JP6511781B2 - Medical stylet - Google Patents

Description

   The present invention relates to a medical stylet, and more particularly to a medical stylet used in connection with a catheter such as, for example, a balloon catheter for intra-aortic balloon pumping for the purpose of measuring blood pressure.

  In recent years, in the medical field, catheters are frequently used for various treatments and examinations. For example, as treatment at the time of cardiac dysfunction, a balloon catheter is inserted into the aorta, and the intra-aortic balloon pumping method (IABP method) is performed to support cardiac function by inflating and deflating the balloon according to the heart beat. It is

  As an intra-aortic balloon catheter used in the IABP method, a catheter having a double tube structure formed of an outer tube and an inner tube located inside the outer tube is generally used.

  In such a dual tube catheter, blood is taken from the distal end opening of the inner tube, and a blood pressure measurement device is attached to the proximal end opening to detect a change in blood pressure. However, in recent years, the outer diameter of the catheter has become smaller from the viewpoint of reducing the load on the patient, and as a result, the inner diameter of the inner tube that constitutes the blood pressure introducing hole also becomes smaller, making accurate blood pressure measurement difficult. If the blood pressure measurement can not be performed in a timely and accurate manner, the treatment such as IABP may not be performed well.

  Therefore, a catheter has been proposed in which a pressure sensor (electrical signal conversion system) is attached to the distal end of the catheter and the blood pressure at the distal end of the catheter is detected as an electrical signal (for example, Patent Document 1).

  However, in the method of taking a pressure signal as an electrical signal through a catheter, electrical noise may occur. In addition, the conductivity of the medium surrounding the pressure sensor is changed, which causes a problem that drift correction of the pressure sensor is required.

  Therefore, as shown in Patent Document 2, for example, an attempt is made to use an optical pressure sensor for a catheter. However, if the optical pressure sensor is embedded and fixed at the distal end of the catheter, it is necessary to pass an optical fiber inside the catheter, so it is necessary to increase the outer diameter of the catheter. In addition, since the structure for reliably embedding the optical pressure sensor in the catheter tends to be complicated, it may be difficult to secure the strength and durability of the catheter.

  As a method of measuring blood pressure without embedding a sensor in the distal end of a catheter, for example, as shown in Patent Document 3, blood pressure is measured with a pressure sensor attached to the distal end of a wire (wire). When it is necessary, it is inserted into the inside of a catheter (for example, the inner tube of a catheter having a double tube structure) to perform measurement. When this method is used, blood may coagulate in the vicinity of the sensor or in the gap between the wire and the catheter. Therefore, if necessary, the catheter such as saline or anticoagulant drug solution from the outside of the body It is desirable that it can be injected into the inside of the However, when an optical pressure sensor is used as a sensor, each of the inside of the wire attached with the sensor and the inside of the cable connecting the device for converting the light signal into blood pressure data from the proximal end of the wire There is a problem that it is necessary to provide an optical fiber and connect these optical fibers, and it is not easy to make sure of the reliable connection of the optical fiber and the structure capable of injecting a liquid into the inside of the catheter.

Japanese Patent Application Laid-Open No. 10-137199 Japanese Patent Application Publication No. 2008-524606 Japanese Patent Application Laid-Open No. 11-342196

   The present invention has been made in view of such circumstances, and its object is to insert the inside of a catheter to accurately detect the pressure at a specific site in the body, and to secure the optical fiber in the wire and in the cable. It is an object of the present invention to provide a medical stylet provided with an optical pressure sensor, in which the connection and the structure capable of injecting a liquid into the inside of the catheter are compatible.

In order to achieve the above object, the medical stylet according to the present invention is
A hollow wire attached with an optical pressure sensor having an opening on the distal end side and detecting a pressure of fluid entering from the opening;
A first optical fiber attached to the inside of the hollow wire and transmitting an optical signal from the optical pressure sensor;
A first connector to which the proximal end of the hollow wire is attached;
A cable connected to the first connector;
And a second optical fiber attached to the inside of the cable.
The first connector is
A port connection connected to a port for passing the hollow wire inside the catheter, and a branch port for letting liquid flow into the inside of the catheter connected to the port connection;
The proximal end of the first optical fiber and the distal end of the second optical fiber are in the first connector such that they do not contact the fluid flowing between the port connection and the branch port. It is connected.

  The medical stylet according to the present invention is used, for example, with a catheter such as a balloon catheter, and after the guide wire is removed from the guide wire insertion hole for introducing the catheter into the body, an optical pressure sensor is inserted into the insertion hole. The hollow wire portion attached can be inserted. By using this optical pressure sensor, the pressure in the body can be accurately detected without being affected by electrical noise and the like.

  Further, by inserting the medical stylet into the catheter, the rigidity of the catheter becomes high, the possibility of the catheter being pushed back by blood flow or the like is reduced, and kink can be effectively prevented.

  Furthermore, in order to pass the hollow wire inside the catheter, the port connection of the first connector is connected to the port of the catheter, and a fluid such as saline or anticoagulant drug solution is introduced from the branch port, The liquid reaches the periphery of the optical pressure sensor located in the lumen of the catheter, and it is possible to suppress the occurrence of thrombus and the like around the sensor and the like, and blood pressure and the like can be accurately detected.

  Furthermore, the connection between the first optical fiber inside the hollow wire and the second optical fiber inside the cable is made not to be in contact with the liquid flowing between the port connection and the branch port in the first connector. Therefore, the connection part of these optical fibers is not easily affected by the liquid flowing in the outside of the first connector or in the first connector, and the connection becomes reliable.

  Preferably, the medical stylet according to the present invention comprises a first ferrule connected to the proximal end of the first optical fiber, and a second ferrule connected to the distal end of the second optical fiber. The proximal end of the first optical fiber and the distal end of the second optical fiber are connected by connecting the first ferrule and the second ferrule.

  By connecting the optical fibers in the first connector using a pair of ferrules, the connection of the optical fibers can be made more reliable.

  Preferably, the medical stylet according to the present invention comprises a second connector coupled to the first connector via the cable, the second connector being at the proximal end of the second optical fiber A connected end ferrule, a second connector body for holding the end ferrule, a cover member for holding the distal end of the second connector body so as to surround it, and a distal end of the cover member And a stress relief member surrounding the outer periphery of the cable.

  By holding the cover member so as to surround the distal end of the second connector body, the operator holds the cover member or the stress relieving member with one hand, and the proximal end of the second connector body It becomes easy to connect to a connection part detachably.

  Preferably, a stylet side electrical connection terminal is attached to a proximal end of the second connector body, and the stylet side electrical connection terminal is detachably connected to the end ferrule of the second connector body. It is detachably connectable to the apparatus-side electrical connection terminal attached to the apparatus-side connection part to which the receiving side ferrule is fixed.

  With this configuration, the connection between the end ferrule and the receiving ferrule can be achieved by connecting the proximal end of the second connector body to the device-side connection portion, and at the same time, the stylet-side electrical connection can be achieved. A connection is made between the terminal and the device side electrical connection terminal.

  Preferably, a memory element connected to the stylet side electrical connection terminal is mounted inside the cover member, and the medical stylet or the medical stylet is connected to the memory element. Data related to the catheter to be stored is stored, and the data can be read through the stylet side electrical connection terminal.

  By this configuration, the device-side connection can receive blood pressure data through the optical fiber and the ferrule, and the data related to the stylet or the catheter for which the stylet is used through the stylet-side electrical connection terminal can be obtained. It can be received. Therefore, data on the currently used catheter can be accurately transmitted to the device side, and the catheter can be controlled based on the accurate data.

  The catheter in which the medical stylet of the present invention is used is preferably used for intra-aortic balloon pumping (IABP).

FIG. 1 is an overall perspective view of a medical stylet according to an embodiment of the present invention. FIG. 2 is an enlarged perspective view of the distal end of the medical stylet shown in FIG. FIG. 3 is a cross-sectional view of an essential part near the optical pressure sensor at the distal end of the medical stylet shown in FIG. FIG. 4 is a cross-sectional view of an essential part in which the vicinity of the optical pressure sensor shown in FIG. 3 is further enlarged. FIG. 5 is a sectional view of an essential part of the front connector shown in FIG. 6 is an enlarged sectional view of an essential part of the front connector shown in FIG. FIG. 7 is a perspective view of the main part showing the details of the joint of the pair of ferrules shown in FIG. FIG. 8 is a cross-sectional view of a balloon catheter showing an example of use of the medical stylet shown in FIG. FIG. 9 is an enlarged sectional view of an essential part of the distal end of the balloon catheter shown in FIG. FIG. 10 is a bottom view of the back connector shown in FIG. FIG. 11 is a cross-sectional view of an essential part along the line XI-XI of the back connector shown in FIG.

  A medical stylet 60 according to an embodiment of the present invention shown in FIG. 1 is used together with, for example, a balloon catheter 20 shown in FIG. First, the balloon catheter 20 shown in FIG. 8 will be described.

  The balloon catheter 20 shown in FIG. 8 is a balloon catheter used in the intra-aortic balloon pumping method, and has a balloon portion 22 that inflates and contracts in accordance with the pulsation of the heart. The balloon portion 22 is formed of a thin film having a film thickness of about 50 to 150 μm. The material of the thin film is not particularly limited, but is preferably a material excellent in antithrombotic properties and flex fatigue resistance, and is made of, for example, polyurethane.

  The outer diameter and the length of the balloon portion 22 are determined according to the inner volume of the balloon portion 22 which largely affects the auxiliary function of the cardiac function, the inner diameter of the arterial blood vessel, and the like. The internal volume of the balloon 22 is not particularly limited, but is 20 to 50 cc, and the outer diameter of the balloon 22 is preferably 12 to 18 mm when inflated, and the length is preferably 150 to 250 mm.

  A distal end tip 25 having a distal end opening 23 is attached to the distal end 22a of the balloon 22 by means such as heat fusion or adhesion. The distal end portion of the inner tube 30 is attached to the inner peripheral side of the distal end tip portion 25 by means such as heat fusion or adhesion.

  The distal end of the outer tube 24 is connected to the proximal end 22 b of the balloon portion 22. The pressure fluid is introduced into and drawn out of the balloon portion 22 through the pressure fluid conducting path 29 formed inside the outer tube 24 so that the balloon portion 22 is expanded and contracted. The connection between the balloon portion 22 and the outer tube 24 is made by heat fusion or adhesion with an adhesive.

  The inner tube 30 axially extends inside the balloon portion 22 and the outer tube 24 and communicates with a wire insertion port 44 of the handle portion 42 described later. A lumen 31 is formed which does not communicate with the pressure fluid channel 29 formed in the inner and outer tubes 24.

  When the balloon catheter 20 is inserted into the artery, the inner tube 30 located in the balloon portion 22 is wound with the balloon portion 22 in a contracted state, and the lumen 31 conveniently inserts the balloon portion 22 into the artery. It is also used as a lumen through which a guide wire used for the purpose is inserted.

  Connected to the proximal end of the outer tube 24 is a handle portion 42 which is placed outside the patient's body. The handle portion 42 is formed separately from the outer tube 24 and fixed by means such as heat fusion or adhesion. The handle portion 42 includes a first passage 47 in which a pressure fluid inlet / outlet 46 for introducing or discharging pressure fluid into or out of the pressure fluid conducting passage 29 in the outer tube 24 and the balloon portion 22 is formed. And a second passage 45 in which a wire insertion port 44 communicating with the second passage 45 is formed.

  The pressure fluid inlet / outlet 46 is connected to, for example, a pressure fluid connector tube of a drive device (not shown), by which the fluid pressure is introduced or drawn out into the balloon portion. The fluid to be introduced is not particularly limited, but helium gas or the like having a small viscosity is used so that the balloon portion expands or contracts quickly according to the drive of the driving device. Further, the drive device (IABP drive device) is not particularly limited, and for example, a device as shown in Japanese Patent Publication No. 2-39265 and WO 2011/114779 may be used.

  In the handle portion 42 of the present embodiment, the first passage 47 in which the pressure fluid inlet / outlet 46 is formed is disposed in a straight shape along the axial center direction of the outer pipe 24 and the second passage in which the wire insertion port 44 is formed. 45 is arranged to be disposed at a predetermined inclination with respect to the axis of the first passage 47.

  Moreover, in the handle portion 42 of the present embodiment, an end portion of the inner pipe 30 is held in the second passage 45, and the inner pipe 30 is disposed eccentrically to be in contact with the inner wall of the outer pipe 24. A first inner tube end holder 48 and a second inner tube end holder 50 are mounted. Since the first passage 47 communicating with the pressure fluid inlet / outlet 46 formed in the handle portion 42 is disposed straight along the axial direction of the outer pipe 24, the wire insertion port is in the axial direction of the outer pipe As compared with the conventional example arranged straight, it is possible to reduce the flow path resistance of the pressure fluid and improve the response of expansion and contraction in the balloon portion.

  The front of the medical stylet 60 shown in FIG. 1 with respect to the attachment port 52 (port for passing a hollow wire inside the catheter) of the second inner tube end holder 50 in which the wire insertion opening 44 is formed. The port connection portion 72 of the connector (first connector) 70 is detachably mounted. The insertion wire 80 of the medical stylet 60 is insertable into the lumen 31 of the inner tube 30. The port connection portion 72 may be detachably attached to the attachment port 52 according to a conventional method, for example, by means of screwing or the like.

  Hereinafter, the medical stylet 60 will be described in detail. As shown in FIG. 1, the medical stylet 60 has an insertion wire 80 and a connector 65 to which the proximal end of the insertion wire 80 is attached.

  As shown in FIGS. 2 and 3, the insertion wire 80 has a hollow wire 82 and a distal end wire 81 inserted and attached to the distal end of the hollow wire 82. The distal end wire 81 is tapered toward the distal end, and at its most distal end, a spherical body 81a having a diameter larger than the outer diameter of the wire 81 near the distal end is integrated. It is molded. By providing the spherical body 81a at the distal end of the wire 81, the distal end of the insertion wire 80 can be easily inserted into the lumen 31 of the inner tube 30 shown in FIG. 8, and the distal end of the insertion wire 80 There is less risk of damaging the inner pipe 30 in parts.

  The outer diameter of the spherical body 81 a is preferably equal to or smaller than the largest outer diameter of the tapered wire 81, and is preferably smaller than the outer diameter of the hollow wire 82. The length L0 of the distal end wire 81 (the length of the portion protruding from the hollow wire 82) is not particularly limited, but is preferably 5 to 50 mm. The outer diameter of the hollow wire 82 is not particularly limited, and is, for example, 0.3 to 0.7 mm. The inner diameter of the hollow wire 82 may be an inner diameter into which the optical pressure sensor 84 and the optical fiber 88 can be inserted. Further, the total length of the insertion wire 80 is also not particularly limited, but preferably 50 to 800 mm.

  The proximal end 81b of the distal end wire 81 is joined to the inside of the mounting distal end 82a of the hollow wire 82, as shown in FIG. The bonding may be laser welding, other welding, bonding with an adhesive, or the like. Near the attachment distal end 82a of the hollow wire 82, at least one, preferably one or more openings 82b are provided, through which the hollow wire 82 can communicate with the inside and the outside through the opening 82b. It has become.

    In this embodiment, the proximal end portion of the distal end wire 81 reaches the proximal end side edge of the opening 82b and slightly protrudes to the opening 82b, but does not necessarily reach the opening 82b. Also good. However, the proximal end of the distal end wire 81 is designed so as not to completely block the opening 82b, and preferably the hollow wire 82 is attached so that the opening area of the opening 82b is not narrowed. It is joined to the inside of the distal end 82a.

  At the proximal end side edge of the opening 82b, an optical pressure sensor 84 is attached to the inside of the hollow wire 82 to detect the pressure of the fluid entering the opening 82b. At the proximal end of the optical pressure sensor 84, the distal end of an optical fiber (first optical fiber) 88 is joined. As shown in FIG. 4, the distal end 88a of the optical fiber 88 enters the recess 84b formed on the proximal end side of the substrate body 84a of the optical pressure sensor 84, and the substrate body 84a is formed by the adhesive 87 or the like. Bonded to

  The substrate main body 84a is made of, for example, glass, and at its tip (distal end), a cavity 85 is formed so that a diaphragm 85 is attached and a light resonance portion is formed behind it. is there. By applying pressure to the diaphragm 85, a difference in path of light transmitted through the optical fiber 88 or the like changes, and the pressure applied to the diaphragm 85 can be detected. The optical pressure sensor 84 is not particularly limited, and for example, those described in JP-A-2008-524606, JP-A-2000-35369, JP-A-2014-507666 and the like can be used.

  In the present embodiment, the diaphragm 85, which is a pressure detection unit of the pressure detection sensor 84, is located at the proximal end of the opening 82b of the hollow wire 82, and accurately measures the blood pressure of the blood transmitted through the opening 82b. It is possible. On the outer periphery of the optical fiber 88 connected to the proximal end of the optical pressure sensor 84, a coating layer 88b is formed of, for example, polyimide resin.

  The vicinity of the distal end of the optical fiber 88 located near the optical pressure sensor 84 is fixed to the inside of the hollow wire 82 by a partition ring 83. In order to fix the partition ring 83 at a predetermined position inside the hollow wire 82, one or more bonding holes 82c are formed at the predetermined position from the opening 82b of the hollow wire 82, as shown in FIGS. It is By injecting the adhesive through the bonding hole 82c, it becomes easy to fix the partition ring 83 in the hollow wire 82 from the opening 82b to the proximal end in a predetermined position, and the opening 82b and the optical Positioning with the pressure sensor 84 can also be performed simultaneously. The pressure detected by the optical pressure sensor 84 can be transmitted as an optical signal through the optical fiber 88.

  In the present embodiment, the distal end wire 81 and the hollow wire 82 are made of, for example, a metal such as stainless steel or nickel-titanium alloy, and they may be made of the same material or different materials. It may be composed of As shown in FIG. 4, a coating layer 82 d made of a fluorine resin such as PTFE may be applied to the outer periphery of the hollow wire 82.

  As shown in FIG. 1, the connector 65 includes a front connector (first connector) 70 to which the proximal end of the hollow wire 82 is attached, a back connector (second connector) 100, and a cable 90 for connecting them. Have. As shown in FIG. 8, the front connector 70 has a port connection 72 connected to the attachment port 52 for passing the insertion wire 80 through the lumen 31 of the balloon catheter 20 as a catheter. The port connection portion 72 is formed at the distal end of the front connector main body (first connector main body) 71 of the front connector 70, and further, a branch port 73 is formed in the front connector main body 71. The connection between the front connector 70 and the hollow wire 82 (insertion wire 80) may be a detachable connection or may be fixed non-removably, but the optical fiber in the front connector 70 and the hollow wire 82 From the viewpoint of keeping the conduction of the electrode 88 for a long period of time, it is preferable to fix and connect in a non-removable manner.

  As shown in FIG. 5, a flush nozzle 72a is attached to the inside of the port connection portion 72 substantially concentrically. The inside of the flash nozzle 72a is in communication with the inside of the branch port 73. A fluid such as saline or anticoagulant solution introduced from the branch port 73 is introduced into the wire insertion port 44 from the tip of the flush nozzle 72a shown in FIG. It flows outside the wire 80 and is led to the distal end opening 23 of the inner tube 30.

  As shown in FIG. 5, a connection port 74 is formed at the proximal end of the front connector main body 71, and a ferrule holding portion 75 is connected to the connection port 74. As shown in FIGS. 6 and 7, inside the ferrule holder 75, the proximal end of the optical fiber 88 mounted inside the hollow wire 82 of the insertion wire 80 is an optical fiber in the cable 90 ( A pair of ferrules (first and second ferrules) 76 and 77 for coupling to the second optical fiber 88A are disposed to abut inside the sleeve 78. Further, on the outer peripheral side of the pair of ferrules 76 and 77 and the sleeve 78, a pipe 78a made of metal such as stainless steel is put, for example, and the inside of the pipe 78a is an adhesive for sealing optical parts Is sealed by the sealing material 78b. By forming the optical fiber 88 mounted inside the hollow wire 82 and the optical fiber in the cable 90 with separate optical fibers and connecting them in the front connector main body 71, the hollow wire 82 portion and It becomes possible to manufacture the cable 90 and the part in a separate manufacturing process, and the productivity of the medical stylet 60 is improved. In addition, optical fibers of different types and diameters can be used as the optical fibers 88 and 88A, and for example, as the optical fiber 88 in the hollow wire 82 for the purpose of narrowing the diameter of the hollow wire 82 As the optical fiber 88A in the cable 90, a general-purpose inexpensive optical fiber can be used by using an expensive optical fiber whose diameter is particularly reduced. Although the ferrules 76 and 77 are used to facilitate connecting the ends of different optical fibers 88 and 88A to each other so as to be able to transmit optical signals, they need not necessarily be used, for example, optical fibers The end portions of 88, 88A may be directly connected by means such as fusion bonding.

  As shown in FIG. 6, the proximal end of the ferrule (second ferrule) 77 to which the distal end of the optical fiber 88A is connected is attached to the distal end of the plug member 79, and the proximal end of the plug member 79. The end side cylindrical portion 79a is connected to the aramid fiber 93 provided for the purpose of supporting and protecting the optical fiber 88A around the optical fiber 88A in the cable 90 by caulking using a caulking ring or the like. From the outside, the distal end 91a of the tube body 91 constituting the cable 90 is also connected by means such as caulking using a caulking ring. In order to further seal the pipe 78a in which the pair of ferrules 76 and 77 and the sleeve 78 are sealed in the inside of the accommodating cylindrical portion 75b of the ferrule holding portion 75, for example, a cured product of an ultraviolet curing adhesive 75 g of filling material is filled.

  The proximal end of the ferrule holding portion 75 is provided with a convex portion 75f extending in the circumferential direction of the inner surface, and the presence of the convex portion 75f allows the proximal end side cylindrical portion 79a of the plug member 79 to be formed. The connection portion between the cable 90 and the cable 90 is prevented from coming off from the proximal end side of the ferrule holding portion 75, so that the connection between the ferrule holding portion 75 and the cable 90 is ensured. Further, at the distal end of the ferrule holding portion 75, an insertion cylindrical portion 75c and an outer peripheral cylindrical portion 75d located on the outer periphery thereof are formed, and in the gap 75e between them, the connection port 74 shown in FIG. The front connector main body 71 and the ferrule holding portion 75 are connected by the insertion of. The connection between the front connector main body 71 and the ferrule holding portion 75 is completed by the connection of the optical fibers 88 and 88A in the housing cylindrical portion 75b of the ferrule holding portion 75 and the filling of the filler 75g in the housing cylindrical portion 75b. It is desirable to do after Further, for connection of the front connector main body 71 and the ferrule holding portion 75, means such as screwing or bonding may be used. A pair of ferrules 76 and 77 and a sleeve 78 are disposed in the insertion cylindrical portion 75c and the housing cylindrical portion 75b of the ferrule holding portion 75, but the periphery is filled with the sealing material 78b and the filling 75g. The liquid introduced from the branch port 73 does not enter the inside of the insertion cylindrical portion 75c and the storage cylindrical portion 75b, and the handle portion shown in FIG. 8 from the flush nozzle 72a disposed on the distal end side thereof It discharges to 42 wire insertion ports 44. Therefore, since the connection portion of the optical fibers 88 and 88A connected by using the pair of ferrules 76 and 77 does not contact the liquid flowing between the port connection portion 72 and the branch port 73, the optical fiber 88, The 88A is assured of a secure connection without being affected by the liquid.

  As shown in FIG. 1, strain reliefs 92 and 94 as stress relieving members are attached to the outer circumferences of both ends of the cable 90. One strain relief 92 is coupled to the proximal end of the ferrule holder 75 of the front connector 70 and covers the distal end of the cable 90. The other strain relief 94 is connected to the distal end of the cover member 106 of the back connector 100 and covers the proximal end of the cable 90.

  As shown in FIGS. 5 and 6, an optical fiber 88A passes through a flexible tube 91 constituting the cable 90, and the proximal end of the optical fiber 88A is back as shown in FIG. It is connected to the end ferrule 102 of the back connector main body (second connector main body) 104 held by the cover member 106 of the connector 100.

  As shown in FIGS. 10 and 11, a grip portion 106a having an outer diameter smaller than that of the other portion is formed on the outer periphery of the cover member 106 on the distal end side, and it is easy to pick with the operator's finger It has become. The proximal end 94a of the strain relief 94 is located inside the grip portion 106a, and the distal end of the cover member 106 engages with the outer periphery of the proximal end 94a of the strain relief 94 and fixed by, for example, an adhesive. Yes.

  The cover member 106 is formed of, for example, a synthetic resin or the like, and in particular, the grip portion 106 a may have flexibility so that the operator can easily pick it up with a finger. At the proximal end of the cover member 106, the distal end 104a of the back connector body 104 is fixed. A pair of stylet side electrical connection terminals 110 are attached to the bottom surface of the back end of the back connector body 104 (see FIG. 10).

  As shown in FIG. 11, the stylet side electrical connection terminal 110 can be detachably connected to the device side electrical connection terminal 210. The device-side electrical connection terminal 210 is mounted on the substrate 211 of the device-side connection portion 204 to which the receiving ferrule 202 to which the proximal end 102 a of the end ferrule 102 of the back connector body 104 is detachably connected is fixed. .

  The device side connection unit 204 is configured as, for example, a female socket 200. The proximal end of the back connector body 104 constitutes a male socket. Therefore, by inserting the proximal end of the back connector body 104 of the back connector 100 into the female socket 200, optical connection between the end ferrule 102 and the receiving ferrule 202 becomes possible, and at the same time, the stylet side electrical connection terminal 110 And the device side electrical connection terminal 210 can be electrically connected.

  In the device-side connection unit 204, the optical fiber 88B is connected to the receiving-side ferrule 202, and the electrical wiring of the substrate 211 is connected to the device-side electrical connection terminal 210. The female socket 200 including the device side connection unit 204 is incorporated in an IABP drive device, a blood pressure measurement display device, or the like (not shown).

  The light signal transmitted to the optical fiber 88B of the female socket 200 includes the pressure signal detected by the optical pressure sensor 84 shown in FIGS. 3 and 4. The light signal is converted into a blood pressure signal by an IABP driving device (not shown) or a blood pressure measurement display device or the like, and is used as a blood pressure data for driving the IABP driving device. Specifically, based on the blood pressure fluctuation data measured by the pressure sensor, the pump device is controlled in accordance with the pulsation of the heart, and the balloon 22 shown in FIG. 8 is inflated in a short cycle of 0.4 to 2 seconds. And to contract. Alternatively, the blood pressure data can be displayed in real time.

  As shown in FIG. 11, a recess 106 b is formed on the inner periphery on the proximal end side of the cover member 106, and a memory element fixed to the bottom of the back connector body 104 in the recess 106 b is provided. An IC chip 112 is disposed. The IC chip 112 is connected to the stylet side electrical connection terminal through the back surface of the back connector body 104. The IC chip 112 can store, for example, data related to the medical stylet 60 or a catheter (balloon catheter 20) to which the medical stylet 60 is connected, and the data can be stored through the electrical connection terminals 110 and 210. Is readable. It is also possible to rewrite data stored inside the IC chip 112 through the electrical connection terminals 110 and 210.

  The data that can be stored in the IC chip 112 is not particularly limited, but data for compensating for individual differences of the optical pressure sensor 84, data regarding the expanded outer diameter and volume of the balloon portion and the product number, or a balloon catheter There is a type of Examples of balloon catheter types include short balloon types, long balloon types, and other special shape types.

  In the IABP driving device, which is not shown, the flow adjustment of the pressure fluid sent from the driving device to the balloon catheter can also be automatically performed based on the data stored in the IC chip 112. That is, when the volume of the balloon portion is small, the flow rate of the pressure fluid sent to the balloon catheter also decreases.

  Further, data to be written to the IC chip 112 of the medical stylet 60 used together with the used balloon catheter is not particularly limited, but, for example, the identification number of the driving device that actually driven the balloon catheter is exemplified. . In that case, even after the balloon catheter 20 and the medical stylet 60 shown in FIG. 8 are removed from the drive device, the drive device in which the balloon catheter 20 is used can be easily identified.

  Therefore, by reading the data of the IC chip 112 and further combining the data of the drive specified from the data, the driving state of the balloon catheter 20 used at the time of clinical research and trouble shooting can be accurately determined later. It becomes easy to grasp, and the time required to analyze the driving state can be shortened.

  When the memory capacity of the IC chip 112 has a margin, the data written to the IC chip 112 is, for example, all the data of the driving state of the driving device which actually driven the balloon catheter 20 or a part of the data. It is good. Data relating to the drive state is, for example, waveform data such as an electrocardiogram, blood pressure, drive pressure, etc. during the drive period, and event data during the drive period.

  By reading such data from the IC chip 112, it becomes easy to grasp the driving state of the used balloon catheter 20 accurately at the time of clinical research and troubleshooting, and it takes time to analyze the driving state. Can be shortened.

  As shown in FIG. 11, in the present embodiment, the cover member 106 holds the distal end portion of the back connector body 104 so that the operator holds the cover member 106 or the strain relief 94 with one hand. Thus, it becomes easy to detachably connect the proximal end of the back connector main body 104 to the device-side connection portion 204 of the female socket 200. Moreover, only by connecting the proximal end of the back connector main body 104 to the device-side connection portion 204, the connection between the end ferrule 102 and the reception-side ferrule 202 is achieved, and at the same time, the stylet connection terminal 110 and the device A connection with the side connection terminal 210 is made.

  The medical stylet 60 according to the present embodiment shown in FIG. 1 is used together with, for example, a balloon catheter 20 shown in FIG. The balloon catheter 20 is conveyed to a predetermined position in the body through a guide wire (not shown) to a lumen 31 for introducing it into the body.

  Thereafter, after the guide wire is removed from the lumen 31, as shown in FIG. 8, the port connection portion 72 of the front connector 70 in the medical stylet 60 is attached to the attachment port 52 of the handle portion 42 of the balloon catheter 20. Be As a result, the insertion wire 80 can be inserted into the lumen 31 of the inner tube 30 from the distal end wire 81 side.

  As shown in FIGS. 2 and 3, the distal end wire 81 is attached to the distal end of the hollow wire 82 and can be shaped with different materials, properties or shapes than the hollow wire 82, eg, flexible , And can be conveniently guided inside the lumen 31 shown in FIG. 8 to easily reach a target position.

  Further, by inserting the medical stylet 60 into the balloon catheter 20, the rigidity of the balloon catheter 20 is enhanced, and the risk of the balloon portion 22 of the balloon catheter 20 being pushed back by the blood flow is reduced, and the kink is also broken. It can be effectively prevented.

  Furthermore, in the present embodiment, as shown in FIG. 3, as the optical pressure sensor 84 is provided on the rear side of the distal end wire 81, as shown in FIG. 8 and FIG. Positioning the position of the proximal end (approximately the same as the position of the optical pressure sensor 84) inside the inner tube 30 at a predetermined distance L2 from the distal end opening 23 of the balloon catheter 20 toward the proximal end it can. As a result, it is possible to accurately measure the blood pressure and the like by the optical pressure sensor 84 without being affected by the thrombus and the like and without being influenced by the electrical noise.

  In the present embodiment, as shown in FIGS. 8 and 9, when the insertion wire 80 of the medical stylet 60 is inserted into and attached to the lumen 31 of the inner tube 30, that is, the medical stylet 60. When the port connection 72 of the front connector 70 is attached to the attachment port 52 of the second inner tube end holder 50 at the handle 42 of the balloon catheter 20, the position of the distal end 81a of the distal end wire 81 is The distal end 81a is located at a predetermined distance L1 from the distal end opening 23 toward the proximal end so as not to project outside the distal end opening 23 of the balloon catheter 20. The predetermined distance L1 prevents the distal end 81a from projecting out of the distal end opening 23 even in the presence of vibration caused by driving of a balloon, and a viewpoint of measuring a more accurate pressure by the optical pressure sensor 84. Preferably, it is 30-250 mm. The predetermined distance L2 is preferably 31 mm or more.

  In the present embodiment, by introducing a liquid such as saline or an anticoagulant drug solution from the branch port 73 shown in FIG. 8, the liquid is around the optical pressure sensor 84 located in the lumen 31 of the balloon catheter 20. It is possible to prevent blood clots and the like from occurring around the sensor 84, and blood pressure and the like can be accurately detected.

  The present invention is not limited to the above-described embodiment, and can be variously modified within the scope of the present invention.

  For example, the medical stylet of the present invention can also be used for catheters other than the balloon catheter used in the IABP method.

20 ... balloon catheter 22 ... balloon portion 23 ... distal end opening 24 ... outer tube 25 ... distal end tip portion 29 ... pressure fluid conduction path 30 ... inner tube 31 ... lumen 42 ... handle portion 44 ... wire insertion port 46 ... pressure Fluid inlet / outlet 52 ... Mounting port 60 ... Medical stylet 65 ... Connector 70 ... Front connector (first connector)
72 ... Port connection part 73 ... Branch port 74 ... Connection port 75 ... Ferrule holding part 76, 77 ... Ferrule 80 ... Wire for insertion 81 ... Distal end wire 82 ... Hollow wire 82a ... Attachment distal end 82b ... Opening 84 ... Optical pressure sensor 88, 88A, 88B ... Optical fiber 90 ... Cable 92, 94 ... Strain relief 100 ... Back connector (second connector)
102 ... end ferrule 104 ... back connector body (second connector body)
106 ... Cover member 110 ... Stylet side electrical connection terminal 112 ... IC chip 200 ... Female socket 202 ... Receiving side ferrule 204 ... Equipment side connection part

Claims (5)

A hollow wire attached with an optical pressure sensor having an opening on the distal end side and detecting a pressure of fluid entering from the opening;
A first optical fiber attached to the inside of the hollow wire and transmitting an optical signal from the optical pressure sensor;
A first connector to which the proximal end of the hollow wire is attached;
A cable connected to the first connector;
A second optical fiber mounted inside the cable;
Have a, the hollow wire is inserted into the interior of the catheter, a medical stylet used to measure the pressure in the body,
The first connector is
A port connection portion detachably connected to a port for passing the hollow wire inside the catheter, and a branch port for allowing liquid to flow into the catheter connected to the port connection portion; The proximal end of the optical fiber and the distal end of the second optical fiber are connected in the first connector so as not to contact the fluid flowing between the port connection and the branch port. Medical stylet.   A first ferrule coupled to the proximal end of the first optical fiber, and a second ferrule coupled to the distal end of the second optical fiber, the first ferrule and the second ferrule The medical stylet according to claim 1, wherein the proximal end of the first optical fiber and the distal end of the second optical fiber are connected by connecting the two.   A second connector coupled to the first connector via the cable, the second connector holding an end ferrule connected to the proximal end of the second optical fiber, and the end ferrule A second connector main body, a cover member for holding the distal end of the second connector main body so as to surround it, and a stress relieving member connected to the distal end of the cover member and surrounding the outer periphery of the cable The medical stylet according to claim 1 or 2. A stylet side electrical connection terminal is attached to the proximal end of the second connector body,
The stylet side electrical connection terminal is detachably attachable to the equipment side electrical connection terminal attached to the equipment side connection portion to which the reception side ferrule to which the end ferrule of the second connector main body is detachably coupled is fixed. The medical stylet according to claim 3, which is connectable to A memory element connected to the stylet side electrical connection terminal is mounted inside the cover member,
The memory element stores data related to the medical stylet or a catheter to which the medical stylet is connected;
The medical stylet according to claim 4, wherein the data can be read through the stylet side electrical connection terminal.

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