JP2017086650A - Infusion needle and needle slip detecting system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a new technique for detecting a needle slip while reducing a burden of a patient who is having an infusion therapy.SOLUTION: An infusion needle includes: a tubular needle tube section 12 having an opened tip part; an infusion supplying part for supplying an infusion to be delivered to the needle tube section; and a pressure transmitting part from which a pressure of the tip is transmitted. The needle tube section 12 has a multi-tube structure having an outer tube 20 and a tubular non-flexible needle 16 provided so as to be movable back-forth inside the outer tube, and includes a first channel between the outer tube 20 and the non-flexible needle 16 and a second channel inside the non-flexible needle 16. The non-flexible needle 16 includes a piercing part 16a at a tip thereof, and configured to be movable between a first position where the piercing part 16a divides a tip of the needle tube section 12 and the first channel, and a second position where the piercing part 16a retracts inside the outer tube 20 from the first position so as to communicate a top of the needle tube section 12 and the first channel. An infusion supplying part communicates with one of the first channel and the second channel, and the pressure transmitting part communicates with the other of the first channel and the second channel.SELECTED DRAWING: Figure 4

Description

  The present invention relates to an infusion needle that punctures a patient's blood vessel and allows a drug solution or the like to pass through, and a needle drop detection system.

  As a method for injecting a drug solution into a patient's blood vessel, a method in which a catheter or an indwelling needle is placed in the blood vessel and the drug solution is injected from the tip is used. For example, in chemotherapy using an anticancer drug as a type of cancer treatment, a catheter or an indwelling needle is placed in a vein, and the anticancer drug (or a drug solution diluted with the anticancer drug) is placed in the blood vessel. It is administered (injected).

  However, some chemical solutions such as anticancer drugs damage not only cancer cells but also normal cells. When such a drug solution is administered, if the indwelling needle or the like is mistakenly removed from the blood vessel, the drug solution leaks into the body tissue outside the blood vessel. There was a risk of damage. Therefore, various methods for detecting that the indwelling needle has moved out of the blood vessel have been proposed.

  For example, in an indwelling needle having a double tube structure, a system has been devised to detect needle drop by transmitting the pressure at the tip portion to the pressure detection means via the annular space outside the double tube (Patent Document). 1).

Japanese Patent No. 5603915

  However, the infusion needle in the above-described detection system is configured by an elongated metal tube having a puncture portion formed at the tip of the needle tube portion, and the puncture portion remains in the body during the infusion, which places a heavy burden on the patient. .

  The present invention has been made in view of such circumstances, and an object of the present invention is to provide a new technique capable of detecting needle dropout while reducing the burden on the patient during infusion.

  In order to solve the above problems, an infusion needle according to an aspect of the present invention includes a tubular needle tube portion having an open end portion, an infusion supply portion to which an infusion solution to be delivered to the needle tube portion is supplied, and pressure at the end portion. A pressure transmitting unit. The needle tube portion has a multi-tube structure having an outer tube and a cylindrical inflexible needle disposed inside the outer tube so as to be able to advance and retreat, and between the outer tube and the inflexible needle. A first flow path and a second flow path inside the inflexible needle. The non-flexible needle has a puncture portion at the distal end, the puncture portion separates the distal end portion of the needle tube portion and the first flow path, and the puncture portion is an outer tube than the first position. And the second position where the tip end of the needle tube portion communicates with the first flow path is configured to be movable, and the infusion supply section is configured to move the first flow path and the second flow path. The pressure transmission unit communicates with the other of the first flow path and the second flow path.

  According to this aspect, by moving the non-flexible needle to the second position which is retracted inside the outer tube from the first position, the puncture portion is not placed in the patient's body during the infusion, and the burden on the patient. Is reduced. In addition, when the inflexible needle moves to the second position, the pressure at the tip of the needle tube portion can be transmitted to the pressure transmission portion via the first flow path or the second flow path.

  The outer tube is between the first inner peripheral surface that contacts the non-flexible needle in the first position and the outer peripheral surface of the non-flexible needle in the state that the non-flexible needle is in the second position. And a second inner peripheral surface on which the first flow path is formed. The second inner peripheral surface may be configured so that the outside of the outer tube does not communicate with the first flow path. Thereby, in a state where the inflexible needle is in the first position, the first flow path is partitioned in a liquid-tight manner, and a filler such as physiological saline can be filled as necessary. it can.

  The inner diameter of the first inner peripheral surface may be smaller than the inner diameter of the second inner peripheral surface. Thereby, even if it does not provide a level | step difference in the outer peripheral surface of an inflexible needle, only the puncture part moves between the 1st position and the 2nd position, and the tip part of the needle tube part and the 1st channel The separated state or the connected state can be switched.

  A retraction mechanism for retreating the non-flexible needle in the first position to the second position may be further provided. Thereby, an inflexible needle can be simply moved to a desired 2nd position.

  Another aspect of the present invention is a missing needle detection system. This system is connected to the infusion needle and the pressure transmission part of the infusion needle, and the inflexible needle is retracted to the second position, and is transmitted via the medium existing in the first channel or the second channel. And a detector for detecting the generated pressure. Thereby, it is possible to detect a change in pressure due to the infusion needle being removed from the patient or displaced from a predetermined position.

  It should be noted that any combination of the above-described constituent elements and a representation obtained by converting the expression of the present invention among methods, other apparatuses, systems, and the like are also effective as an aspect of the present invention.

  According to the present invention, it is possible to detect needle dropout while reducing the burden on the patient during infusion.

It is an external view of the infusion needle which concerns on 1st Embodiment. It is an expanded sectional view near the front-end | tip part of the infusion needle shown in FIG. It is an expanded sectional view of the base end vicinity of the infusion needle shown in FIG. FIG. 3 is an enlarged cross-sectional view of the vicinity of a distal end portion in a state where an inflexible needle is retracted from the infusion needle shown in FIG. 2. It is a mimetic diagram for explaining a needle omission detection system. It is an external view which shows the principal part of the retraction mechanism vicinity of the infusion needle which concerns on 2nd Embodiment. It is AA sectional drawing of the infusion needle shown in FIG.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and repeated descriptions are omitted as appropriate. Moreover, the structure described below is an illustration and does not limit the scope of the present invention at all.

(First embodiment)
[Infusion needle]
FIG. 1 is an external view of an infusion needle according to the first embodiment. FIG. 2 is an enlarged cross-sectional view of the vicinity of the distal end portion of the infusion needle shown in FIG. FIG. 3 is an enlarged cross-sectional view of the vicinity of the proximal end portion of the infusion needle shown in FIG.

  As shown in FIGS. 1 to 3, the infusion needle 10 according to the first embodiment includes a tubular needle tube portion 12 having an open front end portion and a needle tube base portion 14 that is thicker than the needle tube portion 12. . The needle tube portion 12 includes a non-flexible needle 16 having a puncture portion 16 a at the tip, and an outer tube 20 provided so as to surround the outer periphery of the non-flexible needle 16.

  The inflexible needle 16 according to the present embodiment is composed of an elongated cylindrical metal tube, but the material is not limited to metal as long as it has a rigidity and shape that can puncture a desired target. The outer tube 20 is formed of a cylindrical flexible tube (for example, a tube member made of polypropylene or polyethylene) that cannot be expanded or contracted and is difficult to expand or contract.

  The needle tube section 12 has a double (multiple) tube structure in which the inflexible needle 16 is inserted into the outer tube 20, and the outer tube 20 and the inflexible needle 16 are arranged on a concentric axis. Has been.

  The needle tube base portion 14 includes a base body 22 that is coaxially positioned with the needle tube portion 12, and a branch portion 24 branched from the base body 22. The base body 22 and the branch portion 24 are integrally formed. This is a y-shaped plastic member. The base main body 22 has a through hole 26 formed from the front end side 22a to the rear end side 22b. The through hole 26 is a round hole having a different diameter depending on a region.

  The rear end 16b of the non-flexible needle 16 is held by a needle base 28 that is a plastic cylindrical member. The needle base portion 28 is inserted and held in a concave portion 30 having a truncated cone shape provided on the rear end portion side 22 b of the base portion main body 22. In the present embodiment, the concave portion 30 corresponds to the insertion portion. Then, after the infusion needle 10 is punctured into the patient, the user grasps the needle base portion 28 and pulls it out, whereby the puncture portion 16a of the inflexible needle 16 is retracted from the opening of the needle tube portion 12 to a desired position.

  The outer tube 20 has an inner diameter and a shape into which the inflexible needle 16 can be inserted into the inner space. And the puncture part 16a of the inflexible needle 16 in the inserted state is in a state protruding from the distal end opening of the outer tube 20 (FIG. 2). Further, the outer tube 20 has a first inner peripheral surface 20b that contacts the outer peripheral surface 16d of the non-flexible needle 16 in a state where the non-flexible needle 16 is in the position (puncture position) shown in FIG.

  The outer tube 20 is fixed to the base body 22 with its rear end inserted into the through hole 26. In addition, the base body 22 is formed with an annular space 34 communicating with the space 32 of the branch portion 24. Further, as shown in FIG. 3, the end 32 a of the outer tube 20 is positioned on the distal end side of the annular space 34, so that the space 32 and the annular space 34 communicate with each other. A cylindrical space 35 is formed on the rear end side of the annular space 34, and a seal member 36 and a stopper 38 are fixed.

  The seal member 36 is for sealing between the annular space 34 and the recess 30, and for example, a seal member having elasticity made of synthetic rubber or silicon rubber is suitable. The stopper 38 is a cylindrical member disposed between the seal member 36 and the recess 30, and is fitted in the space 35 on the rear end side of the seal member 36. This prevents the seal member 36 from falling out of the space 35.

  The seal member 36 closes a space between the rear end portion of the annular space 34 and the recess 30 in a liquid-tight state by a first seal portion 36 a that is an outer peripheral portion of the seal member 36. The non-flexible needle 16 is held in close contact with the second seal portion 36b in a state in which it can move in the longitudinal direction of the base body 22.

  When the non-flexible needle 16 is inserted into the center of the seal member 36, the second seal portion 36b is brought into close contact with the outer peripheral surface of the non-flexible needle 16 by the elastic force to hold the non-flexible needle 16. In addition, liquid passage from the annular space 34 to the recess 30 is prevented. Note that the seal member 36 is configured so that the second seal portion 36b is in close contact with the outer peripheral surface of the non-flexible needle 16 by the elastic force even when the non-flexible needle 16 is retracted.

  Next, a method for using the infusion needle 10 will be described. When the infusion needle 10 is used, the inflexible needle 16 is inserted into the outer tube 20 in advance, and the puncture portion 16a is set to protrude from the outer tube 20 (the state shown in FIG. 2).

  In order to infuse a patient with a drug solution such as an anticancer drug using the infusion needle 10, the needle tip of the infusion needle 10 (specifically, the puncture portion 16a protruding from the distal end opening of the outer tube 20) is delivered to the patient. Puncture is performed until the distal end opening of the outer tube 20 reaches the blood vessel.

  At this time, a through-hole 16c serving as a flow path is formed inside the non-flexible needle 16, and the drug solution supplied from the drug solution bag via the tube 44 passes through the through-hole 16c from the tip of the needle tube section 12 to the patient. Infused into.

  Next, a situation where the puncture portion 16a of the inflexible needle 16 is retracted inside the outer tube 20 of the infusion needle 10 will be described. FIG. 4 is an enlarged cross-sectional view of the vicinity of the distal end portion in a state where the inflexible needle is retracted from the infusion needle shown in FIG.

  When the infusion needle 10 is punctured into the blood vessel and the distal end opening is exposed to the blood vessel, the non-flexible needle 16 at the puncture position (first position) is placed in the recess 30 of the base body 22 together with the needle base 28. Retract to a predetermined position. The outer tube 20 is located between the outer peripheral surface 16d of the non-flexible needle 16 and the second inner peripheral surface 20c in a state where the non-flexible needle 16 is in an infusion position (second position) that is retracted from the puncture position. An outer peripheral space 40 is formed at the bottom. The second inner peripheral surface 20c is configured so that the outside of the outer tube 20 and the outer peripheral space 40 do not communicate with each other. For example, the second inner peripheral surface 20c is not formed with a hole that communicates with the outside.

  That is, as shown in FIG. 3, a cylindrical outer peripheral space 40 is formed between the outer tube 20 and the non-flexible needle 16. The branch portion 24 of the needle tube base portion 14 is formed with a space 32 as a pressure transmission portion that communicates (connects) the outer peripheral space 40 to a pressure gauge (corresponding to a detection portion) described later.

  Further, the through-hole 16 c that is an internal space of the non-flexible needle 16 serves as a flow path through which a chemical solution or the like flows toward the tip of the needle tube portion 12. The through hole 16 c communicates with a tube 44 attached to the recess 30 as an infusion supply portion to which an infusion to be delivered to the needle tube portion 12 is supplied.

[Needle drop detection system]
Next, the needle drop detection system will be described by taking as an example a case where a liquid medicine is injected into the blood using the above-described infusion needle 10. FIG. 5 is a schematic diagram for explaining a needle drop detection system. The needle drop detection system 100 according to the present embodiment includes the above-described infusion needle 10, tube 44, drug solution bag 46, clamp 48, pressure gauge 50, control unit 52, pressure transmission tube 54, pressure monitor 56, and notification lamp 58. It has. Then, the pressure in the vicinity of the tip of the needle tube portion 12 is transmitted to the pressure gauge 50 via the pressure transmission media 60 and 62 in the outer peripheral space 40 and the space 32.

  The drug solution bag 46 is a container for storing a drug solution such as an anticancer drug. The tube 44 is flexible and has one end connected to the rear end side 22 b of the needle tube base 14 of the infusion needle 10 and the other end connected to the drug solution bag 46. Thereby, the chemical | medical solution in the chemical | medical solution bag 46 can be introduce | transduced in the blood vessel 64 through the tube 44 and the through-hole 16c. In addition, a drip tube 66 is provided in the middle of the tube 44 so that the flow of the chemical solution can be visually confirmed. Further, a clamp 48 is provided on the downstream side of the drip tube 66. The clamp 48 can press the tube 44 manually or in accordance with a signal from the control unit 52 to adjust the flow rate of the chemical solution or stop the flow of the chemical solution.

  The pressure gauge 50 is connected to the branch portion 24 of the infusion needle 10 using a pressure transmission tube 54 in which a pressure transmission medium (air in the present embodiment) is present, and the needle tube is connected by the pressure transmission medium 60, 62, 68. The pressure transmitted from the vicinity of the tip of the part 12 is measured. Further, the control unit 52 has a function of acquiring the pressure value measured by the pressure gauge 50, and also functions as a control unit that controls driving of the clamp 48, the pressure monitor 56, and the notification lamp 58. Further, the control unit 52 determines whether or not the tip of the needle tube unit 12 (outer tube 20) is located in the blood vessel 64 based on the pressure information measured by the pressure gauge 50, and the tip of the needle tube unit 12 is A drive signal is transmitted to the transmitter 69 when it is not located in the blood vessel 64.

  This drive signal is transmitted (transmitted) by the transmitter 69 and received by a receiver 70 installed at a location away from the infusion needle 10, such as a nurse station. And the notification lamp 58 installed in the same place as the receiver 70 lights up and warns according to this drive signal. The drive signal may be transmitted and received by connecting the transmitter 69 and the receiver 70 with a cable or the like, or the transmitter 69 and the receiver 70 may not be connected with a cable or the like. May be transmitted / received (that is, transmission / reception of the drive signal may be wired or wireless). Further, the control unit 52 controls the clamp 48 when the tip of the needle tube unit 12 is not located in the blood vessel 64 to stop the flow of the tube 44 so that the drug solution does not flow to the infusion needle 10 side. The pressure monitor 56 receives a signal from the control unit 52 and displays information on the pressure measured by the pressure gauge 50 at regular time intervals (for example, at intervals of 0.1 seconds).

  Next, injection of the chemical solution and detection of the needle tip position of the infusion needle 10 (particularly, needle omission detection) by the above-described needle omission detection system 100 will be described. First, the infusion needle 10 is punctured into the blood vessel 64 of the patient. One end of the tube 44 whose other end is connected to the chemical solution bag 46 is connected to the base body 22 in advance, and air in the tube 44 and the needle core side space 42 is excluded. And while inject | pouring the chemical | medical solution in the blood vessel 64, the measurement of the pressure transmitted through the infusion needle 10 is started.

  Here, when the outer tube 20 is placed in the blood vessel 64, the pressure in the blood vessel 64 is measured. However, when the outer tube 20 comes out of the blood vessel 64 and is located in a body tissue (for example, subcutaneous tissue) 72 other than the blood vessel 64, the pressure in the body tissue 72 is different from the pressure in the blood vessel 64. When it is detected and the outer tube 20 is completely removed from the body, the atmospheric pressure is detected. Thus, since the pressure detected by the pressure gauge 50 differs (changes) depending on the position of the outer tube 20, whether or not the outer tube 20 is positioned in the blood vessel 64 and the drug solution is normally injected. Can be judged. In other words, the pressure transmitted through the infusion needle 10 can be monitored, and the needle dropout of the infusion needle 10 can be detected by the change in the pressure.

  If the pressure measured by the pressure gauge 50 changes from the pressure in the blood vessel while the infusion needle 10 (outer tube 20) is placed in the blood vessel 64 and the chemical solution is injected, the outer tube 20 is The control unit 52 determines that it is not located in the blood vessel 64, and, for example, drives a notification lamp 58 installed in a nurse station or the like to notify the surroundings. At the same time, the clamp 48 is controlled to stop the flow of the tube 44 so that the drug solution does not flow to the infusion needle 10 side. Further, since the pressure detected by the pressure gauge 50 is displayed on the pressure monitor 56, it is easy to recognize that the pressure near the tip of the outer tube 20 has changed by checking the display on the pressure monitor 56. can do. Thereby, it can be easily determined that the outer tube 20 is not located in the blood vessel 64. The needle omission detection system 100 according to the present embodiment is not limited to determining needle omission based on the absolute value of pressure, and may determine needle omission based on a change in a pulsation pattern.

  Thus, since the infusion needle 10 can transmit the pressure near the tip of the outer tube 20 to the pressure gauge 50 by the pressure transmission media 60, 62, 68, the outer tube transmitted by the pressure transmission media 60, 62, 68. By detecting a change in pressure in the vicinity of the tip of 20, it is possible to accurately detect that the infusion needle 10 has detached from the blood vessel 64. Further, it is not necessary to separately provide a configuration such as a receiving unit outside the infusion needle 10, and the configuration can be simplified. Thereby, the manufacturing cost can be reduced.

  Furthermore, the needle tube portion 12 is configured by a double tube structure in which an inflexible needle 16 is provided in the outer tube 20. An outer peripheral space 40 that functions as a pressure transmission space is formed between the second inner peripheral surface 20 c of the outer tube 20 and the outer peripheral surface 16 d of the non-flexible needle 16. Since the through-hole 16c which functions as an infusion flow path is formed therein, the needle tube portion 12 can be realized with a simple structure.

  Further, since the needle drop detection system 100 includes the pressure monitor 56 that displays information on the pressure transmitted from the vicinity of the tip of the needle tube section 12 via the pressure transmission medium 60, 62, 68, the vicinity of the tip of the needle tube section 12. The change in pressure at can be easily recognized. Thereby, it can be easily detected that the infusion needle 10 is detached from the blood vessel 64. Furthermore, based on the pressure information transmitted from the infusion needle 10, a control unit 52 that determines whether or not the outer tube 20 is located in the blood vessel 64, and a case where the outer tube 20 is not located in the blood vessel 64 And a notification lamp 58 that notifies the user that the infusion needle 10 has detached from the blood vessel 64 can be detected more easily.

  In addition, the control unit 52 includes a transmitter 69 that transmits a signal when it is determined that the outer tube 20 is not located within the blood vessel 64, and a receiver 70 that receives a signal transmitted from the transmitter 69. Since the notification lamp 58 notifies the receiver 70 based on the signal received by the receiver 70, the notification lamp 58 can be installed in a place away from the patient in which the infusion needle 10 is placed, for example, a nurse station. Even if it is in place, it can be detected that the infusion needle 10 has been detached from the blood vessel 64. Further, when the control unit 52 determines that the outer tube 20 is not located in the blood vessel 64, the control unit 52 controls the clamp 48 to stop the infusion. Therefore, when the infusion needle 10 is removed from the blood vessel, the infusion is quickly performed. You can stop.

  In the needle drop detection system 100 according to the above-described embodiment, the flow of the tube 44 is controlled using the clamp 48. However, the present invention is not limited to this. For example, you may make it send a chemical | medical solution from the chemical | medical solution bag 46 to the infusion needle 10 side using an infusion pump. In this case, when the outer tube 20 is not located in the blood vessel 64, the control unit 52 controls (stops) the infusion pump or the like to stop the flow of the chemical solution in the tube 44. Moreover, although the example which inject | pours the chemical | medical solution from the chemical | medical solution bag 46 to the blood vessel was shown in the above-mentioned embodiment, it is not restricted to this. For example, when injecting blood from a blood transfusion bag into a blood vessel, the infusion needle and needle drop detection system according to the present embodiment can be used.

  Further, in the infusion needle 10 according to the above-described embodiment, the outer peripheral space 40 is a pressure transmission space and the through hole 16c is an infusion flow path. However, the present invention is not limited thereto, and the outer peripheral space 40 is an infusion flow path. The through hole 16c may be a pressure transmission space.

  Moreover, in the above-mentioned embodiment, although air was employ | adopted as a pressure transmission medium, it is not limited to this. In short, any material can be used as long as it can transmit the pressure at the tip of the needle tube, and any gas or liquid other than air (for example, physiological saline) can be used as long as it does not adversely affect the patient receiving the infusion. ) May be employed as a pressure transmission medium. In the case of liquid, the response of pressure transmission is improved.

  Next, the function and effect of the infusion needle according to the first embodiment described above will be described along the configuration of the first embodiment.

  The infusion needle 10 according to the first embodiment, a tubular needle tube portion 12 having an open tip, a recess 30 serving as an infusion supply portion to which an infusion to be delivered to the needle tube portion 12 is supplied, and the pressure at the tip are And a space 32 as a pressure transmission portion to be transmitted. The needle tube section 12 has a multi-tube structure having an outer tube 20 and a cylindrical inflexible needle 16 that is disposed in the outer tube 20 so as to be able to advance and retract. And the through-hole 16c as a second flow path inside the non-flexible needle 16. The non-flexible needle 16 has a puncture portion 16a at the tip, and the puncture portion 16a separates the tip portion of the needle tube portion 12 and the outer peripheral space 40 (puncture position), and the puncture portion 16a is the first. By moving backward inside the outer tube 20 rather than the position, it is configured to be movable between a second position (infusion position) where the distal end portion of the needle tube portion 12 communicates with the outer peripheral space 40. The recess 30 as an infusion supply part communicates with the through-hole 16c of the non-flexible needle 16, and the space 32 as a pressure transmission part communicates with the outer peripheral space 40.

  The infusion needle 10 having such a configuration moves the non-flexible needle 16 to the infusion position (see FIG. 4) which is retracted inside the outer tube 20 from the puncture position (see FIG. 2). The puncture portion 16a is not placed in the patient's body, and the burden on the patient is reduced. Further, when the non-flexible needle 16 moves to the infusion position, the pressure at the distal end portion of the needle tube portion 12 can be transmitted to the space 32 via the outer peripheral space 40.

  The outer tube 20 includes a first inner peripheral surface 20b that contacts the non-flexible needle 16 in the puncture position, and an outer peripheral surface of the non-flexible needle 16 in the state where the non-flexible needle 16 is in the infusion position. And a second inner peripheral surface 20c on which an outer peripheral space 40 is formed. The second inner peripheral surface 20c is configured so that the outside of the outer tube 20 and the outer peripheral space 40 do not communicate with each other. Thereby, in a state where the inflexible needle 16 is in the puncture position, the outer peripheral space 40 is partitioned in a liquid-tight manner, and a filler such as physiological saline is filled when necessary when the infusion needle 10 is used. Can be kept.

  Further, as shown in FIG. 4, the inner diameter R1 of the first inner peripheral surface 20b, which is a region near the tip of the outer tube 20, is smaller than the inner diameter R2 of the second inner peripheral surface 20c. As a result, even if the step 16d is not provided on the outer peripheral surface 16d of the non-flexible needle 16, the tip of the needle tube portion 12 and the outer peripheral space 40 are simply moved by moving the puncture portion 16a between the puncture position and the infusion position. Can be switched between a separated state and a connected state.

  When the inflexible needle 16 is in the infusion position in the needle tube portion 12 according to the present embodiment, the dimension G1 of the gap formed between the step portion of the outer tube 20 and the inflexible needle 16 is 1 About 2 mm is preferable.

  In addition, when the non-flexible needle 16 is moved to the infusion position, the needle tube portion 12 according to the present embodiment is configured such that a part (tip portion) of the puncture portion 16a is the first inner peripheral surface 20b of the outer tube 20. Is in contact with. Thereby, it is possible to prevent an unstable state in which the inflexible needle 16 at the infusion position is tilted or wobbled inside the outer tube 20.

  In addition, a preferable dimension and structure as the above-mentioned infusion needle are as follows. When the metallic inflexible needle 16 is used as the inner needle, it is preferably 22 gauge (outer diameter 0.71 mm, inner diameter 0.41 mm) to 24 gauge (outer diameter 0.55 mm, inner diameter 0.30 mm). Further, when the outer tube 20 is used as the outer needle, it is preferably equivalent to 18 gauge (outer diameter of about 1.26 mm) to 20 gauge (outer diameter of about 0.88 mm). The inner diameter R1 of the first inner peripheral surface 20b of the outer tube 20 is such that there is a slight gap that allows the non-flexible needle 16 to slide with the first inner peripheral surface 20b. Slightly larger than the outer diameter. Further, the inner diameter R2 of the second inner peripheral surface 20c of the outer tube 20 is set to such a size that an outer peripheral space 40 is formed between the outer diameter of the non-flexible needle 16 and this outer peripheral space. 40 functions as a pressure transmission part.

  Further, the needle dropout detection system 100 according to the first embodiment is connected to the infusion needle 10 and the space 32 of the branch portion 24 of the infusion needle 10, and the inflexible needle 16 is retracted to the infusion position. And a pressure gauge 50 for detecting the pressure transmitted through the medium existing in the outer peripheral space 40. Thereby, a change in pressure due to the infusion needle 10 being removed from the patient or displaced from a predetermined position can be detected.

(Second Embodiment)
[Infusion needle]
FIG. 6 is an external view showing a main part in the vicinity of the retracting mechanism of the infusion needle according to the second embodiment. 7 is a cross-sectional view taken along the line AA of the infusion needle shown in FIG. In addition, since the needle tube part of the infusion needle according to the second embodiment has the same configuration as the needle tube part 12 of the infusion needle 10 according to the first embodiment, description thereof will be omitted.

  The infusion needle 110 according to the present embodiment differs from the infusion needle 10 according to the first embodiment in the mechanism for retracting the inflexible needle 16. Below, the same code | symbol is attached | subjected to the structure similar to the infusion needle 10 which concerns on 1st Embodiment, and description is abbreviate | omitted suitably.

  As shown in FIGS. 6 and 7, the infusion needle 110 includes a retracting mechanism 120 that retracts the non-flexible needle 16 at the puncture position (first position) to the infusion position (infusion position). Thereby, the non-flexible needle 16 can be easily moved to the desired second position.

  A cylindrical protruding piece base 122 made of a soft material such as an elastomer is provided on the outer peripheral portion of the distal end side 22 a of the base body 22. On the outer peripheral portion of the protruding piece base 122, a flat protruding piece (needle fixing wing) 124 is provided so as to protrude toward both sides of the infusion needle 110. Then, the infusion needle 110 is fixed to the patient by bonding the protruding piece 124 and the patient's arm with an adhesive tape or the like.

  The infusion needle 110 according to the present embodiment is shown in FIG. 2 when the inflexible needle 16 is sufficiently advanced toward the distal end side of the needle tube portion 12 in a state where the inflexible needle 16 is inserted into the outer tube 20. As described above, the non-flexible needle 16 moves to the puncture position with both ends held by the seal member 126 and the first inner peripheral surface 20b of the outer tube 20, and the puncture portion 16a protrudes from the outer tube 20, The needle tip of the needle 110 can be punctured into the blood vessel. Further, when the needle base 28 is pulled out from the state where the non-flexible needle 16 is located at the puncture position, the non-flexible needle 16 is brought into contact with the protruding piece 124 and the first inner peripheral surface of the outer tube 20 as shown in FIG. The puncture part 16a is accommodated in the outer tube 20 by moving to the infusion position with both ends held by 20b. The retraction mechanism 120 according to the present embodiment can easily and accurately move between the puncture position and the infusion position.

  The retracting mechanism 120 is provided with an urging member 128 such as a coil spring provided between the base body 22 and the needle base 28. The biasing member 128 biases the non-flexible needle 16 in the direction of moving from the puncture position to the infusion position. The biasing member 128 is a member arranged in a state of being biased in the columnar space 130 at the rear portion of the base main body 22, and as shown in FIG. 7, one end 128 a of the biasing member is attached to the base main body 22. The sealing member 126 is in contact with the end surface 126 a on the columnar space 130 side, and the other end 128 b of the biasing member is in contact with the end surface 28 a of the needle base 28. Thereby, the urging member 128 urges the needle base 28 to which the non-flexible needle 16 is fixed in a direction to move from the puncture position to the infusion position.

  The retraction mechanism 120 is opposite to the protruding piece 124 of the infusion needle 110 across the non-flexible needle 16 (in other words, opposite to the side facing the arm when the infusion needle 110 is fixed to the arm with an adhesive tape. Is located on the side). As shown in FIGS. 6 and 7, the retraction mechanism 120 includes a locked portion 132 provided on the needle base portion 28 and a puncture position mechanism provided on the base body 22 that can lock the locked portion 132. Locking release capable of releasing the locking between the locking part 134 and the infusion position locking part 136 and the locked part 132 and the puncture position locking part 134 or the infusion position locking part 136 provided in the base body 22 And an operation member 138.

  More specifically, a support arm portion 140 that supports the locked portion 132 in a cantilever state is provided on the outer peripheral portion of the needle base portion 28. The support arm portion 140 is configured to be swingable inside the columnar space 130. The locked portion 132 is a circular protrusion (for example, a circular protrusion having a diameter of 3 to 4 mm) that is sufficiently smaller than a human fingertip.

  Two circular through holes arranged along the moving direction of the inflexible needle 16 are formed on the outer peripheral portion of the base main body 22, and the outside of the base main body 22 communicates with the columnar space 130. Yes. The puncture position locking part 134 is a through hole located on the outer tube 20 side (left side in FIGS. 6 and 7), and the infusion position locking part 136 is on the open side of the columnar space 130 (in FIGS. 6 and 7). It is a through hole located on the right side. The opening dimensions of the puncture position locking part 134 and the infusion position locking part 136 are set to dimensions that are slightly larger than the protrusions of the locked part 132 but are inaccessible to human fingers.

  Furthermore, the penetration (depth) dimension of the puncture position locking part 134 and the infusion position locking part 136 has such a dimension that the locked part 132 does not protrude outside. With these settings, a person's fingertip may inadvertently touch the locked portion 132 locked to the puncture position locking portion 134 or the infusion position locking portion 136, and the engagement of the locked portion 132. It is configured to prevent inconvenience that the stop state is inadvertently released.

  Further, as shown in FIG. 7, the unlocking operation member 138 is cantilevered at the end of the protruding piece base 122 fitted to the tip end side 22 a of the base body 22 on the side opposite to the tip end side 22 a. It is provided in a supported state. The unlocking operation member 138 is placed at the puncture position at a position (specifically, a position facing the puncture position locking portion 134) of the swingable free end facing the outer peripheral surface of the base body 22. An operation protrusion 138 a that can enter the stopper 134 but cannot enter the infusion position locking portion 136 is provided.

  Then, if the locking release operation member 138 is bent toward the puncture position locking portion 134, the locked portion 132 (the dotted line position in FIG. 7) locked by the puncture position locking portion 134 is operated as an operation protrusion. It is comprised so that it can press from the outer side of the base main body 22 by 138a. The unlocking operation member 138 and the support arm 140 are preferably formed of a material that is more flexible than the needle base 28 or the base body 22 (for example, a soft material such as an elastomer or a soft vinyl chloride resin). .

  Next, a method for using the infusion needle 110 will be described. In order to infuse a drug or the like into a patient using the infusion needle 110, the locked portion 132 is locked in advance to the puncture position locking portion 134 and the non-flexible needle 16 is disposed at the protruding position. The infusion needle 110 has a tip (specifically, a puncture projecting from the outer tube 20 in a state where the non-flexible needle 16 is held by the seal member 126 and the first inner peripheral surface 20b of the outer tube 20 at the projecting position. Puncture part 16a) towards the patient's blood vessel. By inserting until the outer tube 20 reaches the inside of the blood vessel, the inside of the blood vessel and the through hole 16c of the inflexible needle 16 communicate with each other.

  When the infusion needle 110 is punctured into the blood vessel, the unlocking operation member 138 of the retracting mechanism 120 is pressed toward the locked portion 132. Then, the locked portion 132 moves to the columnar space 130 side by the pressing force received from the operation protrusion 138a of the lock release operation member 138, and is disengaged from the puncture position locking portion 134, and the support arm portion 140 is moved to the needle base portion 28. Bend to the side. Furthermore, the movement of the needle base 28 and the non-flexible needle 16 is allowed by releasing the locking of the locked portion 132 and the puncture position locking portion 134, and the needle base 28 and the non-flexible needle 16 are allowed to move. Is moved from the puncture position to the infusion position by the urging force of the urging member 128, and the puncture portion 16 a is stored in the outer tube 20.

  And the to-be-latched part 132 which moved to the position which opposes the infusion position latching | locking part 136 is the infusion position latching | locking part 136 by the restoring force of the support arm part 140 of a bending state, as shown by the continuous line in FIG. It enters into the through hole and is locked. As a result, the needle base 28 and the non-flexible needle 16 are reliably and accurately fixed at the infusion position. When the non-flexible needle 16 is fixed at the infusion position in this manner, the non-flexible needle 16 can be utilized as a part of the infusion route without removing the non-flexible needle 16 after puncturing the blood vessel. It is not necessary to provide a member that is used only for puncture to a member separately from a member that is used for infusion.

  Further, the infusion needle 110 having a double lumen structure in which the needle tip does not become too thick can be realized, and the inconvenience associated with severe pain at the time of puncturing the blood vessel can be suppressed. In addition, since there is no need to remove the non-flexible needle 16 from the outer tube 20, there is no possibility that the puncture portion 16a is accidentally stuck into an operator (an operator who prepares an infusion). Furthermore, by moving the non-flexible needle 16 to the infusion position, the puncture portion 16a can be prevented from being exposed in the blood vessel, and the puncture portion 16a can inadvertently damage the blood vessel during the placement of the infusion needle 110. Inconvenience can be avoided.

  As described above, the present invention has been described with reference to each of the above-described embodiments, but the present invention is not limited to each of the above-described embodiments, and the configuration of the embodiments is appropriately combined or replaced. Are also included in the present invention. Further, it is possible to appropriately change the combination and processing order in each embodiment based on the knowledge of those skilled in the art and to add various modifications such as various design changes to each embodiment. Embodiments to which is added can also be included in the scope of the present invention.

  DESCRIPTION OF SYMBOLS 10 Infusion needle, 12 Needle tube part, 14 Needle tube base, 16 Inflexible needle, 16a Puncture part, 16b Rear end, 16c Through-hole, 16d Outer peripheral surface, 20 Outer tube, 20b First inner peripheral surface, 20c Second inner Peripheral surface, 22 base body, 22a tip end side, 22b rear end side, 24 branching portion, 26 through hole, 28 needle base, 30 recess, 32 space, 34 annular space, 35 space, 36 seal member, 36a first Seal part, 36b 2nd seal part, 38 stopper, 40 outer peripheral space, 42 needle core side space, 44 tube, 50 pressure gauge, 52 control part, 54 pressure transmission tube, 64 blood vessel, 100 detection system, 110 infusion needle, 120 Retraction mechanism, 122 protruding piece base, 124 protruding piece, 126 seal member, 126a end face, 128 urging member, 128a one end, 128b other end, 130 columnar space, 132 locked portion, 134 puncture position locking portion, 136 infusion position locking portion, 138 unlocking operation member, 138a operation protrusion, 140 support arm Department.

Claims (5)

A tubular needle tube with an open end;
An infusion supply section to which an infusion to be delivered to the needle tube section is supplied;
A pressure transmission part to which the pressure of the tip part is transmitted,
The needle tube portion is
A multi-tube structure having an outer tube and a cylindrical inflexible needle disposed inside the outer tube so as to be capable of advancing and retracting, wherein a first tube between the outer tube and the inflexible needle 1 flow path and a second flow path inside the inflexible needle,
The non-flexible needle has a puncture portion at a distal end, the puncture portion separates the distal end portion of the needle tube portion and the first flow path, and the puncture portion is closer to the first position. Is configured to be movable in a second position where the tip of the needle tube portion communicates with the first flow path by retreating the inside of the outer tube,
The infusion supply section is in communication with one of the first flow path and the second flow path;
The pressure transmission unit communicates with the other of the first flow path and the second flow path.
An infusion needle characterized by that. The outer tube includes a first inner peripheral surface that is in contact with the inflexible needle in the first position, and an inflexible needle in the state in which the inflexible needle is in the second position. A second inner peripheral surface on which the first flow path is formed between the outer peripheral surface,
2. The infusion needle according to claim 1, wherein the second inner peripheral surface is configured so that the outside of the outer tube does not communicate with the first flow path.   The infusion needle according to claim 2, wherein an inner diameter of the first inner peripheral surface is smaller than an inner diameter of the second inner peripheral surface.   The infusion needle according to any one of claims 1 to 3, further comprising a retraction mechanism that retreats the inflexible needle in the first position to the second position. The infusion needle according to any one of claims 1 to 4,
Connected to the pressure transmission part of the infusion needle, the inflexible needle is transmitted through the medium existing in the first flow path or the second flow path in a state of being retracted to the second position. A detector for detecting pressure;
A needle missing detection system characterized by comprising:

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