The present invention belongs to the field of biomedical devices for improving drug administration operations, in particular chemotherapeutic drug administration.
The present invention belongs to the technical sector of local and systemic treatment in the case of neoplastic pathologies; in particular the present invention applies to the treatment of solid metastases in human oncology and veterinary oncology.
More specifically, the present invention relates to a device and a kit for chemotherapeutic drug inoculation which conveys and draws up the toxic aerosol released by such drugs so as to limit its spreading in the environment; the present invention also discloses a method for using said device and kit for drawing up said toxic aerosol.
Drugs potentially releasing toxic aerosols include, amongst others, chemotherapeutic drugs, which are very toxic substances having a mutagenic potential, whose administration takes place according to appropriate modes.
A variety of medical devices are known in the present status of the art, which are used to protect the operator's body from getting in contact with said toxic drugs; said devices are often devices applied onto operators' bodies in the form of masks, caps, gloves, and glasses and/or peaks; however, said devices, even though protecting operators, do not prevent aerosol from spreading in the environment. Other devices, such as extractor hoods, can only be used upon preparing drugs, i.e. while drawing up a drug in a syringe, whereas they cannot be used in the inoculation steps, other devices, such as surgical aspirators, are only used during the drug inoculation step.
Other medical devices are also known, such as Tevadaptor, applicable to the end portion of syringes in order to capture the toxic substances released upon handling said drugs; however, none of these devices allows for an administration that is completely safe for operators, patients, and the surrounding environment, especially in the case of intra-tumoral inoculation.
No devices are known in the present status of the art that minimize toxic aerosol nebulization of anti-tumoral drugs, especially in those protocols which specify an intra-tumoral injection, such as in the case of electrochemotherapy protocols.
Let's mention here below some patent documents known in the present status of the art.
Patent document CN 105617489 A discloses a device for multifunctional tumor injection. Thanks to the use of a puncture device, a controller, a pipe and a pusher, the functions of use of this multifunctional injector are enhanced, the quantity of drugs to inject is accurately measured, and injection is safe, reliable, convenient and fast to operate and makes application easier.
Patent document EP 2886146 A1 discloses a needle safety device for a drug delivery device comprising a needle cap remover suitable for capturing a needle cap by way of a positive and/or non-positive connection, wherein the cap remover comprises a top end, a shield adapted to cover a needle of the drug delivery device before and after injection, wherein the needle shield comprises a shielding end adapted to engage an injection site and at least one blocking pin which inwardly extends from the top end and/or the needle shield end into the needle cap remover and/or into the needle shield. Therefore, a need arises from the present status of the art for an innovative device that allows to convey all the toxic aerosol released by a drug, in particular a chemotherapeutic drug, toward a sucking device, while making it possible for it to be used in all steps related to handling a drug that potentially releases a toxic aerosol, such as a chemotherapeutic drug, that is to say both during the drug preparation step and during the local inoculation of said drugs, thus minimizing the risk for contaminating the environment and operators.
In particular, a need arises for a device and kit that conveys and draws up the toxic aerosol that might possibly be released from any component parts of a syringe.
In the context of this disclosure, the terms distal and proximal are defined from the viewpoint of a person who makes an injection. Consequently, a distal direction is a direction that points toward the patient's body that receives an injection, and a distal end is an end of an element that is directed toward that patient's body. A proximal end of an element or proximal direction is directed far away from the patient's body that receives an injection and opposite to the distal end or the distal direction, respectively.
The invention discloses a device for conveying the toxic aerosol released by a drug contained in a vial or a syringe toward a suction device; said drug is generally a chemotherapeutic drug.
Further characteristics and advantages of the invention will be more apparent in the light of a detailed description of some preferred, but not exclusive, embodiments of the device and the kit used for sucking a toxic aerosol from a drug and conveying it toward a sucking device, and a method for their use, as illustrated, for explanatory non limitative purposes, with reference to the attached figures, wherein:
Other advantages, characteristics, and modes of use of the device according to the present invention will be apparent from the following detailed description of an embodiment, which is given for explanatory non-limitative purposes, and with a special reference to the attached figures, wherein:
The device 1 according to this invention is a device and kit 100 for inoculation of drugs potentially releasing a toxic aerosol in the environment, such as chemotherapeutic drugs; the device according to this invention is a medical device configured for accommodating a syringe and for limiting the spreading of toxic aerosol in the environment while handling a toxic drug, i.e. both in the inoculation step and in the drug preparation step before inoculation, such as, for instance, drawing up a drug from a vial.
In particular, the device according to this invention is a device for conveying, toward a suction pipe, a toxic aerosol released and delimited by the device itself.
The device according to this invention comprises two embodiments having a cylindrical hollow element 2, which represents a sheath for containing a syringe, in common; the cap used for covering the needle features two different configurations, one of which is compressible and consequently usable for inoculating a toxic drug contained in a syringe (S), and another is used for taking a drug from a vial (F).
Said device 1 for conveying a toxic aerosol from a drug contained in a syringe (S) or in a vial (F) toward a suction pipe comprises a cylindrical hollow element comprising an inner space configured for accommodating a syringe, so that the inner walls of said space slidingly adhere to the outer walls of the syringe barrel, provided with a proximal end 2.10 which includes an opening 2.6 configured in such a way as to allow for the insertion of a syringe barrel, and a flange configured for accommodating a syringe flange, and a distal end 2.11 which includes an opening 2.7 configured in such a way as to allow the cone, fitting, and needle of said syringe to pass through, and a cap configured for being connected to said cylindrical hollow element.
Said device 1 is characterized in that it comprises:
Said device is thus configured in such a way as to convey all the toxic aerosol that might be released from any component parts of a syringe toward a suction device, i.e. both in the case of any leakages of micro-drips of drug or its aerosol, if any, from a syringe needle tip, and in the case of a drug or its aerosol getting out from its connection to the cone, or both in the case of a drug or its aerosol getting out from the inoculation point immediately after inoculation, and a drug or its aerosol getting out from a vial immediately after taking the drug.
In a first configuration of the invention, said cap 3 includes a second portion 5 whose outer surface 5.1 is folded on itself like an accordion, so as to be expandable and compressible; in this configuration, said second portion 5 is made from a soft material, preferably a silicone material, so as to foster the movement of the device upon inoculation; more preferably, said silicone material will be transparent so as to allow for an operator to clearly see the inoculation point and adjust the position of a syringe needle accordingly.
Said cap 3 is configured so that, upon inoculation, it adheres with its edge 5.2 to the surface to be treated thus delimiting a closed space 70; this allows to prevent toxic aerosol from getting out.
The silicone protection 5 makes thus it possible to form a closed area 70 around the inoculation site, which allows, first of all, to prevent a harmful aerosol released by a drug, generally an antitumoral drug, from being spread in the environment; said aerosol will subsequently be conveyed, by way of the grooves 20.1 and 40.1, toward the opening 2.9 in order for it to be conveyed toward a suction pipe.
Said cap 3 is also configured so that subsequently, while inoculation is in progress, varies its own configuration, in that it passes from an expansion status wherein a syringe needle accommodated inside said cylindrical hollow element 2 is internal to said space 70, to a compression status wherein the syringe needle gets out beyond the edge 5.2 of said cap 3, following the movements of the syringe, hence of the cylindrical hollow element 2, toward the patient's body upon drug inoculation.
The silicone protection described with reference to the second portion 5 makes thus it possible to form a closed area, around the inoculation site, internally to which the released toxic aerosol is limited and conveyed toward a suction pipe 6 by way of the grooves 40.1 and 20.1 and through the orifice 2.9.
The device according to this invention is also available in a second configuration suitable for limiting the spreading of a toxic aerosol from a drug contained in a vial (F) in the environment and conveying it toward a suction device; in this configuration, said cap 3′ includes a second portion 5′ having a diameter greater than that of the first portion 4 and including an inner space 50′ configured for accommodating a drug-containing vial; in this embodiment, said second portion 5′ is made from a rigid plastic material or from a semi-rigid silicone material; in this case too, a transparent material is preferred in order to be able to inspect the vial being handled.
After inserting a vial inside the inner space 50′, a gap will be formed all around the vial, from which any leakages of drug taking place while taking it will be conveyed and subsequently drawn up.
The device according to this invention is configured so that, in both embodiments, the first portion 4 of said cap 3; 3′ is slidingly connected to said cylindrical hollow element 2 so as to accommodate the end 2″ of said cylindrical hollow element 2 in the inner space 40, along three quarters of its length, so as to reciprocally secure them.
Also, at the proximal end the convexity 2.2 ends, in an opening 2.5 which protrudes toward the outside of said cylindrical hollow element 2 by way of a fitting 2.4, said opening 2.5 being configured for being connected to a pipe where the toxic aerosol will be conveyed.
Said opening 2.5 is positioned below the flange 2.3.
Also, said flange 2.3 is configured so as to accommodate and restrain the flange of a syringe barrel.
The invention also discloses a kit 100 for conveying and drawing up a toxic aerosol from a drug, comprising a device 1 consisting of at least one cylindrical hollow element 2, at least one cap 3 and at least one cap 3′, at least one suction pipe 6 configured for connecting the opening 2.5 to at least one suction motor 7, and a suction motor 7 configured for drawing up the air contaminated by a toxic aerosol from a drug and purifying it; said suction motor 7 is provided with filters 8 for absorbing the toxic aerosol from a drug so as to purify the output air.
The suction motor will exert a suction force that will allow all the aerosol conveyed in the one space 60 inside the suction pipe 6 to flow through, so as to totally prevent any leakages of toxic substances during inoculation.
The air drawn up by the motor will subsequently be purified through specific removable filters, which will capture molecules present in the aerosol, so as to output clean air; said filters are also chemotherapeutic substance-specific filters.
The filters used for purifying air from the chemical substances present are active charcoal filters.
Said active charcoal filters are filters intended for protection from solid and liquid aerosols, with or without oil, and comprise:
The kit according to this invention is intended for using chemotherapeutic drugs.
The invention also provides a method for using the device and the kit according to the invention comprising the following steps:
The method according to the invention jointly comprises the following further steps:
In one embodiment according to the invention, namely whenever pre-filled syringes are used containing toxic drugs, such as some chemotherapeutic drugs, steps a) thru i) are replaced by the following steps:
In the method according to this invention, the step of drawing up toxic aerosol from a drug is followed by a further step, whereby the air output from the suction motor 7 is purified by way of filters 8 of the suction motor 7.
The method according to the invention makes it possible to convey an aerosol potentially released by a syringe in every step of its use, by first assembling the cap 3′, intended for use with a vial, on the cylindrical element, then the cap 3 intended for drug inoculation; the method according to the invention is particularly used to inoculate chemotherapeutic drugs.
The invention also describes the use of the device 1 and of the kit 100 for handling a drug, contained in syringes or vials, that potentially releases a toxic aerosol in the environment.
The device and kit according to the invention will be used in the case of use of drugs such as antitumoral drugs and drugs for genic therapies.
These drugs include, for explanatory purposes only, some chemotherapeutic drugs for intra-lesional application: platinum-based chemotherapeutic drugs (cisplatinum, carboplatinum, and the like), bleomycin, mitomicyn, fluorouracil, and infusional chemotherapeutic drugs such as vincristine, cyclophosphamide, doxorubicin, cytarabine, actinomycin, mechlorethamine, vinblastine, vindesine, and other chemotherapeutic infusional drugs.
The device and kit according to the invention aims at significantly reducing the risk of environmental contamination deriving from an increasing use of drugs potentially releasing toxic aerosols, such as chemotherapeutic drugs; as a matter of fact, the device and kit according to the invention aim at conveying and drawing up all the aerosol that might be released from any individual parts of a syringe and in every toxic drug handling step.
The device and kit according to the present invention also aims at reducing contamination in health operators in charge of providing assistance during chemotherapeutic drug taking and inoculation steps.
Said device and kit can be used both for human and for veterinary applications.
The scope of the invention is susceptible of numerous modifications and variants, all falling within the inventive concept set forth in the attached claims.
All details can be replaced by other technically equivalent elements, according to the requirements, without departing from the scope of protection of the present invention. Even though the scope has been described with a special reference to the attached figures, the reference numerals used in the description and in the claims are used for making the understanding of the invention easier and do not constitute any limitations to the claimed scope of protection.
Number | Date | Country | Kind |
---|---|---|---|
102019000023496 | Dec 2019 | IT | national |
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/IB2019/061449 | 12/30/2019 | WO |