JP5399817B2 - Insertion aid and catheter - Google Patents

Description

  The present invention relates to a diagnostic catheter used for making various diagnoses by inserting into a body cavity or a lumen of blood vessels, vascular vessels, digestive organs, and the like, and insertion assistance for inserting a guide wire through the catheter. Concerning ingredients.

  In the treatment of a vascular stenosis that causes myocardial infarction or the like, a surgical technique is used in which the affected area is treated percutaneously with a catheter. This surgical technique includes a method of expanding the stenosis with a dilatation catheter having a balloon at the tip, a method of indwelling a metal tube called a stent, a method of excising the stenosis by rotating a grindstone or a cutter with an instrument called a rotablator There are various methods, and a preferable method is selected according to the nature of the stenosis and the patient's condition.

  Diagnosis catheters are mainly used in the percutaneous treatment of such vascular stenosis, as an aid to the decision for observing the properties of the stenosis and selecting treatment methods. It is also used for observation of the state.

  Examples of the diagnostic catheter include an ultrasonic catheter that performs sensing with an ultrasonic detector, and an optical tomographic imaging apparatus that uses low-interference light.

  Of these, the ultrasonic catheter needs to be inserted up to a tortuous place such as the coronary artery of the heart, so when inserting, a guide wire is inserted into the affected area first, and then along the guide wire. I'm going. For this reason, a lumen (hereinafter referred to as a guide wire lumen) is provided at the distal end of the ultrasonic catheter so that the guide wire is inserted and moved according to the guide wire.

  The presence of a guide wire lumen in the direction in which ultrasonic waves are generated by the ultrasonic detector hinders the acquisition of images by the ultrasonic detector, so that the guide wire lumen is generally more inflated than the position of the ultrasonic detector. It is provided only on the distal end side in the body insertion direction.

  In addition, it is desirable to provide an ultrasonic detector for acquiring an image of a living body at the tip of the ultrasonic catheter as much as possible in order to minimize insertion of the catheter into the living body. Therefore, the guide wire lumen provided on the distal end side with respect to the ultrasonic detector inevitably needs to be shortened in the axial direction.

  Therefore, there is a problem that the operability is deteriorated and the catheter does not advance along the guide wire as expected. Thus, for example, Patent Document 1 proposes a catheter in which a guide wire lumen is provided not only on the front end side but also on the rear end side of the ultrasonic detector.

Patent No.4065167

  However, in the catheter described in Patent Document 1, the guide wire lumen is divided into two on the front end side and the rear end side of the ultrasonic detector. It is not easy to insert a guide wire into the cable.

  The present invention has been made to solve the above-described problem, and provides an insertion assisting tool and a catheter capable of improving workability when a guide wire is inserted into a catheter having a divided guide wire lumen. The purpose is to provide.

  The insertion assisting tool of the present invention that achieves the above-described object provides a first guide wire lumen through which a guide wire is inserted, and a first guide wire lumen that is provided on a substantially extension line of the first guide wire lumen and through which the guide wire is inserted. An insertion assisting tool that is removably attached to a catheter having two guidewire lumens and assists the insertion of the guidewire, the gap between the first guidewire lumen and the second guidewire lumen. It has an insertion assisting lumen through which the guide wire can be inserted.

  The insertion assisting device of the present invention configured as described above has an insertion assisting lumen that covers the space between the first guidewire lumen and the second guidewire lumen so that the guidewire can be inserted. By simply inserting a guide wire into the guide wire lumen, the guide wires can be inserted into the two guide wire lumens, and workability can be improved. Furthermore, since the insertion aid is detachably attached to the catheter without using a special tool, it can be easily removed after the operator has inserted the guide wire at the surgical site.

  At least one of the inner wall adjacent to the first guide wire lumen or the second guide wire lumen of the insertion assisting lumen is on an extension line of the inner wall of the adjacent first guide wire lumen or the second guide wire lumen. Alternatively, if the guide wire is moved to the insertion auxiliary lumen from the adjacent first guide wire lumen or the second guide wire lumen, the guide wire is inserted into the insertion auxiliary lumen. It is smoothly inserted without being caught on the inner wall.

  If at least a part of the inner wall of the insertion assisting lumen is positioned on or inside the extension line of the inner wall of the first guidewire lumen or the second guidewire lumen, the insertion assisting lumen can When the distal end of the guide wire moves to the first or second guide wire lumen, the distal end of the guide wire is smoothly inserted without being caught by the inner wall of the first or second guide wire lumen.

  Engaging at least one of a first outer wall defining the first guidewire lumen, a second outer wall defining the second guidewire lumen, and an outer wall of the catheter body tube of the catheter outer wall; If it can be removed from the catheter, the insertion assisting lumen can be arranged at an appropriate position.

  A first clamping member and a second clamping member provided with surfaces facing each other so as to be able to approach and separate from each other, wherein a facing groove is formed in at least one of the facing surfaces, and the insertion assisting lumen is defined by at least a part of the facing groove. By including a clamping member and an elastic member that applies a biasing force in a direction in which the first clamping member and the second clamping member are close to each other, an insertion assisting lumen is provided between the first clamping member and the second clamping member. And the insertion aid can be attached to and detached from the catheter.

  If it is a cylindrical member that engages with the catheter, and has a detachable portion that is deformed or broken so as to be detachable from the catheter, an insertion assisting lumen can be formed inside the cylindrical member, and the insertion The aid can be removed from the catheter.

  The first guide wire lumen and the second guide wire lumen communicate with at least one of the guide wire insertion openings separated from each other and have a guide portion that expands as the distance from the opening increases. The guide wire can be easily inserted into the guide wire lumen and the second guide wire lumen, and workability can be improved.

  A catheter having a first guidewire lumen through which the guidewire is inserted, and a second guidewire lumen provided on a substantially extension line of the first guidewire lumen and through which the guidewire is inserted; A catheter on which any of the insertion aids described above is attached so as to form an insertion auxiliary lumen through which the guide wire can be inserted, covering between the first guide wire lumen and the second guide wire lumen; Then, the user can insert the guide wire into the two guide wire lumens only by inserting the guide wire into one guide wire lumen, and the workability can be improved. Furthermore, since the insertion aid is detachably attached to the catheter, it can be easily removed after the guide wire is inserted.

  If packaging is performed with the insertion aid attached, the guide wire can be inserted into the first or second guide wire lumen simply by removing the packaging from the packaging, thereby improving workability. it can.

It is a top view which shows the ultrasonic catheter which concerns on 1st Embodiment. It is sectional drawing which shows a part of front-end | tip part of the ultrasonic catheter which concerns on 1st Embodiment. It is sectional drawing which shows the connection part vicinity of a sheath front-end | tip part and a sheath main-body part. It is a top view which shows an insertion assistance tool. It is a top view which shows the time of opening the insertion assistance tool. It is a perspective view which shows an insertion assistance tool. It is a fragmentary perspective view which shows one clamping member of an insertion assistance tool. It is sectional drawing which follows the 8-8 line of FIG. It is a top view which shows the packaged ultrasonic catheter. It is sectional drawing at the time of inserting a guide wire in an ultrasonic catheter, (A) shows the time of insertion auxiliary lumen insertion, (B) shows after insertion auxiliary lumen insertion. It is sectional drawing which shows the front-end | tip part of the ultrasonic catheter which concerns on 2nd Embodiment. It is sectional drawing which shows the front-end | tip part of the ultrasonic catheter which concerns on 3rd Embodiment. It is a top view which shows the front-end | tip part of the ultrasonic catheter which concerns on 4th Embodiment. It is sectional drawing which follows the 14-14 line | wire of FIG. It is a top view which shows at the time of removing the insertion assistance tool in the ultrasonic catheter which concerns on 4th Embodiment. It is sectional drawing which shows the time of removing the insertion assistance tool in the ultrasonic catheter which concerns on 4th Embodiment. It is a top view which shows the modification of the insertion assistance tool of the ultrasonic catheter which concerns on 4th Embodiment. It is sectional drawing which follows the 18-18 line of FIG.

Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

<First Embodiment>
As shown in FIG. 1, the ultrasonic catheter 1 according to the first embodiment of the present invention is used without being inserted into a body cavity and a sheath 2 to be inserted into a living body such as a body cavity. It is comprised by the hub 3 arrange | positioned by a person's hand side, and the insertion assistance tool 50 for making insertion of the guide wire 25 easy.

  The sheath 2 has a sheath distal end portion 21 and a sheath main body portion 22. One end of the sheath body 22 is connected to the sheath tip 21, and the hub 3 is connected to the other end of the sheath body 22.

  The sheath distal end portion 21 and the sheath main body portion 22 are provided with observation portion lumens 23 and 24 that communicate with each other. The observation portion lumens 23 and 24 are hollow passages formed in the sheath 2, and are formed from the sheath main body portion 22 to the sheath distal end portion 21.

  An imaging core 40 is disposed in the observation portion lumens 23 and 24. The imaging core 40 has a transducer unit 41 for transmitting and receiving ultrasonic waves toward the tissue in the body cavity, and a drive for attaching the transducer unit (observation unit, ultrasonic transmission / reception unit) 41 to the tip and transmitting rotational power. A shaft 42 and a rotation stabilization coil 43 attached to the vibrator unit 41 are provided.

  As shown in FIG. 2, the transducer unit 41 includes an ultrasonic transducer 411 that transmits and receives ultrasonic waves, and an ultrasonic transducer housing 412 that houses the ultrasonic transducer 411.

  The ultrasonic transducer 411 generates an ultrasonic wave toward the inside of the body and receives an ultrasonic wave reflected and returned, thereby enabling formation of an ultrasonic tomographic image of the affected part. The ultrasonic transducer housing 412 is formed in a concave shape, and holds and protects the ultrasonic transducer 411 in the concave concave portion.

  The drive shaft 42 is flexible and has a characteristic capable of transmitting the rotational power generated in the hub 3 to the vibrator unit 41. For example, a multi-layer coil such as a three-layer coil in which the right and left and the winding directions are alternated The outer diameter of the tube is constant. When the driving shaft 42 transmits the rotational power, the vibrator unit 41 rotates about the extending direction of the observation unit lumen 23, so that the affected part in the body cavity such as blood vessels and vessels can be observed 360 degrees. it can. The drive shaft 42 has a signal line for transmitting a signal detected by the vibrator unit 41 to the hub 3.

  The rotation stabilization coil 43 is attached to the tip of the transducer unit 41 and serves as a guide for the transducer unit 41 to rotate stably when the imaging core 40 rotates. Further, the rotation stabilization coil 43 can enter the metal coil 32 fixed to the distal end of the sheath distal end portion 21. Since the rotation stabilizing coil 43 enters the metal coil 32, the imaging core 40 and the sheath 2 are integrated at the distal end of the sheath distal end portion 21, and the structure is strong against bending when the ultrasonic catheter 1 is inserted into the living body.

  In addition, the observation unit lumens 23 and 24 not only incorporate the imaging core 40 but also serve as a path for the ultrasonic transmission liquid injected from the port 31 of the hub 3. The ultrasonic transmission liquid supplied from the port 31 flows and fills through the observation portion lumens 23 and 24 to the sheath distal end portion 21, that is, from the proximal end side to the distal end side of the sheath 2.

  By filling the sheath 2 with the ultrasound transmission liquid and then inserting the sheath 2 into a body cavity or the like, the ultrasound transmission liquid is arranged between the ultrasonic transducer 411 and the blood vessel wall, and the ultrasonic waves are ultrasonic waves. It is transmitted to the affected area through the transmission liquid and can be reflected back from the affected area. Due to the presence of the ultrasonic transmission liquid, the transducer unit 41 can acquire a video signal by ultrasonic waves. The ultrasonic transmission liquid is discharged into the body from the discharge port 30 provided in the sheath distal end portion 21. For this reason, physiological saline or the like that does not affect the human body is used as the ultrasonic transmission liquid.

  The sheath distal end portion 21 is provided with an X-ray contrast marker 29 so that the distal end position of the ultrasonic catheter can be confirmed under fluoroscopy when inserted into the living body.

  The sheath distal end portion 21 is further provided with a guide wire lumen 26 as a passage for passing the guide wire 25. The guide wire lumen 26 includes a first guide wire lumen 27 and a second guide wire lumen. And a lumen 28.

  The first guide wire lumen 27 is provided on the distal end side of the ultrasonic catheter 1 in the in-vivo insertion direction, and the second guide wire lumen 28 is provided on the rear end side, that is, on the proximal end side of the ultrasonic catheter 1. It has been. The first guide wire lumen 27 and the second guide wire lumen 28 are not connected to each other, but are arranged so that the guide wire passages formed with each other are in a substantially straight line. Therefore, the guide wire 25 can pass through the guide wire lumen 26 in a straight line without bending.

  The guide wire 25 is inserted in advance to the vicinity of the affected part in the living body before the ultrasonic catheter 1 is inserted into the living body, and is used to guide the ultrasonic catheter 1 to the affected part. The ultrasonic catheter 1 is guided to the affected part while passing the guide wire lumen 26 through the guide wire 25.

  The insertion assisting tool 50 can be attached to and detached from the sheath distal end portion 21 of the ultrasonic catheter 1, so that the first guidewire lumen 27 and the second guidewire lumen 28 can be communicated with each other. it can.

  Next, a specific structure in the vicinity of the distal end of the sheath 2 to which the present invention is applied will be described with reference to FIG.

  As shown in FIG. 2, the guide wire lumen 26 is divided into a first guide wire lumen 27 and a second guide wire lumen 28. A first outer wall 21A that defines the first guide wire lumen 27 and a second outer wall 21B that defines the second guide wire lumen 28 are formed on the outer peripheral surface of the sheath distal end portion 21.

  The first guide wire lumen 27 is provided on the distal end side in the insertion direction of the ultrasonic catheter 1 relative to the transducer unit 41 of the imaging core 40, and the second guide wire lumen 28 is provided on the rear end side. ing. Therefore, since the guide wire lumen does not exist on the outer peripheral surface of the sheath distal end portion 21 serving as an ultrasonic path, the transmission / reception of ultrasonic waves by the transducer unit 41 is not hindered by the guide wire lumen 26.

  In addition, by operating the hub 3, the living body can be observed in a wide range by moving the transducer unit 41 back and forth within the observation unit lumen 23 via the drive shaft 42. In this case, transmission / reception of ultrasonic waves is not hindered if the first guidewire lumen 27 and the second guidewire lumen 28 are separated from each other by a range in which the transducer unit 41 moves back and forth.

  The guide wire lumen 26 is not coaxial with the observation portion lumen 23 but is provided separately in parallel. Accordingly, since the guide wire 25 and the imaging core 40 do not pass through the same lumen, the guide wire 25 can smoothly pass through the guide wire lumen 26 without being bent.

  Since the guide wire lumen 26 extends not only to the distal end portion but also to the proximal end side of the ultrasonic catheter 1, the guide wire 25 and the ultrasonic catheter 1 stably cooperate with each other along the guide wire 25. When the sheath 2 is inserted into the living body, the force for inserting the sheath 2 is easily transmitted to the distal end of the sheath 2 in the insertion direction, and the operability of the ultrasonic catheter 1 can be improved.

  Further, when the observation of the affected area is completed and the ultrasonic catheter 1 is extracted from the living body, the guide wire 25 and the sheath distal end 21 are long and parallel to each other. Thus, the guide wire 25 is not bent, and thus the living body is not damaged.

  Further, since the guide wire lumen 26 is composed of the first guide wire lumen 27 and the second guide wire lumen 28, the length of the first guide wire lumen 27 is set to the second guide wire. Even if the guide lumen 25 is shorter than the lumen 28, the guide wire 25 can be appropriately placed along the sheath 2 in the vicinity of the distal end of the sheath 2. Therefore, by shortening the length of the first guide wire lumen 27, the transducer unit 41 of the imaging core 40 can be brought close to the most distal portion of the sheath 2, and the affected part can be appropriately observed.

  Next, with reference to FIG. 3, a specific structure in the vicinity of the connection portion of the sheath tip portion 21 and the sheath body portion 22 of the sheath 2 to which the present invention is applied will be described.

  FIG. 3 is a view showing a structure in the vicinity of the connection portion of the sheath tip and the sheath body.

  The sheath distal end portion 21 is formed more flexibly than the sheath main body portion 22. Therefore, a structure that reinforces the difference in hardness is provided at the connection site between the sheath body 22 and the sheath tip 21.

  As shown in FIG. 3, the sheath body 22 has a resin tube 221 on the outer wall, a metal tube 222 inside, and a resin tube 211 fixed inside. The outer wall of the sheath distal end portion 21 is formed in the same body as the same resin tube 211 extending from the sheath main body portion 22, and is an observation portion that is the same passage as the observation portion lumen 24 formed from the sheath main body portion 22. In addition to the forming lumen 23, a guide wire lumen 26 for passing the guide wire 25 is also formed.

  In the sheath main body 22, the tube has three layers, and the metal tube 222 is also included. Therefore, the sheath main body 22 is harder than the sheath tip 21 having only the resin tube 221. Therefore, if the sheath body 22 and the sheath tip 21 are connected as they are, the sheath 2 may be bent at the connection site due to the difference in hardness. If the sheath tip portion 21 and the sheath body portion 22 are connected via a reinforcing body having an intermediate hardness between the sheath tip portion 21 and the sheath body portion 22, bending at the connection site can be prevented. .

  An example of such a reinforcing body is a reinforcing body 223 shown in FIG. The reinforcing body 223 is fitted with the resin tube 211 and is fitted into the resin tube 221 on the rear end side of the ultrasonic catheter 1 in the in-vivo insertion direction. The reinforcing body 223 is fixed to the resin tube 211 and the resin tube 221 with an adhesive or the like, and is further brought into contact with and bonded to the metal tube 222.

  Next, with reference to FIGS. 4-8, the specific structure of the insertion assistance tool 50 with which this invention is applied is demonstrated.

  The insertion assisting tool 50 includes a first clamping member 51 and a second clamping member 52 that can approach and separate from each other, and a first pressing member 53 and a second pressing member 54 that are connected to the first clamping member 51 and the second clamping member 52. And an elastic member 55.

  The first pressing member 53 and the second pressing member 54 are connected to each other by a pivoting portion 57 so as to be rotatable. Each of the first pressing member 53 and the second pressing member 54 is formed by being bent with a pivoting portion 57 interposed therebetween, and one end of the first pressing member 53 and the second pressing member 54 is rotatably engaged with the first and second holding members 51 and 52. The other ends are pressing portions 531 and 541 for applying force.

  The elastic member 55 is a spring member that is fixed along the inside of the pressing portions 531 and 541 of the first pressing member 53 and the second pressing member 54 and is bent in a coil shape in the vicinity of the pivoting portion 57. The elastic member 55 biases the first pressing member 53 and the second pressing member 54 so that the first pressing member 53 and the second pressing member 54 move in a direction in which they approach each other. The form of the elastic member 55 is not limited to a coiled spring member, and other forms such as a leaf spring and rubber can be applied.

  As shown in FIGS. 6 and 7, the first clamping member 51 and the second clamping member 52 have a first opposing groove 511 and a second opposing groove 521 formed on the surfaces facing each other. The first and second opposing grooves 511 and 521 are formed in a symmetric shape, and come into contact with the outer wall of the sheath tip 21 by contacting the first clamping member 51 and the second clamping member 52. 21 so as to cover. 7 and 8, only the first clamping member 51 is shown for convenience of explanation, and the second clamping member 52 that is symmetrical to the first clamping member 51 has a corresponding portion of the first clamping member 51. Are shown in parentheses and omitted.

  The first opposing groove 511 of the first clamping member 51 includes a tip groove 513 that holds the first outer wall 21A outside the first guide wire lumen 27 and a second outer wall 21B outside the second guide wire lumen 28. Are formed, and a connecting groove 515 formed between the distal end groove 513 and the proximal end groove 514 is formed. Further, the second opposing groove 521 of the second clamping member 52 has a tip groove 523 that holds the first outer wall 21A outside the first guide wire lumen 27 and a second groove outside the second guide wire lumen 28. A base end groove 524 that holds the outer wall 21 </ b> B and a connecting groove 525 formed between the front end groove 523 and the base end groove 524 are formed. As shown in FIGS. 6 and 8, the coupling grooves 515 and 525 of the first and second clamping members 51 and 52 facing each other are combined with the first and second clamping members 51 and 52 in contact with each other. An insertion assisting lumen 56 through which the guide wire 25 can be inserted is configured to cover between the guide wire lumen 27 and the second guide wire lumen 28.

  A distal end side of the inner wall of the insertion assisting lumen 56 is formed with a first taper portion 561 that expands toward the distal end grooves 513 and 523, and a first end portion 562 that is an end portion on the distal end side of the inner wall is a distal end groove 513. , 523 is positioned outside the extension of the inner wall of the first guide wire lumen 27 formed at the sheath distal end portion 21 (see FIG. 8). Accordingly, when the guide wire 25 is inserted from the first guide wire lumen 27 into the insertion assisting lumen 56, the tip of the guide wire 25 can be inserted smoothly without being caught on the end of the inner wall of the insertion assisting lumen 56. it can.

  In order to allow the guide wire 25 to be smoothly inserted without being caught on the first end portion 562 of the insertion assisting lumen 56, the first end portion 562 is disposed outside the extension line of the inner wall of the first guide wire lumen 27. Instead of being positioned, it may be arranged on an extension line.

  Further, the base end side (side where the taper is reduced in diameter) of the first tapered portion 561 is the inner wall of the first guide wire lumen 27 formed in the sheath distal end portion 21 held by the distal end grooves 513 and 523. It is located inside the extension line (see FIG. 8). That is, at least a part of the insertion assisting lumen 56 is positioned on the inner side of the extension line of the inner wall of the first guidewire lumen 27. Thus, when the guide wire 25 is inserted from the second guide wire lumen 28 into the first guide wire lumen 27 via the insertion assist lumen 56, the guide wire 25 is connected to the end of the inner wall of the first guide wire lumen 27. It can be smoothly inserted without being caught on the part.

  In order to smoothly insert the guide wire 25 without being caught on the end portion of the inner wall of the first guide wire lumen 27, at least a part of the insertion auxiliary lumen 56 is extended from the inner wall of the first guide wire lumen 27. Instead of being positioned inside the line, it may be arranged on an extension line.

  Similarly to the distal end side, the proximal end side of the inner wall of the insertion assisting lumen 56 is formed with a second taper portion 563 that expands toward the proximal end grooves 514 and 524, and is an end portion on the proximal end side of the inner wall. The second end portion 564 is located outside the extended line of the inner wall of the second guidewire lumen 28. Thus, when the guide wire 25 is inserted from the second guide wire lumen 28 into the insertion assisting lumen 56, the tip of the guide wire 25 can be smoothly inserted without being caught on the end of the inner wall of the insertion assisting lumen 56. it can.

  In order to smoothly insert the distal end of the guide wire 25 without hooking the second end portion 564 of the insertion assisting lumen 56, the second end portion 564 is made to extend beyond the extension line of the inner wall of the second guide wire lumen 28. You may arrange | position on an extension line instead of being located outside.

  Further, the distal end side (side where the taper is reduced in diameter) of the second tapered portion 563 is the inner wall of the second guide wire lumen 28 formed in the sheath distal end portion 21 held in the proximal end grooves 514 and 524. It is located inside the extension line. That is, at least a part of the insertion assisting lumen 56 is located on the inner side of the extension line of the inner wall of the second guidewire lumen 28. Thus, when the guide wire 25 is inserted from the first guide wire lumen 27 into the second guide wire lumen 28 via the insertion assist lumen 56, the guide wire 25 is connected to the end of the inner wall of the second guide wire lumen 28. It can be smoothly inserted without being caught on the part.

  In order to smoothly insert the guide wire 25 without being caught on the end portion of the inner wall of the second guide wire lumen 28, at least a part of the insertion auxiliary lumen 56 is extended from the inner wall of the second guide wire lumen 28. You may arrange | position on an extension line instead of being located inside a line.

  Next, the operation of the insertion assisting tool 50 of the ultrasonic catheter 1 according to this embodiment will be described.

  As shown in FIG. 9, the ultrasonic catheter 1 is packaged in a bag B in a state where the insertion assisting tool 50 is mounted and provided to the user in a sterilized state. Accordingly, since the insertion assisting tool 50 has already been mounted in a state where the user has taken out the ultrasonic catheter 1 from the bag B, the guide wire 25 is used as the first and second guide wires using the insertion assisting tool 50 as it is. It can be inserted into the lumens 27 and 28 for use.

  When the guide wire 25 is inserted from the distal end side of the first guide wire lumen 27, the guide wire 25 is first inserted from the distal end side of the first guide wire lumen 27 as shown in FIG. . The guide wire 25 moves in the first guide wire lumen 27 and reaches the insertion assisting lumen 56 of the insertion assisting tool 50. At this time, the first tapered portion 561 is formed on the distal end side of the inner wall of the insertion assisting lumen 56, and the first end portion 562 on the distal end side of the inner wall is outside the extension line of the inner wall of the first guide wire lumen 27. Therefore, the guide wire 25 can be smoothly inserted without being caught on the end of the inner wall of the insertion assisting lumen 56.

  When the guide wire 25 in the insertion assisting lumen 56 is further advanced, the guide wire 25 reaches the second guide wire lumen 28 as shown in FIG. At this time, since at least a part of the insertion assisting lumen 56 is located on the inner side of the extension line of the inner wall of the second guide wire lumen 28, the guide wire 25 is connected to the end of the inner wall of the second guide wire lumen 28. It can be smoothly inserted without being caught on the part. When the guide wire 25 is further advanced, the guide wire 25 is pulled out from the second guide wire lumen 28 to the proximal end side. Next, as shown in FIG. 5, the pressing portions 531 and 541 of the first and second pressing members 53 and 54 are pressed with fingers so as to approach each other, and the first and second clamping members 51 and 52 are separated from each other. Let Thereafter, the insertion assisting tool 50 is removed from the sheath distal end portion 21, and the insertion of the guide wire 25 is completed.

  In the present embodiment, since the first taper portion 561 and the second taper portion 563 are provided at both ends of the insertion auxiliary lumen 56, even when the guide wire 25 is inserted through the second guide wire lumen 28, the same applies. The guide wire 25 can be smoothly inserted. When the direction in which the guide wire 25 is inserted is determined on one side, only one of the first tapered portion 561 and the second tapered portion 563 may be formed on the insertion assisting lumen 56. In addition, the first taper portion 561 and the second taper portion 563 are not necessarily provided.

Second Embodiment
As shown in FIG. 11, the ultrasonic catheter according to the second embodiment of the present invention is different from the ultrasonic catheter 1 of the first embodiment in the shape of the insertion assisting lumen 61 of the insertion assisting tool.

  In the insertion assisting tool 60 of the ultrasonic catheter according to the second embodiment, the inner wall surface on the distal end side of the insertion assisting lumen 61 is located on the extension line of the inner wall of the first guidewire lumen 27, and the insertion assisting lumen 61 The inner wall surface on the proximal end side is located on an extension line of the inner wall of the second guide wire lumen 28. According to such an insertion aid 60, even if the first and second guide wire lumens 27 and 28 divided into two are provided, the guide wire 25 is replaced with the first guide wire lumen 27 and the second guide wire. The wire lumen 28 can be continuously and smoothly inserted.

  Note that the “position on the extension line” in this specification includes a case where the difference is small with respect to the diameter of the guide wire 25 and is hardly caught when the guide wire 25 is inserted. If the magnitude of the difference is equal to or less than the radius of the guide wire 25, for example, the guide wire 25 can smoothly move along the step formed by the difference along the shape of the tip of the guide wire 25.

  Further, it is more preferable that the insertion assisting lumen 61 is formed continuously with the first guide wire lumen 27 and the second guide wire lumen 28 with as little gap as possible. The narrower the gap between the insertion assisting lumen and the first guidewire lumen 27 and the second guidewire lumen 28, the more smoothly the guidewire 25 can be moved.

  Since other structures are the same as those of the first embodiment, description thereof is omitted.

<Third Embodiment>
As shown in FIG. 12, the ultrasonic catheter according to the third embodiment of the present invention has a guide wire 25 for the first guide wire on the distal end side with respect to the first guide wire lumen 27 of the insertion aid 70. It differs from the ultrasonic catheter 1 of 1st Embodiment by the point in which the guide part 71 which guides to the lumen | rumen 27 is formed.

  The guide portion 71 of the insertion assisting tool 70 is formed in a tapered shape that expands toward the distal end side. The proximal end side of the guide portion 71 is in contact with the sheath distal end portion 21 where the first guide wire lumen 27 opens, and the inner wall on the proximal end side of the guide portion 71 is an extension of the inner wall of the first guide wire lumen 27. It is formed on the line or inside the extension line. According to such an insertion assisting tool 70, when the guide wire 25 is inserted into the first guide wire lumen 27, the guide wire 25 can be easily inserted into the first guide wire lumen 27 having a very small diameter opening. Can be inserted into.

  In addition, by forming such a guide portion 71 on the proximal end side of the insertion assisting tool 70 with respect to the second guide wire lumen 28, the guide wire 25 can be easily inserted into the second guide wire lumen 28. You can also

  Since other structures are the same as those of the first embodiment, description thereof is omitted.

<Fourth embodiment>
As shown in FIGS. 13 and 14, the ultrasonic catheter according to the fourth embodiment of the present invention is the first embodiment in that the insertion assisting tool 80 is formed by one member surrounding the sheath distal end portion 21. Different from the ultrasonic catheter.

  The insertion assisting tool 80 is a cylindrical member, covers the space between the first guidewire lumen 27 and the second guidewire lumen 28, and a part of the inner wall surface forms the insertion assisting lumen 81. A plurality of cut portions 82 (detachment portions) extending from the distal end side to the proximal end side are formed at the distal end side end portion of the insertion assisting tool 80. The number of cut portions 82 is not limited. On the distal end side end of the insertion assisting tool 80, a knob 83 for the user to pick with a finger is formed between the notches 82.

  In this embodiment, the insertion assisting tool 80 is already attached to the sheath distal end portion 21 in a state provided to the user. However, the insertion assisting tool 80 is attached in such a manner that the user himself covers from the distal end side of the sheath distal end portion 21. May be.

  Next, the operation of the insertion assisting tool 80 of the ultrasonic catheter 1 according to the fourth embodiment will be described.

  Since the ultrasonic catheter is packaged in a bag and provided to the user with the insertion assisting tool 80 attached, the ultrasonic catheter is first removed from the bag.

  Thereafter, the guide wire 25 is inserted from the distal end side of the first guide wire lumen 27. The guide wire 25 moves in the first guide wire lumen 27 and reaches the insertion assisting lumen 81 of the insertion assisting tool 80.

  Further, when the guide wire 25 in the insertion assisting lumen 81 is advanced in the proximal direction, the guide wire 25 reaches the second guide wire lumen 28 and the guide wire 25 is inserted into the second guide wire lumen 28. . At this time, since the insertion assisting lumen 81 is formed between the first guidewire lumen 27 and the second guidewire lumen 28, the guidewire 25 is guided without jumping out of the lumen, and the second guidewire lumen. Good insertion into lumen 28. When the guide wire 25 is further advanced, the guide wire 25 is pulled out from the second guide wire lumen 28 to the proximal end side.

  Next, the knob 83 of the insertion assisting tool 80 is picked with a finger and moved to the proximal end side as shown in FIG. As a result, when the insertion assisting tool 80 is broken or deformed along the cut portion 82 and further completely broken so as to tear to the proximal end side, as shown in FIG. A slit-shaped breaking portion 85 extending to the side is formed. Thereafter, the insertion assisting tool 80 is removed from the sheath distal end portion 21 so as to open the breaking portion 85, and the insertion of the guide wire 25 is completed.

  In this embodiment, since the members 51 and 52 and the elastic member 55 divided into two parts as in the first embodiment are not required, the ultrasonic catheter can be provided without increasing the size and at a low cost. In addition, since a plurality of knobs 83 are formed, the position and size of the breaking part 85 can be adjusted. In addition, even when the breaking portion 85 is not formed well by pulling the knob 83, the breaking portion 85 can be formed again using another knob 83.

  It is to be noted that the detachable portion to be broken or deformed is formed not on the notch portion 82 penetrating from the outer peripheral surface of the insertion assisting tool 80 to the inner peripheral surface, but is formed on the outer peripheral surface or inner peripheral surface of the insertion assisting tool 80 to penetrate to the opposite surface You may provide in the form of the groove part which does not do, or the form which combined the notch part and the groove | channel. Further, the notch 82 (or groove) may be formed from the proximal end side to the distal end side of the insertion assisting tool 80, or may be formed over the entire length from the distal end side to the proximal end side. Good. When the cut portion is formed over the entire length from the distal end side to the proximal end side, it is not necessary to tear and break, and the insertion aid can be removed simply by deforming the cut portion to open. Further, if the insertion assisting tool 80 is made of a material having high tearability, it is not always necessary to provide a notch portion or a groove portion in the separation portion.

  Moreover, the knob | pick part 83 may be formed by bending an edge part to the outer peripheral surface side so that a user may be easy to pick. Further, the guide wire 25 can be inserted not only from the distal end side of the first guide wire lumen 27 but also from the proximal end side of the second guide wire lumen 28.

  FIG. 17 shows a modification of the catheter insertion assisting tool 90 according to the fourth embodiment. On the inner wall surface of the insertion assisting tool 90, an insertion assisting lumen 91 having substantially the same shape as the insertion assisting lumen 56 in the first embodiment is provided. It can also be formed. With such a configuration, the guide wire 25 can be smoothly inserted into the first and second guide wire lumens 28 as in the first embodiment. Or you may form the insertion auxiliary | assistant lumen | rumen of the substantially same shape as the insertion auxiliary | assistant lumen | rumen 61 in 2nd Embodiment.

  The present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims. For example, in the above embodiment, the case where the present invention is applied to an ultrasonic catheter has been described. However, the present invention can also be applied to other diagnostic catheters. For example, the present invention can be applied to a diagnostic catheter using optical interference tomography (OCT). In OCT, measurement light is incident on a living body, and the living body can be observed based on light that has been scattered, absorbed, reflected, or refracted in the living body.

  Moreover, you may apply the guide part 71 of 3rd Embodiment to other embodiment. Further, in order to allow the guide wire 25 to be smoothly inserted, in the first embodiment, the guide wire lumen through which the guide wire 25 is inserted into the end portion of the inner wall of the insertion assisting lumen 56 on the side where the guide wire 25 is inserted. Although it is on the extension line of the inner wall of 26 or outside the extension line, it may be inside the extension line. Further, at least a part of the inner wall of the insertion assisting lumen 56 is located on or inside the extension line of the inner wall of the first guidewire lumen 27 or the second guidewire lumen 28. It may be outside the line. That is, even when the guide wire 25 is inserted through the guide wire 25, the guide wire 25 does not deviate outside the lumen as long as the insertion auxiliary lumen is provided. By swinging in the direction, it can be easily inserted.

1 Ultrasonic catheter (catheter),
21 sheath tip,
21A first outer wall,
21B 2nd outer wall,
22 sheath body,
25 guide wire,
26 Lumen for guide wire,
27 Lumen for first guide wire,
28 Lumen for second guide wire,
50, 60, 70, 80, 90 insertion aids,
51 1st clamping member,
52 second clamping member,
55 elastic members,
56, 61, 81, 91 Insertion assist lumen,
71 Guide,
82 Notch (detachment),
511, 521 facing groove,
531,541 Pressing part.

Claims (9)

Removable into a catheter having a first guidewire lumen through which the guidewire is inserted and a second guidewire lumen provided on a substantially extension line of the first guidewire lumen through which the guidewire is inserted. An insertion aid that is attached and assists the insertion of the guide wire,
An insertion assisting tool comprising an insertion assisting lumen that covers a space between the first guidewire lumen and the second guidewire lumen and through which the guidewire can be inserted.   At least one of the inner wall adjacent to the first guide wire lumen or the second guide wire lumen of the insertion assisting lumen is an extension of the inner wall of the adjacent first guide wire lumen or the second guide wire lumen. Alternatively, the insertion assisting tool according to claim 1, wherein the insertion assisting tool is located outside the extension line.   The at least part of the inner wall of the insertion assisting lumen is located on or inside the extension line of the inner wall of the first guidewire lumen or the second guidewire lumen. The insertion aid described in 1.   Engaging at least one of a first outer wall defining the first guidewire lumen, a second outer wall defining the second guidewire lumen, and an outer wall of the catheter body tube of the catheter outer wall; The insertion assisting tool according to any one of claims 1 to 3, wherein the insertion assisting tool is detachable from the catheter. A first clamping member and a second clamping member provided with surfaces facing each other so as to be able to approach and separate from each other, wherein a facing groove is formed in at least one of the facing surfaces, and the insertion assisting lumen is defined by at least a part of the facing groove. A clamping member;
The insertion assisting device according to claim 4, further comprising an elastic member that applies a biasing force in a direction in which the first clamping member and the second clamping member are close to each other.   The insertion assisting device according to claim 4, wherein the insertion assisting device is a cylindrical member that engages with the catheter, and has a detachable portion that is deformed or broken so as to be detachable from the catheter.   A guide portion that communicates with at least one of guide wire insertion openings of the first guide wire lumen and the second guide wire lumen that are separated from each other and that expands away from the opening. The insertion assistance tool of any one of 1-6. A catheter having a first guidewire lumen through which the guidewire is inserted, and a second guidewire lumen provided on a substantially extension line of the first guidewire lumen and through which the guidewire is inserted. And
The insertion according to any one of claims 1 to 7, so as to cover an interval between the first guide wire lumen and the second guide wire lumen so as to form an insertion auxiliary lumen through which the guide wire can be inserted. A catheter with an auxiliary device.   The catheter according to claim 8, wherein the catheter is packaged in a state where the insertion assisting tool is mounted.

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