WO2012013472A1

WO2012013472A1 - Modular microneedle transport device

Info

Publication number: WO2012013472A1
Application number: PCT/EP2011/061547
Authority: WO
Inventors: Kathrin Van Teeffelen
Original assignee: Robert Bosch Gmbh
Priority date: 2010-07-30
Filing date: 2011-07-07
Publication date: 2012-02-02
Also published as: EP2598198A1; DE102010038733A1

Abstract

The invention relates to a modular microneedle transport device (1; 1') comprising a first module (20; 20') that includes a fluid reservoir (23; 23') for receiving a transport fluid (F), a microneedle unit (22), and a micropump unit (24) for pumping the transport fluid (F) from the fluid reservoir (23; 23') into the microneedle unit (22) and/or vice versa; and further comprising a second module (10; 10') comprising an actuator unit (10a) and a battery-powered control unit (10b); wherein the second module (10; 10') can be mounted in a recess (50) of the first module (20; 20'); and wherein the micropump unit (24) can be mechanically actuated by the actuator unit (10a) by means of a pressure actuation surface (UP) provided in the recess (50) when the second module (10; 10') is mounted.

Description

Description title

Modular microneedle transport device

State of the art

The present invention relates to a modular microneedle transport device.

Although applicable to any micromechanical devices, the present invention and its underlying background with respect to micromechanical devices in silicon technology will be explained.

DE 10 2006 028 781 A1 discloses a method for the production of porous micro-needles arranged on a silicon substrate in an array for the transdermal administration of medicaments. The method includes forming a microneedle array having a plurality of microneedles on the front side of a semiconductor substrate rising from a support region of the semiconductor substrate, and partially porosifying the semiconductor substrate to form porous microneedles, the porosification starting from the front side of the semiconductor substrate and a porous one Reservoir is formed. US 2008/0319392 A1 discloses a microneedle transport device having a reservoir for receiving a transport fluid, a needle assembly, each needle having a bore in fluid communication with the reservoir, a first actuator for driving the needles into the body, and withdrawing the needles from the needle Body and a second actuator, which pumps the transport fluid between the reservoir and the body through the needles, which can be designed bidirectional.

US 2009/0099522 A1 discloses a microneedle system with an analysis device.

DE 10 2005 052 039 A1 discloses a method for producing a micropump and a micropump produced by this method. WO 2005/015021 A1 discloses a method for producing a micromechanical component for fluidic applications and a micropump of a pump membrane made of a polysilicon layer. Microneedle arrays comprising, for example, porous silicon micro-needles are generally used in the field of "transdermal drug delivery" as an extension of medicament patches, as a carrier of a vaccine or also for obtaining body fluid (so-called transdermal fluid) for diagnosis and analysis used by body parameters (eg glucose, lactate, ...).

Millions of people around the world are suffering from illnesses that require long-term, almost constant medication. These include, for example, diabetes mellitus type 1. A drug dosing system, in this case an insulin pumping device, which delivers insulin to the human body, is particularly useful in this type 1, as well as the body gentle dosage of the human pancreas and thus long-term consequences can be reduced.

At present, there are some insulin pumps on the market, which in most cases are quite large and thus it is difficult for patients to hide from their fellow human beings and thus the disease can not be concealed. Furthermore, they are quite high

Purchase cost of the pump apply.

The drive unit, the power supply and the control of such known pumps are reused. The patient merely replaces an insulin cartridge and the needle. There is a variant in which a new insulin cartridge is used, and another variant in which this insulin cartridge is refilled. The

Refilling is more difficult, if not impossible, for particularly young or elderly patients.

In these known pumps, the drive and control unit and the power supply from the rest, that is separated from the reservoir and needle. This prevents the entire system from being thrown away after consuming the insulin supply. Advantages of the invention

The modular microneedle transport device defined in claim 1 has the advantage that the size (flat structure), costs (separation of disposable unit and reusable unit) and operability for the patient over known

Approaches are greatly improved.

The microneedle transport device according to the invention can be constructed extremely flat, that is, it is easy to hide under clothing and thus virtually invisible to an outside viewer.

The microneedle transport device has a preferred development on its underside, that is, where the microneedle device is provided, a patch, which the patient directly adheres to the skin. An elaborate holding system, z. B. via a belt, the patient thus spared. In addition, it is designed so that the patient can handle the pump extremely easy, annoying refilling of the reservoir is eliminated.

Another decisive advantage of the microneedle transport device according to the invention is the cost. Due to the separation into a first module, which has the fluid reservoir, the microneedle device and the micropump device, and a second module, which has an actuator device and a battery-operated control device, only the inexpensive first module is discarded and then a replacement module with the second Module connected. In addition, the micro-needle transport device according to the invention can be equipped with a higher comfort when the reservoir is made of a flexible plastic, who, as the reservoir is pumped over the injection time always empty, over the period of wear is getting smaller. Since the connection of the two modules requires only a mechanical attachment, but no electrical or fluidic connection, the handling is particularly easy for the patient and can avoid sterility problems.

A particularly preferred embodiment provides for positively locking or clipping the second module in a recess of the first module. The features listed in the dependent claims relate to advantageous

Further developments and improvements of the subject matter of the invention.

drawings

Embodiments of the invention are illustrated in the drawing and in the

explained in more detail below description.

Show it:

Fig. 1 a-e schematic cross-sectional views for explaining a

Embodiment of the modular microneedle transport device according to the invention;

Fig. 2 shows an example of an application of the microneedle transport device according to

Fig. 1 on the human body; and

Fig. 3 is a schematic cross-sectional view for explaining another

Embodiment of the modular microneedle transport device according to the invention.

Description of exemplary embodiments

In the figures, like reference numerals designate the same or functionally identical

Elements.

Fig. 1 a-e show schematic cross-sectional views for explaining a

In FIG. 1 ae, reference numeral 1 denotes a microneedle transport device in the form of an insulin pumping device with a round geometry. The microneedle transport device 1 has a first module 20, which has a fluid reservoir 23 for receiving a transport fluid F, a microneedle device 22 and a micropump device 24 for pumping the transport fluid F from the fluid reservoir 23 via a micro-conduit means I into the microneedle device 22. Locked by a locking device R in a form-locking manner. used in the first module 20 is a second module 10, which has an actuator device 10a and a battery-operated control device 10b. For reasons of simplification, the battery is not shown separately. In the present case, the micropump device 24 is a silicon pump chip known per se, which can suck in the transport fluid F in the form of insulin at inlets E and which can inject the transport fluid F via the microlube device I via the microneedle device 22 under the skin of a patient. In the present case, the microneedle device 22 is, for example, an arrangement of porous silicon needles 25, which rise on a silicon substrate. On the underside U of the first module 20, that is on the side of the microneedle device 22, an adhesive plaster device 21 is provided, which in the present case is penetrated by the microneedles 25 and which allows easy mounting of the microneedle transport device 1 on the skin of the patient. Alternatively, it would also be possible, for example, that the adhesive plaster device 21 surrounds only the periphery of the microneedle device 22 on the underside U of the first module 20.

In the present case, the locking device R consists of a circumferential groove N in the first module and a corresponding projection V in the second module (see Figure 1 d, e). The second module 10 can thus be inserted into a recess 50 of the first module such that it bears in a form-fitting manner therein and forms a flush upper side O with the first module 20.

In the direction of the arrow, the second module 10 can apply pressure to the silicon pump chip 24 via the flexible outer wall, such as the first module 20, in a region where the silicon pump chip 24 has a pumping membrane. This pressure P (see FIG. 1 e), which is expended, for example, via a plunger ST, permits actuation of the micropump in the form of the silicon pump chip 24. The battery-operated control unit 10d, for example, predetermines a permanently programmed time sequence via a control line 100 or can be actuated from the outside at the top O by a user set or program.

As shown in Figure 1 c, shows the fluid reservoir 23 for the transport fluid 1 1, which consists of a flexible plastic, a balloon-like behavior. In other words, the size of the upper side O becomes smaller as the fill level of the fluid reservoir 23 decreases

or shrinks together, so that gives the patient a pleasant feeling while wearing. In FIG. 1 d, reference symbol UP denotes a pressure actuation surface on which the plunger ST of the actuator device 10 a shown in FIG. 1 e acts in order to actuate the micropump 24.

Fig. 2 shows an example of an application of the microneedle transport device according to FIG. 1 to the human body.

FIG. 2 shows a comfortable type of insulin pump device described in connection with FIG. 1 a-e, in which a patient M sticks the microneedle transport device 1 onto his abdominal region with the aid of the adhesive paving device 21. The microneedle transport device 1 according to FIG. 1 a-e can be made extremely flat and therefore offers a comfortable wearing feeling for the patient M, especially as it becomes smaller and smaller as the use increases due to the flexible nature of the fluid reservoir 23.

Fig. 3 shows a schematic cross-sectional view for explaining a further embodiment of the modular microneedle transport device according to the invention.

In the embodiment shown in FIG. 3, instead of the round geometry according to FIG. 1 a-e, a rectangular geometry of the microneedle transport device 1 'is provided, in which the second module 20' is displaced decentrally. Also, in this example, the adhesive patch 21 'and the array of microneedle 25' and fluid reservoir 23 'have a proper geometry. As indicated in Figure 1 a and 3, can be due to the flexible property of

Fluid reservoirs 23 and 23 'easily solve the interference fit of the first and second modules 20, 20' and 10, 10 'and thus easily connect

or decoupling to replace the first module make. Although the present invention has been described above with reference to preferred embodiments, it is not limited thereto, but in many ways

modifiable.

Of course, the present invention is not limited to the illustrated angular or circular geometry, but is applicable to any geometry. The microneedle device can have both a plurality of needles and only a single one Needle. The fluid reservoir is not limited to the described flexible plastic, but may also be stiff. It may also have an inner coating so that the plastic does not give undefined substances to the transport fluid, for example insulin. Such an inner coating can be made, for example, from Teflon.

Although in the above example, a porous silicon microneedle device is provided, the invention may alternatively be realized with a hollow needle device made of steel, plastic, silicon or other materials. The filling of the fluid reservoir is expediently carried out in the manufacture of pumps by the manufacturer, but can also, if desired, be performed by the patient himself.

Claims

Claims 1. A modular microneedle transport device (1; 1 ') comprising: a first module (20; 20') having a fluid reservoir (23; 23 ') for receiving a transport fluid (F), a microneedle device (22), and a micropump device (24) for pumping the transport fluid (F) from the fluid reservoir (23, 23 ') into the microneedle device (22) and / or vice versa; a second module (10, 10 '), which has an actuator device (10a) and a

battery operated control device (10b); wherein the second module (10; 10 ') is mountable in a recess (50) of the first module (20; 20'); and wherein the micropump device (24) can be actuated mechanically by means of a pressure actuation surface (UP) provided in the recess (50) by the actuator device (10a) when the second module (10; 10 ') is attached.

2. The modular microneedle transport device (1; 1 ') according to claim 1, wherein the

Fluid reservoir (23, 23 ') is formed of a flexible or rigid plastic and has a degree of filling dependent size of its top (O).

3. Modular microneedle transport device (1, 1 ') according to claim 1 or 2, wherein the micropump device (24) has a micromechanical silicon pumping chip.

4. Modular microneedle transport device (1, 1 ') according to one of the preceding claims, wherein the second module (10, 10') in a recess (50) of the first module (20, 20 ') can be locked or latched.

5. The modular microneedle transport device (1, 1 ') according to any one of the preceding claims, wherein the microneedle device (22) at least partially from a

Bonded adhesive device (21, 21 ') is surrounded.

6. Modular microneedle transport device (1, 1 ') according to one of the preceding claims, wherein the microneedle device (22) at least partially by a

Sticky adhesive device (21, 21 ') is guided.

7. Modular microneedle transport device (1, 1 ') according to one of the preceding

Claims wherein, when the second module (10; 10 ') is mounted, the fluid reservoir (23; 23') forms a substantially flush upper side (O) with the second module (10; 10 ').

A modular microneedle transport device (1; 1 ') as claimed in any one of the preceding claims, wherein the microneedle device (22) comprises a porous silicon microneedle device having one or a plurality of micro-needles (25; 25') of porous silicon.

9. The modular microneedle transport device (1, 1 ') according to any one of the preceding claims, wherein the microneedle device (22) comprises a hollow needle device with one or a plurality of hollow needles.

10. Modular microneedle transport device (1, 1 ') according to one of the preceding claims, wherein the control device (10b) with attached second module (10, 10') is adjustable from the outside.

1 1. A modular microneedle transport device (1; 1 ') according to any one of the preceding claims, wherein the second module (10; 10') is substantially positive fit in the

Recess (50) of the first module (20; 20 ') is attachable.

12. First module (20; 20 '), which a fluid reservoir (23; 23') for receiving a

Transport fluid (F), a microneedle device (22) and a micropump device (24) for pumping the transport fluid (F) from the fluid reservoir (23, 23 ') into the microneedle device (22) and / or vice versa, for use in a modular microneedle device. Transport device (1, 1 ') according to one of claims 1 to 11.

A second module (10; 10 ') comprising an actuator means (10a) and a battery operated control means (10b) for use in a modular microneedle transporting apparatus (1; 1') according to any one of claims 1 to 11.