Abstract:
A drug dispensing system is provided that may be used universally and in which medical substances can be mixed with a carrier solution ( 13 ) in a simple manner. The device and system have a dispensing module ( 6 ) for medical substances and a hydrophilic nonwoven ( 14 ) with a carrier solution ( 13 ). The emission area of substance discharge openings ( 21, 22, 23, 24 ) of the dispensing module ( 6 ) are directed toward the nonwoven ( 14 ).

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of priority under 35 U.S.C. § 119 of German patent application DE 10 2004 010 062.4 filed Mar. 2, 2004 the entire contents of which are incorporated herein by reference.  
       FIELD OF THE INVENTION  
       [0002]     The invention relates to a drug dispensing system with a dispensing module for medical substances and a process for dispensing liquid or particulate substances using a dispensing module.  
       BACKGROUND OF THE INVENTION  
       [0003]     Infusion systems that are designed in the form of a multichannel dispensing system for dispensing different volumes of solutions are used to dispense medical substances. Individual dispensing syringes, which are filled with the solutions selected by the user, are inserted in such systems into syringe holders, wherein the pistons of the dispensing syringes are actuated by a motor drive in order to pump the individual solutions into an infusion line. A central control unit of the multichannel dispensing system monitors the rate of dispensing of the individual solution.  
         [0004]     The drawback of the prior-art multichannel dispensing system is that the dispensing syringes are disposable articles for hygienic reasons and must be disposed of The motor drives, which actuate the pistons, must operate with high precision and are therefore expensive. Due to the limited overall size of multichannel dispensing systems, the volume of the dispensing syringes is limited. Emptied dispensing syringes must therefore be frequently removed and replaced with new ones. In addition, the dispensing rates of the solutions affect each other and high time constants must be accepted in case of a change of the dispensing rates. A multichannel dispensing system of the said type has become known from DE 43 20 365 A1.  
         [0005]     Microdispensing devices, which are based on the direct displacement of the solution to be dispensed, are known from other fields of application. An essential component of microdispensing devices is a pressure chamber, which is partially limited by a displacer in the form of a flexible membrane. By actuating the displacer, the solution to be dispensed is drawn up from a reservoir and then ejected from the pressure chamber via a discharge opening. The suction phase is controlled now such that a small change in the volume of the pressure chamber per unit of time is set.  
         [0006]     In contrast, a great change in volume per unit of time is generated during the phase of dispensing in order to dispense a defined volume of solution. Depending on the viscosity and the surface tension, solutions can be dispensed in the range between 0.01 μL and 0.1 μL with some microdispensing devices. A microdispensing device of this type has become known from DE 198 02 368 C1.  
         [0007]     Certain medical substances, for example, antibiotics, have only a limited shelf life in the liquid form. Dry powdered drug dispensing devices, with which very fine particles of a powdered drug can be made available in predetermined doses, are known for dispensing powdered drugs. A device of this type has become known from EP 826 386 B1. The drug is delivered to the patient via the respiratory tract with the prior-art dry powdered drug dispensing device.  
         [0008]     However, the prior-art microdispensing devices and the dry powdered drug dispensing devices are not suitable for delivering the drugs to a patient intravenously.  
       SUMMARY OF THE INVENTION  
       [0009]     The basic object of the present invention is to provide a drug dispensing system that can be used universally and with which medical substances can be delivered to a patient intravenously in a simple manner.  
         [0010]     In addition, a process for dispensing drop-shaped or particulate substances shall be provided.  
         [0011]     According to the invention, a drug dispensing system is provided with a dispensing module for medical substances and a hydrophilic nonwoven element (nonwoven) with a carrier solution. The dispensing module has substance discharge openings with an area of emission directed toward the nonwoven.  
         [0012]     According to another aspect of the invention, a process for dispensing liquid or particulate substances with a dispensing module includes delivering a carrier solution for taking up substances through a hydrophilic nonwoven. The emission area of the substance discharge openings of the dispensing module is directed toward the nonwoven.  
         [0013]     The advantage of the present invention is essentially that a carrier solution taking up the medical substance is sent through a hydrophilic nonwoven material, wherein substance discharge openings of a dispensing module for the medical substances are directed toward the surface of the nonwoven. The nonwoven is designed such that it binds the carrier liquid independently from the gravitation and the surface of the nonwoven is wetted by the carrier solution by capillary action. As a result, a direct contact is established between the medical substances being dispensed and the carrier solution. The structure of the nonwoven, i.e., the capillarity, is designed such that the surface tension of the carrier solution is sufficient at the entire interface of the nonwoven to prevent air from entering the carrier solution. The pressure conditions on the surface of the nonwoven can be set in a simple manner such that the nonwoven and the dispensing module are enclosed by a gas-tight mixing chamber and a certain working pressure is set within the mixing chamber during dispensing. The nonwoven is located in a mixing channel, which is open toward the mixing chamber and the carrier solution flows through it. The nonwoven completely fills out the mixing chamber, so that the carrier solution must flow through the capillaries of the nonwoven. The maximum allowable pressure difference between the pressure in the mixing chamber and the hydrostatic pressure in the carrier solution is inversely proportional to the capillary diameter of the nonwoven and depends on the surface tension of the carrier solution.  
         [0014]     The mixing channel with the nonwoven is advantageously arranged on the underside of the mixing chamber, and the dispensing module is located opposite on the top side of the mixing chamber. Thus, an intermediate air space, by which wetting of the dispensing module with the carrier solution is prevented, is present between the substance discharge openings of the dispensing module and the nonwoven.  
         [0015]     Another advantage of the dispensing device described in the present invention is that the overall size of the reservoirs for the substances to be dispensed is not limited, unlike in the case of dispensing syringes of prior-art infusion systems, and the reservoir must therefore be replaced at long time intervals only.  
         [0016]     Another advantage is that the dispensing device can be used independently from its position.  
         [0017]     The dispensing module is advantageously designed as a particle dispenser for substances that are in the dry form or as a drop dispenser for liquid substances. It is also possible to arrange the particle dispenser and the drop dispenser in the form of a parallel dispenser on a common valve bank and to dispense in this manner different medical substances simultaneously and independently from one another.  
         [0018]     The carrier solution is preferably a sodium chloride solution, a glucose solution, a Ringer&#39;s solution, a fat emulsion or a nutrient solution.  
         [0019]     A delivery pump, which draws up the carrier solution from a reservoir via the nonwoven and pumps same into an infusion line leading to a patient, is arranged on the outflow side of the nonwoven to transport the carrier solution through the nonwoven.  
         [0020]     The suitable nonwoven materials are advantageously glass fiber, polyethylene with hydrophilic plasma coating, polyolefin or polyester.  
         [0021]     An exemplary embodiment of the present invention is shown in the drawings and will be explained in greater detail below. The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which a preferred embodiment of the invention is illustrated.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0022]      FIG. 1  is a schematic view of drug dispensing system according to the present invention; and  
         [0023]      FIG. 2  is a schematic with a diagram showing the changes in the hydrostatic pressure along the flexible tube system transporting the carrier solution. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0024]     A drug dispensing system I according to the present invention, which is shown in  FIG. 1 , contains two particle dispensers  2 ,  3  and two drop dispensers  4 ,  5 , which together form a parallel dispenser  6  and are arranged on the top side of a mixing chamber  7 . The particle dispensers  2 ,  3  are connected with reservoirs  8 ,  9 , which contain drug powdered drugs, and two reservoirs  10 ,  11  filled with drug solutions are connected to the drop dispensers  4 ,  5 . A mixing channel  12  arranged on the underside of the mixing chamber  7  is provided with a hydrophilic nonwoven  14  and contains a carrier solution  13 . A delivery means  15  arranged on the outflow side of the mixing channel  12  draws in the carrier solution  13  via the nonwoven  14  from a reservoir  16  and pumps same into an infusion line  17 , which is connected with a patient, not shown in  FIG. 1 . A defined delivery pressure is set in the infusion line  17  with a fluid resistor  18 .  
         [0025]     The particle dispensers  2 ,  3 , the drop dispensers  4 ,  5  and the delivery means  15  are connected to a control unit  19 , which performs all control and monitoring operations and generates control pulses for the dispensers  2 ,  3 ,  4 ,  5 . The quantities of the substances to be dispensed can be set by means of an input unit  20  connected with the control unit  19 .  
         [0026]     The hydrophilic nonwoven  14  has a plurality of microstructured capillaries, which are wetted with the carrier solution  13 . The particles or drops released by the dispensers  2 ,  3 ,  4 ,  5  via the substance discharge openings  21 ,  22 ,  23 ,  24  of these dispensers reach the surface of the nonwoven and are brought into contact there with the carrier solution  13  via the capillaries of the nonwoven  14 . The pressure difference between the mixing chamber  7  and the mixing channel  12  must be set via the delivery means  15  such that no air will enter the mixing channel  12  from the mixing chamber via the capillaries of the nonwoven  14 .  
         [0027]     This relationship shall be explained on the basis of a numerical example.  
         [0028]     The possible pressure difference is inversely proportional to the capillary diameter of the nonwoven  14 . In case of a capillary diameter of 25 μm with a glass capillary in water, the pressure difference is approx. 116 mbar. Based on this parameter of the material, the pressure difference between the mixing chamber  7  and the mixing channel  12  must not exceed the value of 116 mbar.  
         [0029]      FIG. 2  illustrates the changes in the hydrostatic pressure p for the flexible tube system transporting the carrier solution  13  along the flow path s. The flow path s is divided into the sections A through E for the sake of greater clarity. The ambient pressure is p 0 .  
         [0030]     The carrier solution  13  is drawn in from the reservoir  16  via a hydrophilic wick  25 . Based on the height difference between the liquid level of the carrier solution  13  and the wick  25 , the hydrostatic pressure p drops below the ambient pressure p 0 . The hydrostatic pressure p decreases by Δp(s) in the sections B and C due to the resistance of the wick  25  and the resistance of the nonwoven  14  in the mixing channel  12 . The flow resistor of the infusion line  17  is added to this in section D. The pressure conditions will then be reversed in the infusion line  17  due to the delivery means  15 , so that the hydrostatic pressure p will be greater than the ambient pressure p 0  on the outflow side of the delivery means  15 , in section E. The delivery means  15  must be set now such that the pressure will not drop below the pressure limit of p min  and that a pressure difference of Δp max  in the nonwoven  14  will not be exceeded in order to prevent air from passing through and into the carrier solution  13 .  
         [0031]     While a specific embodiment of the invention has been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.