DE10100069C1 - Infection protection system for longer-term, partial or total implants, is provided by forcing flow of bioactive fluid from external reservoir around porous surface - Google Patents

Abstract

Infection protection system for implants involves pressurizing a reservoir (8) outside of the body (3), to force a flow of bioactive, isotonic aqueous solution over the porous surface of the implant.

Description

The invention relates to an infection control system for part wisely or entirely in the human or animal body for foreign bodies implanted for a long time, such as artificial organs or catheters covered with a microporous sheath which is the flow of a bioactive isotonic aqueous Solution for flushing the interface between foreign bodies and Body allows.

Foreign bodies such as artificial organs or catheters are common only partially implanted in the human body, for example supply lines with external devices have to stay connected. So catheters are implanted to Solutions for nutrition or medication in the blood vessels or to lead into other compartments of the body. With the distal end, while the catheters are in the body other proximal parts remain outside the body. In this way, catheters are also implanted to liquid out of the body, such as urine from bladder or kidney or blood from surgical wounds. This Foreign bodies sometimes have to be implanted for long periods of time stay.

Furthermore, artificial organs like cardiac support systems only partially implanted because they have an outside proximal drive or energy unit by a Line must remain connected. All of these are foreign bodies so partially implanted in the body and penetrate the Body surface. There must always be implanted foreigners body being explanted when infections go deep into the body has entered an operation that also affects the life of the Can endanger patients. These foreign bodies must also sometimes remain implanted for a long time.  

Infection on such an implanted foreign body first forms on the border at which the three phases Foreign bodies, body tissues and germ-bearing outside world. This is the area where the foreign body passes through the skin penetrates. The microorganisms can at this three-phase limit initially through frequent cleaning and bacteriostatics be mastered. Also have rinses with aqueous solutions have proven to be effective, but can only be used in one small area near the passage area - the proximal area of the implanted foreign body - through be performed. Longer stays make many Microorganisms, however, a biofilm on the surface of the Foreign body in the form of a layer of mucus, for example consists of polysaccharides. Because the body's immune system the body cannot penetrate this biofilm fight the infection effectively. The biofilm still has the property of expanding. It grows in Direction of the nutrient source, in this case towards the Body inside. This creates a bag that is difficult is to rinse and very easy to major infection leads.

Numerous attempts are known this danger by coating the surface of the implanted foreign body with a growable textile to control tissue. So according to DE 39 43 412 A1 before beaten, the catheter surface with a growable To coat textile fabric starting from the surface until the body tissue decreases in its porosity to a easy and safe waxing of the body tissue into the Reach textile fabrics. Experience shows, however, that even this catheter has not been removed from the body tissue for a long time stay overgrown, but also become infected.

From DE 197 28 489 A1 it is also known the catheter surface with an organic tissue made of collagen fibers or to coat collagen polymer fibers. This suggestion  is based on the idea that the natural collagen itself favorable to the ingrowth and permanent prosperity of the na body tissue. However, experience shows that even this measure cannot prevent infections.

From US 5820607 a catheter emerges with a Layer is coated with a material that is bactericidal Contains substances that go out and into the lumen of the catheter can diffuse and thus a microbial infection should prevent. Experience shows, however, that micro organisms after the catheter has been in the body for a long time become resistant and thus the effect of bactericidal Fabric wears off.

In US 4623329 a catheter is described in which also bactericidal substances through its outer wall can diffuse through. According to the invention, they are in one Carrier liquid contained from the outside by a Lei system should be filled. However, if one Concentration balance of the bactericidal substances on both The side of the outer wall is molecular Transport effect ended. The effect is also ended when the concentration of bactericidal substances reaches zero Has. Refilling is however not possible because the pipe system is still connected to the now ineffective carrier liquid is filled and thus no new liquid can penetrate. Refilling would be only possible if you restore the old carrier fluid would remove. But this is with an implanted kathe practically impossible. The effect of this solution is also limited in time. Also can be a the active ingredient has not become resistant to another change.

DE 198 52 848 describes a method for forming a Infection protection cuff for skin passage through a Channel known through human or animal skin.  

In this case, is fed into the body from the outside body-compatible plastic under the skin itself constantly or at defined intervals from the Body-moving sterile infection protection cuff formed between the channel and the surrounding body fabric forms a closed separation layer.

In comparison to this known method, it proposes invention lies another way.

With the exception of this known method, everyone is previously described infection control measures together that they for infection and penetration of Mikroor for a long time cannot prevent ganisms in the body. this applies especially for the suggestions, with the help of diffusion to transport the bactericidal active ingredients. The diffusion is only able to act as a molecular transport to overcome a short path, such as the thickness of a Coating or the thickness of a passage for the active ingredient outer wall. These are paths in the fraction of Millimeters. For the long way from the external proximal Part of the implanted foreign body for implantation in the body However, the distal area is usually a path in the area to overcome from 10 to 30 centimeters for which the diffusion is unsuitable as a transport mechanism. Also, none allowed of the proposed solutions the flushing of the interface between implanted foreign body and body.

The invention has for its object the above mentioned Avoid disadvantages of previous solutions and therefore one convective transport mechanism for the antibacterial Propose active ingredients that cover the entire surface of the implanted foreign body, from which it then the short distances to the microorganisms located there Can overcome diffusion. In addition, a rinse entire interface between the foreign body and the body made possible. This way the task becomes technical solved better and safer way.  

This is achieved in that the above Infection protection system the flow of bioactive isotones aqueous solution is forced by means of pressure that is generated by a volume source. The implanted According to the invention, foreign bodies have a line system which is located under the microporous coat and the convective supply of the bioactive isotonic aqueous solution allows. The volume source is preferably a pump formed, which is arranged outside the body. The Pump is according to the invention as a steam pressure-driven or spring-driven or electromotive medicines ten pump formed, which can be filled at intervals is. However, in inpatients, the volume source also one next to the patient bed on a medication element stand attached and acting as a volume source Infusion bottle.

According to the invention, the entire implanted foreign body is included covered with a microporous coat that is continuous or discontinuous outflow of a bioactive isoto Permitted an aqueous solution. It occurs directly under the Biofilm and mechanically lifts it from the foreign body surface Area from. Furthermore, the rinsing of the biofilm Deprived of food. It also contains bioactive isotones aqueous solution, for example a bactericidal substance, such as for example an antibiotic. Depending on the size of the volu menstroms becomes the bioactive isotonic aqueous solution either resorbed from body tissues or occurs at the passage exhibit.

The pores of the microporous jacket are at one execution Example in terms of diameter advantageously designed so that the microorganisms cannot penetrate them while the isotonic aqueous solution of the bioactive substance can flow. The bioactive substances work in this way advantageous directly where the microorganisms on the Foreign bodies adhere and where they are not covered by mucus  layer are protected. So that the isotonic aqueous solution in the entire surface of the foreign body through the pores of can penetrate inside is under the microporous Sheath a line system arranged that the bioactive isotonic aqueous solution leads to the micropores. This System is powered by a line outside the Body ends and there with a volume source or one Pump is connected. This way, a continuous or a discontinuous flow through the microporous Coat can be effected through.

However, applications in which several are also advantageous bioactive isotonic aqueous solutions through the surface of the Foreign bodies can be pressed. For example, this is a catheter with a bactericidal isotonic aqueous on the outside Solution emerges on the inside, the lumen, but one Fluid that counteracts blood coagulation or that a blood clot dissolves. For example, this would be a catheter for permanent access to the blood vessel system as in hemodialysis is needed. Such an implanted Foreign bodies accordingly require several pipe systems, which if necessary each with their own volume sources are equipped. The resistance of the microorganisms that often observed after long-term use of an antibiotic can, by changing the bioactive substance, such as for example the antibiotic, can be easily overcome.

The advantages achieved with the invention are in particular in that infections are implanted throughout the area Foreign bodies can be avoided completely.

The invention is illustrated in the drawing Embodiments described in more detail. Here show:

Fig. 1 is a longitudinal section of an infection control system for an implanted foreign body;

2 shows a cross section through a catheter.

Fig. 3 shows a cross section through a catheter of another embodiment with multiple conduit systems, and

Fig. 4 is a longitudinal section of a catheter for permanent access to a blood vessel with several separate line systems.

Fig. 1 shows an embodiment of an infection protection system to an implanted foreign body 1 in a longitudinal section. The implanted foreign body 1 is located with its outer proximal part in the bacteria-filled outer space and with the other distal part in the tissue 2 of a patient and penetrates the patient's skin 3 at position 4 . There the microorganisms in the outside penetrate into the body and spread along the surface of the implanted foreign body if they are not prevented from doing so. The entire implanted foreign body is covered with a porous jacket 5 . It sits on the implanted foreign body in such a way that an intermediate space 6 is formed between the implanted foreign body and the porous jacket, which is connected to a line 7 with a pressurized volume source 8 . This volume source 8 can for example be filled with a bioactive isotonic aqueous solution through the puncture port 9 . This bioactive isotonic aqueous solution is promoted by the pressure in the volume source 8 through the lines 6 to the entire surface of the implanted foreign body and exits through its pores. However, part of the foreign body can also be covered by the impenetrable layer 10 , so that part of the surface remains dry.

Fig. 2 shows a cross section through the implanted foreign body 1. The implanted foreign body and the porous jacket 5 are connected here by webs 11 , which transmit the tensile forces resulting from the internal pressure of the liquid in the line system 6 from the porous jacket 5 to the implanted foreign body by 1 .

Fig. 3 shows a cross section through the implanted foreign body with two separate pipe systems 14 and 16 for two different bioactive isotonic aqueous solutions. The interior, the lumen 12 , for example of a catheter, is here lined with the porous jacket 13 and is fed by the line system 14 , while the outer surface is covered by the porous jacket 15 and is fed by the line system 16 . In this way, different bioactive isotonic aqueous solutions can be conveyed to the different areas of the implanted foreign body and released. Each line system can be supplied with its own pump system so that different volume flows can be generated if required.

Fig. 4 shows a longitudinal section through such an implanted foreign body for long-term access to the blood vessel system with two different porous shells 13 and 15 and two different piping systems 14 and 16. This is, for example, a catheter for permanent access to a blood vessel 17 .

Blood can be directed in and out through the lumen 12 of this catheter, as is required, for example, for hemodialysis.

Claims (10)

1.Infection protection system for partially or completely implanted in a human or animal body for a long time, with a microporous coat completely covered foreign bodies, such as artificial organs or catheters, which flow a bioactive isotonic aqueous solution to flush the interface between the foreign body and body enables, characterized in that the flow of the bioactive isotonic aqueous solution is forced by pressure 3 from a volume source ( 8 ) arranged outside the body. 2. Infection protection system according to claim 1, characterized in that the implanted foreign body ( 1 ) has a Lei line system ( 14 , 16 ) which is arranged under the microporous jacket ( 13 , 15 ) and the convective supply line of the bioactive isotonic aqueous solution allows. 3. Infection protection system according to claim 1 or 2, characterized in that the volume source ( 8 ) is designed as a pump which is arranged outside the body. 4. infection protection system according to claim 3, characterized records that the pump as a steam pressure driven or spring-powered or electromotive medi cam pump is designed, which in temporal Clearances with the bioactive isotonic aqueous solution is fillable.   5. Infection protection system according to one of the preceding claims, characterized in that the line system is subdivided into a plurality of feed lines ( 14 or 16 ), so that differently acting bioactive isotonic aqueous solutions to the same or different volume flows men to different areas of the surface of the implanted foreign body ( 1 ) can be fed simultaneously. 6. Infection protection system according to one of the preceding claims, characterized in that the pores of the microporous jacket ( 5 ) have a diameter such that, in contrast to the isotonic aqueous solution, microorganisms cannot penetrate them. 7. Infection protection system according to one of the preceding Claims, characterized in that the bioactive isotonic aqueous solution bacteriostatic or bactericidal is effective. 8. Infection protection system according to one of the preceding Claims, characterized in that the bioactive isotonic aqueous solution on the coagulation system of the Blood works. 9. Infection protection system according to one of the preceding claims, characterized in that the implanted foreign body ( 1 ) has recesses or bulges which anchor it positively in the tissue ( 2 ). 10. Infection protection system according to one of the preceding claims, characterized in that the positive anchoring in the tissue ( 2 ) after the implantation or an implementation is carried out by elements such as inflatable cuffs or collars.