JP3062386B2 - Double lumen catheter with pressure sensor - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION The present invention provides a double lumen catheter with a pressure sensor for measuring central venous pressure.

[0002]

2. Description of the Related Art In central venous pressure measurement, there is a measurement using a low pressure measurement transducer or a direct water column pressure. The double lumen catheter used in these measurements detects intravascular pressure on one side,
The other side is used as a drug solution injection or blood collection line. In such pressure measurement, zero point adjustment is required, and height adjustment of the patient's heart and measuring instruments and the like has to be performed. The detected pressure value is poor in responsiveness due to the blood pressure passing through a physiological saline solution and sensed by a pressure sensor, resulting in a blunt waveform, making it difficult to obtain a true value. Also, when the liquid column meter 51 is used as shown in FIG. 49, the value read from the scale may have a visual error, and in this case also, reliability is lacking. Before use, priming with a physiological saline solution was performed on both sides of the catheter 52, and during the measurement, particularly the pressure measurement line 53 was constantly flushed with a physiological saline solution or the like in order to prevent blood coagulation. In the middle, 54 is a raw food bottle, and 55 is a drug solution container.
The inventor of the present invention has made intensive studies in order to solve the above-mentioned problems, and has arrived at the following invention.

[0003]

Means for Solving the Problems [1] The present invention provides:Kate
Chemical (blood) flow paths 9, 9 inside the teller body 2 through partition walls 8
a and a pressure measuring space 10 are formed, Tip or tip of body 2
The pressure sensors 3, 3a are arranged at a slight distance from the end.
Grooves 17 and 17a to be placed are formed, Behind the body 2
Chemical liquid injection line 1 communicating with chemical liquid (blood) flow paths 9 and 9a
1 and a pressure sensor line communicating with the pressure measuring space 10.
With the 12 The pressure sensors 3, 3a are sensors
-Sensor 4 and table consisting of chip 6 and ceramic substrate 7
Seat 5, 5a, The sensor chip 6 is semiconductive
It consists of a body strain gauge, The ceramic substrate 7 has a hole 27
Formed and the terminals 28 are attached, The pedestal 5, 5
a is a groove 18 for mounting the ceramic substrate 7;
Having a bottom plate 23 in which the ventilation paths 20 and 20a are formed, The mosquito
The pressure sensor is provided in the grooves 17 and 17a of the catheter body 2.
Attach parts 3, 3a, The sensor chip 6 and a drug solution (blood
Liquid) channels 9 and 9a are formed by partition walls 8, pedestals 5, 5a and ceramics.
Double room with pressure sensor arranged via
A catheter 1 is provided.  [2] The present invention provides:Separation wall 8 in catheter body 2, 2e
(Blood) flow path 9, 9a, 9e and pressure measurement space through
10, 10e are formed, Tip or tip of body 2, 2e
Pressure sensors 3, 3a are placed at a slight distance from
Forming grooves 17, 17a and 17e, Body 2, 2
a, the liquid medicine (blood) flow path 9, 9a, 9e
Liquid injection line 11 communicating with the pressure measuring space 1
Equipped with pressure sensor line 12 communicating with 0, 10e
And The pressure sensor units 3 and 3a are a sensor chip 6,
A pedestal 5b in which 6d and 6e are integrally formed with a ceramic substrate;
5c, 5d, and 5e. Said
The sensor chips 6, 6d and 6e are made of semiconductor strain gauges.
And The pedestals 5b, 5c, 5d and 5e have ventilation holes 20d,
Terminals 28 are attached to the bottom plates 25 and 25d on which 20e is formed.
And Grooves 17, 17a of the catheter bodies 2, 2e,
17e, the pressure sensor units 3, 3a are mounted, The above
Sensor chips 6, 6d, 6e and the chemical solution flow paths 9, 9a,
9b, 9e, partition 8 and pedestals 5b, 5c, 5d, 5e
Double lumen catheter with pressure sensor arranged via
Provide the first one.  [3] The present invention provides:In the catheter body 2f via the partition wall 8f
(Medical) (blood) flow paths 9b, 9c, 9f and pressure measurement space
Forming 10b, 10c, 10f, The pressure measurement space 1
The cross sections of 0b, 10c and 10f are formed in a semicircular shape.
The cross sections of the drug solution (blood) channels 9b, 9c, 9f
Constant space 10b, 10c, 1 Formed into a circle with a smaller diameter than 0f
And Keep the tip of the main body 2f or some distance from the tip
Grooves 17 and 17f for disposing pressure sensor sections 3 and 3a
To form The liquid medicine (blood) flow path 9 is provided behind the main body 2f.
b, 9c, 9f and the liquid injection line 11 communicating with the pressure
Pressure sensors communicating with force measurement spaces 10b, 10c, 10f
Wear the surline 12, The pressure sensor section 3f is
Mounting the sensor chip 6f on the ceramic substrate 7f
Consisting of The sensor chip 6f is a semiconductor strain gauge.
Page, The grooves 17, 1 of the catheter body 2f
Attach the pressure sensor 3f to 7f, The sensor
The chip 6f and the chemical (blood) flow paths 9b, 9c, 9f
Pressure placed via partition wall 8f and ceramic substrate 7f
A double lumen catheter 1 with a sensor is provided.

[0004]

FIG. 1 is a schematic view of a double lumen catheter 1 with a pressure sensor according to the present invention (hereinafter, catheter 1) (FIG. 2).
FIG. 1 is a cross-sectional view taken along the line AA in FIG. 1. A catheter 1 is a double-lumen catheter body 2 made of a flexible synthetic resin and provided with a drug solution (blood) flow path 9 and a pressure measurement space 10 via a partition wall 8. (Hereinafter referred to as the main body 2), a pressure sensor unit 3 mounted in front of the main body 2, and a drug solution injection (blood collection) line 1 behind the main body 2 via a connecting member 8a such as a connector.
1 and a pressure sensor line 12. A chemical liquid injection (blood collection) device 14 and the like are mounted behind the chemical liquid injection (blood collection) line 11 via a connecting member such as a three-way cock, and a connection member 13 with, for example, a dedicated pressure monitor is mounted behind the pressure sensor line 12. Is installed. The main body 2 is made of a flexible synthetic resin such as a Teflon-based, polyurethane-based, silicone-based or polyvinyl chloride-based resin, and can have a cross-sectional shape other than the cross-sectional shape shown in FIG.

FIG. 3 is an enlarged view of the pressure sensor section 3 of FIG. 1, and FIG. 4 is an exploded view of FIG. The pressure sensor unit 3 includes a sensor 4 including a sensor chip 6 and a ceramic substrate 7.
And a pedestal 5 on which the sensor chip 6 is mounted. The sensor chip 6 is mounted on the ceramic substrate 7 having the hole 27 formed thereon, and the substrate 7 is mounted on the pedestal 5 to assemble the device.
This makes the sensor 4 less susceptible to other disturbances. The lead wire 16 and the extra fine pipe 1
5 is mounted. The sensor chip 6 constituting the pressure sensor unit 3 is made of silicon (silicon semiconductor strain gauge), and the semiconductor type has high sensitivity and small hysteresis, so that it can be miniaturized and highly accurate, and can accurately grasp the time change of blood pressure. . In addition, it is inexpensive and can be disposable. The ceramic substrate 7 is made of ceramic and is necessary for bonding the lead wire 16 to the ceramic substrate 7 and providing the hole 27 for guiding the atmospheric pressure. The pedestal 5 is made of stainless steel (SUS31
6) It is necessary in order to easily attach the sensor 4 to the flexible main body 2 as described above, which is made of ceramic and has a shape capable of securing an air passage. The lead wire 16 serves to convert the stress generated by the pressure applied to the pressure sensor unit 3 into a signal by the pressure sensor unit 3 and send the signal to a measuring device such as a dedicated monitor connected to the outside. FIG.
As shown in (1), a terminal 28 made of gold plating is formed on the surface of the ceramic substrate 7, and plays a role of joining the lead wire 16 and the sensor chip 6 by a bonding process. The pressure sensor unit 3 assembled as described above can be mounted, for example, in a groove 17 formed at the tip of the main body 2 as shown in FIG. 5 or slightly separated from the tip of the main body 2 as shown in FIG. It can be mounted in the groove 17a formed in the above.

FIG. 7 is an enlarged view of the pedestal 5. The pedestal 5 has a groove 18 for mounting the ceramic substrate 7 on which the sensor chip 6 is mounted at the center, and is mounted on the groove 17 of the main body 2 at both ends. Parts 19, 19 are formed. The cross section of the groove portion 18 is shown in FIG.
BB cross-sectional view), the ventilation paths 20 and 20a are formed. Air passage 20 is formed in the narrow groove-shaped in the bottom plate 23 of the groove 18 (FIG. 8), the bottom plate of the air passage 20a is the groove 18
23 is formed. The ventilation paths 20 and 20a are provided for the following reasons. Since the reference of the pressure sensor value of the present invention is the atmospheric pressure, a hole 27 is provided in the ceramic substrate 7 on which the sensor chip 6 is mounted as shown in FIG. Similarly, ventilation paths 20 and 20a were formed in the pedestal 5 on which the pressure sensor 4 (the sensor chip 6 and the ceramic substrate 7) was mounted. For this reason, atmospheric pressure is reached through the ventilation paths 20 and 20 a of the pedestal 5 and the pressure measurement space 10 of the catheter 1. Rear joint 19
10 or 11 (both in FIG. 7A)
FIG. 12 is a perspective view of FIG. 10, FIG. 13 is a perspective view of FIG. 10, and FIG.
0), and may be formed in a cylindrical shape (FIG. 11). FIG.
The joint portion 19b (FIG. 14) in which the bottom plate 21 provided at the bottom of the joint portion 19 is omitted. In addition, the front joint 19
Is formed in a rounded shape as shown in FIG.
9 does not penetrate through the groove 18.

The ultrafine pipe 15 may be attached to the air passage 20 as shown in FIG. 16 and the ceramic substrate 7 may be disposed thereon, or may be bonded to the bottom of the ceramic substrate 7 with an adhesive or the like as shown in FIG. Then, this may be attached to the ventilation path 20a. The extra-fine pipe 15 is attached to the ventilation paths 20, 20a for the following reason. The standard of the pressure sensor value used in the present invention is the atmospheric pressure.
6. As shown in FIG. 17, the sensor chip 6 is set to the atmospheric pressure through the ventilation paths 20, 20a of the pedestal 5 and the pressure measurement space 10 of the catheter 1. The structure of the pedestal 5, the lead wire 16,
There is a possibility that the ventilation paths 20 and 20a may be blocked by silicon filling, an adhesive, or the like. In order to prevent such a possibility, an extra-fine pipe 15 having a minimum necessary diameter is mounted.

FIG. 18 is a schematic view when the pressure sensor section 3 is mounted on the main body 2. The bottom face of the pedestal 5 is mounted on the groove 17 a of the main body 2 and the joint section 19 is mounted by fitting into the pressure measuring space 10. Is done. Also, in the main body 2 having the groove 17 at the tip end as shown in FIG. 19, the bottom surface of the pedestal 5 and the joint 19 behind the base 5 are connected to the main body 2 in the same manner as in FIG.
And the joint 19 in front of the pedestal 5 and the body 2
Catheter tip 22 having a tapered tip 24
It is mounted by fitting into.

FIG. 20 is a schematic view showing another embodiment of the pedestal (FIG. 21 is a view taken in the direction of arrow D in FIG. 20, and FIG.
The pedestal 5a is formed in a cylindrical shape (see an arrow view), and a pressure measurement tube 10a and a drug solution injection (blood collection) tube 11a are inserted therein, and the front of the pressure measurement tube 10a is closed. The pedestal 5a is attached to the main body 2a by fitting both ends of the tubes 10a, 11a into the pressure measurement space 10 of the main bodies 2a, 2a and the chemical (blood) flow path 9 as shown in FIG.

FIG. 24 is a schematic view showing another embodiment of the pedestal (FIG. 25 is a plan view of FIG. 24, FIG. 26 is a front view of FIG. 24), and a pedestal 5b is formed by integrally molding the ceramic substrate. The terminal 28 and the vent hole 20 are formed in the bottom plate 25 of the groove 18a.
b, the sensor chip 6 is directly mounted thereon, and the ultrafine pipe 15a is mounted below the bottom plate 25 with an adhesive or the like.

FIG. 27 (FIG. 28 is a front view of FIG. 27) shows a pedestal 5c in which a bottom plate 25a is further attached to the lower part of the ultrafine pipe 15a in the pedestal 5b of FIG.

FIG. 29 is a schematic view showing another embodiment of the pedestal (FIG. 30 is a plan view of FIG. 29, and FIG.
FIG. 32 is a cross-sectional view of FIG.
34 is a perspective view of FIG. 29, and FIG.
In the perspective view of FIG. 5, the pedestal 5d has a ventilation hole 20d formed in the bottom plate 25d of the groove 18d, the sensor chip 6 is directly mounted on the ventilation hole 20d, and the ultrafine pipe 15d is mounted below the bottom plate 25d. A hole 26 for passing a lead wire is formed at a rear portion of the pedestal 5d, and a joint portion 19d at a front portion is closed.

FIG. 36 is a schematic view showing another embodiment of the pedestal (FIG. 37 is a front view of FIG. 36, FIG. 38 is a plan view of FIG. 36, and FIG. 39 is a sectional view taken along line DD of FIG. 36). Reference numeral 5e denotes a pedestal 5d in FIG. 29 in which the joint 19d is omitted and the cross section is formed in a semicircular shape. Thereby, it matches the cross-sectional shape (semicircle) of the pressure measurement space 10 of the main body 2 and can be mounted in the groove 17e of the main body 2e as shown in FIG. The pedestal 5e is moved from the front of the main body 2e to the pressure measuring space 10e.
Through the groove 17e, and from there, the silicon 30
It is installed by filling.

In the present invention, the cross section of the main body 2 is shown in FIG.
Alternatively, it can be formed as shown in FIGS. 41 and 42. A pressure measuring space 10f is formed in a semicircular shape as shown in FIG. 43 in a cross section of the main body 2 in FIG. 41, and a liquid solution (blood) flow path 9f having a circular cross section and a small diameter is formed below the pressure measuring space 10f. By forming the ventilation path 29f on the contact surface of the pressure measurement space 10f, the ceramic substrate 7f on which the sensor chip 6f is mounted can be directly mounted on the main body 2f without using a pedestal as shown in FIG. It is sectional drawing in which the board | substrate 7f was attached to the main body 2f.) Ventilation path 2
Although the shape of 9f is concave in FIG. 44, it can be formed in a triangular shape or a semicircular shape as shown in FIGS. 46 and 47.

Next, an example of a method of using the catheter of the present invention will be described. As shown in FIG. 48, a dedicated pressure monitor 31 is attached behind the pressure sensor line 12, and a branch portion 32 such as a three-way cock is provided behind the chemical injection line 11.
The apparatus is set by connecting a blood solution collecting container 35 and a liquid medicine container 34 to which a liquid medicine infusion set 33 is connected, and priming a physiological saline into the liquid medicine (blood) flow path 9 and the liquid medicine injection line 11. The pressure sensor 3 provided in front of the main body is inserted and fixed in the central vein of the patient, and the strain of the sensor 3 is measured by the dedicated pressure monitor 31 via the pressure sensor line 12. The injection of the drug solution and the blood collection are appropriately performed according to the fluctuation of the central venous pressure as in the related art. Central venous pressure is directly detected by sensor unit 3.
Can be displayed on a dedicated pressure monitor as the distortion of
Further, the catheter of the present invention can be used for other purposes as a double sensor catheter by mounting pedestals on both sides of the main body 2.

[0016]

Operation and Effect of the Invention Eliminates zero adjustment work (no zero readjustment after changing patient bed). 2. Since the measurement is performed based on the atmospheric pressure, the detected pressure value and pressure waveform have high reliability and responsiveness. 3. Since the sensor is attached to the catheter body via the pedestal, it is hardly affected by external influences, and the central vein can be measured stably. 4. Priming with a physiological saline solution is performed only on one side of the liquid medicine (blood) channel. 5. Management of measurement sets is easy.

[Brief description of the drawings]

FIG. 1 is an overall view of a double lumen catheter with a pressure sensor.

FIG. 2 is a sectional view taken along line AA of FIG. 1;

FIG. 3 is an enlarged view of the vicinity of the pressure sensor of FIG. 1;

FIG. 4 is an exploded view of FIG. 3;

FIG. 5 is an enlarged view of a catheter tip.

FIG. 6 is an enlarged view of a catheter tip.

FIG. 7 is an enlarged view of a base.

8 is a sectional view taken along line BB of FIG. 7;

FIG. 9 is a sectional view taken along line BB of FIG. 7;

FIG. 10 is a view taken in the direction of arrow A in FIG. 7;

11 is a view taken in the direction of arrow A in FIG. 7;

FIG. 12 is a perspective view of FIG. 10;

FIG. 13 is a perspective view of FIG. 11;

FIG. 14 is a perspective view of FIG. 11;

FIG. 15 is an enlarged perspective view of a front joint portion.

FIG. 16 is a schematic view showing a means for bonding a very fine pipe.

FIG. 17 is a schematic view showing a means for bonding a very fine pipe.

FIG. 18 is a schematic diagram when the pedestal is attached to the catheter body.

FIG. 19 is a schematic diagram when the pedestal is attached to the catheter body.

FIG. 20 is a schematic view showing an embodiment of a pedestal.

FIG. 21 is a view taken in the direction of arrow D in FIG. 20;

FIG. 22 is a view taken in the direction of arrow E in FIG. 20;

FIG. 23 is a schematic diagram when the pedestal is attached to the catheter body.

FIG. 24 is a schematic view showing an embodiment of a base.

FIG. 25 is a plan view of FIG. 24;

FIG. 26 is a front view of FIG. 24;

FIG. 27 is a schematic view showing an embodiment of a pedestal.

FIG. 28 is a front view of FIG. 27;

FIG. 29 is a schematic view showing an embodiment of a pedestal.

FIG. 30 is a plan view of FIG. 29;

FIG. 31 is a sectional view taken along line CC of FIG. 29;

32 is a view as viewed in the direction of arrow F in FIG. 29.

FIG. 33 is a perspective view of FIG. 32;

34 is a view as viewed in the direction of arrow G in FIG. 29.

FIG. 35 is a perspective view of FIG. 34;

FIG. 36 is a schematic view showing an embodiment of a pedestal.

FIG. 37 is a front view of FIG. 36;

FIG. 38 is a plan view of FIG. 36;

39 is a sectional view taken along line DD of FIG. 36.

FIG. 40 is a partially enlarged view of the main body.

FIG. 41 is a sectional view of the main body.

FIG. 42 is a sectional view of the main body.

FIG. 43 is a partially enlarged view of the main body.

FIG. 44 is a schematic view of mounting a sensor on the main body.

FIG. 45 is a sectional view showing a state where the sensor is mounted on the main body.

FIG. 46 is a sectional view of the main body.

FIG. 47 is a sectional view of the main body.

FIG. 48 is a view showing a use state of the catheter of the present invention.

FIG. 49 is a use state diagram of a conventional catheter.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 Double-lumen catheter with a pressure sensor (catheter) 2, 2e, 2f Catheter main body (main body) 3, 3, a, 3f Pressure sensor part 4 Sensor 5, 5, a, 5b, 5c, 5d, 5e Pedestal 6, 6d, 6e, 6f Sensor Chip 7 Ceramic substrate 8, 8f Partition wall 8a Connecting member 9, 9a, 9b, 9c, 9e Chemical liquid (blood) flow path 10, 10b, 10c, 10e, 10f Pressure measurement space 10a Pressure measurement tube 11 Chemical liquid injection line 11a Chemical liquid injection ( Blood collection) tube 12 Pressure sensor line 13 Connecting member 14 Chemical injector 15, 15 a, 15 d Ultrafine pipe 16 Lead wire 17, 17 a, 17 e Groove portion 18, 18 a, 18 b, 18 d Groove portion 19, 19 a, 19 b, 19 d Joint portion 20, 20 a , 20e, 29e, 29f air passages 20b, 20d, 20e Vent hole 21 Bottom plate 22 Catheter tip 23 Bottom plate 24 Taper 25, 25d Bottom plate 27 Hole 28 Terminal 30 Filled silicon

────────────────────────────────────────────────── ─── Continued on the front page (58) Fields investigated (Int. Cl. ⁷ , DB name) A61B 5/02-5/0295 A61M 25/00 Practical file (PATOLIS) Patent file (PATOLIS)

Claims (3)

(57) [Claims] (1)Drug solution inside the catheter body 2 via the partition 8
(Blood) channels 9 and 9a and a pressure measurement space 10 are formed, At the tip of the body 2 or at a slight distance from the tip,
Grooves 17 and 17a for arranging the sensor portions 3 and 3a are formed.
And The medical fluid (blood) flow path 9, 9a communicates with the rear of the main body 2.
The liquid injection line 11 communicates with the pressure measurement space 10
With the pressure sensor line 12 The pressure sensor sections 3 and 3a are connected to the sensor chip 6 and the ceramic
It is composed of the sensor 4 composed of the mix substrate 7 and the pedestals 5, 5a.
Is formed, The sensor chip 6 is composed of a semiconductor strain gauge, The ceramic substrate 7 has a hole 27 and a terminal.
28 is attached, The pedestals 5, 5a are for mounting the ceramic substrate 7 thereon.
Plate 23 formed with grooves 18 and ventilation paths 20 and 20a
Has, The pressure cells are inserted into the grooves 17, 17a of the catheter body 2.
Sensor parts 3 and 3a, The sensor chip 6 is separated from the chemical (blood) flow paths 9 and 9a.
Arranged via wall 8, pedestals 5, 5a and ceramic substrate 7
Double lumenka with pressure sensor
Tetel 1. (2)In the catheter bodies 2 and 2e via the partition wall 8
(Blood) flow path 9, 9a, 9e and pressure measurement space 1
0, 10e, At the tip of the body 2, 2e or at some distance from the tip
Grooves 17, 17a for arranging the pressure sensors 3, 3a,
17e, Behind the main bodies 2, 2a, 2e, the drug solution (blood) flow path 9,
9a, 9e and a liquid injection line 11 communicating with
Pressure sensor line 12 communicating with constant space 10, 10e
Wearing The pressure sensor units 3, 3a are sensor chips 6, 6,
pedestals 5b, 5e, 5d, and 6e in which a ceramic substrate is integrally formed.
c, 5d, and 5e. The above
The sensor chips 6, 6d and 6e are made of semiconductor strain gauges.
And The pedestals 5b, 5c, 5d, 5e are provided with ventilation holes 20d, 20d.
e, the terminals 28 are attached to the bottom plates 25 and 25d, Grooves 17, 17a, 17 of the catheter bodies 2, 2e
e, the pressure sensor units 3, 3a are attached, The sensor chips 6, 6d, 6e and the chemical solution flow path 9,
9a, 9b, 9e, partition 8 and pedestals 5b, 5c, 5d,
With pressure sensor characterized by being arranged via 5e
Double lumen catheter 1. (3)In the catheter body 2f via the partition wall 8f
Chemical (blood) flow paths 9b, 9c, 9f and pressure measurement space 10
forming b, 10c, 10f, The pressure measuring spaces 10b, 10c and 10f have semicircular cross sections.
And the chemical (blood) flow paths 9b, 9c, 9f
Has a cross section from the pressure measurement spaces 10b, 10c, and 10f.
Is also formed in a small diameter circle, Pressure at the tip of main body 2f or at some distance from the tip
Forming grooves 17 and 17f for disposing sensor parts 3 and 3a
And Behind the main body 2f, the chemical (blood) flow paths 9b, 9c, 9
f and the pressure measuring space 1
Pressure sensor line 1 communicating with 0b, 10c, 10f
Wear 2 The pressure sensor unit 3f is provided with a ceramic chip 6f.
It is configured by attaching to the The sensor chip 6f is made of a semiconductor strain gauge, The pressure is applied to the grooves 17, 17f of the catheter body 2f.
Attach the sensor part 3f, The sensor chip 6f and the chemical (blood) flow path 9b,
9c, 9f via the partition 8f and the ceramic substrate 7f
Double lume with pressure sensor characterized by arrangement
Catheter 1.