JP5342222B2 - Medical catheter device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To securely prevent a stent attached on a balloon from displacing and falling down while effectively using advantageousness of a monorail type balloon catheter. <P>SOLUTION: A catheter system is equipped with a sheath 3 through which the catheter 2, provided with the balloon 1 on which a stent 18 is mounted at the distal end side, is inserted. A guide wire inserting path 9 through which a guide wire 8 is inserted from the distal end side to the halfway part of the proximal end side is formed in the catheter 2. An opening 20 for guiding out the guide wire for guiding out the guide wire 8 guided out from the catheter 2 to the lateral side of the sheath 3 is arranged and a guiding out direction guide mechanism 12 for guiding out the guide wire 8 to the lateral side of the sheath 3 through the opening 20 for guiding out the guide wire is arranged in the proximal end side of the sheath 3. <P>COPYRIGHT: (C)2010,JPO&amp;INPIT

Description

  The present invention relates to a catheter device used for medical purposes.

  Conventionally, when a stenosis occurs in a blood vessel of a living body, particularly a blood vessel such as a coronary artery, percutaneous angioplasty is a surgery that expands the stenosis of a blood vessel using a medical balloon catheter to improve blood flow. Surgery (PTA: Percutaneous Transluminal Angioplasty) is performed.

  However, it is known that even if PTA is applied to a site where stenosis in a blood vessel occurs, acute occlusion due to intimal detachment or restenosis occurs with high probability. In order to prevent such acute occlusion and restenosis, stent placement is performed in which a stent formed in a cylindrical shape is implanted in a site where PTA has been applied. The stent used here is inserted into a blood vessel in a reduced diameter state and then expanded to be implanted in the blood vessel to support the inner wall of the blood vessel.

  A stent to be implanted in a blood vessel is inserted into the blood vessel using a catheter provided with a balloon that is expanded by supplying an expansion medium, and is transferred to a desired implantation position in the blood vessel for implantation. That is, the stent is mounted in a state of being reduced in diameter on a balloon provided at the distal end portion of the catheter inserted into the blood vessel, and is transported to the stent implantation site together with the balloon. The stent is expanded by supplying an expansion medium to the balloon and inflated, and is implanted into a lesion site. Once the diameter of the stent has been expanded, the expanded medium is extracted from the balloon and maintained in an expanded state after being reduced, thereby supporting the site where the stent has been implanted from the inside. A flow path for body fluid such as blood is secured.

  By the way, the stent is formed in a cylindrical shape so as to form one flow path from one end side to the other end side. The stent is mounted on a balloon in a reduced state in a reduced diameter state, and is transferred into the blood vessel together with the balloon. However, since the stent is formed as a single cylindrical body and mounted on the balloon, it can be easily displaced and dropped from the balloon by receiving a load such as a frictional force during transfer. It will be caused to. If the stent falls off from above the balloon, the diameter is not expanded even if the balloon is inflated, and the stent cannot be implanted in a desired site. Even if the stent does not fall off the balloon, if the position of the stent is displaced, the stent can receive the expansion force of the balloon uniformly over the entire length, and the other end can be The diameter will not be expanded over the entire length over the end side. Thus, if the diameter of the stent is not uniformly expanded over the entire length, the desired site in the blood vessel cannot be accurately supported.

  Therefore, in order to prevent the stent mounted on the balloon from dropping out of the balloon during the insertion into the blood vessel and causing a positional shift, the present inventor disclosed in WO2004 / 103450 Patent Document 1) A stent supply device in which a balloon catheter equipped with a stent is inserted into a protective sheath is proposed. In this stent supply device, when the stent is protruded from the protective sheath and expanded in diameter, the one end side of the stent is held by the holding member in order to prevent displacement with respect to the balloon.

  As described above, a catheter in which a stent is mounted on a balloon used for performing PTA is inserted into a blood vessel of a living body by the following procedure, and the stent is implanted at an indwelling position in the blood vessel.

  First, a guide wire inserted through the catheter is inserted over the stenosis in the blood vessel prior to the catheter. Next, the catheter is inserted into the stenosis portion along the guide wire inserted through the stenosis portion, and the balloon provided at the distal end portion of the catheter is positioned at the stenosis portion. When the balloon is positioned together with the stent in the stenosis, the sheath is moved with respect to the catheter, the balloon is projected together with the stent from the distal end of the sheath, and the balloon and the stent are positioned at the lesion site. Here, using an inflator or the like, pressure fluid is supplied to the balloon via a pressure fluid supply passage provided in the catheter, the balloon is inflated, the stent is expanded, and the stenosis of the blood vessel is expanded. Give treatment. After the balloon is inflated and the stenosis of the blood vessel is expanded, the pressure fluid supplied to the balloon is extracted and the pressure is reduced. At this time, the expanded stent is detached from the reduced balloon by maintaining the expanded state, and is placed in the stenosis portion in the blood vessel subjected to the expansion treatment to support the inner wall of the blood vessel. maintain. Thereafter, the stent placement is completed by removing the catheter from the body.

  As a catheter used for performing PTA as described above, an over-the-wire type catheter in which a guide wire insertion hole is formed over the entire length from the distal end side to the proximal end side of the catheter, and a guide wire insertion hole. There is a monorail type catheter that is formed from the distal end side of the catheter to a midway portion, and a guide wire drawing port is provided in the midway portion of the catheter.

  Among these catheters, the over-the-wire type catheter has a guide wire insertion hole formed from the proximal end portion to the distal end portion of the catheter, so that when the guide wire is inserted into the stenosis portion, There is an advantage that it is easy to operate.

  On the other hand, in the monorail type catheter, the guide wire is inserted only through the portion from the distal end portion to the middle portion of the catheter, so the guide wire is inserted over the entire length from the distal end side to the proximal end portion side of the catheter. Compared to the over-the-wire type catheter, the insertion amount of the catheter into the guide wire can be reduced. Therefore, it is easy to replace the catheter when performing a procedure such as drawing out the catheter while leaving the guide wire previously inserted into the blood vessel without using an extension guide wire or an exchange device, and inserting the catheter into the blood vessel again. There are advantages that can be made.

  In stent placement, multiple stents may need to be implanted depending on the size of the stenosis and the shape of the blood vessel. In such a case, it is necessary to repeatedly insert into the blood vessel while exchanging the catheter equipped with the stent. At this time, the catheter can be quickly replaced by maintaining the state where the guide wire is inserted into the blood vessel. By adopting a monorail type as a catheter for implanting a stent, it becomes possible to replace the catheter more quickly, and it is possible to efficiently implant a plurality of stents in a blood vessel.

As a monorail type balloon catheter as described above, there are those disclosed in WO 2006/020374 Patent Document 2) and Japanese Patent Application Laid-Open No. 2008-104660 (Patent Document 3).
WO2004 / 103450 WO2006 / 020374 JP 2008-104660 A

  As described above, when a stent is implanted into a blood vessel such as a blood vessel using a catheter with a balloon, it has been proposed to use a sheath so that the stent does not fall off the balloon. The sheath covers the stent mounted on the balloon provided at the distal end of the catheter, and is further moved relative to the catheter. Therefore, the sheath is provided over almost the entire length of the catheter. If the catheter is covered with such a sheath, when the monorail type is adopted for the catheter, the guide wire drawn from the middle part of the catheter is also covered with the sheath, and the advantage of adopting the monorail type is lost.

  Therefore, the present invention provides a medical catheter device that can reliably prevent displacement and dropout of a stent mounted on a balloon provided on a catheter while effectively utilizing the advantages of a monorail catheter. Let it be a technical issue.

  Furthermore, the technical problem of the present invention is to provide a medical catheter device that enables a stent to be rapidly implanted into a blood vessel such as a blood vessel of a living body.

  The present invention proposed to solve the technical problems as described above is a medical catheter device, and this catheter device is provided with a balloon on the distal end side which is expanded by supplying an expansion medium. The catheter and the catheter are inserted, cover the outer peripheral side of the catheter from the distal end side to the proximal end side, hold the balloon provided on the distal end side of the catheter, and open at least the position covering the balloon and the balloon And a sheath that is moved and moved relative to the catheter.

In the catheter constituting the catheter device according to the present invention, an expansion medium supply passage through which an expansion medium for expanding a balloon provided on the distal end side is distributed is formed from the distal end side to the proximal end side. In addition, a guide wire insertion passage through which the guide wire is inserted is formed from the distal end portion to a midway portion on the proximal end side . The guide wire insertion passage is formed in the catheter with the opening end on the distal end side facing the distal end portion of the catheter and the opening end on the proximal end side facing the middle portion of the catheter. The proximal end portion of the sheath is provided with a guide wire lead-out opening for leading the guide wire led out from the catheter toward the side of the sheath, and guides the guide wire led out from the catheter. A lead-out direction guide mechanism for guiding the lead to the side of the sheath through the wire lead-out opening is provided.

  And the bulging part is formed in the part which the base end part side of the guide wire insertion path formed in the catheter corresponds to gradually incline toward the side of the catheter, and the guide wire is formed. The opening end on the proximal end side of the insertion passage faces an inclined opening formed by inclining a part of the bulging portion with respect to the outer peripheral surface of the catheter.

  In the medical catheter device according to the present invention, a guide direction mechanism for relaying a guide wire led out of the catheter from the open end to the open end side of the guide wire insertion passage on the proximal end side. A guide wire relay mechanism is provided for guiding the guide wire.

  For example, the guide wire relay mechanism is disposed along the outer peripheral surface of the catheter with the opening end on one end side facing the opening end on the proximal end side of the guide wire insertion passage. A guide wire drawn out from the opening end on the part side is inserted, and a hollow relay member for guiding the inserted guide wire to a guide direction guide mechanism provided in the sheath, and an opening on the proximal end side of the guide wire insertion path A relay guide member that covers one end side of the relay member from the end and is mounted on the outer peripheral side of the catheter and supports the relay member to the catheter.

  The guide wire relay mechanism is disposed along the outer peripheral surface of the catheter with the opening end on one end side facing the opening end on the proximal end side of the guide wire insertion passage, and the proximal end portion of the guide wire insertion passage A guide wire pulled out from the opening end on the side is inserted and has a hollow relay member that guides the inserted guide wire to a guide mechanism in the lead-out direction provided in the sheath, and this relay member is joined to the outer peripheral surface of the catheter. Thus, the one fixed to the catheter is used.

  In one embodiment of the lead-out direction guide mechanism provided in the sheath, the one end side is fixed to the base end side of the sheath, and the tip end side enters the guide wire lead-out opening from the outer side of the sheath. A wire guide piece attached to the housing.

  Further, the catheter and the sheath are formed of a flexible material that can be freely bent and deformed, and a rigid tubular connecting member is formed on the proximal end portion where the guide wire lead-out opening is formed. Further, a fixed support member for fixing the relative movement between the sheath and the catheter is attached to the proximal end portion of the connection member.

  The sheath and the connecting member connected to the proximal end portion of the sheath are inserted from the proximal end side where the guide wire lead-out opening of the sheath is formed to the proximal end side of the sheath of the connecting member. It is integrally supported by a tube made of synthetic resin that is pressure-bonded over the part side.

  Further, the wire guide piece constituting the lead-out direction guide mechanism is attached to a portion where the connecting member of the sheath is inserted with one end fixed, and the portion fixed to the sheath is a heat-shrinkable synthetic resin tube Covered by.

  Further, in the catheter device according to the present invention, a rigid tubular connecting member is connected to the proximal end portion of the sheath where the guide wire lead-out opening is formed, and the connecting member is formed on the sheath. A further guide wire lead-out opening communicating with the guide wire lead-out opening may be formed.

  In the catheter device according to the present invention, a tubular vascular stent is mounted in a reduced state on a balloon provided on the distal end side of the catheter.

  As a vascular stent to be attached to this medical catheter device, a stent formed by knitting a linear member made of a biodegradable polymer into a cylindrical shape and storing a shape memory of the expanded diameter is used.

  The medical catheter device according to the present invention guides a guide wire led out from the middle of the catheter to the side in a sheath provided to cover the catheter provided with a balloon on the distal end side. By providing the lead-out guide mechanism, it is possible to realize the advantages of the monorail catheter that allows rapid replacement of the catheter while reliably preventing the displacement and dropping of the stent mounted on the balloon.

  Therefore, by using the catheter device according to the present invention, it is possible to quickly exchange a catheter and to quickly implant a plurality of vascular stents.

  In addition, the inclination of the proximal end side of the guide wire insertion passage with respect to the outer peripheral surface of the catheter formed by cutting out a part of the bulging portion bulged so as to be gradually inclined toward the side of the catheter By facing the opening, the opening end of the guide wire insertion passage can be enlarged, and the guide wire can be pulled out from the catheter reliably and easily.

  In addition, the catheter device according to the present invention is pulled out from the guide wire insertion passage by providing a guide wire relay mechanism that relays the guide wire led out of the catheter from the guide wire insertion passage and leads to the guide direction guide mechanism. The guide wire can be reliably guided to the guide direction guide mechanism and guided to the side of the sheath.

  In particular, the guide wire relay mechanism is configured such that the guide wire is guided out of the catheter by the guide wire insertion passage so that the guide direction is regulated by the relay guide member and inserted into the hollow relay member and guided to the guide direction guide mechanism. Therefore, the guide wire can be more reliably guided to the guide direction guide mechanism and guided to the side of the sheath.

  Since the guide wire led out from the guide wire insertion passage is inserted into the relay guide member, it can be prevented from being directly subjected to stress such as frictional force when the sheath and the catheter are moved relative to each other. Can be achieved.

  Furthermore, the lead-out direction guide mechanism provided in the sheath includes a wire guide piece whose distal end side enters the guide wire lead-out opening from the outer side of the sheath, so that the guide wire led out from the catheter can be securely attached to the sheath. Can be pulled out to the side.

  Furthermore, a rigid tubular connecting member is connected to the proximal end portion of the flexible sheath into which the flexible catheter is inserted, thereby facilitating and reliably moving the sheath relative to the catheter. Can be done. Furthermore, since the relative movement of the sheath and the catheter is fixed by the fixing support member, the state where the balloon provided at the distal end portion of the catheter and the vascular stent mounted on the balloon are held in the sheath is maintained. Insertion into the vessel can be performed.

  Furthermore, since the sheath and the coupling member having the distal end coupled to the proximal end of the sheath are integrally supported by a tube made of a synthetic resin that has been crimped and attached, a reliable coupling state can be realized. it can.

  Furthermore, one end is fixed and attached to the portion where the connecting member of the sheath is inserted, and the portion fixed to the sheath of the guide piece is covered with a heat-shrinkable synthetic resin tube. The fixed part can also be a smooth and smooth surface, and the operational feeling of the insertion operation into the vessel can be maintained well.

  Furthermore, in the present invention, the guide wire lead-out direction is stabilized by providing an additional guide wire lead-out opening in the rigid connecting member connected to the sheath, and the guide wire lead-out direction to the guide mechanism is stabilized. A more reliable derivation can be realized.

  And the catheter apparatus which concerns on this invention is mounted | worn in the state by which the cylindrical vascular stent was diameter-reduced on the balloon provided in the front-end | tip part side of the catheter. The vascular stent is held by the sheath, so that the balloon is prevented from falling off or being displaced, and can be inserted into the vascular vessel.

  In particular, the catheter device according to the present invention is such that when a vascular stent whose shape is memorized in an expanded state is used, the diameter of the catheter device expands during insertion into the vascular vessel and falls off the balloon. While preventing, the diameter can be surely expanded at a predetermined implantation position.

  The technical problems and advantages realized by the present invention will be further clarified by the embodiments described below.

  Hereinafter, the catheter is useful for use in percutaneous transluminal angioplasty (PTA), which is a surgery for expanding a stenosis in a blood vessel such as a blood vessel of a living body to improve blood flow. An example applied to the apparatus will be described.

  As shown in FIG. 1, the catheter device according to the present invention includes a catheter 2 provided on the distal end side with a balloon 1 that is expanded by supplying an expansion medium, and an outer periphery of the catheter 2 through which the catheter 2 is inserted. Covering the side from the distal end side to the proximal end side, holding the balloon 1 provided on the distal end side of the catheter 2, and at least between the position covering the balloon 1 and the position opening the balloon 1, And a sheath 3 that is moved relative to the catheter 2.

  As shown in FIG. 2, the catheter 2 constituting the catheter device is formed as a long and tubular body having an outer diameter of about 1 to 2 mm and a total length of about 70 to 150 cm. The catheter 2 is formed using a flexible synthetic resin material so as to be inserted while being bent or deformed following a curved or bent vessel such as a blood vessel.

  A balloon 1 that is expanded when an expansion medium such as a contrast medium is supplied is attached to the distal end side of the catheter 2. As shown in FIG. 3, the catheter 2 is provided with an expansion medium supply passage 4 through which an expansion medium for expanding the balloon 1 attached to the distal end is distributed. The expansion medium supply passage 4 is formed so as to communicate in series from the proximal end side of the catheter 2 to the distal end side where the balloon 1 is provided. As shown in FIG. 2, a through hole 6 communicating with the expansion medium supply passage 4 is formed in the portion of the catheter 2 to which the balloon 1 is attached, and is supplied through the expansion medium supply passage 4. The expansion medium is filled into the balloon 1 through the through-hole 6, and the expansion medium filled in the balloon 1 is sucked.

  Further, a guide wire insertion passage 9 through which a guide wire 8 for guiding the insertion direction of the catheter 2 is inserted when the catheter 2 is inserted into a living body vessel is inserted into a portion extending from the distal end portion to the middle portion of the catheter 2. Is formed. Therefore, as shown in FIG. 4, the portion extending from the distal end side of the catheter 2 to the middle portion is formed by concentrically and independently forming two passages of the expansion medium supply passage 4 and the guide wire insertion passage 9. It is configured as a passage type catheter.

  The expansion medium supply passage 4 and the guide wire insertion passage 9 may be formed by separating the inside of the catheter 2 by a partition wall 5 as shown in FIG.

Here, the guide wire insertion passage 9 is formed in a region where the catheter 2 can be inserted into the living body. For example, the catheter 2 having a total length of 135 cm is formed over a range of 25 to 50 cm from the distal end .

  The guide wire insertion passage 9 is formed such that the opening end on the distal end side faces the distal end portion of the catheter 2 and the opening end on the proximal end side faces the middle portion of the catheter 2. . As shown in FIG. 2, the portion of the guide wire insertion passage 9 of the catheter 2 facing the opening end on the proximal end side is bulged so as to be gradually inclined toward the side and formed as a bulging portion 10. Yes. The opening end on the proximal end side of the guide wire insertion passage 9 faces an inclined opening portion 11 formed by notching one side surface on the proximal end side of the bulging portion 10 obliquely with respect to the major axis of the catheter 2. ing. As shown in FIG. 2, the inclined opening 11 is formed to be inclined with respect to the outer peripheral surface of the catheter 2 so as to have a large opening angle with respect to the pulling direction of the guide wire 8, and thus has a large opening area. . Therefore, the guide wire 8 can be smoothly led out of the catheter 2.

  The distal end portion 2a side where the open end of the guide wire insertion passage 9 of the catheter 2 faces is formed in a tapered shape so that the insertion into the vascular vessel can be performed smoothly.

  Then, as shown in FIG. 1, the guide wire 8 led out from the opening end on the proximal end side of the guide wire insertion passage 9 facing the inclined opening portion 11 formed in the middle portion of the catheter 2 is attached to the sheath 3. A guide wire relay mechanism 13 that relays and guides to the provided guide direction guide mechanism 12 is provided. The detailed configuration of the derivation direction guide mechanism 12 will be described later.

  As shown in FIG. 6, the guide wire relay mechanism 13 has a guide direction 8 in which the guide wire 8 that is drawn out of the catheter 2 from the proximal end of the guide wire insertion passage 9 is provided in the sheath 3. The relay member 14 led to 12 is provided. The relay member 14 is formed of a hollow tube having an inner diameter sufficient for the guide wire 8 to be inserted. The relay member 14 used here is a synthetic material having a smooth and low-friction surface so that the guide wire 8 formed of a thin metal wire having a thickness of about 0.3 mm to 0.6 mm can be smoothly inserted. It is desirable to form with a resin tube. In the present embodiment, the relay member 14 is formed by a tube made of a polyimide-based synthetic resin material.

  Then, as shown in FIG. 6, the relay member 14 formed using a tube faces the opening end on one end side so as to face the inclined opening portion 11 provided on the catheter 2, and opens the opening end on the other end side. Is disposed along the outer peripheral surface of the catheter 2 so as to face or be positioned at the lead-out direction guide mechanism 12.

  The guide wire relay mechanism 13 includes a relay guide member 15 that guides the guide wire 8 led out from the open end on the proximal end side of the guide wire insertion passage 9 so as to surely enter the relay member 14. The relay guide member 15 is formed as a tubular body using tetrafluoroethylene resin (PTFE), which is a material having a low coefficient of friction and excellent lubricity. The relay guide member 15 is attached to the outer peripheral side of the catheter 2 so as to cover one end side of the relay member 14 from a portion where the inclined opening 11 of the catheter 2 is formed. At this time, the relay member 14 is mounted so as to be in close contact with the outer peripheral sides of the catheter 2 and the relay member 14 as shown in FIG. By mounting the relay guide member 15 in this way, the relay member 14 is supported on the outer peripheral surface of the catheter 2 while maintaining the state where the opening end on one end side faces the inclined opening 11.

  As shown in FIG. 7, an adhesive (glue) 16 is attached to the distal end side of the relay guide member 15 so that the stepped portion on the distal end side is smoothly continuous with the outer peripheral surface of the catheter 2. Yes. Further, the relay member 14 is integrated with the catheter 2 by joining an intermediate portion thereof to the catheter 2 with an adhesive 17.

  In the guide wire relay mechanism 13 of the present embodiment, the hollow relay member 14 is supported by the relay guide member 15 and further fixed by using the adhesive 17, so that the guide wire 8 pulled out from the catheter 2. Can be reliably relayed to the lead-out direction guide mechanism 12 provided in the sheath 3.

  Furthermore, the catheter apparatus according to the present invention includes a sheath 3 through which the catheter 2 is inserted. The sheath 3 is made of a material that can be easily elastically deformed following a curved or bent vessel as in the catheter 2. In this embodiment, a nylon tube is used.

  The sheath 3 is formed to have a length covering from the distal end side where the balloon 1 of the catheter 2 is attached to the proximal end side, attached to the balloon 1 attached to the distal end side of the catheter 2, and further mounted on the balloon 1. The vascular stent 18 to be covered is held. Hereinafter, the vascular stent 18 is simply referred to as a stent 18. The sheath 3 holds the stent 18 mounted on the balloon 1, thereby preventing displacement and dropping of the stent 18 with respect to the balloon 1 when the catheter 2 is inserted into a living body vessel.

  The sheath 3 includes a position where the catheter 2 is inserted so that the catheter 2 can be moved forward and backward and covers the balloon 1 attached to the distal end side of the catheter 2, and an open position where the balloon 1 protrudes from the distal end portion and can be expanded. A movement operation is performed on the catheter 2 in between. The balloon 1 attached to the distal end side of the catheter 2 is operated to move the sheath 3 relative to the catheter 2 and is moved to an open position protruding from the distal end side of the sheath 3 so that the expansion medium is supplied. Can be expanded.

  In the catheter device according to the present invention, the stent 18 mounted on the balloon 1 is held by the sheath 3 and inserted into the blood vessel together with the balloon 1 and can be transported to a predetermined implantation position. When the sheath 3 is transported to the desired implantation position, the balloon 3 and the stent 18 can be opened from the sheath 3 by moving the sheath 3 with respect to the catheter 2. Thus, the balloon 1 can be expanded and the stent 18 can be surely expanded in diameter and implanted.

  As described above, the guide wire that is inserted into the proximal end portion side of the sheath 3 that covers the outer peripheral side of the catheter 2 is guided to the outside of the catheter 2 through the inclined opening 11 as described above. A guide wire lead-out opening 20 is provided for leading 8 toward the side of the sheath 3. As shown in FIG. 8, the guide wire lead-out opening 20 is a bulging portion in which a part of the proximal end side of the sheath 3 having a circular cross-sectional shape is deformed and bulged to have a flat cross-sectional shape. A part of 21 is cut off obliquely. Since the guide wire lead-out opening 20 is formed by cutting out a part of the flat bulge 21, the guide wire lead-out opening 20 has a large opening angle with respect to the pull-out direction of the guide wire 8, like the inclined opening 11. In this case, a large opening area is formed by being inclined with respect to the outer peripheral surface of the sheath 3. Therefore, the guide wire 8 can be smoothly led out of the sheath 3.

  In addition, as shown in FIG. 8, the proximal end side of the bulging portion 21 provided with the guide wire lead-out opening 20 of the sheath 3 has a flat cross-sectional shape in a direction perpendicular to the bulging portion 21. It is set as the deformation | transformation part 22 deform | transformed so that it may become. Therefore, a flat portion 22 a of the flat deformed portion 22 is formed on the outer peripheral surface of the sheath 3 so as to be continuous with the guide wire outlet opening 20.

  Further, on the proximal end side of the sheath 3, a guide direction guide mechanism that guides the guide wire 8 led out from the catheter 2 so as to be led out to the lateral side outside of the sheath 3 through the guide wire lead-out opening 20. 12 is provided. As shown in FIGS. 9 and 10, the lead-out direction guide mechanism 12 is configured so that the guide wire 8 led out of the catheter 2 through the guide wire relay mechanism 13 enters the guide wire lead-out opening 20. It has the wire guide piece 23 to guide. The wire guide piece 23 is formed by punching a thin metal plate, for example, a stainless steel plate, and fixes one end 23 a to the proximal end side of the sheath 3, and the wire guide portion 24 formed on the distal end side to the proximal end of the sheath 3. The guide wire lead-in opening 20 is inclined and attached from the outside on the side.

  Here, on the base end side of the sheath 3 to which the wire guide piece 23 is attached, as shown in FIGS. 9 and 10, a heat-shrinkable synthetic resin is provided so as to cover the periphery of the guide wire outlet opening 20. A tube 25 made of a material is attached. The tube 25 is used to maintain the flat shape of the bulging portion 21 in which the guide wire lead-out opening 20 of the sheath 3 is formed.

  And the 1st and 2nd cut | notch 27,28 is pierced in the flat part 22a of the deformation | transformation part 22 of the proximal end part of the sheath 3 and the deformation | transformation part 22 of the proximal end part. Yes.

  As shown in FIGS. 9 and 10, the wire guide piece 23 inserts the wire guide portion 24 on the distal end side into the guide wire lead-out opening portion 20 from the outer side of the proximal end portion of the sheath 3, and the one end portion 23 a side is inserted. It is attached to the sheath 3 by being inserted and engaged from the first cut 27 to the second cut 28. At this time, since the wire guide piece 23 enters the sheath 3 so that the wire guide portion 24 on the distal end side is inclined from the proximal end side to the distal end side of the sheath 3, the relay member 14 or the relay member 14. The guide wire 8 drawn out from the wire can be run on the wire guide portion 24. As a result, the guide wire 8 can be guided to the guide wire lead-out opening 20 and guided to the outside of the side of the sheath 3.

  In addition, the wire guide piece 23 should just be what can guide the drawing-out direction of the guide wire 8 without deform | transforming easily, The shape and material are not specifically limited.

  As described above, a rigid tubular connecting member 26 is connected to the proximal end side of the sheath 3 provided with the lead-out direction guide mechanism 12. The connecting member 26 is a long tubular member, and is formed of a metallic tubular member such as stainless steel or aluminum. This connecting member 26 fixes the long form of the sheath 3 that can be easily bent and deformed, and enables stable insertion / removal operation to and from the vessel, as shown in FIG. Further, the distal end portion is connected to the sheath 3 by being inserted into the proximal end portion of the sheath 3. At this time, the synthetic resin tube 25 mounted on the proximal end side of the sheath 3 is thermally contracted and pressed onto the sheath 3, whereby the connecting member 26 is integrally connected to the sheath 3.

  Incidentally, the portion of the connecting member 26 inserted into the sheath 3 is deformed following the shape of the proximal end portion of the sheath 3. That is, as shown in FIG. 11, the distal end side of the connecting member 26 is a bulging deformation portion 29 that is deformed so as to have a flat cross-sectional shape that bulges along the bulging portion 21 of the sheath 3. As shown in FIG. 12, the base end side continuous with the bulging deformation portion 29 is a flat deformation portion 30 having a flat cross-sectional shape in a direction orthogonal to the bulging deformation portion 29.

  And since the wire guide piece 23 is arrange | positioned at the sheath 3 so that the one end part 23a side may be mounted on the flat deformation | transformation part 30 formed in the connection member 26 which has rigidity, stable attachment is realizable.

  The wire guide piece 23 is melted on the connecting member 26 in a state where the one end side of the wire guide piece 23 protruding outward from the sheath 3 is disposed on the connecting member 26. One end side portion protruding outward of the sheath 3 can be welded to the sheath 3 and the connecting member 26.

  As described above, the Y connector 32 is attached to the base end side of the connecting member 26 to which the sheath 3 is integrally connected, as shown in FIG. The Y connector 32 is provided with a crimping fixing mechanism 34 that fixes the relative movement between the catheter 2 and the sheath 3 inserted from the connecting member 26 to the sheath 3 connected to the connecting member 26.

  The hub 31 is fitted with a connecting tube 35 formed of a heat-shrinkable synthetic resin material attached to the hub 31 to the proximal end portion of the connecting member 26, and the tube 35 is thermally contracted to thereby connect the connecting member. 26. As described above, the hub 31 is attached to the connecting member 26, whereby the Y connector 32 provided with the crimping fixing mechanism 34 is attached to the connecting member 26.

  The catheter device according to the present invention is inserted into the sheath 3 in which the connecting member 26 having the Y connector 32 attached to the proximal end side is connected to the proximal end side, and the catheter 2 with the balloon 1 attached to the distal end portion is inserted. Composed.

  The catheter 2 is inserted into the sheath 3 from the connecting member 26 via the Y connector 32 with the distal end side to which the balloon 1 is attached as the insertion end.

  In the catheter device according to the present invention, a cylindrical stent 18 constituting one flow path from one end side to the other end side is contracted on the balloon 1 attached to the catheter 2 inserted through the sheath 3. Mounted in a diameter state. The stent 18 is mounted on the balloon 1 before the catheter 2 is inserted into the sheath 3 or after the catheter 2 is inserted into the sheath 3, the sheath 3 is moved with respect to the catheter 2 and attached to the distal end side of the catheter 2. The balloon 1 can be protruded from the distal end of the sheath 3.

  The medical catheter device according to the present invention holds the stent 18 mounted on the balloon 1 by the sheath 3. Therefore, this catheter device is particularly useful when a stent 18 that is inserted into a living body and expands its diameter under the influence of the body temperature or the like of the living body is mounted. Therefore, the catheter device according to the present invention has a stent 18 formed by knitting a linear member made of a biodegradable polymer into a cylindrical shape and having a shape memorized in an expanded state. Extremely useful.

  In the catheter device according to the present invention, the catheter 2 and the sheath 3 are made of a material that can be easily elastically deformed so as to be smoothly inserted following a curved or bent vessel. However, in the case of performing insertion / removal operation to / from the blood vessel, the proximal end side portion of the sheath 3 that is grasped by the fingers and becomes the insertion operation portion does not easily deform and maintains a certain form. It is desirable to have such rigidity. Therefore, in the present embodiment, as described above, in order to maintain the shape of the sheath 3 in a certain state, the connecting member 26 made of a metallic tubular member is connected to the proximal end side of the sheath 3. .

  By the way, in the above-described embodiment, only the distal end side of the connecting member 26 is inserted into the proximal end side of the sheath 3, and the sheath 3 and the connecting member 26 are covered with a synthetic resin tube 25 to be integrated. However, the present invention is not limited to this example, and as shown in FIG. 13, the sheath 3 and the connecting member 26 may be integrated without using the tube 25. In the embodiment shown in FIG. 13, the insertion amount of the connecting member 26 into the sheath 3 is increased, and the proximal end side of the sheath 3 is brought into close contact with the outer periphery of the connecting member 26, whereby the sheath 3 and the connecting member are arranged. 26 is integrated. By adopting such a configuration, the tube 25 used in the above-described embodiment can be omitted.

  In the catheter device according to the present invention, the guide wire lead-out opening for leading the guide wire 8 led out from the catheter 2 to the outside of the sheath 3 is further provided on the proximal end side of the sheath 3. You may make it provide in the connection member 26 connected. In this case, the guide wire lead-out opening 120 formed in the connecting member 26 is a portion inserted into the sheath 3 of the connecting member 26 as shown in FIG. It is formed in a portion corresponding to the opening 20 for use.

  By the way, in order to provide the connecting member 26 with the guide wire lead-out opening 120 together with the sheath 3, the guide wire lead-out opening 20 of the sheath 3 is provided on the distal end side of the connecting member 26. The part 21 is inserted up to the formed part. That is, the amount of insertion of the connecting member 26 into the sheath 3 is made larger than that of the above-described embodiment. Then, the shape of the distal end portion side inserted into the sheath 3 of the connecting member 26 is deformed so as to have a flat cross-sectional shape following the shape of the bulging portion 21 of the sheath 3 as shown in FIG.

  In addition, since the connecting member 26 is made of metal, it is difficult to partially deform it into a flat shape. Therefore, as shown in FIG. A bulging portion 126 having a flat cross-sectional shape is formed by bending both sides of the slit groove 127 so as to form a U-shaped cross section.

  Then, the guide wire lead-out opening 120 provided in the connecting member 26 is also formed by cutting out a part of the flat bulging portion 126, similarly to the guide wire lead-out opening 20 provided in the sheath 3. In the present embodiment, a part of the slot 127 on the base end side of the bulging portion 126 constitutes the guide wire lead-out opening 120.

  Note that the wire guide piece 23 is supported with its one end 23a positioned on the connecting member 26 also in the present embodiment.

  A portion of the relay member 14 that guides the guide wire 8 led out from the catheter 2 to the lead-out direction guide mechanism 12 by providing the metal connecting member 26 with the guide wire lead-out opening 120 is shown in FIG. 13, since it can be inserted into the rigid connecting member 26, the lead-out direction of the relay member 14 can be made constant, and the guide wire 8 is reliably guided to the lead-out direction guide mechanism 12. be able to.

  In the above-described embodiment, the relay member 14 constituting the guide wire relay mechanism 13 is configured to be supported on the outer peripheral surface of the catheter 2 using the relay guide member 15, but is shown in FIG. 13. As described above, the relay guide member 15 may be supported without being used. For example, the relay member 14 is arranged by matching the opening end 14 a on one end side with the inclined opening portion 11, and the relay member 14 is fixed to the outer peripheral surface of the catheter 2 using the adhesive 117. With this configuration, the number of parts can be reduced and the configuration can be simplified.

  An example of implanting the stent 18 into a blood vessel, for example, a blood vessel, using the medical catheter device according to the present invention as described above will be described below.

  First, in order to implant the stent 18 in the blood vessel, a catheter device in which the stent 18 is mounted on the balloon 1 is prepared. At this time, the stent 18 is mounted on the balloon 1 in a contracted state with a reduced diameter, and the sheath 3 and the catheter 2 are fixed in a state in which relative movement is restricted by the crimping fixing mechanism 34.

  Next, the proximal end portion of the guide wire 8 inserted into the stenosis portion of the blood vessel is inserted into the guide wire insertion passage 9 from the distal end side of the catheter 2. When the guide wire 8 is further inserted into the guide wire insertion passage 9, the guide wire 8 enters the inclined opening 11 from the opening end on the proximal end side of the guide wire insertion passage 9, and the catheter 2 passes through the inclined opening 11. Derived to the side of the midway. As shown in FIGS. 5 and 6, the guide wire 8 led out of the catheter 2 from the side of the catheter 2 is inserted into the relay member 14 with the opening end on one end side facing the inclined opening 11, The relay member 14 is inserted. As shown in FIG. 9, the guide wire 8 inserted into the relay member 14 is guided by the relay member 14 and along the outer peripheral surface of the catheter 2, the wire guide of the wire guide piece 23 constituting the guide direction guide mechanism 12. Derived on or near the portion 24. The guide wire 8 led out on or in the vicinity of the wire guide portion 24 is inserted into a guide wire lead-out opening 20 provided in the sheath 3 while being guided by the wire guide portion 24, and the sheath 3 is guided through the opening 20. Derived outward on the side.

  With the end of the guide wire 8 led out from the guide wire lead-out opening 20 of the sheath 3 held and fixed, the catheter 2 is inserted into the blood vessel along the guide wire 8 inserted through the blood vessel, The balloon 1 and the stent 18 attached to the distal end portion of the catheter 2 are positioned at the stenosis portion where the stent 18 is implanted. At this time, the catheter 2 is inserted into the blood vessel together with the sheath 3.

  When the balloon 1 is positioned together with the stent 18 in the stenosis, the crimping and fixing mechanism 34 is operated to release the fixation of the sheath 3 and the catheter 2, the sheath 3 is moved relative to the catheter 2, and the balloon 1 is moved to the stent. 18 is protruded from the distal end of the sheath 3 together with the balloon 1 and the stent 18 to face the implantation position. Here, using an inflator or the like, the expansion medium is supplied through the expansion medium supply passage 4 provided in the catheter 2, filled into the balloon 1 through the through hole 6, and the balloon is inflated. When the balloon 1 is inflated, the diameter of the stent 18 mounted on the balloon 1 is expanded. The stent 18 is in a state where the inner wall of the blood vessel is supported from the inside by being expanded in diameter. Here, the expansion medium filled in the balloon is extracted through the expansion medium supply passage 4 and is contracted under reduced pressure. At this time, the expanded stent 18 is detached from the contracted balloon 1 by maintaining the expanded state, and is placed in the stenosis portion in the blood vessel to maintain the state of supporting the inner wall of the blood vessel. Is completed.

  During the implantation process of the stent 18, the catheter 2 and the sheath 3 are fixed by the pressure-bonding fixing mechanism 34 and the movement operation is restricted.

  After the stent 18 is implanted at a predetermined implantation position in this manner, the catheter 2 and the sheath 3 are pulled out from the blood vessel along the guide wire 8. At this time, since the guide wire 8 is led out from the middle part of the sheath 3 covering the catheter 2, the guide wire 8 connects the catheter 2 and the sheath 3 with the guide wire 8 fixed outside the body. It is possible to pull out only the length that is not inserted, and a quick extraction operation can be performed. That is, in the catheter apparatus according to the present invention, the advantages of the monorail catheter apparatus can be realized while including the sheath 3 that holds the stent 18 mounted on the balloon 1 provided in the catheter 2.

  By the way, in stent placement, a plurality of stents 18 may be implanted in a stenotic region of a blood vessel. In such a case, the stent 18 can be implanted while realizing rapid replacement of the catheter device, which is an advantage of the monorail type catheter device. It is also possible to reduce the burden.

  And since the catheter apparatus which concerns on this invention has connected the connection member 26 comprised with the metal tubular member which has rigidity to the base end part of the sheath 3 moved with respect to the catheter 2 relatively, Since the connecting member 26 is grasped and the sheath 3 is advanced and retracted, the relative movement between the catheter 2 and the sheath 3 having flexibility that can be easily deformed following a curved or bent blood vessel is stabilized. Can be done.

  As described above, the catheter device according to the present invention reliably prevents the displacement and dropping of the stent 18 mounted on the balloon 1 provided on the catheter 2 while effectively utilizing the advantages of the monorail balloon catheter. Furthermore, the stent 18 can be rapidly implanted into a blood vessel such as a blood vessel of a living body.

  The vascular stent 18 attached to the catheter device according to the present invention is not limited to the biodegradable polymer stent as described above, and can be used for implanting a balloon expandable stent such as a metal stent. Needless to say, it can be widely used.

FIG. 1 is a side view showing a perspective view of a part of a medical catheter device according to the present invention. FIG. 2 is a side view showing a catheter and a guide wire constituting the catheter device according to the present invention. 3 is a cross-sectional view taken along the line III-III in FIG. 4 is a cross-sectional view taken along the line IV-IV in FIG. FIG. 5 is a cross-sectional view showing another example of a catheter. FIG. 6 is a perspective view showing a guide wire relay mechanism provided in the catheter. FIG. 7 is a side view showing a catheter provided with a guide wire relay mechanism. FIG. 8 is a perspective view showing a guide direction guide mechanism for the guide wire provided in the sheath. FIG. 9 is a perspective view showing a state in which a connecting member is connected to the sheath and a guide wire guide direction guide mechanism is attached. FIG. 10 is a cross-sectional view showing a state in which a connecting member is connected to the sheath and a guide wire guide direction guide mechanism is attached. FIG. 11 is a cross-sectional view of the distal end portion of the connecting member. FIG. 12 is a cross-sectional view of the base end side portion of the connecting member. FIG. 13 is a perspective view showing another example of the catheter device according to the present invention. FIG. 14 is a perspective view showing a main part of another embodiment of the connecting member.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 1 Balloon, 2 Catheter, 3 Sheath, 4 Expansion medium supply path, 8 Guide wire, 9 Guide wire insertion path, 11 Inclination opening part, 12 Lead-out direction guide mechanism, 13 Guide wire relay mechanism, 14 Relay member, 15 Relay guide Member, 18 vascular stent, 20 guide wire outlet opening, 21 bulging portion, 23 wire guide piece, 25 tube, 26 connecting member, 34 crimping fixing mechanism

Claims (12)

A balloon that is expanded by supplying the expansion medium is provided on the distal end side, and an expansion medium supply passage through which the expansion medium for expanding the balloon is distributed is formed from the distal end side to the proximal end side. And a catheter in which a guide wire insertion passage through which the guide wire is inserted is formed from the distal end portion to the middle portion on the proximal end side, and
The catheter is inserted, covers the outer peripheral side of the catheter from the distal end side to the proximal end side, holds the balloon provided on the distal end side of the catheter, and opens at least the position covering the balloon and the balloon A sheath that is operated to move relative to the catheter over a position between
The guide wire insertion passage is formed with the open end on the distal end side facing the distal end portion of the catheter, and the open end on the proximal end side facing the middle portion of the catheter,
On the proximal end side of the sheath, a guide wire lead-out opening for leading the guide wire led out from the catheter toward the side of the sheath is provided, and the guide led out from the catheter is provided. A medical catheter device characterized in that a guide direction guide mechanism for guiding a wire so as to guide the wire to the side of the sheath through the guide wire lead-out opening is provided. In the portion corresponding to the proximal end side of the guide wire insertion passage formed in the catheter, a bulge portion bulged so as to be gradually inclined toward the side of the catheter is formed, and the guide wire The opening end on the proximal end side of the insertion passage faces an inclined opening formed by inclining and cutting a part of the bulging portion with respect to the outer peripheral surface of the catheter. The medical catheter device according to 1.   Further, a guide wire led out from the open end to the outside of the catheter is relayed between the open end on the proximal end side of the guide wire insertion passage and the lead-out direction guide mechanism to the lead-out direction guide mechanism. The medical catheter apparatus according to claim 1, further comprising a guide wire relay mechanism for relaying. The guide wire relay mechanism is
It is disposed along the outer peripheral surface of the catheter with the opening end on one end side facing the opening end on the proximal end side of the guide wire insertion passage, and from the opening end on the proximal end side of the guide wire insertion passage. A hollow relay member through which the drawn-out guide wire is inserted and guides the inserted guide wire to the guide-out direction guide mechanism provided in the sheath;
A relay guide member that covers the one end side of the relay member from the open end on the proximal end side of the guide wire insertion passage and is mounted on the outer peripheral side of the catheter to support the relay member on the catheter. The medical catheter device according to claim 3. The guide wire relay mechanism is
It is disposed along the outer peripheral surface of the catheter with the opening end on one end side facing the opening end on the proximal end side of the guide wire insertion passage, and from the opening end on the proximal end side of the guide wire insertion passage. A guide wire to be drawn out is inserted, and has a hollow relay member that guides the inserted guide wire to the guide direction guide mechanism provided in the sheath, and the relay member is joined to the outer peripheral surface of the catheter. The catheter device according to claim 3, wherein the catheter device is fixed to the catheter.   The lead-out direction guide mechanism has one end fixed to the proximal end of the sheath and a wire guide attached so that the distal end enters the guide wire lead-out opening from the outer side of the sheath. The medical catheter device according to claim 1, further comprising a piece.   The catheter and the sheath are formed of a flexible material that can be freely bent and deformed, and a rigid tubular tube is formed on the proximal end side of the sheath where the guide wire lead-out opening is formed. 2. The medical member according to claim 1, wherein a connecting member is connected, and a connecting member for fixing relative movement between the sheath and the catheter is attached to a proximal end portion of the connecting member. Catheter device.   The connecting member connected to the sheath and the proximal end portion of the sheath is inserted from the proximal end side where the guide wire lead-out opening of the sheath is formed to the proximal end portion side of the sheath of the connecting member. 7. The medical catheter device according to claim 6, wherein the medical catheter device is integrally supported by a synthetic resin tube that is crimped and mounted over the distal end side.   8. The medical device according to claim 7, wherein one end portion of the wire guide piece is fixed to a portion of the sheath where the connecting member is inserted and covered with the heat-shrinkable synthetic resin tube. Catheter device.   The catheter and the sheath are formed of a flexible material that can be freely bent and deformed, and a rigid tubular tube is formed on the proximal end side of the sheath where the guide wire lead-out opening is formed. 2. The medical device according to claim 1, wherein a connecting member is connected, and a further guide wire lead-out opening communicating with the guide wire lead-out opening provided in the sheath is formed in the connecting member. Catheter device.   The medical catheter device according to claim 1, wherein a tubular vascular stent is mounted in a reduced diameter state on a balloon provided on the distal end side of the catheter. 12. The medical catheter according to claim 11 , wherein the vascular stent is formed by knitting a linear member made of a biodegradable polymer into a cylindrical shape, and the shape of the expanded diameter is memorized. apparatus.

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