JP2004024667A - Comb hemostatic apparatus using shape memory material - Google Patents

Comb hemostatic apparatus using shape memory material Download PDF

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Publication number
JP2004024667A
JP2004024667A JP2002187583A JP2002187583A JP2004024667A JP 2004024667 A JP2004024667 A JP 2004024667A JP 2002187583 A JP2002187583 A JP 2002187583A JP 2002187583 A JP2002187583 A JP 2002187583A JP 2004024667 A JP2004024667 A JP 2004024667A
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Japan
Prior art keywords
hemostatic
shape memory
temperature
needle
memory material
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JP2002187583A
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JP3908613B2 (en
Inventor
Yuji Watabe
渡部 祐司
Keiji Oki
黄木 景二
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Japan Science and Technology Agency
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Japan Science and Technology Corp
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a hemostatic apparatus simultaneously stopping bleeding at a plurality of sites by utilizing a characteristic of a shape memory material which varies its shape according to a temperature. <P>SOLUTION: The shape memory material in which a shape memory function of changing a low-temperature-side length L<SB>1</SB>to a high-temperature-side length L<SB>2</SB>after phase transformation is generated is used for a needle support part 11, and a plurality of hemostatic needles 12 are fixed to the needle support part 11. When the hemostatic needles 12 are inserted to blood vessels inside of an internal organ and when this comb hemostatic apparatus 10 is heated by heat of internal organ, a plurality of blood vessels are batch pressed and blood-stopped by the hemostatic needles 12 whose adjacent intervals are narrowed from P<SB>1</SB>to P<SB>2</SB>. Hemostatic needle in which a shape memory function of releasing a twisted state on the low-temperature-side by the phase transformation is generated can be used. <P>COPYRIGHT: (C)2004,JPO

Description

【0001】
【産業上の利用分野】
本発明は、形状記憶材料の形状復元作用を利用し、複数の血管を一括して止血できる止血器具に関する。
【0002】
【従来技術及び問題点】
切離した血管の止血には、クリップ,結紮等によって血管を機械的に圧迫して止血する方法やバイポーラ凝固,超音波凝固,レーザ凝固等により血管を物理的に凝固させて止血する方法が採用されている。しかし、比較的大きな臓器である肝臓,腎臓等の腫瘍を切離する手術では多数の血管が切離されるため、繰返しの止血作業に多くの時間や労力がかかっている。
【0003】
多くの時間や労力は、患者,医師の双方に多大の負担を強いる。その結果、大量出血が予想される長時間の手術に耐えられない患者の臓器を現在の止血技術で切離することは困難で危険な施術になる。従来の止血技術では、出血しているものの表面に露出していない血管を止血することも非常に困難である。物理的な凝固で止血する方法によるとき、表面に露出していない血管を止血することも可能であるが、高価な凝固装置を必要とし、高額医療費の原因にもなっている。
【0004】
【課題を解決するための手段】
本発明は、このような問題を解消すべく案出されたものであり、温度に応じて形状を変える形状記憶材料の特性を利用することにより、複数の血管を迅速且つ容易に結束できる櫛状止血器具を提供することを目的とする。
【0005】
本発明は、その目的を達成するため、針支持部に複数本の止血針を固定した櫛状止血器具において、形状記憶材料の相変態又はガラス転移を針支持部の長さ変化又は止血針の形状変化として発現させている。針支持部の長さ変化で止血針の隣接間隙を狭める場合、低温側長さよりも相変態後又はガラス転移後の高温側長さが短くなる形状記憶機能を付与する。止血針の形状変化で隣接間隙を狭める場合、低温側で付与されている捻転状態が相変態又はガラス転移によって解放される形状記憶機能を付与する。何れの場合も、相変態温度又はガラス転移温度は、保管温度と平常体温との間に調整された形状記憶材料が使用される。
【0006】
【実施の形態】
形状記憶材料は、温度を動作トリガーとした相変態又はガラス転移によって低温側と高温側との間で形状変化を繰り返す材料である。代表的な形状記憶材料であるNi−Ti合金は、生体適合性にも優れ、生体材料としての実績もある。しかし、形状記憶機能を呈する限り、Ni−Ti合金に代えて他の合金や合成樹脂が使用可能なことは勿論である。
【0007】
Ni−Ti合金を形状記憶材料に使用する場合、Ni,Tiの配合比によって相変態温度(動作温度)を調節できる。そのため、冷凍状態等、臓器の温度状態に応じて相変態温度を調節したNi−Ti合金を使用できる。Ni−Ti合金以外の形状記憶材料を使用する場合でも、同様な成分比率や分子量,分子構造等によって相変態温度又はガラス転移温度を止血に必要な温度に調節する。
【0008】
形状記憶材料は、線材,板材等として櫛状止血器具に組み込まれる。
図1の櫛状止血器具10は、針支持部11を形状記憶材料で作り、針支持部11に複数の止血針12を針支持部11に固定している。針支持部11は、低温側の長さLに比較して相変態後又はガラス転移後の長さLが短くなるように形状記憶機能が作りこまれている。櫛状止血器具10を高温に保持すると、相変態又はガラス転移によって針支持部11が高温側長さLになり、止血針12の隣接間隔がp→pと狭くなる。
【0009】
櫛状止血器具10は、止血に先立って相変態温度以下の温度(たとえば、0℃)に保管しておく。保管されている櫛状止血器具10は、針支持部11が低温側長さLになっており、止血針12の隣接間隔pが止血対象の血管よりも広くなっている。この状態で、臓器Aの内部にある血管b,b・・・・bの間に止血針12を差し込む(図2左)。なお、図2では、血管b,b・・・・bと止血針12との位置関係を明示するため、止血面Sから切離面までの臓器Aの図示を省略している。
【0010】
血管b,b・・・・bの間に止血針12が挿し込まれた櫛状止血器具10は、臓器Aからの熱で昇温する。櫛状止血器具10の温度が相変態温度を超えると、相変態によって針支持部11が高温側長さLまで短くなる。針支持部11の短縮によって止血針12の隣接間隔pも狭まる。そのため、臓器Aの内部にある複数の血管b,b・・・・bが止血針12の間で同時に圧迫される(図2右)。したがって、複数の血管b,b・・・・bを簡単な操作で同時に止血でき、止血に要する時間が大幅に短縮される。
【0011】
櫛状止血器具10を用いた止血作業では、止血針12を臓器Aの内部に挿入した後で相変態又はガラス転移によって止血針12の隣接間隔を狭めて血管b,b・・・・bを直接圧迫している。そのため、切離面よりも臓器Aの内側にある血管bであっても、同様に止血針12を患部に挿し込み、臓器Aからの熱で相変態させる簡単な操作手順で止血できる。
【0012】
止血針12による血管b,b・・・・bの圧迫状態は、臓器Aが平常体温(37℃)に戻っても維持される。具体的には、針支持部11に使用されるNi−Ti合金の相変態温度を保管温度〜平常体温の間に設定しておくと、止血後に臓器Aが相変態温度以下に下がることがないので、針支持部11の高温側長さLが維持され、隣接間隔pが狭い止血針12の間で血管b,b・・・・bが圧迫された止血状態が持続する。
【0013】
止血針自体を形状記憶材料で作ることもできる(図3)。この櫛状止血器具20では、形状記憶機能のない材料で針支持部21を作り、形状記憶材料を捻転した止血針22を針支持部21に固定されている。櫛状止血器具20を高温に加熱すると、針支持部21は形状変化しないが、止血針22は捻転状態から解放されフラットな形状に変化する。その結果、止血針22の隣接間隔が狭くなった止血針22で血管b,b・・・・bが圧迫され止血される。
止血針22の形状変化に併せ、図1の場合と同様に変態後の高温側長さLが短くなる針支持部21を使用することも可能である。針支持部21,止血針22の形状変化を併用すると、止血に必要な圧迫力が容易に得られる。
【0014】
形状記憶材料の相変態による形状変化を利用した結紮具自体は、特開昭62−34555号公報,特開昭62−34556号公報で紹介されているが、何れも一つの血管に対する止血を対象にしている。これに対し、本発明の櫛状止血器具10,20では、針支持部11,21に複数の止血針12,22を固定しているので複数箇所の血管を同時に止血できる。すなわち、臓器Aの内部にある血管b,b・・・・bの所定個所に止血針12,22を挿入し、臓器Aの熱で櫛状止血器具10,20が相変態温度又はガラス転移温度以上に加熱されると止血針12,22の間隔がp→pと狭まり、血管b,b・・・・bが圧迫され止血される。温度を動作トリガーにした形状記憶材料の相変態又はガラス転移を使用しているので、10〜20本もの血管を含む広い患部を複数の止血針12,22で一括して止血でき、止血作業も短時間で終了する。
【0015】
【発明の効果】
以上に説明したように、本発明の櫛状止血器具は、温度に応じて形状変化を起こす形状記憶材料の特性を利用して、針支持部に固定した複数の止血針を止血に必要な間隙まで狭めている。止血針の隣接間隙が同時に狭められるため、たとえば10〜20本程度の血管を一括して止血でき、患者,医者に与える負担が大幅に軽減され、止血作業に要する時間も大幅に短縮される。その結果、長時間の手術に耐えられなかった患者に対しても切離手術が可能になる。しかも、外部からのエネルギーを必要としない形状記憶機能を利用しているので、レーザ,超音波等の高価な装置が不要となり、手術コストの大幅な低減も可能である。
【図面の簡単な説明】
【図1】針支持部に形状記憶材料を用いた櫛状止血器具
【図2】同櫛状止血器具を用いた止血作業の説明図
【図3】止血針に形状記憶材料を用いた櫛状止血器具
【符号の説明】
10,20:櫛状止血器具  11:針支持部(形状記憶材料製)  21:針支持部  12:止血針  22:止血針(形状記憶材料製)
:針支持部の低温側長さ  L:針支持部の高温側長さ
:止血針の隣接間隔  p:止血針の隣接間隔
A:臓器  S:臓器内部の止血面 b,b・・・・b:臓器の内部にある血管
[0001]
[Industrial applications]
The present invention relates to a hemostatic device that can collectively stop a plurality of blood vessels by utilizing the shape restoring action of a shape memory material.
[0002]
[Prior art and problems]
In order to stop the bleeding of the isolated blood vessel, a method of mechanically compressing the blood vessel by clipping or ligating to stop the bleeding or a method of physically coagulating the blood vessel by bipolar coagulation, ultrasonic coagulation, laser coagulation, etc. are employed. ing. However, a large number of blood vessels are dissected in an operation to dissect a tumor such as a liver or a kidney, which is a relatively large organ, so that it takes a lot of time and effort for repeated hemostatic work.
[0003]
Much time and effort puts a great burden on both the patient and the physician. As a result, it is a difficult and dangerous operation to isolate a patient's organ that cannot withstand long-term surgery, which is expected to cause massive bleeding, using current hemostatic techniques. With conventional hemostatic techniques, it is also very difficult to stop bleeding but not exposing blood vessels to the surface. According to the method of stopping blood by physical coagulation, it is possible to stop blood vessels not exposed on the surface, but it requires an expensive coagulation apparatus and causes high medical expenses.
[0004]
[Means for Solving the Problems]
The present invention has been devised to solve such a problem. By utilizing the characteristics of a shape memory material that changes its shape in accordance with temperature, it is possible to quickly and easily bind a plurality of blood vessels. It is intended to provide a hemostatic device.
[0005]
In order to achieve the object, the present invention provides a comb-shaped hemostatic device in which a plurality of hemostatic needles are fixed to a needle support, wherein the phase transformation or glass transition of the shape memory material is changed by changing the length of the needle support or the hemostatic needle. It is expressed as a shape change. When the adjacent gap between the hemostatic needles is narrowed by changing the length of the needle support, a shape memory function is provided in which the length on the high-temperature side after the phase transformation or glass transition is shorter than the length on the low-temperature side. When the adjacent gap is narrowed by changing the shape of the hemostatic needle, a shape memory function is provided in which the twisted state provided on the low temperature side is released by the phase transformation or glass transition. In any case, a shape memory material whose phase transformation temperature or glass transition temperature is adjusted between storage temperature and normal body temperature is used.
[0006]
Embodiment
The shape memory material is a material that repeats a shape change between a low temperature side and a high temperature side by a phase transformation or a glass transition triggered by temperature. A Ni—Ti alloy, which is a typical shape memory material, has excellent biocompatibility and has a track record as a biomaterial. However, it goes without saying that other alloys or synthetic resins can be used instead of the Ni-Ti alloy as long as they exhibit the shape memory function.
[0007]
When a Ni-Ti alloy is used for the shape memory material, the phase transformation temperature (operating temperature) can be adjusted by the mixing ratio of Ni and Ti. Therefore, it is possible to use a Ni—Ti alloy whose phase transformation temperature is adjusted according to the temperature state of the organ such as a frozen state. Even when a shape memory material other than a Ni-Ti alloy is used, the phase transformation temperature or glass transition temperature is adjusted to a temperature necessary for hemostasis by the same component ratio, molecular weight, molecular structure, and the like.
[0008]
The shape memory material is incorporated in a comb-shaped hemostatic device as a wire, a plate, or the like.
In the comb-shaped hemostatic device 10 of FIG. 1, a needle support 11 is made of a shape memory material, and a plurality of hemostatic needles 12 are fixed to the needle support 11. Needle support 11, the low temperature side of the length L shape memory function as 1 length L 2 after to phase transformation or after the glass transition compared to shorter is fabricated. Holding the comb hemostatic device 10 to a high temperature, needle support 11 by phase transformation or glass transition is a high temperature side length L 2, narrower distance between the adjacent hemostatic needle 12 and p 1 → p 2.
[0009]
Prior to hemostasis, the comb-shaped hemostatic device 10 is stored at a temperature lower than the phase transformation temperature (for example, 0 ° C.). Comb hemostatic device 10 that are stored, the needle support 11 has become a low-temperature side length L 1, the adjacent spacing p 1 hemostatic needle 12 is wider than the vessel hemostasis target. In this state, the hemostatic needle 12 is inserted between the blood vessels b 1 , b 2, ..., B n inside the organ A (FIG. 2, left). In FIG. 2, in order to clearly show the positional relationship between the blood vessel b 1, b 2 ···· b n and hemostasis needle 12, are omitted organ A to dissection plane from hemostasis surface S.
[0010]
The comb-shaped hemostatic device 10 having the hemostatic needle 12 inserted between the blood vessels b 1 , b 2, ... B n is heated by the heat from the organ A. When the temperature of the comb-shaped hemostatic device 10 exceeds the phase transformation temperature, needle support 11 is shortened to a high temperature side length L 2 by phase transformation. Distance between the adjacent hemostatic needle 12 by shortening the needle support 11 p 2 also narrowed. Therefore, a plurality of blood vessels b 1 , b 2, ..., B n inside the organ A are simultaneously compressed between the hemostatic needles 12 (right in FIG. 2). Therefore, a plurality of blood vessels b 1 , b 2, ..., B n can be simultaneously stopped by a simple operation, and the time required for the stop is greatly reduced.
[0011]
The hemostasis work using a comb-like hemostatic device 10, the vessel b 1 hemostasis needle 12 narrows the distance between the adjacent hemostatic needle 12 by phase transformation or glass transition after insertion into an organ A, b 2 · · · · b n is pressed directly. Therefore, even in vessels b 2 inside the organ A than the separating surface, likewise insert the hemostasis needle 12 in the affected area, it hemostasis in a simple operation procedure for phase transformation in the heat from the organ A.
[0012]
The blood vessels b 1 , b 2, ..., B n are pressed by the hemostatic needle 12 even if the organ A returns to normal body temperature (37 ° C.). Specifically, if the phase transformation temperature of the Ni—Ti alloy used for the needle support 11 is set between the storage temperature and the normal body temperature, the organ A does not drop below the phase transformation temperature after hemostasis. since, it maintained the high temperature side length L 2 of the needle support 11, hemostasis vascular b 1, b 2 ···· b n is compressed between the narrow distance between the adjacent p 2 hemostatic needle 12 persists .
[0013]
The hemostatic needle itself can be made of a shape memory material (FIG. 3). In this comb-shaped hemostatic device 20, the needle support 21 is made of a material having no shape memory function, and the hemostatic needle 22 formed by twisting the shape memory material is fixed to the needle support 21. When the comb-shaped hemostatic device 20 is heated to a high temperature, the shape of the needle support 21 does not change, but the hemostatic needle 22 is released from the twisted state and changes to a flat shape. As a result, the blood vessels b 1 , b 2, ..., B n are pressed by the hemostatic needle 22 in which the distance between the adjacent hemostatic needles 22 is reduced, and the blood is stopped.
Accordance with the shape change of the hemostatic needle 22, it is also possible to use needle support 21 which is the high temperature side length L 2 after transformation as in the case of FIG. 1 is shortened. When the shape changes of the needle support 21 and the hemostatic needle 22 are used together, the compression force necessary for hemostasis can be easily obtained.
[0014]
The ligature itself utilizing the shape change due to the phase transformation of the shape memory material is introduced in JP-A-62-34555 and JP-A-62-34556, all of which are intended for hemostasis of one blood vessel. I have to. On the other hand, in the comb-shaped hemostatic devices 10 and 20 of the present invention, since a plurality of hemostatic needles 12 and 22 are fixed to the needle support portions 11 and 21, hemostasis of a plurality of blood vessels can be simultaneously performed. That is, the hemostatic needles 12 and 22 are inserted into predetermined locations of the blood vessels b 1 , b 2, ... B n inside the organ A, and the heat of the organ A causes the comb-shaped hemostatic instruments 10 and 20 to reach the phase transformation temperature or interval hemostatic needles 12 and 22 when heated above the glass transition temperature narrows and p 1p 2, vascular b 1, b 2 ···· b n is squeezed hemostasis. Since the phase transformation or glass transition of the shape memory material using temperature as an operation trigger is used, a wide affected area including as many as 10 to 20 blood vessels can be collectively stopped using a plurality of hemostatic needles 12 and 22, and the hemostatic work can be performed. Finish in a short time.
[0015]
【The invention's effect】
As described above, the comb-shaped hemostatic device of the present invention utilizes the characteristics of the shape memory material that changes its shape in accordance with the temperature, and allows the plurality of hemostatic needles fixed to the needle supporting portion to have a gap required for hemostasis. Down to Since the adjacent gaps between the hemostatic needles are simultaneously narrowed, for example, about 10 to 20 blood vessels can be collectively stopped, and the burden on the patient and the doctor is greatly reduced, and the time required for the hemostatic operation is greatly reduced. As a result, it is possible to perform a resection operation even for a patient who cannot endure a long operation. In addition, since a shape memory function that does not require external energy is used, expensive devices such as lasers and ultrasonic waves are not required, and the operation cost can be significantly reduced.
[Brief description of the drawings]
FIG. 1 is a comb-shaped hemostatic device using a shape memory material for a needle support portion. FIG. 2 is an explanatory view of a hemostatic operation using the comb-shaped hemostatic device. FIG. 3 is a comb shape using a shape memory material for a hemostatic needle. Hemostatic device [Explanation of symbols]
10, 20: comb-shaped hemostatic device 11: needle support (made of shape memory material) 21: needle support 12: hemostatic needle 22: hemostatic needle (made of shape memory material)
L 1 : low-temperature length of the needle support L 2 : high-temperature length of the needle support p 1 : interval between adjacent hemostatic needles p 2 : adjacent interval between hemostatic needles A: organ S: hemostatic surface inside the organ b 1 , B 2 ... B n : blood vessels inside the organ

Claims (2)

保管温度と平常体温との間に相変態温度又はガラス転移温度が調節され、相変態後又はガラス転移後に長さが短くなる形状記憶材料製の針支持部に複数の止血針を固定していることを特徴とする形状記憶材料を用いた櫛状止血器具。A plurality of hemostatic needles are fixed to a shape memory material needle support part whose phase transformation temperature or glass transition temperature is adjusted between storage temperature and normal body temperature and whose length becomes short after phase transformation or glass transition. A comb-shaped hemostatic device using a shape memory material. 保管温度と平常体温との間に相変態温度又はガラス転移温度が調節され、低温側の捻転状態が高温側で解放されてフラットになる形状記憶機能が付与された形状記憶材料で複数の止血針を作り、該止血針が針支持部に固定されていることを特徴とする形状記憶材料を用いた櫛状止血器具。A plurality of hemostatic needles made of a shape memory material provided with a shape memory function in which the phase transformation temperature or glass transition temperature is adjusted between the storage temperature and the normal body temperature, and the twisted state on the low temperature side is released on the high temperature side and becomes flat. Wherein the hemostatic needle is fixed to a needle supporting portion, wherein a comb-shaped hemostatic device using a shape memory material is provided.
JP2002187583A 2002-06-27 2002-06-27 Comb hemostatic device using shape memory material Expired - Fee Related JP3908613B2 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
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US7598935B2 (en) 2005-05-17 2009-10-06 Lg Electronics Inc. Light emitting device with cross-talk preventing circuit and method of driving the same
CN102631243A (en) * 2011-02-15 2012-08-15 成功大学 Therapeutic device for electromagnetic thermotherapy

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7598935B2 (en) 2005-05-17 2009-10-06 Lg Electronics Inc. Light emitting device with cross-talk preventing circuit and method of driving the same
CN102631243A (en) * 2011-02-15 2012-08-15 成功大学 Therapeutic device for electromagnetic thermotherapy

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