JP3037139U - Stent mounting tools - Google Patents

Abstract

(57) 【Abstract】 PROBLEM TO BE SOLVED: To introduce a stent into a coronary artery stenosis part of the heart to expand the coronary artery to promote normal blood flow and to maintain the stent without deforming or breaking the balloon. Provided is a mounting device which is properly mounted and mounted so that a balloon having a stent can be delivered into an artery without any trouble. SOLUTION: A stent holding part connected to one gripping part and a stent holding part connected to the other gripping part are formed, and the stent holding part facing each other has a width corresponding to the length of the stent. Grooves having an arcuate cross section are formed so as to face each other, both gripping portions are grasped, a stent is held between the facing groove portions, and the stent is mounted and mounted on a balloon.
A plurality of arcuate grooves having different gradual radii are arranged on each stent holding portion according to the actual use. An elastic film is applied to the inner concave surface of each groove.

Description

[Detailed description of the invention]

[0001]

[Technical field to which the invention belongs]

 There is a method called PTCA balloon surgery (percutaneous coronary angioplasty) as a method for treating coronary stenosis as a heart disease by medical means. The present invention uses the stent used in this operation as a balloon. Mounting device for mounting.

More specifically, the stent for expanding the stenosis of the coronary arteries and maintaining the expanded state is provided on the outer circumference of the balloon without causing deformation or damage to the stent and without damaging the balloon. The present invention relates to a tool that can be mounted and mounted efficiently without depending on fingertip technique.

[0003]

[Prior art]

 To mount and mount a stent made of a non-corrosive metal having a bellows-like flex structure consisting of an externally scale-like mesh structure on the balloon, no special tools have been conventionally used, and the practitioner Pick the stent with an inner diameter slightly larger than the outer diameter of the balloon, insert it carefully, feed it on the balloon with your fingertips, and press it evenly from the outer periphery at the specified position to form a balloon. They were dressed, loaded, and worn.

Therefore, the work of mounting and mounting the stent has all depended on the skill of finger practicing by the practitioner's experience and feeling.

[0005]

[Problems to be solved by the device]

 In general, percutaneous coronary angioplasty in which a stent is inserted into a coronary artery stenosis and then expanded to maintain the blood flow in the coronary artery, the patient is given an anti-plasma plate preparation in advance and the femoral base is treated. Insert the injection needle toward the femoral artery in the medial groin area, the elbow artery inside the elbow, or the radial artery outside the wrist, and insert a guide wire into the inside of the injection needle to insert the guide wire into the artery. After feeding the needle and removing the injection needle, insert the guiding catheter along the inserted guide wire, and introduce it along the arteries. Immediately before the stenotic lesion, a contrast agent is injected into the coronary ostium, the contrast agent is injected, and the stenotic lesion is detected by X-ray. Then, by observing the state under the X-ray that the stent has surely entered the stenosis, a pressure of up to about 20 atm is applied to the balloon tube, and the stent carried on the balloon is expanded in the stenosis. Then, the expanded stent is allowed to invade the inner wall of the blood vessel in the stenosis, and then the balloon tube is decompressed and withdrawn.

[0006] At the end of such continuous treatment, the balloon of the stent attachment, which is inserted and introduced, must itself be introduced quickly and smoothly. At that time, the attached stent has a weak attachment pressure. It is needless to say that the insertion and introduction operation should not be hindered due to the sliding of the balloon on the balloon, the deformation of the stent during wearing, etc.

However, in the conventional method of performing the operation of attaching the stent to the balloon with the skill of manual adjustment and relying on the empirical feeling, abnormal attachment of the stent is often apt to occur, and the above-described predetermined process is often performed. It was an obstacle to operation.

The above-mentioned stent is a hollow cylindrical body having a fragile bellows-like flex structure having a scale-like mesh structure on its peripheral surface, and its outer diameter is about several millimeters (often 3 millimeters). ) (The externally enlarged structure is shown in Fig. 6), which is inserted into the balloon and carefully sent to a predetermined location, and from the outer periphery thereof, the fingertips make uniform and even deformations. It is indispensable to squeeze the balloon so that it is not attached and to attach it to the balloon as a preparation prior to the means for expanding and maintaining the expanded stenosis of the coronary arteries by the medical means described later.

However, the stent has the appearance as described above, and the tissue constituting the flex structure is in a state in which the network structure is contracted as shown in FIG. Expand the open end, expand the tissue as shown in Fig. 7, insert it into the balloon and feed it, mount it at the required position, then compress it evenly from the outer circumference to reduce the inner diameter to form a balloon. In this attached state, the network is recompressed and firmly attached to the peripheral wall of the balloon in this attached state. In this case, if the adhesion force to the balloon is insufficient, when the balloon attached with the stent is fed into the artery, the stent slides from the predetermined position, and the stent is targeted to the coronary stenosis target site. It will not be able to be delivered and will seriously hinder the prescribed surgery. On the contrary, when the stent is attached to the balloon, if the stent is partially unevenly compressed or an excessive compressive force is applied from the surroundings, the brittle stent may have the above-mentioned network structure. Undesirable partial deformation or network destruction may damage the balloon or cause unbalanced expansion of the stent when expanding the coronary artery at the target site of stenosis. Since this will result in surgery, the compression / pressurization work from the outer periphery when mounting the stent on the balloon or attaching it to the predetermined position after mounting is empirical with fingertips. It was a great skill to bear.

[0010] Such a stent mounting operation that relies on empirical skill and feeling has been an extremely important issue for the success of the required surgery. The purpose of the present invention is to make it possible to easily and securely mount the stent.

[0011]

[Means for Solving the Problems]

 According to the present invention, in order to achieve this object, a stent holding portion connected to one holding portion and a stent holding portion connected to the other holding portion are pivotally supported by a shaft portion and face each other. Grooves having an arcuate cross-section corresponding to the length of the stent are formed in the holding portion so as to oppose each other along the axial direction of the shaft portion, and grasping both gripping portions, the stent is provided with the opposed groove portions. I tried to hold it in between.

In addition, at the time of holding the stent, the groove portion that directly contacts the stent on the outer peripheral surface of the stent has an inner concave surface on which an elastic film such as rubber for preventing soft deformation and damage of the stent. I got it.

In the case of not relying on the scissors-like tool having the shaft portion, like the scissors and tweezers, the stent holding portion and the gripping portion connected to the stent holding portion are integrally formed at the outer end. May be based on

In addition, when mounting the stent on the balloon, when using such a device for holding the stent, the stent is uniformly pressed from its outer periphery at a predetermined position on the balloon, and the stent is pressed against the balloon. In consideration of tight bundling, and further, when it is necessary to tighten the stent in small increments due to the relationship between the outer diameter of the balloon and the inner diameter of the stent, a plurality of groove portions should be provided. The arc radii of are arranged so that they have stepwise different radii. Also in this case, it is desirable that the inner concave surface of each groove be covered with an elastic film such as rubber to prevent the stent from being deformed or damaged.

A preferred embodiment adapted to the above means will be described in detail below based on the examples shown in the drawings.

[0016]

【Example】

 FIG. 1 is a perspective view showing an example of the simplest basic mounting tool, which is composed of stent holding portions 11 and 12 and gripping portions 21 and 22, and the stent holding portion 11 is integrally connected to the gripping portion 21. In addition, the stent holding portion 12 is also integrally connected to the grip portion 22, which are pivotally supported to each other by the shaft portions 30 and have a pliers-like shape as a whole. In each of the stent holding portions 11 and 12, the longitudinal direction of the grip portions 21 and 22 and the outer end portions 41 and 42 are formed in a bulging shape having a semicircular arc-shaped cross section. The arcuate concave surfaces are opposed to each other, and the groove portions 51 and 52 forming the inner surfaces thereof are covered with a rubber or another elastic film. The accurate cross-sectional shape of the groove portions 51, 52 is formed as an arc surface having a radius equal to or slightly larger than the outer diameter of the stent to be mounted on the balloon before insertion.

The width of the outer end portions 41, 42 having an inflated semicircular arc-shaped cross section in the direction orthogonal to the longitudinal direction of the grip portions 21, 22, that is, in the direction parallel to the pivot axis of the shaft portion 30 is Equivalent to or slightly longer than the length of the stent to be placed. Considering the convenience of mounting the stent on the balloon and attaching the stent to the outer circumference of the tube, a biasing force is applied between the gripping part 21 and the gripping part 22 so that they are separated from each other in the opposite direction. For the purpose, a spring member (not shown) according to a known structure can be constructed. By doing so, a uniform compression pressure is spread from the outer periphery to the stent inserted at a required position with respect to the balloon, which facilitates repeated pinching work for attaching the stent to a predetermined position. .

The embodiment shown in FIG. 2 shows an example of a mounting tool which is more practically applicable to the attachment of stents having different inner diameters to a balloon. The holding part 11 and the gripping part 21, and the stent holding part 12 and the gripping part 22 are integral with each other and are pivotally supported by the shaft part 30, which is similar to the embodiment of FIG. In this case, what is different from the embodiment of FIG. 1 is that groove portions 51a, 51b, 51c having different radii are formed in the stent holding portion 21, and further, the radius is formed at a corresponding position of the stent holding portion 12 facing these. The different groove portions 52a, 52b, 53c are formed, and further, the grip portions 21, 22 are provided with finger-passing holes 23, 24 like scissors.

Each of the above-mentioned groove portions has a length corresponding to the length of the stent in a direction parallel to the central axis direction of the shaft portion 30.

As will be described later, the finger-insertion holes 23 and 24 have different outer diameters by selecting a pair of facing grooves 51a and 52a, 51b and 52b, or 51c and 52c, whichever is more convenient. In addition to sandwiching and holding the stent in place and inserting it into the balloon, for a stent with a large outer diameter, compressive pressure is uniformly applied to the stent at the stationary position from its outer circumference, so that the stent with a smaller outer diameter can be It is pressed by the grooves 51b and 52b of the next stage with a small radius, and further pressed by 51c and 52c, gradually making the stent to be thinned, and it helps to strongly bind this to the balloon. It is.

Therefore, the cross-section radii ra, rb, rc of the pair of groove portions 51a and 52a, 51b and 52b, 51c and 52c have a relation of ra> rb> rc, and these groove portions are respectively formed. As in the case of the embodiment shown in FIG. 1, an elastic film such as rubber is applied along the curved surface so as not to damage the surface of the network of the stent.

By constructing as in the embodiment of FIG. 2, it is possible to easily sandwich a stent having a different thickness and insert it into a balloon according to the thickness with a single mounting tool. Instead, it can be used to give the most appropriate attachment result by adjusting the attachment pressure to the balloon appropriately.

Next, as a structurally simpler example, a third embodiment is shown in FIG. In this embodiment, contrary to the first and second embodiments, the stent holding portion and the gripping portion connected to the stent holding portion are pivotally supported, and the basic embodiment of scissors is used. An example was shown in which a basic form such as so-called hand-held scissors, donuts, or tweezers was used.

In this embodiment, a pair of opposing gripping portions 31 and 32 are united at the outer ends thereof by uniting, and even if a single member is bent into a U-shape to form a main body. Alternatively, one end of each pair of members may be fixed to each other to form a pine needle-shaped open leg shape. In either case, one grip portion 31 and the other grip portion 32 must be made of a material having anti-bending elasticity so that both of them can normally open their legs with respect to the unification point 40. . At the ends of the grips 31 and 32 located on the opposite side of the unifying point 40, stent holding parts 61 and 62 having a width are provided in a direction orthogonal to the longitudinal direction of the grips, These stent holding portions 61 and 62 are formed with groove portions 71 and 72, which are inner concave surfaces having an arcuate cross-section, respectively, on the opposite surfaces. The grip portions 31 and 32 are gripped, and the stent holding portions 61 and 62 that are in contact with each other when gripping the grip portions 31 and 32 make the groove portions 71 and 72 form a hollow cylindrical space.

As in the first and second embodiments, this hollow cylindrical space portion is provided for holding and compressing the stent. It is desirable to apply an elastic coating such as rubber on the surfaces of these groove portions 71 and 72 in order to protect the stent. In the figure, 33 and 34 are slip stoppers provided on the gripping pieces 31 and 32.

In the case of this embodiment, the grasping pieces 31 and 32 that open the legs around the uniting point 40 are also grasped together against the reaction force against the leg opening, and the stent is sandwiched and sent to a predetermined position on the balloon, and a predetermined position is reached. At the position, the stent is pressed from the outer peripheral side to compress the outer diameter and attached to the balloon. This operation is performed in substantially the same manner as in the first and second embodiments described above.

The fourth embodiment shown in FIG. 4 is one in which the groove portions 71 and 72 formed in the stent holding portions 61 and 62 in the third embodiment are arranged in multiple stages instead of forming a single groove portion. The semi-arcuate groove portions 71a, 71b, 71c are arranged in parallel on one gripping portion 61 at right angles to the longitudinal direction, and the other gripping portion 62 also extends in a direction perpendicular to the longitudinal direction. Semi-circular groove portions 72a, 72b, 72c are arranged in parallel.

When the grip portions 31 and 32 are gripped together, the groove portions 71a and 72a, the groove portions 71b and 72b, and the groove portions 71c and 72c form hollow cylindrical portions each having a circular cross section. To do.

Regarding these respective groove portions, when the radius of each of the groove portions 71a and 72a is ra, each radius of each of the groove portions 71b and 72b is rb, and each radius of each of the groove portions 71c and 72c is rc, a relation of ra> rb> rc is established. By setting the radius so as to satisfy the following condition, it is possible to carry out an operation in the same usage condition as in the second embodiment. Regarding the arrangement order of the groove portions 71a, 71b, 71c and the arrangement order of the groove portions 72a, 72b, 72c, the radius ratios may be set in the reverse order. It is preferable to make the radius smaller in the closer part.

[0030]

[Action]

 When the mounting tool according to the present invention is used, the gripping portion is grasped, and the groove to be mounted and mounted on the balloon is sandwiched between the grooves having the semi-arcuate cross section to which the elastic membrane is attached, Since it is not directly held between the fingertips, even when it is inserted into the balloon, an irregular external force is not applied to the stent from the outside, so that the stent is not deformed. In addition, it is easy to securely insert the stent into the balloon from one end of the thin balloon, and even after the insertion work to occupy the stent in a predetermined position, a strong local force is applied to the stent. Therefore, the required work can be performed lightly and efficiently without affecting the stent without causing any deformation.

Furthermore, since each groove for holding the stent has a semi-circular cross section, the groove of the stent can be attached to a predetermined position of the balloon by grasping the grip lightly. Even force acts on the stent from the outer peripheral surface, and it is possible to uniformly shrink and attach without applying unreasonable force locally.As a result, this device is used to mount and mount the stent. When the stent is introduced to the target site using the balloon, it does not cause any accidents or obstacles and has a remarkable effect in performing the most important balloon introduction process.

When a stent having a slightly larger inner diameter is mounted and attached to a balloon having a constant outer diameter, the edges of the outer end portions 41 and 42 in the embodiment shown in FIG. If a comb-like shape with a degree of occlusion is given to the part, and the structure in which the crests and troughs of the comb teeth are inserted into each other, the semicircular cross-section of the grooves 51, 52 will contact each other. It is also possible to use it for the use of a stent having an outer diameter slightly smaller than the given circular thickness, and it is possible to exert a stronger adhesion force to the balloon by the clamping force when gripping the gripping parts 21, 22. it can. In this case, in order to give a uniform diameter reduction result to the stent in the radial direction of its cross section, the tool is rotated around the stent while being gradually tightened, or the stent is attached together with the balloon in the grooves 51 and 52 together. It is necessary to press and attach the stent to the balloon while rotating and applying a small amount of force repeatedly.

[0033]

[Effect of the invention]

 According to the present invention, conventionally, the stent, which is easily deformable, is picked up by the finger head and moved to a fixed position by inserting it with the tip of the finger, and the stent is evenly distributed to each part of the stent. It is held under a pinching pressure, and it is inserted into the balloon and sent to a predetermined position for placement, so there is no need to deform the stent during the process of mounting it in place, and furthermore, Instead of tightening and fastening by empirical adjustment, the force that is evenly distributed from the outer circumference of the stent is applied to the stent to give the required fastening result, so even during the fastening work, It is possible to surely carry out the attachment equipment for the balloon without giving any deformation or tissue destruction to the stent itself.

[Brief description of the drawings]

FIG. 1 is a perspective view showing a stent mounting tool as a first embodiment according to the basic configuration of the present invention.

FIG. 2 is a side view of a stent mounting device showing a second embodiment in which the utility of the present invention is enhanced.

FIG. 3 is a perspective view showing a stent mounting tool according to a third embodiment of the present invention.

FIG. 4 is a side view of a stent mounting tool as a fourth embodiment showing an example in which the practicability is further improved with respect to the embodiment in FIG.

FIG. 5 is an enlarged side view showing a structure of a stent to be mounted and attached to a balloon in a contracted state.

FIG. 6 is an enlarged view showing a network structure in which the stent in FIG. 5 is slightly expanded and a part thereof is further expanded.

7 is an enlarged view of a part of the stent tissue shown in FIG. 6 to show a change in the state of the stent tissue when it is inserted into a balloon.

FIG. 8 is an enlarged view showing a state change when the reticular tissue attached to the balloon is subjected to internal pressure in the affected area and the reticular tissue is expanded at the inner wall of the coronary artery.

[Explanation of symbols]

 11,12 Stent holding part 21,22 Grip part 30 Shaft part 51,52 Groove part 61,62 Stent holding part 31,32 Grip part 51a, 51b, 51c Groove part 52a, 52b, 52c Groove part 71a, 71b, 71c Groove part 72a, 72b , 72c groove

Claims (6)

[Utility model registration claims] 1. A shaft holding section (30) pivotally connects a stent holding section (11) connected to one gripping section (21) and a stent holding section (12) connected to the other gripping section (22). The stent holding portions (11, 12) which are supported and face each other are provided with groove portions (51, 52) having an arcuate cross section having a width corresponding to the length of the stent along the axial direction of the shaft portion (30). A stent mounting tool characterized by being formed so as to face each other. 2. A stent holding part (11) connected to one holding part (21) and a stent holding part (12) connected to the other holding part (22) are pivoted by a shaft part (30). The stent holding portions (11, 12) which are supported and face each other are provided with groove portions (51, 52) having an arcuate cross section having a width corresponding to the length of the stent along the axial direction of the shaft portion (30). A stent mounting tool characterized in that an elastic film made of rubber or the like is adhered to the inner concave surfaces of the groove portions (51, 52) formed so as to face each other and having an arc-shaped cross section. 3. A shaft holding portion (30) pivotally connects a stent holding portion (11) connected to one holding portion (21) and a stent holding portion (12) connected to the other holding portion (22). A plurality of groove portions (51a, 51b, 51a, 51b, 51b, 51b, 51c; 52a, 52b, 52c) are formed so as to face each other, and the arc radii of the plurality of groove portions (51a, 51b, 51c; 52a, 52b, 52c) having arcuate cross-sections facing each other are respectively stepwise. A stent mounting tool characterized by being constructed with different radii. 4. A shaft holding portion (30) pivotally connects a stent holding portion (11) connected to one holding portion (21) and a stent holding portion (12) connected to the other holding portion (12). A plurality of groove portions (51a, 51b, 51a, 51b, 51b, 51b, 51c; 52a, 52b, 52c) are formed so as to face each other, and the arc radii of the plurality of groove portions (51a, 51b, 51c; 52a, 52b, 52c) having arcuate cross-sections facing each other are respectively stepwise. A stent mounting tool having different radii, wherein an inner concave surface of each groove (51a, 51b, 51c; 52a, 52b, 52c) having an arcuate cross section is coated with an elastic film such as rubber. 5. One gripping part (31) connected to the stent holding part (61) and the other gripping part connected to the stent holding part (62).
(32) and the unification point (40) are integrally configured,
In the stent holding portions (61, 62) facing each other, in the direction intersecting with the longitudinal direction of each gripping portion (31, 32), a groove portion having an arc-shaped cross section having a width corresponding to the length of the stent ( 71) and (72) are formed to face each other, and a stent mounting tool characterized by the above-mentioned. 6. One gripping part (31) connected to the stent holding part (61) and the other gripping part connected to the stent holding part (62).
(32) and the unification point (40) are integrally configured,
The stent holding portions (61, 62) facing each other have a plurality of arc-shaped cross-sections each having a width corresponding to the length of the stent in a direction intersecting the longitudinal direction of each gripping portion (31, 32). Groove (71
a, 71b, 71c; 72a, 72b, 72c) are formed so that they face each other, and a plurality of groove portions (71
(a, 71b, 71c; 72a, 72b, 72c) arc-shaped radii having stepwise different radii.