JP2010213895A - Catheter for fistula - Google Patents

Catheter for fistula Download PDF

Info

Publication number
JP2010213895A
JP2010213895A JP2009063907A JP2009063907A JP2010213895A JP 2010213895 A JP2010213895 A JP 2010213895A JP 2009063907 A JP2009063907 A JP 2009063907A JP 2009063907 A JP2009063907 A JP 2009063907A JP 2010213895 A JP2010213895 A JP 2010213895A
Authority
JP
Japan
Prior art keywords
indwelling
organ
tubular member
fistula
fistula catheter
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
Application number
JP2009063907A
Other languages
Japanese (ja)
Other versions
JP5229029B2 (en
Inventor
Yasumasa Koshiro
康雅 小城
Minoru Suzuki
稔 鈴木
Yu Tomiya
有 富谷
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sumitomo Bakelite Co Ltd
Original Assignee
Sumitomo Bakelite Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Sumitomo Bakelite Co Ltd filed Critical Sumitomo Bakelite Co Ltd
Priority to JP2009063907A priority Critical patent/JP5229029B2/en
Publication of JP2010213895A publication Critical patent/JP2010213895A/en
Application granted granted Critical
Publication of JP5229029B2 publication Critical patent/JP5229029B2/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Landscapes

  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

<P>PROBLEM TO BE SOLVED: To provide a catheter for a fistula which has low invasion for a patient because resistance is reduced when inserted and extracted into/from an internal organ, and is inserted and removed safely and easily by a treating person. <P>SOLUTION: The catheter for a fistula includes a tubular member having a nutrition passage for transdermal supply of a liquid substance such as a nutrient and a liquid medicine from an outside of a body to the internal organ, and an intracorporeal indwelling portion formed in tip side of the tubular member and allowing indwelling fixation in an inside of an organ, and the intracorporeal indwelling portion is constituted of an organ contact portion contacting with the internal organ, and an indwelling end portion formed on a distal end side of the organ contact portion, and satisfies a relation: (A)>(B) where (B) represents a hardness of the organ contact portion, and (A) represents a hardness of the indwelling tip portion. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

本発明は、瘻孔用カテーテルに関するものである。   The present invention relates to a fistula catheter.

経口的に栄養を摂取できない患者に対する栄養の投与方法として、経皮内視鏡的胃瘻造設術(以下、「PEG」と略す)による経腸栄養管理が頻繁に行われている。このPEGによる栄養投与を実施する為に瘻孔用カテーテルが使用される。
瘻孔用カテーテルはその留置手技、患者の容態、使用期間、処置者の操作性などから様々な種類が存在するが、一般的に、栄養又は薬液を体外から胃内へ導入するルーメンを内部に有する管状部材と、この管状部材の先端部に付設され、長軸方向に無荷重の場合は管状部材の径方向外側に拡径した形状の体内留置部から構成されている。
As a method for administering nutrition to a patient who cannot take nutrition orally, enteral nutrition management by percutaneous endoscopic gastrostomy (hereinafter abbreviated as “PEG”) is frequently performed. A fistula catheter is used to carry out nutritional administration using this PEG.
There are various types of fistula catheters depending on the indwelling technique, patient condition, period of use, operability of the operator, etc., but generally has a lumen for introducing nutrients or chemicals from outside the body into the stomach. A tubular member and an indwelling portion having a shape that is attached to the distal end portion of the tubular member and expands radially outward of the tubular member when no load is applied in the major axis direction.

上記瘻孔用カテーテルは、通常、留置による劣化や汚れの為、一定期間留置後、新しいカテーテルに交換されるが、瘻孔造設後の初期留置を含め、瘻孔を介して瘻孔用カテーテルの挿入、抜去が繰り返し実施される。
特に非バルーン型のカテーテルでは、伸展具等を用いて、拡径した状態の体内留置部に外力を加え直線的に伸展縮径した状態にし、挿入抵抗及び抜去抵抗を低減させる技術が開示されている(例えば、特許文献1参照)。
さらに、非バルーン型のカテーテルで、管状部材と体内留置部の接合部から体内留置部先端に向かって、体内留置部の肉厚を徐々に増すことで、管状部材と体内留置部の接合部側をより伸ばし、挿入抵抗を低減させる技術が開示されている(例えば、特許文献2参照)。また、体内留置部を帯状部と切欠きの付設された膜状部とで形成し、この切欠きを基点に折り畳み、挿入抵抗、抜去抵抗を低減させる技術も開示されている(例えば、特許文献3参照)。
また、チューブの潰れ(キンク)防止として、コイルスプリングを管状部材に埋め込んだ瘻孔用カテーテルの技術も開示されている(例えば、特許文献4参照)。
The fistula catheter is usually replaced with a new catheter after a certain period of time due to degradation or contamination due to indwelling. However, including the initial indwelling after fistula construction, insertion and removal of the fistula catheter through the fistula Is repeatedly performed.
In particular, in a non-balloon type catheter, a technique for reducing the insertion resistance and the extraction resistance by using an extension tool or the like to apply an external force to the indwelling portion in the expanded state to linearly expand and contract the diameter is disclosed. (See, for example, Patent Document 1).
Furthermore, with a non-balloon type catheter, the thickness of the indwelling portion is gradually increased from the joining portion of the tubular member and the indwelling portion toward the distal end of the indwelling portion, so that the joining side of the tubular member and the indwelling portion is increased. Has been disclosed (see Patent Document 2, for example). Further, a technique for reducing the insertion resistance and the extraction resistance by forming an indwelling portion with a band-like portion and a membrane-like portion provided with a notch and folding the notch as a base point is disclosed (for example, Patent Documents). 3).
In addition, a fistula catheter technique in which a coil spring is embedded in a tubular member is also disclosed as a tube kink prevention (see, for example, Patent Document 4).

米国特許4863438号明細書US Pat. No. 4,863,438 米国特許5336203号明細書US Pat. No. 5,336,203 特開2006−296794号公報JP 2006-296794 A 特許第3675650号明細書Japanese Patent No. 3675650

上記のような従来の瘻孔用カテーテルは、伸展具を用いて、拡径した状態の体内留置部に外力を加え直線的に伸展縮径した状態にするものの、同時に、体内留置部にある伸展させる必要のない部分、さらには管状部材も伸ばしてしまい、体内留置部の最も嵩張る部分に外力を効果的に伝えることができず、その部分を十分に伸展縮径できないという問題点があった。
本発明は上記事情に鑑みてなされたものであり、体外から経皮的に瘻孔用カテーテルを体内臓器に挿入及び抜去する際の抵抗を軽減できることで、患者に対しては低侵襲であり、且つ処置者にとっては安全・容易に挿入及び抜去することができる瘻孔用カテーテルを提供することにある。
The conventional fistula catheter as described above uses an extension tool to apply an external force to the expanded in-vivo indwelling portion to linearly expand and contract the diameter, but at the same time, extends the in-vivo indwelling portion. Unnecessary portions and further tubular members are stretched, and external force cannot be effectively transmitted to the most bulky portion of the indwelling portion, and there is a problem that the portion cannot be sufficiently expanded and contracted.
The present invention has been made in view of the above circumstances, and is less invasive to patients by reducing resistance when a fistula catheter is inserted and removed from a body organ percutaneously from outside the body, and It is an object of the present invention to provide a fistula catheter that can be inserted and removed safely and easily for a treatment person.

このような目的は、下記(1)から(11)に記載の本発明により達成される。
(1)栄養剤または薬液等の液状物質を体外から体内臓器内へ経皮的に補給する栄養通路を有する管状部材と、前記管状部材の先端側に形成され臓器内にて留置固定を可能とする体内留置部と、を有する瘻孔用カテーテルであって、
前記体内留置部は、体内臓器と接触する臓器接触部と、前記臓器接触部の先端側に形成された留置先端部と、から構成されるとともに、
前記臓器接触部の硬度(B)と、前記留置先端部の硬度(A)との関係が、(A)>(B)であることを特徴とする瘻孔用カテーテル。
(2)前記留置先端部は、無荷重の場合は前記管状部材の先端部側から基端部側に向かって凸形状となり、前記管状部材の先端部方向に荷重がかかる場合は凹形状となる凹凸変異部を有する(1)に記載の瘻孔用カテーテル。
(3)前記臓器接触部の硬度(B)と、前記管状部材の硬度(C)との関係が、(C)>(B)である(1)又は(2)に記載の瘻孔用カテーテル。
(4)前記臓器接触部のジュロメーター硬度は、Aスケールで30以上、60以下である(1)から(3)のいずれかに記載の瘻孔用カテーテル。
(5)前記臓器接触部は750%以上の切断時伸びを示す樹脂で形成されている(1)、(3)又は(4)のいずれかに記載の瘻孔用カテーテル。
(6)前記管状部材と前記臓器接触部が一体的に成形されている(1)から(5)のいずれかに記載の瘻孔用カテーテル。
(7)前記臓器接触部と前記留置先端部が一体的に成形されている(1)から(6)のいずれかに記載の瘻孔用カテーテル。
(8)前記留置先端部に体外と体内臓器間にガイドワイヤを挿通させるためのガイドワイヤ挿通孔が付設されている(1)から(7)のいずれかに記載の瘻孔用カテーテル。
(9)前記留置先端部の先端部内側略中心には、当接部が付設されると共に、前記当接部の直下には補強部材が付設されている(1)から(8)のいずれかに記載の瘻孔用カテーテル。
(10)前記管状部材の基端部に、患者の体表部に接触する体外固定部を有する(1)から(9)のいずれかに記載の瘻孔用カテーテル。
(11)
前記管状部材の栄養通路に、前記液状物質が体内臓器から前記管状部材の内腔を経て体外へ逆流することを防ぐ一方弁が付設されている(1)から(10)のいずれかに記載の瘻孔用カテーテル。
Such an object is achieved by the present invention described in the following (1) to (11).
(1) A tubular member having a nutritional passage for supplying a liquid substance such as a nutrient or medicinal solution percutaneously from the outside of the body into the internal organ, and formed at the distal end side of the tubular member, and can be placed and fixed in the organ. A fistula catheter having an indwelling portion,
The indwelling part is composed of an organ contact part that comes into contact with a body organ, and an indwelling tip part formed on the tip side of the organ contact part,
A fistula catheter characterized in that the relationship between the hardness (B) of the organ contact portion and the hardness (A) of the indwelling tip is (A)> (B).
(2) The indwelling distal end portion has a convex shape from the distal end side of the tubular member toward the proximal end portion when there is no load, and a concave shape when a load is applied toward the distal end portion of the tubular member. The fistula catheter according to (1) having a concavo-convex mutation portion.
(3) The fistula catheter according to (1) or (2), wherein the relationship between the hardness (B) of the organ contact portion and the hardness (C) of the tubular member is (C)> (B).
(4) The fistula catheter according to any one of (1) to (3), wherein the durometer hardness of the organ contact portion is 30 or more and 60 or less on an A scale.
(5) The fistula catheter according to any one of (1), (3), and (4), wherein the organ contact portion is formed of a resin that exhibits an elongation at cutting of 750% or more.
(6) The fistula catheter according to any one of (1) to (5), wherein the tubular member and the organ contact portion are integrally formed.
(7) The fistula catheter according to any one of (1) to (6), wherein the organ contact portion and the indwelling distal end portion are integrally formed.
(8) The fistula catheter according to any one of (1) to (7), wherein a guide wire insertion hole for allowing a guide wire to be inserted between an external body and an internal organ is attached to the indwelling distal end portion.
(9) A contact portion is attached to the substantially inner center of the distal end portion of the indwelling tip portion, and a reinforcing member is attached directly below the contact portion. (1) to (8) The fistula catheter according to 1.
(10) The fistula catheter according to any one of (1) to (9), which has an extracorporeal fixing part that contacts a patient's body surface part at a proximal end part of the tubular member.
(11)
One of the valves according to any one of (1) to (10), wherein the nutritional passage of the tubular member is provided with a one-way valve that prevents the liquid substance from flowing back from the body organ through the lumen of the tubular member to the outside of the body. Fistula catheter.

本発明によれば、体外から経皮的に瘻孔用カテーテルを体内臓器に挿入及び抜去する際の抵抗を軽減できることで、患者に対しては低侵襲であり、且つ処置者にとっては安全・容易に挿入及び抜去することができる瘻孔用カテーテルを提供することができる。   According to the present invention, it is possible to reduce resistance when a fistula catheter is inserted into and removed from a body organ percutaneously from outside the body, so that it is minimally invasive to a patient and safe and easy for a treatment person. A fistula catheter that can be inserted and removed can be provided.

本発明による瘻孔用カテーテルの第一の実施形態を示す斜視図である。1 is a perspective view showing a first embodiment of a fistula catheter according to the present invention. 本発明による瘻孔用カテーテル及び従来品の伸展性を示す概略図である。It is the schematic which shows the extensibility of the catheter for fistula by this invention, and a conventional product. 本発明による第一の実施形態の瘻孔用カテーテルに伸展具をセットする前後の状態を示す断面図である。It is sectional drawing which shows the state before and behind setting an extender in the catheter for fistula of 1st embodiment by this invention. 本発明による瘻孔用カテーテルの第二の実施形態を示す斜視図である。It is a perspective view which shows 2nd embodiment of the catheter for fistula by this invention. 本発明による第二の実施形態の瘻孔用カテーテルに伸展具をセットする前後の状態を示す断面図である。It is sectional drawing which shows the state before and behind setting an extender in the catheter for fistula of 2nd embodiment by this invention.

以下、各構成要件について図面を用いて詳細に説明する。
図1は、本発明による瘻孔用カテーテルの第一の実施形態を示す斜視図である。瘻孔用カテーテル1は、栄養剤又は薬剤等の液状物質を体外から体内臓器へ経皮的に補給する栄養通路21を有する管状部材2と、管状部材2の先端部に位置し、体内臓器内にて瘻孔用カテーテル1を留置固定する体内留置部3とが一体的に成形、若しくは取付けられている。さらに、体内留置部3は、体内臓器と接触する臓器接触部32、その先端側の留置先端部31とから構成されていると共に、上記留置先端部31の硬度(A)が上記臓器接触部32の硬度(B)よりも高い硬度で構成されている。
Hereinafter, each component will be described in detail with reference to the drawings.
FIG. 1 is a perspective view showing a first embodiment of a fistula catheter according to the present invention. The fistula catheter 1 is located at the distal end of the tubular member 2 having a nutrient passage 21 for transcutaneously replenishing a liquid substance such as a nutrient or a drug from the outside of the body to the internal organ, and inside the internal organ. The indwelling part 3 for indwelling and fixing the fistula catheter 1 is integrally molded or attached. Further, the indwelling portion 3 includes an organ contact portion 32 that comes into contact with a body organ and an indwelling tip portion 31 on the distal end side thereof, and the hardness (A) of the indwelling tip portion 31 is the organ contact portion 32. The hardness (B) is higher.

一般的な瘻孔用カテーテルの体内留置部のうち体内臓器と接触する部分は、患者の臓器内にて瘻孔用カテーテルの抜去抵抗を大きくして確実に留置固定するため、肉厚が大きくなるように構成されているが、この瘻孔用カテーテルを交換する際は、瘻孔に極力外力を与えないように、伸展具によって直線化し、可能な限り嵩張りを小さくしたい部分でもある。
図2に示すように、従来の瘻孔用カテーテルは体内留置部3が同一硬度で構成されているため、伸展具10を用いて拡径した状態の体内留置部3を伸展具10によってした時に、体内留置部3の伸展させたい臓器接触部32の長さL2のみを伸展するのではなく、さほど伸展させる必要の無い留置先端部31の長さL3を大きく伸展させてしまう。また、伸展させるための荷重も当然大きくなってしまう。
Of the indwelling part of a general fistula catheter, the part that comes into contact with the internal organ is fixed in place by increasing the removal resistance of the fistula catheter in the patient's organ, so that the wall thickness is increased. Although it is configured, when exchanging this fistula catheter, it is also a part where it is desired to make it straight as much as possible and to make the bulk as small as possible so as not to apply external force to the fistula as much as possible.
As shown in FIG. 2, since the indwelling part 3 is configured with the same hardness in the conventional fistula catheter, when the indwelling part 3 in a state of being expanded in diameter using the extending tool 10 is used by the extending tool 10, Instead of extending only the length L2 of the organ contact portion 32 that the indwelling portion 3 is desired to extend, the length L3 of the indwelling distal end portion 31 that does not need to be extended so much is extended greatly. Moreover, naturally the load for extending will also become large.

これに対し、本発明の瘻孔用カテーテル1は、体内留置部3のうち体内臓器と接触する臓器接触部32に比べ、その先端側の留置先端部31を硬く伸展しにくい樹脂で構成することで、高い硬度の留置先端部31よりも、低い硬度の臓器接触部32を管状部材2の軸方向に十分に伸展させることができるため、臓器接触部32に、伸展具10による外力をより効果的に伝えることが可能となる。
すなわち、伸展具10の移動距離が同じ設定の場合、従来の瘻孔用カテーテルに比較し、本発明の瘻孔用カテーテルの構成では、図2に示すとおり、留置先端部31の管状部材2の軸方向への伸びを抑え(L3’’<L3’)、臓器接触部32を管状部材2の軸方向により長く伸ばす(L2’’>L2’)ことができ、体内留置部3の直径をより縮径する(R’’<R’)ことが可能となる。これにより、瘻孔用のカテーテルの理想型と考えられるR’’/R1=1(伸展時)に近づくことが可能となり、患者の瘻孔を介した瘻孔用カテーテル1の挿入及び抜去抵抗が著しく軽減でき、患者に対しては低侵襲であり、且つ処置者にとってはスムーズに交換操作を実施でき、安全・容易な手技を実現できる。
さらに、体内留置部3全体を押し伸ばすのではなく、伸展させたい部分である臓器接触部32に、必要な外力を最小限で伝えることができる為、処置者の操作性も向上できる。
On the other hand, the fistula catheter 1 of the present invention is configured such that the indwelling distal end portion 31 on the distal end side thereof is made of a resin that is hard and difficult to extend as compared with the organ contact portion 32 that contacts the internal organs in the indwelling portion 3. Since the organ contact portion 32 having a lower hardness can be sufficiently extended in the axial direction of the tubular member 2 than the indwelling distal end portion 31 having a higher hardness, the external force by the extender 10 is more effectively applied to the organ contact portion 32. Can be communicated to.
That is, when the moving distance of the extender 10 is the same setting, as shown in FIG. 2, the axial direction of the tubular member 2 of the indwelling distal end portion 31 in the configuration of the fistula catheter of the present invention is compared with the conventional fistula catheter. (L3 ″ <L3 ′), the organ contact portion 32 can be extended longer in the axial direction of the tubular member 2 (L2 ″> L2 ′), and the diameter of the indwelling portion 3 can be further reduced. (R ″ <R ′). This makes it possible to approach R ″ / R1 = 1 (during extension), which is considered to be an ideal type of fistula catheter, and the resistance to insertion and removal of the fistula catheter 1 through the patient's fistula can be significantly reduced. In addition, it is minimally invasive to the patient and can be smoothly exchanged for the treatment person, thereby realizing a safe and easy procedure.
Furthermore, since the necessary external force can be transmitted to the organ contact portion 32 which is a portion desired to be extended rather than pushing the entire indwelling portion 3 as a whole, the operability of the operator can be improved.

さらに、上記管状部材2の硬度(C)も上記臓器接触部32の硬度(B)よりも高い硬度で構成することが好ましい。硬度が低く伸びやすい部分である臓器接触部32を、硬度の高い管状部材2と上記留置先端部31で挟むことで、臓器接触部32に、伸展具10による外力をより効果的に伝えることが可能となる。
これにより、図2に示すように、伸展具10を用いて、拡径した状態の体内留置部3に外力を加え直線的に縮径状態とした時に、管状部材2もその軸方向に大幅に伸びてしまう(L’>>L)という、各部材が同一硬度で形成された従来の瘻孔用カテーテルで見られる現象も解決できる。
すなわち、伸展具10の移動距離が同じ設定の場合、従来の瘻孔用カテーテルに比較し、本発明の瘻孔用カテーテルの構成では、図2に示すとおり、管状部材2の長軸方向への伸び(L1’’<L1’)や、留置先端部31の管状部材2の長軸方向への伸び(L3’’<L3’) を抑え、臓器接触部32を管状部材2の長軸方向により大きく伸ばす(L2’’>L2’)ことができ、上記体内留置部3の直径をより縮径する(R’’<R’)ことが可能となる。これにより、瘻孔用のカテーテルの理想型と考えられるR’’/R1=1(伸展時)に近づくことが可能となり、患者の瘻孔を介した瘻孔用カテーテル1の挿入・抜去抵抗が著しく軽減でき、患者に対しては低侵襲であり、且つ処置者もスムーズに交換操作を実施でき、安全・容易な手技を実現できる。
さらに、瘻孔用カテーテル1全体を押し伸ばすのではなく、伸展させたい部分である臓器接触部32に、必要な外力を最小限で伝えることができる為、処置者の操作性も向上できる。
Furthermore, the hardness (C) of the tubular member 2 is preferably higher than the hardness (B) of the organ contact portion 32. By sandwiching the organ contact portion 32, which is a portion having low hardness and easy to extend, between the tubular member 2 having high hardness and the indwelling distal end portion 31, the external force by the extender 10 can be more effectively transmitted to the organ contact portion 32. It becomes possible.
Thus, as shown in FIG. 2, when the extension tool 10 is used to apply an external force to the in-vivo indwelling portion 3 in the expanded state to linearly reduce the diameter, the tubular member 2 is also greatly increased in the axial direction. The phenomenon seen in the conventional fistula catheter in which each member is formed with the same hardness, which is elongated (L 1 ′ >> L 1 ), can also be solved.
That is, when the moving distance of the extender 10 is the same setting, the structure of the fistula catheter of the present invention is longer than the conventional fistula catheter as shown in FIG. L1 ″ <L1 ′) and the length (L3 ″ <L3 ′) of the indwelling tip 31 in the long axis direction of the tubular member 2 are suppressed, and the organ contact portion 32 is greatly extended in the long axis direction of the tubular member 2 (L2 ″> L2 ′) and the diameter of the indwelling portion 3 can be further reduced (R ″ <R ′). This makes it possible to approach R ″ / R1 = 1 (during extension), which is considered to be an ideal type of fistula catheter, and the insertion / extraction resistance of the fistula catheter 1 through the patient's fistula can be significantly reduced. In addition, it is minimally invasive to the patient, and the treatment person can also perform the replacement operation smoothly, thereby realizing a safe and easy procedure.
Furthermore, since the necessary external force can be transmitted to the organ contact portion 32 which is a portion to be extended, instead of pushing and extending the entire fistula catheter 1, the operability of the operator can be improved.

また、上述したが、瘻孔用カテーテルが患者の瘻孔に留置されている状態では、体内留置部3は患者の臓器内にて瘻孔用カテーテルを留置固定するために十分な嵩張りを持ち、瘻孔用カテーテルを交換する際は、体内留置部3は直線化して挿入及び抜去抵抗が小さくなることが好ましい。すなわち、伸展具10による外力を管状部材の基端部側から先端方向にかけた場合にのみ、体内留置部3が変形、直線化されることが好ましい。
具体的には、図3に示すように、無荷重の場合は上記管状部材2の先端部側から基端部側に向かって凸形状となり、管状部材2の先端方向に荷重がかかる場合は凹形状となる凹凸変異部311が、上記留置先端部31に付設されることが好ましい。
無荷重の場合は、凹凸変異部311が凸形状に形成されているが、瘻孔用カテーテル1の管状部材2を持って、患者の瘻孔から引き抜かれる方向に力が加えられた場合(一般的に事故抜去と呼ばれる)、上記体内留置部3の内側の空洞部314内で、留置先端部31の内側側面部312と凸形状の凹凸変異部311とが縮径方向に反発し合うことで、留置先端部31が縮径されるのを防止することができる。
一方、伸展具10により、体内留置部3の先端部方向に外力をかけた場合、凹凸変異部311が凹形状となり、留置先端部31の内側側面部312と凹形状の凹凸変異部311とが縮径方向に反発し合うことがなくなり、この凹形状となった凹凸変異部311の根元(周囲)を基点とし、体内留置部3の内側の空洞部314を利用して、留置先端部31が傘のように折り畳まれ、縮径される。
In addition, as described above, in the state where the fistula catheter is indwelled in the patient's fistula, the indwelling portion 3 has a sufficient bulk for indwelling and fixing the fistula catheter in the patient's organ, When exchanging the catheter, it is preferable that the indwelling portion 3 is straightened to reduce insertion and removal resistance. That is, it is preferable that the indwelling portion 3 is deformed and straightened only when an external force from the extension device 10 is applied in the distal direction from the proximal end side of the tubular member.
Specifically, as shown in FIG. 3, when no load is applied, the tubular member 2 has a convex shape from the distal end side toward the proximal end side, and when a load is applied in the distal end direction of the tubular member 2, the concave shape is obtained. It is preferable that the uneven | corrugated variation part 311 used as a shape is attached to the said indwelling front-end | tip part 31. FIG.
In the case of no load, the unevenness variation part 311 is formed in a convex shape, but when a force is applied in the direction of being pulled out of the patient's fistula with the tubular member 2 of the fistula catheter 1 (generally In the hollow portion 314 inside the indwelling portion 3, the inside side surface portion 312 of the indwelling distal end portion 31 and the convex uneven portion 311 repel each other in the direction of the diameter reduction. It is possible to prevent the distal end portion 31 from being reduced in diameter.
On the other hand, when an external force is applied to the distal end portion of the indwelling portion 3 by the extender 10, the unevenness variation portion 311 has a concave shape, and the inner side surface portion 312 of the placement distal end portion 31 and the concave unevenness variation portion 311 The indwelling distal end portion 31 is formed using the hollow portion 314 inside the indwelling portion 3 with the root (periphery) of the uneven portion 311 having the concave shape as a base point. Folded like an umbrella and reduced in diameter.

上記留置先端部31と上記管状部材2は、上記臓器接触部32の硬度よりも高い樹脂で構成されれば特に限定しない。この構成であれば、臓器接触部32に伸展具10による外力を集中させることができる。
例として、各部材をシリコーンゴムで構成した場合の硬度の関係を記載する。臓器接触部32のジュロメーター硬度は、Aスケールで30以上、60以下であることが好ましい。管状部材2のジュロメーター硬度は、Aスケールで50以上、75以下であることが好ましい。特に好ましくは、上記範囲内で管状部材2と臓器接触部32の硬度差をより大きくとることである。
臓器接触部32が上記範囲の上限値を超える硬度であると、伸展具10の操作、すなわち臓器接触部32を伸展する為に必要な力が大きくなり、処置者が片手で操作することが困難となる場合がある。上記範囲の下限値未満であると、体内臓器内に瘻孔用カテーテル1を留置固定する能力(アンカー力)が低くなり、留置中の瘻孔からの不意な抜去(事故抜去)が発生するリスクが高くなる。
管状部材2が上記範囲の上限値を超える硬度であると、患者の体表に出てくる部分が硬く、生活に支障をきたし、患者に不快感を与えてしまう。上記範囲の下限値未満であると、管状部材2の潰れ(キンク)のリスクが上がり、栄養剤等の通過に影響を与える可能性が高くなる。
If the said indwelling front-end | tip part 31 and the said tubular member 2 are comprised with resin higher than the hardness of the said organ contact part 32, it will not specifically limit. With this configuration, it is possible to concentrate the external force by the extender 10 on the organ contact portion 32.
As an example, the relationship of hardness when each member is made of silicone rubber will be described. The durometer hardness of the organ contact portion 32 is preferably 30 or more and 60 or less on the A scale. The durometer hardness of the tubular member 2 is preferably 50 or more and 75 or less on the A scale. Particularly preferably, the hardness difference between the tubular member 2 and the organ contact portion 32 is made larger within the above range.
If the organ contact portion 32 has a hardness exceeding the upper limit of the above range, the force required to operate the extender 10, that is, the organ contact portion 32, increases, and it is difficult for the operator to operate with one hand. It may become. If the value is less than the lower limit of the above range, the ability (anchor force) of indwelling and fixing the fistula catheter 1 in a body organ is reduced, and the risk of inadvertent removal (accident removal) from the fistula during placement is high. Become.
If the tubular member 2 has a hardness exceeding the upper limit of the above range, the portion appearing on the patient's body surface is hard, which may interfere with life and cause discomfort to the patient. If it is less than the lower limit of the above range, the risk of crushing (kinking) the tubular member 2 increases, and the possibility of affecting the passage of nutrients and the like increases.

臓器接触部32の切断時伸びは、瘻孔用カテーテル1を一定の留置期間終了後、患者から抜去する為に伸展、縮径した時に臓器接触部32が破断しなければ特に限定しないが、750%以上の切断時伸びを示す樹脂で形成されていることが好ましい。臓器接触部32の断面積により前後するが、R’’/R1=1により近づけるには、図2におけるL2’’はL2の約2倍以上は伸展すべきである(L2’’>2×L2)。さらに、一般的に瘻孔用カテーテルは長期間、患者の臓器内に留置固定されるため、体液等との接触、患者の体動による繰り返しの負荷により、強度低下のリスクも伴う。上記切断時伸びのような十分な強度を持つ樹脂を用いることで、破断のリスクを下げ、安全性の高い瘻孔用カテーテルとすることができる。   The elongation at the time of cutting of the organ contact portion 32 is not particularly limited as long as the organ contact portion 32 does not break when the fistula catheter 1 is extended and contracted to be removed from the patient after a certain indwelling period, but is 750% It is preferably formed of a resin exhibiting the above elongation at break. Although it fluctuates depending on the cross-sectional area of the organ contact portion 32, in order to make it closer to R ″ / R1 = 1, L2 ″ in FIG. 2 should extend about twice or more than L2 (L2 ″> 2 ×). L2). Furthermore, since a fistula catheter is generally indwelling and fixed in a patient's organ for a long period of time, there is a risk of strength reduction due to repeated contact with body fluids and the patient's body movement. By using a resin having sufficient strength such as the elongation at the time of cutting, the risk of breakage can be reduced, and a highly safe fistula catheter can be obtained.

上記管状部材2は、栄養剤又は薬剤等の液状物質を体外から体内臓器へ経皮的に補給する栄養通路21を有していれば、その内外径の寸法は特に限定しない。患者の一般的な瘻孔のサイズに合わせて、5〜10mmの外径であることが好ましい。   If the said tubular member 2 has the nutrient channel | path 21 which supplies liquid substances, such as a nutrient or a chemical | medical agent, percutaneously from an external body to a body organ, the dimension of the inner and outer diameter will not be specifically limited. The outer diameter is preferably 5 to 10 mm in accordance with the size of a general fistula of a patient.

上記留置先端部31と上記臓器接触部32とで構成される体内留置部3の形状は、非バルーン型で、伸展具10で伸展され使用される瘻孔用カテーテルに一般的に用いられる形状であれば特に限定しない。マレコット型、ピラミッド型、ドーム型などのどの形状であっても、形状が同じもので比較すれば、従来の同一硬度の構成と本発明の構成ではその効果は十分確認できる。   The indwelling portion 3 composed of the indwelling distal end portion 31 and the organ contact portion 32 may be of a non-balloon type and generally used for fistula catheters that are extended and used by the extension device 10. There is no particular limitation. Any shape such as a malecot type, pyramid type, dome type, etc., can be confirmed sufficiently by the conventional configuration of the same hardness and the configuration of the present invention when compared with the same shape.

上記凹凸変異部311の形状は、無荷重の場合は上記管状部材2の基端部側に凸形状となり、上記留置先端部31の内側側面部312と凸形状の凹凸変異部311とが縮径方向に反発し合うことで、留置先端部31が縮径されるのを防止する機能と、体内留置部3の先端部方向に荷重をかけた場合は凹形状となり、留置先端部31の内側側面部312と凹形状の凹凸変異部311とが縮径方向に反発し合うことがなく、この凹形状となった凹凸変異部311の根元(周囲)を基点とし、体内留置部3の内側の空洞部314を利用して、留置先端部31が傘のように折り畳まれ、縮径されるという2つの機能を示すことができれば、特に限定しない。円形、小判状、多角形、円錐形状など、どのような形状でも良い。
好ましくは、凹凸変異部311の根元(周囲)が薄肉部313で形成されることが良い。こうすることで、留置先端部31が傘のように折り畳まれて縮径される際の基点としての効果を高めることができると共に、伸展具10による凹凸変異部311の凸形状から凹形状への変異に必要な外力も小さくてすみ、スムーズに変異させることができる。
When the load is not applied, the shape of the concave-convex variation portion 311 is convex toward the proximal end portion of the tubular member 2, and the inner side surface portion 312 of the indwelling distal end portion 31 and the convex concave-convex variation portion 311 are reduced in diameter. The function of preventing the indwelling tip 31 from being reduced in diameter by repelling in the direction, and a concave shape when a load is applied in the direction of the tip of the indwelling portion 3, and the inner side surface of the indwelling tip 31 The portion 312 and the concave-convex uneven portion 311 do not repel each other in the direction of diameter reduction, and the cavity inside the indwelling portion 3 is based on the root (periphery) of the concave-convex portion 311 having the concave shape. There are no particular limitations as long as the indwelling distal end 31 can be folded like an umbrella and reduced in diameter using the portion 314. Any shape such as a circular shape, an oval shape, a polygonal shape, or a conical shape may be used.
Preferably, the root (periphery) of the unevenness variation part 311 is formed by the thin part 313. By doing so, the effect as a base point when the indwelling distal end portion 31 is folded like an umbrella and reduced in diameter can be enhanced, and the convex-concave portion 311 by the extender 10 is changed from the convex shape to the concave shape. The external force required for mutation is small and can be mutated smoothly.

上記管状部材2と上記臓器接触部32の取り付け方法は、伸展具10による外力で破断することがなければ、一体成形、インサート成形、接着などであっても良く、特に限定しない。好ましくは、一体的に成形されることが良く、一般的に行われている接着などによる接合よりも強度を高く確保でき、長期的な使用に優れる。また段差を無くすことができる為、留置中の患者の不快感も低減できる。
一体成形の方法も特に限定しないが、二色成形などが実用的であり、接着などで形成されるものに比較し安価に製造することが可能となる。
The method for attaching the tubular member 2 and the organ contact part 32 may be integral molding, insert molding, adhesion, or the like as long as the tubular member 2 and the organ contact portion 32 are not broken by an external force by the extender 10, and are not particularly limited. Preferably, it is formed integrally, can ensure a higher strength than bonding by bonding or the like that is generally performed, and is excellent in long-term use. Further, since the step can be eliminated, the discomfort of the patient during the detention can be reduced.
The method of integral molding is not particularly limited, but two-color molding or the like is practical, and can be manufactured at a lower cost than those formed by bonding or the like.

上記臓器接触部32と上記留置先端部31の取り付け方法は、伸展具10による外力で破断することがなければ、一体成形、インサート成形、接着などであっても良く、特に限定しない。好ましくは、一体的に成形されることが良く、一般的に行われている接着などによる接合よりも強度を高く確保でき、長期的な使用に優れる。また段差を無くすことができる為、留置中の患者の不快感も低減できる。
一体成形の方法も特に限定しないが、二色成形などが実用的であり、接着などで形成されるものに比較し安価に製造することが可能となる。
The attachment method of the organ contact portion 32 and the indwelling distal end portion 31 may be integral molding, insert molding, adhesion, or the like as long as it is not broken by an external force by the extender 10, and is not particularly limited. Preferably, it is formed integrally, can ensure a higher strength than bonding by bonding or the like that is generally performed, and is excellent in long-term use. Further, since the step can be eliminated, the discomfort of the patient during the detention can be reduced.
The method of integral molding is not particularly limited, but two-color molding or the like is practical, and can be manufactured at a lower cost than those formed by bonding or the like.

本発明の瘻孔用カテーテル1を構成する材料としては、例えば、ポリウレタン樹脂、シリコーンゴム等が挙げられる。臓器接触部32は、弾性、伸展性がある材料であれば特に限定されないが、体内において組織反応性の少ないシリコーンゴムが好ましい。
また、留置先端部31は、臓器接触部32よりも硬度が高く、折り畳まれる機構を持てば、硬質の樹脂や金属であっても良く特に限定しない。
Examples of the material constituting the fistula catheter 1 of the present invention include polyurethane resin and silicone rubber. The organ contact portion 32 is not particularly limited as long as it is a material having elasticity and extensibility, but silicone rubber having a low tissue reactivity in the body is preferable.
Further, the indwelling distal end portion 31 may be made of a hard resin or metal as long as it has a higher hardness than the organ contact portion 32 and has a folding mechanism.

図3は、瘻孔用カテーテル1に伸展具10をセットする前後の状態を示す断面図である。
凹凸変異部311は、体外と体内臓器間を結ぶガイドワイヤを挿通する為のガイドワイヤ挿通孔4が付設されている。これにより、留置されていた瘻孔用カテーテル1に伸展具10をセットし、伸展具10のガイドワイヤ通路11からガイドワイヤ(不図示)を挿入し、瘻孔用カテーテル1のガイドワイヤ挿通孔4を通すことで、ガイドワイヤによる体外と体内臓器間の連結が達成される。
こうすることで瘻孔用カテーテル1の交換操作において、伸展具10で伸展させた瘻孔用カテーテル1をガイドワイヤに沿って抜去し、次にガイドワイヤに沿って新しい瘻孔用カテーテル1を挿入するという一連の操作が可能となり、腹腔内への逸脱を防止し、確実に臓器内へ瘻孔用カテーテル1を挿入することができる。
FIG. 3 is a cross-sectional view showing a state before and after the extension device 10 is set on the fistula catheter 1.
The unevenness variation part 311 is provided with a guide wire insertion hole 4 for inserting a guide wire connecting the outside of the body and the internal organs. As a result, the extender 10 is set on the indwelling fistula catheter 1, a guide wire (not shown) is inserted from the guide wire passage 11 of the extender 10, and the guide wire insertion hole 4 of the fistula catheter 1 is passed. As a result, the connection between the extracorporeal and internal organs by the guide wire is achieved.
In this manner, in the replacement operation of the fistula catheter 1, the fistula catheter 1 extended by the extension tool 10 is removed along the guide wire, and then a new fistula catheter 1 is inserted along the guide wire. Therefore, the deviation into the abdominal cavity can be prevented, and the fistula catheter 1 can be reliably inserted into the organ.

ガイドワイヤ挿通孔4の直径は、使用するガイドワイヤの直径に合わせたものであれば特に限定しない。0.9〜1.5mmであることが好ましく、特に0.9〜1.2mmが好ましい。上記寸法範囲内であれば、特に0.035‘inch(インチ)のガイドワイヤの挿入性に優れる。   The diameter of the guide wire insertion hole 4 is not particularly limited as long as it matches the diameter of the guide wire to be used. It is preferably 0.9 to 1.5 mm, particularly preferably 0.9 to 1.2 mm. If it is in the said dimension range, it is excellent in the insertability of a 0.035 'inch (inch) guide wire especially.

凹凸変異部311には、伸展具10による外力が作用する当接部5が付設されても良い。凹凸変異部311と当接部5とが付設された留置先端部31は、臓器接触部32よりも硬い硬度で構成されれば、軟質の樹脂であってもよい。
凹凸変異部311の当接部5の直下には、補強部材51を付設することが好ましい。上記補強部材51が付設されることで、上記体内留置部3に伸展具10で外力を加えた時に、留置先端部31の破損を防止でき、体内留置部3を縮径状態で患者の瘻孔から挿入及び抜去する操作を安全且つ確実に実施できることとなる。
A contact portion 5 on which an external force by the extension tool 10 acts may be attached to the unevenness variation portion 311. The indwelling distal end portion 31 provided with the unevenness variation portion 311 and the abutting portion 5 may be a soft resin as long as it is configured with hardness that is harder than the organ contact portion 32.
It is preferable to attach a reinforcing member 51 directly below the contact portion 5 of the unevenness variation portion 311. By attaching the reinforcing member 51, when an external force is applied to the in-vivo indwelling portion 3 with the extension tool 10, the indwelling distal end portion 31 can be prevented from being damaged, and the in-vivo indwelling portion 3 is reduced from the patient's fistula in a reduced diameter state. The operation of insertion and removal can be performed safely and reliably.

補強部材51は、ガイドワイヤ挿通孔4によるガイドワイヤ(不図示)の体外と臓器内の連絡に支障を与えなければ、その形状や材質等は特に限定されない。例えば金属又は熱硬化性樹脂等の材質で形成することができる。特に金属製のメッシュであることが好ましく、成形時にメッシュの格子内に樹脂が回りこむことで、金属製のメッシュと上記留置先端部31を構成する樹脂の接触面積を大幅に増すことができ、強度を向上させることができる。   The shape and material of the reinforcing member 51 are not particularly limited as long as the reinforcing member 51 does not hinder the connection between the outside of the guide wire (not shown) and the organ by the guide wire insertion hole 4. For example, it can be formed of a material such as a metal or a thermosetting resin. In particular, it is preferably a metal mesh, and the resin wraps around in the lattice of the mesh at the time of molding, so that the contact area between the metal mesh and the resin constituting the indwelling tip 31 can be greatly increased. Strength can be improved.

また、留置先端部31に付設されるガイドワイヤ挿通孔4、当接部5、補強部材51も、一体的に成形されることが好ましい。   Further, it is preferable that the guide wire insertion hole 4, the contact portion 5, and the reinforcing member 51 attached to the indwelling distal end portion 31 are also integrally formed.

次に、本発明による第二の実施の形態における瘻孔用カテーテルを、図4を用いて説明する。
第二の実施の形態における瘻孔用カテーテル6において、図1と同一構成要素には同一符号を付してその説明を省略し、異なる点について主に説明する。すなわち、第二の実施の形態における瘻孔用カテーテル6において、第一の実施の形態における瘻孔用カテーテル1と異なる点は、管状部材2の患者の体表部に位置する部分に体外固定部7を設けた点と、管状部材2の先端部に一方弁8を付設した点にある。
Next, a fistula catheter according to a second embodiment of the present invention will be described with reference to FIG.
In the fistula catheter 6 in the second embodiment, the same components as those in FIG. 1 are denoted by the same reference numerals, description thereof is omitted, and different points are mainly described. That is, the fistula catheter 6 according to the second embodiment is different from the fistula catheter 1 according to the first embodiment in that the extracorporeal fixing portion 7 is provided at a portion of the tubular member 2 located on the body surface of the patient. The point provided is that the one-way valve 8 is provided at the tip of the tubular member 2.

体外固定部7は、瘻孔用カテーテル6の埋設状態において、患者の体表に位置する部分に設けられ、瘻孔用カテーテル6が患者の体内(臓器内)へ埋没しないようにするものである。上記体外固定部7は上記管状部材2の基端部に付設され、管状部材2の径方向外側に張り出した状態のものであればその形状は特に限定しない。例えば栄養通路21の基端部の開口周りに付設される扁平状物とすることができる。上記体外固定部7は、瘻孔用カテーテル6のうち、留置中に唯一患者に見える部分であるため、扁平状物であれば、嵩張りが少なく、患者の生活に支障をきたさない点で好ましい。
また、本例の体外固定部7には栄養通路21の基端部の開口に嵌合する栓71が、連結部材72を介して取付けられている。栓71は瘻孔用カテーテル6の埋設状態において、栄養又は薬液を体外から胃内へ経皮的に補給しない時、栓71を栄養通路21の基端部の開口に嵌合させることで、胃内の気密を保つことができる。
The extracorporeal fixation unit 7 is provided in a portion located on the surface of the patient's body when the fistula catheter 6 is embedded, and prevents the fistula catheter 6 from being embedded in the patient's body (inside the organ). The shape of the extracorporeal fixing portion 7 is not particularly limited as long as the extracorporeal fixing portion 7 is attached to the proximal end portion of the tubular member 2 and projects outward in the radial direction of the tubular member 2. For example, it can be a flat object attached around the opening of the base end of the nutrient passage 21. The extracorporeal fixation part 7 is the only part of the fistula catheter 6 that can be seen by the patient during indwelling. Therefore, a flat object is preferable in that it is less bulky and does not hinder the patient's life.
Further, a plug 71 that fits into the opening of the base end portion of the nutrient passage 21 is attached to the extracorporeal fixing portion 7 of this example via a connecting member 72. The plug 71 is fitted in the opening of the proximal end portion of the nutrient passage 21 when the nutrient catheter or the chemical solution is not supplied percutaneously from the outside of the body into the stomach in the embedded state of the fistula catheter 6. Can be kept airtight.

また、本例の瘻孔用カテーテル6は、第一の実施形態の瘻孔用カテーテル1に比較し、管状部材2が患者の瘻孔の長さにフィットするように設計されている。つまり本例の瘻孔用カテーテル6の管状部材2は短いため、液状物質が体内臓器から前記管状部材の内腔を経て体外へ逆流することを防ぐ一方弁8が付設されることが好ましい。こうすることで、患者に対し栄養又は薬液を体外から体内へ経皮的に補給することができると共に、体内から液物が体外へ逆流することがない。   Further, the fistula catheter 6 of this example is designed so that the tubular member 2 fits the length of the fistula of the patient as compared with the fistula catheter 1 of the first embodiment. That is, since the tubular member 2 of the fistula catheter 6 of this example is short, it is preferable that the one-way valve 8 is attached to prevent the liquid substance from flowing backward from the internal organs through the lumen of the tubular member. By doing so, nutrition or a chemical solution can be supplied to the patient percutaneously from the outside of the body to the inside of the body, and the liquid does not flow back out of the body.

図5は、本例の瘻孔用カテーテル6に伸展具10をセットする前後の状態を示す断面図である。
一方弁8は、公知の弁が使用でき、その形状は特に限定しない。例として、ダックビル弁を示す。また、本例では一方弁8の付設位置が上記管状部材2の先端部である構成を図示しているが、瘻孔用カテーテル6の栄養通路21内であれば、どの位置でも上記液物の逆流を防止することができ、付設位置についても特に限定しない。
FIG. 5 is a cross-sectional view showing a state before and after the extension device 10 is set on the fistula catheter 6 of this example.
On the other hand, the valve 8 can use a well-known valve, and the shape is not specifically limited. As an example, a duckbill valve is shown. Further, in this example, the configuration in which the one-way valve 8 is attached to the distal end portion of the tubular member 2 is illustrated. However, as long as it is within the nutrient passage 21 of the fistula catheter 6, The attachment position is not particularly limited.

瘻孔用カテーテル6も瘻孔用カテーテル1と同様に、体外固定部7を含み、一体的に成形されることが好ましい。   As with the fistula catheter 1, the fistula catheter 6 preferably includes the extracorporeal fixing part 7 and is integrally molded.

以上、本発明の瘻孔用カテーテルを図示の実施形態に基づいて説明したが、本発明はこれに限定されるものではない。
例えば、管状部材と、臓器接触部と、留置先端部と、留置先端部に付設される凹凸変異部、薄肉部、ガイドワイヤ挿通孔、当接部、また、体外固定部と、一方弁については同様の機能を有し得る任意の構成のものと置換することができる。
The fistula catheter of the present invention has been described based on the illustrated embodiment, but the present invention is not limited to this.
For example, about tubular member, organ contact part, indwelling tip part, uneven mutation part attached to indwelling tip part, thin part, guide wire insertion hole, contact part, extracorporeal fixation part, and one-way valve Any structure that can have a similar function can be substituted.

1 瘻孔用カテーテル
2 管状部材
21 栄養通路
3 体内留置部
31 留置先端部
311 凹凸変異部
312 内側側面部
313 薄肉部
314 空洞部
32 臓器接触部
4 ガイドワイヤ挿通孔
5 当接部
51 補強部材
6 瘻孔用カテーテル
7 体外固定部
71 栓
72 連結部材
8 一方弁
10 伸展具
11 ガイドワイヤ通路
DESCRIPTION OF SYMBOLS 1 Fistula catheter 2 Tubular member 21 Nutritional passage 3 Indwelling part 31 Indwelling tip part 311 Concavity and convexity part 312 Inner side part 313 Thin part 314 Cavity part 32 Organ contact part 4 Guide wire insertion hole 5 Contact part 51 Reinforcing member 6 Fistula Catheter 7 extracorporeal fixing part 71 plug 72 connecting member 8 one-way valve 10 extender 11 guide wire passage

Claims (11)

栄養剤または薬液等の液状物質を体外から体内臓器内へ経皮的に補給する栄養通路を有する管状部材と、前記管状部材の先端側に形成され臓器内にて留置固定を可能とする体内留置部と、を有する瘻孔用カテーテルであって、
前記体内留置部は、体内臓器と接触する臓器接触部と、前記臓器接触部の先端側に形成された留置先端部と、から構成されるとともに、
前記臓器接触部の硬度(B)と、前記留置先端部の硬度(A)との関係が、(A)>(B)であることを特徴とする瘻孔用カテーテル。
A tubular member having a nutrient passage for transcutaneously replenishing a liquid substance such as a nutrient or a medicinal solution into the internal organ from outside the body, and an indwelling body that is formed at the distal end side of the tubular member and can be placed and fixed in the organ A fistula catheter having a portion,
The indwelling part is composed of an organ contact part that comes into contact with a body organ, and an indwelling tip part formed on the tip side of the organ contact part,
A fistula catheter characterized in that the relationship between the hardness (B) of the organ contact portion and the hardness (A) of the indwelling tip is (A)> (B).
前記留置先端部は、無荷重の場合は前記管状部材の先端部側から基端部側に向かって凸形状となり、前記管状部材の先端部方向に荷重がかかる場合は凹形状となる凹凸変異部を有する請求項1に記載の瘻孔用カテーテル。   The indwelling distal end portion has a convex shape from the distal end side to the proximal end portion side of the tubular member when there is no load, and a concave and convex variation portion that becomes concave when a load is applied toward the distal end portion of the tubular member. The fistula catheter according to claim 1. 前記臓器接触部の硬度(B)と、前記管状部材の硬度(C)との関係が、(C)>(B)である請求項1又は2に記載の瘻孔用カテーテル。   The fistula catheter according to claim 1 or 2, wherein a relationship between the hardness (B) of the organ contact portion and the hardness (C) of the tubular member is (C)> (B). 前記臓器接触部のジュロメーター硬度は、Aスケールで30以上、60以下である請求項1乃至3のいずれかに記載の瘻孔用カテーテル。   The fistula catheter according to any one of claims 1 to 3, wherein a durometer hardness of the organ contact portion is 30 or more and 60 or less on an A scale. 前記臓器接触部は750%以上の切断時伸びを示す樹脂で形成されている請求項1、3又は4のいずれかに記載の瘻孔用カテーテル。   The fistula catheter according to any one of claims 1, 3, and 4, wherein the organ contact portion is formed of a resin that exhibits an elongation at the time of cutting of 750% or more. 前記管状部材と前記臓器接触部が一体的に成形されている請求項1から5のいずれかに記載の瘻孔用カテーテル。   The fistula catheter according to any one of claims 1 to 5, wherein the tubular member and the organ contact portion are integrally formed. 前記臓器接触部と前記留置先端部が一体的に成形されている請求項1から6のいずれかに記載の瘻孔用カテーテル。   The fistula catheter according to any one of claims 1 to 6, wherein the organ contact part and the indwelling distal end part are integrally formed. 前記留置先端部に体外と体内臓器間にガイドワイヤを挿通させるためのガイドワイヤ挿通孔が付設されている請求項1から7のいずれかに記載の瘻孔用カテーテル。   The fistula catheter according to any one of claims 1 to 7, wherein a guide wire insertion hole for inserting a guide wire between an external body and an internal body organ is attached to the indwelling distal end portion. 前記留置先端部の先端部内側略中心には、当接部が付設されると共に、前記当接部の直下には補強部材が付設されている請求項1から8のいずれかに記載の瘻孔用カテーテル。   9. The fistula according to claim 1, wherein a contact portion is provided at a substantially inner center of the distal end portion of the indwelling tip portion, and a reinforcing member is provided immediately below the contact portion. catheter. 前記管状部材の基端部に、患者の体表部に接触する体外固定部を有する請求項1から9のいずれかに記載の瘻孔用カテーテル。   The fistula catheter according to any one of claims 1 to 9, further comprising an extracorporeal fixing portion that comes into contact with a patient's body surface portion at a proximal end portion of the tubular member. 前記管状部材の栄養通路に、前記液状物質が体内臓器から前記管状部材の栄養通路を経て体外へ逆流することを防ぐ一方弁が付設されている請求項1から10のいずれかに記載の瘻孔用カテーテル。   11. The fistula according to claim 1, wherein a one-way valve for preventing the liquid substance from flowing backward from the body organ through the nutrient passage of the tubular member to the outside of the body is attached to the nutrition passage of the tubular member. catheter.
JP2009063907A 2009-03-17 2009-03-17 Fistula catheter Expired - Fee Related JP5229029B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2009063907A JP5229029B2 (en) 2009-03-17 2009-03-17 Fistula catheter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2009063907A JP5229029B2 (en) 2009-03-17 2009-03-17 Fistula catheter

Publications (2)

Publication Number Publication Date
JP2010213895A true JP2010213895A (en) 2010-09-30
JP5229029B2 JP5229029B2 (en) 2013-07-03

Family

ID=42973394

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2009063907A Expired - Fee Related JP5229029B2 (en) 2009-03-17 2009-03-17 Fistula catheter

Country Status (1)

Country Link
JP (1) JP5229029B2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106821765A (en) * 2017-03-08 2017-06-13 杭州富善医疗器械有限公司 A kind of stomach stoma and the fixed pad for stomach stoma

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11192310A (en) * 1997-10-14 1999-07-21 Radius Internatl Lp Body access tube
WO2004096115A1 (en) * 2003-04-28 2004-11-11 Sumitomo Bakelite Company Limited Catheter kit for burrow
JP2006035001A (en) * 2003-04-28 2006-02-09 Yutaka Suzuki Catheter kit for ostomy
JP2006296794A (en) * 2005-04-21 2006-11-02 Nippon Sherwood Medical Industries Ltd Internal indwelling appliance
JP2008178456A (en) * 2007-01-23 2008-08-07 Hakko Co Ltd Physical access port

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11192310A (en) * 1997-10-14 1999-07-21 Radius Internatl Lp Body access tube
WO2004096115A1 (en) * 2003-04-28 2004-11-11 Sumitomo Bakelite Company Limited Catheter kit for burrow
JP2006035001A (en) * 2003-04-28 2006-02-09 Yutaka Suzuki Catheter kit for ostomy
JP2006296794A (en) * 2005-04-21 2006-11-02 Nippon Sherwood Medical Industries Ltd Internal indwelling appliance
JP2008178456A (en) * 2007-01-23 2008-08-07 Hakko Co Ltd Physical access port

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106821765A (en) * 2017-03-08 2017-06-13 杭州富善医疗器械有限公司 A kind of stomach stoma and the fixed pad for stomach stoma
CN106821765B (en) * 2017-03-08 2023-11-03 杭州富善医疗器械有限公司 Gastrostomy tube and fixing pad for gastrostomy tube

Also Published As

Publication number Publication date
JP5229029B2 (en) 2013-07-03

Similar Documents

Publication Publication Date Title
JP4599170B2 (en) Catheter with integral part
JP4539976B2 (en) Medical catheter assembly
JP4444209B2 (en) Fistula catheter kit
JP6515084B2 (en) catheter
JP4524243B2 (en) Fistula catheter kit
US7833202B2 (en) Method of gastrostomy, and an infection preventive cover, or catheter kit, and a gastrostomy catheter
KR100828483B1 (en) Esophagus stoma button
US20140066905A1 (en) Catheter Grip and Catheter Assembly
EP1653907A1 (en) Catheter having a balloon member recessedly attached thereto
JP2006507894A (en) Catheter having a balloon portion mounted inverted
JP4119904B2 (en) Medical catheter fixture
JP2010158486A (en) Gastric fistula catheter
JP6094207B2 (en) Gastrostomy catheter
JP5229029B2 (en) Fistula catheter
JP2009225895A (en) Fistula catheter
JP2003180840A (en) Infection-preventing gastrostomy kit
JP2001346887A (en) Esophageal fistula button
JP2009225998A (en) Connector
JP4021421B2 (en) Body access port
JP5018522B2 (en) Method for preparing insertion of indwelling catheter kit for fistula and indwelling catheter kit for fistula
JPH0539704Y2 (en)
JP4527083B2 (en) Esophageal bowl button
JP2003275324A (en) Infection-preventive gastrostomy kit
JP2012249934A (en) Balloon type fistula catheter
JP5758761B2 (en) Fistula catheter

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20111121

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20130205

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20130219

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20130304

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20160329

Year of fee payment: 3

R150 Certificate of patent or registration of utility model

Ref document number: 5229029

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

Free format text: JAPANESE INTERMEDIATE CODE: R150

LAPS Cancellation because of no payment of annual fees