WO2008038430A1 - Indicator for medical tool with cuff - Google Patents

Indicator for medical tool with cuff Download PDF

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Publication number
WO2008038430A1
WO2008038430A1 PCT/JP2007/058547 JP2007058547W WO2008038430A1 WO 2008038430 A1 WO2008038430 A1 WO 2008038430A1 JP 2007058547 W JP2007058547 W JP 2007058547W WO 2008038430 A1 WO2008038430 A1 WO 2008038430A1
Authority
WO
WIPO (PCT)
Prior art keywords
cuff
indicator
internal pressure
index
medical device
Prior art date
Application number
PCT/JP2007/058547
Other languages
French (fr)
Japanese (ja)
Inventor
Kiyoshi Chikashige
Original Assignee
Advanex Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Advanex Inc. filed Critical Advanex Inc.
Publication of WO2008038430A1 publication Critical patent/WO2008038430A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/044External cuff pressure control or supply, e.g. synchronisation with respiration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • the present invention relates to an indicator for a cuffed medical device which is attached to the cuffed medical device and indicates the internal pressure of the cuff of the medical device.
  • an “intratracheal tube” used for artificial respiration has one end inserted through the patient's mouth (oral) or nose (transnasal) and the other end connected to the ventilator.
  • the cuff of the “tracheal tube” is inflated in the trachea, the patient is obstructed below the trachea (lung) and forced to breathe with a ventilator that is in communication through the “intratracheal tube”.
  • pulmonary artery balloon catheter Another example is a “pulmonary artery balloon catheter”.
  • a catheter is inserted into a blood vessel via an appropriate blood vessel such as an arteriole, and the force tail reaches the pulmonary artery through the blood flow.
  • the balloon is inflated, and a sensor placed at the tip of the catheter is used to measure the so-called “wedge insertion pressure” where blood enters the lungs.
  • a pilot balloon has been provided at a branching portion of a medical device with a cuff to which a syringe is connected to inject air into the cuff, and the degree of expansion of this pie mouth banolane is increased. It is detected by checking the appearance and tactile sensation.
  • Patent Document 1 Japanese Unexamined Patent Publication No. 2003-116999
  • the present invention has been made in view of the above circumstances, and an object of the present invention is to provide an indicator for a medical device with a cuff that can quickly determine the internal pressure of the cuff and determine the force accurately.
  • an indicator for a cuffed medical device of the present invention is an indicator for a cuffed medical device that is attached to the cuffed medical device and indicates the internal pressure of the cuff of the medical device,
  • a check valve connectable to injection means such as a syringe for injecting fluid into the cuff; a connection portion connected to the cuffed medical device and communicating with the cuff;
  • An indicator main body provided between the check valve and the connecting portion, and the fluid injected through the check valve by the injection means into the indicator main body.
  • a plurality of balloon-like indicator bodies communicating with the inside of the cuff through the connecting portion are provided so as to be inflatable and inflatable corresponding to the internal pressure of the cuff,
  • the plurality of indicator bodies are configured with different degrees of expansion / contraction corresponding to the internal pressure in the cuff,
  • the indicator body is formed with a window portion that allows at least the degree of expansion / contraction of each of the plurality of indicator bodies to be visually recognized.
  • This indicator for a medical device with a cuff connects an injection means such as a syringe to a check valve, and injects a fluid such as air, so that the fluid passes through a guide path and a connection path into the cuff. enter. Therefore, the cuff can be expanded to a predetermined degree of expansion. Even if the injection means is removed from the check valve in this state, the check valve acts so that the air (fluid) in the cuff does not leak out through the guide line.
  • the plurality of index bodies in the index chamber communicating with the cuff are expanded in accordance with the internal pressure of the cuff.
  • the plurality of indicator bodies are configured to have different degrees of expansion / contraction corresponding to the internal pressure of the cuff, the internal pressure of the cuff is reduced by visually checking each expansion degree from the window portion of the indicator body. It is possible to determine the force quickly and accurately.
  • one indicator body sufficiently expands when the internal pressure of the cuff is appropriate, and the other indicator body fully expands when the internal pressure of the cuff is excessive. Form it as you do. Then, when the internal pressure of the cuff is appropriate, one index body is sufficiently expanded, and the other index body has a small degree of expansion. Therefore, it can be seen that the internal pressure of the cuff is appropriate by visually observing the state where only one of the index bodies is sufficiently expanded.
  • each of the plurality of indicator bodies of the indicator for a cuffed medical device has its mouth The portion may be open to the guide path so that the inside thereof communicates with the cuff through the guide path.
  • the structure of the indicator body is simplified, the assemblability of the indicator body is improved, and the manufacture is facilitated.
  • each of the plurality of index bodies of the cuffed medical instrument indicator is configured to be identifiable.
  • the color of the index body is individually changed so that each can be discriminated, and the index body of the color corresponds to the internal pressure of the cuff to recognize the force. It is possible to quickly and accurately determine whether the internal pressure is appropriate.
  • the indicator for a medical device with a cuff of the present invention when the cuff is held in an inflated state, a plurality of indicator bodies in the indicator chamber communicating with the cuff expands corresponding to the internal pressure of the cuff. It is configured as follows. Therefore, by visually observing the degree of expansion of each of the plurality of indicator bodies from the window portion of the indicator body, it is possible to quickly and accurately determine a decrease in the internal pressure of the cuff. Therefore, there is no inconvenience that it takes time to detect a decrease in internal pressure and a certain amount of experience is required as in the prior art.
  • FIG. 1 is a diagram showing a schematic configuration of a cuffed medical device to which an indicator of the present invention is attached.
  • FIG. 2 is a view showing a conventional medical device with a cuff.
  • FIG. 3 is a side sectional view showing a schematic configuration of an embodiment of the indicator for a cuffed medical device of the present invention.
  • FIG. 4 is an exploded perspective view of the indicator for a cuffed medical device shown in FIG.
  • FIG. 5 is a perspective view of an indicator body.
  • FIG. 6 is a perspective view of an indicator body.
  • FIG. 7 is a front view of one side of the indicator body.
  • FIG. 8 is a cross-sectional view taken along line AA in FIG.
  • FIG. 9 is a perspective view of an index body.
  • Fig. 10 is a side sectional view of the indicator body.
  • FIG. 11 is a diagram for explaining how to use the cuffed medical device.
  • FIG. 1 is a view showing a cuffed medical device to which the indicator 1 of the present invention is attached
  • FIG. 2 is a view showing a conventional cuffed medical device.
  • reference numeral 50 denotes a general endotracheal tube as a cuffed medical device, and this cuffed medical device (intratracheal tube) 50 is a connector 6 that can be connected to an artificial respirator.
  • an injection part 70 for inflating the cuff a tube 80 to be inserted into the patient's trachea, and a cuff (balloon) 90 for occluding the trachea.
  • the connector 60 is entirely cylindrical, and includes a first connection cylinder 61 for connection to a ventilator, a second connection cylinder 62 that is airtightly fitted to a tube body 81 described later, It is configured.
  • the injection portion 70 is configured by a connecting tube 71 connected to a tube 80, a pilot balloon 72, a check valve 73, and a force.
  • Pilot bar The rune 72 is a balloon-like object having openings on both sides, and is used to confirm the internal pressure of the cuff 90 communicating with the pilot balloon 72 by confirming its inflated state by appearance and touch as described above. is there.
  • the check valve 73 is configured to allow air (fluid) to flow only from the side opposite to the pilot balloon 72 and not to escape from the pilot vano lane 72 side, and is connected to the syringe. As a result, it becomes an inflow port for inflowing air.
  • the internal pressure of the cuff 90 is examined (confirmed) by the appearance of the pilot balloon 72 and its tactile sensation. There was a problem that some experience was required.
  • the indicator 1 is connected to the connection tube 71.
  • the indicator 1 includes a cuff side connection portion 2 connected to the connection tube 71, a cylindrical indicator body 3, and a syringe side connection portion 5 having a check valve (not shown). ing.
  • the indicator 1 having such a configuration can easily confirm the internal pressure of the cuff 90 by visually recognizing an indicator body (not shown) in the indicator body 3. The details of the indicator 1 will be described later.
  • the tube 80 includes a tube body 81, a first hole 82 that penetrates the entire length of the tube body 81, a second hole 83 that penetrates a part of the tube body 81, and a tube body 81.
  • the first opening 84 communicates the second hole 83 and the outside on the distal end side (patient side), and the second opening 85 communicates the second hole 83 and the outside on the other end side of the tube body 81.
  • the connection tube 71 is hermetically bonded and fixed to the tube body 81 in the second opening 85.
  • the cuff 90 is a balloon-like one provided so as to cover the first opening 84, and both ends thereof are hermetically bonded and fixed to the outer surface of the tube body 81, so that the inside thereof is the first. 1 It communicates with the outside only through the opening 84. That is, the cuff 90 communicates with the second hole 83 and the connection tube 71 through the first opening 84.
  • the indicator 1 is an embodiment of the indicator for a cuffed medical device according to the present invention. As shown in FIG. 3, the cuff side connecting portion 2 connected to the connecting tube 71, a cylindrical indicator body 3, and the like. , Check valve 4 And a syringe-side connecting portion 5 that is provided.
  • the cuff-side connecting portion 2 includes a cylindrical portion 2a in which the connecting tube 71 is inserted (or extrapolated) and connected to the connecting tube 71, and one end side of the cylindrical portion 2a. And a large-diameter cylindrical connecting tube 2c formed on the outer peripheral edge of the disk portion 2b and connected to the indicator body 3.
  • the cylindrical portion 6 protrudes around the opening 2d of the internal hole (not shown) of the cylindrical portion 2a. Is formed.
  • the cylindrical portion 6 forms a part of a guide path, which will be described later, and is formed in a substantially triangular shape centering on the opening 2d, and an index body, which will be described later, is engaged with each side portion thereof.
  • a notch 6a is formed for the purpose.
  • the indicator body 3 is made of a transparent resin such as polypropylene (PP), and thus the inside thereof is formed so as to be visible, and the whole functions as a window portion in the present invention. As shown in FIGS. 5, 6, 7, and 8, it has a substantially cylindrical shape with a space formed inside.
  • the indicator body 3 has a connection end 3a formed on the peripheral edge portion on one side thereof to be inserted into the connection tube 2c of the cuff side connection portion 2 and connected to the center portion on the other side.
  • a connecting tube 3b connected to the syringe-side connecting portion 5 is formed.
  • the indicator body 3 is formed with an internal hole 7 penetrating from the one side to the other side.
  • This internal hole 7 forms a part of the guide path in the present invention, and as shown in FIGS. 6 and 7, the opening on the side of the connection end 3a is a cylinder formed in the disk portion 2b. Is formed in a substantially triangular shape substantially matching the shape of the internal hole of the shaped portion 6 (see FIG. 4), and the opening shape on the side of the connecting tube 3b is formed in a circular shape as shown in FIGS. ing.
  • a guide path 8 is constructed for introducing the fluid injected by the injection means to the cuff side connection portion 2 side as described later.
  • the indicator body 3 is formed with a plurality of indicator chambers 9, and in the present embodiment, three indicator chambers 9 are formed therein.
  • These indicator rooms 9 have the above plan as shown in Fig. 6 and Fig. 7. It is a space that is arranged at equal intervals around the inner path 8 along the circumferential direction, and is a cylindrical space that opens to the disc portion 2b side of the cuff side connecting portion 2. The opening on the disk part 2b side is sealed by the disk part 2b, so that each index chamber is an independent space.
  • a communication hole 9a is formed for each index chamber 9 for communicating the index chamber 9 made of a space to the outside of the indicator body.
  • a slit 10 is formed between each of the index chambers 9 and the guide path 8 (inner hole 7) so as to communicate with each other.
  • Each of the slits 10 is attached with an index body 11 as shown in FIG.
  • the slit 10 has a notch 10a formed in the indicator body 3 as shown in FIGS. 7 and 8, and a notch 6a in the cylindrical part 6 of the cuff side connecting part 2 shown in FIG. And formed.
  • the indicator body 11 is a balloon-shaped member having a mouth portion 11a and a bag portion ib, and is made of a flexible resin (elastomer) or rubber.
  • the bag portion l ib is formed so as to be inflatable / shrinkable.
  • the opening 1 la of the indicator body 1 1 is composed of an opening 11c and a thick attachment portion l id that forms the periphery of the opening 11c, and the attachment portion 1 Id is locked to the slit 10,
  • the indicator body 11 is attached in the indicator body 3.
  • the indicator body 11 has its mounting portion id arranged in the guide path 8 (inner hole 7), the bag portion ib passing through the slit 10, and placed in the indicator chamber 9, In this state, since the space between the mounting portion 11 d and the inner wall surface of the guide path 8 is hermetically sealed by adhesion or welding, it is attached in the indicator body 3.
  • the indicator body 11 communicates with the cuff 90 via a guide path 8 as described later.
  • a slit 10 that communicates between the guide path 8 and each index chamber 9 is formed by the index body 11.
  • the guide path 8 and the indicator chambers 9 are hermetically separated from each other.
  • index bodies 11 are configured to have different degrees of expansion / contraction corresponding to the internal pressure of the cuff 90 communicating through the guide path 8. That is, in this embodiment, three The two indicator bodies 11 are formed with different thicknesses of the bag portions l ib, and thereby the degree of expansion according to the internal pressure, that is, the degree of expansion / contraction is different.
  • the first indicator body 11 hardly swells in the range where the internal pressure of the cuff 90 is appropriate, and when the internal pressure of the cuff 90 exceeds the appropriate range, that is, the cuff 90
  • the film thickness is set so as to swell when over-swelled.
  • the second indicator body 11 is formed with a film thickness set so that the internal pressure of the cuff 90 swells sufficiently in a proper range and does not swell with a sufficient degree of expansion when it is below the proper range. Yes.
  • the thickness of the third indicator 11 is set so that the inner pressure of the cuff 90 swells sufficiently in the vicinity of the lower limit of the appropriate range, and hardly swells, for example, about half or less of this lower limit. Has been.
  • the three indicator bodies 11 swell at different expansion / contraction degrees according to the internal pressure of the cuff 90. That is, when the internal pressure of the cuff is appropriate, the second index body 11 and the third index body 11 swell with sufficient expansion, and the first index body 11 hardly swells. Therefore, it can be seen that the internal pressure of the cuff is appropriate by visually observing the state in which only one of the index bodies is sufficiently expanded.
  • the internal pressure of the cuff 90 decreases and falls below the lower limit value of the appropriate range, at least the first index body 11 and the second index body 11 both have very small degrees of expansion, In addition, the third index body 11 also has an insufficient degree of expansion. Therefore, it can be seen that the internal pressure of the cuff is too low by visually confirming that all the three indicator bodies 11 are not sufficiently inflated.
  • the third indicator 11 when the internal pressure of the cuff 90 is excessive, by forming the third indicator 11 so as to swell and rupture, it can function as a safety valve.
  • each of these three indicator bodies 11 is configured to be identifiable.
  • each indicator body 11 is configured to be identifiable by changing the color of each indicator body 11 individually. is doing. Specifically, the color of the first index body 11 is “red”, and the color of the second index body 11 is “blue”. The third indicator is colored “green”. In this way, if each of the three index bodies 11 can be identified, it is possible to recognize in advance which color index body 11 corresponds to the internal pressure of the cuff 90. Whether or not the internal pressure is appropriate can be determined more quickly and accurately.
  • the syringe-side connecting portion 5 is generally cylindrical as shown in FIGS. 3 and 4, and has a small-diameter portion 5a at one end thereof, and the small-diameter portion 5a is a connecting tube of the indicator body 3. It is fixed to the indicator body 3 by being inserted into 3b and connected here and hermetically sealed by adhesion or welding. With this configuration, the syringe-side connecting portion 5 has an internal hole 5b communicating with the internal hole 7 of the indicator body 3. As will be described later, the syringe-side connecting portion 5 has an injection means (not shown) such as a syringe connected to the internal hole 5b on the other end side.
  • the inner hole 5b is formed in a tapered shape so that the diameter gradually decreases from the other end side toward the center.
  • a constricted part 5c for narrowing the inner diameter of the inner hole 5b is formed in the central part, and the reverse part is formed in the constricted part 5c. Stop valve 4 is provided.
  • the check valve 4 includes a valve body 12, a coil spring 13, and a fixed shaft 14.
  • the valve body 12 includes a head portion 12a and a cylindrical shaft portion 12b.
  • the head portion 12a is disposed on the narrow diameter portion 5a side of the narrowed portion 5c, and the shaft portion 12b passes through the narrowed portion 5c. Thus, it is arranged to extend on the side opposite to the small diameter portion 5a.
  • the inner surface of the head 12a (the surface facing the constricted portion 5c) is tapered such that the diameter gradually decreases toward the shaft portion 12b, and the surface of the constricted portion 5c facing the inner surface is also the inner surface. It has a reverse taper shape corresponding to the taper shape. With such a configuration, the head portion 12a of the valve main body 12 comes into tight contact with the stenosis portion 5c when contacting the stenosis portion 5c.
  • the coil spring 13 is provided on the outer side of the shaft portion 12b passing through the narrowed portion 5c.
  • the fixed shaft 14 is composed of a head portion 14a and a shaft portion 14b, and the shaft portion 14b is press-fitted into the inner hole of the shaft portion 12b of the valve body 12 so as to be connected thereto.
  • the coil panel 13 is held in a compressed state between the portion 5 c.
  • the head 14a side is pressurized (pressed) with a force larger than the urging force of the coil spring 13 by a syringe or the like, the head 12a of the valve body 12 is separated from the constricted portion 5c and is opened.
  • a groove 14c is formed in the head 14b of the fixed shaft 14. As will be described later, when the injection port of the syringe comes into contact with the head portion 14b, the groove portion 14c does not close the injection port with the head portion 14b, and at least the groove portion 14c is used to connect the inside of the injection port to the syringe side. This is for communicating with the internal hole of the connecting portion 5.
  • the side of the indicator body 3 where the indicator chamber 9 is opened (the side where the cylindrical portion 6 is formed) Insert the indicator body 11 into the indicator room 11 from the opposite side. That is, the attachment portion l id is inserted into the inner hole 7 (guide path 8), and the bag portion l ib is inserted into a notch (not shown) that becomes the slit 10, and in this state, the attachment portion l id and The space between the injection hole 7 (guide path 8) forming the notch is hermetically sealed.
  • the cuff-side connecting portion 2 is joined to the indicator body 3 to which the indicator body 11 is attached on the side where the indicator chamber 9 is opened.
  • the notch 6a of the cylindrical portion 6 of the disc portion 2b is inserted into the bag portion ib of the indicator body 11, and the cylindrical portion 6 is directly inserted into the peripheral portion of the inner hole 7 of the indicator body 3.
  • the cuff side connection part 2 is hermetically sealed to the indicator body 3.
  • the indicator 1 is obtained by inserting the small diameter portion 5a of the syringe side connection portion 5 into which the check valve 4 is previously incorporated into the connection cylinder 3b of the syndicator body 3 and sealing hermetically.
  • the cuffed medical device 50 is used for a patient in accordance with a normal usage method. That is, the distal end side of the tube 80 is inserted from the mouth 100 of the patient, and the cuff 90 reaches the trachea 101.
  • a syringe (not shown) is connected to the syringe-side connecting portion 5 of the indicator 1.
  • the distal end side of the syringe is put into the inner hole, and the head portion 14a of the fixed shaft 14 of the check valve 4 is pressed by the distal end portion.
  • the head 14a is pushed against the urging force of the coil spring 13, whereby the head 12a of the valve body 12 is separated from the constricted portion 5c, and both sides of the constricted portion 5c communicate with each other to open the check valve 4. It becomes a state.
  • the syringe is operated to inject a predetermined amount of air.
  • the injected air passes through the narrowed portion 5c, passes through the internal hole, and flows into the guide path 8 (internal hole 7) of the indicator body 3. Then, the air that has passed through the guide path 8 reaches the inside hole of the cuff side connecting portion 2, and further passes through the inside of the connecting tube 71 connected to the cuff side connecting portion 2 and the inside of the second hole 83 of the tube 80. Through the first opening 84 force, into the cuff 90. By injecting air in this way, the cuff 90 expands to a degree of expansion corresponding to its internal pressure.
  • the cuff 90 becomes a space closed with respect to the atmosphere side by the airtight blockage of the connecting tube 71 side by the indicator 1. Since the opening 11c of the index body 11 in the index chamber 9 communicates with the index body 11 via the guide path 8, the internal pressure of the cuff 90 is applied to the index body 11. At this time, since the index chamber 9 communicates with the atmosphere (outside) through the communication hole 9a, each of the index chambers 9 corresponds to the pressure difference between the internal pressure of the cuff 90 and the atmospheric pressure, that is, corresponding to the internal pressure of the cuff 90. The indicator body 11 inflates the bag portion l ib.
  • the plurality of indicator bodies 11 are configured to have different degrees of expansion / contraction corresponding to the internal pressure of the cuff 90 as described above. By visually checking the degree, as described above, it is possible to quickly reduce the internal pressure of the cuff 90 and to accurately determine the force.
  • the internal pressure (expansion degree) of the cuff 90 is confirmed in this way, the internal pressure is within an allowable range. If it is below the minimum value, the cuff 90 can be inflated at a predetermined internal pressure by connecting the syringe again and injecting air. Even when air is injected with a syringe in this way, the force 90 can be expanded without excess or shortage by checking the degree of S crimp of each index body 11.
  • the indicator 1 is configured such that the plurality of index bodies 11 in the index chamber 9 communicating with the cuff 90 are expanded at different degrees of expansion / contraction according to the internal pressure of the cuff 90. It is made. Therefore, by visually observing the degree of expansion / contraction of each of the plurality of index bodies 11, it is possible to quickly determine a decrease in the internal pressure of the cuff and accurately determine the force. Therefore, there is no inconvenience when it takes a labor force S to detect a decrease in internal pressure as in the past, or when a certain amount of experience is required, and an unexpected accident can be reliably prevented.
  • each indicator body 3 is formed of a transparent resin and functions entirely as a window portion that can be seen through the inside, the degree of expansion / contraction of each indicator body 11 can be easily and quickly performed. Can be confirmed. Furthermore, since each index body 11 is configured to be identifiable by changing the color, by identifying in advance which color index body 11 corresponds to the internal pressure of the cuff 90, Whether or not the internal pressure of cuff 90 is appropriate can be determined more quickly and accurately.
  • the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the gist of the present invention.
  • the shape and structure of the indicator body can be expanded and contracted corresponding to the internal pressure of the cuff 90, and the expansion and contraction degree can be easily visually recognized from the outside, it is adopted in addition to the embodiment described above. Is possible.
  • the degree of expansion / contraction of each index body corresponding to the internal pressure of the cuff is made different by changing the thickness of the bag portion of each index body. For example, the material of each index body is changed. By doing so, the degree of expansion / contraction may be made different from each other.
  • a method for changing the color of each index body is not limited.
  • the structure of the check valve 4, the structure of the guide path 8 for communicating the check valve 4 side and the cuff 90 side, and the like are not limited to the structure of the above-described embodiment, and various forms are possible. Can be adopted.
  • the cuffed medical device to which the present invention is used can be applied to various devices such as a pulmonary artery balloon catheter in addition to the endotracheal tube.
  • the indicator for a medical device with a cuff of the present invention by visually observing the degree of expansion of each of the plurality of index bodies from the window portion of the indicator body, the internal pressure of the cuff is quickly reduced and the force is accurately determined. can do.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Endoscopes (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

An indicator for a medical tool with a cuff being fixed to the medical tool with a cuff and indicating the internal pressure of the cuff. The indicator for a medical tool with a cuff comprises a check valve, a joint for connection with the medical tool with a cuff, and an indicator body provided between the check valve and the joint. A guide channel for guiding fluid injected through the check valve to the joint side, and an index chamber separated from the guide channel airtightly are formed in the indicator body, and a plurality of balloon-like index bodies communicating with the interior of the cuff are provided in the index chamber to be able to expand/contract in response to the internal pressure of the cuff. The plurality of index bodies are arranged to exhibit different degrees of expansion/contraction in response to the internal pressure of the cuff, and the indicator body is provided with a window for making at least the degree of expansion/contraction of each of the plurality of index bodies visible. The indicator for a medical tool with a cuff can judge an internal pressure fall of the cuff quickly and accurately.

Description

明 細 書  Specification
カフ付医療具用インジケータ  Indicator for medical device with cuff
技術分野  Technical field
[0001] 本発明は、カフ付医療具に取り付けられて、この医療具のカフの内圧を示すカフ付 医療具用インジケータに関する。  [0001] The present invention relates to an indicator for a cuffed medical device which is attached to the cuffed medical device and indicates the internal pressure of the cuff of the medical device.
本願 ίま、 2006年 9月 26曰に、 曰本 (こ出願された特願 2006— 260895号 (こ基づさ 優先権を主張し、その内容をここに援用する。  In this application, on September 26, 2006, Tsujimoto (the Japanese Patent Application No. 2006-260895 filed here (claimed priority), the contents of which are incorporated herein by reference.
背景技術  Background art
[0002] 従来、医療分野では、カフ付 (バルーン付)医療具を用いて体内経路を閉塞する方 法が、よく知られている。例えば、人工呼吸を行なう際に用いられる「気管内チューブ 」は、一端が患者の口(経口)若しくは鼻 (経鼻)から挿入され、多端が人工呼吸器へ 接続される。この状態で「気管内チューブ」のカフを気管にて膨張させると、患者は気 管以下 (肺)が閉塞され、「気管内チューブ」内部を通じて連通状態である人工呼吸 器により強制呼吸させられる。  Conventionally, in the medical field, a method of occluding a body passage using a cuffed (ballooned) medical device is well known. For example, an “intratracheal tube” used for artificial respiration has one end inserted through the patient's mouth (oral) or nose (transnasal) and the other end connected to the ventilator. In this state, when the cuff of the “tracheal tube” is inflated in the trachea, the patient is obstructed below the trachea (lung) and forced to breathe with a ventilator that is in communication through the “intratracheal tube”.
[0003] また、他の例として、「肺動脈用バルーンカテーテル」がある。この例では類動脈な どの適切な血管を経由してカテーテルを血管に揷入し、その血流に乗せて力テーテ ルを肺動脈に到達させる。  Another example is a “pulmonary artery balloon catheter”. In this example, a catheter is inserted into a blood vessel via an appropriate blood vessel such as an arteriole, and the force tail reaches the pulmonary artery through the blood flow.
そして、この位置で、バルーンを膨張させカテーテル先端に設置されるセンサーによ り肺に血液が入り込む、レ、わゆる「楔入圧」を測定する。  At this position, the balloon is inflated, and a sensor placed at the tip of the catheter is used to measure the so-called “wedge insertion pressure” where blood enters the lungs.
[0004] しかし、このようなカフ(バルーン)付医療具は、どれもカフの膨張によって体内経路 を閉塞するので、そのカフの過膨張によって、例えば「気管内チューブ」においては 気管粘膜の圧迫による粘膜の損傷、「肺動脈用バルーンカテーテル」においては血 管損傷といった問題が生じていた。 [0004] However, all such medical devices with a cuff (balloon) block the body passage due to the expansion of the cuff. Mucosal damage, “balloon catheters for pulmonary arteries”, had problems such as blood vessel damage.
[0005] このような問題に対し、従来では、カフにより体内経路を閉鎖する際に生じる過膨張 を防止し、その作業性を簡易化するとともに、様々なカフ (バルーン)付医療器具に 使用することのできるカフ(バルーン)の膨張補助用具が提供されている(例えば、特 許文献 1参照)。 [0006] ところで、カフ(バノレーン)付医療具は、過膨張によって前記したような問題が生じる 、一方で、カフの内圧が低下し、予め設定された膨張度が維持できなくなると、気 管が塞がれて人工呼吸器による強制呼吸が不十分になったり、カテーテルを血流に 乗せて肺動脈に到達させる際の浮きとしての機能が低下するとレ、つた問題もある。力 フはゴム等によって形成されるため、流体としての空気が分子レベルでわずかずつ 漏れていき、内圧が低下して膨張度が低くなつてしまうからである。 [0005] In order to solve such problems, conventionally, overexpansion that occurs when a cuff closes a body route is prevented, the workability is simplified, and it is used for various medical devices with cuffs (balloons). A cuff (balloon) inflatable assisting device is provided (see, for example, Patent Document 1). [0006] By the way, in the medical device with a cuff (vanolene), the above-described problems occur due to overexpansion. On the other hand, when the internal pressure of the cuff decreases and the preset degree of expansion cannot be maintained, the trachea is There are also other problems when obstructed due to insufficiency of forced breathing by the ventilator, or when the function of floating when the catheter is placed in the bloodstream and reaches the pulmonary artery is reduced. The force is formed by rubber or the like, so air as a fluid leaks little by little at the molecular level, and the internal pressure decreases and the degree of expansion decreases.
[0007] 従来、このような内圧低下に関しては、例えばカフ付医療具の、カフに空気を注入 するために注射器を接続する分岐部にパイロットバルーンを設けておき、このパイ口 ットバノレーンの膨張度を、外観や触感で確認することにより、検知している。  [0007] Conventionally, with regard to such a decrease in internal pressure, for example, a pilot balloon has been provided at a branching portion of a medical device with a cuff to which a syringe is connected to inject air into the cuff, and the degree of expansion of this pie mouth banolane is increased. It is detected by checking the appearance and tactile sensation.
特許文献 1 :特開 2003— 116999号公報  Patent Document 1: Japanese Unexamined Patent Publication No. 2003-116999
発明の開示  Disclosure of the invention
発明が解決しょうとする課題  Problems to be solved by the invention
[0008] し力、しながら、このように外観や触感でパイロットバルーンの膨張度を確認し、カフ の内圧低下を検知するのでは、膨張度の確認に手間力 Sかかったり、ある程度の経験 が必要になることから、迅速にし力も正確にカフの内圧低下を判断するのは非常に 困難であった。 [0008] However, if the degree of expansion of the pilot balloon is confirmed by the appearance and the tactile sensation in this way, and the decrease in the internal pressure of the cuff is detected, it takes a labor force S to confirm the degree of expansion, and there is some experience. Because it was necessary, it was very difficult to determine the decrease in the internal pressure of the cuff quickly and accurately.
本発明は前記事情に鑑みてなされたもので、その目的は、カフの内圧低下を迅速 にし力、も正確に判断できるようにした、カフ付医療具用インジケータを提供する。 課題を解決するための手段  The present invention has been made in view of the above circumstances, and an object of the present invention is to provide an indicator for a medical device with a cuff that can quickly determine the internal pressure of the cuff and determine the force accurately. Means for solving the problem
[0009] 前記目的を達成するため本発明のカフ付医療具用インジケータは、カフ付医療具 に取り付けられて、該医療具のカフの内圧を示すカフ付医療具用インジケータであつ て、 In order to achieve the above object, an indicator for a cuffed medical device of the present invention is an indicator for a cuffed medical device that is attached to the cuffed medical device and indicates the internal pressure of the cuff of the medical device,
前記カフ内に流体を注入する注射器等の注入手段に接続可能な逆止弁と、 前記カフ付医療具に接続して前記カフ内に連通する接続部と、  A check valve connectable to injection means such as a syringe for injecting fluid into the cuff; a connection portion connected to the cuffed medical device and communicating with the cuff;
前記逆止弁と前記接続部との間に設けられたインジケータ本体と、を備えてなり、 前記インジケータ本体内には、前記注入手段により逆止弁を通って注入された流 体を前記接続部側に案内する案内路と、該インジケータ本体の外側に連通し、かつ 前記案内路に対して気密に隔てられた指標室とが形成され、 前記指標室内には、前記接続部を介して前記カフ内に連通する風船状の指標体 が複数、それぞれ前記カフの内圧に対応して膨縮可能に設けられ、 An indicator main body provided between the check valve and the connecting portion, and the fluid injected through the check valve by the injection means into the indicator main body. A guide path that guides to the side, and an indicator chamber that communicates with the outside of the indicator body and is hermetically separated from the guide path, In the indicator chamber, a plurality of balloon-like indicator bodies communicating with the inside of the cuff through the connecting portion are provided so as to be inflatable and inflatable corresponding to the internal pressure of the cuff,
前記複数の指標体は、前記カフ内の内圧に対応する膨縮度がそれぞれ異なって 構成され、  The plurality of indicator bodies are configured with different degrees of expansion / contraction corresponding to the internal pressure in the cuff,
前記インジケータ本体には、少なくとも前記複数の指標体のそれぞれの膨縮度を 視認可能にする窓部が形成されてレ、る。  The indicator body is formed with a window portion that allows at least the degree of expansion / contraction of each of the plurality of indicator bodies to be visually recognized.
[0010] このカフ付医療具用インジケータは、逆止弁に注射器等の注入手段を接続し、空 気等の流体を注入することにより、該流体が案内路、接続路を通ってカフ内に入る。 したがって、該カフを所定の膨張度に膨張させることができる。そして、この状態で注 入手段を逆止弁から外しても、逆止弁が作用することで、カフ内の空気(流体)は案 内路を通って外に漏れることはない。  [0010] This indicator for a medical device with a cuff connects an injection means such as a syringe to a check valve, and injects a fluid such as air, so that the fluid passes through a guide path and a connection path into the cuff. enter. Therefore, the cuff can be expanded to a predetermined degree of expansion. Even if the injection means is removed from the check valve in this state, the check valve acts so that the air (fluid) in the cuff does not leak out through the guide line.
また、上記のようにカフを膨張させた状態で保持すると、このカフ内に連通する指標 室内の複数の指標体は、それぞれカフの内圧に対応して膨張する。その際、これら 複数の指標体は、前記カフの内圧に対応する膨縮度がそれぞれ異なって構成され ているので、インジケータ本体の窓部からそれぞれの膨張度を視認することで、カフ の内圧低下等を迅速にし力も正確に判断することが可能になる。  Further, when the cuff is held in an expanded state as described above, the plurality of index bodies in the index chamber communicating with the cuff are expanded in accordance with the internal pressure of the cuff. At this time, since the plurality of indicator bodies are configured to have different degrees of expansion / contraction corresponding to the internal pressure of the cuff, the internal pressure of the cuff is reduced by visually checking each expansion degree from the window portion of the indicator body. It is possible to determine the force quickly and accurately.
[0011] 例えば、指標体を二つ設けた場合に、一方の指標体はカフの内圧が適正なときに 十分に膨張し、他方の指標体はカフの内圧が過大であるときに十分に膨張するよう に形成しておく。すると、カフの内圧が適正なときには、一方の指標体は十分に膨張 し、他方の指標体はその膨張度が僅力となる。したがって、このように一方の指標体 のみが十分に膨張している状態を視認することにより、カフの内圧が適正であること が分かる。  [0011] For example, when two indicator bodies are provided, one indicator body sufficiently expands when the internal pressure of the cuff is appropriate, and the other indicator body fully expands when the internal pressure of the cuff is excessive. Form it as you do. Then, when the internal pressure of the cuff is appropriate, one index body is sufficiently expanded, and the other index body has a small degree of expansion. Therefore, it can be seen that the internal pressure of the cuff is appropriate by visually observing the state where only one of the index bodies is sufficiently expanded.
また、カフの内圧が過大であるときには、両方の指標体が十分に膨張し、このような 状態を視認することにより、カフの内圧が過大であることが分かる。  In addition, when the internal pressure of the cuff is excessive, both index bodies expand sufficiently, and by visually recognizing such a state, it can be understood that the internal pressure of the cuff is excessive.
また、カフの内圧が低下したときには、両方の指標体の膨張度が共に僅カ^なるこ とから、このような状態を視認することにより、カフの内圧が低下していることが分かる  When the internal pressure of the cuff is reduced, the expansion of both index bodies is slightly reduced, so it can be seen that the internal pressure of the cuff is reduced by visually checking such a state.
[0012] また、前記カフ付医療具用インジケータの前記複数の指標体はそれぞれ、その口 部が前記案内路に開口することでその内部が該案内路を介して前記カフ内に連通し ていてもよい。 [0012] Further, each of the plurality of indicator bodies of the indicator for a cuffed medical device has its mouth The portion may be open to the guide path so that the inside thereof communicates with the cuff through the guide path.
このようにすれば、前記インジケータ本体の構造が簡易になるとともに、指標体の組 立性も良好になり、製造が容易になる。  In this way, the structure of the indicator body is simplified, the assemblability of the indicator body is improved, and the manufacture is facilitated.
[0013] また、前記カフ付医療具用インジケータの前記複数の指標体は、それぞれが識別 可能に構成されてレ、るのが好ましレ、。  [0013] Further, it is preferable that each of the plurality of index bodies of the cuffed medical instrument indicator is configured to be identifiable.
例えば、前記指標体の色を個々に変えてそれぞれを識別可能に構成しておき、ど の色の指標体がカフの内圧とどのように対応しているかを認識しておくことにより、力 フの内圧が適正であるか否かを迅速にかつ正確に判断できる。  For example, the color of the index body is individually changed so that each can be discriminated, and the index body of the color corresponds to the internal pressure of the cuff to recognize the force. It is possible to quickly and accurately determine whether the internal pressure is appropriate.
発明の効果  The invention's effect
[0014] 本発明のカフ付医療具用インジケータは、カフを膨張させた状態で保持すると、こ のカフ内に連通する指標室内の複数の指標体が、それぞれカフの内圧に対応して 膨張するように構成されている。そのため、インジケータ本体の窓部からこれら複数の 指標体のそれぞれの膨張度を視認することにより、カフの内圧低下等を迅速にしかも 正確に判断することができる。したがって、従来のように内圧低下を検知するのに手 間がかかったり、ある程度の経験が必要になるといった不都合がなくなる。  [0014] In the indicator for a medical device with a cuff of the present invention, when the cuff is held in an inflated state, a plurality of indicator bodies in the indicator chamber communicating with the cuff expands corresponding to the internal pressure of the cuff. It is configured as follows. Therefore, by visually observing the degree of expansion of each of the plurality of indicator bodies from the window portion of the indicator body, it is possible to quickly and accurately determine a decrease in the internal pressure of the cuff. Therefore, there is no inconvenience that it takes time to detect a decrease in internal pressure and a certain amount of experience is required as in the prior art.
図面の簡単な説明  Brief Description of Drawings
[0015] [図 1]本発明のインジケータを取り付けてなるカフ付医療具の概略構成を示す図であ る。  FIG. 1 is a diagram showing a schematic configuration of a cuffed medical device to which an indicator of the present invention is attached.
[図 2]従来のカフ付医療具を示す図である。  FIG. 2 is a view showing a conventional medical device with a cuff.
[図 3]本発明のカフ付医療具用インジケータの一実施形態の、概略構成を示す側断 面図である。  FIG. 3 is a side sectional view showing a schematic configuration of an embodiment of the indicator for a cuffed medical device of the present invention.
[図 4]図 3に示したカフ付医療具用インジケータの分解斜視図である。  4 is an exploded perspective view of the indicator for a cuffed medical device shown in FIG.
[図 5]インジケータ本体の斜視図である。  FIG. 5 is a perspective view of an indicator body.
[図 6]インジケータ本体の斜視図である。  FIG. 6 is a perspective view of an indicator body.
[図 7]インジケータ本体の一方の側の正面図である。  FIG. 7 is a front view of one side of the indicator body.
[図 8]図 7の A— A線矢視断面図である。  8 is a cross-sectional view taken along line AA in FIG.
[図 9]指標体の斜視図である。 園 10]指標体の側断面図である。 FIG. 9 is a perspective view of an index body. Fig. 10 is a side sectional view of the indicator body.
[図 11]カフ付医療具の使用方法を説明するための図である。  FIG. 11 is a diagram for explaining how to use the cuffed medical device.
符号の説明  Explanation of symbols
1 インジケータ(カフ付医療具インジケータ)  1 Indicator (medical instrument indicator with cuff)
2 カフ側接続部 (接続部)  2 Cuff side connection (connection)
3 インジケータ本体  3 Indicator body
4 逆止弁  4 Check valve
5 注射器側接続部  5 Syringe side connection
8 案内路  8 Guideway
9 指標室  9 Indicator room
9a 連通孔  9a Communication hole
11 指標体  11 Indicator
50 カフ付医療具  50 Medical device with cuff
発明を実施するための最良の形態  BEST MODE FOR CARRYING OUT THE INVENTION
[0017] 以下、本発明を詳しく説明する。  [0017] The present invention is described in detail below.
まず、本発明のカフ付医療具用インジケータの説明に先立ち、このインジケータが 取り付けられるカフ付医療具について説明する。図 1は本発明のインジケータ 1を取り 付けてなるカフ付医療具を示す図であり、図 2は従来のカフ付医療具を示す図である  First, prior to the description of the cuffed medical instrument indicator of the present invention, the cuffed medical instrument to which this indicator is attached will be described. FIG. 1 is a view showing a cuffed medical device to which the indicator 1 of the present invention is attached, and FIG. 2 is a view showing a conventional cuffed medical device.
[0018] 図 1、図 2中において符号 50はカフ付医療具としての一般的な気管内チューブで あり、このカフ付医療具 (気管内チューブ) 50は、人口呼吸器と接続可能なコネクタ 6 0と、カフを膨張させるための注入部 70と、患者の気管に挿入されるチューブ 80と、 気管を閉塞するためのカフ(バルーン) 90とから構成されてレ、る。 In FIG. 1 and FIG. 2, reference numeral 50 denotes a general endotracheal tube as a cuffed medical device, and this cuffed medical device (intratracheal tube) 50 is a connector 6 that can be connected to an artificial respirator. 0, an injection part 70 for inflating the cuff, a tube 80 to be inserted into the patient's trachea, and a cuff (balloon) 90 for occluding the trachea.
コネクタ 60は、全体が円筒状のもので、人工呼吸器に接続するための第 1接続筒 6 1と、後述するチューブ本体 81に気密に嵌合させられている第 2接続筒 62と、力 構 成されている。  The connector 60 is entirely cylindrical, and includes a first connection cylinder 61 for connection to a ventilator, a second connection cylinder 62 that is airtightly fitted to a tube body 81 described later, It is configured.
[0019] 注入部 70は、図 2に示すように従来のものでは、チューブ 80に接続された接続チ ユーブ 71と、パイロットバルーン 72と、逆止弁 73と力、ら構成されている。パイロットバ ルーン 72は、両側に開口部を有する風船状のもので、前述したようにその膨張状態 を外観や触感で確認することにより、パイロットバルーン 72に連通するカフ 90の内圧 を確認するためのものである。逆止弁 73は、前記パイロットバルーン 72と反対の側か らのみ空気(流体)の流入を可能にし、パイロットバノレーン 72側からは空気が抜け出 ないように構成されたもので、注射器に接続されて空気を流入するための流入口とな る。 As shown in FIG. 2, the injection portion 70 is configured by a connecting tube 71 connected to a tube 80, a pilot balloon 72, a check valve 73, and a force. Pilot bar The rune 72 is a balloon-like object having openings on both sides, and is used to confirm the internal pressure of the cuff 90 communicating with the pilot balloon 72 by confirming its inflated state by appearance and touch as described above. is there. The check valve 73 is configured to allow air (fluid) to flow only from the side opposite to the pilot balloon 72 and not to escape from the pilot vano lane 72 side, and is connected to the syringe. As a result, it becomes an inflow port for inflowing air.
このような構成の注入部 70では、特にカフ 90の内圧をパイロットバルーン 72の外 観やその触感で調べる (確認する)ため、前述したように外観からの膨張度の確認に 手間がかかったり、ある程度の経験が必要になるといった問題があった。  In the injection portion 70 having such a configuration, in particular, the internal pressure of the cuff 90 is examined (confirmed) by the appearance of the pilot balloon 72 and its tactile sensation. There was a problem that some experience was required.
[0020] そこで、本発明では、図 1に示したように、接続チューブ 71にインジケータ 1を接続 している。このインジケータ 1は、接続チューブ 71に接続するカフ側接続部 2と、円筒 状のインジケータ本体 3と、逆止弁(図示せず)を有してなる注射器側接続部 5とを備 えて構成されている。このような構成からなるインジケータ 1は、そのインジケータ本体 3内の指標体(図示せず)を視認することにより、カフ 90の内圧を容易に確認できる。 なお、このインジケータ 1の詳細については後述する。  Therefore, in the present invention, as shown in FIG. 1, the indicator 1 is connected to the connection tube 71. The indicator 1 includes a cuff side connection portion 2 connected to the connection tube 71, a cylindrical indicator body 3, and a syringe side connection portion 5 having a check valve (not shown). ing. The indicator 1 having such a configuration can easily confirm the internal pressure of the cuff 90 by visually recognizing an indicator body (not shown) in the indicator body 3. The details of the indicator 1 will be described later.
[0021] チューブ 80は、チューブ本体 81と、チューブ本体 81内をその全長に亘つて貫通す る第 1孔 82と、チューブ本体 81内の一部を貫通する第 2孔 83と、チューブ本体 81の 先端側(患者側)で第 2孔 83と外部とを連通させる第 1開口 84と、チューブ本体 81の 他端側で第 2孔 83と外部とを連通させる第 2開口 85とから構成されている。なお、こ の第 2開口 85には、前記接続チューブ 71がチューブ本体 81に対して気密に接着固 定されている。  The tube 80 includes a tube body 81, a first hole 82 that penetrates the entire length of the tube body 81, a second hole 83 that penetrates a part of the tube body 81, and a tube body 81. The first opening 84 communicates the second hole 83 and the outside on the distal end side (patient side), and the second opening 85 communicates the second hole 83 and the outside on the other end side of the tube body 81. ing. Note that the connection tube 71 is hermetically bonded and fixed to the tube body 81 in the second opening 85.
[0022] カフ 90は、前記第一開口 84を覆って設けられた風船状のもので、その両端部がチ ユーブ本体 81の外面に気密に接着され固定されたことにより、その内部が前記第一 開口 84を介してのみ外部に通じている。すなわち、カフ 90は、第 1開口 84を介して 第 2孔 83、接続チューブ 71に連通している。  [0022] The cuff 90 is a balloon-like one provided so as to cover the first opening 84, and both ends thereof are hermetically bonded and fixed to the outer surface of the tube body 81, so that the inside thereof is the first. 1 It communicates with the outside only through the opening 84. That is, the cuff 90 communicates with the second hole 83 and the connection tube 71 through the first opening 84.
[0023] 次に、前記インジケータ 1の詳細について説明する。このインジケータ 1は、本発明 のカフ付医療具用インジケータの一実施形態であり、図 3に示すように、前記接続チ ユーブ 71に接続するカフ側接続部 2と、円筒状のインジケータ本体 3と、逆止弁 4を 有してなる注射器側接続部 5とを備えて構成されている。 Next, details of the indicator 1 will be described. The indicator 1 is an embodiment of the indicator for a cuffed medical device according to the present invention. As shown in FIG. 3, the cuff side connecting portion 2 connected to the connecting tube 71, a cylindrical indicator body 3, and the like. , Check valve 4 And a syringe-side connecting portion 5 that is provided.
[0024] カフ側接続部 2は、図 3、図 4に示すように接続チューブ 71を内挿し(あるいは外挿 し)、接続チューブ 71に接続する円筒部 2aと、この円筒部 2aの一端側に接続する円 板部 2bと、この円板部 2bの外周縁部に形成されて、前記インジケータ本体 3に接続 するための大径円筒状の接続筒 2cとからなる樹脂製のものである。円板部 2bの内面 側、すなわち接続筒 2c側には、図 4に示すように、前記円筒部 2aの内部孔(図示せ ず)の開口 2dの周囲に、筒状部 6が突出した状態に形成されている。この筒状部 6は 、後述する案内路の一部を形成し、かつ前記開口 2dを中心として略三角形状に形 成されており、その各辺部にそれぞれ、後述する指標体を係合させるための切欠 6a を形成している。 [0024] As shown in Figs. 3 and 4, the cuff-side connecting portion 2 includes a cylindrical portion 2a in which the connecting tube 71 is inserted (or extrapolated) and connected to the connecting tube 71, and one end side of the cylindrical portion 2a. And a large-diameter cylindrical connecting tube 2c formed on the outer peripheral edge of the disk portion 2b and connected to the indicator body 3. As shown in FIG. 4, on the inner surface side of the disc portion 2b, that is, on the connecting tube 2c side, the cylindrical portion 6 protrudes around the opening 2d of the internal hole (not shown) of the cylindrical portion 2a. Is formed. The cylindrical portion 6 forms a part of a guide path, which will be described later, and is formed in a substantially triangular shape centering on the opening 2d, and an index body, which will be described later, is engaged with each side portion thereof. A notch 6a is formed for the purpose.
[0025] インジケータ本体 3は、ポリプロピレン(PP)等の透明樹脂からなり、したがってその 内部が視認可能に形成されて、全体が本発明における窓部として機能しており、図 3 、図 4、図 5、図 6、図 7、図 8に示すように、内部に空間部を形成してなる略円筒状の ものである。このインジケータ本体 3には、その一方の側の周縁部に、前記カフ側接 続部 2の接続筒 2cに内挿して接続する接続端 3aが形成され、他方の側には、その 中央部に、前記注射器側接続部 5に接続する接続筒 3bが形成されてレ、る。  [0025] The indicator body 3 is made of a transparent resin such as polypropylene (PP), and thus the inside thereof is formed so as to be visible, and the whole functions as a window portion in the present invention. As shown in FIGS. 5, 6, 7, and 8, it has a substantially cylindrical shape with a space formed inside. The indicator body 3 has a connection end 3a formed on the peripheral edge portion on one side thereof to be inserted into the connection tube 2c of the cuff side connection portion 2 and connected to the center portion on the other side. A connecting tube 3b connected to the syringe-side connecting portion 5 is formed.
[0026] また、このインジケータ本体 3には、その内部に、前記一方の側から他方の側にか けて貫通する内部孔 7が形成されている。この内部孔 7は、本発明における案内路の 一部を形成するもので、図 6、図 7に示すように前記接続端 3a側の開口形状が、前記 の円板部 2bに形成された筒状部 6の内部孔の形状(図 4参照)にほぼ一致する略三 角形状に形成され、図 5、図 8に示すようにその前記接続筒 3b側の開口形状が、円 形状に形成されている。  [0026] In addition, the indicator body 3 is formed with an internal hole 7 penetrating from the one side to the other side. This internal hole 7 forms a part of the guide path in the present invention, and as shown in FIGS. 6 and 7, the opening on the side of the connection end 3a is a cylinder formed in the disk portion 2b. Is formed in a substantially triangular shape substantially matching the shape of the internal hole of the shaped portion 6 (see FIG. 4), and the opening shape on the side of the connecting tube 3b is formed in a circular shape as shown in FIGS. ing.
このような構成のもとにこの内部孔 7と前記カフ側接続部 2の筒状部 6の内部孔とは 、図 3に示したようにインジケータ本体 3にカフ側接続部 2が接続されたことによって連 通し、後述するように注入手段によって注入された流体を前記カフ側接続部 2側に案 内する案内路 8を構成している。  Under such a configuration, the inner hole 7 and the inner hole of the cylindrical part 6 of the cuff side connecting part 2 are connected to the indicator body 3 as shown in FIG. Thus, as described later, a guide path 8 is constructed for introducing the fluid injected by the injection means to the cuff side connection portion 2 side as described later.
[0027] また、このインジケータ本体 3には、その内部に複数の指標室 9、本実施形態では 三つの指標室 9が形成されている。これら指標室 9は、図 6、図 7に示すように前記案 内路 8を中心にして、その外側に周方向に沿って等間隔で配設された空間であり、 前記カフ側接続部 2の円板部 2b側に開口した円柱状の空間である。そして、前記の 円板部 2b側の開口が該円板部 2bによって封止されることにより、各指標室はそれぞ れ独立した空間となっている。また、このインジケータ本体 3の、前記接続筒 3b側の 壁面には、空間からなる指標室 9を該インジケータ本体の外側に連通させる連通孔 9 aが、各指標室 9毎に形成されている。 [0027] In addition, the indicator body 3 is formed with a plurality of indicator chambers 9, and in the present embodiment, three indicator chambers 9 are formed therein. These indicator rooms 9 have the above plan as shown in Fig. 6 and Fig. 7. It is a space that is arranged at equal intervals around the inner path 8 along the circumferential direction, and is a cylindrical space that opens to the disc portion 2b side of the cuff side connecting portion 2. The opening on the disk part 2b side is sealed by the disk part 2b, so that each index chamber is an independent space. In addition, on the wall surface of the indicator body 3 on the side of the connecting tube 3b, a communication hole 9a is formed for each index chamber 9 for communicating the index chamber 9 made of a space to the outside of the indicator body.
[0028] また、前記の各指標室 9と前記案内路 8 (内部孔 7)との間には、これらの間を連通さ せるスリット 10が形成されている。そして、これらスリット 10にはそれぞれ、図 3に示す ように指標体 11が取り付けられている。ここで、スリット 10は、図 7、図 8に示すようにィ ンジケータ本体 3に形成された切欠 10aと、図 4に示した前記カフ側接続部 2の筒状 部 6の切欠 6aとが連続して形成されてレ、る。  [0028] In addition, a slit 10 is formed between each of the index chambers 9 and the guide path 8 (inner hole 7) so as to communicate with each other. Each of the slits 10 is attached with an index body 11 as shown in FIG. Here, the slit 10 has a notch 10a formed in the indicator body 3 as shown in FIGS. 7 and 8, and a notch 6a in the cylindrical part 6 of the cuff side connecting part 2 shown in FIG. And formed.
[0029] 指標体 11は、図 9、図 10に示したように口部 1 1aと袋部 l ibとを備えてなる風船状 のもので、軟質の樹脂(エラストマ一)やゴム等の伸縮自在の材料、例えばシリコンゴ ムからなり、これによつて袋部 l ibが膨縮可能に形成されている。指標体 1 1の口部 1 laは、開口部 11cとこれの周囲を構成する厚肉の取付部 l idとからなり、該取付部 1 Idが前記スリット 10に係止させられたことにより、指標体 11はインジケータ本体 3内 に取り付けられている。  [0029] As shown in Figs. 9 and 10, the indicator body 11 is a balloon-shaped member having a mouth portion 11a and a bag portion ib, and is made of a flexible resin (elastomer) or rubber. The bag portion l ib is formed so as to be inflatable / shrinkable. The opening 1 la of the indicator body 1 1 is composed of an opening 11c and a thick attachment portion l id that forms the periphery of the opening 11c, and the attachment portion 1 Id is locked to the slit 10, The indicator body 11 is attached in the indicator body 3.
[0030] すなわち、指標体 11は、その取付部 l idが案内路 8 (内部孔 7)内に配置され、袋 部 l ibが前記スリット 10を通って前記指標室 9内に配置され、その状態で取付部 11 dと案内路 8の内壁面との間が接着や溶着等によって気密にシールされたことにより、 インジケータ本体 3内に取り付けられてレ、る。  [0030] That is, the indicator body 11 has its mounting portion id arranged in the guide path 8 (inner hole 7), the bag portion ib passing through the slit 10, and placed in the indicator chamber 9, In this state, since the space between the mounting portion 11 d and the inner wall surface of the guide path 8 is hermetically sealed by adhesion or welding, it is attached in the indicator body 3.
[0031] そして、このような構成のもとに指標体 11は、後述するように案内路 8を介して前記 カフ 90内に連通している。また、取付部 l idと案内路 8の内壁面との間が気密にシー ルされたことにより、該案内路 8と前記各指標室 9との間を連通させるスリット 10が指 標体 11によって気密に塞がれ、これにより該案内路 8と前記各指標室 9とは、互いに 気密に隔てられている。  [0031] Based on such a configuration, the indicator body 11 communicates with the cuff 90 via a guide path 8 as described later. In addition, since the space between the mounting portion l id and the inner wall surface of the guide path 8 is hermetically sealed, a slit 10 that communicates between the guide path 8 and each index chamber 9 is formed by the index body 11. The guide path 8 and the indicator chambers 9 are hermetically separated from each other.
また、これら指標体 11は、案内路 8を介して連通する前記カフ 90の内圧に対応す る膨縮度が、それぞれ異なって構成されている。すなわち、本実施形態において三 つの指標体 11は、その袋部 l ibの厚さがそれぞれ異なって形成されており、これに よってその内圧に応じて膨張する度合い、つまり膨縮度が異なっている。 Further, these index bodies 11 are configured to have different degrees of expansion / contraction corresponding to the internal pressure of the cuff 90 communicating through the guide path 8. That is, in this embodiment, three The two indicator bodies 11 are formed with different thicknesses of the bag portions l ib, and thereby the degree of expansion according to the internal pressure, that is, the degree of expansion / contraction is different.
[0032] 具体的には、第 1の指標体 11は、前記カフ 90の内圧が適正である範囲ではほとん ど膨らまず、カフ 90の内圧が適正である範囲を越えたとき、すなわちカフ 90が過膨 張となったときに膨らむように、その膜厚が設定され形成されている。第 2の指標体 1 1は、カフ 90の内圧が適正な範囲において十分に膨らみ、適正な範囲を下回ってい るときには、十分な膨張度で膨らまないように、その膜厚が設定され形成されている。 第 3の指標体 11は、カフ 90の内圧が適正な範囲の下限値近傍において十分に膨ら み、この下限値の例えば半分程度以下ではほとんど膨らまないように、その膜厚が設 定され形成されている。 Specifically, the first indicator body 11 hardly swells in the range where the internal pressure of the cuff 90 is appropriate, and when the internal pressure of the cuff 90 exceeds the appropriate range, that is, the cuff 90 The film thickness is set so as to swell when over-swelled. The second indicator body 11 is formed with a film thickness set so that the internal pressure of the cuff 90 swells sufficiently in a proper range and does not swell with a sufficient degree of expansion when it is below the proper range. Yes. The thickness of the third indicator 11 is set so that the inner pressure of the cuff 90 swells sufficiently in the vicinity of the lower limit of the appropriate range, and hardly swells, for example, about half or less of this lower limit. Has been.
[0033] このような構成のもとに三つの指標体 11は、カフ 90の内圧に応じて異なった膨縮 度で膨らむ。すなわち、カフの内圧が適正なときには、第 2の指標体 11と第 3の指標 体 11とが十分な膨張度で膨らみ、第 1の指標体 11はほとんど膨らまない状態となる。 したがって、このように一方の指標体のみが十分に膨張している状態を視認すること により、カフの内圧が適正であることが分かる。  Based on such a configuration, the three indicator bodies 11 swell at different expansion / contraction degrees according to the internal pressure of the cuff 90. That is, when the internal pressure of the cuff is appropriate, the second index body 11 and the third index body 11 swell with sufficient expansion, and the first index body 11 hardly swells. Therefore, it can be seen that the internal pressure of the cuff is appropriate by visually observing the state in which only one of the index bodies is sufficiently expanded.
また、カフ 90の内圧が過大であるときには、三つの指標体 11がいずれも十分に膨 張することになり、このような状態を視認することにより、カフの内圧が過大であること が分かる。  Further, when the internal pressure of the cuff 90 is excessive, all of the three indicator bodies 11 are sufficiently expanded, and it can be understood that the internal pressure of the cuff is excessive by visually checking such a state.
[0034] また、カフ 90の内圧が低下し、その適正な範囲の下限値を下回ると、少なくとも第 1 の指標体 11と第 2の指標体 11とはその膨張度が共に非常に小さくなり、また第 3の 指標体 11もその膨張度が不十分となる。したがって、このように三つの指標体 11全 てが十分に膨らんでいないのを視認することにより、カフの内圧が低すぎることが分 かる。  [0034] Further, when the internal pressure of the cuff 90 decreases and falls below the lower limit value of the appropriate range, at least the first index body 11 and the second index body 11 both have very small degrees of expansion, In addition, the third index body 11 also has an insufficient degree of expansion. Therefore, it can be seen that the internal pressure of the cuff is too low by visually confirming that all the three indicator bodies 11 are not sufficiently inflated.
なお、特にカフ 90の内圧が過大であるとき、第 3の指標体 11が膨らみ過ぎて破裂 するように形成しておくことにより、これを安全弁として機能させることができる。  In particular, when the internal pressure of the cuff 90 is excessive, by forming the third indicator 11 so as to swell and rupture, it can function as a safety valve.
[0035] また、これら三つの指標体 11は、それぞれが識別可能に構成されているのが好ま しぐ本実施形態では、各指標体 11の色を個々に変えてそれぞれを識別可能に構 成している。具体的には、第 1の指標体 11の色を「赤」、第 2の指標体 11の色を「青」 、第 3の指標体の色を「緑」に着色しておく。このように、三つの指標体 11をそれぞれ 識別可能にしておけば、どの色の指標体 11がカフ 90の内圧とどのように対応してい るかを予め認識しておくことにより、カフ 90の内圧が適正であるか否かをより迅速にか つ正確に判断することができる。 In addition, in the present embodiment, it is preferable that each of these three indicator bodies 11 is configured to be identifiable. In the present embodiment, each indicator body 11 is configured to be identifiable by changing the color of each indicator body 11 individually. is doing. Specifically, the color of the first index body 11 is “red”, and the color of the second index body 11 is “blue”. The third indicator is colored “green”. In this way, if each of the three index bodies 11 can be identified, it is possible to recognize in advance which color index body 11 corresponds to the internal pressure of the cuff 90. Whether or not the internal pressure is appropriate can be determined more quickly and accurately.
[0036] 注射器側接続部 5は、図 3、図 4に示すように全体が円筒状のもので、その一端側 に小径部 5aを有し、この小径部 5aが前記インジケータ本体 3の接続筒 3bに内挿して ここに接続され、接着や溶着等によって気密にシールされたことにより、インジケータ 本体 3に固定されている。そして、このような構成のもとに注射器側接続部 5は、その 内部孔 5bが、前記インジケータ本体 3の内部孔 7に連通している。なお、この注射器 側接続部 5は、後述するようにその他端側において、内部孔 5bに注射器等の注入手 段(図示せず)が接続されている。本実施形態では、その内部孔 5bが、他端側から中 央部に行くに連れて漸次縮径するよう、テーパ状に形成されている。  The syringe-side connecting portion 5 is generally cylindrical as shown in FIGS. 3 and 4, and has a small-diameter portion 5a at one end thereof, and the small-diameter portion 5a is a connecting tube of the indicator body 3. It is fixed to the indicator body 3 by being inserted into 3b and connected here and hermetically sealed by adhesion or welding. With this configuration, the syringe-side connecting portion 5 has an internal hole 5b communicating with the internal hole 7 of the indicator body 3. As will be described later, the syringe-side connecting portion 5 has an injection means (not shown) such as a syringe connected to the internal hole 5b on the other end side. In the present embodiment, the inner hole 5b is formed in a tapered shape so that the diameter gradually decreases from the other end side toward the center.
[0037] また、この注射器側接続部 5の内部孔 5b内には、その中央部に、該内部孔 5bの内 径を狭める狭窄部 5cが形成されており、この狭窄部 5cに、前記逆止弁 4が設けられ ている。  [0037] Further, in the inner hole 5b of the syringe-side connecting part 5, a constricted part 5c for narrowing the inner diameter of the inner hole 5b is formed in the central part, and the reverse part is formed in the constricted part 5c. Stop valve 4 is provided.
逆止弁 4は、弁本体 12、コイルバネ 13と、固定軸 14とから構成されている。弁本体 12は、頭部 12aと円筒状の軸部 12bとからなるもので、頭部 12aが、前記狭窄部 5c の前記小径部 5a側に配置され、軸部 12bが、狭窄部 5cを通って前記小径部 5aと反 対の側に延びて配置されている。  The check valve 4 includes a valve body 12, a coil spring 13, and a fixed shaft 14. The valve body 12 includes a head portion 12a and a cylindrical shaft portion 12b. The head portion 12a is disposed on the narrow diameter portion 5a side of the narrowed portion 5c, and the shaft portion 12b passes through the narrowed portion 5c. Thus, it is arranged to extend on the side opposite to the small diameter portion 5a.
頭部 12aの内面 (狭窄部 5cに対向する面)は、軸部 12b側に行くに連れて漸次縮 径するテーパ状になっており、この内面に対向する狭窄部 5cの面も、該内面のテー パ形状に対応する逆テーパ形状となっている。このような構成によって弁本体 12の 頭部 12aは、狭窄部 5cに当接した際、狭窄部 5cに気密に密着する。  The inner surface of the head 12a (the surface facing the constricted portion 5c) is tapered such that the diameter gradually decreases toward the shaft portion 12b, and the surface of the constricted portion 5c facing the inner surface is also the inner surface. It has a reverse taper shape corresponding to the taper shape. With such a configuration, the head portion 12a of the valve main body 12 comes into tight contact with the stenosis portion 5c when contacting the stenosis portion 5c.
[0038] コイルバネ 13は、狭窄部 5cを通り抜けた部分の軸部 12bに外揷して設けられてい る。 [0038] The coil spring 13 is provided on the outer side of the shaft portion 12b passing through the narrowed portion 5c.
固定軸 14は、頭部 14aと軸部 14bとからなるもので、軸部 14bが前記弁本体 12の 軸部 12bの内部孔に圧入されて連結されたことにより、その頭部 14aと前記狭窄部 5 cとの間に前記コイルパネ 13を圧縮させた状態に保持している。このような構成によ つて逆止弁 4は、固定軸 14の頭部 14a側が加圧されない通常時においては、コイル パネ 13の付勢力によって弁本体 12の頭部 12aが狭窄部 5c側に引つ張られ、該頭部 12aの内面と狭窄部 5cとが気密に密着して閉じた状態となる。一方、注射器等により 、コイルバネ 13の付勢力より大きな力で頭部 14a側を加圧(押圧)すると、弁本体 12 の頭部 12aが狭窄部 5cから離間し、開いた状態となる。 The fixed shaft 14 is composed of a head portion 14a and a shaft portion 14b, and the shaft portion 14b is press-fitted into the inner hole of the shaft portion 12b of the valve body 12 so as to be connected thereto. The coil panel 13 is held in a compressed state between the portion 5 c. With this configuration In the normal state where the head 14a side of the fixed shaft 14 is not pressurized, the check valve 4 is pulled by the head 12a of the valve body 12 toward the constriction 5c side by the urging force of the coil panel 13. The inner surface of the portion 12a and the constricted portion 5c are in close contact with each other in an airtight manner. On the other hand, when the head 14a side is pressurized (pressed) with a force larger than the urging force of the coil spring 13 by a syringe or the like, the head 12a of the valve body 12 is separated from the constricted portion 5c and is opened.
[0039] また、この固定軸 14の頭部 14bには、溝 14cが形成されている。この溝部 14cは、 後述するように頭部 14bに注射器の注入口が当接した際、この注入口を頭部 14bに よって塞ぐことなく、少なくともこの溝部 14cを介して注入口の内部を注射器側接続部 5の内部孔に連通させるためのものである。  [0039] A groove 14c is formed in the head 14b of the fixed shaft 14. As will be described later, when the injection port of the syringe comes into contact with the head portion 14b, the groove portion 14c does not close the injection port with the head portion 14b, and at least the groove portion 14c is used to connect the inside of the injection port to the syringe side. This is for communicating with the internal hole of the connecting portion 5.
[0040] このような構成からなるインジケータ 1を組み立てるには、図 3、図 4に示したように、 まず、インジケータ本体 3の、指標室 9を開口した側 (筒状部 6を形成した側と反対の 側)から指標体 11をそれぞれの指標室 11に揷し入れる。すなわち、その取付部 l id を内部孔 7 (案内路 8)内に挿入するとともに、袋部 l ibを、スリット 10となる切欠(図示 せず)に挿し込み、その状態で取付部 l idと前記切欠を形成する注入孔 7 (案内路 8 )の内壁面との間を気密にシールする。  In order to assemble the indicator 1 having such a configuration, as shown in FIGS. 3 and 4, first, the side of the indicator body 3 where the indicator chamber 9 is opened (the side where the cylindrical portion 6 is formed) Insert the indicator body 11 into the indicator room 11 from the opposite side. That is, the attachment portion l id is inserted into the inner hole 7 (guide path 8), and the bag portion l ib is inserted into a notch (not shown) that becomes the slit 10, and in this state, the attachment portion l id and The space between the injection hole 7 (guide path 8) forming the notch is hermetically sealed.
[0041] 次いで、指標体 11を取り付けたインジケータ本体 3に対し、指標室 9を開口した側 にカフ側接続部 2を接合する。その際、前記円板部 2bの筒状部 6の切欠 6aを、前記 指標体 11の袋部 l ibに挿し入れ、そのまま筒状部 6を前記インジケータ本体 3の内 部孔 7の周辺部に当接させるとともに、その状態でカフ側接続部 2をインジケータ本 体 3に気密にシールする。  [0041] Next, the cuff-side connecting portion 2 is joined to the indicator body 3 to which the indicator body 11 is attached on the side where the indicator chamber 9 is opened. At that time, the notch 6a of the cylindrical portion 6 of the disc portion 2b is inserted into the bag portion ib of the indicator body 11, and the cylindrical portion 6 is directly inserted into the peripheral portion of the inner hole 7 of the indicator body 3. At the same time, in this state, the cuff side connection part 2 is hermetically sealed to the indicator body 3.
その後、シンジケータ本体 3の接続筒 3bに、予め逆止弁 4を組み込んだ注射器側 接続部 5の小径部 5aを内挿し、気密にシールすることにより、インジケータ 1を得る。  After that, the indicator 1 is obtained by inserting the small diameter portion 5a of the syringe side connection portion 5 into which the check valve 4 is previously incorporated into the connection cylinder 3b of the syndicator body 3 and sealing hermetically.
[0042] 次に、このような構成のインジケータ 1を備えたカフ付き医療具 (気管内チューブ) 5 0の使用方法を説明する。  [0042] Next, a method of using the cuffed medical device (intratracheal tube) 50 including the indicator 1 having such a configuration will be described.
図 11に示すように、まず、カフ付き医療具 50を、通常の使用方法通りに患者に対し て用いる。すなわち、患者の口 100からチューブ 80の先端側を揷入し、カフ 90を気 管 101にまで到達させる。  As shown in FIG. 11, first, the cuffed medical device 50 is used for a patient in accordance with a normal usage method. That is, the distal end side of the tube 80 is inserted from the mouth 100 of the patient, and the cuff 90 reaches the trachea 101.
[0043] 次に、インジケータ 1の注射器側接続部 5に注射器(図示せず)を接続する。すなわ ち、注射器の先端側をその内部孔内に入れ、その先端部で逆止弁 4の固定軸 14の 頭部 14aを押圧する。すると、コイルバネ 13の付勢力に抗して頭部 14aが押し込まれ 、これにより弁本体 12の頭部 12aが狭窄部 5cから離間し、狭窄部 5cの両側が連通し て逆止弁 4が開いた状態となる。 Next, a syringe (not shown) is connected to the syringe-side connecting portion 5 of the indicator 1. Snow That is, the distal end side of the syringe is put into the inner hole, and the head portion 14a of the fixed shaft 14 of the check valve 4 is pressed by the distal end portion. Then, the head 14a is pushed against the urging force of the coil spring 13, whereby the head 12a of the valve body 12 is separated from the constricted portion 5c, and both sides of the constricted portion 5c communicate with each other to open the check valve 4. It becomes a state.
[0044] このような状態のもとで注射器を操作し、予め設定した所定量の空気を注入する。 [0044] Under such a state, the syringe is operated to inject a predetermined amount of air.
すると、注入された空気は、狭窄部 5cを通過して内部孔を通り、前記インジケータ本 体 3の案内路 8 (内部孔 7)に流入する。そして、この案内路 8を通過した空気は、カフ 側接続部 2の内部孔内に至り、さらにこのカフ側接続部 2に接続した前記接続チュー ブ 71内、チューブ 80の第 2孔 83内を通って第 1開口 84力、らカフ 90内に流入する。こ のようにして空気が注入されることにより、カフ 90はその内圧に対応した膨張度に膨 張する。  Then, the injected air passes through the narrowed portion 5c, passes through the internal hole, and flows into the guide path 8 (internal hole 7) of the indicator body 3. Then, the air that has passed through the guide path 8 reaches the inside hole of the cuff side connecting portion 2, and further passes through the inside of the connecting tube 71 connected to the cuff side connecting portion 2 and the inside of the second hole 83 of the tube 80. Through the first opening 84 force, into the cuff 90. By injecting air in this way, the cuff 90 expands to a degree of expansion corresponding to its internal pressure.
なお、このようにして案内路 8に空気を通過させると、その一部は指標体 11の取付部 11 dに形成された開口部 11 cを通つてその袋部 11 bに流入する。  When air is passed through the guide path 8 in this way, a part of the air flows into the bag portion 11 b through the opening portion 11 c formed in the attachment portion 11 d of the indicator body 11.
[0045] このようにして空気を注入したら、注射器を前記注射器側接続部 5から取り外す。す ると、逆止弁 4の固定軸 14は、押圧力が解除されたことによってコイルパネ 13に付勢 され、移動する。これにより、弁本体 12も狭窄部 5c側に引っ張られ、該頭部 12aの内 面と狭窄部 5cとが気密に密着することにより、逆止弁 4は閉じる。  [0045] When air is injected in this manner, the syringe is removed from the syringe-side connecting portion 5. Then, the fixed shaft 14 of the check valve 4 is urged by the coil panel 13 by the release of the pressing force and moves. As a result, the valve body 12 is also pulled toward the constricted portion 5c, and the check valve 4 is closed when the inner surface of the head portion 12a and the constricted portion 5c are tightly adhered.
[0046] このようにして逆止弁 4が閉じると、カフ 90は、その接続チューブ 71側がインジケー タ 1によって気密に塞がれることにより、大気側に対して閉じられた空間となる。そして 、指標室 9内の指標体 11はその開口部 11cが案内路 8を介してカフ 90内に通じてい るので、カフ 90の内圧が指標体 1 1にかかるようになる。このとき、指標室 9は連通孔 9 aによって大気中(外側)に通じているため、カフ 90の内圧と大気圧との圧力差によつ て、すなわちカフ 90の内圧に対応して、各指標体 11はその袋部 l ibを膨らませる。  When the check valve 4 is closed in this way, the cuff 90 becomes a space closed with respect to the atmosphere side by the airtight blockage of the connecting tube 71 side by the indicator 1. Since the opening 11c of the index body 11 in the index chamber 9 communicates with the index body 11 via the guide path 8, the internal pressure of the cuff 90 is applied to the index body 11. At this time, since the index chamber 9 communicates with the atmosphere (outside) through the communication hole 9a, each of the index chambers 9 corresponds to the pressure difference between the internal pressure of the cuff 90 and the atmospheric pressure, that is, corresponding to the internal pressure of the cuff 90. The indicator body 11 inflates the bag portion l ib.
[0047] その際、複数の指標体 1 1は、前記したようにカフ 90の内圧に対応する膨縮度がそ れぞれ異なって構成されているので、インジケータ本体 3の外側からそれぞれの膨張 度を視認することにより、前述したようにカフ 90の内圧低下等を迅速にし力、も正確に 判断することができる。  [0047] At that time, the plurality of indicator bodies 11 are configured to have different degrees of expansion / contraction corresponding to the internal pressure of the cuff 90 as described above. By visually checking the degree, as described above, it is possible to quickly reduce the internal pressure of the cuff 90 and to accurately determine the force.
[0048] このようにしてカフ 90の内圧 (膨張度)を確認した際、その内圧が許容される範囲で の最小値を下回っているような場合には、再度注射器を接続して空気を注入すること により、カフ 90を所定の内圧で膨張させることができる。なお、このように注射器で空 気を注入する際にも、各指標体 11の S彭縮度を見ながら行うことにより、過不足なく力 フ 90を膨張させることができる。 [0048] When the internal pressure (expansion degree) of the cuff 90 is confirmed in this way, the internal pressure is within an allowable range. If it is below the minimum value, the cuff 90 can be inflated at a predetermined internal pressure by connecting the syringe again and injecting air. Even when air is injected with a syringe in this way, the force 90 can be expanded without excess or shortage by checking the degree of S crimp of each index body 11.
その後、カフ付医療具 (気管内チューブ) 50のコネクタ 60に接続された人工呼吸器 (図示せず)により、人工呼吸を行わせる。  Thereafter, artificial respiration is performed by a ventilator (not shown) connected to the connector 60 of the cuffed medical device (intratracheal tube) 50.
[0049] 以上述べたようにこのインジケータ 1は、カフ 90内に連通する指標室 9内の複数の 指標体 11が、カフ 90の内圧に対応してそれぞれ異なる膨縮度で膨張するように構 成されている。このため複数の指標体 11のそれぞれの膨縮度を視認することにより、 カフの内圧低下等を迅速にし力も正確に判断することができる。したがって、従来の ように内圧低下を検知するのに手間力 Sかかったり、ある程度の経験が必要になるとい つた不都合がなくなり、不測の事故を招くことも確実に防止される。  [0049] As described above, the indicator 1 is configured such that the plurality of index bodies 11 in the index chamber 9 communicating with the cuff 90 are expanded at different degrees of expansion / contraction according to the internal pressure of the cuff 90. It is made. Therefore, by visually observing the degree of expansion / contraction of each of the plurality of index bodies 11, it is possible to quickly determine a decrease in the internal pressure of the cuff and accurately determine the force. Therefore, there is no inconvenience when it takes a labor force S to detect a decrease in internal pressure as in the past, or when a certain amount of experience is required, and an unexpected accident can be reliably prevented.
[0050] また、インジケータ本体 3が透明樹脂で形成されており、その全体が内部を透かし て見ることのできる窓部として機能するので、各指標体 11の膨縮度を容易にかつ迅 速に確認することができる。さらに、各指標体 11を、それぞれ色を変えて識別可能に 構成しているので、どの色の指標体 11がカフ 90の内圧とどのように対応しているかを 予め認識しておくことにより、カフ 90の内圧が適正であるか否かをより迅速にかつ正 確に判断することができる。  [0050] In addition, since the indicator body 3 is formed of a transparent resin and functions entirely as a window portion that can be seen through the inside, the degree of expansion / contraction of each indicator body 11 can be easily and quickly performed. Can be confirmed. Furthermore, since each index body 11 is configured to be identifiable by changing the color, by identifying in advance which color index body 11 corresponds to the internal pressure of the cuff 90, Whether or not the internal pressure of cuff 90 is appropriate can be determined more quickly and accurately.
[0051] なお、本発明は前記実施形態に限定されることなぐ本発明の要旨を逸脱しない範 囲で種々の変更が可能である。例えば、指標体の形状や構造についても、カフ 90の 内圧に対応して膨縮可能であり、その膨縮度が外から容易に視認できるものであれ ば、前記実施形態のもの以外にも採用可能である。  [0051] It should be noted that the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the gist of the present invention. For example, if the shape and structure of the indicator body can be expanded and contracted corresponding to the internal pressure of the cuff 90, and the expansion and contraction degree can be easily visually recognized from the outside, it is adopted in addition to the embodiment described above. Is possible.
また、前記実施形態では、カフの内圧に対応する各指標体の膨縮度を、各指標体 の袋部の厚さを変えることで互いに異ならせているが、例えば各指標体の材質を変 えることにより、膨縮度を互いに異ならせるようにしてもよい。  In the above-described embodiment, the degree of expansion / contraction of each index body corresponding to the internal pressure of the cuff is made different by changing the thickness of the bag portion of each index body. For example, the material of each index body is changed. By doing so, the degree of expansion / contraction may be made different from each other.
[0052] さらに、前記実施形態では、指標体を三つ備えて構成したが、二つでも、また四つ 以上であってもよい。  [0052] Furthermore, in the above-described embodiment, three index bodies are provided, but there may be two or four or more.
また、各指標体を識別可能に構成する方法としては、それぞれ色を変える方法以 外にも、例えば模様や数字 (文字)等を袋部等の表面に設けておくといった方法を採 用すること力 Sできる。 In addition, as a method of configuring each index body so as to be identifiable, a method for changing the color of each index body is not limited. In addition, it is possible to apply a method in which patterns, numbers (characters), etc. are provided on the surface of the bag or the like.
[0053] また、逆止弁 4の構造や、この逆止弁 4側とカフ 90側とを連通させる案内路 8の構造 等についても、前記実施形態の構造に限定されることなく種々の形態が採用可能で ある。  [0053] Also, the structure of the check valve 4, the structure of the guide path 8 for communicating the check valve 4 side and the cuff 90 side, and the like are not limited to the structure of the above-described embodiment, and various forms are possible. Can be adopted.
さらに、前記実施形態では、本発明が用いられるカフ付医療具としても、前記の気 管内チューブ以外にも、例えば肺動脈用バルーンカテーテルなど、種々のものに適 用可能である。  Furthermore, in the embodiment, the cuffed medical device to which the present invention is used can be applied to various devices such as a pulmonary artery balloon catheter in addition to the endotracheal tube.
産業上の利用可能性  Industrial applicability
[0054] 本発明のカフ付医療具用インジケータによれば、インジケータ本体の窓部から前記 複数の指標体のそれぞれの膨張度を視認することにより、カフの内圧低下等を迅速 にし力も正確に判断することができる。 [0054] According to the indicator for a medical device with a cuff of the present invention, by visually observing the degree of expansion of each of the plurality of index bodies from the window portion of the indicator body, the internal pressure of the cuff is quickly reduced and the force is accurately determined. can do.

Claims

請求の範囲 The scope of the claims
[1] カフ付医療具に取り付けられて、該医療具のカフの内圧を示すカフ付医療具用ィ ンジケータであって、  [1] A cuffed medical device indicator attached to a cuffed medical device and indicating an internal pressure of the cuff of the medical device,
前記カフ内に流体を注入する注射器等の注入手段に接続可能な逆止弁と、 前記カフ付医療具に接続して前記カフ内に連通する接続部と、  A check valve connectable to injection means such as a syringe for injecting fluid into the cuff; a connection portion connected to the cuffed medical device and communicating with the cuff;
前記逆止弁と前記接続部との間に設けられたインジケータ本体と、を備えてなり、 前記インジケータ本体内には、前記注入手段により逆止弁を通って注入された流 体を前記接続部側に案内する案内路と、該インジケータ本体の外側に連通し、かつ 前記案内路に対して気密に隔てられた指標室とが形成され、  An indicator main body provided between the check valve and the connecting portion, and the fluid injected through the check valve by the injection means into the indicator main body. A guide path that guides to the side, and an indicator chamber that communicates with the outside of the indicator body and is hermetically separated from the guide path,
前記指標室内には、前記接続部を介して前記カフ内に連通する風船状の指標体 が複数、それぞれ前記カフ内の内圧に対応して膨縮可能に設けられ、  In the indicator chamber, a plurality of balloon-like indicator bodies that communicate with the inside of the cuff through the connecting portion are provided so as to be inflatable and inflatable corresponding to the internal pressure in the cuff,
前記複数の指標体は、前記カフの内圧に対応する膨縮度がそれぞれ異なって構 成され、  The plurality of indicator bodies are configured with different degrees of expansion / contraction corresponding to the internal pressure of the cuff,
前記インジケータ本体には、少なくとも前記複数の指標体のそれぞれの膨縮度を 視認可能にする窓部が形成されているカフ付医療具用インジケータ。  The indicator for a medical device with a cuff, wherein the indicator main body is formed with a window portion that allows at least the degree of expansion / contraction of each of the plurality of index bodies to be visually recognized.
[2] 前記複数の指標体はそれぞれ、その口部が前記案内路に開口することでその内部 が該案内路を介して前記カフ内に連通している請求項 1記載のカフ付医療具用イン ジケータ。  [2] The medical device with a cuff according to claim 1, wherein each of the plurality of indicator bodies has a mouth portion that opens into the guide path so that the inside thereof communicates with the cuff through the guide path. Indicator.
[3] 前記複数の指標体は、それぞれが識別可能に構成されている請求項 1又は 2に記 載のカフ付医療具用インジケータ。  [3] The cuffed medical instrument indicator according to claim 1 or 2, wherein each of the plurality of indicator bodies is configured to be identifiable.
PCT/JP2007/058547 2006-09-26 2007-04-19 Indicator for medical tool with cuff WO2008038430A1 (en)

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US10238824B2 (en) 2012-12-11 2019-03-26 Tracoe Medical Gmbh Pressure equalization balloon and method for the production thereof
US10105521B2 (en) 2013-01-31 2018-10-23 Medtronic Xomed, Inc. Inflation device for balloon sinus dilation
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US10744287B2 (en) 2017-11-29 2020-08-18 Airway Medix S.A. Laryngeal mask cuffs
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