connected at its rear part; a secondary container (206) with said primary container (204) and said spring (205) are contained inside, so that the pressure at the end of the primary container (204) causes a compression of the spring (205), and its displacement is detected by a position of a cursor on a measuring scale that is connected to a first electronic circuit; - an electrical conductivity detector, composed of: a first terminal, placed at the right border in the distal end of said primary container (204), and a second terminal, placed at the left border in the distal end of said primary container (204), so that applying a voltage between said first and second terminals a weak electric current is generated, the intensity of which is proportional to the type of tissue that is in touch with the device (100), and said intensity is detected by a second electronic circuit.

Description

INJECTIVE ADMINISTRATION SYSTEM BY USING A SYRINGE WITHOUT NEEDLE
The present invention essentially regards a device for medical use comprising an injector without needle, said device being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue. The injector without needle includes an electronic and mechanic control system monitoring the cutaneous tissue to which the same device is applied.
As known, in the state of the art injector devices without needle are widely used, and they are used especially to overcome the drawbacks of the syringe with needle. In fact, the penetration of skin with a needle is not without risk, especially in case that the person providing the injection is not an expert.
The side effects, in the person receiving the injection, can be of different type, like in example: pain, hematoma, formation of scar tissue, infection or abscess, transmission of infective diseases (in case the used needles are not of the single use type). All these problems are independent in respect to the type of medicine injected and are related exclusively to the effect of an injection with a needle.
Nowadays, the actual systems of injection without needle represent a resource available especially for the injection of vaccines for large number of people.
The high pressure ejected through the skin achieved, at the beginning, a good absorption of the substance to be injected, however after many injections, in example of insulin, some problems occurred like underskin lipodystrophy, and high quantity of medicines that caused absorption problems and pain during the same absorption. Then, the modern resources for the injection of insulin have shown their simple use, manegeability, low possibility of error and therefore a good quality of life.
One of the known systems is that called Penjel®, that represents a type of syringe without needle for the underskin injections of medicines and for some interventions of aesthetic surgery. It works in a simple way, similar to the mechanism of the air pressure toy guns. Once it has been loaded, the syringe is placed perpendicular to the skin, and then the device is activated. The high pressure vaporizes the medicine making it to pass through the skin, reaching the underskin layer in a short time, without any pain for the patient. This type of injection allows a uniform diffusion of the medicine, without causing local inflammations that sometimes happen by using standard syringes, and especially it avoids totally the risk of infections.
Penjet® belongs to the class of prefilled syringes without needle, for liquid and lyophilized medicines. It is a single use injector that is prefilled of a prefixed quantity of medicine. It can be injected quickly by a medical doctor or by the same patient.
Another of the known systems is that called Injex®, that represents a syringe without needle that, first avoids the diffuse fear of the injection, and then avoids the risk of transmission of infective diseases that can happen after an accidental contamination by injection. In fact, each year millions of accidental injuries by needles are reported.
This injector belongs to the latest generation, and can be applied in a safe and almost not painful way, increasing therefore the treatment of chronic patients.
Injex® ejects a thin high pressure jet of liquid going through the surface layers of skin. The pressure is generated by the energy of a spring, and it is sufficient to make the medicine to pass through reaching a depth that is comparable to that reached by a standard needle, providing therefore a good level of absorption. Among the other advantages given by this device, it should be remarked the avoided risk of injuries caused by failure of the needle, the impossibility of transmission of infections or virus arising from a mixed use, the decrease of the cost involved in the disposal process of the used materials, and the simplicity of use.
Another further known system is that called PowderJect®, that is composed of a combination of an injection device without needle and a medicine in the form of a powder, using therefore substance that is not liquid.
The system uses the energy given by a jet of helium gas in order to accelerate a fixed quantity of medicine powder at a very high speed, in order to pass through the cutaneous skin. The medicine should be prepared in a powder of dehydrated particles being in a specific range of sizes, or in an advanced formulation with inactive components that are necessary to dilute or stabilize the medicine for an optimal absorption. Therefore, this device defines precise characteristics of the substance to be injected.
The PowderJect® injection device is powered by a micro-cylinder filled of gas that has been properly designed, and uses a small container in order to supply the powder of medicine in the jet of gas. A capsule made of aluminium is filled of helium at a specific pressure and it is soldered by using a laser. The container of medicine and the housing parts are made of a plastic compatible with a medical use, using standard production processes.
In order to operate, the user places the device on the application site and pushes it on the skin so that a safety mechanism, that prevents a non-intentional or wrong activation of the device, is bypassed. As soon as it is pushed on the skin, the user pushes the activation button that breaks the capsule of gas. The compressed gas that is ejected breaks the container of medicine and injects immediately the medicine inside the tissue. After its use, the device is disposed away.
All the above systems of the prior art have some significant drawbacks, that are critical at the time when an injector without needle is used to make an injection in the underskin tissue. Two very critical aspects for this type of operations are the following: the correct adherence on pressure of the device end to the cutaneous tissue where it is applied; the correct placement of the device on the proper tissue for the specific type of injection and used medicine.
In example, in case of injections of insulin, this should be injected into the underskin adipose tissue, in order to achieve the expected effect, taking care of avoiding a penetration into the derma, muscle or even into the peritoneum.
Many studies have shown a difference in the absorption and duration of different insulins, when these are injected into the underskin fat and into the muscle. An intramuscular injection of insulin leads to a faster absorption and could cause unexpected hypoglycemia, that especially in case of very young children can lead to some very serious complications.
Therefore, it is specific objective of the present invention to propose a device for medical use, comprising an injector without needle, said device being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue. The injector without needle includes an electronic and mechanic control system monitoring the cutaneous tissue to which the same device is applied.
Another objective is that said electronic and mechanic control system is able to detect the exact value of pressure at the end of the device placed on the cutaneous tissue where it is applied, and can send a signal that informs the operator when the value of pressure is correct or not. A further objective is that said electronic and mechanic control system is able to detect the exact value of electrical conductivity of the cutaneous tissue placed in touch with the end of the device, and can send a signal that informs the operator when the value of electrical conductivity is correct or not. The electrical conductivity is associated to the type of tissue, for example of muscular type or adipose type.
Another further objective is that said electronic and mechanic control system is able to detect, at the exact point of touch between the end of device and the cutaneous tissue where it is applied, other characteristic physical parameters, like in example humidity, temperature, pH, etc., that can inform the operator when the detected conditions are correct or not.
Another further objective is that the system with rear spring can compensate any noise or any vibration caused from the switch of the spring or gas in the propulsor element, going to delete any noise.
Another objective is that the signal informing the operator that the detected conditions are correct or not, can be expressed as: a light of a LED element emitting green or red light; a continuous or intermittent sound of beep type; a message on a display of a word like 'GO' or 'STOP'; etc.
Therefore, it is specific subject of the present invention a device for medical use comprising an injector body without needle, at the distal or distal and rear end of which an ampule is connected, containing a medicine to be injected, said device being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue, and being characterized in that comprising:
- a propulsor element, in example composed of a container in which a compressed gas is contained; said container being connected to a opening/closing mechanism of electric and/or mechanic type, activated by an operator, and able to eject said gas with high pressure towards said ampule, so that said medicine to be injected is ejected with high pressure inside the underskin tissue;
a pressure detector, composed of: a primary container, with said ampule contained inside, where the distal end of said primary container is protruding at its front part, and having a spring connected at its rear part; a secondary container with said primary container and said spring are contained inside, so that the pressure at the end of the primary container causes a compression of the spring, and its displacement is detected by a position of a cursor on a measuring scale that is connected to a first electronic circuit;
- an electrical conductivity detector, composed of: a first terminal, placed at the right border in the distal end of said primary container, and a second terminal, placed at the left border in the distal end of said primary container, so that applying a voltage between said first and second terminals a weak electric current is generated, the intensity of which is proportional to the type of tissue that is in touch with the device, and said intensity is detected by a second electronic circuit.
The present invention is now being described according to non-limiting examples, with particular reference to the figures of the enclosed drawings, where:
Figure 1 is a lateral perspective view of a device for medical use, according to the prior art, comprising an injector body without needle;
Figure 2 is a schematic view of a device, according to the present invention, comprising a pressure detector and a detector of electrical conductivity, with respective LED element emitting green or red light, that informs the operator when the conditions for injection are correct or not;
Figure 3 is a lateral view of an injector body without needle, belonging to a device for medical used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue;
Figure 4 is a lateral view of an ampule to be connected at the front part of the injector body without needle of Figure 3, according to the prior art;
Figure 5 is a lateral view of an ampule to be connected at the front part of the injector body without needle of Figure 3, according to the present invention, comprising a pressure detector and a detector of electrical conductivity, with respective LED element emitting green or red light, that informs the operator when the conditions for injection are correct or not;
Figure 6 is a view of a block diagram that represents an electronic circuit for detection of pressure and electrical conductivity, and control of a respective LED element emitting green or red light;
Figure 7 is a view of a flow diagram describing how the electronic circuit of Figure 6 works, by enabling or not the injection, according to the measures of pressure and electrical conductivity being in the range of the proper values or not;
Figure 8 is a schematic view of the components of a device, according to an alternative embodiment of the present invention, comprising a pressure detector and a detector of electrical conductivity, where the pressure detector is place in the rear part of the injector body;
Figure 9 is a lateral view of a device, having the components according to the alternative embodiment of Figure 8, where the pressure detector is place in the rear part of the injector body.
It is underlined that only few of the many conceivable embodiments of the present invention are here described, which are just some specific non-limiting examples, having the possibility to describe many other embodiments based on the disclosed technical solutions of the present invention. In different figures, the same elements will be indicated with the same reference numbers.
Figure 1 shows a device for medical use 100, according to the prior art, comprising an injector body without needle 104, at the distal or distal and rear end of which an ampule 101 is connected, containing a medicine to be injected. Said device 100 being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue, and comprising a propulsor element, in example composed of a container in which a compressed gas is contained. Said container is connected to a opening/closing mechanism of electric and/or mechanic type, activated by an operator, and able to eject said gas with high pressure towards said ampule 101. In this way, said medicine to be injected is ejected with high pressure inside the underskin tissue.
The present invention, compared to the devices of the prior art, includes two innovative components, represented in Figure 2, that together permit to increase significantly the precision, safety and effectiveness of the injection of medicines using injectors without needle.
The first component is represented by a pressure detector, composed of: a primary container 204, with said ampule 104 contained inside, and a secondary container 206. The primary container 204 has a protruding front part and a spring 205 connected at its rear part. Said primary container 204 and said spring 205 are contained inside the secondary container 206.
In such a way, the pressure at the end of the primary container 204 causes a compression of the spring 205, and its displacement is detected by a position of a cursor on a measuring scale that is connected to a first electronic circuit.
The second component is represented by an electrical conductivity detector, composed of: a first terminal, placed at the right border in the distal end of said primary container 204, and a second terminal, placed at the left border in the distal end of said primary container 204. In such a way, by applying a voltage between said first and second terminals, a weak electric current is generated. The intensity of this current is proportional to the type of tissue that is in touch with the device 100, and said intensity is detected by a second electronic circuit.
Figures 3 and 4 show an injector body without needle 210, belonging to a device for medical use, according to the prior art, being used to apply a desensitization and immunostimulant therapy to an underskin tissue, and an ampule 220 to be connected to the front part of the same injector body without needle 210.
Instead, in Figure 5 it is represented an ampule 230 to be connected to the front part of injector body without needle 210, according to the present invention, comprising a pressure detector 201 , 202 and a detector of electrical conductivity 203, with respective LED element 209 emitting green 207 or red light 208, that informs the operator when the conditions for injection are correct or not.
With reference to Figure 6, said first and second electronic circuit are integrated in a single electronic board 70 comprising: sensors of pressure and sensors of electrical conductivity 71 , internal communication lines 80, a local memory 72, a control software 75, a LED element 77 emitting green or red light, a microprocessor 74, external communication lines 78, 79 from/to external peripherals. In such a way, the microprocessor 74 can provide the acquisition of pressure and electrical conductivity, and can generate a first signal that informs the operator when the value of pressure is correct or not, and a second signal that informs the operator when the value of electrical conductivity is correct or not. The electrical conductivity is associated to the type of tissue, for example of muscular type or adipose type.
Said first and second signal, that inform the operator when the value of pressure and electrical conductivity are correct or not, are electric signals directed from said microprocessor 74 to said LED element 77.
Said signals activate the green light when both the measures of pressure and electrical conductivity are within a specific range of values, instead they activate the red light when at least among the measures of pressure and electric conductivity are outside said specific range of values.
According to a further embodiment of the present invention, the device for injection of medicines without needle can comprise, in addition or as an alternative, a detector of other physical parameters, composed in example of: a detector of humidity, of temperature, of pH, etc., that can acquire respective measures and generates signals that inform the operator when the detected values of the physical parameters are correct or not.
According to another embodiment of the present invention, the device for injection of medicines without needle can comprise, as an alternative to said LED 77 element emitting a green or a red light, an element that generates a continuous or intermittent sound of beep type; or an element that generates a message on a display of a word like 'GO' or 'STOP'; etc.
In such a way, said signals that inform the operator when the values of the physical parameters are correct or not, are electric signals directed from said microprocessor 74 to a generator of sound or a visual display. Said signals activate respectively a continuous beep or a 'GO' message when all the measures of the physical parameters are within a specific range of values, instead they activate an intermittent beep or a 'STOP' message when at least one among the detected measures is outside said specific range of values.
With reference to Figure 7, it is shown a process 140 to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue. The process 140 uses a device for medical use 100, according to the present invention, comprising an injector body without needle 104, at the distal or distal and rear end of which an ampule 101 is connected, containing a medicine to be injected.
The process 140 comprises the following steps:
- installing the distal end of the injector body without needle 104 with the respective ampule 101 inserted, on touch with the cutaneous tissue to be injected;
- detecting the value of pressure at the point of contact between said distal end of the injector body without needle 104 and the cutaneous tissue to be injected, and comparing the value of pressure 141 with a range of acceptable values;
if the value of pressure is within said range of acceptable values then continue at the next step, otherwise activate the red light 142, keep the device locked and return to the first step;
detecting the value of electrical conductivity at the point of contact between said distal end of the injector body without needle 104 and the cutaneous tissue to be injected, and comparing the value of electrical conductivity 143 with a range of acceptable values;
if the value of electrical conductivity is within said range of acceptable values then continue at the next step, otherwise activate the red light 142, keep the device locked and return to the first step;
- activate the green light and unlock the device 145, enable the mechanism of injection 144.
Therefore, the above examples show that the present invention reaches all the expected objectives. In particular, it permits to achieve a device for medical use, comprising an injector without needle, said device being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue. The injector without needle includes an electronic and mechanic control system monitoring the cutaneous tissue to which the same device is applied.
Furthermore, said electronic and mechanic control system is able to detect the exact value of pressure at the end of the device placed on the cutaneous tissue where it is applied, and can send a signal that informs the operator when the value of pressure is correct or not.
Furthermore, said electronic and mechanic control system is able to detect the exact value of electrical conductivity of the cutaneous tissue placed in touch with the end of the device, and can send a signal that informs the operator when the value of electrical conductivity is correct or not. The electrical conductivity is associated to the type of tissue, for example of muscular type or adipose type.
Then, according to the invention, said electronic and mechanic control system is able to detect, at the exact point of touch between the end of device and the cutaneous tissue where it is applied, other characteristic physical parameters, like in example humidity, temperature, glycemic index, pH, etc., that can inform the operator when the detected conditions are correct or not.
Finally, the signal informing the operator that the detected conditions are correct or not, can be expressed as: a light of a LED element emitting green or red light; a continuous or intermittent sound of beep type; a message on a display of a word like 'GO' or 'STOP'; etc.
In Figure 8 the components of a device are represented, according to an alternative embodiment of the present invention, comprising a pressure detector and a detector of electrical conductivity, where the pressure detector is place in the rear part of the injector body. The same components are shown in Figure 9, being placed in their position on an injector body without needle and related ampule.
The present invention has been described by making reference to some non- limiting examples and following some preferred embodiments; however it goes without saying that modifications and/or changes could be introduced by those skilled in the art without departing from the relevant scope, as defined in the enclosed claims.

Claims

1. Device for medical use (100) comprising an injector body without needle (104), at the distal or distal and rear end of which an ampule (101) is connected, containing a medicine to be injected, said device (100) being used to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue, and being characterized in that comprising:
a propulsor element, in example composed of a container in which a compressed gas or a spring is contained; said container being connected to a opening/closing mechanism of electric and/or mechanic type, activated by an operator, and able to eject said gas with high pressure towards said ampule (101), so that said medicine to be injected is ejected with high pressure inside the underskin tissue;
a pressure detector, composed of: a primary container (204), with said ampule (104) contained inside, where the distal end of said primary container (204) is protruding at its front part, and having a spring (205) connected at its rear part; a secondary container (206) with said primary container (204) and said spring (205) are contained inside, so that the pressure at the end of the primary container (204) causes a compression of the spring (205), and its displacement is detected by a position of a cursor on a measuring scale that is connected to a first electronic circuit;
an electrical conductivity detector, composed of: a first terminal, placed at the right border in the distal end of said primary container (204), and a second terminal, placed at the left border in the distal end of said primary container (204), so that applying a voltage between said first and second terminals a weak electric current is generated, the intensity of which is proportional to the type of tissue that is in touch with the device (100), and said intensity is detected by a second electronic circuit.
2. Device for medical use (100) comprising an injector body without needle (104), at the distal or distal and rear end of which an ampule (101) is connected, containing a medicine to be injected, according to previous claim 1 , characterized in that:
- said first and second electronic circuit are integrated in a single electronic board (70) comprising: sensors of pressure and sensors of electrical conductivity (71), internal communication lines (80), a local memory (72), a control software (75), a LED element (77) emitting green or red light, a microprocessor (74), external communication lines (78, 79) from/to external peripherals,
so that the microprocessor (74) can provide the acquisition of pressure and electrical conductivity, and can generate a first signal that informs the operator when the value of pressure is correct or not, and a second signal that informs the operator when the value of electrical conductivity is correct or not, the electrical conductivity being associated to the type of tissue, for example of muscular type or adipose type.
3. Device for medical use (100) comprising an injector body without needle (104), at the distal or distal and rear end of which an ampule (101) is connected, containing a medicine to be injected, according to previous claim 2, characterized in that:
- said first and second signal, that inform the operator when the value of pressure and electrical conductivity are correct or not, are electric signals directed from said microprocessor (74) to said LED element (77); said signals activate the green light when both the measures of pressure and electrical conductivity are within a specific range of values, instead they activate the red light when at least among the measures of pressure and electric conductivity are outside said specific range of values.
4. Device for medical use (100) comprising an injector body without needle (104), at the distal or distal and rear end of which an ampule (101) is connected, containing a medicine to be injected, according to one or more of previous claims, characterized in that further comprising, in addition or as an alternative: - a detector of physical parameters, composed in example of: a detector of humidity, of temperature, of pH, etc., that can acquire respective measures and generates signals that inform the operator when the detected values of the physical parameters are correct or not.
5. Device for medical use (100) comprising an injector body without needle (104), at the distal or distal and rear end of which an ampule (101) is connected, containing a medicine to be injected, according to the previous claim, characterized in that comprising, as an alternative to said LED (77) element emitting a green or a red light: an element that generates a continuous or intermittent sound of beep type; or an element that generates a message on a display of a word like 'GO' or 'STOP'; etc. so that said signals, that inform the operator when the values of the physical parameters are correct or not, are electric signals directed from said microprocessor (74) to a generator of sound or a visual display; said signals activating respectively a continuous beep or a 'GO' message when all the measures of the physical parameters are within a specific range of values, instead they activate an intermittent beep or a 'STOP' message when at least one among the detected measures is outside said specific range of values.
6. Process (140) to apply a desensitization and/or immunostimulant or any other type of medicine therapy to an underskin tissue, using a device for medical use (100) comprising an injector body without needle (104), at the distal or distal and rear end of which an ampule (101) is connected, containing a medicine to be injected, as specified in previous claim 1 , characterized in that comprising the following steps:
- installing the distal end of the injector body without needle (104) with the respective ampule (101) inserted, on touch with the cutaneous tissue to be injected; - detecting the value of pressure at the point of contact between said distal end of the injector body without needle (104) and the cutaneous tissue to be injected, and comparing the value of pressure (141) with a range of acceptable values;
- if the value of pressure is within said range of acceptable values then continue at the next step, otherwise activate the red light (142), keep the device locked and return to the first step;
- detecting the value of electrical conductivity at the point of contact between said distal end of the injector body without needle (104) and the cutaneous tissue to be injected, and comparing the value of electrical conductivity (143) with a range of acceptable values;
- if the value of electrical conductivity is within said range of acceptable values then continue at the next step, otherwise activate the red light (142), keep the device locked and return to the first step;
- activate the green light and unlock the device (145), enable the mechanism of injection (144).
PCT/IT2016/000123 2016-05-11 2016-05-11 Injective administration system by using a syringe without needle WO2017195226A1 (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020008483A1 (en) 2018-07-05 2020-01-09 MEDIFORM ITALIA S.r.l. Injective administration system by using a syringe without needle that is guided by echography and related process of injection of medicines and immunostimulants by intralymphatic way

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19849301A1 (en) * 1998-10-16 2000-04-20 Ksw Systemtechnik Gmbh Injection process, especially for injecting patients with insulin, involves using a needleless pressure jet, where the pressure and injection signal are controlled based on skin electrical resistance.
US6156008A (en) * 1998-05-04 2000-12-05 Castellano; Thomas P. Device for avoiding subdermal hematomas from an injection
WO2006086774A2 (en) * 2005-02-11 2006-08-17 Massachusetts Institute Of Technology Needle-free transdermal transport device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6156008A (en) * 1998-05-04 2000-12-05 Castellano; Thomas P. Device for avoiding subdermal hematomas from an injection
DE19849301A1 (en) * 1998-10-16 2000-04-20 Ksw Systemtechnik Gmbh Injection process, especially for injecting patients with insulin, involves using a needleless pressure jet, where the pressure and injection signal are controlled based on skin electrical resistance.
WO2006086774A2 (en) * 2005-02-11 2006-08-17 Massachusetts Institute Of Technology Needle-free transdermal transport device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020008483A1 (en) 2018-07-05 2020-01-09 MEDIFORM ITALIA S.r.l. Injective administration system by using a syringe without needle that is guided by echography and related process of injection of medicines and immunostimulants by intralymphatic way

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