JP3530200B2 - Vascular embolic agent - Google Patents
Vascular embolic agentInfo
- Publication number
- JP3530200B2 JP3530200B2 JP19363091A JP19363091A JP3530200B2 JP 3530200 B2 JP3530200 B2 JP 3530200B2 JP 19363091 A JP19363091 A JP 19363091A JP 19363091 A JP19363091 A JP 19363091A JP 3530200 B2 JP3530200 B2 JP 3530200B2
- Authority
- JP
- Japan
- Prior art keywords
- aneurysm
- catheter
- blood
- agent
- embolic agent
- 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 - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
Landscapes
- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Description
【発明の詳細な説明】
【０００１】
【産業上の利用分野】本発明は血管塞栓剤に関するもの
である。本発明の血管塞栓剤は造影性を有し、動脈瘤、
動静脈奇形（ＡＶＭ）などの血管障害の治療に好適に使
用される。
【０００２】
【従来の技術】手術侵襲を加えず、血管カテーテルを応
用して血管障害治療を行う血管内外科治療が行われてい
る。
【０００３】例えば、脳血管障害治療においては、微小
なカテーテルを超選択的に脳動脈患部に留置し、該カテ
ーテルにより導入される塞栓物質により異常血流を遮断
して血管の修復を行うもので、脳動脈瘤、動静脈奇形な
どの治療を目的としている。脳動脈瘤は、成人１００人
に１人が動脈血管内に有する瘤であり、直径約１mmから
約２０mmのものまで広い形状分布を持ち、発生部位も脳
動脈の多枝に渡っている。このうち約３０％は破裂せず
に経過するが、約７０％は破裂をきたし、クモ膜下出血
を起こすといわれている。動静脈奇形は、最も多く、ま
たよく知られた脳血管奇形であり、蛇行、拡張した流入
および流出血管とそのあいだの動静脈吻合を有する血管
の集積からなっている。
【０００４】塞栓術は、このような脳動脈患部を塞栓物
質で閉塞し、病変部の血流を止めて患部を固化し、治療
するもので、必要な場合はさらに固化した患部の摘出を
行う。
【０００５】脳血管は、他の部分とくらべ、外弾性膜を
欠き、血管壁が薄いため、血流の側圧に対して抵抗が弱
く、また、頭蓋内で血管は複雑に走行し、分岐部などに
かかる応力によって障害が生じやすい。
【０００６】このため、種々の塞栓材が研究されてい
る。
【０００７】従来、血管閉塞用の液体として、シアノア
クリレート系の材料が多く用いられてきた（Ｊ．Ｂｉｏ
ｍｅｄ，Ｍａｔｅｒ．Ｒｅｓ.,１７，１６７−１７７
（１９８３）Ｍ．Ｃ．Ｈａｒｐｅｒｓ他）。
【０００８】また最近では、エチレン−ビニルアルコー
ル共重合体（エバールＲ）のジメチルスルホキシド（Ｄ
ＭＳＯ）溶液を閉塞用の材料として用い、血液中でＤＭ
ＳＯを拡散させ、エバールＲを析出させて血管を閉塞す
ることが提案されている（メディカルトリビューン，１
９８９年１０月２６日，４６〜４７頁）。
【０００９】一方、カテーテルを用いて、動脈瘤内部で
切り離し可能なバルーンをふくらませて動脈瘤を塞ぎ、
バルーンを動脈瘤内に留置する方法もとられている（Ｊ
ｏｕｒｎａｌ ｏｆ Ｎｅｕｒｏｓｕｒｇｅｒｙ，４
１，１２５−１４５（１９７４），Ｆ．Ａ．Ｓｅｒｂｉ
ｎｅｎｋｏ）。
【００１０】ほかにも従来から用いられているものとし
て、ポリビニルアルコール（ＰＶＡ）スポンジ、金属コ
イル、アルコールおよび縫合糸などが治療目的に応じて
利用されてきた。
【００１１】
【発明が解決しようとする課題】シアノアクリレート系
の従来の塞栓剤では、血管中で急速に固化重合するた
め、塞栓物質の注入が難しく、注入終了と同時にカテー
テルをシースの外まで一気に抜去しなければならず、取
り扱いが困難であり、閉塞状況が不十分でも再注入でき
ない。また、生体への刺激も大きいという問題があっ
た。
【００１２】エバールをＤＭＳＯ溶媒にとかして用いる
系は、動脈瘤内部に析出したエバールの中心部に、いつ
までも溶媒が残存したり、血管中で析出した物質は、血
液の乱流によって微小な小片が飛散しやすく、また、動
脈瘤出口から血管中にはみ出した部分は、分岐部の流れ
にそって付着するという問題がある。
【００１３】また、溶媒のＤＭＳＯは、化学物質である
ため、臨床応用が限定される場合もあり（第１１回日本
バイオマテリアル学会大会予稿集（１９８９）６８，II
−２２ 岩田博夫ほか）、さらに樹脂製の機器に障害を
与えるなど、望ましい溶媒ではない。
【００１４】また、バルーンを用いる場合では、バルー
ンと瘤内部との反応が弱いので、瘤内部空腔が充分埋ま
らないで、わずかでも内腔が残った場合再発の危険性が
高い。できるだけバルーンを多く埋めようとすると動脈
瘤の形を変えることになり、動脈瘤破裂の危険がある。
また、バルーンをカテーテルから切り離すときにひっぱ
る力をかけねばならないという問題がある。
【００１５】その他、ＰＶＡなどの材料を用いる場合
も、カテーテルを用いて血管内に注入するさいに抵抗が
生じたりするなど、治療上問題点が多い。
【００１６】本発明の目的は、従来技術における問題点
を解決し、カテーテル先端において、固まりがある程度
の硬さと弾力性をもち、片端からちぎれて飛び散った
り、血流にふり回されて不必要な個所に移動せず、動脈
瘤壁に付着して、瘤の形をかえずに内腔を埋め、しかも
カテーテルの抜去が容易である血管塞栓剤を提供するこ
とにある。
【００１７】また、本発明の血管塞栓剤とは、上記動脈
瘤における塞栓物質に限らず、動静脈奇形などの血管奇
形、動静脈瘤、止血、腫瘍の治療などにおいても好適な
塞栓剤を提供するものである。
【００１８】
【課題を解決するための手段】本発明は、トロンビン、
重金属およびポリエチレングリコールを含有する水性懸
濁液からなる血管塞栓剤である。
【００１９】本発明で用いられる重金属はＸ線造影能を
有するものであり、金、銀、ビスマス、トリウムなどの
重金属が好適である。ポリエチレングリコールは重金属
のコロイドを安定化するためのものであり、分子量１万
〜１０万程度のものが好ましい。
【００２０】本発明の血管塞栓剤は、０．０１〜５０％
(w/v）の重金属（例えば、四塩化第二金酸Ｈ（ＡｕＣｌ
4 ）・４Ｈ2 Ｏ）を煮沸し、０．１〜５．０％クエン酸
塩を加えて急速に混合し、室温にまで冷却した後ポリエ
チレングリコール（ＰＥＧ）０．１〜１０％を加え、酢
酸でｐＨ５．９に調節し、金コロイドを調製し、これに
トロンビンおよびＰＥＧを加え、遠心分離し、生成した
沈渣をＰＥＧを含むリン酸緩衝液（ＰＢＳ）（ｐＨ７．
２）に再浮遊させ、トロンビンを加えることによって調
製される。
【００２１】本発明の血管塞栓剤はカテーテルを通して
患部に注入され、その場合、注入溶液における各成分の
濃度は、トロンビン０．１ｕ／ml〜２００ｕ／ml、重金
属０．０１〜５０％、ポリエチレングリコール０．１〜
１０％が適当である。使用されるカテーテルの直径は極
めて小さい（１〜３Ｆｒ，Ｆｒ＝１／３mm）ので、血管
塞栓剤の粘度はできるだけ低粘度であることが好まし
い。また、トロンビン活性は強酸では失活するので、中
性附近が望ましい。
【００２２】
【作用効果】本発明の血管塞栓剤は、トロンビンにより
血液を凝固させて血管を閉塞するものであり、血栓は患
者自身の血液に由来するのであるから炎症性がなく、さ
らには器質化され、瘤ネック部分の血液接触面は内皮細
胞により被覆され、長期的な安定性が保証される。さら
に、本発明の血管塞栓剤は造影剤を含むので、Ｘ線でモ
ニターしながら適確にカテーテル挿入を行うことがで
き、有効な治療が可能である。
【００２３】
【実施例】以下、実施例を示して本発明をさらに具体的
に説明する。
【００２４】０．０１％四塩化第二金酸Ｈ（ＡｕＣ
ｌ4 ）・４Ｈ2 Ｏ（メルク社）１００mlを煮沸し、１％
クエン酸ナトリウム４mlを急速に混合する。５分間加熱
し、還元させ、室温まで冷やした後、３ml当たり５滴の
１％ポリエチレングリコール（ＰＥＧ）（分子量２０，
０００）を加え、０．１Ｍ酢酸でｐＨを５．９に調節し
金コロイド液を得た。
【００２５】上記コロイド金液５０mlに１００ｕ／ml，
５mlのトロンビン液を加え、２〜３分後に１％ＰＥＧ液
を１ml加え、６０，０００×ｇ，１時間，４℃で遠心
し、沈渣を０．２mg／mlのＲＥＧを含むリン酸緩衝溶液
（ＰＢＳ）ｐＨ７．２の１．５mlに再浮遊させ造影性を
有するトロンビン溶液を得た。
【００２６】［試験例］家兎に全身麻酔を施し、右頚動
脈に切開を入れ左頚動脈を吻合した。さらに左頚静脈の
一片を動脈分枝部に移植し、動脈瘤モデル動物を作製し
た。
【００２７】３Ｆｒのカテーテル（テルモ社製）を供試
動物の大腿動脈から挿入し、右頚部、動脈瘤付近まで到
達させた。Ｘ線モニターで瘤内にカテーテルが入ってい
るのを確認した後、前記トロンビン溶液を０．６ml入れ
た。カテーテルを大動脈付近まで挿入した状態で、２時
間経過した後再びａｎｇｉｏ ｇｒａｐｈｙした所瘤内
部は完全に造影されなかった。
【００２８】１ケ月生存させた後頚部を開創し、瘤拡張
について観察したところ、瘤の拡張は認められなかっ
た。また、サンプリングし、一般病理標本作製方法に準
じ標本を作製し観察したところ瘤内部は器質化された血
栓が認められ炎症性はほとんど認められず、良好な治癒
過程が観察された。DETAILED DESCRIPTION OF THE INVENTION
[0001]
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a vasoembolic agent
It is. The vasoembolic agent of the present invention has a contrast property, an aneurysm,
Suitable for treatment of vascular disorders such as arteriovenous malformation (AVM)
Used.
[0002]
2. Description of the Related Art A vascular catheter is applied without invasion of surgery.
Endovascular surgical treatment is used to treat vascular disorders
You.
[0003] For example, in the treatment of cerebrovascular disorders, microscopic
A super-selective catheter is placed in the affected area of the cerebral artery
Block abnormal blood flow with embolic material introduced by the catheter
Cerebral aneurysm, arteriovenous malformation
Which treatment is aimed at. 100 adult cerebral aneurysms
Is an aneurysm that one person has in the arterial blood vessel,
It has a wide shape distribution up to about 20 mm, and the site of occurrence is the brain
It spans multiple branches of the artery. About 30% of them do not burst
But about 70% have rupture and subarachnoid hemorrhage
It is said to cause. Arteriovenous malformations are the most common
Well-known cerebral vascular malformations, meandering, extended influx
With arteriovenous anastomosis between blood vessels and outflow vessels
It consists of a collection of
In embolization, such an affected area of the cerebral artery is obstructed by an embolus.
Obstruction, stop blood flow to the affected area, solidify the affected area, and treat
If necessary, remove the solidified affected area.
Do.
[0005] Cerebral blood vessels have an outer elastic membrane in comparison with other parts.
Chipped, thin blood vessel wall, weak resistance to lateral pressure of blood flow
In addition, blood vessels travel complicatedly in the skull,
Failure is likely to occur due to such stress.
For this reason, various embolic materials have been studied.
You.
[0007] Conventionally, as a liquid for vascular occlusion, cyanoa
Many acrylate-based materials have been used (J. Bio
med, Mater. Res.,17, 167-177
(1983) M.P. C. Harpers et al.).
[0008] Recently, ethylene-vinyl alcohol
Copolymer (EVALR) Dimethyl sulfoxide (D
MSO) solution as a material for occlusion and DM in blood
Diffusion of SO, EvarRPrecipitate blood and occlude blood vessels
(Medical Tribune, 1
Oct. 26, 989, pp. 46-47).
[0009] On the other hand, using a catheter inside the aneurysm
Inflating the detachable balloon to block the aneurysm,
A method of placing a balloon in an aneurysm has been proposed (J
own of Neurosurgery,4
1, 125-145 (1974); A. Serbi
nenko).
[0010] In addition, it is assumed that the
And polyvinyl alcohol (PVA) sponge, metal core
Ill, alcohol and sutures depending on the purpose of treatment
Has been used.
[0011]
SUMMARY OF THE INVENTION Cyanoacrylates
Conventional embolic agents rapidly solidify and polymerize in blood vessels
Injection of embolic material is difficult.
The tel must be pulled out of the sheath at once.
Is difficult to handle and can be re-injected even if the occlusion is inadequate
Absent. Also, there is a problem that irritation to the living body is large.
Was.
Eval used in DMSO solvent
The system is located at the center of the eval that has settled inside the aneurysm.
Solvent remains or substances that precipitate in blood vessels
Small particles are likely to be scattered by the turbulence of the liquid,
The part protruding into the blood vessel from the aneurysm exit is the flow of the bifurcation
There is a problem of adhesion along.
The solvent DMSO is a chemical substance.
Therefore, clinical applications may be limited (11th Japan
Proceedings of the Society of Biomaterials (1989) 68, II
-22 Hiroo Iwata et al.) And further impaired resin equipment
It is not a desirable solvent, as it gives.
In the case of using a balloon,
The reaction between the aneurysm and the inside of the aneurysm is weak, so the cavity inside the aneurysm is sufficiently filled.
No risk of recurrence if only a few lumens remain
high. Try to fill as many balloons as possible
This changes the shape of the aneurysm, and there is a risk of rupture of the aneurysm.
Also, pull the balloon apart when disconnecting the balloon from the catheter.
There is a problem that you have to apply force.
When using other materials such as PVA
Resistance when injecting into a blood vessel using a catheter
There are many therapeutic problems, such as occurrence.
An object of the present invention is to solve the problems in the prior art.
At the tip of the catheter,
It has the hardness and elasticity of splattered from one end and splattered
And move to unnecessary places without being swung by the bloodstream.
Adhering to the aneurysm wall, filling the lumen without changing the shape of the aneurysm, and
To provide a vaso-embolic agent that facilitates removal of the catheter
And there.
The vaso-embolic agent of the present invention is the above-mentioned artery
Not only embolic substances in aneurysms but also vascular abnormalities such as arteriovenous malformations
Suitable for shape, arteriovarice, hemostasis, tumor treatment, etc.
An embolic agent is provided.
[0018]
The present invention provides a thrombin,
Aqueous suspension containing heavy metals and polyethylene glycol
It is a vasoembolic agent consisting of a suspension.
The heavy metal used in the present invention has an X-ray contrast ability.
And gold, silver, bismuth, thorium, etc.
Heavy metals are preferred. Polyethylene glycol is a heavy metal
Is used to stabilize the colloid of
Those having about 100,000 to 100,000 are preferable.
The vaso-embolic agent of the present invention is 0.01 to 50%
(w / v) heavy metal (for example, tetrachloroauric acid H (AuCl
Four) ・ 4HTwoO) is boiled and 0.1-5.0% citric acid
Add salt, mix quickly, cool to room temperature, and mix
Add 0.1-10% of Tylene glycol (PEG) and add vinegar
The pH was adjusted to 5.9 with an acid to prepare a gold colloid.
Thrombin and PEG were added, centrifuged and produced
The precipitate was washed with phosphate buffered saline (PBS) containing PEG (pH 7.
Resuspend in 2) and prepare by adding thrombin.
Made.
The embolic agent of the present invention is passed through a catheter.
Injected into the affected area, in which case each component in the infused solution is
The concentration is 0.1 u / ml to 200 u / ml thrombin, heavy metal
Genus 0.01-50%, polyethylene glycol 0.1-
10% is appropriate. The diameter of the catheter used is pole
Very small (1-3 Fr, Fr = 1/3 mm)
The viscosity of the embolic agent should be as low as possible.
No. Also, thrombin activity is inactivated by strong acid,
Sex is desirable.
[0022]
[Effect] The embolic agent of the present invention is
It clots blood and blocks blood vessels.
It is not inflammatory because it is derived from the blood of the individual
The blood contact surface of the neck of the aneurysm is
Vesicles to ensure long-term stability. Further
In addition, since the vasoembolic agent of the present invention contains a contrast agent, it can be
The catheter can be inserted accurately while monitoring
And effective treatment is possible.
[0023]
The present invention will now be described in more detail with reference to the following examples.
Will be described.
0.01% tetrachloroauric acid H (AuC
lFour) ・ 4HTwoBoil 100 ml of O (Merck), 1%
Mix rapidly 4 ml of sodium citrate. Heat for 5 minutes
And allowed to cool to room temperature, after which 5 drops per 3 ml
1% polyethylene glycol (PEG) (molecular weight 20,
000) and adjusted the pH to 5.9 with 0.1 M acetic acid.
A gold colloid solution was obtained.
100 u / ml of 50 ml of the above colloidal gold solution,
Add 5 ml of thrombin solution, and after 2-3 minutes, add 1% PEG solution
1 ml, and centrifuged at 60,000 × g for 1 hour at 4 ° C.
The sediment was washed with a phosphate buffer solution containing 0.2 mg / ml REG.
(PBS) Resuspend in 1.5 ml of pH 7.2 to improve the contrast
To obtain a thrombin solution.
[Test Example] A rabbit was subjected to general anesthesia, and right neck movement was performed.
An incision was made in the pulse and the left carotid artery was anastomosed. Of the left jugular vein
A piece was transplanted into the branch of the artery to create an aneurysm model animal.
Was.
Test using a 3Fr catheter (manufactured by Terumo Corporation)
Insert from the femoral artery of the animal and reach the right neck and near the aneurysm
Reached. An X-ray monitor shows a catheter in the aneurysm
After confirming that the thrombin solution is
Was. 2 o'clock with the catheter inserted near the aorta
In the aneurysm where the angio graph was again formed after a while
The part was not completely imaged.
After having survived for one month, the neck was opened and the aneurysm was expanded.
Was observed, no dilation was observed
Was. In addition, sampling should be performed according to the general pathological specimen preparation method.
When the same specimen was prepared and observed, the inside of the aneurysm was organized blood.
Good healing with no obstruction and little inflammation
A process was observed.
───────────────────────────────────────────────────── フロントページの続き (72)発明者 橋本 周郎 神奈川県足柄上郡中井町井ノ口1500番地 テルモ株式会社内 (56)参考文献 特開 昭61−44825（ＪＰ，Ａ) 特開 昭63−281660（ＪＰ，Ａ) Ｃｙｔｏｂｉｏｓ，1985年，Ｖｏｌ. 43， Ｎｏ．174Ｓ，ｐ．273−283 (58)調査した分野(Int.Cl.7，ＤＢ名) A61K 38/46 A61K 49/04 A61L 31/00 ＣＡ（ＳＴＮ) ＭＥＤＬＩＮＥ（ＳＴＮ)──────────────────────────────────────────────────続 き Continuation of front page (72) Inventor Shuro Hashimoto 1500 Inoguchi, Nakai-machi, Ashigara-gun, Kanagawa Prefecture Inside Terumo Corporation (56) References JP-A-61-44825 (JP, A) JP-A-63-281660 ( JP, A) Cytobios, 1985, Vol. 43, No. 174S, p. 273-283 (58) Fields investigated (Int. Cl. 7 , DB name) A61K 38/46 A61K 49/04 A61L 31/00 CA (STN) MEDLINE (STN)
Claims (1)
およびポリエチレングリコールを含有する水性懸濁液か
らなる動脈瘤用血管塞栓剤。(57) [Claim 1] An aneurysm vasoembolic agent comprising an aqueous suspension containing thrombin, a heavy metal having X-ray contrast and polyethylene glycol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP19363091A JP3530200B2 (en) | 1991-07-09 | 1991-07-09 | Vascular embolic agent |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP19363091A JP3530200B2 (en) | 1991-07-09 | 1991-07-09 | Vascular embolic agent |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH0517369A JPH0517369A (en) | 1993-01-26 |
| JP3530200B2 true JP3530200B2 (en) | 2004-05-24 |
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| JP19363091A Expired - Fee Related JP3530200B2 (en) | 1991-07-09 | 1991-07-09 | Vascular embolic agent |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US6113629A (en) * | 1998-05-01 | 2000-09-05 | Micrus Corporation | Hydrogel for the therapeutic treatment of aneurysms |
| AU2001266926A1 (en) * | 2000-06-16 | 2002-01-02 | University Of Medicine And Dentistry Of New Jersey | Hemostatic compositions, devices and methods |
| US7094428B2 (en) | 2000-06-16 | 2006-08-22 | The University Of Medicine And Dentistry Of New Jersey | Hemostatic compositions, devices and methods |
| AU2002259107B2 (en) * | 2001-04-30 | 2006-10-26 | Cytimmune Sciences, Inc. | Colloidal metal compositions and methods |
| JP4686970B2 (en) * | 2002-10-29 | 2011-05-25 | 東レ株式会社 | Vascular embolic material |
| GB0500898D0 (en) * | 2005-01-18 | 2005-02-23 | Smith & Nephew | Gold-protein coagulation |
| JP4879873B2 (en) | 2007-12-21 | 2012-02-22 | 本田技研工業株式会社 | Direct fuel injection engine |
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1991
- 1991-07-09 JP JP19363091A patent/JP3530200B2/en not_active Expired - Fee Related
Non-Patent Citations (1)
| Title |
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| Ｃｙｔｏｂｉｏｓ，１９８５年，Ｖｏｌ．４３， Ｎｏ．１７４Ｓ，ｐ．２７３−２８３ |
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| JPH0517369A (en) | 1993-01-26 |
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