WO2015118603A1

WO2015118603A1 - Venous valve cutting blade and production method therefor

Info

Publication number: WO2015118603A1
Application number: PCT/JP2014/052511
Authority: WO
Inventors: 隆俊古屋
Original assignee: 隆俊古屋; 有限会社沼田光機製作所
Priority date: 2014-02-04
Filing date: 2014-02-04
Publication date: 2015-08-13

Abstract

The present invention is provided with: a guide (22) that extends to the front and rear along an axial center (T) and has a circular shape having a diameter that is smaller than the diameter of the lumen (3) of a venous valve (1); a connecting rod (24) that extends to the front from the front end of the guide; a tip-end cutter (30) that is connected to the front end of the connecting rod; and a flexible wire (26) that extends to the rear from the rear end of the guide. The tip-end cutter has, at the rear end, a rear end portion (32) that has a curved surface that is curved toward the rear. The rear end portion has four or more approximately triangular pyramid-shaped cutting blade cones (34) having spaces between each other in the circumferential direction of the axial center. The cutting blade cones each have an apex (42) that is oriented to the rear and use the outer peripheral surface (36) of the tip-end cutter as one of the side surfaces that is in contact with the apex, and sharp-edged blades (40a, 40b) are formed by the three sides that emanate from the apex. One of the three sides extends from the apex toward the axial center.

Description

Venous valve incision blade and method of manufacturing the same

The present invention relates to a venous valve incising blade for incising a venous valve of a vein in an operation using a patient's own vein as a graft, and a manufacturing method thereof.

For example, diseases such as obstructive arteriosclerosis, Buerger's disease, embolism thrombosis, etc. may cause blood flow disturbance due to occlusion of the arteries toward the lower limbs, resulting in ulcers and necrosis in the feet and toes. Such a state is called “severe ischemic limb”.

A more reliable treatment of severe ischemic limbs is a bypass operation in which a patient's own vein (hereinafter, autologous vein) is used as a bypass to an artery such as a leg artery that has become occluded. Such bypass surgery includes, for example, femoral popliteal artery revascularization.
In recent years, obstructive arteriosclerosis has been increasing due to aging due to the extension of life expectancy, an increase in diabetic and dialysis patients, enlightenment of vascular diseases, and the like. In particular, there are concerns about an increase in the number of people suffering from severe ischemic limbs, which is the terminal state. Nevertheless, a relative shortage of vascular surgeons capable of performing femoral popliteal arterial revascularization is currently a problem.

In femoral popliteal arterial revascularization, bypass the central side (closer to the heart) and the peripheral side (away from the heart) of the occluded part of the artery (hereinafter simply referred to as the blocked part) to send arterial blood to the peripheral side from the blocked part Bypass is required. For example, an autologous vein such as the great saphenous vein is an optimum material for the bypass.

Also, as a method of reconstructing the femoral popliteal artery, there are a reverse method (reverse method), a non-reverse method (non-reverse method), and an in situ method (in situ method).

FIG. 1 is an explanatory diagram of the vein 1 and the vein valve 2. FIG. 1A is an explanatory diagram when venous blood flows from the peripheral side P toward the central side C, and FIG. 1B shows the venous blood flowing from the central side C toward the peripheral side P. It is explanatory drawing at the time.

In many cases, the artery and vein 1 are running side by side.
The arteries have a thick, elastic vessel wall that allows arterial blood to flow from the heart toward the periphery as the heart beats.

On the other hand, the vein 1 has a blood vessel wall 5 that is thinner than an artery and less elastic. The venous blood circulating in the periphery such as the toes is sent from the periphery toward the heart by the pump function by the muscles of the lower limbs and the upper limbs and the function of the venous valve 2 that prevents the backflow of venous blood.
The normal venous valve 2 has a structure that cannot be reversed to the peripheral side P.

A plurality of vein valves 2 are formed in the lumen 3 of the vein 1 as shown in FIG. The venous valve 2 is a two-leafed valve, and only the blood flow from the periphery to the center is allowed to pass as shown in FIG. When blood flows from the center toward the periphery, the venous valve 2 is closed as shown in FIG. On the central side C around the venous valve 2, an enormous portion called a venous valve sinus 4 (sinus valvalae) is formed.

Among the operations for femoral popliteal artery revascularization, the reverse method is to release the autologous vein 1 into a graft, reverse the central side C and the peripheral side P, and close the central C end of the graft. An anastomosis to the artery on the peripheral side P from the part, and an anastomosis to the artery on the central side C from the occlusion part at the distal side P end.

The non-reverse method is a technique in which the autologous vein 1 is released and turned into a graft, and then the autologous vein 1 is anastomosed without being reversed. The non-reverse method is different from the reverse method in that the central C end of the graft is anastomosed to the central C artery from the occlusion and the distal P end is anastomosed to the peripheral P artery from the occlusion.

The in situ method is an operation method in which the vein 1 parallel to the artery to be occluded is anastomosed to an adjacent artery and used as a bypass. The in situ method is different from the reverse method and the non-reverse method in that the autologous vein 1 is not released. That is, in the in situ method, only the vein 1 at the site located on the central side C and the distal side P from the occlusion portion is peeled and cut, the blood flow of the branch 6 of the vein 1 branching from the middle portion is blocked, and the upper end thereof And an anastomosis to an artery that runs parallel to the lower end.

In the reverse method, since the central side C and the peripheral side P of the graft are reversed, the direction of blood flow flowing inside the graft (that is, the autologous vein 1) does not change before and after the operation. Therefore, even if the autologous vein 1 is anastomosed to the artery without excising the venous valve 2 by the reverse method, the arterial flow flows without stagnation.

However, blood vessels tend to be thicker as they are closer to the heart. Even if the central side C and the peripheral side P have the same thickness, the blood vessel on the central side C is more elastic in the blood vessel wall 5 than the blood vessel on the peripheral side P, and is rich in elasticity.
Therefore, when the reverse method is adopted, the end of the graft with a small diameter must be anastomosed to the thick artery on the central side C, and the end of the graft with a large diameter must be anastomosed to the thin artery on the distal side P.

On the other hand, with the non-reverse method or the in situ method, the vein 1 of the thick and soft part (central C end) can be anastomosed with the thick part of the artery, and the thin part (the peripheral side P) The vein 1 at the end can be anastomosed. As a result, the blood vessel wall 5 tapers naturally.

However, since the direction of the arterial flow flowing from the central side C toward the peripheral side P is reverse for the autologous vein 1, if the autologous vein 1 is anastomosed to the artery without any processing, the blood flow is caused by the venous valve 2. Will be disturbed. Therefore, in order to perform the non-reverse method or the in situ method, a process for destroying the vein valve 2 of the autologous vein 1 is necessary.

Examples of instruments used to destroy the venous valve 2 include those disclosed in Patent Document 1 and

Non-Patent Documents

1 and 2.

2A to 2E are explanatory views of the venous valve incision device 10 disclosed in Patent Document 1 and Non-Patent Document 1. FIG. FIG. 2A is an overall explanatory view of the venous valve incision device 10. 2B is an enlarged view of H in FIG. 2A when the venous valve incisor 10 is inserted into the vein 1, and FIG. 2C is an AA arrow in FIG. 2B. FIG. 2 (D) is an enlarged view of H in FIG. 2 (A) when the venous valve incisor 10 in FIG. 2 (B) is rotated 90 ° and inserted into the vein 1, FIG. 2 (E). FIG. 3 is a view taken along the line BB in FIG.
In addition, in order to make description easy to understand, the depiction of the second rod-shaped body 12 is omitted in FIGS. 2 (C) and 2 (E). 2C and 2E represent the position of the tip of the cutting blade 15a of the venous valve incisor 10.

A venous valve incision device 10 disclosed in Patent Document 1 or Non-Patent Document 1 has a first rod-like body 15 having an overall shape adapted to the venous valve sinus 4 and a second rod-like shape having the same diameter as the first rod-like body 15. It has a body 12. The venous valve incisor 10 includes a connecting member 14 that connects the first rod-shaped body 15 and the second rod-shaped body 12, and a flexible wire 16 that extends from the rear end of the second rod-shaped body 12.
The 1st rod-shaped body 15 and the 2nd rod-shaped body 12 are formed with the synthetic resin.

The first rod-like body 15 has a rounded conical front end and a cylindrical body. The rear end of the cylindrical body is slightly conical or tapered, and is cut into a V shape to form a blunt cutting edge 15a. Patent Document 1 discloses that the entire shape of the first rod-shaped body 15 is formed so as to fit the venous valve sinus 4. In Non-Patent Document 1, the first rod-shaped body 15 is formed as a venous valve. It is disclosed that the shape of the sinus 4 is reversed.
The second rod-shaped body 12 has a rounded front end, a cylindrical body, and a conical rear end.

The venous valve cutter of Non-Patent Document 2 has four metal bows (hereinafter referred to as blades) that are curved in a bow shape with a blade facing outward, and one end is connected to the wire with the arc facing outward Has been. The blade has a structure that allows the operator to adjust the thickness of the blade according to the thickness of the blood vessel.

Japanese Patent Laid-Open No. 04-122251

In the venous valve incisor 10 disclosed in Patent Document 1 and Non-Patent Document 1 described above, the body of the first rod-shaped body 15 has a cylindrical shape without a taper, and the venous valve sinus 4 is formed by cutting it into a V shape. It is formed in a shape resembling As a result, the venous valve incisor 10 has one cutting blade 15a corresponding to the one-leaf vein valve 2. The shape cut into the V shape results in a shape in which a V-shaped gap is opened between the two cutting edges 15a. Since the first rod-like body 15 has a shape that cuts the cylindrical shape into a V-shape, when the cutting blade 15a is viewed from the side (FIG. 2B), the circumferential direction around the connecting member 14 from that position. When the cutting edge 15a is viewed from a position moved 90 ° in the first, the shape of the rear end of the first rod-like body 15 is different. The former shape is a cylindrical shape (FIG. 2B), while the latter shape is a conical shape (FIG. 2D). In other words, the rear end of the first rod-like body 15 has a shape that becomes flatter toward the rear, that is, a shape in which the thickness gradually decreases.

Since many branches 6 (see FIG. 1) branch from the vein 1, when the processing for destroying the vein valve 2 of the autologous vein 1 is performed, the vein 1 is broken by hooking an instrument on the branch 6. It must be done carefully so that there is no.

However, the venous valve incisor 10 disclosed in Patent Document 1 and Non-Patent Document 1 is flattened toward the rear end and has a shape with a V-shaped gap between the two cutting edges 15a. There is a possibility that the blood vessel wall 5 of the vein 1 is likely to enter between the one rod-like body 15 and the second rod-like body 12.
The venous valve incisor 10 is provided with the tip of the cutting blade 15a slightly inside the outer surface of the first rod 15 on the surface passing through the tips of the two cutting blades 15a. In the direction perpendicular to the passing surface, the tip of the cutting edge 15 a is positioned close to the outer surface of the first rod 15.

Therefore, the blood vessel tissue such as the branch 6 tends to approach the tip of the cutting edge 15a, and there is a possibility that the branch 6 is caught by the cutting edge 15a.

In addition, since the distal end of the cutting blade 15a of the venous valve incisor 10 is blunt, the venous valve 2 is broken when the operator hooks the distal end of the closed venous valve 2 with the flexible wire of the venous valve incisor 10. By pulling 16, the venous valve 2 is blunted. For this reason, when the venous valve 2 is broken by the venous valve incisor 10, the wound surface of the venous valve 2 becomes rough.

Furthermore, since the venous valve incisor 10 has a shape in which the thickness gradually decreases toward the rear end, the angle of the venous valve incisor 10 is an angle in which the tips of the two cutting blades 15a are between the two-leaf vein valves 2. Then, the cutting blade 15a passes through the venous valve 2 (see FIG. 2D and FIG. 2E). Therefore, the line connecting the tip of each cutting blade 15a to the venous valve incisor 10 is an angle that is perpendicular to the edge of the two-leaf vein valve 2 (see FIGS. 2B and 2C). If the venous valve 2 does not pass through the closed state, the venous valve 2 cannot be destroyed. Here, the closed venous valve 2 refers to a state in which the venous valve 2 is fitted between the first rod 15 and the second rod 12.

Therefore, in order to reliably destroy the venous valve 2 with the venous valve incisor 10, the operation of inserting and extracting the venous valve incisor 10 into the vein 1 as disclosed in Non-Patent Document 1 is performed. The vessel 10 had to be repeated 2-3 times while rotating 90-45 °. Accordingly, since the venous valve incisor 10 is reciprocated many times, the endothelium of the blood vessel may be damaged, and the operation time may be prolonged.

In the blade of Non-Patent Document 2, the blade at the tip is sharply pointed and facing outward, so that the blade may be caught on the branch 6 and break the vein 1.

Thus, both the conventional venous valve incisor 10 and the venous valve cutter may be caught on the branch 6. Therefore, the non-reverse method or the in situ method has the advantage that the tapering of the blood vessel wall 5 becomes a natural flow, and the in situ method has the advantage that the burden on the patient and the surgical invasion are small, Currently, these techniques are rarely used.

The present invention has been developed to solve the above-described problems. That is, the object of the present invention is that there is little possibility of damaging the endothelium and branches of blood vessels, and even a less experienced operator can incise a venous valve more safely and easily by reciprocating once in the vein. It is an object of the present invention to provide a venous valve incising blade capable of making the cut end of the valve a smooth cut and a manufacturing method thereof.

According to the present invention, a shape having a cylindrical surface having a diameter smaller than the diameter of the lumen of the vein centering on the axial center extending in the front-rear direction and a front end portion and a rear end portion of a semi-elliptical shape centering on the axial center, Or a spheroid shape having a long axis on the axis and a length of the short axis smaller than the diameter of the lumen, and a guide for moving the axis along the direction of the vein;
A connecting rod connected to the front end of the guide and extending forward along the axis and having a smaller diameter than the guide;
A tip cutter having a circular arc centered on the axis as an outer edge of a cross section by a plane orthogonal to the axis connected to the front end of the connecting rod;
A flexible wire connected to the rear end of the guide and extending backward,
The tip cutter has a rear end portion having a curved surface curved rearward at the rear end,
The maximum diameter of the tip cutter is larger than the diameter of the connecting rod,
The rear end portion has four or more substantially triangular pyramid-shaped cutting cones spaced apart from each other in the circumferential direction of the axial center,
The cutting edge cone has a sharp blade with three edges generated from the apex, with the outer peripheral surface of the tip cutter formed of a circular arc of the circular shape facing one apex, with the apex facing rearward. A substantially triangular pyramid shape to be formed,
A venous valve incision blade is provided, wherein one of the three sides extends from the apex toward the axis.

The tip cutter is a semi-ellipse in which a spheroid whose longitudinal length is longer than the radius of the regular circle is cut along a plane passing through the center point thereof and perpendicular to the axis, and the curved surface curves forward. A semi-ellipsoidal shape obtained by cutting a front end portion that is a body shape and a spheroid whose length in the front-rear direction is shorter than the spheroid of the front end portion by a plane that passes through the center point and is orthogonal to the axis, or a hemisphere A shape having the rear end portion, or an egg shape with a narrow curved surface facing forward.

Further, the apex of the cutting edge cone is a sharp blade with a sharp point or a blunt edge with a sharp tip located on the inner side of the outer peripheral surface of the maximum diameter position of the tip cutter.

Also, the outer cutting edge which is the side in contact with the outer peripheral surface of the tip cutter among the three sides is curved outward.

Further, the outer cutting edge which is the side in contact with the outer peripheral surface of the tip cutter among the three sides is continuous over the entire circumference around the axis.

Of the contact points of the outer cutting blades adjacent to each other, the contact point located on the front side is located on the outer peripheral surface of the maximum diameter position of the tip cutter.

In addition, the maximum radius of the tip cutter is x, the distance from the vertex of the cutting edge cone to the axis is y, the distance from the vertex of the cutting edge cone to the front end of the guide is h, and the axis is included. When the arc of the rear end portion of the section of the tip cutter by a plane is R,
y / x is 1/3 to 1/2,
R / 2x is 0.8 to 1.3,
And x / h is 1.3 or more.

Moreover, according to the present invention, there is provided a method for manufacturing the above-described venous valve incision blade,
There is provided a method for manufacturing a venous valve incision blade, characterized in that the cutting edge cone is formed by making a plurality of incisions at different angles around the axis at the rear end portion of the tip cutter.

According to the venous valve incising blade of the present invention described above, the distal end cutter has four or more cutting edge cones spaced apart from each other in the circumferential direction of the axial center at the rear end portion thereof, so that the operator can adjust the axial center. Even if the venous valve cutting blade is inserted into the vein at any angle from the center, the cutting edge cone can be applied to the venous valve. Therefore, the operator can incise the venous valve by inserting the venous valve incising blade once and pulling it out.

In addition, since the venous valve incising blade of the present invention is provided with four or more cutting blade cones, it is possible to prevent the blood vessel endothelium and the branch branch portion from approaching from the lateral direction to the apex of the one cutting blade cone. This can be prevented by the outer peripheral surface of the cone or the outer peripheral surface of another cutting edge cone. Therefore, the venous valve incision blade of the present invention has a low possibility of damaging the endothelium and branches of blood vessels, and it is safer and easier for an operator who has little experience in femoral popliteal artery revascularization surgery by the non-reverse method or in situ method. The valve can be opened. This ensures safer surgery for the patient.

In the venous valve incision blade of the present invention, the cutting blade cone has a substantially triangular pyramid shape having three sides that form a sharp pointed blade. An incision can be made.

In addition, according to the above-described method for manufacturing a venous valve incising blade of the present invention, a cutting edge cone can be easily provided at the rear end of the tip cutter.

Further, by using the venous valve incision blade of the present invention, even an operator with little experience in femoral popliteal arterial revascularization can safely perform the operation, and therefore femoral popliteal arterial revascularization can be performed. We can expect to increase the number of vascular surgeons. And it leads to being able to save many patients with severe ischemic limbs from lateness and stumps due to delayed treatment.

It is explanatory drawing of a vein and a vein valve. It is explanatory drawing of the venous valve incision machine disclosed by patent document 1 and nonpatent literature 1. It is a whole explanatory view of the venous valve incision blade of the present invention. 4A is an enlarged view of J of FIG. 3 in the venous valve incising blade of the first embodiment of the present invention, and FIG. 4B is a view taken along the line CC of FIG. 4A. It is use explanatory drawing of the venous valve incision blade of this invention. It is explanatory drawing of the function of the venous valve incision blade of this invention. It is an enlarged view of J of FIG. 3 in the venous valve incision blade of 2nd Embodiment of this invention.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. In addition, the same code | symbol is attached | subjected to the common part in each figure, and the overlapping description is abbreviate | omitted.

FIG. 3 is an overall explanatory view of the venous valve incising blade 20 of the present invention.
The venous valve incising blade 20 of the present invention includes a guide 22, a connecting rod 24, a wire 26, and a tip cutter 30. The guide 22, the connecting rod 24, the wire 26, and the tip cutter 30 are made of metal. The guide 22 and the tip cutter 30 are preferably made of stainless steel such as SUS304. The connecting rod 24 and the wire 26 are preferably stainless steel wires such as SUS304. However, the material of the venous valve incision blade 20 of the present invention is not limited to this, and other metals may be used as long as they are harmless to the human body and have heat resistance that can withstand aseptic processing.

(First embodiment)
FIG. 4A is an enlarged view of J in FIG. 3 in the venous valve incising blade 20 according to the first embodiment of the present invention. FIG. 4B is a view taken along the line CC of FIG.

The guide 22 of the present invention is a guide having an axial center T extending in the front-rear direction, and causing the axial center T to follow the running direction of the vein 1. The guide 22 has a cylindrical surface 22a having a diameter smaller than the diameter of the lumen 3 of the vein 1 around the axial center T extending in the front-rear direction, a semi-elliptical front end portion 22b and a rear end portion 22c centered on the axial center T. It has a shape with Alternatively, the guide 22 has a spheroid shape having a long axis on the axis T and a length of the short axis smaller than the diameter of the lumen 3. The shape of the guide 22 is most preferably a shape having a body having a cylindrical surface 22a and a front end portion 22b and a rear end portion 22c of a hemisphere or a semi-ellipsoid. However, the shape is not limited to this, and the shape of the guide 22 may be an egg shape or a lemon shape.

The venous valve incision blade 20 of the present invention has the guide 22 so that the vein 1 can always be held in a stretched state (that is, the lumen 3 of the vein 1 is open and not collapsed). Without the guide 22, the lumen 3 of the vein 1 collapses and the vein valve 2 cannot be cut well. On the contrary, the vein 1 can be fitted into the recess between the tip cutter 30 and the guide 22 by holding the vein 1 in a tensioned state.

The connecting rod 24 of the present invention is a rod connected to the front end of the guide 22 and extending forward along the axis T to have a smaller diameter than the guide 22. The diameter of the connecting rod 24 is smaller than the diameter of the guide 22 and the tip cutter 30. For example, the diameter of the connecting rod 24 is preferably 1/8 to 1/4 of the diameter of the tip cutter 30, and preferably 1/9 to 1/3 of the diameter of the guide 22.

In a state where the venous valve 2 is open, the blade of the tip cutter 30 (a cutting edge cone 34 to be described later) passes through the venous valve 2, so that the venous valve 2 cannot be cut. On the other hand, the venous valve incising blade 20 of the present invention has a guide 22 and a connecting rod 24, and the connecting rod 24 is thinner than the guide 22 and the tip cutter 30, so that the rear end of the tip cutter 30 and the front end of the guide 22 are arranged. Between them, the venous valve 2 can be closed.

Note that the diameter of the cylindrical surface 22 a of the guide 22 or the length of the minor axis of the spheroid is preferably the same as the maximum diameter of the tip cutter 30. However, as long as the guide 22 can fulfill the function of expanding the lumen 3 of the vein 1 and closing the vein valve 2, the diameter of the cylindrical surface 22 a of the guide 22 or the short axis of the spheroid shape is not limited thereto. This length may be larger or smaller than the maximum diameter of the tip cutter 30.

The wire 26 of the present invention is a flexible wire that is connected to the rear end of the guide 22 and extends backward. The wire 26 is preferably a linearly extending wire that is free from wrinkles such as twisting and undulation. In order not to damage the vascular endothelium, the side surface of the wire 26 is preferably composed of a rounded curved surface.

The front end cutter 30 of the present invention is connected to the front end of the connecting rod 24 and has a circular arc centered on the axis T as an outer edge of a cross section by a plane. Further, the tip cutter 30 has a maximum diameter larger than the diameter of the connecting rod 24.
The front end cutter 30 has a rear end portion 32 having a curved surface curved rearward at the rear end.

The tip cutter 30 preferably has an oval shape with a narrow curved surface facing forward.
Or the front-end | tip cutter 30 may have the front-end part 48 which is a semi-ellipsoid shape, and the rear-end part 32 which is a semi-ellipsoid shape or a hemisphere. At this time, the front end portion 48 is a half of which a spheroid whose length in the front-rear direction is longer than the radius of a perfect circle is cut along a plane passing through the center point and perpendicular to the axis T, and the curved surface is curved forward. It is an ellipsoidal shape. The rear end portion 32 is a semi-ellipsoidal shape or a hemisphere obtained by cutting a spheroid whose length in the front-rear direction is shorter than the spheroid of the front end portion 48 along a plane passing through the center point and orthogonal to the axis T. is there.

In this case, the rear side end surface of the front end portion 48 and the front side end surface of the rear end portion 32 may be connected to form an egg shape, or a cylindrical surface is provided between the front end portion 48 and the rear end portion 32. You may have a trunk | drum. The front end portion 48 and the rear end portion 32, or the front end portion 48, the body portion, and the rear end portion 32 are integrally formed.

That is, when the tip cutter 30 is viewed from a direction perpendicular to the axis T (K in FIG. 4; hereinafter, lateral direction), the silhouette of the tip cutter 30 is viewed from any angle centered on the axis T. The shape of is the same. For this reason, the outer peripheral surface 36 prevents the branch 6 from approaching the apex 42 of the distal end cutter 30 regardless of the direction in which the branch 6 of the vein 1 approaches the distal end cutter 30 from the lateral direction around the axis T. be able to. Therefore, the venous valve incising blade 20 of the present invention can prevent the branch 6 from being broken by having the shape of the tip cutter 30 and the four or more cutting edge cones 34.

The maximum diameter (maximum diameter) in the radial direction of the tip cutter 30 is preferably 2.0 mm to 5.0 mm, and most preferably 3.0 mm. However, the maximum diameter of the tip cutter 30 is not limited to this, and may be larger or smaller depending on the diameter of the lumen 3 of the autologous vein 1.

The rear end portion 32 has four or more substantially triangular pyramid-shaped cutting edge cones 34 with the apex 42 facing rearward, spaced apart from each other in the circumferential direction of the axis T. The cutting edge cone 34 has the outer peripheral surface 36 of the tip cutter 30 formed of a circular arc as one of the side surfaces in contact with the vertex 42, and forms three

sharp edges

40a and 40b with three sides generated from the vertex 42. It is a substantially triangular pyramid shaped blade. With this shape, the front end cutter 30 of the present embodiment has a configuration in which the outer edge of the cross section by a plane orthogonal to all the axis centers T from the front end to the rear end includes a circular arc centered on the axis T. ing. The respective cutting edge cones 34 are preferably arranged at equal intervals around the axis T.

The venous valve incision blade 20 of the present invention forms a

sharp blade

40a, 40b having three sharp edges of the cutting blade cone 34, thereby cutting the venous valve 2 with a sharp blade like a scalpel or a scissors. be able to.

The rear end 32 preferably has from 4 to 8 cutting edges 34, most preferably 4. Accordingly, the venous valve 2 can be reliably incised regardless of the angle at which the venous valve incising blade 20 is inserted into the vein 1.
The number of cutting edge cones 34 is preferably an even number. Thereby, as will be described later, the cutting edge cone 34 can be easily formed.

The apex 42 of the cutting edge cone 34 is formed by the outer peripheral surface 36 of the tip cutter 30 and two intersecting surfaces 38 that are surfaces intersecting the axis T.
The three sides of the cutting edge cone 34 are two outer cutting edges 40 a that are sides formed by the outer peripheral surface 36 and each intersecting surface 38, and a middle cutting edge 40 b that is a side formed by the two intersecting surfaces 38.

The intermediate cutting blade 40b is one of the three sides, and forms a blade extending from the apex 42 toward the axis T.

The outer cutting edge 40 a is a side in contact with the outer peripheral surface 36 of the tip cutter 30 among the three sides of the cutting edge cone 34.
The outer cutting edge 40a is preferably curved outward. Since the outer cutting edge 40a is curved outward, the area of the outer peripheral surface 36 of the cutting edge cone 34 is increased, and the width of the cut 46 between the adjacent outer cutting edges 40a can be reduced. Thereby, it is possible to prevent the branch portion 7 (see FIG. 5) of the branch 6 from entering between the notches 46.

Further, the apex 42 of the cutting edge cone 34 composed of the two intersecting surfaces 38 and the outer peripheral surface 36 is located on the inner side of the outer peripheral surface 36 a at the position of the maximum diameter of the tip cutter 30. Thereby, it is possible to prevent the apex 42 from being caught on the branch portion 7 (see FIG. 5).

The apex 42 of the cutting edge cone 34 of the present embodiment is a sharp blade with a sharp point. Thus, the operator can easily pierce the venous valve incising blade 20 of the present embodiment into the thin and soft venous valve 2.

Further, the outer cutting edge 40a is provided over the entire circumference around the axis T. The outer cutting edge 40a is preferably provided continuously over the entire circumference.

Further, the contact 44 located on the front side among the contacts 44 of the outer cutting edges 40a adjacent to each other is preferably located on the outer peripheral surface 36a at the position of the maximum diameter of the tip cutter 30. However, the present invention is not limited to this, and the contact 44 may be in front of or behind the outer peripheral surface 36a at the position of the maximum diameter of the tip cutter 30.

Next, the relationship between the maximum diameter of the front end cutter 30 and the position of the apex 42, the curved surface of the rear end portion 32, or the distance between the front end cutter 30 and the guide 22 will be described.

The maximum radius of the tip cutter 30 is x, and the distance from the apex 42 of the cutting edge cone 34 to the axis T is y. Further, the distance from the apex 42 of the cutting edge cone 34 to the front end of the guide 22 is h, and the arc of the rear end portion 32 of the cross section of the front end cutter 30 by a plane including the axis T is R.
In this case, in the venous valve incising blade 20 of the present invention, y / x is 1/3 to 1/2, R / 2x is 0.8 to 1.3, and x / h is 1.3 or more. It is preferable that

Further, y / x is most preferably 2/3, and R / 2x is most preferably 1 to 1.125.
Further, x / h is most preferably 1.5, but not limited to this, x / h is larger than 1.5 depending on the size, elasticity, and elasticity of the autologous vein 1. May be small. In order to prevent the branching portion 7 of the branch 6 from entering the four cutting edge cones 34 from the recess between the rear end of the front end cutter 30 and the front end of the guide 22, x / h is 1.5 or less. It is better to be larger than 1.5.

Alternatively, z / h is most preferably 0.81 to 0.89, where z is the distance in the front-rear direction from the position of the maximum diameter of the tip cutter 30 to the apex 42.

Next, the manufacturing method of the venous valve incision blade 20 of this invention is demonstrated.
(1) First, a metal is formed into the shape of the tip cutter 30 (a shape having two semi-ellipsoids or an oval shape) by machining or casting. The tip cutter 30 may be formed in these shapes by other methods.

(2) Next, the cutting edge cone 34 is formed in the rear end portion 32 of the front end cutter 30 by making incisions 46 with different angles around the axis T a plurality of times. In the case of FIG. 4, four cutting edges 34 are formed by making cuts 46 in the cross. The number of cuts 46 may be greater or less than this. The shape of the notch 46 is not limited to this, and may be other shapes.

(3) Thereafter, the center of the tip cutter 30 and the front end of the connecting rod 24, the rear end of the connecting rod 24 and the front end of the guide 22, and the rear end of the guide 22 and the tip of the wire 26 are connected. As a connection method, shrink fitting is preferable, but connection may be performed by other methods.

The wire 26 is fixed to the guide 22 by penetrating it, and the tip of the wire 26 and the tip cutter 30 are connected to each other, so that the wire 26 positioned between the rear end portion 32 of the tip cutter 30 and the front end of the guide 22 is used. The connecting rod 24 may be configured.

Next, a method of using the venous valve incising blade 20 of the present invention will be described by taking the non-reverse method as an example.
The venous valve incision blade 20 of the present invention can be used not only for the non-reverse method but also for the in situ method.

Further, the method of using the venous valve incision blade 20 of the present embodiment will be described by taking femoral popliteal artery revascularization as an example. However, the venous valve incision blade of the present invention is also applied to operations other than femoral popliteal artery revascularization. 20 can be used. For example, there is a possibility that the venous valve incising blade 20 of the present invention can also be used when the autologous vein 1 is used as a graft in shunt surgery or heart surgery.

FIGS. 5 (A) to 5 (D) are explanatory views for using the venous valve incising blade 20 of the present invention, and time elapses from FIG. 5 (A) to FIG. 5 (D).

(1) First, the periphery of the vein 1 serving as a graft is peeled and removed, and the central C end of the graft (autologous vein 1) is anastomosed to the central C artery from the occlusion.

(2) Next, the position of the venous valve 2 is confirmed.
Arterial blood flowing from the artery into the autologous vein 1 flows to the venous valve 2 on the most central side C of the autologous vein 1, but does not flow to the peripheral side P from the venous valve 2. Therefore, the surgeon can confirm the pulsation by touching the vein 1 on the central side C with the finger from the venous valve 2 on the most central side C, but touch the pulsation by touching the vein 1 on the peripheral side P from the venous valve 2. I don't know. First, the operator confirms the position of the venous valve 2 by touching the presence or absence of pulsation of the autologous vein 1 in this manner.

(3) Next, as shown in FIG. 5 (A), the venous valve incision blade 20 is inserted into the lumen 3 of the vein 1, and as shown in FIG. The venous valve incising blade 20 of the present invention is advanced until the front end of the guide 22 reaches C.
As shown in FIG. 5A, if the venous valve 2 is pushed toward the central side C at the front end 48 of the tip cutter 30 or the guide 22 of the present invention, the venous valve incision blade 20 can easily enter the vein 1. Can be made.

(4) Next, after confirming that the front end portion of the guide 22 has reached the central side C from the venous valve 2 on the most central side C, the operator pulls the wire 26 toward the hand. Then, as shown in FIG. 5C, the venous valve 2 is closed at a portion where the diameter between the rear end of the front end cutter 30 and the front end of the guide 22 is reduced (that is, around the connecting rod 24). At this time, the surgeon can feel that the tip cutter 30 has been caught by the venous valve 2 by touch of the hand.

(5) When the operator further pulls the wire 26, the apex 42 of the cutting edge cone 34 of the tip cutter 30 is pierced into the venous valve 2, and from there, the venous valve extends in three directions along the outer cutting edge 40a and the intermediate cutting edge 40b. 2 is incised. At this time, the operator can feel the touch when the venous valve 2 is cut with the tip cutter 30 on the finger.

(6) Thereafter, the range of the autologous vein 1 in which pulsation can be felt advances to the next venous valve 2 on the distal side P several cm. The position of the next venous valve 2 is confirmed as described above in (2), the wire 26 is further pulled, and (3) to (5) are repeated for the other venous valves 2 of the autologous vein 1. Then, it is confirmed that all the venous valves 2 have been incised by releasing arterial blood from the peripheral end of the autologous vein 1.

In this way, the venous valve incising blade 20 once opens the venous valve 2 when the guide 22 passes through the venous valve 2, and after the distal end cutter 30 reaches the central side C from the venous valve 2, the operator holds the wire 26 at hand. By pulling toward the side, the open venous valve 2 can be closed. Thereby, the venous valve 2 can be cut by one operation.

Further, the venous valve incising blade 20 is inserted into the autologous vein 1 once and pulled out by being inserted into the vein 1 until the guide 22 reaches the central side C from the venous valve 2 on the most central side C. All the venous valves 2 can be opened.

Next, the function of the venous valve incising blade 20 of the present invention will be described.
FIG. 6 is an explanatory diagram of the function of the venous valve incising blade 20 of the present invention. FIG. 6A is a DD arrow view of FIG. FIG. 6B is an explanatory diagram of the function of the venous valve incising blade 20 of the present invention using FIG. 6C is a DD arrow view of FIG. 5C when the venous valve incising blade 20 of the present invention of FIG. 5C is rotated by 45 °. FIG. 6 (D) is an explanatory view of the function of the venous valve incising blade 20 of the present invention using FIG. 6 (C).
For ease of explanation, in FIG. 6, the guide 22 is not shown, and the shape of the distal end cutter 30 on the central side C from the venous valve 2 is shown by a thin line. Also, the black circles in FIGS. 6B and 6D represent the position of the vertex 42 of the cutting edge cone 34.

The venous valve incising blade 20 has an outer cutting edge 40a provided over the entire circumference centering on the axis T, and the contact 44 located on the front side of the contacts 44 of the adjacent outer cutting edges 40a is the maximum of the tip cutter 30. It is located on the outer peripheral surface 36a at the position of the diameter. Accordingly, the venous valve incising blade 20 advances the venous valve 2 from the four apexes 42 toward the contact 44 between the adjacent apexes 42. Thereby, the incision line 45 by one outer cutting blade 40a is connected to the incision line 45 by other adjacent outer cutting blades 40a only by passing the tip cutter 30 of the venous valve incising blade 20 once before and after the venous valve 2. The venous valve 2 can be cut. Alternatively, the tip cutter 30 of the venous valve incision blade 20 is passed once before and after the venous valve 2, and the incision line 45 by each outer cutting blade 40a is advanced to a position close to the contact 44, and the function of the venous valve 2 is lost. Can be made.

Therefore, by using the venous valve incision blade 20 of the present invention, it is possible to perform the process of passing the front and rear of the venous valve 2 through the tip cutter 30 in one time, so that the number of times of reciprocating the lumen 3 is small. The possibility of damaging vascular tissues such as endothelium and branches 6 can be reduced.

Also, as shown in FIGS. 6B and 6D, the venous valve incising blade 20 can be provided with an incision line 45 by the intermediate cutting blade 40b from the apex 42 toward the axis T. As a result, the intermediate cutting blade 40b can cut the edge of the venous valve 2 no matter what angle the venous valve cutting blade 20 is inserted into the vein 1 around the axis T. When the margin is incised, the venous valve 2 is easily inverted to the distal side P. Thereby, the venous valve incising blade 20 can lose the function of the venous valve 2.

(Second Embodiment)
Next, a venous valve incising blade 20 according to a second embodiment of the present invention will be described.
FIG. 7 is an enlarged view of J in FIG. 3 in the venous valve incising blade 20 according to the second embodiment of the present invention.

The apex 42 of the cutting edge cone 34 of the second embodiment of the present invention is a rounded, blunt edge. Further, in the front end cutter 30 of the present embodiment, the outer edge of the cross section by a plane perpendicular to the axis T from the front end to the rear end excluding the blunt apex 42 is a perfect circle centered on the axis T. The structure includes an arc.
Other configurations, usage methods, and functions of the venous valve incising blade 20 of the present embodiment are the same as those of the first embodiment.

Next, the manufacturing method of the venous valve incision blade 20 of 2nd Embodiment of this invention is demonstrated.
The venous valve incising blade 20 of the second embodiment of the present invention is formed by scraping the apex 42 of the venous valve incising blade 20 of the first embodiment with a file or the like.
Other manufacturing methods of the venous valve incising blade 20 of the present embodiment are the same as those of the first embodiment.

According to the venous valve incision blade 20 of the present invention described above, the distal end cutter 30 has four or more cutting edge cones 34 spaced apart from each other in the circumferential direction of the axial center T at the rear end portion 32. However, even if the venous valve incising blade 20 is inserted into the vein 1 at any angle around the axis T, the cutting blade cone 34 can be applied to the venous valve 2. Therefore, the operator can incise the venous valve 2 by inserting the venous valve incising blade 20 once and pulling it out.

Further, since the venous valve incision blade 20 of the present invention is provided with four or more cutting edge cones 34, the blood vessel endothelium and the branching portion 7 of the branch 6 approach the apex 42 of the one cutting edge cone 34 from the lateral direction. Can be prevented by the outer peripheral surface 36 of one cutting edge cone 34 or the outer peripheral surface 36 of another cutting edge cone 34. Therefore, the venous valve incision blade 20 of the present invention has a low possibility of damaging the endothelium and branch 6 of the blood vessel, and even a surgeon with less experience in femoral popliteal arterial revascularization by the non-reverse method or the in situ method can safely vein. The valve 2 can be incised. This ensures safer surgery for the patient.

In the venous valve incision blade 20 according to the present invention, the cutting edge cone 34 has a substantially triangular pyramid shape having three sides forming the

sharp blades

40a and 40b having sharp points. Thus, the venous valve 2 can be incised.

Also, the cutting blade cone 34 can be easily provided at the rear end of the tip cutter 30 by the above-described method for manufacturing the venous valve incising blade 20 of the present invention.

Further, by using the venous valve incision blade 20 of the present invention, even an operator with little experience in femoral popliteal arterial revascularization can safely perform the operation. Therefore, femoral popliteal arterial revascularization can be performed. We can expect to increase the number of vascular surgeons who can do it. And it leads to being able to save many patients with severe ischemic limbs from lateness and stumps due to delayed treatment.

It should be noted that the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention.

1 vein (autologous vein), 2 vein valve, 3 lumen, 4 vein vein sinus, 5 blood vessel wall, 6 branches, 7 branches, 10 vein valve incisor, 12 second rod, 14 connecting member, 15 first Bar, 15a cutting blade, 16 flexible wire, 20 venous valve cutting blade, 22 guide, 22a cylindrical surface, 22b front end, 22c rear end, 24 connecting rod, 26 wire, 30 tip cutter, 32 rear end, 34 cutting edge cone, 36 outer peripheral surface, 36a outer peripheral surface at the maximum diameter position, 38 intersecting surface, 40a outer cutting blade, 40b middle cutting blade, 42 apex, 44 contacts, 45 incision line, 46 incision, 48 front end, C Central side, P peripheral side, T axis

Claims

A shape having a cylindrical surface with a diameter smaller than the diameter of the lumen of the vein centered around the longitudinal axis and a semi-elliptical front end and a rear end centered on the axis, or on the axis A spheroid shape having a major axis and a minor axis length smaller than the diameter of the lumen, and a guide for causing the axis to follow the direction of the vein;
A connecting rod connected to the front end of the guide and extending forward along the axis and having a smaller diameter than the guide;
A tip cutter having a circular arc centered on the axis as an outer edge of a cross section by a plane orthogonal to the axis connected to the front end of the connecting rod;
A flexible wire connected to the rear end of the guide and extending backward,
The tip cutter has a rear end portion having a curved surface curved rearward at the rear end,
The maximum diameter of the tip cutter is larger than the diameter of the connecting rod,
The rear end portion has four or more substantially triangular pyramid-shaped cutting cones spaced apart from each other in the circumferential direction of the axial center,
The cutting edge cone has a sharp blade with three edges generated from the apex, with the outer peripheral surface of the tip cutter formed of a circular arc of the circular shape facing one apex, with the apex facing rearward. A substantially triangular pyramid shape to be formed,
One of the three sides extends from the apex toward the axis, and the venous valve incising blade is characterized in that
The tip cutter is a semi-ellipsoid in which a spheroid whose longitudinal length is longer than the radius of the perfect circle is cut by a plane passing through the center point thereof and perpendicular to the axis, and the curved surface is curved forward. A semi-ellipsoidal shape obtained by cutting a front end portion which is a shape and a spheroid whose length in the front-rear direction is shorter than the spheroid of the front end portion by a plane passing through the center point and perpendicular to the axis, or a hemisphere The venous valve incising blade according to claim 1, wherein the venous valve incising blade has a shape having the rear end portion or an oval shape with a thin curved surface facing forward.
The apex of the cutting edge cone is a sharp blade with a sharp point or a blunt edge with a sharp tip located inside the outer peripheral surface of the maximum diameter position of the tip cutter. The venous valve incision blade according to 1.
2. The venous valve incision blade according to claim 1, wherein an outer cutting edge which is the side in contact with the outer peripheral surface of the tip cutter among the three sides is curved outward.
2. The venous valve incising blade according to claim 1, wherein an outer cutting edge which is the side in contact with the outer peripheral surface of the tip cutter among the three sides is continuous over the entire circumference around the axis. .
6. The venous valve incising blade according to claim 5, wherein a contact located on the front side among the contacts of the outer cutting blades adjacent to each other is located on an outer peripheral surface of the maximum diameter of the tip cutter. .
The maximum radius of the tip cutter is x, the distance from the vertex of the cutting edge cone to the axis is y, the distance from the vertex of the cutting edge cone to the front end of the guide is h, and the plane including the axis When the arc of the rear end of the cross-section of the front end cutter is R,
y / x is 1/3 to 1/2,
R / 2x is 0.8 to 1.3,
4. The venous valve incising blade according to claim 3, wherein x / h is 1.3 or more.
A method for producing a venous valve incising blade according to claim 1,
A method for manufacturing a venous valve incision blade, characterized in that the cutting edge cone is formed in the rear end portion of the tip cutter by making a plurality of incisions at different angles around the axis as a center.