JP4852137B2 - Catheter and manufacturing method thereof - Google Patents

Description

  The present invention relates to a catheter in which an electronic component is mounted in a tube and a manufacturing method thereof.

  Conventionally, a catheter with electronic components such as a heating resistor, pressure sensor, and temperature measurement thermistor mounted in the front end or middle of the tube is inserted into the patient's body and the electrical signals generated by the electronic components are used. Various examinations and treatments are performed. Such electronic component mounting type catheters are described in, for example, Patent Document 1 and Patent Document 2 below.

  The “front end portion of the tube” is an end portion on one side in the length direction of the tube, which is the leading side in the insertion direction when a catheter (tube) is inserted into the body of a patient. In the following description of the document, the term “front end of the tube” refers to the end of the tube that is the leading side in the insertion direction when the catheter (tube) is inserted into the patient's body. , “The rear end portion of the tube” refers to an end portion on the opposite side of the end portion on the leading side of the insertion direction in the length direction of the tube.

  By the way, in the catheter which mounted the electronic component in the above tubes, the electrical signal which generate | occur | produces from the electronic component which exists in the front-end part or intermediate part of the tube inserted in the patient's body is the tube which has come out of the patient's body. When the electronic component is controlled by a measuring instrument or the like connected to the rear end of the tube, it is remotely controlled by a control device connected to the rear end of the tube outside the patient's body. Therefore, it is necessary to arrange a signal line for transmitting an electrical signal between the electronic component and a measuring instrument, a control device, or the like in the tube of the electronic component mounting type catheter. Conventionally, a signal cable such as a flat cable has been generally used like the catheters described in Patent Document 1 and Patent Document 2. However, in recent years, in this type of catheter, there has been a demand for multi-line signal lines as the electronic components arranged in the tube become highly functional, and signal cables are used for multi-line signal lines. Increasing the number of wires requires a thicker tube through which the signal cable is inserted, resulting in problems such as reduced operability of the catheter within the patient and increased patient pain during catheter operation. ing.

Japanese Patent Laid-Open No. 11-56794 JP 2001-170013 A

  In view of the above circumstances, the problem to be solved by the present invention is to provide a catheter capable of reducing an increase in tube thickness associated with the increase in the number of signal lines connected to the electronic component in the electronic component mounting type catheter. In addition, another object of the present invention is to provide a catheter manufacturing method capable of efficiently manufacturing the catheter.

In order to solve the above problems, the present invention adopts the following configuration.
That is, the present invention
(1) An electronic component is mounted in a front end portion or an intermediate portion of the tube, and a signal line electrically connected to the electronic component is routed from the vicinity of the electronic component to the rear end portion of the tube through the tube. A catheter, characterized in that the signal line comprises a wiring pattern of a flexible printed circuit board inserted into the tube,
(2) The catheter according to (1) above, wherein the flexible printed circuit board has a metal support plate,
(3) The width in the short direction of the metal support plate is smaller than the width in the short direction of the base insulating layer, and there is no metal support plate at both ends in the short direction of the flexible printed circuit board. The catheter according to (2) above,
(4) The catheter according to (3) above, wherein the width of the metal support plate in the short direction is 50 to 2950 μm, and the width of the flexible printed circuit board in the short direction is 100 to 3000 μm,
(5) An electronic component is disposed in a region close to the terminal portion provided on the wiring pattern on the base insulating layer of the flexible printed circuit board, and the terminal of the electronic component and the terminal portion provided on the wiring pattern are metal-welded. Or the catheter according to any one of (1) to (4), wherein the catheter is connected by a conductive adhesive, and the connection portion is sealed with a resin;
(6) Flexible wiring in which a through-hole is provided in the side wall of the front end portion or intermediate portion of the tube, and the width in the longitudinal direction is equal to or greater than the length from the through-hole to the rear end portion of the tube Inserting a circuit board;
Placing an electronic component through a through hole provided in a side wall of the tube in a region close to a terminal portion provided in a wiring pattern on a base insulating layer of the flexible printed circuit board; and
And (7) a method of manufacturing the catheter, comprising: connecting the terminal of the electronic component and the terminal portion provided on the wiring pattern by metal welding or a conductive adhesive, and then sealing the connection portion with resin. ) A step of preparing a flexible printed circuit board in which a through hole is provided in the side wall of the front end portion or the middle portion of the tube and the width in the longitudinal direction is equal to or greater than the length from the through hole to the rear end portion of the tube. When,
An electronic component is placed in a region adjacent to the terminal portion provided on the wiring pattern on the base insulating layer of the flexible printed circuit board, and the terminal of the electronic component and the terminal portion provided on the wiring pattern are metal welded or electrically conductive. Connecting with an adhesive, and
The flexible printed circuit board with the electronic components attached is inserted into the tube, and the connection portion between the terminal of the electronic component and the terminal portion provided in the wiring pattern is sealed with resin through a through hole provided in the side wall of the tube. And a method for manufacturing a catheter.

  In the catheter of the present invention, when the number of signal lines is increased, the number of wiring patterns of the flexible wiring circuit board inserted into the tube may be increased, and the flexible wiring circuit board does not greatly change its own size. Therefore, the number of signal lines can be increased without having to greatly increase the thickness of the tube. Therefore, when the number of signal lines is the same as that of a conventional catheter, the thickness of the catheter (tube) can be reduced, and the patient's body caused by the increase in the thickness of the tube as the number of signal lines increases. Thus, it is possible to eliminate or reduce the patient's pain at the time of catheter operation and the decrease in catheter operability.

  Further, by using the flexible wiring circuit board having the metal support plate, the rigidity of the flexible wiring circuit board is increased, and the work for inserting the flexible wiring circuit board into the tube is facilitated. In addition, unnecessary bending or the like of the catheter is unlikely to occur, and the catheter can be easily advanced in the intended direction, thereby further improving the operability of the catheter within the patient.

  Moreover, the metal support plate of the said flexible wiring board uses the metal support plate whose width | variety of a short direction is smaller than the width | variety of the short direction of a base insulating layer, and is located in the both ends of the short direction of a flexible printed circuit board. By adopting a configuration in which the metal support plate does not exist, the flexible printed circuit board can be inserted into the tube with its both ends in the short direction folded. Therefore, damage to the inner wall of the tube during insertion of the flexible printed circuit board into the tube can be prevented, and the thickness of the tube can be further reduced.

  In addition, an electronic component is disposed in a region adjacent to the terminal portion provided on the wiring pattern on the base insulating layer of the flexible printed circuit board, and the terminal of the electronic component and the terminal portion provided on the wiring pattern are metal-welded. Alternatively, by connecting with a conductive adhesive and sealing the connecting portion with resin, even if the catheter is deformed or receives an impact during the operation of the catheter, the electronic component and the wiring pattern (signal line) A highly reliable catheter in which the electrical connection is stably maintained can be realized.

  Further, according to the catheter manufacturing method of the present invention, the catheter of the present invention that can reduce the thickness of the catheter (tube) can be efficiently manufactured with less work man-hours than the conventional catheter. In addition, since the electronic component can be mounted on the flexible printed circuit board, the electronic component can be accurately positioned in the tube.

It is sectional drawing (longitudinal sectional view) cut by the plane containing the axis line of the catheter by an example of this invention. It is sectional drawing (cross-sectional view) cut by the plane orthogonal to the axis line of the catheter by an example of this invention. FIG. 3 is a perspective view of the flexible printed circuit board (an example of a flexible printed circuit board used in the present invention) shown in FIGS. 1 and 2. It is sectional drawing of the other example of the flexible wiring circuit board used by this invention. FIG. 5 is a cross-sectional view (cross-sectional view) cut along a plane orthogonal to the axis of the catheter in which the flexible printed circuit board shown in FIG. 4 is inserted into the tube. FIG. 6A to FIG. 6D are cross-sectional views for each process showing an example of the catheter manufacturing method of the present invention. FIG. 7A to FIG. 7D are cross-sectional views showing processes performed subsequent to the processes of FIG. 6A to FIG. 6D. It is the top view which looked at the terminal part of the flexible wiring circuit board shown in FIG. 3 from the upper direction. It is a top view which shows the other example of the arrangement | sequence form of the terminal part of the flexible wiring circuit board used by this invention. It is a top view which shows the other example of the exposed form of the terminal part of the flexible printed circuit board used by this invention. It is principal part sectional drawing which shows the state which enclosed the electronic component in the tube of the catheter of this invention.

Hereinafter, the present invention will be described in more detail with reference to the drawings.
1 to 3 show a catheter according to an example of the present invention, FIG. 1 is a cross-sectional view (longitudinal cross-sectional view) cut along a plane including the axis of the catheter, and FIG. 2 is a cross-sectional view cut along a plane perpendicular to the axis of the catheter ( FIG. 3 is a perspective view of the flexible printed circuit board shown in FIGS. 1 shows only a cross section of the front end portion 1A of the tube 1 and a slight length portion connected to the front end portion 1A, the flexible printed circuit board 10 is connected to the rear end portion of the tube 1 (not shown). It is a scale.

  As shown in the example catheter 100, the catheter of the present invention is a catheter having an electronic component 2 mounted in a tube 1, and a signal line electrically connected to the electronic component 2 disposed in the tube 1. Is composed of the wiring pattern 4 of the flexible printed circuit board 10 inserted into the tube 1.

  As described in the background section above, in a catheter in which an electronic component is mounted in a tube, the catheter is usually generated from the electronic component disposed in the front end portion or intermediate portion of the tube after the catheter is inserted into the patient's body. When the electrical signal is processed by a measuring instrument connected to the rear end of the tube outside the patient's body and the operation of the electronic components is controlled, the rear end of the tube going out of the patient's body Remotely controlled by a control device connected to. Accordingly, also in the catheter 100 of this example, the flexible printed circuit board 10 inserted into the tube 1 is connected from the vicinity of the arrangement position of the electronic component 2 in the tube 1 to the rear end portion (not shown) of the tube 1. At the rear end of the tube 1, the end of the wiring pattern 4 that is a signal line is electrically connected to a measuring instrument, a control device, etc. (not shown).

  That is, as shown in the catheter 100 of the example, the catheter of the present invention has a rear end of the tube 1 from the vicinity of the front end portion of the tube 1 serving as the catheter body and the mounting portion (arrangement portion) of the electronic component 2 in the intermediate portion. The signal line that reaches the end is configured by the wiring pattern 4 of the flexible printed circuit board 10, and this configuration enables the signal line to be multi-lined without the need to greatly increase the thickness of the tube 1. . In other words, in the case of a conventional catheter using a signal cable as a signal line connected to an electronic component, if the number of signal cables is increased to increase the number of signal lines, the bundle of signal cables occupies a large volume. In order to allow the signal cable of the book to be inserted, the thickness of the tube has to be increased considerably. On the other hand, in the catheter of the present invention, the signal wire electrically connected to the electronic component is inserted into the tube. The flexible wiring circuit board can be increased in the number of wiring patterns without having to extremely increase the size of the flexible wiring circuit board. The number of can be increased.

  The flexible printed circuit board (FPC) used for the catheter of the present invention is similar to the flexible printed circuit board 10 used in the catheter 100 (FIGS. 1 to 3) of the above-described example. A basic structure is a laminated structure in which the pattern) 4 and the insulating cover layer 5 are laminated in this order. As materials for the base insulating layer 3, the wiring pattern (wiring pattern) 4, and the cover insulating layer 5, known materials conventionally used in flexible wiring circuit boards may be applied.

  Examples of the material for the base insulating layer 3 include polyimide resins, polyester resins, epoxy resins, urethane resins, polystyrene resins, polyethylene resins, polyamide resins, and acrylonitrile-butadiene-styrene (ABS) copolymers. Examples thereof include resins, polycarbonate resins, silicone resins, and fluorine resins. Among these, polyimide resins are preferable from the viewpoints of heat resistance, dimensional stability, chemical resistance, and the like. Moreover, the thickness of the base insulating layer 3 is preferably about 5 to 100 μm, more preferably about 8 to 30 μm, from the viewpoint of flexibility and electrical insulation.

  Examples of the material of the wiring pattern 4 include stainless steel, copper, copper alloy, aluminum, copper-beryllium, phosphor bronze, 42 alloy and the like, and copper and copper alloy are preferable from the viewpoint of conductivity and rigidity. The thickness of the wiring pattern 4 is preferably 3 to 50 μm, and more preferably 5 to 20 μm. If the thickness of the wiring pattern 4 is less than 3 μm, it is easily damaged by mechanical stress such as bending, local pressure and wear, and if it is larger than 50 μm, it becomes difficult to form a fine pitch wiring, Since it becomes difficult to do, it is not preferable. Further, the width of the wiring pattern 4 is preferably 5 to 100 μm, and the space between adjacent wirings in the plurality of wiring patterns (wiring patterns) 4 is caused by generation of unnecessary noise to an electric signal, short circuit due to metal ion migration, etc. It is preferable to make it as narrow as possible within the range in which the above problem does not occur, and generally selected within the range of 5 to 100 μm. Further, a part of the wiring pattern (wiring pattern) 4 (usually the terminal end portion 4A) is not covered with the insulating cover layer 5, and serves as a terminal portion 40 for electrical connection with other conductor members such as metal wires. used. The terminal portion 40 is covered with a highly conductive metal such as nickel, gold, solder, or tin as necessary.

  8 is a plan view showing the vicinity of the terminal portions 4A of the plurality of wiring patterns 4 in the flexible wiring circuit board 10 of the catheter 100 of the example. In the flexible wiring circuit board 10, a plurality of wiring patterns 4 are provided. In the catheter of the present invention, the terminal portions 40 provided on the plurality of wiring patterns 4 of the flexible printed circuit board are arranged as follows. As shown in FIG. 9, you may make it arrange | position in zigzag form. By arranging the terminal portions 40 provided in the plurality of wiring patterns 4 in a staggered manner, as shown in FIG. 9, the area of the terminal portions 40 of each wiring pattern can be enlarged, and connection with a metal wire or the like described later is easy. Therefore, it is preferable. Further, in the flexible printed circuit board 10 of the catheter 100 of the example, the terminal portion 40 is exposed entirely, but as shown in FIG. 10, a part of the wiring pattern 4 is formed from the opening of the insulating cover layer 5. You may form so that it may expose.

  The thickness of the cover insulating layer 5 is preferably 2 to 50 μm. If the thickness is less than 2 μm, a portion of poor insulation is likely to occur due to thickness variation or bending or wear, and if it exceeds 50 μm, the flexibility tends to decrease.

  The flexible printed circuit board (FPC) used in the present invention is on the opposite side of the wiring pattern of the base insulating layer 3 as the flexible printed circuit board 10 used in the catheter of the above example (FIGS. 1 to 3). What laminated | stacked the metal support plate 6 on the surface is preferable. In the case of a flexible printed circuit board having such a metal support plate 6, the metal support plate 6 increases the rigidity of the entire flexible printed circuit board, so that the flexible printed circuit board can be easily inserted into the tube. In addition, unnecessary bending or the like of the catheter is unlikely to occur, and it is easy to advance the catheter in the intended direction when the catheter is inserted into the body. Therefore, the operability when the catheter is inserted into the body is improved.

  Examples of the material of the metal support plate 6 include single elements of metal elements such as stainless steel, steel, nickel, chromium, iron, tin, lead, and aluminum, or two or more alloys selected from these metals. Among these, stainless steel is preferable in terms of a high impact rate.

  The elastic modulus of the metal support plate 6 is preferably 50 GPa or more, more preferably 100 GPa or more in consideration of the insertion property of the flexible printed circuit board into the tube and the operability of the catheter. However, if the elastic modulus is too large, the elastic modulus is preferably 400 GPa or less, more preferably 300 GPa or less because it is difficult to bend after insertion into the tube or lacks flexibility. Here, the “elastic modulus” means a tensile elastic modulus when measured under test conditions of a test piece width of 20 mm, a chuck interval of 100 mm, and a tensile speed of 50 mm / min.

  The thickness of the metal support plate 6 is generally preferably about 10 to 200 μm (more preferably 20 to 50 μm). If the thickness of the metal support plate is less than 10 μm, the flexible printed circuit board is likely to be curled or undulated. As a result, it may be difficult to insert the flexible printed circuit board into the tube. Since the flexibility of the printed circuit board is reduced, it becomes difficult to insert the flexible printed circuit board into the tube, or a roll-to-roll production system (that is, a film (sheet) fed from the unwinding roll is taken up) Production by a method of processing a film (sheet) in the meantime).

  Moreover, in the flexible printed circuit board having such a metal support plate 6, the metal support plate 6 can be processed into a predetermined pattern and used as a wiring pattern if necessary. In this case, the flexible printed circuit board becomes a double-sided wiring (circuit) board, and wiring patterns formed on both sides of the base insulating layer can be used as signal lines. That is, by using a flexible printed circuit board having such a double-sided wiring structure, a catheter having electronic components arranged on both the front and back sides of the flexible printed circuit board can be produced. When such a metal support plate is used as a wiring pattern, the width of one wiring pattern is preferably about 10 to 500 μm, and the space between adjacent wiring patterns is preferably about 10 to 300 μm.

  In the present invention, the total thickness of the flexible printed circuit board (including both the case without a metal support plate and the case with a metal support plate) is preferably 20 to 300 μm (more preferably 30 to 100 μm). When the total thickness is less than 20 μm, handling becomes worse and insertion into the tube becomes difficult. On the other hand, if the total thickness is larger than 300 μm, the flexibility of the catheter is lowered, and the operability when the catheter is inserted into the body is lowered.

  The width (D1 in FIG. 3) in the longitudinal direction (axial direction) of the flexible printed circuit board is the length from the mounting (arrangement) position of the electronic component in the axial direction of the tube 1 to the rear end portion of the tube 1. It is decided according to. That is, it is necessary to make the length equal to or longer than the length from the electronic component mounting (arrangement) position in the axial direction of the tube 1 to the rear end portion of the tube 1, and generally 50 to 1000 mm. Is within the range.

  Further, the width (D2 in FIG. 3) in the short direction of the flexible circuit board is preferably 100 to 3000 μm (more preferably 200 to 1500 μm). If the width of the flexible printed circuit board in the short direction is smaller than 100 μm, the self-supporting property of the flexible printed circuit board will be reduced, making it difficult to insert into the tube, and if larger than 3000 μm, the flexible printed circuit board will be inserted. This is not preferable because the inner diameter and outer diameter of the tube to be increased. In order to facilitate insertion into the tube, the width in the short direction is preferably about 50 to 100 μm smaller than the inner diameter of the tube.

  Moreover, when the flexible printed circuit board has the metal support plate 6, the width in the short direction of the metal support plate 6 is preferably 50 to 2950 μm.

  The flexible printed circuit board 10 used in the catheter 100 (FIGS. 1 to 3) of the above example has the width (D3 in FIG. 2) of the metal support plate 6 in the short direction and the flexible printed circuit board 10 (base insulation). The width (D2) of the layer 3) is the same as the width (D2) in the short direction, but the flexible printed circuit board used in the present invention has a width (in the short direction) of the metal support plate 6 as shown in FIG. D3) may be made smaller than the width (D2) of the insulating base layer 3, and the flexible printed circuit board 20 may be configured such that the metal support plates 6 do not exist at both ends in the short direction of the flexible printed circuit board. By using the flexible printed circuit board having such a structure, as shown in FIG. 5, the base insulating layer 3 of the flexible printed circuit board 20 is bent at both ends in the short direction over the entire length in the longitudinal direction. The tube 1 can be inserted into the tube 1 in a state, and the thickness of the tube 1 can be further reduced. Further, it is possible to prevent the inner wall of the tube from being damaged in the operation of inserting the flexible printed circuit board into the tube 1.

  In the case of such a flexible printed circuit board 20 in which the metal support plates 6 do not exist at both ends in the short direction of the flexible printed circuit board, the metal support plates 6 at both ends in the short direction of the flexible printed circuit board do not exist. The width of the portion in the short direction (D4 in FIG. 4) is preferably 20 to 1000 μm. If the width is less than 20 μm, even if the processing accuracy is slightly lowered, both ends of the metal support plate may be partially exposed to damage the inner wall of the tube, and if the width exceeds 1000 μm, the metal The flexible printed circuit board may not be sufficiently held by the support plate.

  In the catheter of the present invention, as the material of the tube 1 serving as a main body, an insulating resin material such as a fluororesin such as polytetrafluoroethylene, a silicone resin, a high density polyethylene resin, a polyurethane resin, a polyester resin, or polyvinyl chloride is used. . In view of flexibility, heat resistance, chemical resistance, biocompatibility, processability into a tube shape, etc., among these, a fluororesin is preferable.

  The shape of the cross section (transverse cross section) cut by a plane orthogonal to the axis of the tube 1 is not particularly limited, but a shape having no corners such as a circle and an ellipse is preferable (usually a circle). Taking a circular case as an example, the inner diameter is preferably about 0.2 to 3.5 mm, and the outer diameter is preferably about 0.3 to 4 mm. Because the inner diameter and outer diameter of the tube are within such a preferable range, the flexible printed circuit board is excellent in insertability and catheter operability in the patient, and causes pain to the patient during catheter operation in the patient. A difficult catheter can be realized. In addition, it is preferable that an inner diameter determines an outer diameter so that the thickness of a tube may be 0.05-1.0 mm.

  When a tube having a non-circular cross-sectional shape is used, it is preferable to use a tube in which the maximum diameters of the inner and outer circumferences of the cross section are within the preferable numerical ranges of the inner diameter and the outer diameter when the cross section is circular.

  In the catheter of the present invention, the length of the tube (length in the axial direction) is generally 30 mm or more, further 100 mm or more, and the upper limit is usually 1000 mm or less.

  In the catheter of the present invention, as the electronic component 2 mounted in the tube 1, an electronic component conventionally used in an electronic component mounting type catheter can be used without limitation. Specific examples include a heating resistor, a pressure sensor, a temperature measurement thermistor, an ultrasonic oscillator, and a piezoelectric element. The example catheter 100 shown in FIGS. 1 to 3 uses a pressure sensor for the electronic component 2. When configuring a catheter equipped with a pressure sensor, as shown in FIG. 1, the pressure sensor (electronic component 2) is disposed such that its sensitive surface 2A is exposed to the outside from a through hole H provided in the side wall of the tube. .

  In the catheter of the present invention, the connection (electrical connection) between the electronic component and the flexible printed circuit board (wiring pattern) is, for example, as shown in FIG. 1, the terminal portion 40 provided on the wiring pattern 4 of the flexible printed circuit board. And a method using a metal welding technique such as bonding one end and the other end of the metal wire 7 to a terminal (not shown) of the electronic component 2, a terminal portion 40 provided in the wiring pattern, and a terminal of the electronic component Both are performed by a method of covering both with a conductive adhesive layer. As shown in FIG. 1, it is preferable to protect the connection portion between the terminal portion 40 of the wiring pattern 4 and the terminal of the electronic component 2 by sealing with a resin 8. Examples of the sealing resin 8 include an epoxy resin, a fluororesin, and a silicone resin.

  Further, the electronic component 2 is fixed in the tube 1 by a terminal portion 40 provided on the wiring pattern 4 on the base insulating layer 3 of the flexible printed circuit board 10 as in the catheter 100 shown in FIGS. It is preferable to mount (fix) the electronic component 2 in the wiring pattern non-formation region 3 </ b> A that is close to. By doing so, both the wiring pattern 4 and the electronic component 2 follow the movement of the flexible printed circuit board 10, so the load applied to the connecting portion between the two is reduced, and the terminals of the electronic component 2 and the wiring pattern 4 Connection reliability between the terminal portions 40 is improved. For example, as shown in FIG. 1, the electronic component 2 is mounted (fixed) on the insulating base layer 3 by sealing a connection portion between the terminal portion 40 provided on the wiring pattern 4 and the terminal of the electronic component 2. This can be performed by using the resin 8 and applying the resin 8 across the entire periphery of the electronic component 2 from the periphery of the electronic component 2 to the surface of the base insulating layer 3. By doing so, the mounting (fixing) operation of the electronic component 2 and the connection operation between the terminals of the electronic component and the wiring pattern can be performed simultaneously, which is efficient. The electronic component 2 may be fixed with an adhesive to the region 3A adjacent to the terminal portion 40 provided on the wiring pattern 4 on the base insulating layer.

  In addition, like the catheter 100 of an example shown in FIGS. 1-3, when comprising the catheter of the aspect which exposes a part of electronic component 2 from the through-hole H provided in the side wall of the tube 1, the inside of a tube is the inside of a tube. In order to securely block from the outside, it is preferable to apply a sealing resin 9 so as to cover the periphery of the tube wall around the through hole H and the upper surface of the electronic component 2. As the sealing resin 9, for example, an epoxy resin, a fluororesin, a silicone resin or the like is used. If the electronic component 2 does not necessarily have its sensitive surface exposed to the outside of the tube, such as a temperature sensor, for example, as shown in FIG. May be enclosed in the tube 1. In this case, no sealing resin is required.

  In the example catheter 100 shown in FIGS. 1 to 3, the flexible printed circuit board 10 is provided with a single conductor layer (wiring pattern 4). As the flexible printed circuit board, a plurality of conductor layers are provided via via holes. A multi-layer flexible printed circuit board connected in this manner may be used. In the case of a multilayer flexible printed circuit board, more wires and terminals can be installed, so that more electronic components can be mounted and the function of the catheter can be improved.

  The manufacturing method of the flexible printed circuit board used in the present invention is not particularly limited, and a known film (layer) forming technique, film (layer) patterning technique, printing, and the like conventionally used for manufacturing a flexible printed circuit board are used. It can be manufactured by appropriately combining a wiring formation technique, a photolithography technique, and the like. For example, it can be manufactured by a method such as a subtractive method or a semi-additive method.

  When the insulating base layer 3 and the insulating cover layer 5 are formed in a predetermined pattern, for example, a method using a photosensitive resin such as photosensitive polyimide (that is, exposure, development, heat curing treatment, etc. on the photosensitive resin (precursor) layer) A method of forming an insulating resin layer having a predetermined pattern by applying an etching process, and a method of patterning the insulating resin layer by etching with a laser or plasma to pattern the predetermined pattern. From this point, a method using a photosensitive resin is preferable.

  When a flexible printed circuit board having the metal support plate 6 is manufactured, a flexible printed circuit board in which the base insulating layer 3, the wiring pattern 4, and the cover insulating layer 5 are laminated in this order is manufactured, and then the metal support plate 6 is used as the base insulating layer. The base insulating layer 3, the wiring pattern 4, and the cover insulating layer 5 may be laminated in this order on the metal support plate 6.

  In addition, a flexible printed circuit board having a metal support plate 6 having an aspect in which no metal support plate exists at both ends in the short direction of the board or an aspect in which the metal support plate is used as a wiring pattern is prepared. In this case, after the laminated structure including the metal support plate 6 is manufactured, the metal support plate 6 may be partially etched.

Although the manufacturing method of the catheter of this invention is not specifically limited, Manufacturing with the following method is preferable.
For example, in the case of the catheter 100 shown in FIGS. 1 to 3, a tube in which a through hole H is formed on the side wall corresponding to a position (front end or intermediate portion of the tube) where the electronic component is to be mounted in the axial direction. 1 and a flexible printed circuit board 10 whose longitudinal width is equal to or longer than the length from the through hole H of the tube 1 to the rear end of the tube 1, Proximity to the terminal portion 40 provided in the wiring pattern 4 on the base insulating layer 3 of the flexible printed circuit board 10 through the process of inserting the printed circuit board 10 (first process) and the through hole H formed in the side wall of the tube 1. The step (second step) of placing the electronic component 2 on the region 3A to be formed (wiring pattern non-formation region), and the terminal of the electronic component 2 and the terminal portion 4A provided on the wiring pattern 4 are metal-welded. It can is connected by a conductive adhesive, made by a method comprising the said connecting portion is sealed with resin (the third step).

  Further, electronic components are first mounted on the base insulating layer 3 of the flexible printed circuit board 10, and the terminals of the electronic components 2 and the terminal portions 40 provided on the wiring pattern 4 are connected by metal welding or conductive adhesive. Then, the flexible printed circuit board is inserted into the tube 1, and the connection portion between the terminal of the electronic component 2 and the terminal portion 40 provided in the wiring pattern 4 is sealed with resin through the through hole H formed in the side wall of the tube 1. You may make it do.

  When producing a catheter that does not expose a part of the electronic component from the side wall of the tube, the electronic component is mounted on the base insulating layer of the flexible printed circuit board, and the terminal portion provided on the terminal and wiring pattern of the electronic component. And the connecting portion is sealed with resin, and then the flexible printed circuit board is inserted into the tube.

  Hereinafter, the present invention will be described more specifically with reference to examples. However, the present invention is not limited to the following examples.

Example 1
In this example, a flexible printed circuit board having five wiring patterns formed on a stainless steel substrate by a semi-additive method is manufactured, and the catheter is assembled by inserting the flexible printed circuit board into a tube. The flexible printed circuit board has the same structure as the flexible printed circuit board 10 shown in FIG.

(Production of flexible printed circuit board)
First, a photosensitive polyimide precursor 3 ′ was applied on a stainless steel substrate (SUS304) (length: 300 mm, width: 300 mm, thickness: 200 μm, elastic modulus: 205 GPa) as the metal support plate 6 (FIG. 6A). ), Exposure, development, and heating to form a plurality of parallel base insulating layers 3 made of a strip-like polyimide having a width in the short direction of 500 μm, a width in the longitudinal direction of 200 mm, and a thickness of 10 μm (FIG. 6B). )).
FIG. 6 shows only one base insulating layer 3 and its peripheral part.

  Next, a metal thin film (chromium thin film (thickness: 100 nm) / copper thin film (thickness: 100 nm)) 4a is formed by continuous sputtering (FIG. 6C), and then a wiring pattern to be formed by photoresist. A plating mask having a reverse pattern (that is, a pattern having an opening region having the same pattern as the wiring pattern to be formed) 15 was formed.

  Next, by electrolytic copper plating, a copper layer (thickness: 10 μm) is grown on a portion where there is no resist (opening portion of the plating mask 15), and five pieces running parallel to each other along the longitudinal direction of the base insulating layer 3. A wiring pattern 4 was formed (FIG. 6D), and then the plating mask (resist) was removed, and the exposed metal thin film 4a was removed by etching (FIG. 7A). The width of the copper wiring pattern 4 was 20 μm, the length (length in the axial direction) was 200 mm, and the space between adjacent patterns was 20 μm.

  Next, similarly to the base insulating layer 3, the photosensitive polyimide precursor is applied, exposed, developed, and heated in order, and an opening (a polyimide layer non-formation portion) is formed at the terminal portion of the copper wiring pattern 4. ) A cover insulating layer (thickness: 5 μm) 5 made of polyimide having a predetermined pattern provided with 5 a is formed, and nickel (thickness: 5 μm) is formed on the terminal portion of the copper wiring pattern 4 exposed from the opening 5 a of the cover insulating layer 5. / Gold (thickness: 0.2 μm) was plated to form the terminal portion 40 (FIG. 7B).

  Next, a photoresist pattern 16 is formed on the surface of the stainless steel substrate 6 opposite to the surface on which the base insulating layer 3 is formed (FIG. 7C), and the stainless steel substrate 6 is formed using the photoresist pattern 16 as a mask. Both end portions in the width direction were etched away, and the photoresist pattern 16 was further removed, so that both end portions in the width direction of the base insulating layer 3 protruded from the both ends (terminations) in the width direction of the stainless steel substrate 6 by 50 μm. Thus, a flexible printed circuit board 30 having a metal support plate but having no metal support plate at both ends in the short direction (width of the base insulating layer 3 in the short direction: 500 μm, length of the base insulating layer 3) Direction width: 200 mm) was completed (FIG. 7D).

  The flexible printed circuit board 30 is exposed without being covered with the insulating cover layer 5 at one end in the longitudinal direction (axial direction), like the flexible printed circuit board 10 of the example shown in FIG. The terminal portion 4 provided in the wiring pattern 3 on the base insulating layer 3 and the adjacent area are used as an electronic component mounting area (arrangement area).

(Assembly of the catheter)
A fluororesin tube with an inner diameter of 0.6 mm, an outer diameter of 0.8 mm, and a length (axial length) of 200 mm is prepared, with one end in the axial direction closed and the other end opened. Then, a through hole (hole size: 2 mm × 0.4 mm (square)) was formed at a position 5 mm away from the one end of the tube side wall in the axial direction of the tube.

  Next, the pressure sensor (sensor size (length: 3 mm, width: 0.5 mm, thickness: 250 μm), terminal size (80 μm × 80 μm (square))), wiring pattern on the base insulating layer of the flexible printed circuit board After connecting the terminal (electrode) of the pressure sensor and the terminal provided in the wiring pattern by wire bonding using a gold wire, the other side of the tube in the axial direction is placed. Insert the flexible printed circuit board from the end, and seal the gold wire connection between the pressure sensor and the wiring pattern on the flexible printed circuit board with epoxy resin through the through-hole formed in the side wall of the tube. A sealing silicone resin was applied to the gap between the through hole and the electronic component to produce a catheter with a pressure sensor.

  The pressure sensor catheter thus obtained had good flexibility and was able to be inserted into the body of the subject (monitor) with good operability while having five wiring patterns. In addition, the subject did not complain of pain during the insertion of the catheter.

Example 2
A catheter with a pressure sensor was produced in the same manner as in Example 1, except that the flexible printed circuit board used was obtained by removing all the stainless steel substrate from the flexible printed circuit board used in Example 1 above. Such a catheter with a pressure sensor has been reduced in workability in inserting the flexible printed circuit board into the tube as compared with the catheter with the pressure sensor of Example 1, but could be assembled without any problems. In addition, the operability during the insertion of the monitor into the body was slightly lower than that of the catheter with the pressure sensor of Example 1, but the monitor did not complain of pain during the insertion of the catheter.

DESCRIPTION OF SYMBOLS 1 Tube 2 Electronic component 3 Base insulating layer 4 Wiring pattern 5 Cover insulating layer 10 Flexible wiring circuit board 100 Catheter

Claims (2)

A flexible printed circuit board in which a through hole is provided in the side wall of the front end portion or intermediate portion of the tube, and the longitudinal width of the tube is equal to or greater than the length from the through hole to the rear end portion of the tube. And having a metal support plate and a base insulating layer, the width of the metal support plate in the short direction is smaller than the width of the base insulating layer in the short direction, and there are metal support plates at both ends in the short direction A step of inserting a flexible printed circuit board having a configuration that is not folded into both ends in the short direction ; and
Placing an electronic component through a through hole provided in a side wall of the tube in a region close to a terminal portion provided in a wiring pattern on a base insulating layer of the flexible printed circuit board; and
A method of manufacturing a catheter, comprising: connecting a terminal of the electronic component and a terminal portion provided in the wiring pattern by metal welding or a conductive adhesive, and then sealing the connection portion with a resin. A flexible printed circuit board in which a through hole is provided in a side wall of a front end portion or an intermediate portion of a tube, and a width in a longitudinal direction thereof is equal to or longer than a length from the through hole to the rear end portion of the tube , It has a support plate and a base insulating layer, the width of the metal support plate in the short direction is smaller than the width of the base insulating layer in the short direction, and there is no metal support plate at both ends in the short direction. Preparing a flexible printed circuit board ;
An electronic component is placed in a region adjacent to the terminal portion provided on the wiring pattern on the base insulating layer of the flexible printed circuit board, and the terminal of the electronic component and the terminal portion provided on the wiring pattern are metal welded or electrically conductive. Connecting with an adhesive, and
The flexible printed circuit board provided with the electronic component is inserted into the tube with its both ends in the short direction being bent, and through the through-hole provided in the side wall of the tube, the terminal and wiring pattern of the electronic component are connected. And a step of sealing a connecting portion with the provided terminal portion with a resin.

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