JPH0213580B2 - - Google Patents
Info
- Publication number
- JPH0213580B2 JPH0213580B2 JP58047896A JP4789683A JPH0213580B2 JP H0213580 B2 JPH0213580 B2 JP H0213580B2 JP 58047896 A JP58047896 A JP 58047896A JP 4789683 A JP4789683 A JP 4789683A JP H0213580 B2 JPH0213580 B2 JP H0213580B2
- Authority
- JP
- Japan
- Prior art keywords
- terminal
- hydroxyapatite
- sintered
- skin
- biological
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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- Materials For Medical Uses (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
- Endoscopes (AREA)
- Electrotherapy Devices (AREA)
Description
【発明の詳細な説明】
本発明はその要部がハイドロキシアパタイト焼
結体より成る生体用端子に関する。DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a biomedical terminal, the main part of which is made of a sintered hydroxyapatite body.
従来のpercutaneous electrode connector（経
皮的電極つき端子）やcannula（挿管）といた生
体用端子はその一端が生体皮膚上にあり他端が皮
下に埋設されて、血圧、血流速度、温度、心電信
号等の各種生体情報取り出しのための電気的端子
として或いはその貫通孔を介して輸液、各種薬液
等の注入又は人工腎臓透析等のための血流の取り
出し・注入口等として使用されるものであり、主
としてシリコーンゴム・ふつ素樹脂等々の所謂生
体不活性材より形成されたものが既に提案されて
いる。 Conventional percutaneous electrode connectors and cannula terminals have one end placed on the skin of the living body and the other end buried under the skin to monitor blood pressure, blood flow rate, temperature, and heart rate. Used as an electrical terminal for extracting various biological information such as electrical signals, or as an inlet for injecting infusions, various medicinal solutions, etc. through its through-hole, or extracting/injecting blood flow for artificial kidney dialysis, etc. So-called bio-inert materials, such as silicone rubber and fluororesin, have already been proposed.
しかし乍らこれらは生体にとつてはなくまでも
異物に他ならずその生体装着部位は一種の外傷を
受けた状態に置かれるものとなるので両者の間隙
からの細菌感染等により長期間の使用には到底耐
え得ないものであるのみならず、生体固定性に劣
るため例えば揺動による出血の心配或いは心電信
号等の生体電気信号の取り出しに当つては所謂ア
ーチフアクト等の雑音を排除し得ず生体情報の安
定取り出しに欠ける等、幾つかの問題を有するも
のであるため未だ充分に普及し得ないものとなつ
ている。 However, these are nothing but foreign objects, even if they are not to the living body, and the part where they are attached to the living body will be in a state of trauma, so they will not be used for a long time due to bacterial infection etc. from the gap between the two. Not only is it completely unbearable, but it is also inferior in biofixation properties, so there is no need to worry about bleeding due to shaking, or to eliminate noise such as so-called artifacts when extracting bioelectrical signals such as electrocardiogram signals. However, it has several problems, such as a lack of stable retrieval of biometric information, so it has not yet been widely used.
他方、近時ハイドロキシアパタイト焼結体の優
れた生体親和性、更には骨誘導性が解明されると
共にその焼結体による人工歯根、人工骨への利用
が提案、実用されつつあるが、同焼結体の皮膚組
織との生理学的反応性については先行技術に於い
て全然未解明である。 On the other hand, in recent years, the excellent biocompatibility and osteoinductivity of sintered hydroxyapatite have been elucidated, and the use of the sintered body for artificial tooth roots and artificial bones has been proposed and put into practice. The physiological reactivity of the bodies with the skin tissue is completely unknown in the prior art.
上記に鑑み本発明者らは鋭意研究の結果、驚く
べきことにハイドロキシアパタイト焼結体は皮膚
組織に対し単に親和性を有するのみならずこれら
組織と緊密且つ一体的に接合するという事実を知
見し、本発明に到達したものである。 In view of the above, the inventors of the present invention have conducted extensive research and have surprisingly discovered that hydroxyapatite sintered bodies not only have an affinity for skin tissues, but also bond closely and integrally with these tissues. , this invention has been achieved.
以下、本発明生体端子乃至栓或いは、導管につ
きその材料組成及び製法、形状乃至構造、使用の
態様等につき詳細に分説する。 Hereinafter, the material composition, manufacturing method, shape and structure, mode of use, etc. of the bioterminal, plug, or conduit of the present invention will be explained in detail.
材料組成・製法
本発明に於ける“ハイドロキシアパタイト”と
はその化学組成がCa10（PO4）6（OH）2で表わされ
る純粋品のみならず、OHイオンのかわりに１〜
10％のカーボネート（CO3）イオンやフツソ、塩
素イオンを含むこともある。また、これを主成分
とするも焼結性、強度、細孔度等を向上すべくこ
れにCa3（PO4）2、MgO、Na2O、K2O、CaF2、
Al2O3、SiO2、CaO、Fe2O3、MnO、MnO、
ZnO、Ｃ、SrO、PbO、BaO、TiO2、ZrO2等々
の周知各種添加剤を添加混合したものをも包含す
る。又、高分子との複合剤とする場合は、比較的
毒性の少ないポリエチレン、ポリプロピレン、ポ
リメチルメタクリレート、ポリウレタン、ポリエ
ステル、ABS、フツ素、ポリカーボネート、ポ
リスルホン、エポキシ、シリコン、ジアリルフタ
レート、フラン等の樹脂を選ぶことができる。Material Composition/Manufacturing Method “Hydroxyapatite” in the present invention is not only a pure product whose chemical composition is expressed as Ca 10 (PO 4 ) 6 (OH) 2 but also a pure product whose chemical composition is represented by Ca 10 (PO 4 ) 6 (OH) 2,
It may also contain 10% carbonate (CO 3 ) ions, fluorine, and chloride ions. In addition, although this is the main component, Ca 3 (PO 4 ) 2 , MgO, Na 2 O, K 2 O, CaF 2 ,
Al 2 O 3 , SiO 2 , CaO, Fe 2 O 3 , MnO, MnO,
It also includes mixtures of various known additives such as ZnO, C, SrO, PbO, BaO, TiO 2 , ZrO 2 and the like. In addition, when making a composite agent with a polymer, relatively less toxic resins such as polyethylene, polypropylene, polymethyl methacrylate, polyurethane, polyester, ABS, fluorine, polycarbonate, polysulfone, epoxy, silicone, diallyl phthalate, and furan are used. You can choose.
他方、その焼結体は一般にハイドロキシアパタ
イト粉末を金型又はラバープレス等により500〜
3000Kg／cm2程度の圧力下、所望形状に圧縮成形
し、次いでこれを700〜1300℃程度の温度で焼結
処理して得られるものであるが、より詳細は下記
公知技術が参照される。 On the other hand, the sintered body is generally made by molding hydroxyapatite powder into a mold or rubber press, etc.
It is obtained by compression molding into a desired shape under a pressure of about 3000 Kg/cm 2 and then sintering this at a temperature of about 700 to 1300°C. For more details, refer to the following known techniques.
すなわち、特開昭51−40400、同52−142707、
同52−147606、同52−149895、同53−110999、特
公昭57−40776及び同57−40803号各公報。 That is, JP-A No. 51-40400, No. 52-142707,
Publications No. 52-147606, No. 52-149895, No. 53-110999, and Japanese Patent Publication No. 57-40776 and No. 57-40803.
尚、皮膚組織との接合性という観点から本発明
に於いて特に有用な焼結体の相対密度（ハイドロ
キシアパタイト単結晶の密度を基準）は、60〜
99.5％、より好ましくは85〜95％程度である。 The relative density (based on the density of hydroxyapatite single crystal) of the sintered body that is particularly useful in the present invention from the viewpoint of bondability with skin tissue is 60 to 60.
It is about 99.5%, more preferably about 85 to 95%.
形状乃至構造
本発明生体用端子形態は使用目的に応じて所望
のものとなし得るが、その典型的につき添付図面
を参照して詳説すれば次の通りである。Shape and Structure The biomedical terminal configuration of the present invention can be made into any desired shape depending on the purpose of use, and a typical example thereof will be described in detail with reference to the accompanying drawings.
すなわち、第１図は本発明生体用端子の１例を
示す断面図であり、図中、電気的端子として使用
される生体用端子は共にハイドロキシアパタイ
ト焼結体より成る端子頭部２と同底部３とを一体
的に結合して成るものであり、その内部に生体内
外を電気的に連結するための金線、銀線、白金
線、合金線、カーボンフアイバ等の導電性部材４
が埋設されており且つ所要により任意個数の縫合
用孔５が端子底部３に穿孔されている。 That is, FIG. 1 is a cross-sectional view showing one example of the biological terminal of the present invention, and in the figure, the biological terminal used as an electrical terminal has a terminal head 2 and a bottom portion both made of sintered hydroxyapatite. 3, and a conductive member 4 such as gold wire, silver wire, platinum wire, alloy wire, carbon fiber, etc. for electrically connecting inside and outside the living body.
are embedded therein, and an arbitrary number of suture holes 5 are bored in the terminal bottom 3 as required.
上記構造の生体用端子は端子底部３を皮下に
埋設固定し端子頭部２の上端部を皮上に突出配置
して使用されるものであり、生体電気信号等の取
り出し或いはペースメーカ等の生体電気刺激用の
電気的端子として利用される。 The biomedical terminal of the above structure is used with the terminal bottom 3 buried and fixed under the skin, and the upper end of the terminal head 2 protruding above the skin, and is used for extracting bioelectrical signals, etc., or for bioelectrical control of pacemakers, etc. Used as an electrical terminal for stimulation.
同じく第２図は、生体栓として使用される本発
明生体用端子の１例を示す断面図であり、この生
体用端子は前記導電性部材４に代えて生体内外
を連通するための貫通孔６を有していることを除
いては前記例と同一構成を有する（図中、同一符
号は前記例の夫と同一部分を指す）。 Similarly, FIG. 2 is a sectional view showing an example of the biological terminal of the present invention used as a biological plug, and this biological terminal has a through hole 6 in place of the conductive member 4 for communicating between the inside and outside of the biological body. (In the figure, the same reference numerals refer to the same parts as in the previous example.)
他方、ハイドロキシアパタイト焼結体（材）は
皮膚組織との接触部分に介在すれば所定の目的を
達成し得るのであるから、生体用端子の要部のみ
を焼結体とし他を合成樹脂等の異種材で構成する
ようにしてもよく、或いはその要部をハイドロキ
シアパタイト焼結被覆材（特開昭52−82893号、
同53−75209号及び同53−118411号公報等、参照）
で形成してもよい。 On the other hand, since the hydroxyapatite sintered body (material) can achieve the desired purpose if it is placed in the part that comes in contact with the skin tissue, only the main part of the biomedical terminal is made of sintered body and the rest is made of synthetic resin, etc. It may be made of different materials, or the main part may be made of a sintered hydroxyapatite covering material (Japanese Patent Application Laid-Open No. 82893/1989).
(See Publications No. 53-75209 and No. 53-118411, etc.)
It may be formed by
以上から明らかなように、本発明生体用端子は
多様な形状・構造及び寸法をとり得るものであつ
て特定形態に限定されるものではない。 As is clear from the above, the biomedical terminal of the present invention can have various shapes, structures, and dimensions, and is not limited to a specific form.
使用態様
前述の通り、本発明によりハイドロキシアパタ
イト焼結体による生体用端子は生体適合性を有す
るのみならず表皮、真皮等の皮膚組織と界面接合
し生体に安定的に固定されるものであることが明
らかにされたので、例えば心臓ペースメーカに外
部電源を連結するための端子として、或いは血液
透析用孔として、更にはその先端に超音波検知素
子等の各種センサ素子を有する生体内導線と外部
測定機とを連結する端子等々として広範に適用さ
れるものであるので診断及び治療の分野、或いは
動物実験の分野等で極めて有用なものと言い得
る。Mode of Use As mentioned above, the biological terminal made of sintered hydroxyapatite according to the present invention not only has biocompatibility, but also interfacially bonds with skin tissues such as the epidermis and dermis, and is stably fixed to the living body. It has been clarified that, for example, it can be used as a terminal for connecting an external power source to a cardiac pacemaker, or as a hole for hemodialysis, or as an in-vivo lead wire with various sensor elements such as an ultrasonic detection element at its tip, and for external measurement. It can be said to be extremely useful in the fields of diagnosis and treatment, or in the field of animal experiments, as it is widely used as a terminal for connecting devices and the like.
以下、本発明を実験例により詳細に説明する
実験例
１ 生体用端子の製造
ハイドロキシアパタイト粉末は、0.5モル／
水酸化カルシウムと0.3モル／リン酸溶液
を徐々に滴下し、37℃で１日反応させて合成
し、これを濾過乾燥して得た。この合成粉末３
ｇを内径15mmの金型に充填し、径0.05mmの金細
線と共に800Kg／cm2の圧力で圧縮成形しカサ密
度1.6ｇ／cm3の圧粉体を得た。これを端子頭部
形状（第１図参照）に旋盤及び歯科用ダイヤモ
ンドバーで切削、加工した。同様に前記合成粉
末4.5ｇを内径30mmの金型に金細線と共に充填
圧縮成形、切削加工して端子底部（第１図参
照）とした。次いで、両圧粉体の金細線を接合
し、更に両者間に予め水を加え乳鉢でよく練つ
たゲル状アパタイト粉末を塗布し、接着した。
これを1250℃で１時間焼結処理して圧縮強度
5000Kg／cm2、曲げ強度1200Kg／cm2、相対密度95
％且つ接着部も均一に焼結した。第１図に図示
の通りの生体用端子を得た。 Below, the present invention will be explained in detail using experimental examples.Experimental Example 1 Production of biomedical terminal Hydroxyapatite powder was 0.5 mol/
Calcium hydroxide and a 0.3 mol/phosphoric acid solution were gradually added dropwise and reacted for one day at 37°C to synthesize the product, which was then filtered and dried. This synthetic powder 3
g was filled into a mold with an inner diameter of 15 mm and compression molded together with a fine gold wire of 0.05 mm in diameter at a pressure of 800 Kg/cm 2 to obtain a green compact with a bulk density of 1.6 g/cm 3 . This was cut and processed into the terminal head shape (see Figure 1) using a lathe and a dental diamond bur. Similarly, 4.5 g of the synthetic powder was filled into a mold with an inner diameter of 30 mm together with a thin gold wire, compression molded, and cut to form a terminal bottom (see FIG. 1). Next, the thin gold wires of both compacts were joined together, and gel-like apatite powder, which had been thoroughly kneaded in a mortar with water added in advance, was applied between the two to bond them together.
This was sintered at 1250℃ for 1 hour to achieve compressive strength.
5000Kg/cm 2 , bending strength 1200Kg/cm 2 , relative density 95
% and the bonded area was evenly sintered. A biological terminal as shown in FIG. 1 was obtained.
ここに於いて、端子底部は直径24mm、厚さ３
mm、端子頭部首部分の平均径は６mmである。 Here, the bottom of the terminal is 24mm in diameter and 3mm thick.
mm, and the average diameter of the terminal head and neck portion is 6 mm.
尚、焼結温度を1100℃とした場合に得られる
焼結体にあつては、相対密度85％、圧縮強度
3000Kg／cm2、曲げ強度700Kg／cm2であつた。 The sintered body obtained when the sintering temperature is 1100℃ has a relative density of 85% and a compressive strength of
It had a bending strength of 3000Kg/cm 2 and a bending strength of 700Kg/cm 2 .
２ 動物実験
上記生体用端子を雑種成犬の側復部皮膚に埋
設し、経時観察した結果、端子は底部及び首部
分に於いて術後約２週目で皮膚組織と強く結合
接着して引つ張つても取れない状態となり、１
年経過後でも肉眼的には炎症反応などの異常所
見は何ら認められなかつた。2 Animal experiment The above-mentioned biological terminal was implanted in the skin of the lateral incision of an adult mongrel dog, and as a result of time-lapse observation, the terminal was strongly bonded to the skin tissue in the bottom and neck area about 2 weeks after surgery and pulled. It becomes a state where it cannot be removed even if it is stretched, and 1
Even after a year had passed, no abnormal findings such as inflammatory reactions were observed macroscopically.
また、通常の組織学的検索でも炎症細胞など
は認められはかつた。 In addition, no inflammatory cells were detected by normal histological examination.
他方、対照とした同形状のシリコーンゴム製
端子にあつては術後４週目でも皮膚との接着は
全然認められず既に炎症性の発赤が認められ
た。又、２ケ月日には炎症が進行し化膿し始
め、３ケ月目には脱落した。 On the other hand, in the case of a control silicone rubber terminal of the same shape, no adhesion to the skin was observed even 4 weeks after the operation, and inflammatory redness was already observed. In addition, after two months, the inflammation progressed and it started to suppurate, and after three months, it fell off.
添付第１乃至２図は本発明生体用端子の模式断
面図である。
２……端子頭部、３……端子底部、４……導電
性部材、５……縫合用孔、６……貫通孔。
Attached Figures 1 and 2 are schematic cross-sectional views of the biomedical terminal of the present invention. 2... Terminal head, 3... Terminal bottom, 4... Conductive member, 5... Suture hole, 6... Through hole.
Claims (1)
とを一体的に結合して成り、少なくとも皮膚組織
との接触部分がハイドロキシアパタイト焼結体よ
り成り且つ生体内外を電気的に連結するための導
電性部材４及び／又は生体内外を機械的に連結す
るための貫通孔６を有することを特徴とする生体
用端子。1 Terminal bottom 3 having terminal head 2 and suture hole 5
A conductive member 4 for electrically connecting the inside and outside of the living body and/or a conductive member 4 for electrically connecting the inside and outside of the living body and/or a conductive member 4 for electrically connecting the inside and outside of the living body, and at least the part that contacts the skin tissue is made of a hydroxyapatite sintered body. A biomedical terminal characterized by having a through hole 6 for the purpose of
Priority Applications (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP58047896A JPS59174146A (en) | 1983-03-24 | 1983-03-24 | Terminal for living body |
| CA000450058A CA1247960A (en) | 1983-03-24 | 1984-03-21 | Transcutaneously implantable element |
| DE8484301977T DE3482893D1 (en) | 1983-03-24 | 1984-03-23 | ITEM FOR TRANSCUTANEOUS IMPLANTATION. |
| EP84301977A EP0120689B1 (en) | 1983-03-24 | 1984-03-23 | Transcutaneously implantable element |
| US07/577,820 US5035711A (en) | 1983-03-24 | 1990-09-05 | Transcutaneously implantable element |
| US07/581,122 US5026397A (en) | 1983-03-24 | 1990-09-10 | Transcutaneously implantable element |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP58047896A JPS59174146A (en) | 1983-03-24 | 1983-03-24 | Terminal for living body |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS59174146A JPS59174146A (en) | 1984-10-02 |
| JPH0213580B2 true JPH0213580B2 (en) | 1990-04-04 |
Family
ID=12788161
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP58047896A Granted JPS59174146A (en) | 1983-03-24 | 1983-03-24 | Terminal for living body |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS59174146A (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0761307B2 (en) * | 1986-06-24 | 1995-07-05 | 京セラ株式会社 | In-vivo member |
| JPH02107229A (en) * | 1988-10-15 | 1990-04-19 | Inax Corp | Electrode |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS59146635U (en) * | 1983-03-22 | 1984-10-01 | ポリウレタン化成株式会社 | Bump cushion for vehicle shock absorber |
-
1983
- 1983-03-24 JP JP58047896A patent/JPS59174146A/en active Granted
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS59146635U (en) * | 1983-03-22 | 1984-10-01 | ポリウレタン化成株式会社 | Bump cushion for vehicle shock absorber |
Also Published As
| Publication number | Publication date |
|---|---|
| JPS59174146A (en) | 1984-10-02 |
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