Wrist mounted micro -jet fluid delivery device
FIELD OF THE INVENTION
The present invention generally relates to the field of needle-less fluid delivery and an improved device for submitting fluids without a needle and methods of delivery. In particular the invention relates to a wearable drug-delivery device, e.g. a wrist-mounted transdermal drug delivery device and method of assembling the same.
BACKGROUND OF THE INVENTION
Document WO 2008/142636 A2 discloses a wearable drug delivery device. The device employs a high speed jet pump for transdermal, needle-less drug delivery. It is worn by a patient for long-term treatment. A reservoir for storing the drug is comprised in the form of a cartridge. The cartridge is replaceable while the pump remains fixed to a patient. The pump and the cartridge are mounted together by a bayonet.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an alternative micro-jet fluid delivery device and delivery method. An advantage of the present invention is that it allows facilitated handling and provides improved characteristics with respect to hygienic and sterility issues at the device-skin interface.
This object is achieved by a micro -jet fluid delivery device according to claim 1. Advantageous further embodiments of the invention are given in the dependent claims. The present invention provides a micro-jet fluid delivery device comprising a first housing part and a second housing part, wherein the first housing part comprises:
an actuator to operate a jet pump,
driver electronics to control the jet pump,
- a first threaded or bayonet connector;
wherein the second housing part (320) comprises:
a fluid container,
a nozzle for forming a micro -jet,
second threaded or bayonet connector, and wherein the first and the second threaded or bayonet connector are arranged to cooperate in a manner that the first and the second housing part are formed into a fixed assembly.
The pump may be a jet pump or any other pump able to delivery fluid at a pressure so that it may be micro-jetted transdermally. The first and/or second fixing means may be threaded fixing means although other fixing methods are included within the scope of the invention such as a bayonet coupling. Both a threaded and a bayonet connection require rotational movement to make the connection.
The device of the present invention may be formed as a device that can be attached to the wrist of a person, like a watch. For this purpose the device preferably includes a housing and a strap for attachment around the wrist. Accordingly the device of the present invention may be formed as a wrist-mounted needless delivery device for transdermal delivery of a fluid such as a drug. The device of the present invention may be used for the delivery of medicinal drugs or recreational drugs.
In this text, transdermal implies all layers comprised in a mammal's skin underneath the stratum corneum which performs as the interface with the outside world. In order of increasing depth with regard to the stratum corneum, these layers are the epidermis, the dermis and the hypodermis, wherein the latter layer is also referred to as the subcutis or subcutaneous fat.
The device of the present invention presents the significant additional advantage that it separates the reusable parts and the disposable parts of the device while at the same time providing a fixing structure to assemble the two parts, that is rigid enough to support the interaction of the actuator of the pump, e.g. jet pump and the micro-jet nozzle to allow for a controlled supply of the fluid.
Beneficially according to a further development of an embodiment of the present invention the second housing part is arranged in such a manner that it is the only part of the assembly that contacts the skin of the user. This allows that only the disposable part needs to be sterilized; and at the same time the material of the first housing does not need to be selected to withstand aggressive sterilizing agents.
Expediently according to a further development of an embodiment of the present invention, the first housing part comprises a static part and a movable part, whereas the movable part is coupled to the first fixing means, e.g. first threaded fixing means. In this manner, the first fixing means, e.g. the first threaded fixing means can be operated from outside and the first and the second housing part can be assembled in an easy way. Beneficially according to a further development of an embodiment of the present invention the operating means and the first fixing means, e.g. the first threaded fixing means can be manufactured in one part and be kept by first guiding means that allow a rotating movement of the operating means and the first fixing means, e.g. the first threaded fixing means with respect to the first housing part. In this manner, if the device is
manufactured from plastic material, the tolerances of the first housing part and the integral operating and fixing means can be arranged and provided in such a manner, that the parts can be assembled by a snap-in connection.
Advantageously according to a further development of an embodiment of the device according to the present invention a display is provided in the first housing part, which allows control of parameters of the micro-jet fluid delivery device; for instance if an injection is at present performed and the frequency of the injections can be displayed. The display may be any suitable display, e.g. a digital display known from wristwatches such as an LCD display, an OLED display, etc. Furthermore an indication or an alarm can be given, e.g. once the container for the fluid for instance containing a dissolved drug is empty or has a low volume. This alarm can be an audio, an optical or a tactile alarm, for example.
Expediently according to a further development of an embodiment of a device according to the present invention a power source is provided inside the device, which is coupled to the driver electronics. In this manner, a controlled actuation of the pump, e.g. jet pump by the driver electronics is ensured and the fluid can be submitted in any amount and any frequency under the control of the driver electronics supplying power according to preset parameters to the electromechanical actuator. The power source may be assisted by solar cells or power generation devices known from watches which make use of the mechanical movement of the wrist to generate electrical power.
Advantageously according to a further development of an embodiment of the present invention the power source is coupled by contacts whereby the contacts are distributed over the first and second housing parts. This allows making the pump only operable once the device is assembled.
Beneficially according to a further development of an embodiment of the present invention the power source is arranged in the second housing part. In this manner, the device is integrated in the first housing part and can be enclosed completely by plastic material, as no replaceable parts are in there and thus can be made water-resistant. On the other hand, providing the battery in the disposal part allows it to always have defined operating conditions for the pump, e.g. jet pump and to secure that always enough power is left to submit the total amount of fluid included in the fluid container. This embodiment is specifically beneficial in case non-rechargeable batteries are being employed. If a
rechargeable battery is installed, preferably it is mounted in the durable part of the device, i.e. the first housing.
Advantageously according to a further development of an embodiment of the device according to the present invention, cooperating second and third guiding means arranged in the first and second housing part are provided, which allows to keep the second housing part in a fixed position. In accordance with embodiments of the present invention, a rotational operation of the operating means is provided while assembling the first and the second housing part to build the micro-jet fluid delivery device (e.g. to form a threaded or bayonet connection). In this manner, a disposable cartridge may be used on the forearm of a user, the first housing part can be placed on top of it, the strap can be loosely fixed around the arm and while turning the operating part, the first and the second housing part can be screwed together, while the second and third guiding means engage each other in order to avoid a rotational movement of the cartridge. This allows a facilitated handling of the fluid delivery device.
Expediently a further development of an embodiment of the device according to the present invention comprises a membrane in the second housing part. This allows it to always have defined pumping conditions for the electromechanical actuator and thus predefined and e.g. stored pumping parameters such as pumping frequency and an actuation voltage of the electromechanical actuator will lead to the same amount of fluid to be delivered subcutaneously.
Beneficially according to a further development of an embodiment of the device according to the present invention the second housing part is arranged as a disposable cartridge. This allows it to be a pre-fabricate cartridge containing a variety of drugs to be administered by the fluid delivery device and to maintain high hygienic sterility standards, while at the same time allowing a facilitated handling for the user. In particular such a disposable cartridge may be manufactured by the manufacturer of the fluid delivery device and provided to a drug provider for filling and distribution.
Expediently according to a further development of an embodiment of the present invention the first housing part and the second housing part may be manufactured from different materials, wherein only the second housing part advantageously needs to be able to withstand sterilizing agents and/or temperatures. This allows for a cost-effective manufacturing and at the same time to protect the electronic components in the first housing part.
Expediently according to a further development of an embodiment of the device according to the present invention the operating means is arranged as a ring with indentations for easy gripping with the fingers of a hand, and knows that the ring may be turned to operate the device and at the same time it allows to securely exert force on the ring, e.g. when bringing the first housing part and the second housing part together, e.g. by screwing the first housing part and the second housing part together.
Advantageously according to a further development of an embodiment of the device according to the present invention the device comprises coding means, in order to encode the drug contained in the fluid container and/or parameters to submit the drug via the jet pump. In this manner different cartridges may be provided with already predefined operating parameters for the jet pump and thus only a minimum of adjustments need to be provided; such as for instance putting in the age and the weight of a patient into the watch.
Advantageously according to a further development of an embodiment of the device according to the present invention the coding means is associated to the contacts and/or the position of the contacts or another electrical parameter that is detectable by using the contacts and can be processed by the driver electronics in order to properly submit the drug contained in the fluid container.
The present invention also provides a method of attaching a disposable cartridge on the forearm of a user, the method comprising: placing a first housing part on top of the cartridge, loosely fixing the strap around the wrist of the user, turning the operating part, so that the first and the second housing part are joined together, while second and third guiding means engage each other in order to prevent a rotational movement of the cartridge.
BRIEF DESCRIPTION OF THE DRAWINGS
Below advantageous further developments of the invention will be further explained based on examples and embodiments shown in drawings, wherein:
Fig. 1 shows a micro-jet fluid delivery device according to an embodiment of the present invention,
Fig. 2 shows a schematic cross-section of the embodiment shown in Fig. 1, Fig. 3 shows a more detailed cross-section of an interior part of an embodiment of the device according to the present invention, and Fig. 4 shows two views from below and above respectively on the first housing part and the second housing part.
The present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto but only by the claims. The drawings described are only schematic and are non-limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn on scale for illustrative purposes. Where the term "comprising" is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun e.g. "a" or "an", "the", this includes a plural of that noun unless something else is specifically stated.
The term "comprising", used in the claims, should not be interpreted as being restricted to the means listed thereafter; it does not exclude other elements or steps. Thus, the scope of the expression "a device comprising means A and B" should not be limited to devices consisting only of components A and B. It means that with respect to the present invention, the only relevant components of the device are A and B.
Furthermore, the terms first, second, third and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.
Moreover, the terms top, bottom, over, under and the like in the description and the claims are used for descriptive purposes and not necessarily for describing relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other orientations than described or illustrated herein.
Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments. Similarly it should be appreciated that in the description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention.
Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.
Furthermore, some of the embodiments are described herein as a method or combination of elements of a method that can be implemented by a processor of a computer system or by other means of carrying out the function. Thus, a processor with the necessary instructions for carrying out such a method or element of a method forms a means for carrying out the method or element of a method. Furthermore, an element described herein of an apparatus embodiment is an example of a means for carrying out the function performed by the element for the purpose of carrying out the invention.
Throughout discussing the drawings same reference signs refer to functionally same entities and for the sake of efficiency redundant description thereof is avoided.
DETAILED DESCRIPTION OF THE EMBODIMENTS
Generally no standard parameters for transdermal fluid delivery can be used, as the morphological and mechanical properties, such as thickness and tension of the tissue vary from subject to subject; and further also depend on the anatomical location as to where the fluid jet is applied.
A fluid delivery device for instance may be used to apply the drug insulin or to provide a vaccination. By using the proper control parameters for the fluid jet, the penetration depth of the fluid jet can be adjusted and a corresponding pain sensation of the user can be reduced, while a corresponding drug uptake can be optimized. In order to use the fluid delivery device according to the present invention in a first step, a second housing part may be sterilized underneath, as well as the stratum corneum may be sterilized and then the lower side of the second housing part and the stratum corneum, which both have been prepared and sterilized can be brought into contact, while the first housing part is then placed on top of the second housing part and screwed together, by using the operating means, e.g. a ring resembling the one of a diving watch, the two parts are rotated, e.g. screwed together to complete the fluid delivery device.
Fig. 1 gives an example of an embodiment of a fluid delivery device of the present invention. It may for instance be used to administer drugs in liquid form to a wearer respectively user of the device. In general the fluid delivery device 200 comprises a fixing means 220 or a strap, to fix the device on the wrist of a user like usually well-known from wearable wrist watches, as well as a first housing part 230, operating means 210 in form of a ring being rotatable and a display of the fluid delivery device, in this case the fluid delivery device shows the current time which is 12 hours and 36 minutes, and indicates that injections are currently administered at a frequency of 1 Hz. Furthermore the device may display an alarm, once the fluid container for instance containing a liquid drug is empty, and
additionally may indicate the current battery capacity of the power source. Furthermore the display may give an indication of a drug that is currently administered, in case a plurality of drugs needs to be administered by the same device.
Accordingly, the device of the present invention may be formed as a device that can be attached to the wrist of a person, like a watch. For this purpose the device includes a housing and a strap for attachment around the wrist. Accordingly the device of the present invention may be provided as a wrist -mounted needless delivery device for transdermal delivery of a fluid such as a drug. The device of the present invention may be used for the delivery of medicinal drugs or recreational drugs. It has the specific advantage that infection by sharing hypodermic needles is reduced.
An arrow 223 indicates a direction of a turning the operating means or the operating ring, in order to join e.g. by screwing or bayoneting the first housing part and the second housing part together by means of turning the ring in the right direction. In the other direction, of course the device will then disassemble itself, by pushing out the second housing part and allowing it to withdraw for instance a fluid container and dispose of it.
Fig. 2 shows a cross-section of the embodiment of Fig. 2. The same parts of the fluid delivery device in this case are marked by the same reference signs and are not described again, for the sake of efficiency. In this case a second housing part 320 can be seen, which comprises a lower surface 365, which is in direct contact with the stratum corneum of a user, once the fluid delivery device will be worn. In this case an actuator 345 is indicated as well as first threaded fixing means 350 and second threaded fixing means 310. Instead of a threaded fixing means a bayonet fixing means could be used. Arrows 340 indicate a direction of assembly of the first housing part 320 and the second housing part 230. In this case it can well be identified, that the operating means 210 are coupled to the first threaded or bayonet fixing means 350. By turning the operating means 210 the first threaded or bayonet fixing means 350 will start rotating, and in case of engaging the second threaded or bayonet fixing means 310 the first housing part 320 and the second housing part 230 will be joined, e.g. screwed together. In case of the embodiment shown in Fig. 2, the operating means 210 is movable relative to the first housing part 230 and is guided by first guiding means 308. The dimensions used in this drawing are not representative of the actual dimensions to be used in a manufactured product and serve only the purpose to demonstrate the configuration.
In this case, the first guiding means 308 may be attached to the operating means 210 and may be manufactured in one piece and in case of an assembly may be snapped into the first housing part 230 by a pushing operation, if proper tolerances are selected during manufacturing. In order to avoid a rotating movement of the second housing part 320, once it is joined, e.g. screwed to the first housing part 230, the first housing part may comprise a groove that engages a notch 360 which is provided on the second housing part 320. In this manner while rotating, e.g. screwing together the first housing part and the second housing part in twisting the operating means 210 the first housing part 365 is fixed by the notch 360 and only an axial movement in a direction of the arrow 340 is possible, and thus, the fluid delivery device according to this embodiment may even be assembled, once the second housing part 320 is already placed on the wrist area of a user and the second housing part 230 is placed on top of it in order to assemble the fluid delivery device.
Fig. 3 shows a cross-section of another embodiment of a fluid delivery device of the present invention 400. A first housing part 230 shown; and a second housing part 320 are assembled together by means of first threaded or bayonet fixing means 350 and second threaded or bayonet fixing means 310 each respectively attached to the first housing part 230 and the second housing part 320. In an embodiment, the first housing part is shown to have outer threads, whereas the second housing part is shown to have complementary inner threads, it may however well be the other way round, because there is no constructive reason to have particular threaded fixing means at a respective housing part. With 365 a surface of the second housing part is shown, that comes into contact with the epidermis stratum corneum. In addition fluid containers 455 and 460 are shown, which may be connected to each other or form a single unit. Above that a nozzle 435 for forming a micro -jet is shown as well as a membrane 430 of the micro-jet pump. In addition a fluid supply channel 437 supplying the drug fluid to an area below the membrane 430 is shown. Furthermore Fig. 3 depicts an electromechanical actuator 420, as well as driver electronics 415 and a power supply 410. In this case, the power supply is connected by a first supply line 476 to a first contact 472 in the bottom surface 485 of the first housing part and driving electronics 415 is connected via a second supply line 474 to another second contact 470 on the bottom surface 485 of the first housing part. These two contacts 472 and 470 cooperate with another contact 477 that is integrated in the second housing part and bridges the second 470 and first 472 contact to allow a current to flow from the power supply 410 to the driver electronics 415. The first housing part in its upper area may be similar to a wrist mounted device like a watch, e.g. including a watch display in order to indicate a present time and to display parameters of the fluid- respectively drug administration such as a frequency of the micro -jet pulses as well as if an injection is taking place at present or not. Furthermore a battery indicator and a fill indicator of the fluid container may be provided there. It is conceivable, that the location of the first 472 and second 470 contacts may be different, and that they may cooperate with a different third contact 477 at a different location at the second housing part 320. It is also conceivable, that a plurality of contacts may cooperate in a different manner in order to provide a coding which is detectable by the driver electronics 415, in order to derive the type of a drug that is in the fluid container
automatically and basic parameter for its submission.
Fig. 4 on the left-hand side shows a view from above 450 on the second housing part 230. A membrane 430 is shown as well as a third contact 477. Also second threaded fixing means 310 are depicted as well as the support structure of the second housing part 480. It is to be noted, that the second housing part needs not to be provided in a round configuration. Only the second threaded fixing means 310 obviously needs to be round. The support structure 480 may also comprise a rectangular or a quadratic shape of any configuration. In this case, in order to avoid a rotating movement of the second housing part 230 a notch 360 may be provided on it to provide guidance during a fixing operation.
On the right-hand side a view from below on the first housing part 230 is shown depicted by 440. By 437 a plunger attached to the electromechanical actuator 420 is shown, as well as a Bottom surface 485 of the first housing part 230. The first and second contacts that cooperate with the third contact 477 on the second housing part 320, are indicated by 470 and 472, respectively. First threaded fixing means are shown and indicated by reference sign 320. Furthermore a groove 362 is incorporated in the first housing part 230.
The configuration shown in Fig. 4 allows provision of the first housing part and the second housing part in a sealed configuration. In case the second housing part 320 is a disposable cartridge, the first housing part and the second housing part may be
manufactured of different materials, whereby the material for the first housing part needs not to be able to withstand aggressive sterilization agents or high sterilization temperatures, which is a requirement for the material of the second housing part. It can be clearly seen from Fig. 4, that the second housing part 320 has a larger diameter than the first housing part 230 and thus this part is the only part which contacts the epidermis of a user.