JPWO2018092387A1 - Catheter assembly - Google Patents

Abstract

Provided is a catheter assembly that has high pushability and followability to a blood vessel, and can be inserted from the radial artery and more easily reach the iliac artery or a peripheral artery than the iliac artery. A radial artery (percutaneously inserted from V1 and inserted into the iliac artery (V3) or a peripheral artery rather than the iliac artery (V3), and a guiding catheter (20) And the inner catheter body (70) has a distal tubular portion (71) located on the distal side and a distal end coupled to the distal tubular portion (71). The difference between the Shore D hardness of the distal tubular portion (71) subtracted from the Shore D hardness of the proximal tubular portion (72) is 30D or more and 40D or less. Yes, in the assembled state, the distal portion of the distal tubular portion (71) protrudes distally from the guiding catheter body (40) and the boundary between the distal tubular portion (71) and the proximal tubular portion (72) The part (73) is located inside the guiding catheter body (40).

Description

  The present invention relates to a catheter assembly having a guiding catheter and an inner catheter that is inserted into the lumen of the guiding catheter.

  In recent years, a technique for treating a lower limb artery by TRI (Trans-Radial Intervention) in which a catheter is inserted from the radial artery of the wrist has been performed. Such a procedure using TRI has been spreading because the patient's postoperative burden is small. However, if the same procedure is applied to the lower limb artery, the procedure from the insertion site into the living body lumen to the lesion site is performed. Since the distance is long, it is necessary to use a long guiding catheter.

  Since the radial artery is thinner than the femoral artery or the like, the outer diameter of the guiding catheter is necessarily reduced. On the other hand, a treatment catheter inserted into a guiding catheter is required to have a larger outer diameter in order to exert a sufficient effect at a target site such as a treatment site. Therefore, the guiding catheter into which the treatment catheter is inserted is required to have a larger inner diameter. Therefore, the guiding catheter becomes thin and has insufficient rigidity, so that there is a possibility that the target catheter cannot be reached. Moreover, since a thin guiding catheter is easy to bend, it is likely to be kinked at a bent portion of a blood vessel.

  Therefore, in recent years, a catheter assembly in which another catheter is inserted inside the guiding catheter has been proposed in order to improve the reachability of the guiding catheter (see, for example, Patent Document 1). By inserting the inner catheter into the lumen of the guiding catheter and inserting the guide wire into the lumen of the inner catheter, the gap between the guiding catheter and the guide wire is compensated by the inner catheter. Kink property and reachability can be improved.

JP 2014-230710 A

  In order to reach the guiding catheter from the radial artery to the iliac artery, or to the periphery of the iliac artery, it is necessary to pass through a thick, linear descending aorta, and it is hard due to calcification and tortuous iliac bone It may be necessary to pass through the artery. When a guiding catheter inserted from the radial artery passes through the descending aorta that is thicker and straighter than the radial artery, it tends to bend in a wide blood vessel. However, if it is excessively bent, it becomes difficult to push and pushability is increased. descend. Furthermore, when the iliac artery distal to the descending aorta is meandering, the guiding catheter has a tracking capability that allows it to pass through the bend while deforming following the shape of the meandering iliac artery. Necessary.

  The present invention has been made to solve the above-described problems, and has high pushability and followability to blood vessels, and is inserted from the radial artery into the iliac artery or a peripheral artery rather than the iliac artery. It is an object to provide a catheter assembly that can be easily reached.

  A catheter assembly according to the present invention that achieves the above object is a catheter assembly that is inserted percutaneously from the radial artery and inserted into the iliac artery or a peripheral artery rather than the iliac artery, and is a tubular guide. A guiding catheter having a guiding catheter body and a guiding catheter hub provided at a proximal end of the guiding catheter body, an inner catheter body insertable into the guiding catheter body, and a proximal end of the inner catheter body An inner catheter including an inner catheter hub that is connectable to the guiding catheter hub, the inner catheter body including a distal tubular portion located on a distal side, and a proximal portion of the distal tubular portion. A proximal tubular portion located on the distal side and having a distal end coupled to the distal tubular portion; The difference obtained by subtracting the Shore D hardness of the proximal tubular portion from the D hardness is 30D or more and 40D or less. In the assembled state in which the guiding catheter hub and the inner catheter hub are connected, the distal tubular portion The distal portion protrudes distally from the guiding catheter body, and the boundary between the distal tubular portion and the proximal tubular portion is located inside the guiding catheter body.

  Since the catheter assembly configured as described above includes the proximal tubular portion having a moderately higher Shore D hardness than the distal tubular portion, the pushing force is easily transmitted to the distal side. For this reason, since it is thick and linear, the proximal tubular part can be prevented from being bent too much in the descending aorta where the elongated body to be inserted is bent and difficult to move, and high pushability can be exhibited. In addition, since it has a distal tubular part with a moderately lower Shore D hardness than the proximal tubular part, the distal tubular part exhibits high followability to meandering iliac arteries, etc., and bends flexibly While moving. Thus, the catheter assembly can more easily reach the peripheral arteries than the iliac arteries from the radial artery to the iliac artery or beyond the iliac artery. And since the difference of Shore D hardness of a distal tubular part and a proximal tubular part is 30D or more and 40D or less and is not too large, a proximal tubular part does not become too hard and a distal tubular part is soft. It can suppress becoming too much. If the proximal tubular portion becomes too hard, the blood vessel tends to be damaged, and if the distal tubular portion becomes too soft, the meandering blood vessel cannot be linearly deformed by the proximal tubular portion. And, by directly connecting the proximal tubular part exhibiting high pushability to the distal tubular part exhibiting high followability, it follows the shape of the iliac blood vessel located at the tip of the long and linear descending aorta. The pushing force can be effectively transmitted to the moving distal tubular portion. In addition, since the boundary portion is located inside the guiding catheter body, even if the inner catheter body tries to bend excessively at the boundary portion between the distal tubular portion and the proximal tubular portion, the bending is suppressed by the guiding catheter body. The For this reason, the excessive bending of a catheter assembly is suppressed and the inside of a blood vessel can be advanced favorably. Further, since the boundary portion is located inside the guiding catheter body, the proximal portion of the distal tubular portion is located inside the distal portion of the guiding catheter body. For this reason, the distal portion of the guiding catheter body is bent together with the distal tubular portion that is flexibly bent, and is guided to the distal tubular portion that moves in the meandering iliac artery, and the distal portion of the guiding catheter body Can pass through the iliac artery smoothly. Thus, the catheter assembly can be inserted through the radial artery and more easily reach the iliac artery or a peripheral artery than the iliac artery.

  The guiding catheter body includes an intermediate portion, a distal tip positioned on the distal side of the intermediate portion and more flexible than the intermediate portion, and bent on the proximal side of the intermediate portion than the intermediate portion. A base portion having high rigidity, and in the assembled state, the boundary portion may be located inside the base portion. Thereby, the flexible distal tubular portion having a low Shore D hardness of the inner catheter body penetrates the distal portion, the intermediate portion, and the tip end of the base portion of the guiding catheter body. For this reason, the excessive bending of a boundary part can be suppressed by the base part with high bending rigidity of a guiding catheter main body. In addition, since the rigidity of the guiding catheter body gradually becomes softer toward the distal side within the range of the flexible distal tubular portion of the inner catheter body, the distal tubular portion that advances in the blood vessel while flexibly bending Following this, the guiding catheter body can bend flexibly and advance in the blood vessel.

  In the assembled state, the protruding length of the distal tubular portion from the guiding catheter body may be 10 to 50 mm. Since the distance between each peak of the meandering curvature of the iliac artery is about 10 to 20 mm, the distal end of the distal tubular portion has a protruding length of 10 to 50 mm. Can be preceded to the next peak of meandering in the iliac artery to allow the guiding catheter to follow the distal tubular section well. When the distal tubular part enters the iliac artery and the distal end of the guiding catheter body reaches the iliac artery, the outer diameter of the guiding catheter body is larger than the outer diameter of the distal tubular part. Because of its large size, the passability changes greatly. For this reason, when the distal end of the guiding catheter reaches the peak before the distal end of the distal tubular section exceeds the peak of the meandering blood vessel, the distal tubular section Since it is before straightening the meandering peak to some extent, it becomes difficult for the distal tubular portion to cross the peak, and it becomes excessively bent before the peak, so that the pushing force from the hand cannot be properly transmitted. On the other hand, the protruding length of the distal tubular portion is 10 to 50 mm, so that the distal tubular portion precedes the next peak of the meandering in the iliac artery, and the meandering is straightened to some extent by the distal tubular portion. The guiding catheter body can be satisfactorily followed by the distal tubular portion while being corrected.

  The distal tubular portion may have an axial length of 100 to 120 mm. The total length of the iliac artery is about 150 mm, and the flexible distal tubular portion is similar to or slightly shorter than the total length of the iliac artery, so that the distal tubular portion is curved following the meandering iliac artery. However, the proximal tubular portion following the distal tubular portion can be guided to the iliac artery.

  In the assembled state, the axial length of the portion where the distal tubular portion and the guiding catheter body overlap may be 50 mm or more. The peak-to-peak distance of the common iliac artery is 10 to 20 mm, and the guiding catheter can pass through the iliac artery when the distal tubular portion is at least the peak-to-peak distance.

  The distal tubular portion may have a Shore D hardness of 30D or more and 50D or less. If the Shore D hardness of the distal tubular portion is less than 30D, the distal tubular portion is too soft and it is difficult to deform the tortuous iliac artery to some extent linearly with the distal tubular portion, It becomes difficult to pass the proximal tubular portion, which is harder than the tubular portion, to the iliac artery following the distal tubular portion. The meandering iliac artery is somewhat straightened by the distal tubular portion, and can be further linearly deformed by the proximal tubular portion following the distal tubular portion. By making the meandering iliac arteries somewhat straight, it is possible to guide devices such as balloon catheters to peripheral arteries beyond the iliac artery or iliac artery using the lumen of the guiding catheter Become. Moreover, when the Shore D hardness of a distal tubular part exceeds 50D, since a distal tubular part is too hard, there exists a possibility of damaging a blood vessel. Further, if the distal tubular portion is too hard, it is insufficient to bend following the meandering iliac artery, and it is difficult to cross the iliac artery.

It is a top view which shows the catheter assembly which concerns on embodiment. It is a top view which shows the guiding catheter and inner catheter of embodiment. It is sectional drawing which shows the proximal part of the catheter assembly which concerns on embodiment. It is sectional drawing which shows the distal part of the catheter assembly which concerns on embodiment. It is sectional drawing which follows the AA line of FIG. It is a figure which shows the state which inserted the catheter assembly which concerns on embodiment from the radial artery, and reached the peripheral artery rather than the iliac artery. It is a figure which shows the state which inserted the catheter assembly which concerns on embodiment into the blood vessel. It is a figure which shows the state which the distal part of the catheter assembly which concerns on embodiment has advanced the iliac artery. It is a figure which shows the state which the distal part of the catheter assembly which concerns on embodiment reached the periphery rather than the iliac artery. It is a figure which shows the state which pulled out the inner catheter from the guiding catheter. It is a figure which shows the state which inserted the balloon catheter into the blood vessel through the guiding catheter.

  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. In the following description, the proximal side of the catheter assembly is referred to as “proximal side”, and the side inserted into the living body is referred to as “distal side”.

  As shown in FIGS. 1 and 2, the catheter assembly 10 according to the embodiment of the present invention has a double structure including a guiding catheter 20 and an inner catheter 30. The catheter assembly 10 is inserted percutaneously into the radial artery V1, as shown in FIG. 6, with the inner catheter 30 inserted into the lumen of the guiding catheter 20. The catheter assembly 10 passes through the descending aorta V2 (the thoracic aorta and the abdominal aorta), becomes harder due to calcification and the like, and passes through the iliac artery V3 or through the iliac artery V3, more than the iliac artery V3. Pushed to a peripheral artery (eg, superficial femoral artery V5). The iliac artery V3 includes a common iliac artery and an external iliac artery between a branch B that branches into two iliac arteries V3 and an entrance C of the common femoral artery V4. In FIG. 6, the catheter assembly 10 is inserted into the radial artery V1 of the right arm, but can also be inserted into the radial artery V1 of the left arm. In FIG. 6, the catheter assembly 10 is inserted into the iliac artery V3 of the right leg, but can be inserted into the iliac artery V3 of the left leg. After the distal portion of the catheter assembly 10 reaches the target site more distal than the iliac artery V3, the inner catheter 30 is removed from the guiding catheter 20, and a balloon catheter is utilized using the lumen of the guiding catheter 20. It is possible to introduce various treatment liquids such as a treatment catheter such as a contrast medium, a drug solution, and physiological saline into a target site. The inner catheter 30 compensates for the gap between the guiding catheter 20 and the guide wire 120, improves the kink resistance, pushability, operability, etc. of the catheter assembly 10, and the distal end of the guiding catheter 20 And the guide wire 120 are restrained from causing a step, thereby reducing blood vessel damage. Paper 1 “Iliac Artificial After Endovascular Repair of Abdominal Acoustic Aneurisms: Correlation with Iliic Currature and Diameter1. The total length of the bone artery V3 is about 150 mm, and the distance E between the peaks P of the meandering curvature of the iliac artery V3 is about 10 to 20 mm. Note that the total length of the iliac artery V3 is the length of the mean axis S (see FIG. 8) meandering the iliac artery V3.

  The guiding catheter 20 includes a tubular guiding catheter body 40, a guiding catheter hub 50 fixed to the proximal end of the guiding catheter body 40, and a kink protector 60. The inner catheter 30 includes an inner catheter body 70 that can be inserted into the guiding catheter body 40, and an inner catheter hub 80 that is disposed at the proximal end of the inner catheter body 70.

  When the inner catheter main body 70 is inserted into the proximal end side of the guiding catheter hub 50 and the guiding catheter hub 50 and the inner catheter hub 80 are brought into contact with each other and fixed by a locking mechanism described later, as shown in FIG. The guiding catheter 20 and the inner catheter 30 are assembled (assembled state). If the guiding catheter hub 50 and the inner catheter hub 80 can be connected, the locking mechanism may not be provided.

  First, the guiding catheter 20 will be described. The guiding catheter body 40 of the guiding catheter 20 is configured by a flexible tubular body as shown in FIGS. 2 to 5, and has a substantially central portion extending over the entire length of the guiding catheter body 40. A guiding catheter lumen 41 is formed.

  The guiding catheter body 40 includes an inner layer 42 that forms an inner surface within a guiding catheter lumen 41, an outer layer 43 that forms an outer surface, a reinforcing layer 44 positioned between the inner layer 42 and the outer layer 43, and an outer layer. 43, and a flexible tip 45 provided on the tip side of 43. The guiding catheter body 40 has an intermediate portion 46 composed of an outer layer 43 and an inner layer 42 on the proximal side of the distal tip 45, and the outer layer 43, the reinforcing layer 44, and the inner layer 42 on the proximal side of the intermediate portion 46. It has the base 47 comprised by these. The intermediate portion 46 has a higher bending rigidity than the distal tip 45, and the base portion 47 has a higher bending rigidity than the intermediate portion 46. The reinforcing layer 44 may be provided not only at the base portion 47 but also at the intermediate portion 46. The inner layer 42 may be provided up to the tip end 45.

  Examples of the constituent material of the outer layer 43 include various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene. , One or a combination of two or more of these (polymer alloy, polymer blend, laminate, etc.) can be mentioned.

  The constituent material of the inner layer 42 is made of a material that, when a device such as a treatment catheter or a guide wire is inserted into the guiding catheter lumen 41, at least a portion in contact with these devices has low friction. It is preferable. Thereby, the device inserted with respect to the guiding catheter main body 40 can be moved to an axial direction with a smaller sliding resistance, and operativity improves. Of course, the entire inner layer 42 may be made of a low friction material. Examples of the low friction material include fluorine resin materials such as polytetrafluoroethylene (PTFE).

  Further, since insertion of the catheter assembly 10 into the body is performed while confirming the position under fluoroscopy, the constituent material of the guiding catheter body 40 includes an X-ray opaque material (X-ray contrast medium). Is preferably blended. As the radiopaque material, for example, barium sulfate, bismuth oxide, tungsten, or the like can be used. Such a radiopaque material is not limited to being present over the entire length of the guiding catheter body 40 but may be present in a part of the guiding catheter body 40. It is more preferable that the distal tip 45 contains a contrast agent because the distal end of the guiding catheter 20 can be visually recognized.

  The reinforcing layer 44 is for reinforcing the guiding catheter body 40 and has a reinforcing material composed of a plurality of reinforcing wires 441. The material of the outer layer 43 or the inner layer 42 enters the gaps between the plurality of reinforcing wires 441 in the reinforcing layer 44. Examples of the reinforcing material include those in which the reinforcing wire 441 is formed in a spiral shape or a net shape. The reinforcing wire 441 is made of a metal such as stainless steel or NiTi. As a specific example of the linear body, a flat-plate-like one obtained by crushing a stainless steel wire into a flat-plate shape so that the radial thickness of the guiding catheter body 40 can be reduced. In addition, examples of the reinforcing material include a spiral shape using a plurality of about 8 to 32, a knitted material (braided body), and the like. The number of reinforcing wires 441 is preferably a multiple of 8 in order to reinforce the tube in a well-balanced manner. The reinforcing wire 441 is not limited to the above-described flat wire, and may be a round wire or an elliptic wire, for example. One reinforcing wire 441 may be a bundle of two or more wires.

  By having such a reinforcing layer 44, it is possible to ensure sufficient rigidity and strength without increasing the wall thickness of the guiding catheter body 40, that is, while relatively increasing the inner diameter of the guiding catheter body 40. it can. As a result, it is possible to obtain a guiding catheter 20 in which a treatment catheter having a relatively large outer diameter can be inserted, has excellent pushability and torque transmission, and is unlikely to cause kinking or crushing.

  The distal tip 45 is formed more flexibly than the base 47 and the intermediate portion 46. Thereby, the damage of the blood vessel by the front-end | tip of the guiding catheter main body 40 can be reduced at the time of insertion in the body of the catheter assembly 10 of an assembly state.

  The constituent material of the tip 45 is, for example, various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluorine rubber, styrene-butadiene rubber, styrene, polyolefin, polyurethane, and polyester. And various thermoplastic elastomers such as polyamide, polybutadiene, trans polyisoprene, fluororubber, and chlorinated polyethylene.

  The outer diameter of the guiding catheter body 40 is, for example, 1.7 to 2.6 mm, preferably 2.2 mm to 2.5 mm, and more preferably 2.3 mm to 2.4 mm. If the outer diameter is too large, the operability when the guiding catheter body 40 is inserted into the artery and traveled is lowered, and the burden on the patient may be increased.

  The inner diameter of the guiding catheter body 40 is, for example, 1.5 to 2.4 mm, preferably 2.0 mm to 2.3 mm, more preferably 2.15 mm to 2.25 mm. If the inner diameter is too small, the treatment catheter or the like that can be inserted into the guiding catheter body 40 has a small outer diameter accordingly, and the range of selection of treatment devices to be inserted is limited, which is not preferable. .

  The length of the guiding catheter body 40 is 1200 mm or more, preferably 1300 mm to 1600 mm so that the guiding catheter body 40 can be inserted from the radial artery V1 and reach the iliac artery V3 or a peripheral artery than the iliac artery V3. Yes, more preferably 1500 mm.

  The guiding catheter hub 50 is fixed to the proximal end of the guiding catheter body 40. The guiding catheter hub 50 has a guiding catheter hub lumen 54 that communicates with the guiding catheter lumen 41. The guiding catheter hub lumen 54 opens at the proximal guiding catheter hub opening 55. A male threaded portion 53 is formed on the outer peripheral surface of the proximal portion of the guiding catheter hub 50. The male screw portion 53 can be screwed with a female screw portion 82 formed in a screwing portion 81 (described later) provided rotatably on the inner catheter hub 80. The male screw portion 53 and the female screw portion 82 constitute a lock mechanism that holds the guiding catheter hub 50 and the inner catheter hub 80 in a connected state.

  The constituent material of the guiding catheter hub 50 is, for example, various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene. And combinations thereof (polymer alloys, polymer blends, laminates, etc.).

  In such a guiding catheter hub 50, the inner catheter 30 is inserted from the guiding catheter hub opening 55 in the assembled state. After the inner catheter 30 is removed, for example, a guide wire, catheters (for example, Insertion or removal of long objects (linear bodies) such as balloon catheters or stent placement catheters, endoscopes, ultrasonic probes, temperature sensors, contrast media (X-ray contrast media), drug solutions, physiological saline Various liquids such as can be injected.

  The kink protector 60 is attached so as to cover a portion connecting the guiding catheter body 40 and the guiding catheter hub 50, and suppresses kinking of the guiding catheter 20 at the site.

  Next, the inner catheter 30 will be described. As shown in FIGS. 2 to 5, the inner catheter main body 70 provided in the inner catheter 30 includes a distal tubular portion 71 located on the distal side and a proximal tubular portion located on the proximal side of the distal tubular portion 71. 72. An inner catheter lumen 75 penetrating from the distal end to the proximal end along the axis is formed in the central portion of the inner catheter body 70. The outer diameter of the inner catheter body 70 substantially matches the inner diameter of the guiding catheter body 40. It should be noted that the outer diameter of the inner catheter body 70 does not have to match the inner diameter of the guiding catheter body 40 as long as the inner catheter body 70 can be inserted into and removed from the guiding catheter body 40. Then, the inner catheter body 70 is arranged in the guiding catheter body 40, so that the outer surface of the inner catheter body 70 is in contact with the inner surface of the guiding catheter body 40 without a gap or through a minute gap. Adjacent.

  In the assembled state, the distal portion of the distal tubular portion 71 protrudes from the guiding catheter body 40 to the distal side. Accordingly, the distal tubular portion 71 is located on the most distal side when the catheter assembly 10 is pushed forward in the blood vessel, and easily contacts the blood vessel wall. The distal tubular portion 71 is more flexible than the proximal tubular portion 72. The distal tubular portion 71 has lower Shore D hardness and bending rigidity than the proximal tubular portion 72. Shore D hardness is a hardness by a durometer test measured according to ISO868. The outer peripheral surface of the distal end portion of the distal tubular portion 71 is smoothly formed with a curvature so that the living tissue that comes into contact with it is not damaged. It is preferable that the distal tubular portion 71 is flexible so that the distal tubular portion 71 advances while following the meandering iliac artery V3. However, compared with the guiding catheter for the coronary artery or the head, the distal tubular portion 71 needs to be able to move in a thick blood vessel and meanders such as the iliac artery V3 that has become hard due to calcification or the like. It is preferable not to be too soft so that the blood vessel can be pushed forward while being straightened to some extent. If the distal tubular portion 71 is too soft, the direction is not determined inside the thick blood vessel. If the distal tubular portion 71 is too soft, it is difficult to push the meandering iliac artery V3 while correcting it straightly. The Shore D hardness of the distal tubular portion 71 is, for example, 30 to 50D, preferably 35 to 45D. The bending rigidity of the distal tubular portion 71 is preferably 50 to 150 gf. When the Shore D hardness of the distal tubular portion 71 is less than 30D, it is difficult for the distal tubular portion 71 to correct the iliac artery V3 to a shape close to a straight line, and the distal tubular portion 71 is greatly bent inside the meandering iliac artery V3. It ’s difficult to push in because it ’s stuck. When the Shore D hardness of the distal tubular portion 71 exceeds 50D, the distal tubular portion 71 can be pushed into the meandering iliac artery V3, but it is too hard to easily damage the blood vessel.

  The proximal tubular portion 72 has higher bending rigidity and Shore D hardness than the distal tubular portion 71. The proximal tubular portion 72 is preferably somewhat rigid so that it can pass through the thick and linear descending aorta V2 and transmit the pushing force to the distal tubular portion 71. If the proximal tubular portion 72 is too soft, the proximal tubular portion 72 is deflected inside a thick blood vessel such as the descending aorta V2, the direction is not fixed, and the pushing force cannot be transmitted effectively. If the proximal tubular portion 72 is too hard, it cannot be deformed along the meandering iliac artery V3, and it becomes difficult to enter and pass through the iliac artery V3. The Shore D hardness of the proximal tubular portion 72 is, for example, more than 68D and less than 90D, preferably 72 to 80D. The bending rigidity of the proximal tubular portion 72 is preferably 300 to 400 gf. When the Shore D hardness of the proximal tubular portion 72 is 68D or less, the proximal tubular portion 72 is too soft and cannot effectively transmit the pushing force. When the Shore D hardness of the proximal tubular portion 72 is 90D or more, it becomes difficult to pass through the meandering artery.

  The distal tubular portion 71 and the proximal tubular portion 72 having greatly different hardnesses are connected directly adjacent to each other. Since the proximal tubular portion 72 exhibiting high pushability is directly connected to the distal tubular portion 71 exhibiting high followability, the proximal tubular portion 72 is located at the tip of the long and straight descending aorta V2. The pushing force can be effectively transmitted to the distal tubular portion 71 moving in the iliac artery V3. As long as the distal tubular portion 71 can pass through the meandering iliac artery V3, the guiding catheter 20 can be used to insert a treatment device such as a balloon catheter, so that the hardness of the inner catheter body 70 is along the axial direction. It is not necessary to change gradually. That is, the catheter assembly 10 is unlikely to push a relatively thin and curved blood vessel over a long range, like a coronary artery or head guiding catheter. For this reason, the inner catheter main body 70 does not include a physical property transition portion whose rigidity gradually changes toward the distal side within a certain long range, which is common in guiding catheters for coronary arteries and heads. Further, when the hardness of the inner catheter main body 70 is gradually changed, it is necessary to shorten the length of the hard portion such as the proximal tubular portion 72. However, when the length of the hard portion such as the proximal tubular portion 72 is shortened, the pushability in a thick and long blood vessel such as the descending aorta V2 is lowered. For this reason, in order to ensure the longest possible rigid proximal tubular portion 72 that can move in a thick and long blood vessel while having a flexible distal tubular portion 71 that can pass through a meandering blood vessel, the distal end is greatly different in hardness. The tubular portion 71 and the proximal tubular portion 72 are preferably connected directly adjacent. In addition, if the hardness of the distal tubular portion 71 and the proximal tubular portion 72 is too large, it is not preferable because the proximal tubular portion 72 becomes too hard and the distal tubular portion 71 becomes too soft. The difference in Shore D hardness between the distal tubular portion 71 and the proximal tubular portion 72 is 30D or more and 40D or less, more preferably 34D or more and 38D or less. The difference in bending rigidity between the distal tubular portion 71 and the proximal tubular portion 72 is 150 to 300 gf, more preferably 180 to 250 gf, and still more preferably 200 to 250 gf.

  In the assembled state, the boundary 73 between the distal tubular portion 71 and the proximal tubular portion 72 is located inside the base 47 of the guiding catheter body 40. Since the boundary portion 73 is located inside the base portion 47 of the guiding catheter body 40, the guiding portion can be guided even if the inner catheter body 70 tries to bend excessively at the boundary portion 73 between the distal tubular portion 71 and the proximal tubular portion 72. Deflection is suppressed by the catheter body 40. For this reason, the excessive bending of the catheter assembly 10 is suppressed, and the inside of the blood vessel can be favorably advanced. Further, since the boundary portion 73 is located inside the guiding catheter body 40, the proximal portion of the distal tubular portion 71 is located inside the distal portion of the guiding catheter body 40. For this reason, the distal portion of the guiding catheter body 40 is guided by the distal tubular portion 71 that flexibly moves in the meandering iliac artery V3, and can smoothly pass through the iliac artery V3.

  The axial length L1 of the distal tubular portion 71 is not particularly limited, but is preferably 100 to 120 mm, and is preferably the same as or slightly shorter than the entire length (about 150 mm) of the iliac artery V3. Accordingly, the distal tubular portion 71 can be advanced while following the meandering iliac artery V3, and the proximal tubular portion 72 following the distal tubular portion 71 can be guided to the iliac artery V3. it can.

  In the assembled state, the protruding length L2 of the distal tubular portion 71 from the guiding catheter body 40 is not particularly limited, but is preferably 10 to 50 mm, and more preferably 40 mm. According to the paper 1, the peak-to-peak distance E in the iliac artery V3 is about 10 to 20 mm. Therefore, when the protruding length L2 of the distal tubular portion 71 is 10 to 50 mm, the distal tubular portion 71 The distal end can be preceded to the next peak P of meandering in the iliac artery V3 to allow the distal tubular portion 71 to follow the guiding catheter well. When the protruding portion 74 of the distal tubular portion 71 protruding from the guiding catheter body 40 enters the iliac artery V3, and the distal end of the guiding catheter body 40 reaches the iliac artery V3, the guide Since the outer diameter of the ding catheter main body 40 is larger than the outer diameter of the protrusion 74, the passability changes greatly. Therefore, before the distal end of the distal tubular portion 71 exceeds one peak P of the meandering iliac artery V3, the distal end of the guiding catheter body 40 has its peak P. When reaching the near side (beyond the previous peak P), it is before the distal tubular portion 71 straightens the meandering peak P to some extent. As a result, it becomes difficult for the distal tubular portion 71 to exceed the peak P, and the distal tubular portion 71 is bent excessively before the peak P, so that the pushing force from the hand is not properly transmitted. On the other hand, when the protruding length L2 of the distal tubular portion 71 is 10 to 50 mm, the distal tubular portion 71 precedes the next peak P of the meandering in the iliac artery V3, and the distal tubular portion The guiding catheter body 40 can be made to follow the distal tubular portion 71 satisfactorily while correcting the meandering to some extent by the 71.

  In the assembled state, the axial length L3 of the overlapping portion 76 (see FIG. 4) where the distal tubular portion 71 and the guiding catheter body 40 overlap each other is the peak P of the meandering curvature (curvature) of the iliac artery V3. It is preferable that the distance E is longer than the distance E, and therefore, it is preferable that the distance is 50 mm or more. The distance E between the peaks P of the meandering curvature (curvature) of the iliac artery V3 is about 10 to 20 mm, and the distal tubular portion is at least the distance between the peaks. Can pass V3.

  The outer diameter of the inner catheter body 70 substantially matches the inner diameter of the guiding catheter body 40. The outer diameter of the inner catheter body 70 is, for example, 1.2 mm to 2.5 mm, and preferably 1.8 mm to 2.3 mm.

  The inner diameter of the inner catheter body 70 is substantially the same as or somewhat larger than the outer diameter of the guide wire 120 to be used. The inner diameter of the inner catheter body 70 is, for example, 0.3 mm to 1.4 mm, and preferably 0.8 mm to 1.2 mm.

  The length of the inner catheter body 70 is longer than the guiding catheter body 40 and is 1200 mm or more so that it can be inserted from the radial artery V1 to reach the iliac artery V3 or to a peripheral artery than the iliac artery V3. And preferably 1300 mm to 1800 mm, more preferably 1600 mm.

  The constituent materials of the distal tubular portion 71 and the proximal tubular portion 72 are, for example, styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, chlorinated polyethylene-based, etc. These include various thermoplastic elastomers and the like, and one or a combination of two or more of these may be mentioned. Further, since the insertion of the catheter assembly 10 into the body is performed while confirming the position under fluoroscopy, the constituent materials of the distal tubular portion 71 and the proximal tubular portion 72 (particularly, the distal tubular portion 71) It is preferable that a radiopaque material (X-ray contrast agent) is blended therein. As the radiopaque material, for example, barium sulfate, bismuth oxide, tungsten, or the like can be used.

  The inner catheter hub 80 is fixed to the proximal end of the inner catheter body 70 as shown in FIGS. The inner catheter hub 80 has an inner catheter hub lumen 84 that communicates with the inner catheter lumen 75. The inner catheter hub lumen 84 opens at the proximal inner catheter hub opening 85. A rotatable threaded portion 81 is provided on the outer surface of the inner catheter hub 80. On the inner peripheral surface of the screwing portion 81, a female screw portion 82 that can be screwed with the male screw portion 53 of the guiding catheter hub 50 is formed. A cylindrical portion 86 that can be inserted into the guiding catheter hub opening 55 of the guiding catheter hub 50 is formed at the distal side of the inner catheter hub 80. The tubular portion 86 is inserted into the guiding catheter hub opening 55 so as to be in close contact with the guiding catheter hub lumen 54.

  The constituent material of the inner catheter hub 80 is, for example, various thermoplastic elastomers such as styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber, and chlorinated polyethylene. And a combination of one or more of these.

  Next, the usage method of the catheter assembly 10 which concerns on this embodiment is demonstrated. Here, a method in which the catheter assembly 10 is inserted from the radial artery V1 and a stenosis located in a peripheral artery from the iliac artery V3 is treated by the balloon catheter 100 will be described as an example.

  First, before introducing the catheter assembly 10 into the blood vessel, the guiding catheter 20 and the inner catheter 30 are assembled as shown in FIGS. When assembling, the inner catheter 30 is inserted into the guiding catheter hub opening 55 from the inner catheter main body 70 side, and the inner catheter 30 is pushed forward until the tubular portion 86 is inserted into the guiding catheter hub opening 55. When the threaded portion 81 is rotated after the tubular portion 86 is inserted into the guiding catheter hub opening 55, the male threaded portion 53 is threadedly engaged with the female threaded portion 82 as shown in FIG. Thereby, when the catheter assembly 10 is inserted into the blood vessel, the guiding catheter 20 and the inner catheter 30 can be operated integrally, so that the operation becomes easy and the guiding catheter 20 and the inner catheter 30 can be expected. The safety is improved by suppressing the disconnection.

  Next, as shown in FIG. 7, the operator punctures the radial artery V1 by a known method and inserts a short guide wire. Thereafter, a catheter introducer 110 having a dilator inserted into the lumen of the sheath 111 is inserted into the puncture site of the radial artery V1 along the short guide wire. Then, after the distal end of the catheter introducer 110 is advanced by a predetermined amount toward the central side, the short guide wire and the dilator are removed from the catheter introducer 110. Thus, the operator can introduce the catheter assembly 10 into the radial artery V1 via the sheath 111.

  Next, the operator introduces the catheter assembly 10 with the guide wire 120 inserted into the inner catheter lumen 75 and the inner catheter hub lumen 84 into the radial artery V1 via the sheath 111. Next, with the guide wire 120 advanced, the catheter assembly 10 is pushed through the descending aorta V2 to the iliac artery V3 as shown in FIG. At this time, in the catheter assembly 10, the inner catheter body 70 is disposed inside the guiding catheter body 40, and the inner catheter is placed in a gap between the outer surface of the guide wire 120 and the inner surface of the guiding catheter body 40. The main body 70 is located. The distal tubular portion 71 of the inner catheter 30 protrudes more distally than the guiding catheter body 40. For this reason, while being able to reduce the damage of the blood vessel by the distal end part of the guiding catheter main body 40, it can suppress that the distal end part of the guiding catheter main body 40 turns up by receiving resistance from the blood vessel. Moreover, since the outer peripheral surface of the distal end portion of the distal tubular portion 71 has a curvature and is smooth, it can smoothly contact the blood vessel and reduce the damage to the blood vessel.

  The catheter assembly 10 passes through the thick and straight descending aorta V2 before reaching the iliac artery V3. At this time, since the proximal tubular portion 72 has a certain degree of hardness, the proximal tubular portion 72 can be pushed forward with a direction of travel determined within a thick blood vessel.

  When the catheter assembly 10 passes the descending aorta V2, the catheter assembly 10 reaches the meandering iliac artery V3, and enters the meandering iliac artery V3 while being bent from the distal tubular portion 71. At this time, since the inner catheter main body 70 is disposed inside the guiding catheter, the kinking of the guiding catheter main body 40 that is easy to kink thin can be suppressed. In addition, since the boundary portion 73 of the inner catheter body 70 is located inside the guiding catheter body 40, even if the inner catheter body 70 tries to bend excessively at the boundary portion 73, the guiding catheter body 40 is bent. It is suppressed. For this reason, the excessive bending of a catheter assembly is suppressed and the inside of a blood vessel can be advanced favorably. Moreover, since the boundary part 73 is located inside the base 47 having high rigidity of the guiding catheter body 40, the base part 47 of the guiding catheter body 40 can favorably suppress excessive bending of the boundary part 73.

  Further, since the distal tubular portion 71 located on the most distal side of the catheter assembly 10 is flexible and has high followability to blood vessels, the iliac artery V3 is curved while following the meandering iliac artery V3. You can push in. At this time, since the distal tubular portion 71 has a certain degree of hardness, the meandering iliac artery V3 can be straightened to some extent. For this reason, the guiding catheter body 40 and the proximal tubular portion 72 following the distal tubular portion 71 can smoothly advance through the meandering iliac artery V3. Further, since the proximal tubular portion 72 is rigid, it is difficult to bend in the thick and linear descending aorta V2, and the pushing force can be effectively transmitted to the distal tubular portion 71.

  As shown in FIG. 9, after the distal end of the guiding catheter body 40 passes through the iliac artery V3 and reaches the vicinity of the stenosis, the pushing of the catheter assembly 10 is stopped. Next, the screwing portion 81 is rotated to release the screwing between the male screw portion 53 and the female screw portion 82 (see FIG. 3). Thereafter, as shown in FIG. 10, the inner catheter 30 is removed from the guiding catheter 20 while leaving the guiding catheter 20 and the guide wire 120 in the blood vessel.

  After the inner catheter 30 is completely pulled out from the guiding catheter 20, a Y connector is connected to the guiding catheter hub 50, and the balloon catheter 100 is connected to the guiding catheter 20 via the Y connector as shown in FIG. insert. A guide wire 120 is inserted into the guide wire lumen of the balloon catheter 100. Thereafter, the balloon 101 is expanded at the stenosis, and the balloon 101 is pushed to widen the stenosis. Thereafter, the balloon 101 is deflated, and the balloon catheter 100 and the guide wire 120 are removed from the guiding catheter 20.

  The treatment performed through the guiding catheter 20 is not limited to the treatment using the balloon catheter 100. For example, a stent may be disposed on the outer surface of the balloon 101. When the stent is disposed on the outer surface of the balloon 101, when the balloon 101 is expanded, the stent is expanded while being plastically deformed. Thereafter, when the balloon 101 is deflated, the plastically deformed stent is not deflated but is placed on the inner wall surface of the blood vessel, and the state where the blood vessel is pushed and expanded can be favorably maintained by the stent. Further, a catheter other than the balloon catheter 100, an endoscope, an ultrasonic probe, a temperature sensor or other long object is inserted or removed via the guiding catheter 20, or a contrast agent (X-ray contrast agent), a chemical solution, Various liquids such as physiological saline can be injected.

  Thereafter, the guiding catheter 20 is withdrawn from the sheath 111, the sheath 111 is withdrawn from the radial artery V1, and the puncture site by the sheath 111 is hemostatic, thereby completing the procedure.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, at least one of the guiding catheter body 40 and the inner catheter body 70 may be configured to be curved.

  Examples of the present invention and comparative examples will be described below. Under the conditions shown in Tables 1 to 3, catheter assemblies of Examples 1 and 2 and Comparative Examples 1 to 5 were produced.

  The guiding catheter was common to Examples 1 and 2 and Comparative Examples 1 to 5. The axial length of the guiding catheter body was 1500 mm. The inner diameter of the guiding catheter body was 2.20 mm over the entire length. The outer diameter of the base of the guiding catheter was 2.37 mm, and the outer diameter of the intermediate portion and the tip was 2.43 mm. The constituent material of the outer layer of the base part and the intermediate part was polyamide, and the constituent material of the inner layer of the base part and the intermediate part was polytetrafluoroethylene. The thickness of the inner layer was 10 μm. The reinforcing layer was formed by braiding flat reinforcing wires. The constituent material of the reinforcing wire was stainless steel. The dimension of the cross section of the reinforcing wire was 25 μm × 160 μm. In addition, the long direction in the cross section of the reinforcing wire was arranged along the circumferential direction of the guiding catheter. The constituent material of the tip was a polyamide elastomer. A hydrophilic coat was coated on the outer peripheral surface in the range of 300 mm from the distal end of the guiding catheter body. The constituent material of the hydrophilic coat was a dimethylacrylamide-glycidyl methacrylate copolymer.

  The inner catheter was the same in Examples 1 and 2 and Comparative Examples 1 to 5, and only the constituent materials of the distal tubular portion and the proximal tubular portion were changed. The inner diameter of the inner catheter body was 2.10 mm, and the inner diameter was 1.15 mm. The axial length of the distal tubular portion was 110 mm. The protruding length of the inner catheter from the guiding catheter was 40 mm. The constituent materials of the distal tubular portion and the proximal tubular portion were made of the same kind of materials having different rigidity so as to be easily fused at the boundary portion. The constituent material of the distal tubular portion and the proximal tubular portion was a polyester elastomer.

  Test model in which blood vessels from the radial artery to the iliac artery to the superficial femoral artery were modeled using silicone as a material using the catheter assemblies according to Examples 1 and 2 and Comparative Examples 1 to 5 The test was carried out. In the test, the operability was judged from the pushability in the meandering blood vessel (Pushability) and the followability to the meandering blood vessel (Trackability). The results are shown in Table 1.

  As a result, in Comparative Examples 1 to 4, the proximal tubular portion had insufficient hardness (rigidity) and indentability was insufficient.

  In Examples 1 and 2, the proximal tubular portion had sufficient hardness (rigidity), and high pushability was obtained. In Examples 1 and 2, since the Shore D hardness of the distal tubular portion and the proximal tubular portion is moderately separated, high followability to a meandering blood vessel model was obtained.

  In Comparative Example 5, the proximal tubular portion was too hard, so that it did not enter the meandering portion of the blood vessel model, and the followability was insufficient.

  In Example 1, since the melting points of the materials of the distal tubular portion and the proximal tubular portion were closer than those in Example 2, the fusion between the distal tubular portion and the proximal tubular portion was easy.

  Furthermore, this application is based on the JP Patent application number 2016-226107 for which it applied on November 21, 2016, The content of those indications is referred and is incorporated as a whole.

DESCRIPTION OF SYMBOLS 10 Catheter assembly 20 Guiding catheter 30 Inner catheter 40 Guiding catheter main body 45 Tip tip 46 Intermediate | middle part 47 Base 50 Guiding catheter hub 70 Inner catheter main body 71 Distal tubular part 72 Proximal tubular part 73 Boundary part 74 Protrusion part 76 Overlapping portion 80 Internal catheter hub 100 Balloon catheter (treatment device)
120 Guide wire E Distance between peaks L1 Length of distal tubular portion L2 Protruding length L3 Length of overlapping portion P Peak
V1 radial artery V2 descending aorta V3 iliac artery V4 common femoral artery V5 superficial femoral artery

Claims (6)

A catheter assembly that is inserted percutaneously from the radial artery and inserted to the peripheral artery rather than the iliac artery or iliac artery,
A guiding catheter comprising a tubular guiding catheter body and a guiding catheter hub provided at the proximal end of the guiding catheter body;
An inner catheter including an inner catheter body that can be inserted into the guiding catheter body, and an inner catheter hub provided at a proximal end of the inner catheter body and connectable to the guiding catheter hub;
The inner catheter body is
A distal tubular portion located distally;
A proximal tubular portion located proximal to the distal tubular portion and having a distal end coupled to the distal tubular portion;
The difference obtained by subtracting the Shore D hardness of the proximal tubular portion from the Shore D hardness of the distal tubular portion is 30D or more and 40D or less,
In the assembled state in which the guiding catheter hub and the inner catheter hub are connected, the distal portion of the distal tubular portion protrudes distally from the guiding catheter body, and the distal tubular portion and the proximal tubular portion are The boundary part is a catheter assembly located inside the guiding catheter body. The guiding catheter body includes:
An intermediate portion, a distal tip positioned on the distal side of the intermediate portion and more flexible than the intermediate portion, and a base portion positioned on the proximal side of the intermediate portion and having higher bending rigidity than the intermediate portion; Have
The catheter assembly according to claim 1, wherein in the assembled state, the boundary portion is located inside the base portion.   3. The catheter assembly according to claim 1, wherein in the assembled state, a protruding length of the distal tubular portion from the guiding catheter body is 10 to 50 mm.   The catheter assembly according to any one of claims 1 to 3, wherein an axial length of the distal tubular portion is 100 to 120 mm.   The catheter assembly according to any one of claims 1 to 4, wherein, in the assembled state, an axial length of a portion where the distal tubular portion and the guiding catheter main body overlap each other is 50 mm or more.   The catheter assembly according to any one of claims 1 to 5, wherein the distal tubular portion has a Shore D hardness of 30D or more and 50D or less.