JP2015066007A - Medical catheter device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To discharge air inside a sheath by flowing fluid introduced into the sheath in which a catheter is inserted together with the air while allowing it to be inserted in a vessel while protecting a vessel inner wall.SOLUTION: A medical catheter device includes: a catheter 1 to which a balloon 4 attached with a stent 5 is fitted; a sheath 1 in which the catheter is inserted and which is relatively moved with respect to the catheter across a position covering the stent on the balloon and a position facing outward; and an insertion guide part material 26 which is provided with an insertion guide part 27 whose diameter gradually reduces from a base end part side to an insertion end part side, which projects the insertion end part side from a distal end of the sheath, and is fitted to the distal end side of the catheter. In the insertion guide member, a contact prevention part 27a preventing the distal end side of the sheath from coming into contact with the vessel inner wall when the sheath is inserted in the vessel together with the catheter, and a fluid flow path 32 for flowing the fluid to be supplied in the sheath outside are formed on the base end part side.

Description

  The present invention relates to a medical catheter device that is useful when a vascular stent is implanted in a blood vessel such as a blood vessel of a living body.

  Conventionally, when a stenosis occurs in a blood vessel of a living body, particularly a blood vessel such as a coronary artery, a percutaneous blood vessel, which is an operation for expanding the stenosis of a blood vessel using a balloon-equipped catheter device to improve blood flow Plastic 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 configured so as to be inserted into a blood vessel in a contracted state and then expanded to support the inner wall of the blood vessel.

  A stent that supports a blood vessel from its inside is inserted into the blood vessel using a catheter to which a balloon that is expanded by supplying an expansion medium is attached, 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 on the distal end side, which is the insertion end side of the catheter into the blood vessel, and is transferred to the stent implantation site together with the balloon. The stent transferred to the implantation site is expanded by supplying an expansion medium to the balloon and inflated, and implanted into a lesion site in the blood vessel. Once the diameter of the stent is expanded, the expanded medium is maintained after the expansion medium is extracted from the balloon and reduced, and the site where the stent is implanted is supported from the inside, and the blood flow path in the blood vessel Secure.

  By the way, a stent to be implanted in a blood vessel of a living body such as a blood vessel 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. Since this stent is formed as a single cylindrical body and mounted on the balloon, it receives a load such as a frictional force during the transfer, so that the position of the mounting position relative to the balloon may be displaced and the balloon may drop off. It will cause it. If the stent falls off from above the balloon, the diameter of the stent cannot be expanded even if the balloon is inflated, so that it can be implanted at a desired site. In addition, even if the stent does not fall off the balloon, if the position of the balloon is shifted, the expansion force of the balloon can be uniformly received over the entire length. The diameter is not expanded evenly. Thus, if the diameter of the stent is not expanded uniformly over the entire length, it becomes impossible to accurately support a desired site in the blood vessel.

  Therefore, in order to prevent the stent mounted on the balloon from falling off the balloon and causing displacement during insertion into the blood vessel, the present inventors have protected the balloon catheter on which the stent on the balloon is mounted. Has proposed a catheter device for supplying a stent inserted into a sheath (Patent Document 1).

  In this catheter 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. In this catheter device, a stent mounted on a balloon attached to the distal end of the catheter is housed in a protective sheath and is sent into a blood vessel or other living body into the vessel. Can be reliably prevented from falling off.

Furthermore, the inventors of this application have proposed what is disclosed in Patent Document 2 as another example of a catheter device in which a catheter having a stent mounted on a balloon is inserted into a protective sheath.
WO2004 / 103450 WO2011-036852

  A catheter device in which a catheter to which a balloon to which a stent is attached having a reduced diameter is attached is inserted into a sheath is inserted into a vessel with the distal end side of the catheter as an insertion end. A balloon to be attached to the outer peripheral side in a state where the stent is reduced in diameter is attached to the distal end side of the catheter. The catheter device inserted into the vascular vessel can project the stent mounted on the balloon from the sheath into the vascular vessel by moving the sheath relative to the catheter.

  In this type of catheter device, the sheath is formed as a long tubular body. Then, the distal end of the sheath serving as the insertion end to the vascular vessel is formed so as to open the insertion hole into which the catheter is inserted in order to project the stent mounted on the balloon outward. The distal end of the sheath with the insertion hole opened is a cut surface obtained by cutting the tubular body along a plane perpendicular to the axial direction. Sharp protrusions are formed at the outer periphery of the cut surface. If there is a sharp protrusion at the distal end of the sheath on the outermost periphery of the catheter device, the protrusion may come into contact with the inner wall of the vessel and damage the inner wall of the vessel when inserted into the vessel. There is.

  Therefore, it is desirable to prevent the distal end of the sheath from directly contacting the inner wall of the vessel when the catheter device is inserted into the vessel.

  In addition, in a catheter device used for implanting a stent in a living vessel, a fluid such as physiological saline is introduced into the sheath through which the catheter is inserted in order to prevent air from entering the vessel. Then, an operation of discharging the air in the sheath is performed. The fluid introduced into the sheath for discharging air is supplied from the proximal end side which is the insertion operation portion side of the catheter device and flows out from the distal end of the sheath, thereby discharging the air in the sheath. Therefore, it is necessary to provide a mechanism for allowing the fluid supplied to the sheath together with the air in the sheath to flow out of the apparatus on the distal end side of the sheath.

  Therefore, the present invention protects the inner wall of the vessel without damaging the inner wall of the vessel when the catheter device in which the catheter with the balloon attached to the outer peripheral side of the vessel is attached to the sheath is inserted into the vessel. While allowing insertion into the vessel, the fluid introduced into the sheath through which the catheter is inserted flows out of the device together with the air, and the air in the sheath is discharged to prevent air from entering the vessel Thus, an object of the present invention is to provide a catheter device that can be inserted into a blood vessel.

  The present invention proposed in order to achieve the above-described object is an expansion medium for supplying an expansion medium for expanding a balloon, to which a balloon to which a tubular vascular stent is attached on the outer peripheral side is attached. Between the catheter provided with the supply passage, the position where the catheter is inserted, and the position where the balloon where the vascular stent is mounted is covered and the position where the vascular stent mounted on the balloon faces outward A cylindrical sheath that is moved relative to the catheter and an insertion guide that gradually decreases in diameter from the proximal end side toward the insertion distal end side, and the insertion distal end side from the distal end of the sheath. An insertion guide member that protrudes and is attached to the distal end side of the catheter and is inserted into the vessel integrally with the catheter is provided. The insertion guide member is formed with a contact prevention portion on the proximal end side of the insertion guide portion to prevent the distal end of the sheath from contacting the inner wall of the vessel when the sheath is inserted into the vessel together with the catheter. In addition, a fluid flow passage is formed to flow out the fluid supplied into the sheath.

  The fluid flow path formed in the insertion guide member is a groove formed on the outer peripheral surface of the insertion guide part, and the groove part is formed from the proximal end side of the insertion guide part toward the insertion distal end side. Yes.

  The fluid circulation portion formed in the insertion guide member is a through hole formed through the insertion guide portion, and the through hole extends from the proximal end side of the insertion guide portion to the insertion distal end portion side. Is formed.

  The contact prevention part formed in the insertion guide member is an abutting part that abuts on the end face on the distal end side of the sheath and covers the end face on the distal end side of the sheath.

  Moreover, the contact prevention part formed in the insertion guide member is a base end part of the insertion guide part having an outer peripheral diameter identical to the outer peripheral diameter of the distal end of the sheath.

  The insertion guide member has a cylindrical attachment portion that fits the distal end of the catheter at the proximal end portion of the insertion guide portion, and the attachment portion is attached to the outer peripheral side of the distal end of the catheter and attached to the catheter. And inserted into the vessel together with the catheter.

  A guide wire insertion hole is formed in the catheter, and a guide wire lead-out hole communicating with the guide wire insertion hole formed in the catheter is formed in the insertion guide member attached to the distal end side of the catheter. Is formed.

  Furthermore, fixing means for fixing the relative movement between the sheath and the catheter may be attached to the proximal end side of the sheath.

  The catheter device according to the present invention prevents the outer periphery of the distal end on the insertion end side of the sheath from coming into contact with the inner wall of the vessel by the insertion guide member attached to the distal end of the catheter. The inner wall of the vessel into which the device is inserted can be prevented from being damaged, and the vessel can be protected. Since the insertion guide member that covers the distal end side of the sheath is provided with a fluid flow passage, the insertion guide member is attached to the distal end of the catheter. The air in the sheath through which the catheter is inserted can be surely discharged to the outside of the apparatus by flowing out of the apparatus.

  By forming the fluid flow passage formed in the insertion guide member as a groove on the open outer peripheral surface of the insertion guide portion, the formation of the fluid flow passage is facilitated.

  In addition, by forming the fluid flow passage provided in the insertion guide member as a through hole inside the insertion guide portion, the entire surface on the distal end side of the sheath can be covered with the insertion guide member, and insertion into the vascular vessel Sometimes, the outer periphery on the distal end side of the sheath can be more reliably prevented from contacting the inner wall of the vessel, and the vessel can be protected.

  By supporting the distal end side of the balloon by an insertion guide member attached to the distal end of the catheter, it is possible to prevent displacement of the attachment position of the balloon and to accurately expand the diameter of the vascular stent mounted on the balloon. Can do.

  By providing the guide wire insertion hole in communication with the catheter and the insertion guide member, the catheter device can be accurately and easily inserted into a bent vessel or the like using the guide wire.

  The catheter device is provided with a fixing means for fixing the sheath and the catheter, so that the relative movement between the sheath and the catheter can be regulated, and the state where the distal end of the sheath is covered by the insertion guide member can be maintained. Sometimes it can be more reliably avoided that the outer periphery on the distal end side of the sheath contacts the inner wall of the vessel.

It is a perspective view which shows the external appearance of the medical catheter apparatus which concerns on this invention. It is sectional drawing which shows the catheter and sheath of the catheter apparatus which concern on this invention. It is sectional drawing of the catheter which comprises the catheter apparatus which concerns on this invention. It is a perspective view which shows the distal end side of a catheter and a sheath, and the insertion guide member attached to the distal end of a catheter. It is the perspective view which looked at the insertion guide member from the base end side. It is sectional drawing which shows the state which attached the insertion guide member to the distal end of the catheter. It is a perspective view which shows the state which attached the insertion guide member to the distal end of the catheter. It is a perspective view which shows the other example of an insertion guide member. It is the perspective view which looked at the other example of the insertion guide member from the base end part side. FIG. 10 is a cross-sectional view showing a state where the insertion guide member shown in FIGS. 8 and 9 is attached to the distal end of the catheter.

  Hereinafter, the present invention will be described with reference to an example in which the present invention is applied to a catheter device that is useful for implanting a vascular stent at a desired site in a blood vessel such as a blood vessel of a living body.

  As shown in FIGS. 1 and 2, the catheter device according to the present embodiment includes a catheter 1 and a protective sheath 2 into which the catheter 1 is inserted. The protective sheath 2 is formed as a tubular body, and the catheter 1 is inserted through a through hole 3 formed at the center. The sheath 2 into which the catheter 1 is inserted can be advanced and retracted with respect to the catheter 1.

  As shown in FIG. 2, the catheter 1 constituting the catheter device is formed as a long tubular body having an outer diameter of about 1 to 2 mm and a total length of about 70 to 150 cm. This catheter 1 is formed of the same material as that conventionally used. Specifically, it is formed using a polymer material that has flexibility that can be bent and deformed following a blood vessel such as a blood vessel of a living body into which the catheter 1 is inserted, and that is small in elongation in the long axis direction.

  As shown in FIG. 2, a balloon 4 that is expanded by supplying an expansion medium such as a contrast medium is attached to the distal end side of the catheter 1. A stent 5 to be implanted at a desired position in the blood vessel is mounted on the outer peripheral side of the balloon 4. The stent 5 is formed in a cylindrical shape constituting one flow path from one end side to the other end side, for example, using a linear body made of biodegradable polymer. The stent 5 formed in a cylindrical shape is attached to the outer peripheral side of the balloon 4, and the diameter of the balloon 5 is expanded as the balloon 4 is expanded.

  Here, as for the distal end, a side that becomes an insertion end when the catheter device is inserted into the blood vessel is referred to as a distal end, and a side on which the operator grasps and operates the catheter device is referred to as a proximal end.

  The proximal end side of the stent 5 mounted on the balloon 4 is supported by the stent holding member 6. The stent holding member 6 is displaced with respect to the balloon 4 when the diameter of the stent 5 is expanded. This is supported, and the diameter of the balloon 4 is supported so as to be surely expanded in accordance with the expansion of the balloon 4.

  As shown in FIG. 3, the catheter 1 is provided with a guide wire insertion passage 8 through which a guide wire 7 for guiding the insertion direction of the catheter device into the blood vessel is inserted and a balloon 4 when the catheter device is inserted into the blood vessel. The expansion medium supply passage 9 through which the expansion medium to be expanded circulates is formed concentrically. The guide wire insertion passage 8 is located at the center of the catheter 1 and is formed through the entire length from the proximal end to the distal end of the catheter 1. The expansion medium supply passage 9 is formed as a continuous communication passage continuously extending from the proximal end of the catheter 1 to the distal end side of the balloon 4 so as to surround the guide wire insertion passage 8. Has been. The distal end side of the expansion medium supply passage 9 is closed. A communication hole 10 communicating with the expansion medium supply passage 9 is formed in a portion of the catheter 1 to which the balloon 3 is attached. The expansion medium supplied to the expansion medium supply passage 9 is filled into the balloon 4 through the communication hole 10, or the expansion medium filled in the balloon 4 is sucked.

  A first connecting member 11 is attached to the proximal end side of the catheter 1. The first connecting member 11 is provided with a guide wire port 12 communicated with the guide wire insertion passage 8 and an integration port 13 communicated with the expansion medium supply passage 9.

  The guide wire 7 that guides the insertion of the catheter device into the blood vessel is inserted into the guide wire insertion passage 8 and pulled out of the catheter 1 through the guide wire port 12. Although not shown, an indeflator is connected to the integration port 13. An expansion medium for expanding the balloon 4 is supplied from the indeflator. The expansion medium supplied from the indeflator is circulated from the integration port 13 to the expansion medium supply passage 9 and filled into the balloon 4 through the communication hole 10 formed in the catheter 1 to expand the balloon 4. When the balloon 4 is expanded, the stent 5 attached to the outer peripheral side of the balloon 4 is expanded in diameter as the balloon 4 is expanded.

  As shown in FIG. 2, the catheter 1 having the configuration as described above has a protective sheath 2 that covers the outer peripheral side of the catheter 1 from the distal end side to which the balloon 4 is attached to the proximal end side. It is inserted inside.

  In the present embodiment, the sheath 2 through which the catheter 1 is inserted is connected to the first tubular body 15 covering the distal end side where the balloon 4 to which the stent 5 is attached is provided, and the first tubular body 15. The second tubular body 16 that covers the proximal end side of the catheter 2 is connected. The first tubular body 15 is formed of a tubular body having flexibility that can be bent and deformed, and the second tubular body 16 is formed of a tubular body that is less likely to extend in the major axis direction than the first tubular body 15. ing. Specifically, the first tubular body 15 is formed of a synthetic resin tubular body, and the second tubular body 16 is made of a metal that is less likely to extend in the major axis direction than at least the first tubular body 15. It is formed of a tubular body. The inner diameter of the sheath 1 configured by connecting the first and second tubular bodies 15 and 16 is large enough to allow relative movement of the catheter 1 with the stent 5 mounted on the balloon 4 attached to the distal end side. It is said. The outer diameter of the sheath 2 is about 1 to 3 mm in order to enable insertion into a human blood vessel.

  As shown in FIG. 2, the sheath 2 has a length sufficient to cover at least a portion of the catheter 1 to be inserted into the blood vessel, and the second connecting member 21 that pulls out the catheter 1 to the proximal end side thereof. Is attached. The second connecting member 21 includes a catheter port 22 for pulling out the catheter 1 inserted through the sheath 2 and a physiological saline solution or the like introduced into the sheath 2 for removing air in the sheath 2. An integration port 23 for fluid supply is provided.

  The second connecting member 21 is attached to the sheath 2 via a connecting hub 24 attached to the end portion on the proximal end side of the sheath 1. The proximal end portion of the catheter port 22 provided on the second connecting member 21 is a crimping fixing mechanism that constitutes a fixing means for fixing the relative movement between the catheter 1 and the sheath 2 drawn from the proximal end side of the sheath 2. 25 is provided. The crimping fixing mechanism 25 rotates the screw portion 25 a so that the tightening portion advances and retracts in the catheter port 22, crimps the catheter 2, and fixes the movement with respect to the sheath 1.

  In the catheter device according to the present embodiment having the above-described configuration, the catheter 1 having the stent 5 mounted on the balloon 4 is inserted into the sheath 2 from the distal end side. And it assembles by attaching the 1st connection member 11 to the proximal end side of the catheter 1 protruded from the catheter port 22 provided in the 2nd connection member 21 connected to the proximal end side of the sheath 2. FIG.

  By the way, the distal end side of the through hole 3 formed in the sheath 2 is opened so that the distal end side of the catheter 1 protrudes from the sheath 2 as shown in FIG. When the distal end side of the catheter 1 protrudes from the distal end of the sheath 2, the stent 5 mounted on the balloon 4 protrudes to the outside of the sheath 2, and the support by the sheath 2 is released. The stent 5 expands in diameter following the expansion of the balloon 4 when the support by the sheath 2 is released.

  In the present embodiment, the end surface 2a on the distal end side of the sheath 2 is formed as a cut surface substantially perpendicular to the axial direction as shown in FIG. 4 and opens the distal end side of the through-hole 3. .

  An insertion guide member 26 is attached to the distal end side of the catheter 1 inserted through the sheath 2 as shown in FIGS. The insertion guide member 26 includes an insertion guide portion 27 that enters the blood vessel prior to the sheath 2 and the catheter 1 when inserted into the blood vessel. As shown in FIGS. 4 and 5, the insertion guide portion 27 is inserted into the blood vessel from the proximal end portion so as to smoothly enter the blood vessel without damaging the inner wall of the blood vessel. It is formed in a spindle shape that gradually decreases in diameter toward the tip end side. An end surface 27 a on the proximal end side of the insertion guide portion 27 is formed as a flat surface having an outer peripheral diameter substantially the same as the outer peripheral diameter on the distal end side of the sheath 2.

  An attachment portion 28 for attaching the insertion guide member 26 to the catheter 1 is provided on the proximal end side of the insertion guide portion 27. As shown in FIGS. 4 and 5, the attachment portion 28 is formed in a cylindrical shape, is fitted to the outer peripheral side of the distal end side of the catheter 1, and is inserted into the through hole 3 on the distal end side of the sheath 2. Attached to the distal end side of the catheter 1. Here, the attachment portion 28 is formed in a cylindrical shape having an outer peripheral diameter slightly smaller than the inner peripheral diameter of the through hole 3 in order to ensure smooth movement of the sheath 2. Further, the attachment portion 28 is formed in a cylindrical shape having an inner peripheral diameter that is the same as or slightly smaller than the outer peripheral diameter of the distal end side of the catheter 1 so as to be integrally attached to the far end side of the catheter 1. The

  The insertion guide member 26 is attached to the catheter 1 by inserting the attachment portion 28 into the through hole 3 of the sheath 2 from the distal end side and fitting the attachment portion 28 to the outer peripheral portion on the distal end side of the catheter 1. . At this time, the insertion guide member 26 is formed so that the proximal end portion of the insertion guide portion 27 is larger than the inner peripheral diameter of the through-hole 3, so that the insertion guide portion 27 is moved distally of the sheath 2 as shown in FIG. It is attached to the distal end side of the catheter 1 in a state of protruding from the end.

  As shown in FIG. 6, the outer peripheral portion on the distal end side of the catheter 1 is a reduced diameter portion 29 that gradually decreases in diameter toward the distal end, and the bottom side of the cylindrical attachment portion 28 is the catheter 1. It is desirable to use a reduced diameter portion 30 that follows the reduced diameter portion 29. By providing the reduced diameter portions 29 and 30 as described above, it becomes easy to insert the distal end side of the catheter 1 into the cylindrical attachment portion 28. When the attachment portion 28 is fitted to the distal end side of the catheter 1, the distal end of the catheter 1 and the attachment portion 28 can be closely fitted to each other, and the insertion guide member 26 is attached to the catheter 1. It can be attached in an integrated manner.

  In order to fix and attach the insertion guide member 26 and the catheter 1 more reliably, the attachment portion 28 and the catheter 1 may be joined by an adhesive.

  In the present embodiment, the insertion guide member 26 is formed so that the outer peripheral diameter on the proximal end side of the insertion guide portion 27 is larger than the inner peripheral diameter on the distal end side of the through hole 3 formed in the sheath 2. Therefore, as shown in FIGS. 2 and 6, the end surface 27 a on the proximal end side of the insertion guide portion 27 is brought into contact with the end surface 2 a on the distal end side of the sheath 2, and the insertion guide portion 27 is moved to the distal end of the sheath 2. It is attached to the distal end of the catheter 1 in a state of protruding from the end.

  In the present embodiment, the end surface 27 a on the proximal end side of the insertion guide portion 27 is formed as a surface having the same outer diameter as the end surface 2 a on the distal end side of the sheath 2. Therefore, when the sheath 2 is moved relative to the catheter 1 and the end surface 2 a on the distal end side of the sheath 2 is abutted against the end surface 27 a on the proximal end side of the insertion guide portion 27, The end surface 2a is covered with the end surface on the insertion guide portion side. As shown in FIGS. 6 and 7, the sheath 2 and the insertion guide portion 27 are abutted without causing any step between the end surfaces 2 a and 27 a that are abutted against each other. The outer peripheral surface of the sheath 2 and the outer peripheral surface of the insertion guide portion 27 are smoothly continuous surfaces, and the outer periphery of the end surface 2a on the distal end side of the sheath 2 contacts the inner wall of the blood vessel when inserted into the blood vessel. To prevent.

  In this way, the end surface 27a on the proximal end side of the insertion guide portion 27 that abuts the end surface 2a on the distal end side of the sheath 2 and smoothly connects the outer peripheral surface of the sheath 2 to the outer peripheral surface of the insertion guide portion 27 is: It becomes an inner wall contact prevention part which prevents that the outer periphery of the end surface 2a of the distal end side of the sheath 2 contacts a vascular inner wall.

  As shown in FIG. 6, the insertion guide member 26 attached to the distal end of the catheter 1 is provided with a guide wire insertion hole 31 through which the guide wire 7 inserted through the guide wire insertion passage 8 is inserted. The guide wire insertion hole 31 communicates with the cylindrical attachment portion 28 so that the proximal end portion of the insertion guide portion 27 penetrates from the distal end side to the distal end side.

  Further, on the outer peripheral surface of the insertion guide portion 27, there is a groove portion 32 constituting a fluid flow passage for discharging fluid such as physiological saline supplied into the sheath 2 through the integration port 23 to the outside of the sheath 2. Is formed. As shown in FIGS. 4 and 5, the groove portion 32 is formed so as to communicate from the proximal end portion of the insertion guide portion 27 to a midway portion on the distal end portion side. 6 and 7, when the insertion guide member 26 is attached to the distal end of the catheter 1, the proximal end portion 32a of the groove portion 32 faces the through hole 3 facing the end surface 2a on the distal end side. It is formed to the depth to be.

  The catheter device that protrudes from the distal end of the sheath 2 and has the insertion guide member 26 attached to the distal end side of the catheter 1 so as to cover the end surface 2a on the distal end side of the sheath 2 is in the initial state of being inserted into the blood vessel. 2, the stent 5 mounted on the balloon 4 is in a state of being housed in the sheath 2. At this time, the sheath 2 is in a state in which the end surface 2 a on the distal end side is in contact with the end surface 27 a on the proximal end side of the insertion guide portion 27. When the end surface 27a on the proximal end side of the insertion guide portion 27 contacts the end surface 2a on the distal end side of the sheath 2, the distal end of the through hole 3 formed in the sheath 2 is covered with the insertion guide portion 27. It becomes a state. In the catheter device according to the present embodiment, since the groove portion 32 that constitutes the fluid flow path is formed on the outer peripheral surface of the insertion guide portion 27 of the insertion guide member 26, the physiology supplied into the sheath 2 from the integration port 23. A fluid such as saline can be discharged from the distal end of the sheath 2 to the outside, and the air remaining in the sheath 2 can be discharged together with the fluid.

  Since the groove portion 32 provided on the outer peripheral surface of the insertion guide portion 27 is formed at a depth that faces a part of the through hole 3 facing the distal end of the sheath 2 outward, the outer side of the sheath 2 on the distal end side is formed. A part of the periphery also faces the groove 32. Therefore, it is desirable that the groove 32 be formed to have a width capable of preventing the inner wall of the blood vessel from entering the groove 32 and contacting the outer periphery on the distal end side of the sheath 2.

  By the way, the groove portion 32 formed on the outer peripheral surface of the insertion guide portion 27 has a through hole 3 facing the end surface 2a on the distal end side of the sheath 2 when the insertion guide member 26 is attached to the distal end of the catheter 1. Any one may be used as long as it has a configuration in which a part thereof is opened and the fluid supplied into the sheath 2 can flow out. For example, the groove 32 has a shape in which a part on the proximal end side of the insertion guide part 27 is cut out to a depth sufficient to open a part of the through hole 3 facing the end surface 2 a on the distal end side of the sheath 2. But you can.

  Furthermore, a plurality of groove portions 32 formed on the outer peripheral surface of the insertion guide portion 27 may be provided at equal intervals in the circumferential direction of the insertion guide portion 27. In the present embodiment, four groove portions 32 are formed at equal intervals in the circumferential direction of the insertion guide portion 27.

  By providing the plurality of groove portions 32 at equal intervals on the outer peripheral surface of the insertion guide portion 27, the fluid can be discharged from the entire circumference of the through-hole 3 through which the catheter 1 is inserted, thereby enabling smooth discharge of the fluid. To do.

  In the initial state before the stent 5 mounted on the balloon 4 is implanted in the blood vessel, the catheter device of the present embodiment configured as described above is configured such that the catheter 1 is placed in the sheath 2 as shown in FIG. It will be in the state pulled in. At this time, the stent 5 mounted on the balloon 4 attached to the far end side of the catheter 1 is placed in a state of being supported from the outer peripheral side by the sheath 1 as shown in FIG. Further, as shown in FIG. 6, the sheath 2 is in a state in which the end surface 2 a on the distal end side is in contact with the end surface 27 a on the proximal end side of the insertion guide portion 27.

  When the catheter device is in the initial state, the catheter 1 inserted through the sheath 2 is fixed to the sheath 2 by tightening the proximal end portion pulled out from the catheter port 22 of the second connection member 21 by the crimping fixing mechanism 25. Thus, the relative movement with respect to the sheath 2 is restricted.

  When the catheter device is in the initial state, physiological saline, which is a fluid for discharging air, is supplied from the integration port 23 into the sheath 2. When physiological saline is supplied into the sheath 2, the air remaining in the sheath 2 flows from the distal end of the sheath 2 through the groove portion 32 provided on the outer peripheral surface of the insertion guide portion 27 of the insertion guide member 26. Is discharged outside. At this time, by supplying physiological saline until the sheath 2 is filled, the air in the sheath 2 can be completely discharged. In addition, the excess of the physiological saline supplied in the sheath 2 is discharged | emitted outside the sheath 2 through the groove part 32 provided in the insertion guide part 27. FIG.

  In the initial state of insertion into a blood vessel, the catheter device according to the present embodiment covers the distal end of the sheath 2 with the insertion guide member 26 attached to the distal end of the catheter 1, and the outer peripheral surface of the sheath 2 and the insertion guide member The outer peripheral surface of 26 is formed as a smoothly continuous surface, and projections and projections at the distal end of the sheath 2 are prevented from protruding from the outer peripheral surface and coming into contact with the inner wall of the vessel. Accidents that could cause you to be prevented. In addition, this catheter device allows the physiological saline supplied into the sheath 2 to flow out of the sheath 2 and reliably discharge the air in the sheath 2 through which the catheter 1 has been inserted. The stent 5 can be safely implanted at a desired implantation position in the blood vessel without mixing air therein.

  The insertion guide member 26 is inserted while contacting the inner wall of the blood vessel when the catheter device is inserted into the blood vessel. Therefore, it is desirable that the insertion guide member 26 is formed of a synthetic resin such as a silicone resin having a small friction coefficient and flexibility that does not give a large load to the blood vessel when inserted into the blood vessel.

  In the embodiment described above, the fluid flow passage for discharging the fluid such as physiological saline supplied into the sheath 2 to the outside of the sheath 2 is constituted by the groove portion 32 formed on the outer peripheral surface of the insertion guide portion 27. However, as shown in FIGS. 8, 9, and 10, it may be formed as a fluid circulation hole 33 that penetrates the inside of the insertion guide portion 27. As shown in FIG. 10, the fluid circulation hole 33 constituting the fluid flow passage is opened at one end side to the end surface 27 a on the proximal end side of the insertion guide portion 27 and the other end side toward the distal end side of the insertion guide portion 27. It is made open.

  Note that when the insertion guide member 26 is attached to the catheter 1, the fluid flow passage 33 is arranged so that the open end 33 a on one end side faces the through hole 3 that opens at the distal end of the sheath 2 as shown in FIG. 10. Form.

  Also in this embodiment, it is desirable to provide a plurality of fluid flow passages 33. By forming a plurality of fluid flow passages 33, the fluid can be discharged from the entire circumference of the through hole 3 of the sheath 2 through which the catheter 1 is inserted, and the fluid can be discharged smoothly. The plurality of fluid flow paths 33 are desirably formed at equal intervals in the circumferential direction of the insertion guide portion 27.

  In the catheter device according to the present embodiment, since the fluid flow hole 33 constituting the fluid flow passage is formed inside the insertion guide portion 27, the end surface 2 a on the distal end side of the sheath 2 is used as the base of the insertion guide portion 27. It can be completely covered by the end surface 27a on the end side. Moreover, since the fluid flow passage 33 is formed so as to penetrate the insertion guide portion 27 and open to the distal end side of the insertion guide portion 27, the physiological saline supplied into the sheath 2 is inserted into the insertion guide member. 26 can be discharged and discharged from the tip of the 26, and the air in the sheath 2 can be discharged more reliably.

  The insertion guide member 26 of the present embodiment is also preferably formed of a synthetic resin such as a silicone resin having a small friction coefficient and flexibility that does not give a large load to the blood vessel when inserted into the blood vessel.

  In the embodiment described above, the insertion guide member 26 is attached to the catheter 1 by fitting the cylindrical attachment portion 28 provided on the proximal end side of the insertion guide portion 27 to the distal end of the catheter 1. However, the base end face of the insertion guide part 27 may be attached to the end face on the distal end side of the catheter 1 by using an adhesive or the like without providing the attaching part 28.

  As described above, in the catheter device according to the present invention, the insertion guide member 26 attached to the distal end of the catheter 1 prevents the distal end of the sheath 2 from contacting the inner wall of the blood vessel. The blood vessel into which the catheter device is inserted can be protected. Further, a fluid flow passage is provided in the insertion guide member 26 so that a fluid such as physiological saline supplied to the sheath 2 can be circulated to flow out of the sheath 2, so that the air in the sheath 2 can be reliably supplied. Can be discharged and can be safely inserted into a blood vessel.

  Furthermore, since the catheter device according to the above-described embodiment can regulate the relative movement by fixing the catheter 1 and the sheath 2 to the crimping and fixing mechanism 25, the movement of the sheath 2 is suppressed when inserted into the blood vessel, The distal end side of the sheath 2 can be reliably covered with the insertion guide member 26, and the outer periphery on the distal end side of the sheath 2 can be prevented from contacting the inner wall of the blood vessel and damaging the inner wall of the blood vessel.

  DESCRIPTION OF SYMBOLS 1 Catheter, 2 sheath, 2a End surface of the distal end side of a sheath 3 Through-hole, balloon, 5 Stent, 8 Guide wire insertion hole, 9 Expansion medium supply path, 25 Crimp fixing mechanism, 26 Insert guide member, 27 Insert guide part , 27a End surface on the base end side, 28 mounting portion, 32 groove portion constituting the fluid flow passage, 33 fluid flow hole

Claims (8)

A catheter to which a balloon to which a tubular vascular stent is attached on the outer peripheral side is attached, and an expansion medium supply passage for supplying an expansion medium for expanding the balloon;
The catheter is inserted and the catheter is interposed between a position that covers the balloon on which the vascular stent is mounted and a position on which the vascular stent mounted on the balloon faces outward. A tubular sheath that is relatively moved;
An insertion guide portion that gradually decreases in diameter from the proximal end side toward the insertion distal end side is provided, and the insertion distal end portion projects from the distal end of the sheath and is attached to the distal end side of the catheter An insertion guide member that is inserted into the vessel integrally with the catheter,
The insertion guide member is a contact prevention portion for preventing contact of the distal end of the sheath with the inner wall of the vessel when the sheath is inserted into the vessel together with the catheter on the proximal end side of the insertion guide portion. And a fluid flow passage for discharging the fluid supplied into the sheath to the outside is formed.   The fluid flow passage formed in the insertion guide member is a groove formed in the outer peripheral surface of the insertion guide portion, and the groove portion is formed from the proximal end side to the insertion distal end side of the insertion guide portion. The medical catheter device according to claim 1, wherein the medical catheter device is provided.   The fluid circulation portion formed in the insertion guide member is a through hole formed through the insertion guide portion, and the through hole extends from the proximal end side to the insertion distal end portion side of the insertion guide portion. The medical catheter device according to claim 1, wherein the medical catheter device is formed.   2. The contact preventing portion formed on the insertion guide member is a contact portion that contacts the distal end surface of the sheath and covers the distal end surface of the sheath. The medical catheter device according to any one of?   The contact prevention part formed in the said insertion guide member is a base end part of the said insertion guide part which has the outer periphery diameter same as the outer periphery diameter of the distal end of the said sheath, The Claim 1 to 3 characterized by the above-mentioned. The medical catheter device according to any one of the above.   The insertion guide member has a cylindrical attachment portion that fits the distal end of the catheter at the proximal end portion of the insertion guide portion, and the attachment portion is fitted to the outer peripheral side of the distal end of the catheter. The medical catheter device according to any one of claims 1 to 5, wherein the medical catheter device is attached to the catheter and inserted into the vessel integrally with the catheter.   The catheter has a guide wire insertion hole formed therein, and the insertion guide member attached to the distal end of the catheter has a guide wire communicating with the guide wire insertion hole formed in the catheter. The medical catheter device according to any one of claims 1 to 6, wherein an extraction hole is formed.   The medical catheter according to any one of claims 1 to 8, wherein a fixing means for fixing relative movement between the sheath and the catheter is attached to a proximal end portion side of the sheath. apparatus.

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