Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2001-04-25
2003-06-10
Calvert, John J. (Department: 3765)
Surgery
Instruments
Cutting, puncturing or piercing
C600S567000
Reexamination Certificate
active
06575992
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a needle set which can be profitably used for double-blind test for strictly evaluating the therapeutic effect of acupuncture in which it is masked from both of the subject and the practitioner whether a true needle or a placebo needle is used, how deep the needle is inserted, what is the diameter of the needle, and where the needle is inserted (acupoint or non-acupoint). This invention further relates to a safety needle and placebo needle suitably used as a member of the double-blind needle set. This invention further relates to a safety needle which does not cause any infection in the patient, the practitioner, and the disposer for used needles.
BACKGROUND ART
It is said that the most excellent and practical method among the methods for evaluating the therapeutic effect of acupuncture is a single-blind method in which only the subject is blinded. In the experiment based on the single-blind method, the control group receives placebo stimulation resembling a needle insertion on an acupoint while the experimental group receives stimulation with true needle insertion at the same acupoint; the results from the two groups are compared; and the therapeutic effect is evaluated.
The currently proposed methods for giving placebo stimulation includes the following three:
(1) To place a guide tube instead of a needle on a site of the skin, and tap the top end of the guide tube;
(2) To transform the tip of a needle into impenetrable to the skin, place the transformed tip on a site of the skin, and press the upper end of the needle (see, for example, The Lancet, vol. 352, Aug. 1998, pp. 364-365); and
(3) To place an electrode for percutaneous electrical stimulation on a site of the skin.
Methods (1), (2) and (3) are all employed in experiments based on the single-blind method. With methods (1) and (2), it is possible to completely make the subject unaware of whether the stimulation applied is by a true needle inserted or by a placebo needle pressed, as long as the experiment is properly conducted. This was indeed confirmed for method (2) (see, for example, The Lancet, vol. 352, Aug. 1, 1998, pp. 364-365). However, with method (3), it is hardly possible to mask the nature of stimulation from the subject, because the shape of device used for stimulation, sensation the subject felt induced by a stimulation, etc. are clearly different from those of true needle insertion.
However, with all the above methods aimed at giving placebo stimulation, it is impossible to make the practitioner unaware of the nature of stimulation, that is, the methods can not mask the practitioner whether he applied a true needle or a placebo needle. Namely, all the above methods are inadequate to serve as a placebo stimulation to be given to a control group. When the practitioner applies a needle to a subject, the practitioner feels, through his fingers and hands, the needle making a puncture on the skin, penetrating the skin, and advancing deep into the human body, or he is aware of the point at needling before needle application. Thus, it has been thought impossible to mask the nature of stimulation from the practitioner. Under such current situations, the Consensus Development Conference of US National Health Institute (NIH) concludes that, for the evaluation of acupuncture, it can not help adopting single-blind test because in acupuncture study it is possible to mask the nature of stimulation only from the subject (The Lancet, vol. 352, Sep. 19, 1998, p. 992).
However, because, with single-blind test, expectation or zeal of the practitioner during therapy is transmitted to the subject, a demand is manifest for double-blind method which can mask the nature of stimulation from the practitioner as well as from the subject, to scrutinize the effect of acupuncture.
The acupuncture therapy currently widely in use is based on the insertion technique using the guide tube. The therapy based on the insertion technique is executed with a needle and the guide tube separately prepared. The practitioner inserts the needle into a guide tube by one hand, and forms Oshide(the hand by which to hold the guide tube or the needle during the needle insertion or the needle removal) by placing the thumb and the index finger of the other hand being lightly in contact with each other on a site of the skin; and inserts the guide tube contained the needle between the pads of the thumb and the index finger of Oshide and holds the guide tube adjusting a needle insertion angle being preferable; and taps the top end of the needle handle with the pad of the index finger of Sashide(or the hand by which to insert or remove the needle) to open thereby a puncture on the skin(usually, the guide tube used for the insertion therapy has the length shorter by about 3-4 mm than the total length of the needle, and thus the needle is inserted by that difference into the human body by tapping with the pad of the index finger). After the puncture is opened, the guide tube alone is removed to leave the partly sticking needle on the site; the Oshide directly holds the needle body, and inserts it into the human body with the holding needle. When the needle reaches to a desired depth, the Oshide keeps holding the needle body, or leaves the needle to stand there for an arbitrary period (in-situ needle). Then, the Oshide is formed around the needle to extract it from the body. Immediately after removal, the used needle including its needle body and its tip is bare.
As seen above, during the insertion therapy with a guide tube, the guide tube and the needle body are separated. Thus, the Oshide directly contacts with the needle body when the practitioner inserts or removes the needle into or from the body. Accordingly, before insertion, the needle body may be contaminated through contact with the fingers and hands of the practitioner. Because, for removal, the needle uncovered with the guide tube is extracted from the patient's body, the practitioner's fingers and hands may be contaminated with the patient's body fluid through contact with the bare needle body and tip of the needle. The same risk persists even when the practitioner wears gloves during therapy.
The practitioner or the disposer who handles acupuncture needles may damage himself by accidental contact with a used needle with its bare needle body and its tip. Currently, at acupuncturist training schools and clinical centers used needles are disposed into a cylindrical trash case having a bottom diameter of 8 cm and a height of 17 cm. If the case becomes full, used needles are removed by hand and put into a cardboard box for medical waste. During disposal, when the practitioner put away used needles into a trash case, or when disposer transfers used needles from the trash case to a cardboard box, he may damage himself by accident. Indeed, there was reported such a case.
To prevent contamination in acupuncture therapy, a method is proposed in which the practitioner wears finger covers or operation gloves during therapy. However, this method poses a number of problems: wearing covers or gloves is a nuisance to the practitioner, and the practitioner's fingers and hands may contact with the contaminated surfaces of covers and gloves.
A variety of means to prevent infection during therapy, or during disposal of used needles have been proposed.
Recently, covering the needle body with a coat (Japanese Patent Laid-Open No. Sho 57-131446) and covering the lowest end of a needle with a tube sufficiently small to enter through the inner space of a guide tube (Japanese Patent Laid-Open No. Sho 57-177752) are proposed. With these methods, a needle body and a guide tube are separated from each other during therapy, and they are separately disposed of after therapy. Namely, when disposed of, both the needle body and its tip are bare, and thus these methods do not take into account the risk of a third person who may be exposed, after therapy, to contamination by touching such a needle body or a guide tube accidentally.
The first object of this invention
Calvert John J.
Hanada College: Japan School of Acupuncture, Moxibustion and Phy
Hurley Shaun R
Jordan and Hamburg LLP
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