EP2427162B1 - Accessoire d'acupuncture, en particulier aiguille d'acupuncture - Google Patents

Accessoire d'acupuncture, en particulier aiguille d'acupuncture Download PDF

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Publication number
EP2427162B1
EP2427162B1 EP10747790.3A EP10747790A EP2427162B1 EP 2427162 B1 EP2427162 B1 EP 2427162B1 EP 10747790 A EP10747790 A EP 10747790A EP 2427162 B1 EP2427162 B1 EP 2427162B1
Authority
EP
European Patent Office
Prior art keywords
acupuncture
boundary surface
needle
body according
acupuncture body
Prior art date
Legal status (The legal status 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 status listed.)
Not-in-force
Application number
EP10747790.3A
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German (de)
English (en)
Other versions
EP2427162A2 (fr
Inventor
Ulrich Werth
Karlheinz Schmidt
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Centro de Medicina Neuro-regenerativa S L
Original Assignee
CENTRO DE MEDICINA NEURO-REGENERATIVA S L
CT DE MEDICINA NEURO REGENERATIVA S L
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.)
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Publication date
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Publication of EP2427162A2 publication Critical patent/EP2427162A2/fr
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Publication of EP2427162B1 publication Critical patent/EP2427162B1/fr
Not-in-force legal-status Critical Current
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Classifications

    • 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

Definitions

  • the invention relates to an acupuncture body of a needle-like shape, which is used for permanent or temporary application in living tissue and which improves the achievable therapeutic effect of acupuncture by its increased effectiveness on the one or more acupuncture points.
  • the invention thus joins the field of research results in which peripheral nerve stimulations demonstrably result in therapeutic effects.
  • the prior art also offers a number of suggestions for increasing the effectiveness of acupuncture needles and acupuncture implants.
  • an acupuncture needle is described with a flexible handle, with the help of the acupuncture needle should be set into vibration.
  • the acupuncture needle aims in a similar direction DE 10 2008 014 503 A1 in that protrusions arranged on a head part and producing the stimulating effect can be acted upon by vibrations parallel to the skin.
  • An acupuncture needle is described, whose shaft is at least partially provided with a surface structure, which is preferably designed as a relief-like structure and / or as a recessed structure. Alternatively, a groove and / or helical and / or an annular surface structure may also be provided. Further, reference is made to diamond-shaped shank recesses and to symmetrical or asymmetrical surface structures.
  • the object of the invention is to further increase the effectiveness of acupuncture needles. This object is achieved with the features of claim 1, advantageous embodiments are the subject of the dependent claims.
  • an acupuncture body needle-like shape which temporarily with a portion of the Acupuncture body in living tissue or which is permanently used as an implant in living tissue provided that at least in a portion of the surface of the insertable into the tissue acupuncture body whose interface to the acupuncture point representing perforation of a vascular-nerve connective tissue bundle of the superficial body fascia 1) a Shape deviation with a mean surface roughness in the range of 0.01 microns - 250 microns, wherein there is a biological interaction in the form of stimulus reflexes between the interface and the respective vessel-nerve connective tissue bundle in the inserted state.
  • H. Heine Anatomical Structures of Acupuncture Points, German Journal of Acupuncture, 2/1988, p. 26, 30
  • the boundary surface in the sense of this invention always has a depth which permits at least the formation of the average roughness depth from the range of 0.01 ⁇ m to 250 ⁇ m.
  • the term interface will be retained below, although mathematically it is the outer layer or coating of the acupuncture body.
  • such fourth and higher order are preferably used, ie roughnesses in the form of grooves, scales, crests but also
  • the surfaces structured in accordance with the invention can therefore also have, in addition to a macrostructured surface, at least one coating with a microstructured and / or nanostructured interface with the living tissue. It is also possible to equip subareas, also contiguous with different shape deviations in the roughness.
  • a coating of a coarse microstructure (structure size> 20 microns) at least partially a finer microstructure (feature size 0.5-20 microns) is superimposed or the coarse microstructure at least partially a finer microstructure and both Structures at least partially a nanostructure (structure size 10-500 nm) is superimposed.
  • such structures can be produced, for example, by pulsing a metallic base body into an electrolytic bath with a stream, wherein the electrolysis bath is mixed with special ions.
  • average roughness depths of the boundary surface of 0.5 ⁇ m-100 ⁇ m and of 5 ⁇ m-80 ⁇ m have proved to be advantageous.
  • the shape deviations in the interface of the needle-like acupuncture body may include the needle shaft or the tip or portions thereof, preferably the shaft and the tip or each subsections to optimally ensure the interfacial contact with the respective vascular-nerve connective tissue bundle in acupuncture.
  • the acupuncture bodies can be produced both from a wire provided with deviations in shape by cutting to length and shaping of the tip, and also by treatment of needle-like basic bodies which achieves the shape deviations.
  • the tip can be formed directly when cutting to length, or the tip can not be molded completely.
  • the wire or the base body need not necessarily be formed as a solid body. Rather, an advantageous embodiment also provides that the wire or the needle-like basic body of metal filaments, which are selectively interconnected by twisting or crimping and / or preferably by diffusion bonding, there is.
  • the interface having a shape deviation is the surface of a needle-like acupuncture body made by sintering, or that the interface is the surface of a needle-like acupuncture body prepared by supercooling a molten metal.
  • microstructure is either fine-grained equiaxial or coarse-grained dendritic. Both structures can correspond to the interface provided according to the invention.
  • the interface consists of an abrasive surface layer, which the middle Roughness depths in the range of 0.01 microns - 250 microns.
  • the interface has a geometric pattern with a high degree of self-similarity. This is the case, for example, if the individual objects of the interface consist of several smaller copies of themselves, which can already be the reason for the roughness.
  • the shape deviation of the surface of the acupuncture bodies is not exclusively a matter of strict fractality, but a statistical self-similarity is quite sufficient.
  • the fractal interfaces of the boiling curve are in one of 3rd to 5th iteration formed approximated, without the invention being limited thereto.
  • the material side is provided in advantageous embodiments, that the interface is formed of an inert material (iridium oxide, niobium oxide, titanium nitride) or of an inert ceramic-like structure or of a vitreous or polymeric material or a combination thereof or that the interface is formed as a coating of gold, platinum, Al, Cu, iridium, palladium or stainless steel or their alloys, or that the interface is formed as a coating of IrOx, TiN, platinum black, platinum-gray, nanotubes or that the interface consists of a porous titanium coating in which coarse titanium powder is sintered on a pure titanium core, or that as an interface ground titanium nitride powder of angular particles is sintered on a needle-like body.
  • an inert material iridium oxide, niobium oxide, titanium nitride
  • the interface is formed of an inert ceramic-like structure or of a vitreous or polymeric material or a combination thereof or that the interface is formed as
  • the interface can be prepared by applying the interface forming the layer by means of reactive sputtering (CVD, PVD or MOCVD) or thermal spraying or ion plating or a thin-film technology.
  • CVD reactive sputtering
  • PVD PVD
  • MOCVD metal-organic chemical vapor deposition
  • the process parameters can be selected such that the particles of a layered material are only briefly heated, at the most being partially melted and rapidly quenched upon striking the main body of the acupuncture body.
  • the rough surface of the syringes remains, resulting in a rough surface of the acupuncture body.
  • Coumpound particles are coated by vacuum plasma spraying.
  • a compounding of titanium particles angular Ti powder having a particle size> 150 .mu.m preferably> 200 microns
  • an additive in particular a sintering aid (silicon or cobalt), which forms a eutectic with titanium or an alloy thereof and the at low temperature melts as pure titanium.
  • the interface according to the invention can also be produced by removal processes.
  • a preferred mechanical removal method is the bombardment with particles, for example in the order of 50 microns and pressures of 3 bar.
  • the interface can be prepared by etching, for example using acids or alkalis.
  • fractal interfaces can be advantageously produced by etching.
  • the interface of the coating has electrically and / or chemically differentiable properties.
  • the interface may have an anisotropic charge distribution over the surface, so that there is an interaction with the electrical potentials of the cells of the vascular-nerve-connective tissue bundle of the superficial body fascia.
  • An electrical differentiability of the interface can also be effected by doping the interface with different metals.
  • the interface formed according to the invention is provided as a lubricant with a bioresorbable or biodegradable coating.
  • the bioresorbable or biodegradable coating in a further embodiment of the acupuncture body, it is also possible to achieve a time-controlled onset of action and / or course of action of the interface with the respective vascular-nerve-connective tissue bundle.
  • acupuncture bodies While only one acupuncture body and its interface formation has been described so far, a further embodiment provides that two or more acupuncture bodies are combined into a bundle and at the same time can be introduced into the living tissue, wherein preferably acupuncture bodies with different roughness of the interfaces in a bundle can be used.
  • Fig. 1 to 3 is an acupuncture body 1 shown in various views, in a longitudinal section, in a section of the interface 2 and in Fig. 3 in cross section.
  • the acupuncture body 1 which can be used temporarily with a section of the acupuncture body 1 or permanently as an implant in living tissue, consists of the shaft 4 and the tip 5, which form the main body 3.
  • the acupuncture body 1 is provided with a coating whose interface 2 to the acupuncture point representing perforation of a vascular nerve-connective tissue bundle of superficial body fascia a shape deviation with a mean roughness depth in the range of 0.01 .mu.m to 250 .mu.m, wherein between the interface and the respective vessel-nerve connective tissue bundle in the inserted state, a biological interaction in Form of stimulus reflexes exists.
  • the interface 2 consists of a porous titanium coating, in which coarse titanium powder is sintered onto a pure titanium core.
  • the interface 2 fractal is formed.
  • the interface 2 is designed with edged and / or scaly, outwardly facing boundary edges of the fractal 6 and may also have tips.
  • Fig. 5 shows in a section a fractally formed interface 2, which is approximated to the boiling curve in the 4th iteration.
  • the acupuncture bodies 1 preferably serve the purpose of implant acupuncture on the ear in the context of the treatment of neurological diseases.

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  • Health & Medical Sciences (AREA)
  • Rehabilitation Therapy (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Finger-Pressure Massage (AREA)

Claims (16)

  1. Accessoire d'acupuncture en forme d'aiguille, qui peut être inséré temporairement dans un tissu vivant avec un segment de l'accessoire d'acupuncture (1) ou qui peut être inséré durablement dans un tissu vivant en tant qu'implant, accessoire dont la surface limite (2), par rapport à la perforation, représentant le point d'acupuncture, d'un faisceau vaisseau-nerf-tissu conjonctif du fascia superficiel, présente une aspérité dans au moins une zone partielle de la surface de l'accessoire d'acupuncture (1) pouvant être inséré dans le tissu, caractérisé en ce que l'aspérité présente des rugosités sous forme d'écailles, de calottes et/ou de géométrie fractale, avec une profondeur brute moyenne dans la plage de 0,01 µm - 250 µm, de telle sorte que, entre la surface limite (2) et le faisceau vaisseau-nerf-tissu conjonctif respectif, quand l'accessoire est introduit, il y a une interaction biologique sous forme de réflexes d'excitation.
  2. Accessoire d'acupuncture selon la revendication 1, caractérisé en ce que,
    dans le cas d'un corps de base (3), composé d'une tige d'aiguille (4) et d'une pointe (5), ou composé uniquement d'une tige d'aiguille (4), la surface limite (2) comprend la tige d'aiguille (4) ou la pointe (5) des segments partiels de celles-ci, mais de préférence la tige d'aiguille (4) et la pointe (5) ou respectivement des segments partiels de celles-ci.
  3. Accessoire d'acupuncture selon une des revendications 1 ou 2, caractérisé en ce que
    le corps de base (3) de type aiguille est composé de fils métalliques qui sont raccordés les uns aux autres ponctuellement par retordage ou frisage et/ou de préférence par soudage par diffusion.
  4. Accessoire d'acupuncture selon une des revendications 1 à 3, caractérisé en ce que
    la surface limite (2) est appliquée, en tant que revêtement, sur un corps de base (3) de type aiguille, le corps de base (3) de type aiguille présentant de préférence une surface macrostructurée avec une surface limite (2) revêtue.
  5. Accessoire d'acupuncture selon une des revendications 1 à 4, caractérisé en ce que
    la surface limite (2) est la surface d'un accessoire d'acupuncture (1) de type aiguille fabriqué par frittage, ou la surface limite (2) est la surface d'un accessoire d'acupuncture (1) de type aiguille fabriqué par surfusion d'un métal fondu, ou la surface limite (2) est la surface d'un accessoire d'acupuncture (1) de type aiguille fabriqué à partir de fils métalliques, les fils métalliques étant raccordés les uns aux autres ponctuellement par retordage ou frisage et/ou de préférence par soudage par diffusion.
  6. Accessoire d'acupuncture selon la revendication 1, caractérisé en ce que
    la surface limite (2), de constitution fractale, de la courbe de Koch est approchée dans une itération parmi la 3ème à 5ème itération et/ou la surface limite (2) de constitution fractale dispose de pointes et/ou la surface limite (2) est réalisée avec des bords de limitation de fractales (6) à arêtes vives et/ou à écailles dirigés vers l'extérieur.
  7. Accessoire d'acupuncture selon une des revendications 1 à 6, caractérisé en ce que
    dans le cas de la surface limite (2), une microstructure plus fine avec une dimension de structure 0,5 - 20 µm est superposée à un revêtement composé d'une microstructure grossière avec une dimension de structure > 20 µm, ou une microstructure plus fine est superposée à la microstructure grossière, ou encore une nanostructure avec une dimension de structure 10 - 500 nm est superposée aux deux structures.
  8. Accessoire d'acupuncture selon une des revendications 1 à 4, caractérisé en ce que
    la surface limite (2) se compose d'une couche superficielle abrasive, dans le cas de laquelle de la poudre broyée de nitrure de titane composée de particules à arêtes vives est mise en place par frittage sur un corps de base de type aiguille ou dans le cas de laquelle de la poudre de titane grossière est mise en place par frittage sur un noyau de titane pur pour l'obtention d'un revêtement poreux de titane ou dans le cas de laquelle le revêtement est formé d'un matériau inerte, d'oxyde d'iridium, d'oxyde de niobium, de nitrure de titane ou d'une structure inerte de type céramique ou d'un matériau polymère ou de type verre ou d'une combinaison de ceux-ci, ou le revêtement est constitué de IrOx, TiN, noir de platine, gris de platine, nanotubes.
  9. Accessoire d'acupuncture selon une des revendications 1 à 6, caractérisé en ce que
    la surface limite (2) est fabriquée en rendant rugueuse après coup la surface de particules frittées, de préférence par un décapage chimique humide.
  10. Accessoire d'acupuncture selon une des revendications 1 à 9, caractérisé en ce que
    la surface limite (2) est fabriquée par un procédé d'abrasion, de préférence par un procédé de décapage.
  11. Accessoire d'acupuncture selon une des revendications 1 à 10, caractérisé en ce que
    la profondeur de rugosité moyenne de la surface limite (2) se situe dans la plage de 0,5 µm - 100 µm, et présente de préférence une profondeur de rugosité moyenne dans la plage de 5 µm - 80 µm.
  12. Accessoire d'acupuncture selon une des revendications 1 à 11, caractérisé en ce que
    la surface limite (2) dispose de caractéristiques pouvant être différenciées de façon électrique et/ou chimique.
  13. Accessoire d'acupuncture selon la revendication 12, caractérisé en ce que
    la surface limite (2) présente une distribution de charge anisotrope sur la surface, et en ce qu'il existe une interaction avec les potentiels électriques des cellules du faisceau vaisseau-nerf-tissu conjonctif du fascia superficiel.
  14. Accessoire d'acupuncture selon la revendication 12 ou 13, caractérisé en ce que
    la possibilité de différenciation électrique ou respectivement chimique de la surface limite (2) est produite en dopant la surface limite (2) avec des métaux différents.
  15. Accessoire d'acupuncture selon une des revendications 12 à 14, caractérisé en ce que
    l'utilisation de technologies de semi-conducteurs dans la surface limite (2) permet d'induire des flux de courant.
  16. Accessoire d'acupuncture selon une des revendications 1 à 15, caractérisé en ce que
    la surface limite (2) est munie, à titre de lubrifiant, d'un recouvrement biorésorbable ou biodégradable,
    le recouvrement biorésorbable ou biodégradable pouvant produire une entrée en action, commandée dans le temps, et/ou une évolution des effets de la surface limite (2) sur le faisceau vaisseau-nerf-tissu conjonctif respectif.
EP10747790.3A 2009-05-08 2010-05-06 Accessoire d'acupuncture, en particulier aiguille d'acupuncture Not-in-force EP2427162B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE200910021214 DE102009021214A1 (de) 2009-05-08 2009-05-08 Akupunkturkörper, insbesondere Akupunkturnadel
PCT/DE2010/000540 WO2010127672A2 (fr) 2009-05-08 2010-05-06 Accessoire d'acupuncture, en particulier aiguille d'acupuncture

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Publication Number Publication Date
EP2427162A2 EP2427162A2 (fr) 2012-03-14
EP2427162B1 true EP2427162B1 (fr) 2014-07-16

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EP (1) EP2427162B1 (fr)
DE (1) DE102009021214A1 (fr)
WO (1) WO2010127672A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111719113A (zh) * 2019-03-19 2020-09-29 中山大学 针灸针具的表面改质方法

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DE10259642A1 (de) * 2002-12-18 2004-07-22 Fssb Chirurgische Nadeln Gmbh Chirurgische Nadel
EP1900330A2 (fr) * 2006-09-13 2008-03-19 AESCULAP AG & Co. KG Aiguille chirurgicale et méthode de fabrication d'une aiguille chirurgicale

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DE19804246A1 (de) * 1998-02-04 1999-08-05 Fumedica Intertrade Ag Nadeln zur Verwendung in der Chirurgie
DE10259642A1 (de) * 2002-12-18 2004-07-22 Fssb Chirurgische Nadeln Gmbh Chirurgische Nadel
EP1900330A2 (fr) * 2006-09-13 2008-03-19 AESCULAP AG & Co. KG Aiguille chirurgicale et méthode de fabrication d'une aiguille chirurgicale

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111719113A (zh) * 2019-03-19 2020-09-29 中山大学 针灸针具的表面改质方法
CN111719113B (zh) * 2019-03-19 2021-08-17 中山大学 针灸针具的表面改质方法

Also Published As

Publication number Publication date
EP2427162A2 (fr) 2012-03-14
WO2010127672A2 (fr) 2010-11-11
WO2010127672A3 (fr) 2011-03-24
DE102009021214A1 (de) 2010-11-11

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