JP2006110184A - Suturing material - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a suturing material with which cut-off peripheral nerves are easily connected and a good result of treatment is obtained as a result. <P>SOLUTION: The suturing material consists of a cylinder having a plurality of through holes extended radially. The suturing material preferably consists of: the cylinder having the plurality of through holes extended radially; and a suture with a needle, wherein the suture with the needle passes through at least one of the holes in the cylinder, and a site sutured using the needle can be pulled into the hollow of the cylinder by drawing the suture. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

The present invention relates to a suture material that can easily connect the cut ends of peripheral nerves and can be expected to achieve high therapeutic results.

A nerve is composed of the epithelial membrane and a bundle of a plurality of nerve fibers coated on the epithelial membrane. Furthermore, the nerve fiber bundle is covered with the perineurium which is a connective tissue.
As a method of connecting nerves cut by illness or accident, ideally, it is preferable to join individual nerve fibers, but the nerve fibers (axons) are extremely thin, 10-20μ, which is impractical. Thus, perineuric sutures for suturing nerve fiber bundles were considered. However, even in the case of perineuric suture, the technique is complicated, and there is a risk that the sutured portion may become scarred. Therefore, at present, a method is generally used in which the nerve fiber bundles are pulled together with the epithelial membrane and the supraneuronal membranes are sutured together with a suture thread. When such an operation method is performed, how accurately the nerve fiber bundles covered with the epithelium can be joined to each other is important in the therapeutic effect.

When supraneuronal membranes are sutured with sutures, nerve fiber bundles are attracted too much, causing buckling, or conversely, a large gap is formed due to insufficient pulling, and pulling is appropriate. However, it is difficult to accurately join nerve fibers together due to unevenness (offset) or off-set of nerve fibers, and it is difficult to say that the therapeutic results of peripheral nerve sutures have improved dramatically over the past 50 years. .

Even when a gap is generated between nerve fiber bundles, nerve fibers can be stretched and joined when the gap is 1 mm or less or when there is an appropriate nerve regeneration aid. . Regarding the regeneration of peripheral nerves, since the announcement of the silicone tube model by Lundberg et al. Reported in 1982, attempts have been made to extend the distance between stumps that can be regenerated using a silicone tube. A nerve regeneration tube made of a bioabsorbable polymer has also been proposed. For example, Patent Document 1 discloses a nerve regeneration assisting material composed of a bundle of collagen fibers coated with laminin and fibronectin. Patent Document 2 includes a tube of a biodegradable absorbent material and a collagen body having a cavity penetrating the tube along the tube substantially parallel to the axis of the biodegradable absorbent material. The gap contains collagen, laminin, and the like. An artificial neural tube filled with a matrix gel containing is disclosed.

However, also for nerve regeneration using such a nerve regeneration tube, it is difficult to induce nerve fibers into the tube without excess or deficiency and obtain stable treatment results, and it has not been established as a treatment method.
JP-A-5-237139 WO98 / 22155

The present invention has been made in view of the above-described situation, and an object of the present invention is to provide a suturing material that can easily connect cut peripheral nerves and can achieve high therapeutic results as compared to epithelial suturing.

The present invention is a suture material comprising a cylindrical body having a plurality of holes penetrating in the radial direction.
The present invention is a suturing material comprising a tubular body having a plurality of holes penetrating in the radial direction and a suture with a needle, and the suture with a needle penetrates at least one of the holes of the tubular body. The suture material has a structure in which the sutured portion is pulled into the lumen of the cylindrical body by pulling the suture.
The present invention is described in detail below.

FIG. 1 is a schematic view showing a preferred example of the suturing material of the present invention.
The suturing material of the present invention comprises a cylindrical body.
The cylindrical body has a role of a guide when joining nerves and the like, and at the same time, has a role of covering joint portions of the joined nerves and preventing the joint portion from being separated by an external force or the like.

The cylindrical body has a hole penetrating in the radial direction. By having such a hole, a suture with a needle and a suture which will be described later can be easily passed, and can be used for joining nerves and the like.
The number and position of the holes are not particularly limited. For example, as described later, two holes are provided near the center in the length direction of the cylindrical body in the length direction, and a plurality of holes are provided in the circumferential direction. It is conceivable that two are provided in the vicinity of each end in the length direction of the shape body so as to face each other in the circumferential direction, or two or more are provided in parallel in the length direction. Furthermore, it sets suitably according to the number of sutures with needles and sutures to be used. The suturing material shown in FIG. 1 has a total of 12 holes 2, six in line with the length of the cylindrical body 1 and six in the circumferential direction.
The diameter of the hole is not particularly limited as long as the suture thread with needle or the suture thread can pass therethrough, and is appropriately selected according to the thickness of the suture thread with needle or the suture thread to be used.

The inner diameter of the cylindrical body is not particularly limited, and is preferably slightly larger than the outer diameter of a target nerve or the like. The preferable lower limit of the inner diameter of the cylindrical body is 0.3 mm, and the preferable upper limit is 12 mm. If it is less than 0.3 mm, the lumen may be blocked at the time of suturing, and if it exceeds 12 mm, the nutrient component may not reach the center of the cylindrical body sufficiently. A more preferable lower limit is 0.5 mm, and a more preferable upper limit is 10 mm.
Although it does not specifically limit as thickness of the said cylindrical body, A preferable minimum is 10 micrometers and a preferable upper limit is 500 micrometers. If it is less than 10 μm, sufficient strength may not be maintained, and if it exceeds 500 μm, nutrient components may not be sufficiently transmitted.

Although it does not specifically limit as a structure of the said cylindrical body, For example, it is preferable to consist of at least 1 structure selected from the group which consists of sponge, braid, a knitted fabric, a textile fabric, a nonwoven fabric, a spiral mesh, and a film. Of these, a film is preferred. A composite of sponge and braid, knitted fabric, woven fabric, non-woven fabric or spiral mesh can also be suitably used. Sponge can prevent the invasion of connective tissue and the like from the outside if the pore diameter is appropriately adjusted, and can expect the blood vessel from the surroundings, and is excellent in permeation of nutritional components and waste products. When nerves are connected using the suturing material of the present invention, sufficient nutrition can be supplied to the nerve tissue and waste products can be efficiently removed. Although the sponge body has a problem in terms of strength, the composite body with braid, knitted fabric, woven fabric, non-woven fabric or spiral mesh gives sufficient strength while maintaining excellent permeability of nutrients and the like. be able to.

The cylindrical body is preferably transparent. When the cylindrical body is transparent, the joining state of the nerve stumps can be visually observed when joining the peripheral nerves and the like, and it is easy to adjust to the optimum joining state. Become.

The cylindrical body is preferably made of a bioabsorbable polymer. By being composed of a bioabsorbable polymer, it is hydrolyzed and absorbed in the living body after a certain period of time after the operation, so it is not necessary to take it out again by surgery or the like, and the burden on the patient can be minimized.
The bioabsorbable polymer is not particularly limited, and may be a bioabsorbable synthetic polymer or a bioabsorbable natural polymer.
The bioabsorbable synthetic polymer is not particularly limited, and examples thereof include polylactic acid, polyglycolic acid, poly-ε-caprolactone, lactic acid-glycolic acid copolymer, glycolic acid-ε-caprolactone copolymer, and lactic acid-ε. -Caprolactone copolymer, poly-p-dioxanone, polytrimethylene carbonate, polycitric acid, polymalic acid, poly-α-cyanoacrylate, poly-β-hydroxy acid, polytrimethylene oxalate, polytetramethylene oxalate, poly Examples include orthoester, polyorthocarbonate, polyethylene carbonate, poly-γ-benzyl-L-glutamate, poly-γ-methyl-L-glutamate, poly-L-alanine and the like.
The bioabsorbable natural polymer is not particularly limited, and examples thereof include polysaccharides such as starch, alginic acid, hyaluronic acid, chitin, pectic acid and derivatives thereof, and proteins such as gelatin, collagen, albumin and fibrin. .

By containing a cell adhesion factor on the inner wall, the cylindrical body can promote adhesion and elongation of nerve axons and promote regeneration thereof.
The cell adhesion factor is not particularly limited, and examples thereof include collagen, laminin, fibronectin, and nerve cell specific antibody.
The cell adhesion factor can be adhered to the inner wall of the cylindrical body by a method such as coating.

When the nerves or the like to be joined are separated and the nerve fibers cannot be directly joined, the suture material of the present invention can be used as a nerve regeneration tube. In this case, it is preferable to fill the lumen of the cylindrical body with a material for inducing regeneration of nerve axons to be a scaffold for nerve regeneration. Examples of a material that induces regeneration of nerve axons and serves as a scaffold for nerve regeneration include, for example, a fiber bundle made of a bioabsorbable synthetic polymer, a collagen fiber bundle, a collagen gel, a collagen sponge, collagen, laminin, and the like. And matrix gels containing

A suture material comprising a cylindrical body having a plurality of holes penetrating in the radial direction and a suture with a needle, wherein the suture with a needle penetrates at least one of the holes of the cylindrical body, and the suture A suturing material having a structure in which a portion sutured using a needle by pulling the needle is pulled into the lumen of the cylindrical body is also one aspect of the present invention.

Another aspect of the suturing material of the present invention comprises a cylindrical body having a plurality of holes penetrating in the radial direction and a suture with a needle.
The needle-attached suture is not particularly limited, and conventionally known sutures that are usually used for sutures in surgical operations and the like can be used.
The needle-attached suture may be one in which a needle is attached only to one end of the suture, or may be one in which needles are attached to both ends of the suture.
The diameter of the suture thread and the size of the needle are not particularly limited, and may be appropriately selected according to the target nerve or the like and the size of the cylindrical body.

The suture is preferably made of the above-described bioabsorbable polymer. By being composed of a bioabsorbable polymer, it is hydrolyzed and absorbed in the living body after a certain period of time after the operation, so that the possibility of becoming a source of infection without remaining in the body as a foreign body is reduced.

Only one suture with a needle may be combined with the cylindrical body, or two or more may be combined. When two or more needle-attached sutures are combined in one cylindrical body, it is preferable that the needle-attached sutures have different colors. By using different colors, visual discrimination becomes easy and workability and accuracy are improved.

The needle-attached suture passes through at least one of the holes of the cylindrical body, and pulls a part of the suture to retract the site sutured using the needle to the inside of the cylindrical body. It has a structure.
Examples of the site to be sutured using the needle include stumps of cut peripheral nerves to be joined, end portions of a neuroepithelium including stumps of cut peripheral nerves to be joined, and the like. It is done.

FIG. 2 is a schematic diagram showing a preferred example of the suturing material of the present invention and an example of a method for joining nerves using the suturing material of the present invention. Hereinafter, the suturing material of the present invention will be described with reference to the drawings.
In the suturing material 3 of the present invention shown in FIG. 2 a, two holes 11 are provided in the length direction near the center of the cylindrical body 4, and through these two holes 11, A needle-attached suture thread 5 having needles 6 attached to both ends of the suture thread is attached so that portions where the needles 6 are attached extend outward from the lumen of the tubular body 4. In the suturing material 3 of the present invention shown in FIG. 2a, two needle-attached sutures 5 are attached to the cylindrical body 4 in this manner.

In order to join the peripheral nerves cut using the suture material 3 of the present invention shown in FIG. 2a, first, the needles 6 at both ends of the sutures with needles 5 are used to join them. A suture is tied to the neuroepithelium 7 of the nerve (9). In this state, the nerve is guided to the inside of the cylindrical body 4 by pulling the suture thread that has come out from the hole 11 provided in the vicinity of the center of the cylindrical body 4 in the longitudinal direction (FIG. 2b).
If the suture is knotted (10) when the stumps of the nerve fiber bundle 8 are completely joined in the cylindrical body 4, the nerve can be fixed in a joined state (FIG. 2c).

FIG. 3 is a schematic view showing another preferred example of the suturing material of the present invention. The suturing material 3 ′ of the present invention shown in FIG. 3 can be suitably used as a nerve regeneration tube particularly when the distance of nerves to be joined is long.
In the suturing material 3 ′ of the present invention shown in FIG. 3a, two holes 11 ′ are provided in the vicinity of each end in the length direction of the cylindrical body 4 ′ so as to face each other in the circumferential direction. From the outside of the two holes 11 ', the suture thread 5' with the needle 6 'attached to both ends of the suture thread is outside the portion of the tubular body 4' where the needle 6 'is attached. It is attached to extend. In the suturing material 3 ′ of the present invention shown in FIG. 3 a, two needle-attached sutures 5 ′ are attached to each end of the cylindrical body 4 ′ in this manner.

In order to join the peripheral nerves cut using the suture material 3 ′ of the present invention shown in FIG. 3a, first, the needles at both ends of the sutures with needles 5 ′ are used. A suture is tied to the neuroepithelium 7 'at both nerve stumps (9'). In this state, if the suture thread coming out from the outside of the hole 11 ′ provided near the end in the length direction of the cylindrical body 4 ′ is pulled, the nerve is guided into the cylindrical body 4 ′ ( FIG. 3b).
If the suture is knotted (10 ') when both the stumps of the nerve have completely entered the cylindrical body 4', the nerve is fixed in a state of being opposed to each other at a certain distance in the cylindrical body 4 '. (Fig. 3c).
If the distance between the opposing nerve fibers 8 ′ is within 1 mm, it is possible to induce the regeneration of nerve axons in the lumen of the tubular body 4 ′ in particular, without filling with a material to be used as a scaffold for nerve regeneration, Axons extend from the nerve fiber bundle 8 'to connect the nerves. Further, even when the distance between the opposing nerve fiber bundles 8 'exceeds 1 mm, the nerve axon regeneration is guided into the lumen of the tubular body 4' and filled with a material to be used as a scaffold for nerve regeneration. By doing so, the nerve is connected by axon extension from the nerve fiber bundle 8 '.

By using the suturing material of the present invention, it is possible to simply and surely join together tissues that require precise joining, including nerves.
A nerve suturing material comprising the suturing material of the present invention is also one aspect of the present invention.

According to the present invention, it is possible to provide a suturing material that can easily connect cut peripheral nerves and can achieve high therapeutic results.

Hereinafter, the present invention will be described in more detail with reference to examples. However, the present invention is not limited to these examples.

Example 1
(1) Production of suture material A solution in which L-lactide-ε-caprolactone copolymer (L-lactide component content 50 mol%) was dissolved in dioxane to a concentration of 5 wt% was prepared. A film with a diameter of 2 mm was inserted into the solution, and the film was taken out and dried. By repeating the operation, a film was formed around the sacrifice, and then the rod was pulled out and both ends were cut off. A cylindrical body having a thickness of 2 mm, a thickness of 100 μm, and a length of 10 mm was obtained.

Near the center of the cylindrical body in the length direction of the obtained cylindrical body, two holes with a 1 mm interval are provided side by side in the length direction, and 10-0 poly from the inside of the cylinder through the two holes. Insert a suture thread made of glycolic acid with a needle for operation and put the thread end out of the cylinder from one hole. It was. A similar operation was performed on the opposite one side of the cylindrical body to produce a suturing material having the configuration shown in FIG. 2a.

(2) Evaluation by animal experiment The tibial nerve of a male Wistar rat (body weight: about 250 g) was excised, and the nerve stumps were joined using the prepared suture material. That is, first, using the needles at both ends of the suture with a needle, the suture was tied to the neuroepithelium directly above the same nerve fiber bundle, which is a mark of the nerve stumps to be joined. In this state, the nerve stump was guided with care so as not to twist into the inside of the tubular body by pulling the suture thread coming out from the outside of the hole provided near the center in the longitudinal direction of the tubular body. When the distance between the nerve stumps reached within 1 mm, the suture was knotted to complete the nerve joining. The operation was very simple. When the tibial nerve was necropsied 12 weeks after the operation, the nerve was completely connected.

(Example 2)
(1) Production of suture material A solution in which L-lactide-ε-caprolactone copolymer (L-lactide component content 50 mol%) was dissolved in dioxane to a concentration of 5 wt% was prepared. A film with a diameter of 2 mm was inserted into the solution, and the film was taken out and dried. By repeating the operation, a film was formed around the sacrifice, and then the rod was pulled out and both ends were cut off. A cylindrical body having a thickness of 2 mm, a thickness of 100 μm, and a length of 10 mm was obtained.
Two holes are provided in the vicinity of the end of the cylindrical body in the length direction of the obtained cylindrical body so as to oppose each other in the circumferential direction, and 10-0 polyglycol from the inside of the cylindrical body through the two holes. After inserting the suture thread with acid surgical needle, the thread end was taken out of the cylinder from one hole, the thread end was again inserted into the cylinder from the other hole, and the thread end was taken out from the end of the cylinder . A similar operation was performed on the other end of the cylindrical body.

50 bundles of monofilament yarns made of L-lactide-ε-caprolactone copolymer (L-lactide component content 75 mol%) having a diameter of 80 μm were inserted into the lumen of the obtained cylindrical body as a scaffold material. A suturing material having the structure shown in FIG. 3a was produced.

(2) Evaluation by animal experiment The tibial nerve of a male Wistar rat (body weight: about 250 g) was excised, and the nerve was connected using the produced suture material. That is, first, the suture was tied to the neuroepithelium of both nerve stumps to be joined using the needles at both ends of the suture with needle. In this state, the suture was pulled through a hole provided near the end of the cylindrical body, and the nerve was guided to the inside of the cylindrical body. When the end of the nerve entered a position of 1 mm where the hole in the cylindrical body was pierced, the suture was knotted, and the joining of the nerves was completed. At this time, the distance between nerves was about 8 mm. The operation was very simple. When the tibial nerve was necropsied 12 weeks after the operation, the nerve was completely connected.

According to the present invention, it is possible to provide a suturing material that can easily connect cut peripheral nerves and can achieve high therapeutic results.

It is a schematic diagram which shows a suitable example of the suturing material of this invention. It is a schematic diagram showing a suitable example of the suturing material of the present invention and an example of a method for joining nerves using the suturing material of the present invention. It is a schematic diagram showing a suitable example of the suturing material of the present invention and an example of a method for joining nerves using the suturing material of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Cylindrical body 2 Hole 3, 3 'Suture material 4, 4' Cylindrical body 5, 5 'Needle-attached suture 6, 6' Needle 7, 7 'Neural membrane 8, 8' Nerve fiber bundle 9, 9 '' Nodule (epithelium)
10, 10 'nodule (stitching material)
11, 11 'hole

Claims (6)

A suturing material comprising a cylindrical body having a plurality of holes penetrating in a radial direction. A suture material comprising a cylindrical body having a plurality of holes penetrating in the radial direction and a suture with a needle, wherein the suture with a needle penetrates at least one of the holes of the cylindrical body, A suturing material having a structure in which a sutured portion is pulled into a lumen of the cylindrical body by pulling the suture. The suture material according to claim 2, wherein the needle-attached suture has needles attached to both ends of the suture. The suture material according to claim 1, 2 or 3, wherein the tubular body and / or the suture thread is made of a bioabsorbable polymer. The suture material according to claim 1, 2, 3, or 4, wherein a lumen of the cylindrical body is filled with a material that induces regeneration of nerve axons and serves as a scaffold for nerve regeneration. A nerve suturing material comprising the suturing material according to claim 1, 2, 3, 4 or 5.

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