WO2016072017A1 - Bonding material for biological tissue, and bonding method for biological tissue - Google Patents

Bonding material for biological tissue, and bonding method for biological tissue Download PDF

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Publication number
WO2016072017A1
WO2016072017A1 PCT/JP2014/079593 JP2014079593W WO2016072017A1 WO 2016072017 A1 WO2016072017 A1 WO 2016072017A1 JP 2014079593 W JP2014079593 W JP 2014079593W WO 2016072017 A1 WO2016072017 A1 WO 2016072017A1
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biological tissue
porous body
biological
bonding material
living
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PCT/JP2014/079593
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French (fr)
Japanese (ja)
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井上　晃
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オリンパス株式会社
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Priority to PCT/JP2014/079593 priority Critical patent/WO2016072017A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses

Definitions

  • the present invention relates to a biological tissue bonding material and a biological tissue bonding method.
  • an energy treatment tool that joins living tissues using energy such as high frequency, heat, and ultrasonic waves is known (see, for example, Patent Document 1).
  • the energy treatment tool locally heats the living tissue by applying energy to the living tissue, denatures the protein, and simultaneously removes moisture from the living tissue, thereby achieving bonding between the living tissues.
  • a medical stapler that mechanically joins living tissues using staples
  • such an energy treatment device has an advantage that no foreign matter is left in the living body.
  • power is unstable.
  • Patent Document 1 a moisture permeation preventing member is disposed at a joint from which moisture has been removed by supplying energy, and the joint is protected from moisture of surrounding tissues by the moisture permeation prevention member, thereby maintaining the joining force at the joint. I am trying.
  • the present invention has been made in view of the above-described circumstances, and provides a living tissue bonding material and a living tissue bonding method capable of increasing the bonding force between living tissues in bonding of living tissues using energy. With the goal.
  • a first aspect of the present invention includes a porous body made of a biocompatible material, and the porous body opens to a surface hole formed on an outer surface and an inner surface of the surface hole. Is a biological tissue bonding material having pores having small pore diameters.
  • the biological tissue bonding material described above is disposed between two overlapping biological tissues, and the two biological tissues with the biological tissue bonding material disposed therebetween are stacked.
  • a biological tissue joining comprising: a pressurizing step for pressurizing in a direction; and an energy supplying step for joining the two living tissues by supplying energy to the two living tissues in a pressurized state by the pressurizing step Is the method.
  • the bonding force between living tissues can be increased in the bonding of living tissues using energy.
  • FIG. 2 is another scanning electron micrograph of the biological tissue bonding material of FIG.
  • FIG. 2 is another scanning electron micrograph of the biological tissue bonding material of FIG.
  • FIG. 2 shows the energy treatment tool used in the biological tissue joining method using the biological tissue joining material of FIG.
  • FIG. 2 shows the process of arrange
  • the biological tissue bonding material 1 includes a plate-like porous body 2 made of a biocompatible material, as shown in FIG.
  • the porous body 2 is formed from a biopolymer or a synthetic polymer.
  • the biopolymer collagen, gelatin, chitosan, cellulose, polysaccharides or derivatives thereof are preferably used.
  • the synthetic polymer polylactic acid, glycolic acid or polyethylene glycol is preferably used.
  • the porous body 2 may be formed of a bioabsorbable material that is decomposed and absorbed over time in the living body.
  • FIG. 1 shows a porous body 2 made of a collagen sponge as an example.
  • the porous body 2 has a large number of surface holes 3 opening on the outer surface and a smaller diameter than the surface holes 3, and a large number opening on the inner surface of the surface hole 3.
  • Pores 4. 2 and 3 are enlarged views of the surface of the porous body 2 made of collagen sponge.
  • the pore diameters of the surface hole 3 and the pore 4 are dimensions that cause capillary action on the liquid contained in the living tissue.
  • the inner diameter of a thin tube capable of sucking physiological saline by capillary action is 0.01 ⁇ m to several mm. Since the composition of the liquid contained in the living tissue approximates the composition of physiological saline, the pore diameters of the surface hole 3 and the pore 4 may be 0.01 ⁇ m to several mm.
  • the pore diameter of the surface hole 3 is several hundred ⁇ m, and the pore diameter of the pore 4 is preferably 0.01 ⁇ m to several ⁇ m.
  • the suction force of the liquid due to capillary action is inversely proportional to the hole diameter, and the smaller the hole diameter, the greater the suction force.
  • the pore diameter of the pore 4 is 0.01 ⁇ m to several ⁇ m, a strong suction force is exerted on the surface of the living tissue that has entered the surface hole 3, and the surface of the living tissue is made to be the inner surface of the surface hole 3.
  • the living tissue can enter the pores 4.
  • the specific surface area per unit weight of the porous body 2 is 0.1 m 2 / g or more and 500 m 2 / g or less.
  • the biological tissue bonding material 1 is used when bonding a biological tissue using the energy treatment tool 5.
  • the energy treatment device 5 includes an elongated cylindrical sheath 6, an openable and closable upper jaw 7 a and lower jaw 7 b provided at the distal end of the sheath 6, and the upper jaw 7 a and lower jaw. 7b and a flat plate 8 provided so as to be able to project and retract.
  • the living tissue H1 and the living tissue H2 are sandwiched between the upper jaw 7a and the lower jaw 7b, and the upper jaw 7a and the lower jaw 7b are closed so that the outer sides of the living tissues H1 and H2 are closed. Hold it.
  • the plate 8 on which the biological tissue bonding material 1 is placed is projected from between the upper jaw 7a and the lower jaw 7b, and the plate 8 is interposed between the biological tissue H1 and the biological tissue H2. Is inserted, the biological tissue bonding material 1 is disposed between the biological tissue H1 and the biological tissue H2, and the plate 8 is retracted into the sheath 6 (arrangement step).
  • the living tissues H1 and H2 which are overlapped via the living tissue bonding material 1 by holding the living tissues H1 and H2 with a stronger force by the upper jaw 7a and the lower jaw 7b. Are pressed in the stacking direction (pressurizing step).
  • the flexible biological tissues H1 and H2 pressed against the outer surface of the porous body 2 are deformed along the outer surface shape of the porous body 2 and enter the surface hole 3, and further from the surface hole 3. Enter the inside of the hole 4.
  • the state in which the biological tissues H1, H2 are pressurized by the upper jaw 7a and the lower jaw 7b until the entry of the biological tissues H1, H2 into the surface holes 3 and the pores 4 is stabilized for a predetermined time, preferably Is maintained for 0.1 to 30 seconds (maintenance step). Since the time for the living tissues H1 and H2 to enter the surface holes 3 and the pores 4 is ensured by the maintaining step, the anchor effect between the porous body 2 and the living tissues H1 and H2 is further enhanced, The joining force between the tissues H1 and H2 can be further increased.
  • vibration may be applied to the biological tissues H1, H2 in a pressurized state to promote the penetration of the biological tissues H1, H2 into the surface hole 3.
  • the vibration may be given by shaking the hand holding the sheath 6 or may be given by ultrasonically vibrating the jaws 7a and 7b. Since the penetration of the living tissues H1 and H2 into the surface holes 3 and the pores 4 is promoted by the vibration of the living tissues H1 and H2, the anchor effect between the porous body 2 and the living tissues H1 and H2 is further increased. This can increase the bonding force between the living tissues H1 and H2.
  • the jaws 7a, 7b supply the biological tissues H1, H2.
  • Supply of energy for example, high frequency, heat, or ultrasonic waves
  • the living tissues H1 and H2 when the temperature rises due to the supply of energy, the extracellular matrix contained in the living tissues H1 and H2 dissolves and exudes from the surface of the living tissues H1 and H2, and further energy is supplied.
  • the living tissues H1 and H2 are solidified by protein denaturation and moisture evaporation.
  • the biological tissues H1 and H2 are fixed to the porous body 2 using the extracellular matrix as an adhesive while maintaining the shape of the surface holes 3 and pores 4, and the biological tissues H1 and H2 are bonded to each other. Bonding is performed via the porous body 2.
  • the porous body 2 is in a state in which the concavo-convex shape of the surfaces of the biological tissues H1 and H2 meshes with the concavo-convex structure of the porous body 2 formed by the surface holes 3 and the pores 4. 2 and the living tissues H1 and H2 are fixed.
  • the anchor effect which is a mechanical coupling
  • the living tissues H1 and H2 can be strongly bonded to each other through the porous body 2, and a high bonding force sufficient for practical use can be exhibited even in the bonding of thick living tissues such as the large intestine and the small intestine. There is an advantage that can be.
  • the porous body 2 is formed from a biopolymer or a synthetic polymer.
  • the porous body 2 is formed from a biocompatible ceramic. May be.
  • FIG. 8 shows the surface of a porous body 2 made of apatite as an example of the porous body 2 made of ceramic.
  • FIG. 9 is an enlarged view of the inner surface of the surface hole 3 of FIG. Even when the porous body 2 made of ceramic is used, the same high bonding force as that of the porous body 2 made of biopolymer or synthetic polymer can be obtained by the anchor effect by the surface holes 3 and the pores 4. .
  • the biological tissue joining material 1 provided only with the porous body 2 was demonstrated, in addition to the porous body 2, the biological tissue joining material 1 is biocompatible which hardens
  • An adhesive for example, a liquid containing an extracellular matrix such as collagen or elastin may be included.
  • the surface hole 3 may be formed penetrating in the thickness direction of the plate-like porous body 2.
  • the pores 4 are formed in a direction crossing the longitudinal direction of the surface holes 3 as shown in FIG.
  • the biological tissue H1 that has entered the surface hole 3 from one side of the porous body 2 and the biological tissue H2 that has entered the surface hole 3 from the other side are formed inside the porous body 2.
  • the porous body 2 is disposed closer to the thickness direction.
  • the porous body 2 is formed of a biopolymer or a synthetic polymer, the porous body 2 is dissolved or softened by supplying energy and is compressed and deformed according to the pressure from the jaws 7a and 7b.
  • the distance between the living tissue H1 and the living tissue H2 is further reduced.
  • the living tissue H1 and the living tissue H2 are partially bonded directly via an extracellular matrix or an adhesive, and the bonding force between the living tissues H1 and H2 Can be further enhanced.
  • the porous body 2 is plate-shaped, but instead, it may be granular as shown in FIG.
  • FIG. 11 shows a porous bead made of apatite as an example of the granular porous body 2.
  • the same high bonding force as that of the plate-like porous body 2 can be obtained due to the anchor effect by the surface holes and pores.
  • the biological tissue bonding material including the granular porous body 2 is used, for example, in the energy treatment device 5 in which a plurality of discharge ports 9 are formed on both upper and lower surfaces of the plate 8 as shown in FIG.
  • the plurality of discharge ports 9 are connected to a bonding material supply unit (not shown) such as a syringe through passages (not shown) formed inside the plate 8 and the sheath 6.
  • the biological tissue bonding material is supplied into the passage from the bonding material supply unit, and is disposed between the biological tissues H1 and H2 by being discharged from the discharge port 9 of the plate 8 inserted between the biological tissues.
  • the granular porous body 2 may be dispersed in the adhesive described above. By doing in this way, high fluidity

Abstract

A bonding material for a biological tissue (1) is provided with a porous body (2) comprising a biocompatible material. The porous body (2) has surface holes (3) that are formed in the outer surface thereof, and pores (4) that open on the inner surface of the surface holes (3) and that have a smaller hole diameter than the surface holes (3).

Description

生体組織接合材および生体組織接合方法Biological tissue bonding material and biological tissue bonding method
　本発明は、生体組織接合材および生体組織接合方法に関するものである。 The present invention relates to a biological tissue bonding material and a biological tissue bonding method.
　従来、高周波、熱、超音波等のエネルギを用いて生体組織同士を接合するエネルギ処置具が知られている（例えば、特許文献１参照。）。エネルギ処置具は、生体組織にエネルギを与えることによって生体組織を局所的に加熱し、タンパク質を変性させるのと同時に生体組織から水分を除去することによって、生体組織同士の接合を達成している。このようなエネルギ処置具は、ステープルを用いて機械的に生体組織を接合する医療用ステープラと比べて、生体内に異物を残すことが無いというメリットがある一方、生体組織同士の接合部における接合力が不安定であるデメリットがある。特許文献１では、エネルギの供給によって水分を除去した接合部に水分浸透防止部材を配置し、該水分浸透防止部材によって接合部を周辺組織の水分から保護することによって、接合部における接合力の維持を図っている。 2. Description of the Related Art Conventionally, an energy treatment tool that joins living tissues using energy such as high frequency, heat, and ultrasonic waves is known (see, for example, Patent Document 1). The energy treatment tool locally heats the living tissue by applying energy to the living tissue, denatures the protein, and simultaneously removes moisture from the living tissue, thereby achieving bonding between the living tissues. Compared to a medical stapler that mechanically joins living tissues using staples, such an energy treatment device has an advantage that no foreign matter is left in the living body. There is a disadvantage that power is unstable. In Patent Document 1, a moisture permeation preventing member is disposed at a joint from which moisture has been removed by supplying energy, and the joint is protected from moisture of surrounding tissues by the moisture permeation prevention member, thereby maintaining the joining force at the joint. I am trying.
特許第５１２３４３５号公報Japanese Patent No. 5123435
　しかしながら、特許文献１のエネルギ処置具では、大腸のように厚い生体組織を接合するには、接合力が足りない可能性があり、接合力のさらなる増強が望まれている。
　本発明は、上述した事情に鑑みてなされたものであって、エネルギを用いた生体組織の接合において生体組織間の接合力を高めることができる生体組織接合材および生体組織接合方法を提供することを目的とする。 However, in the energy treatment device of Patent Document 1, there is a possibility that the joining force is insufficient to join a thick biological tissue like the large intestine, and further enhancement of the joining force is desired.
The present invention has been made in view of the above-described circumstances, and provides a living tissue bonding material and a living tissue bonding method capable of increasing the bonding force between living tissues in bonding of living tissues using energy. With the goal.
　本発明の第１の態様は、生体適合性材料からなる多孔質体を備え、該多孔質体が、外表面に形成された表面孔と、該表面孔の内面に開口し、該表面孔よりも小さな孔径を有する細孔とを有する生体組織接合材である。 A first aspect of the present invention includes a porous body made of a biocompatible material, and the porous body opens to a surface hole formed on an outer surface and an inner surface of the surface hole. Is a biological tissue bonding material having pores having small pore diameters.
　本発明の第２の態様は、上記に記載の生体組織接合材を、重なり合う２つの生体組織間に配置する配置ステップと、前記生体組織接合材が間に配置された前記２つの生体組織を積層方向に加圧する加圧ステップと、該加圧ステップによって加圧状態にある前記２つの生体組織に対してエネルギを供給して前記２つの生体組織を互いに接合するエネルギ供給ステップとを含む生体組織接合方法である。 According to a second aspect of the present invention, the biological tissue bonding material described above is disposed between two overlapping biological tissues, and the two biological tissues with the biological tissue bonding material disposed therebetween are stacked. A biological tissue joining comprising: a pressurizing step for pressurizing in a direction; and an energy supplying step for joining the two living tissues by supplying energy to the two living tissues in a pressurized state by the pressurizing step Is the method.
　本発明によれば、エネルギを用いた生体組織の接合において生体組織間の接合力を高めることができるという効果を奏する。 According to the present invention, there is an effect that the bonding force between living tissues can be increased in the bonding of living tissues using energy.
本発明の一実施形態に係る生体組織接合材を示す走査型電子顕微鏡写真である。It is a scanning electron micrograph which shows the biological tissue bonding | jointing material which concerns on one Embodiment of this invention. 図１の生体組織接合材を拡大観察した走査型電子顕微鏡写真である。It is the scanning electron micrograph which expandedly observed the biological tissue bonding | jointing material of FIG. 図１の生体組織接合材を拡大観察したもう１つの走査型電子顕微鏡写真である。FIG. 2 is another scanning electron micrograph of the biological tissue bonding material of FIG. 図１の生体組織接合材を用いた生体組織接合方法において使用されるエネルギ処置具を示す図である。It is a figure which shows the energy treatment tool used in the biological tissue joining method using the biological tissue joining material of FIG. 図４のエネルギ処置具を用いて生体組織間に生体組織接合材を配置する工程を説明する図である。It is a figure explaining the process of arrange | positioning a biological tissue bonding material between biological tissues using the energy treatment tool of FIG. 図４のエネルギ処置具を用いて生体組織を加圧する工程を説明する図である。It is a figure explaining the process of pressurizing a biological tissue using the energy treatment tool of FIG. 図６の加圧状態にある生体組織および生体組織接合材の積層方向の拡大断面図である。It is an expanded sectional view of the lamination direction of the biological tissue in the pressurized state of FIG. 6, and a biological tissue bonding material. 本発明の一実施形態の変形例に係る生体組織接合材を示す走査型電子顕微鏡写真である。It is a scanning electron micrograph which shows the biological tissue bonding material which concerns on the modification of one Embodiment of this invention. 図８の生体組織接合材を拡大観察した走査型電子顕微鏡写真である。It is the scanning electron micrograph which expanded and observed the biological tissue bonding | jointing material of FIG. 本発明の一実施形態のもう１つの変形例に係る生体組織接合材を示す走査型電子顕微鏡写真である。It is a scanning electron micrograph which shows the biological tissue bonding material which concerns on another modification of one Embodiment of this invention. 本発明の一実施形態のもう１つの変形例に係る生体組織接合材を示す走査型電子顕微鏡写真である。It is a scanning electron micrograph which shows the biological tissue bonding material which concerns on another modification of one Embodiment of this invention. 図１１の生体組織接合材を用いた生体組織接合方法において使用されるエネルギ処置具のプレートを示す斜視図である。It is a perspective view which shows the plate of the energy treatment tool used in the biological tissue joining method using the biological tissue joining material of FIG.
　以下に、本発明の一実施形態に係る生体組織接合材１について図面を参照して説明する。
　本実施形態に係る生体組織接合材１は、図１に示されるように、生体適合性材料からなる板状の多孔質体２を備えている。
　多孔質体２は、生体高分子または合成高分子から形成される。生体高分子としては、コラーゲン、ゼラチン、キトサン、セルロース、多糖類またはこれらの誘導体が好適に用いられる。合成高分子としては、ポリ乳酸、グリコール酸またはポリエチレングリコールが好適に用いられる。多孔質体２は、生体内において継時的に分解および吸収される生体吸収性材料から形成されていてもよい。図１には、コラーゲンスポンジからなる多孔質体２が一例として示されている。 Below, the biological tissue bonding | jointing material 1 which concerns on one Embodiment of this invention is demonstrated with reference to drawings.
The biological tissue bonding material 1 according to the present embodiment includes a plate-like porous body 2 made of a biocompatible material, as shown in FIG.
The porous body 2 is formed from a biopolymer or a synthetic polymer. As the biopolymer, collagen, gelatin, chitosan, cellulose, polysaccharides or derivatives thereof are preferably used. As the synthetic polymer, polylactic acid, glycolic acid or polyethylene glycol is preferably used. The porous body 2 may be formed of a bioabsorbable material that is decomposed and absorbed over time in the living body. FIG. 1 shows a porous body 2 made of a collagen sponge as an example.
　多孔質体２は、図２および図３に示されるように、外表面に開口する多数の表面孔３と、該表面孔３よりも小さい孔径を有し、表面孔３の内面に開口する多数の細孔４とを有している。図２および図３は、コラーゲンスポンジからなる多孔質体２の表面を拡大したものである。表面孔３および細孔４の孔径は、生体組織に含まれる液体に対して毛細管現象を発生する寸法である。具体的には、生理食塩水を毛細管現象によって吸い上げることができる細い管の内径は、０．０１μｍ～数ｍｍである。生体組織に含まれる液体の組成は、生理食塩水の組成と近似しているので、表面孔３および細孔４の孔径は、０．０１μｍ～数ｍｍであればよい。 As shown in FIGS. 2 and 3, the porous body 2 has a large number of surface holes 3 opening on the outer surface and a smaller diameter than the surface holes 3, and a large number opening on the inner surface of the surface hole 3. Pores 4. 2 and 3 are enlarged views of the surface of the porous body 2 made of collagen sponge. The pore diameters of the surface hole 3 and the pore 4 are dimensions that cause capillary action on the liquid contained in the living tissue. Specifically, the inner diameter of a thin tube capable of sucking physiological saline by capillary action is 0.01 μm to several mm. Since the composition of the liquid contained in the living tissue approximates the composition of physiological saline, the pore diameters of the surface hole 3 and the pore 4 may be 0.01 μm to several mm.
　さらに、表面孔３の孔径は数１００μｍであり、細孔４の孔径は、０．０１μｍ～数μｍであることが好ましい。毛細管現象による液体の吸引力は孔径に反比例し、孔径が小さい程、大きな吸引力が得られる。表面孔３の孔径を数１００μｍとすることによって、毛細管現象による吸引力を生体組織に対して発揮しつつ、柔軟な生体組織を表面孔３の内面に沿って変形させて生体組織を表面孔３内に容易に入り込ませることができる。また、細孔４の孔径を０．０１μｍ～数μｍとすることによって、表面孔３内に入り込んだ生体組織の表面に対して強い吸引力を発揮し、生体組織の表面を表面孔３の内面に強固に固定することができるとともに、細孔４内にも生体組織を入り込ませることができる。 Furthermore, the pore diameter of the surface hole 3 is several hundred μm, and the pore diameter of the pore 4 is preferably 0.01 μm to several μm. The suction force of the liquid due to capillary action is inversely proportional to the hole diameter, and the smaller the hole diameter, the greater the suction force. By setting the diameter of the surface hole 3 to several 100 μm, the living tissue is deformed along the inner surface of the surface hole 3 while exerting a suction force by capillary action on the living tissue, so that the living tissue is transformed into the surface hole 3. It can easily get inside. Further, by setting the pore diameter of the pore 4 to 0.01 μm to several μm, a strong suction force is exerted on the surface of the living tissue that has entered the surface hole 3, and the surface of the living tissue is made to be the inner surface of the surface hole 3. In addition, the living tissue can enter the pores 4.
　多孔質体２の単位重量当たりの比表面積は、０．１ｍ２／ｇ以上５００ｍ２／ｇ以下である。比表面積を上記範囲とすることで、表面孔３および細孔４による高いアンカー効果（後述）を得ることができ、生体組織間の接合力を効果的に向上することができる。 The specific surface area per unit weight of the porous body 2 is 0.1 m 2 / g or more and 500 m 2 / g or less. By setting the specific surface area within the above range, a high anchor effect (described later) by the surface holes 3 and the pores 4 can be obtained, and the bonding force between living tissues can be effectively improved.
　次に、このように構成された生体組織接合材１の作用について説明する。
　本実施形態に係る生体組織接合材１は、エネルギ処置具５を用いて生体組織を接合する際に使用される。エネルギ処置具５は、図４に示されるように、細長い筒状のシース６と、該シース６の先端に設けられた開閉可能な上ジョー７ａおよび下ジョー７ｂと、該上ジョー７ａと下ジョー７ｂとの間において突没可能に設けられた平板状のプレート８とを備える。 Next, the effect | action of the biological tissue bonding | jointing material 1 comprised in this way is demonstrated.
The biological tissue bonding material 1 according to the present embodiment is used when bonding a biological tissue using the energy treatment tool 5. As shown in FIG. 4, the energy treatment device 5 includes an elongated cylindrical sheath 6, an openable and closable upper jaw 7 a and lower jaw 7 b provided at the distal end of the sheath 6, and the upper jaw 7 a and lower jaw. 7b and a flat plate 8 provided so as to be able to project and retract.
　まず、上ジョー７ａと下ジョー７ｂとの間に、生体組織Ｈ１と生体組織Ｈ２とを重ね合わせた状態で挟み、上ジョー７ａと下ジョー７ｂとを閉じることによって生体組織Ｈ１，Ｈ２の外側を把持する。次に、図５に示されるように、生体組織接合材１を載置したプレート８を上ジョー７ａと下ジョー７ｂとの間から突出させ、生体組織Ｈ１と生体組織Ｈ２との間にプレート８を挿入し、生体組織接合材１を生体組織Ｈ１と生体組織Ｈ２との間に配置してプレート８をシース６内に引っ込める（配置ステップ）。 First, the living tissue H1 and the living tissue H2 are sandwiched between the upper jaw 7a and the lower jaw 7b, and the upper jaw 7a and the lower jaw 7b are closed so that the outer sides of the living tissues H1 and H2 are closed. Hold it. Next, as shown in FIG. 5, the plate 8 on which the biological tissue bonding material 1 is placed is projected from between the upper jaw 7a and the lower jaw 7b, and the plate 8 is interposed between the biological tissue H1 and the biological tissue H2. Is inserted, the biological tissue bonding material 1 is disposed between the biological tissue H1 and the biological tissue H2, and the plate 8 is retracted into the sheath 6 (arrangement step).
　次に、図６に示されるように、上ジョー７ａおよび下ジョー７ｂによってさらに強い力で生体組織Ｈ１，Ｈ２を把持することによって、生体組織接合材１を介して重なり合っている生体組織Ｈ１，Ｈ２を積層方向に加圧する（加圧ステップ）。これにより、多孔質体２の外表面に押し付けられた柔軟な生体組織Ｈ１，Ｈ２が、多孔質体２の外表面形状に沿って変形して表面孔３内に入り込み、さらに表面孔３から細孔４の内部へ入り込む。 Next, as shown in FIG. 6, the living tissues H1 and H2 which are overlapped via the living tissue bonding material 1 by holding the living tissues H1 and H2 with a stronger force by the upper jaw 7a and the lower jaw 7b. Are pressed in the stacking direction (pressurizing step). As a result, the flexible biological tissues H1 and H2 pressed against the outer surface of the porous body 2 are deformed along the outer surface shape of the porous body 2 and enter the surface hole 3, and further from the surface hole 3. Enter the inside of the hole 4.
　このときに、図７に示されるように、多孔質体２の外表面と接触する生体組織Ｈ１，Ｈ２には、生体組織Ｈ１，Ｈ２に含まれる液体が毛細管現象によって表面孔３内に吸引されるのに伴って、表面孔３内への吸引力Ｆが作用する。さらに、表面孔３の内面に接触する生体組織Ｈ１，Ｈ２には、生体組織Ｈ１，Ｈ２に含まれる液体が毛細管現象によって細孔４内に吸引されるのに伴って、細孔４内への吸引力Ｆが作用する。これら吸引力Ｆによって、生体組織Ｈ１，Ｈ２は、表面孔３および細孔４の内部に確実に入り込み、かつ、表面孔３の内面に対して強固に固定される。これにより、多孔質体２と生体組織Ｈ１，Ｈ２との間において高いアンカー効果が得られ、生体組織Ｈ１、Ｈ２間の高い接合力が得られる。 At this time, as shown in FIG. 7, in the living tissues H1 and H2 that are in contact with the outer surface of the porous body 2, the liquid contained in the living tissues H1 and H2 is sucked into the surface holes 3 by capillary action. Accordingly, a suction force F into the surface hole 3 acts. Furthermore, in the living tissues H1 and H2 that are in contact with the inner surface of the surface hole 3, the liquid contained in the living tissues H1 and H2 is sucked into the pores 4 by capillary action, and is introduced into the pores 4. A suction force F acts. By these suction forces F, the living tissues H1 and H2 surely enter the surface holes 3 and the pores 4 and are firmly fixed to the inner surfaces of the surface holes 3. Thereby, a high anchor effect is obtained between the porous body 2 and the living tissues H1 and H2, and a high bonding force between the living tissues H1 and H2 is obtained.
　次に、生体組織Ｈ１，Ｈ２の表面孔３および細孔４の内部への入り込みが安定するまで、上ジョー７ａおよび下ジョー７ｂによって生体組織Ｈ１，Ｈ２を加圧した状態を、所定時間、好ましくは０．１秒～３０秒間、維持する（維持ステップ）。維持ステップにより、表面孔３および細孔４の内部に生体組織Ｈ１，Ｈ２が入り込む時間が確保されるので、多孔質体２と生体組織Ｈ１，Ｈ２との間のアンカー効果をより高めて、生体組織Ｈ１，Ｈ２間の接合力をさらに高めることができる。 Next, the state in which the biological tissues H1, H2 are pressurized by the upper jaw 7a and the lower jaw 7b until the entry of the biological tissues H1, H2 into the surface holes 3 and the pores 4 is stabilized for a predetermined time, preferably Is maintained for 0.1 to 30 seconds (maintenance step). Since the time for the living tissues H1 and H2 to enter the surface holes 3 and the pores 4 is ensured by the maintaining step, the anchor effect between the porous body 2 and the living tissues H1 and H2 is further enhanced, The joining force between the tissues H1 and H2 can be further increased.
　維持ステップにおいては、加圧状態の生体組織Ｈ１，Ｈ２に対して振動を与えて、生体組織Ｈ１，Ｈ２の表面孔３内への入り込みを促進してもよい。振動は、シース６を把持している手を震わすことによって与えてもよく、ジョー７ａ，７ｂを超音波振動させることによって与えてもよい。生体組織Ｈ１，Ｈ２の振動によって生体組織Ｈ１，Ｈ２の表面孔３および細孔４の内部への入り込みが促進されるので、多孔質体２と生体組織Ｈ１，Ｈ２との間のアンカー効果をさらに高めて、生体組織Ｈ１，Ｈ２間の接合力をさらに高めることができる。 In the maintenance step, vibration may be applied to the biological tissues H1, H2 in a pressurized state to promote the penetration of the biological tissues H1, H2 into the surface hole 3. The vibration may be given by shaking the hand holding the sheath 6 or may be given by ultrasonically vibrating the jaws 7a and 7b. Since the penetration of the living tissues H1 and H2 into the surface holes 3 and the pores 4 is promoted by the vibration of the living tissues H1 and H2, the anchor effect between the porous body 2 and the living tissues H1 and H2 is further increased. This can increase the bonding force between the living tissues H1 and H2.
　次に、生体組織Ｈ１，Ｈ２の加圧状態を維持したまま、図示しない電源から上ジョー７ａおよび下ジョー７ｂへエネルギ源の供給を開始することによって、ジョー７ａ，７ｂから生体組織Ｈ１，Ｈ２へエネルギ（例えば、高周波、熱、または、超音波）の供給を開始する（エネルギ供給ステップ）。生体組織Ｈ１，Ｈ２においては、エネルギの供給によって温度が上昇することによって、生体組織Ｈ１，Ｈ２に含まれていた細胞外基質が溶解して生体組織Ｈ１，Ｈ２の表面から滲出し、さらにエネルギを供給し続けると、タンパク質の変性および水分の蒸発によって生体組織Ｈ１，Ｈ２が固化する。これにより、生体組織Ｈ１，Ｈ２が、表面孔３および細孔４の内部に入り込んだ形状のまま、細胞外基質を接着剤として多孔質体２に固定され、生体組織Ｈ１と生体組織Ｈ２とが多孔質体２を介して接合される。 Next, by starting supply of an energy source from a power source (not shown) to the upper jaw 7a and the lower jaw 7b while maintaining the pressurized state of the biological tissues H1, H2, the jaws 7a, 7b supply the biological tissues H1, H2. Supply of energy (for example, high frequency, heat, or ultrasonic waves) is started (energy supply step). In the living tissues H1 and H2, when the temperature rises due to the supply of energy, the extracellular matrix contained in the living tissues H1 and H2 dissolves and exudes from the surface of the living tissues H1 and H2, and further energy is supplied. When the supply is continued, the living tissues H1 and H2 are solidified by protein denaturation and moisture evaporation. As a result, the biological tissues H1 and H2 are fixed to the porous body 2 using the extracellular matrix as an adhesive while maintaining the shape of the surface holes 3 and pores 4, and the biological tissues H1 and H2 are bonded to each other. Bonding is performed via the porous body 2.
　このように、本実施形態によれば、表面孔３および細孔４によって形成された多孔質体２の凹凸構造内に生体組織Ｈ１，Ｈ２の表面の凹凸形状が噛み合った状態で、多孔質体２と生体組織Ｈ１，Ｈ２とが固定される。これにより、生体組織Ｈ１，Ｈ２と多孔質体２との間には、細胞外基質による接着力に加えて、機械的な結合であるアンカー効果が生じる。このアンカー効果によって、生体組織Ｈ１，Ｈ２同士を多孔質体２を介して強固に接合することができ、大腸や小腸のような厚い生体組織の接合においても実用に足る高い接合力を発揮することができるという利点がある。 As described above, according to the present embodiment, the porous body 2 is in a state in which the concavo-convex shape of the surfaces of the biological tissues H1 and H2 meshes with the concavo-convex structure of the porous body 2 formed by the surface holes 3 and the pores 4. 2 and the living tissues H1 and H2 are fixed. Thereby, in addition to the adhesive force by an extracellular matrix, the anchor effect which is a mechanical coupling | bonding arises between the biological tissue H1, H2 and the porous body 2. Due to this anchor effect, the living tissues H1 and H2 can be strongly bonded to each other through the porous body 2, and a high bonding force sufficient for practical use can be exhibited even in the bonding of thick living tissues such as the large intestine and the small intestine. There is an advantage that can be.
　なお、本実施形態においては、多孔質体２が、生体高分子または合成高分子から形成されていることとしたが、これに代えて、多孔質体２が、生体適合性を有するセラミックから形成されていてもよい。図８は、セラミックからなる多孔質体２の一例として、アパタイトからなる多孔質体２の表面を示している。図９は、図８の表面孔３の内面を拡大観察したものである。セラミックからなる多孔質体２を使用した場合にも、表面孔３および細孔４によるアンカー効果によって、生体高分子または合成高分子からなる多孔質体２と同様の高い接合力を得ることができる。 In the present embodiment, the porous body 2 is formed from a biopolymer or a synthetic polymer. Instead, the porous body 2 is formed from a biocompatible ceramic. May be. FIG. 8 shows the surface of a porous body 2 made of apatite as an example of the porous body 2 made of ceramic. FIG. 9 is an enlarged view of the inner surface of the surface hole 3 of FIG. Even when the porous body 2 made of ceramic is used, the same high bonding force as that of the porous body 2 made of biopolymer or synthetic polymer can be obtained by the anchor effect by the surface holes 3 and the pores 4. .
　また、本実施形態においては、多孔質体２のみを備える生体組織接合材１について説明したが、生体組織接合材１は、多孔質体２に加えて、エネルギの供給によって硬化する生体適合性の接着剤、例えば、コラーゲンやエラスチン等の細胞外基質を含む液体を含んでいてもよい。このようにすることで、接着剤による生体組織Ｈ１，Ｈ２と多孔質体２との接着力によって、生体組織間の接合力をさらに高めることができる。 Moreover, in this embodiment, although the biological tissue joining material 1 provided only with the porous body 2 was demonstrated, in addition to the porous body 2, the biological tissue joining material 1 is biocompatible which hardens | cures by supply of energy. An adhesive, for example, a liquid containing an extracellular matrix such as collagen or elastin may be included. By doing in this way, the joining force between living tissue can further be raised by the adhesive force of living tissue H1, H2 and the porous body 2 by an adhesive agent.
　また、本実施形態においては、表面孔３が、板状の多孔質体２の厚さ方向に貫通形成されていてもよい。この場合、細孔４は、図１０に示されるように、表面孔３の長手方向に交差する方向に形成される。
　このようにすることで、多孔質体２の一側から表面孔３内に入り込んだ生体組織Ｈ１と、他側から表面孔３内に入り込んだ生体組織Ｈ２とが、多孔質体２の内部で該多孔質体２の厚さ方向により近接して配置される。特に、多孔質体２が生体高分子または合成高分子から形成されている場合には、エネルギの供給によって多孔質体２が溶解または軟化し、ジョー７ａ，７ｂからの圧力に従って圧縮変形することによって、生体組織Ｈ１と生体組織Ｈ２との距離がさらに近くなる。これにより、多孔質体２の内部においては、生体組織Ｈ１と生体組織Ｈ２とが部分的に細胞外基質または接着剤を介して直接接着されるようになり、生体組織Ｈ１，Ｈ２間の接合力をさらに高めることができる。 Further, in the present embodiment, the surface hole 3 may be formed penetrating in the thickness direction of the plate-like porous body 2. In this case, the pores 4 are formed in a direction crossing the longitudinal direction of the surface holes 3 as shown in FIG.
By doing so, the biological tissue H1 that has entered the surface hole 3 from one side of the porous body 2 and the biological tissue H2 that has entered the surface hole 3 from the other side are formed inside the porous body 2. The porous body 2 is disposed closer to the thickness direction. In particular, when the porous body 2 is formed of a biopolymer or a synthetic polymer, the porous body 2 is dissolved or softened by supplying energy and is compressed and deformed according to the pressure from the jaws 7a and 7b. The distance between the living tissue H1 and the living tissue H2 is further reduced. Thereby, in the inside of the porous body 2, the living tissue H1 and the living tissue H2 are partially bonded directly via an extracellular matrix or an adhesive, and the bonding force between the living tissues H1 and H2 Can be further enhanced.
　また、本実施形態においては、多孔質体２が板状であることとしたが、これに代えて、図１１に示されるように、顆粒状であってもよい。図１１には、顆粒状の多孔質体２の一例として、アパタイトからなる多孔質ビーズが示されている。このように、顆粒状の多孔質体２を使用した場合にも、表面孔および細孔によるアンカー効果によって、板状の多孔質体２と同様の高い接合力を得ることができる。 Further, in the present embodiment, the porous body 2 is plate-shaped, but instead, it may be granular as shown in FIG. FIG. 11 shows a porous bead made of apatite as an example of the granular porous body 2. As described above, even when the granular porous body 2 is used, the same high bonding force as that of the plate-like porous body 2 can be obtained due to the anchor effect by the surface holes and pores.
　顆粒状の多孔質体２を備える生体組織接合材は、例えば、図１２に示されるように、プレート８の上下両面に複数の吐出口９が形成されたエネルギ処置具５に使用される。複数の吐出口９は、プレート８およびシース６の内部に形成された通路（図示略）を介して、シリンジのような接合材供給部（図示略）に接続される。生体組織接合材は、接合材供給部から通路内に供給され、生体組織の間に挿入されているプレート８の吐出口９から吐出されることによって、生体組織Ｈ１，Ｈ２間に配置される。顆粒状の多孔質体２は、上述した接着剤内に分散されていてもよい。このようにすることで、顆粒状の多孔質体２に高い流動性を付与し、通路内において円滑に移動させることができる。 The biological tissue bonding material including the granular porous body 2 is used, for example, in the energy treatment device 5 in which a plurality of discharge ports 9 are formed on both upper and lower surfaces of the plate 8 as shown in FIG. The plurality of discharge ports 9 are connected to a bonding material supply unit (not shown) such as a syringe through passages (not shown) formed inside the plate 8 and the sheath 6. The biological tissue bonding material is supplied into the passage from the bonding material supply unit, and is disposed between the biological tissues H1 and H2 by being discharged from the discharge port 9 of the plate 8 inserted between the biological tissues. The granular porous body 2 may be dispersed in the adhesive described above. By doing in this way, high fluidity | liquidity can be provided to the granular porous body 2, and it can be made to move smoothly in a channel | path.
１　生体組織接合材
２　多孔質体
３　表面孔
４　細孔
Ｈ１，Ｈ２　生体組織 DESCRIPTION OF SYMBOLS 1 Biological tissue bonding material 2 Porous body 3 Surface hole 4 Pore H1, H2 Biological tissue

Claims (6)

  1. 　生体適合性材料からなる多孔質体を備え、
    　該多孔質体が、外表面に形成された表面孔と、該表面孔の内面に開口し、該表面孔よりも小さな孔径を有する細孔とを有する生体組織接合材。     A porous body made of a biocompatible material is provided,
    A biological tissue bonding material, wherein the porous body has surface holes formed on an outer surface, and pores that are open on the inner surface of the surface holes and have a smaller diameter than the surface holes.
  2. 　前記細孔が、生体組織に含まれる液体を毛細管現象によってその内部に吸引する孔径を有する請求項１に記載の生体組織接合材。 The living tissue bonding material according to claim 1, wherein the pores have a pore diameter for sucking a liquid contained in the living tissue into the inside thereof by capillary action.
  3. 　前記多孔質体が、板状であり、
    　前記表面孔が、前記多孔質体を厚さ方向に貫通する請求項１または請求項２に記載の生体組織接合材。     The porous body is plate-shaped,
    The biological tissue bonding material according to claim 1, wherein the surface hole penetrates the porous body in a thickness direction.
  4. 　請求項１から請求項３のいずれかに記載の生体組織接合材を、重なり合う２つの生体組織間に配置する配置ステップと、
    　前記生体組織接合材が間に配置された前記２つの生体組織を積層方向に加圧する加圧ステップと、
    　該加圧ステップによって加圧状態にある前記２つの生体組織に対してエネルギを供給して前記２つの生体組織を互いに接合するエネルギ供給ステップとを含む生体組織接合方法。     An arrangement step of arranging the biological tissue bonding material according to any one of claims 1 to 3 between two overlapping biological tissues;
    A pressurizing step of pressurizing the two biological tissues with the biological tissue bonding material disposed therebetween in the stacking direction;
    A biological tissue joining method comprising: supplying energy to the two biological tissues in a pressurized state by the pressurizing step to join the two biological tissues together.
  5. 　前記加圧ステップと前記エネルギ供給ステップとの間に、前記生体組織を加圧状態に所定時間維持する維持ステップを含む請求項４に記載の生体組織接合方法。 The living tissue joining method according to claim 4, further comprising a maintaining step of maintaining the living tissue in a pressurized state for a predetermined time between the pressurizing step and the energy supplying step.
  6. 　前記維持ステップにおいて、加圧状態の前記生体組織に対して振動を与える請求項５に記載の生体組織接合方法。 The biological tissue bonding method according to claim 5, wherein in the maintaining step, vibration is applied to the biological tissue in a pressurized state.
PCT/JP2014/079593 2014-11-07 2014-11-07 Bonding material for biological tissue, and bonding method for biological tissue WO2016072017A1 (en)

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JP2009160302A (en) * 2008-01-09 2009-07-23 National Institute For Materials Science Composite porous scaffold
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