JPS63242272A - Composition for expanding balloon of balloon catheter - Google Patents
Composition for expanding balloon of balloon catheterInfo
- Publication number
- JPS63242272A JPS63242272A JP62076229A JP7622987A JPS63242272A JP S63242272 A JPS63242272 A JP S63242272A JP 62076229 A JP62076229 A JP 62076229A JP 7622987 A JP7622987 A JP 7622987A JP S63242272 A JPS63242272 A JP S63242272A
- Authority
- JP
- Japan
- Prior art keywords
- balloon
- composition
- catheter
- expansion according
- expanding
- 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.)
- Granted
Links
- 239000000203 mixture Substances 0.000 title claims description 20
- 239000000499 gel Substances 0.000 claims description 10
- 238000001879 gelation Methods 0.000 claims description 9
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 6
- 239000003431 cross linking reagent Substances 0.000 claims description 6
- 238000002347 injection Methods 0.000 claims description 6
- 239000007924 injection Substances 0.000 claims description 6
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 6
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 claims description 5
- 239000003607 modifier Substances 0.000 claims description 5
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 206010053648 Vascular occlusion Diseases 0.000 claims description 3
- IBVAQQYNSHJXBV-UHFFFAOYSA-N adipic acid dihydrazide Chemical group NNC(=O)CCCCC(=O)NN IBVAQQYNSHJXBV-UHFFFAOYSA-N 0.000 claims description 3
- UIUJIQZEACWQSV-UHFFFAOYSA-N succinic semialdehyde Chemical group OC(=O)CCC=O UIUJIQZEACWQSV-UHFFFAOYSA-N 0.000 claims description 3
- 208000021331 vascular occlusion disease Diseases 0.000 claims description 3
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims description 2
- 239000000463 material Substances 0.000 description 5
- 210000004204 blood vessel Anatomy 0.000 description 4
- 239000000945 filler Substances 0.000 description 4
- 229920001296 polysiloxane Polymers 0.000 description 4
- 238000002594 fluoroscopy Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N ether Substances CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- -1 ether polyol Chemical class 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000012948 isocyanate Substances 0.000 description 2
- 150000002513 isocyanates Chemical class 0.000 description 2
- 229920005862 polyol Polymers 0.000 description 2
- 239000004945 silicone rubber Substances 0.000 description 2
- 210000003270 subclavian artery Anatomy 0.000 description 2
- 206010008111 Cerebral haemorrhage Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000002583 angiography Methods 0.000 description 1
- 238000011888 autopsy Methods 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 229910000416 bismuth oxide Inorganic materials 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000002872 contrast media Substances 0.000 description 1
- TYIXMATWDRGMPF-UHFFFAOYSA-N dibismuth;oxygen(2-) Chemical compound [O-2].[O-2].[O-2].[Bi+3].[Bi+3] TYIXMATWDRGMPF-UHFFFAOYSA-N 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 229920002631 room-temperature vulcanizate silicone Polymers 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Landscapes
- Materials For Medical Uses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.
Description
【発明の詳細な説明】
（産業上の利用分野）
本発明は脈管、特に血管の流路を閉塞するためのバルー
ンカテーテルの分離可能なバルーンを拡張するのに用い
られる充填用組成物に関する。DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to a filling composition used to expand a separable balloon of a balloon catheter for occluding a flow path in a blood vessel, particularly a blood vessel.
（従来の技術）
従来、閉塞用バルーンカテーテルは脳出血での責任血管
の閉塞、癌に対する栄養補給管の閉塞等を目的に使用さ
れる。この様な閉塞用バルーンカテーテルとして例えば
特表昭５７−５００７２０に目的部位に於いて分離可能
なバルーンカテーテルが開示されているが、このバルー
ンカテーテルに於いては充填物に液体を用いており、こ
の為分離後充填物が漏れないようにバールン自体に逆止
弁を設けなければならず、バルーン構造が複雑になり、
さらに誤ってバールンを拡張した場合バルーンを再収縮
させることができない。また単にバルーンをカテーテル
先端部に嵌合により取り付け、液体によりバールンを拡
張し留置するのみでは、注入孔より充填物が短時間の内
に外部に漏出しバルーンがしぼんでしまう。更に充填物
にシリコーンＲＴＶ （シリコーンラバーＫＥ １２Ｒ
ＴＶ、信越化学工業（株））を使用することが考えられ
るが、シリコーンＲＴＶは非常に粘度が高く、これをバ
ルーン内に注入する為にはカテーテルの管系が太くなっ
てしまう欠点がある。更にシリコーンＲＴＶは硬化時間
が長くこのような目的に適していない。(Prior Art) Conventionally, occlusion balloon catheters have been used for the purpose of occluding blood vessels responsible for cerebral hemorrhage, occluding feeding tubes for cancer, and the like. As such a balloon catheter for occlusion, for example, Japanese Patent Publication No. 57-500720 discloses a balloon catheter that can be separated at the target site. Therefore, a check valve must be installed on the balloon itself to prevent the filled material from leaking after separation, making the balloon structure complicated.
Further, if the balloon is expanded by mistake, the balloon cannot be deflated again. Furthermore, if the balloon is simply attached to the distal end of the catheter by fitting, and the balloon is expanded with liquid and left in place, the filling material will leak out from the injection hole within a short period of time and the balloon will deflate. Furthermore, silicone RTV (Silicone Rubber KE 12R) is added to the filling.
It is possible to use silicone RTV (Shin-Etsu Chemical Co., Ltd.), but silicone RTV has a very high viscosity, and in order to inject it into the balloon, the catheter tube system becomes thick. Furthermore, silicone RTV has a long curing time and is not suitable for this purpose.
（発明が解決しようとする問題点）
本発明は拡張用充填物をバルーン内に容易に充填するこ
とができ、かつバルーンとカテーテルを分離した場合、
バルーンに逆止弁を設けることなく拡張状態を長期に亘
り安定に保持させることができるバルーン拡張用組成物
を提供することを目的とする。(Problems to be Solved by the Invention) The present invention allows the expansion filler to be easily filled into the balloon, and when the balloon and catheter are separated,
An object of the present invention is to provide a composition for balloon expansion that can stably maintain an expanded state for a long period of time without providing a check valve to the balloon.
（問題点を解決するための手段） ′
本発明は上記問題点を解決するための手段として、脈管
閉塞用バルーンへの注入時に流動性を持たせ、注入一定
時間後にゲル化し流動性を失う組成物を上記バルーン拡
張用の充填物として採用した。(Means for Solving the Problems) 'The present invention, as a means for solving the above problems, provides fluidity when injected into a vascular occlusion balloon, and gels and loses fluidity after a certain time of injection. The composition was employed as a filler for the balloon expansion described above.
このバルーン拡張用組成物はバルーンへの注入時におい
て２５℃で粘度３００ ｃｐｓ以下、好ましくは２００
ｃｐｓ以下であり、かつ注入後ゲル化までの時間が２
分以上３０分以内好ましくは５分〜２０分の範囲である
ことが好ましい。粘度（２５℃）が３００ ｃｐｓ以上
であるとバルーンへの注入が困難である。また、ゲル化
時間が３０分以上であると患者の負担が大きくなり好ま
しくない。具体的には部分ケン化ポリビニルアルコール
等の変性ポリビニルアルコールを主成分とし、これに、
アジピン酸ジヒドラジド又はサクシニックセミアルデヒ
ド等の架橋剤を添加したもの、又は例えば有機イソシア
ネートとエーテルポリオールとの反応物からなるウレタ
ンプレポリマーに水、必要に応じ、さらに硬化調整剤を
加えたものなどを上記組成物として用いることができる
。This balloon expansion composition has a viscosity of 300 cps or less, preferably 200 cps or less at 25°C when injected into the balloon.
cps or less, and the time to gelation after injection is 2
The time is preferably from 5 minutes to 20 minutes, preferably from 5 minutes to 20 minutes. If the viscosity (at 25° C.) is 300 cps or more, it will be difficult to inject into a balloon. Moreover, if the gelation time is 30 minutes or more, the burden on the patient will increase, which is not preferable. Specifically, the main component is modified polyvinyl alcohol such as partially saponified polyvinyl alcohol, and
A crosslinking agent such as adipic acid dihydrazide or succinic semialdehyde is added, or a urethane prepolymer made of a reaction product of an organic isocyanate and an ether polyol is added with water and, if necessary, a curing modifier. It can be used as the above composition.
（作用）
上記例示のバルーン拡張用組成物は硬化以前においては
流動性が極めて大きく、はとんど水に近いものである。(Function) The balloon expansion composition exemplified above has extremely high fluidity before hardening, and is almost water-like.
そのため、カテーテル内径は非常に細いものでも充填可
能であり、充填後一定時間の後ゲル化し流動性は全く無
くなる。この為バルーンをカテーテルと切り離したとし
ても、バルーンに逆止弁がなくとも充填物が漏出するよ
うなことがない。この事によりカテーテル及びバルーン
の構造が簡単且つ小型にする事が可能になる。更にこの
物質は架橋剤の配合量等によりゲル化時間が調整できる
為、このように使用に適している。Therefore, it is possible to fill even a catheter with a very small inner diameter, and after a certain period of time after filling, it gels and loses its fluidity. Therefore, even if the balloon is separated from the catheter, the filling material will not leak out even if the balloon does not have a check valve. This allows the structure of the catheter and balloon to be simple and compact. Furthermore, since the gelation time of this substance can be adjusted by adjusting the amount of crosslinking agent added, etc., it is suitable for this use.
更にこれらの充填剤は一般のウレタンと異なり硬化に際
し顕著な発熱を伴わず生体に対し悪影響を与えない。Furthermore, unlike general urethane, these fillers do not generate significant heat during curing and do not have any adverse effects on living organisms.
実施例１
ヘキスト合成（株）製モビニール ゲル６０（商標）（
主剤：部分ケン化ポリビニルアルコール架橋剤；ＧＭ−
１（商標）：アジピン酸ジヒドラジド、ＧＭ−７（商標
）：サクシニックセミアルデヒド等）を以下の配合で混
ぜた処、以下の表１に示すゲル化時間であった。またこ
れらの配合は内径；０．６０ｍｍ長さ； ９０ｃｍｍの
カテーテルを通し先端に嵌合したバルーンにシリンジで
容易に注入可能であった。またバルーンに注入ゲル化の
後、バルーンとカテーテルを分離してもゲルが漏出する
ようなことはなかった。Example 1 Movinyl Gel 60 (trademark) manufactured by Hoechst Synthesis Co., Ltd.
Main ingredient: Partially saponified polyvinyl alcohol crosslinking agent; GM-
1 (trademark): adipic acid dihydrazide, GM-7 (trademark): succinic semialdehyde, etc.) were mixed in the following formulations, and the gelation time was shown in Table 1 below. Moreover, these formulations could be easily injected with a syringe through a catheter with an inner diameter of 0.60 mm and a length of 90 cm and into a balloon fitted at the tip. Furthermore, even after the gel was injected into the balloon and the catheter was separated from the catheter, the gel did not leak out.
実施例２
フリーマンケミカル社製含水ポリウレタン ゲル、ＡＱ
ＵＡＰＯＬ （商標）（主剤；有機イソシアネート＋エ
ーテルポリオールのプレポリマー。Example 2 Hydrous polyurethane gel manufactured by Freeman Chemical Co., AQ
UAPOL (trademark) (base ingredient; prepolymer of organic isocyanate + ether polyol.
硬度調整剤；側鎖をもつグリコール）を用い下記表２に
示す時間でゲル化した。ウレタンゲルの場合においても
流動性、ゲル化後のバルーンよりの充填物の漏出の問題
はなかった。Using a hardness modifier (glycol having a side chain), gelation was performed for the time shown in Table 2 below. Even in the case of urethane gel, there were no problems with fluidity or leakage of the filled material from the balloon after gelation.
表 ２
主剤 硬度調整剤 水 ゲル化時間１０％ ４
５％ ４５％ ３ ｍ１ｎ２０％ ０％ ８
０％ １ ｍ４ｎ実施例３
前述のモビニルゲル６０を用い雑犬（メス、体重工ＯＫ
ｇ）の左鎖骨下動脈にバルーンの留置をおこなった。す
なわち、ガイドシースを通常の血管造影の手技により雑
犬の左鎖骨下動脈に留置した。Table 2 Main agent Hardness modifier Water Gelation time 10% 4
5% 45% 3 m1n20% 0% 8
0% 1 m4n Example 3 Mixed dog (female, heavy lifting OK) using Movinyl Gel 60 mentioned above.
g) A balloon was placed in the left subclavian artery. That is, a guide sheath was placed in the left subclavian artery of a mongrel dog using a standard angiography technique.
次いで、分離可能なバルーンカテーテル（カテーテル内
径０．６ｍ）を上記ガイドシース内に挿入し、留置部位
間で導入した。このカテーテル先端に嵌合されたバルー
ンはシリコンゴム製で約２ＩＩＩｊ！間で充填物の注入
ができるようになっていた。Next, a separable balloon catheter (catheter inner diameter 0.6 m) was inserted into the guide sheath and introduced between the indwelling sites. The balloon fitted to the tip of this catheter is made of silicone rubber and weighs approximately 2IIIj! Filling material could be injected between the two.
次に、下記表３に示す割合で充填剤を調整しバルーンに
約１ｍ／Ｘ線透視下で注入し、バルーンを拡張した。充
填物のゲル化ののち、バルーンとカテーテルを切り離し
、バルーンの留置を行なったなお酸化ビスマスは留置位
置等をＸ線透視により確認する為に配合している４ケ月
後剖検したところ、バルーンの縮小は認められず、また
血管の閉塞も完全であり、バルーン表面は内皮化血栓で
覆われていた。Next, a filler was prepared in the proportion shown in Table 3 below and injected into the balloon at a rate of about 1 m/under X-ray fluoroscopy, and the balloon was expanded. After gelation of the filling, the balloon and catheter were separated and the balloon was indwelled. Bismuth oxide was added to confirm the indwelling position using X-ray fluoroscopy. An autopsy performed 4 months later revealed that the balloon had shrunk. was not observed, the blood vessel was completely occluded, and the balloon surface was covered with endothelialized thrombus.
（発明の効果）
本発明に係わる脈管閉塞用バルーンカテーテルのバール
ン拡張用組成物はバルーンの注入時においては高い流動
性を有するため、細い内径を持つカテーテルであっても
注入が容易であり、これによりカテーテルの径の小サイ
ズ化が図れる。更に注入後ゲル状に固化するため、バル
ーンに逆止弁等を取付ける必要がない。この為バルーン
の小型化が図れ、また構造も非常に簡単になる。更にこ
れらのゲルはＸ線造影物室を混入もでき透視によるバル
ーンの位置、サイズの確認が容易である。(Effects of the Invention) The composition for expanding the bulge of the balloon catheter for vascular occlusion according to the present invention has high fluidity when injecting the balloon, so it can be easily injected even into a catheter with a small inner diameter. This allows the diameter of the catheter to be reduced. Furthermore, since it solidifies into a gel-like state after injection, there is no need to attach a check valve or the like to the balloon. Therefore, the balloon can be made smaller and its structure can be made very simple. Furthermore, these gels can also contain an X-ray contrast material chamber, making it easy to confirm the position and size of the balloon through fluoroscopy.
Claims (10)
性を有し、注入一定時間後にゲル化し流動性を失うこと
を特徴とするバルーンカテーテルのバールン拡張用組成
物。(1) A composition for expanding the bulge of a balloon catheter, which has fluidity when injected into the burn of a balloon catheter, and gels and loses fluidity after a certain time of injection.
求の範囲第１項記載のバールン拡張用組成物。(2) The composition for expanding a bulge according to claim 1, wherein the balloon is a balloon for vascular occlusion.
００ｃｐｓ以下であり、かつ注入後ゲル化までの時間を
２分以上３０分以内とした特許請求の範囲第１項記載の
バールン拡張用組成物。(3) When injected into the balloon, the viscosity is 3 at 25°C.
00 cps or less, and the time required for gelation after injection is 2 minutes or more and 30 minutes or less.
架橋剤を混合してなることを特徴とする特許請求の範囲
第３項記載のバールン拡張用組成物。(4) The composition for burl expansion according to claim 3, characterized in that the main component is modified polyvinyl alcohol, and a crosslinking agent is mixed therein.
ルアルコールである特許請求の範囲第３項記載のバール
ン拡張用組成物。(5) The composition for burl expansion according to claim 3, wherein the modified polyvinyl alcohol is partially saponified polyvinyl alcohol.
の範囲第４項記載のバルーン拡張用組成物。(6) The composition for balloon expansion according to claim 4, wherein the crosslinking agent is adipic acid dihydrazide.
請求の範囲第４項記載のバルーン拡張用組成物。(7) The composition for balloon expansion according to claim 4, wherein the crosslinking agent is succinic semialdehyde.
混合してなることを特徴とする特許請求の範囲第４項記
載のバルーン拡張用組成物。(8) The composition for balloon expansion according to claim 4, characterized in that it contains a urethane prepolymer as a main component and water is mixed therein.
合してなることを特徴とする特許請求の範囲第１項記載
のバルーン拡張用組成物。(9) The balloon expansion composition according to claim 1, which is a mixture of a urethane prepolymer, a hardness modifier, and water.
の範囲第９項記載のバルーン拡張用組成物。(10) The composition for balloon expansion according to claim 9, wherein the hardness modifier is a side chain type glycol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62076229A JPS63242272A (en) | 1987-03-31 | 1987-03-31 | Composition for expanding balloon of balloon catheter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62076229A JPS63242272A (en) | 1987-03-31 | 1987-03-31 | Composition for expanding balloon of balloon catheter |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS63242272A true JPS63242272A (en) | 1988-10-07 |
| JPH0380514B2 JPH0380514B2 (en) | 1991-12-25 |
Family
ID=13599336
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP62076229A Granted JPS63242272A (en) | 1987-03-31 | 1987-03-31 | Composition for expanding balloon of balloon catheter |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS63242272A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2003527402A (en) * | 2000-03-13 | 2003-09-16 | バイオキュア・インコーポレーテッド | Embolization composition |
| JP2014087663A (en) * | 2006-09-11 | 2014-05-15 | Pluromed Inc | Atraumatic occlusion balloons and skirts, and methods of use thereof |
-
1987
- 1987-03-31 JP JP62076229A patent/JPS63242272A/en active Granted
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2003527402A (en) * | 2000-03-13 | 2003-09-16 | バイオキュア・インコーポレーテッド | Embolization composition |
| JP4871476B2 (en) * | 2000-03-13 | 2012-02-08 | バイオコンパティブルズ ユーケー リミテッド | Embolization composition |
| JP2014087663A (en) * | 2006-09-11 | 2014-05-15 | Pluromed Inc | Atraumatic occlusion balloons and skirts, and methods of use thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0380514B2 (en) | 1991-12-25 |
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