Safety indwelling needle

Details Safety indwelling needle Safety indwelling needle

2002-03-29

2003-09-09

Kennedy, Sharon (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

Reexamination Certificate

active

06616631

ABSTRACT:

TECHNICAL FIELD
The present invention relates to a safety indwelling needle comprised of a soft outer needle to be inserted and placed within a blood vessel and a hard inner needle which is fitted in the outer needle and pierces the skin of a patient to introduce the outer needle into a blood vessel.
BACKGROUND ART
As a known method for infusing a medical fluid or the like into a patient, an outer needle (catheter) is inserted and placed in the human body to infuse the fluid through this outer needle. As a device for guiding the outer needle, indwelling needles have been known to insert and place the outer needle using the inner needle fitted in the outer needle.
The inner needle is discarded after placement of the outer needle in the human body, but it takes a certain time before the inner needle is discarded. Therefore, if an indwelling needle has no safety mechanism there is a risk of pricking the fingers etc. of health care workers by the inner needle during this period or a so-called needlestick accident occurring. If the patient is infected with the HIV virus or the like, there is a risk that the health care worker might catch the virus or the like from a needlestick accident.
In order to solve this problem, many types of safety indwelling needles which avoid needlestick injuries by covering the inner needle immediately after use have been developed. For example, Japanese Patent Application Laid-Open Hei 3 No.15481 offers a cannula inserting device for retracting a needle hub, which might cause a needlestick, into a hollow handle by means of an urging means.
Alternatively, Japanese Patent Application Laid-Open No.2000-167051, Japanese Patent Application Laid-Open No.2000-185096 etc. present technologies relating to a safety indwelling needle (puncture device) having a retracting mechanism for retracting the inner needle immediately after use into the holder sleeve. These technologies present techniques whereby the inner needle is retracted by means of an urging means when an actuating element is operated in a peripheral direction of the holder sleeve so that the actuating element is fixed to a cutout formed in the holder sleeve.
However, since the device disclosed in Japanese Patent Application Laid-Open 3 No.15481 is constructed so that the mechanism will be released by pressing an element corresponding to a trigger inwardly from the outside of the holder cylinder, this configuration frequently causes wrong actuation such that the trigger is pressed erroneously and the inner needle is retracted when it shouldn't.
On the other hand, the safety indwelling needles disclosed in Japanese Patent Application Laid-Open No.2000-167051, Japanese Patent Application Laid-Open No.2000-185096 etc., are free from the problem of the wrong actuation due to unintended pressing, but these configurations need an actuation in the peripheral direction of the holder sleeve after retraction of the inner needle. Therefore, there is the problem with the devices which causes difficulties in handling, depending on the left or right handedness. In order to solve this problem, two types of products for left and right handedness need to be prepared, which increases in the cost of manufacture and management, and also forces the users to select one from these two types.
The present invention has been devised under the above circumstances, it is therefore an object of the present invention to provide a technology for a safety indwelling needle which is almost never erroneously actuated and free from the problem of the actuation depending on the handedness.
DISCLOSURE OF INVENTION
In order to attain the above object, the present application provides the invention having the following configurations.
The present invention is directed to a safety indwelling needle, comprised of a soft outer needle to be inserted and placed within a blood vessel, a hard inner needle, with an inner needle hub, which is fitted in the outer needle, pierces the skin of a patient to introduce the outer needle into the blood vessel and a holder sleeve having an open distal end and a closed proximal end and capable of holding the inner needle, characterized in that: the holder sleeve incorporates an urging means f or urging the inner needle toward the proximal end side and an actuator which engages the inner needle at a near distal end portion of the holder sleeve so that the inner needle can be released and a tip of the inner needle is projected from the holder sleeve; the actuator has an inner needle hub fixed at a front end thereof and is formed with an actuating member projected outside the holder sleeve; the holder sleeve has a slit which extends to the proximal end side of the sleeve so as to hold and allow the actuating member of the actuator to slide and assures the path of movement of the actuator released from the near distal end portion of the holder sleeve; and the inner needle is adapted to be released from the holder sleeve when the actuating member is moved away from the holder sleeve within a same plane that includes the axis of the holder sleeve.
The inner needle (
12
) is a hard needle provided with an inner needle hub (
12
a
) at the proximal end thereof. It is usually a metal, mostly made of stainless steel. The tip of the inner needle (
12
) is beveled in order to facilitate puncture.
The outer needle (
11
) is placed into the human body after puncture and usually formed of a flexible resin.
The holder sleeve (
1
) is usually formed of a translucent resin or the like. When the inner needle (
12
) is punctured into the human body, the blood passes through the inner needle (
12
) and reaches the inner needle hub (
12
a
). Formation of these portions with a translucent material allows for confirmation of the blood reaching the inner needle hub (
12
a
), hence makes possible visual recognition that the inner needle (
12
) has reached a blood vessel.
The inner diameter of the holder sleeve (
1
) is set greater than the inner needle hub (
12
a
) and set smaller than the proximal part of the outer needle (
11
) or the outer needle hub (
11
a
), so that the inner needle (
12
) can be retracted thereinto but the outer needle (
11
) will not be retracted.
The holder sleeve (
1
) incorporates an actuator (
6
) which engages an inner needle (
12
) at the near distal end portion of the holder sleeve (
1
) so that the inner needle (
12
) can be released and the tip of the inner needle is projected from the holder sleeve (
1
). An inner needle hub (
12
a
) is fixed to this actuator (
6
). An actuating member (
6
a
) is formed so as to project outside the holder sleeve (
6
). The holder sleeve (
1
) has a slit (
2
) which extends toward the proximal end side so as to hold and allow this actuating member (
6
a
) to slide and assures the path of movement of the actuator (
6
) released from the near distal end portion of the holder sleeve (
1
).
As the urging means, string-like rubber (not shown), etc., may be employed other than a coil spring (
8
) which contracts when no load is applied.
The movement path of actuation is adapted to be included in the same plane that includes the axis of the holder sleeve (
1
). Hence, the problem due to the handedness can be eliminated, differing the case where the actuation is made by the rotational movement about the axis of holder sleeve
In the position in which the inner needle (
12
) is fixed by the actuator (
6
) at the near distal end portion of the holder sleeve (
1
) so that the inner needle (
12
) can be released and the needle tip is projected from the holder sleeve (
1
), the inner needle (
12
) and outer needle (
11
) are punctured into the skin of a patient. When the inner needle (
12
) and outer needle (
11
) have reached a blood vessel, the flow of blood through the blood vessel is stopped by hand while the holder sleeve (
1
) on another hand is pulled away from the patient so as to withdraw the inner needle (
12
) from the blood vessel. Then the actuating member (
6
a
) of actuator (
6
) is operated so as to release the actuator (
6
) from the near distal end portion of

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