JPH04253840A - Catheter with sensor - Google Patents

Abstract

PURPOSE:To enable automatic connection quick and with a high reliability by a method wherein a part of an interconnector substrate is made tubular, a connection land is arranged radially at the tubular part and a lead and a sensor are fixed temporarily on the connection land to be soldered integral. CONSTITUTION:A wiring means comprising a lead 3 is connected to an interconnection substrate 5 which is connected electrically to a sensor 1 provided near an insertion end of a catheter to give and take signals externally. The lead 3 is arranged spirally on the outer circumference of an inner skin 8 as tube for lumen of the catheter or linearly along the length thereof. Then, an antithrombotic resinous coat is applied on outer surfaces of the interconnection substrate 5 and the lead 3 by an extrusion molding or thermal shrinkage molding in such a manner as to be buried integral into a layer of an outer skin 7 of the catheter.

Description

[Detailed description of the invention]

0001

[Field of Industrial Application] The present invention relates to the structure of a medical catheter with a sensor that is inserted into the body to detect biological information such as the pressure, ion concentration, acid concentration, or gas concentration of body fluids for diagnosis and treatment. . More specifically, the present invention includes mounting a microsensor attached to the tip of a catheter on an interconnect board, and connecting a lead wire embedded in the outer skin of the catheter to this interconnect board. This invention relates to a sensor-equipped catheter that enables reliable and quick assembly.

0002

[Prior Art] This type of sensor-equipped catheter is shown in Fig. 6.
As shown, a sensor 1 and a connecting electrode 11 of the sensor 1
A requisite number of lead wires 3 whose ends 6 are individually electrically connected to the sensor 1 and other parts of the lead wires 3 other than the sensor 1 are covered with synthetic resin, rubber, etc. to hide and protect them. flexible tube
Each of the lead wires 3 is connected to an external device to send and receive signals to and from the sensor 1, and is currently used in many fields as a means for testing various living organisms.

0003

[Problems to be Solved by the Invention] In the conventional sensor-equipped catheter as described above, the outer dimensions of the sensor 1 and the connecting electrodes are extremely small, and it is difficult to connect the ends 6 of each lead wire 3 by soldering, etc. It is very difficult to join the soldering process by using the soldering process, which impairs the reliability of the electrical connection, and it is also difficult to automate such a soldering process.

Furthermore, it is necessary to insert each lead wire 3 into the flexible tube 19 before or after the soldering process as described above, but it is not necessary to insert the lead wire 3 into the flexible tube 19 having a small diameter. This also causes considerable difficulty.

Furthermore, since it is necessary to provide a space for the lead wire insertion as a separate lumen, the usable lumen cross-sectional area is limited within the limited outer diameter of the catheter. There is also the inconvenience of a decrease.

[0006]

[Means for Solving the Problems] The present invention uses an interconnect board instead of the conventional method of directly connecting a lead wire to a sensor, and connects the lead wire to the sensor via the interconnect board. Electrical interconnection is planned, and the sensor and lead wires are soldered together using appropriate jigs and laser means to make it possible to automate as much as possible. The present invention provides a catheter with a sensor configured to be embedded in the tube wall of the outer skin of the catheter to prevent a reduction in the lumen cross-sectional area.

Therefore, the sensor-equipped catheter according to the present invention has a sensor, a lead wire buried in the catheter outer shell for taking out the output from the sensor, and an electrical interconnection between these. In a sensor-equipped catheter equipped with an interconnect board for making connections, a part of the interconnect board is formed into a tubular shape, connection lands are arranged radially in the tubular part, and the interconnect board is formed in advance. Temporarily fix the lead wire on the specified connection land using a jig, and
The sensor is temporarily fixed in a predetermined position using an appropriate alignment jig, and the sensor is soldered all at once using means such as infrared rays or laser, so that automation can be achieved as much as possible.

Various means can be used to embed the lead wire in the tube wall of the catheter outer sheath, but after soldering the lead wire, a straight line is placed on the outer periphery of the catheter inner layer tube. This lead wire can be arranged in a shape or in a spiral shape, and then extrusion molding can be performed to form a resinous covering.

Furthermore, during extrusion molding of the catheter tube, the lead wire is simultaneously embedded in the outer skin of the tube in a spiral or linear manner, and the lead wire is shaped into the desired length. After cutting, it is also possible to remove the insulating resin portion of the lead wire at the end and perform soldering.

0010

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be further explained below with reference to the illustrated embodiments. FIG. 1 is a conceptual cross-sectional view of the essential parts of a catheter with a sensor according to the present invention, in which 7 shows the outer skin of the tubular catheter, and 8 shows the outer skin of the tubular catheter. The endothelium of the catheter, which constitutes the flexible tube that serves as the structural substrate, is shown in Figure 2.
As shown in FIG. 2, a lumen 9 is formed inside for the insertion of a guide wire, collection of body fluids, injection of medical fluids, etc. As the material for this flexible tube, Teflon, vinyl chloride, high density polyethylene, tetrafluoroethylene, etc. can be used. 5 is an interconnect board that functions as a relay member for electrical connection between the sensor 1 and the lead wire 3, and as shown in FIGS. It is arranged in a tubular shape so as to be embedded in the outer skin 7, and has a region 12 that projects flatly in the longitudinal direction of the catheter, and a region 12 that is formed in a tubular shape along the outer periphery of the catheter inner skin 8. region 13. Then, the sensor 1 is connected to the joint portion 2 by the connection land 14 arranged inward of the region 12,
Further, the lead wire 3 is connected by a connection land 15 disposed toward the outside of the region 13. Figure 3 shows sensor 1.
, the above-mentioned electrical interconnections between the interconnect board 5 and the lead wires 3 are conceptually shown.

The lead wire 3 is wound spirally around the outer periphery of the catheter inner skin 8 or linearly arranged along the outer skin 7 and connected to a connector (not shown) at the end of the catheter. The outer skin 7 of the catheter functions as a jacket with excellent antithrombotic properties provided to protect the outer surfaces of the sensor 1, interconnect board 5, and lead wire 3. 1
0 is an opening formed in the outer skin 7 so that the sensor 1 comes into contact with body fluids, and the catheter outer skin 7 is made of the same material as the catheter inner skin 8 by extrusion molding or heat shrink molding. At that time, the lead wire 3
It is also possible to embed it in this outer skin 7 in one piece. In such an integrated structure, the buried lead wire 3 also increases the mechanical strength of the catheter tube, improving pressure resistance, compressive strength, tensile strength, etc., and making it suitable for catheter procedures. It is possible to ensure rigidity that can improve operational controllability or responsiveness, that is, torque control.

FIG. 2 shows a conceptual cross-sectional view of the sensor-equipped catheter according to the present invention, and one or more lumens 9 may be provided, and the lumen 9 may be a perfect circle as shown in the figure. It is also possible to form it in other irregular cross-sectional shapes.

FIG. 4 shows the interconnect board 5 in an expanded state, and in addition to the T-shaped configuration shown in the figure,
Although not shown, it is formed as an L-shaped or Y-shaped flexible wiring board prototype, and a wiring pattern 16 for electrical relaying is appropriately formed by photolithography. The connection land 14 for mounting and connecting the sensor 1 and the connection land 15 for connecting the lead wire 3 are connected to each other by penetrating the flexible insulating base material 17 and the surface protection material 18 separately, as shown in FIG. Although they are formed to protrude from the wiring pattern 16 in the opposite direction, for example, the connection lands 14 and 15 may be formed to protrude from the same plane in accordance with the arrangement of the joint portion 2 of the sensor 1. You can also do it. In any case, the plurality of connection lands 14 are arranged at positions corresponding to the joint part 2 of the sensor 1, that is, the arrangement of the IO electrodes, and are irradiated with YAG laser or infrared rays using an appropriate positioning jig. It is possible to solder all at once.

[0014] Normally, sensors used in medical catheters are minute, and their IO electrodes are minute electrodes with a diameter of about 100 μm, and the distance between the electrodes is also minute. It becomes necessary to arrange them with minute diameter and high density. Therefore, as a technique for forming holes in the flexible insulating base material 17 to form such minute connection lands 14, for example, a microphotolithographic method as disclosed in Japanese Patent Application No. 1-288434 is used. It can be suitably adopted. On the other hand, regarding the connection land 15 to which the lead wire 3 is bonded, since the tubular region 13 has a relatively large area, a surface protection material 18 with holes formed in predetermined positions is placed on the wiring pattern 16. Existing methods such as pasting on the top surface can be applied, but the lead wire 3 used
If it is necessary to form a minute land according to the wire diameter of the wire, it is of course possible to employ the microphotolithography method as described above.

As the material of the flexible insulating base material 17 constituting the interconnect board 5, it is preferable to use a polyimide film having a thickness of about 12.5 to 75 μm and having excellent heat resistance and flexibility. Similar to the base material 17, the surface protection material 18 is an imide, acrylic or epoxy varnish with a thickness of about 5 to 25 μm, or a polyimide film with a thickness of about 12.5 to 75 μm, which is highly heat resistant and flexible. can be used. By using such a thin sheet material, region 13 of interconnect board 5 can be easily cathedralized.
This allows the catheter endothelium 8 to be formed into a tubular shape along the outer periphery, and the diameter of the outer sheath 7 of the catheter can be reduced.

With the above structure, the sensor 1 provided near the insertion end of a medical catheter for use in collecting body fluids, injecting medical fluids, or treating vascular occlusion by balloon dilation, etc. It has an interconnect board 5 electrically connected to the interconnect board 5, and a lead to the interconnect board 5.
It can be configured to connect a wiring means such as a wire 3 or the like to exchange signals with the outside. The lead wire 3 is arranged spirally around the outer periphery of the endothelium 8, which serves as a tube for the lumen of the catheter, or linearly in the longitudinal direction thereof.
In addition, by providing an antithrombotic resin coating on the outer surfaces of the interconnect substrate 5 and the lead wires 3 by extrusion molding, heat shrink molding, or the like, the interconnect substrate 5
The lead wire 3 can also be constructed so as to be embedded integrally within the layer of the outer sheath 7 of the catheter.

[0017]

[Effects of the Invention] According to the sensor-equipped catheter of the present invention, the connection lands of the interconnect board can be arranged with high precision in accordance with the shape and arrangement of the IO electrodes of the sensor, so that it is possible to arrange the connection lands of the interconnect board with high accuracy using an appropriate jig. It is possible to perform a batch soldering process by using a heating means, and it is possible to realize a quick and reliable automatic connection.

Furthermore, since a part of the interconnect board can be formed into a tubular shape and the connection lands can be arranged radially in the tubular part, the area of the connection part can be reduced even when a plurality of lead wires are soldered. It is possible to solder the lead wires all at once by using a heating means and a jig to form and hold the lead wires in advance, which allows for a quick and reliable automatic connection. can be achieved.

Even if it is necessary to provide a plurality of sensors in a catheter, the above-mentioned automatic connection can be achieved by modifying the interconnect board and lead wires.

According to the catheter of the present invention, unlike the conventional sensor-equipped catheter in which a lumen for inserting the lead wire is separately provided, the lead wire can be inserted into the catheter. Since the lumen can be embedded integrally in the outer skin of the catheter, it is possible to secure the necessary cross-sectional area of the lumen as a conduit for body fluids or medical fluids, and at the same time improve the pressure resistance, compressive strength and In order to improve mechanical strength such as tensile strength, rigidity that can ensure good operational controllability or responsiveness in catheter procedures, in other words one-to-one torque control, is reliably achieved. can.

[Brief explanation of the drawing]

FIG. 1 is a conceptual vertical cross-sectional configuration diagram of essential parts of a sensor-equipped catheter according to an embodiment of the present invention.

[Figure 2] Conceptual cross-sectional configuration diagram of the main parts in Figure 1

[Fig. 3] An enlarged perspective configuration diagram of main parts conceptually showing a state in which a sensor and a lead wire are connected to an interconnect board.

[Figure 4] Explanation diagram of a developed flexible wiring board as a prototype of an interconnect board

[Figure 5] Cross-sectional configuration diagram of main parts in Figure 4

[Fig. 6] Explanatory diagram of the configuration of a catheter with a sensor according to a conventional structure

[Explanation of symbols]

1 Sensor 2 Sensor joint 3 Lead wire 4 Lead wire connection part 5 Interconnect board 6 Lead wire end 7 Catheter outer skin 8 Catheter endothelium 9 lumens 10 Sensor opening 11 Connection electrode 12 Sensor connection area 13 Tubular area for connecting lead wires 14 Connection land for sensor 15 Lead wire connection land 16 Wiring pattern 17 Flexible insulation base material 18 Surface protection material 19 Flexible tube for coating

Claims (5)

[Claims] Claim 1: In a diagnostic or therapeutic catheter, the catheter is electrically connected to a sensor provided near the insertion end of the catheter, and is provided between a tubular inner skin and an outer skin of the catheter. A sensor comprising an interconnect board arranged in a tubular shape, and configured so that wiring means provided on the catheter outer sheath is connected to the interconnect board to send and receive signals to and from the outside. attached catheter. 2. A sensor-equipped catheter according to claim 1, wherein said wiring means has a highly conductive lead wire embedded in said catheter outer sheath in a linear or spiral manner. 3. A wiring pattern is formed all at once on the interconnect board, and a connection land for mounting the sensor and a land for connecting the lead wire are connected to the interconnect board. 3. The sensor-equipped catheter according to claim 1, wherein the sensor-equipped catheter is disposed on the same surface of the substrate or on both sides of the substrate. 4. The developed interconnect board has an L-shape, a T-shape, or a Y-shape, and the sensor mounting portion is flat and the lead wire connection portion is tubular. 4. The sensor-equipped catheter according to claim 1, wherein the sensor-equipped catheter is formed in any one of claims 1 to 3. 5. The sensor-equipped catheter according to claim 4, wherein the lead wire connection lands of the interconnect board are arranged radially in a tubular region.