AT512226A1 - ADERLASS ADEL - Google Patents

Abstract

Artery needle (1), comprising a first end (2) and a second end and extending between the two ends along the longitudinal axis of the needle cavity (6), which opens as a needle channel at both ends of the needle in each case an opening. The needle channel (6) has a variable diameter, which passes through a minimum value (d2) between the two openings. In addition, the needle has a remanent magnetization, which is aligned substantially in the longitudinal direction of the needle, has a maximum in a central region of the needle and decreases towards the two ends.

Description

* · · · P12193

Bloodletting needle and bloodletting system

The invention relates to a bloodletting needle having a first and a second end and a needle channel, namely a cavity extending between the two ends along the longitudinal axis of the needle, which opens at each end of the needle in each case an opening, wherein the first end of the needle bevelled so that this skew forms a needle point. Moreover, the invention relates to a bloodletting system containing this needle.

In a bloodletting, the patient is removed from a blood vessel - usually from a vein, usually in the elbow. For this purpose, the blood vessel is opened, in particular by piercing with a hollow needle, which is recommended for reasons of hygiene and better handling of the bloodletting process and faster healing of the puncture wound. With the tip of the needle, the blood vessel is punctured; The blood flows through the hollow needle and can be collected at the end or at the end of a tube connected to the needle. The collected blood can then be used for diagnostic or other purposes.

In Hildegardmedizin a special bloodletting procedure is described. This allows the separation of thrombosis-prone, thick blood from the valuable, thin, oxygen-rich blood. However, this is only possible if the blood can flow without turbulence, without congestion and turbulence. The medical Hildegard writings say that this can only be achieved by incising the vein. When using conventional needles, however, there is turbulence and dissipation of mixed blood (Mischblauseitung), which on the one hand cause unfavorable physiological effects and on the other hand complicate the diagnosis or even thwart.

It is therefore an object of the subject invention to improve the performance of bloodletting by means of a needle which ensures laminar flow of the drained blood, if possible along the entire path of blood collection.

This object is achieved on the basis of a needle of the type described in the introduction, in which, according to the invention, the needle channel has a variable diameter, PI2193

which passes through a minimum value between the two openings. Likewise, the object is achieved by a bloodletting system, which includes a bloodletting needle of the type mentioned and a hose connected thereto.

This solution according to the invention provides a bloodletting needle, namely a needle for performing a bloodletting, and a bloodletting needle / tube system in which the bloodletting needle is combined with a specially designed tube for connection to the needle. The bloodletting needle / tube system is called here shortly Aderlasssystem, and the Aderlassnadel invention also laminar needle. By the already mentioned and discussed below properties of the needle or Aderlasssystems is avoided that occur during the bloodletting as well as when collecting the blood removed turbulence. This favors desired physiological effects in the patient and also allows a more differentiated diagnosis based on the derived blood.

In addition, to suppress the occurrence of turbulence, interior coating of the cavity having a smooth surface is favorable. The inner coating may in particular consist of a silicone-based plastic. A particularly reliable laminar flow also results if the length and the inner diameter of the needle in a ratio of about 41: 1 to each other.

This inner coating can be suitably used to realize the variable inside diameter according to the invention over a variable thickness of the coating. In particular, the variable thickness between the two openings can pass through a maximum value, so that the variable diameter of the needle channel is due to the variable thickness of the inner coating.

In order to additionally improve the flow properties, the needle may have a remanent magnetization. In doing so, when the remanent magnetization is substantially aligned (i.e., with respect to its major component) in the longitudinal direction of the needle, it is particularly beneficial for positively influencing the flow behavior of the blood. Likewise, it is favorable if the remanent magnetization has a maximum in a middle region of the needle and decreases toward the two ends. P12193

According to a further advantageous aspect of the invention, the needle point is designed such that the first end skew is a foremost - i. directly at the needle tip befindliches - segment which extends at a first angle (which is smaller than 90 °) to the longitudinal axis, and then the slope at a shallower angle to the longitudinal axis as the first angle.

In an advantageous embodiment of the Aderlassnadel invention favorable properties are achieved when piercing the needle, characterized in that the skew, then to the foremost segment, forms a rear segment with a constant second angle, wherein the second angle is smaller than the first angle. The first angle (cti) is favorably in a range between 20 ° and 45 °, preferably from 30 ° to 35 °.

In the bloodletting needle / tube system of the present invention, laminar flow of blood at the outlet port (located at the end of the connected tube opposite the needle) is promoted when the outlet port is chamfered, preferably at an angle 0C3 = 23 ° ,

The invention together with further features and advantages will be explained below with reference to an embodiment of a laminating needle, which is not to be understood as limiting the scope of the invention and is shown in the accompanying figures. The figures show:

1 shows the laminar needle of the embodiment in a plan view;

FIG. 2 shows the front end of the laminating needle in a side view; FIG.

3 shows the course of the inner diameter of the lumen of the laminate needle in a schematic longitudinal section;

Fig. 4 shows the formation of the inner coating of the cavity of the needle;

Fig. 5 shows the magnetization of the needle;

Fig. 6 shows the process of magnetizing the needle;

Figures 7a and 7b show the effect of puncture with the needle on the electrostriction of the vascular membrane;

Fig. 8 shows various reactions of the body due to the puncture; P12193

9 shows the blood-letting system, with the needle with the adapter connection at the top and the outlet opening of the tube at the bottom;

10 shows the turbulence-free transition between hose and needle;

Figures 11 and 12 show recoverable blood strata with two and three layers, respectively, in a bloodletting with the bloodletting system;

FIG. 13 shows possible variants of the turn-up course in a blood stratification; FIG.

Figs. 14a and 14b are microscopic images of withdrawn blood; and

15 is a graph showing results of conductance measurements at various endpoints of the meridians, full bars representing measurements after bleeding with conventional instruments, and hatched bars representing measurement results after bleeding with the bloodletting system of the present invention.

Phlebotomy needle

Fig. 1 and 2 show an embodiment of the laminate needle 1 according to the invention; Shown is the pointed end of the needle in a respective plan view (Fig. 1) and side view (Fig. 2). Visible is the end 2 of the needle, which is formed with a skew 3, which forms a tip 4 at the foremost end. In the skew is the opening 5 of the cavity extending along the needle, which forms a needle channel 6 (lumen, see Fig. 3). The needle 1 is made of stainless steel 5KS-304 or FeCuNi alloy and has in the illustrated embodiment at a length of about 43 mm an inner diameter of between 1.05 mm at the narrowest point and about 1.10 mm varies the two ends.

As is apparent from Fig. 2, the needle 1 has a top sharpening. This is designed as a special long cut over the length L of the skew 3, namely ground off with two inclination angles aj and a2. The skew 3 is thus divided into two segments 31, 32 corresponding respectively to the angles 04 and a2. The front, first segment 31 is preferably shorter than the second segment 32, for example in a 1/3: 2/3 ratio to each other; however, other divisions that more or less deviate from the 1: 2 ratio are also possible. The first segment (e.g., the first third) is thus preferably at the point of the needle. The second segment 32 connects at a smaller angle a2. In terms of height, the two segments are approximately the same height (i.e., perpendicular to the axis); thus, the length of the second segment corresponding to its shallower angle is greater than that of the first segment - here e.g. 2/3 of the entire tip length L. This allows a painless, reduced puncture and achieved by the effect of two bevels during puncture better membrane maser vibration. Favorable values of the first angle 0¾ lie in a range between 20 ° and 45 °, preferably from 30 ° to 35 °; the second angle cc2 is selected with a correspondingly smaller value, for example between 15 ° and 30 °.

Referring to Fig. 3, the needle also has an inner surface of the needle channel 6 which is very smooth, e.g. an extremely smooth surface with a silicone coating 8 whose thickness varies over the length of the needle channel. The inner coating 8 of the needle is e.g. achieved by being sprayed, as illustrated in FIG. 4, by means of a fine nozzle needle 7, which emanates at its end a silicone-based material 8a; while this nozzle needle is pulled through slower in the middle part of the needle than at the end parts. It thus forms a continuous towards the middle thickening of the silicone coating. Thus, a taper of the cross-section in the μ range, or in other words a variable inner diameter with di > d2 < d3 (where dß «dj). This creates a slight functional nozzle effect of the cavity of the needle.

This coating results in an optimal laminar flow of the blood flowing through the needle. This is due on the one hand to the low frictional resistance, on the other hand by the mentioned profile of the silicone coating in the pm range.

In addition, the needle has a magnetization profile which is illustrated in Fig. 5, which shows a schematic longitudinal sectional view of a middle piece of the needle. The magnetization M and associated magnetic field lines are indicated in FIG.

To create the magnetization profile, the center of the needle is exposed to a strong magnetic field by exposing the needle between two oppositely oriented permanent magnets; Here, the needle is moved transversely to the longitudinal direction so that the middle part of the needle between the two magnets is performed - see. Fig. 6-Through the magnetizable components of the needle material, there is a remanent magnetization. There remains a slight, but sufficiently large magnetization of the needle whose main component is oriented parallel to the longitudinal direction, in the P12193

Middle region (Fig. 5) is strongest and gradually weaker towards the ends. In interaction with the magnetically influenceable components of the blood, this leads to an improved laminar flow of viscous liquids. This applies in particular to erythrocytes whose outer membrane is known to be negatively charged. This could be proven by experiments: Liquids with increasing viscosity were passed through the needle. The magnetized needle showed significantly better flow characteristics than the unmagnetized needle. These were on average higher by 2 viscosity levels.

The needle allows a turbulence-free flow of the blood (laminar flow). This laminar flow profile is achieved by the conical, silicone-coated profile as already described and by the likewise mentioned magnetic profile. The profile acts similar to a wing in which an adherent laminar flow is achieved. Through the profile of a nozzle effect is achieved. This leads to an accelerated blood flow, and an unhindered flow of the blood is achieved. By the suction effect, a blockage of the needle is prevented and allows to drain very thick blood prone to thrombosis unhindered. The magnetic cone, which supports the nozzle function, is achieved by a permanent magnetic field. This magnetic field reduces the adhesion. This prevents the destruction of the platelets. Thus, the coagulation process is reduced. The erythrocytes also remain undamaged. The phenomenon of the roll of money remains as it flows through the erythrocytes. The interaction between the magnetic field of the needle wall and the negative membrane surface tension of the erythrocytes deflects the red blood cells and forces them into a laminar flow.

With regard to the dimensions of the Aderlassnadel invention was found that a length of 43 mm to 1.05 mm diameter led to optimal laminar flow conditions, corresponding to a length-diameter ratio of about 41: 1. This was determined in 235 flow tests. The length may vary to some extent, namely a few millimeters, for example ± 3 mm. P12193

Reinforced membrane-maser vibration and stitch technique

As already mentioned, the design of the needle leads to favorable penetration behavior, in particular with regard to the so-called membrane-maser oscillation. The vascular system of humans is electrostatically charged. E > ies causes so-called electrostriction, i. an increased vascular membrane tension; this is illustrated in the diagram of Fig. 7a. Due to the tip grinding of the needle and a special insertion technique, a stronger expansion of the vascular membrane is achieved during the puncture.

As shown in Fig. 7b, the puncturing stimulus leads to an expansion of the membrane, and there is an electromagnetic maser oscillation. The maser oscillation will be received by receptors in the vessels and transmitted to the brain via the afferent neural pathways. As is known from pain physiology, these stimuli trigger vital responses and immune-enhancing mechanisms in the brain. This is illustrated in FIG. The design of the needle, in particular the two-stage top sharpening, results in the puncture an enhanced membrane-maser oscillation with the associated positive consequences for the patient, in particular an increased immune stimulation and hormonal regulation.

phlebotomy system

Referring to Fig. 9, the needle 1 is a component of a blood-letting system 10. The blood-letting system 10 comprises, in addition to the blood-letting needle according to the invention, a plastic tube 9 of a certain length and a diameter selected to match. To connect the laminating needle 1 to the laminar tube 9, the needle and tube can be connected by means of an adapter device made of plastic, which comprises a needle adapter 11 and matching tube adapter 12. Through the use of an adapter can be achieved by twisting a firm and dense, but at the same time without problem detachable connection between the laminar needle 1 and the laminar tube 9. The adapter type shown corresponds to a Luer connection; As a variant of the adapter connection shown, of course, other known from the prior art, suitable adapter connections can be used. PI2193

As already mentioned, an adapter device for connecting the needle is provided at one end of the hose. At the other end, the hose has a discharge opening 13 with a specific selected acute angle. The tube 9 is preferably as well as the needle 1 equipped with an inner coating 14, for example of silicone-based material.

The special angle of the outflow opening 13 of the tube 9 prevents too rapid expansion pressure loss. It thereby lengthens and stabilizes the laminar flow and prevents too rapid expansion pressure which leads to turbulence of the outflowing blood. The tube system also allows a safe drainage, collecting the blood and provides the conditions for the vital diagnostics of the blood.

The tube 9 is preferably made of polyvinyl chloride and is thus free of latex and diethylhexyl phthalate. Advantageously, the tube is also equipped on the inside with a silicone coating. This extremely smooth surface reduces the adhesion of the blood and prevents platelet aggregation. In the blood vessel system, the smoothness is produced by the endothelium. The silicone coating comes very close to the endothelial surface of the vascular system in terms of smoothness. Laminar boundary layers have a significantly lower wall friction compared to turbulent boundary layers. This is achieved by the silicone coating.

The interaction of the described features of the core-lance needle / tube system 10 according to the invention achieves a laminar flow in which the value of the Reynolds number Re = wd / v is significantly below 2320, which corresponds to the critical value of the turnover in corresponds to a turbulent flow in a pipe with a circular cross-section. This is achieved in particular by (1) the smooth surface coating, (2) favorable choice of the length and diameter ratios, (3) absence of internal adapter resistances, and (4) design of the outflow opening with an acute angle.

In conventional needles, turbulence occurs in the flow of blood flowing through the needle. Here, as already mentioned, the diameter of importance. If the needle is too thin, there will be accumulation of turbulence in front of the end of the needle. a thicker needle causes turbulence in the canal of the needle.

In too thick hoses, but also in too thin hoses, turbulences occur. For the medium blood, a ratio of diameter to length of the tube could be determined by experiments in which blood flows in laminar flow. The length S of the tube is e.g. 975 mm, its diameter is 3 mm (inside) or 4.1 mm (outside). The length of the tube is chosen in view of the diastolic pressure in the bloodstream of the patient, namely such that the hydrostatic pressure of the blood column is below the diastolic pressure. In this case, the length can vary to some extent, namely by a few millimeters, for example ± 10 mm. The inner diameter is chosen so that thick blood can flow well through the tube.

The aforementioned absence of internal adapter resistors is achieved in that the adapter junctions are not mounted against the current direction, but only - seen in the direction of flow - represent further transitions. This is shown in FIG. The flow direction of the flow is indicated by an arrow. The step-like transition is associated with an increase in the diameter. For example, the subsequent pipe part is slipped on the outside of the approach with a smaller diameter. This eliminates flow impediments that would otherwise cause turbulence

Outflow opening at an acute angle

The outflow opening controls the speed of blood flow; In addition, a reduction of the expansion pressure of the passing blood is possible.

The venous blood typically has a pressure of 60 to 85 mmHg on exiting the venous system. In addition, when passing through the hose system, the kinetic energy is added by the drop height of the discharged blood, the drop height being determined by the length of the hose, thus approximately 975 mm when the hose is vertical. The flow rate of a laminar flow of a viscous liquid is determined by the known law of Hagen-Poiseuille; Accordingly, the flow rate depends inter alia on the pressure difference between the beginning and end of the tube and the viscosity of the liquid. The length of the tubing and the pointed-angle orifice of the blood-drain needle / tube system can absorb the expansion pressure that would result in turbulent flow. P12193

Based on studies carried out on 920 straight- and high-angle vents, clear results were obtained: at an angle «3 = 23 ° (see Figure 9) of the outflow opening, a laminar outflow of blood results, which produces the fractal and Shift assessment by means of the vital diagnosis of veined blood allows. Different geometries, e.g. when the outlet opening is straight (a = 90 °) leads to turbulence, with turbulently mixed blood makes a vital diagnosis using the vein bleeding impossible. The laminar flow of the blood is achieved by the interaction of the needle and tube design features described herein.

Consequently, for physicians who use the Hildegard bloodletting Ewald Töth perform, the bloodletting laminar needle / tube system according to the invention an absolutely indispensable equipment.

Comparative studies

Comparative studies were conducted based on 1200 Hildegard bloodlettings using standard needles and tubes and the bleeding tube system of the present invention.

The vital findings are based on the characteristics of the extracted blood. Blood is a suspension of different cells in the plasma. The characteristics of the blood change depending on the pH, toxic load, Endobiontenentwicklung, blood lipid load, viscosity, surface tension, occurrence of free radicals, change in Bioterrains, colloidal capacity, etc. These properties are in Hildegard bloodletting in the vital findings of Blood is evaluated by visual examination of the blood. For this comprehensive diagnosis, a laminar inflow of the blood into the diagnostic vessel is necessary. Due to the conditions in the venous system, the blood flows laminar. By means of the bloodletting system according to the invention, this laminar flow is maintained, and optimum haemodynamics of the blood are ensured.

In conventional tubing systems, blood usually clots within 2-5 minutes due to resistance-related turbulence, i. in the needle tube system. With the PI2193 • · · φ φ φ φφ φ :::: \ tr.-:. On the other hand, the bleeding system according to the invention coagulates the blood by an average of 5-10 minutes later. Therefore, unimpeded bloodletting can be performed.

In conventional needle and tube systems, turbulences occur, through which various blood conditions are mixed, preventing phase separation. Therefore, an isolated discharge of contaminated blood is not possible, which thwarts a vital diagnosis. Also, a detoxification of the blood is not possible to any significant extent.

In contrast, with the aid of the bloodletting / laminar needle / tube system according to the invention, the laminar flow existing in the venous vascular system is also obtained during the discharge. Therefore, separation of stressed, thick, dark blood from pure, thin, bright blood is possible.

These separation phases are clearly visible in the drained blood. At such removed blood can be seen a blood stratification. A layer, surface and fractal diagnosis is thus possible for the doctor who performs the bloodletting. There are therefore optimal diagnostic options, as well as a toxins releasing effect of bloodletting.

Referring to Figs. 11 to 13, various types of blood stratifications in a beaker are illustrated in schematic form. Fig. 11 shows a classical blood stratification in 2 phases. Here, a pure, bright blood layer, the turnover zone and an impure dark blood layer occurs. With a careful derivation of the blood 3 classic blood layers and variations can arise; this is illustrated in FIG. 12. Fig. 13 illustrates possible variations of the cover history, which allows a corresponding detailed vital diagnostics on the blood. As a result of the suppression of turbulences, the bleed-out laminar needle / tube system according to the invention thus enables a separate outflow of the various blood compositions. Thus, among other things, a complete separate discharge of the burdened, in particular thrombosis endangered, blood is achieved. PI2193 PI2193

• · ♦ t ·· ♦ ·· ·

Microscopic examinations and further studies

FIGS. 14a and 14b each show a microscopy image of blood taken in a conventional manner (FIG. 14a) or with the bloodletting system according to the invention (FIG. 14b). In Figure 14a, it can be seen that removal with conventional needles and tubing causes erythrocytes to be disrupted, platelet aggregation increased, and the conversion of fibrinogen accelerated, resulting in accelerated fibrin formation. The figure of FIG. 14b, on the other hand, verdeulticht that the bloodletting laminar needle / tube system according to the invention protects the erythrocytes, reduces early thrombosis and retards fibrin formation; The quality of the derived blood is significantly better due to the gentle laminar flow.

Referring to FIG. 15, the effectiveness of a Hildegard bloodletting performed with the bloodletting system of the present invention can be demonstrated by bioelectrical functional and regulatory diagnostics. The optimal Homotoxinausleitung by laminar Ableitsysteme improves the regulatory capacity of the meridian organ functional circuits. This is detected by conductance measurements at the end points of the meridians. Optimum conductivities in biological systems show values of 20-50 in the physiological scale. The black bars in the graph of Fig. 15 show post-bleed readings taken with conventional needle and tube systems. The hatched bars in FIG. 15 show post-bleed measurement results made with the bloodletting system of the present invention. The results were determined for 250 patients per group examined, and significantly better results could be achieved for the bloodletting system according to the invention. Of the 250 patients in whom the Hildegard bloodletting was performed with the bloodletting system according to the invention, 11% showed laboratory-proven blood value improvement. By contrast, out of 250 patients using conventional needle and tube systems, only 3% showed improvements in blood counts.

Vienna, the 2'L <(<.) · /,

Claims (10)

P12193 ·· ···· 1. An artery needle (1) having first and second ends and a needle channel (6) in the form of a cavity (6) extending between the two along the longitudinal axis of the needle, opening into an opening at both ends of the needle , wherein the first end (2) of the needle is chamfered and the chamfer (3) thus formed forms a needle point (4), characterized in that the needle channel (6) has a variable diameter, which between the two openings a minimum value (d2 ) goes through. 2. Aderlassnadel according to claim 1, characterized in that the cavity (6) has an inner coating (8,14) with a smooth surface. 3. Aderlassnadel according to claim 2, characterized in that the inner coating (8, 14) preferably consists of a silicone-based plastic and having a variable thickness, which passes through a maximum value between the two openings, and the variable diameter of the needle channel through the variable Thickness of the inner coating is conditional. 4. Aderlassnadel according to any one of the preceding claims, characterized by a remanent magnetization, which is aligned substantially in the longitudinal direction of the needle. 5. Aderlassnadel according to claim 6, characterized in that the remanent magnetization in a central region of the needle has a maximum and decreases towards the two ends. A wire-dispensing needle according to any one of the preceding claims, characterized in that the first-end slope (3) has a foremost segment (31) which is at a first angle (<Xi) less than 90 ° to the longitudinal axis, and subsequently the Slanting at a shallower angle to Längsache than the first angle runs. P12193 A wire-dispensing needle according to claim 8, characterized in that the bevel, apart from the foremost segment (31), forms a rear segment (32) of constant second angle (0C2), the second angle being less than the first angle. 8. Aderlassnadel according to claim 8 or 9, characterized in that the first angle (ai) is in a range between 20 ° and 45 °, preferably from 30 ° to 35 °. 9. Aderlass system comprising a bloodletting needle (1) according to one of the preceding claims and a hose (9) connectable thereto. 10. A needle according to claim 9, wherein the tube (9) at the end opposite the needle has an outlet opening (13), wherein the outlet opening is chamfered, preferably at an angle «3 = 23 °. Vienna, 2 Nov. 2, 2011