JP4828984B2 - Puncture tool - Google Patents

Description

  The present invention relates to a puncture device that includes a wireless IC tag and detects that a needle tip has been inserted into a blood vessel.

  When injecting or collecting blood, it is necessary to puncture a blood vessel such as a vein with a sharp needle tip at the tip, and to inject a drug solution or collect blood after confirming that the needle tip is inside the blood vessel. is there. However, even if the needle tip does not reach the blood vessel, the injection of the drug solution or blood collection cannot be achieved, and the patient will suffer a lot of pain such as pain and internal bleeding. . Therefore, it is necessary for an injection needle, an indwelling needle, or the like to detect that the needle tip has reached the inside of the blood vessel.

  Patent Document 1 discloses a catheter which is provided with a groove through which blood passes on the outer wall of the needle from the tip of the needle inserted into the blood vessel to the middle of the needle and covers the entire needle except the needle tip. The indwelling needle which formed the blood channel between the inner surfaces of this is disclosed. In the indwelling needle of Patent Document 1, when the needle is stabbed, the needle tip portion is not visible, but when the needle tip reaches the blood vessel, the blood enters the groove outside the body, so the needle tip is in the blood vessel. You can know that there is.

  Patent Document 2 discloses a method that utilizes a change in electrical characteristics of a human body part as a method for detecting a central venous puncture that punctures a deep part of a human body or a puncture position of an epidural needle for anesthesia. This one method uses an electrically connectable conductive puncture needle and a probe needle, punctures the probe into a terminal vein that is easy to puncture, and then flows electricity, and the puncture needle is vascularized due to a change in electrical resistance. Make sure you have reached

Patent Document 3 utilizes the fact that the electrical characteristics differ depending on the site in the human body, and flows electricity through two or more cables with the terminals exposed at the tip of the needle, and changes each time the tip of the needle passes through the living tissue. A technique for detecting a change in current is disclosed. The technique of Patent Document 3 relates to an epidural needle for anesthesia that detects that the tip of the needle has reached the epidural space, which is the target site, by detecting a change in current.
Japanese Patent Laid-Open No. 11-089939 JP 2002-28247 A JP2004-242936

  In the indwelling needle with a groove as in Patent Document 1, the needle portion is pulled out of the body, and only the outer catheter is placed in the blood vessel to inject the drug solution. However, since the indwelling needle of Patent Document 1 has a blood flow path formed outside the needle, when the needle is extracted, blood may scatter and contaminate the doctor or nurse.

  Moreover, since the needle | hook of patent document 2 and patent document 3 using the electrical characteristic of a human body has connected the needle | hook and the meter which measures an electric current with a cable, handling is inconvenient and it is not suitable as a disposable medical device.

  The present invention has been made in view of the above-described problems, and an object of the present invention is to provide a puncture device that detects that a needle tip has reached a blood vessel with a simple structure while having safety.

The present invention corresponding to an embodiment for solving the above-described problem is a puncture device including an indwelling needle and a catheter, and is connected to the IC tag disposed in the proximal end portion of the catheter and the IC tag. An antenna, first and second electrode portions connected to the IC tag, and a sheath portion of the catheter loaded with the indwelling needle, and connected to the first and second electrode portions, respectively. First and second wiring members, wherein the first and second wiring members are exposed at a distal end portion of the sheath portion, and are not electrically connected to each other in the sheath portion, When the indwelling needle is punctured into the patient's body and the exposed portions of the first and second wiring members come into contact with blood, the first and second wiring members and the blood pass through the first and second wiring members. The second electrode portion is conductive, and the IC tag is Upon detecting the conduction of the first and second electrode portions, and to store the conduction history in the storage unit provided in the IC tag.

According to another aspect of the present invention for solving the above problems, an IC tag, an antenna connected to the IC tag, first and second electrode portions connected to the IC tag, and the first A needle made of a conductive material connected to one electrode portion and having a cutting edge formed at the tip thereof, and disposed on the needle so as to be insulated from the needle and connected to the second electrode portion. The wiring member is exposed near the tip of the needle, the needle is punctured into the patient's body, and the needle and the exposed portion of the wiring member contact blood. The first and second electrode portions are conducted through the wiring member and the blood , and the IC tag is provided on the IC tag upon detecting conduction in the first and second electrode portions. The continuity history is stored in the storage unit .

  According to still another aspect of the present invention for solving the above problem, the IC tag includes a communication unit that communicates with an external device via the antenna. When the continuity is detected, the IC tag Communication with the external device is performed.

  According to the present invention, it is possible to provide a puncture device that detects that the needle tip has reached a blood vessel with a simple structure while providing safety.

  Hereinafter, embodiments according to the present invention will be described with reference to the drawings. The following embodiments do not limit the invention described in the claims, and all the combinations of features described in the embodiments are essential to the solution means of the present invention. Not exclusively.

  The puncture device of the present invention establishes wireless communication between the IC tag and an external device when the needle tip of the puncture device reaches the human tissue using the electrical characteristics of the human body. This confirms whether or not the needle tip has reached a desired site (for example, inside a blood vessel) depending on whether or not wireless communication is established.

  FIG. 1 is a block diagram showing a chip configuration of an IC chip corresponding to the first embodiment and the second embodiment. However, this chip configuration is given as an example, and does not limit the chip configuration of the IC chip in the present invention. In the present chip configuration, only important elements for explaining the present invention will be described.

  The IC tag 100 is disposed in the puncture device 10 and includes an IC chip 102 and an antenna 110. The IC chip 102 includes a control unit 104, a storage unit 106, and an RF unit 108. The control unit 104 reads out information stored in the storage unit 106 and transmits the information to the RF unit 108 in response to an instruction from the external device 120 serving as an IC tag reader. The frequency used is 13.56 MHz, 2.45 GHz, 860 to 960 MHz, or the like. In this case, the communicable distance is about 50 cm at 13.56 MHz and about 100 cm at 2.45 GHz. In addition, the control unit 104 writes predetermined information into the storage unit 106. For example, the storage unit 106 writes a non-writable EEPROM for storing a manufacturer name, drug name, usage, capacity, warning, contraindication, sterilization temperature or time, and information such as a patient name and a doctor name in charge on the user side. Alternatively, a RAM that stores electrical state changes may be included.

  Further, according to the present invention, the IC tag 100 is desirably a passive type IC tag to which power is supplied from the external device 120 by communication. However, the IC tag 100 may include a power supply unit that supplies power to the IC tag 100.

  Furthermore, the puncture device according to the present invention includes a conductive portion 114 connected to the IC tag 100. The conductive portion 114 acts so that the IC tag 100 does not operate normally even when power is supplied by communication from the external device 120 in a state where the puncture tool is not punctured into the human body. Specifically, the conductive portion 114 has a conduction pattern that conducts by puncturing, and the operation of the IC tag 100 is controlled by the presence or absence of conduction in the conduction pattern. Therefore, the IC tag 100 does not operate normally when the puncture device is not punctured. However, if puncturing is performed on the human body, the conduction pattern is conducted through the tissue of the human body, and the IC tag 100 can operate normally. In this case, the IC tag 100 can communicate with the external device 120.

  The RF unit 108 is for controlling wireless communication, and includes a transmitter and a receiver. The transmitter and receiver need only be those normally used in IC tags. In brief, the transmitter includes a modulator, a filter, and an amplifier, modulates the digital signal, removes unnecessary components by the filter, amplifies the amplified signal, and radiates from the antenna 110. The receiver includes a filter, an amplifier, a demodulator, and a filter. The antenna 110 receives a signal propagated through space, and extracts a necessary band by the filter. Further, the receiver amplifies this with an amplifier and performs frequency conversion with the decoder to decode the signal.

  The external device 120 includes a transmission unit 121, a reception unit 122, a notification unit 123, and a control unit 124.

  The transmission unit 121 includes a 2.45 GHz band oscillator, a modulator, an amplifier, an antenna, and the like. The operation clock from the 2.45 GHz band oscillator that is a signal source and the control unit 123 is modulated by the modulator, and the IC is operated from the antenna. A question wave is transmitted to the tag 100.

  The receiving unit 122 detects response waves from the IC tag 100 and generates ID information and the like. The notification unit 123 includes a display and a speaker, and notifies the user of the puncture device 10 whether or not the puncture has been completed based on communication with the IC tag 100. For example, the completion of the puncture can be notified by display on the display or voice notification through a speaker. The control unit 124 performs frequency control when transmitting / receiving to / from the IC tag 100.

[First embodiment]
FIG. 2 a is a cross-sectional view showing an example of the puncture device 10 corresponding to the first embodiment. The puncture device 200 according to this embodiment is characterized in that a catheter including an indwelling needle includes the conductive portion 114 and the IC tag 100. In the present embodiment, wireless communication is performed between the IC tag 100 and the external device 120, and it is determined whether or not the catheter has reached a desired site depending on whether or not predetermined information can be received from the IC tag 100. The technology is mainly described.

  The puncture device 200 includes a proximal end portion 202 and a tubular sheath portion 207, and includes a catheter that is indwelled on the human body after puncture, and an indwelling needle 201 having a sharp needle tip. The indwelling needle 201 is loaded into the catheter and protrudes from the distal end portion of the sheath portion 207 of the catheter. The indwelling needle 201 also has a hollow region 203 for injecting a drug into the human body or collecting blood after puncturing. The puncture tool 200 includes a pair of electrode portions 204a (first electrode portions), an electrode portion 204b (second electrode portions), and wiring portions 206a and 206b as the conductive portion 114 and the IC tag 100 capable of wireless communication. Including. Further, the first electrode portion and the second electrode portion are not limited to a pair, and a plurality of electrode portions may be provided. Although the description of the antenna 110 is omitted in FIG. 2 a, the IC tag 100 is connected to the antenna 110 and can communicate with the external device 120. The antenna 110 may be installed on the surface of an extension tube (not shown) of the catheter, for example.

  The IC tag 100 is disposed on the needle base of the proximal end portion 202 of the catheter. The pair of electrode portions 204a and 204b are connected to the IC tag 100 and the wiring portions 206a and 206b. The wiring portions 206a and 206b are conductive wires such as copper or conductive metal, and are disposed in the vicinity of the catheter tip as shown in FIG. 2a. The wiring portions 206a and 206b are further covered with a catheter sheath portion 207 so as not to conduct in a state before puncturing.

  The material of the sheath is not particularly limited, but polyolefin, olefin elastomer, polyester, soft polyvinyl chloride, polyurethane, urethane elastomer, polyamide, amide elastomer, polytetrafluoroethylene, fluororesin elastomer, polyimide, ethylene-acetic acid Polymer materials such as vinyl copolymers and silicon rubber can be used.

  When the sheath portion 207 is formed from a polymer material, for example, it is possible to improve the rigidity by using a superelastic alloy pipe, an embedded coil or an embedded mesh made of metal, and the like.

  Further, as shown in FIG. 2a, the wiring parts 206a and 206b are cut at the tips, and the tips 208a and 208b are not connected to each other. Therefore, the electrodes 204a and 204b do not conduct in the state before puncturing. In the IC tag 100, the control unit 104 monitors the conduction state between the electrodes 204a and 204b. When the continuity between the electrodes cannot be obtained, the control unit 104 does not transmit predetermined information (for example, flag information indicating completion of puncture) from the external device 120.

  FIG. 2 b is a diagram illustrating an example of a connection form corresponding to FIG. 2 a between the control unit 104 and the conduction unit 114. In FIG. 2b, the electrodes 204a and 204b are connected to the control unit 104, respectively. A wiring portion 206a is connected to the electrode 204a, and a wiring portion 206b is connected to the electrode 204b. In a state before puncturing, the wiring portions 206a and 206b are physically separated from each other. The control unit 104 can detect a state where the electrodes 204a and 204b are not conductive.

  On the other hand, when the indwelling needle 201 is punctured in the affected part, for example, when collecting blood, the distal end sections 208a and 208b of the wiring parts 206a and 206b located near the distal end of the indwelling needle 201 come into contact with body fluid (blood). . The wiring parts 206a and 206b can be conducted by using body fluid as a medium, whereby the electrode parts 204a and 204b shift to a conducting state. The control unit 104 can detect this conduction state due to puncturing, and can store a threshold value (such as a current value) for determining conduction in the storage unit 106 using the RF unit 108. Note that a plurality of threshold values may be stored in the storage unit 106, for example. In this case, a flag corresponding to each threshold value may be transmitted so that the puncture situation can be monitored. Alternatively, the continuity history that has reached any of the plurality of threshold values stored in the storage unit 106 may be stored in the storage unit 106, and the past puncture history may be read out by external access. Thereby, the use log | history of the puncture tool 200 can be confirmed, and it can prevent using it twice.

  In this case, the external device 120 can detect the completion of puncturing based on the flag information transmitted from the IC tag 100.

  Note that the wiring portions 206a and 206b may be configured as a part of the antenna 110 of the IC chip 102 so that communication with the external device 120 is enabled by conduction. In this case, before the puncture, the antenna 110 does not function, and communication between the IC tag 100 and the external device 120 cannot be established. On the other hand, after puncturing, the function of the antenna 110 is secured by the conduction of the wiring portions 206a and 206b, and communication between the IC tag 100 and the external device 120 can be established. In this case, if the external device 120 can establish communication with the IC tag 100, it can detect that the puncture has been completed.

  Thus, when the indwelling needle 201 of the puncture device 200 is inserted into the blood vessel and the external device 120 detects the completion of puncture, a predetermined message is displayed or notified by the notification unit 123 of the external device 120, and the user performs puncture. It can be confirmed that it has been performed reliably.

  Next, a cross-sectional configuration of the puncture device 200 will be described with reference to FIG. FIG. 3 is a diagram illustrating an example of a cross-sectional configuration of the puncture device 200 corresponding to the first embodiment.

  FIG. 3 shows a case where the cross section is viewed in the direction of the arrow when the puncture device 200 is cut along the dotted line connecting 210a and 210b in FIG. 2a. In the cross section at this time, the indwelling needle 201 is disposed in the hollow region of the sheath 207 of the catheter. The sheath portion 207 includes a pair of electrode portions 204a (first electrode portion) and wiring portions 206a and 206b connected to the electrode portion 204b (second electrode portion). Here, as for wiring part 206a and 206b, as shown to FIG. 2 a, it is desirable that only front-end | tip part 208a and 208b is exposed from the sheath part 207, and other parts are covered with the sheath part 207. Further, it is most effective to arrange the exposed tip portions 208a and 208b on the blade surface side and 180 ° opposite side.

  This is because the indwelling needle 201 is generally a conductive metal, and thus prevents the wiring parts 206a and 206b from contacting the indwelling needle 201. With such a structure, when the puncture device 200 is inserted into a blood vessel, the conductive state of the electrode portions 204a and 204b is ensured only when the tip portions 208a and 208b of the wiring portions 206a and 206b are in contact with blood. The Rukoto.

  Note that the communication distance of the IC tag 100 is proportional to the size of the antenna 110. Therefore, in order to ensure a sufficient communication distance, the antenna 110 may be wound around the needle base of the indwelling needle 201 and arranged.

  According to the puncture device 200 corresponding to the above-described embodiment, it is possible to detect the completion of puncture without providing a groove portion for drawing blood in the indwelling needle of the catheter. Therefore, even when the needle 201 is pulled out, the blood accumulated in the groove portion can be safely injected and collected without being scattered. Further, the puncture device 200 includes the IC tag 100 that can wirelessly communicate with the external device 120, and can detect completion of puncture. Accordingly, it is not necessary to use a cable or the like, and it is small and can be used in exactly the same manner as a conventional puncture device, so that injection and blood collection can be easily performed.

[Second Embodiment]
Next, a second embodiment of the present invention will be described. FIG. 4 a is a cross-sectional view showing an example of the configuration of the puncture device 10 corresponding to the second embodiment. The puncture device 400 according to the present embodiment is characterized in that a current pattern by a conductive part is formed on a needle rod of an injection needle loaded in a syringe, and an IC tag is formed on a needle base.

  In the present embodiment, whether the needle tip of the puncture tool 400 has reached a desired site depends on whether wireless communication is performed between the IC tag 100 and the external device 120 and predetermined information can be received from the IC tag 100. The technique for determining whether or not is described mainly.

  The puncture device 400 includes a needle 401 having a sharp needle tip and a needle base 407. The needle 401 is inserted into the needle base 407 and has a hollow region 404 for injecting a drug into the human body or collecting blood after puncturing. Furthermore, the needle 401 includes a wiring portion 402 and an insulator 403 in the needle rod. In addition, as a material of the needle 401, for example, a conductive metal such as stainless steel is used. The needle base 407 includes an IC tag 100 capable of wireless communication and electrode portions 405a and 405b connected to the IC tag 100.

  In the present embodiment, the wiring portion 402 is electrically separated from the conductive needle 401 by a film made of the insulator 403. The wiring portion 402 is also connected to one of the pair of electrode portions 405 a and 405 b, and only the tip portion 408 of the wiring portion 402 is exposed to the outside of the insulator 403. As shown in FIG. 4a, the needle 401 is directly connected to the other electrode part 405a or 405b. According to the present embodiment, a pair of conductive parts is connected to a pair of electrode parts as in the first embodiment by using a needle 401 that is a conductive metal as a part of the wiring. There is no need.

  Although the description of the antenna 110 is omitted in FIG. 4 a, the IC tag 100 is connected to the antenna 110 and can communicate with the external device 120. The antenna 110 may be installed on the surface of a main body such as a needle base 407 or a syringe.

  As shown in FIG. 4a, since the wiring portion 402 and the needle 401 are in an electrical connection state interrupted by the insulator 403, the electrode portions 405a and 405b do not conduct in the state before puncturing. Examples of the material of the insulator 403 include olefin resins such as polyvinyl chloride resin, polyethylene, and polypropylene. In the IC tag 100, the control unit 104 monitors the conduction state between the electrodes 405a and 405b. When the continuity between the electrodes cannot be obtained, the control unit 104 does not transmit predetermined information (for example, flag information indicating completion of puncture) from the external device 120.

  FIG. 4 b is a diagram illustrating an example of a connection form corresponding to FIG. 4 a between the control unit 104 and the conduction unit 114. The conduction part 114 corresponding to the embodiment includes a needle 401, a wiring part 402, an insulator 403, and electrode parts 405a and 405b. In FIG. 4b, the electrode parts 405a and 405b are connected to the control part 104, respectively. A wiring portion 402 is further connected to the electrode portion 405a, and a needle 401 is further connected to the electrode 405b. In the state before puncturing, since the electrical connection between the wiring portion 402 and the needle 401 is interrupted by the insulator 403, the control portion 104 detects a state where the electrode portions 405a and 405b are not conductive. Can do.

  On the other hand, when the needle 401 is punctured into the affected part when blood is collected, the tip part 408 of the wiring part 408 located in the vicinity of the tip of the needle 401 comes into contact with body fluid (blood). In this case, the needle 401 and the wiring part 402 can be made conductive through the body fluid, whereby the electrodes 405a and 405b shift to a conductive state. The control unit 104 can detect this conduction state due to puncturing, and can store a threshold value (such as a current value) for determining conduction in the storage unit 106 using the RF unit 108. Note that a plurality of threshold values may be stored in the storage unit 106, for example. In this case, a flag corresponding to each threshold value may be transmitted so that the puncture situation can be monitored. Alternatively, the continuity history that has reached any of the plurality of threshold values stored in the storage unit 106 may be stored in the storage unit 106, and the past puncture history may be read out by external access. Thereby, the use log | history of the puncture tool 200 can be confirmed, and it can prevent using it twice.

  In this case, the external device 120 can detect the completion of puncturing based on the flag information transmitted from the IC tag 100.

  Next, a cross-sectional configuration of the puncture device 400 will be described with reference to FIG. FIG. 5 is a diagram illustrating an example of a cross-sectional configuration of the puncture device 400 corresponding to the second embodiment. FIG. 5 shows a case where the cross section is viewed in the direction of the arrow when the puncture device 400 is cut along the dotted line connecting 410a and 410b in FIG. 4a. In the cross section at this time, the insulator 403 is filled in the groove above the needle 401, and the wiring portion 402 is disposed in the insulator 403. As described above, the electrical connection between the needle 401 and the wiring portion 402 is interrupted by the insulator 403.

  According to the puncture device 400 corresponding to the above-described embodiment, the completion of puncture can be detected without providing a groove portion for drawing blood into the indwelling needle using the conductivity of the needle itself. Therefore, even when the needle 401 is pulled out, the blood accumulated in the groove portion can be safely injected and collected without scattering. Further, the puncture device 400 includes the IC tag 100 that can wirelessly communicate with the external device 120, and can detect completion of puncture. Accordingly, it is not necessary to use a cable or the like, and it is small and can be used in exactly the same manner as a conventional puncture device, so that injection and blood collection can be easily performed.

It is a block diagram which shows the chip | tip structure of an IC chip corresponding to 1st Embodiment and 2nd Embodiment. It is sectional drawing which shows an example of the puncture tool corresponding to 1st Embodiment. It is a figure which shows an example of the connection form of the control part 104 and the conduction | electrical_connection part 114 corresponding to 1st Embodiment. It is sectional drawing which shows an example of the catheter corresponding to 1st Embodiment. It is sectional drawing which shows an example of the puncture tool corresponding to 2nd Embodiment. It is a figure which shows an example of the connection form of the control part 104 and the conduction | electrical_connection part 114 corresponding to 2nd Embodiment. It is sectional drawing which shows an example of the needle | hook corresponding to 2nd Embodiment.

Claims (3)

A puncture device including an indwelling needle and a catheter,
An IC tag disposed within the proximal end of the catheter;
An antenna connected to the IC tag;
First and second electrode portions connected to the IC tag;
First and second wiring members disposed in a sheath of the catheter loaded with the indwelling needle and connected to the first and second electrode parts, respectively.
The first and second wiring members are exposed at the distal end of the sheath, and are electrically disconnected from each other within the sheath;
When the indwelling needle is punctured into a patient's body and the exposed portions of the first and second wiring members are in contact with blood, the first and second wiring members and the blood are used to connect the first and second wiring members. And the second electrode portion is conductive,
When the IC tag detects continuity in the first and second electrode portions, the puncture tool stores a continuity history in a storage unit provided in the IC tag . IC tag,
An antenna connected to the IC tag;
First and second electrode portions connected to the IC tag;
A needle composed of a conductive material connected to the first electrode portion and having a cutting edge formed at the tip;
A wiring member disposed on the needle and insulated from the needle, and connected to the second electrode portion;
The wiring member is exposed near the tip of the needle,
When the needle is punctured into a patient's body and the needle and the exposed portion of the wiring member come into contact with blood, the first and second electrode portions are interposed via the needle, the wiring member, and the blood. Conducting,
When the IC tag detects continuity in the first and second electrode portions, the puncture tool stores a continuity history in a storage unit provided in the IC tag . The IC tag includes communication means for communicating with an external device via the antenna,
The puncture device according to claim 1 or 2, wherein when the continuity is detected, the communication unit communicates with the external device.

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