JP2016174828A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device which enables efficient and effective treatment to be performed on a treatment target site within a living body while ensuring introduction property into a body cavity of a relatively small diameter.SOLUTION: A medical device 10 comprises a balloon catheter 100 and a scoring device 200 which are introduced into a body cavity 420 from introduction positions different from each other, and are combined with each other in a state in which they are delivered to a narrow section N, thereby making it possible to perform a predetermined treatment on the narrow section N.SELECTED DRAWING: Figure 6

Description

  The present invention relates to a medical device used for performing a predetermined treatment in a living body.

  Conventionally, in the medical field, in performing various treatments on a treatment target site such as a stenosis part formed in a body cavity of a living body, by combining a plurality of medical members and combining the functions of each member, Attempts have been made to improve the effect and improve the efficiency of the procedure.

  For example, Patent Document 1 below discloses a medical device including a balloon catheter and a blade that adds a scoring function to the balloon catheter by being assembled in the balloon catheter in a living body.

JP 2012-81267 A

  In the above-described conventional medical device, the blade is configured to be mounted at a position that is separated from the central axis of the balloon by a predetermined distance in the radial direction over the entire length in the longitudinal direction of the balloon catheter. Yes. For this reason, when a blade is used, the diameter of the medical device is increased as compared with a case where a balloon catheter is used alone. When attempting delivery, the introduction of the medical device may be hindered, and in some cases, the use of the medical device may be abandoned.

  As described above, when a medical device is inserted into a small-sized blood vessel or the like, since the blood vessel access device is generally limited to a small diameter, the size of the medical device to be used becomes a problem. . In addition, in catheter treatment that attempts to treat a stenosis via a thin blood vessel or the like, a balloon catheter alone may not be able to perform sufficient treatment due to factors such as insufficient expansion force or displacement of the balloon. In addition, the scoring balloon with a scoring function added to the balloon of the balloon catheter has fewer varieties than general balloon catheters. Difficult to choose.

  The present invention has been made in view of the above-described problems, and is efficient and effective for a treatment target site existing in a living body while ensuring introduction into a relatively small body cavity. An object of the present invention is to provide a medical device that enables various treatments to be performed.

  The medical instrument of the present invention is a medical instrument that is introduced into a body cavity of a living body and used for performing a predetermined treatment on a treatment target site existing in the living body, and is independent of the body cavity. The first treatment member and the second treatment member are introduced, and the first treatment member is inserted into the body cavity, and the first body shaft includes the first body shaft and the first body shaft. A first distal end portion located on the body cavity insertion side, a first proximal end portion located on the hand operation side, and a first treatment portion provided on the first distal end portion, and the second The treatment member includes a second main body shaft to be inserted into the body cavity, a second distal end portion located on the insertion side in the body cavity and a second base located on the hand operation side of the second main body shaft. An end portion is configured to be accommodated in the second body shaft, and the second body shaft A second treatment portion configured to be able to be inserted and removed from a distal end opening provided in the distal end portion, and the first main body shaft and the second main body shaft are configured so as not to be inserted into each other, The medical treatment is characterized in that the treatment can be performed on the treatment target site when the first treatment section is inserted into the second treatment section at a predetermined position in the body cavity. Instruments.

  According to the medical device according to the present invention, the first treatment member and the second treatment member in a state before being combined are introduced into the body cavity of the living body through different introduction positions, so that the medical device has a small diameter. It can be introduced in the state. In addition, after delivering the first treatment member and the second treatment member to the treatment target site, it is possible to add a predetermined function to the medical instrument by combining the treatment members. Therefore, it is possible to provide a medical instrument that can perform an efficient and effective treatment on a treatment target site existing in a living body while ensuring introduction into a relatively small body cavity. Can do.

It is a figure showing the whole medical instrument composition concerning an embodiment. It is a figure for demonstrating each part of a 2nd treatment member (scoring device), Comprising: (A) is an expanded sectional view which shows the front-end | tip part of a scoring device, (B) is FIG. 2 (A). It is a perspective sectional view expanding and showing the 2B portion shown. It is a figure which shows typically the leg of the biological body used as the object of the procedure using a medical device. 4A to 4C are cross-sectional views for explaining examples of use of medical instruments. 5A to 5C are cross-sectional views for explaining examples of use of medical instruments. FIGS. 6A and 6B are cross-sectional views for explaining a medical device according to the first modification. 10 is a cross-sectional view showing a medical instrument according to Modification 2. FIG. It is a figure which shows the medical device which concerns on the modification 3, Comprising: (A) is a perspective view which expands and shows the principal part of a 2nd treatment member (scoring device), (B) is the 1st before expansion deformation. The front view which shows the 2 treatment member (scoring device) of FIG. 2, (C) is a front view which shows the 2nd treatment member after expansion deformation.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

  FIG. 1 is a diagram schematically illustrating an overall configuration of a medical instrument according to an embodiment, FIG. 2 is a diagram illustrating a configuration of each part of a second treatment member (scoring device) included in the medical instrument, and FIG. The figure which showed typically the object of the procedure using a medical device, and the leg of a living body, and Drawing 4-Drawing 5 are sectional views showing simply the example of use of the medical device concerning an embodiment.

  As shown in FIG. 1, the medical device 10 according to the present embodiment includes a balloon catheter 100 that constitutes a first treatment member, and a scoring device 200 that constitutes a second treatment member.

  The balloon catheter 100 is a well-known one used in the medical field, and can be used to expand a stenosis N as a treatment target site formed in a body cavity such as a blood vessel. On the other hand, the scoring device 200 adds a scoring function to the balloon 110 of the balloon catheter 100 when performing the treatment with the balloon catheter 100, thereby enabling an efficient and effective treatment with the balloon catheter 100. It is.

  First, the balloon catheter 100 will be described with reference to FIG. The balloon catheter 100 is described as an example of the embodiment, and the balloon catheter according to the present invention is not limited to the configuration described here.

  The balloon catheter 100 is a medical device that spreads and treats a stenosis by inserting the shaft 120 into a living organ and expanding the balloon 110 disposed on the distal end side of the shaft 120 at the stenosis (lesion). .

  In the present embodiment, the balloon catheter 100 is configured as a balloon catheter for treating a stenosis N formed in an artery running in the lower limb of a living body. However, the balloon catheter 100 is configured to be used for the purpose of treating and improving a stricture formed in a living organ such as a coronary artery, other blood vessels, bile ducts, trachea, esophagus, urethra, and other organs. May be.

  The balloon catheter 100 includes an elongated shaft (first main body shaft) 120 having flexibility and an extension disposed on a distal end portion (first distal end portion) 120a located on the body cavity insertion side of the shaft 120. A deformable and contractible balloon 110 (corresponding to a “first treatment portion”), and a hub 150 disposed on a proximal end portion (first proximal end portion) 120b located on the hand operation side of the shaft 120, Is provided.

  The balloon catheter 100 is a so-called rapid exchange type in which an opening 125 through which the guide wire 140 is led out is provided near the distal end side of the shaft 120. However, the balloon catheter 100 may be a so-called over-the-wire type balloon catheter formed such that the guide wire lumen extends from the distal end of the shaft 120 to the proximal end.

  The shaft 120 is formed by inserting a hollow tubular member called an inner tube shaft into a hollow tubular member also called an outer tube shaft, and arranging the inner tube shaft and the outer tube shaft concentrically with each other. It consists of a heavy pipe structure.

  A guide wire lumen into which the guide wire 140 can be inserted is formed on the inner tube shaft. A lumen for a pressurized medium for expanding the balloon 110 is formed between the outer peripheral surface of the inner tube shaft and the outer tube shaft.

  The guide wire 140 is inserted into the guide wire lumen with the distal end opening 123 provided at the distal end of the inner tube shaft and the proximal end opening 125 provided at the proximal end of the inner tube shaft as inlets or outlets, respectively. .

  As the guide wire 140, those known in the medical field can be used as appropriate, for example, superelastic alloys such as nickel-titanium alloys and copper-zinc alloys, metal materials such as stainless steel, and resins having relatively high rigidity. A long wire such as a material covered with a resin material such as polyvinyl chloride, polyethylene, polypropylene, or ethylene-propylene copolymer can be used.

  As a constituent material of the inner tube shaft and the outer tube shaft constituting the shaft 120, various materials used in known balloon catheters can be appropriately used. As an example, polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, or thermoplastic resin such as soft polyvinyl chloride can be used.

  The hub 150 includes a connection device 151 that can be connected in a liquid-tight and air-tight manner to a supply device (not shown) such as an indeflator for supplying a pressurized medium. The connecting portion 151 of the hub 150 can be configured by, for example, a known luer taper configured such that a fluid tube or the like can be connected / separated.

  A pressurized medium (for example, a physiological saline, a contrast medium, etc.) used for expanding the balloon 110 can flow into the shaft 120 via the connection portion 151 of the hub 150. The pressurized medium is supplied to the balloon 110 via a pressurized medium lumen formed in the shaft 120.

  The balloon 110 includes an expansion effective portion (pressurizing portion) 116 that pushes the constriction portion in accordance with expansion deformation, a distal-side tapered portion that is continuous with the distal end side of the expansion effective portion 116, and a base that is continuous with the proximal end side of the expansion effective portion 116. An end-side taper portion. The distal end portion of the balloon 110 is fixed in a liquid-tight and air-tight manner to the inner tube shaft included in the shaft 120, and the proximal end portion of the balloon 110 is fixed in a liquid-tight and air-tight manner in the outer tube shaft included in the shaft 120. .

  The constituent material of the balloon 110 is not particularly limited. For example, polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-acetic acid. Vinyl copolymers, thermoplastic resins such as polyurethane, polyamide elastomer, polystyrene elastomer, silicone rubber, latex rubber, and the like can be used.

  X-rays are provided on each part of the balloon catheter 100 and the guide wire 140 so that the relative positional relationship with the scoring device 200 can be confirmed outside the living body while being used in the living body. A contrast marker can be provided. The X-ray contrast marker can be configured by, for example, embedding Pt, Pt alloy, W, W alloy, Ag, Ag alloy or the like in each member or bonding these materials.

  Moreover, it is preferable that the shape of the X-ray contrast marker is formed to have a predetermined length along each extending direction in the balloon catheter 100 and the guide wire 140, for example. With this configuration, it is possible to perform a quick and accurate procedure depending on the relationship with X-ray contrast markers 221a and 221b provided on the scoring device 200 described later.

  Next, the scoring device 200 will be described.

  As shown in FIG. 1, a scoring device 200 is configured to be a long tubular member (second body shaft) 210 configured to be introduced into a living body, and to be accommodated in the tubular member 210, and to be tubular. A scoring member (corresponding to a “second treatment portion”) 230 provided so as to be freely inserted and removed by a distal end opening 213 provided in a distal end portion (second distal end portion) 210a located on the body cavity insertion side of the member 210; And a proximal end portion (second proximal end portion) 210b on which a hand operating portion 240 for operating the movement of the scoring member 230 in and out of the tubular member 210 is disposed.

  In the medical instrument 10 according to the present embodiment, the shaft 120 of the balloon catheter 100 and the tubular member 210 of the scoring device 200 are configured so that they cannot be inserted into each other.

  In the description of the embodiment, the direction in which the tubular member 210 extends is referred to as the longitudinal direction or the axial direction, the side of the tubular member 210 that is introduced into the living body is referred to as the distal end side, and the side on which the hand operating unit 240 is disposed is based on. It is called the end side. The distal end portion means a predetermined range from the distal end to the proximal end side, and the proximal end portion means a predetermined range from the proximal end to the distal end side.

  As shown in FIGS. 1 and 2A, the tubular member 210 has a hollow shape including a distal end opening 213 and a lumen 211 connected to the distal end opening 213. As a material constituting the tubular member 210, for example, the same material as that constituting the shaft 120 of the balloon catheter 100 described above can be used.

  As shown in FIG. 2A, the distal end portion of the tubular member 210 is formed in a tapered shape in which the diameter of the lumen 211 gradually increases toward the distal end side. Since the distal end portion of the tubular member 210 is formed in a tapered shape, the scoring member 230 can be smoothly put in and out of the tubular member 210.

  The scoring member 230 is composed of a linear member having shape memory properties. As shown in FIGS. 1 and 2A, the scoring member 230 is in a contracted state while being accommodated in the tubular member 210, and when the scoring member 230 is projected from the distal end opening 213 of the tubular member 210, It is shaped in advance so as to expand and deform into a predetermined shape with the protrusion.

  Specifically, as shown in FIG. 5A, when the scoring member 230 protrudes from the tubular member 210, the scoring member 230 is in a position eccentric from the axial center (central axis along the longitudinal direction) of the tubular member 210. 210 is expanded and deformed so as to form an insertion portion 235 into which insertion is possible. The scoring member 230 forms a space corresponding to the insertion portion 235 by being deformed so as to be spirally wound. Note that the shape of the insertion portion 235 and the density (interval) of the spiral shape can be appropriately changed according to the specification of the balloon 110 and the like, and are not particularly limited.

  The scoring member 230 is, for example, titanium-based (Ti—Ni, Ti—Pd, Ti—Nb—Sn, etc.), copper-based alloy, stainless steel (SUS304), β titanium steel, Co—Cr alloy, nickel titanium. It can be composed of an alloy having spring properties such as an alloy, other resin materials, or the like.

  The hand operation unit 240 is configured such that a user or the like who uses the medical instrument 10 can hold it with fingers. Further, the hand operation unit 240 is provided with a winding shaft 243 to which the scoring member 230 is connected, and a rotary dial 241 capable of operating winding and feeding of the scoring member 230 by the winding shaft 243. Yes.

  When the scoring device 200 is used, if the scoring member 230 is to be moved to the distal end side, the rotary dial is rotated in the direction of the arrow a1 in FIG. Then, in conjunction with the rotation of the rotary dial 241, the winding shaft 243 rotates and the scoring member 230 is sent out toward the distal end side as indicated by an arrow b1. On the other hand, when it is desired to move the scoring member 230 to the proximal end side, the rotary dial is rotated in the direction of the arrow a2 in FIG. Then, in conjunction with the rotation of the rotary dial 241, the winding shaft 243 rotates and the scoring member 230 is pulled toward the base end side as indicated by an arrow b <b> 2. In this way, by operating the rotary dial 241, the scoring member 230 protrudes from the distal end opening 213 of the tubular member 210 and is easily inserted into the lumen 211 via the distal end opening 213. Can do. Further, the protruding amount of the scoring member 230 from the distal end opening 213 of the tubular member 210 can be adjusted easily and accurately.

  As shown in FIGS. 1 and 2A, a hollow insertion member 220 into which the balloon catheter 100 can be inserted is installed on the outer surface of the scoring device 200 on the distal end side.

  The insertion member 220 is configured by a tubular member that includes a lumen 221, a distal end opening 223 that continues to the distal end side of the lumen 221, and a proximal end opening 225 that continues to the proximal end side of the lumen 221.

  The distal end opening 223 of the insertion member 220 is disposed so as to face the distal end side of the tubular member 210 through which the scoring member 230 is inserted. For this reason, as shown in FIG. 5A, when the balloon catheter 100 is inserted into the insertion member 220 when performing the treatment using the medical instrument 10, the distal end portion of the balloon catheter 100 is opened to the distal end opening of the tubular member 210. It can be guided to the part 213 side. As a result, the balloon 210 can be easily inserted into the insertion portion 235 formed by the scoring member 230 protruding from the distal end opening 213 of the tubular member 210. Note that the guide wire 140 inserted into the tubular member 210 prior to the balloon catheter 100 can be similarly guided in the direction of movement of its distal end.

  As shown in FIG. 1, the insertion member 220 is provided with X-ray contrast markers 221 a and 221 b extending along the longitudinal direction of the tubular member 210. For example, when an X-ray contrast marker is formed on the shaft 120 of the balloon catheter 100 with a certain length in the axial direction, the X-ray contrast marker on the balloon catheter 100 side and each X-ray contrast marker on the insertion member 220 side By confirming the positional relationship (overlapping, parallel relationship, etc.) in the axial direction with respect to 221a and 221b, it is possible to easily and quickly confirm whether or not the balloon catheter 100 is inserted through the insertion member 220. Similarly, the guide wire 140 inserted into the tubular member 210 prior to the balloon catheter 100 can be easily and quickly confirmed whether or not the guide wire 140 is inserted into the insertion member 220.

  In the present embodiment, two X-ray contrast markers 221a and 221b are provided at the upper and lower positions so that it can be more clearly confirmed whether or not the balloon catheter 100 has been inserted into the insertion member 220. The number of X-ray contrast markers formed on the insertion member 220 may be one, or three or more. Further, the X-ray contrast marker formed on the insertion member 220 preferably extends in parallel with the longitudinal direction of the tubular member 210. However, if the X-ray contrast marker is configured to have a certain length, the insertion of the balloon catheter 100 is possible. Since it is possible to determine whether or not there is, it does not have to be formed so as to extend in parallel. Each X-ray contrast marker 221a, 221b can be formed by the same method as the method of forming the X-ray contrast marker on the balloon catheter 100 described above.

  As shown in FIG. 2A, the lumen 221 of the insertion member 220 can be formed in a tapered shape whose diameter gradually decreases from the proximal opening 225 side toward the distal opening 223 side. By forming the lumen 221 in such a shape, the operation of inserting the balloon catheter 100 into the insertion member 220 can be performed more smoothly. Note that the lumen 221 of the insertion member 220 may be formed to have a certain diameter in the axial direction, for example.

  As shown in FIG. 2B, the scoring member 230 has a shape in which the shape of the axial orthogonal cross section is substantially a triangle. As shown in FIG. 5B, when the balloon 110 is expanded with the balloon 110 inserted into the insertion portion 235, each top portion 231 located in the outer peripheral direction of the scoring member 230 damages the narrowed portion N. This increases the effectiveness of the expansion function of the balloon 110. Furthermore, when the scoring member 230 bites into the stenosis N, a locking force is applied between the scoring member 230 and the balloon 110 and the stenosis N in the assembled state. As a result, the expansion function for expanding the constriction N by the balloon 110 can be further enhanced.

  The above-mentioned “acting a locking force” means that the stenosis N is expanded by applying some mechanical action to the stenosis N, rather than simply pressing the outer surface of the balloon 110 against the stenosis N. It means that it is in a state where it is possible to enhance the action to be performed. For example, by providing the scoring member 230 with a sharp shape or member that is easy to bite into the constriction N, or by providing the scoring member 230 with a structure or shape that causes a larger frictional force than the balloon 110, You may comprise so that the scoring function may be added to the balloon 110. FIG. Further, for example, it is possible to add a scoring function by a method of providing a groove, a roughened portion, a protrusion, or the like on the surface of the scoring member 230.

  The cross-sectional shape of the scoring member 230 is not limited to a triangle, and can be appropriately changed as long as the scoring function can be exhibited. For example, the scoring member 230 can be formed into another polygon.

  In order to prevent the balloon 110 from being damaged by the scoring member 230, for example, the surface located inside the insertion portion 235 formed by the scoring member 230 is considered to be in contact with the balloon 110. It is preferable to form a part having a smaller frictional force than other parts, or to provide a part to which the function of locking as described above is not added.

  Next, a usage example of the medical instrument 10 will be described.

  As shown in FIG. 3, the medical device 10 can be used for the purpose of treating a stenosis N formed in an artery running on a lower limb 400 of a living body, for example.

  Since the artery running through the lower limb 400 is generally small in diameter, a puncture serving as an introduction port formed prior to the introduction of the medical device 10 must be formed small. For this reason, there is a possibility that smooth introduction work cannot be performed in a state where the devices 100 and 200 of the medical instrument 10 are assembled. From this point of view, in this embodiment, the balloon catheter 100 and the scoring device 200 included in the medical instrument 10 are introduced into the living body through perforations formed at different positions on the surface of the living body. The introduction position of the balloon catheter 100 is a first introduction position P1 for convenience, and the introduction position of the scoring device 200 is a second introduction position P2 for convenience.

  The blood vessels in which the introduction positions P1 and P2 are set can be appropriately changed according to the position or the like where the stenosis portion N to be treated is formed, and thus are not particularly limited. The introduction positions P1 and P2 are set in the artery 410. Further, for example, each of the introduction positions P1 and P2 can be set in the above-knee popliteal artery 420.

  In the following description, a procedure example for treating the stenosis N formed in the above-knee popliteal artery 420 will be described.

  As shown in FIG. 3, when starting the procedure, the introduction tools 310 and 320 are set on the living body in order to enable approach from the introduction positions P1 and P2. As each of the introduction tools 310 and 320, for example, a known vein indwelling needle or the like that can deal with a blood vessel of a small diameter lower limb can be used.

  Next, as shown in FIG. 4A, the tip of the scoring device 200 is delivered to the vicinity of the stenosis N formed in the above-the-knee popliteal artery 420 via the below-the-knee popliteal artery 410. . The scoring device 200 can be positioned with respect to the stenosis N by a known method using an X-ray image or the like.

  Next, as shown in FIG. 4B, the scoring member 230 is projected from the distal end opening 213 of the tubular member 210. By this operation, the insertion portion 235 is formed in the narrowed portion N.

  Next, as illustrated in FIG. 4C, the guide wire 140 is inserted through the insertion portion 235. At this time, it is possible to easily guide the distal end portion of the guide wire 140 into the insertion portion 235 by inserting and moving the guide wire 140 through the lumen 221 of the insertion member 220.

  Next, as shown in FIG. 5A, the balloon 110 of the balloon catheter 100 is inserted into the insertion portion 235 of the scoring device 200 along the guide wire 140. At this time, the balloon 110 can be easily guided into the insertion portion 235 by inserting the balloon catheter 100 through the lumen 221 of the insertion member 220 and moving it.

  Next, as shown in FIG. 5B, the balloon 110 is expanded and deformed. The scoring member 230 is pressed against the stenosis N as the balloon 110 is expanded and deformed. Thereby, each top part 231 (refer FIG. 2 (B)) of the scoring member 230 can be made to bite into the constriction part N, and can be mechanically locked. When the balloon 110 is further expanded, pressure (pressing force) is applied to the stenosis N in a state where the scoring member 230 is engulfed in the stenosis N, so that the stenosis N is efficiently expanded. It becomes possible to make it.

  After the expansion of the constriction N, the balloon 110 is appropriately contracted and deformed. Then, the balloon 110 and the guide wire 140 are removed from the living body. Thereafter, as shown in FIG. 5C, the scoring member 230 is accommodated in the tubular member 210, and the scoring member 230 is removed from the living body together with the tubular member 210. The procedure can be completed by the above procedure.

  The medical instrument 10 according to the present embodiment described above is configured as a medical instrument that is introduced into a body cavity of a living body and used to perform a predetermined treatment on the stenosis N existing in the living body. The balloon catheter 100 is introduced into the body cavity from different introduction positions P1 and P2 (see FIG. 3) and combined with each other in a state of being delivered to the stenosis N, so that treatment for the stenosis N can be performed. And a scoring device 200.

  According to the medical instrument 10 configured as described above, since the balloon catheter 100 and the scoring device 200 in a state before being combined are introduced into the body cavity of the living body via different introduction positions P1 and P2, medical treatment is performed. The instrument 10 can be introduced in a state of being reduced in diameter. In addition, after delivering the balloon catheter 100 and the scoring device 200 to the stenosis N, it is possible to add a predetermined scoring function to the medical instrument 10 by combining the balloon catheter 100 and the scoring device 200. . Therefore, it is possible to provide a medical instrument 10 capable of performing an efficient and effective treatment on the stenosis N existing in the living body while ensuring introduction into a relatively small body cavity. be able to.

  In addition, the first treatment member is configured by a balloon catheter 100 including a balloon 110 configured to be expandable and contractible in a living body, and the second treatment member is configured to be attachable to the balloon 110. Since the scoring device 200 is configured to damage the stenosis N with the expansion deformation of the stenosis and apply a locking force, the medical instrument 10 capable of efficiently expanding the stenosis N is provided. Can be provided.

  In addition, the scoring member 230 is accommodated in the lumen 211 of the tubular member 210 in a contracted state, and deformed into an expanded shape that can be attached to the outer surface of the balloon 110 as the tubular member 210 protrudes from the distal end opening 213. Therefore, the scoring member 230 can be contracted relatively compactly until it is delivered to the stenosis N, and the movement in the living body can be performed smoothly.

  Further, since the scoring member 230 forms an insertion portion 235 into which the balloon 110 can be inserted at a position eccentric from the axial center of the tubular member 210 as the tubular member 210 protrudes from the distal end opening 213, the balloon 110 is inserted. The balloon 110 and the scoring member 230 can be combined by a simple operation of inserting into the portion 235. Therefore, it is possible to save time and labor required for combining the balloon 110 and the scoring member 230, and it is possible to realize a quick procedure.

  Further, by using the insertion member 220 provided in the scoring device 200, the distal end portion of the balloon catheter 100 can be easily guided to the distal end side of the distal end opening 213 of the tubular member 210. Furthermore, by using the X-ray contrast markers 221a and 221b formed on the insertion member 220, it is possible to easily confirm whether or not the balloon catheter 100 is inserted into the insertion member 220. It becomes possible to realize a more rapid procedure.

  In addition, since the scoring device 200 is configured by a linear member that is shaped in advance so as to expand with the protrusion from the distal end opening 213 of the tubular member 210, the scoring device 200 can be introduced into a small body cavity. It is possible to add a scoring function to the balloon 110 by a simple operation of taking in and out from the distal end opening 213 while securing the above.

  Next, a modified example will be described. In the description of each modification, the description of the same members as those already described, points that can be configured in the same manner, similar procedures in the procedure, and the like will be omitted as appropriate.

  FIGS. 6A and 6B show a usage example of the medical instrument 510 according to the first modification.

  In this modification, the balloon 110 is positioned and disposed in the constriction N as shown in FIG. 6A, and then the scoring member 230 is wound around the outer periphery of the balloon 110 as shown in FIG. 6B. Work to place. Even when the balloon 110 and the scoring member 230 are assembled in such a procedure, the scoring function can be added to the balloon 110 in the same manner as in the procedure described in the above-described embodiment. Thus, it is possible to efficiently expand the constriction N.

  In FIG. 7, the usage example of the medical device 520 which concerns on the modification 2 is shown.

  In the present modification, the shape of the insertion portion 235 formed by the scoring member 230b is formed in a tapered shape that gradually tapers toward the distal end side of the tubular member 210.

  Since the insertion portion 235 is formed in a tapered shape, the balloon 110 can be disposed so as to be fitted into the insertion portion 235. For this reason, the fixing force between the balloon 110 and the scoring member 230 can be increased, and the balloon 110 and the scoring member 230 can be prevented from being displaced when the balloon 110 is expanded. it can. As a result, it becomes possible to expand the constriction N more efficiently. Further, when the insertion portion 235 has a tapered shape, the balloon 110 can be easily placed in the insertion portion 235. Therefore, the installation of the insertion member 220 for guiding the balloon 110 into the insertion portion 235 is omitted as appropriate. May be.

  When the insertion portion 235 is formed in the tapered shape shown in the figure, for example, the distal end portion (balloon) of the balloon catheter 100 is inserted into a hole located at the forefront of the insertion portion 235 (for example, a hole having a diameter of about 0.5 to 1 mm). The distal end of the catheter 100 and the tapered portion on the distal end side may be disposed so as to penetrate, and the other part of the balloon 110 may be disposed in the insertion portion 235. Further, in the case of such a configuration, the scoring member 230 and the balloon 110 are positioned by, for example, confirming that the balloon 110 has been captured by the insertion portion 235 with the hand feeling, or scoring the member 230 and the balloon 110. It can be performed by confirming the position of the X-ray contrast marker provided in.

  8A to 8C show usage examples of the medical instrument according to the third modification.

  In this modification, the scoring member 610 is made of a sheet material that is shaped in advance so as to expand with the protrusion from the distal end opening 213 of the tubular member 210.

  As shown in FIG. 8B, the scoring member 610 has a shape wound in the circumferential direction in a state of being accommodated in the lumen 211 of the tubular member 210 and protrudes from the distal end opening 213 of the tubular member 210. Then, as shown in FIGS. 8A and 8C, it expands and deforms so as to spread outward in the radial direction. Further, when expanded, the insertion portion 615 into which the balloon 110 can be inserted is formed on the inner surface side.

  A concave groove 618 for adding a scoring function is formed on the outer surface of the scoring member 610. For example, as shown in FIG. 8C, a plurality of the concave groove portions 618 can be provided along the circumferential direction of the scoring member 610 with an equal interval therebetween. The groove 618 may have a shape other than a linearly extending stripe shape, for example, a spiral shape. Further, a function similar to that of the groove 618 may be added by forming intermittently formed protrusions or grid-like grooves on the scoring member 610.

  A long operation member 611 that is operated when the scoring member 610 is moved in the living body or the tubular member 210 is attached to the upper side of the scoring member 610. For example, the operation member 611 can be configured to be connected to the take-up shaft 243 of the hand operation unit 240 and move in conjunction with the operation of the take-up shaft 243.

  The scoring member 610 can be constituted by, for example, a sheet material made of a known resin material. In addition, the scoring member 610 can be formed of a plate material, a mesh material, or the like that is configured to be expanded and deformed in the same manner as the sheet material as it protrudes from the tubular member 210. In addition, the scoring member 610 can also be formed in the taper shape (refer FIG. 7) demonstrated in the modification 2 mentioned above.

  As mentioned above, although the medical device which concerns on this invention was demonstrated through embodiment and the some modification, this invention is not limited only to the structure demonstrated in embodiment and each modification, and description of a claim It is possible to change appropriately based on this.

  The medical instrument may be configured by a combination other than a balloon catheter and a scoring device. For example, a configuration in which two guide wires are combined in a living body and a treatment for inserting (penetrating) a stenosis or the like is performed. It may be used to do. In addition, the medical device only needs to be configured to have at least a first treatment member and a second treatment member. For example, the medical device is introduced from an introduction position different from the first treatment member and the second treatment member. It is also possible to further comprise other treatment members.

  In addition, the use purpose of the medical device is not limited to the expansion of the stenosis, and may be configured to be used for other treatment (procedure), for example. The body cavity to be introduced is not limited to the blood vessel described in the embodiment, and may be a biological organ such as a bile duct, trachea, esophagus, urethra, and other organs.

  In addition, it has been described that the distal end portion of the tubular member is formed in a tapered shape in which the diameter of the lumen gradually increases toward the distal end side, but the shape of the distal end portion of the tubular member is not limited to this. For example, the tubular member may have the same diameter over the entire length, or there is no problem even if the tubular member has a tapered shape in which the diameter gradually decreases toward the distal end side.

  In the present embodiment, the scoring member is wound and delivered by the rotary dial of the hand operation unit. However, the present invention is not limited to this, and the user can score directly with the fingers. The ring member may be operated.

  In addition, for example, an external device that supplies heat (cold heat, heat) and vibration to the scoring member can be provided separately so that it can cope with various treatments, or the scoring member can be rotated in vivo. For example, the configuration of the hand operating unit may be modified so that it can be operated so that it can cope with various treatments.

10, 510 medical device,
100 balloon catheter (first treatment member),
110 balloon (first treatment section),
116 Extended effective part,
120 shaft (first body shaft),
140 guidewire,
200 scoring device (second treatment member),
210 tubular member (second body shaft),
211 Lumen of tubular member,
213, a tip opening of the tubular member,
220 insertion member,
221 Lumen of the insertion member,
221a, 221b X-ray contrast marker,
230, 230b, 610 scoring member,
231 top,
235 insertion part,
240 Hand control unit,
310, 320 introducer,
400 lower limbs of living body,
410 Inferior popliteal artery (body cavity),
420 above the knee popliteal artery (body cavity),
N stenosis (treatment target site),
P1 first introduction position,
P2 Second introduction position.

Claims (7)

A medical instrument that is introduced into a body cavity of a living body and used to perform a predetermined treatment on a treatment target site existing in the living body,
A first treatment member and a second treatment member that are independently introduced into the body cavity;
The first treatment member includes a first main body shaft to be inserted into the body cavity, a first distal end portion located on the insertion side in the body cavity on the first main body shaft, and a first operation portion located on the hand operation side. 1 proximal end portion, and a first treatment portion provided at the first distal end portion,
The second treatment member includes a second body shaft to be inserted into the body cavity, a second distal end portion located on the body cavity insertion side and a hand operation side on the second body shaft. 2 base end portions and a second treatment portion configured to be housed in the second body shaft and configured to be able to be inserted and removed from a distal end opening provided in the second distal end portion. And
The first main body shaft and the second main body shaft are configured such that they cannot be inserted into each other, and the first treatment section is inserted into the second treatment section at a predetermined position in the body cavity. Thus, the medical instrument can perform the treatment on the treatment target site. The first treatment member has a balloon catheter including a balloon configured such that the first treatment unit can be expanded and contracted in vivo.
The second treatment member includes the second treatment portion configured to be insertable with the balloon, and the second treatment portion is accompanied by an expansion deformation of the balloon in a state where the balloon is inserted. The medical device according to claim 1, comprising a scoring member that scratches the treatment target site. The second treatment member is
The distal end opening, and a lumen connected to the distal end opening, and the second body shaft through which the scoring member is movably inserted into the lumen;
The medical device according to claim 2, wherein the scoring member is accommodated in the lumen in a contracted state, and is deformed into an expanded shape that can be attached to the outer surface of the balloon as it protrudes from the distal end opening. .   The medical instrument according to claim 3, wherein the scoring member forms an insertion part into which the balloon can be inserted at a position deviated from an axis of the second main body shaft as it protrudes from the tip opening. The second treatment member is
A hollow insertion member that is disposed on the outer surface of the second body shaft on the distal end side and guides the movement of the balloon catheter so that the balloon is inserted into the insertion portion;
The medical instrument according to claim 4, wherein the insertion member is provided with an X-ray contrast marker along a longitudinal direction of the second main body shaft.   The medical instrument according to claim 4 or 5, wherein the insertion portion has a tapered shape that gradually tapers toward a distal end side of the second main body shaft.   The medical device according to any one of claims 2 to 6, wherein the scoring member has a linear member and / or a sheet material that is preliminarily shaped so as to expand with the protrusion from the distal end opening. Instruments.