EP2427162B1 - Acupuncture body, particularly acupuncture needle - Google Patents
Acupuncture body, particularly acupuncture needle Download PDFInfo
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- 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
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- acupuncture
- boundary surface
- needle
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- acupuncture body
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- 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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Description
Die Erfindung betrifft einen Akupunkturkörper nadelartiger Form, der zur permanenten oder temporären Applikation in lebendes Gewebe eingesetzt wird und der durch seine erhöhte Wirksamkeit auf den oder die jeweiligen Akupunkturpunkte den erzielbaren therapeutischen Effekt der Akupunktur verbessert.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.
Die Erfindung reiht sich damit ein in das Feld der Forschungsergebnisse, bei denen periphere Nervenstimulationen nachweislich zu therapeutischen Effekten führen.The invention thus joins the field of research results in which peripheral nerve stimulations demonstrably result in therapeutic effects.
So konnte im Rahmen einer Studie der Duke Universität North Carolina (USA), die in Zusammenarbeit mit der ETH Lausanne (EPFL)durchgeführt wurde, nachgewiesen werden, dass mit einer auf das Rückenmark wirkenden Elektrostimulations-methode die Parkinsonkrankheit wirksam behandelt werden kann. Auf das mit erheblichen Risiken verbundene Einpflanzen von Elektroden in das Gehirn, wie dies bisher bei der tiefen Hirnstimulation der Fall war, kann bei Anwendung dieser Methode verzichtet werden. Stattdessen wird das Rückenmark mit einem kleinen tragbaren Generator verkabelt, der schwache Stromsignale aussendet (vgl.
Der Stand der Technik bietet auch eine Reihe von Anregungen zur Erhöhung der Wirksamkeit von Akupunkturnadeln und von Akupunkturimplantaten.The prior art also offers a number of suggestions for increasing the effectiveness of acupuncture needles and acupuncture implants.
So wird in der
In der
Im Gegensatz zu diesen technischen Lösungen, die eine zusätzliche Stimulierung durch eine Bewegung der Akupunkturnadel oder des Akupunkturimplantates erreichen, widmet sich eine zweite Gruppe von Entwicklungen der konstruktiven Ausbildung von ausschließlich den Akupunkturnadeln selbst.In contrast to these technical solutions, which achieve additional stimulation by movement of the acupuncture needle or the acupuncture implant, a second group of developments is dedicated to the constructive training of exclusively the acupuncture needles themselves.
In der
Diese im
Aufgabe der Erfindung ist es, die Wirksamkeit von Akupunkturnadeln weiter zu erhöhen. Gelöst wird diese Aufgabe mit den Merkmalen des Anspruches 1, vorteilhafte Ausgestaltungen sind Gegenstand der Unteransprüche.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.
Es wurde im Ergebnis umfangreicher Untersuchungen festgestellt, dass die Wirksamkeit von Akupunkturnadeln auch durch Strukturierungen der Oberfläche im Mikro-und im Nanobereich erhöht werden kann. Damit eröffnet sich die grundsätzliche Möglichkeit der Nutzung von Technologien, die in der Vergangenheit mit einer völlig konträren Funktion benutzt wurden, nämlich solchen, die die Gewebeverträglichkeit und das Verwachsen von Knochen- und Muskelgewebe mit Implantaten aus Metall oder Keramik verbessern. Insoweit wird mit der vorliegenden Erfindung für derartige Materialien und Technologien ein bisher unbekannter Wirkungs-Mittel-Zusammenhang offenbart, eine neue Lehre zum technischen Handeln vermittelt.Extensive research has shown that the effectiveness of acupuncture needles can also be increased by micro and nano surface structuring. This opens up the fundamental possibility of using technologies that have been used in the past with a completely contrary function, namely those that improve the tissue compatibility and the ingrowth of bone and muscle tissue with metal or ceramic implants. In that regard, the present invention for such materials and technologies discloses a hitherto unknown effect-means relationship, imparting a new teaching on technical action.
Erfindungsgemäß ist bei einem Akupunkturkörper nadelartiger Form, der temporär mit einem Abschnitt des Akupunkturkörpers in lebendes Gewebe oder der als Implantat dauerhaft in lebendes Gewebe einsetzbar ist, vorgesehen, dass mindestens in einem Teilbereich der Oberfläche des in das Gewebe einsetzbaren Akupunkturkörpers dessen Grenzfläche zu der den Akupunkturpunkt darstellenden Perforation eines Gefäss-Nerven-Bindegewebsbündels der oberflächlichen Körperfaszie 1) eine Gestaltabweichung mit einer mittleren Rauhtiefe aus dem Bereich von 0,01 µm - 250 µm aufweist, wobei zwischen der Grenzfläche und dem jeweiligen Gefäss-Nerven-Bindegewebsbündel im eingesetzten Zustand eine biologische Wechselwirkung in Form von Reizreflexen besteht.
1)
1)
Die Grenzfläche im Sinne dieser Erfindung weist bedingt durch die beanspruchte Rauheit stets eine Tiefe auf, die mindestens die Ausbildung der mittleren Rautiefe aus dem Bereich von 0,01 µm - 250 µm gestattet. Zum besseren Verständnis wird der Begriff Grenzfläche nachfolgend beibehalten, obwohl es sich mathematisch gesehen um die äußere Schicht oder eine Beschichtung des Akupunkturkörpers handelt.Due to the claimed roughness, 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 μm to 250 μm. For better understanding, the term interface will be retained below, although mathematically it is the outer layer or coating of the acupuncture body.
Während in Asien der Wirkmechanismus der Akupunktur nach wie vor als energetisch-qualitative Lebenskraft-Konzepte verstanden wird, gibt die westliche Forschung der biologisch-quantitativen Deutung als Reiz-Reflextherapie den Vorrang. In diesem Sinn ist der verwendete Begriff biologische Wechselwirkung zu - verstehen.While in Asia, the mechanism of action of acupuncture is still understood as energetic-qualitative life force concepts, the Western research of biological-quantitative interpretation as stimulus reflex therapy gives priority. In this sense, the term used is to understand biological interaction.
Bei den vorgeschlagenen Gestaltabweichungen werden bevorzugt solche vierter und höherer Ordnung genutzt, also Rauheiten in Form von Riefen, Schuppen, Kuppen aber auchIn the case of the proposed shape deviations, such fourth and higher order are preferably used, ie roughnesses in the form of grooves, scales, crests but also
Rauheiten der Gefügestruktur und des Gitteraufbaues wie sie in der DIN 4760 systematisiert sind.Roughness of the microstructure and the lattice structure as they are systematized in DIN 4760.
Dabei ist es nicht nur möglich, sondern bei besonderen Ausführungen sogar vorteilhaft, wenn diese Rauheiten in Kombination mit anderen die Grenzschicht charakterisieren.It is not only possible, but even advantageous for special designs, when these roughness in combination with others characterize the boundary layer.
Die erfindungsgemäß strukturierten Oberflächen können also auch zusätzlich zu einer makrostrukturierten Oberfläche mindestens eine Beschichtung mit einer mikro- und/oder nanostrukturierten Grenzfläche zum lebenden Gewebe aufweisen.
Möglich ist es auch, Teilbereiche, auch aneinandergrenzende mit unterschiedlichen Gestaltabweichungen in der Rauhtiefe auszustatten.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.
Bei einer weiteren Ausführung ist vorgesehen, dass bei der Grenzfläche einer Beschichtung aus einer groben Mikrostruktur (Strukturgröße > 20 µm) mindestens abschnittsweise eine feinere Mikrostruktur (Strukturgröße 0,5-20 µm) überlagert ist oder der groben Mikrostruktur mindestens abschnittsweise eine feinere Mikrostruktur und beiden Strukturen noch mindestens abschnittsweise eine Nanostruktur (Strukturgröße 10-500 nm) überlagert ist. Verfahrenstechnisch lassen sich derartige Strukturen z.B. herstellen, indem ein metallischer Grundkörper in einen Elektrolysebad pulsierend mit einem Strom beaufschlagt wird, wobei das Elektrolysebad mit speziellen Ionen versetzt ist.In a further embodiment it is provided that at the interface of 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. In terms of process technology, 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.
Innerhalb der oben genannten Gestaltabweichung mit einer mittleren Rauhtiefe aus dem Bereich von 0,01 µm - 250 µm haben sich als vorteilhaft mittlere Rauhtiefen der Grenzfläche von 0,5 µm - 100 µm und von 5 µm - 80 µm erwiesen.Within the abovementioned shape deviation with an average roughness depth in the range from 0.01 μm to 250 μm, average roughness depths of the boundary surface of 0.5 μm-100 μm and of 5 μm-80 μm have proved to be advantageous.
Die Gestaltabweichungen in der Grenzfläche des nadelartigen Akupunkturkörpers können dabei den Nadelschaft oder die Spitze oder davon Teilabschnitte umfassen, vorzugsweise den Schaft und die Spitze oder jeweils Teilabschnitte, um bei der Akupunktur den Grenzflächenkontakt mit dem jeweiligen Gefäss-Nerven-Bindegewebsbündel optimal sicherzustellen.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.
Die Akupunkturkörper lassen sich sowohl aus einem mit Gestaltabweichungen versehenen Draht durch Ablängen und Anformen der Spitze herstellen als auch durch eine die Gestaltabweichungen erzielende Behandlung von nadelartigen Grundkörpern.
Bei im Querschnitt dünnen Drähten kann das Anformen der Spitze direkt beim Ablängen vorgenommen werden oder auf das Anformen der Spitze kann gänzlich verzichtet werden.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.
For wires that are thin in cross-section, the tip can be formed directly when cutting to length, or the tip can not be molded completely.
Der Draht oder die Grundkörper müssen dabei nicht unbedingt als Vollkörper ausgebildet sein. Vielmehr sieht eine vorteilhafte Ausbildung auch vor, dass der Draht oder der nadelartige Grundkörper aus Metallfäden, die durch Zwirnen oder Kräuseln und/oder vorzugsweise durch Diffusionsverschweißen punktuell miteinander verbundenen sind, besteht.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.
Die Oberfläche eines solchen nadelartigen, aus Metallfäden, die durch Zwirnen oder Kräuseln und/oder vorzugsweise durch Diffusionsverschweißen punktuell miteinander verbunden
sind, hergestellten Akupunkturkörpers kann bei einer derartigen Ausführung bereits allein Grenzfläche mit denThe surface of such a needle-like, made of metal threads, which are selectively connected by twisting or crimping and / or preferably by diffusion bonding
are prepared acupuncture body in such a design already alone interface with the
beanspruchten Gestaltabweichungen sein und/oder es erfolgt zumindest in Teilbereichen eine zusätzliche mikro- und/oder nanostrukturierte Beschichtung.be claimed shape deviations and / or there is at least in some areas an additional micro- and / or nanostructured coating.
Bei weiteren Ausführungen ist vorgesehen, dass die Grenzfläche mit einer Gestaltabweichung die Oberfläche eines nadelartigen durch Sintern hergestellten Akupunkturkörpers ist oder dass die Grenzfläche die Oberfläche eines nadelartigen durch Unterkühlen einer Metallschmelze hergestellten Akupunkturkörpers ist.In other embodiments, it is contemplated that 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.
Beim Unterkühlen einer Metallschmelze wird u.a. der Effekt genutzt, dass unter bestimmten Abkühlbedingungen eine Kristallisation von Dendriten erfolgt, die nachfolgend fragmentieren. Die daraus resultierende Mikrostruktur ist entweder feinkörnig äquiaxial oder grobkörnig dendritisch. Beide Strukturen können der erfindungsgemäß vorgesehenen Grenzfläche entsprechen.When subcooling a molten metal, i.a. used the effect that crystallization of dendrites takes place under certain cooling conditions, which subsequently fragment. The resulting microstructure is either fine-grained equiaxial or coarse-grained dendritic. Both structures can correspond to the interface provided according to the invention.
Ferner wird bei einer weiteren Ausführung vorgeschlagen, dass die Grenzfläche aus einer abrasiven Oberflächenschicht besteht, die die mittleren Rauhtiefen aus dem Bereich von 0,01 µm - 250 µm aufweist.Furthermore, in a further embodiment, it is proposed that the interface consists of an abrasive surface layer, which the middle Roughness depths in the range of 0.01 microns - 250 microns.
Neben den eingangs genannten allgemeinen Gestaltabweichungen vierter und höherer Ordnung mit deren zugehörigen genormten Rauhigkeitskennwerten haben sich Akupunkturkörper bewährt, deren Oberfläche durch eine räumliche Fraktalität gekennzeichnet ist.In addition to the fourth and higher order general shape deviations mentioned above with their associated standardized roughness characteristics, acupuncture bodies whose surface is characterized by a spatial fractality have proved successful.
Das bedeutet, dass die Grenzfläche ein geometrisches Muster mit einem hohen Maß an Selbstähnlichkeit aufweist. Das ist beispielsweise der Fall, wenn die einzelnen Objekte der Grenzfläche aus mehreren verkleinerten Kopien ihrer selbst bestehen, was bereits die Rauhigkeit ausmachen kann.
Dabei geht es bei der Gestaltabweichung der Oberfläche bei den Akupunkturkörpern nicht ausschließlich um eine strenge Fraktalität, sondern eine statistische Selbstähnlichkeit ist durchaus als ausreichend anzusehen.This means that 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.
Unter dem Gesichtspunkt des Verständnisses des Wirkmechanismus der Akupunktur als Reiz-Reflextherapie und deren Verbesserung durch die erfindungsgemäßen Lösungen sind aus der Vielfalt der Fraktale insbesondere solche interessant, bei denen die Grenzfläche mit kantigen und/oder schuppigen, nach außen weisenden Begrenzungsrändern von Fraktalen ausgeführt sind und/oder bei denen die fraktal ausgebildete Grenzfläche über Spitzen verfügt.From the point of view of understanding the mechanism of action of acupuncture as a stimulus-reflex therapy and their improvement by the solutions according to the invention are of the variety of fractals in particular those in which the interface with angular and / or scaly, outwardly facing boundary edges of fractals are executed and / or where the fractally formed interface has peaks.
Bei einer bevorzugten Ausführung sind die fraktal ausgebildeten Grenzflächen der Kochkurve in einer der 3. bis 5. Iteration angenäherten ausgebildet, ohne dass die Erfindung darauf beschränkt ist.In a preferred embodiment, the fractal interfaces of the boiling curve are in one of 3rd to 5th iteration formed approximated, without the invention being limited thereto.
Soweit die Grenzfläche als Beschichtung ausgebildet ist, ist in vorteilhaften Ausführungen materialseitig vorgesehen,
dass die Grenzfläche aus einem inerten Material (Iridiumoxid, Niobiumoxid, Titannitrid) oder aus einer inerten keramikartigen Struktur oder aus einem glasartigen oder polymeren Material oder einer Kombination daraus ausgebildet ist oder
dass die Grenzfläche als Beschichtung aus Gold, Platin, A1, Cu, Iridium, Palladium oder rostfreiem Stahl oder deren Legierungen ausgebildet ist oder
dass die Grenzfläche als Beschichtung aus IrOx, TiN, Platin-Black, Platin-Gray, Nanoröhrchen ausgebildet ist oder
dass die Grenzfläche aus einer porösen Titanbeschichtung besteht, bei der grobes Titanpulver auf einen reinen Titankern aufgesintert ist oder
dass als Grenzfläche gemahlenes Titannitridpulver aus kantigen Partikeln auf eine nadelartigen Grundkörper aufgesintert ist.Insofar as the interface is designed as a coating, 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.
Verfahrensseitig lässt sich die Grenzfläche herstellen, indem die die Grenzfläche bildende Schicht mittels reaktiver Kathodenzerstäubung (CVD, PVD oder MOCVD) oder thermischen Spritzverfahren oder Ionenplattierung oder einer Dünnschichttechnologie aufgebracht ist.In terms of the process, 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.
So können beim thermischen Spritzen die Verfahrensparameter so gewählt werden, dass die Partikel eines Schichtwerk-stoffes nur kurzzeitig erhitzt werden, wobei sie höchstens teilweise aufschmelzen und beim Auftreffen auf den Grundkörper des Akupunkturkörpers rasch abgeschreckt werden. So bleibt die rauhe Oberfläche der Spritzkörper erhalten, was zu einer rauhen Oberfläche des Akupunkturkörpers führt.
In einem speziellen Verfahren erfolgt ein Beschichten mit Coumpoundpartikeln mittels Vakuum-Plasma-Spritzen. Zur Erzeugung der Coumpoundpartikel erfolgt ein Compoundieren von Titanpartikeln (kantiges Ti-Pulver mit einer Korngröße > 150 µm vorzugsweise > 200 µm) mit einem Additiv , insbesondere einem Sinterhilfsmittel (Silizium oder Cobalt), das mit Titan oder einer Legierung daraus ein Eutektikum bildet und das bei niedriger Temperatur schmilzt als reines Titan.Thus, during thermal spraying, 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. Thus, the rough surface of the syringes remains, resulting in a rough surface of the acupuncture body.
In a special process, Coumpound particles are coated by vacuum plasma spraying. To produce the Coumpoundpartikel a compounding of titanium particles (angular Ti powder having a particle size> 150 .mu.m preferably> 200 microns) with 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.
Neben auftragenden Verfahren lassen sich die erfindungsgemäße Grenzfläche auch durch Abtragungsverfahren herstellen.
Ein bevorzugtes mechanisches Abtrageverfahren ist der Beschuss mit Partikeln z.B. in einer Größenordnung von 50 µm und Drücken um 3 bar.
Ebenso ist die Grenzfläche durch Ätzverfahren z.B. unter Verwendung von Säuren oder Laugen herstellbar. Insbesondere auch fraktale Grenzflächen sind durch Ätzverfahren vorteilhaft herstellbar.In addition to applying methods, 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.
Likewise, the interface can be prepared by etching, for example using acids or alkalis. In particular, fractal interfaces can be advantageously produced by etching.
In weiterer Ausgestaltung des Akupunkturkörpers wird vorgeschlagen, dass die Grenzfläche der Beschichtung über elektrisch und/oder chemisch differenzierbare Eigenschaften verfügt.In a further embodiment of the acupuncture body, it is proposed that the interface of the coating has electrically and / or chemically differentiable properties.
Die Grenzfläche kann dabei eine anisotrope Ladungsverteilung über die Fläche aufweisen, so dass eine Wechselwirkung mit den elektrischen Potentialen der Zellen des Gefäss-Nerven-Bindegewebsbündels der oberflächlichen Körperfaszie besteht.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.
Eine elektrische Differenzierbarkeit der Grenzfläche ist auch durch Dotierung der Grenzfläche mit unterschiedlichen Metallen bewirkbar.An electrical differentiability of the interface can also be effected by doping the interface with different metals.
Ebenso ist vorgesehen, dass durch die Anwendung von Halbleitertechnologien in der Grenzfläche elektrische Potentiale bzw. Stromflüsse induzierbar sind.Likewise, it is provided that electrical potentials or current flows can be induced by the use of semiconductor technologies in the interface.
Um zu verhindern, dass bei bestimmten Grenzflächenstrukturen Verletzungen und Entzündungen der Haut auftreten, die das Behandlungsergebnis infrage stellen könnten, ist bei einer weiteren Ausführung vorgesehen, dass die erfindungsgemäß ausgebildete Grenzfläche als Gleitmittel mit einem bioresorbierbaren oder biologisch abbaubaren Überzug versehen ist.In order to prevent injuries and inflammations of the skin which might jeopardize the treatment result in certain interface structures, it is provided in a further embodiment that the interface formed according to the invention is provided as a lubricant with a bioresorbable or biodegradable coating.
Durch den bioresorbierbaren oder biologisch abbaubaren Überzug ist in weiterer Ausgestaltung des Akupunkturkörpers auch ein zeitlich gesteuerter Wirkungseintritt und/oder Wirkungsverlauf der Grenzfläche auf das jeweilige Gefäss-Nerven-Bindegewebsbündel erreichbar.Due to 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.
Während bisher jeweils nur ein Akupunkturkörper und dessen Grenzflächenausbildung beschrieben wurde, sieht eine weitere Ausgestaltung vor, dass zwei oder mehr Akupunkturkörper zu einem Bündel zusammengefasst und gleichzeitig in das lebende Gewebe einbringbar sind, wobei bevorzugt Akupunkturkörper mit unterschiedlichen Rauheiten der Grenzflächen bei einem Bündel einsetzbar sind.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.
Anhand der in den Zeichnungen dargestellten Ausführungen soll der Akupunkturkörper erläutert werden. Es zeigen
- Fig. 1
- den Akupunkturkörper in einem Längsschnitt,
- Fig. 2
- ein Ausschnitt der Grenzfläche,
- Fig. 3
- den Akupunkturkörper im Querschnitt,
- Fig. 4
- eine fraktale Grenzfläche und
- Fig. 5
- einen Schnitt einer fraktalen Grenzfläche.
- Fig. 1
- the acupuncture body in a longitudinal section,
- Fig. 2
- a section of the interface,
- Fig. 3
- the acupuncture body in cross section,
- Fig. 4
- a fractal interface and
- Fig. 5
- a section of a fractal interface.
In den
Mindestens in einem Teilbereich der Oberfläche des in das Gewebe einsetzbaren Akupunkturkörpers 1, hier der Schaft 4 und die Spitze 5, ist der Akupunkturkörper 1 mit einer Beschichtung versehen, deren Grenzfläche 2 zu der den Akupunkturpunkt darstellenden Perforation eines Gefäss-Nerven-Bindegewebsbündels der oberflächlichen Körperfaszie eine Gestaltabweichung mit einer mittleren Rauhtiefe aus dem Bereich von 0,01 µm - 250 µm aufweist, wobei zwischen der Grenzfläche und dem jeweiligen Gefäss-Nerven-Bindegewebsbündel im eingesetzten Zustand eine biologische Wechselwirkung in Form von Reizreflexen besteht.
Die Grenzfläche 2 besteht hier beispielhaft aus einer porösen Titanbeschichtung, bei der grobes Titanpulver auf einen reinen Titankern aufgesintert ist.In the
At least in a portion of the surface of the usable in the tissue acupuncture body 1, here the
By way of example, the
In den
Die Akupunkturkörper 1 dienen neben den bekannten Indikationen bevorzugt der Zweckbestimmung der Implantatakupunktur am Ohr im Rahmen der Behandlung neurologischer Erkrankungen.In addition to the known indications, the acupuncture bodies 1 preferably serve the purpose of implant acupuncture on the ear in the context of the treatment of neurological diseases.
Claims (16)
- An acupuncture body having a needle-like shape which can be temporarily inserted in living tissue with a section of the acupuncture body (1) or permanently inserted in living tissue as an implant, wherein
at least in a partial region of the surface of the acupuncture body (1) that can be inserted in the tissue, the boundary surface (2) thereof with the perforation of a vessel-nerve-connecting-tissue bundle of the superficial body fascia constituting the acupuncture point exhibits a different design, characterized in that
said different design has a roughness in the form of scales, cones and/or fractal geometry with an average peak-to-valley height in the range of 0.01 µm-250 µm, so that a biological interaction in the form of stimulation reflexes exists in the inserted state between the boundary surface (2) and the respective vessel-nerve-connecting-tissue bundle. - The acupuncture body according to claim 1, characterized in that
with a base body (3) consisting of a needle shaft (4) and a tip (5) or consisting only of a needle shaft (4), the boundary surface (2) comprises the needle shaft (4) or the tip (5) or partial sections thereof, but preferably the needle shaft (4) and the tip (5) or partial sections of them. - The acupuncture body according to any of claims 1 or 2, characterized in that
the needle-like base body (3) consists of metal threads connected to each other at certain points by twisting or curling and/or preferably by diffusion welding. - The acupuncture body according to any of claims 1 to 3, characterized in that
the boundary surface (2) is applied as a coating to a needle-like base body (3), wherein the needle-like base body (3) preferably has a macro-structured surface with a coated boundary surface (2). - The acupuncture body according to any of claims 1 to 4, characterized in that
the boundary surface (2) is the surface of a needle-like acupuncture body (1) manufactured by sintering, or the boundary surface (2) is the surface of a needle-like acupuncture body (1) manufactured by undercooling of molten metal, or the boundary surface (2) is the surface of a needle-like acupuncture body (1) made of metal threads, wherein the metal threads are connected to each other at certain points by twisting or curling and/or preferably by diffusion welding. - The acupuncture body according to claim 1, characterized in that
the fractal-formed boundary surface (2) approximates the Koch curve in one of the 3rd to 5th iterations and/or the fractal-formed boundary surface (2) has tips and/or the boundary surface (2) is formed with angular and/or scaly border edges of fractals (6) pointing outwards. - The acupuncture body according to any of claims 1 to 6, characterized in that
at the boundary surface (2) of a coating consisting of a coarse microstructure with a structural size of > 20 µm, a finer microstructure with a structural size of 0.5-20 µm is superposed, or that the coarse microstructure is superposed with a fine microstructure and both structures are additionally superposed with a nanostructure with a structural size of 10-500 nm. - The acupuncture body according to any of claims 1 to 4, characterized in that
the boundary surface (2) consists of an abrasive surface coating in which a porous titanium coating is created by sintering ground titanium nitride powder with angular particles onto a needle-like base body or by sintering coarse titanium powder onto a pure titanium core or in which the coating is formed from an inert material, iridium oxide, niobium oxide, titanium nitride or from an inert ceramic-type structure or from a glass-like or polymeric material or a combination thereof or in which the coating is made of IrOx, TiN, platinum black, platinum gray, nanotubes. - The acupuncture body according to any of claims 1 to 6, characterized in that
the boundary surface (2) is manufactured by retroactively roughening the surface of sintered particles, preferably using wet chemical etching. - The acupuncture body according to any of claims 1 to 9, characterized in that
the boundary surface (2) is manufactured using an abrasive process, preferably an etching process. - The acupuncture body according to any of claims 1 to 10, characterized in that
the average peak-to-valley height of the.boundary surface (2) is in the range of 0,5 µm-100 µm, preferable having an average peak-to-valley height in the range of 5 µm-80 µm. - The acupuncture body according to any of claims 1 to 11, characterized in that
the boundary surface (2) has electrically and/or chemically differentiating properties. - The acupuncture body according to claim 12, characterized in that
the boundary surface (2) has an anisotropic charge distribution across the surface and that an interaction occurs with the electric potentials of the cells of the vessel-nerve-connecting-tissue bundle of the superficial body fascia. - The acupuncture body according to claim 12 or 13, characterized in that
the electric and/or chemical differentiability of the boundary surface (2) is caused by doping the boundary surface (2) with different metals. - The acupuncture body according to any of claims 12 to 14, characterized in that
electric currents can be induced in the boundary surface (2) through the application of semiconductor technologies. - The acupuncture body according to any of claims 1 to 15, characterized in that
the boundary surface (2) is provided with a bioresorbable or biodegradable film as a lubricant, wherein
the bioresorbable or biodegradable film can cause a timed onset and/or progress of the effect of the boundary surface (2) on the respective vessel-nerve-connecting-tissue bundle.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE200910021214 DE102009021214A1 (en) | 2009-05-08 | 2009-05-08 | Acupuncture body, in particular acupuncture needle |
PCT/DE2010/000540 WO2010127672A2 (en) | 2009-05-08 | 2010-05-06 | Acupuncture body, particularly acupuncture needle |
Publications (2)
Publication Number | Publication Date |
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EP2427162A2 EP2427162A2 (en) | 2012-03-14 |
EP2427162B1 true EP2427162B1 (en) | 2014-07-16 |
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ID=42932547
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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EP10747790.3A Not-in-force EP2427162B1 (en) | 2009-05-08 | 2010-05-06 | Acupuncture body, particularly acupuncture needle |
Country Status (3)
Country | Link |
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EP (1) | EP2427162B1 (en) |
DE (1) | DE102009021214A1 (en) |
WO (1) | WO2010127672A2 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111719113A (en) * | 2019-03-19 | 2020-09-29 | 中山大学 | Surface modification method of acupuncture needle |
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DE19804246A1 (en) * | 1998-02-04 | 1999-08-05 | Fumedica Intertrade Ag | Needles for use in surgery |
DE10259642A1 (en) * | 2002-12-18 | 2004-07-22 | Fssb Chirurgische Nadeln Gmbh | Surgical needle, for sutures through tissue, is polished mechanically to give structured projections and recesses, to be treated with a non-stick materials and dark gilding for low contrast without gloss |
EP1900330A2 (en) * | 2006-09-13 | 2008-03-19 | AESCULAP AG & Co. KG | Surgical needle and method for manufacturing a surgical needle |
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DE3220718A1 (en) | 1982-06-02 | 1983-02-24 | Jürgen Dipl.-Ing. Geißer (FH), 7900 Ulm | Acupuncture needle with predetermined magnetic field strength |
JPH0221877A (en) * | 1988-07-11 | 1990-01-24 | Ikuo Ogata | Acupuncture needle containing or covered with semiconductor material |
RU2074699C1 (en) * | 1993-10-18 | 1997-03-10 | Савельев Александр Викторович | Method and needle for glaciopuncture |
DE10147450A1 (en) | 2001-01-29 | 2003-04-03 | Ulrich Werth | Manipulating needle-like body involves establishing body as implant in living tissue, contactlessly applying artificially produced magnetic, electric, electromagnetic and/or acoustic field |
JP3722363B2 (en) * | 2001-10-11 | 2005-11-30 | セイリン株式会社 | Needle |
US20050049632A1 (en) * | 2002-01-22 | 2005-03-03 | Yukio Inokuti | Ceramic-coated instruments for medical use, ceramic-coated instruments for studying living organisms and process for producing the same |
DE202004005880U1 (en) | 2004-04-14 | 2004-06-09 | Schwa-Medico, Medizinische Apparate, Vertriebsgesellschaft mbH | acupuncture needle |
WO2006077742A1 (en) * | 2004-12-28 | 2006-07-27 | Nabtesco Corporation | Skin needle producing device and skin needle producing method |
KR20080018368A (en) * | 2006-08-24 | 2008-02-28 | 오제희 | A needle |
JP4829166B2 (en) | 2007-04-10 | 2011-12-07 | 東洋レヂン株式会社 | Contact needle |
DE202008013068U1 (en) | 2007-10-11 | 2008-12-18 | Suzhou Industrial Park JiaJian Technology Trading Co., Ltd | acupuncture needle |
-
2009
- 2009-05-08 DE DE200910021214 patent/DE102009021214A1/en not_active Withdrawn
-
2010
- 2010-05-06 WO PCT/DE2010/000540 patent/WO2010127672A2/en active Application Filing
- 2010-05-06 EP EP10747790.3A patent/EP2427162B1/en not_active Not-in-force
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Publication number | Priority date | Publication date | Assignee | Title |
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DE19804246A1 (en) * | 1998-02-04 | 1999-08-05 | Fumedica Intertrade Ag | Needles for use in surgery |
DE10259642A1 (en) * | 2002-12-18 | 2004-07-22 | Fssb Chirurgische Nadeln Gmbh | Surgical needle, for sutures through tissue, is polished mechanically to give structured projections and recesses, to be treated with a non-stick materials and dark gilding for low contrast without gloss |
EP1900330A2 (en) * | 2006-09-13 | 2008-03-19 | AESCULAP AG & Co. KG | Surgical needle and method for manufacturing a surgical needle |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN111719113A (en) * | 2019-03-19 | 2020-09-29 | 中山大学 | Surface modification method of acupuncture needle |
CN111719113B (en) * | 2019-03-19 | 2021-08-17 | 中山大学 | Surface modification method of acupuncture needle |
Also Published As
Publication number | Publication date |
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EP2427162A2 (en) | 2012-03-14 |
WO2010127672A3 (en) | 2011-03-24 |
WO2010127672A2 (en) | 2010-11-11 |
DE102009021214A1 (en) | 2010-11-11 |
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