WO2022063873A1 - Aiguilles d'acupuncture métalliques biodégradables - Google Patents

Aiguilles d'acupuncture métalliques biodégradables Download PDF

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Publication number
WO2022063873A1
WO2022063873A1 PCT/EP2021/076156 EP2021076156W WO2022063873A1 WO 2022063873 A1 WO2022063873 A1 WO 2022063873A1 EP 2021076156 W EP2021076156 W EP 2021076156W WO 2022063873 A1 WO2022063873 A1 WO 2022063873A1
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WO
WIPO (PCT)
Prior art keywords
needle
needles
acupuncture
weight
magnesium
Prior art date
Application number
PCT/EP2021/076156
Other languages
German (de)
English (en)
Inventor
Jan-Marten Seitz
Original Assignee
Syntellix Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Syntellix Ag filed Critical Syntellix Ag
Publication of WO2022063873A1 publication Critical patent/WO2022063873A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H39/00—Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture
    • A61H39/08—Devices for applying needles to such points, i.e. for acupuncture ; Acupuncture needles or accessories therefor
    • A61H39/086—Acupuncture needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body

Definitions

  • 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.
  • 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 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.
  • the alloys 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/aberichtes/veroe Hotunqen/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- sake-de-zernat-4-forschunq-und-eu-.
  • 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.
  • 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.
  • 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.
  • 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/implantatakuticianur/implantatakuticianur.html).
  • 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.
  • 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.
  • 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.
  • At least 0.155 pg of magnesium alloy per hour are introduced into the body from a degradable acupuncture needle.
  • 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 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.
  • purity refers to the proportion by weight of magnesium in the magnesium metal used.
  • 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
  • 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.
  • 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.
  • FIG. 5 and FIG. 5 Another preferred embodiment is disclosed in FIG. 5 and FIG.
  • wire sections of magnesium wires or alloy wires from the magnesium alloys according to the invention 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.
  • FIG. 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
  • FIG. 5 biodegradable magnesium implant needle in the form of a pen L Length of the needle or of the implant
  • FIG. 6 biodegradable spindle-shaped magnesium implant needle
  • 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
  • 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).
  • TCM Chinese medicine
  • 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.
  • 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).
  • Permanent needles are mainly used in a special form of acupuncture, ear acupuncture.
  • acupuncture points 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Rehabilitation Therapy (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Finger-Pressure Massage (AREA)

Abstract

L'invention concerne des aiguilles d'acupuncture, des aiguilles permanentes et des aiguilles en implants pour le corps humain et animal, qui sont constituées de magnésium ou d'alliages de magnésium spéciaux dégradables dans le corps. Alors que les aiguilles d'acupuncture classiques en acier spécial ou en titane restent inaltérées dans le corps, les aiguilles ou implants d'acupuncture selon l'invention commencent à subir un processus de désintégration immédiatement après avoir été insérés. Les produits de décomposition libérés au point de piqûre émettent des stimuli chimiques et des signaux aux cellules corporelles environnantes, qui s'additionnent avec les stimuli mécaniques et électriques des aiguilles métalliques et entraînent une augmentation considérable de l'effet. L'invention décrit la composition d'alliages biodégradables appropriés, la forme et la configuration d'aiguilles d'acupuncture et d'implants d'aiguilles appropriées, ainsi que des produits semi-finis pour leur fabrication, et donne des indications sur des applications possibles.
PCT/EP2021/076156 2020-09-23 2021-09-23 Aiguilles d'acupuncture métalliques biodégradables WO2022063873A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020124795.8 2020-09-23
DE102020124795.8A DE102020124795A1 (de) 2020-09-23 2020-09-23 Biodegradierbare metallische Akupunkturnadeln

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115804872A (zh) * 2022-11-29 2023-03-17 上海交通大学 可降解镁基金属丝材在制备溶脂材料中的应用

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115044845B (zh) * 2022-06-09 2023-05-05 中南大学 一种提升生物可降解Mg-Zn-Sc-Zr合金综合性能的方法
US20240173196A1 (en) * 2022-11-29 2024-05-30 David S. Miller Method for releasing contracted tissue

Citations (4)

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Publication number Priority date Publication date Assignee Title
DE102005007616A1 (de) * 2005-02-18 2006-09-07 Ulrich Dipl.-Ing. Hausmann Resorbierbare Magnesiumnadel
DE102006001598A1 (de) * 2006-01-11 2007-07-12 Karl-Otto Launicke Resorbierbare Akupunkturnadel
EP2735373A1 (fr) 2012-10-30 2014-05-28 Spirig Pharma AG Dispositif de distribution
US8840736B2 (en) 2004-09-07 2014-09-23 Biotronik Vi Patent Ag Endoprosthesis comprising a magnesium alloy

Patent Citations (4)

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US8840736B2 (en) 2004-09-07 2014-09-23 Biotronik Vi Patent Ag Endoprosthesis comprising a magnesium alloy
DE102005007616A1 (de) * 2005-02-18 2006-09-07 Ulrich Dipl.-Ing. Hausmann Resorbierbare Magnesiumnadel
DE102006001598A1 (de) * 2006-01-11 2007-07-12 Karl-Otto Launicke Resorbierbare Akupunkturnadel
EP2735373A1 (fr) 2012-10-30 2014-05-28 Spirig Pharma AG Dispositif de distribution

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F.W. BACHJ.-M. SEITZ, SCHWER AUF DRAHT, SELBSTAUFLÖSENDE MAGNESIUMDRÄHTE IN DER BIOMEDIZINTECHNIK, Retrieved from the Internet <URL:https://www.uni-hanno-ver.de/en/universitaet/aktuelles/veroeffentlichungen/unimagazin/ausgaben/1-2-2010/>
FLORIAN RÖTZER, DER MENSCH: 30 BILLIONEN ZELLEN / TELEPOLIS, 15 January 2016 (2016-01-15), Retrieved from the Internet <URL:https://www.heise.de/tp/features/Der-Mensch-30-Billionen-Zellen-und-39-Billionen-Bakterien-3377757.htmI>
H. KUHLEMANNALTAMEDINET GMBH, NATURHEIL-MAGAZIN, Retrieved from the Internet <URL:https://www.naturheilmagazin.de/natuerlich-heilen/naturheilkundliche-methoden/akupunktur/grundlagen-der-akupunktur.html>
I. HÜBENER, DIE WELT, 7 July 2011 (2011-07-07), Retrieved from the Internet <URL:https://www.welt.de/gesundheit/article13472096/Freie-Radikale-moeglicherweise-nuetzlich-bei-Krebs.html>
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M. SMOLLICH, DEUTSCHE APOTHEKER ZEITUNG, Retrieved from the Internet <URL:https://www.deutsche-apotheker-zeituno.de/daz-az/2016/daz-2-2016/mitantioxidanzien-gegen-freie-radikale>
R. EIFLER: "Technologie Informationen Niedersachsen", 2013, pages: S14

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115804872A (zh) * 2022-11-29 2023-03-17 上海交通大学 可降解镁基金属丝材在制备溶脂材料中的应用
CN115804872B (zh) * 2022-11-29 2024-02-27 上海交通大学 可降解镁基金属丝材在制备溶脂材料中的应用

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