DE102011015073A1 - Apparatus for optimizing skin penetrating devices by stimulation, is formed as independent device that is loose or not permanently connected with typical skin penetration - Google Patents

Abstract

The apparatus is formed as an independent device that is loose or not permanently connected with a typical skin penetration. The apparatus is tightly integrated at or in the skin penetration. The apparatus is formed as vibrator, electric stimulator or thermal stimulator. A stimulus area (1) is characterized at the intended skin contact position.

Description

The invention optimizes skin penetration devices, for example, engraving and / or cutting devices, such as blood sampling lancing devices, by way of example patent US-A-5 026 388 , Injectors such as pens for insulin application in diabetes, single-dose syringes for vaccinations and similar dermal punches and overpressure injectors, by means of stimulation.

All of these skin cutters have in common that they cause pain when penetrating the skin. Individuals, for example, diabetes sufferers, rely on daily multiple blood measurement and possibly also insulin injection. These would greatly welcome any reduction in the perception of pain through these procedures.

The partial reduction of pain perception has become the invention WO002001062150A1 . DE000060112193T2 . EP000001171036B1 by means of "stimulus projections" at the point platform of the lancing device, to stimulate pressure sensory nerves of the skin busy. The fact that, in simple terms, the pressure at the puncture site, which causes a kind of distraction and / or blockage in the brain before the triggering of the piercing needle, means that the following sudden stabbing pain is no longer perceived as much.

However, this pioneering approach has the disadvantage that it is used only in lancet lancing devices and depending on the application, different pressure and placement sometimes more, sometimes less well. Also, the pain deflection is expandable.

The problem of reducing the sensation of pain by peephole now solves the invented apparatus more widely and reliably.

The classic structure of a skin piercer is used here. Now this is supplemented by a device that brings a pressure-vibration stimulus or electrical stimulation stimulus in the region of the puncture site. A warm / cold stimulus does not seem to be well suited because he is subjectively perceived as unpleasant earlier than the others, but this is individually different.

The additional stimulus, in addition to the pressure stimulus, causes a further, stronger, deeper-acting stimulation of the region of the future puncture site. The stimulation causes a distraction stimulus, but it should not cause any "pain"! As a result, the stimulation acts more reliable overall, stronger and reduces application errors, for example, in the case of too little pressure of the piercer housing tip on the skin. The aftereffect, the non-registration of the pain after the sting, is also more lasting.

The following descriptions contain references to the sketch section starting on page 10.

1 . 2 . 3 Reference here specifically to the drawings with the examples shown in perspective. The numbers in brackets () refer to similar parts in all sketches.

According to the invention, an auxiliary apparatus is now used or integrated to or in the known skin piercers. This can be present in various forms as well as autonomously as a separate device to immediately "next to the skin piercer / puncture site" to keep 1 , The stimulation platform ( 1 ), which has an area of approximately 1 cm 2 and is pressed onto the skin next to or around the puncture site, has elevations which, in the most advantageous form, taper to blunt cones towards the tip and are 1 to 2 mm high. Also, other shapes, heights and arrangements of several of these surveys or cones may find application as well as not pronounced. The stimulus area ( 1 ) may also be so pronounced that typical skin twisters 1 ( 11 ) itself or by means of an auxiliary device ( 9 ), dock the device, press it on the skin and fix it while working. The stimulus area must be shaped so that the dermal piercer can perform its work, for example a passage for the lancet or needle and a bearing / support ( 10 ) for the non-piercing, otherwise resting directly on the skin housing part. This device can be equipped with a holder 1 ( 9 ) attached to the skin piercer, on combination devices and the like, connected by another connection with other devices or in the housing 2 + 3 ( 12 ) here insulin pen, be integrated.

This device should bring the "additional / distraction / stimulus" as well as possible into the immediate vicinity and / or the contact point of the skin penetrant to the skin. This is achieved by the fact that it is formed for example by means of the operation of a minivibrator, as it is used in a mobile phone 1 . 2 . 3 ( 4 ) or a vibration unit as in patent WO002006005233A1 Sketch 2/5 to 5/5, is described forms. This is placed on / in / next to the housing of the skin piercer and / or pressed so that the skin contact point in vibration ( 3 ) and a pressure and another stimulation stimulus (vibration, electric shock, heat, cold) is effected. It can also be the tip of the skin piercer (for example, in lancet punches as a removable cap with a central hole for the needle formed 1 ( 2 )) in vibration ( 3 ), which transfers them into the tissue. These Top ( 2 ) can be firmly or movably connected to the skin piercer housing in order to forward the vibration maximally.

A suitable "vibrator" can be used in addition to an unbalance pager motor ( 4 ) or by means of a transmission have a vibration or shock stimulation function. So the movement on brackets ( 5 ) additionally movable or movably mounted "stimulus pens or stimulus pimples" ( 1 ), which are arranged around the hole for the needle of the contact platform, protrude through holes from this transferred. These in turn direct the stimulation stimulus in / to the skin in the area of the puncture site. The summit ( 2 ) / Contact Platform ( 1 ) of the skin piercer itself may be designed to be suitable, for example as in WO002001062150A1 for lancets ( 6 ), With stimulus lifts on the contact platform to the skin, to transmit the stimulation stimulus well.

The following descriptions are in the sketches with the housing parts ( 7 ), but the designated housing content is not specific. Thus, the addressed parts are assumed to be functionally installed in the housing.

In the case of an electrostimulator, these stimulus pens ( 1 ) or other suitably designed electrodes, the current in the skin and are thus formed conductive current. They are connected to an electronic system that closes the circuit between at least one positive pole and one negative pole through the skin (line). When the Stromimplulses delivered by the pulse electronics so creates a small surge, which is perceived as a small shock but should cause no pain. The electrostimulator should deliver a frequency of several beats per second, preferably more than 20.

The stimulators which are required for the function current are ideally connected by means of a switch to the lift mechanisms of the dermal punches, so that they start their function during "cocking" and, once released, terminate the work again. Also, electronic or mechanical devices may be provided which start the function only when sufficient pressure or vice versa. These stimulators, which form a separate unit and are mounted outside of the skin peen housing, can have their own on-off switches and autonomous electronics. In all variants, by means of a regulator, such as a rotational resistance, an electronic or integrated circuit, the vibration frequency, current timing or other settings can be controlled. By means of an integrated in the stimulator or engraver body display or a display, suitable electronics and sensors, the contact pressure, the clock frequency or other data can be shown to the user to help him find an ideal setting of the device, or by means of a memory different Stechorte to assign different settings to the body. This sensor data can also be remotely transmitted to another display or storage device or set via the return path. Here, for example, via a line connection (plug ( 8th )) Radio such as "Bluetooth" find a suitable external device, smartphone, tablet computer or computer use, which can communicate over a suitable program, such as an app, with the skin piercer and vice versa. The different stimulation types can be used alone or in combination.

The power supply of the stimulators can be done in the simplest case, for example, in an autonomous, external vibration unit by means of built-in power source such as battery, button cell, battery, capacitor or external power supply. When installed in the skin piercer housing stimulator, such a power source can also be integrated in the engraver housing. An external power source can also be connected via a plug ( 8th ). The stimulation peephole can also be built so that the power source is rechargeable. Here the plug ( 8th ) are also used for the external power source for the charging process. Furthermore, contacts ( 8th ) may be integrated on the suitable housing such that the stimulation skin piercer can be inserted or connected in an additional charging and storage apparatus designed as a docking station.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US Pat. No. 5,026,388 A [0001]
• WO 002001062150 A1 [0003, 0012]
• DE 000060112193 T2 [0003]
• EP 000001171036 B1 [0003]
• WO 002006005233 A1 [0011]

Claims (10)

Apparatus in a suitable form, material and form, for introducing a stimulus of mechanical, electrical or thermal nature to living tissues, such as skin, suitable as a kind of distracting stimulus from a skin penetration scenario. Apparatus according to claim 1, as a standalone device which is loose or not permanently connected to a typical skin penetrator. Apparatus according to claim 1 which is integral with a skin penetrant. Apparatus according to the preceding claims having the form of a vibrator, electrostimulator or thermal stimulator. Apparatus according to the preceding claims with a stimulus area at the intended skin contact point = stimulus area, which is smooth in the mechanical variant, characterized by firm irritation elevations (burls, cones) or by moving parts of the stimulus area, such as movable stimulus pins. In the embodiment based on electronics (electric shock), the stimulus area contains, in addition to another form of the stimulus area described here, at least one positive and one negative electrical pole, devices that emit a small electric shock by means of electrodes. In the expression as a thermal stimulus area, this is additionally pronounced as the thermal conduction area of a thermal source. The irritation of the apparatus according to the above claims based on the mechanical variant, on the one hand by a vibration, by an unbalance motor, linear weight motor, (electro) magnetic imbalance, a relay with swing weight (similar doorbell) or waves (such as ultrasound), if the stimulus - the Stimulus pencils, is / are solid. In the case of movable stimulus pens or mechanics or gear mechanics that move a stimulus pens, stimulus pens are put into pressure-increasing / decreasing or vibrating states by the aforementioned drive sources and conduct this stimulus to the intended puncture site of a pincer. In the electronic (electric shock) based form, a suitable device delivers electric shocks of appropriate strength with a suitable frequency to / at the intended puncture site of a skin piercer. The apparatus of the preceding claims may be of an irritant type alone or in combination with the other described stimuli. The apparatus has the typical, further necessary for the intended function of an electrical device components that may be regulated or unregulated on. In addition to the aforementioned, these are basically mainly a mechanical or electronic energy source or connection possibility of an external energy supply for this purpose. Furthermore, lines or tracks, contacts, mechanical, electrical and / or electronic components / circuits and switches, lamps, LEDs, displays, displays, motors, thermocouples, sensors, and other advantageous components. Ideally, the apparatus starts by performing its work with a lift or "sharply" doing the peephole and terminates it after firing. Functions such as the timing and / or stimulus intensity can be fixed. When rechargeable energy sources are used for the equipment, they can be placed next to a charging cable and charged through contacts or induction in a docking station, which may also serve for proper tidying or protection. The apparatus can be so pronounced via a suitable device, electronics, software that it can be connected, for example, by a line connection, docking device or radio control, such as Bluetooth, by means of an additional device, such as a suitable smartphone, tablet computer, a computer or another suitable device, Exchange, display, store, control and otherwise interact with data.

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