JP6582825B2 - Thrombus aspiration catheter and stylet - Google Patents

Description

  INDUSTRIAL APPLICABILITY The present invention is used for aspirating and removing a thrombus (including debris (foreign matter) such as free atheroma) introduced into the body percutaneously and percutaneously by negative pressure applied from the proximal side of the catheter. And a stylet inserted into the thrombus aspiration catheter.

  Thrombotic diseases occur not only in heart (coronary artery) diseases represented by acute myocardial infarction but also in blood vessels of hands and feet. Conventionally, treatment of thrombotic diseases has been performed surgically, but it is being replaced by interventional treatment (percutaneous catheter treatment), which is a minimally invasive treatment that has been rapidly spreading in recent years. This is because minimally invasive treatment has been performed in consideration of QOL (Quality of Life) for a patient receiving treatment from a highly invasive treatment in surgical treatment.

  The present invention relates to a catheter used for thrombus aspiration treatment which is one of the intervention treatments. The thrombus suction treatment is a treatment method in which a thin tube called a catheter is inserted into a blood vessel such as an arm or a leg to reach a treatment site, and the thrombus itself clogged in the blood vessel is sucked and removed from the body. The catheter used for this treatment is called a thrombus suction catheter, for example, and is used in combination with a suction tool.

  By the way, there are curved portions in the blood vessels of the legs and arms, and there may be a thrombus in the tip of the catheter where the catheter is inserted beyond the curved portion. Suction is difficult. This is because, in the curved portion of the blood vessel, since the inserted catheter is positioned along the outer peripheral side of the curved portion, it is difficult to bring the suction port opened at the distal end of the catheter closer to the thrombus.

  In response to such a problem, Japanese Patent Application Laid-Open No. 2009-201891 (Patent Document 1) proposes a catheter in which the vicinity of the distal end portion is bent at a predetermined angle.

  However, a plurality of types of catheters described in Patent Document 1 having different diameters and the like are prepared depending on a patient, a site, and the like. However, there is a problem that the number of types of thrombus aspiration catheters that need to be prepared increases, making it difficult to manufacture, manage, and prepare.

JP 2009-201891 A

  Here, the present invention has been made in the background as described above, and the problem to be solved is that the present invention can be efficiently applied to blood vessels having different bending modes depending on a patient or a part. An object of the present invention is to provide a thrombus aspiration catheter having a novel structure capable of sucking and removing a thrombus attached to the inner surface of a blood vessel, and a stylet inserted into the thrombus aspiration catheter.

  Hereinafter, the aspect of this invention made | formed in order to solve such a subject is described. In addition, the component employ | adopted in each aspect as described below is employable by arbitrary combinations as much as possible. In addition, aspects or technical features of the present invention are not limited to those described below, but are described in the entire specification and drawings, or can be understood by those skilled in the art from those descriptions. It should be understood that it is recognized on the basis of.

A first aspect of the present invention is a thrombus suction catheter that includes a catheter body and a stylet that can be inserted into the catheter body and that has a curved portion at a distal end portion thereof, and that sucks and removes a thrombus. The catheter body is provided with a thrombus suction lumen that is maintained in communication with the stylet inserted, while the distal end portion of the catheter body is proximal to the distal end portion. The bending stiffness of the stylet inserted from the proximal end side into the catheter body reaches the distal end portion, and the bending deformation is made smaller than that of the portion located at the distal end portion. The distal end of the catheter body is held closer to the blood vessel wall than the center in the blood vessel by the curved deformation of the distal end portion, and the catheter body Suction port of the end, so as to open toward the vessel inner surface, and wherein the thrombus suction catheter is inclined to the length direction of the catheter body is open.

According to the thrombus aspiration catheter having the structure according to this aspect, the stylet having a curved portion at the distal end portion is inserted into the catheter body, so that the thrombus aspiration catheter can be changed according to the shape of the stylet. It can be bent and deformed into a curved state. That is, for example, by making the curved portion of the stylet conform to the blood vessel shape of the patient, the suction port provided at the distal end portion of the thrombus aspiration catheter can be brought close to the thrombus attached to the inner surface of the blood vessel. The suction efficiency can be improved. In particular, since the thrombus aspiration lumen maintains the communication state even when the stylet is inserted, the thrombus suction treatment can be performed while maintaining the curved shape of the catheter with the stylet. Problems such as the suction lumen being blocked and the thrombus not being sucked can be avoided. Further, according to the thrombus aspiration catheter structured according to this embodiment, since the bending rigidity of the catheter body is larger at the proximal end portion than at the distal end portion, a stylet provided with a curved portion is inserted. At the same time, bending deformation along the stylet is unlikely to occur at the proximal end portion of the thrombus aspiration catheter. Therefore, problems such as an increase in the insertion resistance of the stylet due to the deformed portion of the thrombus suction catheter being caught on the inner surface of the blood vessel during the insertion of the stylet can be avoided. Furthermore, since the thrombus suction catheter is efficiently bent and deformed when the stylet reaches the tip portion where the bending rigidity of the catheter body is reduced, the suction port generally provided at the tip of the thrombus suction catheter is connected to the inner surface of the blood vessel. It is also possible to effectively approach the thrombus adhering to. In addition, according to the thrombus aspiration catheter structured according to this aspect, since the suction port is inclined and opened with respect to the length direction of the catheter, the stylet is inserted and the thrombus aspiration catheter is bent and deformed. When this is done, the suction port can be opened toward the thrombus adhering to the inner surface of the blood vessel, and the thrombus can be sucked efficiently.

According to a second aspect of the present invention, in the thrombus aspiration catheter according to the first aspect, a connector having an insertion port into which the stylet is inserted and a thrombus aspiration port is attached at the proximal end of the catheter body. It is what has been.

  According to the thrombus aspiration catheter structured according to this aspect, the connector is provided with an insertion port for inserting a stylet and a thrombus aspiration port for aspirating the thrombus. At this time, the insertion of the stylet and the connection of the suction device are compatible, and the thrombus suction with the stylet inserted can be easily realized.

According to a third aspect of the present invention, the thrombus aspiration catheter according to the first or second aspect includes a plurality of types of stylets in which the shapes of the curved portions are different from each other.

  According to the thrombus aspiration catheter structured according to this aspect, a stylet corresponding to a specific site of a blood vessel in a specific patient is prepared by preparing a plurality of types of stylets having different curved shapes. Therefore, it is possible to select a stylet that conforms to or approximates the blood vessel shape of the patient from a plurality of types of stylets, thereby improving manufacturing efficiency and reducing costs. Further, when treating different sites in the blood vessel, the bending shape of the thrombus aspiration catheter can be changed by exchanging the stylet, and the thrombus aspiration efficiency can be further improved.

A fourth aspect of the present invention is a stylet constituting the thrombus aspiration catheter according to any one of the first to third aspects.

  According to the stylet structured according to this embodiment, the thrombus aspiration catheter can be bent and deformed by the bending portion provided at the distal end portion by being inserted into the catheter body. That is, by appropriately adjusting the bending angle of the bending portion, the thrombus suction catheter can be deformed into a desired shape. For example, by making the shape in accordance with the blood vessel shape of the patient, the thrombus suction efficiency can be improved. Can be.

  In the thrombus aspiration catheter having a structure according to the present invention, the catheter body can be deformed into a curved state according to the shape of the curved portion of the stylet. It can be transformed into a shape suitable for thrombus suction, and thrombus suction efficiency can be improved.

The front view which shows the thrombus suction catheter as one Embodiment of this invention. The longitudinal cross-sectional view which shows the catheter main body which comprises the thrombus aspiration catheter shown by FIG. (A) is a front view which shows the stylet which comprises the thrombus aspiration catheter shown by FIG. 1, Comprising: (b) is a principal part enlarged view which shows the front-end | tip part of a stylet. It is explanatory drawing for demonstrating the use condition of the thrombus aspiration catheter shown by FIG. 1, Comprising: The figure which expands and shows the principal part cross section of the connector vicinity in the proximal end of a catheter main body. Explanatory drawing for demonstrating another aspect of the thrombus aspiration catheter which concerns on this invention.

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

  First, FIG. 1 shows a thrombus aspiration catheter 10 as one embodiment of the present invention. The thrombus aspiration catheter 10 is percutaneously introduced into the body, and a thrombus generated in the blood vessel is aspirated by a negative pressure exerted from the proximal end side of the thrombus aspiration catheter 10 and removed from the body. In the following description, the distal end side refers to the left side in FIG. 1 in which a suction port 12 for aspirating a thrombus is provided, and the proximal end side is a diagram to which a suction device such as a syringe is connected. Say right side of 1.

  More specifically, the thrombus aspiration catheter 10 has a structure in which the stylet 16 shown in FIG. 3 can be inserted into the catheter body 14 shown in FIG.

  The catheter body 14 has a structure in which a distal end tip 20 is provided at the distal end of a tube 18 made of a long hollow structure having flexibility. Furthermore, in this embodiment, a Y-shaped connector 22 as a connector is attached to the proximal end of the catheter body 14. In the initial shape shown in FIG. 2, the catheter body 14 extends substantially linearly in the left-right direction in FIG. 2. For example, in the initial shape, the catheter body 14 faces the suction port 12 provided at the tip inward. Arbitrary curved shapes may be provided.

  The outer diameter of the tube 18 of the present embodiment is substantially constant over the entire length in the length direction, and a central lumen 24 extends in the length of the entire length in a substantially constant circular cross section. Extends through. Moreover, the tube 18 of this embodiment is comprised from three parts which have mutually different bending rigidity in a length direction. That is, the tube 18 includes a distal end portion 26 provided on the distal end side and provided with the distal tip 20, a proximal end portion 28 to which the Y-shaped connector 22 is attached, and between the distal end portion 26 and the proximal end portion 28. The bending rigidity decreases stepwise from the proximal end portion 28 to the distal end portion 26 by, for example, different materials, structures, thickness dimensions, and the like. It is supposed to be.

  The lengthwise dimensions of the distal end portion 26, the intermediate portion 30, and the proximal end portion 28 are not particularly limited, and can be appropriately designed and changed according to the shape of the blood vessel into which the thrombus aspiration catheter is inserted. In addition, the tube 18 does not necessarily need to be composed of three parts having different bending stiffnesses. The bending stiffness may be substantially uniform or gradually change over the entire length, or two or four different bending stiffnesses may be used. It may be composed of two or more parts and change stepwise.

  In addition, the specific structure of the tube 18 is not particularly limited, and may be formed of a single layer of a synthetic resin material such as polytetrafluoroethylene (PTFE), or the tubular braided body is embedded inside It may be a laminated structure or the like that is fixed by using. As the laminated structure, for example, the inner layer 26a, 30a, 28a and the outer layer 26b, 30b, 28b are formed of synthetic resin in each of the distal end portion 26, the intermediate portion 30, and the proximal end portion 28, and the intermediate layer 26c, 30c and 28c are constituted by a mesh-like cylindrical braided body made of fibers or wires made of metal such as stainless steel or Ni-Ti alloy or synthetic resin. In the present invention, the inner layer 26a, 30a, 28a is made of PTFE, or PTFE is applied to the inner peripheral surfaces of the inner layers 26a, 30a, 28a to reduce the friction coefficient of the inner peripheral surface. 16 is suitable for insertion.

  Further, in order to ensure the visibility by X-ray during the operation, for example, a contrast agent such as bismuth oxide, bismuth sulfate, bismuth carbonate or the like is added to the molded resin layer of the tube 18, or the outer layers 26b, 30b after molding. , 28b, a contrast chip made of stainless steel, gold, platinum, iridium or the like is preferably fixed.

  Further, the distal end portion 26, the intermediate portion 30 and the proximal end portion 28 of the tube 18 may be formed separately and then later fixed by welding or adhesion, or may be sequentially connected and fixed simultaneously with molding. Is possible. Alternatively, the outer layers 26b, 30b, and 28b made of different materials can be formed on the intermediate molded body integrally including the inner layers 26a, 30a, and 28a and the intermediate layers 26c, 30c, and 28c.

  Further, the distal tip 20 provided at the distal end of the distal end portion 26 of the tube 18 may be integrally formed with the distal end portion 26, or formed separately from an appropriate resin material and fixed by adhesion or welding. May be. A proximal end portion of the distal end tip 20 is a proximal end cylindrical portion 34 having substantially the same outer diameter as the distal end portion 26 of the tube 18, and is integrally connected to the distal end portion 26.

  Further, the opening on the tip side of the tip 20 has a substantially “saw” shape cut obliquely, and a suction port 12 for sucking a thrombus is formed obliquely. That is, the peripheral wall end surface on the distal end side of the distal tip 20 extends in an oblique direction inclined with respect to the central axis of the tube 18 from one place on the circumference, and in the axial direction when viewed from a direction perpendicular to the central axis. It has a substantially oval shape that extends. As a result, the suction port 12 is inclined with respect to the central axis extending in the length direction of the tube 18 and opens obliquely forward or diagonally, and the opening area is perpendicular to the axis of the central lumen 24. It is set larger than the sectional area in the direction.

  Furthermore, the tip 20 is provided with a small-diameter cylindrical tip tube portion 32 located at the most distal portion of the peripheral wall of the suction port 12, and the inner hole of the tip tube portion 32 has a tip tip 20. A guide wire lumen 38 is formed by extending in the axial direction from the inner peripheral surface of the guide wire lumen 38. In the present embodiment, the guide sleeve 36 is inserted and fixed to the inner peripheral surface of the distal end cylindrical portion 32 to improve the shape stability. Incidentally, the reinforcing structure of the guide sleeve by such a guide sleeve 36 is described in detail in, for example, Japanese Patent Application Laid-Open No. 2007-7388 previously proposed by the present applicant.

  Also in the tip 20, preferably, a contrast agent is blended in the molding material, or a contrast tip or the like is fixed to the outer peripheral surface, so that the tip 20 can be viewed under fluoroscopy. It is said.

  On the other hand, a Y-shaped connector 22 is attached to the end of the base end portion 28 of the tube 18. This Y-shaped connector 22 is provided with first and second cylindrical portions 42 and 44 that are branched from each other with respect to a press-fit portion 40 having a double cylindrical structure to which the proximal end portion 28 of the tube 18 is fitted and fixed. The structure is made.

The first cylindrical portion 42 extends proximally over substantially the same center axis from the press-fit portion 40, the proximal opening of the central lumen 24 of the tube 18 is connected to the first tubular portion 42 . Thus, the central lumen 24 of the catheter body 14 is communicated with the inner bore of the first tubular portion 42 of the Y-connector 22, and is open at the proximal end side opening 46 of the first cylindrical portion 42 . The central lumen 24 of the catheter body 14 is also communicated with an inner hole of the distal end cylindrical portion 32 provided in front of the suction port 12 of the distal end tip 20, thereby forming a guide wire insertion passage. In this embodiment, the catheter is an over-the-wire type catheter.

Further, the second cylinder portion 44 provided with a branch structure from the middle portion in the longitudinal direction of the first cylinder portion 42 extends obliquely outward from the first cylinder portion 42. The central lumen 24 of the tube 18, through the inner hole of the first cylindrical portion 42 is communicated with the second cylindrical portion 44, is open at the proximal end side opening 47 of the second cylindrical portion 44 ing. As will be described later, in the present embodiment, the proximal end opening of the second cylindrical portion is passed from the central lumen 24 provided with the suction port 12 in the catheter body 14 through the inner holes of the first and second cylindrical portions. The thrombus is sucked and removed from the portion 47 to the outside, and the thrombus suction lumen is constituted by the central lumen 24 in the catheter body 14.

  As described above, in the thrombus aspiration catheter 10 of this embodiment in which the distal tip 20 is provided on the distal end side of the catheter body 14 and the Y-shaped connector 22 as a connector is mounted on the proximal end side of the catheter body 14, The stylet 16 can be inserted through the proximal end side opening of the central lumen 24 of the catheter body 14 through the proximal end side opening 46 of the first tubular portion 42 of the U-shaped connector 22. In the present embodiment, the insertion port of the stylet 16 is configured by the proximal end side opening 46 of the first cylindrical portion 42 in the Y-shaped connector 22.

  As shown in FIG. 3A, the stylet 16 has a structure in which a hub 50 is fixed to the base end of the stylet body 48.

  The stylet body 48 is made of a linear material having rigidity higher than that of the tube 18 such as stainless steel or Ni—Ti alloy, and is retained in the original shape with a certain degree of elasticity and restored to the original shape even after deformation. It has become so. Further, the tip 51 of the stylet body 48 is a free end, and a curved portion 52 having a predetermined radius of curvature is provided at the tip. Thereby, the front-end | tip 51 of the stylet main body 48 of this embodiment is extended toward the downward direction in Fig.3 (a) used as the tangent direction of the front-end | tip of the curved part 52. FIG. Here, as shown in an enlarged view of the tip portion of the stylet 16 in FIG. 3B, the tip 51 of the stylet body 48 is chamfered and rounded by polishing or the like so as to eliminate corner portions. desirable. The stylet body 48 is preferably made of a metal having a contrast property or attached with a contrast marker so as to be visible under fluoroscopy.

  Further, the outer diameter dimension of the stylet body 48 is sufficiently smaller than the inner diameter dimension of the central lumen 24, and the length dimension of the stylet body 48 is at least that of the Y-shaped connector 22 attached to the catheter body 14. The length extends from the proximal end side opening 46 of one cylindrical portion 42 to the distal end portion 26 of the tube 18. In addition, a deviation distance A (see FIG. 3B) in the direction perpendicular to the axis from the curved portion 52 to the tip 51 of the stylet body 48 is set larger than the inner diameter dimension of the central lumen 24.

  Thereby, when the stylet 16 is inserted into the catheter body 14, the distal end 51 of the stylet body 48 and the vicinity of the proximal end 53 of the curved portion 52 are in contact with the inner peripheral surface of the central lumen 24. It moves in the length direction of the catheter body 14. When the curved portion 52 of the stylet 16 reaches the distal end portion 26 of the catheter body 14, the distal end portion 26, which is relatively soft, is bent by the contact between the curved portion 52 of the stylet 16 and the distal end 51. It is bent and deformed by force.

  In particular, in the present embodiment, since the bending rigidity of the proximal end portion 28 of the tube 18 is relatively large, the deformation in the proximal end portion 28 when the curved portion 52 of the stylet body 48 passes through the proximal end portion 28. Can be suppressed. In addition, since the outer diameter of the stylet body 48 is sufficiently smaller than the inner diameter of the central lumen 24, the stylet body 48 is inserted into the central lumen 24 in addition to the guide wire. However, the communication state of the central lumen 24 is maintained, and a sufficient passage cross-sectional area for thrombus suction is secured.

  A mark or the like for aligning the opening direction of the suction port 12 of the catheter body 14 and the bending direction of the bending portion 52 of the stylet body 48 in the circumferential direction is provided at a corresponding portion such as the Y-shaped connector 22 and the hub 50. It may be provided.

  Next, an example of how the thrombus aspiration catheter 10 having the above structure is used will be described.

  When a thrombus aspiration treatment is performed using the thrombus aspiration catheter 10, first, the guide wire 54 is inserted into the blood vessel of the patient, and the tip of the guide wire 54 is arranged so as to reach the treatment site. Thereafter, the guide wire 54 is inserted through the guide wire lumen 38, the central lumen 24 and the first tubular portion 42 of the catheter body 14, and the catheter body 14 is inserted into the blood vessel while being guided by the guide wire 54. 14 suction ports 12 reach the treatment site in the blood vessel. It is assumed that the target treatment site is beyond the curved portion of the blood vessel and a thrombus is present on the inner peripheral side of the curved portion.

  As shown in FIG. 4, a cap including a rubber plug 56 is screwed into the proximal end side opening 46 (insertion port) of the first cylindrical portion 42 of the Y-shaped connector 22 so as to be liquid. While being tightly sealed, the guide wire 54 and the stylet 16 can be inserted and removed through the rubber plug 56 while maintaining the sealed state by the rubber plug 56. In addition, a fixing cap is screwed into the proximal end side opening 47 (thrombus suction port) of the second cylindrical portion 44 of the Y-shaped connector 22, and the tube 60 that is an external conduit is connected in a liquid-tight manner. The tube 60 is connected to a suction device 62 such as a syringe or a suction device that exerts a suction force by a negative pressure on the thrombus.

  Then, the stylet 16 is inserted from the proximal end side opening 46 of the first tubular portion 42 of the Y-connector 22 attached to the catheter body 14, and the curved portion 52 is inserted into the blood vessel on the front side of the suction treatment portion. The curved part is reached. As a result, the distal end portion of the catheter main body 14 extending along the outer peripheral side in the curved portion of the blood vessel is bent along the shape of the stylet 16 as shown in FIG. The mouth 12 is deformed and moved so as to approach the inner peripheral side of the curved portion where the thrombus exists in the blood vessel.

  In this state, by applying the suction force by the suction device 62 to the thrombus from the suction port 12 through the central lumen 24, the suction force from the suction port 12 is also applied to the thrombus attached to the inner peripheral side of the curved portion of the blood vessel. Thus, the thrombus can be sucked through the thrombus suction lumen (the central lumen 24) and removed to the outside of the blood vessel. As is clear from this, in the present embodiment, the thrombus suction port is configured by the proximal end side opening 47 of the second cylindrical portion 44 in the Y-shaped connector 22.

  As described above, in the thrombus aspiration catheter 10 of the present embodiment, the catheter body 14 is bent according to the curved shape of the stylet 16 inserted into the catheter body 14 and is held in a predetermined curved deformation state. By making the stylet 16 a curved shape that matches the blood vessel shape of the patient, the suction port 12 of the thrombus suction catheter 10 can be brought closer to the thrombus adhering to the inner surface of the blood vessel, and the thrombus suction efficiency can be improved. .

  Further, in the tube 18 in the catheter main body 14 of the thrombus suction catheter 10 of the present embodiment, the bending rigidity is gradually reduced toward the distal end side at the distal end portion 26, the intermediate portion 30 and the proximal end portion 28. When the let 16 is inserted, the amount of bending deformation of the proximal end portion 28 of the tube 18 can be suppressed, and the insertion resistance of the stylet can be reduced and the procedure can be facilitated. On the other hand, at the distal end portion 26 of the tube 18, bending deformation corresponding to the curved shape of the stylet 16 is advantageously generated, and since the suction port 12 is provided at the distal end portion 26, the suction port 12 can be effectively used. Can approach a thrombus. In particular, since the suction port 12 is provided so as to be inclined with respect to the length direction of the thrombus suction catheter 10, the suction of the thrombus can be performed more easily and efficiently by directing the opening toward the inner peripheral side of the curved portion. Can be done automatically.

  Further, in this embodiment, a Y-shaped connector 22 is provided, and in the Y-shaped connector 22, an insertion port (a proximal end side opening 46 of the first cylindrical portion 42) and a thrombus suction port (second cylindrical portion) Since the proximal end opening 47) of 44 is provided separately, the thrombus can be easily sucked in the state in which the stylet 16 is inserted, that is, the distal end portion of the thrombus suction catheter 10 is bent and deformed.

  While the embodiments and examples of the present invention have been described above, the present invention is not limited to the specific descriptions in the embodiments, and various changes and modifications based on the knowledge of those skilled in the art. , And can be implemented in a mode with improvements.

  For example, the thrombus aspiration catheter 64 may be configured by combining a plurality of stylets 66a, 66b, 66c in which at least one of the bending angle, the bending portion, the bending rigidity, etc. of the bending portion 52 is different from each other. . Specifically, for example, the stylet 66 shown in FIG. 5 shows a combination structure of three types of stylets 66a, 66b, and 66c whose bending angles increase toward the lower side in FIG. That is, by preparing a plurality of stylets 66a, 66b, 66c whose curvature angles are different from each other in advance, and selecting and using a stylet that more closely matches the blood vessel shape of the patient, The bending angle of the thrombus aspiration catheter 64 can be made more suitable for thrombus aspiration. Alternatively, for example, when thrombus suction is performed at a plurality of locations in the blood vessel, the folding angle of the thrombus suction catheter 64 can be changed by exchanging the stylet during the operation, and the thrombus suction efficiency can be improved. Can be illustrated. Furthermore, by inserting a plurality of stylets into the catheter body 14 at the same time, it is possible to deal with more complicated curved blood vessels.

  Further, the position where the curved portion 52 is provided is not limited to the strict leading edge of the stylet body, as long as it is a tip portion that means the tip side from the center in the length direction of the stylet body. Furthermore, the base end side from the curved portion does not need to be linear. For example, the entire stylet body may be formed with a large radius of curvature, and a curved portion with a small radius of curvature may be provided only at the distal end portion. good. It is also possible to provide a plurality of curved portions at different positions in the length direction at the tip portion of the stylet body. Therefore, the shape of the stylet body is not limited in any way, and can be appropriately designed and changed according to the blood vessel shape of the patient.

  Furthermore, in the said embodiment, the Y-shaped connector 22 was provided in the base end of the catheter main body 14, However, The concrete structure of the connector with which the base end of the catheter main body 14 is mounted | worn is not limited. For example, a connector having a single port provided with a sealing material is employed, and a hollow tube and a stylet connected to the thrombus suction lumen are inserted into the single port, and a guide wire is inserted as necessary. You may do it.

  Moreover, in the said embodiment, although it was set as the single lumen in the catheter main body 14, a double lumen and a triple lumen are also employable. Thereby, for example, the insertion lumen of the guide wire 54 and the thrombus suction lumen can be set as separate lumens, or the insertion lumen of the stylet can be set as another lumen.

The thrombus suction catheter 10 of the above embodiment is an over-the-wire type catheter. However, for example, a rapid exchange type catheter can be formed by providing a guide wire lumen independently. In addition, this invention originally includes each aspect as described in the following (i)-(vi), The effect is also added.
(I) includes a catheter body and a stylet that is insertable into the catheter body and has a curved portion at a distal end portion, and the stylet is inserted into the catheter body. A thrombus aspiration catheter characterized by being provided with a thrombus aspiration lumen for maintaining a communication state.
(Ii) The bending stiffness at the distal end portion of the catheter body is smaller than the bending stiffness at the proximal end portion, and the curved portion of the stylet is inserted into the distal end portion of the catheter body. The thrombus aspiration catheter according to (i).
(Iii) The thrombus aspiration catheter according to (i) or (ii), wherein a connector including an insertion port into which the stylet is inserted and a thrombus aspiration port is attached at the proximal end of the catheter body.
(Iv) The thrombus suction catheter according to any one of (i) to (iii), wherein a suction port provided at a distal end of the catheter main body is inclined and opened with respect to the length direction of the catheter main body.
(V) The thrombus aspiration catheter according to any one of (i) to (iv), including a plurality of types of the stylets in which the shapes of the curved portions are different from each other.
(Vi) A stylet constituting the thrombus aspiration catheter according to any one of (i) to (v).
In the invention described in (i) above, a stylet with a curved portion provided at the distal end portion is inserted into the catheter body, whereby the thrombus aspiration catheter is bent according to the shape of the stylet and bent. Can be transformed into That is, for example, by making the curved portion of the stylet conform to the blood vessel shape of the patient, the suction port provided at the distal end portion of the thrombus aspiration catheter can be brought close to the thrombus attached to the inner surface of the blood vessel. The suction efficiency can be improved. In particular, since the thrombus aspiration lumen maintains the communication state even when the stylet is inserted, the thrombus suction treatment can be performed while maintaining the curved shape of the catheter with the stylet. Problems such as the suction lumen being blocked and the thrombus not being sucked can be avoided.
In the invention described in (ii) above, since the bending rigidity of the catheter body is larger at the proximal end portion than at the distal end portion, when a stylet provided with a curved portion is inserted, a thrombus aspiration catheter In the base end portion, bending deformation along the stylet is unlikely to occur. Therefore, problems such as an increase in the insertion resistance of the stylet due to the deformed portion of the thrombus suction catheter being caught on the inner surface of the blood vessel during the insertion of the stylet can be avoided. In addition, since the thrombus suction catheter is efficiently bent and deformed when the stylet reaches the distal end portion where the bending rigidity of the catheter body is reduced, the suction port provided at the tip of the thrombus suction catheter is generally provided on the inner surface of the blood vessel. It is also possible to effectively approach the thrombus adhering to.
In the invention described in (iii) above, the connector is provided with an insertion port for inserting the stylet and a thrombus suction port for sucking the thrombus. Thus, the thrombus suction with the stylet inserted can be easily realized.
In the invention described in (iv) above, since the suction port is inclined and opened with respect to the length direction of the catheter, when the stylet is inserted and the thrombus suction catheter is bent and deformed, the suction port Can be opened toward the thrombus adhering to the inner surface of the blood vessel, and the thrombus can be efficiently aspirated.
In the invention described in the above (v), it is not necessary to manufacture a stylet corresponding to a specific site of a blood vessel in a specific patient by preparing a plurality of types of stylets having different curved portions. In addition, a stylet conforming to or close to the blood vessel shape of the patient can be selected from a plurality of types of stylets, so that the manufacturing efficiency can be improved and the cost can be reduced. Further, when treating different sites in the blood vessel, the bending shape of the thrombus aspiration catheter can be changed by exchanging the stylet, and the thrombus aspiration efficiency can be further improved.
In the invention described in (vi) above, the thrombus aspiration catheter can be bent and deformed by the bending portion provided at the distal end portion by being inserted into the catheter body. That is, by appropriately adjusting the bending angle of the bending portion, the thrombus suction catheter can be deformed into a desired shape. For example, by making the shape in accordance with the blood vessel shape of the patient, the thrombus suction efficiency can be improved. Can be.
In the thrombus aspiration catheter having the structure according to the invention described in the above (i) to (vi), the catheter body can be deformed into a curved state according to the shape of the curved portion of the stylet. By appropriately setting the angle, the catheter body can be deformed into a shape suitable for thrombus suction, and thrombus suction efficiency can be improved.

10, 64: thrombus aspiration catheter, 12: suction port, 14: catheter body, 16, 66a, 66b, 66c: stylet, 22: Y-shaped connector (connector), 24: central lumen (thrombus aspiration lumen), 46: Proximal end opening (insertion port), 47: Proximal end opening (thrombotic suction port), 52: Curved portion

Claims (4)

A thrombus aspiration catheter for aspirating and removing a thrombus , comprising a catheter body and a stylet that is insertable into the catheter body and provided with a curved portion at a distal end portion ;
While the catheter body is provided with a thrombus aspiration lumen that maintains a communication state with the stylet inserted ,
The distal end portion of the catheter body has a bending rigidity smaller than that of the proximal end portion of the catheter body, and the curved portion of the stylet inserted from the proximal end side into the catheter body is the distal end portion. By reaching the part, it is designed to be curved and deformed,
The distal end of the catheter body is held closer to the blood vessel wall than the center in the blood vessel by the curved deformation of the distal end portion, and
A thrombus aspiration catheter, characterized in that the suction port at the distal end of the catheter body is inclined with respect to the longitudinal direction of the catheter body so as to open toward the inner surface of the blood vessel . The thrombus aspiration catheter according to claim 1, wherein a connector including an insertion port into which the stylet is inserted and a thrombus aspiration port is attached to a proximal end of the catheter body. The thrombus aspiration catheter according to claim 1 or 2 , comprising a plurality of types of the stylets whose shapes of the curved portions are different from each other. The stylet which comprises the thrombus aspiration catheter of any one of Claims 1-3 .

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