RU2834183C1 - Nicotine cartridge - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to nicotine-containing cartridge assembly (1) for use in a medical electronic nicotine delivery device. Nicotine-containing cartridge assembly (1) comprises assembled body (3) having an inner surface limiting an internal volume which includes reservoir (4). Reservoir (4) has internal volume (8) of the reservoir, which contains a composition containing nicotine or its salts in amount of 2 wt.% to 6 wt.%, propylene glycol in amount of 50 wt.% to 65 wt.%. and water in amount of 35 wt.% to 50 wt.%. Assembly also contains anti-counterfeiting element (22) installed on the outer surface of assembled housing (3). Anti-counterfeit element (22) is configured to allow use of the cartridge assembly of the electronic nicotine delivery device (2) and comprises a plurality of electrically conductive pads (23) mounted on a substrate attached to housing (3) of cartridge assembly (1), and configured to form electrical contact with corresponding electrical contact elements (24) on circuit board (25) inside housing (26) of medical electronic nicotine delivery device (2). Electroconductive platforms (23) are arranged according to a predetermined scheme having predetermined electrical characteristics.

EFFECT: invention makes it possible to create a device having an increased resource, which is sufficient for the period of treatment, wherein the treatment is intended to help a person quit smoking.

17 cl, 11 dwg

Description

FIELD OF APPLICATION OF THE INVENTION

[0001] The invention relates to a nicotine-containing cartridge assembly for use in a medical electronic nicotine delivery device, having an increased resource that is sufficient for a period of treatment, wherein the treatment is intended to help a person quit smoking.

PREREQUISITES FOR THE CREATION OF THE INVENTION

[0002] In recent years, electronic delivery systems have been developed and continue to be developed - devices for delivering nicotine into liquids. They are mainly developed in the tobacco industry to supply smoking systems.

[0003] However, there is still only one medical device for delivering nicotine on the market that helps people quit smoking. This medical device provides a rapid reduction in cravings for smoking, and is sold under the trade name Nicorette™ QuickMist™, and is an oral spray intended for application to the mucous membrane from which the nicotine composition is readily absorbed into the bloodstream to provide a rapid reduction in cravings for smoking. The composition of the nicotine liquid in this product is described in WO2007133140. Under the trade name Nicorette, a number of medical products with different characteristics are presented, including patches, chewing gum, lozenges and sprays, all of which are developed and marketed to help people quit smoking. If the product is a medical device, it must be designed to be safe and to meet the requirements for medical devices in the various countries for which it is being developed.

[0004] Free-form nicotine is a highly unpleasant chemical compound that is highly toxic, volatile, and corrosive to many materials. Therefore, all of the various components within the device, as well as other parts that come into contact with the nicotine composition, must be resistant to nicotine. No decomposition products may be formed that may be toxic to the person using the medical device. The nicotine composition used in the medical device must not contain components or produce any compounds that are harmful to health during use of the regulated medical device, other than e-cigarettes, which are not regulated.

[0005] WO2019154811 describes a cartridge assembly used in combination with an electronic nicotine delivery system that delivers a controlled dose of nicotine to a user on demand. The cartridge assembly includes a reservoir with a material for holding liquid nicotine or a liquid nicotine solution and is constructed from a material that is chemically resistant to nicotine or a nicotine solution.

[0006] Document EP3574902 describes a pharmaceutical composition containing nicotine. The composition can be nebulized at ambient temperature for delivery via a puff. This composition also relates to a method for delivering nicotine to a subject via a puff, and in particular by using a nebulizer.

[0007] None of the cited documents relating to the prior art relate to the invention or to the same technical problem to be solved.

SUMMARY OF THE INVENTION

[0008] The inventors have drawn attention to the problem of developing a medical electronic nicotine delivery device that has a sufficient resource to help the user quit smoking. According to the recommendations of some doctors, when quitting smoking, a 6-week replacement therapy is necessary, followed by a 6-week gradual reduction in smoking. This means that for a smoker who smokes 20 cigarettes per day, the components of the medical device that are in contact with the nicotine composition in any form must withstand approximately 20,000 puff cycles. One of the components that is used in the medical electronic nicotine delivery device is a wick that is in contact with the nicotine composition. The wick can be made of a porous material, such as a polymeric porous material, which can be a thermoplastic polyester. It has been found that wicks degrade and / or change during the life cycle of the medical device. The inventors of the present invention, faced with this problem of wick change during service life, found that by varying the amount of ingredients in the nicotine composition in specific ranges, as well as using only nicotine in free form, propylene glycol and the presence of water led to an increase in the service life of the wick, which withstood more than 20,000 cycles. In addition, the inventors found that the nicotine composition indicated in the present document does not significantly affect other components of the device, such as fibrous material that may be present in the reservoir.

[0009] The present invention provides a nicotine-containing cartridge assembly (1) for use in a medical electronic nicotine delivery device (2), comprising:

a housing (3) in assembly, having an internal surface defining an internal volume, wherein the internal volume includes a reservoir (4), wherein the reservoir has an internal volume, wherein the internal volume (8) of the reservoir (4) contains a composition consisting essentially of or consisting of:

a. nicotine or its salt in an amount of from about 2% w/w to about 6% w/w,

b. propylene glycol in an amount of from 50% w/w to about 65% w/w; and

with water in an amount of from about 35% w/w to about 50% w/w, or containing them.

[0010] It has been found that such a composition in a cartridge assembly is particularly compatible and does not result in significant degradation during use of the cartridge.

[0011] The reservoir may be configured to receive a wick of a medical electronic nicotine device such that the wick contacts the composition. In this configuration, the compatibility of the composition with the wick materials is particularly advantageous.

[0012] The reservoir may comprise an opening that allows a wick to be inserted therethrough. The opening is a cutout that allows the wick to enter the reservoir and contact the composition contained within. When the reservoir has a top wall, a bottom wall, and side walls, the opening may be located in the bottom wall of the reservoir.

[0013] As described herein, a wick that can be used with the cartridge assembly can be formed from a number of suitable materials. It has been found that the present invention is particularly effective with porous polymeric materials, such as porous thermoplastic polymeric materials. Such polymeric materials include polyesters, in particular thermoplastic polyesters. Useful thermoplastic polyesters include polyethylene terephthalate (PET) and polybutylene terephthalate (PBT). The wick can consist of only one material, such as a polymeric material. This reduces the risk of producing contaminants during use of the wick. The wick can be a rigid wick that has sufficient rigidity to maintain its own shape without external support when inserted into the reservoir, especially during repeated insertions.

[0014] The wick may be porous if it is formed from a fibrous material. In other words, the wick contains a plurality of fibers, such as polymer fibers. These may be compacted together to form the wick. This approach has been found to be particularly effective in producing a wick with the required rigidity and without the use of additional, possibly contaminating, substances.

[0015] The wick may be subjected to heat by a medical electronic nicotine delivery device to form an aerosol from the composition. The function of the wick is to transfer the composition from the reservoir to the heated area of the wick. The heating may be provided by a heater that surrounds the wick along a portion of its length. The heater may be a heating element encapsulated in an inert material such as ceramic.

[0016] The internal volume of the reservoir may contain a fibrous material or a sponge, wherein the fibrous material or sponge contains the composition. This is a convenient way to retain the composition inside the reservoir before contact with the wick during use. An advantage of such a configuration is the compatibility of the present compositions with fibrous materials and sponges. The fibrous material or sponge may be saturated with the composition. The fibrous material is a material containing a plurality of fibers. The sponge is a continuous matrix of material with open porosity that can retain the composition.

[0017] It has been found that particularly effective fibrous materials and sponges contain polymeric materials, such as thermoplastic polymeric materials. Such polymeric materials include polyesters, in particular thermoplastic polyesters. Thermoplastic polyesters used include polyethylene terephthalate (PET) and polybutylene terephthalate (PBT). The fibrous material or sponge in the reservoir may consist of only one material, such as a polymeric material. This reduces the risk of producing contaminants within the composition.

[0018] The present invention also provides a nicotine-containing cartridge assembly (1) for use in a medical electronic nicotine delivery device (2), comprising:

a) a housing (3) in assembly, having an internal surface, defining an internal volume, wherein the internal volume includes a reservoir (4), wherein the reservoir (4) has side walls (7), having an internal surface and an external surface, wherein the internal surface of the side walls (7) defines an internal volume (8) of the reservoir (4); wherein the reservoir (4) contains a composition, consisting essentially of or consisting of:

a) nicotine or its salt in an amount of from about 2% w/w to about 6% w/w,

b) propylene glycol in an amount of from 50% w/w to about 65% w/w; and

c) water in an amount of from about 35% w/w to about 50% w/w, or containing them,

d) two channels (12) formed between the outer surface of the side walls (7) of the reservoir (4) and the inner surface of the housing (3) in assembly, wherein the channels (12) have open upper ends (13) and open lower ends (14) and are designed to allow the passage of aerosol nicotine; and

e) a collector (15) for holding and distributing aerosol nicotine, wherein the collector (15) is located above the upper wall (5) of the reservoir (4), wherein the collector (15) has an open upper end (16) and two open lower ends (17), as well as two internal channels (18) connecting the open upper end (16) with open lower ends (17), wherein the open lower ends (17) are secured to the open upper ends (13) of the channels (12) and are in fluid communication with the channels (12).

[0019] The use of such a special nicotine composition in the reservoir allows for increased compatibility of the nicotine composition with other components of the medical electronic nicotine delivery system. For example, the special nicotine composition in the reservoir can maintain the quality of the wick over an expected service life of at least 20,000 cycles. It also has good compatibility with materials that can be used in the reservoir.

[0020] The present invention also provides a kit comprising a nicotine cartridge assembly as described herein and a medical electronic nicotine delivery device as described herein.

[0021] The present invention also provides a kit comprising at least one nicotine cartridge assembly described herein (e.g., at least two nicotine cartridge assemblies).

[0022] The present invention also provides a medical electronic nicotine delivery system comprising a medical electronic nicotine delivery device as described herein and comprising a cartridge assembly as described herein.

[0023] The present invention also provides a medical electronic nicotine delivery device comprising a housing, a cartridge assembly described herein, an electrical module, a power source, a heater, and a vaporization chamber.

[0024] The present invention also provides the use of a medical electronic nicotine delivery device with a nicotine-containing cartridge assembly as described herein for treating a person who is addicted to tobacco and suffers from cravings to smoke.

[0025] The present invention further provides the use of a nicotine-containing composition for reducing the degradation of a component of a medical electronic nicotine delivery system during use of the system, wherein the composition comprises

nicotine or its salt in an amount of from about 2% w/w to about 6% w/w,

propylene glycol in an amount of from 50% w/w to about 65% w/w; and water in an amount of from about 35% w/w to about 50% w/w.

[0026] The present invention is particularly effective for reducing the degradation of a wick as described herein and a fibrous material or sponge in a reservoir as described herein.

[0027] In order to market a device and a cartridge containing a nicotine composition as a medical device, all components, as well as the nicotine composition and chemicals, must be manufactured in accordance with good manufacturing practices (GMP) to ensure their registration as a medical product, and thus are subject to higher requirements than when marketing, for example, an electronic cigarette.

BRIEF DESCRIPTION OF GRAPHIC MATERIALS

[0028] Fig. 1 is a perspective view of the cartridge assembly.

[0029] Fig. 2 is a schematic side view of the cartridge assembly shown in Fig. 1.

[0030] Fig. 3 is a schematic side view of the cartridge assembly shown in Fig. 1.

[0031] Fig. 4 is a schematic side view of the cartridge assembly shown in Fig. 1.

[0032] Fig. 5 is a cross-sectional view of the cartridge assembly shown in Fig. 1.

[0033] Fig. 6 is a cross-sectional view of the cartridge assembly shown in Fig. 1.

[0034] Fig. 7 is a second exploded schematic view of the components of the cartridge assembly.

[0035] Fig. 8 is a schematic perspective view of an electronic nicotine delivery device for delivering nicotine from a cartridge assembly as shown in Fig. 16.

[0036] Fig. 9 is a schematic representation of an electronic nicotine delivery system.

[0037] Fig. 10 is a cross-sectional view of the electronic nicotine delivery system shown in Fig. 9.

[0038] Fig. 11 is a partially cut-away perspective view of the electronic nicotine delivery system of the present invention shown in Fig. 9.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Definitions

[0039] In the context of the present application and invention, the following definitions apply.

[0040] The amount of nicotine present in the composition is calculated on the basis of nicotine in the form of free base.

[0041] The term "% w/w" is intended to indicate the percentage of ingredient(s) relative to the total percentage by weight.

[0042] The term "cycle" means a period of time that begins when the user begins to puff, then the heater in the device begins to heat and heats the nicotine composition, wherein the nicotine composition is converted into vapor/aerosol and transferred from the device through the mouthpiece into the human body, after which the device turns off. A cycle can be from about 30 seconds to one minute.

NICOTINE COMPOSITION IN A TANK

[0043] The nicotine composition present in the reservoir (4) has been designed to meet a number of criteria; after complete conversion to vapor/aerosol, the composition must provide a certain amount of nicotine in one cycle, as defined above, to reduce the craving for smoking, i.e. 2-6 mg in one cycle, not lead to the formation of visible smoke, since the medical device should not be associated with a cigarette, not affect the service life of the wick or any other part of the cartridge or device in contact with the nicotine composition, especially the wick and any fibrous material. In addition, the composition should not contain compounds harmful to health, such as fragrances and flavorings.

[0044] These problems were solved by developing a nicotine composition consisting essentially of or consisting of nicotine or a salt thereof in an amount of from about 2% w/w to about 6% w/w, propylene glycol in an amount of from 50% w/w to about 65% w/w, and water in an amount of from about 35% w/w to about 50% w/w, or containing them. The composition should not substantially contain other chemical compounds, including other chemical compounds should not be present in the composition in order to reduce the possibility of forming toxic compounds when the composition is heated.

[0045] The amount of nicotine in the composition may vary depending on the degree of dependence of the consumer thereon and may be, for example, from about 2% w/w to about 6% w/w, including 2% w/w, 3% w/w, 4% w/w, 5% w/w, or 6% w/w.

[0046] Propylene glycol is present in an amount of from 50% w/w to about 65% w/w, such as in an amount of from 55% w/w to 60% w/w, 56% w/w, 57% w/w, 58% w/w, 59% w/w, 60% w/w, 61% w/w, 62% w/w, 63% w/w, 64% w/w, or 65% w/w.

[0047] Water is present in an amount of from about 35% w/w to about 50% w/w, such as 36% w/w, 37% w/w, 38% w/w, 39% w/w, 40% w/w, 41% w/w, 42% w/w, 43% w/w, 44% w/w, 45% w/w, 46% w/w, 47% w/w, 48% w/w, or 50% w/w.

[0048] These amounts of nicotine, propylene glycol and water are particularly advantageous because they provide an increase in the service life of the wick so that it can withstand more than 20,000 cycles. Such an increase is observed in particular when the wick consists essentially of or consists of a porous (and not necessarily rigid) material, such as porous thermoplastic polyester or another polymer (for example, porous polyethylene terephthalate or PET), or contains them.

[0049] In addition, these amounts of nicotine, propylene glycol and water also advantageously retain fibrous material that may be present in the reservoir, as described below. The fibrous material improves contact between the nicotine composition in the reservoir and the wick. In the absence of fibrous material, as the nicotine composition in the reservoir is depleted, contact between the nicotine composition and the wick may become difficult and possibly interrupted.

[0050] Examples of nicotine salts include, but are not limited to, nicotine salts of the following acids: formic (2:1), acetic (3:1), propionic (3:1), butyric (3:1), 2-methylbutyric (3:1), 3-methylbutyric (3:1), valeric (3:1), lauric (3:1), palmitic (3:1), tartaric (1:1) and (2:1), citric (2:1), malic (2:1), oxalic (2:1), benzoic (1:1), gentisic (1:1), gallic (1:1), phenylacetic (3:1), salicylic (1:1), phthalic (1:1), picric (2:1), sulfosalicylic (1:1), tannic (1:5), pectic (1:3), alginic (1:2), hydrochloric (2:1), chloroplatinic (1:1), tungstosilicon (1:1), pyruvic (2:1), glutamic (1:1), and aspartic (1:1). While the use of free base nicotine is inherently preferred, the use of such salts may be desirable to lower the pH, thereby potentially reducing irritation from liquid formulations containing high concentrations of nicotine.

[0051] The nicotine composition does not contain glycerin, ethanol, flavoring additives, fragrances or other ingredients in order to be as safe as possible, and cannot produce any toxic compounds during the use of the cartridge in the cycles of the medical device.

CARTRIDGE

[0052] According to the present invention, as shown in Fig. 111, a cartridge assembly (1) for a medical electronic device (2) for delivering nicotine is described. The cartridge assembly (1) comprises a housing (3) assembled with a reservoir (4) configured to hold a nicotine composition. The reservoir (4) may be elongated. The lower part of the cartridge may include a plug (10), described in more detail below with reference to Fig. 7, which is removably retained in an opening or cutout (29) for a wick before use and is removed when the cartridge is used.

[0053] The cartridge assembly (1) is preferably made of a chemically resistant medical grade material, such as a thermoplastic material. The cartridge assembly (1) may be made of any suitable nicotine-resistant polymeric material or metallic material, including stainless steel. The wick (11) is preferably chemically resistant to nicotine, is heat-resistant and is preferably rigid to prevent destruction during insertion into the reservoir (4) or during use. A more detailed description of the wick (11) is given below. The fibrous material or sponge (9) or any liquid retaining element may be placed in the reservoir (4) and extends to a position close to the first/lower end of the reservoir (4). When the wick (11) is inserted into the cartridge assembly (1), the fibrous material/sponge (9) can come into contact with the wick (11) such that the liquid located in the reservoir (4) moves through the wick (11) to the heater (32), preferably an electric heater or heating element, inside the housing (26) of the electronic nicotine delivery system (2).

[0054] As described herein, the cartridge assembly (1) is configured to be used in a medical electronic device (2) for delivering nicotine.

[0055] The housing (3) assembly comprises two air ducts/channels (12) which pass inside the housing (3) assembly outside and along the tank (4).

[0056] As indicated above, the disposable cartridge assembly (1) with tamper-resistant protection is used as an integral component in the electronic nicotine delivery system (2) for smoking cessation. Fig. 1-11 shows the cartridge assembly (1) in more detail according to the present invention. In one embodiment, the cartridge assembly (1) comprises a housing assembly (3) having an inner surface defining an inner volume. The inner volume of the housing (3) as an assembly includes a reservoir (4), wherein the reservoir (4) has an upper wall (5) with an optional opening (6a) formed therein, a lower wall and side walls (7) having an inner surface and an outer surface, wherein the inner surface of the side walls (7) defines an inner volume (8) of the reservoir (4). The inner volume (8) of the reservoir (4) may contain a fibrous material (9) saturated with nicotine or a sponge.

[0057] The cartridge assembly (1) also includes an opening (6b) formed in the lower wall of the housing (3) in the tank assembly (4) to allow the wick (11) to be inserted from the electronic nicotine delivery device (2). The cartridge assembly (1) further includes two channels (12) formed between the outer surface of the side walls (7) of the tank (4) and the inner surface of the housing (3) in the assembly, wherein the channels (12) have open upper ends (13) near the upper wall (5) of the tank (4) and open lower ends (14) near the lower wall of the tank (4). The channels (12) are configured to retain and distribute aerosol nicotine, as described in more detail below.

[0058] The cartridge assembly (1) also further includes a manifold (15) located above the upper wall (5) of the reservoir (4), wherein the manifold (15) is configured to retain and distribute aerosol nicotine. In one embodiment, the manifold (15) includes an open upper end (16), two open lower ends (17) and two internal channels (18) connecting the open upper end (16) to the open lower ends (17), wherein the open lower ends (17) of the manifold (15) are secured to the open upper ends (13) of the channels (12) of the cartridge assembly (1) so as to form a continuous path from the open upper end (16) to the open lower ends (14) of the channels (12) for communicating with the aerosolized nicotine.

[0059] The cartridge assembly (1) also further includes a mouthpiece (19) located above the manifold (15) and having an outlet (20) in fluid communication with the internal channels (18) of the manifold (15). In this case, the mouthpiece (19) is designed to deliver aerosol nicotine into the user's mouth. The mouthpiece (19) can be connected to the housing (3) assembly by any suitable means, including a locking connection (42), as shown in detail in Fig. 14 and 7.

[0060] The cartridge assembly (1) further includes at least one of a counterfeit protection element (22) and a reuse protection element (21) mounted on the outer surface of the housing assembly (3). The counterfeit protection element (22) is configured to prevent the use of an unauthorized cartridge assembly in the electronic nicotine delivery system (2), while the reuse protection element (21) is configured to prevent the reuse of the cartridge assembly (1) after removal from the electronic nicotine delivery system (2), as shown in Figs. 1 and 7.

[0061] Fig. 11 shows a female coupling component (34) in the housing (26) of the electronic nicotine delivery device (2), which cooperates with a male component (35), shown in Fig. 1, on the outer surface of the housing (3) in the assembly of the cartridge unit (1). These female/male components can have any suitable shape or any suitable mechanisms for fixing the cartridge unit (1) on the electronic nicotine delivery device (2).

[0062] Fig. 7 shows a plug (10) that closes the open bottom of the cartridge, sealing the reservoir (4) so that the composition held in the reservoir (4) will remain inside the reservoir (4) and will be protected from contamination. The plug (10) can be made of any suitable material that is resistant to nicotine/nicotine composition. The plug (10) is designed to prevent accidental leakage of nicotine/nicotine composition contained in the reservoir (4).

[0063] As indicated above, more specific descriptions of the cartridge assembly (1) and the medical electronic nicotine delivery device (2), as well as a description of the nicotine formulations and the operation of the device are provided below.

[0064] Fig. 1-11 shows a more detailed illustration of the cartridge assembly (1) and the device (2) of the present invention. As shown in Fig. 111, the cartridge assembly (1) comprises a plug (10) at a first/lower end and a mouthpiece (19) at a second/upper end opposite the first/lower end. A reservoir (4) is provided in the housing assembly (3) between the first end and the second end. In various embodiments, the housing assembly (3) is formed elongated and comprises an elongated passage extending from the first end of the housing assembly (3) to the second end of the housing assembly (3). The reservoir (4) is located in a central position between channels/air ducts (12) forming the elongated passage. Two channels/air ducts (12) extend along opposite sides of the reservoir (4) from the open lower ends (14) to two internal channels (18) in the manifold (15). The mouthpiece (19) provides a favorable tactile response for the user. The cartridge assembly (1) can be used for a period of time until the nicotine composition is used up, after which the cartridge is replaced and a new cartridge is inserted into the device (2). The mouthpiece (19) can be made as a single piece with the rest of the cartridge assembly (1).

[0065] The open lower ends (14) pass into air passages/channels (12). Two internal channels (18) merge into an open upper end (16) in the manifold (15), forming an inhalation opening of the mouthpiece (19), through which the user inhales nicotine vapor. The two internal channels (18) provide an input or output of air, such as vapor, from the nicotine composition located in the reservoir. The two internal channels (18) effectively mix the nicotine aerosol as it passes through them.

[0066] The wick (11) may extend into the reservoir (4) when the cartridge assembly (1) is inserted into the medical electronic nicotine delivery device (2) to facilitate the transfer of nicotine from the reservoir (4) to the heater (32) inside the housing (26) of the medical electronic nicotine delivery device (2) when the plug (10) is removed. When the wick (11) is inserted, it penetrates into the internal volume (8) of the reservoir (4) to contact with the nicotine composition contained in the reservoir, wherein the nicotine-saturated fibrous material (9) can be located inside the internal volume (8) of the reservoir (4), and the wick (11) is configured to contact with the nicotine-saturated fibrous material (9) to transfer nicotine from the fibrous material (9) to the heater (32) inside the housing (26), and the heater (32) heats the nicotine composition so that it turns into vapor and is inhaled by a person using the said device, and the person's craving for smoking is reduced. In one embodiment, the fibrous material (9) is made of a porous material, such as a thermoplastic polymer, for example polyester. Examples are polyethylene terephthalate (PET), polybutylene terephthalate (PBT) or a mixture thereof or a mesh, as well as stainless steel. It is important to note that any acceptable material can be used.

[0067] The wick (11) may be made of any suitable material that is resistant to nicotine and has acceptable heat resistance. The wick (11) consists essentially of or consists of a porous material, such as a porous polymer, for example a thermoplastic polymer, preferably a thermoplastic polyester (for example porous polyethylene terephthalate or PET), or contains them. The wick (11) is preferably rigid. It is important to note that the wick (11) of the present invention should preferably not be made of cotton, since such a wick may wrinkle, since it is not rigid enough to withstand repeated insertion into and removal from the cartridge assembly (1). The wick may be porous when made of a fibrous material, such as a fibrous polymer.

[0068] The element (21) of protection against repeated use may include a plurality of springs 27, which are designed with the possibility of destruction, modification or damage upon removal of the cartridge assembly (1) from the electronic system (2) of nicotine delivery. By introducing such an element of protection against repeated use, i.e. a spring, which is destroyed upon removal of the cartridge assembly (1) from the housing (26) of the medical electronic device (2) of nicotine delivery, the risk of repeated use of the cartridge assembly (1) is minimized. Reducing the risk of repeated use of the cartridge assembly (1) to a minimum does not allow the use of refilled or otherwise modified cartridges with the medical electronic device (2) of nicotine delivery.

[0069] The fibrous material (9) can be made in the form of one or more fragments, substantially filling the entire internal volume (8) of the reservoir (4). When the wick (11) is engaged with the fibrous material (9) or penetrates it, it begins to move the solution present inside the reservoir (4) from the reservoir (4). The wick (11) can be impregnated or saturated with a nicotine composition. The fibrous material (9) can comprise one block of fibrous material.

[0070] The mouthpiece (19) passes in two opposite flaps (36) which smoothly fit to the housing (26) of the electronic nicotine delivery device (2) (see Fig. 8). The flaps (36) provide a relatively rigid connection between the cartridge assembly (1) and the housing (26) when the cartridge assembly (1) is fully inserted into the housing (26). The housing (3) as an assembly of the cartridge assembly (1) may be provided with a tamper evident device or an anti-counterfeiting element (22). The anti-counterfeiting element (22) may comprise a plurality of electrically conductive pads (23) (for example, three pads) located at predetermined external locations on the housing assembly (3). It is important to note that the plurality of pads (23) are in a specific configuration; for example, in a linear configuration. In alternative approaches, it is possible to use a different number of pads (23) in any suitable configuration matching the electrical contact elements (24) on the inner side of the housing (26) (see Fig. 11). When the cartridge assembly (1) is inserted into the housing (26), three pads (23) make contact with the electrical contact elements (24), which close a circuit that measures the resistance. In essence, when the cartridge assembly (1) is moved relative to the housing (26) and inside it, the anti-counterfeiting element (22) is affected by the corresponding electrical contact elements (24) on the inner wall of the housing (26). Any simple circuit, such as a Wheatstone bridge, can be used to measure the resistance. If the resistance matches the predetermined resistance value programmed into the controller of the electronic nicotine delivery device (2), the cartridge assembly (1) is suitable for the medical electronic nicotine delivery device (2), and the medical electronic nicotine delivery device (2) will operate. If the resistance does not match, the cartridge assembly (1) is not suitable for the medical electronic device (2) for delivering nicotine, and the medical electronic device (2) for delivering nicotine will not work. It is important to note that the plurality of pads (23), for example three pads (23), can have the same resistance values or different resistance values. The measured value is the total resistance when filling the circuit by inserting the cartridge assembly (1) into the housing (26). Other electrical characteristics can be measured instead of or in addition to the resistance values, for example the capacitance. Again, there are well-known simple circuits that can be used to measure capacitance, as well as for any number of other electrical parameters. The plurality of electrical contact elements (24) can be made of any suitable material and mounted on the mounting board (25) by any suitable means. The choice of material is determined by the selected measured parameter, which can also affect the means of attaching the plurality of electrical contact elements (24) to the mounting board (25).

[0071] The cartridge assembly (1) and the medical electronic nicotine delivery device (2) may comprise a reuse protection element(s), as briefly described above. A plurality of springs (27) may be arranged in such a configuration/position that they provide contact with a plurality of electrical pads (28) (see Fig. 11) inside the housing (26). In this position/configuration, electrical properties such as electrical resistance can be determined between the plurality of springs (27). A mounting board (25) inside the housing (26) contacts the plurality of springs (27) on the electrical pads (28), when the cartridge assembly (1) is in position inside the housing (26) and determines predetermined electrical properties. More specifically, the plurality of springs (27) come into contact with elements inside the housing (26) to close a circuit when the cartridge assembly (1) is inserted into the housing (26). A controller in the medical electronic nicotine delivery device (2) determines that the circuit is closed by measuring a specific electrical parameter, such as resistance; However, other parameters can also be used. After the cartridge assembly (1) is removed from the housing (26), one or more of the plurality of springs (27) (for example, one or both springs (27), when two springs are installed) are bent beyond the path by the element (37) of the housing (26) so that, upon reinsertion, the spring(s) (27) no longer enter (enter) into contact with the corresponding electrical pads (28) in the housing (26), and the circuit is not closed. The element (37), which bends one or more springs (27), can be a simple wedge-shaped protrusion, which bends the springs (27) only after the cartridge assembly (1) is removed. Alternatively, one or more springs (27) can be broken, and not simply bent; however, part of the spring (27) can fall into the housing (26) and get stuck there. Preferably, the springs (27) may comprise any suitable electrically conductive material that is configured to bend or configured to bend. In an embodiment in which the springs (27) are configured to break off rather than bend, the springs (27) may be formed from an electrically conductive but brittle material. Furthermore, in alternative embodiments, the springs (27) may be replaced by any suitable electrically conductive material that, when properly aligned, forms a complete circuit, such as a conductive foil that is torn off when the cartridge assembly is removed from the housing (26).

[0072] The housing (26) can be arranged with an internal edge that will separate the springs (27) when the cartridge is removed from the housing (26). If the same cartridge assembly (1) is inserted again, the electrical pads (28) mounted on the mounting board (25) will not properly contact the springs (27), and the electrical properties determined by the electronic circuit will not correspond to the stored data. As a result, the medical electronic device (2) for delivering nicotine will not be ready for proper use.

[0073] The cartridge assembly (1) and its various components must be made of a material that is resistant to nicotine or its salts. Examples of materials include any type of polymeric material such as polyester, polyacrylonitrile (PAN) resin (Anobex™), cyclic olefin copolymer or high density polyethylene (HDPE). As defined above, the cartridge assembly (1) may be sealed at the bottom with a plug (10), as well as a housing (3) assembly and a mouthpiece (19) to prevent particles from the environment from entering the cartridge assembly (1) during storage and transportation.

[0074] Although the foregoing description and drawings represent examples of the embodiment of the present description, it should be understood that various additions, modifications and substitutions can be made thereto without departing from the spirit, scope and range of equivalents of the appended claims. In particular, it will be understood by those skilled in the art that the present invention can be embodied in other forms, structures, designs, proportions, sizes, as well as with other elements, from other materials and components, without departing from its spirit or essential characteristics. In addition, numerous changes can be made to the methods/processes described herein within the scope of the present description.

JOB

[0075] As shown in Fig. 1-11, the medical electronic nicotine delivery device (2) includes a power source (31) and a heater (32), preferably an electric heater or a heating element, located inside a receiving compartment (39) (see Fig. 11). The receiving compartment (39) has at least one air inlet (38), see Fig. 9 and 10, and provides openings (see Fig. 10) in close proximity to the bottom wall of the housing (3) assembly, described in detail above, and near the heater (32). In the assembled state, the receiving compartment (39), the heater (32) and the cartridge assembly (1) together form an evaporation chamber (33) (see Fig. 11). The assembled electronic nicotine delivery system (2) also provides a predetermined air flow from at least one air inlet (38) through the evaporation chamber (33), channels (12) and outlet (20) of the mouthpiece (19), so that the user can inhale the nicotine aerosol formed therein. The assembled medical electronic nicotine delivery device (2) additionally provides a passage for liquid from the reservoir (4) to the heater (32), preferably a wick (11), more preferably an elongated wick, as described above. The housing (26) can also provide the possibility of connection to an external electrical source and/or data exchange, such as a USB port (40), see Fig. 10, for supplying and/or replenishing electrical energy to a power source (31), preferably a rechargeable battery.

[0076] The power source (31) has sufficient power to power the heater (32), the programmable controller (not shown) and any required feedback to the user (e.g., a backlight), an external computer or a network. The programmable controller receives information from the pressure sensor (detecting a puff by the user) and, possibly, other sensors (such as temperature sensors) to regulate the power supplied to the heater (32), and controls the temperature sensor(s), which can stop the power supply to the heater (32) to prevent unwanted and/or dangerous thermal events. The programmable controller can ensure the collection, storage and transmission of data to the external computer. The data can be transmitted via a wireless connection. The power source (31) can be any suitable portable power source (31), such as a main or additional battery or a fuel cell.

[0077] In order to isolate the electrically resistive heating elements from other heat-sensitive components of the medical electronic device (2) for delivering nicotine, the heater (32) is mounted on a holder (41). The holder (41) can be made of any suitable material with sufficient mechanical characteristics to support all elements attached thereto and to provide an insulating function, i.e. low thermal conductivity. The heater (32) comprises at least one electrically resistive heating element contained in a heat-dissipating material. The dissipation of heat through the heat-dissipating material substantially evens out the thermal profile generated by the heating element(s) to prevent the formation of localized heat spots on the surface of the heater (32).

[0078] As indicated above, the cartridge assembly (1) preferably includes a reservoir (4) containing a nicotine composition, and a mouthpiece (19) for drawing nicotine aerosol from the medical electronic nicotine delivery device (2). The assembled medical electronic nicotine delivery device (2) provides a passage for liquid from the reservoir (4) to the heater (32). In a preferred embodiment, the passage for liquid is a wick (11) (optionally an elongated wick) extending from the reservoir (4) to the heater (32). The wick (11) closely contacts the surface of the heater (32), allowing thermal energy to vaporize the nicotine composition moved thereto by the wick (11). As the nicotine composition vaporizes, the wick (11) moves additional nicotine composition to the heater (32) through capillary action.

[0079] The assembled medical electronic device (2) for delivering nicotine also provides a vaporization chamber (33) near the heater (32). It is in the vaporization chamber (33) that the heater (32) vaporizes the nicotine composition moved by the wick (11), and the vaporized nicotine composition combines with the outside air drawn in through one or more inlet openings (38) to form a nicotine aerosol. The vaporization chamber (33) also communicates with the outlet opening (20) of the mouthpiece (19) via internal channels (18) in the cartridge assembly (1) so that the user can draw the nicotine aerosol into his mouth.

[0080] When the user draws air through the outlet opening (20) from the mouthpiece (19), the negative pressure causes air to flow into the assembled medical electronic device (2) for delivering nicotine through one or more air inlet openings (38). In particular, air is drawn from the evaporation chamber (33) through the channels (12) and the internal channels (18), reducing the air pressure in the evaporation chamber (33). The drawn air is replaced through the air inlet openings (38) in the housing (26) near the evaporation chamber (33). The reduced air pressure in the evaporation chamber (33) is detected by a pressure sensor located near the printed circuit board (43) outside the evaporation chamber (33). The reduced air pressure near the pressure sensor activates a switch operatively connected to the pressure sensor. This pressure sensor, in turn, activates the heater (32), which, in turn, heats the nicotine composition in contact with it on the surface of the wick (11). The nicotine composition evaporates and combines with air in the evaporation chamber (33), forming a nicotine aerosol. The nicotine aerosol is sucked out of the evaporation chamber (33) through the channels (12) and the internal channels (18) and is delivered to the mouthpiece (19) and, ultimately, to the user's mouth. As the nicotine composition evaporates from the reservoir (4) along the wick (11) to the heater (32), additional solution is drawn. The volume of the nicotine composition withdrawn from the reservoir (4) is replaced by air drawn through at least one air inlet (38). In one embodiment, after a predetermined time (e.g., set by a programmable controller), the power supply to the heater (32) is stopped, the vaporization chamber (33) cools down and no further nicotine aerosol is formed. Subsequently, the user stops inhaling from the medical electronic device (2) for delivering nicotine, ending his "treatment". Alternatively, the user may stop inhaling from the medical electronic device (2) for delivering nicotine before the predetermined time. In this case, the pressure in the vaporization chamber (33) will return to atmospheric pressure, and the pressure sensor will send a signal to the switch to stop the power supply to the heater (32).

[0081] In a final aspect, the invention relates to a medical electronic device (2) for delivering nicotine, comprising a housing (26), a cartridge assembly (1) as defined above, an electrical module (30), a power source (31), a heater (32) and an evaporation chamber (33).

[0082] It will further be understood by one skilled in the art that the embodiments can be used with numerous modifications of structure, design, proportions, dimensions, materials and components and otherwise to create examples of implementation of the description specifically adapted for use in particular conditions and in accordance with functional requirements without departing from the principles described herein. Accordingly, the embodiments described herein are to be considered in all respects as illustrative and not restrictive. The appended claims are to be interpreted in a broad sense and include other variations and embodiments of the description that can be made by those skilled in the art without departing from the scope and range of equivalents.

Claims (36)

1. A nicotine-containing cartridge unit (1) for use in a medical electronic device (2) for delivering nicotine, comprising: a housing (3) assembled, having an internal surface defining an internal volume, which includes a reservoir (4), wherein the reservoir (4) has an internal volume (8) of the reservoir, which contains a composition containing: a) nicotine or its salts in an amount of 2 to 6% by weight; b) propylene glycol in an amount of 50 to 65% by weight and c) water in an amount of 35 to 50% by weight; and an anti-counterfeiting element (22) mounted on the outer surface of the housing (3) in assembly, wherein the anti-counterfeiting element (22) is configured to permit the use of the cartridge assembly of the electronic device (2) for delivering nicotine and comprises a plurality of electrically conductive pads (23) mounted on a substrate attached to the housing (3) in assembly of the cartridge assembly (1) and configured to form an electrical contact with corresponding electrical contact elements (24) on a mounting board (25) inside the housing (26) of the medical electronic device (2) for delivering nicotine, wherein the electrically conductive pads (23) are arranged according to a predetermined pattern having predetermined electrical characteristics. 2. The cartridge unit according to claim 1, wherein the reservoir (4) is configured to receive a wick (11) of the medical electronic device (2) for delivering nicotine so that the wick (11) contacts the composition. 3. The cartridge assembly according to claim 2, wherein the reservoir (4) comprises an opening (6) allowing the wick (11) to be inserted through it. 4. The cartridge unit (1) according to item 2 or 3, in which the wick comprises a porous polymer. 5. The cartridge assembly (1) according to claim 4, wherein the porous polymer is a porous polyester. 6. A cartridge assembly according to any of the preceding claims, wherein the internal volume (8) of the reservoir comprises a fibrous material or sponge, wherein the fibrous material or sponge contains the composition. 7. A cartridge assembly according to any of the preceding claims, wherein the reservoir has a top wall (5), a bottom wall and side walls (7) having an inner surface and an outer surface, wherein the inner surface of the side walls (7) defines an internal volume (8) of the reservoir. 8. The cartridge assembly according to claim 7, further comprising two channels (12) formed between the outer surface of the side walls (7) of the reservoir (4) and the inner surface of the housing (3) in assembly, wherein the channels (12) have open upper ends (13), open lower ends (14) and are designed with the possibility of conducting aerosol nicotine. 9. A nicotine-containing cartridge unit (1) for use in a medical electronic device (2) for delivering nicotine, comprising: a housing (3) in assembly, having an internal surface, defining an internal volume, which includes a reservoir (4), having an upper wall (5), a lower wall and side walls (7), having an internal surface and an external surface, wherein the internal surface of the side walls (7) defines an internal volume (8) of the reservoir, which contains a composition containing: a) nicotine or its salts in an amount of 2 to 6% by weight; b) propylene glycol in an amount of 50 to 65% by weight and c) water in an amount of 35 to 50% by weight; two channels (12) formed between the outer surface of the side walls (7) of the reservoir (4) and the inner surface of the housing (3) in assembly, wherein the channels (12) have open upper ends (13), open lower ends (14) and are designed with the possibility of conducting aerosol nicotine; and a collector (15) for holding and distributing aerosol nicotine, located above the upper wall (5) of the reservoir (4) and having an open upper end (16) and two open lower ends (17), as well as two internal channels (18) connecting the open upper end (16) with open lower ends (17), wherein the open lower ends (17) of the collector are secured to the open upper ends (13) of the channels (12) and are in fluid communication with the channels (12). 10. The cartridge assembly (1) according to claim 9, further comprising a mouthpiece (19) located above the manifold (15) and having an outlet (20) in fluid communication with at least one internal channel (18) of the manifold (15), wherein the mouthpiece (19) is configured to deliver aerosol nicotine to the user's mouth. 11. A cartridge assembly (1) according to any of the preceding claims, wherein the composition in the reservoir (4) comprises: a) nicotine or its salt in an amount of 2 to 6% by weight; b) propylene glycol in an amount of 60% by weight and c) water in the amount of 40% by weight. 12. The cartridge assembly (1) according to any of the preceding claims, further comprising a reuse protection element (21) mounted on the outer surface of the housing (3) as an assembly, wherein the reuse protection element (21) is configured to prevent the cartridge assembly (1) from being reused after being removed from the medical electronic nicotine delivery device (2). 13. A nicotine-containing cartridge unit (1) for use in a medical electronic device (2) for delivering nicotine, comprising: a housing (3) assembled, having an internal surface defining an internal volume, which includes a reservoir (4), wherein the reservoir (4) has an internal volume (8) of the reservoir, which contains a composition containing: a) nicotine or its salts in an amount of 2 to 6% by weight; b) propylene glycol in an amount of 50 to 65% by weight and c) water in an amount of 35 to 50% by weight; and a reuse protection element (21) mounted on the outer surface of the housing (3) as an assembly and comprising one or more springs (27) configured to create electrical contact with corresponding electrical contact pads (28) mounted on a mounting board (25) inside the housing (26) of the medical electronic nicotine delivery device (2), wherein the one or more springs (27) are configured to be destroyed when the cartridge assembly (1) is removed from the housing (26) to prevent reuse of the cartridge assembly (1) after removal from the medical electronic nicotine delivery device (2). 14. A nicotine delivery kit comprising at least one nicotine cartridge assembly (1) according to any of the preceding claims and a medical electronic nicotine delivery device (2). 15. The kit according to item 14, comprising at least two cartridge units (1). 16. A medical electronic nicotine delivery system comprising a cartridge assembly according to any one of claims 1-13 and a medical electronic nicotine delivery device. 17. A medical electronic nicotine delivery system according to claim 16, wherein the medical electronic delivery device comprises a housing (26), an electrical module (30), a power source (31), a heater (32) and an evaporation chamber (33).