JP4624019B2 - catheter - Google Patents

Description

  The present invention relates to a catheter that is inserted into a body cavity such as a blood vessel, a vascular vessel, or a digestive tract, or a lumen, and is used for various treatments and diagnoses, and in particular, for displaying a lumen cross-sectional image and the like. It relates to the catheter used.

  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. In this surgical technique, a method of pushing the stenosis part with a dilatation catheter having a balloon at the tip, a method of placing a metal tube called a stent, and a tool called a rotablator (trademark) are used to remove the stenosis part by rotating a grindstone or a cutter. There are various methods, such as a method to perform, and a preferable method is selected according to the property of the stenosis and the condition of the patient.

  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.

Among these, the ultrasonic catheter needs to be inserted to a tortuous part such as a coronary artery of the heart. Therefore, when inserting the ultrasonic catheter, a guide wire is inserted into the affected area first, and this guide is inserted. Advance the ultrasound catheter along the wire. 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 the ultrasonic catheter is moved according to the guide wire (for example, Patent Document 1). ).
JP 2004-97286 A

  However, in the case of using the above-described conventional catheter, for example, the affected part may have to use guide wires for both the main blood vessel and the side branch blood vessel at the branching portion of the blood vessel. In this case, it is difficult to insert a guide wire into the side branch blood vessel when a stent is first placed in the main blood vessel at the bifurcation.

  In addition, for example, when there are a plurality of affected parts, it is necessary to treat or diagnose the first affected part, and once the catheter is pulled out of the body, the guide wire needs to be inserted again to the other affected part.

  The present invention has been made in order to solve the problems associated with the prior art described above, and a catheter that can be appropriately inserted into a target position in a living body where it is difficult to insert a guide wire and has good workability. The purpose is to provide.

A catheter according to the present invention that achieves the above object includes an observation unit used for in-vivo observation, an observation unit lumen in which the observation unit is disposed inside and extending in the in-vivo insertion direction, and the observation unit lumen A first guidewire lumen that is provided on the distal end side in the living body insertion direction relative to the observation section and through which the first guidewire can be inserted, and is substantially parallel to the observation section lumen. A second guidewire lumen through which a second guidewire provided on the rear end side opposite to the in-vivo insertion direction than the observation section can be inserted, and the first guidewire lumen; The second guide wire lumen is arranged at a position on the outer periphery of the observation portion lumen so as to sandwich the observation portion lumen .

  According to the present invention configured as described above, since the second guide wire inserted through the second guide wire lumen can be operated while observing with the observation unit, the second guide wire can be easily guided to the target position. it can. Further, since the two guide wire lumens extend at different positions in the circumferential direction on the outer periphery of the catheter body, the guide wires inserted through the two guide wire lumens do not interfere with each other, and operability is improved. Is excellent.

  Embodiments of the present invention will be described with reference to the drawings.

  FIG. 1 is a view showing a catheter of the present invention, and FIG. 2 is an enlarged sectional view showing the vicinity of the distal end portion of the catheter shown in FIG.

  The catheter 1 includes a sheath 2 that is inserted into a living body such as a body cavity, and a hub (operation unit) 3 that is not inserted into the body cavity and is disposed on the user's hand side for operation by the user.

  The sheath 2 has a sheath distal end portion 21 positioned on the distal end side and a sheath main body portion 22 positioned on the user's hand side. The hub 3 is connected to the proximal side of the sheath body 22.

  The sheath distal end portion 21 and the sheath main body portion 22 are provided with an imaging core lumen (observation portion lumen) 23 that communicates with each other. The imaging core lumen 23 is a hollow passage formed in the sheath 2, and is formed from the sheath main body portion 22 to the sheath distal end portion 21.

  An imaging core 40 is arranged in the lumen 23 for the imaging core. The imaging core (observation unit, ultrasonic detector) 40 includes a vibrator unit 41 for transmitting and receiving ultrasonic waves toward the body cavity tissue, and a drive for attaching the vibrator 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, holds the ultrasonic transducer 411 in the concave concave portion, and protects the ultrasonic transducer 411.

  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 lumen 23 for the imaging core, so that the affected part in the body cavity such as a blood vessel and a vessel 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 catheter 1 is inserted into the living body. The metal coil 32 is made of a radiopaque metal such as gold, platinum, or tungsten. When the catheter 1 is inserted into a living body and diagnosis is performed using an X-ray transmission image, the ultrasonic coil 411 is used. It can also act as a marker for confirming the position in the living body.

  In addition, the imaging core lumen 23 incorporates the imaging core 40 and also serves 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 through the imaging core lumen 23 to the sheath distal end portion 21, that is, from the proximal end side to the distal end side of the sheath 2, and is filled.

  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 catheter can be confirmed under fluoroscopy when inserted into the living body.

  The sheath distal end portion 21 further includes a first guide penetrating from the opening 271 on the distal end side in the in-vivo insertion direction to the most advanced opening 272 as a passage for passing the first guide wire 25. A wire lumen 27 is provided.

  The first guide wire lumen 27 is not coaxial with the imaging core lumen 23, and is provided separately in parallel.

  The first guide wire 25 is inserted in advance to the vicinity of the affected part in the living body before the catheter 1 is inserted into the living body, and is used to guide the catheter 1 to the affected part. The catheter 1 is guided to the affected area while passing the first guide wire 25 through the first guide wire lumen 27.

  The sheath distal end portion 21 is further provided with a second guide wire lumen 28 as a passage for passing the second guide wire 26 on the rear end side in the in-vivo insertion direction with respect to the ultrasonic transducer 411.

  The second guidewire lumen 28 is provided substantially parallel to the imaging core lumen 23 at a position substantially opposite to the first guidewire lumen 27 on the outer periphery of the imaging core lumen 23, and is an ultrasonic transducer. 411 extends from the rear end side in the in-vivo insertion direction to the insertion port 33 which is an opening provided in the hub 3.

  The opening 281 on the distal end side of the second guidewire lumen 28 is provided on the proximal side of 3 mm to 10 mm from the central portion of the ultrasonic transducer 411 in the axial direction of the catheter 1. The reason why it is provided at such a position is as follows. That is, when the opening 281 is provided closer to the ultrasonic transducer 411 than 3 mm, the traveling direction of the second guide wire 26 that appears from the opening 281 is closer to the distal side than the visual field range of the ultrasonic transducer 411. Further, it becomes difficult to obtain the traveling direction of the second guide wire 26 with an ultrasonic image, and it cannot be confirmed accurately. Further, when the opening 281 is provided at a position apart from 10 mm, the traveling direction of the second guide wire 26 that appears from the opening 281 is closer to the base end side than the visual field range of the ultrasonic transducer 411. Further, it becomes difficult to obtain the traveling direction of the second guide wire 26 with an ultrasonic image, and it cannot be confirmed accurately.

  As shown in FIG. 2, the opening 281 includes a deflecting unit 282 that deflects the traveling direction of the second guide wire 26 in a direction away from the major axis direction of the catheter 1. The deflecting portion 282 is obtained by bending the distal end portion of the second guide wire lumen 28 extending in parallel with the long axis direction of the catheter 1 by 30 to 90 degrees in a plane including the long axis of the catheter 1. As a result, the second guide wire 26 smoothly advances in the direction of the side branch blood vessel described later.

  The second guide wire 26 can be inserted into the living body through the second guide wire lumen 28 from the insertion port 33 after the catheter 1 is inserted into the living body. That is, the second guide wire 26 can be guided to the purpose from the insertion port 33 while the catheter 1 is inserted into the body.

  Next, a method for manufacturing the sheath 2 will be described with reference to the drawings.

  3 is a cross-sectional view of the sheath 2 shown in FIG.

  When manufacturing the sheath 2, first, as shown on the left side of FIG. 3, a single-layer tube 28 a serving as the second guide wire lumen 28 and a single-layer tube 23 a serving as the imaging core lumen 23 are prepared. Then, as shown on the right side of FIG. 3, if a part of the outer periphery of the single-layer tube 28 a and the single-layer tube 23 a is bonded, a substantially parallel second guide wire lumen 28 and imaging core lumen 23 can be obtained. it can.

  In addition, the manufacturing method of the sheath 2 is not restricted to the method shown in FIG. 4 to 7 are AA cross-sectional views shown in FIG. 2 obtained by another manufacturing method.

  That is, as shown in FIG. 4, the multilayer tube 28 b and the multilayer tube 23 b may be bonded instead of the single layer tube 28 a and the single layer tube 23 a. In the case of using the multilayer tubes 28b and 23b, as in the case shown in FIG. 3, the second guide wire lumen 28 and the imaging core are substantially parallel by bonding at a part of the outer periphery of the multilayer tubes 28b and 23b. Lumen 23 can be obtained.

  As another method, as shown in FIG. 5, a tube 50 having a size capable of forming the second guide wire lumen 28 and the imaging core lumen 23 is prepared. Then, if the passages 28c and 23c substantially parallel to this are formed, the second guide wire lumen 28 and the imaging core lumen 23 are obtained substantially in parallel.

  Here, as shown in FIG. 6, two passages substantially parallel to the tube 50 are formed, and the single-layer tubes 28d and 23d are also inserted into the passages so as to be substantially parallel to the sheath tip 21. Two guide wire lumens 28 and imaging core lumens 23 can be formed. Note that the single-layer tubes 28d and 23d may be multilayer tubes.

  As yet another method, as shown in FIG. 7, a single-layer tube 28e to be the second guidewire lumen 28 and a single-layer tube 23e to be the imaging core lumen 23 are prepared. Then, the single-layer tube 28e and the single-layer tube 23e are inserted into the heat-shrinkable tube 60 having a diameter larger than that of the two tubes arranged in parallel, and the heat-shrinkable tube 60 is heated to shrink. By doing so, the single-layer tubes 28e and 23e can be fixed substantially in parallel. Note that the single-layer tubes 28e and 23e may be multilayer tubes.

  FIG. 8 shows a case where the multilayer tubes 28f and 23f are used in the same manner as that shown in FIG. Here, a resin having a high melting point is used as the resin material used for the inner layers of the multilayer tubes 28f and 23f, and a thermoplastic resin having a low melting point is used as the resin material used for the outer layers. It is desirable to use the same resin as the resin material for both tubes. The outer layer is thicker than the inner layer. When the multi-layer tubes 28f and 23f are inserted into the heat shrink tube 60 similar to that shown in FIG. 7 in parallel, and the heat shrink tube 60 is heated and shrunk, the outer layer resin having a low melting point is melted. A substantially circular perforated tube as shown in FIG. The heat-shrinkable tube 60 can be peeled off and removed after the porous tube is formed. By removing the heat-shrinkable tube 60, a tube similar to that shown in FIG. 6 can be produced relatively easily.

  In addition, the tube in the various methods mentioned above can use a resin tube, a metal tube, those multilayer tubes, etc., for example. As a material suitable for these tubes, specifically, high-density polyethylene (HDPE) is preferred as a single-layer or inner-layer tube. Further, as the outer layer tube and the tube 50 (reinforcing portion) in FIG. 6, linear low density polyethylene (LLDPE) or polyester elastomer is preferable. Examples of the heat shrinkable tube include polyolefin, polyvinyl chloride, and polyvinylidene fluoride.

  The various methods described above are described for the joining of the second guide wire lumen 28 and the imaging core lumen 23, but the same applies to the joining of the first guide wire lumen 27 and the imaging core lumen 23. Applicable to.

  Next, the usage method of this embodiment is demonstrated, referring drawings.

  FIG. 9 is a view showing a method of using the catheter 1.

  The catheter 1 is used for diagnosis and treatment using a catheter such as PCI (percutaneous coronary angioplasty) and PTA (percutaneous angioplasty).

  For example, FIG. 9 shows a case where the affected part is at a branching portion of a blood vessel and a stent is provided in the main vessel blood vessel 81 and the side branch vessel 82. In this case, first, the first guide wire 25 is inserted to the vicinity of the affected area, the catheter 1 is guided to the affected area along the first guide wire 25, and the state of the affected area is observed (diagnosed) by an ultrasonic image. As a result of the diagnosis, if it is determined that the stent placement treatment is appropriate, the catheter 1 is removed leaving the first guide wire 25, and then a stent delivery catheter (not shown) is guided along the first guide wire 25 to the affected area. The stent 70 is installed in the main blood vessel 81 at the blood vessel branching portion. Thereafter, the stent delivery catheter is removed leaving the first guide wire 25 and replaced with the catheter 1 again. Thereafter, the second guide wire 26 is inserted into the insertion port 33, and the second guide wire 26 is guided into the blood vessel through the second guide wire lumen 28. The second guide wire 26 inserted into the main blood vessel 81 is guided to the side branch blood vessel 82 from the mesh space of the stent 70 while observing the inside of the blood vessel by the ultrasonic transducer 411. Thereafter, the catheter 1 is pulled out of the body with the second guide wire 26 left, and a balloon catheter (not shown) is inserted along the second guide wire 26 to widen the mesh space of the stent 70. Then, the balloon catheter is pulled out, the second guide wire 26 is inserted into the first guide wire lumen 27, and another stent delivery catheter (not shown) is inserted into the blood vessel. Another stent (not shown) is inserted, and a side branch vessel is widened while further expanding the mesh gap of the stent 70 using a balloon (not shown). That is, two stents are formed in a Y shape across the main blood vessel 81 and the side branch blood vessel 82.

  For example, when there are a plurality of affected parts, the first guide wire 25 is inserted to the first affected part, the catheter 1 is guided to the affected part along the first guide wire 25, and the affected part is treated or diagnosed. The second guide wire 26 can be guided to another blood vessel having the third affected part while observing the inside of the blood vessel by the ultrasonic transducer 411.

  Thus, according to the present embodiment, when the target blood vessel is difficult to select by a stent or the like, the second guide wire 26 can be operated while performing image diagnosis. Can be inserted into the blood vessels.

  Further, when there are a plurality of affected parts, the second guide wire 26 can be easily guided to the next affected part while observing with the ultrasonic transducer 411 without pulling out the catheter 1 after treating or diagnosing the previous affected part. And workability can be improved.

  Further, when the first guide wire 25 and the second guide wire 26 are used at the same time, the first guide wire 25 and the second guide wire 26 do not pass coaxially. Are not entangled by interference and have excellent operability.

  Further, since the guide wire lumens 27 and 28 are not provided in the direction in which the ultrasonic transducer 411 rotates and scans, one ultrasonic transducer 411 guides by rotating and scanning the ultrasonic transducer 411. All 360 degrees around the insertion direction can be measured without being obstructed by the wire lumens 27 and 28.

  In addition, since there is no portion where the first guidewire lumen 27 and the second guidewire lumen 28 overlap in the insertion direction, the catheter 1 can be thinned and can be used for a thin blood vessel or the like.

  Furthermore, since the ultrasonic transducer 411 is provided in the imaging core lumen 23, a radial scan for rotating the ultrasonic transducer 411 at high speed can be performed safely. That is, since the radial scan can be performed, the ultrasonic transducer 411 can be configured with a single element, and thus the catheter 1 can be reduced in size (thinner diameter). In addition, even when the ultrasonic transducer 411 is damaged, the influence on the living body can be prevented.

  FIG. 10 is a view showing a catheter according to another embodiment. In addition, about the member which has the same function as embodiment mentioned above, in order to avoid duplication using the same code | symbol, the description is abbreviate | omitted.

  As shown in FIG. 10, the catheter 1 a is on the extension line of the first guide wire lumen 27, on the opposite side of the ultrasonic transducer 411 in the in-vivo insertion direction, and substantially parallel to the imaging core lumen 23. A three guidewire lumen 90 can be provided. In this case, since the first guide wire 25 is inserted through both the first guide wire lumen 27 and the third guide wire lumen 90 and the catheter 1a is easily along the first guide wire 25, for example, the blood vessel is thick. In this case, it is possible to prevent such a drawback that the first guide wire 25 is bent when the catheter 1a is removed from the body.

  Further, since the guide wire lumens 27, 28, and 90 are not provided in the direction in which the ultrasonic transducer 411 rotates and scans, one ultrasonic transducer 411 can be rotated by scanning the ultrasonic transducer 411. All 360 degrees around the insertion direction can be measured without being obstructed by the guide wire lumens 27, 28, 90.

  In the above embodiment, the case where the present invention is applied to an ultrasonic catheter has been described. However, the present invention is not limited to this, and can 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.

An ultrasonic catheter (shown in FIGS. 1 to 2) under the following conditions was prepared.
Total length: 1530mm
Outer diameter: 0.8 mm (first guide wire lumen 27 parts)
: 0.8 mm (observation part (peripheral part of ultrasonic transducer 411))
: 1.7mm (base end)
Inner diameter: 0.4 mm (first guide wire lumen 27)
: 0.48 mm (second guide wire lumen 28)
: 0.74 mm (Lumen 23 for imaging core)
Length of first guide wire lumen 27: 20 mm
Length from the tip to the ultrasonic transducer 411: 30 mm
Length from ultrasonic transducer 411 to opening 281: 8 mm
First guidewire lumen 27 material: HDPE (inner layer)
: LLDPE (outer layer)
Observation member quality: HDPE (inner layer)
: LLDPE (outer layer)
Base member material: HDPE (inner layer of lumen 23 for imaging core, inner layer of lumen 28 for second guide wire)
: Stainless steel SUS304 (imaging core lumen 23 middle layer)
: LLDPE (outer layer)
Surface coating: A hydrophilic lubricating coating layer was provided from the tip to 120 mm.

It is a figure which shows the catheter of this invention. It is an expanded sectional view which shows the front-end | tip vicinity of the catheter shown in FIG. It is AA sectional drawing of the sheath front-end | tip part shown in FIG. It is AA sectional drawing of the other example of the sheath front-end | tip part shown in FIG. It is AA sectional drawing of the other example of the sheath front-end | tip part shown in FIG. It is AA sectional drawing of the other example of the sheath front-end | tip part shown in FIG. It is AA sectional drawing of the other example of the sheath front-end | tip part shown in FIG. It is AA sectional drawing of the other example of the sheath front-end | tip part shown in FIG. It is a figure which shows the usage method of the catheter shown in FIG. It is a figure which shows the catheter which concerns on other embodiment.

Explanation of symbols

1 catheter,
2 sheath,
3 Hub,
21 sheath tip,
22 sheath body,
23 Lumen for imaging core,
25 first guide wire,
26 second guide wire,
27 Lumen for first guide wire,
28 Lumen for second guide wire,
29 X-ray contrast markers,
33 insertion slot,
40 Imaging Core,
41 vibrator unit,
42 drive shaft,
43 Rotation stabilization coil,
90 Lumen for third guide wire,
411 ultrasonic transducer,
412 Ultrasonic transducer housing.

Claims (10)

An observation unit used for in-vivo observation;
The observation part is arranged inside, and the lumen for the observation part extended in the in-vivo insertion direction;
A first guidewire lumen that is substantially parallel to the observation unit lumen, provided on a distal end side in the living body insertion direction from the observation unit, and through which the first guidewire can be inserted;
A second guide wire lumen that is substantially parallel to the observation portion lumen and through which a second guide wire provided on a rear end side opposite to the in vivo insertion direction from the observation portion can be inserted. And
The first guidewire lumen and the second guidewire lumen are disposed at a position on the outer periphery of the observation portion lumen so as to sandwich the observation portion lumen .   The catheter according to claim 1, wherein the first guide wire lumen has an opening on a distal end side provided at a distal end of the catheter.   The catheter according to claim 1 or 2, wherein the second guide wire lumen has an opening on a rear end side provided in an operation portion that can be operated by a user of the catheter.   The first guide wire is provided on the rear end side opposite to the in-vivo insertion direction from the observation portion on the extension line of the first guide wire lumen and substantially parallel to the observation portion lumen. The catheter according to any one of claims 1 to 3, further comprising a third guide wire lumen that can be inserted therethrough.   The said observation part is an ultrasonic transducer | vibrator, While detecting an ultrasonic wave which reflects and returns, while emitting an ultrasonic wave toward the inside of a body, The observation part of Claim 1 characterized by the above-mentioned. catheter.   The catheter according to claim 5, wherein the ultrasonic transducer can be rotated and scanned around an axis of the observation unit lumen.   The catheter according to claim 1, wherein the first guide wire lumen has an opening on a proximal end side provided on a distal end side with respect to the observation portion.   The catheter according to claim 1, wherein the second guide wire lumen has an opening on a distal end side provided on a proximal end side with respect to the observation portion.   The catheter according to claim 8, wherein the opening on the distal end side of the second guide wire lumen is provided on the proximal side from 3 mm to 10 mm from the center of the observation section.   The catheter according to claim 8, wherein the opening on the distal end side of the second guide wire lumen has a deflecting portion that deflects the traveling direction of the guide wire in a direction away from the major axis direction of the catheter.

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