Medical device with germ barrier.

The invention relates to a medical device for the supply or removal of liquids by injection, infusion or transfusion, which has a terminal connected to a supply or discharge connection piece as well as a closure member for the neck.

In the field of medical technology find such medical devices, such as cannulae, catheters, drainage tubes, in the most diverse design use. They allow the repeated supply or extraction of liquids, for which reason the nozzle is to be closed subsequent to the respective supply or removal of liquid by means of the closure element.

As is known, make the connections at injection, infusion or. Transfusion products, which also enteral nutrition products and urine products are to be included, a potential danger zone of contamination / contamination when multiple use is (see study Prof. Daschner / Freiburg "Bacterial problems in infusion therapy" published "Clinical Pharmacology and Experimental Medicine", VII Kollogium Bad Kreuznach 1980).

In practice it has been found that in the neck, which is designed as a rule as a positive or negative socket, after feeding or removal of liquid a so-called residual drop remains, which can become contaminated until the next feeding or removal of liquid and thus is supplied to the patient directly in a subsequent extraction, for example, mounted by means of a syringe, the patient indirectly or at a supply of liquid in the device.

It is an object of the present invention to form the medical device of the type mentioned so that the sterility of the liquid in the device as a whole is ensured, that is also the residual drop, although this should also apply several drops of course are to be understood. The device is to be formed in the delivery and extraction area as a closed system.

The object is achieved, a fact that the closure element is provided with a germination inhibiting or germicidal property containing element that extends in sealed neck in this, the element is designed as a pin and tightly closed by the closure element neck between it and the pin radial gap remains. The pen comes in sealed neck in contact with the rest drops and acts due to its bacteriostatic or germicidal capacity as germ barrier. Basically every pin material is considered to be suitable, that is biocompatible. Preferably, however, thought of antimicrobial agents in the form of metals and metal compounds, in particular those which have an oligodynamic metal effect, is known. Reference is made in this connection to Wallhäußer, Karlheinz: practice of sterilization - disinfection - Preservative - identification of germs - Industrial Hygiene / 4, revised. u. erw. Ed -. Thieme, 1988, there paragraphs 6 and 7, in particular 7:26 ..

From US-A-4,666,427 an exclusively for supplying liquids suitable medical device with a feed nozzle as well as a closure element for the nozzle is known. There, the closure element is designed as a sealing plug whose outer diameter corresponds to the inner diameter, so that between these no gap remains. The plug is porous and total air-permeable, so that the aqueous liquid can evaporate through this what is intended here. This particles, such as bacteria are adhered to the stopper and die after evaporation of water from. The destruction can be assisted by addition of an antimicrobial substance to the porous plugs or by coating the closure plug it. This open system can therefore avoid only greater fluid loss by evaporation due to the mounted below the injection site valve. For all Konnexionsstellen without such protection through the valve, the system is unsuitable because unpredictable amounts can evaporate to liquid. Apart from this, the system is also suitable for supplying only and not also for the removal of liquids, since the valve prevents this. Finally, the open system ensures no permanent antimicrobial properties, as it can not be ruled out that having through the porous plugs germs air enters the nozzle. - In contrast, the inventive medical device is in sealed neck is as a closed system, so that a permanent sterility or sterility is guaranteed.

Advantageously, the germ-inhibiting or germicidal property having pin of ceramic, glass, metal or plastic with an oligodynamic metal effect coating comprising, in particular a silver chloride coating. It is considered in this context to be particularly advantageous when the carrier element for the coating is configured in highly porous, thus resulting in a coating over a larger effective surface. However, it is also conceivable that the element the germ-inhibiting or germicidal property having complete, the oligodynamic metal effect having metal consists of a, for example silver.

A particular embodiment of the invention provides that the closure element is designed as a stopper, with a case sealed neck partially protruding into the socket plug approach, preferably, the inserted in the manner of a closure / sealing cone which receives the pin advantageously in an axial bore of the plug approach is. - However, it is also possible that the pin and the plug form a single component.

Suitably penetrated the pin in this sealed neck until its the plug remote end, between the pin and the stub is a radial gap should remain. Upon closing of the neck of the pin displaces so a portion of the residual drop into the radial gap, which the oligodynamic effect can be increased, since the rest of drops surrounds the entire accessible surface of the pin.

A development of the invention provides that the closure element on the spigot is screwed, moreover, the nozzle should be a conical nozzle opening and the plug neck of the plug correspondingly conically formed, the taper of nozzle opening and plug approach should in particular meet the conical extension of a syringe.

Further features of the invention are shown in the description of the figures and in the dependent claims, is being noted that all individual features and all combinations of individual features represent further inventive embodiments.

In the figures, the invention is in one embodiment illustrated, for example, without being limited thereto. It shows:<dl id="dl0001"><dt>figure 1</dt><dd> a section through the connection of a medical device for delivering or withdrawing fluids for all types of injection, infusion or transfusion terminals or other removal or supply locations in medical devices, in particular plastic disposable products, shown with stopper,</dd><dt>figure 2</dt><dd> a section of Figure 1, shown without plugs, but with bolt, partially shown syringe,</dd><dt>figure 3</dt><dd> the terminal according to Figure 2 after the disconnection of the syringe and</dd></dl> Figure 1 shows the medical device in the realm of the invention substantially terminal. The device consists therein substantially consists of a housing 1, a terminal 2 with a liquid channel 3, and opening into the terminal 2 feeding or dispensing nozzle 4, which is tightly closed by a closure plug. 5

As illustrated in the representation of Figure 1, the neck 4 has an external thread 6 and the sealing plug 5 has an internal thread 7 on, thus it is possible to unscrew the breech plug 5 onto the neck 4th Furthermore, as in particular the representation of the figure is given in 3, the area enclosed by the nozzle 4 opening in its associated (based on the presentation of the figures) upper portion opening portion 8 in the form of a downwardly tapering truncated cone (female luer lock approach) formed, to which the liquid channel 3 through a cylindrical opening portion adjoins. 9 According to the conicity of the opening portion 8, a stopper projection 10 of the plug 5 is formed as a truncated cone (male Luer lock cone) which receives a pin 12 in an axial bore eleventh This is held in the bore 11 by a clamping, latching welding or adhesive bond permanently. The pin 12 extends to the the nozzle 4 facing inner wall area 13 of the liquid channel 3 and has a circular cross section, wherein between the protruding from the stopper projection 10 pin portion 14 and the associated inner wall of the neck 4 a radial gap 15 is formed. The pin is made of ceramic and is provided with an oligodynamic silver chloride coating.

Figure 2 shows a partially-filled syringe 16 with a conical extension 17 whose taper of the plug approach corresponds to 10 and is provided with a lug 18 with female thread according to the embodiment of the plug 5, so that the syringe, as shown in this figure, sealing with can be connected to the medical device. It is thus a removal of fluid from the medical device in the syringe or a feeding liquid from the syringe into the medical device possible. After such is done, the syringe 16 is unscrewed from the connecting piece 4, remaining after the Dekonektion, as shown in the representation of Figure 3, in the transition region from the liquid flow path 3 to the opening portion 9 of the connecting piece 4 is a radical drop 20. When screwing on of the plug 5 to the piece 4 displaces the pin 12 with its pin region 14 the rest drops 20 which deflects in the radial gap 15 and thus the pin portion 14 completely surrounds and because of the oligodynamic metal effect its coating the germ barrier effect.

The housing 1 of the medical device and the stopper 5, that is also the stopper projection 10 are preferably made of plastic, so that only the recorded by the stopper projection 10 pin 12, in particular, only the coating belongs the oligodynamic metal effect.

LIST OF REFERENCE NUMBERS

<dl id="dl0002"><dt>1</dt><dd> housing</dd><dt>2</dt><dd> Connection</dd><dt>3</dt><dd> liquid channel</dd><dt>4</dt><dd> Support</dd><dt>5</dt><dd> plugs</dd><dt>6</dt><dd> external thread</dd><dt>7</dt><dd> internal thread</dd><dt>8th</dt><dd> opening portion</dd><dt>9</dt><dd> opening portion</dd><dt>10</dt><dd> plug approach</dd><dt>11</dt><dd> axial bore</dd><dt>12</dt><dd> pen</dd><dt>13</dt><dd> inner wall area</dd><dt>14</dt><dd> pin section</dd><dt>15</dt><dd> Radial gap / dead space</dd><dt>16</dt><dd> syringe</dd><dt>17</dt><dd> conical extension</dd><dt>18</dt><dd> approach</dd><dt>19</dt><dd> internal thread</dd><dt>20</dt><dd> rest drops</dd><dt>21</dt><dd> cannula hub</dd><dt>22</dt><dd> Kaülenschlauch</dd><dt>23</dt><dd> cannula wings</dd><dt>24</dt><dd> Zuspritzöffnung</dd><dt>25</dt><dd> tube valve</dd></dl>