JP6868867B2 - Medical materials - Google Patents

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 atrium and a ventricle on the left and right, and is composed of two atriums and two ventricles, a right atrium, a right ventricle, a left atrium, and a left ventricle. 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 aisle, a second anchor used to be located proximal to the second end of the aisle, 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 and 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, an 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 atrium anchor and the right atrium anchor remain in the heart. The left atrium anchor and the right atrium anchor include one or more arms, which extend radially outward 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 extraction 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 easily operated without being prepared 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 by a tubular body having a stitch-like structure using a wire rod, and the tubular diameter at a substantially central portion of the tubular body is larger than the tubular diameter of another portion. Also has a small shape, and the first tubular portion on the first end side in the longitudinal direction of the tubular body and the second tubular portion on the other end side of the medical material are formed around the substantially central portion. Both ends are engaged with the wire rod of the first end portion and the wire rod of the second end portion, respectively, and the second end portion is formed from the first end portion side via the substantially central portion. The tubular body includes an elastic member that is passed through the inside of the first tubular portion and the second tubular portion to the side, and a porous layer composed of a non-woven fabric, a sponge, a film, or a composite thereof. The first porous layer is arranged along the inner surface at three locations on the inner surface of the first tubular portion in the longitudinal direction of the first tubular portion, and the first porous layer is substantially on the central portion side in the longitudinal direction of the first tubular portion. A second porous layer is arranged on the opposite side of the central portion, and a third porous layer is arranged on the opposite side of the substantially central portion in the longitudinal direction of the first tubular portion. Is characterized in that the longitudinal direction is shorter than that of the first porous layer and the second porous layer.

Preferably, the shape is an hourglass type, a figure eight shape or a double spindle type, and the porous layers provided at the three locations may be configured to have an umbrella shape along the shape. it can.
More preferably, when the elastic member is in the contracted state, the first end portion and the second end portion approach each other about the substantially central portion and are closed by the medical material. As the cylinder diameter of the other portion is expanded to a size corresponding to the defect hole and the cylinder diameter of the other portion is expanded, the first porous layer and the second porous layer are expanded. It can be configured to expand to a size corresponding to the defect hole closed by the medical material.

More preferably, when the elastic member is in the stretched state, the first end portion and the second end portion are separated from each other about the substantially central portion, and the medical material is stored. The diameter of the other portion is reduced to a size corresponding to the catheter, and as the diameter of the other portion is reduced, the first porous layer, the second porous layer, and the third porous layer are reduced. The porous layer of the above can be configured to be reduced in size to accommodate the catheter in which the medical material is housed.

More preferably, the elastic member can be configured to be a coil spring having a diameter smaller than the cylinder diameter at the substantially central portion.
More preferably, the end portion of the elastic member is configured so as to be a small cylinder portion provided outside the tubular body of the stitch-like structure and joined to the small cylinder portion screwable with the operation wire. be able to.

More preferably, the wire rod or the porous layer can be configured to be a bioabsorbable material.

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 a simple 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 (the coil spring 140 is contracted state) of the defect hole closing material 100 which is an example of the medical material which concerns on this invention. It is an overall view (the coil spring 140 is an intermediate state) of the defect hole closing material 100 which is an example of the medical material which concerns on this invention. It is an overall view (coil spring 140 in an extended state) of the defect hole closing material 100 which is an example of the medical material which concerns on this invention. It is an overall view (the coil spring 140 is in a contracted state and the extended state) of the defect hole closing material 100 which is an example of the medical material which concerns on this invention. (A) is a partial side view of the defect hole closing material 100 of FIG. 2, and (B) is a cross-sectional view taken along the line AA. It is a conceptual diagram in the case where the defect hole closing material 100 which is an example of the medical material which concerns on this invention is used for the catheter treatment of the atrial septal defect. It is an enlarged view (the 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 overall view (the coil spring 140 is in a contracted state) of the defect hole closing material 400 which is an example of the medical material which concerns on the modification of this invention. It is an overall view (the coil spring 140 is an intermediate state) of the defect hole closing material 400 which is an example of the medical material which concerns on the modification of this invention. It is a partially enlarged view of FIG.

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 passage closures 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 embodiments, the stitch-like structure of the defect hole closing material (closing plug) 100 will be described as knitting bioabsorbable fibers (an example of a wire rod), but the present invention is limited thereto. It's not a thing. 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 tissue has the first feature to the fourth feature described later and has the first action to the fourth. As long as it is a material that exerts its action, it may be knitted with a wire rod other than the bioabsorbable fiber. It is preferable that such a wire rod has a certain degree of hardness in order to have shape retention (shape retention).

[Constitution]
FIG. 1 is an overall view of the defective hole closing material 100 according to the present embodiment (coil spring 140 is in a contracted state), and FIG. 2 is an overall view of the defective hole closing material 100 (coil spring 140 is in an intermediate state). 3 shows an overall view of the defective hole closing material 100 (coil spring 140 is in an extended state), and FIG. 4 shows an overall view of the defective hole closing material 100 (a coil spring 140 is in a contracted state and an extended state). Note that FIG. 3 shows a state in which the entire defect hole closing material 100 is housed in the catheter 300, and FIG. 4 shows a state in which half of the defect hole closing material 100 (on the side of the first tubular portion 110) is stored in the catheter 300. It is a figure which shows each state. The defect hole closing material 100, which is entirely housed inside the catheter 300 shown in FIG. 3 (the space formed by the inner wall 310), is attached to the catheter 300 from the first tubular portion 110 side to the second tubular portion 120. When the opening 320 is pushed out in the Y direction indicated by the arrow, the state shown in FIG. 4 is obtained, and when the first tubular portion 110 is further pushed out in the Y direction indicated by 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 an intermediate state between the contracted state and the extended state of the coil spring 140, which is a virtual 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 tubular diameter of A second tubular portion 120 on the end portion 122) side of the 2 is formed. What is characteristic is that both ends are engaged with the wire 114 of the first end 112 and the wire 124 of the second end 122, respectively, from the first end 112 side via the substantially central portion 130. The point is that the coil spring 140, which is an example of the elastic member passed through the inside of the first tubular portion 110 and the second tubular portion 120 up to the second end 122 side, is provided. The elastic member may be a member other than the coil spring 140 as long as it has elasticity and can exhibit the action described later by the elasticity, and is not limited to the coil spring 140.

Further characteristic is that porous layers composed of non-woven fabric, sponge, film and any of these complexes are arranged along the inner surface at three locations on the inner surface of the cylinder. .. The material of the porous layer is not limited, but the tubular body (first tubular portion 110 and second tubular portion 120) which is a portion other than the substantially central portion 130 of the defect hole closing material 100. As the cylinder diameter is expanded / reduced, the porous layer needs to have the flexibility to change the shape of the porous layer along the inner surface shape of the cylinder.

More specifically, the first porous layer 161 is on the substantially central portion 130 side in the longitudinal direction of the first tubular portion 110, and the second porous layer 161 is on the opposite side of the substantially central portion 130 in the longitudinal direction of the second tubular portion 120. The porous layer 162 is arranged, and the third porous layer 163 is arranged on the opposite side of the substantially central portion 130 in the longitudinal direction of the first tubular portion 110. The third porous layer 163 is characterized in that the longitudinal direction is shorter than that of the first porous layer 161 and the second porous layer 162. Here, the lengths of the first porous layer 161 and the second porous layer 162 in the longitudinal direction are the same, and these are collectively referred to as the porous layer 160 (in the following description and drawings). May 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 FIG. 5 (A). Note that FIG. 5B is a cross-sectional view of the defect hole closing material 100 (more specifically, the first tubular portion 110), but the cross section of the coil spring 140, the cross section of the bioabsorbable fiber 150, and the first porous body. Only the appearance of the layer 161 is shown, and the stitches of the bioabsorbable fiber 150 that can be visually recognized from the direction of arrow A are not shown. Further, in FIGS. 1 to 5, the bioabsorbable fiber 150 arranged on the back side of the paper surface in order to facilitate understanding of the existence of the coil spring 140 and the stitches of the bioabsorbable fiber 150 is not shown. In order to facilitate understanding of the external shape of the defective hole closing material 100, there is a portion where the external shape of the defective hole closing material 100 is shown by a dotted line. Further, of all the figures, only FIG. 2 is a porous layer (first tubular portion) along the inner surface of the tubular body (first tubular portion 110 and second tubular portion 120) of the defect hole closing material 100. A state in which the porous layer 161, the second porous layer 162, and the third porous layer 163) are arranged (that is, hatching on the back side of the paper surface of the bioabsorbable fiber 150 as shown in FIG. 2 (A)). The other figure shows the change in the position, shape and shape of the porous layer (that is, the porous layer with hatching on the front side of the paper surface of the bioabsorbable fiber 150). It merely shows a state in which the layer is represented (a state in which the porous layer appears to exist on the outside of the bioabsorbable fiber 150).

As shown in these figures (particularly FIG. 2), the defect hole closing material 100 has two tubular bodies (first tubular portion 110 and second tubular portion 120) of a stitch-like structure using a bioabsorbable material. ), And its shape is composed of two such 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.
Then, as can be understood from the two views of the porous layer shown in FIG. 2 (B) and the perspective view of the porous layer shown in FIG. 2 (C), the first porous layer 161 and the second porous layer The 162 and the third porous layer 163 (porous layers provided at three locations) have an umbrella shape that follows such an hourglass shape, a figure eight shape, a double spindle shape, or a peanut shape. Is. The umbrella shape described here typically means the shape shown in the perspective view of FIG. 2 (C). However, as described above, since the porous layer has flexibility and the shape of the porous layer changes as the shape of the tubular body changes, the tubular body of the defect hole closing material 100 in which the coil spring 140 shown in FIG. 2 is in an intermediate state. A shape that matches the shape of (the first tubular portion 110 and the second tubular portion 120) means an umbrella shape that is a typical shape of the porous layer.

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 obtained 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 binding or / or heat-setting the central portion 130, the cylinder diameter of the substantially central portion 130 is made smaller than the diameter of the other portions, and then the binding of the substantially central portion 130 is released or heat is applied. By opening the set to form a substantially central portion 130 in which the diameter of the substantially central portion 130 is larger than the diameter of the coil spring 140, the overall shape of the defect hole closing material 100 is composed of two cylinders. It may be formed in an hourglass shape, a figure eight shape, a double spindle shape or a peanut shape. Then, as will be described in detail later, by forming such a shape, 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. When the second tubular portion 120 is pushed out from the opening 320 of the catheter 300 in the direction of arrow Y from the tubular portion 110 side of 1, the second tubular portion 120 is released from the space formed by the inner wall 310 of the catheter 300. When the coil spring 140 of the second tubular portion 120 contracts to the state shown in FIG. 4 and the first tubular portion 110 is further pushed out in the Y direction indicated by the arrow, the first tubular portion 110 is formed by the inner wall 310 of the catheter 300. It is possible to realize a change in shape in which the coil spring 140 of the first tubular portion 110 contracts to be in the state shown in FIG. 1 after being released from the space to be formed.

Further, the defect hole closing material 100 has one end engaged with the first end 112 (for example, hooked on the loop of the wire 114 of the first end 112) and the other end with the second end. The first is engaged with the portion 122 (for example, hooked on the loop of the wire rod 124 of the second end portion 122) from the first end portion 112 side to the second end portion 122 side via the substantially central portion 130. A coil spring 140 passed through the inside of the cylinder portion 110 and the second cylinder portion 120 is provided. The loop-shaped wire 114 and the wire 124 are made of bioabsorbable fiber 150.

As shown in FIG. 1, when the coil spring 140 is in the contracted state, the first end portion 112 and the second end portion approach each other with the substantially central portion 130 as the center, and other than the substantially central portion 130. The cylinder diameters of the first cylinder portion 110 and the second cylinder portion 120, which are other portions, are expanded. Particularly preferably, when the coil spring 140 is in the contracted state, the first tubular portion which is a portion other than the substantially central portion 130 up to a size corresponding to the defect hole closed by the defect hole closing material 100. The cylinder diameters of the 110 and the second cylinder 120 are expanded. Then, as 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 in this way, the first porous layer 161 and the second tubular portion 120 are expanded. The porous layer 162 of the above is expanded to a size corresponding to the defect hole closed by the defect hole closing material 100.

Then, as shown in FIG. 3, by accommodating the defect hole closing material 100 in the catheter 300 or the like, when the coil spring 140 is in the extended state, the first end portion 112 and the second end portion 122 are formed. The diameters of the first tubular portion 110 and the second tubular portion 120, which are other portions, are reduced so as to be separated from each other with the central portion 130 as the center. Particularly preferably, when the coil spring 140 is in the extended state, the first tubular portion 110 and the second tubular portion are other portions up to a size corresponding to the catheter 300 in which the defect hole closing material 100 is housed. The cylinder diameter of 120 is reduced. Then, as the cylinder diameters of the first tubular portion 110 and the second tubular portion 120, which are other portions, are reduced in this way, the first porous layer 161 and the second porous layer 162 and the like are formed. The third porous layer 163 is reduced to a size corresponding to the catheter 300 in which the defect hole closing material 100 is housed.

By using the coil spring 140 having a diameter smaller than the cylinder diameter of the substantially central portion 130 in this way, the first end portion 112 and the other end portion in the longitudinal direction of the cylinder body in the defect hole closing material 100 are used. Can be brought closer to or separated from the end portion 122 of the. When the coil spring 140 is in the contracted state, as shown in FIG. 1, the first end portion 112 and the second end portion 122 come close to each other, and the cylinder diameter of the other portion of the substantially central portion 130 (first). When the cylinder portion 110 and the cylinder diameter of the body portion in the second cylinder portion 120 are expanded and the coil spring 140 is in the extended state, the first end portion 112 and the second end portion 122 are shown in FIG. The cylinder diameter of the other portion of the substantially central portion 130 (the cylinder diameter of the body portion in the first cylinder portion 110 and the second cylinder portion 120) is reduced. Further, as shown in FIG. 4, when the second tubular portion 120 is pushed out from the catheter 300 in the Y direction indicated by the arrow, the shape of the second tubular portion 120 whose shape is regulated by the inner wall 310 of the catheter 300 freely changes. As a result, only the portion of the coil spring 140 contained in the second tubular portion 120 contracts, and only the tubular diameter of the body portion in the second tubular portion 120 is expanded. Further, when the first tubular portion 110 is pushed out from the catheter 300 in the Y direction indicated by the arrow, the shape of the first tubular portion 110 whose shape is regulated by the inner wall 310 of the catheter 300 can also be freely changed, and the coil spring 140 The portion included in the first tubular portion 110 is also contracted, and the tubular diameter of the body portion in the first tubular portion 110 is also expanded as shown in FIG.

Then, in the defect hole closing material 100, the porous layer (first porous layer 161 and second porous layer 162 and third) composed of any of a non-woven fabric, a sponge, a film and a composite thereof The porous layer 163) of the above is arranged on the inner surface of the tubular body. The first tubular portion 110 and the second tubular portion 120 are composed of a woven fabric (coarse) of bioabsorbable fiber 150, a knitted fabric, a braided woven fabric, or a tubular knitted fabric, and the whole is a stitch. It is said to be a woven fabric. 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. The porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) is a non-woven fabric or sponge, assuming that a chemical is applied, impregnated, embedded, or the like. , Film, or a complex of these. Further, the porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) is not limited to a bioabsorbable material, and is a material that is not absorbed by a living body. It doesn't matter. Further, the porous layer (the first porous layer 161 and the second porous layer 162 and the third porous layer 163) has other than the substantially central portion 130 in order to have flexibility as described above. (1st cylinder 110 and 2nd cylinder 120) are arranged on the inner surface of the first cylinder 110 and the second cylinder 120 as the diameter of the cylinder (first cylinder 110 and second cylinder 120) is expanded / reduced. The resulting porous layers (first porous layer 161, second porous layer 162, and third porous layer 163) are also expanded (by changing the shape in the same manner as the shape of the cylinder). It will be reduced.

As described above, basically, except for the coil spring 140, the first tubular portion 110, the second tubular portion 120, and the porous layer (first porous layer 161, second porous layer 162, and second porous layer). Since all of the porous layer 163) of 3 is made of a bioabsorbable material, the entire defect hole closing material 100 excluding the coil spring 140 has bioabsorbability. 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. The defect hole closing material 100 in the material, the stitch shape, the fibrous structure and the fiber cross section so as not to be damaged is the porous layer (the first porous layer 161 and the second porous layer 162 and the third porous. It is formed including the quality layer 163).

Normally, the coil spring 140 is made of, for example, a nickel-titanium alloy and does not have bioabsorbability, but a magnesium-based alloy described later may be used to have bioabsorbability. If an alloy having bioabsorbability is used for the coil spring 140, it is advantageous in that it reacts to X-ray imaging, and if an alloy having no bioabsorbability is used, the metal member will not remain in the body for a lifetime. It is advantageous in that it does not cause the problem of concern about problems in the remote period.

The bioabsorbable fiber 150 constituting the first tubular portion 110 and the second tubular portion 120 is, 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 biodegradable alloy. An example of such a biodegradable 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. The bioabsorbable fiber 150 is suitable for coating or impregnating an X-ray opaque 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, for example, 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, an hourglass type, figure 8 composed of two cylinders, squeezed at substantially the center 130 by a string of the same material as the first cylinder 110 and the second cylinder 120. Formed into a double spindle or peanut shape. The diameters of the first cylinder 110 and the second cylinder 120 are smaller than the inner diameter of the catheter when the diameter is reduced, and have a size suitable for catheter treatment of atrial septal defect when the diameter is expanded. .. 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.

The bioabsorbable material constituting the porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) is not particularly limited, and for example, polyglycolic acid or polylactide (polyglycolic acid, polylactide). D, L, DL form), polycaprolactone, glycolic acid-lactide (D, L, DL form) copolymer, glycolic acid-ε-caprolactone copolymer, lactide (D, L, DL form) -ε-caprolactone Examples thereof include synthetic absorbent polymers such as copolymers, poly (p-dioxanone), glycolic acid-lactide (D, L, DL) -ε-caprolactone copolymers. These may be used alone or in combination of two or more. Among them, polyglycolic acid, lactide (D, L, DL form) -ε-caprolactone copolymer, glycolic acid-ε-caprolactone copolymer and glycolic acid-lactide (D, At least one selected from the group consisting of L, DL form) -ε-caprolactone copolymer is suitable and is composed of any of non-woven fabric, sponge, film or a composite thereof. In particular, as a preferred embodiment, a non-woven fabric can be exemplified.

Further, the material of the porous layer (the first porous layer 161 and the second porous layer 162 and the third porous layer 163) may be a biodegradable alloy. An example of such a biodegradable alloy is a magnesium-based alloy as a raw material.
When the porous layer (the first porous layer 161 and the second porous layer 162 and the third porous layer 163) is a non-woven fabric, it may be hydrophilized. The hydrophilization treatment is not particularly limited, and examples thereof include plasma treatment, glow discharge treatment, corona discharge treatment, ozone treatment, surface graft treatment, and ultraviolet irradiation treatment. Among them, plasma treatment is preferable because the water absorption rate can be dramatically improved without changing the appearance of the non-woven fabric layer. The porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) may be a sponge layer or a film layer, or a composite layer of a non-woven fabric and a sponge layer. , A composite layer of a non-woven fabric and a film layer, a composite layer of a sponge layer and a film layer, and a composite layer of a non-woven fabric and a sponge layer and a film layer may be used.
The porous layers (first porous layer 161, second porous layer 162, and third porous layer 163) are such that a drug suitable for catheter treatment of atrial septal defect is held. It is also preferable to do so.
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) One end is engaged with the first end 112 (hooked on the loop-shaped wire 114 of the first end 112), and the other end is engaged with the second end 122 (second feature). (Hooked on the loop-shaped wire 124 of the end 122 of 2), the first cylinder 110 and the second cylinder from the first end 112 side to the second end 122 side via the substantially central portion 130. A coil spring 140 passed through the inside of the portion 120 is provided.
(Third feature) First tubular portion 110, second tubular portion 120, coil spring 140 (when formed of an alloy based on magnesium) and a porous layer (first porous layer 161). , The second porous layer 162 and the third porous layer 163), all of which are composed of bioabsorbable materials (the coil spring 140 does not necessarily have to be bioabsorbable). ).
(Fourth Feature) The first porous layer 161 is located on the substantially central portion 130 side in the longitudinal direction of the first tubular portion 110, and the first porous layer 161 is located on the opposite side of the substantially central portion 130 in the longitudinal direction of the second tubular portion 120. The second porous layer 162 is arranged on the opposite side of the substantially central portion 130 in the longitudinal direction of the first tubular portion, and the third porous layer 163 is arranged along the inner surface at three locations on the inner surface of the tubular body. The third porous layer 163 is shorter in the longitudinal direction than the first porous layer 161 and the second porous layer 162.

Then, according to the first feature and the second feature, when the second tubular portion 120 is pushed out from the catheter 300 with respect to the defect hole closing material 100 housed in the catheter 300, the shape is restricted by the inner wall 310 of the catheter 300. The shape of the second tubular portion 120 that has been formed can be freely changed, and only the portion contained in the second tubular portion 120 of the entire coil spring 140 contracts and the body portion in the second tubular portion 120. When the first tubular portion 110 is pushed out from 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 also be freely changed, and the coil spring. The portion of the entire 140 contained in the first tubular portion 110 is also contracted, and the tubular diameter of the body portion in the first tubular portion 110 is also expanded. Then, as the cylinder diameter of the body portion is expanded in this way, the first porous layer 161 and the second porous layer 162 correspond to the defect holes closed by the defect hole closing material 100. Expanded to size.
In particular, the defect hole closing material 100 is suitable for catheter treatment of atrial septal defect in that it exhibits the following effects.

(First action) By stretching the entire coil spring 140, the cylinder diameter of the defect hole closing material 100 including the porous layer can be made smaller than the inner diameter of the catheter 300 and set in the catheter 300. ..
(Second action) It is set in the catheter 300 and sent to the position of the hole opened in the atrial septum, and the first end 112 is pushed by an applicator or the like in the living body to push the second tubular portion 120 to the catheter 300. When pushed into the living body, the coil spring 140 of the second tubular portion 120 contracts to expand the tubular diameter of the body portion of the second tubular portion 120, and the second porous layer 162 forms the defect hole. It is expanded to a size corresponding to the defect hole closed by the closing material 100, and when the first end 112 is pushed with an applicator or the like and the first cylinder 110 is pushed out from the catheter 300 into the living body, the first cylinder The coil spring 140 of 110 also contracts to expand the cylinder diameter of the body portion in the first cylinder portion 110, and the first porous layer 161 corresponds to the defect hole closed by the defect hole closing material 100. 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 with the central portion 130 as the center, and are in the atrial septum. It can close the holes in the septum.

(Third action) Since all the materials (the coil spring 140 may be excluded) constituting the defect hole closing material 100 are bioabsorbable materials, they are finally absorbed into the living body, which is a problem in a remote period. There is almost no possibility of.
(Fourth Action) The first porous layer 161 and the second porous layer 162 included in the defect hole closing material 100 have an umbrella shape that tapers in the traveling direction (Y direction indicated by an arrow). Therefore (because it does not spread in the direction of travel), there is little resistance when pushing out in the direction of arrow Y, and the third porous layer 163 tapers in the direction of travel (direction of arrow Y). Although it has an unshaped umbrella shape, its longitudinal direction is shorter than that of the first porous layer 161 and the second porous layer 162, so that resistance when extruding in the arrow Y direction is small. Then, the hole opened in the atrial septum can be reliably closed by the first tubular portion 110 and the second tubular portion 120, and the first porous layer 161 and the second porous layer. Further, in this case, the third porous layer 163 can close the space (hole) at the substantially center of the cross section perpendicular to the longitudinal direction of the defect hole closing member 100 formed by providing the coil spring 140. ..
In order to easily understand such an action, a 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 lower aorta and receives venous blood from the whole body, the pulmonary artery and the tricuspid valve 260 to the lung. Two atriums of the right ventricle 220 that pumps venous blood, the left atrium 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 atrium 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 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.

First, in vitro, the entire coil spring 140 is pulled in a direction in which the first end 112 and the second end 122 of the defect closing material 100 that expands to an appropriate size with respect to the defect hole 252 are separated from each other. The tubular diameter of the defect hole closing material 100 including the porous layer (first porous layer 161, second porous layer 162, and third porous layer 163) is smaller than the inner diameter of the catheter 300. Then, it is set in the catheter 300. A catheter 300 containing a defect hole closing material 100 is inserted from the femoral vein (see FIG. 3), the catheter 300 is moved in the direction of arrow X (1)), and the catheter 300 is moved from the right atrium 210 side through the defect hole 252 to the left. The catheter 300 containing the defect hole closing material 100 is brought closer to the atrium 230 side.

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. In the living body, when the second tubular portion 120 is pushed out from the catheter 300 in the Y direction indicated by an applicator or the like, 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. , Only the portion of the coil spring 140 contained in the second tubular portion 120 contracts, and only the tubular diameter of the body portion in the second tubular portion 120 and the second porous layer 162 are shown in FIG. Is extended as

Further, when the first tubular portion 110 is pushed out from the catheter 300 in the Y direction indicated by an applicator or the like, the shape of the first tubular portion 110 whose shape is regulated by the inner wall 310 of the catheter 300 can also be freely changed. , The portion of the coil spring 140 contained in the first tubular portion 110 also contracts, and the tubular diameter of the body portion in the first tubular portion 110 as well as the first porous layer 161 and the third porous layer 163. Is also extended as shown in FIG.

That is, when the defect hole closing material 100 is extruded from the catheter 300 with an applicator or the like, the second tubular portion 120 and the second porous layer 162 arranged on the left atrium side first expand, and then the right atrium. The first tubular portion 110 and the first porous layer 161 and the third porous layer 163 arranged on the side are expanded later. As a result, the first tubular portion 110 and the second porous layer 162 arranged on the right atrium side, the second tubular portion 120 arranged on the left atrium side, and the first porous layer 161 and the third porous layer 162. The porous layer 163 approaches the substantially central portion 130 (defective hole 252) at the center, and the first tubular portion 110 and the second porous layer 162, the second tubular portion 120, and the first porous portion are approached. Layer 161 and the third porous layer 163 expand. Finally, as shown in FIG. 9, the first tubular portion 110 and the second porous layer 162, the second tubular portion 120, the first porous layer 161 and the third porous layer 163. The atrial septum 250 is sandwiched from both sides thereof, and the defect hole closing material 100 can close the defect hole 252 opened in the atrial septum 250. Further, the expanded third porous layer 163 can close the space (hole) at the substantially center of the cross section perpendicular to the longitudinal direction of the defect hole closing member 100 formed by providing the coil spring 140.

After that, the catheter 300 is moved in the direction of arrow X (2), and the catheter 300 is taken out of the living body to complete the treatment. As a result, a defect hole closing material 100 (may exclude the coil spring 140) 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 coil spring 140 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.

When the coil spring 140 is not provided, it is necessary to fix the form of the defect hole closing material 100 to the form shown in FIG. 9 before placing the defect hole closing material 100 in the living body. For example, bioabsorption It has been considered that the bioabsorbable fiber 150 is heat-set in the living body so that the sex fiber 150 has heat-sealing property. However, the defect hole closing material 100 is advantageous because the form of the defect hole closing material 100 can be fixed to the form shown in FIG. 9 by the coil spring 140.

As described above, according to the defect hole closing material 100 according to the present embodiment, all of the defect hole closing material 100 is composed of a bioabsorbable material (the coil spring 140 may be excluded) and is finally absorbed into the body. Therefore, there is almost no possibility of a malfunction in the remote period. Further, since the cylinder diameter of the defect hole closing material 100 easily changes together with the porous layer by providing the coil spring 140, the cylinder diameter of the defect hole closing material 100 and the size of the porous layer are finely changed to form a catheter. It can be set easily. Further, at the position of the defect hole, the coil spring 140 is provided only by pushing the defect hole closing material 100 from the catheter 300, so that the cylinder diameter of the defect hole closing material 100 is thickened together with the porous layer and the two cylinders are close to each other. It can be easily changed to the like, and its morphology can be easily fixed, and the defect hole opened in the atrial septum can be closed. In particular, the space (hole) at the substantially center of the vertical cross section of the defect hole closing material 100 formed by providing the coil spring 140 can be closed by the third porous layer 163, and the coil spring 140 can be closed. The merit (action effect) can be fully exhibited, and the demerit (space (hole) at the substantially center of the cross section perpendicular to the longitudinal direction of the defect hole closing material 100) due to the provision of the coil spring 140 is eliminated. , The defect hole opened in the atrial septum can be reliably closed.

<Modification example>
Hereinafter, the defect hole closing material (closing plug) 400, which is an example of the medical material according to the modified example of the present invention, will be described with reference to FIGS. 10 to 12. In the defect hole closing material 400 according to the present modification, the end portion of the elastic member (coil spring 140) in the defect hole closing material 100 described above is a tubular body having a stitch-like structure (first tubular portion 110 and second tubular portion 110 and second). It is the same as the above-mentioned defect hole closing material 100 except that it is a small cylinder portion provided outside the tubular portion 120) and is joined to the small cylinder portion that can be screwed with the operation wire 500. , The part that overlaps with the above explanation is not repeated here.

FIG. 10 shows an overall view of the defective hole closing material 400 (the coil spring 140 is in the contracted state) and corresponds to FIG. 1, and FIG. 11 shows an overall view of the defective hole closing material 400 (the coil spring 140 is in the intermediate state). A diagram corresponding to FIG. 2 is shown, and a partially enlarged view of FIG. 11 is shown in FIG. 12, respectively.
As shown in these figures, both ends 142 of the coil spring 140 have a female threaded portion 412 that can be screwed with a male threaded portion 512 provided at the tip end 510 of the operation wire 500 inserted inside the catheter 300. It is joined to the provided small cylinder portion (more specifically, a tubular metal piece 410). The metal piece 410 is provided outside the tubular body of the stitch-like structure (first tubular portion 110 and second tubular portion 120). Here, in the coil spring 140, as in the case of the defect hole closing member 100, one end of the coil spring 140 is engaged with the first end portion 112 (for example, the coil spring 140 is hooked on the loop of the wire rod 114 of the first end portion 112). ), The other end is engaged with the second end 122 (eg, hooked on the loop of the wire 124 of the second end 122). Then, the coil spring 140 in which the metal pieces 410 are joined to both end portions 142 extends from the first end portion 112 side to the second end portion 122 side via the substantially central portion 130 in the first tubular portion 110 and the second. It is passed through the inside of the tubular portion 120 of the above. Even if the small cylinder is made of a material other than metal, even if the metal piece 410 is joined to only one end of the coil spring 140 instead of 142 at both ends, the male screw part is attached to the metal piece 410 to the operation wire 500. A female screw portion may be provided.

Then, as described above, it can be exemplified that a nickel-titanium alloy is adopted for the coil spring 140 and stainless steel is adopted for the metal piece 410. As a joining method in the case of such a combination of metals, joining by caulking can be exemplified.
The defect hole closing material 400 having the above structure is used in the same manner as the above-mentioned usage mode of the defect hole closing material 100. Particularly preferably, in the defect hole closing material 400, a female that can be screwed with both end portions 142 of the coil spring 140 and a male screw portion 512 provided at the tip end portion 510 of the operation wire 500 inserted inside the catheter 300. Since it is joined to the metal piece 410 provided with the screw portion 412, it can be used as follows.

As shown in FIG. 7, in vitro, the first end 112 and the second end 122 of the defect closing material 100 that expands to an appropriate size with respect to the defect hole 252 are pulled in a direction in which they are separated from each other. The entire coil spring 140 is stretched so that the cylinder diameter of the defect hole closing material 100 is smaller than the inner diameter of the catheter 300, and the coil spring 140 is set in the catheter 300. At this time, although not shown in FIG. 7, one of the male screw portions 512 provided at the tip portion 510 of the operation wire 500 inserted into the catheter 300 and both end portions 142 of the coil spring 140 are joined. The metal piece 410 is screwed with the female screw portion 412 of the above.

Then, in the living body, as shown in FIG. 7 or 8, the second tubular portion 120 or the first tubular portion 110 is pushed out from the catheter 300 in the Y direction indicated by the arrow. In this case, because the coil spring 140 is connected to the tip of the operation wire 500 via the metal piece 410 (because the inflexible metal member is connected to the bioabsorbable fiber 150). , The operation wire 500 can be (extruded) operated from outside the living body to push it out in the Y direction indicated by the arrow with good operability.

Then, as shown in FIG. 9, both the cylinder diameter of the body portion of the second cylinder portion 120 of the defect hole closing member 400 and the cylinder diameter of the body portion of the first cylinder portion 110 are expanded. After that, although not shown in FIG. 9, the operation wire 500 is operated (rotated) from outside the living body to release the screw between the male screw portion 512 and the female screw portion 412. After that, the catheter 300 and the operation wire 500 are moved in the direction of arrow X (2), and the catheter 300 and the operation wire 500 are taken out of the living body to complete the treatment.

As described above, according to the defect hole closing material 400 according to the present modification, the operability of the defect hole closing material 100 described above can be further improved.
It should be noted that the embodiments disclosed this time are exemplary 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 it 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 hole 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 even if it remains in the body, there is almost no possibility of a malfunction in the remote period.

100, 400 Medical materials (closing plugs)
110 First cylinder 112 First end 120 Second cylinder 122 Second end 130 Approximately central 140 Coil spring 150 Bioabsorbable fiber 160 Porous layer (first porous layer 161, first 2 Porous layer 162)
163 Porous layer (third porous layer)
200 Heart 250 Interatrial Septum 252 Defect Hole 300 Catheter

Claims (7)

A medical material formed by a tubular body of a mesh-like structure using a wire rod.
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 in the longitudinal direction of the tubular body and a second tubular portion on the other end side of the medical material are formed around the substantially central portion.
Both ends are engaged with the wire rod at the first end and the wire rod at the second end, respectively, and the wire from the first end side to the second end side via the substantially central portion. An elastic member passed through the inside of the first tubular portion and the second tubular portion is provided.
Porous layers composed of non-woven fabrics, sponges, films, and composites thereof are arranged at three locations on the inner surface of the tubular body along the inner surface.
The first porous layer is formed on the substantially central side in the longitudinal direction of the first tubular portion.
A second porous layer is formed on the opposite side of the substantially central portion in the longitudinal direction of the second tubular portion.
A third porous layer is arranged on the opposite side of the substantially central portion in the longitudinal direction of the first tubular portion.
The medical material, wherein the third porous layer is shorter in the longitudinal direction than the first porous layer and the second porous layer. The shape is an hourglass type, a figure eight shape or a double spindle shape.
The medical material according to claim 1, wherein the porous layers provided at the three locations have an umbrella shape that conforms to the shape. When the elastic member is in a contracted state, the first end portion and the second end portion approach each other with the substantially central portion as the center, and correspond to a defect hole closed by the medical material. The cylinder diameter of the other part is expanded to the size of the above,
As the cylinder diameter of the other portion expands, the first porous layer and the second porous layer are expanded to a size corresponding to the defect hole closed by the medical material. The medical material according to claim 1 or 2, characterized in that. When the elastic member is in the stretched state, the first end portion and the second end portion are separated from each other about the substantially central portion to correspond to a catheter in which the medical material is stored. The cylinder diameter of the other part is reduced to the size,
As the cylinder diameter of the other portion is reduced, the first porous layer, the second porous layer, and the third porous layer correspond to the catheter in which the medical material is housed. The medical material according to claim 1 or 2, wherein the medical material is reduced to the size of the above. The medical material according to any one of claims 1 to 4, wherein the elastic member is a coil spring having a diameter smaller than the cylinder diameter at the substantially central portion. A claim, wherein the end portion of the elastic member is a small cylinder portion provided outside the tubular body of the stitch-like structure and is joined to a small cylinder portion screwable with an operation wire. The medical material according to any one of 1 to 4. The medical material according to any one of claims 1 to 4, wherein the wire rod or the porous layer is a bioabsorbable material.

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