EP0082081B1 - 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.

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:

- Need to have 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, we know 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 point 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; indeed, if these needles (as described for example in US-A-3,856,019 and US-A-3,976,078) have a generally cylindrical shape, are made of stainless steel and have a pointed tip, they carry further, at their non-pointed end, a sleeve and / or balls which, while complicating the industrial manufacture of needles, give rise to heavy and unbalanced needles. Furthermore, all of the 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.

• - un corps de forme générale cylindrique ayant un diamètre compris entre 0,35 et 0,50 mm, de préférence égal à 0,45 mm, et une longueur totale comprise entre environ 30 et environ 80 mm, de préférence environ 50 mm,
• - une pointe de forme ogivale ladite aiguille étant en acier inoxydable et étant caractérisée en ce que sa partie cylindrique porte, sur une partie de sa longueur, au moins une partie plane 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 ménagée ladite partie plane.

The present invention therefore relates to an acupuncture needle, delivered in sterile packaging and intended for single use, consisting of

• a body of generally cylindrical shape having a diameter of between 0.35 and 0.50 mm, preferably equal to 0.45 mm, and a total length of between approximately 30 and approximately 80 mm, preferably approximately 50 mm,
• - a pointed tip of said needle being made of stainless steel and being characterized in that its cylindrical part carries, over part of its length, at least one flat part 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 formed.

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 about 1 mm.

It is clear that, for reasons of industrial supply and also to prevent certain human tissues from being damaged during the handling of the needle, the needle according to the invention is produced from a cylindrical metallic wire with cross-section. circular. 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 an enlarged view of the needle; and
• Figure 2 also shows an enlarged 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 légerement 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 1 à 3 mm,
• - en 6 la partie cylindrique amincie la partie 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 1 to 3 mm,
• - in 6 the cylindrical part thins part 4 of the needle.

The needle thus produced has a weight less than about 1.5 decigrams and preferably less at 1 decigram. It has been specified that the cylindrical part of the needle comprises "" at least one flat 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 three to six of these planar parts were available, preferably five flat parts, arranged side by side. Each planar part will have a length (in the direction of the axis of the initial cylinder) d 'about 1.4 to 2 mm and the various planar parts will be separated by a cylindrical part of length between about 1.5 and about 3 mm. It should be noted that the planes of each of the planar parts may be located in the same plane or in different planes; it is always preferable for ease of handling, that these planes are different. The width of each planar part is between approximately 1.1 D and approximately 1.9 D if the diameter of the part is called D cylindrical with the understanding that in to us cases D is less than about 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). 6It will be necessary during this packaging to take the necessary precautions so that the tips of the needles are protected. 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 are placed in the cotton or the foam has been produced, said needles are trapped in a cardboard or a plastic sheet which may include the necessary inscriptions; then the pouches obtained are sealed 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.

The deposits of these metals and / or alloys can be carried out by known methods; as we are aiming at 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 known 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. On a réalisé une aiguille en acier inoxydable de 50 mm de longeur à partir d'une tige cylindrique de 0,45 mm de diamètre. On a réalisé une pointe très fine à l'une des extrémité de cette aiguille et, au voisinage de l'autre extrémité de l'aiguille, on a, par écrasement, réalisé trois parties planes dont la longueur (selon l'axe de l'aiguille) est comprise, pour chaque partie, entre 1 et 3 mm et est de préférence de l'ordre de 1,6 mm. La largeur de chaque partie plane est d'environ 0,75 mm et la distance entre chaque partie plane est d'environ 1,6 m m, On dispose ainsi d'une aiguille d'acupuncture aisément manipulable par le praticien.

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. A 50 mm long stainless steel needle was produced from a 0.45 mm diameter cylindrical rod. We made a very fine point at one end of this needle and, in the vicinity of the other end of the needle, we made, by crushing, three flat parts whose length (along the axis of l 'needle) is comprised, for each part, between 1 and 3 mm 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 microns thick was deposited over the entire needle.

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

Claims (6)

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 0.45mm, 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.

2. Needle according to claim 1, characterized in that said cylindrical part (2,6), where at least one flat portion (3,5) is provided, presents an extra thickness with respect to the other cylindrical part, which is such that the width D is at the most equal to about 1 mm.

3. Needle according to any one of claims 1 or 2, characterized in that the stainless steel is coated with a superficial metal layer of thickness between about 0.1 and 2 microns.

4. Needle according to claim 3, characterized in that the superficial metal coating is made in metal selected from gold, silver, platinum, copper, nickel or alloys containing said metals.

5. Method for the industrial production of a needle according to any one of claims 1 or 2, characterized in that said method consists in the following steps:'

cutting a stainless steel wire;

- sharpening one end of the needle into a point;

- producing the flat portion by stamping.

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