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JP6206838B2 - Tissue self-joining body insertion tube - Google Patents
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JP6206838B2 - Tissue self-joining body insertion tube - Google Patents

Tissue self-joining body insertion tube Download PDF

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JP6206838B2
JP6206838B2 JP2013102403A JP2013102403A JP6206838B2 JP 6206838 B2 JP6206838 B2 JP 6206838B2 JP 2013102403 A JP2013102403 A JP 2013102403A JP 2013102403 A JP2013102403 A JP 2013102403A JP 6206838 B2 JP6206838 B2 JP 6206838B2
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tube
insertion tube
tissue
joining
groove
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JP2013255789A5 (en
JP2013255789A (en
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増澤 徹
徹 増澤
敏行 青代
敏行 青代
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Ibaraki University NUC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08Tubes; Storage means specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/855Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857Implantable blood tubes
    • A61M60/859Connections therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/855Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)
  • External Artificial Organs (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)

Description

本発明は、生体内組織との接合が行われる体内挿入管、特に、人工心臓と接合される脱血管や送血管又はそれらの一部として使用されるものであり、細菌等による感染症の防止に大きな効果を有する組織自己接合型体内挿入管及び該体内挿入管と体内器官組織との接合方法に関する。   The present invention is used as an in-vivo insertion tube that is joined to a tissue in a living body, in particular, a blood removal tube or blood feed tube that is joined to an artificial heart, or a part thereof, and prevents infection by bacteria or the like. The present invention relates to a tissue self-joining in-vivo insertion tube and a method for joining the in-vivo insertion tube and body organ tissue.

補助人工心臓を取付けるには、脱血管や送血管を介して心臓に取り付ける必要がある。その際、脱血管の心臓への取付けは、図15の(a)に示すように、脱血管17のカフ(つば)18を用いて心臓19に針と糸を用いた巾着縫合20で行われている。同様に、図15の(b)に示すように、送血管21の動脈19への取付けも縫合で行われている。しかし、このような縫合は、脱血管とカフの接続部分又は送血管と心臓との接続部分にわずかな隙間が生じて、その隙間から細菌が侵入し様々な感染症を引き起こすことが報告されている。   In order to attach an auxiliary artificial heart, it is necessary to attach it to the heart via a blood removal vessel or a blood vessel. At that time, attachment of the blood vessel to the heart is performed with a purse string suture 20 using a needle and a thread for the heart 19 using a cuff 18 of the blood vessel 17 as shown in FIG. ing. Similarly, as shown in FIG. 15 (b), the blood vessel 21 is attached to the artery 19 by suturing. However, it has been reported that such a suture causes a slight gap in the connection part between the devascularization and the cuff or the connection part between the blood sending tube and the heart, and bacteria enter the gap to cause various infectious diseases. Yes.

人工心臓の脱血管や送血管を心臓に取り付けるときに生じる接合部分の隙間を除去する方法としては、超音波メスや電気メス等の高エネルギーや医療用接着剤等を用いた生体組織接合が考えられる。超音波メスは、冠動脈バイパス手術等で使用されており、数mmの血管を切断する際、血管の切断面を接合して閉鎖することで止血を行う方法に用いられる。電気メスは、対極板間に電圧をかけ生体組織に電流を流し、それによって発生する熱を利用し接合する装置である。それ以外にも、アルゴン(Ar)レーザやYAGレーザを用いて組織を変性させる組織凝固を利用するレーザメスがある。しかし、これらの高エネルギーを利用する装置は、高エネルギーによって組織を炭化させやすく生体組織損傷が激しいという問題を抱えている。また、電気メスは、人体への電気ショックや他機器への雑音障害等が懸念されている。   As a method for removing gaps in the joints that occur when attaching artificial blood vessels or blood-feeding vessels to the heart, high-energy ultrasonic medical scalpels, electric scalpels, etc., and tissue bonding using medical adhesives are considered. It is done. The ultrasonic scalpel is used in coronary artery bypass surgery or the like, and is used in a method for hemostasis by joining and closing a cut surface of a blood vessel when a blood vessel of several mm is cut. An electric scalpel is a device that applies a voltage between counter electrodes to cause an electric current to flow through a living tissue and uses the heat generated thereby to join. In addition, there is a laser knife that uses tissue coagulation to denature tissue using an argon (Ar) laser or a YAG laser. However, these devices using high energy have a problem that tissue is easily carbonized by the high energy and the tissue damage is severe. Moreover, electric scalpels are concerned about electric shocks to the human body, noise disturbances to other devices, and the like.

医療用接着剤は、例えば、生体血管の代替として使用する人工血管等の軟組織用の接着に利用されており、材料としてはシアノアクリレートやフィブリン系が主に利用されている。医療用接着剤は、作業性に優れ、短時間接着が特徴であるが、生体への毒性と抗菌性の点で問題がある。また、使用中に接着剤劣化や接着剤成分浸み出しなどによって、生体への悪影響だけでなく、接着性の大幅な低下も起こる場合があり、使用範囲が限定される。   For example, medical adhesives are used for bonding soft tissues such as artificial blood vessels used as a substitute for biological blood vessels, and cyanoacrylates and fibrin-based materials are mainly used as materials. Medical adhesives are excellent in workability and feature short-time adhesion, but have problems in terms of toxicity to the living body and antibacterial properties. In addition, due to adhesive deterioration or adhesive component leaching during use, not only adverse effects on the living body but also a significant decrease in adhesiveness may occur, limiting the range of use.

上記の高エネルギーや医療用接着剤等に依存しない生体組織接合方法として、特許文献1には、一部又は全体が、線状から形成される多孔性構造体又は多孔性成形体から構成される多孔性構造体からなる血液循環補助用インフローカニューレが開示されている。前記の特許文献1及び特許文献2に記載の多孔性構造体は、血栓による血行障害や疾患の防止のために、前記多孔性構造体の凹凸や孔によって生じる空隙を利用して血栓を安定的にアンカリングするために配置・固定されるものである。   As a biological tissue bonding method that does not depend on the above high energy, medical adhesive, or the like, Patent Document 1 partially or entirely includes a porous structure or a porous molded body formed in a linear shape. An inflow cannula for assisting blood circulation made of a porous structure is disclosed. The porous structures described in Patent Literature 1 and Patent Literature 2 described above stably stabilize the thrombus using voids formed by the irregularities and pores of the porous structure in order to prevent blood flow disorders and diseases caused by the thrombus. It is arranged and fixed for anchoring.

また、特許文献3には、心臓の心内膜がカニューレの外周面に沿って延伸してその延伸部が切れ、この切れた心内膜片が血液中に混入して血管を閉塞してしまうのを防止するために、管状の本体部と、その本体部の外周面を周回するように配置された筒状の多孔質体とを有するカニューレが提案されている。   Further, in Patent Document 3, the endocardium of the heart extends along the outer peripheral surface of the cannula and the extended portion is cut, and the cut endocardial piece is mixed in the blood and occludes the blood vessel. In order to prevent this, a cannula having a tubular main body and a cylindrical porous body arranged so as to go around the outer peripheral surface of the main body has been proposed.

さらに、特許文献4及び5には、生体内組織として消化管や血管等の吻合、又は人工血管と生体血管との接続のために利用する体内挿入管が提案されている。前記の特許文献4に記載の生体吸収性連結管は、抜け止めのためにフランジを有する構造を備えるものである。また、前記の特許文献5には、耐食性の金属材料より一体に形成された中空の円筒部材からなり、該円筒部材の周壁には、複数の貫通孔が形成され、該円筒部材の外周には、周方向に沿った少なくとも1つの周方向溝が形成された人工血管用接続部が開示されている。   Furthermore, Patent Documents 4 and 5 propose an in-vivo insertion tube used for anastomosis of a digestive tract or a blood vessel or a connection between an artificial blood vessel and a biological blood vessel as an in-vivo tissue. The bioabsorbable connecting pipe described in Patent Document 4 has a structure having a flange for preventing the removal. Further, the above-mentioned Patent Document 5 is composed of a hollow cylindrical member integrally formed from a corrosion-resistant metal material, and a plurality of through holes are formed in the peripheral wall of the cylindrical member, and the outer periphery of the cylindrical member is formed on the outer periphery of the cylindrical member. An artificial blood vessel connecting portion in which at least one circumferential groove along the circumferential direction is formed is disclosed.

特開2010−264274号公報JP 2010-264274 A 特開2010−104806号公報JP 2010-104806 A 特開2008−279188号公報JP 2008-279188 A 特開平9−38119号公報Japanese Patent Laid-Open No. 9-38119 特許第3568756号公報Japanese Patent No. 3568756

上記で述べたように、脱血管や送血管の心臓への取付け又は血管の接合や接続を行う際に、従来の巾着縫合では細菌が浸入しないように接合部分を隙間なく高強度で接合することが難しい。また、高エネルギーや医療用接着剤等を用いた生体組織接合は、生体への損傷や毒性等の悪影響があるだけでなく、高い接合強度を得るには高度の熟練と技術を要する。   As mentioned above, when attaching a blood vessel to the heart, or joining or connecting a blood vessel to the heart, the joint part should be joined with high strength without gaps so that bacteria do not enter with conventional purse string sutures. Is difficult. In addition, biological tissue joining using high energy, medical adhesive, and the like not only has adverse effects such as damage to the living body and toxicity, but also requires high skill and skill to obtain high joint strength.

前記の特許文献1及び2には、多孔性構造体からなる血液循環補助用インフローカニューレ(挿入管)が開示されているが、この多孔性構造体からなるテクストチャードサーフェースは、血栓を安定的にアンカリングするために形成されるものであり、接合部分に該当する心臓壁と接触する部分だけでなく、さらに心臓内部まで延びる構造となっている。また、このインフローカニューレはカフ(つば)とカフ押さえねじを有することから、心臓との接合強度を向上するために多孔性構造体が形成されたものではないことは明らかであり、多孔性構造体による接合強度の向上という技術課題については全く認識されていなかった。   In Patent Documents 1 and 2 described above, an inflow cannula (insertion tube) for assisting blood circulation made of a porous structure is disclosed. The texturized surface made of this porous structure stabilizes thrombus. It is formed for anchoring, and has a structure extending not only to the portion that contacts the heart wall corresponding to the joint portion but also to the inside of the heart. In addition, since this inflow cannula has a cuff and a cuff holding screw, it is clear that a porous structure is not formed in order to improve the bonding strength with the heart. The technical problem of improving the joint strength by the body was not recognized at all.

前記の特許文献3に記載のカニューレは、心内膜と接する部分に多孔質体を配置することによって、心内膜が該多孔質体に侵潤することにより、心内膜がカニューレの外周面に沿って延伸するのを抑制するものである。したがって、この多孔質体は心臓との接合強度を向上するために形成されたものではない。さらに、多孔質体の材料として例示された樹脂は弾性特性を有するため、強固な接合強度を期待することはできない。   In the cannula described in Patent Document 3, the endocardium is infiltrated into the porous body by disposing the porous body in a portion in contact with the endocardium, so that the endocardium becomes the outer peripheral surface of the cannula. It suppresses extending | stretching along. Therefore, this porous body is not formed in order to improve the bonding strength with the heart. Furthermore, since the resin exemplified as the material of the porous body has elastic characteristics, it cannot be expected to have a strong bonding strength.

また、前記の特許文献4に記載の生体吸収性連結管、及び前記の特許文献5に記載の人工血管接続具は、それぞれ消化管や血管等の糸針による縫合や医療用接着剤による接着接合、及び人工血管と生体血管との縫着を助けるためのものである。したがって、これらの体内挿入管は、生体組織と強固に接合できるような構造を有しておらず、縫合や縫着等による接合部分から細菌が浸入するという問題を解決することはできない。   In addition, the bioabsorbable connecting tube described in Patent Document 4 and the artificial blood vessel connector described in Patent Document 5 are sutured by a needle such as a digestive tract or a blood vessel, or adhesively bonded by a medical adhesive, respectively. And for assisting the sewing between the artificial blood vessel and the biological blood vessel. Therefore, these in-vivo insertion tubes do not have a structure that can be firmly joined to a living tissue, and cannot solve the problem that bacteria enter from a joined portion by stitching or sewing.

本発明は、上記した従来の問題点に鑑みてなされたものであって、補助人工心臓の脱血管又は送血管と心臓との接合、又は人工血管と生体血管との接合を、従来より迅速で、且つ簡便に行うとともに、細菌が侵入する隙間が形成されることなく高い接合強度を得るために、人工心臓装着支援を始めとする生体組織との高強度接合技術の確立の一環として、複合低エネルギー接合方法に適用できる組織自己接合型体内挿入管及び該体内挿入管と体内器官組織との接合方法を提供することにある。   The present invention has been made in view of the above-described conventional problems, and it is possible to perform blood vessel removal of an auxiliary artificial heart or a joint between a blood sending tube and a heart, or a joint between an artificial blood vessel and a biological blood vessel more quickly than before. As a part of the establishment of high-strength bonding technology with living tissue including support for artificial heart attachment, in order to obtain a high bonding strength without forming gaps for bacteria to enter, An object of the present invention is to provide a tissue self-joining in-vivo insertion tube applicable to the energy joining method and a joining method of the in-body insertion tube and the internal organ tissue.

本発明は、従来行われていた縫合や縫着に代わるものとして、心臓や血管等の体内器官組織との接合強度を上げることができる組織自己接合型体内挿入管の構造と構成について鋭意検討した結果、体内挿入管の体内器官組織と接触する側に、体内器官組織の変形又は変位による投錨(アンカリング)効果が得られるような表面形状を形成すること、さらに、この投錨効果を高めるために体内器官組織の変形又は変位を容易にするような構造を体内挿入管に具備させることによって、上記の課題を解決できることを見出して本発明に到った。   The present invention has been intensively studied on the structure and configuration of a tissue self-joining body insertion tube that can increase the joint strength with internal organ tissues such as the heart and blood vessels, as an alternative to conventional sutures and stitches. As a result, on the side of the body insertion tube that comes into contact with the body organ tissue, to form a surface shape that can provide an anchoring effect due to deformation or displacement of the body organ tissue, and to enhance this anchoring effect It has been found that the above problems can be solved by providing the body insertion tube with a structure that facilitates deformation or displacement of the body organ tissue.

すなわち、本発明の構成は以下の通りである。
(1)本発明は、体内器官組織に覆われた状態で前記体内器官組織と接触して加熱及び/又は微小振動を加えて接合される体内挿入管であって、前記体内挿入管には、少なくとも、前記体内器官組織と接触する側に前記体内器官組織の一部が変形又は変位により侵入することにより投錨効果が得られる大きさの溝、孔又は窪みが形成され、前記体内挿入管と前記体内器官組織との接合時に前記溝、孔又は窪みに負圧を作用させるための通路が前記体内挿入管に形成され、前記体内器官組織と接触して加熱及び/又は微小振動を加えて接合された後の引張強度が0.01MPa以上であることを特徴とする組織自己接合型体内挿入管を提供する。
(2)本発明は、前記(1)に記載の組織自己接合型体内挿入管が、前記の体内器官組織の変形又は変位を起こさせるための溝、孔又は窪みが形成された管を外管とし、該外管の内部に、さらに血液、輸液又は配線の通路として機能する内部空洞を有する内管を備え、前記の溝、孔又は窪みに負圧を作用させるための通路が、前記外管及び内管の少なくとも何れか一つに形成されていることを特徴とする組織自己接合型体内挿入管を提供する。
(3)本発明は、前記(2)に記載の組織自己接合型体内挿入管が、次の(A)、(B)、及び(C)、すなわち(A)前記外管の溝、孔又は窪みから、前記体内挿入管の外部に向けて、前記体内挿入管と前記体内器官組織との間に存在する空気を排出又は吸引することによって前記の溝、孔又は窪みに負圧を作用させるための通路を前記の外管又は内管に備えること、(B)前記外管の溝、孔又は窪みから、前記内管の内部空洞に向けて、前記体内挿入管と前記体内器官組織との間に存在する空気を排出又は吸引することによって前記の溝、孔又は窪みに負圧を作用させるための通路を前記内管に備えること、及び(C)前記外管の溝、孔又は窪みから、前記内管の内部空洞に向けて、前記体内挿入管と前記体内器官組織との間に存在する空気を排出又は吸引するによって前記の溝、孔又は窪みに負圧を作用させるための通路を前記外管と内管の両者に備えること、から成る構成群の中から選ばれる何れか一つを有することを特徴とする組織自己接合型体内挿入管を提供する。
(4)本発明は、前記の外管と内管が、緩衝剤又は弾性体を介して固定されることを特徴とする前記(2)又は(3)に記載の組織自己接合型体内挿入管を提供する。
(5)本発明は、前記の組織自己接合型体内挿入管が、前記溝、孔又は窪みに負圧を作用させるための通路と直結する排出口又は吸引口を備えることを特徴とする前記(1)〜(4)の何れかに記載の組織自己接合型体内挿入管を提供する。
(6)本発明は、前記の組織自己接合型体内挿入管が、加熱用熱源を備えることを特徴とする前記(1)〜(5)の何れかに記載の組織自己接合型体内挿入管を提供する。
(7)本発明は、前記の体内挿入管が、人工心臓脱血管であることを特徴とする前記(1)〜(6)の何れかに記載の組織自己接合型体内挿入管を提供する。
[発明の効果]
That is, the configuration of the present invention is as follows.
(1) The present invention is an in-vivo insertion tube that is heated and / or micro-vibrated in contact with the in-vivo organ tissue in a state covered with the in-vivo organ tissue, At least a groove, a hole, or a recess having a size capable of obtaining a throwing effect is formed on a side in contact with the body organ tissue by a part of the body organ tissue being deformed or displaced, and the body insertion tube and the body A passage for applying a negative pressure to the groove, hole, or depression when formed in the body organ tissue is formed in the body insertion tube, and is joined by heating and / or microvibration in contact with the body organ tissue. And a tissue self-joining body insertion tube having a tensile strength of 0.01 MPa or more .
(2) In the present invention, the tissue self-joining in-vivo insertion tube according to (1) described above is an outer tube in which a groove, hole, or depression for causing deformation or displacement of the internal organ tissue is formed. And an inner tube having an inner cavity that functions as a passage for blood, infusion, or wiring inside the outer tube, and a passage for applying a negative pressure to the groove, hole, or depression is the outer tube. And a self-joining tissue insertion tube, characterized in that it is formed in at least one of the inner tube and the inner tube.
(3) In the present invention, the tissue self-joining intracorporeal insertion tube according to (2) described above is (A), (B), and (C), that is, (A) a groove, hole, or In order to apply a negative pressure to the groove, hole, or dent by discharging or sucking air existing between the body insertion tube and the body organ tissue from the depression toward the outside of the body insertion tube. (B) between the insertion tube and the internal organ tissue from the groove, hole or depression of the external tube toward the internal cavity of the internal tube. Providing the inner pipe with a passage for applying a negative pressure to the groove, hole or depression by exhausting or sucking air present in the pipe, and (C) from the groove, hole or depression of the outer pipe, Exists between the body insertion tube and the body organ tissue towards the internal cavity of the inner tube Any one selected from the group consisting of providing both the outer tube and the inner tube with a passage for applying a negative pressure to the groove, hole or recess by discharging or sucking air. A self-joining tissue insertion tube is provided.
(4) The tissue self-joining intracorporeal insertion tube according to (2) or (3), wherein the outer tube and the inner tube are fixed via a buffer or an elastic body. I will provide a.
(5) The present invention is characterized in that the tissue self-joining in-vivo insertion tube includes a discharge port or a suction port directly connected to a passage for applying a negative pressure to the groove, hole, or depression. A tissue self-joining body insertion tube according to any one of 1) to (4) is provided.
(6) The tissue self-joining intracorporeal insertion tube according to any one of (1) to (5), wherein the tissue self-joining intracorporeal insertion tube includes a heat source for heating. provide.
(7) The present invention provides the tissue self-joining intracorporeal insertion tube according to any one of (1) to (6), wherein the intracorporeal insertion tube is an artificial heart devascularization.
[Effect of the invention]

本発明による体内器官挿入管は、体内器官組織と接触する側に、前記体内器官組織の変形又は変位による投錨(アンカリング)効果が得られるような溝、孔又は窪みを有するだけでなく、体内挿入管と体内器官組織との間に存在する空気を排出又は吸引して前記溝、孔又は窪みに負圧を作用させるための通路を備えることによって、接合部分に負圧が付与されるときに、体内器官組織の前記の溝、孔又は窪みへの変形又は変位が容易となり、接合界面に接合強度を低下させるようなボイドや隙間の発生を防止して、接合強度を高める効果が期待できる。   The internal organ insertion tube according to the present invention has not only a groove, a hole, or a depression on the side in contact with the internal organ tissue, which can provide an anchoring effect due to deformation or displacement of the internal organ tissue. When a negative pressure is applied to the joint portion by providing a passage for exhausting or sucking air existing between the insertion tube and the body organ tissue to apply a negative pressure to the groove, hole, or depression. The body organ tissue can be easily deformed or displaced into the groove, hole, or depression, and the effect of increasing the bonding strength by preventing the generation of voids and gaps that reduce the bonding strength at the bonding interface can be expected.

また、本発明によれば、体内挿入管を外管と内管の二重管構造とすることによって、体内器官組織との接合強度を高めるための機能及び血液、輸液又は配線の通路としての機能を別々に分けて、それぞれ外管及び内管として形成できるため、外管形状の設計変更だけで体内挿入管の形状を自由に変えることができる。それによって、外管の形状を体内器官組織の形状との接合位置に合わせたような体内挿入管を作製することができるようになり、様々な形状からなる体内器官組織との接合が可能となる。さらに、外管及び内管の少なくとも何れか一つは前記溝、孔又は窪みに負圧を作用させるための通路を備えるため、体内挿入管と体内器官組織との間に存在する空気の排出又は吸引によって大きな投錨効果が得られるような体内器官組織の変形と変位が起こり、接合強度の一層の向上を図ることができる。   In addition, according to the present invention, the body insertion tube has a double tube structure of an outer tube and an inner tube, thereby increasing the bonding strength with the body organ tissue and functioning as a blood, infusion or wiring passage. Since these can be separately formed and formed as an outer tube and an inner tube, the shape of the body insertion tube can be freely changed only by changing the design of the outer tube shape. As a result, it is possible to produce an in-vivo insertion tube in which the shape of the outer tube matches the position of joining with the shape of the internal organ tissue, and it is possible to join the internal organ tissue having various shapes. . Furthermore, since at least one of the outer tube and the inner tube includes a passage for applying a negative pressure to the groove, hole, or depression, it is possible to discharge air existing between the body insertion tube and the body organ tissue or The internal organ tissue is deformed and displaced so that a large throwing effect can be obtained by suction, and the joint strength can be further improved.

本発明による体内挿入管と体内器官組織との接合方法は、複合低エネルギー接合で行うことができるだけでなく、接合部分に隙間が無く高い接合強度が得られるため、従来よりも、接合を迅速で、且つ簡便に行うことができる。さらに、接合部分からの細菌浸入の防止は、接合後に細菌の浸入によって誘因される血栓の発生を抑制する効果を生むため、安心で安全性の高い接合方法を構築することができる。   The joining method of the body insertion tube and the body organ tissue according to the present invention can be performed not only by composite low energy joining, but also because the joining portion has no gap and high joining strength can be obtained. And it can be performed easily. Furthermore, prevention of bacterial invasion from the joined portion produces an effect of suppressing the generation of thrombus induced by the invasion of bacteria after joining, so that a safe and highly safe joining method can be constructed.

本発明の組織自己接合型体内挿入管の一例として脱血管を示す図である。It is a figure which shows the devascularization as an example of the tissue self-joining type | mold insertion tube of this invention. 本発明の組織自己接合型体内挿入管に形成される、負圧を作用させるための通路を備えた溝、孔及び窪みを示す断面模式図である。It is a cross-sectional schematic diagram which shows the groove | channel, the hole, and the hollow provided with the channel | path for making a negative pressure act formed in the tissue self-joining type | mold insertion tube of this invention. 複合低エネルギーによる体内器官組織と本発明の体内挿入管との接合メカニズムの一例を示す図である。It is a figure which shows an example of the joining mechanism of the internal organ tissue by composite low energy and the in-vivo insertion tube of this invention. 本発明による負圧を作用させるための通路を備えた一重管構造の体内挿入管を、心臓の脱血管として適用した例を示す図である。It is a figure which shows the example which applied the in-vivo insertion tube of the single-pipe structure provided with the channel | path for making the negative pressure act by this invention as a blood-vessel removal. 本発明による一重管構造の体内挿入管において、溝の部分及び排出口又は吸引口の部分の各切断面を示す図である。It is a figure which shows each cut surface of the part of a groove | channel and the part of a discharge port or a suction port in the insertion tube of the single tube | pipe structure by this invention. 本発明による一重管構造の体内挿入管において、負圧を作用させるための通路の形成例を示す図である。It is a figure which shows the example of formation of the channel | path for making a negative pressure act in the insertion tube of the single tube | pipe structure by this invention. 溝、孔又は窪みが形成され、内部に負圧を作用させるための通路を備える外管と内管とを有する本発明による二重管構造の体内挿入管を示す図である。It is a figure which shows the insertion tube of the double tube | pipe structure by this invention which has an outer tube | pipe and the inner tube | pipe provided with the channel | path for making a groove | channel, a hole, or a hollow and a negative pressure act inside. 外管と内管とを有し、外管又は内管が負圧を作用させるための通路を備える二重管構造の体内挿入管の断面を模式的に示す図である。It is a figure which shows typically the cross section of the body insertion tube of a double tube structure which has an outer tube | pipe and an inner tube | pipe and is provided with the channel | path for an outer tube | pipe or an inner tube | pipe to apply a negative pressure. 外管と内管とを有し、内管の周囲に負圧を作用させるための通路を備える体内挿入管を示す図である。It is a figure which has an outer tube | pipe and an inner tube | pipe and is provided with the body insertion pipe | tube provided with the channel | path for applying a negative pressure around the inner tube | pipe. 外管と内管とを有し、内管の周囲に負圧を作用させるための通路を備える体内挿入管と体内器官組織との接合状態を示す図である。It is a figure which has the outer tube | pipe and the inner tube | pipe, and shows the joining state of the body insertion pipe | tube provided with the channel | path for making a negative pressure act around an inner tube | pipe, and a body organ tissue. 外管と内管とを有し、負圧を作用させるための通路が外観の溝から内管の内部空洞に繋がる構造を有する別の形態の体内挿入管を示す図である。It is a figure which shows the internal insertion pipe of another form which has a structure which has an outer tube | pipe and an inner tube | pipe, and the channel | path for applying a negative pressure is connected to the internal cavity of an inner tube | pipe from the groove | channel of an external appearance. 本発明の体内挿入管と体内器官組織との接合において、ピエゾ素子による微小振動を利用した接合方法を示す図である。It is a figure which shows the joining method using the micro vibration by a piezo element in joining of the body insertion tube and body organ tissue of this invention. 本発明による組織自己接合型脱血管の試作機の概略図を示す図である。It is a figure which shows the schematic of the prototype of the tissue self-joining type blood-vessel by this invention. 本発明の体内挿入管と心臓との接合部分における引張による接合強度測定結果を示す図である。It is a figure which shows the joining strength measurement result by the tension | tensile_strength in the junction part of the body insertion tube and heart of this invention. 脱血管のカフを用いて心臓と縫合する従来方法を示す図である。It is a figure which shows the conventional method of suturing with the heart using the cuff of a devascularization.

図1は、本発明の組織自己接合型体内挿入管の一例として脱血管を示す図である。図1の(a)には、本発明の体内層挿入管1において、心臓との接合が行われる上部の周辺に切込み溝2が4本形成された脱血管の例である。図1の(b)は、溝2が環状に断続して形成された脱血管の例である。また、図2は、本発明の組織自己接合型体内挿入管に形成される溝、孔及び窪みの断面模式図を示す。本発明の体内挿入管1には、体内器官組織との接合部分に溝2の形状だけでなく、孔3又は窪み4を形成する。溝2、孔3及び窪み4は、それぞれ負圧を作用させるための通路5を介して体内挿入管1の内部空洞7と繋がっている。図2に示す溝2、孔3及び窪み4は、図1の(a)又は(b)に示すように、体内器官組織との接合部分に周回するように、又はそれぞれ独立して形成することができる。   FIG. 1 is a diagram showing devascularization as an example of the tissue self-joining intracorporeal insertion tube of the present invention. FIG. 1 (a) shows an example of devascularization in the body layer insertion tube 1 of the present invention in which four cut grooves 2 are formed around the upper part where the heart is joined. FIG. 1B shows an example of a blood removal vessel in which the groove 2 is formed in an annular shape. FIG. 2 is a schematic cross-sectional view of grooves, holes, and depressions formed in the tissue self-joining body insertion tube of the present invention. In the body insertion tube 1 of the present invention, not only the shape of the groove 2 but also the hole 3 or the depression 4 are formed at the joint portion with the body organ tissue. The groove 2, the hole 3, and the recess 4 are connected to the internal cavity 7 of the body insertion tube 1 through a passage 5 for applying a negative pressure. As shown in FIG. 1 (a) or (b), the groove 2, the hole 3 and the recess 4 shown in FIG. 2 are formed so as to circulate around the joint portion with the body organ tissue or independently. Can do.

本発明の体内挿入管1は、生体器官組織との接合部分に隙間なく、高い接合強度を有する組織自己接合を行うために、前記体内器官組織と接触する側に、溝2、孔3又は窪み4を形成することを特徴とする。これらの溝2、孔3又は窪み4は、圧力が付与された状態で熱や微小振動等の低エネルギー接合を行う際に、体内器官組織に覆われた接合部分で、前記体内器官組織の変形や変位を行わせて投錨効果を得る目的で形成する。効果的な投錨効果は、通路5を通じて形成される負圧で体内器官組織の一部が変形又は変位し、溝2、孔3又は窪み4へ浸入した後、それらの内部に確実に保持されることによって達成される。そのため、糸等による縫合や縫着又は医療用接着剤を使用しないで、高い接合強度を有する組織自己接合を行うことができる。したがって、縫合や縫着で使用されるカフ(つば)等の特別な構造を形成しなくてもよい。   The in-vivo insertion tube 1 of the present invention has a groove 2, a hole 3 or a depression on the side in contact with the body organ tissue in order to perform tissue self-joining having high joint strength without a gap at the joint portion with the living organ tissue. 4 is formed. These grooves 2, holes 3, or recesses 4 are joint portions covered with the body organ tissue when performing low energy joining such as heat or microvibration in a state where pressure is applied. It is formed for the purpose of obtaining a throwing effect by causing displacement. The effective anchoring effect is that a part of the body organ tissue is deformed or displaced by the negative pressure formed through the passage 5 and enters the groove 2, the hole 3 or the recess 4 and then is securely held inside them. Is achieved. Therefore, tissue self-joining having high joint strength can be performed without using sutures or sewing with a thread or the like or a medical adhesive. Therefore, it is not necessary to form a special structure such as a cuff used for sewing or sewing.

図3は、複合低エネルギーによる体内器官組織と本発明の体内挿入管との接合メカニズムの一例を示す。心臓や血管等の体内器官組織はタンパク質のコラーゲン分子やコラーゲン線維等を多く含んでいる。これらの体内器官組織を、表面に溝、孔又は窪みを形成した体内挿入管に配置して(図3の(a))、通路5によって体内挿入管から負圧を作用することで密着させ(図3の(b))、同時に加熱する(図3の(c))。それによって、図3の(d)に示すように、体内器官組織内のコラーゲン線維が変形又は変位して、体内挿入管の凹凸内へ侵入すると同時に又は侵入後に、コラーゲン線維等を含む体内器官組織がゲル化する。加熱を止めてから温度が下がり始め、ゲル化した部分が凝固することで体内器官組織を体内挿入管に接合させることができる。図3に示すような組織自己接合型の接合方法は、体内挿入管の凹凸内へ侵入した体内器官組織によって投錨効果が十分に得られる場合に接合強度が高くなる。しかしながら、高強度の接合を達成するためには、負圧を作用させるための通路の形成及び接合方法や接合条件だけではなく、体内挿入管の材質及び体内器官組織と接触する側に形成する溝、孔又は窪みの開口部の径又は面積及び深さ等について十分に検討を行う必要がある。   FIG. 3 shows an example of a joining mechanism between a body organ tissue and a body insertion tube of the present invention by composite low energy. Body organ tissues such as the heart and blood vessels contain many protein collagen molecules and collagen fibers. These body organ tissues are placed in a body insertion tube having grooves, holes, or depressions formed on the surface ((a) of FIG. 3), and are made to adhere to each other by applying negative pressure from the body insertion tube through the passage 5 ( (B) in FIG. 3 and heating are performed simultaneously ((c) in FIG. 3). As a result, as shown in FIG. 3 (d), the collagen fibers in the body organ tissue are deformed or displaced, and at the same time or after the intrusion into the irregularities of the body insertion tube, the body organ tissue including collagen fibers and the like. Gels. After the heating is stopped, the temperature starts to decrease, and the gelled portion is solidified, whereby the body organ tissue can be joined to the body insertion tube. The tissue self-joining type joining method as shown in FIG. 3 increases the joining strength when the anchoring effect is sufficiently obtained by the internal organ tissue that has entered the irregularities of the body insertion tube. However, in order to achieve high-strength bonding, not only the formation of the passage for applying negative pressure and the bonding method and bonding conditions, but also the groove formed on the side in contact with the material of the body insertion tube and the body organ tissue It is necessary to sufficiently examine the diameter or area and depth of the opening of the hole or the depression.

まず、体内挿入管については、図3に示す負圧状態の時に変形が少ないことが求められる。また、加熱処理の際に体内挿入管から体内器官組織への熱伝導性が高くなければ、加熱温度を高くしたり加熱時間を長くする必要があるため、体内器官組織への熱的ダメージの問題が起こる。低エネルギー接合において、加熱処理の代わりに、又は加熱処理とともに微小振動を付与する場合は、体内挿入管が柔らかいと微小振動エネルギーの伝達が低下するため、体内挿入管にはある程度の剛性が求められる。したがって、本発明においては、体内挿入管の材質としては、高剛性の金属、セラミックス又は樹脂複合材料が好適である。さらに、体内挿入管は生体内で使用されるため、生体適合性に優れるものでなければならない。そのため、ステンレス、チタニウム、シリコン又は繊維強化プラスチックからなる体内挿入管がさらに好ましい。これらの体内挿入管としては、表面がフッ素、炭素又はチタニウム等の原子を含むように表面処理したものを使用してもよい。   First, the body insertion tube is required to be less deformed in the negative pressure state shown in FIG. Also, if the thermal conductivity from the body insertion tube to the body organ tissue is not high during the heat treatment, it is necessary to increase the heating temperature or lengthen the heating time, which causes a problem of thermal damage to the body organ tissue. Happens. In low energy bonding, when micro vibration is applied instead of heat treatment or together with heat treatment, if the body insertion tube is soft, transmission of micro vibration energy is reduced, so that the body insertion tube requires a certain degree of rigidity. . Therefore, in the present invention, a highly rigid metal, ceramics, or resin composite material is suitable as the material for the body insertion tube. Furthermore, since the body insertion tube is used in vivo, it must be excellent in biocompatibility. Therefore, an in-vivo insertion tube made of stainless steel, titanium, silicon, or fiber reinforced plastic is more preferable. As these insertion tubes, those that have been surface-treated so that the surface contains atoms such as fluorine, carbon, or titanium may be used.

図3に示すように、体内器官組織が高分子のタンパク質やコラーゲン線維を含むため、体内器官組織と接触する側に表面粗さ(JIS B 0601で定義されるRa)が1〜20μmの範囲で形成した表面凹凸を一様に有する体内挿入管では、体内器官組織の変形又は変位が小さな表面凹凸に十分に追随することができず、微小なボイドや界面剥離等が発生して十分な投錨効果が得られず、結果的に接合強度が低下する。   As shown in FIG. 3, since the internal organ tissue contains high molecular protein or collagen fiber, the surface roughness (Ra defined by JIS B 0601) is in the range of 1 to 20 μm on the side in contact with the internal organ tissue. In-vivo insertion tubes with uniformly formed surface irregularities can not sufficiently follow the surface irregularities in the deformation or displacement of internal organ tissue, and microscopic voids and interfacial delamination occur, resulting in a sufficient throwing effect As a result, the bonding strength is reduced.

このように、体内挿入管と体内器官組織との接合強度(接着力)を向上させるには、単に体内挿入管の表面粗さだけでは限界がある。本発明は、表面粗さで接合強度を上げる従来方法とは異なり、接合時に確実な投錨効果が得られるように、負圧を作用させたときに体内器官組織の変形又は変位を十分に起こさせ、それによって接合強度の大幅な向上を図った点に大きな特徴を有する。そのため、本発明の体内挿入管は、従来の表面粗さよりもやや大きな表面凹凸を形成する必要がある。したがって、本発明の体内挿入管に形成する溝、孔又は窪みは、図1の(a)に示すように体内挿入管1の周方向に連続的に形成される場合、溝2の溝幅、又は孔3及び窪み4の開口径が20μmを超え10mm以下であることが好ましい。溝幅又は開口径が20μm以下では体内器官組織の変形又は変位が不十分となり投錨効果がほとんど得られず、一方、10mmを超えると、溝2、孔3又は窪み4に侵入していた体内器官組織が簡単に抜ける現象が発生して、同様に十分な投錨効果が得られない。ここで、溝2、孔3又は窪み4は、体内挿入管1の周方向でいくつかに分割された形状としてもよい。また、図1の(b)に示すように、溝2、孔3又は窪み4が独立して形成される場合には、体内器官組織の変形又は変位による投錨効果が十分に得られるように、溝2の溝幅、又は孔3及び窪み4の開口面積は、3×10−4mm(円直径に換算して約20μm)以上であることが好ましい。開口面積の上限は、前記体内器官組織との接合強度が確保されるように、80mm(円直径に換算して約10mm)であることが好ましい。 Thus, in order to improve the joint strength (adhesive force) between the body insertion tube and the body organ tissue, there is a limit only by the surface roughness of the body insertion tube. Unlike the conventional method in which the bonding strength is increased by the surface roughness, the present invention sufficiently causes deformation or displacement of the internal organ tissue when a negative pressure is applied so that a reliable anchoring effect can be obtained at the time of bonding. This has a great feature in that the bonding strength is greatly improved. Therefore, the in-vivo insertion tube of the present invention needs to form surface irregularities that are slightly larger than the conventional surface roughness. Therefore, when the groove, hole or depression formed in the body insertion tube of the present invention is continuously formed in the circumferential direction of the body insertion tube 1 as shown in FIG. Or it is preferable that the opening diameter of the hole 3 and the hollow 4 exceeds 20 micrometers and is 10 mm or less. When the groove width or opening diameter is 20 μm or less, the deformation or displacement of the internal organ tissue is insufficient and the anchoring effect is hardly obtained. On the other hand, when it exceeds 10 mm, the internal organ that has entered the groove 2, the hole 3 or the recess 4 The phenomenon that the tissue is easily removed occurs, and a sufficient anchoring effect cannot be obtained as well. Here, the groove 2, the hole 3, or the dent 4 may have a shape divided into several in the circumferential direction of the body insertion tube 1. In addition, as shown in FIG. 1 (b), when the groove 2, the hole 3 or the depression 4 is formed independently, so that a throwing effect due to deformation or displacement of the body organ tissue can be sufficiently obtained. The groove width of the groove 2 or the opening area of the hole 3 and the depression 4 is preferably 3 × 10 −4 mm 2 (about 20 μm in terms of a circle diameter) or more. The upper limit of the opening area is preferably 80 mm 2 (about 10 mm in terms of circular diameter) so as to ensure the bonding strength with the internal organ tissue.

さらに、溝、孔又は窪みの開口部の最大深さは、20μmを超え10mm以下であることが好ましい。開口部の最大深さが20μm以下では、投錨効果がほとんど得られず、一方、10mmを超えると、溝、孔又は窪みに侵入していた体内器官組織が簡単に抜ける現象が発生して、同様に十分な投錨効果が得られない。本発明においては、体内器官組織との接合後に行う引張試験において、体内挿入管を長手軸方向に引張ったときに測定される引張による接合強度が0.01MPa以上、好ましくは0.02MPa以上であれば、溝、孔又は窪みの開口部の径又は面積と最大深さは、前記の範囲内で任意に設定することができる。   Furthermore, it is preferable that the maximum depth of the opening of the groove, hole, or depression is more than 20 μm and not more than 10 mm. When the maximum depth of the opening is 20 μm or less, the anchoring effect is hardly obtained. On the other hand, when it exceeds 10 mm, the body organ tissue that has invaded the groove, hole, or depression is easily removed. A sufficient throwing effect cannot be obtained. In the present invention, in a tensile test conducted after joining with a body organ tissue, the joining strength by tension measured when the body insertion tube is pulled in the longitudinal axis direction is 0.01 MPa or more, preferably 0.02 MPa or more. For example, the diameter or area and the maximum depth of the opening of the groove, hole, or recess can be arbitrarily set within the above range.

本発明の接合方法は、圧力、熱及び微小振動の少なくとも1つを用いて、好ましくは2つ以上を組み合わせた低エネルギー接合を行う。接合の際に負荷される圧力、熱及び微小振動の各条件は、それぞれ0.01〜10MPa、50〜250℃、及び1Hz〜1MHzの範囲である。加熱時の圧力が0.01MPa未満で、温度が50℃未満で、振動が1Hz未満であると、単独付与の場合はもちろんのこと、振動と熱及び圧力を合わせて複合エネルギーにして付与した場合でも、体内器官組織との接合強度を十分に高めることができない。仮に、接合作業後に両者が接合しているように見えても、使用中に体内挿入管の剥離や抜けが発生するため、振動と熱及び圧力の条件は上記に示す下限値以上でなければならない。また、圧力が10MPa、加熱時の温度が250℃、振動が1MHzをそれぞれ超えると、体内起案組織へのダメージが大きくなったり、体内挿入管の破損が起きる。また、体内器官組織の接合部分において応力や発熱による局所的な剥離が起きるため、体内接合組織に対する接合強度が全体的に低下すると共に、耐久信頼性や安全性の点でも問題がある。そのため、振動と熱及び圧力の条件は前記に示す上限値以下にする必要がある。   The bonding method of the present invention performs low energy bonding, preferably a combination of two or more, using at least one of pressure, heat, and micro vibration. The conditions of pressure, heat, and microvibration applied during the bonding are in the range of 0.01 to 10 MPa, 50 to 250 ° C., and 1 Hz to 1 MHz, respectively. When the pressure during heating is less than 0.01 MPa, the temperature is less than 50 ° C., and the vibration is less than 1 Hz, not only in the case of single application, but also in the case where the vibration, heat and pressure are combined and applied as composite energy However, the bonding strength with body organ tissues cannot be sufficiently increased. Even if it seems that both are joined after joining work, peeling and removal of the body insertion tube occur during use, so the conditions of vibration, heat and pressure must be above the lower limit shown above . In addition, when the pressure is 10 MPa, the heating temperature is 250 ° C., and the vibration exceeds 1 MHz, damage to the body-initiated tissue increases or the body insertion tube breaks. In addition, since local peeling due to stress or heat generation occurs at the joint portion of the body organ tissue, the joint strength with respect to the body joint tissue is reduced as a whole, and there are also problems in terms of durability reliability and safety. For this reason, the vibration, heat, and pressure conditions must be equal to or lower than the upper limit values shown above.

上記の加熱処理は、体内挿入管を体内器官組織で覆った状態で前記体内器官組織の外部から加熱治具を用いて行うか、挿入前の体内挿入管を恒温槽に入れて所定の温度に加温して行う。また、体内挿入管の中にニクロム線等の抵抗加熱線を挿入するか、又は体内挿入管の周方向に抵抗加熱線を巻回して、外部から加熱する方法を採用することもできる。このとき、加熱方式としては、抵抗加熱方式だけでなく、アーク加熱、誘導加熱、誘電加熱又は赤外線加熱等の別の方法を用いてもよい。   The above heat treatment is performed using a heating jig from outside the body organ tissue with the body insertion tube covered with the body organ tissue, or the body insertion tube before insertion is placed in a constant temperature bath to a predetermined temperature. Perform with warming. Also, a method of heating from the outside by inserting a resistance heating wire such as a nichrome wire into the body insertion tube or winding a resistance heating wire in the circumferential direction of the body insertion tube can be adopted. At this time, as the heating method, not only the resistance heating method but also other methods such as arc heating, induction heating, dielectric heating or infrared heating may be used.

本発明の体内挿入管は、低エネルギー接合時に、高分子のタンパク質やコラーゲン線維を含む体内器官組織の溝、孔又は窪みへの変形又は変位を助けて投錨効果を確実に得るために、体内挿入管の外部表面に形成する溝、孔又は窪みから、前記体内挿入管の血液、輸液又は配線の通路として機能する内部空洞又は前記体内挿入管の外部に向けて、前記体内挿入管と前記体内組織との間に存在する空気を排出又は吸引するための連結通路、すなわち溝2、孔3又は窪み4に負圧を作用させるための通路を備える必要がある。   The body insertion tube of the present invention is inserted into the body in order to ensure the anchoring effect by helping the deformation or displacement of the body organ tissue containing macromolecular proteins and collagen fibers into grooves, holes or depressions during low energy joining. The internal insertion tube and the internal tissue from a groove, hole, or depression formed on the external surface of the tube toward an internal cavity that functions as a passage for blood, infusion, or wiring of the internal insertion tube or outside the internal insertion tube It is necessary to provide a connecting passage for exhausting or sucking air existing between them, that is, a passage for applying a negative pressure to the groove 2, the hole 3 or the recess 4.

図4に、溝2に負圧を作用させるための通路5を備えた一重管構造の体内挿入管1を、心臓の脱血管として使用した例を示す。通路5は、体内連結管1に形成された溝2の底部と空間的に繋がっており、排出口又は吸引口6を通して、体内挿入管1の外部に向けて該外部の大気に開放される形状を有している。図4の(a)に示すように、本発明の体内挿入管は、血液、輸液又は配線の通路として機能する内部空洞7を有する。体内挿入管の内部空洞7内に示す矢印は、血液又は輸液の流路方向となる。体内挿入管1の周囲にはニクロム線等の加熱抵抗線8が巻回されており、加熱処理は、体内挿入管が体内器官組織によって覆われて圧着された後、前記加熱抵抗線8を用いて温度を上げて行う。この方法は、接合部分の局所的な加熱を行うことができるため、温度を必要以上に上げる必要がなく、加えて、加熱部分を最小の面積で行うことができ、体内器官組織への熱的ダメージを低減する効果がある。   FIG. 4 shows an example in which a single-tube structure body insertion tube 1 having a passage 5 for applying a negative pressure to the groove 2 is used as a blood removal vessel. The passage 5 is spatially connected to the bottom of the groove 2 formed in the body connecting tube 1 and has a shape that opens to the outside of the body insertion tube 1 through the discharge port or suction port 6. have. As shown in FIG. 4A, the in-vivo insertion tube of the present invention has an internal cavity 7 that functions as a passage for blood, infusion, or wiring. The arrow shown in the internal cavity 7 of the body insertion tube is the flow direction of blood or infusion. A heating resistance wire 8 such as a nichrome wire is wound around the body insertion tube 1, and the heat treatment is performed using the heating resistance wire 8 after the body insertion tube is covered and crimped by the body organ tissue. Raise the temperature. Since this method can locally heat the joint portion, the temperature does not need to be increased more than necessary, and in addition, the heated portion can be performed with a minimum area, and the body tissue can be thermally heated. Has the effect of reducing damage.

図4の(b)に示すように、通路5は、接合時に体内器官組織9と体内挿入管1との間に存在する空気22を排出する機能を有するものである。体内挿入管の表面に形成する溝2には排出用の通路が無いと接合時の体内器官組織9の変形又は変位によって空気22が溜まりやすい。溝2に代えて、孔又は窪みを形成した体内挿入管の場合も同じような現象が見られる。表面に空気22を逃す構造を採用しない場合は、開口深部の圧力が高くなって体内器官組織の変形又は変位を阻害するように作用する。そのため、体内器官組織9の密着性を上げるには、接合時に外部から付与する圧力を高くしなければならなくなる。しかし、図4の(b)に示すように、通路5を有する構造であれば、開口深部に溜まる空気22は、減圧処理等によって排出口又は吸引口6を通して排出又は吸引されるため負圧が発生し、体内挿入管と体内器官組織との密着性が向上して両者の界面に隙間や剥離が無くなり、結果的に体内器官組織の変形又は変位による投錨効果が確実に得られて、接合強度を向上することができる。   As shown in FIG. 4B, the passage 5 has a function of discharging the air 22 existing between the body organ tissue 9 and the body insertion tube 1 at the time of joining. If there is no discharge passage in the groove 2 formed on the surface of the body insertion tube, the air 22 tends to accumulate due to deformation or displacement of the body organ tissue 9 at the time of joining. A similar phenomenon can be seen in the case of a body insertion tube in which a hole or a depression is formed instead of the groove 2. When a structure for releasing air 22 on the surface is not employed, the pressure in the deep part of the opening is increased and acts to inhibit deformation or displacement of the internal organ tissue. For this reason, in order to improve the adhesion of the internal organ tissue 9, it is necessary to increase the pressure applied from the outside during joining. However, as shown in FIG. 4B, in the structure having the passage 5, the air 22 accumulated in the deep opening is discharged or sucked through the discharge port or the suction port 6 by a decompression process or the like, so that a negative pressure is generated. This improves the adhesion between the internal insertion tube and the internal organ tissue, eliminates gaps and separation at the interface between the two, and as a result, the anchoring effect due to the deformation or displacement of the internal organ tissue is reliably obtained, and the bonding strength Can be improved.

図4に示す一重管構造の体内挿入管において、左側半分の溝2の部分及び排出口(又は吸引口)6の部分の各切断面を図5に示す。図5の(a)に示す溝2の部分及び排出口(又は吸引口)6の部分の各切断面をA−A’及びB−B’として、それぞれ示したのが図5の(b)及び(c)である。図5に示すように、溝2に負圧を作用させる通路5は、溝2と排出口又は吸引口6と連結している。通路5の形成は、例えば、体内挿入管1の内部にドリル等の掘削治具によって通路5を形成した後、掘削入口部分を金属又はプラスチック等の気密栓23によって塞ぐことによって行うことができる。このとき、気密栓23の脱落防止と気密性向上のために、接着剤等による固定又は補強を行っても良い。また、図5に示す一重管構造の体内挿入管は、コンピュータ制御による3次元造形装置(3次元プリンター)を使用して製作することもできる。   FIG. 5 shows respective cut surfaces of the left half groove 2 and the discharge port (or suction port) 6 in the single-tube insertion tube having a single tube structure shown in FIG. FIG. 5B shows the cut surfaces of the groove 2 portion and the discharge port (or suction port) 6 portion shown in FIG. 5A as AA ′ and BB ′, respectively. And (c). As shown in FIG. 5, the passage 5 for applying a negative pressure to the groove 2 is connected to the groove 2 and the discharge port or suction port 6. The passage 5 can be formed, for example, by forming the passage 5 in the body insertion tube 1 with a drilling jig such as a drill and then closing the excavation inlet portion with an airtight plug 23 made of metal or plastic. At this time, fixing or reinforcement with an adhesive or the like may be performed in order to prevent the airtight stopper 23 from falling off and to improve airtightness. Moreover, the in-vivo insertion tube having a single tube structure shown in FIG. 5 can also be manufactured using a computer-controlled three-dimensional modeling apparatus (three-dimensional printer).

図6は、本発明による一重管構造の体内挿入管において、負圧を作用させるための通路の形成例を示す図である。図6には本発明の体内挿入管1の右側断面図だけを示しており、連結通路5が体内連結管に形成された溝2の底部から体内挿入管1の内部空洞7に向けて直接繋がって開放される形状を有している。図6の(a)に示す通路5は、開口径が溝2の底面から内部空洞に向かって一定の大きさを有する。通路5の開口径を一定の大きさで形成する場合は、接合時に減圧吸引による負圧を調整する必要がある。それに対して、図5の(b)に示す通路5は、開口径が内部空洞7に向けて次第に小さくなる形状を有する。これは、接合時に体内器官組織9が内部空洞7にまで侵入するのを抑える効果がある。   FIG. 6 is a view showing an example of formation of a passage for applying a negative pressure in a body insertion tube having a single-pipe structure according to the present invention. FIG. 6 shows only the right-side cross-sectional view of the body insertion tube 1 of the present invention. The connection passage 5 is directly connected from the bottom of the groove 2 formed in the body connection tube toward the internal cavity 7 of the body insertion tube 1. The shape is open. The passage 5 shown in FIG. 6A has a constant opening diameter from the bottom surface of the groove 2 toward the internal cavity. In the case where the opening diameter of the passage 5 is formed with a constant size, it is necessary to adjust the negative pressure by vacuum suction during joining. On the other hand, the passage 5 shown in FIG. 5B has a shape in which the opening diameter gradually decreases toward the internal cavity 7. This has an effect of suppressing the internal organ tissue 9 from entering the internal cavity 7 at the time of joining.

次に、外管と内管からなる二重管構造を有する組織自己接合型体内挿入管について図面を用いて説明する。   Next, a tissue self-joining body insertion tube having a double tube structure composed of an outer tube and an inner tube will be described with reference to the drawings.

図7は、上記で述べた体内器官組織の変形又は変位を起こさせるための溝、孔又は窪みが形成された管を外管10とし、外管10の内部に、さらに血液、輸液又は配線の通路として機能する内部空洞7を有する内管11を備える体内挿入管を示す図である。図7の(a)は体内挿入管の外観を、図7の(b)は体内挿入管の断面図をそれぞれ示す図である。   FIG. 7 shows that the outer tube 10 is a tube in which a groove, hole, or depression for causing deformation or displacement of the body organ tissue described above is formed, and inside the outer tube 10, blood, infusion, or wiring It is a figure which shows the body insertion pipe provided with the inner pipe | tube 11 which has the internal cavity 7 which functions as a channel | path. FIG. 7A is an external view of the body insertion tube, and FIG. 7B is a cross-sectional view of the body insertion tube.

図7に示すように、本発明の体内挿入管は外管10と内管11の二重管構造とすることによって、体内器官組織との接合強度を高めるための機能及び血液、輸液又は配線の通路としての機能を別々に分けることができる。それによって、血液、輸液又は配線の通路として機能する内管形状はそのままにして、体内器官組織との接合強度を高めるための機能を有する外管の形状を自由に設計変更することが可能となる。したがって、体内器官組織の形状と接合位置に合わせたような外管形状を有する体内挿入管を作製することができるため、様々な形状からなる体内器官組織との接合に適用が可能となり、幅広い適用を図ることができる。   As shown in FIG. 7, the body insertion tube of the present invention has a double tube structure of the outer tube 10 and the inner tube 11, thereby increasing the bonding strength with the body organ tissue and blood, infusion or wiring. The function as a passage can be divided separately. As a result, it is possible to freely change the design of the shape of the outer tube having a function for increasing the bonding strength with the body organ tissue while keeping the shape of the inner tube functioning as a passage for blood, infusion or wiring. . Therefore, it is possible to produce an in-vivo insertion tube having an outer tube shape that matches the shape of the internal organ tissue and the joining position, so that it can be applied to the joining with internal organ tissues of various shapes, and can be applied widely. Can be achieved.

図7に示す体内挿入管1は、体内挿入管と体内器官組織との間に存在する空気を排出又は吸引して、負圧を作用させるための通路5を外管に備えた例を示している。負圧を作用させる通路5は、図7に示す外管10だけでなく、内管11又は外管と内管とが接する面で両者の管に備えることもできる。   The body insertion tube 1 shown in FIG. 7 shows an example in which the outer tube is provided with a passage 5 for discharging or sucking air existing between the body insertion tube and the body organ tissue and applying a negative pressure. Yes. The passage 5 for applying the negative pressure can be provided not only in the outer tube 10 shown in FIG. 7 but also in the inner tube 11 or a surface where the outer tube and the inner tube are in contact with each other.

図8は、本発明の体内挿入管に具備される、溝、孔又は窪みに負圧を作用させる通路の構成群であり、体内挿入管の左側断面図だけを模式的に示している。図8の(a)は、(A)外管10の溝2、孔3又は窪み4から体内挿入管の外部に向けて、前記体内挿入管と前記体内組織との間に存在する空気を排出又は吸引して、負圧を作用させるための通路5を外管10に備える構成である。図8の(a)に示す体内挿入管は、通路5が外管10の内部に形成されているが、本発明では内管11と接する側の外管10の表面を所定の厚さで切削して段差を設けて、その段差を通路として用いても良い。逆に、外管10と接する側の内管11の表面を所定の厚さで切削して段差を設けて、その段差を通路として用いて排出口又は吸引口6と繋げることもできる。図8の(b)は、(B)外管10の溝、孔又は窪みから内管11の内部空洞に向けて、前記体内挿入管と前記体内組織との間に存在する空気を排出又は吸引して、負圧を作用させるための通路5を前記内管11に備える構成であり、例として表面に溝2と孔3が形成された体内挿入管を示している。また、図8の(c)は、(C)外管10の溝、孔又は窪みから内管11の内部空洞に向けて、前記体内挿入管と前記体内組織との間に存在する空気を排出又は吸引して、負圧を作用させるための通路5を前記外管と内管の両者に備える構成であり、例として表面に窪み4が形成された体内挿入管を示している。図8の(c)に示す窪み4は、外管に備える通路5を経由して、内管に備える通路5に繋がっており、結果的に、窪みから内管の空洞までは空間的に連結している。図8に示す溝2、孔3又は窪み4は、上記で述べたように、開口の径又は面積及び最大深さが図2の場合と同じ範囲に規定される。   FIG. 8 shows a group of passages for applying a negative pressure to a groove, hole, or depression provided in the in-vivo insertion tube of the present invention, and schematically shows only a left sectional view of the in-vivo insertion tube. (A) of FIG. 8 (A) discharges air existing between the body insertion tube and the body tissue from the groove 2, hole 3 or recess 4 of the outer tube 10 toward the outside of the body insertion tube. Or it is the structure which equips the outer tube | pipe 10 with the channel | path 5 for attracting | sucking and applying a negative pressure. In the insertion tube shown in FIG. 8A, the passage 5 is formed inside the outer tube 10, but in the present invention, the surface of the outer tube 10 on the side in contact with the inner tube 11 is cut to a predetermined thickness. Then, a step may be provided, and the step may be used as a passage. Conversely, the surface of the inner tube 11 on the side in contact with the outer tube 10 can be cut to a predetermined thickness to provide a step, and the step can be used as a passage to be connected to the discharge port or the suction port 6. FIG. 8B shows (B) discharging or aspirating air existing between the body insertion tube and the body tissue from the groove, hole, or depression of the outer tube 10 toward the inner cavity of the inner tube 11. Thus, the inner tube 11 is provided with a passage 5 for applying a negative pressure. As an example, a body insertion tube having a groove 2 and a hole 3 formed on the surface thereof is shown. 8C, (C) the air existing between the body insertion tube and the body tissue is exhausted from the groove, hole or depression of the outer tube 10 toward the inner cavity of the inner tube 11. Or it is the structure which equips both the said outer tube | pipe and the inner tube | pipe with the channel | path 5 for attracting | sucking and applying a negative pressure, and has shown the insertion tube in the body by which the hollow 4 was formed in the surface as an example. The depression 4 shown in FIG. 8C is connected to the passage 5 provided in the inner pipe via the passage 5 provided in the outer pipe. As a result, the depression and the cavity of the inner pipe are connected spatially. doing. As described above, the groove 2, the hole 3 or the recess 4 shown in FIG. 8 is defined in the same range as the case of FIG.

図8に示す外管10又は内管11は、体内挿入管1と体内器官組織との間に存在する空気を排出又は吸引して、負圧を作用させるための通路5を備えるため、溝、孔又は窪みの開口深部に溜まる空気は減圧処理によって排出口又は吸引口6を通して排出又は吸引される。これは、体内挿入管と体内器官組織との密着性が向上して両者の界面に隙間や剥離が無くなる効果を生む。それによって、体内器官組織の変形と変位による投錨効果が大きくなるため、接合強度の一層の向上を図ることができる。   The outer tube 10 or the inner tube 11 shown in FIG. 8 is provided with a passage 5 for exhausting or sucking air existing between the body insertion tube 1 and the body organ tissue and applying a negative pressure. The air accumulated in the deep opening of the hole or the depression is discharged or sucked through the discharge port or the suction port 6 by the decompression process. This produces an effect of improving the adhesion between the body insertion tube and the body organ tissue and eliminating gaps and separation at the interface between the two. As a result, the throwing effect due to deformation and displacement of the internal organ tissue is increased, so that the joint strength can be further improved.

以上のように、本発明の二重管構造を有する体内挿入管は、溝、孔又は窪みに負圧を作用させるための通路を、二重管の外管、内管、及び外管と内管の間の何れかに形成することができる。   As described above, the body insertion tube having the double tube structure of the present invention has a double channel outer tube, an inner tube, and an outer tube and an inner tube as a passage for applying a negative pressure to a groove, a hole or a depression. It can be formed anywhere between the tubes.

図9は、外管10と内管11とから構成され、内管11の周囲に負圧を作用させる通路5を備える二重構造の体内挿入管を示す。図9の(a)及び(b)は、それぞれ体内挿入管の外観図と断面図である。図9の(b)に示すように、内管11に備える通路5は、外管11に形成した溝2と繋がっている。図9の12は、負圧の状態にするときに減圧処理を行うための空気吸引穴であり、外管10の形成される通路5の一部としてみなすことができる。さらに、図9に示す外管10と内管11からなる二重管構造は、外管と内管がゴムや熱可塑性エラストマー等からなるOリング13を介して固定される。Oリング13は弾性体であるため、外管と内管との装着が容易であり、同時に両者の密着性を向上できる。Oリング13を用いることによって、両者を高い気密性を有した状態で強固に固定できる。本発明では、Oリング等の弾性体の代わりに、発泡性プラスチック、不織布又は金属製の緩衝リング等の緩衝剤を使用してもよい。   FIG. 9 shows a double-structured body insertion tube that includes an outer tube 10 and an inner tube 11 and includes a passage 5 that applies a negative pressure around the inner tube 11. FIGS. 9A and 9B are an external view and a cross-sectional view of the body insertion tube, respectively. As shown in FIG. 9B, the passage 5 provided in the inner tube 11 is connected to the groove 2 formed in the outer tube 11. Reference numeral 12 in FIG. 9 denotes an air suction hole for performing a decompression process when the negative pressure state is set, and can be regarded as a part of the passage 5 in which the outer tube 10 is formed. Further, in the double tube structure including the outer tube 10 and the inner tube 11 shown in FIG. 9, the outer tube and the inner tube are fixed via an O-ring 13 made of rubber, thermoplastic elastomer or the like. Since the O-ring 13 is an elastic body, it is easy to attach the outer tube and the inner tube, and at the same time, the adhesion between them can be improved. By using the O-ring 13, both can be firmly fixed with high airtightness. In the present invention, instead of an elastic body such as an O-ring, a buffering agent such as foamable plastic, non-woven fabric, or metal buffer ring may be used.

図9に示すOリング13は、外管の材質よりも熱伝導性が低い材料を使用することによって、外管と内管の断熱性を確保することができる。この場合、体内器官組織との接合において、体内器官組織に覆われた外管をその周囲に巻かれたニクロム線等の抵抗加熱線8によって加熱するときに、温度の上昇は外管で大きいものの、内管では熱伝導が抑えられるため温度上昇を抑えることができ、接合作業が行いやすくなる。また、接合部分のみの加熱が可能となるため、接合部分を除く体内器官組織への熱的なダメージを小さくできるという利点もある。本発明においては、外管及び内管が金属で作製され、Oリングとして金属よりも熱伝導性の低いゴムや熱可塑性エラストマー等を使用することによって、Oリングによる断熱性の効果を奏することができる。本発明において加熱時の温度上昇を短時間で効率的に行う場合は、抵抗加熱線などから構成される加熱用熱源を外管だけでなく、内管にも備えることができる。   The O-ring 13 shown in FIG. 9 can ensure heat insulation between the outer tube and the inner tube by using a material having lower thermal conductivity than the material of the outer tube. In this case, when the outer tube covered with the body organ tissue is heated by the resistance heating wire 8 such as a nichrome wire wound around the outer tube at the junction with the body organ tissue, the temperature rise is large in the outer tube. In the inner pipe, heat conduction is suppressed, so that the temperature rise can be suppressed, and the joining work is facilitated. In addition, since only the joined portion can be heated, there is an advantage that thermal damage to the internal organ tissue excluding the joined portion can be reduced. In the present invention, the outer tube and the inner tube are made of metal, and by using rubber or thermoplastic elastomer having a lower thermal conductivity than the metal as the O-ring, the effect of heat insulation by the O-ring can be achieved. it can. In the present invention, when the temperature rise during heating is efficiently performed in a short time, a heating heat source composed of a resistance heating wire or the like can be provided not only in the outer tube but also in the inner tube.

図9に示す体内挿入管1を用いて、体内器官組織との接合を行ったときの接合状態を図10に示す。図10に示すように、体内挿入管1は、加熱及び/又は微小振動等の低エネルギー接合時に、体内挿入管1の外部表面に形成する溝2から、内管11の周囲に形成された通路5を介して、外管10の外部に向けて、体内挿入管1と体内組織9との間に存在する空気を排出又は吸引して負圧状態を形成する。それによって、体内器官組織9の溝2への変形又は変位を助けて投錨効果が確実に得られるようになり、低エネルギー接合後は体内挿入管1と体内器官組織9との間の接合強度(接着力)が大幅に向上する。   FIG. 10 shows a joined state when joining with a body organ tissue using the body insertion tube 1 shown in FIG. As shown in FIG. 10, the body insertion tube 1 has a passage formed around the inner tube 11 from the groove 2 formed on the outer surface of the body insertion tube 1 at the time of low energy bonding such as heating and / or microvibration. 5, the air existing between the body insertion tube 1 and the body tissue 9 is discharged or sucked toward the outside of the outer tube 10 to form a negative pressure state. Thereby, deformation or displacement of the body organ tissue 9 into the groove 2 is helped to ensure a throwing effect, and after low energy joining, the joint strength between the body insertion tube 1 and the body organ tissue 9 ( Adhesion) is greatly improved.

図11は、内管と外管とからなる二重管構造を有する別の形態の体内挿入管を示す図である。図11の(a)及び(b)は、それぞれ体内挿入管の外観図と断面図である。この体内挿入管は、図11の(b)に示すように、負圧を作用させるための通路5が外管10の溝2から内管11の内部空洞7に繋がる構造を有する。また、接合時に外管10と体内器官組織との間に存在する空気を内管11の内部空洞7を介して外部へ排出又は吸引する構造であるために、図10の示す体内挿入管とは異なり、排出口又は吸引口6が内管11に形成されている。それら以外は、図9及び図10に示す体内挿入管と基本的に同じ構造と構成を有する。   FIG. 11 is a diagram showing another form of the body insertion tube having a double tube structure including an inner tube and an outer tube. FIGS. 11A and 11B are an external view and a cross-sectional view of the body insertion tube, respectively. As shown in FIG. 11 (b), the body insertion tube has a structure in which a passage 5 for applying a negative pressure is connected from the groove 2 of the outer tube 10 to the inner cavity 7 of the inner tube 11. In addition, since the structure is such that air existing between the outer tube 10 and the body organ tissue at the time of joining is discharged or sucked to the outside through the inner cavity 7 of the inner tube 11, the in-vivo insertion tube shown in FIG. In contrast, a discharge port or suction port 6 is formed in the inner tube 11. Other than those, it has basically the same structure and configuration as the in-vivo insertion tube shown in FIGS.

本発明の体内挿入管は、人工心臓装着の際に使用される脱着管及び送血管、特に、従来の技術では接合が困難であった脱血管として使用されるときに、接合強度の向上に対して大きな効果を示す。また、本発明の体内挿入管はカフ(つば)等を有する特殊な構造とする必要がなくなるため、それ以外の生体内組織の接合又は接続のために適用でき、例えば消化管や血管等の吻合、人工血管と生体血管との接続、胃瘻、人工肛門など消化器と挿入管の接合、又はその挿入管が皮膚貫通して体外に出てくる部分の接合に使用可能である。その他にも人工心臓のエネルギー供給ケーブルの皮膚貫通部接合等にも使用可能である。その際に、体内挿入管の形状をこれらの用途の形状に合わせて設計することは、通常行われる設計変更の範囲内で容易である。   The intracorporeal tube of the present invention is used for the improvement of the joint strength when it is used as a desorption tube and a blood supply tube used when an artificial heart is mounted, particularly as a devascularization that is difficult to join by the conventional technology. Show significant effects. Further, the in-vivo insertion tube of the present invention is not required to have a special structure having a cuff or the like, and can be applied for joining or connecting other tissues in the living body. For example, an anastomosis of a digestive tract, a blood vessel, etc. It can be used to connect an artificial blood vessel and a biological blood vessel, to join a digestive organ and an insertion tube such as a gastric fistula and an artificial anus, or to join a portion where the insertion tube penetrates the skin and comes out of the body. In addition, it can be used for joining the skin penetration part of the energy supply cable of the artificial heart. At that time, it is easy to design the shape of the body insertion tube in accordance with the shape of these applications within the range of design changes that are normally made.

本発明の体内挿入管と体内器官組織との接合方法は、次に示す工程を含んで行われる。   The method for joining a body insertion tube and body organ tissue according to the present invention includes the following steps.

まず、図4〜図7に示すように、一重管構造を有する組織自己接合型体内挿入管の工程としては、(D)本発明の体内挿入管が体内器官組織によって覆われるような状態で、前記体内挿入管と体内器官組織とを接触させる工程、(E)前記溝、孔又は窪みに負圧を作用させる通路に直結する排出口又は吸引口から空気を吸引することによって前記体内挿入管と前記体内器官組織との接触部を負圧にする工程、及び(F)前記負圧を取り除いた後、又は前記負圧にした状態で、前記体内器官組織との接触部を加熱及び/又は微小振動を加えて前記の体内挿入管と体内器官組織とを接合する工程、を含む。   First, as shown in FIG. 4 to FIG. 7, as a process of the tissue self-joining body insertion tube having a single tube structure, (D) in a state where the body insertion tube of the present invention is covered with the body organ tissue, The step of bringing the body insertion tube into contact with the body organ tissue; (E) the body insertion tube by sucking air from a discharge port or a suction port directly connected to a passage that applies a negative pressure to the groove, hole, or depression; A step of applying a negative pressure to the contact portion with the body organ tissue, and (F) heating and / or minutely the contact portion with the body organ tissue after removing the negative pressure or in the state of the negative pressure. And applying a vibration to join the body insertion tube and body organ tissue.

次に、図7〜図11に示すように、二重管構造を有する組織自己接合型体内挿入管の場合は、(G)前記体内挿入管の外管が前記体内組織によって覆われるような状態で、前記体内挿入管と前記体内器官組織とを接触させる工程、(H)前記溝、孔又は窪みに負圧を作用させる通路に直結する排出口又は吸引口から空気を吸引することによって前記外管と前記体内器官組織との接触部を負圧にする工程、及び(I)前記負圧を取り除いた後、若しくは前記負圧にした状態で、前記体内器官組織との接触部を加熱及び/又は微小振動を加えて前記体内挿入管の外管と体内器官組織とを接合する工程、を含む。   Next, as shown in FIGS. 7 to 11, in the case of a tissue self-joining body insertion tube having a double tube structure, (G) a state in which an outer tube of the body insertion tube is covered with the body tissue The step of bringing the body insertion tube into contact with the body organ tissue, (H) the outside by sucking air from a discharge port or a suction port directly connected to a passage that applies a negative pressure to the groove, hole, or depression; A step of applying a negative pressure to a contact portion between a tube and the body organ tissue; and (I) heating and / or heating the contact portion with the body organ tissue after removing the negative pressure or in the state of the negative pressure. Alternatively, a step of applying a minute vibration to join the outer tube of the body insertion tube and the body organ tissue is included.

さらに、上記の2つの接合方法において、前記負圧にする工程を、体内器官組織との接触部に外部から圧力を加える工程と組み合わせて行うこともできる。すなわち、本発明の一重管構造又は二重管構造を有する体内挿入管を用いて、前記の(E)若しくは(H)の工程は、前記負圧にする工程を、体内器官組織との接触部に外部から圧力を加える工程と組み合わせて行い、前記の(F)若しくは(I)の工程は、前記の圧力及び負圧の少なくとも何れかを取り除いた後、若しくは前記の圧力と負圧を同時に付与した状態で、前記前記体内組織との接触部を加熱及び/又は微小振動を加えることを特徴とする接合方法である。   Furthermore, in the above two joining methods, the step of making the negative pressure can be performed in combination with a step of applying pressure from the outside to the contact portion with the body organ tissue. That is, using the in-vivo insertion tube having a single-tube structure or a double-tube structure of the present invention, the step (E) or (H) is a step of setting the negative pressure to a contact portion with a body organ tissue. The step (F) or (I) is applied after removing at least one of the pressure and the negative pressure, or simultaneously applying the pressure and the negative pressure. In this state, the contact portion with the body tissue is heated and / or subjected to minute vibrations.

上記の負圧にする工程において、負圧状態は真空ポンプ等を用いて減圧処理を行って形成できる。このときの負圧は、−0.01MPa以上(圧力の絶対値としては0.01MPa以下)であれば良く、あえて高真空状態にする必要はない。本発明による接合を負圧状態で行う場合は、体内挿入管の外部に備える排出口又は吸引口が体内器官組織に完全に覆われていなければ、減圧処理によって連結通路を高い負圧にすることができない。そのため、体内器官組織の接合部分は減圧処理時に使用する真空ポンプ圧力計で容易に確認することができ、さらに、圧力計を見ながらその接合位置の調整を行うこともできる。このようにして連結通路を高い負圧にすることができる位置を定めることができれば、その負圧によって体内器官組織の接合部分がずれることがない。したがって、本発明においては、接合部分の検知と調整及び強固な固定を行うため、負圧処理によって体内器官組織の接合を行うことが大きな特徴である。   In the negative pressure step, the negative pressure state can be formed by performing a pressure reduction process using a vacuum pump or the like. The negative pressure at this time may be −0.01 MPa or more (the absolute value of the pressure is 0.01 MPa or less), and does not have to be in a high vacuum state. When the joining according to the present invention is performed under a negative pressure state, if the discharge port or the suction port provided outside the body insertion tube is not completely covered with the body organ tissue, the connection passage is made a high negative pressure by the decompression process. I can't. Therefore, the joint portion of the body organ tissue can be easily confirmed with a vacuum pump pressure gauge used at the time of the decompression process, and the joint position can be adjusted while looking at the pressure gauge. Thus, if the position which can make a connection channel | path a high negative pressure can be defined, the junction part of a body organ tissue will not shift | deviate by the negative pressure. Therefore, in the present invention, in order to detect and adjust the joint portion and firmly fix the joint portion, it is a major feature that the body organ tissue is joined by negative pressure processing.

上記の負圧にする工程と同時に、又はその工程の後にで行われる接合工程で利用する加圧、加熱、及び微小振動は、上記でも述べたように、それぞれ0.01〜10MPa、50〜250℃、及び1Hz〜1MHzの範囲で行う。微小振動による接合方法としては、例えば、図12に示すように、圧電素子を利用した受動素子であるピエゾ素子24を用いる方法が挙げられる。図12に示す体内挿入管1は一重管構造を有するものを例として示したものであり(なお、体内挿入管1の表面に形成される溝、孔又は窪みは図示を省略している。)、体内器官組織9の周囲に配置するピエゾ素子24によって、体内挿入管1と体内器官組織9との接合界面に微小振動エネルギーを加える。   The pressurization, heating, and microvibration used in the joining step performed simultaneously with or after the negative pressure step are 0.01 to 10 MPa and 50 to 250, respectively, as described above. The measurement is performed at a temperature in the range of 1 ° C. to 1 MHz. As a joining method by micro vibration, for example, as shown in FIG. 12, there is a method using a piezo element 24 which is a passive element using a piezoelectric element. The in-vivo insertion tube 1 shown in FIG. 12 is shown as an example having a single tube structure (note that grooves, holes or indentations formed on the surface of the in-body insertion tube 1 are not shown). The micro vibration energy is applied to the junction interface between the body insertion tube 1 and the body organ tissue 9 by the piezo element 24 arranged around the body organ tissue 9.

本発明においては、上記の負圧処理とともに、体内器官組織の周囲から圧力の付与を同時に行ってもよい。体内器官組織の接合部分と接合強度だけでなく、接合方法、接合条件(時間等)及び接合装置に応じて、負圧処理又は負圧処理と圧力付与の両者の方法を組み合わせることができる。   In the present invention, in addition to the above-described negative pressure treatment, pressure may be simultaneously applied from around the body organ tissue. Depending on the joining method, joining conditions (time, etc.) and joining device as well as the joining part and joining strength of the internal organ tissue, negative pressure treatment or both methods of negative pressure treatment and pressure application can be combined.

次に、具体的な実施形態によって本発明を説明する。   Next, the present invention will be described by specific embodiments.

<第1の実施形態>
図11の(a)に示す体内挿入管において破線で囲んだ部分を抽出して試作を行った組織自己接合型血管を図13に示す。図13の(a)及び(b)は、それぞれ外観図及び断面図である。組織自己接合型脱血管1は、生体適合性に優れるステンレス製であり、全長が37mm、外径が21mm、内径が14mmの外管10と内管11からなる二重管構造である。外管10と内管11は、Oリング13によって固定・断熱される。本実施形態は試作用のため血流又は輸流の通路はなくし、上下に栓14をして、内管の排出口又は吸引口6を介して、真空ポンプを用いて減圧処理することによって負圧の発生が容易な構造とした。また、図13の(b)に示すように、外管10の溝側面には加熱用抵抗加熱線8としてニクロム線が取り付けられており、さらに、溝近くに温度測定用として熱電対15が配置されている。抵抗加熱線8であるニクロム線と熱電対15はそれぞれ配線されて内管内の空洞を通して、導線出口16から外部へ引き出されている。導線出口16は内管内の空洞を密封するため、シリコーンゴムで埋める。
<First Embodiment>
FIG. 13 shows a tissue self-joining blood vessel that was experimentally produced by extracting the portion surrounded by a broken line in the in-vivo insertion tube shown in FIG. FIGS. 13A and 13B are an external view and a cross-sectional view, respectively. The tissue self-joining type blood removal vessel 1 is made of stainless steel having excellent biocompatibility, and has a double tube structure including an outer tube 10 and an inner tube 11 having a total length of 37 mm, an outer diameter of 21 mm, and an inner diameter of 14 mm. The outer tube 10 and the inner tube 11 are fixed and insulated by an O-ring 13. Since this embodiment is for trial use, there is no passage for blood flow or infusion, and plugs 14 are provided at the top and bottom, and the pressure is reduced by using a vacuum pump through the discharge port or suction port 6 of the inner tube. The structure facilitates the generation of pressure. Further, as shown in FIG. 13 (b), a nichrome wire is attached as a resistance heating wire 8 for heating on the groove side surface of the outer tube 10, and a thermocouple 15 is disposed near the groove for temperature measurement. Has been. The nichrome wire as the resistance heating wire 8 and the thermocouple 15 are respectively wired and drawn out from the lead wire outlet 16 through the cavity in the inner tube. The conductor outlet 16 is filled with silicone rubber to seal the cavity in the inner tube.

本実施形態の組織自己接合型脱血管の外管表面に形成した溝は、開口幅が2.5mmであり、深さが1.5mmにしたものの2本を外管の周方向に連続して形成する。2本の溝の間隔は2mmである。接合時における外管の加熱温度は、温度制御システムによって制御する。本実施形態の組織自己接合型脱血管は、図13の(a)に示す幅Wの領域で体内組織器官と接合する。体内組織器官としては、具体的に豚の心臓を使用した。   The groove formed on the outer tube surface of the tissue self-joining type blood vessel of this embodiment has an opening width of 2.5 mm and a depth of 1.5 mm, and two grooves are continuously formed in the circumferential direction of the outer tube. Form. The interval between the two grooves is 2 mm. The heating temperature of the outer tube at the time of joining is controlled by a temperature control system. The tissue self-joining type blood vessel of the present embodiment is joined to a body tissue organ in a region having a width W shown in FIG. Specifically, a porcine heart was used as the body tissue organ.

接合後の組織自己接合型脱血管と心臓との接合強度は、引張試験を行うことによって求める。引張強度は、上側に荷重変換器を固定し、下側に固定した直動アクチュエータによって鉛直方向に引張荷重を加える引張試験機を用いて、心臓−脱血管径方向と心臓−脱血管軸方向との2方向を測定する。心臓−脱血管径方向の場合は、荷重変換器に心臓を取付ける上部チャックを固定し、直動アクチュエータに脱血管を取付ける下部チャックを固定して、鉛直方向に引張荷重を加えて測定する。一方、心臓−脱血管軸方向の場合は、荷重変換器に心臓を乗せる溝形鋼(チャンネル)を固定し、直動アクチュエータに脱血管を取付けるチェックを固定して、鉛直方向に引張荷重を加えて測定する。   The joint strength between the tissue self-joining type blood vessel after joining and the heart is obtained by conducting a tensile test. Tensile strength is determined by using a tensile tester in which a load transducer is fixed on the upper side and a tensile load is applied in the vertical direction by a linear motion actuator fixed on the lower side. Are measured in two directions. In the case of the cardiac-devascularization radial direction, the upper chuck for attaching the heart to the load transducer is fixed, the lower chuck for attaching the devascularization to the linear motion actuator is fixed, and a tensile load is applied in the vertical direction for measurement. On the other hand, in the case of the heart-devascularization axis direction, the grooved steel (channel) for placing the heart on the load transducer is fixed, the check for attaching the devascularization to the linear actuator is fixed, and a tensile load is applied in the vertical direction. To measure.

径方向引張及び軸方向引張による接合強度の測定結果を、それぞれ図14の(a)及び(b)に示す。図14には、真空ポンプによる減圧処理で脱血管内の圧力を−0.1MPaの負圧に設定し、接合温度及び接合時間をそれぞれ80℃〜100℃及び60〜90秒の範囲で変えて引張で測定した接合強度の結果が示されている。   The measurement results of the joint strength by radial tension and axial tension are shown in FIGS. 14 (a) and 14 (b), respectively. In FIG. 14, the pressure in the blood removal vessel is set to a negative pressure of −0.1 MPa by decompression processing using a vacuum pump, and the joining temperature and the joining time are changed in the range of 80 ° C. to 100 ° C. and 60 to 90 seconds, respectively. The result of bond strength measured by tension is shown.

図14の(a)及び(b)から分かるように、径方向引張及び軸方向引張で測定した接合強度は、接合温度の上昇とともに高くなる。また、接合時間も長くなるほど、両者の接合強度が高くなる傾向にある。また、引張による接合強度は軸方向が径方向よりも高くなる。これは、接合によって形成された心筋組織の凹凸部が軸方向に対して抵抗になるためと考えられる。このように、本実施形態の組織自己接合型脱血管は心臓との接合強度が高く、優れた接合性を有する。また、接合後の心臓の接合面を分解して観察すると、すべての接合条件において心臓の接合断面は脱血管の外管の溝と対になる凹凸が形成されており、接合によって形成される心臓の凹凸は、外管の溝側面でも接合されていることが確認できた。したがって、本実施形態の組織自己接合型脱血管を使用する接合方法は接合部分に隙間無く高強度で接合を行うことができるため、細菌の浸入を防止できる優れた接合方法である。   As can be seen from FIGS. 14A and 14B, the bonding strength measured by radial tension and axial tension increases as the bonding temperature increases. Also, the longer the bonding time, the higher the bonding strength between the two. Moreover, the joint strength by tension becomes higher in the axial direction than in the radial direction. This is considered because the uneven | corrugated | grooved part of the myocardial tissue formed by joining becomes resistance with respect to an axial direction. As described above, the tissue self-joining type blood vessel removal according to the present embodiment has high bonding strength with the heart and has excellent bonding properties. Further, when the joint surface of the heart after joining is disassembled and observed, the joint cross section of the heart is formed with irregularities that are paired with the groove of the outer tube of the devascularization under all joining conditions, and the heart formed by joining It was confirmed that the unevenness was also joined to the groove side surface of the outer tube. Therefore, the joining method using the tissue self-joining type blood vessel removal according to the present embodiment is an excellent joining method that can prevent the invasion of bacteria because the joining portion can be joined with high strength without a gap.

<第2の実施形態>
図13に示す体内挿入管はOリング13を有するものであり、外管10と内管11との間で断熱効果を奏する。この外管10と内管11との間の断熱効果を、Oリングを用いないで外管を内管の外側にはめ合いで固定した脱血管の場合と対比するために、100℃120秒間加熱したときの外管と内管との温度差を過渡伝熱解析シミュレーションによって求めた。解析シミュレーションにおいて、各材料(ステンレス鋼、栓として使用するフッ素ゴム、及びニクロム線等)の物性値は、密度、熱伝導率及び比熱を用いた。その結果、第1の実施形態の脱血管は、外管が一様に100℃で内管が50℃であるのに対して、Oリング無しの脱血管は外管及び内管がともに90℃であることが分かった。この結果は、実測値とも良く合っており、Oリングを使用することによって、本発明の二重管構造の脱血管は、外管と内管との間で断熱効果を得ることができる。
<Second Embodiment>
The in-vivo insertion tube shown in FIG. 13 has an O-ring 13 and provides a heat insulating effect between the outer tube 10 and the inner tube 11. In order to compare the heat insulation effect between the outer tube 10 and the inner tube 11 with the case of devascularization in which the outer tube is fixed to the outside of the inner tube without using an O-ring, heating is performed at 100 ° C. for 120 seconds. The temperature difference between the outer tube and the inner tube was obtained by transient heat transfer analysis simulation. In the analysis simulation, the physical properties of each material (stainless steel, fluoro rubber used as a stopper, nichrome wire, etc.) used density, thermal conductivity, and specific heat. As a result, in the devascularization of the first embodiment, the outer tube is uniformly 100 ° C. and the inner tube is 50 ° C., whereas in the devascularization without an O-ring, both the outer tube and the inner tube are 90 ° C. It turns out that. This result is in good agreement with the actually measured value. By using the O-ring, the blood vessel removal with the double tube structure of the present invention can obtain a heat insulating effect between the outer tube and the inner tube.

また、Oリング有りの場合は外管の温度が100℃であるのに対して、Oリング無しでは外管の温度が90℃とやや低くなっている。これは、Oリング無しの場合は、内管への熱伝達が大きいために外管の温度が上がりきれず、やや低下するためと考えられる。このように、Oリングは、外管の設定温度を保持する効果が得られることから、本発明の接合において効率的な加熱を行う際に、脱血管を含め体内挿入管の構成として有用である。   Further, when the O-ring is present, the temperature of the outer tube is 100 ° C., but without the O-ring, the temperature of the outer tube is slightly low at 90 ° C. This is presumably because in the case of no O-ring, the heat transfer to the inner tube is large, and the temperature of the outer tube cannot be increased and is slightly decreased. As described above, since the effect of maintaining the set temperature of the outer tube is obtained, the O-ring is useful as a configuration of the in-vivo insertion tube including blood removal when performing efficient heating in the joining of the present invention. .

<第3の実施形態>
図9に示すように、外管10と、外管10と接する境界面に負圧を作用させる通路5を形成し、内部空洞を有する内管11とを備える二重管構造の脱血管を試作した。この体内挿入管の外管は、周方向に開口幅が2.5mmであり、深さが1.0mmである溝2が2本形成され、2本の溝の間は2mmに設定されている。溝2の底部には、外管10と接する内管11の境界面に深さ0.5mmの部分を切削加工して形成した通路5と連結する穴が設けてある。
<Third Embodiment>
As shown in FIG. 9, a trial devascularization of a double tube structure including an outer tube 10 and a passage 5 for applying a negative pressure to the boundary surface in contact with the outer tube 10 and an inner tube 11 having an internal cavity. did. The outer tube of the body insertion tube has an opening width of 2.5 mm in the circumferential direction, two grooves 2 having a depth of 1.0 mm are formed, and the gap between the two grooves is set to 2 mm. . The bottom of the groove 2 is provided with a hole connected to the passage 5 formed by cutting a portion having a depth of 0.5 mm on the boundary surface of the inner tube 11 in contact with the outer tube 10.

本実施形態の組織自己接合型脱血管に加温性能を実験したところ,第1の実施形態と同様の性能を確認した。第1の実施形態と同じ方法、条件で体内組織器官として使用する豚の接合を行い,同様の接合性能、接合強度結果を得た。   When the heating performance was tested on the tissue self-joining type blood vessel removal of the present embodiment, the same performance as in the first embodiment was confirmed. A pig used as a body tissue organ was joined under the same method and conditions as in the first embodiment, and similar joining performance and joining strength results were obtained.

第1〜第3の実施形態においては、主に二重管構造の脱血管について具体的に説明したが、図4及び図5に示すような一重管構造の脱血管においても同様な効果が得られることは言うまでもない。   In the first to third embodiments, the degassing of the double tube structure has been specifically described. However, the same effect can be obtained also in the devascularization of the single tube structure as shown in FIGS. Needless to say.

以上のように、本発明によれば、体内器官組織との接合において接合部分に隙間無く、高い接合強度を得ることができる。これは、体内器官組織と接触する側に前記体内器官組織の変形又は変位を起こさせるための溝、孔又は窪みを形成するだけでなく、さらに、体内挿入管と体内器官組織との間に存在する空気を排出又は吸引して、前記溝、孔又は窪みに負圧を作用させるための通路を備えることによって、大きな投錨(アンカリング)効果が得られるためである。それによって、接合部分に負圧が付与されるときに体内器官組織の前記の溝、孔又は窪みへの変形又は変位が容易となり、接合界面に接合強度を低下させるようなボイドや隙間の発生が抑制され、接合強度の一層の向上を図ることができる。したがって、本発明による体内挿入管と体内器官組織との接合方法は、従来方法で問題となっていた細菌の浸入を防止することができ、安全性が高く、且つ耐久信頼性に優れる方法である。また、本発明の体内挿入管はカフ(つば)等を有する特殊な構造とする必要が無くなるため、心臓の脱血管や送血管としてだけではなく、それ以外の生体内組織の接合又は接続のために適用できる。例えば消化管や血管等の吻合、又は人工血管と生体血管との接続に使用できるため、その有用性は極めて高い。   As described above, according to the present invention, a high bonding strength can be obtained without a gap at the bonding portion in bonding with a body organ tissue. This not only forms a groove, hole or depression for causing deformation or displacement of the internal organ tissue on the side in contact with the internal organ tissue, but also exists between the internal insertion tube and the internal organ tissue. This is because a large anchoring effect can be obtained by providing a passage for discharging or sucking air to apply a negative pressure to the groove, hole or recess. As a result, when negative pressure is applied to the joint portion, deformation or displacement of the body organ tissue into the groove, hole, or depression is facilitated, and voids or gaps that reduce the joint strength at the joint interface are generated. It is suppressed and the joint strength can be further improved. Therefore, the method for joining the body insertion tube and body organ tissue according to the present invention is a method that can prevent the invasion of bacteria, which has been a problem in the conventional method, is highly safe, and has excellent durability and reliability. . Further, the in-vivo insertion tube of the present invention does not need to have a special structure having a cuff or the like, so that it is not only used as a heart blood removal vessel or a blood supply tube but also for joining or connecting other in vivo tissues. Applicable to. For example, it can be used for anastomoses such as digestive tracts and blood vessels, or for connection between artificial blood vessels and biological blood vessels, so that its usefulness is extremely high.

1・・・体内挿入管、2・・・溝、3・・・孔、4・・・窪み、5・・・連結通路、6・・・排出口又は吸引口、7・・・内部空洞、8・・・加熱抵抗線、9・・・体内器官組織、10・・・外管、11・・・内管、12・・・空気吸引孔、13・・・Oリング、14・・・栓、15・・・熱電対、16・・・導線出口、17・・・脱血管、18・・・カフ(つば)、19・・・心臓、20・・・巾着縫合、21・・・送血管、22・・・空気、23・・・・気密栓、24・・・ピエゾ素子。 DESCRIPTION OF SYMBOLS 1 ... Body insertion tube, 2 ... Groove, 3 ... Hole, 4 ... Depression, 5 ... Connection channel, 6 ... Discharge port or suction port, 7 ... Internal cavity, 8 ... heating resistance wire, 9 ... body organ tissue, 10 ... outer tube, 11 ... inner tube, 12 ... air suction hole, 13 ... O-ring, 14 ... plug 15 ... Thermocouple, 16 ... Conductor outlet, 17 ... Devascularized, 18 ... Cuff (19), 19 ... Heart, 20 ... Drawstring suture, 21 ... Blood vessel , 22 ... Air, 23 ... Airtight stopper, 24 ... Piezo element.

Claims (7)

体内器官組織に覆われた状態で前記体内器官組織と接触して加熱及び/又は微小振動を加えて接合される体内挿入管であって、
前記体内挿入管には、少なくとも、前記体内器官組織と接触する側に前記体内器官組織の一部が変形又は変位により侵入することにより投錨効果が得られる大きさの溝、孔又は窪みが形成され、前記体内挿入管と前記体内器官組織との接合時に前記溝、孔又は窪みに負圧を作用させるための通路が形成され
前記体内器官組織と接触して加熱及び/又は微小振動を加えて接合された後の引張強度が0.01MPa以上であることを特徴とする組織自己接合型体内挿入管。
A body insertion tube that is joined by heating and / or microvibration in contact with the body organ tissue in a state of being covered with the body organ tissue,
The body insertion tube is formed with at least a groove, a hole, or a recess having a size that allows a throwing effect to be obtained when a part of the body organ tissue penetrates due to deformation or displacement on the side in contact with the body organ tissue. A passage for applying a negative pressure to the groove, hole or depression when the body insertion tube and the body organ tissue are joined is formed ,
A tissue self-joining intracorporeal insertion tube having a tensile strength of 0.01 MPa or more after being joined to the body organ tissue by heating and / or microvibration .
請求項1に記載の組織自己接合型体内挿入管は、前記の体内器官組織の変形又は変位を起こさせるための溝、孔又は窪みが形成された管を外管とし、該外管の内部に、さらに血液、輸液又は配線の通路として機能する内部空洞を有する内管を備え、前記の溝、孔又は窪みに負圧を作用させるための通路が、前記の外管及び内管の少なくとも何れか一つに形成されていることを特徴とする組織自己接合型体内挿入管。   The tissue self-joining internal insertion tube according to claim 1, wherein a tube in which a groove, a hole or a depression for causing deformation or displacement of the body organ tissue is formed as an outer tube, And an inner tube having an internal cavity that functions as a blood, infusion, or wiring passage, and the passage for applying a negative pressure to the groove, hole, or depression is at least one of the outer tube and the inner tube. A tissue self-joining body insertion tube characterized by being formed into one. 請求項2に記載の組織自己接合型体内挿入管は、次の(A)、(B)、及び(C)、すなわち
(A)前記外管の溝、孔又は窪みから、前記体内挿入管の外部に向けて、前記体内挿入管と前記体内器官組織との間に存在する空気を排出又は吸引することによって前記溝、孔又は窪みに負圧を作用させるための通路を前記の外管又は内管に備えること、
(B)前記外管の溝、孔又は窪みから、前記内管の内部空洞に向けて、前記体内挿入管と前記体内器官組織との間に存在する空気を排出又は吸引することによって前記溝、孔又は窪みに負圧を作用させるための通路を前記内管に備えること、及び
(C)前記外管の溝、孔又は窪みから、前記内管の内部空洞に向けて、前記体内挿入管と前記体内器官組織との間に存在する空気を排出又は吸引することによって前記溝、孔又は窪みに負圧を作用させるための通路を前記の外管と内管の両者に備えること、
から成る構成群の中から選ばれる何れか一つを有することを特徴とする組織自己接合型体内挿入管。
The tissue self-joining body insertion tube according to claim 2 is the following (A), (B), and (C), that is, (A) From the groove, hole, or depression of the outer tube, A passage for applying a negative pressure to the groove, hole or depression by exhausting or sucking air existing between the body insertion tube and the body organ tissue toward the outside is provided in the outer tube or the inner tube. Preparing for the tube,
(B) The groove, hole or depression of the outer tube is exhausted or aspirated from the body insertion tube and the body organ tissue toward the inner cavity of the inner tube to exhaust or suck the air, Providing the inner tube with a passage for applying a negative pressure to the hole or the depression; and (C) from the groove, hole or depression of the outer tube toward the inner cavity of the inner tube, Providing both the outer tube and the inner tube with a passage for applying a negative pressure to the groove, hole, or depression by discharging or sucking air existing between the body organ tissue;
A tissue self-joining intracorporeal tube having any one selected from the group consisting of:
前記の外管と内管は、緩衝剤又は弾性体を介して固定されることを特徴とする請求項2又は3に記載の組織自己接合型体内挿入管。   The tissue self-joining intracorporeal insertion tube according to claim 2 or 3, wherein the outer tube and the inner tube are fixed via a buffer or an elastic body. 前記組織自己接合型体内挿入管は、前記溝、孔又は窪みに負圧を作用させるための通路と直結する排出口又は吸引口を備えることを特徴とする請求項1〜4の何れかに記載の組織自己接合型体内挿入管。 5. The tissue self-joining body insertion tube includes a discharge port or a suction port directly connected to a passage for applying a negative pressure to the groove, hole, or depression. 6. Tissue self-joining body insertion tube. 前記組織自己接合型体内挿入管は、加熱用熱源を備えることを特徴とする請求項1〜5の何れかに記載の組織自己接合型体内挿入管。 The tissue self-joining body insertion tube according to any one of claims 1 to 5, wherein the tissue self-joining body insertion tube includes a heating heat source. 前記体内挿入管が、人工心臓脱血管であることを特徴とする請求項1〜6の何れかに記載の組織自己接合型体内挿入管。   The tissue self-joining body insertion tube according to any one of claims 1 to 6, wherein the body insertion tube is an artificial heart blood removal vessel.
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