JP2007330696A - Atherectomy catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To remove an occlusive material which stenoses or occludes a lumen of a tubular organ easily, quickly, reliably, and safely. <P>SOLUTION: An atherectomy catheter 1 includes an outer tube 2, an inner tube 3 which is inserted into the outer tube 2 rotatably about an axis and movably in the axial direction relative to the outer tube 2, first and second removing members 5a, 5b which are fixed to a distal end portion of the inner tube 3 and are accommodated in the outer tube 2 to drill and remove the occlusive material, and a guide member 6 which is mounted on the inner tube 3 and penetrates through the inner tube 3 so that the guide member 6 works as the axis of the inner tube 3 when the inner tube 3 rotates. The first and second removing members 5a, 5b protrude from the distal end portion of the outer tube 2 and turn developed in which the removing members expand radially owing to an elastic restoring force of itself and have the opened distal end portion when removing the occlusive material, and the removing members drill the occlusive material with the distal end portion by rotating the first and second removing members 5a, 5b about the guide member 6 working as the axis through the inner tube 3 and moving the removing members to the distal end portion. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to an atherectomy catheter that removes an obstruction that narrows or occludes the lumen of a tubular organ.

  Generally, atherosclerosis is caused by the precipitation of fat within the patient's intimal layer. It is thought that a relatively soft thing is deposited at the beginning, and as time passes, a cholesterol component is taken in and develops into a calcified atheroma layer. Due to this developed atheroma layer, the blood vessel becomes stenotic or occluded, and blood flow is obstructed. If left untreated, it may cause angina or myocardial infarction in the case of the heart, necrosis of the hand and toe tissues due to ischemia in the case of the limbs, and intermittent claudication.

  Atherotomy is a procedure in which such a developed arteriosclerotic layer is excised from the blood vessel using a catheter. Usually, atherectomy is not performed alone and is used in combination with balloon angioplasty. Furthermore, in order to maintain the lumen formed by resection of the arteriosclerotic layer and balloon formation, a stent placement operation in which a stent is placed is performed. Even if such a procedure is performed, a new arteriosclerotic layer may develop inside the stent as pointed out by many research reports. In this case, atherectomy, balloon angioplasty, and stent placement are often performed again. Recently, studies have been made to reduce the stenosis rate by coating the stent with a drug expected to have an effect of preventing arteriosclerosis.

  Now, atherectomy may be performed for chronic occlusions where the blood flow is completely blocked in its indication. In some cases, the intima develops as the blood flow becomes very low. Various techniques have been published for such lesions.

  For example, in the catheter described in Patent Document 1, the rotor itself has expandability, and the expandability of the sheath means as the rotor is utilized until the necessary inner diameter is secured in the blood vessel. , Pull and push this sheath means over and over again.

  On the other hand, another cause of clogging blood vessels is occlusion due to thrombus. The thrombosis may be caused by blood vessels bleeding for some reason, and the thrombosis may flow and accumulate in the periphery, but the surface of the atheroma layer is easily damaged. In some cases, platelets in the circulating blood collect and form a thrombus to occlude blood vessels, and some coexist with the atheroma layer. Balloon removal techniques have been used for many years to remove accumulated thrombus.

  By the way, in the catheter described in Patent Document 1, a basket-shaped sheath means (shearing) whose tip is closed against a narrowed or blocked lesion such as a lesion of the developed arteriosclerotic layer or a lesion with a thrombus. The operation | work which penetrates a member once is required. Further, it is necessary to repeat the pulling and pushing while rotating the sheath means until the inner diameter of the blood vessel is expanded to a necessary diameter.

  However, in the case of a lesion that is close to or occluded, the contrast agent is difficult to flow even under fluoroscopy, so it is difficult to determine where the lesion is approached, and a sheath means is attached to the lesion. It is difficult to pass through accurately. As described above, the catheter described in Patent Document 1 has a drawback in that it requires not only a lot of time and labor but also a skill level for the work.

JP-T-2004-503265

  An object of the present invention is to provide an atherectomy catheter capable of easily, quickly, reliably and safely removing an obstruction that narrows or occludes a lumen of a tubular organ.

Such an object is achieved by the present inventions (1) to (33) below.
(1) a flexible outer tube;
An inner tube that has flexibility and is inserted into the outer tube so as to be rotatable about the axis and movable in the axial direction with respect to the outer tube;
An atherectomy catheter comprising a first removal member and a second removal member, which are fixed to the distal end portion of the inner tube and housed in the outer tube, and remove an obstruction that narrows or closes the lumen of the tubular organ. There,
The atherectomy catheter is characterized in that each of the first removal member and the second removal member protrudes from a distal end portion of the outer tube, expands in a radial direction, and is in a deployed state in which the distal end is opened.

  (2) The first removal member has a thin, substantially cylindrical shape, and a plurality of protrusions protruding in the distal direction are provided at a distal end portion thereof along the circumferential direction. The atherectomy catheter according to (1) above, wherein the removal member has a thin, substantially cylindrical shape, and a plurality of protrusions protruding in the distal direction are provided along the circumferential direction at the distal end.

  (3) The first removal member has a plurality of openings on the side surface that occupy 4 to 97% of the area of the side surface in the deployed state, and the second removal member is in the deployed state. The atherectomy catheter according to the above (1) or (2) having a plurality of openings on the side surface that occupy 4 to 97% of the area of the side surface.

  (4) The atherectomy catheter according to any one of (1) to (3), wherein each of the first removal member and the second removal member has a net shape.

  (5) Each of the first removal member and the second removal member is concentric with respect to the axis of the inner tube, and the first removal member is on the inner surface side of the second removal member. The atherectomy catheter according to any one of (1) to (4), wherein the atherectomy catheter is disposed so as to be positioned at the position.

  (6) The atherectomy catheter according to (5), wherein an outer diameter of the distal end portion of the first removal member is smaller than an outer diameter of the distal end portion of the second removal member in the deployed state.

  (7) In the deployed state, the outer diameter of the distal end portion of the first removal member is 25 to 65% of the outer diameter of the distal end portion of the second removal member. .

(8) In the deployed state, the axial position of the tip of the first removal member substantially coincides with the axial position of the tip of the second removal member;
The atherectomy catheter according to any one of (5) to (7), wherein the first removal member and the second removal member are configured to excavate the obstruction at substantially the same time.

  (9) In the unfolded state, the axial position of the distal end of the first removal member is located on the distal end side relative to the axial position of the distal end of the second removal member. 8) The atherectomy catheter according to any one of the above.

  (10) The atherectomy catheter according to (9), wherein in the deployed state, a distal end side of the first removal member protrudes 1 to 10 mm from a distal end of the second removal member.

  (11) In the deployed state, at least one of the outer diameter of the distal end portion of the first removal member and the outer diameter of the distal end portion of the second removal member is gradually reduced toward the distal end. The atherectomy catheter according to any one of 1) to (10).

  (12) At least a part of the first removal member and at least a part of the second removal member are each formed of a shape memory alloy according to any one of (1) to (11). Atherectomy catheter.

  (13) The atherectomy catheter according to any one of (1) to (12), further including a fixing unit that fixes the movement of the inner tube in the axial direction with respect to the outer tube.

  (14) When the axial movement of the inner pipe is fixed, the fixing means allows the outer pipe to rotate around the axis of the inner pipe, and the inner circumference of the outer pipe and the inner pipe The atherectomy catheter according to the above (13), which has a function of blocking the passage of the fluid in the first flow path formed between the outer periphery and the outer periphery.

  (15) A connector having a port portion communicating with a first flow path formed between an inner periphery of the outer tube and an outer periphery of the inner tube is provided at a base end portion of the outer tube. The atherectomy catheter according to any one of 1) to (14).

(16) A connector having a port portion communicating with a first flow path formed between an inner periphery of the outer tube and an outer periphery of the inner tube is provided at a proximal end portion of the outer tube,
The atherectomy catheter according to (13) or (14), wherein the fixing means is provided in the connector.

  (17) In the above (16), the fixing means includes a valve body installed inside a proximal end portion of the connector, and an operation unit that presses the valve body toward the inner tube or releases the press. The described atherectomy catheter.

  (18) The atherectomy according to any one of the above (1) to (17), wherein the inner tube has a rotation assisting means for making the rotational torque transmission property of the proximal end portion larger than that of the distal end portion. catheter.

(19) First and second convex portions provided on the outer periphery of the distal end portion of the inner tube, and a first tubular body and a second tubular body into which the distal end portion of the inner tube is inserted Have
The distal end portion of the inner tube is inserted into the first tubular body so that the first tubular body is located on the proximal side from the first convex portion on the inner tube, and the outer periphery of the inner tube And fixing the first tubular body on the outer periphery of the inner tube in a state where the proximal end portion of the first removal member is arranged between the inner periphery of the first tubular body and The first removal member is fixed to the inner tube;
The distal end portion of the inner tube is inserted into the second tubular body so that the second tubular body is located on the proximal side from the second convex portion on the inner tube, and the outer periphery of the inner tube By fixing the second tubular body on the outer periphery of the inner tube in a state where the base end portion of the second removal member is arranged between the inner periphery of the second tubular body and the second tubular body, The atherectomy catheter according to any one of (1) to (18), wherein the second removal member is fixed to the inner tube.

  (20) The above-described (1) to (19), comprising a long guide member having flexibility and being attached to the inner tube and serving as a shaft when the inner tube rotates through the inner tube. An atherectomy catheter according to any one of the above.

  (21) The atherectomy catheter according to (20), wherein the guide member has a hub that can be fitted to a hub provided at a proximal end portion of the inner tube at the proximal end portion.

  (22) The atherectomy catheter according to (20), in which the first removal member and the second removal member are each spaced apart from the guide member in the deployed state.

  (23) When the hub of the inner pipe and the hub of the guide member are fitted, the distal end side of the guide member is positioned on the distal end side of the first removal member and the second removal member. The atherectomy catheter according to the above (21), which protrudes 1 to 8 mm from the distal end of the removal member.

  (24) A hub is provided at a base end portion of the guide member, and a rotation auxiliary tool for rotating the inner tube, the first removal member, and the second removal member is connected to the hub. The atherectomy catheter according to the above (20) or (21).

  (25) The atherectomy catheter according to any one of (1) to (24), wherein the guide member is made of any one of a superelastic alloy, stainless steel, and a resin.

  (26) At least the distal end portion of the guide member is made of an X-ray contrast member that is visible under X-ray fluoroscopy, or any of the above (20) to (25) in which the X-ray contrast portion is provided An atherectomy catheter according to the above.

  (27) Any one of the above (20) to (26), wherein a tapered portion whose outer diameter gradually decreases toward the distal end is provided at the distal end of the guide member, and the distal end of the tapered portion is rounded. The atherectomy catheter described in 1.

  (28) The outer tube includes an outer layer, an intermediate layer, and an inner layer, the intermediate layer functions as a reinforcing material, and the inner layer is made of a low friction material. An atherectomy catheter according to any one of the above.

  (29) The atherectomy catheter according to (28), wherein the intermediate layer is made of a metal wire or carbon fiber, and the inner layer is made of a fluorine-based resin.

  (30) The atherectomy catheter according to any one of (1) to (29), wherein an X-ray contrast unit that is visible under X-ray fluoroscopy is provided at least at a distal end portion of the outer tube.

  (31) The obstruction excavated by the first removal member and the second removal member via a first flow path formed between an inner periphery of the outer tube and an outer periphery of the inner tube. The atherectomy catheter according to any one of (1) to (30), wherein the atherectomy catheter is configured so as to be able to discharge a fluid containing the fluid.

  (32) The atherectomy according to the above (31) configured to be able to inject a fluid into the tubular organ through a second flow path formed at least in part in the lumen of the inner tube. catheter.

  (33) Injecting the fluid through the first channel, adjusting the flow rate of the fluid, and injecting the fluid through the second channel, and adjusting the flow rate of the fluid The atherectomy catheter according to the above (32), comprising a discharge means.

  According to the present invention, when the obstruction is removed, the first removal member and the second removal member expand in the radial direction and the leading end is opened. As the second removal member rotates while moving forward, an obstruction that narrows or occludes the lumen of a tubular organ (for example, a blood vessel or the like) can be easily and quickly excavated and removed safely. .

  In particular, in the case where a long guide member having flexibility is provided which is attached to the inner tube and is inserted into the inner tube and rotates as the inner tube, the first removing member and the first removing member Since the two removal members rotate about the guide member as an axis, the removal member can be rotated easily, reliably and stably, and the obstruction can be removed easily and reliably.

  Moreover, since it has the 1st removal member and the 2nd removal member, the operation | work which is divided into 2 times using two atherectomy catheters provided with mutually different removal members is performed by one operation. The obstruction can be removed in a short time.

  Thus, in the present invention, as in the prior art, using a guide wire to distinguish between the true and false cavities in the lesion and searching for the true lumen, the guide wire is once penetrated into the lesion, Eliminates the need to repeatedly move the sheath means (shearing member) back and forth and removes obstructions easily, quickly, reliably and safely without damaging or piercing the tubular organ and without requiring skill. Thus, the burden on the operator can be reduced and the burden on the patient can be reduced.

  Hereinafter, the atherectomy catheter of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

  In this embodiment, the case where the atherectomy catheter of the present invention is applied to a catheter for removing an obstruction that narrows or occludes the lumen of a blood vessel will be described.

  FIG. 1 is a side view showing an embodiment of the atherectomy catheter of the present invention, and FIG. 2 is a side view of the outer tube and connector of the atherectomy catheter shown in FIG. 3 is a cross-sectional view of the atherectomy catheter shown in FIG. 1. FIG. 3 (a) is a cross-sectional view taken along line AA in FIG. 1, and FIG. 3 (b) is a cross-sectional view in FIG. FIG. 3C is a cross-sectional view taken along the line CC in FIG. 1, and FIG. 3D is a cross-sectional view taken along the line DD in FIG. . 4 is a side view of the inner tube, the first removal member, and the second removal member of the atherectomy catheter shown in FIG. 1, and FIG. 5 is the atherectomy catheter shown in FIG. FIG. 6 is a side view showing the first removal member and the second removal member side of the atherectomy catheter shown in FIG. 5, and FIG. 7 is FIG. The side view which shows the front-end | tip part side of the inner tube | pipe (before a 2nd convex part is formed) of the atherectomy catheter to show, FIG. 8 is the partial cross section which shows the state which fixed the 1st removal member to the front-end | tip part of the inner tube | pipe FIG. 9 is a partial cross-sectional view showing a state in which a second convex portion is formed at the distal end portion of the inner tube to which the first removal member is fixed, and FIG. FIG. 11 is a partial cross-sectional view showing a state in which the removing member and the second removing member are fixed. FIG. 12 is a side view of the guide member of the atherectomy catheter shown in FIG. 1, and FIG. 13 is a view of the guide member of the atherectomy catheter shown in FIG. FIG. FIG. 14 is a diagram for explaining the operation of the atherectomy catheter shown in FIG. 5 (until the first removal member and the second removal member remove the obstruction). FIG. FIG. 14B is a diagram showing a state where the first removal member and the second removal member are in contact with the obstruction, and FIG. 14B is a diagram illustrating the first removal member and the second removal member excavating and removing the obstruction. FIG. 14C is a diagram showing a state in which the first removal member and the second removal member have removed most of the obstruction. FIG. 15 is a side view in which a rotation assist tool and an injection / discharge device are connected to the atherectomy catheter.

  For convenience of explanation, in FIGS. 1, 2, and 4 to 15, the left side is assumed to be “tip” and the right side is assumed to be “base end”. Further, in FIG. 3, only the cross section is shown.

  The atherectomy catheter (catheter) 1 shown in these drawings is an unnecessary object generated in a blood vessel (tubular organ) such as an artery, that is, an unnecessary object for narrowing or blocking the lumen of the blood vessel (tubular organ). It is a medical device that secures blood flow by excavating (breaking) (crushing) and removing an obstruction (blood vessel obstruction) (performing blood vessel communication).

  As shown in FIG. 1, the atherectomy catheter 1 is rotatable about an axis and movable in the axial direction with respect to the outer tube 2, the connector 4 provided at the proximal end of the outer tube 2, and the outer tube 2. And excavating an inner tube 3 inserted into the outer tube 2 and an obstruction which is fixed (attached) to the distal end of the inner tube 3 and stored in the outer tube 2 to narrow or block the lumen of the blood vessel. The first removal member 5a and the second removal member 5b to be removed in this manner, and a guide member 6 that is attached to the inner tube 3 and serves as a shaft when the inner tube 3 rotates through the inner tube 3 is inserted. ing. Hereinafter, the atherectomy catheter is also simply referred to as “catheter”. In addition, the obstruction includes not only an unnecessary object that obstructs the lumen of the blood vessel but also various unnecessary objects that constrict the lumen even if the obstruction is not completely obstructed. Specifically, examples of the obstruction include a thrombus, a fatty spot, and an arteriosclerotic layer.

  As shown in FIGS. 1 and 2, the outer tube 2 has a cylindrical shape (cylindrical shape) with a constant diameter from the proximal end portion to the distal end portion. As shown in FIGS. 3 (a) and 3 (b), the outer tube 2 is composed of an inner layer 21, an intermediate layer 22 provided on the outer periphery thereof, and an outer layer 23 provided on the outer periphery thereof. It has a three-layer structure and is flexible so that it can bend freely along the bend of the blood vessel when inserted into the blood vessel.

  The dimensions of the outer tube 2 are not particularly limited. For example, the outer diameter (diameter) is about 1.5 to 3.5 mm, and the inner diameter (diameter) is about 1.0 to 3.0 mm. The length is preferably about 30 to 150 cm.

  The inner layer 21 of the outer tube 2 is preferably made of a low friction material. Examples of the constituent material of the inner layer 21 include a fluorine resin such as polytetrafluoroethylene.

  The intermediate layer 22 of the outer tube 2 is preferably configured to function as a reinforcing material. Examples of the constituent material of the intermediate layer 22 include stainless steel, tungsten, nickel, titanium, nickel / titanium alloy, nickel / cobalt alloy, nickel / manganese alloy, and carbon fiber. That is, the intermediate layer 22 is preferably composed of a mesh formed by braiding a predetermined wire such as the metal wire or carbon fiber.

  Examples of the constituent material of the outer layer 23 of the outer tube 2 include polyolefins such as polyethylene, polypropylene and polybutadiene, polyvinyl chloride, polyurethane, polyether polyurethane, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polybutylene terephthalate, Examples include various thermoplastic elastomers such as polyamide, polyether polyamide, polyester polyamide, styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluororubber, chlorinated polyethylene, etc. Further, a blend of two or more of these, or a laminate of two or more of these may be used.

  Such an outer tube 2 preferably enhances at least the X-ray contrast property of the distal end portion so as to be visible under fluoroscopy when removing the obstruction in the blood vessel. In this case, for example, an X-ray contrast unit composed of at least the constituent material of the outer layer 23, for example, an X-ray opaque material such as barium sulfate, platinum, gold, tungsten, or the like, or made of the X-ray opaque material. May be provided. In the present embodiment, as shown in FIGS. 1 and 2, an X-ray contrast unit (marker) 24 is provided at the distal end portion of the outer tube 2.

  As shown in FIGS. 3A and 3B, the inner tube 3 has a cylindrical shape (tubular shape) having an outer diameter that can be inserted through the outer tube 2, and the outer periphery of the inner tube 3. The first flow path X is formed between the inner periphery of the outer pipe 2 and the outer circumference. The inner tube 3 is also flexible like the outer tube 2.

  The constituent material of the inner tube 3 is, for example, polyester such as polyether ether ketone, polyethylene terephthalate, polybutylene terephthalate, fluorine such as polyimide, polyamide, polyether polyamide, polyester polyamide, ABS resin, AS resin, polytetrafluoroethylene, etc. In addition, a resin obtained by blending two or more of these, or a laminate of two or more of these may be used.

  The dimensions of the inner tube 3 are not particularly limited. For example, the outer diameter (diameter) is about 0.8 to 1.8 mm, the inner diameter (diameter) is about 0.5 to 1.5 mm, and the axial direction is axial. The length is preferably about 50 to 170 cm.

  As shown in FIG. 4, the first removal member 5a and the second removal member 5b for excavating and removing the obstruction generated in the blood vessel are fixed to the distal end portion of the inner tube 3, respectively. Yes.

  As shown in FIG. 1, each of the first removal member 5a and the second removal member 5b is housed in the outer tube 2 and contracted (clogged) (contained state), and FIG. As shown, it is configured to project from the tip portion of the outer tube 2 and to expand in the radial direction by its own elastic restoring force and to open its tip. The first removal member 5a and the second removal member 5b are each in a natural state when in the deployed state, and at that time, the tip portions thereof are separated from the guide member 6. When removing the obstruction, each of the first removal member 5a and the second removal member 5b protrudes from the distal end portion of the outer tube 2, expands in the radial direction by its own elastic restoring force, and its distal end Is opened.

  Hereinafter, the first removal member 5a and the second removal member 5b in the deployed state will be typically described.

  As shown in FIGS. 4 and 5, each of the first removal member 5a and the second removal member 5b has a thin, substantially cylindrical shape (generally a mortar shape), and the tip portion thereof has a tip direction. A plurality of protruding portions 51 are provided along the circumferential direction. Thereby, an obstruction can be excavated easily and reliably.

  Moreover, the side wall part of the 1st removal member 5a and the side wall part of the 2nd removal member 5b have comprised net shape, respectively. That is, each of the first removal member 5a and the second removal member 5b has a plurality of openings 53 on the side surface (side wall portion). Thereby, the obstruction excavated by the first removal member 5a and the second removal member 5b can be discharged through the opening 53, and a predetermined fluid can be discharged into the blood vessel through the opening 53. Can be injected.

  The ratio of the opening 53 to the area of the side surface of the first removal member 5a is preferably about 4 to 97%, and more preferably about 20 to 70%. The ratio of the opening 53 to the area of the side surface of the second removing member 5b is preferably about 4 to 97%, and more preferably about 20 to 70%.

  If the ratio of the opening 53 is less than the lower limit value, the first removal member 5a and the second removal member 5b may not be able to self-expand depending on other conditions.

  Moreover, when the ratio which the opening part 53 accounts exceeds the said upper limit, depending on other conditions, at the time of excavation, the 1st removal member 5a and the 2nd removal member 5b are respectively from the state which twisted or expand | deployed. May change to a contracted state.

  The ratio of the opening 53 to the area of the side surface of the first removal member 5a and the ratio of the opening 53 to the area of the side surface of the second removal member 5b may be the same or different. Good.

  The opening 53 has a substantially rhombus shape having a pair of corners in the axial direction, and the first removal member 5a and the second removal member 5b are accommodated in the outer tube 2 and contracted. In each case, each of the rhomboid openings 53 has a small pair of corners in the axial direction and another pair of corners (a pair of corners in a direction substantially perpendicular to the axial direction). It is deformed so that the corner of

  And when the 1st removal member 5a and the 2nd removal member 5b protrude from the front-end | tip part of the outer tube | pipe 2, the opening part 53 of a rhombus will respectively be in the state which the angle | corner of a pair of corner | angular part of an axial direction contracted The corners of the other pair of corners are smaller than in the contracted state, and the first removal member 5a and the second removal member 5b are expanded in the radial direction, respectively. Opened and the tip is opened (returns to the natural state).

  With such a configuration, the first removal member 5a and the second removal member 5b can be in a deployed state smoothly and reliably. Further, the protrusion 51 at the tip has a mountain shape (V shape).

  As a constituent material of the first removal member 5a and the second removal member 5b, for example, it is preferable to use, for example, a shape memory alloy. In this case, a part thereof may be made of a shape memory alloy. Examples of the shape memory alloy include Ti—Ni alloys such as Ti—Ni and Ti—Ni—Cu, Cu alloys such as Cu—Al—Mn and Cu—Al—Ni, and Fe—Mn—Si. Examples thereof include ferromagnetic shape memory alloys such as Fe-based alloys, Au-Cd-based alloys, Ag-Cd-based alloys, Ni-Mn-Ga, and Fe-Pd.

  The constituent material of the first removing member 5a and the constituent material of the second removing member 5b may be the same or different.

  Further, the first removal member 5a and the second removal member 5b are concentric (substantially coaxial) with respect to the axis (center axis) of the inner tube 3, and the first removal member 5a is the first removal member 5a. 2 so as to be located on the inner surface side (guide member 6 side) of the removing member 5b, that is, the first removing member 5a is located on the inner circumferential side, and the second removing member 5b is located on the outer circumferential side. Has been placed.

  For this reason, the diameter of the 1st removal member 5a is set smaller than the diameter of the 2nd removal member 5b, and the outer diameter of the front-end | tip part of the 1st removal member 5a is the front-end | tip of the 2nd removal member 5b. It is smaller than the outer diameter of the part.

  In this case, the outer diameter of the distal end portion of the first removal member 5a is preferably about 25 to 65% of the outer diameter of the distal end portion of the second removal member 5b, and is about 30 to 60%. More preferred. Thereby, the obstruction | occlusion object can be excavated and removed more easily and reliably.

  The axial position of the distal end (front end surface) of the first removing member 5a is located on the distal side from the axial position of the distal end of the second removing member 5b, and the first removing member 5a is The obstruction is excavated in advance, and subsequently (after this), the second removal member 5b excavates the obstruction.

  In this case, the distal end side of the first removal member 5a preferably protrudes from the distal end of the second removal member 5b by about 1 to 10 mm, and more preferably protrudes by about 3 to 6 mm. Thereby, the obstruction | occlusion object can be excavated and removed more easily and reliably.

  In the present invention, the axial position of the tip of the first removal member 5a may be substantially coincident with the axial position of the tip of the second removal member 5b. In this case, the first removal member 5a and the second removal member 5b excavate the obstruction substantially simultaneously.

  In addition, it is preferable that at least one of the outer diameter of the distal end portion of the first removal member 5a and the outer diameter of the distal end portion of the second removal member 5b gradually decreases toward the distal end. In the illustrated example, a more preferable form is shown, and the outer diameter of the distal end portion of the first removal member 5a and the outer diameter of the distal end portion of the second removal member 5b are gradually reduced toward the distal end. . Thereby, the obstruction | occlusion object can be excavated and removed more easily and reliably.

  The dimensions of the first removal member 5a and the second removal member 5b are not particularly limited, and are appropriately set according to the purpose, application location, material, various conditions, etc. It is preferable to set a predetermined value within the range.

The thickness of the first removal member 5a is preferably about 0.1 to 0.3 mm, for example.
The outer diameter (diameter) of the tip of the first removal member 5a is preferably about 1 to 3 mm, for example, and the outer diameter (diameter) near the center is about 2 to 4 mm, for example. Is preferred.

  Moreover, it is preferable that the axial length of the 1st removal member 5a is about 15-45 mm, for example.

  Moreover, it is preferable that the thickness of the 2nd removal member 5b is about 0.1-0.3 mm, for example.

  The outer diameter (diameter) of the second removal member 5b is set to a value corresponding to the inner diameter of the blood vessel. That is, the outer diameter (diameter) of the tip of the second removal member 5b is preferably about 3 to 6 mm, for example, and the outer diameter (diameter) near the center is about 5 to 10 mm, for example. Is preferred.

  Moreover, it is preferable that the axial length of the 2nd removal member 5b is about 10-40 mm, for example.

  The method of fixing (adhering) the first removing member 5a and the second removing member 5b to the distal end portion of the inner tube 3 is not particularly limited, and can be performed, for example, as follows.

First, the first removal member 5 a is fixed to the distal end portion of the inner tube 3.
As shown in FIG. 7, an inner tube 3 is prepared in which a ring-shaped convex portion (first convex portion) 31 a is provided on the outer periphery of the tip portion. In this case, for example, a photocurable resin can be applied to the outer periphery of the distal end portion of the inner tube 3, and the photocurable resin can be cured to form the convex portion 31a.

  Further, a tubular body (first tubular body) 55a shown in FIG. The inner diameter (diameter) of the tubular body 55a is set to a value equal to or smaller than the outer diameter (diameter) of the convex portion 31a plus twice the thickness of the first removal member 5a. Moreover, as a constituent material of the tubular body 55a, stainless steel etc. are mentioned, for example.

  As shown in FIG. 8, after the proximal end portion of the first removal member 5a is squeezed and inserted into the tubular body 55a, the proximal end portion of the inner tube 3 is inserted into the first removal member 5a and the tubular body 55a. Inserted from the distal end side, the convex portion 31a is brought into contact with the inner side of the proximal end portion of the first removal member 5a squeezed by the tubular body 55a and stopped. The tubular body 55a is located on the proximal end side with respect to the convex portion 31a on the inner tube 3. As a result, the tubular body 55a is placed on the outer periphery on the proximal end side of the convex portion 31a of the inner tube 3, and the proximal end portion of the first removal member 5a is disposed between the outer periphery of the inner tube 3 and the inner periphery of the tubular body 55a. Is placed.

  Then, the base end of the first removal member 5a is protruded from the base end of the tubular body 55a to the base end side by a predetermined length, and the tube 56a is covered on the base end portion. Examples of the constituent material of the tube 56a include various resin materials.

  Next, the photocurable resin 57a is supplied from the proximal end side of the tube 56a to be cured, and the end portion of the first removal member 5a is fixed to the inner tube 3 together with the tubular body 55a. Subsequently, the photocurable resin 57a is applied and cured so as to fill the step between the end of the tube 56a and the inner tube 3. Thus, the 1st removal member 5a is fixed with respect to the inner tube 3 by fixing the tubular body 55a on the outer periphery of the inner tube 3 with the photocurable resin 57a (adhesive).

  The convex portion 31a caulks the proximal end portion of the first removing member 5a in cooperation with the tubular body 55a, the tube 56a, and the photocurable resin 57a, and firmly fixes the first removing member 5a to the inner tube 3. . The same applies to convex portions 31b described later.

  Next, the second removal member 5b is fixed to the distal end portion of the inner tube 3 in the same manner as the first removal member 5a.

  That is, first, as shown in FIG. 9, a ring-shaped convex portion (second convex portion) 31 b is provided on the outer periphery of the distal end portion of the inner tube 3. In this case, for example, a photocurable resin can be applied to the outer periphery of the distal end portion of the inner tube 3, and the photocurable resin can be cured to form the convex portion 31b. Moreover, the position of the convex part 31b is made into the base end side from the base end part (photocurable resin 57a) of the tube 56a, and the distance between the base end of the tube 56a and the front end of the convex part 31b is, for example, 3 It is preferable to be about 10 mm.

  Further, a tubular body (second tubular body) 55b shown in FIG. The inner diameter (diameter) of the tubular body 55b is not more than a value obtained by adding a value twice the thickness of the second removal member 5b to the outer diameter (diameter) of the convex portion 31b. Moreover, as a constituent material of the tubular body 55b, stainless steel etc. are mentioned, for example.

  As shown in FIG. 10, after the proximal end portion of the second removal member 5b is squeezed and inserted into the tubular body 55b, the proximal end side of the inner tube 3 is placed between the second removal member 5b and the tubular body 55b. The projection 31b is inserted from the distal end side, and is brought into contact with the inner side of the proximal end portion of the second removal member 5b squeezed by the tubular body 55a and stopped. The tubular body 55b is located on the proximal side with respect to the convex portion 31b on the inner tube 3. Thereby, the tubular body 55b is put on the outer periphery on the proximal end side from the convex portion 31b of the inner tube 3, and the proximal end portion of the second removal member 5b is disposed between the outer periphery of the inner tube 3 and the inner periphery of the tubular body 55b. Is placed.

  Then, the base end of the second removal member 5b is protruded from the base end of the tubular body 55b by a predetermined length to the base end side, and the tube 56b is covered on the base end portion. Examples of the constituent material of the tube 56b include various resin materials.

  Next, the photocurable resin 57b is supplied from the proximal end side of the tube 56b to be cured, and the end of the second removal member 5b is fixed to the inner tube 3 together with the tubular body 55b. Subsequently, the photocurable resin 57b is applied and cured so as to fill the step between the end of the tube 56b and the inner tube 3. Thus, by fixing the tubular body 55b to the outer periphery of the inner tube 3 with the photocurable resin 57b (adhesive), the second removal member 5b is fixed to the inner tube 3, and this second The removal member 5b is disposed on the outer peripheral side of the first removal member 5a.

  For example, the tubular body 55a may be crimped and the first removal member 5a may be fixed (adhered) to the distal end portion of the inner tube 3. Similarly, the tubular body 55b may be crimped and the second removal member 5b. May be fixed to the tip of the inner tube 3.

  Further, as shown in FIG. 4, a pipe (inner tube reinforcing body) 71 is put on the proximal end portion of the inner tube 3 as rotation assisting means. Thereby, the rotational torque transmission property of the proximal end portion of the inner tube 3 becomes larger than the rotational torque transmission property of the distal end portion, and the inner tube 3, the first removal member 5a, and the second removal member 5b are connected to the outer tube. 3 is easy to rotate around the axis. Examples of the constituent material of the pipe 71 include various metal materials such as stainless steel.

  The rotation assisting means is not limited to the pipe 71, and may be realized by, for example, configuring the base end portion of the inner tube 3 with various metal materials such as stainless steel.

  An inner tube hub 72 is provided at the proximal end (base end portion) of the inner tube 3. The inner tube hub 72 is provided with a hole (not shown) along the axis, and a knob portion 73 formed in a flat shape so that it can be rotated with fingers on the side surface. On the side, a connecting portion 74 is provided.

  As shown in FIG. 2, the connector 4 provided at the proximal end portion of the outer tube 2 is a Y connector and has a port portion 4 </ b> A. The inner periphery of the connector 4 and the outer periphery of the inner tube 3 are A first flow path X (see FIGS. 3A and 3B) is formed therebetween. That is, the port portion 4A communicates with the first flow path X. The connector 4 is coupled to the proximal end portion of the outer tube 2 by tightening the fastening member 20.

  Further, as shown in FIG. 11, a ring-shaped valve element 41 is installed inside the base end portion of the connector 4, and a pusher (operation portion) 42 is provided on the base end side. It is provided so as to be movable in the axial direction.

  The valve body 41 has ribs 41 a formed along the inner periphery thereof, and is engaged so as not to move toward the distal end side of the connector 4 at a stepped portion 43 formed by expanding the diameter at the proximal end portion of the connector 4. It has been stopped.

  On the inner peripheral surface of the outer portion 42 a of the pusher 42, a female screw 42 b that is screwed with a male screw 43 a formed on the outer peripheral surface of the base end portion of the connector 4 is formed. In this case, when the pusher 42 is rotated in a predetermined direction (when rotated), the pusher 42 moves in the distal direction along the connector 4, whereby the proximal end portion of the connector 4 and the valve body 41 are moved. When the pusher 42 is pressed toward the inner tube 3 side and is rotated in the opposite direction to the above (when rotated), the pusher 42 moves in the proximal direction along the connector 4, thereby the connector 42. 4 and the pressure to the inner pipe 3 side of the valve body 41 are released.

  When the pusher 42 moves in the distal direction and the proximal end portion of the connector 4 and the valve body 41 are pressed toward the inner tube 3, the axial movement of the inner tube 3 is fixed (blocked) with respect to the outer tube 2. Is done. At this time, rotation around the axis of the inner tube 3 is allowed with respect to the outer tube 2, and the passage of the fluid in the first flow path X is blocked (sealed) by the valve body 41.

Further, when the pusher 42 moves in the proximal direction and the pressing of the proximal end portion of the connector 4 and the valve body 41 toward the inner tube 3 side is released, the axial direction of the inner tube 3 with respect to the outer tube 2 is released. Movement is allowed.
Therefore, the valve body 41 and the pusher 42 constitute the main part of the fixing means.

  As shown in FIG. 12, the guide member 6 has an elongated shape having flexibility. That is, it is a linear body having flexibility. When removing the obstruction, the guide member 6 protrudes for a predetermined length from the distal ends of the first removal member 5a and the second removal member 5b. The guide member 6 can identify the position of the obstruction by abutting against the obstruction, and further, the tip of the guide member 6 is pierced into the center of the obstruction, and the inner tube 3 and the first removal member. By using the shafts when the 5a and the second removal member 5b rotate, it is possible to suppress blurring of the rotation shafts of the first removal member 5a and the second removal member 5b, and to prevent damage to the blood vessel wall. The obstruction can be removed with certainty.

  Although the dimension of the guide member 6 is not specifically limited, It is preferable that the outer diameter is about 0.5-1.2 mm.

  Further, a tapered portion 62 whose outer diameter gradually decreases toward the distal end is provided at the distal end of the guide member 6, and the distal end of the tapered portion 62 is rounded. Safety is improved by rounding the tip of the tapered portion 62.

  Moreover, it is preferable that the guide member 6 enhances at least the X-ray contrast property of the distal end portion so that the guide member 6 is visible under X-ray fluoroscopy when removing the obstruction in the blood vessel. That is, it is preferable that at least the distal end portion of the guide member 6 is composed of an X-ray contrast member or is provided with an X-ray contrast portion (marker).

  Moreover, it is preferable that the guide member 6 is comprised with either of a superelastic alloy, stainless steel, and resin. That is, as the constituent material of the guide member 6, for example, nickel, titanium, nickel-titanium alloy, nickel-cobalt alloy, nickel-manganese alloy, stainless steel, carbon steel, and the like, polyether ether ketone, polyethylene terephthalate, Examples include polyesters such as polybutylene terephthalate, polyimides, polyamides, polyether polyamides, polyester polyamides, ABS resins, AS resins, and fluorine-based resins such as polytetrafluoroethylene. Furthermore, two or more of these are combined. May be used.

  A guide hub 63 is provided at the base end of the guide member 6. As shown in FIGS. 1 and 5, the guide member 6 is inserted into the inner tube 3, and the guide hub 63 is fitted into the connecting portion 74 of the inner tube hub 72 of the inner tube 3. It is attached to the tube 3 and fixed.

  Further, in a state where the guide hub 63 and the connecting portion 74 of the inner tube hub 72 are fitted and the guide member 6 is attached to the inner tube 3, the distal end side of the guide member 6 is the distal end of the first removal member 5a ( The first removal member 5a and the second removal member 5b protrude from the removal member located on the distal end side by a predetermined length. The predetermined length is preferably about 1 to 8 mm, and more preferably about 2 to 5 mm.

  By setting the predetermined length within the above range, the inner tube 3, the first removal member 5a, and the second removal member 5b can function reliably as a shaft while maintaining safety. .

  As shown in FIG. 3D, the guide hub 63 is formed with a lumen 64 that has a substantially semicircular cross-sectional shape and penetrates in the axial direction. When the guide hub 63 is fitted into the inner tube hub 72 of the inner tube 3, the lumen of the inner tube 3, the lumen of the inner tube hub 72, and the lumen 64 of the guide hub 63 communicate with each other. A flow path Y is formed.

A connecting portion 65 is provided at the base end portion of the guide hub 63.
Here, in this atherectomy catheter 1, the inner tube 3, the first removal member 5a, the second removal member 5b, and the rotation auxiliary tool 8 that rotates the guide member 6 can be connected. The rotation assisting tool 8 is configured to be connected to, for example, the connecting portion 65 of the guide hub 63.

  Further, the fluid containing the obstruction excavated by the first removal member 5a and the second removal member 5b can be discharged out of the body through the first flow path X, and the second flow path A predetermined fluid can be injected into the blood vessel via Y.

  In this case, for example, the discharge portion 91 of the injection / discharge device (injection / discharge means) 9 is connected to the port portion 4 </ b> A of the connector 4, and the injection / discharge device 9 is injected to the connecting portion 65 of the guide hub 63 via the rotation auxiliary tool 8. The unit 92 is connected. In this configuration example, the fluid including the obstruction is sucked through the discharge unit 91 and discarded (discharged) from the discharge port 93. On the other hand, the injection part 92 injects the fluid in the storage container 95 connected to the injection port 94 into the blood vessel.

  That is, by the operation (drive) of the discharge portion 91 of the injection / discharge device 9, the fluid including the obstruction excavated by the first removal member 5a and the second removal member 5b is sucked and discharged. At this time, the flow rate of the fluid can be adjusted, that is, the flow rate per unit time can be adjusted.

  In addition, a predetermined fluid is injected into the blood vessel by the operation (drive) of the injection portion 92 of the injection / discharge device 9. At this time, the flow rate of the fluid can be adjusted, that is, the flow rate per unit time can be adjusted.

Next, an operation (an example of a usage method) of the atherectomy catheter 1 will be described.
When performing the treatment for removing the obstruction in the blood vessel, the inner tube 3 to which the first removal member 5a and the second removal member 5b are fixed is inserted into the outer tube 2 in advance, and the first removal is performed. The member 5a and the second removing member 5b are housed inside the outer tube 2 in a reduced diameter state. The inner tube 3 and the outer tube 2 are inserted to a target site in the blood vessel by a guide wire operation (not shown) through a sheath (not shown). The situation at that time is monitored by X-ray contrast or the like.

  When the inner tube 3 and the outer tube 2 reach the target site of the blood vessel, the guide wire is removed, and then the guide member 6 is inserted into the inner tube 3 from its tip, and the guide hub 63 is connected to the inner tube hub. 72. Thereby, the guide member 6 is fixed to the inner tube 3.

  Next, the pusher 42 of the connector 4 is rotated to loosen the valve body 41, and in this state, the inner tube 3 is pushed forward with respect to the outer tube 2 (or the outer tube 2 is moved to the proximal end with respect to the inner tube 3). Pull to the side). As a result, as shown in FIG. 13, the first removal member 5a and the second removal member 5b protrude from the distal end portion of the outer tube 2 and expand in the radial direction by their own elastic restoring force. The leading end is opened and the guide member 6 protrudes from the leading end of the first removal member 5a by a set length. Then, the entire atherectomy catheter 1 is moved in the distal direction, the guide member 6 is advanced, the distal end portion of the guide member 6 is pierced into the obstruction (lesioned portion) H, and then the pusher 42 of the connector 4 is rotated. Then, the valve body 41 is tightened inside, and the inner tube 3 is fixed to the outer tube 2 so as to be rotatable.

  Next, as shown in FIG. 14A, the inner tube 3 is rotated about the guide member 6 while moving the entire atherectomy catheter 1 in the distal direction (moving forward). Thereby, the 1st removal member 5a and the 2nd removal member 5b move to the front-end | tip direction, rotating with the guide member 6 as an axis | shaft.

  As a result, as shown in FIG. 14B, the first removing member 5a and the second removing member 5a and the second removing member 5b enter the obstruction H as the guide member 6, the first removing member 5a, and the second removing member 5b enter. Each of the protrusions 51 at the tip of the removal member 5b excavates the obstruction H.

  At this time, first, the first removal member 5a having a small diameter (small diameter) excavates the obstruction in advance, so that the obstruction H corresponds to the outer diameter of the first removal member 5a. A hole with an inner diameter (size) is formed. Then (subsequently), the second removal member 5b having a large diameter (large diameter) excavates the remaining obstruction H having a tubular shape and expands the hole. In this way, the blood vessel that has been occluded by the obstruction H penetrates (opens).

  Here, when the obstruction H is removed only by the large-diameter removal member corresponding to the second removal member 5b, a relatively large load is applied to the large-diameter removal member. However, in the atherectomy catheter 1, Since the outer diameter of the first removal member 5a is relatively small, the load applied to the first removal member 5a is relatively small, and the second removal member 5b having a large diameter is the first removal member. Since only the hole formed by 5a is enlarged, the load applied to the second removal member 5b is relatively small. Thereby, the twist of the 1st removal member 5a and the 2nd removal member 5b can be prevented, and the fluctuation | variation of an excavation position and its diameter is blocked | prevented, and, thereby, the obstruction | occlusion object H is excavated smoothly and reliably. be able to.

In this way, by performing forward movement and rotation of the guide member 6, the first removal member 5a, and the second removal member 5b, as shown in FIG. 14C, the first removal member 5a and the first removal member 5a. The obstruction H can be reliably removed by the two removing members 5b. In this case, even if the obstruction H is, for example, a hard atheroma such as a calcified lesion occurring in a blood vessel, it can be reliably excavated and removed.
The removed obstruction H is discharged to the outside through the first flow path X.

  As described above, according to the atherectomy catheter 1, the first removal member 5a and the second removal member 5b are moved to the lesioned part of the blood vessel, and from there, the first removal member 5a and the second removal member 5b are moved. When the removal member 5b is moved in the distal direction while rotating, the obstruction H can be gradually excavated and removed by the protrusions 51 of the first removal member 5a and the second removal member 5b. H can be excavated and removed easily, quickly, reliably and safely.

  Further, since the first removal member 5a and the second removal member 5b rotate around the guide member 6, the removal member 5 can be rotated easily, reliably and stably.

  Further, since the first removal member 5a having a small diameter and the second removal member 5b having a large diameter are coaxially provided, an atherectomy catheter provided with the removal member having a small diameter and a removal member having a large diameter are provided. Using the atherectomy catheter, an operation that must be performed in two steps can be performed in one operation, and the obstruction H can be removed in a short time.

  As described above, in the atherectomy catheter 1 of the present embodiment, as in the prior art, the true lumen and the false lumen in the lesioned part are distinguished using a guidewire and the true lumen is searched for by hand, and the guidewire is used as the lesioned part. There is no need to pierce once and move the sheath means (shearing member) back and forth repeatedly, and the obstruction H can be easily, quickly, and reliably without damaging or piercing the blood vessel or requiring skill. In addition, it can be removed safely, the burden on the operator can be reduced, and the burden on the patient can be reduced.

  Moreover, since the excavated obstruction | occlusion object H is discharged | emitted outside via the 1st flow path X, safety | security is high.

  In addition, when removing the obstruction | occlusion object H, while occluding the obstruction | occlusion object H excavated from the 1st flow path X, physiological saline etc. can also be inject | poured from the 2nd flow path Y. In this way, it is possible to continue removing the obstruction H without causing the blood vessel to contract or deform due to a pressure difference generated by suction when the excavated obstruction H is discharged to the outside.

  As described above, by removing the obstruction H, it is possible to secure blood flow by communicating with the blood vessel, to create a route for the next device, and to perform the next treatment step (expansion with a balloon, stent, etc.), etc. Can be easily performed.

  Although the atherectomy catheter of the present invention has been described based on the illustrated embodiment, the present invention is not limited to this, and the configuration of each part is replaced with an arbitrary configuration having the same function. be able to. In addition, any other component may be added to the present invention.

  In the present invention, it is only necessary to have at least a first removal member and a second removal member as members (removal members) for removing the obstruction. That is, the number of removal members is not limited to two and may be three or more.

Moreover, the site | part (location) from which an obstruction is removed by the atherectomy catheter of this invention is not restricted to a blood vessel, In addition, a bile duct, a urethra, etc. are mentioned, for example.
Moreover, as an obstruction | occlusion object, a thrombus, a fatty spot, an arteriosclerosis layer, a calculus, etc. are mentioned, for example.

It is a side view which shows embodiment of the atherectomy catheter of this invention. It is a side view of the outer tube | pipe and connector of the outer tube | pipe and connector of the atherectomy catheter shown in FIG. It is sectional drawing of the atherectomy catheter shown in FIG. It is a side view of the inner tube | pipe of the atherectomy catheter shown in FIG. 1, a 1st removal member, and a 2nd removal member. It is an atherectomy catheter shown in FIG. 1, Comprising: It is a side view when the 1st removal member and the 2nd removal member are a deployment state. It is a side view which shows the 1st removal member and 2nd removal member side of the atherectomy catheter shown in FIG. It is a side view which shows the front-end | tip part side of the inner tube | pipe (before a 2nd convex part is formed) of the atherectomy catheter shown in FIG. It is a fragmentary sectional view showing the state where the 1st removal member was fixed to the tip part of an inner pipe. It is a fragmentary sectional view showing the state where the 2nd convex part was formed in the tip part of the inner pipe to which the 1st removal member was fixed. It is a fragmentary sectional view showing the state where the 1st removal member and the 2nd removal member were fixed to the tip part of an inner pipe. It is sectional drawing of the connector and pusher of the atherectomy catheter shown in FIG. It is a side view of the guide member of the atherectomy catheter shown in FIG. It is a figure which shows the state which abutted the obstruction | occlusion object in the guide member in the atherectomy catheter shown in FIG. It is a figure for demonstrating the effect | action (until a 1st removal member and a 2nd removal member remove an obstruction | occlusion object) of the atherectomy catheter shown in FIG. It is the side view which connected the rotation assistance tool and the injection / discharge device to the atherectomy catheter.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Atherectomy catheter 2 Outer tube 20 Fastening member 21 Inner layer 22 Intermediate layer 23 Outer layer 24 X-ray contrast part 3 Inner tube 31a, 31b Convex part 4 Connector 41 Valve body 41a Rib 42 Pusher 42a Outer part 42b Female screw 43 Step part 43a Male Screw 4A Port portion 5a First removing member 5b Second removing member 51 Projection portion 53 Opening portion 55a, 55b Tubular body 56a, 56b Tube 57a, 57b Photo-curing resin 6 Guide member 62 Tapered portion 63 Guide hub 64 Lumen 65 connection part 71 pipe 72 inner pipe hub 73 knob part 74 connection part 8 rotation auxiliary tool 9 injection / discharge device 91 discharge part 92 injection part 93 discharge port 94 inlet 95 storage container 100 blood vessel H obstruction X first flow path Y first 2 channels

Claims (15)

A flexible outer tube;
An inner tube that has flexibility and is inserted into the outer tube so as to be rotatable about the axis and movable in the axial direction with respect to the outer tube;
An atherectomy catheter comprising a first removal member and a second removal member that are fixed to the distal end portion of the inner tube and housed in the outer tube and that remove an obstruction that narrows or closes the lumen of the tubular organ. There,
The atherectomy catheter is characterized in that each of the first removal member and the second removal member protrudes from a distal end portion of the outer tube, expands in a radial direction, and is in a deployed state in which the distal end is opened.   The first removal member has a thin, substantially cylindrical shape, and a plurality of protrusions protruding in the distal direction are provided along a circumferential direction at a distal end portion of the first removal member. The atherectomy catheter according to claim 1, wherein the atherectomy catheter has a thin, substantially cylindrical shape, and a plurality of protrusions protruding in the distal direction are provided along the circumferential direction at the distal end.   Each of the first removal member and the second removal member is concentric with respect to the axis of the inner tube, and the first removal member is located on the inner surface side of the second removal member. The atherectomy catheter according to claim 1 or 2, arranged as described above.   4. The atherectomy catheter according to claim 3, wherein, in the deployed state, an axial position of a distal end of the first removal member is located on a distal end side with respect to an axial position of the distal end of the second removal member.   5. The at least one of the outer diameter of the distal end portion of the first removal member and the outer diameter of the distal end portion of the second removal member is gradually reduced toward the distal end in the deployed state. An atherectomy catheter according to any one of the above.   The atherectomy catheter according to any one of claims 1 to 5, further comprising fixing means for fixing the axial movement of the inner tube with respect to the outer tube.   When the axial movement of the inner pipe is fixed, the fixing means allows the outer pipe to rotate around the axis of the inner pipe, and the inner means of the outer pipe and the outer circumference of the inner pipe The atherectomy catheter according to claim 6, which has a function of blocking passage of fluid in a first flow path formed therebetween.   The atherectomy catheter according to any one of claims 1 to 7, wherein the inner tube has a rotation assist means at its proximal end portion for making the rotational torque transmission property of the proximal end portion larger than that of the distal end portion. A first convex portion and a second convex portion provided on an outer periphery of the distal end portion of the inner tube; and a first tubular body and a second tubular body into which the distal end portion of the inner tube is inserted. ,
The distal end portion of the inner tube is inserted into the first tubular body so that the first tubular body is located on the proximal side from the first convex portion on the inner tube, and the outer periphery of the inner tube And fixing the first tubular body on the outer periphery of the inner tube in a state where the proximal end portion of the first removal member is arranged between the inner periphery of the first tubular body and The first removal member is fixed to the inner tube;
The distal end portion of the inner tube is inserted into the second tubular body so that the second tubular body is located on the proximal side from the second convex portion on the inner tube, and the outer periphery of the inner tube By fixing the second tubular body on the outer periphery of the inner tube in a state where the base end portion of the second removal member is arranged between the inner periphery of the second tubular body and the second tubular body, The atherectomy catheter according to any one of claims 1 to 8, wherein the second removal member is fixed to the inner tube.   The atherectomy according to any one of claims 1 to 9, further comprising a long guide member having a flexible shape that is attached to the inner tube and serves as a shaft when the inner tube is rotated through the inner tube. catheter.   The atherectomy catheter according to claim 10, wherein the guide member has a hub that can be fitted with a hub provided at a proximal end portion of the inner tube at the proximal end portion.   A hub is provided at a base end portion of the guide member, and a rotation auxiliary tool for rotating the inner tube, the first removal member, and the second removal member is connected to the hub. Item 12. An atherectomy catheter according to Item 10 or 11.   Fluid containing the obstruction excavated by the first removal member and the second removal member via a first flow path formed between the inner periphery of the outer tube and the outer periphery of the inner tube The atherectomy catheter according to any one of claims 1 to 12, wherein the atherectomy catheter is configured to be discharged from the body.   The atherectomy catheter according to claim 13, configured to inject fluid into the tubular organ through a second flow path formed at least partially in the lumen of the inner tube.   Injecting / discharging means for discharging fluid through the first flow path, adjusting the flow rate of the fluid, injecting fluid through the second flow path, and adjusting the flow rate of the fluid 15. An atherectomy catheter according to claim 14.

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