WO2013128469A1 - Apparatus for drying drug-coated medical devices - Google Patents

Apparatus for drying drug-coated medical devices Download PDF

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Publication number
WO2013128469A1
WO2013128469A1 PCT/IN2013/000107 IN2013000107W WO2013128469A1 WO 2013128469 A1 WO2013128469 A1 WO 2013128469A1 IN 2013000107 W IN2013000107 W IN 2013000107W WO 2013128469 A1 WO2013128469 A1 WO 2013128469A1
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WO
WIPO (PCT)
Prior art keywords
valves
vacuum
processing unit
conduit
containers
Prior art date
Application number
PCT/IN2013/000107
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French (fr)
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WO2013128469A4 (en
Inventor
Rahul Mahendrakumar GAYWALA
Ankur Jaykumar RAVAL
Original Assignee
Sahajanand Medical Technologies Private Limited
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Application filed by Sahajanand Medical Technologies Private Limited filed Critical Sahajanand Medical Technologies Private Limited
Publication of WO2013128469A1 publication Critical patent/WO2013128469A1/en
Publication of WO2013128469A4 publication Critical patent/WO2013128469A4/en

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Classifications

    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum

Definitions

  • the present invention in general relates to a drying apparatus and particularly, but not exclusively, to an apparatus for drying drug-coated medical devices.
  • Vacuum drying is generally used for materials that are susceptible to damage or can undergo a transformation if exposed to high temperatures during drying.
  • a suction or vacuum pressure created during vacuum drying helps remove moisture and prevent oxidation or other chemical reactions that may otherwise occur when certain materials are brought in contact with air.
  • vacuum drying is also used in situations where a solvent is to be recovered from a mixture or where drying is done to achieve very low levels of moisture. Accordingly, vacuum drying finds application in various industries, such as pharmaceutical industry, chemical industry, and electrical and electronics component manufacturing. In an example, vacuum drying forms a part of the printing process in industrial printing processes.
  • vacuum drying is employed in drug coating processes in which bare medical devices, such as stents, are coated with drug coating solutions and dried, before being used for medical purposes. Accordingly, such medical devices are coated with a drug coating solution, made by mixing and dissolving a drug and certain biodegradable polymers in an organic solvent, such as dichloromethane, by a spray coating process, and subsequently dried to substantially remove the organic solvent from the drug coating solution.
  • a drug coating solution made by mixing and dissolving a drug and certain biodegradable polymers in an organic solvent, such as dichloromethane
  • the apparatus includes a vacuum pump for generating a negative pressure and a plurality of containers, each for holding a drug-coated medical device to be dried.
  • Each of the plurality of containers is connected to the vacuum pump through a conduit.
  • the apparatus further includes a plurality of valves, one valve being provided in each conduit to regulate a connection between a container from among the plurality of containers connected to the vacuum pump through the conduit.
  • the apparatus includes a processing unit configured to individually control each of the plurality of valves for regulating the drying operation in the plurality of containers.
  • the apparatus includes a feedback mechanism coupled to the processing unit for facilitating regulation of the ⁇ drying operation in the plurality of containers.
  • Figure 1(a) and figure 1(b) illustrate a perspective view of an apparatus for drying drug-coating on medical devices, according to an embodiment of the present subject matter.
  • Figure 1(c) illustrates a detailed schematic showing various components of the apparatus as shown in Figure 1(a), according to an embodiment of the present subject matter.
  • Figure 2 illustrates a detailed schematic showing various functional components of the apparatus shown in Figure 1(a) and 1(b), according to an embodiment of the present subject matter.
  • vacuum drying processes find application in a variety of processes, including industrial processes, domestic processes, and medical processes.
  • One such example is application of vacuum for drying drug coated medical devices, such as a stents, for manufacturing drug-eluting medical devices.
  • a vacuum desiccator for vacuum drying of medical devices, a vacuum desiccator is employed.
  • the vacuum desiccator can include a storage compartment connected to a vacuum pump to generate a vacuum in the storage compartment for drying components placed in the storage compartment.
  • the storage compartment can accommodate one or more medical devices coated with a drug solution coating, such as a drug-polymer composition, for drying.
  • the organic solvent is removed from the coating on the medical device by evaporation, due to application of negative pressure.
  • conventional vacuum desiccators are usually formed as a sealable enclosure to which vacuum is applied.
  • the drug-coated medical devices are placed inside the vacuum desiccator, the vacuum desiccator is sealed, and a negative pressure is applied to the vacuum desiccator using the vacuum pump.
  • the vacuum desiccator can be connected to the vacuum pump connected through a valve. Using the valve, an appropriate pressure level is maintained in the desiccator for a predetermined period for drying the drug coating on the medical devices. At the end of the predetermined period, the application of negative pressure is interrupted, and the dried medical devices are removed and replaced by another lot to be dried.
  • the efficacy of the drug-eluting medical devices is determined by the microstructure of the drug-polymer coating on the medical device and the weight of the coating, after the solvent has been substantially removed during the drying process.
  • the drug eluting properties of the medical device are based on factors associated with the drying process, such as maintaining uniform vacuum pressure in the vacuum desiccator for a specific period of time, and minimal contact with the ambient atmosphere and other medical devices during the drying process.
  • the medical devices such as stents
  • the medical devices are usually individually dried in the vacuum desiccator.
  • individually drying the medical devices may cause non uniform vacuum level in the vacuum desiccator that each medical device is exposed to, due to continual opening of the desiccator after the completion of drying of each device.
  • the opening of the vacuum desiccator after drying of each medical device leads to loss of vacuum inside the desiccator, and building the vacuum to the appropriate level may take time.
  • the medical devices can be collectively dried in lots; say 10 medical devices at a time.
  • the primary concern is the time gap between the placing of the devices in the desiccator and the completion of coating process of the last medical device.
  • the medical devices are individually coated and the drying of the earlier coated medical devices is delayed until the last device of the lot is coated.
  • This can be understood with the help of the following example.
  • a lot of 10 stents is to be coated and dried in the vacuum desiccator. Before the drying process can be commenced, one has to wait till all the stents are coated first, and after the completion of coating of all 10 stents, they can be transferred to the vacuum desiccator. As a result, the overall time taken for the completion of the drying process is large and may not be economical in case of an industrial process.
  • the conventional apparatus for drying is unable to provide a precise control on the drying process, as a result of which the optimal characteristics of the drug coating may not be achieved.
  • the apparatus includes a vacuum pump connected to a plurality of docking ports, each through a conduit.
  • the vacuum pump can generate a negative pressure or, in other words, create a vacuum in the docking ports.
  • Each docking port can be configured to receive a container which in turn can accommodate the medical device, such as a drug coated stent. Therefore, during operation, the drug coated medical devices to be dried can be placed in the containers, and subsequently, each container can be disposed in a docking port. When the container is disposed in the docking port, an air-tight seal is formed between the container and the docking port so that a vacuum is developed inside the apparatus and is not lost, for example, due to leakage.
  • the provision of a separate container for each medical device ensures a uniform and independent vacuum level for each drug coated medical device in the different containers at different docking ports.
  • each conduit connecting the docking port to the vacuum pump can include a valve to control the vacuum in that docking port.
  • the valve can further be provided with a timing device, such as a countdown timer. Based on the timer, the exposure of the medical device in each container can be controlled by controlling the valve.
  • the valve for the first conduit can be opened for a duration of 10 minutes to expose the medical device in the first docking port to the vacuum for 10 minutes for drying, and closed after the completion of 10 minutes.
  • the valve in the second conduit can be opened for 15 minutes to expose the medical device to the vacuum for that duration, and subsequently closed.
  • the duration for application of vacuum to different medical devices can be independently controlled. Further, upon the completion of the predetermined time duration, the valve can be closed to isolate one docking port form the rest of the system. Subsequently, the container can be removed from the docking port, and the medical device can be replaced by another one to be dried. Since the open docking port is isolated from the rest of the apparatus by the valve, there is no affect on the vacuum created inside the apparatus. Once the container is repositioned in the docking port, the timing device can be reset and the valve reopened to apply vacuum for drying the medical device now positioned.
  • a processing unit is provided in the apparatus, and is connected to the timing devices and the valves for controlling the valves during operation of the apparatus.
  • the processing unit can control the opening and closing of the various valves in the conduits connecting the docking ports to the vacuum pump. Accordingly, the processing unit of the apparatus can ensure that each drug coated medical device experiences a predefined cycle of vacuum, for example, pertaining to the drying characteristics and the drug eluting properties.
  • the apparatus includes one or more feedback mechanisms coupled to the processing unit for facilitating the regulation of the operation of the apparatus.
  • the feedback mechanism can include a pressure-regulating mechanism having a pressure gauge connected to each of the conduits, to individually regulate the vacuum pressure in each of the containers.
  • the press- regulating mechanism can include a non-return valve which connects the vacuum pump to the docking ports.
  • the non-return valve can be disposed in the conduit connecting the vacuum pump to the docking ports, and positioned in such a way that a single non-return valve can be shut down to isolate the vacuum pump from all the docking ports. Such control of isolating the vacuum pump from the rest of the apparatus can be exercised by the processing unit.
  • the apparatus allows individual control of time of application of vacuum pressure at each docking port, different medical devices having different drying characteristics and drying times can be dried effectively. Additionally, the independent operation at each docking port allows removal of each medical device after drying and being replaced by another medical device to be dried. As a result, the waiting time between coating of the medical devices and placing them inside the container for drying, and hence their exposure to the atmosphere, is substantially reduced. Therefore, the overall effectiveness of the drying process is substantially increased. [0024]
  • Figure 1(a), figure 1(b), and figure 1(c) illustrate an apparatus 100 for drying drug-coated medical devices.
  • Figure 1(a) and figure 1 (b) depict a perspective view of the apparatus 100 showing the various components, while figure 1(c) illustrates a schematic layout of the apparatus 100 and the various components of the apparatus 100.
  • medical devices such as drug-eluting stents
  • drug coating a drug- polymer coating
  • the drug-coating on the medical device is dried before the medical devices can be further used.
  • the apparatus 100 can be implemented for drying of the drug-coated medical devices, for preparing the medical devices for further therapeutic purposes.
  • the apparatus 100 includes a vacuum pump 102 connected, through conduits 110, to a plurality of docking ports 112, individually referred to as docking port 112.
  • each docking port 112 can be connected to the vacuum pump 102 through one or more conduits 110, depending upon, for example, size of conduits and vacuum pressure to be maintained in the docking port 112.
  • the conduits 110 can be formed as a single manifold having a plurality of sub-ducts branching out from the single manifold.
  • the single manifold can branch out into a plurality of sub-ducts and can connect the vacuum pump 102 to the docking ports 112 the such that each docking port receives two sub-ducts.
  • the apparatus 100 can include containers 114, each container 114 being capable of holding a drug-coated medical device for drying.
  • the docking ports 112 can each receive a container 114, such that an open end of the container 114 is exposed to the conduit 110.
  • the container 114 can be a glass or plastic vial.
  • the container 114 when placed in the docking ports 112, can form an air-tight seal with the docking port 112.
  • a gasket say an o-ring or a U-seal, can be provided at each of. the docking ports 112 to form the air-tight seal with the containers 114.
  • the vacuum pump 102 can create a negative pressure, i.e., a vacuum, inside the apparatus 100, which is maintained as a result of the air- tight sealing of the containers 114 with the docking ports 112.
  • the negative pressure hence created assists in drying of the drug-coated medical devices placed in the containers 114.
  • the operation of the apparatus 100 is explained in detail later with reference to figure 2.
  • the apparatus 100 can further include a plurality of valves (not shown in the figures), each conduit 110 connecting the vacuum pump 102 to the docking ports 112 having a valve.
  • the valves can be configured as solenoid valves.
  • the valves can be other electrically, mechanically, electronically, or magnetically controlled valves.
  • the valves can be depicted as a solenoid valve manifold 126, which collectively represents the various solenoid valves connected in the conduits 110.
  • the solenoid valve manifold 126 can have ten solenoid valves, each connected in one conduit 110 and servicing one docking port from the docking ports 112.
  • all the valves can be configured similarly; however, in other implementations, different valves may be configured differently, for example, based on operational requirements of the apparatus 100.
  • the valves can be regulated to control the connection of the respective docking ports 112, and hence, the containers 114 and the drug- coated medical devices, to the vacuum pump 102. In other words, the valves can control the exposure of the medical devices to the vacuum, for drying.
  • the valves can be configured as 2-way valves.
  • the valves can be configured as 2-way, 2-position, normally open solenoid valves.
  • the valves can be provided at the junction of the manifold and the sub-ducts, and in such an implementation, the valves can be configured as multi-way valves.
  • a 3-way 2-position valve can be provided at each junction between the manifold and the two sub-ducts servicing one docking port.
  • the apparatus 100 can include a processing unit 106 to control an operation of the apparatus 100.
  • the processing unit 106 can be configured as an electrically controlled printed circuit board (PCB).
  • the processing unit 106 apart from other things, can be configured to regulate an operation of the apparatus 100.
  • the working of the processing unit 106 to regulate the operation of the apparatus 100 is explained in detail later with reference to Fig. 2.
  • the processing unit 106 can be configured to regulate the timing of opening and closing of the valves.
  • the apparatus 100 can include one or more feedback mechanisms which are coupled to the processing unit 106.
  • the feedback mechanism can include pressure-regulating mechanism.
  • the pressure-regulating mechanism can include a pressure gauge (not shown in figures) to regulate and adjust the predetermined vacuum level to be attained in the apparatus 100 and facilitates the processing unit 106 in operating the apparatus 100.
  • the pressure gauge can be analog or digital and can provide feedback to the processing unit 106 regarding whether the vacuum pressure is achieved or not, based on the pressure gauge reading.
  • the pressure-regulating mechanism can include a vacuum regulator 108 connected, on one hand to the pressure gauge, and on other hand, to the vacuum pump 102 and to the processing unit 106.
  • the processing unit 106 can monitor the pressure in the apparatus 100 based on the pressure gauge and control the operation of the vacuum pump 102 through the vacuum regulator 108.
  • the vacuum regulator 108 can be a mechanical pressure regulator.
  • the processing unit 106 can monitor any loss of vacuum pressure level in the apparatus 100, say from the pressure gauge, on account of a failure, such as a leakage, in the apparatus 100. In the event of such a fault during operation, the processing unit 106 can appropriately control the operation of the vacuum pump, say shut-down the vacuum pump 102, and may issue a warning to a user of the apparatus 100. For example, the processing unit 106 may switch on a warning light or a warning siren or both, to notify a user that the operation of the apparatus 100 is faulty.
  • the processing unit , 106 can control the vacuum pump 102 during normal operation of the apparatus 100 for drying the drug coated medical devices.
  • the pressure-regulating mechanism of the apparatus 100 can include a non-return valve (not shown in figures).
  • the vacuum pump 102 can be connected to the docking ports 112 through the non-return valve, say positioned in a main conduit 110.
  • the non-return valve can be disposed in the conduit connecting the vacuum pump 102 to the docking ports 112, and positioned in such a way that a single non-return valve can be shut down to isolate the vacuum pump from all the docking ports 112.
  • the non-return valve can be controlled by the processing unit 106.
  • the processing unit 106 can shut-off the nonreturn valve and isolate the vacuum pump from the rest of the apparatus 100. Accordingly, the vacuum pump 102 can be shut down to save power, until, say a higher vacuum pressure is required in the apparatus 100 or the predetermined vacuum pressure is not maintained.
  • the non-return valve may be controlled mechanically independent of the processing unit 106.
  • each valve can be connected to a timing device 116, the timing device 116 being further connected to the processing unit 106.
  • the timing device 116 can include an indicator 120 to indicate the time elapsed, or as in ease of countdown timers, time left for the countdown to finish.
  • the indicator 120 can, in one example, be a digital indicator, and in another example, can be an analog indicator.
  • the timing device 116 can further include a switch 118, the switch 118 being controlled by the processing unit 106 for regulating the opening and closing of the respective valve based on the timing device 116.
  • the timing device 116 can facilitate the processing unit 106 in regulating the operation of the valves by operating the switches.
  • the apparatus 100 can include a switched-mode power supply
  • the apparatus 100 can include a plurality of cooling fans 124 to prevent overheating, say of the electrical and electronic components of the apparatus 100, which may otherwise lead to damage of the components of the apparatus 100 and shorten the working life of the apparatus 100 or the components.
  • the cooling fans 124 can provide cooling for the SMPS 122 and the valves. As a result, the components of the apparatus 100 are protected from damage due to overheating.
  • FIG. 2 illustrates a schematic diagram showing functional components of the apparatus 100, according to an embodiment of the present subject matter.
  • the vacuum pump 102 responsible for building the appropriate amount of vacuum pressure inside the apparatus 100, is connected to a work piece 202 through the vacuum regulator 108 and the pressure gauge 204.
  • the work piece 202 can be understood to be the drug-coated medical device placed in the container 114 disposed at the docking port 112, the same being connected to the vacuum pump 102 through the conduit 110.
  • the vacuum regulator 108 works in conjunction with the pressure gauge 204, and both are responsible for vacuum regulation function in the apparatus 100.
  • the conduit 110 can include the solenoid valve manifold 126, which collectively represents the various solenoid valves in the apparatus 100.
  • the valves in the solenoid valve manifold can be regulated to control the connection of the respective docking ports 112, and hence the containers 114 and the drug-coated medical devices, to the vacuum pump 102.
  • the solenoid valve manifold 126 can be a normally open 2-way 2-position solenoid valve.
  • each solenoid valve can be configured as an electrically-controlled, single-winding solenoid valve.
  • the solenoid valves in the solenoid valve manifold 126 can be configured as 3-way, 2-position, normally open valves.
  • the vacuum regulator 108 and the valves in the conduit 110 can be connected to the processing unit 106.
  • the processing unit 106 can control the operation of the apparatus 100 by monitoring the vacuum level in the apparatus 100, based on the vacuum level set using the vacuum regulator 108.
  • the processing unit 106 monitors the vacuum regulator 108 and the pressure gauge 204 to maintain the predefined level of vacuum in the apparatus 100.
  • a user may set the vacuum pressure to be achieved in the apparatus 100, using the vacuum regulator 108 and the processing unit 106 may regulate the pressure inside the apparatus 100 based on the readings of the pressure gauge 204.
  • the processing unit 106 can control the operation of the valves in the conduit 110 by receiving the inputs from the timing device 116 connected to the valves.
  • the processing unit 106 can be configured to regulate each of the valves to control the extent of exposure of the drug-coated medical devices at each docking port 112 to the vacuum inside the apparatus 100.
  • each timing device 116 can be connected to a switch 118, and based on an input of the indicator 120 of the timing device 116, the processing unit 106 can directly regulate the opening and closing of the valve by operating the switch 118.
  • the timing device 116 may set off the switches 118 which can directly operate the valves based on the inputs of the indicator 120.
  • the indicator 120 of the valve in a first conduit can be set to open the valve for a duration of 10 minutes to expose the medical device at the first docking port to the vacuum for drying and close the valve after the completion of the 10 minute duration.
  • the indicator 120 of the valve in the second conduit can be set to open the valve for 15 and subsequently close the valve.
  • valves in the different conduits are configured to operate simultaneously as well as independently.
  • the independent operation of the valves is governed by the processing unit 106.
  • the valve in the first conduit and the valve in the second conduit can be timed to operate for 10 and 15 minutes, respectively.
  • the processing unit 106 can close the valve in the first conduit and isolate that docking port 112 from the rest of the apparatus 100 without disturbing the vacuum level in the rest of the apparatus 100.
  • the operation continues in the other docking port 112 connected to the second conduit.
  • the previous docking port 112 can be loaded with another medical device to be dried and the timing device 116 associated with the valve in the first conduit can be re-programmed and reset for a different drying cycle. Consequently, the docking port 112 can be reused for the drying operation for a different cycle. Accordingly, the valve is reopened to expose the fresh medical device to the vacuum in the apparatus 100.
  • the apparatus 100 as described herein ensures a uniform and independent vacuum level for each drug coated medical device in the different containers 114 at different docking ports 112. As a result, the apparatus 100 also ensures that each drug coated medical device is exposed to the vacuum for a predefined timed cycle, for example, pertaining to the drying characteristics and the drug-eluting properties. Further, the problem of contamination from other medical devices and by. coming in contact with the ambient atmosphere/air is practically eliminated. In addition, based on the predefined drying characteristics of each drug coating, the duration for application of vacuum to different medical devices can be independently controlled.
  • the apparatus 100 allows individual control of time of application of vacuum pressure at each docking port 112, different medical devices having different drying characteristics and drying times can be dried, without compromising the vacuum pressure built in the apparatus 100. Additionally, the independent operation at each docking port 1 12 allows removal of each medical device after drying and being replaced by another medical device to be dried. As a result, the waiting time between coating of the medical devices and placing them inside the container for drying, and hence their exposure to the atmosphere, is substantially reduced. [0045] Although implementations of the apparatus 100 for drying drug-coated medical devices have been described in language specific to structural features and/or methods, it is to be understood that the appended claims are not necessarily limited to the specific features or methods described. Rather, the specific features and methods are disclosed as implementations the apparatus 100 for drying drug-coated medical devices.

Abstract

An apparatus (100) for drying drug-coated on medical devices (202) is described herein. In an embodiment, the apparatus (100) includes a vacuum pump (102) for generating a negative pressure and a plurality of containers (114), each for holding a drug-coated medical device (202) to be dried. Each of the plurality of containers (114) is connected to the vacuum pump (102) through a conduit (110). The apparatus (100) further includes a plurality of valves, one valve being provided in each conduit (110) to regulate a connection between a container (114) from among the plurality of containers (114) connected to the vacuum pump (102) through the conduit (110). Additionally, the apparatus (100) includes a processing unit (106) and a feedback mechanism coupled to the processing unit (106) for regulating drying operation in the plurality of containers (114).

Description

APPARATUS FOR DRYING DRUG-COATED MEDICAL DEVICES
FIELD OF INVENTION
[0001 J The present invention in general relates to a drying apparatus and particularly, but not exclusively, to an apparatus for drying drug-coated medical devices. BACKGROUND
[0002] Vacuum drying is generally used for materials that are susceptible to damage or can undergo a transformation if exposed to high temperatures during drying. In addition, a suction or vacuum pressure created during vacuum drying helps remove moisture and prevent oxidation or other chemical reactions that may otherwise occur when certain materials are brought in contact with air. Further, vacuum drying is also used in situations where a solvent is to be recovered from a mixture or where drying is done to achieve very low levels of moisture. Accordingly, vacuum drying finds application in various industries, such as pharmaceutical industry, chemical industry, and electrical and electronics component manufacturing. In an example, vacuum drying forms a part of the printing process in industrial printing processes.
[0003] In another example, in case of the pharmaceutical industry, various processes require application of vacuum drying. For instance, vacuum drying is employed in drug coating processes in which bare medical devices, such as stents, are coated with drug coating solutions and dried, before being used for medical purposes. Accordingly, such medical devices are coated with a drug coating solution, made by mixing and dissolving a drug and certain biodegradable polymers in an organic solvent, such as dichloromethane, by a spray coating process, and subsequently dried to substantially remove the organic solvent from the drug coating solution.
SUMMARY
[0004] The present subject matter described herein relates to an apparatus for drying drug-coatings on medical devices. In an embodiment, the apparatus includes a vacuum pump for generating a negative pressure and a plurality of containers, each for holding a drug-coated medical device to be dried. Each of the plurality of containers is connected to the vacuum pump through a conduit. The apparatus further includes a plurality of valves, one valve being provided in each conduit to regulate a connection between a container from among the plurality of containers connected to the vacuum pump through the conduit. Additionally, the apparatus includes a processing unit configured to individually control each of the plurality of valves for regulating the drying operation in the plurality of containers. Further, the apparatus includes a feedback mechanism coupled to the processing unit for facilitating regulation of the · drying operation in the plurality of containers.
[0005] This summary is provided to introduce concepts related to an apparatus for drying drug-coated on medical devices. These concepts are further described below in the detailed description. This summary is not intended to identify essential features of the claimed subject matter nor is it intended for use in determining or limiting the scope of the claimed subject matter.
BRIEF DESCRIPTION OF THE FIGURES
[0006] The detailed description is described with reference to the accompanying
Figure(s). In the Figure(s), the left-most digit(s) of a reference number identifies the Figure in. which the reference number first appears. The use of the same reference number in different Figure(s) indicates similar or identical items. The features, aspects and advantages of the subject matter will be better understood with regard to the following description, and the accompanying drawings.
[0007] Figure 1(a) and figure 1(b) illustrate a perspective view of an apparatus for drying drug-coating on medical devices, according to an embodiment of the present subject matter.
[0008] Figure 1(c) illustrates a detailed schematic showing various components of the apparatus as shown in Figure 1(a), according to an embodiment of the present subject matter.
[0009] Figure 2 illustrates a detailed schematic showing various functional components of the apparatus shown in Figure 1(a) and 1(b), according to an embodiment of the present subject matter.
DETAILED DESCRIPTION
[0010] Generally, vacuum drying processes find application in a variety of processes, including industrial processes, domestic processes, and medical processes. One such example is application of vacuum for drying drug coated medical devices, such as a stents, for manufacturing drug-eluting medical devices.
[0011] Conventionally, for vacuum drying of medical devices, a vacuum desiccator is employed. The vacuum desiccator can include a storage compartment connected to a vacuum pump to generate a vacuum in the storage compartment for drying components placed in the storage compartment. For example, the storage compartment can accommodate one or more medical devices coated with a drug solution coating, such as a drug-polymer composition, for drying. In the above example, during the drying of the medical device using the vacuum desiccator, the organic solvent is removed from the coating on the medical device by evaporation, due to application of negative pressure.
[0012] Therefore, conventional vacuum desiccators are usually formed as a sealable enclosure to which vacuum is applied. During the drying process, the drug-coated medical devices are placed inside the vacuum desiccator, the vacuum desiccator is sealed, and a negative pressure is applied to the vacuum desiccator using the vacuum pump. To control a vacuum level in the vacuum desiccator, the vacuum desiccator can be connected to the vacuum pump connected through a valve. Using the valve, an appropriate pressure level is maintained in the desiccator for a predetermined period for drying the drug coating on the medical devices. At the end of the predetermined period, the application of negative pressure is interrupted, and the dried medical devices are removed and replaced by another lot to be dried.
[0013] Generally, the efficacy of the drug-eluting medical devices is determined by the microstructure of the drug-polymer coating on the medical device and the weight of the coating, after the solvent has been substantially removed during the drying process. The drug eluting properties of the medical device are based on factors associated with the drying process, such as maintaining uniform vacuum pressure in the vacuum desiccator for a specific period of time, and minimal contact with the ambient atmosphere and other medical devices during the drying process.
[0014] In the conventional vacuum drying process, the medical devices, such as stents, are usually individually dried in the vacuum desiccator. However, individually drying the medical devices may cause non uniform vacuum level in the vacuum desiccator that each medical device is exposed to, due to continual opening of the desiccator after the completion of drying of each device. The opening of the vacuum desiccator after drying of each medical device leads to loss of vacuum inside the desiccator, and building the vacuum to the appropriate level may take time. [0015] On the other hand, in certain other cases, the medical devices can be collectively dried in lots; say 10 medical devices at a time. In such cases, however, while drying the medical devices, the primary concern is the time gap between the placing of the devices in the desiccator and the completion of coating process of the last medical device. In most cases, the medical devices are individually coated and the drying of the earlier coated medical devices is delayed until the last device of the lot is coated. This can be understood with the help of the following example. Consider that a lot of 10 stents is to be coated and dried in the vacuum desiccator. Before the drying process can be commenced, one has to wait till all the stents are coated first, and after the completion of coating of all 10 stents, they can be transferred to the vacuum desiccator. As a result, the overall time taken for the completion of the drying process is large and may not be economical in case of an industrial process.
[0016] Further, during the time gap between the first medical device and the last medical device of the lot being coated, the previously coated devices are exposed to the atmosphere and may get contaminated. In addition, since the different medical devices are exposed to the atmosphere for different time durations, the medical devices may take different time periods for drying in the desiccators, to achieve required characteristics of the drug coating. Hence, the conventional apparatus for drying is unable to provide a precise control on the drying process, as a result of which the optimal characteristics of the drug coating may not be achieved.
[0017] Further, with the medical devices being placed in a common drying chamber, the chances of contamination among the various medical devices are also high. Additionally, in case of a loss in vacuum level due to any failure in the system, such as leakage in the system or failure of the vacuum pump, the faults may not be detected and may affect the quality of drying of the medical devices. As a result, the microstructure of the drug solution coating is adversely affected, which in turn adversely affects the efficacy of the drug eluting stent hence manufactured. [0018] The present subject matter described herein relates to an apparatus for drying drug-coatings on medical devices. According to an embodiment, the apparatus includes a vacuum pump connected to a plurality of docking ports, each through a conduit. During operation, the vacuum pump can generate a negative pressure or, in other words, create a vacuum in the docking ports. Each docking port can be configured to receive a container which in turn can accommodate the medical device, such as a drug coated stent. Therefore, during operation, the drug coated medical devices to be dried can be placed in the containers, and subsequently, each container can be disposed in a docking port. When the container is disposed in the docking port, an air-tight seal is formed between the container and the docking port so that a vacuum is developed inside the apparatus and is not lost, for example, due to leakage. The provision of a separate container for each medical device ensures a uniform and independent vacuum level for each drug coated medical device in the different containers at different docking ports. Further, the problem of contamination from other medical devices and by coming in contact with the ambient atmosphere/air is practically eliminated. [0019] Further, according to an implementation, each conduit connecting the docking port to the vacuum pump can include a valve to control the vacuum in that docking port. The valve can further be provided with a timing device, such as a countdown timer. Based on the timer, the exposure of the medical device in each container can be controlled by controlling the valve. For example, the valve for the first conduit can be opened for a duration of 10 minutes to expose the medical device in the first docking port to the vacuum for 10 minutes for drying, and closed after the completion of 10 minutes. On the other hand, the valve in the second conduit can be opened for 15 minutes to expose the medical device to the vacuum for that duration, and subsequently closed.
[0020] Hence, based on the drying characteristics and requirements of each drug coating, the duration for application of vacuum to different medical devices can be independently controlled. Further, upon the completion of the predetermined time duration, the valve can be closed to isolate one docking port form the rest of the system. Subsequently, the container can be removed from the docking port, and the medical device can be replaced by another one to be dried. Since the open docking port is isolated from the rest of the apparatus by the valve, there is no affect on the vacuum created inside the apparatus. Once the container is repositioned in the docking port, the timing device can be reset and the valve reopened to apply vacuum for drying the medical device now positioned.
[0021] Further, according to an implementation, a processing unit is provided in the apparatus, and is connected to the timing devices and the valves for controlling the valves during operation of the apparatus. In an implementation, based on the inputs from the timing device, the processing unit can control the opening and closing of the various valves in the conduits connecting the docking ports to the vacuum pump. Accordingly, the processing unit of the apparatus can ensure that each drug coated medical device experiences a predefined cycle of vacuum, for example, pertaining to the drying characteristics and the drug eluting properties.
[0022] In addition, the apparatus includes one or more feedback mechanisms coupled to the processing unit for facilitating the regulation of the operation of the apparatus. In an implementation, the feedback mechanism can include a pressure-regulating mechanism having a pressure gauge connected to each of the conduits, to individually regulate the vacuum pressure in each of the containers. In addition, in an implementation, the press- regulating mechanism can include a non-return valve which connects the vacuum pump to the docking ports. In said implementation, the non-return valve can be disposed in the conduit connecting the vacuum pump to the docking ports, and positioned in such a way that a single non-return valve can be shut down to isolate the vacuum pump from all the docking ports. Such control of isolating the vacuum pump from the rest of the apparatus can be exercised by the processing unit.
[0023] Since the apparatus according to the present subject matter, allows individual control of time of application of vacuum pressure at each docking port, different medical devices having different drying characteristics and drying times can be dried effectively. Additionally, the independent operation at each docking port allows removal of each medical device after drying and being replaced by another medical device to be dried. As a result, the waiting time between coating of the medical devices and placing them inside the container for drying, and hence their exposure to the atmosphere, is substantially reduced. Therefore, the overall effectiveness of the drying process is substantially increased. [0024] These and other advantages of the present subject matter would be described in a greater detail in conjunction with .the following figures. It should be noted that the description and figures merely illustrate the principles of the present subject matter.
[0025] Figure 1(a), figure 1(b), and figure 1(c) illustrate an apparatus 100 for drying drug-coated medical devices. Figure 1(a) and figure 1 (b) depict a perspective view of the apparatus 100 showing the various components, while figure 1(c) illustrates a schematic layout of the apparatus 100 and the various components of the apparatus 100. As would be understood, medical devices, such as drug-eluting stents, are often coated with a drug- polymer coating (referred to as drug coating hereinafter), say for pharmacological purposes. For effective operation of such medical devices, the drug-coating on the medical device is dried before the medical devices can be further used. The apparatus 100 can be implemented for drying of the drug-coated medical devices, for preparing the medical devices for further therapeutic purposes.
[0026] For the sake of brevity, description of figure 1(a), figure 1(b), and figure 1(c) is provided in conjunction. With reference to the aforementioned figures, according to an embodiment, the apparatus 100 includes a vacuum pump 102 connected, through conduits 110, to a plurality of docking ports 112, individually referred to as docking port 112. As will be understood, each docking port 112 can be connected to the vacuum pump 102 through one or more conduits 110, depending upon, for example, size of conduits and vacuum pressure to be maintained in the docking port 112. Further, according to an implementation, the conduits 110 can be formed as a single manifold having a plurality of sub-ducts branching out from the single manifold. Accordingly, few sub-ducts from the plurality of sub-ducts can connect each of the docking ports 112 to the vacuum pump 102. For example, the single manifold can branch out into a plurality of sub-ducts and can connect the vacuum pump 102 to the docking ports 112 the such that each docking port receives two sub-ducts.
[0027] Further, the apparatus 100 can include containers 114, each container 114 being capable of holding a drug-coated medical device for drying. In an embodiment, the docking ports 112 can each receive a container 114, such that an open end of the container 114 is exposed to the conduit 110. In an example, the container 114 can be a glass or plastic vial. In an implementation, the container 114, when placed in the docking ports 112, can form an air-tight seal with the docking port 112. In an example, a gasket, say an o-ring or a U-seal, can be provided at each of. the docking ports 112 to form the air-tight seal with the containers 114. During operation of the apparatus 100, the vacuum pump 102 can create a negative pressure, i.e., a vacuum, inside the apparatus 100, which is maintained as a result of the air- tight sealing of the containers 114 with the docking ports 112. The negative pressure hence created assists in drying of the drug-coated medical devices placed in the containers 114. The operation of the apparatus 100 is explained in detail later with reference to figure 2.
[0028] According to an aspect of the present subject matter, the apparatus 100 can further include a plurality of valves (not shown in the figures), each conduit 110 connecting the vacuum pump 102 to the docking ports 112 having a valve. In an example, the valves can be configured as solenoid valves. In another example, the valves can be other electrically, mechanically, electronically, or magnetically controlled valves. Further, as shown in figure 1(b), in an example, the valves can be depicted as a solenoid valve manifold 126, which collectively represents the various solenoid valves connected in the conduits 110. In an example, if there are ten conduits 110, the solenoid valve manifold 126 can have ten solenoid valves, each connected in one conduit 110 and servicing one docking port from the docking ports 112. In an implementation, all the valves can be configured similarly; however, in other implementations, different valves may be configured differently, for example, based on operational requirements of the apparatus 100. The valves can be regulated to control the connection of the respective docking ports 112, and hence, the containers 114 and the drug- coated medical devices, to the vacuum pump 102. In other words, the valves can control the exposure of the medical devices to the vacuum, for drying.
[0029] Further, in an example, in case the conduits 110 are individual ducts or in the other case in which the conduits 110 are formed as a single manifold with sub-ducts, then the valves can be configured as 2-way valves. In an implementation, the valves can be configured as 2-way, 2-position, normally open solenoid valves. In another example, in case the conduits 110 are formed as a single manifold divided into sub-ducts, the valves can be provided at the junction of the manifold and the sub-ducts, and in such an implementation, the valves can be configured as multi-way valves. For instance, in the above mentioned example in which the single manifold branches out in such a way that each docking port receives two sub-ducts, at each junction between the manifold and the two sub-ducts servicing one docking port a 3-way 2-position valve can be provided.
[0030] In addition, in an implementation, say in which the valves are electrically or electronically controlled solenoid valves, the apparatus 100 can include a processing unit 106 to control an operation of the apparatus 100. In an example, the processing unit 106 can be configured as an electrically controlled printed circuit board (PCB). The processing unit 106, apart from other things, can be configured to regulate an operation of the apparatus 100. The working of the processing unit 106 to regulate the operation of the apparatus 100 is explained in detail later with reference to Fig. 2. [0031] Further, in an implementation, the processing unit 106 can be configured to regulate the timing of opening and closing of the valves. Additionally, according to an aspect, the apparatus 100 can include one or more feedback mechanisms which are coupled to the processing unit 106. The feed back mechanisms provide feedback to the processing unit 106, based on conditions in the apparatus 100, and facilitate the processing unit 106 in regulating the operation of the apparatus. Accordingly, in an implementation, the feedback mechanism can include pressure-regulating mechanism. In said implementation, the pressure-regulating mechanism can include a pressure gauge (not shown in figures) to regulate and adjust the predetermined vacuum level to be attained in the apparatus 100 and facilitates the processing unit 106 in operating the apparatus 100. The pressure gauge can be analog or digital and can provide feedback to the processing unit 106 regarding whether the vacuum pressure is achieved or not, based on the pressure gauge reading. Further, the pressure-regulating mechanism can include a vacuum regulator 108 connected, on one hand to the pressure gauge, and on other hand, to the vacuum pump 102 and to the processing unit 106. In an example, the processing unit 106 can monitor the pressure in the apparatus 100 based on the pressure gauge and control the operation of the vacuum pump 102 through the vacuum regulator 108. Further, in one example, the vacuum regulator 108 can be a mechanical pressure regulator.
[0032] Further, as part of operation of the feedback mechanism, the processing unit
106 can monitor any loss of vacuum pressure level in the apparatus 100, say from the pressure gauge, on account of a failure, such as a leakage, in the apparatus 100. In the event of such a fault during operation, the processing unit 106 can appropriately control the operation of the vacuum pump, say shut-down the vacuum pump 102, and may issue a warning to a user of the apparatus 100. For example, the processing unit 106 may switch on a warning light or a warning siren or both, to notify a user that the operation of the apparatus 100 is faulty.
[0033] Further, in addition to regulating the operation of the vacuum pump 102 at the time of failure, the processing unit , 106 can control the vacuum pump 102 during normal operation of the apparatus 100 for drying the drug coated medical devices. According to an implementation, as part of the feedback mechanism, the pressure-regulating mechanism of the apparatus 100 can include a non-return valve (not shown in figures). In said implementation, the vacuum pump 102 can be connected to the docking ports 112 through the non-return valve, say positioned in a main conduit 110. In said implementation, the non-return valve can be disposed in the conduit connecting the vacuum pump 102 to the docking ports 112, and positioned in such a way that a single non-return valve can be shut down to isolate the vacuum pump from all the docking ports 112. Further, in said implementation, the non-return valve can be controlled by the processing unit 106. In an example, once the predetermined vacuum level is attained in the apparatus 100, the processing unit 106 can shut-off the nonreturn valve and isolate the vacuum pump from the rest of the apparatus 100. Accordingly, the vacuum pump 102 can be shut down to save power, until, say a higher vacuum pressure is required in the apparatus 100 or the predetermined vacuum pressure is not maintained. In another example, the non-return valve may be controlled mechanically independent of the processing unit 106.
[0034] Accordingly, in an implementation, each valve can be connected to a timing device 116, the timing device 116 being further connected to the processing unit 106. The timing device 116 can include an indicator 120 to indicate the time elapsed, or as in ease of countdown timers, time left for the countdown to finish. The indicator 120 can, in one example, be a digital indicator, and in another example, can be an analog indicator. Further, in said implementation, the timing device 116 can further include a switch 118, the switch 118 being controlled by the processing unit 106 for regulating the opening and closing of the respective valve based on the timing device 116. Hence, the timing device 116 can facilitate the processing unit 106 in regulating the operation of the valves by operating the switches. [0035] Additionally, the apparatus 100 can include a switched-mode power supply
(SMPS) 122 to serve as a switching regulator for the apparatus 100. The SMPS 122 can provide a regulated voltage to the components of the apparatus 100, thereby facilitating effective operation and protecting the components from damage. [0036] In addition, the apparatus 100 can include a plurality of cooling fans 124 to prevent overheating, say of the electrical and electronic components of the apparatus 100, which may otherwise lead to damage of the components of the apparatus 100 and shorten the working life of the apparatus 100 or the components. For example, the cooling fans 124 can provide cooling for the SMPS 122 and the valves. As a result, the components of the apparatus 100 are protected from damage due to overheating.
[0037] Figure 2 illustrates a schematic diagram showing functional components of the apparatus 100, according to an embodiment of the present subject matter. In said embodiment, as shown in Figure 2, the vacuum pump 102, responsible for building the appropriate amount of vacuum pressure inside the apparatus 100, is connected to a work piece 202 through the vacuum regulator 108 and the pressure gauge 204. The work piece 202 can be understood to be the drug-coated medical device placed in the container 114 disposed at the docking port 112, the same being connected to the vacuum pump 102 through the conduit 110. As mentioned earlier, the vacuum regulator 108 works in conjunction with the pressure gauge 204, and both are responsible for vacuum regulation function in the apparatus 100. [0038] Additionally, as explained previously, the conduit 110 can include the solenoid valve manifold 126, which collectively represents the various solenoid valves in the apparatus 100. The valves in the solenoid valve manifold can be regulated to control the connection of the respective docking ports 112, and hence the containers 114 and the drug-coated medical devices, to the vacuum pump 102. In an example, as shown, the solenoid valve manifold 126 can be a normally open 2-way 2-position solenoid valve. Further, each solenoid valve can be configured as an electrically-controlled, single-winding solenoid valve. Further, in another example, the solenoid valves in the solenoid valve manifold 126 can be configured as 3-way, 2-position, normally open valves. As will be understood from the foregoing description, the vacuum regulator 108 and the valves in the conduit 110 can be connected to the processing unit 106. [0039] Further, as explained previously, the processing unit 106 can control the operation of the apparatus 100 by monitoring the vacuum level in the apparatus 100, based on the vacuum level set using the vacuum regulator 108. The processing unit 106 monitors the vacuum regulator 108 and the pressure gauge 204 to maintain the predefined level of vacuum in the apparatus 100. A user may set the vacuum pressure to be achieved in the apparatus 100, using the vacuum regulator 108 and the processing unit 106 may regulate the pressure inside the apparatus 100 based on the readings of the pressure gauge 204.
[0040] Further, the processing unit 106 can control the operation of the valves in the conduit 110 by receiving the inputs from the timing device 116 connected to the valves. The processing unit 106 can be configured to regulate each of the valves to control the extent of exposure of the drug-coated medical devices at each docking port 112 to the vacuum inside the apparatus 100. In an example, as mentioned earlier, each timing device 116 can be connected to a switch 118, and based on an input of the indicator 120 of the timing device 116, the processing unit 106 can directly regulate the opening and closing of the valve by operating the switch 118. In another example,. the timing device 116 may set off the switches 118 which can directly operate the valves based on the inputs of the indicator 120.
[0041] For example, the indicator 120 of the valve in a first conduit can be set to open the valve for a duration of 10 minutes to expose the medical device at the first docking port to the vacuum for drying and close the valve after the completion of the 10 minute duration. On the other hand, the indicator 120 of the valve in the second conduit can be set to open the valve for 15 and subsequently close the valve.
[0042] Further, as explained previously, the valves in the different conduits, as described in the example above, are configured to operate simultaneously as well as independently. The independent operation of the valves is governed by the processing unit 106. In the above example, the valve in the first conduit and the valve in the second conduit can be timed to operate for 10 and 15 minutes, respectively. Subsequently, upon completion of the operation cycle of the medical device in the docking port 112 of the first conduit, that is, after 10 minutes, the processing unit 106 can close the valve in the first conduit and isolate that docking port 112 from the rest of the apparatus 100 without disturbing the vacuum level in the rest of the apparatus 100. Hence, while the docking port 112 connected to the first conduit is isolated from the operation, in the meantime, the operation continues in the other docking port 112 connected to the second conduit. Further, the previous docking port 112 can be loaded with another medical device to be dried and the timing device 116 associated with the valve in the first conduit can be re-programmed and reset for a different drying cycle. Consequently, the docking port 112 can be reused for the drying operation for a different cycle. Accordingly, the valve is reopened to expose the fresh medical device to the vacuum in the apparatus 100.
[0043] Therefore, the apparatus 100 as described herein ensures a uniform and independent vacuum level for each drug coated medical device in the different containers 114 at different docking ports 112. As a result, the apparatus 100 also ensures that each drug coated medical device is exposed to the vacuum for a predefined timed cycle, for example, pertaining to the drying characteristics and the drug-eluting properties. Further, the problem of contamination from other medical devices and by. coming in contact with the ambient atmosphere/air is practically eliminated. In addition, based on the predefined drying characteristics of each drug coating, the duration for application of vacuum to different medical devices can be independently controlled.
[0044] Since, the apparatus 100 according to the present subject matter allows individual control of time of application of vacuum pressure at each docking port 112, different medical devices having different drying characteristics and drying times can be dried, without compromising the vacuum pressure built in the apparatus 100. Additionally, the independent operation at each docking port 1 12 allows removal of each medical device after drying and being replaced by another medical device to be dried. As a result, the waiting time between coating of the medical devices and placing them inside the container for drying, and hence their exposure to the atmosphere, is substantially reduced. [0045] Although implementations of the apparatus 100 for drying drug-coated medical devices have been described in language specific to structural features and/or methods, it is to be understood that the appended claims are not necessarily limited to the specific features or methods described. Rather, the specific features and methods are disclosed as implementations the apparatus 100 for drying drug-coated medical devices.

Claims

I/We claim:
1. An apparatus (100) for drying drug-coated medical devices (202), the apparatus (100) comprising: a vacuum pump (102) for generating a negative pressure; a plurality of containers (1 14), each for holding a drug-coated medical device (202) to be dried, wherein each of the plurality of containers (1 14) is connected to the vacuum pump (102) through a conduit (1 10); a plurality of valves, one valve being provided in each conduit (1 10) to regulate a connection between a container (1 14) from among the plurality of containers (1 14) connected to the vacuum pump (102) through the conduit (1 10); a processing unit (106) configured to individually control each of the plurality of valves for regulating drying operation in the plurality of containers (1 14); and a feedback mechanism coupled to the processing unit (106) for facilitating regulation of the drying operation in the plurality of containers (1 14).
2. The apparatus (100) as claimed in claim 1 further comprising a plurality of docking ports (1 12), each capable of receiving a container (114) from among the plurality of containers (114) to form an air-tight seal therebetween, wherein each of the plurality of docking ports (1 12) is coupled to the vacuum pump (102) through the conduit (1 10).
3. The apparatus (100) as claimed in claim 1, wherein the conduit (1 10) is formed as a single manifold branching into a plurality of sub-ducts, each sub-duct connected to each of the plurality of containers (114).
4. The apparatus (100) as claimed in claim 3, wherein the feedback mechanism comprises at least one non-return valve disposed in the single manifold of the conduit (1 10), wherein the processing unit (106) is configured to control the at least one nonreturn valve for isolating the vacuum pump (102) from the plurality of containers (114).
5. The apparatus (100) as claimed in claim 1 , wherein the plurality of valves are configured as at least one of electrically-controlled valves, mechanically-controlled valves, electronically-controlled valves, and magnetically-controlled valves.
6. The apparatus (100) as claimed in claim 1, wherein the plurality of valves is configured as at least one of 2-way 2-position valves and 3-way 2-position valves.
7. The apparatus (100) as claimed in claim 1 , further comprising a timing device (1 16) connected to each of the plurality of valves, the timing device (1 16) being further connected to the processing unit (106), the processing unit (106) being configured to control each of the plurality of valves based on the timing device (116).
8. The apparatus (100) as claimed in claim 7, wherein the timing device (1 16) comprises a switch (118) controllable by the processing unit (106) for regulating operation of connected valve.
9. The apparatus (100) as claimed in claim 1, wherein the feedback mechanism further comprises a pressure gauge (204) connected to the each conduit (1 10) to determine a vacuum pressure in the each conduit (110) for regulating operation of each of the plurality of valves.
10. The apparatus (100) as claimed in claim 9, wherein the pressure gauge (204) is further connected to the processing unit (106), the processing unit (106) being configured to control the plurality of valves based on the vacuum pressure.
PCT/IN2013/000107 2012-03-02 2013-02-19 Apparatus for drying drug-coated medical devices WO2013128469A1 (en)

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IN574/MUM/2012 2012-03-02

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Citations (5)

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Publication number Priority date Publication date Assignee Title
US3245152A (en) * 1964-05-12 1966-04-12 Natelson Samuel Tray lyophilization apparatus
US3255534A (en) * 1963-03-21 1966-06-14 United Fruit Co Vacuum apparatus
US4823478A (en) * 1987-11-30 1989-04-25 Fts Systems, Inc. Freeze dryer for unattended operation
US6122836A (en) * 1998-05-07 2000-09-26 S.P. Industries, Inc., The Virtis Division Freeze drying apparatus and method employing vapor flow monitoring and/or vacuum pressure control
WO2010134953A1 (en) * 2009-05-18 2010-11-25 Robert Warren Modular freeze drying system

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3255534A (en) * 1963-03-21 1966-06-14 United Fruit Co Vacuum apparatus
US3245152A (en) * 1964-05-12 1966-04-12 Natelson Samuel Tray lyophilization apparatus
US4823478A (en) * 1987-11-30 1989-04-25 Fts Systems, Inc. Freeze dryer for unattended operation
US6122836A (en) * 1998-05-07 2000-09-26 S.P. Industries, Inc., The Virtis Division Freeze drying apparatus and method employing vapor flow monitoring and/or vacuum pressure control
WO2010134953A1 (en) * 2009-05-18 2010-11-25 Robert Warren Modular freeze drying system

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