JP6160024B2 - Treatment device for varicose vein removal - Google Patents

Description

  The present invention relates to a treatment tool for removing varicose veins for removing a vein at a site where varicose veins are formed.

  As a treatment method for removing varicose veins, (1) a method of injecting a sclerosing agent into varicose veins to occlude blood vessels, and (2) inserting a wire into the venous lumen where varicose veins are formed, There is known a method in which a vein stump is ligated to the tip of the wire, and the vein is inverted from the ligated site, and then removed and collected. The following patent document 1 and patent document 2 disclose those methods and effects as treatment tools for inverting the vein and removing it. Hereinafter, a varicose vein removal treatment tool used for the purpose of inversion and extraction of a vein is referred to as a vein stripper or more simply a stripper.

JP 2002-291755 A JP 2003-061967 A

  The stripper of Patent Document 1 is formed of a stranded wire as a whole, so that followability and tensile strength are good, but since there is no so-called waist, the blood vessel is located in a deep part of the body Or, when the blood vessel is meandering, the insertability of the stripper is very low.

  On the other hand, in the stripper disclosed in Patent Document 2, the bending strength is reinforced and the insertability is improved by a combination of a metal rod and a stranded metal wire, but the flexibility and elasticity of the metal rod are low. Due to the large ratio, it has been difficult for the stripper (metal bar) itself to bend along the blood vessel, or to deform the shape of the metal bar in advance along the site and arrangement of the blood vessel. As a result, in this type of stripper, the insertability was good, but the followability (of blood vessels) was a problem. Under the circumstances as described above, an object of the present invention is to provide a vein stripper that achieves both insertion into a blood vessel and followability.

  In the present invention, the above-described problems have been solved by the following means. That is, the solving means of the present invention is provided with a tube connecting portion to which an inner flexible tube is circumscribed or inscribed on one end side of a plastic hollow metal tube, One end is provided with a blood vessel insertion portion that is tapered so that the distal end side is thin and the proximal end side is thick, and the tube is formed longer than the metal tube, and an opening formed at the distal end portion of the metal tube Is a treatment device for removing varicose veins characterized by communicating with the lumen of the metal tube and the lumen of the tube.

  Furthermore, more desirable results can be obtained by adopting the following embodiments. For example, in a three-point bending test to be described later, the initial elastic modulus of the metal tube or metal rod (hereinafter referred to as a metal tube or the like) is in the range of 15,000 to 21,000 N / mm2, and the bending stress is low. The treatment tool for removing varicose veins having a maximum value of 9.0 to 13.0 N is desirable. Due to the flexibility and plasticity of the metal tube and the like, the operator can manually deform the shape of the metal tube and maintain the shape according to the arrangement of the blood vessel. If the maximum value of the initial elastic modulus or bending stress is small, it is easy to bend and process, but the waist is not strong, so the insertion into the blood vessel is poor. On the other hand, if the initial elastic modulus and the maximum value of the bending stress are too large, the handleability deteriorates.

  In the buckling test described later, the varicose vein removal treatment tool in which plastic deformation of the metal tube or the like starts with a pressing force of 30 N or more is desirable. While the above metal tube has flexibility and plasticity as described above, plastic deformation does not deform unless a pressing force of 30 N or more is applied, and retains the shape that has been processed in advance, while being unique to the metal. In order to demonstrate the strength of the waist, it is easy to insert a metal tube or the like into the blood vessel.

  The treatment tool for removing varicose veins as described above, wherein the length of the tube is 1.5 to 2.2 times the length of the metal tube or the like. When using the stripper of the present invention to reverse or remove a blood vessel, even if the blood vessel is disconnected, if the tube is 1.5 times longer than the length of the metal tube, etc. This is because it can be performed easily and safely.

  The treatment tool for removing varicose veins, in which both ends of the metal tube or the like are connected by circumscribing so as to cover the flexible tube, is also preferable. In the above aspect, the metal tube can be easily inserted into the tube, and the connection operation is facilitated. Also, when removing the vein, the metal tube etc. must be grasped and pulled (both the metal tube etc. and the tube), but the elastic flexible tube is joined to the outer surface of the metal tube etc. If the tube is extended in the axial direction, the inner diameter of the tube is reduced, and the tube is difficult to be detached from a metal tube (substantially no change in outer diameter).

  Alternatively, in order to make it difficult to separate the tube and the metal tube, the outer diameter of the tube connecting end of the metal tube and the inner diameter of the connecting end of the tube such as the metal tube are antagonized to increase the fitting strength between them. This is one means. For example, when the outer diameter of a tube connection end of a metal tube or the like is D and the inner diameter of the connection end of the tube such as a metal tube is I, D / I is 1.05 to 1.20. It is a tool.

  In a mode other than adjusting the dimensions of the connection end of the metal pipe or the tube or the tube, the tube connection end part of the metal pipe or the like, the connection end part of the metal pipe or the like of the tube, or both, The treatment tool for removing varicose veins is also preferable. When removing a blood vessel in which varicose veins are formed, it is necessary to draw a metal tube or the like to which the tube is connected. However, the locking means is attached to one or both of the metal tube and the connection end of the tube. This is because, by forming, both can be prevented from easily separating during stretching.

  As the locking means, various modes are conceivable. For example, it is easy to form an annular groove, an annular protrusion, or both as a locking means at a connection end of a metal tube or a tube. And effective. The effect can be obtained by either one of the annular groove and the annular protrusion, but those having both can obtain a more reliable locking effect.

  For example, the treatment tool for removing varicose veins, in which one of the locking means is an annular groove and the other is an annular protrusion that can be complementarily engaged with the annular groove, connects a metal tube or the like and a tube. Also, when both are pulled, they are not easily separated, which is preferable.

  In addition to the above, the varicose vein removal treatment tool provided with a shape or function in which the locking means is a substantially irreversible connection is preferable.

  As the material and dimensions, if the metal tube or the like is made of aluminum, the balance between flexibility, plasticity and waist strength is good. When the material is aluminum, the varicose vein removal treatment tool is preferably a solid metal rod and the rod has an average outer diameter in the range of 3.0 to 3.5 mm. If the metal tube or the like is made of aluminum, it is light but has an appropriate waist strength and can be easily inserted into a blood vessel. Further, since the surgeon can deform the metal tube or the like in advance according to the site and arrangement of the blood vessel using the flexibility and plasticity, it is very easy to handle.

  The flexible tube is preferably made of a vinyl chloride resin or a polyolefin resin. This is because it has moderate flexibility, has been used for many years, and safety has been established. Moreover, if it is the material which can shape | mold a tube so that it may be transparent according to a use, since the tube lumen | bore and the liquid which flows there can be confirmed, it is easy to handle. The tube thickness is preferably in the range of 0.5 mm to 1.0 mm. If it is too thin, it may be damaged when pulled, and if it is too thick, insertability, followability and flexibility in the blood vessel are impaired.

  Because the metal tube etc. is plastic, it is possible for the operator to deform the shape of the metal tube etc. before the operation, one end of the metal tube etc. is tapered and the other end is flexible Since the tube is connected, not only the operator can easily perform the operation of inserting the stripper into the blood vessel, but also the operation of turning the blood vessel inside or out of the blood vessel using the stripper is easy and safe. Can be done. In addition, since the metal tube etc. has an appropriate rigidity, when the practitioner inserts the metal tube etc. into the blood vessel, it can be pushed in even by using the strength of the waist even in a resistant part. It is. Further, since the tube is formed longer than the metal tube or the like, it is easy to handle even when the vein is cut off, and the removal operation becomes easy.

In the case of a metal tube, since the opening formed at the distal end of the metal tube communicates with the lumen of the metal tube and the lumen of the tube, the tube proximal end is used before or during treatment. From the side, an anesthetic, a disinfectant solution, an anti-inflammatory agent, or the like can be injected into the affected area through a metal tube and an opening formed in the tip, which is convenient.

It is a schematic diagram which shows one embodiment of the treatment tool (stripper) for varicose vein removal of this invention. It is the schematic which shows preferable embodiment of the structure of the connection part of the metal pipe and tube of the stripper of this invention. It is the schematic which shows the state which deform | transformed and adjusted the stripper of this invention according to the blood vessel arrangement | positioning of an affected part before surgery. It is the schematic which shows the stripper of this invention which changed and adjusted the front-end | tip from skin so that it might be pierced easily. It is a schematic diagram which shows the state which ligated the vicinity of the connection part of a metal tube etc. and a tube, and the central side blood vessel so that it may become easy to invert and extract the blood vessel in which the varicose vein was formed. It is the schematic which shows embodiment which can respond with the thing of this invention, when the length of a stripper (a metal tube etc., connection tubes) is insufficient. It is a graph which shows the change of the pressing force at the time of performing a 3 point | piece bending test. It is a graph which shows the change of the bending stress at the time of performing a buckling test.

  Hereinafter, preferred embodiments of the present invention will be described in more detail based on the drawings. FIG. 1 is one of the preferred embodiments of the venous stripper 1 of the present invention. The stripper 1 is connected to the metal tube at the tube connection portion 2 as one end, the metal tube portion 5 including the blood vessel insertion portion 3 and the central portion 4 as the other end, and the tube connection portion 2. It consists of the flexible tube 6. The blood vessel insertion portion 3 of the metal tube 5 is tapered so that the distal end side is thin and the proximal end side, that is, the tube connection portion 2 side is thicker. Further, the distal end of the blood vessel insertion portion is R (curved surface) processed so as not to accidentally break through the blood vessel at the time of insertion.

  As shown in FIG. 2, an annular groove 7 is formed on the outer surface of the metal tube of the distal tube connecting portion 2, and an annular protrusion 8 is formed at a position corresponding to the annular groove 7 on the lumen side of the flexible tube 6. Is formed. The annular groove 7 and the annular protrusion 8 function as locking means when both the metal tube 5 and the tube 6 are connected, and when the metal tube 5 is inserted into the lumen of the tube 6 and connected as shown in the figure, Even if the annular protrusion 8 is fitted in the annular groove 7 and the metal tube and the tube 6 are pulled, they cannot be easily detached. In the above embodiment, the annular groove is formed in the metal tube and the annular protrusion is formed in the tube lumen. Conversely, the annular protrusion may be formed in the metal tube and the annular groove may be formed in the tube lumen. Further, the annular protrusion or the annular groove may be provided near the entire circumference to the extent that a required engagement strength can be obtained, even if it is not completely annular.

  The metal tube 5 has a diameter of 2.0 to 3.0 mm, a material made of aluminum, and a length (total length) from the tube connection portion 2 to the blood vessel insertion portion 3 is 500 mm. The dimension of the stripper is desirably adjusted between 300 and 600 mm in total length depending on the state of the affected part and the target patient. The material of the metal tube is important for its insertability, workability, and adjustment (deformation) before the treatment, but an aluminum tube was selected because of its ease of handling and availability. As will be described later, if it is not necessary to inject an anesthetic, disinfectant, or anti-inflammatory agent into the blood vessel through the tube, through the lumen of the metal tube, it may not be tubular, but a solid rod shape. Can also be used.

  The tube 6 made of a vinyl chloride resin having an outer diameter of 3.7 mm, a thickness of 0.6 mm, and a length of 950 mm to 1100 mm was selected. The inner diameter of the tube 6 is preferably the same as or slightly smaller than the outer diameter of the metal tube 5. As described above, the means and strength of the locking means can be taken into account by adjusting the dimensions of both (tube 6 and metal pipe 5).

  An opening 9 is formed in the blood vessel insertion portion 3 of the metal tube 5. In the case of the insertion portion 3, the opening 9 may be formed either at the distal end portion of the metal tube 5 or at the side tube portion slightly deviated from the distal end portion. The injection site and other parts can be formed as necessary. The opening 9 communicates with the lumen of the metal tube 5 and the lumen of the tube 6, and therefore, an anesthetic is supplied from the proximal side of the tube before or after the treatment, to a necessary site in the blood vessel. Can be administered. Instead of the anesthetic agent, a disinfectant solution or an anti-inflammatory agent may be administered.

  Hereinafter, a use case of the stripper of the present invention and an operation for removing a blood vessel in which a varicose vein has been formed using the stripper (hereinafter also referred to as a stripping operation) will be described. When the stripper of the present invention is used for the great saphenous vein (GSV), the shape of the stripper is previously curved and deformed in an arcuate shape along the GSV run, and the central (blood vessel) branch required for incision of 1 cm of the buttocks After the treatment, insert a stripper in the direction of the lower leg, rotate the stripper at the lower knee bifurcation, make it easy to pierce, remove the affected blood vessel from the incision of about 4mm formed on the skin, and remove it It was.

  When it was difficult to insert the stripper into the blood vessel, the tip of the stripper was deformed by hand under the echo guide and the treatment was performed. When the blood vessel is disconnected at the time of removing the blood vessel, the blood vessel is inverted in the direction opposite to that pulled for the removal operation, and then removed. If this is not possible, it is possible to select a Babcock-style procedure in which a knot is formed in the tube and used as a hook to remove the blood vessel.

1. Material (stripper)
As the metal rod, select aluminum diameter: 3.0 mm, total length: 500-600 mm, and use the flexible tube connected to the end of the infusion set made of vinyl chloride resin with added plasticizer did. The inner diameter of the tube was almost the same as or slightly smaller than the outer diameter of the metal rod, and the total length was 1000 mm.

2. Treatment The metal rod portion of the stripper was deformed into an arc shape in accordance with the curvature of the GSV (FIG. 3) and inserted from the SFJ (femoral vein saphenous vein, junction) side. At this time, if the central blood vessel is ligated and separated, the procedure is easy. Conventionally, when a blood vessel is inserted into the stripper and the tip cannot pass from the distal end of the blood vessel, an incision is often added. However, the stripper of the present invention has plasticity and has a waist. The stripper can be guided (inserted / passed) under the echo guide even if there are parts that meander or cannot pass through the blood vessel, and the tip angle of the metal rod can be bent under the skin. Can be changed. Furthermore, even when the stripper cannot pass through the blood vessel, it can be punctured in the middle of the blood vessel, and in that case, the operation can be performed with a small skin incision.

  When the stripper enters the blood vessel and reaches the target site of the peripheral blood vessel (the site where the GSV branches about 5 cm below the knee), the metal rod should be manually Deform and process. That is, as shown in FIG. 4, the bending point 10 is formed by bending the proximal end side of the metal rod 5, that is, the portion close to the tube connecting portion 2 side by hand. Then, the metal tube is gripped near the bending point 10 or between the tube connecting portions 2 from the bending point 10 and the tip end side of the metal tube is rotated 90 degrees around the axis. By the above operation, the stripper tip can be easily exposed from the target site of the peripheral blood vessel. Alternatively, the same effect as described above can be obtained by pressing the center of the thigh from the outside and deforming the metal tube into a dogleg shape in the skin.

  The target site skin is incised with a scalpel about 4 mm in advance, the part of the skin that strikes the tip of the strip metal rod is further incised with a scalpel, and the end of the stripper is pierced. When it is difficult to pierce the tip, it can be easily guided by grasping the tip of the metal rod and bending the tip with mosquito forceps from the incision.

  After the center is cut off on the SFJ side of the GSV sandwiched between mosquito forceps, as shown in FIG. 5, the tube connecting portion 2 on the base end side of the metal rod and the metal rod 5 are covered all around (at the connecting portion 2). The three ends of the tube end portion and the vein wall 11 covering the tube end portion are overlapped in the order shown in the figure at the position P corresponding to the annular groove 7 formed in the metal rod with the suture thread 12 or the like. To ligate. Similarly, the metal rod and the blood vessel wall are ligated as shown in the drawing even at a location R slightly away from the joint between the tube and the metal rod to the proximal end side of the metal rod. By the above ligation, when the blood vessel is pulled and removed, the blood vessel is held by the stripper and can be prevented from being detached. As a result, treatment such as inversion and extraction of the blood vessel is easy and reliable. Further, the tube 6 and the blood vessel wall 11 are ligated with the remaining thread 12 at a location Q slightly separated from the joint between the tube and the metal rod to the tube proximal end side. Thereby, the inversion and removal of the blood vessel is easy and reliable.

Even when the blood vessel is disconnected during the stripping operation, the stripper of the present invention can continue the operation safely and effectively by the following operation.
(1) Reverse stripping At the knee incision, the GSV is scooped with a hook, the peripheral blood vessel is ligated and disconnected, and the stroke is reversed from the normal direction, that is, from the knee stump to the SFJ direction. Ripping. (Proceed with the treatment by pushing in the metal tube / metal bar and pulling the tube.)

(2) Babcock type stripping by tube ligation When stripping in the reverse direction is impossible, the tube part is tied once or twice to form a large diameter part and stripping in the normal direction to the Babcock type. When (inversion, extraction operation) is performed and the vein can be extracted to the knee, only the vein is pulled out from the knee incision portion, and the large diameter portion is pulled back in the SFJ direction, so that no additional incision is necessary. In this way, even when a blood vessel is disconnected, it is possible to cope with it without preparing a special instrument or instrument. The operation of tying the tube is simple and quick, but if it is troublesome, it is desirable to attach a retrofit type hinged Babcock to the desired part of the tube.

  In the conventional stripper, when the length is insufficient, a thread is tied to the base end portion of the metal rod. However, in the stripper of the present invention, as shown in FIG. It is possible to form an annular loop by inserting the tip 5 (blood vessel insertion part side) 3 and so on, and it is possible to cope with a shortage of length by forming the loop.

  205 cases in which stripping operation was performed using the stripper of the present invention by the above-described procedure: 205 cases, and as a comparative example, cases in which stripping operation was performed using a conventional stripper: 121 The results are shown below for an example. In the example using the product of the present invention, the initial success rate was 88.3%, and the ratio that the blood vessel was cut off and it was necessary to use the Babcock procedure was as low as 6.3%. On the other hand, in the comparative example using the conventional stripper, the initial success rate was 80.1%, and the ratio that required the use of Babcock treatment was 15.7%. Admitted.

[Method of physical property test]
[Buckling test]
Of the physical properties of the metal tube, which is part of the important features of the stripper of the present invention, a buckling test as shown below was conducted in order to measure the pressing force before starting plastic deformation, the so-called waist strength. It was.
(1) Measuring device
(a) Shimadzu Autograph AG-IS
(b) Load cell used: 500N
(2) Test piece
(a) Material: Aluminum
(b) Shape: Solid rod
(c) Dimensions: 3.0mm, 225.0mm

(2) Test method
(a) The lower end of the solid metal rod was sandwiched between chucks, and the upper end was pressed against a metal plate connected to the load cell to hold both ends.
(b) The test piece was pressed from the vertical direction (end), and the pressing force (maximum value) applied to the load cell when plastic deformation started was measured. The moving speed of the metal plate is 100 mm / min. The results are shown in Table 1. FIG. 8 shows a graph in which the pressing force changes with the movement of the metal plate. The vertical axis represents the pressing force (N) applied to the test piece, and the horizontal axis represents the moving distance of the metal plate. The maximum point displacement indicates the distance that the metal plate has moved from the position where the test piece is first set to the position where the pressing force is maximum. The measurement was performed a total of four times, changing the test piece.

[3-point bending test]
Similarly, among the physical properties of the metal tube, which is part of the important characteristics of the stripper, the initial elastic modulus, that is, the flexibility when deforming the metal rod in advance according to the shape of the blood vessel, and the plasticity that maintains the deformed shape In order to measure, a three-point bending test as shown below was performed.

(1) Measuring device
(a) Shimadzu Autograph AG-IS
(b) Load cell used: 500N
(2) Test piece
(a) Material: Aluminum
(b) Shape: Solid rod
(c) Dimensions: 3.0mm, 150.0mm

(2) Test method
(a) Hold both ends of the test piece placed in the horizontal direction (distance between fulcrums of 100 mm), and hit the edge of a 1 mm thick metal plate connected to the load cell in the middle of the test piece. The initial elastic modulus and the maximum value of the pressing force causing plastic deformation were measured by moving the metal plate from the bottom to the bottom. The moving speed is 500 mm / min. The results are shown in Table 2. Moreover, the graph which shows the change of the pressing force at the time of performing a 3-point bending test is shown in FIG. The vertical axis indicates the magnitude of the pressing force (N), and the horizontal axis indicates the moving distance (mm) of the metal plate connected to the load cell. In the three-point bending test, the maximum point displacement indicates the distance that the metal plate has moved from the position where the test piece is first set to the position where the bending stress is maximized. In the bending test, the measurement was performed four times by changing the test piece as in the buckling test.

  The treatment device for removing varicose veins of the present invention is suitable for treating varicose veins formed in veins, especially for treating varicose veins of the lower limbs easily and reliably.

1. 1. Vein stripper 2. Tube connection part 3. Blood vessel insertion part Central part 5. Metal tube (part)
6). (Flexible) tube 7. Annular groove 8. 8. An annular protrusion Opening 10. Bending point11. Vascular wall 12. (Suture) thread 13. Tube proximal end

P. Ligation site (region where metal tube, tube, blood vessel wall are layered in this order)
Q. Ligation site (region where tube and blood vessel wall are layered in this order)
R. Ligation site (region where metal tube and blood vessel wall are layered in this order)

Claims (11)

A tube connecting portion to which an inner flexible tube is connected is provided on one end of a plastic hollow metal tube, and the other end of the metal tube is tapered so that the distal end is thin and the proximal end is thick. Provided with a processed blood vessel insertion portion, the tube is formed longer than the metal tube, and an opening formed at the tip of the metal tube communicates with the metal tube lumen and the tube lumen. A treatment device for removing varicose veins. In a three-point bending test, an initial elastic modulus of the metal tube is in a range of 15,000 to 21,000 N / mm2, and a maximum value of a bending stress is in a range of 9.0 to 13.0 N. The treatment tool for removing varicose veins according to 1. The varicose vein removal treatment tool according to any one of claims 1 and 2, wherein in the buckling test, the plastic deformation of the metal tube starts with a pressing force of 30 N or more. The varicose vein removal treatment tool according to any one of claims 1 to 3, wherein the length of the tube is 1.5 to 2.0 times the length of the metal tube . The treatment tool for removing varicose veins according to any one of claims 1 to 4, wherein the flexible tube is circumscribed and connected to an end of the metal tube . The D / I is 1.05-1.20, where D is the outer diameter of the tube connection end of the metal tube and I is the inner diameter of the metal tube connection end of the tube. The varicose vein removal treatment device described. The locking means is formed so that it becomes difficult to detach after connecting both to the tube connection end of the metal tube, the metal tube connection end of the tube, or both. The treatment tool for removing varicose veins according to any one of 6 items. The varicose vein removal treatment tool according to claim 7, wherein the locking means is an annular groove or an annular protrusion. The treatment tool for removing varicose veins according to any one of claims 7 and 8, wherein one of the locking means is an annular groove, and the other is an annular protrusion that can be complementarily engaged with the annular groove. . The treatment device for removing varicose veins according to any one of claims 7 to 9, wherein the locking means is provided with a shape or a function that provides a substantially irreversible connection. The varicose vein removal treatment device according to any one of claims 1 to 10, wherein the flexible tube is made of a transparent synthetic resin.

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