JP2016032595A - Intraluminal spacer for radiotherapy - Google Patents

Intraluminal spacer for radiotherapy Download PDF

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JP2016032595A
JP2016032595A JP2014156988A JP2014156988A JP2016032595A JP 2016032595 A JP2016032595 A JP 2016032595A JP 2014156988 A JP2014156988 A JP 2014156988A JP 2014156988 A JP2014156988 A JP 2014156988A JP 2016032595 A JP2016032595 A JP 2016032595A
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spacer
intraluminal
radiotherapy
catheter
intracavity
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JP6651122B2 (en
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大野 達也
Tatsuya Ono
達也 大野
佳樹 久保田
Yoshiki Kubota
佳樹 久保田
睦 田代
Mutsumi Tashiro
睦 田代
伸之 亀井
Nobuyuki Kamei
伸之 亀井
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DIP KK
Gunma University NUC
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Gunma University NUC
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Abstract

PROBLEM TO BE SOLVED: To provide an intraluminal spacer having a simplified configuration enabling easy manufacturing and cleaning while exhibiting excellent function for reducing side effect and excellent therapeutic effect.SOLUTION: During a therapeutic operation in which radiation is externally irradiated or/and intraluminally irradiated to an intraluminal tumor or/and a tumor adjacent to an intraluminal part that is reachable from outside, an intraluminal spacer 1A for radiotherapy is used by inserting from outside into the intraluminal part so as to form a predetermined distance between a portion to be treated and a normal tissue adjacent thereto. The spacer includes an inserting part 120 which is stored between the intraluminal part and a base end part 110 exposed outside of the body at an insertion point, the inserting part 120 having an outer shape and size which can be inserted into and taken out of the intraluminal part from outside while being corresponding or approximate to an inner shape and size in a state where the intraluminal part is inwardly opened, thereby maintaining an open state of the intraluminal part by the insertion.SELECTED DRAWING: Figure 1

Description

本発明は、所定の腫瘍に放射線を照射する治療において、治療箇所に隣接している正常組織に放射線が過剰に作用することを防止するため、治療箇所と正常組織との間で所定の距離を確保するように腔内に挿入されて用いられる放射線治療用腔内スペーサーに関する。   In the treatment of irradiating a predetermined tumor with radiation, the present invention provides a predetermined distance between the treatment site and the normal tissue in order to prevent the radiation from acting excessively on the normal tissue adjacent to the treatment site. The present invention relates to an intraluminal spacer for radiotherapy that is used by being inserted into a cavity so as to ensure.

体内の腫瘍に対し外部から放射線を照射する治療において、治療箇所に隣接している部位の正常組織に与えるダメージが問題となりやすいが、外部照射で一般的に用いられるエックス線は、体表付近で線量が最大で体表から深くなるに従って線量が低下する性質を有しているため、腫瘍に所定レベル以上の線量を照射するには、治療箇所に至るまでの正常組織に高い線量が照射される結果となってしまう。   In the treatment of externally irradiating a tumor in the body, damage to normal tissue in the site adjacent to the treatment site tends to be a problem, but X-rays commonly used for external irradiation are doses near the body surface. Because the dose decreases as the depth increases from the body surface to the maximum, in order to irradiate the tumor with a dose higher than the predetermined level, the normal tissue up to the treatment site is irradiated with a high dose End up.

斯かる放射線の外部照射に伴う副作用の問題に対して、近年では放射線の入射部位で線量が低く所定の深さで急激に高い線量を発揮しながらその位置でほぼ消滅するという特徴を有した重粒子線治療が開発されており、正常組織に対する副作用を最小限に抑えながら腫瘍に対し高線量を照射できる治療方法として、注目を集めている。   In recent years, with respect to the problem of side effects associated with external irradiation of such radiation, there has been a feature that in recent years, the dose is low at the incident site of radiation, and a high dose is rapidly exhibited at a predetermined depth while almost disappearing at that position. Particle beam therapy has been developed, and is attracting attention as a treatment method capable of irradiating a tumor with a high dose while minimizing side effects on normal tissues.

また、体外から到達できる体腔部またはこれに隣接した位置の腫瘍については、体腔部に挿入・配置した線源を介してピンポイントで放射線の照射を行う腔内照射を併用する場合もある。さらに、本願発明者らは、体腔部から病巣内部に線源を直接挿入して行う組織内照射の手法を研究しており、これを重粒子線による外部照射及びガンマ線による腔内照射に併用するという新たな治療方法にも取り組んでいる。   In addition, for a body cavity that can be reached from outside the body or a tumor at a position adjacent to the body cavity, intracavitary irradiation in which radiation is irradiated at a pinpoint via a radiation source inserted and arranged in the body cavity may be used in combination. Furthermore, the inventors of the present application have been studying a technique of intra-organization irradiation performed by directly inserting a radiation source from the body cavity into the lesion, and this is used in combination with external irradiation with heavy particle beams and intra-cavity irradiation with gamma rays. We are also working on a new treatment method.

しかし、上述した重粒子線治療を含む外部照射による治療においては、がん組織に隣接した部位の正常組織への副作用を充分に回避することが困難である。例えば、図15(A)の子宮頸がんにおける治療箇所の部分断面図に示すように、その腫瘍40に外部照射を行う場合、放射線の照射箇所は破線で示す範囲となるのが一般的であるところ、これに隣接している直腸6も照射範囲に含まれてしまう。   However, in the treatment by external irradiation including the heavy particle radiotherapy described above, it is difficult to sufficiently avoid the side effects on the normal tissue at the site adjacent to the cancer tissue. For example, as shown in the partial cross-sectional view of the treatment site in cervical cancer in FIG. 15A, when external irradiation is performed on the tumor 40, the radiation irradiation site is generally in a range indicated by a broken line. At some point, the rectum 6 adjacent to this is also included in the irradiation range.

そこで、膣5や直腸6のように外部から挿入して比較的容易に到達できる体腔部やこれに近接した部位に存在する腫瘍40については、その腔内に所定の形状を有したスペーサーを挿入し、腔内を通常時の閉じた状態から適度に開いた状態に広げることにより、高線量に曝される畏れのある正常組織と腫瘍との間に所定の距離を確保した状態にして、外部照射を実施することも考えられる。   Therefore, with respect to the tumor cavity 40 existing in a body cavity portion that is relatively easily reachable by insertion from the outside, such as the vagina 5 and the rectum 6, and a tumor 40 existing in the vicinity thereof, a spacer having a predetermined shape is inserted into the cavity. Then, by expanding the cavity from a normally closed state to a moderately open state, a predetermined distance is secured between the normal tissue that is likely to be exposed to a high dose and the tumor, and the external space It is also conceivable to carry out irradiation.

例えば、独国特許第4413490号公報には、体腔に沿うように形成された円筒状の形状を有し体腔部に挿入することで腔内を開くスペーサー機能と放射線遮蔽機能を発揮することに加え、円筒の外壁部分に沿って小線源治療用のカテーテルを挿通可能な挿通孔を備えたアプリケータデバイスが提案されており、特表2013−533787号公報には、円筒内周側に形成した溝と円筒の中心に挿入した円柱状部材とで前記カテーテルの挿通孔を形成させる方式とされ、前記カテーテル挿通孔を容易に形成可能としながら使用後の掃除と滅菌作業を容易化したものも提案されている。   For example, German Patent No. 4413490 discloses a cylindrical shape formed along a body cavity and exhibits a spacer function and a radiation shielding function for opening the inside of the cavity by being inserted into the body cavity part. An applicator device having an insertion hole through which a catheter for brachytherapy can be inserted along the outer wall portion of the cylinder has been proposed. In Japanese Patent Publication No. 2013-533787, an applicator device is formed on the inner peripheral side of the cylinder. A method is also proposed in which the insertion hole of the catheter is formed by a groove and a columnar member inserted in the center of the cylinder, and the catheter insertion hole can be easily formed and the cleaning and sterilization work after use is facilitated. Has been.

しかしながら、これらのデバイスは形状が単純な円柱形であるため、挿入する体腔部が開いた状態の内部形状に必ずしも一致するものではないことから、体腔部において適度に開かない部分も生じるため、スペーサーとしての副作用軽減機能は不充分と言わざるを得ない。また、前者のデバイスでは、その外壁に基端側から先端側に亘って長いカテーテル挿通孔を形成することが技術上困難であり、且つ、使用後の洗浄・消毒に手間を要してしまう。さらに、後者のデバイスでは、カテーテル挿通孔が洗浄に適した形状ではあるが、デバイスの長手方向に平行または先端部だけ中心軸方向に傾斜したもののみであり、組織内照射に使用する場合は的確な位置・角度にカテーテルを案内・保持することが容易ではない。   However, since these devices have a simple cylindrical shape, the body cavity portion to be inserted does not necessarily match the internal shape of the open state, and therefore a portion that does not open appropriately in the body cavity portion also occurs. As a side effect reducing function, it must be said that it is insufficient. In the former device, it is technically difficult to form a long catheter insertion hole on the outer wall from the proximal end side to the distal end side, and it takes time and effort for cleaning and disinfection after use. Furthermore, in the latter device, the catheter insertion hole has a shape suitable for cleaning, but it is only parallel to the longitudinal direction of the device or inclined in the central axis direction by the tip, and is appropriate when used for tissue irradiation. It is not easy to guide and hold the catheter at a proper position and angle.

独国特許第4413490号公報German Patent No. 4413490 特表2013−533787号公報Special table 2013-533787 gazette

本発明は、上記のような問題点を解決しようとするものであり、放射線治療用の腔内スペーサーについて、製造及び洗浄の容易化を可能とする簡易な構成でありながら、優れた副作用軽減機能を有するとともに優れた治療効果を発揮可能なものとすることを課題とする。   The present invention is intended to solve the above-described problems, and has an excellent side-effect reduction function with a simple configuration that enables easy manufacture and cleaning of an intracavity spacer for radiotherapy. It is an object of the present invention to have an excellent therapeutic effect.

そこで、本発明は、外部から挿入して到達可能な体腔部の腫瘍又は/及び前記体腔部に近接した部位の腫瘍に放射線を外部照射又は/及び腔内照射して行う治療の際に、治療箇所とこれに隣接した正常組織との間に所定の距離を形成させるために前記体腔部に外部から挿入されて用いられるスペーサーにおいて、前記スペーサーは挿入位置で体外に露出する基端部と腔内に収まる挿入部からなり、その挿入部は前記体腔部が内面側を開いた状態の内面形状・サイズに一致又は近似しながら前記腔内に外部から挿脱可能な外形・サイズとされており、挿入により前記腔内を開いた状態に維持することを特徴とするものとした。   Therefore, the present invention provides a method for treating a tumor in a body cavity that can be inserted from the outside and / or a tumor in a region close to the body cavity by performing external irradiation or / and intra-cavity irradiation. In the spacer used by being inserted from the outside into the body cavity part in order to form a predetermined distance between the site and the normal tissue adjacent thereto, the spacer is a base end part that is exposed outside the body at the insertion position and the intracavity The insertion portion is configured to have an outer shape and size that can be inserted into and removed from the inside of the cavity while matching or approximating the inner surface shape and size of the state where the body cavity portion opens the inner surface side, The inside of the cavity is kept open by insertion.

このように、通常は閉じている体腔部の内面側が適度に開いている状態、例えば膣腔内にペニスが挿入された状態や排便時の直腸の状態の内面形状・サイズにその外面形状・サイズが一致又は近似するようにスペーサーの挿入部を形成したことで、簡易な構成でありながら患者に大きな苦痛を与えるほど腔内を過剰に広げない範囲で治療箇所と正常組織との間に適度な距離を形成できるため、スペーサーとして優れた副作用軽減機能を発揮できることに加え、副作用が軽減される結果、治療箇所に対してより高い線量を与えることが可能となって、優れた治療効果も期待できるものとなる。   In this way, the outer surface shape and size of the normally closed body cavity part is appropriately opened, for example, the penis is inserted into the vaginal cavity and the rectal state during defecation Since the spacer insertion part is formed so as to match or approximate, the space between the treatment site and the normal tissue is moderate within a range that does not excessively expand the cavity so as to cause great pain to the patient even though it is a simple structure. Because it can form a distance, in addition to being able to demonstrate an excellent side effect reducing function as a spacer, side effects can be reduced, so that a higher dose can be given to the treatment site, and an excellent therapeutic effect can also be expected It will be a thing.

また、この放射線治療用腔内スペーサーにおいて、挿入する体腔部は膣腔であり、前記挿入部が性交時のペニスと同様の外面形状・サイズを有していることを特徴としたものとすれば、挿入・脱抜操作において患者に過剰な苦痛を与えることなく膣腔内を適度な状態に開くことができるものとなる。   Further, in this intraluminal spacer for radiotherapy, the body cavity portion to be inserted is a vaginal cavity, and the insertion portion has the same outer shape and size as the penis at the time of sexual intercourse. Thus, the vaginal cavity can be opened to an appropriate state without causing excessive pain to the patient during the insertion / withdrawal operation.

さらに、上述した放射線治療用腔内スペーサーにおいて、その基端部の端面から挿入部の先端側外面まで小線源治療用のカテーテルを挿通させるカテーテル挿通孔が複数貫通して設けられており、そのカテーテル挿通孔で挿通した前記カテーテルを目的箇所に案内しその位置で固定可能とされていることを特徴としたものとすれば、外部照射におけるスペーサー機能のみならず、小線源治療用アプリケータに対するアタッチメント機能を発揮するものとなる。   Further, in the above-mentioned intratherapeutic spacer for radiotherapy, a plurality of catheter insertion holes for penetrating a catheter for brachytherapy from the end surface of the proximal end portion to the outer surface on the distal end side of the insertion portion are provided. If the catheter inserted through the catheter insertion hole is guided to the target location and can be fixed at that position, not only the spacer function in external irradiation but also the applicator for brachytherapy The attachment function will be demonstrated.

この場合、その複数のカテーテル挿通孔には、その少なくとも先端側部分が挿入部の長手方向中心軸線に対し遠心方向に傾斜したものが含まれており、先端側開口部から突出するカテーテルを斜め遠心方向に案内・固定することを特徴としたものとすれば、例えば組織内照射を実施する際に、スペーサーの外周方向にある腫瘍に対し線源を挿入しやすいものとなる。 In this case, the plurality of catheter insertion holes include those in which at least the distal end side portion is inclined in the centrifugal direction with respect to the longitudinal central axis of the insertion portion, and the catheter protruding from the distal end side opening portion is obliquely centrifuged. If it is characterized by guiding and fixing in the direction, for example, when performing intra-organization irradiation, the radiation source can be easily inserted into the tumor in the outer circumferential direction of the spacer.

さらに、上述した放射線治療用腔内スペーサーは、長手方向に2又は3つに分割された複数の分割体で構成され、この複数の分割体が互いに隣接する端部側に連結構造を有して連結・一体化してなるものであり、その連結位置で連結・分離操作が可能とされていることを特徴としたものとすれば、スペーサーとしては患者ごとに異なる腔内形状に合致するよう様々な形状の分割体を組み合わせて用いることが可能となり、カテーテル挿通孔を有したものでは、各分割体のカテーテル挿通孔の孔長が短くなって製造が容易になるとともに洗浄作業も容易なものとなり、且つ、組織内照射を含む小線源治療において、治療箇所の形状や位置に応じたカテーテル挿通孔を有する分割体を組み合わせることで、正確な位置にカテーテルを固定可能としてより有効な治療を実現しやすいものとなる。   Further, the above-mentioned intrathecal spacer for radiotherapy is composed of a plurality of divided bodies that are divided into two or three in the longitudinal direction, and the plurality of divided bodies have a connecting structure on the end portions adjacent to each other. If it is formed by connecting and integrating, and the connecting and separating operations are possible at the connecting position, various spacers can be used to match different intracavity shapes for each patient. It becomes possible to use a combination of divided parts of the shape, and those having a catheter insertion hole, the hole length of the catheter insertion hole of each divided body is shortened, making the manufacturing easier and cleaning work easier. In addition, in brachytherapy including intra-organization irradiation, a catheter can be fixed at an accurate position by combining divided bodies having catheter insertion holes according to the shape and position of the treatment site. The ones that easy to achieve a more effective treatment.

この場合、その各分割体に形成されたカテーテル挿通孔の少なくとも基端側開口部側は、円錐状に拡開されていることを特徴としたものとすれば、挿入するカテーテルが開口部で引っ掛かりにくくなることに加え、洗浄作業時に洗浄水をカテーテル挿通孔内に導入しやすいものとなる。   In this case, if the catheter insertion hole formed in each of the divided bodies is characterized in that at least the proximal opening side is expanded conically, the catheter to be inserted is caught by the opening. In addition to being difficult, the cleaning water can be easily introduced into the catheter insertion hole during the cleaning operation.

さらにまた、上述した放射線治療用腔内スペーサーにおいて、その挿入部の内側部分所定位置には、位置確認のためのマーカーとして機能する金属製の小片が埋設されていることを特徴としたものとすれば、術者がX線やCT画像等でスペーサーの位置をマーカーで認識しながら操作を行えるようになって、より的確な治療を実現しやすいものとなる。   Furthermore, in the above-mentioned intracavity spacer for radiotherapy, a small piece of metal that functions as a marker for position confirmation is embedded in a predetermined position inside the insertion portion. In this case, the operator can perform the operation while recognizing the position of the spacer with the marker by using an X-ray or CT image, and it becomes easy to realize more accurate treatment.

さらにまた、上述した放射線治療用腔内スペーサーにおいて、その挿入部の内側部分には、線量測定用フィルムを外部から挿脱可能な状態で内装するための隙間が形成されていることを特徴としたものとすれば、スペーサーの各部分に対する放射線の照射状況を確認することができ、副作用を軽減しながら最大の治療効果を発揮させる指標に利用することができる。   Furthermore, in the above-mentioned intracavity spacer for radiotherapy, a gap is formed in the inner portion of the insertion portion so that the dose measurement film can be inserted and removed from the outside. If so, the irradiation state of each part of the spacer can be confirmed, and it can be used as an index to exert the maximum therapeutic effect while reducing side effects.

腔内が開いた状態の内面形状・サイズに近似するようにスペーサーの挿入部を形成した本発明によると、製造及び洗浄の容易化を可能とする簡易な構成でありながら、優れた副作用軽減機能を有しながら優れた治療効果を発揮可能なものとなる。   According to the present invention in which the insertion portion of the spacer is formed so as to approximate the inner surface shape / size in the state where the cavity is open, an excellent side effect reduction function while being a simple configuration that enables easy manufacture and cleaning. It is possible to exhibit an excellent therapeutic effect while having

(A)は本発明における第1の実施の形態の放射線治療用腔内スペーサーの左側面図、(B)は(A)の平面図である。(A) is a left side view of the intraluminal spacer for radiotherapy according to the first embodiment of the present invention, and (B) is a plan view of (A). 図1の放射線治療用腔内スペーサーを外部照射時に使用している状態を示す部分縦断面図である。It is a fragmentary longitudinal cross-section which shows the state which is using the intraluminal spacer for radiotherapy of FIG. 1 at the time of external irradiation. 図1の放射線治療用腔内スペーサーの応用例を示す左側面図、(B)は(A)の平面図である。FIG. 2B is a left side view showing an application example of the radiation therapy intracavity spacer of FIG. 1, and FIG. (A)は図3(B)の放射線治療用腔内スペーサーを分解した状態を示す平面図、(B)は(A)の上側の部品の断面側の状態を示す左側面図である。(A) is a top view which shows the state which decomposed | disassembled the radiotherapy intracavity spacer of FIG. 3 (B), (B) is a left view which shows the state of the cross section side of the upper part of (A). (A)は本発明における第2の実施の形態の放射線治療用腔内スペーサーの左側面図、(B)は背面図、(C)は正面図、(D)は(C)のA−A線断面図である。(A) is a left side view of a radiotherapy intracavity spacer according to a second embodiment of the present invention, (B) is a rear view, (C) is a front view, and (D) is an AA of (C). It is line sectional drawing. 図5の放射線治療用腔内スペーサーに小線源治療用のカテーテルを挿通した状態を示す左側面図である。FIG. 6 is a left side view showing a state in which a brachytherapy catheter is inserted through the radiation therapy intracavity spacer of FIG. 5. (A)は図5の放射線治療用腔内スペーサーの応用例を示す左側面図、(B)は(A)の背面図、(C)は(A)の正面図、(D)は(A)の右側面図である。(A) is a left side view showing an application example of the radiation therapy intracavity spacer of FIG. 5, (B) is a rear view of (A), (C) is a front view of (A), and (D) is (A) ) Is a right side view. (A)は図7の放射線治療用腔内スペーサーに小線源治療用のカテーテルを挿通した状態を示す左側面図、(B)は(A)の基端側の状態を示す拡大した背面図、(C)は(A)の放射線治療用腔内スペーサーを使用している状態を示す部分縦断面図である。(A) is a left side view showing a state in which a brachytherapy catheter is inserted into the radiation therapy intracavity spacer of FIG. 7, and (B) is an enlarged rear view showing a state of the proximal end side of (A). (C) is a fragmentary longitudinal cross-sectional view which shows the state which uses the intra-cavity spacer for radiotherapy of (A). (A)は図7の放射線治療用腔内スペーサーの変形例を示す背面図及び左側面図及び正面図、(B)は(A)の放射線治療用腔内スペーサーを使用している状態を示す部分縦断面図、(C)は(A)の放射線治療用腔内スペーサーで小線源治療を行った場合の放射線照射状況の一例を示す部分横断面図である。7A is a rear view, a left side view, and a front view showing a modification of the radiotherapy intracavity spacer of FIG. 7, and FIG. 7B shows a state in which the radiotherapy intracavity spacer of FIG. 7A is used. (C) is a partial cross-sectional view showing an example of a radiation irradiation situation when a brachytherapy is performed with the intraluminal spacer for radiotherapy in (A). (A)は図5の放射線治療用腔内スペーサーの応用例を示す背面図及び左側面図及び正面図、(B)は図7の放射線治療用腔内スペーサーの応用例を示す背面図及び左側面図及び正面図、(C)は図9の放射線治療用腔内スペーサーの応用例を示す背面図及び左側面図及び正面図である。5A is a rear view, a left side view, and a front view showing an application example of the radiation treatment intracavity spacer in FIG. 5, and FIG. 7B is a rear view and a left side showing an application example of the radiation treatment intracavity spacer in FIG. FIG. 10C is a rear view, a left side view, and a front view showing an application example of the radiation therapy intracavity spacer of FIG. 9. (A)は本発明における第3の実施の形態の放射線治療用腔内スペーサーの左側面図、(B)は(A)の基端面の構成を示す背面図、(C)は(A)のA−Aに沿う断面図である。(A) is a left side view of the radiation therapy intracavity spacer according to the third embodiment of the present invention, (B) is a rear view showing the configuration of the base end face of (A), and (C) is a part of (A). It is sectional drawing which follows AA. (A)は図11の放射線治療用腔内スペーサーの先端部を交換用の分割体に交換した状態を示す左側面図、(B)は(A)の放射線治療用腔内スペーサーの先端部に使用する他の交換用の分割体の左側面図、(C)は(A)の放射線治療用腔内スペーサーの先端部に使用する他の交換用の分割体の左側面図、(D)は(A)の放射線治療用腔内スペーサーの胴部に使用する交換用の分割体の左側面図である。(A) is a left side view showing a state in which the distal end portion of the radiotherapy intracavity spacer in FIG. 11 is replaced with a replacement split body, and (B) is the distal end portion of the radiotherapy intracavity spacer in (A). (C) is a left side view of another replacement segment to be used, (C) is a left side view of another replacement segment to be used at the distal end of the radiotherapy intracavity spacer in (A), and (D) is It is a left view of the division body for replacement | exchange used for the trunk | drum of the intraluminal spacer for radiotherapy of (A). (A)は図3及び図11の放射線治療用腔内スペーサーの応用例を分割状態で示す平面図、(B)は(A)の挿入部を構成する分割体の基端面の構成を示す背面図、(C),(D)は(B)の変形例を示す背面図である。(A) is a plan view showing an application example of the radiotherapy intracavity spacer of FIGS. 3 and 11 in a divided state, and (B) is a back view showing the configuration of the base end face of the divided body constituting the insertion portion of (A) FIGS. 3C and 3D are rear views showing a modification of FIG. (A)は図13の放射線治療用腔内スペーサーの変形例を分割し状態で示す平面図、(B)は(A)の分割前の状態を示す左側面図である。(A) is a plan view showing a modified example of the radiotherapy intracavity spacer in FIG. 13 in a divided state, and (B) is a left side view showing a state before the division in (A). (A)は外部照射時の放射線の照射状況を示す部分縦断面図、(B)は腔内照射時の放射線の照射状況を示す部分横断面図である。(A) is a partial longitudinal cross-sectional view which shows the irradiation condition of the radiation at the time of external irradiation, (B) is a partial cross-sectional view which shows the irradiation condition of the radiation at the time of intracavity irradiation.

以下に、図面を参照しながら本発明を実施するための形態を説明する。尚、本発明において、腔内照射には腔内に小線源治療用のカテーテルを挿入して行うもののほか、腔内に挿入したカテーテルをさらに延出して腫瘍組織に直接挿入して行う組織内照射も含まれるものとする。   Hereinafter, embodiments for carrying out the present invention will be described with reference to the drawings. In the present invention, intraluminal irradiation is performed by inserting a catheter for brachytherapy into the cavity, or by extending the catheter inserted into the cavity and inserting it directly into the tumor tissue. Irradiation shall be included.

図1(A)は、本実施の形態である放射線治療用腔内スペーサー1Aを示し、(B)はその平面図を示している。本発明は、外部からスペーサーを挿入して到達可能な体腔部の腫瘍又は/及び前記体腔部に近接した部位の腫瘍に放射線を外部照射又は/及び腔内照射して行う治療の際に、治療箇所とこれに隣接した部位の正常組織との間に所定の距離を形成させるために体腔部に挿入して用いられるものであるが、本実施の形態の説明においては、挿入対象の体腔部が膣腔で治療対象が子宮頸がんの場合で、外部照射する放射線が重粒子線である場合を説明するものとする。   FIG. 1A shows a radiation treatment intracavity spacer 1A according to the present embodiment, and FIG. 1B shows a plan view thereof. The present invention provides a method for treating a tumor in a body cavity that can be reached by inserting a spacer from the outside, and / or a tumor in a site close to the body cavity, by performing external irradiation or / and intra-cavity irradiation. In order to form a predetermined distance between a part and a normal tissue of a part adjacent thereto, it is used by being inserted into a body cavity part, but in the description of the present embodiment, the body cavity part to be inserted is The case where the treatment target is cervical cancer in the vaginal cavity and the radiation to be externally irradiated is a heavy particle beam will be described.

本実施の形態の放射線治療用腔内スペーサー1Aは、合成樹脂を所定形状に成形してなるものであるが、その素材としては人体組織と同様の放射線透過性を確保する観点と、複数回の滅菌消毒を実施可能な耐久性を確保する観点から、高濃度ポリエチレン(比重0.94〜0.97)、ポリエチレン(比重0.91〜0.93)、アクリル(比重1.17〜1.20)が好適である。   The intraluminal spacer 1A for radiotherapy according to the present embodiment is formed by molding a synthetic resin into a predetermined shape, and as a material thereof, from the viewpoint of ensuring the same radiation transmissivity as a human tissue, a plurality of times High concentration polyethylene (specific gravity 0.94 to 0.97), polyethylene (specific gravity 0.91 to 0.93), acrylic (specific gravity 1.17 to 1.20) from the viewpoint of ensuring durability that can be sterilized. ) Is preferred.

この放射線治療用腔内スペーサー1Aは、挿入位置で体外に露出して術者が把持及び操作を行う部分となる基端部110と、腔内に収まる挿入部120からなる。その挿入部120は、膣腔が内面側を開いた状態の内面形状・サイズに一致又は近似しながらその腔内に外部から挿脱可能な外形・サイズとされており、挿入することで膣腔が充分に開いた状態を維持するようになっている点を特徴としている。   The intra-cavity spacer 1A for radiotherapy includes a proximal end portion 110 that is exposed to the outside at the insertion position and is a portion that is grasped and operated by an operator, and an insertion portion 120 that fits in the cavity. The insertion portion 120 has an outer shape and size that can be inserted into and removed from the outside while matching or approximating the inner shape and size of the vaginal cavity with the inner surface open. Is characterized by maintaining a fully open state.

即ち、本願発明者らは、膣腔が内面側を開いた状態の形状・サイズが、性交時のペニスの外面形状・サイズにほぼ一致することを見出したことから、膣腔を充分且つ適度に開いた状態を維持させるために用いるスペーサーの挿入部120も、これと一致又は近似した外形・サイズとなるようにしたものである。尚、図1(B)に示すように、挿入時に挿入部120の上下の向きを術者が把握可能とするために、外部に露出する基端部110には窪みによる印110aを設けてある。また、膣壁は伸縮性に富んだ組織であることから、治療箇所と隣接する正常組織との距離を充分に確保する観点から、挿入部120が実際の前記ペニスに対し径がやや大きくなったり、先端側膨大部の挿入部全体に対する長さの比率がやや大きくなったりしてもよい。   That is, the present inventors have found that the shape and size of the state in which the vaginal cavity is open on the inner surface side substantially matches the outer surface shape and size of the penis at the time of sexual intercourse. The spacer insertion portion 120 used for maintaining the open state is also configured to have an outer shape / size that matches or approximates this. As shown in FIG. 1 (B), in order to allow the surgeon to grasp the vertical direction of the insertion portion 120 during insertion, the base end portion 110 exposed to the outside is provided with a mark 110a due to a depression. . In addition, since the vaginal wall is a tissue rich in elasticity, the diameter of the insertion portion 120 may be slightly larger than the actual penis from the viewpoint of ensuring a sufficient distance between the treatment site and the adjacent normal tissue. The ratio of the length of the tip side enormous portion to the entire insertion portion may be slightly increased.

図2は、本実施の形態の放射線治療用腔内スペーサー1Aを膣腔5内に挿入した状態で、子宮4の頸部側にある腫瘍(子宮頸がん)40に重粒子線による外部照射を行っている状態を示している。図15(A)に示したように、スペーサーを用いない場合は、太破線で示す放射線の高線量域に直腸6が含まれてしまうのに対し、本実施の形態の放射線治療用腔内スペーサー1Aを挿入した状態では、図のように膣腔5が充分に開いて直腸6を腫瘍40から離れた位置に移動させ、高線量域の外側の状態で維持している。   FIG. 2 shows external irradiation with heavy particle beams on a tumor (cervical cancer) 40 on the cervix side of the uterus 4 in a state where the intracavity spacer 1A for radiotherapy according to the present embodiment is inserted into the vaginal cavity 5. It shows the state of doing. As shown in FIG. 15A, when the spacer is not used, the rectal 6 is included in the high-dose region of the radiation indicated by the thick broken line, whereas the intrathecal spacer for radiotherapy according to the present embodiment. In the state where 1A is inserted, the vaginal cavity 5 is sufficiently opened as shown in the figure, and the rectum 6 is moved to a position away from the tumor 40 and maintained outside the high dose range.

図3(A)は、前述した放射線治療用腔内スペーサー1Aの応用例としての放射線治療用腔内スペーサー1Bを示し、(B)はその平面図を示している。この応用例では、前述した放射線治療用腔内スペーサー1Aを左右に分割してなる左右分割体3a,3bが、図4(A)に示すように接合・分離可能なものとされ、接合面に放射線の照射状況を把握するための線量測定用フィルム(ガフクロミックフィルム:米国登録商標)を挟んだ状態で使用できるようになっている。   FIG. 3A shows a radiotherapy intracavity spacer 1B as an application example of the aforementioned radiotherapy intracavity spacer 1A, and FIG. 3B shows a plan view thereof. In this application example, the left and right divided bodies 3a and 3b formed by dividing the above-described radiation therapy intracavity spacer 1A into left and right are made connectable and separable as shown in FIG. It can be used in a state where a dosimetry film (Gafchromic film: US registered trademark) for grasping the irradiation state of radiation is sandwiched.

即ち、この放射線治療用腔内スペーサー1Bは、基端部111側でボルト50,50により左右分割体3a,3bが締結されて接合されており、ボルト50,50を緩めて外すことで左右分割体3a,3bは分離することができる。また、左右分割体3a,3bには、これらを接合した状態で挿入部121の接合面に線量測定用フィルムを挟み込む隙間を形成するように、各々凹部31,41が形成されている。   That is, the intraluminal spacer 1B for radiotherapy is joined to the left and right divided bodies 3a and 3b by bolts 50 and 50 on the base end 111 side, and is divided into left and right by loosening and removing the bolts 50 and 50. The bodies 3a, 3b can be separated. Further, the left and right divided bodies 3a and 3b are respectively formed with recesses 31 and 41 so as to form gaps for sandwiching the dose measuring film between the joint surfaces of the insertion portion 121 in a state where they are joined.

そして、線量測定用フィルムを挟み込んだ状態で体腔内に挿入しながら放射線治療を実施した後に、線量測定用フィルムを取り出してその状態を確認することで、スペーサー挿入位置において各部分に照射された放射線量を把握することが可能となるため、治療効果及び正常組織に対する影響を判断しながらさらなる副作用の軽減に役立てることができる。   Then, after performing radiation therapy while inserting the dose measuring film in the body cavity, the radiation irradiated to each part at the spacer insertion position is taken out by checking the state after taking out the dose measuring film. Since it becomes possible to grasp the amount, it can be used to further reduce side effects while judging the therapeutic effect and the influence on normal tissue.

尚、この応用例においては、レントゲン撮影で画像上明確に現れるタングステンやステンレス等による金属球60,60,60を挿入部121内にマーカーとして埋設してあり、放射線治療の際に、術者がX線やCT画像等でスペーサーの位置を確認しながら操作を行えるようになっており、正常組織への影響を軽減しながら優れた治療効果を実現しやすいものとなっている。   In this application example, metal balls 60, 60, 60 made of tungsten, stainless steel, or the like that clearly appear on the image by X-ray photography are embedded as markers in the insertion portion 121. The operation can be performed while confirming the position of the spacer with an X-ray or CT image, and it is easy to realize an excellent therapeutic effect while reducing the influence on the normal tissue.

図5(A)は、本発明における第2の実施の形態の放射線治療用腔内スペーサー1Cを示しており、(B)はその背面図、(C)はその正面図、(D)は(C)のA−A線断面図を示している。この実施の形態おいて、放射線治療用腔内スペーサー1Cは、スペーサー機能に加えて小線源治療用のアプリケータ補助具としてアタッチメント機能を備えている点を特徴としている。   FIG. 5A shows a radiotherapy intracavity spacer 1C according to the second embodiment of the present invention, in which FIG. 5B is a rear view thereof, FIG. 5C is a front view thereof, and FIG. The sectional view on the AA line of C) is shown. In this embodiment, the intraluminal spacer 1C for radiotherapy is characterized in that it has an attachment function as an applicator auxiliary tool for brachytherapy in addition to the spacer function.

即ち、アプリケータとしては、円柱状の挿入部122の先端側が半球状に形成されて、開口部から直線的な形状の体腔部であれば広く適用できるようになっているが、これに加え、その基端部112の端面から挿入部122の先端面まで、小線源治療用のカテーテルを挿通するための複数のカテーテル挿通孔71a,・・・,71b,・・・が設けられており、これらに挿入したカテーテルを目的箇所に案内して挿通孔の位置・向きで保持(固定)するようにしたものである。   That is, as the applicator, the tip end side of the cylindrical insertion portion 122 is formed in a hemispherical shape, and can be widely applied to a body cavity portion having a linear shape from the opening portion. A plurality of catheter insertion holes 71a,..., 71b,... Are provided from the end surface of the base end portion 112 to the distal end surface of the insertion portion 122 for inserting a catheter for brachytherapy. The catheter inserted therein is guided to the target location and held (fixed) at the position and orientation of the insertion hole.

この放射線治療用腔内スペーサー1Cは、図示したように極めて単純な形状であることから比較的低コストで容易に製造することができ、その洗浄・滅菌も比較的容易である。図6は、この放射線治療用腔内スペーサー1Cに、小線源治療用のカテーテル100,100,100を挿通した状態を示しているが、各カテーテル100に内装した線源が術者所望の位置でしっかりと保持・固定されており、外部照射におけるスペーサー機能のみならず、外部照射に併用する腔内照射・組織内照射においても、優れたアタッチメント機能を発揮することができる。   Since this radiation therapy intracavity spacer 1C has an extremely simple shape as shown in the drawing, it can be easily manufactured at a relatively low cost, and its cleaning and sterilization are also relatively easy. FIG. 6 shows a state in which the brachytherapy catheters 100, 100, 100 are inserted into the radiation therapy intracavity spacer 1C. The radiation source built in each catheter 100 is the position desired by the operator. In addition to the spacer function in external irradiation, an excellent attachment function can be exhibited not only in intracavity irradiation and tissue irradiation used in combination with external irradiation.

図7(A)は、前述した放射線治療用腔内スペーサー1Cの応用例としての放射線治療用腔内スペーサー1Dを示しており、(B)は背面図、(C)は正面図、(D)は右側面図を示している。この放射線治療用腔内スペーサー1Dでは、基端部113の端面から挿入部122の先端面まで、小線源治療用のカテーテルを挿通させる複数のカテーテル挿通孔72a,・・・が設けられているのに加えて、基端部113の端面から挿入部122の先端寄り側面まで、カテーテル挿通孔72b,72b,72c,72cが、挿入部122の長手方向の中心軸線に対し傾斜して設けられており、図のように先端側開口部から突出するカテーテルを斜め遠心方向に案内・保持できるようになっている点を特徴としている。   FIG. 7A shows a radiotherapy intracavity spacer 1D as an application example of the radiotherapy intracavity spacer 1C described above, (B) is a rear view, (C) is a front view, and (D). Shows a right side view. In the intra-radiotherapy spacer 1D, a plurality of catheter insertion holes 72a,... For inserting a brachytherapy catheter are provided from the end surface of the base end portion 113 to the distal end surface of the insertion portion 122. In addition, catheter insertion holes 72b, 72b, 72c, and 72c are provided to be inclined with respect to the central axis in the longitudinal direction of the insertion portion 122 from the end surface of the base end portion 113 to the side surface near the distal end of the insertion portion 122. As shown in the figure, the catheter protruding from the opening on the distal end side can be guided and held in an obliquely centrifugal direction.

そのため、患者毎に異なる膣腔の形状や腫瘍の位置・形状に応じて線源を正確に適用しやすいものとなっている。また、図8(C)に示すように、遠心方向に突出するカテーテル挿通孔72b,72bにカテーテル100,100を挿通して突出させることで、前述した放射線治療用腔内スペーサー1Cでは充分に対応出来なかった位置の組織内照射を実施することも可能となる。   Therefore, it is easy to apply the radiation source accurately according to the shape of the vaginal cavity and the position / shape of the tumor which are different for each patient. Further, as shown in FIG. 8 (C), the above-described intrathecal spacer 1C for radiotherapy is sufficient by inserting and projecting the catheters 100, 100 through the catheter insertion holes 72b, 72b protruding in the centrifugal direction. It is also possible to carry out in-tissue irradiation at a position where it was not possible.

図9(A)は、前述した放射線治療用腔内スペーサー1Dの変形例としての放射線治療用腔内スペーサー1Eを示しており、中央が左側面図、左が基端面の構成を示す背面図、右が先端面の構成を示す正面図である。この変形例では、前述の放射線治療用腔内スペーサー1Dにおいて遠心方向に傾斜して設けたカテーテル挿通孔をさらに傾斜させ、さらに基端側寄りの外周面に開口させてなるカテーテル挿通孔73b,73b,73c,73cを設けた点を特徴としている。   FIG. 9A shows a radiotherapy intracavity spacer 1E as a modification of the above-mentioned radiotherapy intracavity spacer 1D, the center is a left side view, and the left is a rear view showing the configuration of the base end face. The right is a front view showing the configuration of the tip surface. In this modification, the catheter insertion holes 73b and 73b are formed by further inclining the catheter insertion holes provided in the above-mentioned radiation therapy intracavity spacer 1D so as to be inclined in the centrifugal direction and opening them further on the outer peripheral surface closer to the proximal end side. , 73c, 73c.

このような構成としたことで、カテーテル100を先端位置から基端寄りに離れた位置にて、さらに遠心方向に傾斜させて突出させることができることから、線源配置の自由度が格段に増したものとなっている。そして、線源を組織内に直接挿入して行う組織内照射においても、適用可能な腫瘍の範囲をさらに広げたものとして、さらに的確な治療を実施しやすいものとしている。   By adopting such a configuration, the catheter 100 can be protruded by being further inclined in the centrifugal direction at a position away from the distal end position toward the proximal end, thereby greatly increasing the degree of freedom of the radiation source arrangement. It has become a thing. And even in the tissue irradiation performed by directly inserting the radiation source into the tissue, the range of applicable tumors is further expanded, so that more accurate treatment can be easily performed.

例えば、子宮頸がんでは、初期の病巣は子宮頸にあるのが通常であるためアタッチメントの先端側で対応できるが、進行した状態では図15(B)に示すように4時及び8時方向に浸潤する傾向があり、通常のアタッチメントでは太破線の範囲でしか高線量を照射することができない。これに対し、この放射線治療用腔内スペーサー1Eを用いれば、図9(C)において太破線で示すように、膀胱や直腸側に広げることなく4時及び8時方向にも高線量を照射することが可能となるため、進行した子宮頸がんにも的確に対応しながら副作用を最小限に抑えやすいものとなる。   For example, in cervical cancer, since the initial lesion is usually in the cervix, it can be dealt with on the tip side of the attachment, but in the advanced state, as shown in FIG. In a normal attachment, a high dose can be irradiated only within the range of the thick broken line. On the other hand, when this intraluminal spacer 1E for radiotherapy is used, as shown by a thick broken line in FIG. 9C, a high dose is irradiated also at 4 o'clock and 8 o'clock without spreading to the bladder or rectum side. Therefore, it is easy to minimize side effects while accurately dealing with advanced cervical cancer.

図10は、上述した円柱形の実施例の先端部に膨大部を形成した場合の背面図・左側面図・正面図を示しており、(A)は放射線治療用腔内スペーサー1Cの応用例、(B)は放射線治療用腔内スペーサー1Dの応用例、(C)は放射線治療用腔内スペーサー1Eの応用例である。このように、先端側に膨大部を形成したことで、例えば膣腔においては、子宮近くの腔内をストレート形状よりも充分に広げられるようになり、隣接した正常組織へのダメージをより回避やすいことに加え、傾斜して突出させるカテーテルにあっては、遠心方向に突出させながらより大きな傾斜角度を確保することができる。   FIG. 10 shows a rear view, a left side view, and a front view when an enormous portion is formed at the tip of the above-described columnar embodiment, and FIG. 10A shows an application example of the intrathecal spacer 1C for radiotherapy. (B) is an application example of the radiotherapy intracavity spacer 1D, and (C) is an application example of the radiotherapy intracavity spacer 1E. Thus, by forming the enormous portion on the distal end side, for example, in the vaginal cavity, the cavity near the uterus can be expanded more than the straight shape, and it is easier to avoid damage to adjacent normal tissue. In addition, in a catheter that is inclined and protruded, a larger inclination angle can be secured while protruding in the centrifugal direction.

図11(A)は、本発明における第3の実施の形態の放射線治療用腔内スペーサー1Iを示しており、(B)は(A)の基端面の構成を示す背面図、(C)は(A)のA−Aに沿う断面図である。この実施の形態においては、上述した放射線治療用腔内スペーサー1Cの基端部112を、術者が把持しやすいように大径化した基端部118とするとともに、挿入部122を基端部から分離可能な挿入部128としながら、これをさらに胴部128aと先端部128bの2つに分離できるようにした点を特徴としている。   FIG. 11A shows a radiation therapy intracavity spacer 1I according to the third embodiment of the present invention, FIG. 11B is a rear view showing the configuration of the base end face of FIG. It is sectional drawing which follows AA of (A). In this embodiment, the proximal end portion 112 of the above-mentioned radiotherapy intracavity spacer 1C is a proximal end portion 118 whose diameter is increased so as to be easily grasped by an operator, and the insertion portion 122 is a proximal end portion. It is characterized in that the insertion portion 128 is separable from the insertion portion 128 and can be further separated into the body portion 128a and the distal end portion 128b.

即ち、この放射線治療用腔内スペーサー1Iは、長手方向に3つに分割された複数の分割体で構成され、図11(C)に示すように、互いに隣接する端部側に凹凸嵌合による連結構造を各々有して、この部分で連結して一体化しており、その連結位置で連結・分離操作が可能とされている。そのため、従来は細いカテーテル挿通孔をスペーサーの全長に亘って形成することが技術上困難であり、その清掃作業にも手間を要していたのに対し、このように各分割体におけるカテーテル挿通孔の長さが従来の2分の1〜3分の1程度に短縮されたことで、ドリルによる穿設も容易になるとともにその洗浄も容易なものとなった。   In other words, this intraluminal spacer 1I for radiotherapy is composed of a plurality of divided bodies that are divided into three in the longitudinal direction, and as shown in FIG. Each has a connecting structure and is connected and integrated at this portion, and the connecting / separating operation can be performed at the connecting position. For this reason, conventionally, it has been technically difficult to form a thin catheter insertion hole over the entire length of the spacer, and the cleaning operation has been troublesome. Was shortened to about one-half to one-third of the conventional length, so that drilling was easy and cleaning was easy.

また、各分割体について、患者の状況に応じた様々な外形・カテーテル挿通孔の配置を有したものを用意しておけば、スペーサーとして患者の腔内形状に合わせた外形の組み合わせにしたり、小線源治療用のアタッチメントとして患者の腔内形状及び腫瘍の形状・位置に合致するカテーテル挿通孔の組み合わせにしたりすることが、治療現場で容易に実現可能なものとなる。   In addition, if each divided body is prepared with various outer shapes and arrangements of catheter insertion holes according to the patient's situation, it can be combined with the outer shape according to the intracavity shape of the patient as a spacer, As an attachment for the radiation source treatment, a combination of a catheter insertion hole that matches the intracavity shape of the patient and the shape / position of the tumor can be easily realized at the treatment site.

さらに、この放射線治療用腔内スペーサー1Iを膣腔内に挿入して使用する場合に、挿入の際の潤滑性を確保して内腔面を傷つけないようにするため、コンドームを被せて使用するケースも多いが、コンドームの基端側がずれ動かないように、基端部112には山形構造による窪み118cが形成してある点も特徴としている。   Further, when the intraluminal spacer 1I for radiotherapy is inserted into the vaginal cavity, it is used with a condom in order to ensure lubricity during insertion and not damage the lumen surface. There are many cases, but a feature is that the base end portion 112 is formed with a depression 118c having a chevron structure so that the base end side of the condom does not move.

これに加えて、各分割体のカテーテル挿通孔76a,76bの基端側開口部は、円錐状(漏斗状)に拡開されており、挿入するカテーテル100の先端側が各開口部で引っ掛かりにくくなるとともに、洗浄作業時に洗浄水をカテーテル挿通孔78a,78b内に導入しやすくなっている。尚、連結時に各分割体の向きを正確に合わせられるようにするため、接合面の形状を楕円形としたり、正確な向きで嵌合する凹凸構造を設けたりすることが好ましい。   In addition, the proximal end side opening portions of the catheter insertion holes 76a and 76b of each divided body are expanded in a conical shape (funnel shape), and the distal end side of the catheter 100 to be inserted is less likely to be caught by each opening portion. At the same time, it is easy to introduce cleaning water into the catheter insertion holes 78a and 78b during the cleaning operation. In addition, it is preferable that the shape of the joint surface is an ellipse or a concavo-convex structure that fits in the correct orientation is provided so that the orientations of the respective divided bodies can be accurately aligned at the time of connection.

図12(A)は、前述した放射線治療用腔内スペーサー1Iの先端部128bを、膨大部を構成する交換用分割体としての先端部128Jに交換した放射線治療用腔内スペーサー1Jであり、(B)は先端側が遠心方向に傾斜したカテーテル挿通孔77bを備えた交換用の分割体としての先端部128k、(C)は膨大部を構成しながら先端側がさらに遠心方向に傾斜したカテーテル挿通孔78bを備えた交換用の分割体としての先端部128L、(D)は長手方向中間部分で遠心方向に傾斜して外周面に開口したカテーテル挿通孔79bを備えた交換用の分割体としての胴部128mである。このように、各分割体において様々な態様が想定され、その組み合わせの多様性を実現することができる。   FIG. 12 (A) is a radiotherapy intracavity spacer 1J in which the distal end portion 128b of the above-mentioned radiotherapy intracavity spacer 1I is replaced with a distal end portion 128J as a replacement split body constituting the enormous portion. B) is a distal end portion 128k as a replacement divided body having a catheter insertion hole 77b whose distal end side is inclined in the centrifugal direction, and (C) is a catheter insertion hole 78b whose distal end side is further inclined in the centrifugal direction while forming a huge portion. A distal end portion 128L as a replacement divided body provided with a body part as a replacement divided body provided with a catheter insertion hole 79b that is inclined in the centrifugal direction at an intermediate portion in the longitudinal direction and opened to the outer peripheral surface. 128 m. Thus, various aspects are assumed in each divided body, and diversity of the combination can be realized.

図13(A)は、放射線治療用腔内スペーサー1B,1Iの応用例である放射線治療用腔内スペーサー1Kを分割した状態で示しており、(B)は(A)の挿入部129を構成する分割体の基端面の構成を示す背面図、(C),(D)は(B)の変形例を示す背面図である。この応用例では、放射線の照射状況を把握するための線量測定用フィルムを、分割体の接合面から内部に挿入して内装可能とした点を特徴としている。   FIG. 13 (A) shows a state in which the radiation therapy intracavity spacer 1K, which is an application example of the radiation therapy intracavity spacers 1B and 1I, is divided, and FIG. 13 (B) constitutes the insertion portion 129 of (A). The rear view which shows the structure of the base end surface of the division body to perform, (C), (D) is a rear view which shows the modification of (B). This application example is characterized in that a dose measuring film for grasping the radiation irradiation state is inserted into the interior from the joint surface of the divided body so that the interior can be installed.

この線量測定用フィルムを挿入する空間となる隙間129bは、その開口部が図13(B)に示すように直線状のもののほか、(C)に示すように十字形、(D)に示すように円形というように、その形状に合わせてフィルムを挿入可能な形状が実施可能である。また、図14(A)に示すように、3つに分割可能な放射線治療用腔内スペーサー1Lとすれば、その連結状態の平面図である図(B)に示すように、基端側から挿入できない形状のフィルムも内装できる隙間129cを形成することができる。   As shown in FIG. 13B, the gap 129b serving as a space for inserting the dose measuring film has a linear shape as shown in FIG. 13B, a cross shape as shown in FIG. 13C, and as shown in FIG. It is possible to implement a shape in which a film can be inserted in accordance with the shape, such as a circular shape. Further, as shown in FIG. 14 (A), if the intra-radiotherapy spacer 1L that can be divided into three is used, as shown in FIG. It is possible to form a gap 129c in which a film having a shape that cannot be inserted can be incorporated.

以上、述べたように、放射線治療用の腔内スペーサーについて、本発明により製造及び洗浄を容易にする簡易な構成としながら、優れた副作用軽減機能を有しながら優れた治療効果を発揮できるようになった。   As described above, the intraluminal spacer for radiotherapy can exhibit an excellent therapeutic effect while having an excellent side effect reduction function while having a simple configuration that facilitates manufacture and cleaning according to the present invention. became.

1A,1B,1C,1D,1E,1F,1G,1H,1I,1J,1K,1L, 放射線治療用腔内スペーサー、3a,3b 左右分割体、5 膣腔、6 直腸、31,41 凹部、60 金属球、40 腫瘍、71a,71b,72a,72b,72c,73a,73b,73c,76a,76b,77b,78b,79b カテーテル挿通孔、100 カテーテル、110,111,112,113,114,118,119 基端部、120,121,122,123,124,128,129 挿入部、128a,128m,128o 胴部、128b,128j,128k,128l,128n 先端部   1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J, 1K, 1L, Intracavity spacer for radiation therapy, 3a, 3b Left and right divided bodies, 5 Vaginal cavity, 6 Rectum, 31, 41 Concavity, 60 Metal sphere, 40 Tumor, 71a, 71b, 72a, 72b, 72c, 73a, 73b, 73c, 76a, 76b, 77b, 78b, 79b Catheter insertion hole, 100 Catheter, 110, 111, 112, 113, 114, 118 , 119 Base end portion, 120, 121, 122, 123, 124, 128, 129 Insertion portion, 128a, 128m, 128o trunk portion, 128b, 128j, 128k, 128l, 128n Tip portion

Claims (8)

外部から挿入して到達可能な体腔部の腫瘍又は/及び前記体腔部に近接した部位の腫瘍に放射線を外部照射又は/及び腔内照射して行う治療の際に、治療箇所とこれに隣接した正常組織との間に所定の距離を形成させるために前記体腔部に外部から挿入されて用いられるスペーサーにおいて、前記スペーサーは挿入位置で体外に露出する基端部と腔内に収まる挿入部からなり、前記挿入部は前記体腔部が内面側を開いた状態の内面形状・サイズに一致又は近似しながら前記腔内に外部から挿脱可能な外形・サイズとされており、挿入により前記腔内を開いた状態に維持することを特徴とする放射線治療用腔内スペーサー。   When a treatment is performed by externally irradiating or / and intracavitally irradiating a tumor in the body cavity that can be inserted from the outside and / or a tumor in the vicinity of the body cavity, and adjacent to the treatment site In the spacer used by being inserted into the body cavity part from the outside in order to form a predetermined distance between the normal tissue, the spacer is composed of a proximal end part which is exposed outside the body at the insertion position and an insertion part which fits in the cavity. The insertion portion has an outer shape and size that can be inserted into and removed from the inside of the cavity while matching or approximating the inner shape and size of the body cavity portion with the inner surface open. An intracavity spacer for radiotherapy characterized by maintaining an open state. 前記体腔部は膣腔であり、前記挿入部が性交時のペニスと同様の外面形状・サイズを有している、ことを特徴とする請求項1に記載した放射線治療用腔内スペーサー。   The intracavity spacer for radiotherapy according to claim 1, wherein the body cavity part is a vaginal cavity, and the insertion part has the same outer shape and size as a penis during sexual intercourse. 前記基端部の端面から前記挿入部の先端側外面まで小線源治療用のカテーテルを挿通させるカテーテル挿通孔が複数貫通して設けられており、前記カテーテル挿通孔で挿通した前記カテーテルを目的箇所に案内しその位置で固定可能とされている、ことを特徴とする請求項1又は2に記載した放射線治療用腔内スペーサー。   A plurality of catheter insertion holes through which the catheter for brachytherapy is inserted from the end surface of the base end portion to the outer surface on the distal end side of the insertion portion are provided, and the catheter inserted through the catheter insertion hole is a target location. The intraluminal spacer for radiotherapy according to claim 1, wherein the spacer is capable of being guided and fixed at the position. 前記その複数のカテーテル挿通孔には、少なくとも先端側部分が前記挿入部の長手方向中心軸線に対し遠心方向に傾斜したものが含まれており、先端側開口部から突出する前記カテーテルを斜め遠心方向に案内・固定する、ことを特徴とする請求項3に記載した放射線治療用腔内スペーサー。   The plurality of catheter insertion holes include those in which at least the distal end side portion is inclined in the centrifugal direction with respect to the longitudinal central axis of the insertion portion, and the catheter protruding from the distal end side opening portion is obliquely centrifuged The intraluminal spacer for radiotherapy according to claim 3, wherein the spacer is guided and fixed. 長手方向に2又は3つに分割された複数の分割体で構成され、前記複数の分割体が互いに隣接する端部側に連結構造を有して連結・一体化してなるものであり、その連結位置で連結・分離操作が可能とされている、ことを特徴とする請求項1,2,3又は4に記載した放射線治療用腔内スペーサー。   Consists of a plurality of divided bodies that are divided into two or three in the longitudinal direction, and the plurality of divided bodies are connected and integrated with a connecting structure on the side of adjacent ends. The intraluminal spacer for radiotherapy according to claim 1, 2, 3, or 4, characterized in that connection / separation operation is possible at a position. 前記各分割体に形成されたカテーテル挿通孔の少なくとも基端側開口部側は、円錐状に拡開されている、ことを特徴とする請求項5に記載した放射線治療用腔内スペーサー。   6. The intrathecal spacer for radiotherapy according to claim 5, wherein at least a proximal end side opening portion side of the catheter insertion hole formed in each divided body is expanded in a conical shape. 前記挿入部の内側部分所定位置には、位置確認のためのマーカーとして機能する金属製の小片が埋設されている、ことを特徴とする請求項1,2,3,4,5又は6に記載した放射線治療用腔内スペーサー。   The metal small piece which functions as a marker for position confirmation is embed | buried under the inner part predetermined position of the said insertion part, The 1, 2, 3, 4, 5 or 6 characterized by the above-mentioned. Intracavity spacer for radiation therapy. 前記挿入部の内側部分には、線量測定用フィルムを外部から挿脱可能な状態で内装するための隙間が形成されている、ことを特徴とする請求項1,2,3,4,5,6又は7に記載した放射線治療用腔内スペーサー。   A gap is formed in the inner portion of the insertion portion for internally installing the dose measuring film in a state where it can be inserted and removed from the outside. The intraluminal spacer for radiotherapy as described in 6 or 7.
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