WO2022063873A1

WO2022063873A1 - Biodegradable metal acupuncture needles

Info

Publication number: WO2022063873A1
Application number: PCT/EP2021/076156
Authority: WO
Inventors: Jan-Marten Seitz
Original assignee: Syntellix Ag
Priority date: 2020-09-23
Filing date: 2021-09-23
Publication date: 2022-03-31
Also published as: DE102020124795A1

Abstract

The invention relates to acupuncture needles, permanent needles and implant needles for the human and animal body, which needles consist of magnesium or particular magnesium alloys which are biodegradable in the body. Whereas conventional acupuncture needles made of stainless steel or titanium do not undergo any change in the body, with the needles or acupuncture implants according to the invention, a dissolution process starts as soon as they are inserted. The decomposition products which are released at the insertion point send chemical stimuli and signals to the surrounding somatic cells, which stimuli and signals add to the mechanical and electrical stimuli of the metal needles and bring about a significant increase in effect. The invention describes the composition of suitable biodegradable alloys, the shape and design of suitable acupuncture needles and needle implants, and semi-finished products for the production thereof, and suggests possible applications.

Description

Biodegradable metallic acupuncture needles

field of invention

The invention relates to acupuncture needles, permanent needles and implant needles for the human and animal body, which consist of magnesium alloys that are degradable in the body. Furthermore, the shape and form of suitable acupuncture needles and needle implants as well as semi-finished products for their production and possible applications are disclosed.

State of the art

Implants made of biodegradable magnesium alloys have been used in human medicine for more than 10 years with growing success. So far, however, they have only been used in two medical areas: stents in vascular surgery and implants in bone surgery. They replace and supplement permanent implants made of stainless steel or titanium in these areas of application.

US 8840736 B2 discloses degradable magnesium stents that keep a narrowed blood vessel open but are resorbed by the body over the course of a year, leaving the treated blood vessel open after the stent has degraded. Biodegradable magnesium implants, which have been replacing or supplementing implants made of titanium or stainless steel in bone surgery for some time due to a number of advantages, are described in EP-A-2 735 373. They stabilize bone fractures over the period of healing, but then completely dissolve in the bone and/or convert into bone substance. After about a year they are no longer available. The surgical removal of implants from the bone by a second operation is no longer necessary. The reaction between magnesium or magnesium alloys in stents and bone implants with the body fluid is referred to as degradation, biodegradation or biocorrosion. The absorption of degradation products by the body is called bioresorption. The water contained in all body fluids, ie blood, lymph, saliva, skin, bone marrow, etc., reacts with the bioresorbable magnesium alloys and ultimately leads to their complete dissolution.

The special position of magnesium compared to other metals used in medicine such as chromium, titanium, aluminum and stainless steel is that magnesium only develops toxic effects in the human body at comparatively high concentrations.

For example, while traces of chromium, aluminum or nickel ions can have a highly toxic effect on the organism, sodium, potassium and magnesium ions are the essential components of the organism's electrolytes. They even have to be present in the blood and tissues in a certain concentration range in order to stabilize and control the osmotic conditions between the cell interior, which is separated by a cell membrane, and the cell environment. Magnesium ions play an important role in the metabolism of bone, muscle and nerve cells.

Acupuncture is a healing treatment based on the specifications of traditional Chinese medicine (TCM) (H. Kuhlemann, AltaMediNet GmbH in "Naturheilmagazin"; https://www.naturheilmaqazin.de/natuerlich-heilen/naturheilkundliche-methoden/akupunktur/ qrundlaqen-der-akupunktur.html). Needles are inserted subcutaneously at specific points in the human body. The essential know-how of acupuncture medicine consists in knowing the body regions or the body points on which this treatment has an effect.

Acupuncture needles are placed on the so-called reactive zones of the body in order to change the flow of energy in the nervous system through mechanical stimuli and the effect on the electrical potential of the body and especially the nerve cells. The effectiveness of acupuncture is sometimes increased by heating the needles after they have been inserted or by placing magnets on the needles. Description of the invention

The present invention relates to a special field of application in medicine - the therapy of neurophysiological diseases or disorders by acupuncture.

Acupuncture needles or needle implants are mostly made of stainless steel (VA, V2A or V4A), sometimes of titanium, more rarely of copper, bronze, brass, silver or gold. Needles made of magnesium or magnesium alloys have not previously been described or used.

In order to be able to use magnesium alloys as acupuncture needles, the alloys must have a special stability and elasticity so that wires with such a thin diameter can be drawn from a semi-finished product that needles with a diameter of 0.2 to 0.8 mm can be made from them ( FW Bach, JM Seitz, Hard on wire, self-dissolving magnesium wires in biomedical engineering, https://www.uni-hannover.de/en/universitaet/aktuelles/veroeffentlichunqen/unimaqazin/ausqaben/1 -2- 2010/).

The necessary stability is achieved through the addition of certain alloying elements, in particular zinc, zirconium, yttrium and rare earth metals, but also through special alloying measures. Forming processes and heat treatments or powder-metallurgical production are used for grain refinement or to increase the phase volume in order to achieve high strength, among other things (R. Eifler in ti - Technologie Informations Niedersachsen, Issue 3/4, 2013, S 14. https:/ /www.yumpu.com/de/document/read/22566436/technoloqie-informationen-de-zernat-4-forschunq-und-eu-.

Classic acupuncture needles or acupuncture implants made of stainless steel or titanium are only subject to very little corrosion in the body. In order to avoid allergies or poisoning, particular value is placed on these "inert" properties. Sometimes classic needles are even coated with silicone as a precaution to avoid any interaction with bodily fluids.

In contrast, the acupuncture needles and acupuncture implants according to the invention consist of biodegradable magnesium alloys, which are exposed to a dissolving process in the body immediately after being inserted. No protective overlays or coatings are used. The depth of the puncture is like in traditional Chinese medicine between 4 and 40 mm and an interaction with the body fluids is sought.

An advantage of the needles according to the invention is that they are very safe to use for self-medication, ie acupuncture treatment by the patient himself. In contrast to steel needles, there is no need for surgical intervention when a needle is torn off or broken off, as the needles dissolve.

At the puncture site of a needle according to the invention or in the vicinity of a needle implant placed subcutaneously in the body, a tiny quantity of magnesium ions is released within a few minutes and introduced into the body. If alloying elements such as calcium, zinc, selenium, molybdenum, phosphorus, silver, etc. are included, atoms or ions of these elements are also introduced into the body. In addition, hydroxide ions and hydrogen radicals are produced in very small amounts according to the decomposition reaction

(24.3) (36) (24.3) (34) (2) where the hydrogen formed is formed primarily as the H radical (H-). Only in a second step do hydrogen radicals unite to form the hydrogen molecule.

In recent scientific literature, the thesis that free radicals damage cells or even cause tumors is very controversial. The administration of so-called antioxidants, which are supposed to bind or destroy free radicals, is now considered ineffective and even contraindicated in tumor therapy. M. Smollich, Deutsche Apotheker Zeitung, https://www.deutsche-apotheker-zeitung.de/daz-az/2016/daz-2-2016/mit-antioxidanzien-qegen-freie-Radicale and I. Hübener, in WELT , https://www.welt.de/gesundheit/article13472096/Freie-Radikale-moeglichglich-nu- etzlich-bei-Krebs.htmlle.

It is also often overlooked that the ubiquitous, vital oxygen, the O2 molecule, is a biradical that does not have any cytotoxic, but mainly healing effects.

In the literature it is described that hydrogen exerts a beneficial influence on body tissue. According to studies, it has anti-inflammatory and anti-inflammatory effects prevents spontaneous cell death by inhibiting caspase-3 and boosting the formation of Bcl-2.

The magnesium needles or acupuncture implants according to the invention thus act on the one hand like classic needles as metallic foreign bodies that exert mechanical and electrical stimuli on the nerve tracts running at the puncture site, but they also send chemical signals to the body, caused by the corrosion caused by them Ions and the decomposition products mentioned above. In this connection it is important that the surface of the needles according to the invention is depassivated before being introduced into the body. Any metal oxide layer covering the surface is removed by depassivation. Depassivation can be achieved by mechanical grinding and polishing, or by briefly immersing in 5% citric acid, ascorbic acid, or acetic acid. Usually 2 to 10 seconds are sufficient for this. On surfaces that have been depassivated in this way (see FIG. 7), the dissolution of the needles in the body starts more quickly and to a greater extent than with needles that have not been depassivated.

The amount of ions or decomposition products released from the needles according to the invention is extremely small, it can be compared with homeopathic amounts or with amounts of drugs used in hormonal disorders. Information on the amounts of ions released and decomposition products from the needles according to the invention can be found in the examples.

By releasing the ions and radicals that are produced during the decomposition of the magnesium alloy, a doubling or tripling of the classic acupuncture effect is achieved. It can be assumed that with implant needles according to the invention, which remain in the body for several weeks to months, effects are achieved which go beyond the effect of acupuncture and entail a lasting influence on the entire organism.

A common area of application for classic acupuncture treatments is the therapy of so-called tennis elbow, a painful inflammatory disease of the tendons in the lower and upper arm in the area of the elbow. It is caused by overexertion when playing tennis, but also by cramping and poor posture when working with the mouse on the computer. The pain can be so severe that active movement of the arm becomes impossible. For treatment, it is recommended to cut through the nerve causing the pain by means of an operation. Other therapies for tennis elbow include massage, shock wave therapy and electro-physiotherapy treatments, as well as acupuncture. Improvements in the state of pain are also achieved with classic so-called ear acupuncture (auriculomedicine) (R. Klowersa, Berlin, homepage, http://aurikulo.de/cms/implantatakupunktur/implantatakupunktur.html).

In self-experiments on the inventor's body, a phenomenon was observed which, among other things, gave rise to the present invention. Surprisingly, it turned out that the effect of acupuncture on tennis elbow is significantly improved if acupuncture needles made of a bioresorbable magnesium alloy are used instead of acupuncture needles made of stainless steel. It is reported that after just 4 hours there is a significant reduction in pain, which is only observed over the course of a few days with classic, conventional ear acupuncture.

Ear acupuncture goes back to the French doctor Paul Nogier, who published his research results in 1956. Diagnostics and therapy are carried out in the ear reflex zone. Nogier found that the entire body has corresponding points on the ear. In the 1960s, the so-called auriculomedicine celebrated a triumph around the world and was also received with enthusiasm in China. In Germany, around 10,000 doctors and non-medical practitioners use this acupuncture method, which requires intensive training.

After the success of ear acupuncture, so-called permanent needles were used from the late 1970s, mainly for chronic diseases such as chronic pain, addiction or neurological disorders. These needles usually remain in the ear for 1-3 weeks and are covered with a small plaster. Due to the longer duration of exposure, a stronger stimulus is exerted on the body. Classic permanent needles are often made of stainless steel or steel with a gold coating, more rarely made of titanium. Permanent needles are not to be confused with implant needles. In the present invention, pure magnesium indwelling needles and magnesium alloy indwelling needles were used to treat migraine, see Example 2.

Since a small wound channel remains open during application when permanent needles are used, there is a risk of inflammation. For this reason, the method of implant acupuncture has recently become widespread (A. Wirz-Ridolfi and B. Fabrowicz, Switzerland. Z. Ganzheitsmed. 2016 (28) 262-266, https://www.karqer. com/ar- tickle/Fulltext/448969; and https://www.blum-akupunktur.de/products/Akupunktur/Akupunktur Nadeln/Dauer Nadeln/Implantate-Templantate/TEMPLAX-Primo-12-Montene.html.

Implant acupuncture is a special form of long-term acupuncture. It can be performed on the ear, but recently it has also been used on the reactive zones of the entire body. Instead of short-term treatment with classic acupuncture needles or permanent needles, tiny implant needles are placed on the known acupuncture points. After 1-2 days, the needle grows invisibly into the auricle or subcutaneously into the body and does not have to be removed again. This permanently stimulates the known reflex points. In Example 3 of the present invention, three magnesium-zinc alloy implant needles were placed in a patient's ear to aid in alcohol withdrawal therapy.

In medical teaching - as in acupuncture medicine - the idea of the human body as a gigantic organizational unit, consisting of about 30 trillion cells and about 40 trillion bacteria, which are connected in a highly complex network and whose correct function (" Health”) is regulated and controlled by an almost unimaginable flood of electrical and chemical signals and messenger substances (Florian Rötzer, Der Mensch: 30 Trillionzellen / Telepolis, 15. Jan. 2016; https://www.heise.de/tp/features /The-Human-30-Trillion-Cells-and-39-Trillion-Bacteria-3377757.html).

In this context, "disease" means a disruption in the control circuits of the complex body network, caused by 5 fundamentally different factors:

1 Mechanical impact (injury, fractures, blunt force)

2 Invasion by foreign organisms or DNA (infection with bacteria, viruses)

3 Regulation disorder due to external factors (poisoning, unbalanced diet, electric shock, radiation, addictive substances)

4 Regulatory disorder due to internal, endocrine causes, in particular defective protein synthesis with the consequences of hormonal dysfunction, enzyme disorders, abnormal blood pressure, etc.)

5 Regulatory disturbances caused by internal, hitherto largely unknown factors (mental illnesses, depression, migraines, MS, Parkinson's disease and Alzheimer's, perhaps also cell degeneration) Type (3) disorders, such as poisoning, can be triggered by even the tiniest amounts of substance and lead to the death of the organism.

Conventional medicine treats type (4) disorders with extremely small amounts of highly active substances supplied from outside, e.g. artificial hormones, in order to achieve healing or improvement.

Acupuncture treatments with the magnesium needles or implant needles according to the invention are particularly suitable for type 4 and 5 diseases.

As explained in Example 1, at least 0.155 pg of magnesium alloy per hour are introduced into the body from a degradable acupuncture needle.

In addition to magnesium of at least 99.8% purity, the following alloys are also used as the metal for the production of the acupuncture needles, permanent needles or biodegradable acupuncture implants according to the invention:

Base metal Magnesium having a purity of at least 99.8% by weight, alloyed with 0.01 to 10.0% by weight zinc, 0.01 to 5.0% by weight calcium and 0.10 to 2.0% by weight Zirconium. Additionally and optionally, the alloys may contain: 0.00 to 2.0% by weight strontium, 0.00 to 2.0% by weight manganese, 0.00 to 3.0% by weight yttrium, 0.00 to 3. 0% by weight of scandium and a total of 0.00 to 5.0% by weight of the rare earths cerium, lanthanum, neodymium and dysprosium and a total of less than 0.5% by weight of the other rare earth metals.

The term "purity" refers to the proportion by weight of magnesium in the magnesium metal used.

Optionally, the magnesium or the alloys can contain a total of 0.001% by weight (10 ppm) to 1.0% by weight (10,000 ppm) of the elements selenium, sulfur, molybdenum, copper, silicon, phosphorus, iron, potassium, lithium and silver.

The alloy, the composition of which corresponds to the above framework, is produced by melting in a vacuum induction furnace under an argon atmosphere, cast into ingots and extruded into thin rods under protective gas. The rods can be extruded and then shaped into cylinders, pins or tubes, or into thin wires using the wire drawing process, or rolled into strips or foils (FW Bach, J.-M. Seitz, Schwer auf Draht, Selbstauflosende MagnesiumdrIRE in der Biomedical engineering; https://www.uni-hannover.de/en/universitaet/aktuelles/veroeffentlichungen/unimagazin/sendungen/1-2-2010/: R. Eifler in ti - Technologie Informations Niedersachsen, issue 3/4, 2013, p. 14, https://www.vumpu.com/de/document/read/22566436/technology-information-de-zernat-4-forschunq-und-eu-

Suitable sections are cut from wires and heat-treated at around 200°C under protective gas (argon is preferred) for 5-10 hours, during which the phase fraction is increased and the alloys harden. Finally, the wire sections are converted into the final form of acupuncture needles (Figures 1 and 2), permanent needles (Figures 3 and 4) or needle implants (Figures 5 and 6) by pressing, pulling, rolling and bending. After packaging, the needles are sterilized using gamma radiation or another suitable sterilization method.

The invention relates to both acupuncture needles, permanent needles and needle implants made of magnesium and those made of biodegradable magnesium alloys.

A preferred embodiment is disclosed in FIG. 1 and FIG. The acupuncture needles have a needle length (Ln) of 5 to 150 mm, preferably 15 to 50 mm and particularly preferably 10 to 30 mm and a needle diameter d _n of 0.2 to 0.8 mm, preferably 0.3 - 0. 5 mm and particularly preferably 0.4 mm. The handle of the needles (Lg) is generally 5 to 30 mm long, preferably 10 to 20 mm and 1 to 10 mm, preferably 2 to 5 mm, in diameter (dg). Like the needle, the handle can be made of magnesium (FIG. 1), but it can also be made of a suitable plastic or another metal, such as steel (FIG. 2). The needles are generally used only once.

Another preferred embodiment is disclosed in FIG. 3 and FIG. The following dimensions are typical of these acupuncture permanent needles: length of the needle (Ln) 2 to 10 mm, preferably 3-7 mm, particularly preferably 5 mm; diameter (dn) 0.2 to 0.8 mm, preferably 0.3-0.5 mm and particularly preferably 0.35 mm; Grip part or cap diameter (D) 5 mm to 12 mm, preferably 6-10 mm, particularly preferably 8 mm; Handle or cap thickness (K) 0.3 to 1.5 mm, preferably 0.4-1.0 mm, particularly preferably 0.6 mm (see FIG. 3). Such single-use acupuncture needles are similar in shape and design to the well-known "thumb pins", but have a thinner needle. The cap of the needle can be made of magnesium or plastic, only the needle attached to it is decisive for the inventive purpose. It must consist of magnesium or a magnesium alloy according to the invention hen. Needles according to Figure 4 can be made from Mg wires or ribbons by creating a handle by rolling the wire into a spiral. If necessary, this spiral can be stabilized by gluing plastic or spot welding of the wire cores.

Another preferred embodiment is disclosed in FIG. 5 and FIG. To produce these needle implants, wire sections of magnesium wires or alloy wires from the magnesium alloys according to the invention are used, which have a diameter (D) of 0.2 to 0.8 mm and a length (L) of 5 to 50 mm. Preferred are 0.35 mm in diameter (D) and 3.0 to 5.0 mm in length (L). The wire sections can be sharpened on one or both sides to facilitate insertion under the skin. Wires and ribbons can also be formed into spindle-shaped implants by pressing and rolling. These needle implants completely dissolve in the body over the course of a few months.

All needles and implants are sterilized prior to use or packaged sterile and sold in sterile packaging.

Statistical analysis of weight loss measurements from biodegradable magnesium needles removed after 1 week revealed an average weight loss of 0.05 mg (50 pg). The corresponding measurements (weighing) are difficult and not very accurate, since in individual cases the implants also increase in mass due to adhesions or reaction of the decomposition products with blood and protein. Nevertheless, it can be concluded from the measurements summa summarum that already in the short time of 1 to 24 hours, in which an acupuncture needle for single use is generally inserted, or 1 week for permanent needles, the corrosion of the needle material in the examples described manner, combined with the formation of magnesium ions, hydrogen atoms or hydrogen radicals, hydrogen molecules, hydroxyl radicals and hydroxide ions. In addition to the mechanical irritation of the body cells and the influence on the electrical potential of the nerve cells, the products formed from the biocorrosion, in particular the presumably highly effective hydrogen and hydroxyl radicals, also have an effect on the nerve tracts in the body (I. Hübener, in DIE WELT , 07.07.2011; https://www.welt.de/gesundheit/article13472096/Freie-Radikale-moeglichglich-nuetzlich-bei-Krebs.html An effect of the hydrated magnesium ions on the cell membranes can also be assumed.

If you look at the body cells alone, these are about 3 x 10 building blocks. According to scientific calculations, a body cell consists of around 42 million protein molecules. An overview of the human body data used to explain the invention is compiled in Table 1.

Table 1 :

Taking the number of ions eluted from a single dissolving magnesium needle in 1 hour to be 3.84 x

(see example 1), then 3.84 x 10 ¹⁵ / 30 x 10 ¹² Mg ions hit a body cell, that is 1.28 x 10 ² = 128 atoms.

For the therapy of glaucoma - a degenerative disease of the optic nerves - dem

Patients daily 1 drop (standardized 0.05 ml) of a solution of 50 pg / ml des (R)

drug lantanoprost (Pfizer), a prostaglandin derivative, administered into the eye. That is 2.5 pg per eye or - calculated with the molecular weight of 432 - 3.48 times

10 prostaglandin molecules. Since the drug is distributed not only in the eye, but throughout the body, 3.48 x 10 / 30 x hit

= 116 drug molecules every body cell. Despite this low dosage, the drug lan-(R)tanoprost has made hundreds of thousands, if not millions, of glaucoma surgeries around the world unnecessary.

These extremely simple calculations will not reflect reality correctly, but they make it clear that even extremely small amounts of substances are not negligible in their effectiveness at the molecular level. This is the only way to explain the extreme effects of hormones or toxins such as ricin, botulinum toxin, snake or insect venom, etc., and this is also how the effect-enhancing effects of the dissolving magnesium needles in this invention can be explained.

The invention is explained in more detail with reference to the following figures:

Figure 1 biodegradable acupuncture needle made of magnesium or magnesium alloy in a classic form with a metal handle Ln length of the magnesium needle dn diameter of the needle Lg length of the handle dg diameter of the handle

FIG. 2 biodegradable acupuncture needle made of magnesium or magnesium alloy in a classic form with a plastic handle Ln length of the magnesium needle dn diameter of the needle Lg length of the handle dg diameter of the handle

Figure 3 biodegradable magnesium permanent needle with cap

Ln length of magnesium or magnesium alloy needle dn diameter of magnesium needle

D diameter of head or cap

K thickness of cap

Figure 4 biodegradable magnesium permanent needle in spiral form

Ln length of magnesium or magnesium alloy needle dn Diameter of the magnesium needle or spiral wire

D diameter of the wire spiral

FIG. 5 biodegradable magnesium implant needle in the form of a pen L Length of the needle or of the implant

D diameter of the implant

FIG. 6 biodegradable spindle-shaped magnesium implant needle

L Length of needle or implant

D diameter of the implant

FIG. 7 depassivated surface of a biodegradable Mg acupuncture implant, 30 s depassivation in 10% strength by weight aqueous citric acid, magnification 80 times

Figure 8 Magnesium ribbon, depassivated, 3mm x 0.3mm; Semi-finished product for producing the implants according to the invention

FIG. 9 Magnesium strip, depassivated, 30 s in 10% by weight aqueous citric acid, semi-finished product for the production of implants according to the invention

The following examples describe possible applications of the invention.

example 1

Acupuncture treatment of tennis elbow with degradable magnesium acupuncture needles according to the invention.

The shape and form of the needles used correspond to those of FIGS. 1 and 2. An acupuncture needle according to the invention consists of a wire of a special magnesium alloy described elsewhere in this invention with an average wire diameter of 0.3 mm. One needle is inserted into the body at 6 reflex points on the arm and upper arm at a depth of 5 to 10 mm. 5mm is the minimum puncture depth for an acupuncture treatment according to the method of traditional Chinese medicine (TCM). The needles can also be inserted deeper, up to 40 mm, depending on the body region to be treated and the type of disease (H. Kuhlemann, AltaMediNet GmbH in "Naturheilmagazin"; https://www.naturheilmaqazin.de/natuerlich-heilen/ naturopathic-methods/acupuncture/qrundlaqen-der-akupunktur.html).

The body-contacting mass of magnesium alloy from a single needle is 0.61 mg. (Calculation: 0.15 mm x 0.15 mm x 3.14 x 5 mm x 1.74 mg/mm ³ ; volume of the inserted part of the needle).

In the course of 1 hour (duration of a typical TCM acupuncture treatment), about the four thousandth part of the magnesium needle inserted into the body is dissolved. This value is obtained if the degradation period of a bone implant made of magnesium is set at approx. 24 weeks and transferred accordingly (calculation: 24 x 7 x 24 = 4,032 h) and a linear course of the corrosion is considered.

Thus, during the one hour treatment period, at least 0.62/4,000 = 0.000155 mg or 0.155 pg of the alloy dissolves from the needle. In addition to magnesium ions, primarily hydroxyl radicals and hydrogen atoms are formed at the puncture site according to the decomposition reaction, which are then converted into hydrogen and hydroxide ions. This only extremely small amount of magnesium ions as well as hydrogen radicals and hydroxyl radicals causes a more intensive response of the body to the acupuncture stimulus compared to traditional acupuncture, which results in faster pain relief and a faster and more lasting release from further pain sensations expresses.

A consideration at the molecular or atomic level is appropriate at this point. In 24.3 grams of magnesium (atomic weight) or - simplified - a magnesium alloy there are 6.022 x 10 ²³ metal atoms (Avogadro's constant). 0.155 pg of the alloy therefore contains 3.84 x10 ¹⁵ atoms or ions, which pass from the dissolving alloy into the body (calculation of the number of atoms: 0.155 x10' ⁶ x 6.022x10 ²³ / 24.3). The total number of cells in the human body is assumed to be 30 trillion (30x10 ¹² ). This number correlates with the latest measurements of the weight of individual body cells of 2 to 3 nanograms (How much does a cell weigh? / https://www.deutsche-apotheker-zeitunq.de/daz-az/2017/daz-45-2017/wie- much-weighs-a-cell). The volume of a person weighing 75 kg is about 70 ^dm3 or 70,000 ^cm3 . Consequently, there are 4.3 x 10 ⁸ body cells in 1 cm ³ , which is roughly the region in which the acupuncture needle acts directly (calculation: 30x10 ¹² / 7x10 ⁴ ). Thus, in acupuncture with a needle according to the invention with a thickness of 0.3 mm, a puncture depth of 5 mm and a treatment duration of 1 hour, at least about 8.9 million magnesium ions hit each body cell in the vicinity of the puncture. (Calculation: 3.84 x 10 ¹⁵ / 4.3 x 10 ⁸ = 0.89 x 10 ⁷ = 8.9 x 10 ⁶ ). In addition, corresponding to the decomposition reaction, 17.6 million OH radicals or hydroxide ions and 2 million hydrogen atoms.

example 2

Acupuncture treatment of migraine with degradable magnesium - permanent needles according to the invention.

Permanent needles are mainly used in a special form of acupuncture, ear acupuncture. There are around 200 known acupuncture points on the human ear, which can be assigned to specific body regions or organs. Before acupuncture, the relevant ear areas are systematically examined. This examination is time-consuming and must be carried out precisely, since the ear points are very small, measuring 0.2 to 0.4 mm.

Three permanent needles made of pure magnesium were placed in the ear of a patient suffering from migraine pain. Each indwelling needle had a needle diameter d _n of 0.30 mm, a length L _n of 3 mm and an arrow-shaped tip and corresponded in shape and design to Figure 3. The mass of the body-contacting needle was 0.37 mg. The diameter of the plastic cap D was 8 mm and the thickness of the cap K was 1 mm. The needles remained in place for 5 days, then some fell off by themselves, some were removed. Acupuncture significantly reduced the patient's migraine pain.

Example 3

Acupuncture treatment of an addiction with degradable magnesium implant needles according to the invention.

Implant acupuncture is a special form and further development of ear acupuncture (A. Wirz-Ridolfi and B. Fabrowicz, Switzerland. Z. Ganzheitsmed. 2016 (28) 262- 266, https://www.karqer.com/Article/ fulltext/448969). As already mentioned, around 200 known reflex points on the ear, which can be assigned to the organs of specific body zones. The use of an implant creates a continuous stimulus at the reflex point. The stimuli generated in the ear are picked up by three cranial nerves and transmitted to the central nervous system. The triggered stimulus reaches the brain via neuronal loops and from there via the nerve tracts to the affected organ. But also in the brain itself certain areas, in this case areas of the hypothalamus, are influenced. This can trigger the formation of control and effect hormones, which activate and manipulate the body's self-healing powers over a longer period of time. Unlike classic acupuncture with a duration of 0.5 - 1 hour or permanent needles, which remain in the body for a week, acupuncture implants constantly send stimuli to the nerve tracts and into the organism over weeks and months. Implant ear acupuncture is useful for many chronic diseases or disorders such as allergies, chronic joint pain, headaches and migraines, restless legs syndrome, tinnitus, nicotine addiction, sleep disorders or obesity.

The needle grows invisibly into the auricle after 1-2 days. This reduces the risk of inflammation because there is no open puncture channel. The reflex points known in ear acupuncture can be permanently stimulated.

In the present invention, implant needles made of magnesium-zinc alloy were used instead of steel and titanium acupuncture needles. The acupuncture implants are tiny, they are the size of a pinpoint and correspond in shape and design to FIGS. 5 and 6. Other configurations are also conceivable. The needles remain permanently and invisibly in the ear. Since the needles are made of a bioresorbable magnesium alloy, they dissolve in the body. They can then be set again if necessary. These biodegradable magnesium implants are well suited for long-term therapies. In the present case, four magnesium-zinc implant needles according to FIG. 5 with a length L of 3 mm and a thickness D of 0.30 mm and a weight of 0.37 mg each were placed in the ear of an addict to support abstinence.

Claims

patent claims

(1) Acupuncture needles, permanent needles or needle implants, characterized in that they consist of magnesium or a biodegradable magnesium alloy, the purity of the magnesium being at least 99.8%.

(2) Acupuncture needle, permanent needle or needle implant according to claim 1, characterized in that the biodegradable magnesium alloy has the following alloy components: Magnesium with a purity of at least 99.8% by weight, 0.01 to 10.0% by weight zinc, 0. 0.1 to 5.0% by weight calcium, 0.10 to 2.0% by weight zirconium; and optionally 0.00 to 2.0% by weight strontium, 0.00 to 2.0% by weight manganese, 0.00 to 3.0% by weight yttrium, 0.00 to 3.0% by weight scandium, a total of 0.00 to 5.0% by weight of the rare earths cerium, lanthanum, neodymium and dysprosium and a total of less than 0.5% by weight of the other rare earth metals.

(3) Acupuncture needle, permanent needle or needle implant according to claim 1 or 2, characterized in that the magnesium or the magnesium alloy additionally contain at least one of the elements selenium, sulfur, molybdenum, copper, silicon, phosphorus, iron, potassium, lithium or silver.

(4) Acupuncture needle, permanent needle or needle implant according to claim 3, characterized in that the amount of the elements selenium, sulfur, molybdenum, copper, silicon, phosphorus, iron, potassium, lithium or silver is 0.001% by weight to 1.0% by weight. % amounts to.

(5) acupuncture needle, permanent needle or needle implant according to one or more of claims 1 to 4, characterized in that the surface thereof is depassivated before being introduced into the body.

(6) Acupuncture needle, permanent needle or needle implant according to claim 5, characterized in that the surface is depassivated by introducing it into aqueous solutions of citric acid, ascorbic acid or acetic acid, which has an acid concentration of 0.5 to 30% by weight, preferably 1 up to 10% by weight.

(7) Acupuncture needle according to one or more of Claims 1-6, characterized in that it has: a needle length (L _n ) of 5 to 150 mm, preferably 15 to 50 mm and particularly preferably 10 to 30 mm; a needle diameter (d _n ) of 0.2 to 0.8 mm, preferably 0.3 to 0.5 mm and particularly preferably 0.4 mm; a handle length (L _n ) of 5 to 30 mm, preferably 10 to 20 mm; and y a handle diameter (d _n ) of 1 to 10 mm, preferably 2 to 5 mm (d _n ). y

(8) Indwelling needle according to one or more of Claims 1 - 6, characterized in that it has: a needle length (L _n ) of 2 to 10 mm, preferably 3 to 7 mm and particularly preferably 5 mm; a needle diameter (d _n ) of 0.2 to 0.8 mm, preferably 0.3 to 0.5 mm and particularly preferably 0.35 mm;

Handle part or cap diameter (D) 5-12 mm, preferably 6-10 mm, particularly preferably 8 mm; and

Handle or cap thickness (K) 0.3 to 1.5 mm, preferably 0.4-1.0 mm, particularly preferably 0.6 mm. - 19 -

(9) Needle implant according to one or more of Claims 1 - 6, characterized in that it has: a diameter (D) of 0.2 - 0.8 mm, preferably 0.3 - 0.5 mm and particularly preferably 0.35 mm; and a length (L) of 5 to 50 mm, preferably 10 - 20 mm, particularly preferably 3 to 5 mm.

(10) A method for the production of acupuncture needles, permanent needles or needle implants according to one or more of claims 1-9, characterized in that a / e wire, cylinder, pin, tube, tape or foil, which / r / s made of magnesium or a biodegradable magnesium alloy, divided into suitable sections, the sections heat treated under protective gas at a temperature of approximately 200 °C for several hours, pressed, drawn, rolled or bent into the final shape and then optionally sterilized.

(11) Use of acupuncture needles, permanent needles or needle implants according to one or more of claims 1-9 for the treatment of the human or animal body.