JP5069945B2 - Skin button - Google Patents
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- JP5069945B2 JP5069945B2 JP2007127336A JP2007127336A JP5069945B2 JP 5069945 B2 JP5069945 B2 JP 5069945B2 JP 2007127336 A JP2007127336 A JP 2007127336A JP 2007127336 A JP2007127336 A JP 2007127336A JP 5069945 B2 JP5069945 B2 JP 5069945B2
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- skin
- nonwoven fabric
- metal
- skin button
- metal nonwoven
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- 229910052751 metal Inorganic materials 0.000 claims description 57
- 239000002184 metal Substances 0.000 claims description 57
- 239000004745 nonwoven fabric Substances 0.000 claims description 54
- 210000001519 tissue Anatomy 0.000 claims description 32
- 239000000835 fiber Substances 0.000 claims description 19
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 18
- 239000010936 titanium Substances 0.000 claims description 18
- 229910052719 titanium Inorganic materials 0.000 claims description 18
- 239000000463 material Substances 0.000 claims description 17
- 206010033675 panniculitis Diseases 0.000 claims description 15
- 210000004304 subcutaneous tissue Anatomy 0.000 claims description 15
- 239000011148 porous material Substances 0.000 claims description 13
- 210000000056 organ Anatomy 0.000 claims description 12
- 229910000389 calcium phosphate Inorganic materials 0.000 claims description 9
- 239000001506 calcium phosphate Substances 0.000 claims description 9
- -1 calcium phosphate compound Chemical class 0.000 claims description 9
- 235000011010 calcium phosphates Nutrition 0.000 claims description 9
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 8
- 229910052586 apatite Inorganic materials 0.000 claims description 8
- 230000010261 cell growth Effects 0.000 claims description 8
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims description 8
- VSIIXMUUUJUKCM-UHFFFAOYSA-D pentacalcium;fluoride;triphosphate Chemical compound [F-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O VSIIXMUUUJUKCM-UHFFFAOYSA-D 0.000 claims description 8
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 8
- 229910001069 Ti alloy Inorganic materials 0.000 claims description 6
- 230000002093 peripheral effect Effects 0.000 claims description 6
- 239000013543 active substance Substances 0.000 claims description 5
- 238000002844 melting Methods 0.000 claims description 5
- 230000008018 melting Effects 0.000 claims description 5
- 102000004127 Cytokines Human genes 0.000 claims description 4
- 108090000695 Cytokines Proteins 0.000 claims description 4
- 102000004190 Enzymes Human genes 0.000 claims description 4
- 108090000790 Enzymes Proteins 0.000 claims description 4
- 229920002683 Glycosaminoglycan Polymers 0.000 claims description 4
- 102000004895 Lipoproteins Human genes 0.000 claims description 4
- 108090001030 Lipoproteins Proteins 0.000 claims description 4
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 claims description 4
- 239000003242 anti bacterial agent Substances 0.000 claims description 4
- 229940088710 antibiotic agent Drugs 0.000 claims description 4
- 150000004676 glycans Chemical class 0.000 claims description 4
- 239000003102 growth factor Substances 0.000 claims description 4
- 150000003904 phospholipids Chemical class 0.000 claims description 4
- 229920001282 polysaccharide Polymers 0.000 claims description 4
- 239000005017 polysaccharide Substances 0.000 claims description 4
- 102000004169 proteins and genes Human genes 0.000 claims description 4
- 108090000623 proteins and genes Proteins 0.000 claims description 4
- 210000001835 viscera Anatomy 0.000 claims description 4
- 239000000758 substrate Substances 0.000 claims description 3
- 230000037368 penetrate the skin Effects 0.000 claims description 2
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 230000000717 retained effect Effects 0.000 claims 1
- 210000003491 skin Anatomy 0.000 description 69
- 210000002615 epidermis Anatomy 0.000 description 12
- 230000000149 penetrating effect Effects 0.000 description 7
- 239000012237 artificial material Substances 0.000 description 6
- 210000004027 cell Anatomy 0.000 description 5
- 210000004207 dermis Anatomy 0.000 description 5
- 208000015181 infectious disease Diseases 0.000 description 5
- 230000033001 locomotion Effects 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 238000002513 implantation Methods 0.000 description 4
- 210000004204 blood vessel Anatomy 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 238000005245 sintering Methods 0.000 description 3
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 238000006073 displacement reaction Methods 0.000 description 2
- 210000002950 fibroblast Anatomy 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- 230000009545 invasion Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 208000005422 Foreign-Body reaction Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 238000009933 burial Methods 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 239000003575 carbonaceous material Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 238000000608 laser ablation Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 210000002901 mesenchymal stem cell Anatomy 0.000 description 1
- 210000000496 pancreas Anatomy 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000004544 sputter deposition Methods 0.000 description 1
Landscapes
- External Artificial Organs (AREA)
- Materials For Medical Uses (AREA)
- Electrotherapy Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
本発明は生体皮下組織内に固着され、生体内の臓器・組織・細胞もしくは植え込み型人工臓器（人工心臓、人工膵臓など）と生体外の機器（人工臓器駆動源、人工臓器制御装置、薬液注入装置、体内物質サンプリング装置、生体信号計測装置など）との接続などに使用される皮膚ボタンに関する。 The present invention is fixed in a living body subcutaneous tissue, and is an in vivo organ / tissue / cell or implantable artificial organ (artificial heart, artificial pancreas, etc.) and in vitro equipment (artificial organ drive source, artificial organ control device, chemical solution injection) Device, body substance sampling device, biological signal measuring device, etc.).
従来、人工材料を生体内に植え込むと生体は異物の侵入と判断し、線維性の被膜（線維性カプセル）で包んで（カプセル化）正常細胞から隔離し、異物から生体を守ろうとする反応が起こることが知られている。この反応はとくに皮膚部においては、皮膚を貫通した人工材料の周辺皮膚組織が材料に沿って下降性の成長（ダウングロース）をおこし、人工材料を生体外に排出するように働く。このダウングロースした生体組織と人工材料の境界部位には強固な密着性はなく、この部位からの細菌感染の危険性は非常に大きい。 Conventionally, when an artificial material is implanted in a living body, it is judged that the living body has entered a foreign body, wrapped in a fibrous coating (fibrous capsule) (encapsulated), isolated from normal cells, and a reaction to protect the living body from the foreign body It is known to happen. In particular, in the skin part, the peripheral skin tissue of the artificial material penetrating the skin causes downward growth (downgrowth) along the material and works to discharge the artificial material out of the living body. The boundary part between the down-growth living tissue and the artificial material does not have strong adhesion, and the risk of bacterial infection from this part is very great.
また、植え込み型の人工心臓などの人工臓器からケーブル（電線）を外部の電源などの機器に接続するものとして、皮膚に平盤状の部材を貼り付け、生体内から延びたケーブルを平盤状の部材に貫通させ、外部の機器に接続する方法がとられていた。この方法は貫通部材と生体組織との密着強度が弱く、ケーブルに外力がかかったり身体の動きに応じて皮膚が動いて貫通部材と生体組織との境界に負荷がかかった際に、その境界組織が損傷を受けたり、痛みを感じたりすることがあった。また、ケーブルのほか、カテーテルやチューブ、ガイドワイヤなどの可撓性を有する長尺部材を上記の平盤状の部材に貫通させることもある。 In addition, as a cable (electric wire) is connected to an external power supply or other device from an artificial organ such as an implantable artificial heart, a flat plate-like member is attached to the skin, and the cable extending from the living body is flat. The method of making it penetrate to the member and connecting to an external apparatus was taken. In this method, the adhesion strength between the penetrating member and the living tissue is weak, and when the external force is applied to the cable or the skin moves in accordance with the movement of the body and a load is applied to the boundary between the penetrating member and the living tissue, the boundary tissue Was damaged or felt painful. In addition to the cable, a flexible long member such as a catheter, a tube, or a guide wire may be passed through the flat plate member.
上記の問題を解消するために、特許文献1では、生体親和性がよく、かつ多層構造を有する炭素質材料（組織導入部材）を、皮下組織層に対し垂直に位置するよう設けられた管状部材の周囲に巻きつけて皮下組織との結合力を向上させた皮膚ボタンを提案している。ところで皮膚（表皮、真皮）は皮下組織（筋、骨など）と直接的に結合しているわけでなく、皮下の組織の動きに関係なく皮膚に加わった外力によって動くことが知られている。このため、身体を動かした際など、皮膚と皮下組織とは各々別々の変位で動くため、例えば身体を伸ばしたときと曲げたときでは皮膚と皮下組織との間に位置ずれが生じる。 In order to solve the above problems, in Patent Document 1, a tubular member provided with a carbonaceous material (tissue introduction member) having a good biocompatibility and having a multilayer structure so as to be positioned perpendicular to the subcutaneous tissue layer A skin button that has been wound around the skin to improve the bond strength with the subcutaneous tissue is proposed. By the way, it is known that the skin (epidermis, dermis) is not directly connected to the subcutaneous tissue (muscles, bones, etc.), but moves by an external force applied to the skin regardless of the movement of the subcutaneous tissue. For this reason, when the body is moved, the skin and the subcutaneous tissue move with different displacements. Therefore, for example, when the body is stretched and bent, a displacement occurs between the skin and the subcutaneous tissue.
しかし特許文献1の技術は、ケーブルなどが貫通する皮下組織全体（表皮、真皮、筋）を貫通部材の周囲に巻きつけた組織導入部材によって一度に固着させてしまうため、皮膚の自由な動きを阻害してしまう。これにより身体を動かした際には、違和感や痛みを感じることもある。さらに、皮膚面と垂直に組織導入部材を設けており、皮膚組織は０．５〜数ミリメートルと非常に薄いことから皮膚組織と組織導入部材との接触面積は非常に小さく、皮膚のみに大きな外力が加わった場合に、接触境界の組織が損傷を受けることは容易に想像される。 However, the technique of Patent Document 1 fixes the entire subcutaneous tissue (epidermis, dermis, muscle) through which the cable penetrates, etc. at once by the tissue introduction member wound around the penetrating member, so that the free movement of the skin is prevented. It will interfere. As a result, when you move your body, you may feel discomfort and pain. Furthermore, since the tissue introduction member is provided perpendicular to the skin surface and the skin tissue is very thin, 0.5 to several millimeters, the contact area between the skin tissue and the tissue introduction member is very small, and a large external force is applied only to the skin. It is easily imagined that the tissue at the contact boundary will be damaged when
本発明は、上記の問題点を解決するためになされたもので、皮膚貫通部において貫通するケーブルなどの長尺部材による外力および身体を動かした際に皮膚が動くことで発生する外力などに対して、貫通部材と皮膚組織との境界にかかる応力を緩和させることができ、感染の原因となる皮膚の大きいダウングロースを防止しうる皮膚ボタンを提供することを目的とする。 The present invention has been made to solve the above-described problems. For external force generated by a long member such as a cable penetrating in the skin penetrating portion and external force generated by moving the skin when the body is moved. Thus, an object of the present invention is to provide a skin button that can relieve the stress applied to the boundary between the penetrating member and the skin tissue and can prevent large downgrowth of the skin that causes infection.
本発明の皮膚ボタンは、生体の皮下組織内において皮膚組織側に固着され、生体内臓器もしくは人工臓器と外部機器との接続に使用される皮膚ボタンであり、皮膚を貫通するように配置される軸部およびその軸部の一端に設けられて生体内に埋め込まれるフランジを有する純チタンまたはチタン合金製の基材と、前記フランジの軸部側の面に接合される金属不織布とを備えており、前記軸部が、前記生体内臓器もしくは人工臓器と外部機器とを結ぶ長尺部材が保持される、少なくとも１個以上の軸方向の貫通孔を備え、前記金属不織布が、１辺もしくは径が１００μｍ未満の金属繊維からなり、かつ、１００〜４００μｍの連通したポアを有することを特徴としている。長尺部材には、ケーブル、チューブのほか、ガイドワイヤなど、体内に植え込まれる人工臓器と外部機器とを連結する種々のものが含まれる。 The skin button of the present invention is a skin button that is fixed to the skin tissue side in the subcutaneous tissue of a living body and is used to connect an internal organ or an artificial organ and an external device, and is disposed so as to penetrate the skin. A shaft portion and a base made of pure titanium or titanium alloy having a flange provided at one end of the shaft portion and embedded in the living body, and a metal nonwoven fabric bonded to the surface of the flange on the shaft portion side. The shaft portion includes at least one axial through-hole that holds an elongated member that connects the living organ or artificial organ and an external device, and the metal nonwoven fabric has one side or a diameter. It is characterized by being made of metal fibers of less than 100 μm and having a continuous pore of 100 to 400 μm. The long member includes, in addition to a cable and a tube, various members that connect an artificial organ to be implanted in the body and an external device, such as a guide wire.
このような皮膚ボタンにおいては、前記金属不織布が、１辺もしくは径が５〜１００μｍ範囲内で複数のサイズからなる金属繊維を絡合させることで構成されているものが好ましい。さらに前記金属不織布が純チタン、チタン合金、コバルト−クロム合金からなる群から選ばれたいずれか１種または２種以上の金属の繊維からなり、前記基材のフランジの表面に対して前記金属不織布が、融点（Ｔｍ）の０．３〜０．９倍の温度で焼結接合されたものが好ましい。 In such a skin button, it is preferable that the metal nonwoven fabric is constituted by intertwining metal fibers having a plurality of sizes within one side or a diameter of 5 to 100 μm. Further, the metal nonwoven fabric is made of any one or two or more kinds of metal fibers selected from the group consisting of pure titanium, titanium alloy, and cobalt-chromium alloy, and the metal nonwoven fabric with respect to the surface of the flange of the base material However, those sintered and bonded at a temperature 0.3 to 0.9 times the melting point (Tm) are preferable.
前記基材の外周表面が、ヒドロキシアパタイト又は炭酸アパタイトを含むリン酸カルシウム化合物によってコートされているものが良い。また、金属繊維の少なくとも表面がヒドロキシアパタイト又は炭酸アパタイトを含むリン酸カルシウム化合物によってコートされたものが良い。さらに前記金属不織布の内部ないし表面に、細胞成長因子、サイトカイン、抗生物質、細胞成長制御因子、酵素、蛋白、多糖類、燐脂質、リポ蛋白、ムコ多糖類よりなる群から選択される１種又は２種以上の生理活性物質あるいは生理活性助剤が保持されているものが好ましい。さらに前記金属不織布の内部ないし表面に細胞が接着されているものが好ましい。 The outer peripheral surface of the base material is preferably coated with a calcium phosphate compound containing hydroxyapatite or carbonate apatite. Further, it is preferable that at least the surface of the metal fiber is coated with a calcium phosphate compound containing hydroxyapatite or carbonate apatite. Furthermore, on the inside or surface of the metal nonwoven fabric, one or more selected from the group consisting of cell growth factors, cytokines, antibiotics, cell growth control factors, enzymes, proteins, polysaccharides, phospholipids, lipoproteins, mucopolysaccharides or Those holding two or more kinds of physiologically active substances or physiologically active assistants are preferred. Furthermore, the thing which the cell adhere | attached the inside or surface of the said metal nonwoven fabric is preferable.
本発明の皮膚ボタンは、表皮面を向いたフランジの表面に、１辺もしくは径が１００μｍ未満の金属繊維からなり、１００〜４００μｍの連通したポアを有する金属不織布を備えていることで、金属不織布に対して生体組織がポアを介して強固に結合する。 The skin button of the present invention is provided with a metal nonwoven fabric having one side or a diameter of less than 100 μm and having a continuous pore of 100 to 400 μm on the surface of the flange facing the skin surface. In contrast, the living tissue is firmly bonded via the pore.
また金属不織布が１００〜４００μｍの連通したポアを有しているため、金属不織布が生体組織と固着した際に新生血管の侵入が期待され、優れた長期生体適合性を得ることができる。 Further, since the metal nonwoven fabric has pores communicating with 100 to 400 μm, when the metal nonwoven fabric adheres to the living tissue, invasion of new blood vessels is expected, and excellent long-term biocompatibility can be obtained.
さらに金属不織布が基材のフランジの軸部側の表面に配置されているので、生体内に埋め込んだときは、金属不織布が皮膚組織層に対して水平方向に位置する。よって皮膚が動いた場合に皮膚ボタンは皮膚の動きに容易に追従し、かつ皮膚組織層に対して垂直方向に取りつけられた場合よりも皮膚組織と不織布との接触面積が大幅に増加するため、この境界面にかかる単位面積当たりの負荷を大幅に低減させることができる。また、皮膚組織層を貫通する軸部の表面には不織布が配備されないため、この軸部に沿ってわずかなダウングロースをおこさせることができ、軸部の皮膚組織に凹状の立体構造を持たせることができる。この表皮の立体的な構造によって、皮膚ボタン近傍の皮膚表面に外力がかかった場合でも、表皮組織と皮膚ボタンとの結合部にかかる力を緩衝させることが可能となる。 Furthermore, since the metal nonwoven fabric is disposed on the surface of the base portion on the shaft portion side of the flange, the metal nonwoven fabric is positioned in the horizontal direction with respect to the skin tissue layer when embedded in the living body. Therefore, when the skin moves, the skin button easily follows the movement of the skin, and the contact area between the skin tissue and the nonwoven fabric is greatly increased compared to the case where the skin button is attached in the direction perpendicular to the skin tissue layer. The load per unit area on the boundary surface can be greatly reduced. Moreover, since the nonwoven fabric is not provided on the surface of the shaft portion that penetrates the skin tissue layer, slight downgrowth can be caused along the shaft portion, and the skin tissue of the shaft portion has a concave three-dimensional structure. be able to. Due to the three-dimensional structure of the epidermis, even when an external force is applied to the skin surface near the skin button, the force applied to the joint between the epidermis tissue and the skin button can be buffered.
軸部を貫通する長尺部材に急に外力が加わった場合においては、皮膚ボタンはその周辺の皮膚ごと動くことが可能なため、皮膚組織と不織布との接触面にかかる瞬間的な力を緩衝させることができる。これらの効果から、感染抑止にもっとも重要となる表皮と人工材料との境界面にかかる負荷を小さく抑え、ダウングロースを防止し、長期に安定した皮膚ボタンを得ることができる。 When an external force is suddenly applied to the long member that penetrates the shaft, the skin button can move with the surrounding skin, so the momentary force applied to the contact surface between the skin tissue and the nonwoven fabric is buffered. Can be made. From these effects, the load applied to the interface between the epidermis and the artificial material, which is most important for infection control, can be suppressed, downgrowth can be prevented, and a stable skin button can be obtained for a long time.
前記金属不織布が、１辺もしくは径が５〜１００μｍの範囲内で複数のサイズからなる金属繊維を絡合させることで構成されている場合は、生体組織と固着した際に感染予防となる新生血管の侵入に必要な１００〜４００μｍの連通したポアを容易に構築でき、また使用目的にあわせたポアサイズのコントロールが容易となる。 When the metal nonwoven fabric is constituted by entanglement of metal fibers having a plurality of sizes within one side or a diameter of 5 to 100 μm, a new blood vessel that prevents infection when adhered to a living tissue It is possible to easily construct pores having a size of 100 to 400 μm necessary for the penetration of the pores, and to easily control the pore size according to the purpose of use.
前記金属不織布が純チタン、チタン合金、コバルト−クロム合金からなる群から選ばれたいずれか１種または２種以上の金属の繊維からなり、前記基材のフランジの表面に対して前記金属不織布が、融点（Ｔｍ）の０．３〜０．９倍の温度で焼結接合されている場合は、金属不織布の生体適合性が高く、しかも焼結接合により強固に接合されているので、長期間にわたって安定した皮膚ボタンを得ることができる。 The metal nonwoven fabric is made of any one or two or more kinds of metal fibers selected from the group consisting of pure titanium, titanium alloy, and cobalt-chromium alloy, and the metal nonwoven fabric is on the surface of the flange of the base material. In the case of being sintered and bonded at a temperature 0.3 to 0.9 times the melting point (Tm), the biocompatibility of the metal nonwoven fabric is high, and it is strongly bonded by sintering bonding, A stable skin button can be obtained.
前記基材の外周表面が、ヒドロキシアパタイトまたは炭酸アパタイトを含むリン酸カルシウム化合物によってコートされている場合、あるいは金属繊維の少なくとも表面にヒドロキシアパタイト又は炭酸アパタイトを含むリン酸カルシウム化合物によってコートする場合は、生体適合性が向上し、金属単体よりも生体組織との早期固着が期待できる。 When the outer peripheral surface of the base material is coated with a calcium phosphate compound containing hydroxyapatite or carbonate apatite, or when at least the surface of the metal fiber is coated with a calcium phosphate compound containing hydroxyapatite or carbonate apatite, biocompatibility is obtained. It can be improved and early fixation with a living tissue can be expected rather than a single metal.
また前記金属不織布の内部ないし表面に、細胞成長因子、サイトカイン、抗生物質、細胞成長制御因子、酵素、蛋白、多糖類、燐脂質、リポ蛋白、ムコ多糖類よりなる群から選択される１種又は２種以上の生理活性物質あるいは生理活性助剤が保持されている場合は、生理活性物質あるいは生理活性助剤の作用で金属不織布の早期固着をさらに期待できる。また金属不織布の内部ないし表面に繊維芽細胞などの細胞を接着させる場合は、生体埋設後に生体組織との早期一体化が得られる。 In addition, inside or on the surface of the metal nonwoven fabric, one or more selected from the group consisting of cell growth factors, cytokines, antibiotics, cell growth control factors, enzymes, proteins, polysaccharides, phospholipids, lipoproteins, mucopolysaccharides When two or more kinds of physiologically active substances or physiologically active assistants are held, it is possible to further expect early fixing of the metal nonwoven fabric by the action of the physiologically active substance or physiologically active assistant. In addition, when cells such as fibroblasts are adhered to the inside or the surface of the metal nonwoven fabric, early integration with a living tissue can be obtained after being embedded in the living body.
図１および図２は本発明の皮膚ボタンの実施形態を示す平面図および断面図であり、図２では皮下組織下に装着した状態を示す。なお、これらの実施形態は、本発明の理解を容易にするため一助としての具体例を開示するものであり、これによって、本発明を限定するものではない。 1 and 2 are a plan view and a cross-sectional view showing an embodiment of a skin button of the present invention, and FIG. 2 shows a state where the skin button is mounted under a subcutaneous tissue. These embodiments disclose specific examples as an aid for facilitating the understanding of the present invention, and the present invention is not limited thereby.
図１および図２に示す皮膚ボタン１０は、軸部１１と、その軸部の下端外周に設けたフランジ１２とを備えた、純チタン製の基材１３を有する。軸部１１には、生体内臓器もしくは人工臓器と外部機器とを結ぶケーブルやチューブなどの長尺部材が保持される１つの貫通孔１４を設けている。この実施形態では軸部１１および貫通孔１４は円形断面であり、この場合は軸部１１は円筒状である。ただし軸部１１や貫通孔１４の断面形状は四角形や楕円など、円形以外であってもよい。また、２個以上の貫通孔１４を設けることもできる。貫通孔１４には、ケーブルやチューブなどの長尺部材のうち、同種類のものを複数本挿入したり、あるいはケーブルとチューブの両方など、異なる種類の長尺部材を挿入することもできる。フランジ１２の上面（軸部側の表面）には、環状溝１５が形成され、その環状溝１５に金属不織布１６を充填している。環状溝１５の内面側は軸部１１の表面と連続している。また図２の符号２０は表皮を、符号２１は真皮を、符号２２は皮下組織をそれぞれ示す。 The skin button 10 shown in FIGS. 1 and 2 has a base material 13 made of pure titanium provided with a shaft portion 11 and a flange 12 provided on the outer periphery of the lower end of the shaft portion. The shaft portion 11 is provided with one through hole 14 for holding a long member such as a cable or a tube connecting an internal organ or artificial organ and an external device. In this embodiment, the shaft portion 11 and the through hole 14 have a circular cross section, and in this case, the shaft portion 11 is cylindrical. However, the cross-sectional shapes of the shaft portion 11 and the through hole 14 may be other than a circle such as a rectangle or an ellipse. Also, two or more through holes 14 can be provided. A plurality of the same types of long members such as cables and tubes can be inserted into the through-hole 14, or different types of long members such as both cables and tubes can be inserted. An annular groove 15 is formed on the upper surface (surface on the shaft portion side) of the flange 12, and the annular groove 15 is filled with a metal nonwoven fabric 16. The inner surface side of the annular groove 15 is continuous with the surface of the shaft portion 11. 2 represents the epidermis, 21 represents the dermis, and 22 represents the subcutaneous tissue.
金属不織布１６は、１辺もしくは径が100μm未満の純チタンからなる金属繊維を絡合させたものであり、１００〜４００μｍの連通したポアを有している。金属繊維の断面形状は、円形であってもよく、四角形ないし多角形や楕円などであってもよい。また基材の外周面は、ヒドロキシアパタイトまたは炭酸アパタイトを含むリン酸カルシウム化合物によってコートされている。ただし部分的にコートしてもよい。さらに金属不織布１６の表面または内部についても、ヒドロキシアパタイトまたは炭酸アパタイトを含むリン酸カルシウム化合物によってコートするのが好ましい。 The metal nonwoven fabric 16 is made by entangled metal fibers made of pure titanium having one side or a diameter of less than 100 μm, and has a continuous pore of 100 to 400 μm. The cross-sectional shape of the metal fiber may be a circle, or may be a quadrangle, a polygon, an ellipse, or the like. The outer peripheral surface of the substrate is coated with a calcium phosphate compound containing hydroxyapatite or carbonate apatite. However, it may be partially coated. Further, the surface or the inside of the metal nonwoven fabric 16 is preferably coated with a calcium phosphate compound containing hydroxyapatite or carbonate apatite.
金属不織布１６の成形およびフランジ１２の表面部への貼り付けは、例えば、金属繊維をフランジ１２の環状溝１５に詰め込み、金型に入れ、融点（純チタン：１６６８度）の０．３〜０．９倍の温度で、真空焼結することによって行うことができる。ただしあらかじめリング状に成形して仮焼結しておき、その後に環状溝１５に嵌入し、焼結して接合してもよい。基材１３の外周面へのリン酸カルシウム化合物のコートは、スパッタやレーザーアブレーション法などによって行うことができる。 For forming the metal nonwoven fabric 16 and attaching it to the surface portion of the flange 12, for example, metal fibers are packed in the annular groove 15 of the flange 12, put into a mold, and a melting point (pure titanium: 1668 degrees) of 0.3 to 0. It can be carried out by vacuum sintering at 9 times the temperature. However, it may be formed into a ring shape in advance and pre-sintered, and then fitted into the annular groove 15 and sintered and joined. The coating of the calcium phosphate compound on the outer peripheral surface of the substrate 13 can be performed by sputtering or laser ablation.
このように皮膚ボタン１０は、図２に示すように、フランジ１２の金属不織布１６が皮膚組織側になるよう皮下組織２２に配置し、軸部１１を表皮２０に貫通させるように生体に埋め込んで使用する。皮膚ボタン１０は、１００〜４００μｍの連通したポアを有する金属不織布１６を備えていることで、埋め込み施術後、生体組織が金属不織布１６のポアを介して強固に結合する。また純チタン不織布１６が純チタン製の基材１３のフランジ１２の表面部に融点（Ｔｍ）の０．３〜０．９倍の温度で焼結接合により強固に接合されており、かつ、金属不織布１６が表皮２０および真皮２１からなる皮膚組織層に対して水平方向に位置する。よって皮膚が動いた場合に皮膚ボタン１０は皮膚の動きに容易に追従する。 In this way, as shown in FIG. 2, the skin button 10 is placed in the subcutaneous tissue 22 so that the metal nonwoven fabric 16 of the flange 12 is on the skin tissue side, and is embedded in a living body so that the shaft portion 11 penetrates the epidermis 20. use. The skin button 10 includes the metal nonwoven fabric 16 having pores communicating with each other in a range of 100 to 400 μm, so that the living tissue is firmly bonded via the pores of the metal nonwoven fabric 16 after the implantation operation. The pure titanium nonwoven fabric 16 is firmly joined to the surface portion of the flange 12 of the pure titanium base material 13 by sintering joining at a temperature of 0.3 to 0.9 times the melting point (Tm), and a metal The nonwoven fabric 16 is positioned in the horizontal direction with respect to the skin tissue layer composed of the epidermis 20 and the dermis 21. Therefore, when the skin moves, the skin button 10 easily follows the movement of the skin.
また、基材１３の軸部１１には金属不織布１６が配備されないため、この軸部１１に沿ってわずかなダウングロース（図２の符号２３）をおこさせることができ、貫通部の皮膚組織に凹状の立体構造を持たせることができる。この表皮２０の立体的な構造によって、皮膚ボタン１０近傍の皮膚表面に外力がかかった場合でも、表皮組織と皮膚ボタン１０との結合部にかかる力を緩衝させることが可能となる。 Further, since the metal nonwoven fabric 16 is not provided on the shaft portion 11 of the base material 13, a slight downgrowth (reference numeral 23 in FIG. 2) can be caused along the shaft portion 11, and the skin tissue of the penetration portion can be caused. A concave three-dimensional structure can be provided. Due to the three-dimensional structure of the epidermis 20, even when an external force is applied to the skin surface near the skin button 10, the force applied to the joint between the epidermis tissue and the skin button 10 can be buffered.
貫通孔１４を貫通するケーブルに急に外力が加わった場合においては、皮膚ボタン１０はその周辺の皮膚ごと動くことが可能なため、皮膚組織と金属不織布１６との接触面にかかる瞬間的な力を緩衝させることができる。これらの効果から、感染抑止にもっとも重要となる表皮２０と人工材料との境界面にかかる負荷を小さく抑え、感染の原因となる大きいダウングロースを防止し、長期に安定した皮膚ボタンを得ることができる。 When an external force is suddenly applied to the cable passing through the through hole 14, the skin button 10 can move together with the surrounding skin, and therefore, an instantaneous force applied to the contact surface between the skin tissue and the metal nonwoven fabric 16. Can be buffered. From these effects, it is possible to suppress the load on the interface between the epidermis 20 and the artificial material, which is most important for infection control, to prevent a large downgrowth that causes infection, and to obtain a stable skin button for a long time. it can.
前記実施形態では、基材１３を純チタン製としているが、α＋β型、β型などのチタン合金製とすることもできる。また、前記実施形態では、金属不織布として純チタン繊維を用いているが、これについてもα＋β型、β型などのチタン合金あるいはコバルト−クロム合金の金属繊維からなる金属不織布を用いることもできる。さらに金属不織布１６の内部または表面に、細胞成長因子、サイトカイン、抗生物質、細胞成長制御因子、酵素、蛋白、多糖類、燐脂質、リポ蛋白、ムコ多糖類よりなる群から選択される１種又は２種以上の生理活性物質あるいは生理活性助剤を保持させるのが好ましい。また、金属不織布の内部ないし表面に、繊維芽細胞、間葉系幹細胞などの細胞を接着させるのが好ましい。 In the said embodiment, although the base material 13 is made from pure titanium, it can also be made from titanium alloys, such as (alpha) + (beta) type and (beta) type. Moreover, in the said embodiment, although pure titanium fiber is used as a metal nonwoven fabric, the metal nonwoven fabric which consists of titanium fibers, such as (alpha) + (beta) type | mold, (beta) type | mold, or a metal fiber of a cobalt-chromium alloy can also be used for this. Further, in the inside or the surface of the metal nonwoven fabric 16, one or more kinds selected from the group consisting of cell growth factors, cytokines, antibiotics, cell growth control factors, enzymes, proteins, polysaccharides, phospholipids, lipoproteins, mucopolysaccharides or It is preferable to hold two or more kinds of physiologically active substances or physiologically active auxiliaries. Further, it is preferable to adhere cells such as fibroblasts and mesenchymal stem cells to the inside or the surface of the metal nonwoven fabric.
［実験例］生体内植え込みによる本発明の効果を実証するために、以下の実験を行った。
［実験例１］純チタン円柱（外径：１０ｍｍ、表面積７８．５ｍｍ２フランジなし、貫通孔なし）の表面に１辺が８０μｍの断面四角形の純チタン繊維からなる不織布（ポアサイズ：２００μｍ）を焼結により貼り付けた実験材料を作成し、その実験材料をラットの皮下に埋植し、一定期間後の皮下組織と不織布の引っ張り強度を測定した。
[Experimental Example] In order to demonstrate the effect of the present invention by in vivo implantation, the following experiment was conducted.
Experimental Example 1 pure titanium cylindrical baked:: (200 [mu] m pore size) (outer diameter 10 mm, no surface area 78.5 mm 2 flange, through no holes) non-woven fabric one side to the surface of consists of pure titanium fiber square cross section of 80μm An experimental material pasted by ligation was prepared, and the experimental material was implanted under the skin of a rat, and the tensile strength of the subcutaneous tissue and the nonwoven fabric after a certain period was measured.
その結果を図３のグラフに示す。このグラフによれば、２週間で１０Ｎ、１０週で１７Ｎと、良好な引っ張り強さを示すことが分かる。この引っ張り強さは、図３のグラフから分かるように、基材である純チタン円柱と不織布の接合強度の１／１０程度である。このことから、不織布が生体と固着した際に不織布にかかる応力により、不織布が基材から剥がれることがないことがうかがえる。 The result is shown in the graph of FIG. According to this graph, it can be seen that the tensile strength is 10 N for 2 weeks and 17 N for 10 weeks, which is good. As can be seen from the graph of FIG. 3, this tensile strength is about 1/10 of the bonding strength between the pure titanium cylinder as the base material and the nonwoven fabric. This indicates that the nonwoven fabric is not peeled off from the base material due to the stress applied to the nonwoven fabric when the nonwoven fabric adheres to the living body.
本発明の皮膚ボタンの効果を実証するために以下の実験を行った。
［実験例２］フランジを有する純チタンの基材（軸部外径：６ｍｍ、長さ１１ｍｍ、フランジ外径：１５ｍｍ、厚さ３ｍｍ、ただし貫通孔なし）のフランジ表面に１辺が８０μｍの純チタン繊維からなる不織布（ポアサイズ：２００μｍ、厚さ２ｍｍ）を接合した実験材料をラットの皮膚に埋植した。
In order to demonstrate the effect of the skin button of the present invention, the following experiment was conducted.
[Experimental Example 2] Pure titanium base material with flanges on a flange surface of a shaft (outer diameter of shaft part: 6 mm, length of 11 mm, flange outer diameter: 15 mm, thickness of 3 mm, but no through hole). An experimental material joined with a non-woven fabric (pore size: 200 μm, thickness 2 mm) made of titanium fibers was implanted in the skin of a rat.
埋植期間５週後の一例を図４および図５に示す。不織布近傍の組織観察を実施した結果、顕著な異物反応や炎症は観られなかった。また不織布内に新生血管の侵入が確認され、血流を十分に確保でき、長期に安定した成績が得られた。 An example after 5 weeks of implantation is shown in FIGS. As a result of observing the structure in the vicinity of the nonwoven fabric, no significant foreign body reaction or inflammation was observed. Moreover, the invasion of new blood vessels was confirmed in the nonwoven fabric, blood flow was sufficiently secured, and stable results were obtained for a long time.
１０ 皮膚ボタン
１１ 軸部
１２ フランジ
１３ 基材
１４ 貫通孔
１５ 環状溝
１６ 金属不織布
２０ 表皮
２１ 真皮
２２ 皮下組織
２３ ダウングロース
DESCRIPTION OF SYMBOLS 10 Skin button 11 Shaft part 12 Flange 13 Base material 14 Through-hole 15 Annular groove 16 Metal nonwoven fabric 20 Epidermis 21 Dermis 22 Subcutaneous tissue 23 Downgrowth
Claims (7)
皮膚を貫通するように配置される軸部およびその軸部の一端に設けられて生体内に埋め込まれるフランジを有する純チタンまたはチタン合金製の基材と、
前記フランジの軸部側の面に接合された金属不織布とを備えており、
前記軸部が、前記生体内臓器もしくは人工臓器と外部機器とを結ぶ長尺部材が保持される、少なくとも１個以上の軸方向の貫通孔を備え、
前記金属不織布が、１辺もしくは径が１００μｍ未満の金属繊維からなり、かつ、１００〜４００μｍの連通したポアを有することを特徴とする皮膚ボタン。 It is a skin button that is fixed to the skin tissue side in the subcutaneous tissue of a living body, and is used to connect an internal organ or artificial organ to an external device,
A base made of pure titanium or titanium alloy having a shaft portion arranged to penetrate the skin and a flange provided at one end of the shaft portion and embedded in the living body;
A metal nonwoven fabric joined to the shaft side surface of the flange,
The shaft portion includes at least one axial through-hole in which a long member that connects the internal organ or artificial organ and an external device is held;
A skin button, wherein the metal nonwoven fabric is composed of metal fibers having a side or a diameter of less than 100 μm and has a continuous pore of 100 to 400 μm.
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