JP2015066331A - Catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a catheter that can attain an excellent backup property.SOLUTION: A catheter is introduced into and detained in a biological lumen. The catheter in a shape before being introduced into the biological lumen includes a catheter body having a bending part, and a hub. At least part of an outside surface of the catheter body is coated with a surface-lubricating layer 33. The bending part has: an inner bending surface located on an inner side of the bending part; and an outer bending surface located on an outer side of the bending part. At least part of the outer bending surface is provided with a low lubricant part 7 that has lubricity lower than that of the surface-lubricating layer.

Description

  The present invention relates to a catheter, in particular a guiding catheter. In particular, the present invention relates to a catheter having a curved shape with excellent backup performance, and particularly to a guiding catheter.

  Conventionally, in percutaneous coronary angioplasty (PCI), a guiding catheter for a coronary artery is used for the purpose of guiding a treatment device such as a guide wire, a microcatheter, and a balloon catheter into the coronary artery. This guiding catheter usually has a main body, a distal end portion, and a curved portion provided between the main body and the distal end portion. The bending portion is for making the guiding catheter correspond to the blood vessel shape of the coronary artery, and for example, those having many shapes such as Judkins type and Amprats type are known.

  One of the important performances required for guiding catheters is backup performance (retention performance, backup power). The backup performance of the guiding catheter depends on the frictional force at the aortic arch wall as well as the geometrical factors such as the thickness of the guiding catheter and the angle of contact with the aortic arch wall. In order to realize strong backup performance, it is preferable that the frictional force in the aortic arch is high. On the other hand, as a less invasive technique in recent years, instead of a technique for inserting a catheter from a femoral artery, a technique for inserting a catheter from an arm artery, particularly the brachial artery or radial artery, is becoming widespread. In order to move the catheter smoothly in a thinner blood vessel, good lubricity (surface lubricity) of the device surface is required. Also, when operating the guiding catheter, a technique of inserting the guiding catheter relatively deeply into the coronary artery (deep engagement) is often performed. Operation is required. For this reason, it is preferable that the guiding catheter tip has good lubricity.

  On the other hand, a method of reducing the friction between the catheter and the blood vessel wall by coating the catheter surface with a hydrophilic lubricant is widely used. For example, in Patent Document 1, hyaluron is fixed on the inner and outer surfaces as a lubricant. Guided catheters have been reported.

JP 2001-129074 A

  However, when the outer surface is coated with a hydrophilic lubricant as in the guiding catheter disclosed in Patent Document 1, the frictional force against the aortic arch wall is also reduced, so that strong backup performance cannot be expected. There was a problem. In particular, when it is placed on a living body lumen wall where heart beats such as coronary arteries are transmitted, backup performance is lowered, and the device may move in an unintended direction due to heart beats.

  Therefore, the present invention has been made in view of the above circumstances, and an object of the present invention is to provide a catheter that can achieve good backup performance while ensuring smooth delivery to a treatment target.

  Another object of the present invention is to provide a highly maneuverable and / or safe catheter, particularly a guiding catheter.

  As a result of intensive studies to solve the above problems, the present inventors have provided a low-lubricating portion on the outer surface of the curved portion with respect to a catheter having a curved portion provided with a surface-lubricating layer. The inventors have found that the above problems can be solved, and have completed the present invention.

  That is, the above-mentioned objects are catheters that are introduced and placed in a living body lumen, and the catheter has a catheter body portion having a curved portion and a hub in a shape before being introduced into the living body lumen. And at least a part of the outer surface of the catheter main body is covered with a surface-lubricating layer, and the curved portion includes an inner curved surface inside the curved portion and an outer curved surface outside the curved portion. And at least a part of the outer curved surface is provided with a low-lubrication part having lower lubricity than the surface-lubricating layer.

  The catheter of the present invention enables smooth introduction and operation of the catheter during delivery in the living body lumen, and can show a high back-up property with respect to the living body lumen wall when placed in the living body lumen. For this reason, by using the catheter of this invention, a catheter can be smoothly introduce | transduced into a desired site | part and it can hold | maintain reliably.

It is the schematic of the catheter (guiding catheter) which concerns on one Embodiment of this invention. It is sectional drawing in the A-A 'line of the catheter shown in FIG. Here, FIG. 2A is a cross-sectional view taken along the line AA of the catheter main body without the low lubrication part, and FIG. 2B is a cross-sectional view taken along the line AA ′ of the catheter main body with the low lubrication part. FIG. It is explanatory drawing which shows typically 1st embodiment which uses the catheter shown in FIG. It is explanatory drawing which shows typically 2nd embodiment which uses the catheter shown in FIG. It is the schematic of the catheter (guiding catheter) which concerns on other embodiment of this invention. It is explanatory drawing which shows typically 1st embodiment which uses the catheter shown in FIG. It is a schematic diagram of the evaluation test apparatus (friction measuring machine) of the surface lubricity used in the Example. 4 is a graph showing test results for evaluating the lubricity of a low-lubrication part with respect to ultraviolet irradiation time in Example 1.

  The present invention is a catheter that is introduced and indwelled in a living body lumen, the catheter having a catheter main body portion having a curved portion and a hub in a shape before being introduced into the living body lumen, At least a part of the outer surface of the catheter main body is covered with a surface-lubricating layer, and the curved portion is an inner curved surface inside the curved portion (hereinafter also simply referred to as “inner curved surface”) and the It has an outer curved surface (hereinafter, also simply referred to as “outer curved surface”) outside the curved portion, and at least a part of the outer curved surface has low lubricity that is lower in lubricity than the surface lubricating layer. There is provided a catheter provided with a portion (hereinafter, also simply referred to as “low lubrication portion”). The present invention is characterized in that a low-lubricating portion is disposed on the outer outer surface of the curved portion of the catheter body portion that contacts the living body lumen wall when the catheter having the surface lubricating layer is placed in the living body lumen. To do.

  As described above, when the guiding catheter is placed in the living body lumen, one factor that determines the backup force of the guiding catheter is the frictional force at the site that contacts the living body lumen wall of the guiding catheter. . For this reason, as described in Patent Document 1, when hyaluronic acid is fixed to the surface of the guiding catheter (covered with a surface lubricating layer), the operability in the body lumen can be improved, but the guiding catheter is When indwelling in a living body lumen, a frictional force at a portion in contact with the living body lumen wall is lowered by the surface lubricating layer, so that a good backup force cannot be expected.

  On the other hand, in the catheter of the present invention, the low lubrication part is installed on the outer curved surface outside the curved part that comes into contact with the living body lumen wall when placed in the living body lumen. For this reason, when the catheter is indwelled at a position in a predetermined biological lumen (for example, blood vessel), the low lubrication portion comes into contact with the biological lumen wall. At this time, since the lubricity of the low-lubrication portion is low, the catheter can be effectively held in its position by the high frictional force (that is, high backup property) between the catheter and the living body lumen wall at the contact portion. . On the other hand, when the catheter is inserted into the living body lumen, the catheter can be smoothly introduced to a desired position due to the presence of the surface lubricating layer covering the outer surface. Therefore, by using the catheter of the present invention, it is possible to improve the indwellability (back-up property) at the desired position while maintaining good operability at the time of introduction to the desired position.

  Embodiments of the present invention will be described below. In addition, this invention is not limited only to the following embodiment. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may be different from the actual ratios.

  In the present specification, “X to Y” indicating a range means “X or more and Y or less”, and “weight” and “mass”, “wt%” and “mass%”, “part by weight” and “ “Part by mass” is treated as a synonym. Unless otherwise specified, measurement of operation and physical properties is performed under conditions of room temperature (20 to 25 ° C.) / Relative humidity 40 to 50%.

[catheter]
The catheter of the present invention may be used for any application, but is introduced into the living body lumen when used, and is used after being introduced at least temporarily in contact with the living body lumen wall. It is preferred that Specifically, the catheter is inserted or placed in a blood vessel such as an IVH catheter, a thermodilution catheter, an angiographic catheter, a vasodilator catheter (for example, a PCTA catheter), a catheter with a stent, a guiding catheter, or a microcatheter. Catheters; gastric tube catheters, nutritional catheters; oxygen catheters, intratracheal suction catheters, etc., orally or nasally inserted or indwelled in the airways or trachea; urinary catheters, urinary catheters, urethral balloon catheters And the like inserted into or placed in the urethra or ureter, etc .; catheters inserted or placed in various body cavities, organs, tissues such as suction catheters, drainage catheters, rectal catheters, and the like. Among these, in terms of high demand for backup performance, a guiding catheter, particularly a guiding catheter used in a living body lumen such as a blood vessel (for example, a head, an abdomen, or a heart blood vessel) is preferable. .

  Hereinafter, the present invention will be described in detail by taking a guiding catheter as a preferred embodiment of the present invention as an example. However, the present invention is not limited to the following, and a catheter introduced and placed in another living body lumen. Can be applied in the same manner or appropriately modified.

  FIG. 1 is a schematic view of a catheter (guiding catheter) according to an embodiment of the present invention. The catheter shown in FIG. 1 is a catheter in a natural state (a state in which no external force is applied; the same applies hereinafter) before being introduced into a living body lumen. As shown in FIG. 1, a guiding catheter 1 according to the present invention has a catheter body 2 and a hub 9. The catheter main body 2 is composed of a distal end portion 3, a main body portion 2 ', and a bending portion 6 provided between the distal end portion 3 and the main body portion 2'.

  The tip portion 3 is a portion extended from the curved portion 6, and various conventionally known structures can be employed. For example, the distal end portion 3 may have a looped shape or a substantially linear shape, and the distal end portion 3 is a member for imparting functions such as cleaning, suction, illumination, and imaging. May be attached.

  The main body portion 2 ′ is a portion that connects the bending portion 6 and the hub 9 in the catheter main body portion 2, and is a region that does not include the bending portion 6 described later.

  The bending portion 6 is between the distal end portion 3 and the main body portion 2 ′ in the catheter main body portion 2 and has an inner curved surface inside the bending portion and an outer curved surface outside the bending portion. Here, the “curved portion” means a portion having a curvature with a curvature radius (R) of 100 mm or less in a natural state, and preferably a portion having a curvature with a curvature radius (R) of 5 to 100 mm. The “inner curved surface inside the curved portion” means a part or all of the surface of the catheter main body corresponding to the semicircle on the curved side (inner side) in the cross section of the curved portion. Similarly, the “outer curved surface outside the curved portion” means a part or all of the surface of the catheter main body corresponding to the semicircle on the extended side (outer side).

  In FIG. 1, the bending portion 6 includes a first bending region 4 on the distal end portion 3 side, a second bending region 4 ′ on the base end side, and between the first bending region 4 and the second bending region 4 ′. The first intermediate region 5 is provided. The first curved region 4 and the second curved region 4 'are provided in a state curved in the same direction. Further, a hub 9 as an injection port for injecting a therapeutic device (for example, a PTCA catheter), a contrast medium, or the like is formed at the proximal end portion of the catheter body 2.

  FIG. 5 is a schematic view of a catheter (guiding catheter) according to another embodiment of the present invention. A guiding catheter 21 shown in FIG. 5 is different from the guiding catheter shown in FIG. 1 in that the bending portion has four bending regions. That is, the bending portion includes the first bending region 24, the second bending region 24 ′, the third bending region 24 ″, the fourth bending region 24 ′ ″, the first bending region 24, and the first bending region 24 from the distal end portion 23 side. A first intermediate region 25 provided between the second curved region 24 ′, a second intermediate region 25 ′ provided between the second curved region 24 ′ and the third curved region 24 ″, and the third A third intermediate region 25 ″ is provided between the curved region 24 ″ and the fourth curved region 24 ′ ″. The first curved region 24, the second curved region 24 ′, and the third curved region 24 ″ are provided in a curved state in the same direction, and the fourth curved region 24 ′ ″ includes the first curved region 24, the second curved region 24 ′ ″, and the second curved region 24 ′ ″. The curved region 24 ′ and the third curved region 24 ″ are provided in a curved state in the opposite direction. Further, a therapeutic device (for example, a PTCA catheter) is provided at the proximal end portion of the catheter main body (main body 22 ′). ), An injection port for injecting a contrast agent, etc. Thus, the curved portion has a plurality of curved regions in a natural state, and each curved region is curved in a different direction. It may be provided in a state.

  In addition, although the form which has two or four curved area | regions was demonstrated above, this invention is not limited to the said form. Usually, there are 1 to 6 curved regions per catheter, and preferably 2 to 4 per catheter. In consideration of the indwellability in a desired living body lumen, the bending portion is preferably installed on the distal end side of the catheter, and more preferably 5 to 200 mm from the distal end of the catheter.

  At least a part of the outer surface of the catheter main body 2 is covered with a surface lubricating layer (not shown). Thus, the presence of the surface lubricity layer can improve operability such as exhibiting lubricity in an aqueous liquid such as body fluid or blood, and allowing the catheter to be easily inserted into a living body lumen. Further, the coating with the surface lubricating layer can reduce the damage to the tissue mucous membrane during the catheter introduction operation. Here, the present invention encompasses both forms in which part or all of the surface of the base material (catheter body) constituting the catheter has surface lubricity. The catheter does not need to have lubricity on the entire surface (the entire surface), but a surface lubrication layer is formed at least on the surface part (some or all) that comes into contact with body fluids or blood It is preferred that For this reason, a surface lubricity layer does not need to be formed in the base end part side of a catheter, for example. In addition to the outer surface of the catheter main body, a surface lubrication layer may be formed in the lumen of the catheter (inner wall of the lumen). When the catheter has a plurality of lumens, a surface lubricating layer may be provided in all lumen lumens, or a surface lubricating layer may be provided in some lumen lumens. Further, the surface lubrication layer need not be provided on the entire lumen of the catheter (the inner wall of the lumen), and the surface lubrication layer may be provided only on a part thereof.

  At least a part of the outer curved surface is provided with a low lubrication portion. The low lubrication portion is a portion having a lower lubricity than the surface lubrication layer formed on the outer surface of the catheter body portion 2, and the catheter body portion that comes into contact with the living body lumen wall when placed in the living body lumen. Of the outer curved surface. Here, considering the backup property of the low lubrication part, the friction coefficient of the low lubrication part is preferably 0.3 to 4, more preferably 0.5 to 3. Thereby, when the catheter is placed at a predetermined position in a predetermined living body lumen (for example, blood vessel), a high back-up property can be exhibited and the catheter can be firmly held at the predetermined position. In this specification, the “friction coefficient” is a value measured by the following method.

(Friction coefficient measurement method)
A straight bar shape is inserted into a catheter that has been cut to a length sufficient for measurement, and a linear shape is used as a sample. As shown in FIG. 7, a double-sided tape is applied to the back surface of the glass petri dish 51, and the sample is fixed in the petri dish 51 so that the measurement surface of the sample is located at the top. The petri dish 51 is filled with pure water, set on the sample stage of the friction measuring device 50 (manufactured by Trinity Lab, Handy Tribomaster TL201), and a weight of 53 g is applied to a cylindrical rubber terminal (φ = 10 mm) 52 by a weight 53. Then, the sliding resistance value (initial sliding resistance value) (gf) after reciprocating once at a distance of 10 mm at a moving speed of 1000 mm / min is measured. In addition, evaluation is performed by n = 3 and let the average value be a sliding resistance value. Divide the sliding resistance value by the load value to obtain the coefficient of friction. When the length of the region to be measured is less than 10 mm, the moving distance may be appropriately changed according to the measurement length.

  The formation position on the outer curved surface of the low lubrication part is not particularly limited, and varies depending on the shape of the catheter, the introduction position, the indwelling position and the like. For example, when the catheter of FIG. 1 is used as a guiding catheter for a percutaneous transluminal coronary angioplasty (PTCA) catheter for applying to a stenosis of a coronary artery, the following forms may be mentioned. That is, for example, as shown in FIG. 3, when the guiding catheter 1 is inserted from the femoral artery (not shown) to the aortic arch 14 and the tip 3 is engaged with the left coronary artery 12, The outer curved surface of the curved region 4 ′ contacts the contralateral aortic arch wall. For this reason, it is preferable that the low lubrication part 7 is provided in the outer curved surface of 2nd curved area | region 4 '. For example, as shown in FIG. 4, when the guiding catheter 1 is inserted from the right radial artery (not shown) to the aortic arch 14 and the tip 3 is engaged with the right coronary artery 15, The outer curved surface of the two curved region 4 'contacts the contralateral aortic arch wall. For this reason, it is preferable that the low lubrication part 7 is provided in the outer curved surface of 2nd curved area | region 4 '.

  Further, when the catheter of FIG. 5 is used as a guiding catheter for a percutaneous transluminal coronary angioplasty (PTCA) catheter for applying to a stenosis of a coronary artery, the following forms may be mentioned. That is, for example, as shown in FIG. 6, when inserting the guiding catheter 21 from the right radial artery (not shown) to the aortic arch 14 and engaging the distal end portion 23 with the left coronary artery 12, The outer surface of the second intermediate region 25 ′ between the second curved region 24 ′ and the third curved region 24 ″ contacts the contralateral aortic arch wall. For this reason, the second curved region 24 ′ and the third curved region It is preferable that the low lubrication part 27 is provided in the outer surface of 2nd intermediate | middle area | region 25 'between area | region 24' '. In addition, the above is an example of the usage pattern of a catheter, and it cannot be overemphasized that it does not become a form as mentioned above depending on the usage pattern of the catheter of FIG.1 and FIG.5 and a patient. That is, the catheter has a curved portion on the distal end side of the catheter main body, and can be engaged with the branch portion of the biological lumen depending on the shape of the curved portion when placed in the biological lumen. Therefore, the catheter should just be provided with the low lubrication part in the site | part which a biological lumen wall contacts in the curved part of a catheter.

  As described above, the low lubrication portion is preferably provided on the outer curved surface of the curved region and / or the intermediate region. That is, the curved portion has two curved regions and an intermediate region provided between the two curved regions, the two curved regions are curved in the same direction, and the low lubrication portion is It is preferable to be provided on the outer curved surface of at least one region selected from the curved region and the intermediate region.

  The installation length of the low lubrication part (length “H” in FIG. 4) is not particularly limited as long as the desired backup performance can be achieved. The installation length of the low lubrication part (length “H” in FIG. 4) is 0.5 to 10 times the contact length with the living body lumen wall when placed in the living body lumen. It is preferable that it is 1 to 5 times. Or the installation length (length "H" in FIG. 4) of the low lubrication part is preferably 5 to 200 mm, and more preferably 10 to 100 mm. With such an installation length, since the low lubrication portion comes into contact with the living body lumen wall more efficiently and more reliably when placed in the living body lumen, higher backup performance can be achieved. The contact length with the living body lumen wall when placed in the living body lumen is determined by a person skilled in the art (doctor or medical device manufacturing company) according to the shape of the catheter or the type of living body lumen site to be placed. This means the maximum length that can be predicted by a person skilled in the art (physician or medical device manufacturer). For example, the contact length with the wall of the living body lumen when placed in the living body lumen is usually 5 to 250 mm, and preferably 10 to 200 mm. In particular, when inserted into the aortic arch as a guiding catheter for a percutaneous transluminal coronary angioplasty (PTCA) catheter, when the distal end of the catheter is engaged with the left or right coronary artery, it is placed in the living body lumen. The contact length with the living body lumen wall at this time is usually 5 to 100 mm, and preferably 10 to 50 mm.

  In the present invention, the inner curved surface facing the outer curved surface of the catheter main body portion where the low lubrication portion is present is covered with the lubricating layer having higher surface lubricity than the low lubrication portion. Therefore, in one section of the curved portion of the catheter main body, there is a portion where both the surface lubricating layer and the low lubricating portion exist on the outer surface. Thereby, the catheter can be smoothly introduced and operated at the time of delivery in the living body lumen before placing the catheter. The lubrication layer coated on the inner curved surface may be a surface lubrication layer formed on the outer surface of the catheter body. By doing so, it is possible to reduce the trouble of covering the inner curved surface with the lubricating layer. Furthermore, it is also preferable to provide a highly lubricated portion having higher lubricity than the surface lubricious layer formed on the outer surface of the catheter main body portion on the inner curved surface. Since the portion provided with the low lubrication part has a high frictional force with the living body lumen wall, the operability during insertion of the catheter may be reduced. However, as shown in FIG. 2B, by providing the high lubrication portion 8 with high surface lubricity on the inner outer surface corresponding to the low lubrication portion 7, overall lubricity in the concentric direction including the low lubrication portion is improved. it can. For this reason, even if such a low lubrication part exists, the fall of the operativity at the time of catheter insertion can be suppressed / prevented effectively.

  The present invention can be similarly applied to a guiding catheter other than the above-described guiding catheter. Specifically, a Judkins type guiding catheter, an Amplatz type guiding catheter, a hockey type guiding catheter, and a guiding catheter described in JP-A-10-85338 And a guiding catheter described in JP-A-2001-129074.

  FIG. 2 is a cross-sectional view taken along line A-A ′ of the catheter shown in FIG. 1. As shown in FIG. 2, the catheter body portion whose outer surface is covered with the surface lubricating layer has a structure in which an inner layer 31, an outer layer 32, and a surface lubricating layer 33 are concentrically laminated from the inside toward the outside. It has become. The constituent materials of the inner layer and the outer layer are not limited to the following, but are polyamide resins (for example, nylon 11, nylon 12, nylon 6), polyester-based polyamide resins (for example, Glease (trade name, manufacturer DIC)), Polyether-based polyamide resin (for example, at least one hard segment is selected from nylon 11, nylon 12 and nylon 6, and at least one soft segment is selected from ethylene glycol, propylene glycol and tetramethylene glycol), Polyurethane, acrylonitrile-butadiene-styrene copolymer synthetic resin (ABS resin), polyester elastomer resin, polyurethane elastomer resin, fluororesin (perfluoroalkoxy fluororesin (PFA), polyteto Fluoroethylene resin (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), etc.), or the like can be used. In particular, it is preferable to use an ABS resin or a polyether-based polyamide resin as a constituent material for the inner layer and the outer layer, because moderate strength can be imparted to the curved portion. Further, by using a fluorine-based resin, preferably PTFE, for the inner layer, the operability with a guide wire or a treatment catheter inserted into the lumen can be improved. In addition, since insertion of the catheter is performed while confirming the position under X-ray fluoroscopy, for example, an X-ray opaque material such as barium sulfate, bismuth oxide, or tungsten is added to the material constituting the catheter body. It is preferable to keep it. Thereby, the insertion state and position of the catheter can be easily confirmed under fluoroscopy. Further, the inner layer and the outer layer can be bonded by an appropriate adhesive, or can be fused by heat, or can be integrally formed by coating molding or the like. The outer layer may have a multilayer structure in which different resins are laminated. The outer surface resin thus molded is coated with a hydrophilic material described later to form a surface lubricity layer.

  In addition, as shown in FIG. 2, the reinforcing material 34 is preferably embedded in the outer layer 32 over the entire circumference or in contact with the outer surface of the inner layer 31. It is preferable that the reinforcing material is buried substantially over the entire length excluding a predetermined length from the distal end portion of the catheter main body in the longitudinal direction of the catheter main body. The reinforcing material is preferably a metal mesh. The position of the tip of the metal mesh is preferably in the range of 0.5 to 150 mm, more preferably 1 to 100 mm, from the tip of the catheter body. By embedding such a reinforcing material, it is possible to prevent the catheter body from being bent and to improve torque transmission when the catheter body is rotated. The cross section of the wire constituting the reinforcing material may be circular, rectangular or substantially elliptical. It should be noted that the reinforcement body of a predetermined length from the distal end of the catheter body is not embedded because if the reinforcing material is contained up to the distal end portion of the catheter body portion, there is a possibility that the blood vessel wall may be damaged at the distal end portion of the catheter. This is because the catheter becomes too hard when the reinforcing material is inserted near the tip. The length of the portion where the reinforcing material is not provided is appropriately determined depending on the material of the catheter main body, the inner and outer diameter differences, and the like. For example, the larger the difference between the inner and outer diameters of the catheter body or the larger the elastic force, the longer the length of the portion where the reinforcing material is not provided.

  As described above, the guiding catheter has at least one curved portion, but the method for forming the curved portion in the guiding catheter is not particularly limited, and a conventionally known method may be appropriately selected. For example, the tip of the resin cylinder into which the inner core for maintaining the lumen diameter is inserted can be heated and molded in a prescribed-shaped mold. As the heating method, means such as electric heating, hot air, steam, heating oil, far infrared rays, and high frequency heating can be selected.

  As described above, at least a part of the outer surface of the catheter main body of the guiding catheter is covered with the surface lubricating layer. Here, the thickness of the surface lubricity layer is not particularly limited as long as sufficient lubricity is obtained, but the surface lubricity layer is firmly fixed to the catheter base material and has excellent surface lubricity during use. It is preferable to have a thickness that can be exhibited. From such a viewpoint, the thickness of the surface lubricating layer (the thickness of the surface lubricating layer when not swollen) is preferably 0.1 to 20 μm, more preferably 0.5 to 10 μm, and still more preferably 1 to 1. A range of 5 μm is desirable. If it is such thickness, a uniform film can be formed easily and surface lubricity can fully be exhibited.

  The material constituting the surface lubricating layer may be any material as long as it absorbs water and exhibits lubricity. For example, a hydrophilic material etc. are mentioned. Specific examples are shown below.

  Examples of the hydrophilic material constituting the surface lubricating layer include polyvinyl pyrrolidone, polyvinyl alcohol, polyethylene oxide polymer materials, cellulose polymer materials such as carboxymethyl cellulose, and acrylamide polymer materials such as polyacrylamide and polydimethylacrylamide. And hydrophilic polymers such as hyaluronic acid, polyacrylic acid, maleic anhydride polymer such as maleic anhydride-methyl vinyl ether copolymer, water-soluble nylon (registered trademark), and derivatives thereof. These hydrophilic polymers can absorb water when wet and exhibit lubricity. In order to firmly fix these hydrophilic polymers to the catheter (catheter base material), an appropriate amount of a crosslinking agent is added, or a reactive functional group is introduced into the hydrophilic polymer that forms the surface lubricating layer. It is preferable to crosslink the hydrophilic polymer by, for example.

  As a method for introducing a reactive functional group into a hydrophilic polymer, a monomer having a reactive functional group (hereinafter also referred to as “reactive monomer”) and a hydrophilic monomer are copolymerized. The method of letting it be mentioned. Here, the reactive monomer means a monomer having a reactive functional group capable of performing a crosslinking reaction or the like. In the present specification, the “reactive functional group” means that it can undergo a crosslinking reaction with other monomers or react (bond) with a catheter substrate by heat treatment, light irradiation, electron beam irradiation, radiation irradiation, plasma irradiation, or the like. ) Refers to a functional group that can be

  The reactive functional group is not particularly limited, and may be a functional group such as an epoxy group, an acid halide group, an aldehyde group, an isocyanate group, or an acid anhydride group. Among these, the monomer having a reactive functional group (reactive monomer) is a monomer having an epoxy group, an isocyanate group, or an aldehyde group from the viewpoint of ease of handling, efficiency of a crosslinking reaction, and the like. Are preferred, and monomers having an epoxy group are particularly preferred. These reactive functional groups may be present alone or in a plurality in the reactive monomer.

  The reactive monomer used in the present invention has a reactive functional group and is more hydrophobic than a hydrophilic monomer used in the production of the copolymer in body fluids or aqueous solvents. It is preferable. Specific examples of such reactive monomers include monomers having an epoxy group in the molecule such as glycidyl acrylate, glycidyl methacrylate (GMA), methyl glycidyl methacrylate, and allyl glycidyl ether; (meth) acrylic acid Monomers with acid halide groups in the molecule such as chloride, (meth) acrylic acid bromide, (meth) acrylic acid iodide; (meth) acrylaldehyde, crotonaldehyde, acrolein, methacrolein and other aldehyde groups in the molecule Monomers having an isocyanate group such as (meth) acryloyloxymethyl isocyanate, (meth) acryloyloxyethyl isocyanate, (meth) acryloyloxypropyl isocyanate, (meth) acryloyl isocyanate in the molecule Body; the like can be exemplified; maleic anhydride, itaconic anhydride, a monomer having an acid anhydride group such as citraconic anhydride in the molecule. Among these, as the monomer having a reactive functional group, a monomer having an epoxy group is preferable, and glycidyl acrylate or glycidyl methacrylate, in which the reaction is accelerated by heat or the like and handling is relatively easy, is more preferable. These reactive monomers can be used alone or in combination of two or more.

  Further, the hydrophilic monomer is not particularly limited. For example, acrylamide and its derivatives, vinyl pyrrolidone, acrylic acid and methacrylic acid and their derivatives, polyethylene glycol acrylate and its derivatives, sugar and phospholipids in the side chain. Examples thereof include water-soluble monomers such as maleic anhydride and maleic anhydride. More specifically, acrylic acid, methacrylic acid, N-methylacrylamide, N, N′-dimethylacrylamide, acrylamide, acryloylmorpholine, N, N′-dimethylaminoethyl acrylate, vinylpyrrolidone, 2-methacryloyloxyethyl phosphorylcholine, 2-methacryloyloxyethyl-D-glycoside, 2-methacryloyloxyethyl-D-mannoside, vinyl methyl ether, 2-hydroxyethyl (meth) acrylate, 4-hydroxybutyl (meth) acrylate, 2-hydroxypropyl (meth) acrylate , 2-hydroxybutyl (meth) acrylate, 6-hydroxyhexyl (meth) acrylate, 1,4-cyclohexanedimethanol mono (meth) acrylate, 1-chloro-2-hydro Cypropyl (meth) acrylate, diethylene glycol mono (meth) acrylate, 1,6-hexanediol mono (meth) acrylate, pentaerythritol tri (meth) acrylate, dipentaerythritol penta (meth) acrylate, neopentyl glycol mono (meth) acrylate , Trimethylolpropane di (meth) acrylate, trimethylolethane di (meth) acrylate, 2-hydroxy-3-phenyloxypropyl (meth) acrylate, 4-hydroxycyclohexyl (meth) acrylate, 2-hydroxy-3-phenyloxy (Meth) acrylate, 4-hydroxycyclohexyl (meth) acrylate, cyclohexanedimethanol mono (meth) acrylate, poly (ethylene glycol) methy Ether acrylate, and poly (ethylene glycol) methyl ether methacrylate. From the viewpoint of ease of synthesis and operability, N, N-dimethylacrylamide, acrylamide, acrylic acid, methacrylic acid, N, N-dimethylaminoethyl acrylate, 2-hydroxyethyl methacrylate, and vinylpyrrolidone are preferable. More preferred are N, N′-dimethylacrylamide and N, N′-dimethylaminoethyl acrylate, and particularly preferred is N, N′-dimethylacrylamide. These hydrophilic monomers can be used alone or in combination of two or more. In order to develop good lubricity, the hydrophilic polymer is preferably a copolymer of a reactive monomer and a hydrophilic monomer, and is formed from a monomer having a reactive functional group. More preferably, it is a block copolymer (block copolymer of a reactive monomer and a hydrophilic monomer) having a block to be formed and a block formed from a hydrophilic monomer. When such a block copolymer is used, good results are obtained in the strength and lubricity of the surface lubricating layer.

  In a more preferred embodiment of the present invention, the hydrophilic polymer comprises a reactive domain having an epoxy group-containing monomer as at least one structural unit and a hydrophilic monomer as at least one structural unit. A block copolymer having a hydrophilic domain. When the epoxy group which is a reactive functional group reacts with an adjacent epoxy group, the adjacent hydrophilic polymer forms a crosslinked structure, and the strength of the surface lubricating layer can be increased.

  The ratio of the hydrophilic monomer to the reactive monomer in the hydrophilic polymer is not particularly limited. In consideration of good lubricity, strength of the coating, strong binding property to the catheter substrate, the molar ratio of the hydrophilic monomer to the reactive monomer is preferably 1: 1 to 100: 1, More preferably 5: 1 to 80: 1, and still more preferably 10: 1 to 50: 1. If it is such a ratio, the ratio of the hydrophilic part of a hydrophilic polymer and a reactive part can be made into a favorable range. Within such a range, the surface lubricating layer can sufficiently exhibit high lubricity due to the hydrophilic portion, and can exhibit high durability (lubrication maintenance property) and coating strength due to the reactive portion.

  The production method (polymerization method) of the hydrophilic polymer for polymerizing the hydrophilic polymer is not particularly limited, and a known polymerization method can be used. In general, a simple method using a polymerization initiator is used. The polymer may be polymerized. When the hydrophilic polymer of the present invention is a block copolymer or graft copolymer, for example, living polymerization, polymerization using a macromonomer, polymerization using a polymer polymerization initiator, polycondensation, etc. However, it is not particularly limited.

  As the hydrophilic polymer (surface lubricating layer) of the present invention, maleic anhydride-methyl vinyl ether copolymer and glycidyl methacrylate-dimethylacrylamide copolymer are preferable, and glycidyl methacrylate-dimethylacrylamide copolymer (especially block copolymer). Coalescence) is more preferred.

  The hydrophilic material exhibits lubricity when wet (water absorption), and reduces the frictional resistance between the catheter and the inner wall of the living body lumen. These hydrophilic materials are coated by a conventionally known technique such as dip coating, spray coating or surface graft polymerization, and fixed as a surface lubricating layer.

[Catheter manufacturing method]
The method for producing the catheter of the present invention is not particularly limited, and known methods can be applied in the same manner or appropriately modified. For example, after coating the outer periphery (outer surface) of the catheter with a surface lubricating layer made of a hydrophilic material, a low-lubricated portion with reduced lubricity can be obtained by selectively irradiating a predetermined position on the curved portion with energy rays. Can be formed. Due to the presence of such a low lubrication portion, the coefficient of friction when contacting a living body lumen wall (for example, the aortic arch wall) increases (lubricity decreases). For this reason, it is possible to provide a guiding catheter that ensures good backup performance and has high operability and safety.

  That is, according to a preferred embodiment of the method for producing a catheter of the present invention, (ii) after forming a surface lubricating layer on the catheter surface, (ii) irradiating at least a part of the obtained surface lubricating layer with energy rays Thus, the low lubrication portion is formed. Hereinafter, although the preferable manufacturing method (formation method of a surface lubricity layer and a low lubrication part) of the catheter of this invention is demonstrated, this invention is not limited to the following method.

(Process (i))
In this step, a surface lubricating layer is formed on the catheter surface. In this step, the material constituting the surface lubricating layer is as described above. Further, this step (i) is not particularly limited except that the above hydrophilic material is used, and can be applied in the same manner as in a known method or appropriately modified.

  Specifically, the hydrophilic polymer (particularly, a block copolymer is preferred) is dissolved in a solvent to prepare a coating solution (lubricant coating agent, coating solution), and the coating solution is coated on the catheter substrate. Then, after forming the coating layer, a method of forming the surface lubricating layer by subjecting the coating layer to a heat treatment to cause the hydrophilic polymer (block copolymer) to undergo a crosslinking reaction can be mentioned. That is, the method for forming the surface lubricating layer includes at least a lubricating coating agent coating step for coating the catheter base material with a lubricating coating agent, and a heating step for performing a heat treatment on the coating layer formed with the lubricating coating agent. It is preferable. By such a method, good lubricity and durability can be imparted to the catheter surface.

  In the above method, the solvent used for dissolving the hydrophilic polymer according to the present invention is not particularly limited as long as it can dissolve the hydrophilic polymer. Specifically, water, alcohols such as methanol, ethanol, isopropanol and ethylene glycol, ketones such as acetone and methyl ethyl ketone, esters such as ethyl acetate, halides such as chloroform, olefins such as hexane, tetrahydrofuran and butyl ether Examples thereof include ethers such as benzene, aromatics such as toluene, and amides such as N, N-dimethylformamide (DMF), but are not limited thereto. These may be used alone or in combination of two or more.

  The concentration of the hydrophilic polymer in the coating liquid is not particularly limited. From the viewpoint of obtaining coating properties and desired effects (lubricity and durability), the concentration of the hydrophilic polymer in the coating solution is 0.01 to 20% by weight, more preferably 0.05 to 15%. % By weight, more preferably 0.1 to 10% by weight. When the concentration of the hydrophilic polymer is in the above range, the lubricity and durability of the obtained surface lubricity layer can be sufficiently exhibited. In addition, a uniform surface lubricating layer having a desired thickness can be easily obtained by a single coating, which is preferable in terms of operability (for example, ease of coating) and production efficiency. However, even if it is out of the above range, it can be sufficiently utilized as long as it does not affect the operational effects of the present invention.

  The method for applying the coating solution to the catheter base surface is not particularly limited, and is a coating / printing method, dipping method (dipping method, dip coating method), spraying method (spray method), spin coating method, mixing. A conventionally known method such as a solution-impregnated sponge coating method can be applied. Of these, the dipping method (dipping method, dip coating method) is preferably used. In addition, when forming a surface lubricity layer also on the narrow narrow inner surface of a catheter, a catheter (catheter base material) may be immersed in a coating liquid, and the inside of a system may be depressurized and deaerated. By degassing under reduced pressure, the solution can quickly penetrate into the narrow and narrow inner surface, and the formation of the surface lubricating layer can be promoted.

  Further, when the surface lubrication layer is formed only on a part of the catheter, only a part of the catheter (catheter base material) is immersed in the coating liquid, and the coating liquid is part of the catheter (catheter base material). By coating the surface, a surface lubricating layer can be formed on a desired surface portion of the catheter (catheter base material).

  If it is difficult to immerse only a part of the catheter in the coating solution, protect the surface part of the catheter that does not require the formation of a surface lubrication layer with an appropriate member or material that can be attached or detached. (Coating, etc.) After immersing the catheter in the coating solution and coating the coating solution on the catheter, remove the protective member (material) on the surface portion of the catheter that does not require the formation of a surface lubricious layer, Thereafter, a surface lubricity layer can be formed on a desired surface portion of the catheter by reacting by heat treatment or the like. However, in the present invention, the forming method is not limited to these forming methods, and the surface lubricating layer can be formed by appropriately using a conventionally known method. For example, when it is difficult to immerse only a part of the catheter in the mixed solution, instead of the immersing method, another coating technique (for example, a coating liquid is applied to a predetermined surface portion of a medical device with a spray device) , A bar coater, a die coater, a reverse coater, a comma coater, a gravure coater, a spray coater, a coating method using a doctor knife, etc.) may be applied. In the case where it is necessary to form a surface lubrication layer on both the outer surface and the inner surface of the catheter, the dipping method (dipping method) can be used since both the outer surface and the inner surface can be coated at once. ) Is preferably used.

  Thus, after immersing a catheter in the coating liquid containing a hydrophilic polymer, the catheter is taken out from the coating liquid and subjected to heat treatment. Here, the heat treatment conditions (temperature, time, etc.) of the coating liquid are not particularly limited as long as the surface lubricating layer containing the hydrophilic polymer can be formed on the catheter. Specifically, the heating temperature is preferably 60 to 200 ° C., more preferably 80 to 160 ° C., further preferably more than 80 ° C. and 150 ° C. or less, and particularly preferably 90 to 140 ° C. The heating time is preferably 15 minutes to 24 hours, more preferably 1 to 10 hours. By setting it as such conditions, the cross-linking reaction by the reactive functional group of hydrophilic polymer occurs, and the firm surface lubrication layer which does not peel easily from a catheter can be formed.

  In addition, when the reactive functional group contained in the hydrophilic polymer is an epoxy group, the epoxy group can be self-crosslinked by heating, but it reacts with an epoxy reaction catalyst or an epoxy group to promote the crosslinking reaction. A polyfunctional crosslinking agent that may be used may be included in the coating solution.

  Also, the pressure condition during the heat treatment is not limited at all, and it can be performed under normal pressure (atmospheric pressure), or under pressure or reduced pressure.

  As the heat treatment means (apparatus), for example, an oven, a vacuum dryer or the like can be used.

  After forming a hydrophilic polymer film (coating layer) on the surface of the substrate by the above method, a strong surface lubricating layer that does not easily peel from the substrate by crosslinking reactive functional groups is obtained. Can be formed. For this reason, the medical device according to the present invention can exhibit excellent lubricity and durability.

(Step (ii))
In this step, at least a part of the surface lubricating layer formed in the step (i) is irradiated with energy rays to form a low lubricating portion. By irradiating the surface lubricating layer with energy rays, the lubricity of the irradiated part is lowered. Here, the mechanism by which the lubricity of the irradiated part is lowered by irradiation with energy rays is unknown, but is presumed as follows. The present invention is not limited to the following mechanism. That is, when the hydrophilic polymer is a copolymer of a reactive monomer and a hydrophilic monomer, the hydrophilic portion acts so as to exhibit lubricity in a body fluid or an aqueous solvent. On the other hand, when the copolymer is irradiated with energy rays, active sites are generated at hydrophilic sites, a crosslinking reaction takes place starting from the active sites, and the crosslink density of the surface lubricating layer increases, thereby increasing surface lubrication. The degree of swelling of the functional layer decreases. For this reason, the hydrophilic part in a surface lubricity layer reduces and a low lubrication part is formed.

  The step of irradiating the energy beam is not particularly limited as long as the irradiation amount of the energy beam to the catheter surface is uniform, and a known method can be used. In addition, when it is desired to gradually and gradually change the lubricity (friction coefficient), the lubricity (friction coefficient) may be controlled by gradually changing the irradiation amount of the energy beam, but the operability (line It is preferable to uniformly irradiate the energy rays from the viewpoints of easy control of the source) and ensuring backup performance.

  In addition, from the viewpoint of improving the irradiation efficiency of energy rays and achieving uniform irradiation, the energy rays generated by the radiation source are reflected on the first surface lubricating layer after the energy rays from the source are reflected by the reflector. May be irradiated. Energy beam irradiation can be applied to both batch processing and continuous processing.

  The energy ray may be anything as long as it can modify the surface of the surface lubricity layer and reduce the lubricity in the surface lubricity layer (increase the friction coefficient). Specific examples include ultraviolet rays, γ rays, and electron beams. Among these, ultraviolet rays are preferable from the viewpoint of easy control of the irradiation amount and the irradiation range. When ultraviolet rays are used as the energy rays, the region irradiated with ultraviolet rays can increase the friction coefficient by about 3 to 50 times compared to the region not irradiated with ultraviolet rays.

  Therefore, the irradiation conditions when ultraviolet rays are used as energy rays will be described in detail below.

  In this specification, “ultraviolet rays” generally refers to electromagnetic waves having a wavelength of 10 to 400 nm. Although it does not restrict | limit especially as an ultraviolet ray source, A low pressure mercury lamp (wavelength: 254 nm), a high pressure mercury lamp (wavelength: 365 nm), a deuterium lamp (wavelength: 185-400 nm), a xenon excimer lamp (wavelength: 172 nm), a metal halide lamp (Wavelength: 200 to 450 nm) or the like can be used. Moreover, a fluorescent lamp, a yellow lamp, etc. may be sufficient. Among these, it is preferable to use a mercury lamp such as a low-pressure mercury lamp or a high-pressure mercury lamp.

  Here, the irradiation condition of the energy beam is not particularly limited, but it is preferable that the low lubrication part having the friction coefficient as described above can be formed. The coefficient of friction of the low-lubrication part (the degree of decrease in surface lubricity) can be appropriately controlled by controlling the type, wavelength, irradiation time, etc. of the energy beam used.

Although the illumination intensity of ultraviolet rays is not particularly limited, it is preferably ¹ to 1,000 mW / cm ² . The irradiation energy is not particularly limited, but is preferably 100 to 20,000 mJ / cm ² . By setting it as such a range, the low lubrication part which has the above friction coefficients can be formed.

  The irradiation time of ultraviolet rays is not particularly limited, and is appropriately selected depending on the type of hydrophilic material forming the surface lubricating layer. Specifically, the ultraviolet irradiation time is preferably 1 second to 30 minutes, more preferably 10 seconds to 20 minutes, still more preferably 1 to 15 minutes, and more preferably 3 to 10 minutes. It is particularly preferred.

  Further, the irradiation atmosphere of ultraviolet rays may be in an air atmosphere or in an inert gas atmosphere.

  By the irradiation conditions as described above, a region with high lubricity and a region with low lubricity can be formed in the surface lubricating layer made of the same material.

  The energy ray irradiation can be selectively performed at a predetermined position of the surface lubricating layer of the curved portion of the catheter by irradiating the device with a finely focused energy ray. Or it is also possible to irradiate only a part of the surface lubricating layer with the energy beam by sequentially moving the catheter or the energy beam. Or you may irradiate an energy beam with respect to a catheter in a wide range. In such a case, the surface lubricating layer is protected (covered) with another member (material) so that part of the surface lubricating layer is irradiated with energy rays and the other portion is not irradiated with energy rays. ) Specifically, a portion other than the desired portion where the low lubrication portion is to be formed is covered with a mask, and the catheter is irradiated with energy rays. Note that it is preferable to reduce the lubricity by irradiating only the outer curved surface contacting the living body lumen wall (for example, the aortic arch wall) with energy rays.

  As described above, a catheter provided with a low lubrication portion at a desired position can be easily manufactured. Further, when the obtained catheter is placed at a position in a predetermined living body lumen (for example, a blood vessel), the low lubrication part comes into contact with the living body lumen wall, and the low lubrication part of the catheter and the living tube By the frictional force with the cavity wall (that is, high back-up property), it can be firmly held in the same position. On the other hand, when the catheter is inserted into the living body lumen, the catheter can be smoothly introduced to a desired position due to the presence of the surface lubricating layer covering the outer surface other than the low lubrication portion. Therefore, by using the catheter of the present invention, it is possible to improve the indwellability at the desired position while maintaining good operability at the time of introduction to the desired position.

  The effects of the present invention will be described using the following examples and comparative examples. However, the technical scope of the present invention is not limited only to the following examples. In the following examples, the operation was performed at room temperature (25 ° C.) unless otherwise specified. Unless otherwise specified, “%” and “part” mean “% by weight” and “part by weight”, respectively.

Example 1
Polyamide elastomer (Grill amide ELG5660 manufactured by EMS, Shore hardness D62, hard segment: nylon 12, soft segment: polytetramethylene glycol, soft segment content in elastomer: 27 wt%; both ends of the elastomer are sealed No) was press-molded to obtain a sheet having a thickness of 1 mm.

  Separately, 5 wt. Of a block copolymer (DMAA: GMA (molar ratio) = 12: 1) having N, N-dimethylacrylamide (DMAA) as a hydrophilic monomer and glycidyl methacrylate (GMA) as a reactive monomer. A DMF solution (1) dissolved at a ratio of% was prepared. Similarly, a block copolymer (DMAA: GMA (molar ratio) = 38: 1) having N, N-dimethylacrylamide (DMAA) as a hydrophilic monomer and glycidyl methacrylate (GMA) as a reactive monomer is obtained. A DMF solution (2) dissolved at a ratio of 5% by weight was prepared.

  The prepared sheet was cut into 1.5 cm × 5 cm and immersed in the DMF solutions (1) and (2) prepared above, respectively, and then heat-treated at 130 ° C. for 3 hours to obtain a thickness (not yet) on the surface. Sheets (1) and (2) on which a surface lubricating layer having a thickness (when swollen) was 3 μm were formed.

Next, ultraviolet rays (wavelength: 254 nm, illuminance: 16 mW / cm ² ) are applied to the surface lubrication layers of the sheets (1) and ( ² ) for a predetermined time using an ultraviolet irradiation device PL16-110 manufactured by Sen Engineering. Irradiated.

  Using the sheet thus obtained as a sample, the friction coefficient was evaluated in accordance with the above-described method for measuring the friction coefficient. FIG. 8 shows the relationship between the ultraviolet irradiation time and the friction coefficient of the obtained sample. From the results shown in FIG. 8, it can be said that in any coating agent, the lubricity of the surface lubrication layer is lowered according to the ultraviolet irradiation time, and the surface lubricity can be arbitrarily controlled.

Example 2
A guide wire coated with polyvinylpyrrolidone (Chikai, manufactured by Asahi Intec Co., Ltd.) was irradiated with ultraviolet rays for 300 seconds using the same ultraviolet irradiation apparatus as in Example 1. The obtained guide wire was used as a sample, and surface lubricity was evaluated according to the method for measuring the friction coefficient. In addition, the evaluation was similarly performed also about the guide wire which has not irradiated the ultraviolet-ray as a comparison object.

  As a result, the friction coefficient of the guide wire not irradiated with ultraviolet rays was 0.078, whereas the friction coefficient of the sample irradiated with ultraviolet rays increased to 0.32, and the surface lubricating layer was lubricated by the irradiation of ultraviolet rays. The sex was decreasing.

Example 3
6Fr. Judkins-type guiding catheter (Heartrail II, JL-3.5, manufactured by 6Fr. Terumo Corporation, the same shape as FIG. 1) (tip portion length 5 mm, first curved region curvature radius 5 mm, first intermediate region length 20 mm, second curved shape) N, N-dimethylformamide (dimethylacrylamide: glycidylmethacrylate = 38: 1) containing 4.5% by weight of dimethylacrylamide-glycidylmethacrylate block copolymer (400 mm at the tip side) with respect to a region curvature radius of 10 mm and a total length of 1000 mm) It was immersed in a DMF) solution, pulled up at a speed of 15 mm / sec, and dip-coated. Thereafter, a heat treatment was performed at 110 ° C. for 3 hours to form a surface lubricating layer having a thickness (non-swelled thickness) of 3 μm on the tube surface.

  Thereafter, the region other than the outer 25 mm length and the width of 1.5 mm outside the second curved region was masked, and ultraviolet rays were irradiated for 600 seconds using the same ultraviolet irradiation device as in Example 1 to form a low lubrication portion. After the above operation, the mask was removed, and a guiding catheter 1 having a surface lubricating layer on the outer surface and having a low lubricating portion on the outer curved surface of the second curved region was obtained. When the friction coefficient of the surface lubrication layer in the region not irradiated with ultraviolet light and the friction coefficient in the region irradiated with ultraviolet light (low lubrication portion) were evaluated according to the above-described method for measuring the friction coefficient, 0.055 respectively. And 2.5.

  A guide wire (radio focus guide wire M, diameter 0.89 mm, manufactured by Terumo Corporation) was inserted into the obtained guiding catheter 1. In this state, the guiding catheter 1 was inserted from the femoral artery site of a silicone blood vessel model imitating a human blood vessel shape, and the distal end portion of the guiding catheter 1 was engaged with the left coronary artery entrance. At this time, the outer curved surface of the second curved region contacted the contralateral aortic arch wall. The operation of the guiding catheter 1 so far has a low resistance and can be easily operated.

  Thereafter, when the guide wire was inserted into the left coronary artery and the operation of moving the guide wire back and forth was repeated, the engagement of the guiding catheter 1 was not easily disengaged, and good backup performance was exhibited.

Comparative Example 1
A guiding catheter 2 was prepared in the same manner as in Example 3 except that the step of irradiating ultraviolet rays was omitted, and the entire outer periphery of the 400 mm tip was covered with a surface lubricating layer and had no low lubricating portion. A ding catheter 2 was obtained. The friction coefficient of the surface lubricating layer was 0.055.

  When the obtained guiding catheter 2 was evaluated by the same operation as in the example, the operation until the guiding catheter 2 was engaged with the left coronary artery entrance was less resistant and could be easily operated. When the guide wire was inserted into the left coronary artery, the tip portion was quickly disengaged, resulting in poor backup performance.

Comparative Example 2
6Fr. The same evaluation as in the example was performed using the Judkins type guiding catheter as it was, and in the operation until the guiding catheter was engaged with the left coronary artery entrance, the resistance was higher than in Example 3 and Comparative Example 1. The operability was inferior. After that, when the guide wire was inserted into the left coronary artery and the operation of moving the guide wire back and forth was repeated, the guiding catheter was not easily disengaged and showed good backup performance.

  From the above results, by using the catheter of the present invention, it is possible to smoothly introduce and operate the catheter at the time of living body lumen delivery, and to provide high back-up performance to the living body lumen wall when placed in the living body lumen. It was shown that it can be shown.

1, 21 ... guiding catheter,
2 ... catheter body,
2 ', 22' ... main body,
3, 23 ... tip part,
4, 24 ... first curved region,
4 ', 24' ... 2nd curved area,
24 "... third curved region,
24 "'... the fourth curved region,
5, 25 ... 1st intermediate area,
25 '... the second intermediate region,
25 "... third intermediate region,
6 ... curved part,
7, 27 ... low lubrication part,
8 ... High lubrication part,
9, 29 ... Hub,
12 ... Left coronary artery,
13 ... Stenosis of coronary artery,
14 ... Aortic arch,
15 ... right coronary artery,
31 ... inner layer,
32 ... Outer layer,
33 ... surface lubricity layer,
34 ... Reinforcing material,
50 ... friction measuring machine,
51 ... Glass Petri dish,
52 ... Rubber terminal,
53 ... Weight,
54 ... Sample.

Claims (5)

A catheter that is introduced and placed in a body lumen,
The catheter has a catheter body portion having a curved portion and a hub in a shape before being introduced into a living body lumen,
The outer surface of at least a portion of the catheter body is coated with a surface lubricious layer;
The curved portion has an inner curved surface inside the curved portion and an outer curved surface outside the curved portion,
A catheter in which at least a part of the outer curved surface is provided with a low-lubrication portion having lower lubricity than the surface-lubricity layer.   The catheter according to claim 1, wherein a highly lubricated portion having higher lubricity than the surface lubricious layer is provided on an inner curved surface corresponding to an outer curved surface of the catheter main body portion where the low lubrication portion exists. The curved portion has two curved regions and an intermediate region provided between the two curved regions,
The two curved regions are curved in the same direction,
The catheter according to claim 1 or 2, wherein the low lubrication portion is provided on an outer curved surface of at least one region selected from the two curved regions and the intermediate region.   The catheter according to any one of claims 1 to 3, wherein a coefficient of friction of the low lubrication part is 0.3 to 4.   The catheter according to any one of claims 1 to 4, wherein the catheter is a guiding catheter.