Apparatus and method for coating injection medical devices

Abstract

An apparatus (1) for applying a coating to an injection medical device, comprising a feed tank (10) loadable with a coating substance, an output nozzle (80) for delivering the coating substance to the injection medical device, and a supply assembly (20) interposed between and in fluid communication with the feed tank (10) and the output nozzle (80) for removing the coating substance from the feed tank (10) and supplying it to the output nozzle (80). The supply assembly (20) comprises at least one sterilizing filter (30a, 30b) for filtering the coating substance removed from the feed tank (10).

Description

Technical Field

[0001] The present invention relates to an apparatus for coating an injectable medical device and a method for coating such an injectable medical device. Background Technology

[0002] As is well known, injection medical devices are widely used in the medical field. They generally consist of a glass cylinder with a coated inner surface and a sealing plunger that slides and engages within the glass cylinder, delivering drugs to the patient via injection.

[0003] These medical injection devices include syringes, cartridges, and auto-injectors (or automatic injectors) for subcutaneous and / or intravenous administration.

[0004] In such devices, in order to obtain the required sliding characteristics of the plunger within the cylinder of the injecting medical device (such as the cylinder of a syringe) to prevent wear on the surface of the syringe cylinder and to provide a protective layer between the drug and the cylinder, a lubricating coating substance, typically silicone oil-based, is usually applied to the inner surface of the syringe cylinder.

[0005] The apparatus used for applying a coating material mainly includes an inlet tank for filling the coating material, an output nozzle connected to the inlet tank for conveying the coating material by atomizing it with compressed air, and a pump that operates between the inlet tank and the output nozzle to pump the coating material to the output nozzle.

[0006] The coating material delivered to injectable medical devices must be sterile, meaning it is free of biological contaminants. Typically, pre-sterilized coating materials are introduced into the feed tank. Therefore, the coating material must be sterilized on-site before being introduced into the feed tank, or it may have been pre-sterilized at the time of purchase.

[0007] The applicant noted that sterilizing the coating material before introducing it into the feed tank would place a burden on operators. Furthermore, sterilizing the coating material before introducing it into the feed tank would create a risk of contact between the coating material and biological contaminants, potentially leading to contamination.

[0008] The applicant also found that purchasing pre-sterilized coating materials would increase costs, and the time between supplying the coating material and introducing it into the feed tank would increase the risk of contamination of the coating material.

[0009] Therefore, the applicant believes it is necessary to take precautions before and during the introduction of the coating material into the feed tank.

[0010] The applicant recognized that by introducing the unsterilized coating material into the feed tank and sterilizing it during the process of supplying the coating material from the feed tank to the output nozzle, it was possible to avoid supplying the unsterilized coating material and sterilizing it before introducing it into the feed tank. Furthermore, all the precautions that would otherwise be necessary to eliminate the risk of contamination of the coating material upon entering the feed tank could be avoided. Summary of the Invention

[0011] Therefore, a first aspect of the present invention relates to an apparatus for applying a coating to an injectable medical device, the apparatus comprising:

[0012] - A feed tank that can hold coating materials;

[0013] - Output nozzle for delivering the coating material into an injectable medical device;

[0014] - A supply assembly disposed between the feed tank and the output nozzle and in fluid communication with the feed tank and the output nozzle, the supply assembly being used to remove coating material from the feed tank and deliver it to the output nozzle;

[0015] The supply component includes at least one sterilization filter for filtering coating material removed from the feed tank.

[0016] According to the present invention, the feed tank is filled with unsterilized coating material. Since no precautions are needed to prevent biological contamination of the coating material, the filling process of the feed tank is simplified and accelerated.

[0017] Each sterilization filter removes biocontaminants from the coating material as it is supplied from the feed tank to the output nozzle. Therefore, the filtration of the coating material is automated, requiring no additional operator intervention beyond introducing the material into the feed tank. Furthermore, the positioning of the sterilization filters within the supply assembly ensures that the coating material does not come into contact with the external environment after sterilization, thus eliminating any risk of biocontamination.

[0018] A second aspect of the present invention relates to a method for applying a coating to an injectable medical device, comprising:

[0019] - Introduce the coating material into the feed tank;

[0020] - Remove the coating material from the feed tank;

[0021] - The coating material is filtered after it has been removed from the feed tank;

[0022] - After filtering the coating material, the coating material is supplied to the output nozzle;

[0023] - Atomize the coating material into the output nozzle;

[0024] - After the coating material is atomized, it is delivered to the injection medical device through the output nozzle;

[0025] The coating material is filtered through at least one sterilization filter.

[0026] Throughout the specification and the appended claims, the term "sterilizing filter" is used to refer to a filter with a sufficiently fine mesh size to intercept and capture at least 99%, preferably substantially 100%, of bacteria in the coating material.

[0027] The term "fluid connectivity" when referring to two or more components is used to indicate that these components are hydraulically connected so that fluid can flow from one component to another, possibly after a valve between these components is opened.

[0028] The term "thermal insulation material" is used to indicate that the thermal conductivity is equal to or less than 100%. Materials.

[0029] In at least one of the above aspects, the present invention may include one or more of the following features, which may exist individually or in combination with each other.

[0030] Preferably, the entire apparatus of the present invention, or at least the portion of the apparatus located upstream of the sterilization filter, is arranged within a laminar flow hood to be in an environment class suitable for the production of sterile parts (Class 5 of ISO 14644-1).

[0031] Preferably, the feed tank is kept at room temperature.

[0032] Preferably, the coating material is fed into the feed tank at room temperature.

[0033] Preferably, the coating material is kept at room temperature inside the feed tank.

[0034] Preferably, an auxiliary component is provided for pressurizing the coating material inside the feed tank.

[0035] Preferably, the auxiliary component is configured to provide sufficient pressure to the coating material in the feed tank to move the coating material from the feed tank toward the sterilization filter.

[0036] More preferably, the auxiliary component is configured to remove the coating material from the feed tank and pass it through a sterilization filter.

[0037] Preferably, the viscosity of the coating material is greater than 10000 cSt.

[0038] More preferably, the viscosity of the coating material is less than 15000 cSt.

[0039] In a particularly preferred embodiment, the viscosity is between 11,000 cSt and 14,000 cSt, more preferably between 12,000 cSt and 13,000 cSt, for example, about 12,500 cSt.

[0040] The applicant discovered that by providing a coating material with a viscosity an order of magnitude greater than the commonly used approximately 1000 cSt on injectable medical devices, the coating obtained in the injectable medical devices can more effectively maintain its lubricating properties over a longer period of time, and reduces the likelihood of the coating material releasing particles into the injectable medical device (which could thus alter the performance of the medical product injected by the injectable medical device).

[0041] Preferably, the feed tank includes at least one transparent wall section through which the level of coating material inside the feed tank can be checked without opening the feed tank.

[0042] Preferably, the mesh size of the at least one sterilization filter is less than 0.50 μm.

[0043] Preferably, the mesh size of the at least one sterilization filter is greater than 0.08 μm.

[0044] In a particularly preferred embodiment, the mesh size of the at least one sterilizing filter is between 0.10 μm and 0.35 μm, more preferably between 0.20 μm and 0.24 μm, for example, about 0.22 μm.

[0045] Preferably, the supply assembly includes a supply pump disposed between and in fluid communication with the at least one sterilizing filter and the output nozzle, the supply pump being configured to pump the coating material to the output nozzle.

[0046] Preferably, the supply pump is a positive displacement pump.

[0047] Preferably, the supply assembly includes a plurality of heating elements for heating the coating material removed from the feed tank before it is conveyed through the output nozzle. Indeed, the applicant has found that when heated, the coating material flows more readily through the various conduits and components of the device of the present invention, especially when using high-viscosity coating materials as in the preferred embodiment of the invention.

[0048] Preferably, the supply assembly includes a first storage tank located between and in fluid communication with the first sterilization filter and the output nozzle, wherein the first storage tank is used to receive and temporarily store coating material removed from the feed tank and to be supplied to the output nozzle.

[0049] Preferably, the first storage tank can be configured in a filling state, in which the first storage tank receives and stores the coating material removed from the feed tank.

[0050] Storing the sterilized coating material in the first tank allows the coating material to be supplied to the output nozzle when the feed tank is operated (e.g., cleaning or filling operation) or the first sterilized filter is operated (e.g., cleaning or replacement operation).

[0051] Preferably, a first level detector is provided to measure the level of the coating material in the first storage tank.

[0052] Preferably, the first level detector includes a weighing sensor for measuring the pressure of the coating material in the first storage tank.

[0053] Preferably, the first storage tank can be configured in a depressurized state, in which the coating material stored in the first storage tank is maintained at a pressure below atmospheric pressure.

[0054] Preferably, the pressure is between 50 mbar and 400 mbar, more preferably between 100 mbar and 300 mbar, for example, about 200 mbar.

[0055] Depressurizing the coating material in the first storage tank for a period of time can remove air bubbles that form after the coating material passes through the first sterilization filter. This measure is particularly useful when the viscosity of the coating material is particularly high, as air bubbles are more likely to form in such cases.

[0056] Preferably, when the first storage tank is under pressure, it is tightly isolated from other components of the device of the present invention.

[0057] Preferably, the first storage tank can be configured in a heated state, in which the coating material stored in the first storage tank is heated to a temperature of 100°C or higher, preferably 120°C.

[0058] Heating the coating material in the first tank improves its rheological properties (especially when the coating material has a high viscosity) and facilitates its supply to the output nozzle. This improved rheological properties allow for more uniform and precise delivery from the output nozzle, resulting in a uniform and thin coating on the medical device.

[0059] Preferably, the supply assembly includes at least one first heating element for heating the coating material stored in the first storage tank.

[0060] The first heating element can be any element configured to release heat energy and form a heat exchange relationship with the coating material stored in the first tank.

[0061] Preferably, the at least one first heating element is installed in a first insulating jacket that is at least partially made of insulating material and located outside the first storage tank.

[0062] The first heating element may include, for example, one or more resistors or one or more conduits formed within or associated with the first insulation jacket and in which heating fluid circulates.

[0063] In other embodiments, the first heating element is a heating coil (e.g., a resistor or a conduit through which a suitable heating fluid circulates) placed inside a first tank.

[0064] Preferably, the first storage tank can be detached from the first insulation jacket.

[0065] This makes it convenient to perform maintenance or cleaning operations on the first storage tank.

[0066] Preferably, the first temperature sensor is associated with the first storage tank so that the temperature reached by the coating material inside the first storage tank can be monitored.

[0067] Preferably, the first storage tank can be configured in a supply state, in which coating material stored in the first storage tank is removed from the first storage tank and supplied to the output nozzle.

[0068] Preferably, under the above-described supply conditions, the pressure of the coating material stored in the first storage tank is greater than atmospheric pressure.

[0069] Preferably, the pressure is less than 2.5 bar, more preferably less than 2 bar.

[0070] In this way, the coating material can flow smoothly out of the first storage tank, reducing the risk of cavitation in the supply pump.

[0071] Preferably, the first storage tank can be selectively configured in a filling state or a supply state.

[0072] Preferably, the first storage tank can be selectively configured in a filling state, a depressurization state, a heating state, or a supply state.

[0073] Preferably, the supply assembly includes a second storage tank located between and in fluid communication with the second sterilization filter and the output nozzle, wherein the second storage tank is configured to receive and temporarily store coating material removed from the feed tank and to be supplied to the output nozzle.

[0074] Preferably, the second storage tank can be configured in a filling state, in which the second storage tank receives and stores the coating material removed from the feed tank.

[0075] Storing the sterilized coating material in the second tank allows the coating material to be supplied from the feed tank to the second tank when the first tank is in a state unsuitable for receiving the coating material, such as when it is under pressure, heated, or being supplied. Furthermore, the coating material can also be supplied from the second tank to the output nozzle when more coating material is loaded into the first tank, when the first tank may be replaced, or when operations are performed on the feed tank (e.g., cleaning or filling operations) or on the first sterilization filter (e.g., cleaning or replacement operations).

[0076] Therefore, providing two storage tanks allows one tank to be filled with coating material from the feed tank, or to be cleaned or replaced, or to have its respective sterilization filter cleaned or replaced when it is installed upstream of each tank, while the other tank, which previously contained coating material, supplies coating material to the output nozzle, and vice versa, thereby achieving a substantially continuous supply of coating material to the output nozzle.

[0077] In some embodiments, the supply assembly includes a single sterilization filter arranged downstream of the feed tank and upstream of two storage tanks.

[0078] Preferably, a second level detector is provided to measure the liquid level of the coating material in the second storage tank.

[0079] Preferably, the second level detector includes a weighing sensor for measuring the pressure of the coating material in the second storage tank.

[0080] Preferably, the second storage tank can be configured in a depressurized state, in which the coating material stored in the second storage tank is maintained at a pressure less than atmospheric pressure.

[0081] Preferably, the pressure is between 50 mbar and 400 mbar, more preferably between 100 mbar and 300 mbar, for example, about 200 mbar.

[0082] Depressurizing the coating material in the second tank can remove air bubbles formed after the coating material passes through the second sterilization filter or a single sterilization filter upstream of both tanks.

[0083] Preferably, when the second storage tank is under pressure, it is tightly isolated from other components of the device of the present invention.

[0084] Preferably, the second storage tank can be configured in a heated state, in which the coating material stored in the second storage tank is heated to a temperature of 100°C or higher, preferably 120°C.

[0085] Heating the coating material in the second storage tank can improve the rheological properties of the coating material, as described above regarding the first storage tank.

[0086] Preferably, the supply assembly includes at least one second heating element for heating the coating material stored in the second storage tank.

[0087] The second heating element can be any element configured to release heat energy and form a heat exchange relationship with the coating material stored in the second tank.

[0088] Preferably, the at least one second heating element is installed in a second insulating jacket that is at least partially made of insulating material and located outside the second storage tank.

[0089] The second heating element may include, for example, one or more resistors or one or more conduits formed within or associated with the second insulation jacket and in which heating fluid circulates.

[0090] In other embodiments, the second heating element is a heating coil (e.g., a resistor or a conduit through which a suitable heating fluid circulates) placed inside a second tank.

[0091] Preferably, the second storage tank can be removed from the second insulation jacket for, for example, maintenance or cleaning operations.

[0092] Preferably, the second temperature sensor is associated with the second storage tank to monitor the temperature reached by the coating material inside the second storage tank.

[0093] Preferably, the second storage tank can be configured in a supply state, in which coating material stored in the second storage tank is removed from the second storage tank and supplied to the output nozzle.

[0094] In this way, the coating material, after proper filtration, degassing and heating, can be supplied from the second tank to the output nozzle while the first tank is being filled, depressurized or heated.

[0095] Preferably, under the above-described supply conditions, the pressure of the coating material stored in the second storage tank is greater than atmospheric pressure.

[0096] Preferably, the pressure is less than 2.5 bar, more preferably less than 2 bar, so as to facilitate the outflow of coating material from the second storage tank and reduce the risk of cavitation in the supply pump.

[0097] Preferably, the second storage tank can be selectively configured in a filling state or a supply state.

[0098] Preferably, the second storage tank can be selectively configured in a filling state, a depressurization state, a heating state, or a supply state.

[0099] Preferably, the control unit is operatively connected to the first and second storage tanks.

[0100] Preferably, the control unit is configured to set the supply state in the first storage tank when the second storage tank is in the filling state.

[0101] Preferably, the control unit is configured to set the supply state in the first storage tank when the second storage tank is in a depressurization state.

[0102] Preferably, the control unit is configured to set the supply state in the first storage tank when the second storage tank is in a heating state.

[0103] Preferably, the control unit is configured to set the supply state in the second storage tank when the first storage tank is in the filling state.

[0104] Preferably, the control unit is configured to set the supply state in the second storage tank when the first storage tank is in a depressurization state.

[0105] Preferably, the control unit is configured to set the supply state in the second storage tank when the first storage tank is in a heating state.

[0106] Preferably, the control unit is configured to control the first heating element based on a signal received from the first temperature sensor.

[0107] Preferably, the control unit is configured to control the second heating element based on a signal received from the second temperature sensor.

[0108] Preferably, the control unit is configured to switch from a heating state to a supply state of the first storage tank based on a signal received from a first temperature sensor.

[0109] Preferably, the control unit is configured to switch from a heating state to a supply state of the second storage tank based on a signal received from a second temperature sensor.

[0110] Preferably, the control unit is configured to switch from a filling state to a depressurization state of the first storage tank based on a signal received from the first level detector.

[0111] Preferably, the control unit is configured to switch from the filling state of the second storage tank to the depressurization state based on a signal received from the second level detector.

[0112] Preferably, the control unit is configured to switch from a supply state to a filling state of the first storage tank based on a signal received from the first level detector.

[0113] Preferably, the control unit is configured to switch from the supply state of the second storage tank to the filling state based on a signal received from the second level detector.

[0114] Preferably, the supply component includes a first fluid circuit, with a first end connected to the feed tank, a second end connected to the first storage tank, and a third end connected to the second storage tank.

[0115] Preferably, the supply component includes a second fluid circuit, with a first end connected to the first storage tank, a second end connected to the second storage tank, and a third end connected to the output nozzle.

[0116] Preferably, the first fluid circuit includes a first conduit connecting the feed tank to the first sterilization filter, a second conduit connecting the first sterilization filter to the first storage tank, a third conduit connecting the feed tank to the second sterilization filter, and a fourth conduit connecting the second sterilization filter to the second storage tank.

[0117] Preferably, the first catheter and the third catheter can be completely independent of each other, or they can share a common catheter branch.

[0118] Preferably, the supply pump belongs to the second fluid circuit.

[0119] Preferably, the first conduit of the second fluid circuit connects the first storage tank to the supply pump.

[0120] Preferably, the second conduit of the second fluid circuit connects the second storage tank to the supply pump.

[0121] Preferably, the third conduit of the second conduit connects the supply pump to the output nozzle.

[0122] Preferably, the supply assembly includes at least one heat-insulating jacket detachably disposed around at least a portion of the second fluid circuit.

[0123] Removing the insulation jacket from a portion of the second fluid circuit (on which the insulation jacket rests) allows for easy disassembly of this portion of the circuit, which is necessary for periodic cleaning of this part of the circuit. This periodic cleaning is especially necessary when the coating material used is high-viscosity silicone.

[0124] Preferably, the supply assembly includes at least one third heating element for heating at least a portion of the second fluid circuit.

[0125] The third heating element can maintain the coating material in the second fluid circuit at a certain temperature, for example, to optimize the rheological properties of the coating material, promote its flow in the second fluid circuit, and make the output nozzle spray uniformly.

[0126] Preferably, the at least one third heating element is arranged within the at least one heat-insulating jacket.

[0127] Preferably, the at least one third heating element comprises a resistor.

[0128] Preferably, the supply component includes at least one temperature sensor associated with the insulation jacket.

[0129] Preferably, the temperature sensor is integrated into the at least one heat insulation jacket.

[0130] Preferably, the control unit is configured to control the at least one third heating element based on signals received from each temperature sensor.

[0131] In a particularly preferred embodiment, a first heat insulation jacket is provided on the first conduit of the second fluid circuit.

[0132] Preferably, a second heat insulation jacket is provided on the second conduit of the second fluid circuit.

[0133] Preferably, a third heat insulation jacket is provided on the third conduit of the second fluid circuit.

[0134] Therefore, all the conduits connecting the first and second storage tanks to the supply pump and the supply pump to the output nozzle can be disassembled, cleaned, replaced, or reassembled, as each conduit is equipped with its own removable heat insulation jacket.

[0135] Preferably, the first conduit and the second conduit of the second fluid circuit have equal lengths.

[0136] Preferably, the first conduit and the second conduit of the second fluid circuit have equal fluid channel cross-sections.

[0137] Preferably, the first and second conduits of the second fluid circuit have a constant fluid channel cross-section.

[0138] In this way, the properties of the coating material supplied from the first or second storage tank to the output nozzle will not change.

[0139] Preferably, when the coating material is fed into the feed tank, the feed tank is under atmospheric pressure.

[0140] Preferably, removing the coating material from the feed tank includes pressurizing the feed tank.

[0141] Preferably, filtering the coating material after it has been removed from the feed tank includes passing the coating material through a sterilization filter under pressure in the feed tank.

[0142] Preferably, the coating material removed from the feed tank is heated when supplied to the output nozzle while the feed tank is kept at room temperature.

[0143] Preferably, the coating material removed from the feed tank is filtered while being kept at room temperature and then heated.

[0144] Preferably, the coating material to be supplied to the output nozzle from the feed tank is selectively introduced into the first or second storage tank.

[0145] Preferably, the coating material selectively enters the first or second storage tank due to the pressurization of the feed tank.

[0146] Preferably, when the coating material is supplied from the first storage tank to the output nozzle, the coating material stored in the first storage tank is maintained at a value of less than 2.5 bar, more preferably less than 2 bar.

[0147] Preferably, when the coating material is supplied from the first storage tank to the output nozzle, the pressure of the coating material stored in the first storage tank is maintained at a value greater than atmospheric pressure.

[0148] Preferably, when the coating material is supplied from the second storage tank to the output nozzle, the pressure of the coating material stored in the second storage tank is maintained at less than 2.5 bar, more preferably less than 2 bar.

[0149] Preferably, when the coating material is supplied from the second storage tank to the output nozzle, the pressure of the coating material stored in the second storage tank is maintained at a value greater than atmospheric pressure.

[0150] Preferably, supplying the coating material to the output nozzle includes selectively supplying the coating material from either the first or second storage tank to the output nozzle.

[0151] Preferably, a depressurized state is established in the first storage tank before the coating material is supplied from the first storage tank to the output nozzle.

[0152] Preferably, creating a depressurization state in the first storage tank includes reducing the pressure of the coating material in the first storage tank to a value below atmospheric pressure, preferably between 50 mbar and 400 mbar, more preferably between 100 mbar and 300 mbar, for example, about 200 mbar.

[0153] Preferably, the depressurization state in the first storage tank is maintained for 5 to 30 minutes.

[0154] Preferably, a depressurization cycle is performed in the first storage tank, in which case the pressurization condition is maintained for at least 20 minutes.

[0155] Alternatively, several depressurization cycles (e.g., 3-4 cycles) can be performed in the first tank, in which case the pressurized state is maintained for about 5 minutes in each depressurization cycle.

[0156] Preferably, the first storage tank is tightly isolated from the feed tank and the output nozzle before the depressurization state is established in the first storage tank.

[0157] Preferably, a depressurized state is established in the second storage tank before the coating material is supplied from the second storage tank to the output nozzle.

[0158] Preferably, creating a depressurization state in the second storage tank includes reducing the pressure of the coating material in the second storage tank to a value below atmospheric pressure, preferably between 50 mbar and 400 mbar, more preferably between 100 mbar and 300 mbar, for example, about 200 mbar.

[0159] Preferably, the depressurization state in the second storage tank is maintained for 5 to 30 minutes.

[0160] Preferably, a depressurization cycle is performed in the second storage tank, in which case the pressurization state is maintained for at least 20 minutes.

[0161] Alternatively, several depressurization cycles (e.g., 3-4 cycles) can be performed in the second tank, in which case the pressurized state is maintained for about 5 minutes in each depressurization cycle.

[0162] Preferably, the second storage tank is tightly isolated from the feed tank and the output nozzle before the reduced pressure state is established in the second storage tank.

[0163] Preferably, the first storage tank is heated before the coating material is supplied from the first storage tank to the output nozzle.

[0164] Preferably, the coating material stored in the first storage tank is heated to a temperature of 100°C or higher, more preferably 120°C, before the coating material is supplied from the first storage tank to the output nozzle.

[0165] Preferably, the second storage tank is heated before the coating material is supplied from the second storage tank to the output nozzle.

[0166] Preferably, the coating material stored in the second storage tank is heated to a temperature of 100°C or higher, more preferably 120°C, before the coating material is supplied from the second storage tank to the output nozzle.

[0167] Preferably, after the pressure reduction state is established in the first storage tank, the first storage tank is heated.

[0168] Preferably, after the pressure reduction state is established in the second storage tank, the second storage tank is heated.

[0169] Preferably, supplying the coating material from the first tank to the output nozzle includes pressurizing the first tank after the depressurization state has been formed in the first tank.

[0170] Preferably, supplying the coating material from the second tank to the output nozzle includes pressurizing the second tank after the depressurization state is formed in the second tank. Brief description of the attached figures

[0171] The features and advantages of the present invention will become apparent from the following detailed description of some embodiments of the invention with reference to the accompanying drawings, wherein these embodiments are provided by way of non-limiting example only, in which:

[0172] Figure 1 An apparatus for applying a coating to an injectable medical device according to an embodiment of the present invention is shown;

[0173] Figure 2 It shows Figure 1 A schematic diagram showing the first detail of the device;

[0174] Figure 3 It shows Figure 1 A schematic diagram showing the second detail of the device;

[0175] Figure 4 It shows Figure 1 A schematic diagram showing the third detail of the device. Detailed Implementation

[0176] Figure 1 The subject of the invention—an apparatus for coating an injection medical device—is schematically illustrated, denoted by reference numeral 1.

[0177] The equipment 1 includes an inlet tank 10, which can be filled with coating material by an operator.

[0178] The feed tank 10 includes an access sleeve 11 through which the coating material enters.

[0179] The inlet sleeve 11 is configured to allow for a tight seal isolation of the feed tank 10 by, for example, closing a special valve (not shown).

[0180] Equipment 1 or at least feed tank 10 and inlet sleeve 11 are arranged inside a laminar flow hood.

[0181] The feed tank 10 includes a sidewall 10a, preferably cylindrical. At least a portion of the sidewall 10a is made of a material that is at least partially transparent, such as glass, so that an operator can check the content of the coating material inside the feed tank 10 without opening the feed tank 10. The sidewall 10a has a scale for measuring the amount of coating material inside the feed tank 10.

[0182] The feed tank 10 also includes a lower wall 10b and an upper wall 10c, preferably made of stainless steel. A side wall 10a extends between the lower wall 10b and the upper wall 10c.

[0183] The feed tank 10 is configured to gradually release the coating material. The feed tank 10 is maintained at room temperature. The coating material enters and remains at room temperature.

[0184] The device 1 includes a supply assembly 20 for removing coating material from the feed tank 10.

[0185] The auxiliary component (service member) 21 is associated with the feed tank 10.

[0186] The auxiliary component 21 is used to pressurize the coating material in the feed tank 10 so that it flows out into the supply component 20.

[0187] Auxiliary components 21 may include, for example, a pressure pump or a compressed air line connected to a compressor.

[0188] The supply assembly 20 includes a first fluid circuit 22 in fluid communication with the feed tank 10 for receiving coating material flowing out of the feed tank 10. In particular, the first fluid circuit 22 includes a first end 23 at which it is connected to the feed tank 10.

[0189] The supply assembly 20 also includes a first sterilization filter 30a for filtering the coating material flowing from the feed tank 10. The first sterilization filter 30a is configured to remove biological contaminants from the coating material, preferably all of them.

[0190] In a preferred embodiment, the mesh size of the first sterilization filter 30a is 0.22 μm (micrometers).

[0191] The first sterilization filter 30a is located in the first fluid circuit 22 and is in fluid communication with the feed tank 10 through a first conduit. The first conduit has a first conduit branch 31 extending from the feed tank 10 to the first connector 33 and a second conduit branch 32a extending from the first connector 33 to the first sterilization filter 30a.

[0192] The first catheter branch 31 and the second catheter branch 32a are preferably made of stainless steel or high-temperature resistant plastic materials, such as PTFE (polytetrafluoroethylene) or FEP (fluorinated ethylene propylene).

[0193] The auxiliary component 21 is used to provide sufficient pressure to the coating material so that it passes through the first sterilization filter 30a at a predetermined flow rate.

[0194] Supply component 20 also includes a first storage tank 40, such as Figure 2 As shown, it is preferably made of stainless steel.

[0195] The first storage tank 40 is located downstream of the first sterilization filter 30a and is in fluid communication with the feed tank 10 through the first sterilization filter 30a, so as to temporarily store the coating material removed from the feed tank 10 and filtered by the first sterilization filter 30a.

[0196] The first fluid circuit 22 includes a second conduit 41 extending from the first sterilization filter 30a to the first storage tank 40, thereby enabling fluid communication between the first sterilization filter 30a and the first storage tank 40. The first fluid circuit 22 also includes a second end 42, through which the first fluid circuit 22 is connected to the first storage tank 40, and through which the coating material enters the first storage tank 40.

[0197] The second conduit 41 is preferably made of stainless steel or high-temperature resistant plastic material, such as PTFE or FEP.

[0198] The pressure provided by the auxiliary component 21 to the coating material causes the coating material to flow from the feed tank 10 through the first conduit branch 31, the second conduit branch 32a, the first sterilization filter 30a and the second conduit 41, until it reaches the first storage tank 40.

[0199] A first pressurization member 44 (e.g., a pressure pump or a compressed air line connected to a compressor) is associated with a first storage tank 40 to selectively and in a controlled manner pressurize the coating material stored in the first storage tank 40. Specifically, the first pressurization member 44 is configured to pressurize the coating material in the first storage tank 40 to a pressure greater than atmospheric pressure and less than 2.5 bar, preferably less than 2 bar.

[0200] A first pressure-reducing component 45 (such as a vacuum pump) is associated with a first storage tank 40 to selectively and in a controlled manner reduce the pressure of the coating material stored in the first storage tank 40. Specifically, the first pressure-reducing component 45 is configured to reduce the pressure of the coating material in the first storage tank 40 to less than atmospheric pressure, preferably between 50 mbar and 400 mbar, more preferably between 100 mbar and 300 mbar, for example, about 200 mbar.

[0201] The first storage tank 40 includes a first fill level detector 46 for detecting the fill level of the first storage tank 40. For example, the first fill level detector 46 may include a load cell for measuring the pressure of the coating material inside the first storage tank 40.

[0202] A first heating element 47 is associated with a first storage tank 40 to selectively and in a controlled manner heat the first storage tank 40 and the coating material therein. The first heating element 47 is detachably mounted on the first storage tank 40, preferably mounted on the outside of the first storage tank 40.

[0203] In a preferred embodiment, the first heating element 47 is integrated in a first insulating jacket 48, which is at least partially made of insulating material and is positioned outside the first tank 40. The first heating element 47 may include, for example, a resistor or a heating tube (coil) in which heating fluid circulates.

[0204] The first thermal insulation jacket 48 is used to provide thermal insulation for the first storage tank 40 to prevent heat loss from the first heating element 47. The first storage tank 40 can be removed from the first thermal insulation jacket 48, for example, for maintenance or cleaning operations.

[0205] The first temperature sensor 49a is associated with the first insulation jacket 48, and therefore also with the first storage tank 40, for monitoring the temperature of the first insulation jacket 48 and (therefore) the temperature of the first storage tank 40 and the temperature of the coating material contained in the first storage tank 40. Preferably, the first temperature sensor 49a includes a temperature sensor disposed within the first insulation jacket 48 to detect whether the temperature of the coating material contained in the first storage tank 40 reaches 120°C.

[0206] The supply assembly 20 also includes a second sterilization filter 30b and a second storage tank 50 located downstream of the second sterilization filter 30b. A schematic diagram of the second sterilization filter 30b and the second storage tank 50 is shown below. Figure 3 As shown, they are similar to the first sterilization filter 30a and the first storage tank 40, respectively.

[0207] The second sterilization filter 30b is used to filter the coating material removed from the feed tank 10 and supplied to the second storage tank 50.

[0208] Similar to the first sterilization filter 30a, the second sterilization filter 30b is also used to remove biological contaminants from the coating material, preferably all of them, and has a mesh size of 0.22 μm.

[0209] The second sterilization filter 30b is disposed in the first fluid circuit 22 and is in fluid communication with the feed tank 10 through a third conduit. The third conduit includes a first conduit branch 31 extending from the feed tank 10 to the first connector 33 and a third conduit branch 32b extending from the first connector 33 to the second sterilization filter 30b.

[0210] The third conduit branch 32b is also preferably made of stainless steel or high-temperature resistant plastic material, such as PTFE or FEP.

[0211] The auxiliary component 21 is configured to provide sufficient pressure to the coating material so that it passes through the second sterilization filter 30b at a predetermined flow rate.

[0212] The second storage tank 50 is in fluid communication with the feed tank 10 via the second sterilization filter 30b. The second storage tank 50 is used to temporarily store the coating material removed from the feed tank 10 and filtered by the second sterilization filter 30b.

[0213] In a preferred embodiment, the second storage tank 50 is made of stainless steel.

[0214] The first fluid circuit 22 includes a fourth conduit 51 extending from the second sterilization filter 30b to the second storage tank 50 for fluid communication between the second sterilization filter 30b and the second storage tank 50.

[0215] The second fluid circuit 22 also includes a third end 52, at which the first fluid circuit 22 is connected to the second storage tank 50, and the coating material enters the second storage tank 50 through this end.

[0216] The fourth conduit 51 is preferably made of stainless steel or high-temperature resistant plastic material, such as PTFE or FEP.

[0217] The coating material can enter the second storage tank 50 from the feed tank 10. The pressure provided by the auxiliary component 21 to the coating material causes the coating material to flow from the feed tank 10 through the first conduit branch 31, the third conduit branch 32b, the second sterilization filter 30b and the fourth conduit 51 until it reaches the second storage tank 50.

[0218] In an embodiment not shown, device 1 includes a single sterile filter in place of the two sterile filters 30a and 30b described above. This single sterile filter may be disposed within the first conduit branch 31, while the first connector 33 may be disposed between the single sterile filter, the first storage tank 40, and the second storage tank 50. Alternatively, the single sterile filter may be placed at the first connector 33. In both cases, the second conduit branch 32a and the second conduit 41 constitute a single conduit.

[0219] Through the first connector 33, the coating material can flow alternately and in a controllable manner from the feed tank 10 through the first conduit branch 31, the second conduit branch 32a, the first sterilization filter 30a, and the second conduit 41 to the first storage tank 40, or from the feed tank 10 through the first conduit branch 31, the third conduit branch 32b, the second sterilization filter 30b, and the fourth conduit 51 to the second storage tank 50.

[0220] like Figure 1 As shown, the first fluid circuit 22 includes an inlet valve 43, for example, located at the connector 33, for isolating the first tank 40 or the second tank 50 from the first fluid circuit 22 in a controlled manner.

[0221] The inlet valve 43 is controlled to selectively guide the coating material from the feed tank 10 to the first storage tank 40 or the second storage tank 50.

[0222] Preferably, the inlet valve 43 is a three-way valve.

[0223] Alternatively, a first inlet valve, for example located at the second end 42, and a second inlet valve, for example located at the third end 52, may be provided to isolate the first storage tank 40 or the second storage tank 50 from the first fluid circuit 22 in a controlled manner, respectively.

[0224] A second pressurizing component 54, such as a pressure pump or a compressed air line connected to a compressor, is associated with a second storage tank 50 to selectively and in a controlled manner pressurize the coating material stored in the second storage tank 50. The second pressurizing component 54 is configured to pressurize the coating material in the second storage tank 50 to a pressure greater than atmospheric pressure and less than 2.5 bar, preferably less than 2 bar.

[0225] A second pressure-reducing component 55 (such as a vacuum pump) is associated with the second storage tank 50 to selectively and in a controlled manner reduce the pressure of the coating material stored in the second storage tank 50. The second pressure-reducing component 55 is used to reduce the pressure of the coating material in the second storage tank 50 to below atmospheric pressure, preferably between 50 mbar and 400 mbar, more preferably between 100 mbar and 300 mbar, for example, about 200 mbar.

[0226] The second storage tank 50 includes a second level detector 56 for detecting the filling level of the second storage tank 50. The second level detector 56 may include, for example, a weighing sensor for measuring the pressure of the coating material in the second storage tank 50.

[0227] The second heating element 57 is associated with the second storage tank 50 to heat the coating material therein in a controlled manner. The second heating element 57 is detachably mounted on the second storage tank 50, preferably mounted on the outside of the second storage tank 50.

[0228] In a preferred embodiment, the second heating element 57 is integrated into a second insulating jacket 58, which is at least partially made of insulating material and is positioned outside the second tank 50. The second heating element 57 may include, for example, a resistor or a heating tube (coil) in which heating fluid circulates.

[0229] The second insulation jacket 58 is used to provide thermal insulation for the second storage tank 50 to prevent the heat provided by the second heating element 57 from being lost. The second storage tank 50 can be removed from the second insulation jacket 58, for example, for maintenance or cleaning operations.

[0230] The second temperature sensor 59a is associated with the second insulation jacket 58 and (therefore) the second storage tank 50 for measuring the temperature of the second insulation jacket 58 and (therefore) the temperature of the second storage tank 50 and the coating material contained therein. Preferably, the second temperature sensor 59a includes a temperature sensor located inside the second insulation jacket 58 for detecting whether the temperature of the coating material contained in the second storage tank 50 reaches 120°C.

[0231] The supply assembly 20 also includes a second fluid circuit 60 in fluid communication with the first storage tank 40 and the second storage tank 50.

[0232] The second fluid circuit 60 includes a first end 61 connected to the first storage tank 40 and a second end 62 connected to the second storage tank 50.

[0233] like Figure 2 and Figure 3As shown, a first outlet valve 64 is installed, for example, at a first end 61, for controlling the isolation of the first storage tank 40 from the second fluid circuit 60. Similarly, a second outlet valve 65 is arranged, for example, at a second end 62, for controlling the isolation of the second storage tank 50 from the second fluid circuit 60.

[0234] like Figure 1 As shown, the supply assembly 20 also includes a supply pump 70 in fluid communication with the first storage tank 40 and the second storage tank 50. The supply pump 70 is arranged in the second fluid circuit 60 and is preferably a volumetric pump.

[0235] In a preferred embodiment, the supply pump 70 includes a heating element 70a for heating the coating material within the pump. For example, the heating element 70a may include one or more resistors mounted on or integrated into the housing of the supply pump 70.

[0236] The second fluid circuit 60 includes a first conduit 71 connecting the first tank 40 to the supply pump 70 and a second conduit 72 connecting the second tank 50 to the suction head of the supply pump 70.

[0237] The first conduit 71 and the second conduit 72 are preferably made of stainless steel or high-temperature resistant plastic materials, such as PTFE or FEP.

[0238] The first conduit 71 and the second conduit 72 converge at the second joint 73 located between the first storage tank 40, the second storage tank 50, and the supply pump 70. (As follows) Figure 1 As shown, the first conduit 71 and the second conduit 72 may include a common portion between the second connector 73 and the supply pump 70.

[0239] Preferably, the lengths and fluid channel cross-sections of the first conduit 71 and the second conduit 72 are equal. Furthermore, the first conduit 71 and the second conduit 72 have constant fluid channel cross-sections along their lengths.

[0240] The coating material can be selectively and in a controlled manner supplied to the supply pump 70 from the first tank 40 through the first conduit 71 or from the second tank 50 through the second conduit 72.

[0241] The first outlet valve 64 and the second outlet valve 65 can be controlled to allow the coating material to be supplied alternately from the first storage tank 40 or the second storage tank 50.

[0242] The device 1 includes at least one output nozzle 80 for delivering coating material and maintaining fluid communication with the supply component 20.

[0243] The second fluid circuit 60 includes a third conduit 81 extending from the supply pump 70 (particularly from the delivery head of the supply pump 70) to the output nozzle 80 to maintain fluid communication between the supply pump 70 and the output nozzle 80. The second fluid circuit 60 also includes a third end 82, which is connected to the output nozzle 80 and through which the coating material is delivered to the output nozzle 80.

[0244] The third conduit 81 is preferably made of stainless steel or high-temperature resistant plastic material, such as PTFE or FEP.

[0245] Multiple third heating elements 90 are associated with the second fluid circuit 60 for heating the coating material flowing therein. One of the third heating elements 90 is schematically shown as... Figure 4 As shown.

[0246] In a preferred embodiment, the third heating element is integrated in a respective heat-insulating jacket 91 made of heat-insulating material and is detachably mounted on a respective portion of the second fluid circuit 60.

[0247] For example, the third heating element 90 may include a resistor or a heating conduit through which heating fluid circulates.

[0248] like Figure 4 As shown, each heat insulation jacket 91 also includes a temperature sensor 92 for measuring the temperature of the portion of the third heating element 90 acting in the second fluid circuit 60.

[0249] exist Figure 1 In the illustrated embodiment, a first heat insulation jacket 91a and an associated heating element 90 of a plurality of heat insulation jackets 91 are applied to the portion of the first conduit 71 extending from the first end 61 to the second connector 73; a second heat insulation jacket 91b and an associated third heating element 90 of a plurality of heat insulation jackets 91 are applied to the portion of the second conduit 72 extending from the second end 62 to the second connector 73; a third heat insulation jacket 91d and an associated third heating element 90 of a plurality of heat insulation jackets 91 are applied to the common portion of the first conduit 71 and the second conduit 72 extending from the second connector 73 to the supply pump 70; and a fourth heat insulation jacket 91c and an associated third heating element 90 of a plurality of heat insulation jackets 91 are applied to the third conduit 81 extending from the supply pump 70 to the output nozzle 80.

[0250] In its preferred embodiment, the device 1 includes a plurality of output nozzles 80 and a plurality of corresponding third conduits 81, each including a respective fourth heat insulation jacket 91c and a respective third heating element 90.

[0251] Each output nozzle 80 is used to spray the coating material onto its respective injection medical device.

[0252] Each output nozzle 80 may be equipped with its own heating element 85 for heating the delivered coating material. For example, such a heating element may be a resistor applied to the output nozzle 80 or a resistor integrated into the output nozzle 80.

[0253] Each output nozzle 80 is configured to atomize the coating material by supplying pressurized gas from a suitable delivery gas (e.g., compressed air) source 100. The gas source 100 is configured to deliver gas at a pressure of 5 psi (0.34 bar) to 150 psi (10.34 bar), more preferably about 30 psi (2.07 bar).

[0254] The gas source 100 is associated with each output nozzle 80 via a corresponding conduit 101.

[0255] Device 1 includes a movable support frame for supporting multiple injection medical devices, particularly the cylinders of individual syringes.

[0256] The output nozzle 80 and the syringe cylinder support can move relative to each other to insert / remove each output nozzle 80 into / out of its respective cylinder.

[0257] In a preferred embodiment, the relative movement between the output nozzle 80 and the cylindrical support frame is achieved by moving the cylindrical support frame relative to the fixed output nozzle 80.

[0258] The first storage tank 40 can be configured in a filling condition to receive and store coating material removed from the feed tank 10. In the filling condition, the inlet valve 43 is open toward the second conduit branch 32a and closed toward the third conduit branch 32b.

[0259] The first storage tank 40 can also be configured in a depressurized state, in which the coating material therein is depressurized to remove air bubbles. In this depressurized state, the inlet valve 43 is closed to the second conduit branch 32a, the first outlet valve 64 is closed, and the first pressure-reducing component 45 is open.

[0260] The first storage tank 40 can also be configured in a heated state, in which the coating material therein is heated. In this heated state, the inlet valve 43 is closed to the second conduit branch 32a, the first outlet valve 64 is closed, and the first heating element 47 is turned on.

[0261] The first storage tank 40 can also be configured in a supply state, in which the coating material therein is removed and supplied to the output nozzle 80. In this supply state, the inlet valve 43 is closed to the second conduit branch 32a, the first outlet valve 64 is open, and the first pressurizing element 44 is activated.

[0262] Similarly, the second storage tank 50 can also be configured in a filling state, in which it receives and stores the coating material removed from the feed tank 10. In this filling state, the inlet valve 43 is open toward the third conduit branch 32b and closed toward the first conduit branch 32a.

[0263] The second storage tank 50 can also be configured in a depressurized state, in which the coating material stored therein is depressurized to remove air bubbles. In this depressurized state, the inlet valve 43 is closed to the third conduit branch 32b, the second outlet valve 65 is closed, and the second depressurization member 55 is open.

[0264] The second storage tank 50 can also be configured in a heated state, in which the coating material stored therein is heated. In this heated state, the inlet valve 43 is closed to the third conduit branch 32b, the second outlet valve 65 is closed, and the second heating element 57 is turned on.

[0265] The second storage tank 50 can also be configured in a supply state, in which the coating material stored in the tank is removed and supplied to the output nozzle 80. In this supply state, the inlet valve 43 is closed to the third conduit branch 32b, the second outlet valve 65 is open, and the second pressurizing member 54 is activated.

[0266] The device 1 also includes a control unit 5, which is operatively connected to at least the inlet valve 43, the first outlet valve 64, the second outlet valve 65, the first pressurizing component 44, the first depressurizing component 45, the first heating element 47, the second pressurizing component 54, the second depressurizing component 55, and the second heating element 57.

[0267] The control unit 5 is configured to alternately set the first storage tank 40 and the second storage tank 50 to the supply state, and to alternately maintain the first storage tank 40 or the second storage tank 50 in the supply state after the initial transient.

[0268] When one of the first storage tank 40 and the second storage tank 50 is in a supply state, the control unit 5 configures the other of the first storage tank 40 and the second storage tank 50 to a filling state, then a depressurization state, and then a heating state. In particular, the control unit 5 is configured to maintain the depressurization state for 5 to 30 minutes.

[0269] To apply a coating material to the injectable medical device, the coating material is fed into the feed tank 10. Preferably, the coating material comprises silicone oil. Preferably, the viscosity of the injected coating material is greater than 10,000 cSt, between 11,000 cSt and 14,000 cSt, more preferably between 12,000 cSt and 13,000 cSt, for example, about 12,500 cSt. Preferably, the coating material is not pre-sterilized. Preferably, the coating material and the feed tank are at room temperature.

[0270] Subsequently, the coating material is removed from the feed tank 10, and the coating material in the feed tank 10 is pressurized by the auxiliary component 21. The coating material thus leaves the feed tank 10, flows into the first conduit branch 31, and flows into the second conduit branch 32a through the first connector 33 and the inlet valve 43. In this case, the inlet valve 43 is open towards the second conduit branch 32a and closed towards the third conduit branch 32b.

[0271] Then, the coating material is filtered through the first sterilization filter 30a and enters the first storage tank 40 through the second conduit 41.

[0272] In this way, the coating material is stored in the first storage tank 40.

[0273] Subsequently, the second conduit branch 32a is closed by the inlet valve 43 to isolate the coating material stored in the first storage tank 40.

[0274] Next, the coating material stored in the first storage tank 40 is depressurized. This depressurization is performed by the first depressurization member 45. The pressure of the coating material in the first storage tank 40 is reduced to a value below atmospheric pressure, preferably between 50 mbar and 400 mbar, more preferably between 100 mbar and 300 mbar, for example, about 200 mbar, for a duration of 5 to 30 minutes, in order to remove any air bubbles.

[0275] After the coating material stored in the first storage tank 40 is depressurized, it is heated by the first heating element 47. In particular, the coating material is heated to 100°C or higher, preferably 120°C. Alternatively, the coating material may be heated before or during the depressurization of the first storage tank 40.

[0276] After the coating material enters the first storage tank 40, the inlet valve 43 closes the second conduit branch 32a and opens the third conduit branch 32b. In this way, the coating material can enter the second storage tank 50 from the feed tank 10 through the second sterilization filter 30b.

[0277] The coating material is therefore stored in the second storage tank 50.

[0278] Next, the third conduit branch 32b is closed via inlet valve 43 to isolate the coating material stored in the second storage tank 50.

[0279] Next, the coating material stored in the second tank 50 is depressurized. This depressurization is performed by the second depressurization member 55. The pressure of the coating material in the second tank 50 is reduced to a value below atmospheric pressure, preferably between 50 mbar and 400 mbar, more preferably between 100 mbar and 300 mbar, for example, about 200 mbar, for a duration of 5 to 30 minutes to remove any air bubbles.

[0280] After the coating material stored in the second storage tank 50 is depressurized, it is heated by the second heating element 57. In particular, the coating material is heated to 100°C or higher, preferably 120°C. Alternatively, the coating material may be heated before or during the depressurization of the second storage tank 50.

[0281] Subsequently, by operating the supply pump 70, the first outlet valve 64 is opened while the second outlet valve 65 remains closed. The coating material in the first storage tank 40 is pressurized by the first pressurizing member 44, and the coating material is delivered from the first storage tank 40 to the output nozzle 80. The pressure of the coating material in the first storage tank 40 is increased to a value greater than atmospheric pressure and less than 2.5 bar, preferably less than 2 bar.

[0282] In this way, the coating material will flow out from the first storage tank 40, pass through the first conduit 71, the supply pump 70 and the third conduit 81, until it reaches the output nozzle 80.

[0283] When the coating material is conveyed from the first storage tank 40 to the output nozzle 80, the coating material is further heated, particularly by the third heating element 90.

[0284] As the coating material is conveyed from the first storage tank 40 to the output nozzle 80, more coating material from the feed tank 10 is fed into the second storage tank 50 as described above, where it is stored, depressurized, and heated.

[0285] When the coating material in the first storage tank 40 exceeds or falls below a predetermined minimum level, the supply of coating material from the first storage tank 40 to the output nozzle 80 is interrupted, specifically by closing the first outlet valve 64. Next, coating material is supplied from the second storage tank 50 to the output nozzle 80. In this way, the supply of coating material to the output nozzle 80 is not interrupted.

[0286] To deliver the coating material from the second storage tank 50 to the output nozzle 80, the second outlet valve 64 is opened while the first outlet valve 65 remains closed. The coating material is pressurized in the second storage tank 50, particularly by the second pressurizing member 54. The pressure of the coating material in the second storage tank 50 is increased to a value greater than atmospheric pressure and less than 2.5 bar, preferably less than 2 bar.

[0287] In this way, the coating material flows out from the second storage tank 50, passes through the second conduit 72, the supply pump 70 and the third conduit 81, until it reaches the output nozzle 80.

[0288] When the coating material is conveyed from the second storage tank 50 to the output nozzle 80, the coating material is further heated, particularly by the third heating element 90.

[0289] As the coating material is conveyed from the second storage tank 50 to the output nozzle 80, more coating material from the feed tank 10 is fed into the first storage tank 40 as described above, where it is stored, depressurized, and heated.

[0290] When the coating material in the second storage tank 50 exceeds or falls below a predetermined minimum level, the process of supplying the coating material from the second storage tank 50 to the output nozzle 80 will be interrupted, specifically by closing the second outlet valve 65. Subsequently, the cycle is restarted by supplying the coating material from the first storage tank 40 to the output nozzle 80.

[0291] By supplying pressurized gas from gas source 100, the coating material supplied to output nozzle 80 is atomized in output nozzle 80.

[0292] The atomized coating material is then delivered from the output nozzle 80 to the injection medical device to obtain an average thickness (measured by optical reflectometry) between 100 nm and 200 nm on the latter, wherein the standard deviation of the thickness is 50 nm or less, preferably 40 nm or less, more preferably 30 nm or less, and even more preferably 20 nm or less.

[0293] Of course, those skilled in the art can make many modifications and variations to the invention to meet specific and occasional needs, but all such modifications and variations fall within the scope of protection defined by the claims.

Claims

1. An apparatus for applying a coating to an injectable medical device, the apparatus comprising: A feed tank capable of holding coating materials; Output nozzle; A supply assembly is located between and in fluid communication with the feed tank and the output nozzle, the supply assembly being configured to remove the coating material from the feed tank and deliver the coating material to the output nozzle; The feature is that the output nozzle is used to deliver the coating material to an injectable medical device, and the supply assembly includes at least one sterile filter for filtering the coating material removed from the feed tank.

2. The device according to claim 1, characterized in that, The supply assembly includes a first storage tank located between and in fluid communication with the first sterilizing filter and the output nozzle, wherein the first storage tank is configured to receive and temporarily store coating material removed from the feed tank and to be supplied to the output nozzle; and The first storage tank may be selectively configured in the following states: In the filling state, the first storage tank receives and stores the coating material removed from the feed tank; In the supply state, coating material stored in the first storage tank is removed from the first storage tank and supplied to the output nozzle.

3. The device according to claim 2, characterized in that, The supply assembly includes a second storage tank located between and in fluid communication with the second sterilization filter and the output nozzle, wherein the second storage tank is configured to receive and temporarily store coating material removed from the feed tank and to be supplied to the output nozzle; and The second storage tank may be selectively configured in the following states: In the filling state, the second storage tank receives and stores the coating material removed from the feed tank; In the supply state, the coating material stored in the second storage tank is removed from the second storage tank and supplied to the output nozzle.

4. The device according to claim 2, characterized in that, The supply component also includes: A second storage tank is located between and in fluid communication with the second sterilization filter and the output nozzle, wherein the second storage tank is configured to receive and temporarily store coating material removed from the feed tank and to be supplied to the output nozzle; At least one first heating element is used to heat the coating material stored in the first storage tank; At least one second heating element is provided for heating the coating material stored in the second storage tank.

5. The device according to claim 4, characterized in that: The at least one first heating element is arranged inside a first heat insulation jacket, which is located outside the first storage tank, and one or more resistors are installed inside the first heat insulation jacket or heating fluid circulates therein. The at least one second heating element is arranged inside a second insulation jacket located outside the second storage tank, and one or more resistors are installed inside the second insulation jacket or a heating fluid circulates therein.

6. The device according to claim 5, characterized in that, The first storage tank can be removed from the first insulation jacket, and the second storage tank can be removed from the second insulation jacket.

7. The device according to claim 2, characterized in that, The device also includes: A second storage tank is located between and in fluid communication with the second sterilization filter and the output nozzle, wherein the second storage tank is configured to receive and temporarily store coating material removed from the feed tank and to be supplied to the output nozzle; The second storage tank can be selectively configured in the following states: a filling state, wherein the second storage tank receives and stores coating material removed from the feed tank; and a supply state, wherein the coating material stored in the second storage tank is removed from the second storage tank and supplied to the output nozzle; The device further includes a control unit operably connected to the first storage tank and the second storage tank, wherein the control unit is configured to: When the second storage tank is in the filling state, the supply state is set in the first storage tank, and When the first storage tank is in the filling state, the supply state is set in the second storage tank.

8. The device according to claim 3, characterized in that, The supply component also includes: A first fluid circuit, wherein a first end of the first fluid circuit is connected to the feed tank, a second end of the first fluid circuit is connected to the first storage tank, and a third end of the first fluid circuit is connected to the second storage tank; The second fluid circuit has a first end connected to the first storage tank, a second end connected to the second storage tank, and a third end connected to the output nozzle.

9. The device according to claim 8, characterized in that, The supply assembly includes at least one heat-insulating jacket that is detachably placed around at least a portion of the second fluid circuit.

10. The device according to claim 9, characterized in that, The supply assembly also includes at least one third heating element disposed within the at least one heat-insulating jacket.

Images