JP4583881B2 - Joining method - Google Patents

Description

The present invention relates to a joining method .

  An operation for replacing a part of a biological blood vessel with an artificial blood vessel, that is, an artificial blood vessel transplantation operation is performed.

  Some artificial blood vessels used in such operations have a main tube and a branch tube whose end is bonded to the side of the main tube (end-side bonding).

  The joint between the main tube and the branch tube in this artificial blood vessel is done by suturing, but it is virtually impossible to completely close the joint gap by suturing, and blood leaks from this site during the operation. In many cases, the use of hemostatic agents such as fibrin glue is forced.

  In order to close the gap between the joints, a method has been proposed in which a liquid prepolymer is coated and polymerized, or the polymer is dissolved in a solvent and applied (for example, see Patent Document 1), but the operation is complicated. In addition to this, there was concern about toxicity due to unreacted substances or residual solvent.

  Also in Patent Document 1, the joining of the main tube and the branch tube is based on the premise of stitching, and there has been no example in which a joining method other than suturing has been put to practical use.

Japanese Patent No. 2842547

The objective of this invention is providing the joining method which can join the 1st artificial blood vessel and the 2nd artificial blood vessel simply and reliably .

These objects, Ru is achieved by the following aspects of the invention (1) and (2).

( 1 ) A joining method for joining an end portion of a second artificial blood vessel to a side portion of a first artificial blood vessel having a tube wall composed of an inner layer, an outer layer, and an intermediate layer positioned therebetween,
Forming a hole penetrating the tube wall in a side portion of the first artificial blood vessel and forming an intermediate layer exposed portion in which the intermediate layer is exposed by deleting a part of the outer layer around the hole; and Intermediate layer exposed portion forming step;
A joining method comprising: a second artificial blood vessel fusion step of fusing an end portion of the second artificial blood vessel to the intermediate layer exposed portion via a seal member.

( 2 ) The method according to ( 1 ), further including a suturing step of suturing a portion around the hole and a joint portion at an end portion of the second artificial blood vessel after the second artificial blood vessel fusion step. Joining method.

  According to the present invention, the first artificial blood vessel and the first artificial blood vessel can be obtained by interposing a sealing material (seal member) between the peripheral portion of the hole of the first artificial blood vessel and the end portion of the second artificial blood vessel. It is possible to easily and reliably join the two artificial blood vessels, and thus it is possible to reliably prevent blood from leaking from the joint portion between these artificial blood vessels.

  Further, when the tube wall of the first artificial blood vessel is composed of the inner layer, the outer layer, and the intermediate layer located between them, the intermediate layer and the sealing material are made of the same kind of material, The one artificial blood vessel and the second artificial blood vessel can be joined more easily and reliably.

Hereinafter, the joining method of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

<First Embodiment>
Figure 1 is a perspective view showing a first embodiment of the artificial blood vessel assembly, Figure 2 is a detail longitudinal section of the joint between the first artificial blood vessel and the second artificial blood vessels in the artificial blood vessel assembly shown in Figure 1 FIG. 3 and FIG. 3 to FIG. 6 are diagrams for explaining the joining method of the first artificial blood vessel and the second artificial blood vessel in order. In the following, for convenience of explanation, the upper side in FIGS. 1 to 6 is referred to as “upper” and the lower side is referred to as “lower”.

  As shown in FIG. 1, an artificial blood vessel assembly 1 includes a first artificial blood vessel (main tube) 6 and a second artificial blood vessel (branch tube) 2 branched from a side portion 61 of the first artificial blood vessel 6. Have.

  Each of the first artificial blood vessel 6 and the second artificial blood vessel 2 has a cylindrical shape as a whole.

  The tube wall 62 of the first artificial blood vessel 6 and the tube wall 22 of the second artificial blood vessel 2 each have a bellows shape. Thereby, each of the first artificial blood vessel 6 and the second artificial blood vessel 2 can be easily bent (bent). Further, the first artificial blood vessel 6 and the second artificial blood vessel 2 can be easily expanded or contracted in the respective central axis directions (longitudinal directions).

  As shown in FIG. 2, a circular hole 64 penetrating the tube wall 62 is formed in the tube wall 62 (side portion 61) of the first artificial blood vessel 6.

  Note that the size of the hole 64 is preferably, for example, approximately equal to or slightly larger than the average inner diameter of the second artificial blood vessel 2. As a result, blood flow is disturbed and thrombus formation is prevented from occurring at the boundary between the first artificial blood vessel 6 and the second artificial blood vessel 2, and a more ideal blood flow can be secured. it can.

  As shown in FIG. 1, the average inner diameter of the first artificial blood vessel 6 is set larger than the average inner diameter of the second artificial blood vessel 2. In this way, by having different inner diameters (thicknesses), the artificial blood vessel assembly 1 having a size that can be suitably replaced with a predetermined biological blood vessel (for example, an aortic arch and a brachiocephalic artery branched therefrom) is constructed. Can do.

  In addition, the average internal diameter of the 1st artificial blood vessel 6 is not specifically limited, For example, it is preferable that it is 8-40 mm, and it is more preferable that it is 20-30 mm. Moreover, the average internal diameter of the 2nd artificial blood vessel 2 is not specifically limited, For example, it is preferable that it is 6-14 mm, and it is more preferable that it is 8-12 mm.

  Moreover, the length of the 1st artificial blood vessel 6 is not specifically limited, For example, it is preferable that it is 15-100 cm, and it is more preferable that it is 30-60 cm.

  Moreover, the length of the 2nd artificial blood vessel 2 is not specifically limited, For example, it is preferable that it is 5-40 cm, and it is more preferable that it is 15-30 cm.

  In such an artificial blood vessel joined body 1, the lower end portion (end portion) 21 of the second artificial blood vessel is joined to the side portion 61 of the first artificial blood vessel 6, and the central axis 23 of the second artificial blood vessel and The central axis 63 of the first artificial blood vessel 6 is substantially orthogonal (see FIG. 2). Since the configuration of the tube wall 62 of the first artificial blood vessel 6 and the configuration of the tube wall 22 of the second artificial blood vessel are substantially the same, the first artificial blood vessel 6 will be representatively described below.

  As shown in FIG. 2, the tube wall 62 of the first artificial blood vessel 6 is composed of an inner layer 3, an outer layer 5, and an intermediate layer 4 positioned therebetween.

  The constituent material of the inner layer 3 is not particularly limited. For example, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytetrafluoroethylene (PTFE), ester-based or ether-based polyurethane, polyester-polyether block co-polymer A polyester resin such as a polymer or a polyester-polyester block polymer can be used.

  In addition, the thickness of the inner layer 3 is not specifically limited, For example, it can be set as about 50-500 micrometers.

  The constituent material of the intermediate layer 4 is not particularly limited, and for example, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluoro rubber, chlorinated Various thermoplastic elastomers, such as a polyethylene type, are mentioned, and those having at least one of them as a main material can be used.

  Among these, as the constituent material of the intermediate layer 4, a thermoplastic elastomer having no unsaturated bond in the main chain is particularly preferable. Thereby, when the artificial blood vessel conjugate 1 is placed in the living body, it is possible to prevent the intermediate layer 4 from being deteriorated due to oxidation. Examples of such thermoplastic elastomers include styrene-based styrene-ethylene-butylene-styrene block copolymers (SEBS), styrene-ethylene-propylene-styrene block copolymers (SEPS), and styrene-ethylene. -Ethylene-propylene-styrene block copolymer (SEEPS) etc. are mentioned.

  In addition, the thickness of the intermediate | middle layer 4 is not specifically limited, For example, it can be set as about 100-500 micrometers.

  The constituent material of the outer layer 5 is not particularly limited, and for example, the same constituent material as that of the inner layer 3 described above can be used.

  In addition, the thickness of the outer layer 5 is not specifically limited, For example, it can be set as about 50-500 micrometers.

  In the artificial blood vessel assembly 1 having such a configuration, the exposed intermediate layer 4 (intermediate layer exposed portion 41) in the first artificial blood vessel 6 and the lower end portion 21 of the second artificial blood vessel 2 are made of a sealing material (seal Part) 7 and is heat-sealed (see FIG. 2). The intermediate layer exposed portion 41 can be exposed by deleting a part of the outer layer 5 around the hole 64.

  Moreover, as shown in FIG. 2, the lower end part 21 is comprised by the flange part which protrudes toward the outward over the perimeter. Thereby, a joining area with the sealing material 7 is increased, and the second artificial blood vessel 2 is more reliably joined.

  The sealing material 7 is obtained by melting and solidifying a sheet-like sealing member 71 described later between the first artificial blood vessel 6 (intermediate layer 4) and the second artificial blood vessel 2 (lower end portion 21). is there.

  As shown in FIG. 4D, the sealing material 7 has a ring shape (annular shape) in which the shape surrounds the hole 64. That is, the sealing material 7 has substantially the same shape as the opening (lower end 21) of the second artificial blood vessel 2. Thereby, when joining the 1st artificial blood vessel 6 and the 2nd artificial blood vessel 2 (thermal fusion), the position alignment of the 2nd artificial blood vessel 2 with respect to the sealing material 7 can be made easy, Therefore The first artificial blood vessel 6 and the second artificial blood vessel 2 can be reliably joined.

  The constituent material of the sealing material 7 (seal member 71) is preferably the same type of constituent material as that of the intermediate layer 4. Thereby, by heating the sealing material 7 and the intermediate layer 4 (intermediate layer exposed portion 41), the sealing material 7 and the intermediate layer 4 can be easily (simple) and reliably joined (thermal fusion), Therefore, the first artificial blood vessel 6 and the second artificial blood vessel 2 can be joined more easily (simple) and reliably.

  Moreover, the thickness of the sealing material 7 is not specifically limited, For example, it is preferable that it is 50-500 micrometers, and it is more preferable that it is 100-300 micrometers.

  Further, the outer diameter of the sealing material 7 is not particularly limited, and is preferably substantially equal to or slightly larger than the average outer diameter of the second artificial blood vessel 2.

  As shown in FIG. 2, the portion (edge) around the hole 64 of the first artificial blood vessel 6 and the joint portion 211 at the lower end portion 21 of the second artificial blood vessel 2 are sutured by the suture thread 8. It is preferable. Thereby, the 1st artificial blood vessel 6 and the 2nd artificial blood vessel 2 can be joined more reliably.

  In addition, it is preferable that the peripheral part of the hole 64 and the joining part 211 are sewn over the perimeter of them.

  Next, a joining method for joining the lower end portion 21 of the second artificial blood vessel 2 to the side portion 61 of the first artificial blood vessel 6 will be described.

[1] Hole and intermediate layer exposed portion forming step (hole forming step)
First, the joining position at which the second artificial blood vessel 2 is joined (fused) on the side portion 61 of the first artificial blood vessel 6 is determined.

  Next, as shown in FIG. 3A, a hole 64 penetrating the tube wall 62 is formed at the joining position of the side portion 61 of the first artificial blood vessel 6 using, for example, a punch (not shown). To do. As described above, the size of the hole 64 is set to be approximately equal to or slightly larger than the inner diameter of the second artificial blood vessel 2. In addition, when using a punch, it is preferable to insert, for example, a punched floor plate (receiving portion) into the first artificial blood vessel 6.

  Further, as the hole 64 is formed, the outer layer 5 around the hole 64 is removed in a ring shape (deleted). Thereby, the ring-shaped intermediate layer exposed portion 41 can be formed.

[2] Second Artificial Vascular Fusion Process [2-1] Seal Member Fusion Process As shown in FIGS. 3B and 4C, a seal member 71 larger than the size of the intermediate layer exposed portion 41 is provided. The intermediate layer exposed portion 41 is placed so as to cover the hole 64.

  Thereafter, the seal member 71 is heated and fused along the shape of the intermediate layer exposed portion 41 using a heater (not shown), for example, in a ring shape.

  Next, the outer peripheral portion (edge) of the seal member 71 fused to the intermediate layer exposed portion 41 (side portion 61) is removed, and a hole 72 corresponding to the hole 64 is provided in the seal member 71. As a result, a ring-shaped seal member 71 (seal material 7) is formed (see FIG. 4D).

[2-2] Second artificial blood vessel preparation step The length of the second artificial blood vessel 2 to be joined is determined. When the length of the second artificial blood vessel 2 is 20 cm, for example, a longer artificial blood vessel is cut into a length of 20 cm.

  In addition, the cutting | disconnection location in the 2nd artificial blood vessel 2 is not specifically limited, For example, it is preferable that it is the bottom part of the bellows valley in the tube wall 22, or the peak part of a mountain.

  When cutting at the bottom of the valley, as shown in FIG. 5 (e), the lower end 21 of the second artificial blood vessel 2 is turned over (expanded), and the turned-up portion is used as the joint portion 211. Can do.

  When cutting at the top of the mountain, the surface on the back side of the slope of the mountain, that is, the inner peripheral surface in the vicinity of the cut portion can be used as the joining portion 211 as it is.

  In addition, when it cut | disconnects at the bottom part of a trough, it is not limited to turning over the lower end part 21, For example, you may fold the lower end part 21 outside.

[2-3] Second Artificial Vascular Fusion Process As shown in FIGS. 5E and 5F, the seal member 71 is fused to the first artificial blood vessel 6 in [2-1]. Then, the lower end portion 21 of the second artificial blood vessel 2 manufactured in [2-2] is heat-sealed to the intermediate layer exposed portion 41.

[3] Suture Step As shown in FIG. 6, the portion around the hole 64 and the joint portion 211 of the second artificial blood vessel 2 are sutured using the suture thread 8.

  By passing through the above steps, the first artificial blood vessel 6 and the second artificial blood vessel 2 can be easily and reliably joined, so that blood leaks from the joint between these artificial blood vessels. It can be surely prevented. Moreover, the artificial blood vessel joined body 1 of such joining can be obtained.

  The method for removing the outer layer 5 in the ring shape in [1] is not particularly limited. For example, the outer layer 5 is removed using a removal jig (not shown) having a diameter larger than the diameter of the hole 64. Alternatively, the outer layer 5 may be peeled off (peeled off) with a fingertip.

  In [2], after the sealing member 71 is fused to the side portion 61 of the first artificial blood vessel 6, the lower end portion 21 of the second artificial blood vessel 2 is fused to the fused sealing member 71. However, the present invention is not limited to this. For example, after the sealing member 71 is fused to the lower end portion 21 of the second artificial blood vessel 2, the side portion 61 of the first artificial blood vessel 6 is joined to the fused sealing member 71. May be fused.

  In [2-1], a disc-shaped seal member 71 that matches the outer shape of the intermediate layer exposed portion 41 may be fused. In that case, the removal of the outer peripheral portion of the seal member 71 is omitted, and the hole 72 can only be provided in the seal member 71.

  In [2-1], a ring-shaped sealing member 71 that matches the shape of the intermediate layer exposed portion 41 may be fused. In that case, removing the outer peripheral portion of the seal member 71 and providing the hole 72 can be omitted.

Further, after [3], the joint portion between the portion around the hole 64 and the joint portion 211 of the second artificial blood vessel 2 may be heated again.
In the joining method of the present invention, the above [3] can be omitted.

<Second Embodiment>
FIG. 7 is a perspective view showing a second embodiment of the artificial blood vessel assembly .

Hereinafter, the second embodiment of the artificial blood vessel joined body will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is the same as the first embodiment except that the number of second artificial blood vessels (number of formation) is different.

  In the artificial blood vessel joined body 1A shown in FIG. 7, four second artificial blood vessels 2a, 2b, 2c and 2d are provided (joined) on the side portion 61 of the first artificial blood vessel 6.

  The second artificial blood vessels 2a, 2b and 2c are provided at equal intervals along the central axis direction (longitudinal direction) of the first artificial blood vessel 6.

  Further, the second artificial blood vessel 2d differs from the second artificial blood vessel 2a by about 90 degrees around the central axis 63 of the first artificial blood vessel 6 (along the circumferential direction of the first artificial blood vessel 6). (Direction).

  By providing a plurality of (four in the present embodiment) second artificial blood vessels in this way, a predetermined biological blood vessel (for example, the aortic arch and the brachiocephalic artery and the left common carotid artery branched therefrom) Thus, the artificial blood vessel assembly 1 having a shape (configuration) that can be suitably replaced can be formed.

  Note that the second artificial blood vessels 2a, 2b, and 2c are not limited to being provided at equal intervals, and may be provided so that the intervals are different, for example.

  Further, the second artificial blood vessel 2a and the second artificial blood vessel 2d are not limited to being provided in directions different from each other by 90 degrees. For example, 30 degrees, 45 degrees, 60 degrees, 120 degrees, and 150 degrees are provided. Alternatively, they may be provided in directions different by 180 degrees.

  In addition, the second artificial blood vessel is not limited to being provided in plural in the central axis direction and the circumferential direction of the first artificial blood vessel 6, for example, only in the central axis direction of the first artificial blood vessel 6. A plurality of them may be provided, or a plurality of them may be provided only in the circumferential direction of the first artificial blood vessel 6.

  Further, the number of the second artificial blood vessels is not limited to three provided in the central axis direction of the first artificial blood vessel 6, and for example, two or four or more may be provided.

  Further, the number of the second artificial blood vessels is not limited to two provided in the circumferential direction of the first artificial blood vessel 6, and for example, three or more second artificial blood vessels may be provided.

<Third Embodiment>
FIGS. 8 to 10 are diagrams for sequentially explaining the method of joining the first artificial blood vessel and the second artificial blood vessel. Hereinafter, for convenience of explanation, the upper side in FIGS. 8 to 10 is referred to as “upper” and the lower side is referred to as “lower”.

Hereinafter, the third embodiment of the artificial blood vessel assembly will be described with reference to these drawings, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is the same as the first embodiment except that the joining method for joining the lower end portion of the second artificial blood vessel to the side portion of the first artificial blood vessel is different.

[1] Seal member fusion process First, a joining position for joining (fusing) the second artificial blood vessel 2 in the side portion 61 of the first artificial blood vessel 6 is determined.

  Next, as shown in FIGS. 8A and 8B, a seal member 71 is placed at the joining position of the side portion 61 of the first artificial blood vessel 6.

  Thereafter, the seal member 71 is heated and fused in a ring shape using, for example, a heater (not shown).

[2] Hole Formation Step The outer peripheral portion (edge) of the seal member 71 fused to the side portion 61 is removed, and the seal member 71 and the tube wall 62 of the first artificial blood vessel 6 are disposed inside the seal member 71. A hole 64 penetrating (side portion 61) is provided. As a result, a ring-shaped seal member 71 (seal material 7) is formed (see FIG. 9C).

[3] Second Artificial Vascular Fusion Process As shown in FIGS. 9D and 10E, the seal member 71 fused to the first artificial blood vessel 6 in the above [2] is used. The lower end portion 21 of the second artificial blood vessel 2 is heat-sealed to the side portion 61.

[4] Suture Step As shown in FIG. 10 (f), the portion around the hole 64 and the joint portion 211 of the second artificial blood vessel 2 are sutured using the suture thread 8.

  By passing through the above processes, the 1st artificial blood vessel 6 and the 2nd artificial blood vessel 2 can be joined easily and reliably. Moreover, the artificial blood vessel joined body 1 of such joining can be obtained.

  In [1], the outer layer 5 at the joining position of the side portion 61 of the first artificial blood vessel 6 may be removed before the sealing member 71 is placed.

  In [1], a disc-shaped seal member 71 that matches the outer shape of the joint portion 211 (lower end portion 21) of the second artificial blood vessel 2 may be fused. In that case, removing the outer peripheral portion of the seal member 71 can be omitted.

As mentioned above, although the joining method of this invention was demonstrated about each embodiment shown in figure, this invention is not limited to these, Each part which comprises an artificial blood vessel conjugate | zygote is arbitrary which can exhibit the same function. It can be replaced with that of the configuration. Moreover, arbitrary components may be added.

  Further, the first artificial blood vessel and the second artificial blood vessel are not limited to the fact that both the tube walls have a bellows shape. For example, only one tube wall may have a bellows shape.

  Further, the central axis of the second artificial blood vessel is not limited to being substantially orthogonal to the central axis of the first artificial blood vessel. For example, the second artificial blood vessel is inclined with respect to the central axis of the first artificial blood vessel. May be. In this case, the side hole of the first artificial blood vessel may have a circular shape, but is preferably elliptical.

  In addition, the first artificial blood vessel and the second artificial blood vessel are not limited to both the tube walls having a multilayer structure. For example, only one of the tube walls may have a multilayer structure or a single layer structure. Alternatively, both tube walls may have a single layer structure.

  In addition, as the constituent material of the intermediate layer, the materials described above can be used, and among them, in particular, a material whose melting point (thermal deformation temperature) is 10 ° C. or more lower than the melting point or thermal decomposition temperature of the inner layer or the outer layer. It is preferable that the material is lower by 30 ° C. or more. Thereby, when the second artificial blood vessel is fused to the first artificial blood vessel, it is possible to prevent or suppress (reduce) the deterioration of the inner layer and the outer layer due to heating.

  Further, as the constituent material of the intermediate layer, the materials as described above can be used, but an oil component such as a compatible low molecular weight resin, mineral oil or squalane may be added to these materials. . Thereby, the temperature (thermal deformation temperature) at which the intermediate layer is thermally deformed can be lowered.

  Further, when joining the first artificial blood vessel and the second artificial blood vessel, the intermediate layer at the lower end of the second artificial blood vessel is exposed in the same manner as the intermediate layer around the hole of the first artificial blood vessel. May be.

  In addition, the first artificial blood vessel and the second artificial blood vessel are not limited to being joined by heat fusion, and may be joined by, for example, ultrasonic fusion, high frequency fusion, or the like.

  Further, the formation of the hole in the first artificial blood vessel is not limited to using a punch, and for example, scissors, a thermal iron, a laser beam, a razor (cutter), or the like may be used.

It is a perspective view which shows 1st Embodiment of an artificial blood vessel conjugate | zygote . It is a detailed longitudinal cross-sectional view of the junction location of the 1st artificial blood vessel and the 2nd artificial blood vessel in the artificial blood vessel conjugate | zygote shown in FIG. It is a figure for explaining the joining method of the 1st artificial blood vessel and the 2nd artificial blood vessel later on. It is a figure for explaining the joining method of the 1st artificial blood vessel and the 2nd artificial blood vessel later on. It is a figure for explaining the joining method of the 1st artificial blood vessel and the 2nd artificial blood vessel later on. It is a figure for explaining the joining method of the 1st artificial blood vessel and the 2nd artificial blood vessel later on. It is a perspective view which shows 2nd Embodiment of an artificial blood vessel conjugate . It is a figure for explaining the joining method of the 1st artificial blood vessel and the 2nd artificial blood vessel later on. It is a figure for explaining the joining method of the 1st artificial blood vessel and the 2nd artificial blood vessel later on. It is a figure for explaining the joining method of the 1st artificial blood vessel and the 2nd artificial blood vessel later on.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1, 1A Artificial blood vessel conjugate 2, 2a, 2b, 2c, 2d Second artificial blood vessel 21 Lower end portion 211 Joint portion 22 Tube wall 23 Central axis 3 Inner layer 4 Intermediate layer 41 Intermediate layer exposed portion 5 Outer layer 6 First artificial Blood vessel 61 Side portion 62 Tube wall 63 Central axis 64 Hole 7 Seal material 71 Seal member 72 Hole 8 Suture thread

Claims (2)

A joining method for joining an end portion of a second artificial blood vessel to a side portion of a first artificial blood vessel having a tube wall composed of an inner layer, an outer layer, and an intermediate layer positioned therebetween,
Forming a hole penetrating the tube wall in a side portion of the first artificial blood vessel and forming an intermediate layer exposed portion in which the intermediate layer is exposed by deleting a part of the outer layer around the hole; and Intermediate layer exposed portion forming step;
A joining method comprising: a second artificial blood vessel fusion step of fusing an end portion of the second artificial blood vessel to the intermediate layer exposed portion via a seal member. The joining method according to claim 1 , further comprising a suturing step of suturing a portion around the hole and a joint portion at an end of the second artificial blood vessel after the second artificial blood vessel fusion step.

Images