JP2021016478A - Medical material - Google Patents

Abstract

To provide a defect hole closing material implementing a minimally invasive treatment having little possibility of a failure in a post-discharge period, for the atrial septal defect.SOLUTION: A defect hole closing material 100 has an hourglass shape formed of two cylindrical bodies (a first cylindrical part 110 and a second cylindrical part 120) having mesh-like tissue of bioabsorbable fibers, and includes, at the second end portion 122 side, a joint portion 422 that joins a delivery cable 500 passed from a first end portion 112 side via an approximately central portion 130 to a second end portion 122 side, where the delivery cable 500 is so formed as to pass through from the first end portion 112 side to the outside of the defect hole closing material 100.SELECTED DRAWING: Figure 2

Description

The present invention relates to a medical material for treating a defect formed in a living tissue, and more particularly to a medical material which is set in a catheter and sent to a treatment site through a blood vessel and indwelled in the living body.

The human heart is divided into left and right chambers by a tissue called the septum, and each has an atrioventricular chamber and a ventricle on each of the left and right ventricles. Atrial septal defect (ASD), in which a hole called a defect hole is congenitally opened in the atrial septum that separates the right atrium and the left atrium due to developmental disorders during the fetal period in the heart having such a structure. There is a disease called Defect).

There are the following two methods for treating this atrial septal defect. One is surgery performed by cutting the chest, and the other is catheter treatment using a closure plug without cutting the chest.
Surgery (patch surgery) uses an artificial heart-lung machine, opens the chest, and closes the defect hole with a patch. In catheter treatment, a closing plug is set in the catheter, the catheter is inserted into a blood vessel, the catheter is delivered to a target position (defective hole), and then the closing plug is released and placed in the body. In this catheter treatment, a small jig (device) called an elongated folded closure plug is sent from the vein at the base of the foot (femoral vein) to the position of the hole opened in the atrial septum without incising the chest to close the hole. It is a thing. The advantage of this catheter treatment is that it can be treated with a very small skin incision (several millimeters) from an inconspicuous place at the base of the foot (stomach) without performing thoracotomy that requires general anesthesia. ..

Japanese Patent Application Laid-Open No. 2008-512139 (Patent Document 1) discloses an assembly (closure plug) used for catheter treatment of atrial septal defect. This assembly seals the passage (defective hole) of the heart. This assembly extends through a first anchor used to be located proximal to the first end of the passage, a second anchor used to be placed proximal to the second end of the passage, and a passage. Consists of a closure device that seals the passage of the heart, including a flexible extension used to connect to the first and second anchors, the second anchor being movable relative to the flexible extension, first It consists of a supply system that changes the length of the flexible extension between the and second anchors and supplies the closure device to the passage of the heart, the supply device being set to move through the lumen of the guide catheter. , Includes wires that control movement along the flexible extension of the second anchor.

Then, in Patent Document 1, the patent foramen ovale (PFO) closing device (closing plug) includes a left atrium anchor, a right atrium anchor, a tether and a lock, and is via the left atrium anchor and the tether. It is disclosed that the right atrial anchor and lock that bind to the left atrial anchor remain in the heart to seal the PFO.

Japanese Patent Application Laid-Open No. 2008-512139

In the case of patch surgery, there is a problem that an artificial heart-lung machine is used and the length of hospital stay is long due to its high invasiveness. In the case of catheter treatment, artificial heart-lung machine is not used, and since it is less invasive, the length of hospital stay is short, which is preferable.
As disclosed in Patent Document 1, the left atrial anchor and the right atrial anchor remain in the heart. The left and right atrium anchors then include one or more arms, the arms extending outward radially from the hub, which arms are preferably formed from rolled sheets of binary nickel titanium alloy. Has been done. Then, these left atrium anchors and right atrium anchors are expanded in vivo to close the defect hole, but once the anchor expansion is started, it cannot be easily restored. The anchor is folded using a dedicated take-out device having a complicated structure and difficult to operate from outside the living body as disclosed in Patent Document 1.

However, for example, when the anchor is caught in a living tissue in the atrium and is injured, there may be no time to fold the anchor with such a dedicated extraction device. In such cases, there is no choice but to switch to open chest surgery immediately. This has the problem of eventually undergoing highly invasive thoracotomy.
Further, since the metal defect hole closure plug remains in the body for a lifetime, there is a problem that there is a concern about a problem in a remote period.

The present invention has been developed in view of the above-mentioned problems of the prior art, and an object of the present invention is to provide a minimally invasive catheter treatment that can be released and placed at a treatment site in a living body, and to have a complicated structure. The purpose is to provide medical materials that can be operated easily and reliably without preparation and that have almost no possibility of malfunction in the remote period even if they remain in the body.

In order to achieve the above object, the medical material according to the present invention takes the following technical measures.
That is, the medical material according to the present invention is a medical material formed of a cylinder of a stitch-like structure using a wire rod having bioabsorbability, and the diameter of the substantially central portion of the cylinder is different. The first tubular portion on the side of the first end, which is one end in the longitudinal direction of the tubular body, and the second end, which has a shape smaller than the tubular diameter of the portion of A second tubular portion on the end side is formed, and the first end portion and the second end portion are separated from each other around the substantially central portion, and the tubular diameter of the other portion is reduced. When the medical material is stored in the catheter, the second end side becomes the distal end side of the catheter, and the medical material is transferred from the first end side via the substantially central portion. A joint for joining the delivery cable passed to the end side of 2 is provided on the second end side, and the delivery cable can be passed from the first end side to the outside of the medical material. It is characterized in that it is formed in such a way.

Preferably, the joint portion is a hollow cylindrical object provided with a female screw, and is configured to be joined by screwing a male screw provided on the tip end side of the delivery cable into the female screw. can do.
More preferably, the hollow cylindrical object is capable of being screwed with the male screw by opening the first tubular portion side and being provided with the female screw, and the opposite side of the first tubular portion side is closed. It can be configured as it is.

More preferably, the delivery so that the defect hole closing material advances toward the opening of the catheter while the entire medical material joined to the delivery cable by the joint is housed in the catheter. The cable is operated so that the first tubular portion is ejected from the tip of the catheter following the second tubular portion to the outside of the catheter, whereby the first end portion and the second end portion are formed. Can be configured to approach the substantially central portion of the catheter so that the diameter of the other portion is expanded to a size corresponding to the defect hole closed by the medical material.

More preferably, the medical material further includes a loop to which one end thereof is joined to the first end side and a dropout prevention member larger than the inner diameter of the catheter is joined to the other end, and the total length of the loop. Can be configured to be longer than the overall length of the catheter.

According to the medical material of the present invention, minimally invasive catheter treatment that can be released and indwelled at a treatment site in a living body can be performed by easy and reliable operation without having a complicated structure. Furthermore, according to the medical material of the present invention, even if it remains in the body, there is almost no possibility of a defect in a remote period.

It is an overall view of the defect hole closing material 100 which is an example of the medical material which concerns on this invention (the distance between the 1st end and the 2nd end is close). It is an overall view of the defect hole closing material 100 (the distance between the first end portion and the second end portion is an intermediate state). It is an overall view of the defect hole closing material 100 (the entire defect hole closing material is housed in the catheter 300, and the distance between the first end portion and the second end portion is separated). It is an overall view of the defect hole closing material 100 (a state in which the second tubular portion is taken out of the catheter 300 and the first tubular portion is housed in the catheter 300). (A) is a partial side view of the defect hole closing material 100 in the state of FIG. 2, and (B) is a cross-sectional view taken along the line AA. It is a conceptual diagram when the defect hole closing material 100 is used for the catheter treatment of the atrial septal defect. It is an enlarged view (No. 1) of the part B of FIG. 6 which shows the procedure of catheter treatment. It is an enlarged view (No. 2) of the part B of FIG. 6 which shows the procedure of catheter treatment. It is an enlarged view (No. 3) of the part B of FIG. 6 which shows the procedure of catheter treatment. It is an enlarged view of the joint portion 422 provided at the distal end side end portion of the defect hole closing material 100 and the delivery cable 500 joined to the joint portion 422 by screwing. (A) is an enlarged view of the catheter 300 including the distal end side end portion (second end portion 122) of the defect hole closing material 100 and the delivery cable 500, and (B) is a perspective view thereof. It is a figure in which (A) the defect hole closing material 600 which is an example of the medical material which concerns on the modification of this invention was pulled out to the outside of a catheter 300, and (B) the defect hole closing material 600 itself. It is a figure.

Hereinafter, the medical material according to the present invention will be described in detail with reference to the drawings. In the following, as an example of the medical material according to the present invention, a defect hole closing material used for catheter treatment will be described, but other openings or passages, for example, a heart such as a ventricular septal defect and patent ductus arteriosus. It is also suitable for other openings in the body, and openings or passages in other parts of the body (eg, stomach) such as arteriovenous fistulas. Therefore, the defect hole closing material according to the embodiment of the present invention is not limited to the use for closing the hole of the atrial septal defect.

Further, in the following embodiment, the stitch-like structure of the defect hole closing material (closing plug) 100, which is an example of the medical material according to the present invention, is described as knitting bioabsorbable fibers (an example of a wire rod). However, the present invention is not limited to this. Any material that can be used for catheter treatment to close the defect hole formed in the living body may be used, and the knitted structure and the material thereof have the first feature to the second feature described later and the first action to the first action. The material is not limited as long as it exhibits the action of 3, and for example, the material may be knitted with a wire rod other than the bioabsorbable fiber. As such a wire rod, it is preferable that the wire rod has a certain degree of hardness in order to have the shape retention property of the defect hole closing material (different from the shape retention property by the shape retention member described later).
[Basic configuration]
FIG. 1 shows an overall view of the defect hole closing material 100 according to the present embodiment (a state in which the distance between the first end 112 and the second end 122 is close), and FIG. 2 shows the defect hole closing material 100. Another overall view (the distance between the first end 112 and the second end 122 is in the intermediate state) is shown in FIG. 3, which is still another overall view of the defective hole closing material 100 (overall of the defective hole closing material 100). Is housed in the catheter 300 and the distance between the first end 112 and the second end 122 is separated). FIG. 4 shows yet another overall view (second cylinder) of the defect hole closing material 100. A state in which the portion 120 is taken out of the catheter 300 and the first tubular portion 110 is housed in the catheter 300) is shown. Regarding the storage relationship of the defect hole closing material 100 in the catheter 300, FIG. 3 shows a state in which the entire defect hole closing material 100 is stored in the catheter 300, and FIG. 4 shows the state in which the defect hole closing material 100 is stored in the catheter 300. It is a figure which shows the state in which a half (the side of the 1st cylinder 110) is housed in a catheter 300, respectively.

In terms of time transition, the defect hole closing material 100 in which the entire catheter 300 is housed inside (the space formed by the inner wall 310) shown in FIG. 3 is used, and the second tubular portion 120 is used as the opening of the catheter 300. When the 320 is extended in the Y direction of the arrow, the state shown in FIG. 4 is obtained, and when the first tubular portion 110 is extended in the Y direction of the arrow, the state shown in FIG. 1 is obtained. Here, the state of the defect hole closing material 100 shown in FIG. 2 is a virtual state in which the distance between the first end portion 112 and the second end portion 122 is an intermediate state.

As shown in these figures, the defect hole closing material 100 is generally formed of a tubular body having a stitch-like structure using a wire rod, and the diameter of the substantially central portion 130 of the tubular body is the other portion. The first tubular portion 110 and the other end portion (the first) on the side of the first end 112 in the longitudinal direction of the tubular body in the defect hole closing member 100, which has a shape smaller than the diameter of the tubular portion 130. A second tubular portion 120 on the end portion 122) side of the 2 is formed.

What is characteristic is that the first end 112 and the second end 122 are separated from each other with the central portion 130 as the center, and the diameter of the other portion is reduced to close the defect hole in the catheter 300. When the material 100 is stored (state shown in FIG. 3), the second end 122 side becomes the tip side of the catheter 300. In this case, the defect hole closing material 100 is referred to as an operation wire 500 (hereinafter referred to as a delivery cable 500) that is passed from the first end 112 side to the second end 122 side via the substantially central portion 130. A joint portion 422 for joining (may be) is provided on the second end portion 122 side. Further, the defect hole closing material 100 allows the delivery cable 500 to be passed from the first end 112 side to the outside of the defect hole closing material 100 (for example, the delivery cable to the first end 112). A hole through which the 500 cable body 510 passes) is formed.

Here, as shown in FIGS. 10 and 11, the joint portion 422 is a hollow cylindrical object (for example, made of metal) provided with a female screw 424, and is located on the tip end side of the cable body 510 of the delivery cable 500. The male screw 514 provided is screwed into the female screw 424 to be joined. In the living body, the cable body 510 is rotated (rotated) in the direction opposite to the direction in which the male screw 514 is screwed into the female screw 424 to open the joint by this screwing, and the defect hole closing material 100 And the delivery cable 500 can be separated.

Here, as shown in FIGS. 10 and 11, the hollow cylindrical object forming the joint portion 422 has a first tubular portion 110 side open and a female screw 424 is provided, and the cable main body of the delivery cable 500 is provided. It can be screwed with the male screw 514 provided on the tip end side of the 510, and the opposite side of the first tubular portion 110 side is closed.
When the opposite side of the first tubular portion 110 side is closed in this way, the delivery cable can be easily operated when pushing the defective hole closing material in the sheath so that the defective hole closing material is not twisted. It is preferable in that it can be used.

As will be described in detail in [Usage] described later, the defect hole closing material 100 is in a state where the entire defect hole closing material 100 joined to the delivery cable 500 by the joint portion 422 is housed in the catheter 300. The delivery cable 500 is operated (so that the defect hole closing material 100 advances in the direction of the opening 320 of the catheter 300) so that the first tubular portion 110 follows the second tubular portion 120 from the tip of the catheter 300. By being brought out of the 300, the first end 112 and the second end 122 approach each other around the substantially central portion 130, and correspond to the defect hole closed by the defect hole closing material 100. The cylinder diameter of other parts is expanded to the size.

At this time, since the joint portion 422 is provided on the second end portion 122 side and the tip end portion of the delivery cable 500 is joined to the joint portion 422, (the joint portion 422 joined to the tip end portion of the delivery cable 500). Is pulled out of the catheter 300 so that both the second tube 120 and the first tube 110 are pushed out (as in the case where is provided on the side of the first end 122). Is taken out of the catheter 300. When extruded, the defect hole closing material 100 is twisted, and the first end portion 112 and the second end portion 122 cannot be appropriately approached with respect to the substantially central portion 130 and are closed by the defect hole closing material 100. The cylinder diameter of other parts may not be appropriately expanded to the size corresponding to the defective hole, but when pulled, the defect hole closing material 100 is suppressed from twisting and the first end portion 112 And the second end 122 are appropriately close to each other about the central portion 130, and the diameter of the other portion is appropriately expanded to a size corresponding to the defect hole closed by the defect hole closing material 100. Can be done.

Further, FIG. 5 (A) shows a partial side view of the defect hole closing material 100, and FIG. 5 (B) shows a sectional view taken along the line AA of FIGS. 2 and 5 (A), respectively. Note that FIG. 5B is a cross-sectional view of the defect hole closing material 100 (more specifically, the second tubular portion 120), but the cross section of the cable body 510 of the delivery cable 500 is shown in the direction of arrow A. The stitches of the bioabsorbable fiber 150 visible from the above are not shown. Further, in FIGS. 1 to 5, they are arranged on the back side of the paper surface in order to facilitate understanding of the existence of the cable body 510 of the delivery cable 500 located inside the defect hole closing material 100 and the stitches of the bioabsorbable fiber 150. The bioabsorbable fiber 150 is not shown, and the appearance shape of the defect hole closing material 100 is shown by a dotted line in order to facilitate understanding of the appearance shape of the defect hole closing material 100. ..

As shown in these figures (particularly FIG. 2), the defect hole closing material 100 is formed by two tubular bodies (first tubular portion 110 and second tubular portion 120) having a stitch-like structure using a bioabsorbable material. ), And its shape is composed of such two cylinders, for example, an hourglass type, a figure eight shape, and a double spindle type (a spindle shape with a thick center and thin ends in an elongated rod shape). It has a shape called (two consecutive shapes) or a peanut shape (the appearance shape of a peanut shell containing two fruits). The defect hole closing material 100 having such a shape has a shape in which the substantially central portion 130 is narrowed so that the diameter of the substantially central portion 130 of the tubular body is smaller than the diameter of the other portions. That is, the first tubular portion 110 on the first end 112 side and the second tubular portion 120 on the second end 122 side are formed around the substantially central portion 130.

Although not limited, the defect hole closing material 100 has a first tubular portion 110 and a second tubular portion 110 so that the tubular diameter of the substantially central portion 130 is smaller than the tubular diameter of the other portion. The tubular portion 120 of the above is integrally knitted, and the overall shape of the defect hole closing material 100 is formed into an hourglass type, a figure eight shape, a double spindle type or a peanut shape composed of two cylinders. To.
In this case, using such an hourglass-shaped, figure-eight-shaped, double-spindle-shaped or peanut-shaped formwork (three-dimensional paper pattern), one bioabsorbable fiber 150 is formed according to the formwork. By knitting, the entire shape of the defect hole closing material 100 is formed. Further, but not limited to, the defect hole closing material 100 is heat-set after the first tubular portion 110 and the second tubular portion 120 are integrally knitted to form a tubular body having substantially the same diameter. By doing so, the substantially central portion 130 in which the diameter of the substantially central portion 130 is smaller than the diameter of the other portions and the diameter of the substantially central portion 130 is larger than the diameter of the cable body 510 of the delivery cable 500 is formed. The defect hole closing material 100 may be formed into an hourglass shape composed of two cylinders, a figure eight shape, a double spindle shape, or a peanut shape as the whole shape of the defect hole closing material 100.

Then, as will be described in detail later, by realizing such a shape by knitting, the defect hole closing material 100 in which the entire catheter 300 is housed inside (the space formed by the inner wall 310) shown in FIG. The delivery cable 500, whose tip is joined to the joint 422 on the second end 122 side, is operated (so that the defect hole closing material 100 advances in the direction of the opening 320 of the catheter 300) to operate the catheter 300. A space in which the second tubular portion 120 is formed by the inner wall 310 of the catheter 300 by projecting the second tubular portion 120 from the opening 320 at the tip of the catheter 300 in the Y direction so as to pull it out of the catheter 300. The second tubular portion 120 is in the state shown in FIG. 4, and the delivery cable 500 is further operated (so that the defect hole closing material 100 advances (further) toward the opening 320 of the catheter 300). Then, the first tubular portion 110 is pulled out from the opening 320 at the tip of the catheter 300 in the direction of arrow Y so as to be pulled out of the catheter 300, so that the first tubular portion follows the second tubular portion 120. The shape change (time transition shape) that the portion 110 is also released from the space formed by the inner wall 310 of the catheter 300 and the first tubular portion 110 (and the second tubular portion 120) is in the state shown in FIG. (Change) can be realized.

As shown in FIG. 1, when the defect hole closing material 100 is not housed in the catheter 300 and exists isolated in the space, the first end portion 112 and the second end portion 122 are formed. The cylinder diameters of the first tubular portion 110 and the second tubular portion 120, which are other portions other than the substantially central portion 130, are expanded by approaching the substantially central portion 130. Regarding the expanded cylinder diameter, the first cylinder portion 110 and the second cylinder portion (which are other parts other than the substantially central portion 130) up to the size corresponding to the defect hole closed by the defect hole closing material 100. It is particularly preferable that the cylinder diameter of 120 is expanded.

Then, as shown in FIG. 3, when the defect hole closing material 100 is housed in the catheter 300 and the like, the defect hole closing material 100 is not isolated in the space but the freedom in the radial direction is restricted. The end portion 112 of 1 and the second end portion 122 are separated from each other about the substantially central portion 130, and the cylinder diameters of the first tubular portion 110 and the second tubular portion 120, which are other portions, are reduced. ing. Regarding the reduced cylinder diameter, the first cylinder portion 110 and the second cylinder portion 120 (which are parts other than the substantially central portion 130) up to the size corresponding to the catheter 300 in which the defect hole closing material 100 is housed. It is particularly preferable that the diameter of the cylinder is reduced.

The diameter of the cable body 510 of the delivery cable 500 is smaller than the cylinder diameter of the substantially central portion 130.
In this way, the defect hole closing material 100 is not restricted in the radial direction by storing it in the catheter 300, for example, or by pulling it out from the catheter 300 to the outside of the catheter 300. In this way, the first end 112 in the longitudinal direction of the cylinder in the defect hole closing material 100 and the second end 122, which is the other end, are separated from each other (stored in the catheter 300). It can be approached (pulled out of the catheter 300). As shown in FIG. 1, the defect hole closing material 100 is pulled out from the catheter 300 to the outside of the catheter 300 to limit the radial freedom, and the first end 112 and the second end The diameter of the other part of the central portion 130 (the diameter of the body portion in the first tubular portion 110 and the second tubular portion 120) is expanded by approaching the 122, and the diameter is accommodated in the catheter 300. When the freedom of direction is restricted, as shown in FIG. 3, the first end 112 and the second end 122 are separated from each other, and the diameter of the other part of the substantially central 130 (first cylinder 110). And the cylinder diameter of the body portion in the second cylinder portion 120) is reduced.

Further, as shown in FIG. 4, when the second tubular portion 120 was pulled out from the catheter 300 in the Y direction indicated by the arrow, the shape was restricted by the inner wall 310 of the catheter 300 (freedom in the radial direction was restricted). The shape of the second tubular portion 120 can be freely changed, and only the tubular diameter of the body portion of the second tubular portion 120 is expanded. Further, when the first tubular portion 110 is pulled out from the catheter 300 in the Y direction indicated by the arrow, the shape of the first tubular portion 110 is restricted by the inner wall 310 of the catheter 300 (freedom in the radial direction is restricted). The shape can be freely changed, and the diameter of the body portion of the first cylinder portion 110 is also expanded.

Then, in the defect hole closing material 100, the first tubular portion 110 and the second tubular portion 120 are woven fabrics (coarse ones) of bioabsorbable fibers 150, knitting, braided woven fabrics, or tubular knitting. It is composed of knitted fabric, and the whole is a knitted structure. As confirmed here, this stitch-like structure is not limited to the knitting formed by knitting, and as described above, the mesh-like structure is formed by a coarse woven structure such as a screen door. including. That is, it may be a structure called a stitch-like structure or a structure called a mesh-like structure.

As described above, basically, except for the joint portion 422 made of, for example, a metal piece made of metal (for example, stainless steel), the first tubular portion 110 and the second tubular portion 120 are all made of a bioabsorbable material. Therefore, the entire defect hole closing material 100 except for the joint portion 422 has bioabsorbability (the delivery cable 500 does not constitute the medical material according to the present invention and does not remain in the living body. So the material is not particularly limited). Further, the treatment for closing the defect hole is performed by changing the shape of the defect hole closing material 100, and even if the shape of the defect hole closing material 100 changes in the living body in this way, the tissue in the living body is treated. A defect hole closing material 100 is formed in the material, stitch shape, fibrous structure and fiber cross section so as not to be damaged, including the joint 422.

Normally, stainless steel or the like is used for the joint portion 422 and does not have bioabsorbability, but a magnesium-based alloy described later may be used to provide bioabsorbability. Using a bioabsorbable alloy for the joint 422 is advantageous in that it responds to roentgen imaging, and using a bioabsorbable alloy means that the metal member will not remain in the body for a lifetime, so it is remote. It is advantageous in that it does not cause the problem of concern about defects in the period.

The bioabsorbable fibers 150 constituting the first tubular portion 110 and the second tubular portion 120 are, for example, polyglycolic acid, polylactide (D, L, DL polymer), polycaprolactone, glycolic acid-lactide (D). , L, DL polymer), glycolic acid-ε-caprolactone copolymer, lactide (D, L, DL polymer) -ε-caprolactone copolymer, poly (p-dioxanone), glycolic acid-lactide (D) , L, DL form) -ε-caprolactone copolymer, etc. It is considered to be at least one kind, and is used in a form processed into any one of monofilament yarn, multifilament yarn, twisted yarn, braided cord, etc., but monofilament yarn It is preferably used in the form of.

Further, the material of the bioabsorbable fiber 150 may be a bioabsorbable alloy. An example of such a bioabsorbable alloy is a magnesium-based alloy as a raw material.
The diameter of the bioabsorbable fiber 150 is about 0.001 mm to 1.5 mm, and the fiber diameter and type suitable for the catheter treatment to be applied are selected. Further, the cross section of the bioabsorbable fiber 150 may be any of a circle, an ellipse, and other irregular shapes (for example, a star shape), provided that the tissue in the living body is not damaged. Further, the surface of the bioabsorbable fiber 150 may be hydrophilized by plasma discharge, electron beam treatment, corona discharge, ultraviolet irradiation, ozone treatment or the like. In addition, the bioabsorbable fiber 150 is suitable for coating or impregnating an X-ray impermeable material (for example, barium sulfate, gold chip, platinum chip, etc.) or for treating a drug (for example, catheter treatment for atrial septal defect). ) Adhesion treatment, or coating treatment with a natural polymer such as collagen or gelatin or a synthetic polymer such as polyvinyl alcohol or polyethylene glycol may be used.

The first tubular portion 110 and the second tubular portion 120 have a plurality of bioabsorbable fibers 150 (for example, eight ports) around a silicone rubber tube (not shown) having an outer diameter desired as a monofilament yarn. Alternatively, it is manufactured into a braided woven fabric using a braided machine having 12 yarn feeding ports, or is knitted into a knitted structure of a cylinder having substantially the same diameter by a circular knitting machine (not shown). After knitting, as described above, it is formed into an hourglass type, a figure eight shape, a double spindle type or a peanut shape composed of two cylinders, a first cylinder 110 and a second cylinder 120. To. The tubular diameters of the first tubular portion 110 and the second tubular portion 120 are smaller than the inner diameter of the catheter 300 when the diameter is reduced, and the diameter is suitable for catheter treatment of atrial septal defect when the diameter is expanded. Be prepared. For example, when the diameter is expanded, the cylinder diameters of the first cylinder portion 110 and the second cylinder portion 120 are about 5 mm to 80 mm, preferably about 15 mm to 25 mm. Further, the lengths of the first tubular portion 110 and the second tubular portion 120, and the density of the stitch-like tissue of the defect hole closing material 100 are also provided with a density suitable for catheter treatment of atrial septal defect. The diameter and length of the first tubular portion 110 and the second tubular portion 120 do not have to be the same, and may be changed so as to be suitable for catheter treatment of atrial septal defect.

As described above, the defect hole closing material 100 according to the present embodiment has the following features.
(First feature) It is formed into an hourglass type, a figure eight shape, a double spindle type or a peanut shape composed of a first tubular portion 110 and a second tubular portion 120 squeezed in a substantially central portion 130. ing.
(Second feature) The joint portion 422 that joins the operation wire 500 passed from the first end portion 112 side to the second end portion 122 side via the substantially central portion 130 is attached to the second end portion 122 side (2nd feature). The delivery cable 500 is provided on the distal end side of the catheter 300) so that the delivery cable 500 can be passed from the first end 112 side to the outside of the defect hole closing material 100.

Then, according to the first feature and the second feature, when the second tubular portion 120 is extended from the catheter 300 to the outside of the catheter 300 with respect to the defect hole closing material 100 housed in the catheter 300, the inner wall of the catheter 300 is formed. The shape of the second tubular portion 120 whose shape was regulated by 310 can be freely changed, and only the diameter of the tubular portion of the second tubular portion 120 is expanded, and further, the catheter 300 to the first tubular portion 110 When the catheter 300 is taken out of the catheter 300, the shape of the first tubular portion 110 whose shape is regulated by the inner wall 310 of the catheter 300 can be freely changed, and the tubular diameter of the body portion of the first tubular portion 110 is also expanded. .. Then, the cylinder diameter of the body portion is expanded to a size corresponding to the defect hole closed by the defect hole closing material 100. In particular, the defect hole closing material 100 exhibits the following effects, and thus the atrial septum. Suitable for catheter treatment of defects.
(First action) The first end 112 and the second end 122 are separated from each other around the substantially central portion 130 (the first end 112 and the second end 122 are separated from each other). By reducing the diameters of the other parts, the first cylinder 110 and the second cylinder 120, the diameter of the defect hole closing material 100 is reduced to the inner diameter of the catheter 300. It can be made thinner and set in the catheter 300.
(Second action) Since the joint portion 422 is provided on the second end portion 122 side and the tip end portion of the delivery cable 500 is joined to the joint portion 422, the second tubular portion 120 is also the first tubular portion. Since the portion 110 is not pushed out of the catheter 300 so as to be pushed out, but is pushed out of the catheter 300 so as to be pulled out, the defect hole closing material 100 is twisted when pushed out, and the first end portion The cylinder diameter of the other portion is appropriately expanded to a size corresponding to the defect hole in which the 112 and the second end portion 122 cannot be appropriately approached with respect to the substantially central portion 130 and are closed by the defect hole closing material 100. It is suppressed that the defect hole closing material 100 is not twisted in this way by pulling it, and the first end portion 112 and the second end portion 122 are centered on the substantially central portion 130. The diameter of the cylinder of the other portion can be appropriately expanded to a size corresponding to the defect hole that is appropriately approached and closed by the defect hole closing material 100. As a result, the first tubular portion 110 arranged on the right atrium side and the second tubular portion 120 arranged on the left atrium side approach each other around the substantially central portion 130 and open to the atrial septum. You can close the hole.
(Third action) Since all the materials (the joint portion 422 may be excluded) constituting the defect hole closing material 100 are bioabsorbable materials, they are finally absorbed into the living body, which causes a defect in a remote period. There is almost no possibility of.

The case where the defect hole closing material 100 is used for catheter treatment of atrial septal defect will be described with reference to FIGS. 6 to 9.
[Usage]
FIG. 6 is a conceptual diagram when the defect hole closing material 100 is used for catheter treatment of atrial septal defect, and FIGS. 7 to 9 are enlarged views of part B of FIG. 6 showing the procedure of this catheter treatment. Shown. In the following, only the matters specific to the usage mode of the defect hole closing material 100 according to the present embodiment will be described, and the general matters will be described in the same manner as the known catheter treatment for atrial septal defect. Since there is, I will not repeat the detailed explanation here.

As shown in FIG. 6, the human heart 200 is connected to the right atrium 210 via the upper and inferior aorta and receives venous blood from the whole body, the pulmonary artery and the tricuspid valve 260 to the lung. Two ventricles 2 of the right ventricle 220 that pumps venous blood, the left ventricle 230 that is connected to the pulmonary vein and receives arterial blood from the lung, and the left ventricle 240 that is connected to the left ventricle 230 via the aorta and mitral valve 270 and pumps arterial blood throughout the body. It is composed of ventricles. Atrial septal defect is a disease in which a defect hole 252 is opened in the atrial septum 250 that separates the right atrium 210 and the left atrium 230. In FIG. 6, for easy understanding, the distal end side (tip side from the breaking line) of the catheter 300 is shown by a virtual line, and the defect hole closing material 100 housed in the catheter 300 is shown by a solid line. There is.

First, in vitro, the defect hole closing material 100 is pulled in a direction in which the first end portion 112 and the second end portion 122 of the defect hole closing material 100 that expands to an appropriate size with respect to the defect hole 252 are separated from each other. The diameter of the cylinder is smaller than the inner diameter of the catheter 300, and the catheter 300 is set. Insert the catheter 300 containing the defect hole closing material 100 from the femoral vein (see FIG. 3), and insert the catheter 300 (containing the defect hole closing material 100) into the catheter 300 (along with the stored defect hole closing material 100). The catheter 300 containing the defect hole closing material 100 is brought closer to the left atrium 230 side through the defect hole 252 from the right atrium 210 side by moving in the direction X (1).

As shown in FIGS. 6 and 7, the catheter 300 containing the defect hole closing material 100 is stopped at a position such that the substantially central portion 130 of the defect hole closing material 100 corresponds to the vicinity of the defect hole 252. The delivery cable 500 is operated (so that the defect hole closing material 100 advances in the direction of the opening 320 of the catheter 300), and the tip portion of the delivery cable 500 is joined to the junction portion 422 on the distal end side in the living body. Therefore, the second tubular portion 120 is not pushed out of the catheter 300 so as to be pushed out from the catheter 300, but the second tubular portion 120 is pulled so that the arrow is outward from the catheter 300 to the catheter 300. It is issued in the indicated Y direction. Then, the shape of the second tubular portion 120 whose shape is regulated by the inner wall 310 of the catheter 300 can be freely changed, and only the tubular portion of the body portion in the second tubular portion 120 is shown in FIG. It is extended as shown in.

Further, the delivery cable 500 is operated (so that the defect hole closing material 100 advances (further) toward the opening 320 of the catheter 300), and in the living body, the delivery cable 500 is connected to the junction 422 on the distal end side. Since the tip of the catheter 300 is joined, the first tubular portion 110 is pushed out of the catheter 300 so that the first tubular portion 110 is pushed out, but the first tubular portion 110 follows the second tubular portion 120. It is pulled out from the catheter 300 in the direction Y indicated by the outside of the catheter 300. Then, the shape of the first tubular portion 110 whose shape is regulated by the inner wall 310 of the catheter 300 can be freely changed, and only the tubular portion of the body portion in the first tubular portion 110 is shown in FIG. It is extended as shown in.

That is, at a position where the substantially central portion 130 of the defect hole closing material 100 corresponds to the vicinity of the defect hole 252, the delivery cable 500 is inserted (so that the defect hole closing material 100 advances in the direction of the opening 320 of the catheter 300). When operated, the second tubular portion 120 arranged on the left atrium side expands first, and then the first tubular portion 110 arranged on the right atrium side expands later. As a result, the first tubular portion 110 arranged on the right atrium 210 side and the second tubular portion 120 arranged on the left atrium 230 side approach each other with the substantially central portion 130 (defective hole 252) as the center. , The first tubular portion 110 and the second tubular portion 120 are expanded. Finally, as shown in FIG. 9, the atrial septum 250 was sandwiched from both sides by the first tubular portion 110 and the second tubular portion 120, and opened to the atrial septum 250 by the defect hole closing material 100. The defect hole 252 can be closed.

Then, in the body, the cable body 510 is rotated (rotated) so that the male screw 514 rotates (rotates) in the direction opposite to the direction in which the male screw 514 is screwed into the female screw 424, and the defect hole due to this screwing is performed. The joint between the closing material 100 and the delivery cable 500 is opened. At this time, the defect hole closing material 100 provided so as to close the defect hole 252 does not rotate (rotate).

After that, the catheter 300 (which houses the delivery cable 500) is moved in the direction of arrow X (2), and the catheter 300 (and the delivery cable 500) is taken out of the living body to complete the treatment. As a result, a defect hole closing material 100 (may exclude the joint portion 422) made entirely of a bioabsorbable material is placed in the living body (to be exact, in the vicinity of the defect hole 252). Since all the materials of the defect hole closing material 100 placed in the living body in this way are bioabsorbable materials (the joint portion 422 may be excluded), they are finally absorbed in the living body, which causes a defect in a remote period. There is almost no possibility of.

Then, in such a usage mode, when the operation wire 500 pushes the first tubular portion 110 from the catheter 300 and then the second tubular portion 120 in the Y direction indicated by the arrow, the defect hole closing material 100 is twisted. A cylinder of another portion up to a size corresponding to a defect hole in which the first end portion 112 and the second end portion 122 cannot be appropriately approached with respect to the substantially central portion 130 and are closed by the defect hole closing material 100. The diameter may not expand properly, but when pulled, the defect hole closing material 100 is suppressed from twisting, and the first end 112 and the second end 122 are substantially central 130. The diameter of the cylinder of the other portion can be appropriately expanded to a size corresponding to the defect hole closed by the defect hole closing material 100, which is appropriately approached around the center.

As described above, according to the defect hole closing material 100 according to the present embodiment, all of the material is composed of a bioabsorbable material (the joint portion 422 may be excluded) and is finally absorbed into the body. Therefore, there is almost no possibility of a malfunction in the remote period. Further, when the defect hole closing material 100 is extruded from the catheter 300, the defect hole closing material 100 is twisted, and the first end portion 112 and the second end portion 122 appropriately approach each other with the substantially central portion 130 as the center. In some cases, the cylinder diameters of other parts (first cylinder portion 110 and second cylinder portion 120) may not be appropriately expanded to a size corresponding to the defect hole closed by the defect hole closing material 100. When a joint portion 422 is provided on the second end portion 122 side, and the tip end portion of the delivery cable 500 is joined to the joint portion 422 and pulled to pull out the defect hole closing material 100 from the catheter 300, such a case is used. The defect hole closing material 100 is suppressed from twisting, and the first end portion 112 and the second end portion 122 are appropriately approached with respect to the substantially central portion 130 and closed by the defect hole closing material 100. The cylinder diameter of the other portions (first tubular portion 110 and second tubular portion 120) can be appropriately expanded to a size corresponding to the defect hole. As a result, at the position of the defect hole, the cylinder diameter of the defect hole closing material 100 can be changed to two cylinders simply by operating the delivery cable 500 so that the defect hole closing material 100 advances in the direction of the opening 320 of the catheter 300. A defect hole opened in the atrial septum, which can be easily changed so that (the first tubular portion 110 and the second tubular portion 120) approach each other, and its morphology can be easily fixed. Can be closed.
<Modification example>
Hereinafter, the defect hole closing material 600 according to the modified example of the present embodiment will be described with reference to FIG. FIG. 12 (A) is a view in which the defect hole closing material 600 according to the present modification is pulled out of the catheter 300, and FIG. 12 (B) is a view showing the defect hole closing material 600 according to the present modification. It is a diagram of itself.

The defect hole closing material 600 has a loop (long ring) 610 formed of the same material as the bioabsorbable fiber 150, and the bioabsorbable fiber at the first end 112 in the first tubular portion 110 on the root side. The loop end is joined to the first end of the first tubular portion 110 by being hooked on the stitches of 150, and the other configurations are the same as those of the defect hole closing material 100 described above. Therefore, the description of these same configurations will not be repeated here.

As shown in FIG. 12A, the loop end opposite to the loop end hooked and joined to the stitch of the first end 112 of the loop 610 passes through the inside of the catheter 300 and is a living body. It is taken out and joined to the dropout prevention member 620. That is, the total length L of the loop 610 is longer than the length from the inlet to the exit of the catheter 300. Further, the size of the dropout prevention member 620 is larger than the inner diameter of the catheter 300, and the loop 610 is prevented from being pulled into the inside of the catheter 300. It is also preferable to use this dropout prevention member 620 as a management tag.

According to the defect hole closing material 600 according to the present modification, as shown in FIG. 12 (A), after the defect hole closing material 600 is placed in the living body, any position of the loop 610 is cut in vitro and cut. The loop 610 can be pulled out from the stitch of the first end 112 by pulling one end (the one to which the drop-out prevention member 620 is attached), and the loop 610 can be recovered in vitro. Further, when the defect hole closing material 600 falls off inside the heart from a position provided so as to close the defect hole 252, the dropout prevention member 620 is used as a catheter 300 without cutting the loop 610 of the defect hole closing material 600. It can be withdrawn from the body and collected in vitro through the catheter 300. As described above, since the defect hole closing material 600 in the living body is connected to the outside of the living body by the loop 610 passed through the inside of the catheter 300, it is not necessary to recover the defect hole closing material 600 by thoracotomy.

It should be noted that the embodiments disclosed this time are examples in all respects and are not restrictive. The scope of the present invention is shown by the scope of claims rather than the above description, and is intended to include all modifications within the meaning and scope equivalent to the scope of claims.

The present invention is suitable for a medical material set in a catheter for treating a defect formed in a living tissue, can be released and indwelled at a treatment site, can be treated with minimal invasiveness, and is a medical material. It is particularly preferable in that there is almost no possibility of malfunction in the remote period even if it remains in the body, and that operability is preferable.

100, 600 Medical materials (closing plugs)
110 First tube 112 First end 120 Second tube 122 Second end 130 Approximately central 150 Bioabsorbable fiber 200 Heart 250 Atrial septum 252 Defect hole 300 Catheter 500 Delivery cable (operation wire) )
610 loop 620 dropout prevention member

Claims (5)

It is a medical material formed by a tubular body of knitted tissue using a wire rod having bioabsorbability.
It has a shape in which the diameter of the substantially central portion of the cylinder is smaller than the diameter of other portions.
A first tubular portion on the first end side, which is one end in the longitudinal direction of the tubular body, and a second tubular portion on the second end side, which is the other end, are formed around the substantially central portion. Being done
When the first end portion and the second end portion are separated from each other about the substantially central portion and the cylinder diameter of the other portion is reduced to accommodate the medical material in the catheter. The second end side is the tip side of the catheter,
The medical material is
The second end side is provided with a joint portion for joining the delivery cable that is passed from the first end side to the second end side via the substantially central portion.
A medical material, which is formed so that the delivery cable can be passed from the first end side to the outside of the medical material. The joint is a hollow cylindrical object provided with a female screw.
The medical material according to claim 1, wherein a male screw provided on the tip end side of the delivery cable is joined by screwing into the female screw. The hollow cylindrical object is
The first tubular portion side is opened and the female screw is provided so that the male screw can be screwed.
The medical material according to claim 2, wherein the opposite side of the first tubular portion side is closed. The delivery cable is operated so that the defect hole closing material advances in the direction of the opening of the catheter while the entire medical material bonded to the delivery cable by the joint is housed in the catheter. By ejecting the first tubular portion from the tip of the catheter to the outside of the catheter following the second tubular portion, the first end portion and the second end portion are substantially centered. Any of claims 1 to 3, wherein the tubular diameter of the other portion is expanded to a size corresponding to the defect hole closed by the medical material by approaching the portion. Medical materials listed in the catheter. The medical material further comprises a loop to which one end is joined to the first end side and the other end is joined to a dropout prevention member larger than the inner diameter of the catheter.
The medical material according to any one of claims 1 to 4, wherein the total length of the loop is longer than the total length of the catheter.

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