WO2020008483A1

WO2020008483A1 - 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

Info

Publication number: WO2020008483A1
Application number: PCT/IT2018/000094
Authority: WO
Inventors: Mario Mancini
Original assignee: MEDIFORM ITALIA S.r.l.
Priority date: 2018-07-05
Filing date: 2018-07-05
Publication date: 2020-01-09

Abstract

Injection device (100) without needle that is guided by echography, comprising an injector body (104), at the distal end of which an ampule (101) is connected, containing a medicine to be injected into an underskin tissue (205) of a patient, in particular to a lymph node (206), comprising: - a propulsor element, in example composed of a container in which a compressed gas is contained; said container being connected to a button (207) of a opening/closing mechanism, activated by an operator, and able to eject said gas with high pressure towards said ampule (101), so that said medicine is injected with high pressure inside the underskin tissue, in particular to said lymph node (206), characterized in that further comprising: - an echographic system having circular detection means, composed of: a container (204), with said ampule (101) contained inside, where the distal end of said container (204) is protruding at the front part of the injection device (100); a circular probe (203), placed at the front part of said container (204), that transmits and receives an ultrasound signal; an electronic system managing said probe (203), generating the transmission of an impulse, receiving an echo back and processing the received signal; a wireless data transmission system; and an image visualization system available to said operator; - a dynamic rotary mechanism, composed of mechanical means able to make said ampule (101) to rotate in respect to the longitudinal axis during the positioning in the skin, to increase therefore the adhesion of its end to the surface of the skin (202) of the patient and to decrease the risk of the medicine to go out and be lost laterally on the surrounding skin area; - a positioning detector, composed of: a sensor of pressure, a sensor of inclination, a sensor of end run in respect to said rotary mechanism, all placed in said container (204); and an electronic system that manages all said sensors of pressure, inclination, and end run, generates the respective control signals, receives and processes data related to the physical measures detected, and generates the control signal addressed to external devices, i.e. LEDs (201), supporting the activities of said operator, so that the echographic system is able to detect and visualize the underskin anatomical structures, and the positioning detector permits to achieve and maintain the optimal conditions of use, related to device (100), in touch with the surface of skin (202) of the patient.

Description

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.

The present invention essentially regards a medical device represent by a injection device without needle. It comprises an injector body, at the distal end of which an ampule is connected, containing a medicine to be injected into an underskin tissue of a patient, in particular to a lymph node.

The injecting device withou needle comprises an echographic system having circular detection means, able to detect and visualize the underskin anatomical structures, and comprises a positioning detector that permits to achieve and maintain the optimal conditions of use, related to the same device in touch with the surface of the patient's skin.

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.

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 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, up to reach the underskin layer in a short time, without any pain for the patient.

The Penjet® system 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 known system is that called Injex®, that 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 to 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 deleted risk of injuries due to the 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 PowderJecl ®, that is composed of a combination of an inection device without needle and a medicine in the form of a powder, using therefore a not liquid substance.

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 requires precise characteristics of the substance to be injected.

In order to operate, the user places the device on the application site and pushes an activation button that breaks the capsule of gas on one side. 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.

In the international application WO/2017/195226 the technical problems have been studied and solved of a correct adhesion between the device front end and the surface skin, and of a correct location of the device on a proper type of tissue related to the type of injection and medicine to be injected. In fact, the device that has been there disclosed comprises an electronic and mechanic control system able to detect the exact value of pressure at the front end of the device when placed on the cutaneous tissue, and comprises an electronic and mechanic control system able to detect the proper value of electrical conductivity of the cutaneous tissue in touch with the device.

One of the current uses of the injector without needle is the injection of allergenic vaccines. Recently it has been demonstrated that, by injection of an allergene directly in a lymph node, it is achieved a significant decrease of the side effects and necessary dosing.

However, one of the main drawbacks of the existing devices is that they are not able to support this type of injections, because the operator cannot have a proper visualization or exact perception of the lymph node location.

Furthermore, another unsolved technical problem is to guarantee a constant pressure all during the medicine injection, by having all during the time a proper adhesion of the device to the surface skin.

Therefore, the pressure should be kept constant and the operator should not make any small movements or inclinations that could cause the medicine to go out and be lost on the surrounding skin area.

Therefore, it is specific objective of the present invention to propose an injection device without needle that is guided by echography, comprising an injector body, at the distal end of which an ampule is connected, containing a medicine to be injected into an underskin tissue of a patient, in particular to a lymph node, and at the same time the device being able to supervise that a contact pressure would be kept constant all during the injection operation.

Another objective is that the injection device comprises an echographic system having circular detection means, able to detect and visualize the underskin anatomical structures, and comprising a positioning detector that permits to achieve and maintain the optimal conditions of use, related to the same device in touch with the surface of the patient's skin.

Another further objective is that the injection device comprises a sensore of pressure, a sensor of inclination, and a sensor of end run of a rotary mechanism; the rotary mechanism being able to make said ampule to rotate in respect to the longitudinaie axis, and to increase therefore the adhesion of its front end to the surface of the patient's skin.

Another further objective is that the signal informing the operator that the conditions detected by the positioning detector 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 an injection device without needle that is guided by echography, comprising an injector body, at the distal end of which an ampule is connected, containing a medicine to be injected into an underskin tissue of a patient, in particular to a lymph node, comprising:

- a propulsor element, in example composed of a container in which a compressed gas is contained; said container being connected to a button of a opening/closing mechanism, activated by an operator, and able to eject said gas with high pressure towards said ampule, so that said medicine is injected with high pressure inside the underskin tissue, in particular to said lymph node,

characterized in that further comprising: - an echographic system having circular detection means, composed of: a container, with said ampule contained inside, where the distal end of said container is protruding at the front part of the injection device; a circular probe, placed at the front part of said container, that transmits and receives an ultrasound signal; an electronic system managing said probe, generating the transmission of an impulse, receiving an echo back and processing the received signal; a wireless data transmission system; and an image visualization system available to said operator;

- a dynamic rotary mechanism, composed of mechanical means able to make said ampule to rotate in respect to the longitudinal axis during the positioning in the skin, to increase therefore the adhesion of its end to the surface of the skin of the patient and to decrease the risk of the medicine to go out and be lost laterally on the surrounding skin area;

- a positioning detector, composed of: a sensor of pressure, a sensor of inclination, a sensor of end run in respect to said rotary mechanism, all placed in said container; and an electronic system that manages all said sensors of pressure, inclination, and end run, generates the respective control signals, receives and processes data related to the physical measures detected, and generates the control signal addressed to external devices, i.e. LEDs, supporting the activities of said operator,

so that the echographic system is able to detect and visualize the underskin anatomical structures, and the positioning detector permits to achieve and maintain the optimal conditions of use, related to device in touch with the surface of skin of the patient.

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 perspective view of an injection device without needle, according to the present invention, orientated laterally and placed on a plan, having an ampule filled by medicine taken apart;

Figure 2 is a lateral view of the main body of the same injection device without needle of Figure 1 , without the ampule;

Figure 3 is a front perspective view of the same injection device without needle of Figure 1 , without the ampule;

Figure 4 is a rear perspective view of the same injection device without needle of Figure 1 , where the ampule has been installed, ready to inject a medicine within the underskin tissue of a patient;

Figure 5 is a front perspective view of the same injection device without needle of Figure 1 , where the ampule has been installed; Figure 6 is a lateral view of the same injection device without needle of Figure 5, where the ampule has been installed, during the motion of pushing a gas contained inside;

Figure 7 is a view of two images representing a lymph node, inside the underskin tissue of a patient, detected by echography;

Figure 8 is a schematic view of the main components of the injection device without needle guided by echography of the present invention;

Figure 9 is a view of a block diagram that represents an electronic circuit for detection of pressure, inclination and end run in a rotary mechanism, and controlling a LED element having green light or red light;

Figure 10 is a view of a flow diagram representing the funtions of the electronic circuit of Figure 9, that enables or not the injection, according to the detected values of pressure, inclination and end run in a rotary mechanism, respectively being in a proper range or not.

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.

Figures 1, 2 and 3 show an medical device 100 comprising an injector body 104 without needle, at the distal end of which an ampule 101 is connected, containing a medicine to be injected into an underskin tissue 205 of a patient. Figure 5 shows more in particular as the ampule 101 is screwed to the front part of the injector body 104.

The device 100 includes a propulsor element that is composed, in example, of a container (not represented in figure) in which a compressed gas is contained. In order to achieve a compression of said gas, there can be installed, in example, a loading mechanism, as that shown in Figure 6, that makes the handle to rotate (following the arrow), pushing automatically the gas inside the container. The same container is connected to a button 207 of a opening/closing mechanism, activated by an operator, and able to eject said gas with high pressure towards said ampule 101. In such a way, as shown in Figure 4, said medicine is injected with high pressure inside the underskin tissue 205 of the patient.

The present invention, in respect to devices of the prior art, comprises some additional components that achieve to increase significantly the precision and effectiveness of the medicine injections using devices without needle.

The first component of the injection device 100 without needle is represented by an echographic system having circular detection means, and further composed of: a container 204, with said ampule 101 contained inside, where the distal end of said container 204 is protruding at the front part of the injection device 100; a circular probe 203, placed at the front part of said container 204, that transmits and receives an ultrasound signal; an electronic system managing said probe 203, generating the transmission of an impulse, receiving an echo back and processing the received signal; a wireless data transmission system; and an image visualization system available to said operator.

In such a way, the echographic system having circular detection means, permits to detect and visualize the underskin anatomical structures, and the operator can easily detect a lymph node, and can provide the medicine injection inside of it. The images of Figure 7 show an example of a lymph node 206, placed inside the underskin tissue of a patient, as visualized by an echographic system.

The second component of the injection device 100 without needle is represented by a rotary mechanism, composed of mechanical means able to make said ampule 101 to rotate in respect to the longitudinal axis, and increase therefore the adhesion of its end to the surface of the skin 202 of the patient.

The third component of the injection device 100 without needle is represented by a positioning detector, composed of: a sensor of pressure, a sensor of inclination, a sensor of end run in respect to said rotary mechanism, all placed in said container 204; and an electronic system that manages all said sensors of pressure, inclination, and end run, generates the respective control signals, receives and processes data related to the physical measures detected, and generates the control signal addressed to external devices, i.e. LEDs 201 , supporting the activities of said operator.

In such a way, the positioning detector permits to achieve and maintain the optimal conditions of use, related to device 100, with reference to pressure expressed by the operator, inclination in respect to the skin surface, and touch with the surface of the skin 202 of the patient.

Figure 8 shows a block diagram of the main components of the injection device without needle 100 of the present invention.

In particular, the components being in touch with the patient's skin 301 are: the sensors 302 (of pressure, inclination and end run), the syringe 305 (or ampule, as being defined previously); the circular probe 308 of the echographic system.

The signals coming from the sensors 302 are processed by an electronic system 303, and activate the light of LEDs 304 with green light or red light, according to the detection or not of the optimal use conditions (of pressure, inclination and end run). At the same time, the signals coming from the circular probe 308 are processed by an electronic system 309, and transmitted to a display 310, so that the underskin anatomical structures of the patient are visualized.

The operator 307, according to the detection of the optimal use conditions visualized by LEDs 304 (green light / red light), and according to the detected anatomical structures visualized on screen 310 ( lymph node), could decide at the right time to activate the injection device 306 in order to provide an injection of medicin into the underskin tissue of the patient.

With reference to Figure 9, the general electronic system, that permits the device to work, is composed of: an electronic board 70 further comprising: sensors of pressure, inclination and end run 71, internal communication lines 80, a local memory 72, a control software 75, a LED element 77 emitting a green or a 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, inclination and end run, and can generate a signal that informs the operator when the values of pressure, inclination and end run 71 are correct or not.

Said signal, that informs the operator when the of pressure, inclination and end run are correct or not, is an electric signal directed from said microprocessor 74 to said LED element 77. The signal activates the green light when all the measures of pressure, inclination and end run are within a respective predefined range of values, instead it activates the red light when at least one among the measures of pressure, inclination and end run results to be outside of said respective predefined range of values.

According to an alternative embodiment of the present invention, the injection device 100 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, the signal that informs the operator when the values of the physical parameters are correct or not, can be an electric signal directed from said microprocessor 74 to a generator of sound or a visual display. Said signal activates respectively a continuous beep or a 'GO' message when all the measures of the physical parameters are within a respective predefined range of values, instead it activates an intermittent beep or a 'STOP' message when at least one among the detected measures is outside said respective predefined range of values. With reference to Figure 10, it is shown a process 140 for injection of a medicine to an underskin tissue 205 of a patient, in particular to a lymph node 206, using an injection device 100 without needle that is guided by echography.

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 202 of the patient;

- activating the mechanism of rotation 148, able to make said ampule 101 to rotate, i.e. of 90 degrees in respect to the longitudinal axis, until the signal of end run has been detected;

- 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 to the next step, otherwise activate the red light 142, keep the device locked and return to the first step;

- detecting the value of inclination 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 inclination 143 with a range of acceptable values;

- if the value of inclination is within said range of acceptable values then continue to 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 an injection device without needle that is guided by echography, comprising an injector body, at the distal end of which an ampule is connected, containing a medicine to be injected into an underskin tissue of a patient, in particular to a lymph node, and at the same time the device being able to supervise that a contact pressure would be kept constant all during the injection operation.

Furthermore, the injection device comprises an echographic system having circular detection means, able to detect and visualize the underskin anatomical structures, and comprises a positioning detector that permits to achieve and maintain the optimal conditions of use, related to the same device in touch with the surface of the patient's skin. Further according to the invention, the injection device comprises a sensore of pressure, a sensor of inclination, and a sensor of end run of a rotary mechanism; the rotary mechanism being able to make said ampule to rotate in respect to the longitudinale axis, and to increase therefore the adhesion of its front end to the surface of the patient's skin.

Finally, according to the invention, the signal informing the operator that the conditions detected by the positioning detector 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.

The present invention has been described by making reference to some nonlimiting 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. Injection device (100) without needle that is guided by echography, comprising an injector body (104), at the distal end of which an ampule (101) is connected, containing a medicine to be injected into an underskin tissue (205) of a patient, in particular to a lymph node (206), comprising:

- a propulsor element, in example composed of a container in which a compressed gas is contained; said container being connected to a button (207) of a opening/closing mechanism, activated by an operator, and able to eject said gas with high pressure towards said ampule (101), so that said medicine is injected with high pressure inside the underskin tissue, in particular to said lymph node (206),

characterized in that further comprising:

- an echographic system having circular detection means, composed of: a container (204), with said ampule (101) contained inside, where the distal end of said container (204) is protruding at the front part of the injection device (100); a circular probe (203), placed at the front part of said container (204), that transmits and receives an ultrasound signal; an electronic system managing said probe (203), generating the transmission of an impulse, receiving an echo back and processing the received signal; a wireless data transmission system; and an image visualization system available to said operator;

- a dynamic rotary mechanism, composed of mechanical means able to make said ampule (101) to rotate in respect to the longitudinal axis during the positioning in the skin, to increase therefore the adhesion of its end to the surface of the skin (202) of the patient and to decrease the risk of the medicine to go out and be lost laterally on the surrounding skin area;

- a positioning detector, composed of: a sensor of pressure, a sensor of inclination, a sensor of end run in respect to said rotary mechanism, all placed in said container (204); and an electronic system that manages all said sensors of pressure, inclination, and end run, generates the respective control signals, receives and processes data related to the physical measures detected, and generates the control signal addressed to external devices, i.e. LEDs (201), supporting the activities of said operator,

so that the echographic system is able to detect and visualize the underskin anatomical structures, and the positioning detector permits to achieve and maintain the optimal conditions of use, related to device (100), in touch with the surface of skin (202) of the patient.

2. Injection device (100) without needle that is guided by echography, comprising an injector body (104), at the distal end of which an ampule (101) is connected, containing a medicine to be injected, according to previous claim 1 , characterized in that:

- said electronic circuit is given by an electronic board (70) comprising: sensors of pressure, inclination and end run (71), internal communication lines (80), a local memory (72), a control software (75), a LED element (77) emitting a green or a 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, inclination and end run, and can generate a signal that informs the operator when the values of pressure, inclination and end run (71) are correct or not.

3. Injection device (100) without needle that is guided by echography, comprising an injector body (104), at the distal end of which an ampule (101) is connected, containing a medicine to be injected, according to previous claim 2, characterized in that:

said signal, that informs the operator when the of pressure, inclination and end run are correct or not, is an electric signal directed from said microprocessor (74) to said LED element (77); said signal activates the green light when all the measures of pressure, inclination and end run are within a respective predefined range of values, instead it activates the red light when at least one among the measures of pressure, inclination and end run results to be outside of said respective predefined range of values.

4. Injection device (100) without needle that is guided by echography, comprising an injector body (104), at the distal 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, 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 signal, that informs the operator when the values of the physical parameters are correct or not, is an electric signal directed from said microprocessor (74) to a generator of sound or a visual display, said signal activating respectively a continuous beep or a 'GO' message when all the measures of the physical parameters are within a respective predefined range of values, instead it activates an intermittent beep or a 'STOP' message when at least one among the detected measures is outside said respective predefined range of values.

5. Process (140) for injection of a medicine to an underskin tissue (205) of a patient, in particular to a lymph node (206), using an injection device (100) without needle that is guided by echography, as that 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 (202) of the patient;

- activating the mechanism of rotation (148), able to make said ampule (101) to rotate, i.e. of 90 degrees in respect to the longitudinal axis, until the signal of end run has been detected;

- 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 to the next step, otherwise activate the red light (142), keep the device locked and return to the first step;

- detecting the value of inclination 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 inclination (143) with a range of acceptable values;

- if the value of inclination is within said range of acceptable values then continue to 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