JP5481246B2 - Extravasation detection device and infusion device - Google Patents

Description

  The present invention relates to an extravasation detecting device and an infusion device for detecting that a catheter for indwelling in a blood vessel is detached from a blood vessel and a drug solution leaks into a subcutaneous tissue.

  The catheter for indwelling in blood vessels is used for treatments such as injecting a drug solution into blood vessels by instillation by placing a distal end opening in the blood vessel. An example of the structure of an intravascular placement catheter is described in Patent Document 1, and the distal end of the intravascular placement catheter is placed in the blood vessel, so that the drug solution is administered from the drug solution bag through the catheter into the blood vessel. .

  By the way, there is chemotherapy with an anticancer agent as a kind of cancer treatment. As chemotherapy using an anticancer agent, there is a method in which a catheter is placed in a blood vessel of a vein and a drug solution obtained by diluting the anticancer agent with an infusion is administered into the blood vessel.

JP 2003-720 A

  However, when this type of drug solution is administered, if the drug solution is accidentally leaked into the subcutaneous tissue outside the blood vessel, leaving the leaked drug solution will cause irreversible damage to the tissue. there is a possibility.

  In general, whether or not a drug solution is being administered into the blood vessel during the administration of the drug solution is judged by the medical staff, or the fact that the drug solution is not accurately administered into the blood vessel is caused by extravasation by the patient himself / herself It can only be found when pain is noticed and complains, or when apparent redness or swelling of the skin is apparent. Therefore, it is desirable to easily and surely detect that the distal end opening of the catheter is detached from the blood vessel and leaks into the tissue, and to prevent the chemical liquid from leaking out of the blood vessel as much as possible. It is rare. Therefore, in order to solve the above problems, the present invention provides an extravasation detection device that can easily and surely detect that the distal end opening of a catheter placed in a blood vessel is detached from the blood vessel and the drug solution leaks into the tissue. And an infusion device.

In the extravasation detection device of the present invention, the distal end opening is left in the blood vessel, the medicinal solution line portion through which the medicinal solution passes, and the medicinal solution line portion are completely separated, and a part of the blood in the blood vessel is removed. An intravascular placement catheter having a blood detection line portion for guiding, a light emitting portion disposed corresponding to the blood detection line portion of the intravascular placement catheter, and for applying light to the blood detection line portion; A light receiving unit that receives the light applied to the blood detection line unit and generates a light reception signal; and when the behavior of the blood is detected in the blood detection line unit based on the light reception signal of the light reception unit, When it is determined that the distal end opening of the intravascular placement catheter is placed in the blood vessel, and the behavior of the blood is not detected in the blood detection line portion, the distal end opening of the intravascular placement catheter Characterized in that it comprises a control unit to determine that the chemical out from the vessel is leaking out of the blood vessel.
According to the said structure, it can detect easily and reliably that the catheter indwelled in the blood vessel remove | deviates from a blood vessel, and a chemical | medical solution leaks into a structure | tissue.

Preferably, the blood detection line portion is formed in parallel to the axial direction of the intravascular indwelling catheter from the distal end opening of the intravascular indwelling catheter into the thick portion of the intravascular indwelling catheter. It is characterized by being a hollow part.
According to the above configuration, if the distal end opening of the intravascular catheter is located in the blood vessel, the control unit performs the blood behavior along the blood detection line unit based on the light reception signal from the detection unit. Can be reliably detected.

Preferably, the detection unit includes a holding unit disposed on an outer peripheral surface of the intravascular placement catheter, and the holding unit sandwiches the light emitting unit and the light receiving unit with the intravascular placement catheter interposed therebetween. It is characterized by being held facing each other.
According to the above configuration, the light emitting unit and the light receiving unit can be reliably held by the holding unit with respect to the intravascular catheter.
Preferably, the light receiving unit includes a plurality of light receiving elements arranged along an axial direction of the intravascular placement catheter.
According to the above configuration, the plurality of light receiving elements of the light receiving unit receive light from the light emitting unit, so that the control unit can change the behavior of blood generated along the blood detection line unit based on the light reception signal from the detection unit. Can be detected.

  According to the present invention, it is possible to provide an extravasation detection device and an infusion device that can easily and surely detect that a distal end portion of a catheter placed in a blood vessel is detached from the blood vessel and the drug solution leaks into the tissue. it can.

It is a block diagram which shows Embodiment 1 of the extravasation detection apparatus of this invention. It is a side view which has a partial cross section which shows the example of an internal structure of the vicinity of the front-end | tip of the catheter for in-vessel indwelling. It is a side view which has a partial cross section which shows the example of an internal structure of the detection part of the catheter for indwelling blood vessels shown in FIG. It is a perspective view which shows the vicinity of the front-end | tip of a catheter. It is a flowchart which shows the operation example of the extravasation detection apparatus of FIG.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings.
(Embodiment 1)
FIG. 1 is a block diagram showing Embodiment 1 of the extravasation detection apparatus of the present invention.
In the extravasation detection apparatus 1 shown in FIG. 1, the distal end 5B of an intravascular indwelling catheter (hereinafter simply referred to as a catheter) 5 of an intravascular indwelling catheter assembly 2 is placed in a blood vessel (vein) 100. . In FIG. 1, the drug solution W in the drug solution bag 200 is fed into the blood vessel 100 of the patient's vein through the drip tube 3, the flexible tube 4 and the catheter 5. An arrow H in the blood vessel 100 indicates blood flow. The patient's blood vessel 100 is in the skin 101, and the distal opening 5 </ b> B of the catheter 5 is placed in the blood vessel 100 through the skin 101.

  As shown in FIG. 1, the extravasation detection device 1 includes an indwelling catheter assembly 2 including a detection unit 10, a control unit 11, an output unit 12, a notification unit 13, and a communication unit 14. . The notification unit 13 is a buzzer for notifying a medical worker or the like with a sound according to a signal generated by the output unit 12 according to a command from the control unit 11. In response to a signal generated by the output unit 12 in response to a command from the control unit 11, the communication unit 14 wirelessly transmits, for example, a remote station to the nurse station 15, which is an alarm notification target. An alarm “notice” is announced.

2 and 3 show an example of the structure of the catheter 5, and FIG. 2 is a side view having a partial cross section showing an example of the internal structure in the vicinity of the distal end opening 5B of the catheter 5. FIG. FIG. 3 is a side view having a partial cross section showing an example of the internal structure of the detection unit 10 of the catheter 5 shown in FIG. FIG. 4 is a perspective view showing the vicinity of the distal end opening 5 </ b> B of the catheter 5.
The catheter 5 shown in FIGS. 2 to 4 is made of, for example, a transparent thermoplastic resin material, and has the same inner diameter along the axial direction L thereof. The distal end opening 5 </ b> B of the catheter 5 is formed obliquely in a direction that intersects the axial direction L of the catheter 5.

As shown in FIGS. 2 to 4, the catheter 5 has a drug solution line portion 29 and, for example, preferably four blood detection line portions 20. The drug solution line portion 29 is a hollow portion formed continuously along the axial direction L of the catheter 5 and plays a role of guiding the drug solution W from the drug solution bag 200 and feeding it into the blood vessel 100. The four blood detection line parts 20 are formed separately from the chemical liquid line part 29.
In the present embodiment, the blood detection line unit 20 has a length of about 5 to 10 cm in consideration of venous pressure, and is isolated from the drug solution line unit within the thickness of the catheter 5 outside the drug solution line unit 29. The catheter 5 having a substantially circular cross section is formed every 90 degrees along the circumferential direction and parallel to the axial direction L of the catheter 5. Each blood detection line unit 20 is a long hole having a circular cross section and formed along the axial direction L. The first end 21 of each blood detection line unit 20 reaches the distal end opening 5B of the catheter 5, and the second end 22 of the blood detection line unit 20 is provided with a variable capacitance unit F so as to be a closed end. It has become. The variable capacity part F is formed of a balloon or the like and functions to adjust the internal volume with respect to the blood entering the blood detection line part 20.

  An inner surface 5D of the catheter 5 shown in FIG. 2 forms a chemical liquid line portion 29 for the chemical liquid W. As shown in FIG. 1, after being guided into the blood vessel 100 by a puncture needle (not shown) constituting the intravascular placement catheter assembly 2 by a known technique, the distal end opening 5B is opened after the puncture needle is removed. In a state where the blood detection line unit 20 is indwelled in the blood vessel 100, each blood detection line unit 20 guides a part of blood in the blood flow H, and the blood passes through the blood detection line unit 20 due to blood surface behavior, that is, blood pulsation. A blood operation monitor line is formed for monitoring the movement up and down along the axial direction L.

As shown in FIGS. 2 and 3, the detection unit 10 is fixed at a position in the middle of the outer peripheral surface of the catheter 5. The detection unit 10 includes a cylindrical holding unit 30, a light emitting unit 31, and a light receiving unit 32. The holding unit 30 is disposed so as to be in close contact with the outer peripheral surface 5 </ b> C of the catheter 5. The holding unit 30 is made of, for example, a plastic material, and a black light shielding film is preferably formed on the outer peripheral surface of the holding unit 30 in order to prevent ambient light from entering the holding unit 30.
As shown in FIG. 3, a light emitting unit 31 is disposed in the recess 30 </ b> R inside the holding unit 30. Similarly, the light receiving unit 32 is disposed in the recess 30 </ b> T inside the holding unit 30. The concave portion 30R and the concave portion 30T are arranged opposite to each other at an angle of 180 degrees with the catheter 5 interposed therebetween. The formation length of the recess 30T in the axial direction L is longer than the formation length of the recess 30R in the axial direction L.

  For example, a light emitting diode or a semiconductor laser can be used for the light emitting unit 31 shown in FIG. The light receiving unit 32 includes a plurality of light receiving elements 41 to 47. The light receiving elements 41 to 47 are arranged at the same interval along the axial direction L, and the light receiving elements 41 to 47 are, for example, photodiode arrays. In the example of FIG. 3, the light emitting unit 31 faces the light receiving element 44 at the center of the light receiving elements 41 to 47 so that the light LT generated by the light emitting unit 31 can be received by each of the light receiving elements 41 to 47. It is arranged at the position to do.

The light emitting unit 31 shown in FIG. 3 generates light LT by a drive signal from the control unit 11. The light LT can be received by the light receiving elements 41 to 47. When the light receiving elements 41 to 47 receive the light LT, a light reception signal is transmitted to the control unit 11. In the region where the light receiving elements 41 to 47 are arranged, the blood detection line unit 20 already described is formed.
Compared to the case where the light LT of the light emitting unit 31 is received by the light receiving elements 41 to 47 in a state where the blood is not guided into the blood detection line unit 20, the state where the blood is guided into the blood detection line unit 20 When the light LT of the light emitting unit 31 is received by the light receiving elements 41 to 47, the light LT is attenuated by this blood, so that the amount of light L received by the light receiving elements 41 to 47 decreases.

In addition, when blood is guided into the blood detection line unit 20 and the movement of the blood moves up and down along the axial direction L in the blood detection line unit 20 due to the behavior of the blood surface, that is, blood pulsation, each light receiving element The amount of light received by 41 to 47 varies along the axial direction L. The control unit 11 determines that the distal end opening 5 </ b> B of the catheter 5 is indwelled in the blood vessel 100 using the change in the amount of light received by each of the light receiving elements 41 to 47.
Otherwise, if the amount of light received by each of the light receiving elements 41 to 47 does not change, the control unit 11 assumes that the distal end opening 5B of the catheter 5 is located outside the blood vessel 100, and the control unit 11 It can be determined that the chemical solution is leaking from the blood vessel.

Next, an example of operation of the extravasation detection apparatus 1 described above will be described with reference to FIG.
FIG. 5 is a flowchart showing an operation example of the extravasation detection apparatus 1, and includes steps S1 to S5.
In step S <b> 1 shown in FIG. 5, as shown in FIG. 1, the medical staff punctures the tip 101 of the catheter 5 into the skin 101 and the blood vessel 100 and inserts the tip 5 into the blood vessel 100. In step S2, if a part of the blood has entered the blood detection line unit 20 shown in FIGS. 2 and 3 due to the blood flow H in the blood vessel 100 in FIG. 1, in step S3, the distal end opening of the catheter 5 is obtained. 5B is located in the blood vessel 100 as shown in FIG. As described above, when the distal end opening 5B of the catheter 5 is positioned in the blood vessel 100 as shown in FIG. 1, the drug solution W in the drug solution bag 200 is stored in the drug tube 3, the tube 4, and the catheter 5. The liquid can be normally fed into the blood vessel 100 through the line portion 29.

  In step S4, when the chemical solution is being fed, the detection unit 10 shown in FIG. 3 causes the blood flow in the blood vessel 100 to cause a part of the blood in the blood detection line unit 20 shown in FIGS. Then, it is detected at predetermined time intervals or continuously whether the blood surface is pulsating. That is, as shown in FIG. 3, when the light LT of the light emitting unit 31 of the detection unit 10 is received by each of the light receiving elements 41 to 47, the control unit 11 changes the light reception signal from each of the light receiving elements 41 to 47. Thus, while it can be confirmed that the pulsation of the blood surface is reciprocating along the axial direction L, that is, while the light receiving signals 41 to 47 vary, the blood flow H in the blood vessel 100 It is determined that a part of the blood has entered the blood detection line unit 20 shown in FIGS.

However, when there is no change in the received light signal from each of the light receiving elements 41 to 47 and the control unit 11 determines that there is no blood surface pulsation in the blood detection line unit 20, in step S5, the control unit 11 Then, it is determined that the distal end opening 5B of the catheter 5 is disengaged from the blood vessel 100 shown in FIG.
Thus, when the control unit 11 determines the extravasation of the drug solution, the control unit 11 instructs the notification unit 13 and the communication unit 14 so that the notification unit 13 notifies the alarm with sound, and the communication unit 14. Can notify the alarm of “extravascular leakage” wirelessly to the nurse station 15 that is the subject of notification, for example, at a remote location.
Thereby, it can be easily and reliably detected that the distal end opening 5B of the catheter 5 is detached from the blood vessel 100 and the chemical liquid is leaking out of the blood vessel. Then, it is possible to easily and reliably notify the medical staff and the patient himself that the chemical solution is leaking out of the blood vessel.

  In the extravasation detection device of each embodiment of the present invention described above, for example, when administering a drug solution obtained by diluting an anticancer agent with an infusion, the tip of the catheter is accidentally detached from the blood vessel and the anticancer agent Even if the drug solution containing spilled out of the blood vessel, the leak of the drug solution from the blood vessel can be detected easily and reliably, so that the tip of the catheter is released from the blood vessel and the drug solution leaks into the tissue. This can be easily and reliably known by medical personnel and patients themselves.

  An extravasation detection device according to an embodiment of the present invention includes a drug solution line portion in which a distal end opening is indwelled in a blood vessel and allows a drug solution to pass therethrough, and a blood detection line portion that guides a part of blood in the blood vessel. A light emitting unit that is disposed corresponding to the blood detection line unit of the catheter and that irradiates light to the blood detection line unit; a light receiving unit that receives light applied to the blood detection line unit and generates a light reception signal; When the blood behavior is detected in the blood detection line part based on the light reception signal of the head part, it is determined that the distal end opening of the catheter is located in the blood vessel, and the blood behavior is not detected in the blood detection line part. In some cases, a control unit is provided that determines that the distal end opening of the catheter is detached from the blood vessel and the drug solution leaks out of the blood vessel. Thereby, it is possible to easily and reliably detect that the distal end opening of the catheter is detached from the blood vessel and the drug solution leaks into the tissue.

  The blood detection line part is a hollow part formed in parallel to the catheter axial direction from the distal end opening of the catheter into the thick part of the catheter, so that the distal end opening of the catheter is positioned in the blood vessel. For example, the control unit can reliably detect the behavior of blood generated along the blood detection line unit based on the light reception signal from the detection unit.

The detection unit has a holding unit disposed on the outer peripheral surface of the catheter, and the holding unit holds the light emitting unit and the light receiving unit opposite to each other with the catheter interposed therebetween. However, it can be reliably held by the holding portion.
Preferably, since the light receiving unit includes a plurality of light receiving elements arranged along the axial direction of the catheter, the plurality of light receiving elements of the light receiving unit receive light from the light emitting unit, so that the control unit receives from the detection unit. Based on the received light signal, the behavior of blood generated along the blood detection line portion can be detected.

Each embodiment of the present invention can be arbitrarily combined. By the way, this invention is not limited to the said embodiment, A various modified example is employable. As the light emitting unit 31, for example, a light emitting diode (LED) or a laser diode (LD) can be used. For example, when the blood vessel 100 shown in FIG. 1 is a vein, the light emitting unit 31 is blood such as reduced hemoglobin. It is possible to generate light LT having a wavelength (near 660 nm) having an absorption peak in a specific element. The light emitting unit 31 may continuously emit the light LT or may emit pulses (intermittent light emission). The wavelength of the light LT emitted from the light emitting unit 31 is not particularly limited.
In the embodiment of the present invention shown in FIGS. 1 to 4, the four blood detection line portions 20 are parallel to the axial direction L of the catheter 5 from the distal end opening portion 5 </ b> B of the catheter 5 into the thick portion of the catheter 5. However, one to three blood detection line portions 20 may be formed, or five or more blood detection line portions 20 may be formed.
In addition, the extravasation detection device described above may be provided in an infusion device such as an infusion pump or a syringe pump.

  DESCRIPTION OF SYMBOLS 1 ... Extravasation detection apparatus, 5 ... Catheter, 5B ... End opening part of catheter, 10 ... Detection part, 11 ... Control part, 20 ... Blood detection line part, 29 ... Chemical solution line part, 31 ... Light emitting part, 32 ... Light receiving part

Claims (5)

A distal end opening is placed in the blood vessel, and there is a chemical liquid line part for passing the chemical liquid, and a blood detection line part that is completely separated from the chemical liquid line part and guides a part of the blood in the blood vessel. An intravascular catheter;
A light emitting portion that is disposed corresponding to the blood detection line portion of the tip opening and that applies light to the blood detection line portion, and receives the light applied to the blood detection line portion and generates a light reception signal. A light receiver;
When the behavior of the blood is detected in the blood detection line unit based on the light reception signal of the light receiving unit, it is determined that the distal end opening is indwelled in the blood vessel, and the blood detection line unit A blood vessel comprising: a controller that determines that the tip of the catheter for indwelling in the blood vessel is detached from the blood vessel and the liquid medicine leaks out of the blood vessel when the behavior of the blood is not detected. Outside leakage detection device.   The blood detection line portion is a hollow portion formed in parallel to the axial direction of the intravascular indwelling catheter from the distal end of the intravascular indwelling catheter into the thick portion of the intravascular indwelling catheter. The extravasation detection device according to claim 1.   The detection unit includes a holding unit disposed on an outer peripheral surface of the intravascular indwelling catheter, and the holding unit faces the light emitting unit and the light receiving unit across the intravascular indwelling catheter. The extravasation detection apparatus according to claim 1, wherein the extravasation detection apparatus is held.   The extravasation detection apparatus according to any one of claims 1 to 3, wherein the light receiving section includes a plurality of light receiving elements arranged along an axial direction of the intravascular placement catheter. An infusion device comprising the extravasation detection device according to any one of claims 1 to 4.

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