EP0082081A1 - Disposable acupuncture needle and method of making the same - Google Patents

Abstract

1. Sterile packed disposable acupuncture needle, constituted by - a body of general cylindrical shape (2, 6) having a diameter between 0.35 and 0.50 mm and preferably 0.45 mm, and an overall length of between about 30 and 80 mm, and preferably about 50 mm, - one pointed end (1), said needle being in stainless steel and being characterized in that its cylindrical part (2, 6) is provided, over part of its length, with at least one flat portion (3, 5) obtained by deformation of the cylindrical part, said deformation resulting in a widening of said part, going from 1.1 D to 1.9 D, D being the width of said cylindrical part where said flat portion is formed.

Description

The present invention relates to new disposable acupuncture needles.

• - nécessite de disposer d'aiguilles stériles non susceptibles de transmettre certaines maladies virales. En effet si, notamment entre chaque utilisation,les aiguilles ne sont pas soumises à une stérilisation complète, il y a risque de transmission de maladies virales d'un patient à l'autre. Or, on sait que, dans l'état de la technique, les stérilisations réalisables sur les aiguilles d'acupuncture actuelles sont difficiles et le plus souvent incomplètes au stade du cabinet médical.
• - Nécessité de disposer d'aiguilles dont la pointe est en parfait état. Cette nécessité vient du fait que dans l'acupuncture la pointe de l'aiguille doit atteindre avec précision certains sites situés au voisinage immédiat de la surface de la peau. Or chaque utilisation d'une aiguille provoque une certaine détérioration de la pointe de ladite aiguille; cette détérioration a d'ailleurs pour conséquence que l'action de l'aiguille devient douloureuse et éventuellement nocive pour les tissus traversés.
• - Nécessité de disposer d'aiguilles qui sont d'une part aisément manipulables et d'autre part suffisamment légères pour que, mises en place, leur pointe ne se déplace pas lorsque le praticien lâche l'aiguille.

Acupuncture is a treatment technique that is both very old and potentially very interesting for the future, but which poses a certain number of problems with regard to the needles used. The main issues are:

• - requires sterile needles not capable of transmitting certain viral diseases. Indeed, if, in particular between each use, the needles are not subjected to complete sterilization, there is a risk of transmission of viral diseases from one patient to another. However, it is known that, in the state of the art, the sterilizations that can be performed on current acupuncture needles are difficult and most often incomplete at the medical office stage.
• - Need to have needles whose tip is in perfect condition. This necessity comes from the fact that in acupuncture the tip of the needle must precisely reach certain sites located in the immediate vicinity of the surface of the skin. However, each use of a needle causes a certain deterioration of the tip of said needle; this deterioration also has the consequence that the action of the needle becomes painful and possibly harmful for the tissues crossed.
• - Need to have needles which are on the one hand easily manipulated and on the other hand light enough so that, put in place, their tip does not move when the practitioner releases the needle.

However, the needles currently available on the market do not make it possible to solve these various problems, in particular by the fact that the manipulation of known needles is always carried out by the installation, at the non-pointed end of the needle, of a sleeve or balls which, while complicating the industrial manufacture of needles, give rise to heavy and unbalanced needles. Furthermore, all known needles are intended to be used a very large number of times, hence the additional difficulties arising from the progressive deterioration of the tips and the obligation of extensive sterilization between each use.

The present invention aims to overcome the various problems set out above on the basis of the basic idea that to ensure absolute safety of the act of acupuncture it was necessary to have disposable needles.

But the realization of this idea - and simultaneously the solution of the other problems mentioned above - implies that one can develop a disposable needle that can be easily manufactured industrially and can therefore be cost acceptable.

• a) - elle est d'une longueur comprise entre environ 30 et environ 80 mm, de préférence environ 50 mm
  • - elle a, dans sa partie cylindrique, un diamètre compris entre 0,35 et 0,50 mm, de préférence environ 0,45 mm
  • - et elle est en acier résistant inoxydable
• b) - elle comporte une pointe ogivale
  • - et sa partie cylindrique porte, sur une partie de sa longueur, au moins une partie plane, cette partie plane étant obtenue par déformation de la partie cylindrique, cette déformation aboutissant à un élargissement de ladite partie allant de 1,1 D à 1,9 D si on appelle D la largeur de ladite partie cylindrique à l'endroit où est réalisée ladite "partie plane".

The present invention therefore relates to an acupuncture needle, delivered in sterile packaging, intended for single use and having the following characteristics:

• a) - it is between about 30 and about 80 mm in length, preferably about 50 mm
  • - it has, in its cylindrical part, a diameter between 0.35 and 0.50 mm, preferably about 0.45 mm
  • - and it is made of resistant stainless steel
• b) - it has an ogival point
  • - and its cylindrical part carries, over part of its length, at least one flat part, this flat part being obtained by deformation of the cylindrical part, this deformation resulting in an enlargement of said part going from 1.1 D to 1, 9 D if D is called the width of said cylindrical part at the place where said "flat part" is made.

In certain particular cases it is possible that the cylindrical part of said needle, part in which "at least one flat part" is produced, has a slight excess thickness compared to the other cylindrical part of the needle. It is however essential that this additional thickness is such that the width D of said cylindrical part having an additional thickness remains less than approximately 1 mm.

It is clear that, for reasons of industrial supply and also to prevent certain human tissues from being injured when handling the needle, the needle according to the invention is made from a cylindrical metal wire with circular section. In this case, the width D will obviously be the diameter of the wire.

• La figure 1 représente, grossie, une vue de l'aiguille; et
• la figure 2 représente, également grossie, une coupe suivant II-II de l'aiguille.

An acupuncture needle according to the invention can be shown diagrammatically as in FIGS. 1 and 2.

• Figure 1 shows, enlarged, a view of the needle; and
• Figure 2 shows, also enlarged, a section along II-II of the needle.

• - en 1 la pointe très effilée de l'aiguille,
• - en 2 la partie cylindrique qui forme le corps principal de l'aiguille; cette partie cylindrique a avantageusement un diamètre de 0,45 mm,
• - en 3 la partie plane de l'aiguille suivie en 4 d'une nouvelle partie de forme cylindrique qui peut avoir un diamètre analogue à celui de la partie cylindrique 2.

In this figure 1, we distinguish:

• - in 1 the very tapered tip of the needle,
• - in 2 the cylindrical part which forms the main body of the needle; this cylindrical part advantageously has a diameter of 0.45 mm,
• - in 3 the flat part of the needle followed in 4 by a new part of cylindrical shape which may have a diameter similar to that of the cylindrical part 2.

• - en coupe (partie hachurée) la partie plane 5 de l'aiguille; cette partie plane a une forme sensiblement rectangulaire; cette partie rectangulaire, obtenue par exemple par simple déformation du cylindre, a une longueur légèrement supérieure au diamètre initial du cylindre; pour fixer les idées, il suffit que la longueur de la partie 3 de l'aiguille (longueur comptée le long de l'axe) soit de l'ordre de à 3 mm,
• - en 6 la partie cylindrique amincie 4 de l'aiguille.

In Figure 2, we see:

• - in section (hatched part) the flat part 5 of the needle; this planar part has a substantially rectangular shape; this rectangular part, obtained for example by simple deformation of the cylinder, has a length slightly greater than the initial diameter of the cylinder; to fix the ideas, it suffices that the length of part 3 of the needle (length counted along the axis) is of the order of 3 mm,
• - In 6 the thinned cylindrical part 4 of the needle.

The needle thus produced has a weight of less than approximately 1.5 decigrams and preferably less than 1 decigram.

It has been specified that the cylindrical part of the needle comprises "at least one planar part"; this part (or these parts) is obviously intended for the manipulation of the needle by the practitioner. Experience has shown that said manipulation could be facilitated if there were 3 to 6 of these flat parts, preferably 5 flat parts, arranged side by side. Each flat part will have a length (in the direction of the axis of the initial cylinder) of about 1.4 to 2 mm and the various flat parts will be separated by a cylindrical part of length between approximately 1.5 and approximately 3 mm. It will be noted that the planes of each of the planar parts can be located in the same plane or in different planes; it is preferable, always to facilitate handling, that these plans be different. The width of each flat part is between approximately 1.1 D and approximately 1.9 D if the diameter of the cylindrical part is called D, it being understood that in all cases D is less than approximately 1 mm.

• - découpage du fil d'acier (acier inoxydable dit ressort) à la longueur voulue;
• - affûtage des aiguilles; bien évidemment la partie pointure de l'aiguille (et son mode de réalisation) devra être aussi effilée que possible compte tenu du matériau de départ utilisé;
• - réalisation de la déformation de la partie cylindrique de l'aiguille pour obtenir la (ou les) partie plane; cette déformation s'effectue par emboutissage; dans tous les cas il a été trouvé qu'il convenait que cette partie plate ne soit pas située à l'extrémité de l'aiguille mais à une certaine distance (au moins 0,4 mm) de cette extrémité; dans le cas où l'on réalise plus de deux parties plates (cinq par exemple) l'emboutissage sera effectué en au moins deux opérations successives par exemple dans la première opération on réalisera deux parties plates voisines et dans la deuxième opération on réalisera les trois autres parties planes.

The preparation of acupuncture needles according to the invention comprises the following operations:

• - cutting of steel wire (stainless steel called spring) to the desired length;
• - sharpening of needles; obviously the shoe size part of the needle (and its embodiment) should be as tapered as possible taking into account the starting material used;
• - Realization of the deformation of the cylindrical part of the needle to obtain the plane part (s); this deformation is effected by stamping; in all cases, it has been found that this flat part should not be situated at the end of the needle but at a certain distance (at least 0.4 mm) from this end; in the case where more than two flat parts are made (five for example) the stamping will be carried out in at least two successive operations for example in the first operation two neighboring flat parts will be carried out and in the second operation the three will be carried out other flat parts.

The needles thus produced are then packaged for delivery in a sterile manner. The packaging can be done for each needle individually or for a series (5 or preferably 10 needles). During this packaging, take the necessary precautions to protect the tips of the needles. This is how we can proceed to the packaging either by pricking a certain number of needles in a plastic foam with open pores, or pricking the needles in a piece of cotton cloth and protecting the points by folding down, on these points, part of said fabric. When the needles have been placed in the cotton or foam, said needles are trapped in a cardboard or a plastic sheet which may include the necessary inscriptions; then the pouches obtained are placed in a blister and sterilized by known methods (ethylene oxide or irradiation for example). All of these packaging operations have the advantage of being perfectly industrializable, which makes it possible to obtain the finished marketable product with an acceptable cost price.

We also know that acupuncturists sometimes seek to have, in addition, the possibility of exciting the centers targeted by the acupuncture needle by subjecting the needle to a very slight difference in potential. Although the needle described above achieves this objective, it has been found that it is often desirable to coat said needles with a coating of highly conductive metal or unalterable alloy.

The metals and alloys which can be used are gold, silver, platinum, copper and possibly nickel or an alloy of these metals.

Deposits of these metals and / or alloys can be carried out by known methods; as the aim is a simple surface coating of the needle (thickness of the coating preferably between 0.1 and 2 microns), the metal deposits can be produced by electrolysis of a suitable suitable solution.

• - une amélioration de la visibilité de l'aiguille lorsque celle-ci est mise en place sur le patient;
• - une amélioration de la conductibilité électrique et électrostatique de l'aiguille;
• - utilisation d'une surface en métal généralement précieux considérée comme moins oxydable donc plus propre et plus facilement stérile;
• - effets psychologiques positifs sur les patients.

The advantages of needles thus coated are multiple; among these advantages we can cite:

• - an improvement in the visibility of the needle when it is placed on the patient;
• - an improvement in the electrical and electrostatic conductivity of the needle;
• - use of a generally precious metal surface considered to be less oxidizable, therefore cleaner and more easily sterile;
• - positive psychological effects on patients.

The following nonlimiting example illustrates the invention.

A 50 mm long stainless steel needle was made from a 0.45 mm diameter cylindrical rod. A very fine point was made at one end of this needle and _f in the vicinity of the other end of the needle, three flat parts have been produced by crushing, the length of which (along the axis of the needle) is between 1 and 3 mm for each part and is preferably of the order of 1.6 mm. The width of each flat part is approximately 0.75 mm and the distance between each flat part is approximately 1.6 mm. This provides an acupuncture needle that can be easily manipulated by the practitioner.

The needle thus obtained was soaked in an electrolysis tank containing a soluble gold salt. By electrolysis lasting approximately 2 minutes, a layer of gold approximately 0.4 micron thick was deposited over the entire needle.

The needle thus obtained has many advantages, in particular as regards its safety and conductivity, and its stability, after correct positioning, due to its low mass.

Claims (5)

1. Acupuncture needle, delivered in sterile packaging and intended for single use, characterized in that it has the following characteristics: a) - it has a total length of between approximately 30 and approximately 80 mm, preferably equal to approximately 50 mm; - It has, in its cylindrical part a diameter between 0.35 and 0.50 mm, preferably equal to about 0.45 mm; - and it is made of stainless steel; b) - it has a pointed tip - and its cylindrical part carries, over a part of its length, at least one flat part obtained by deformation of the cylindrical part, this deformation resulting in a widening of said part going from 1.1 D to 1.9 D if we call D the width of said cylindrical part at the place where said "flat part" is formed. 2. Needle according to claim 1, characterized in that said cylindrical part where at least one flat part is arranged has an additional thickness, this additional thickness being such that the width D is at most equal to approximately 1 mm. 3. Needle according to one of claims 1 and 2, characterized in that the stainless steel is coated with a metal surface layer with a thickness of about 0.1 to 2 microns. 4. Needle according to claim 3, characterized in that the surface metal layer is made of a metal chosen from gold, silver, platinum, copper, nickel and the alloys of said metals. 5. Process for the industrial preparation of a needle according to one of claims 1 and 2, characterized in that the following operations are carried out successively: - cutting of a stainless steel wire; - realization of the point by sharpening; - Realization of said flat part by at least one stamping.

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