JP6019608B2 - Medical tube fixture - Google Patents

Medical tube fixture Download PDF

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JP6019608B2
JP6019608B2 JP2012031196A JP2012031196A JP6019608B2 JP 6019608 B2 JP6019608 B2 JP 6019608B2 JP 2012031196 A JP2012031196 A JP 2012031196A JP 2012031196 A JP2012031196 A JP 2012031196A JP 6019608 B2 JP6019608 B2 JP 6019608B2
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holding member
clip
lumen
arm
tube
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JP2012187395A (en
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小池 紀夫
紀夫 小池
松田 裕介
裕介 松田
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Nipro Corp
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0266Holding devices, e.g. on the body using pads, patches, tapes or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0286Holding devices, e.g. on the body anchored in the skin by suture or other skin penetrating devices

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Media Introduction/Drainage Providing Device (AREA)

Description

本発明は、カテーテルや輸液、透析回路用などの医療用チューブを、身体や点滴架台、ベット、医療機器などの固定部に固定するための医療用チューブ固定具に関する。   The present invention relates to a medical tube fixture for fixing a medical tube such as a catheter, an infusion solution, or a dialysis circuit to a fixing portion of a body, a drip stand, a bed, a medical device, or the like.

体内に導入されたカテーテルなどの医療用チューブの体外部を、皮膚や医療機器などの固定部に固定する手段として、チューブと固定部とを縫合糸により縛って固定するものや、チューブに取り付けられたカフを皮下組織と癒着させるものがあるが、チューブに対する固定力が小さかったり、操作の煩雑性があり、またチューブの破損の可能性、固定後のチューブの位置調整などの問題がある。これらの問題解決のために、たとえば特許文献1,2のカテーテル固定具が使用されている。   As a means to fix the external body of a medical tube such as a catheter introduced into the body to a fixing part such as skin or medical equipment, the tube and the fixing part are fixed by tying with a suture thread, or attached to the tube. However, there are problems in that the fixing force to the tube is small, the operation is complicated, the tube may be damaged, and the position of the tube after fixing is adjusted. In order to solve these problems, for example, the catheter fixtures of Patent Documents 1 and 2 are used.

特許文献1は、カテーテルが挿入されるホルダ部の底部から両側にそれぞれ翼形部を延設するとともに、ホルダ部の底部にスリットを軸心方向に形成し、ホルダ部に外嵌するC形のばね部材によりホルダ部を加圧してカテーテルを把持する金属製クリップを設けたものである。   Patent Document 1 discloses a C-shaped configuration in which an airfoil portion is extended on both sides from a bottom portion of a holder portion into which a catheter is inserted, a slit is formed in an axial direction on the bottom portion of the holder portion, and is fitted around the holder portion. A metal clip for holding the catheter by pressing the holder portion with a spring member is provided.

特許文献2は、カテーテルが挿入される筒状部の底部から両側にそれぞれ翼形部を延設するとともに、筒状部の上部にスリットを軸心方向に形成し、長手方向に開口部が形成されて筒状部に外嵌めされる内腔部を有するカバー部を設けたものである。   In Patent Document 2, an airfoil portion is extended on both sides from the bottom portion of the tubular portion into which the catheter is inserted, a slit is formed in the axial direction on the upper portion of the tubular portion, and an opening portion is formed in the longitudinal direction. A cover portion having a lumen portion that is externally fitted to the cylindrical portion is provided.

特許第3747330号公報Japanese Patent No. 3747330 特開2003−154012号公報Japanese Patent Laid-Open No. 2003-154012

しかし、特許文献1では金属製クリップを使用することから、医療検査で汎用されているX線やMRI、CT検査時に金属製クリップを取り外す必要があるという問題点があった。   However, in Patent Document 1, since a metal clip is used, there is a problem that it is necessary to remove the metal clip at the time of X-ray, MRI, or CT inspection that is widely used in medical examinations.

また特許文献2では、カバー部により筒状部を介してカテーテルを把持するため、カテーテルの固定力が十分に得られないこと、固定後にカテーテルを移動させる場合、カバー部の取り外しが容易でないことなどの問題点があった。   Further, in Patent Document 2, since the catheter is gripped by the cover portion via the cylindrical portion, the catheter cannot be sufficiently fixed, and when the catheter is moved after fixation, the cover portion is not easy to remove. There was a problem.

本発明は上記問題点を解決して、医療検査時の取り外しも不要で、チューブに対する十分な固定力が得られ、チューブの位置調整時にクリップの取り外しも容易な医療用チューブ固定具を提供することを目的とする。   The present invention solves the above-described problems, and provides a medical tube fixture that does not require removal during a medical examination, provides a sufficient fixing force to the tube, and allows easy clip removal when adjusting the position of the tube. With the goal.

請求項1記載の発明は、チューブを保持する保持部材と、当該保持部材を介してチューブを把持可能な樹脂製のクリップとを具備し、
前記保持部材が前記クリップより低硬度な樹脂により形成されるとともに、当該保持部材に、チューブが嵌合される内腔を有するホルダ部と、当該ホルダ部の底部からそれぞれ両側に伸びる翼形部と、前記ホルダ部の底部に内腔軸心方向に形成されて内腔に連通するスリットとを設け、
前記クリップに、C形断面に形成されて前記ホルダ部を包囲し開口端に形成された加圧部により、ホルダ部と翼形部との間のネック部を把持してチューブを固定可能な嵌合体と、前記加圧部からそれぞれ側方に伸びるアーム部と、前記アーム部に所定範囲で上下方向に揺動自在に支持され前記加圧部を前記アーム部を介して開放可能な拡開翼とを設け、
前記ネック部に受圧溝を内腔軸心方向に形成し、
前記加圧部に、前記受圧溝に喰い込む突起を突設したものである。
The invention of claim 1 comprises a holding member that holds the tube, and a resin clip that can hold the tube via the holding member,
The holding member is formed of a resin having a hardness lower than that of the clip, and the holding member has a holder portion having a lumen into which a tube is fitted, and an airfoil portion extending from the bottom portion of the holder portion to both sides, respectively. The bottom of the holder portion is provided with a slit formed in the axial direction of the lumen and communicating with the lumen;
A fitting that can fix the tube by gripping the neck part between the holder part and the airfoil part by the pressurization part that is formed in a C-shaped cross section and surrounds the holder part and formed at the open end. A combined wing, an arm part extending laterally from the pressurizing part, and an expansion blade supported by the arm part so as to be swingable in a vertical direction within a predetermined range and capable of opening the pressurizing part via the arm part And
Forming a pressure receiving groove in the neck portion in the axial direction of the lumen;
A protrusion that bites into the pressure receiving groove protrudes from the pressurizing portion.

請求項2記載の発明は、請求項1記載の構成において、
突起は、内腔軸心と直角方向の頂辺を有する鋭角状に形成され、複数個が内腔軸心方向に所定間隔をあけて配置されたものである。
The invention according to claim 2 is the configuration according to claim 1,
Protrusions are formed at an acute angle shape having a lumen axial direction perpendicular to the top side, in which are arranged at predetermined intervals in the plurality the inner腔軸center direction.

請求項3記載の発明は、請求項1記載の構成において,
突起は、先端部に内腔軸心方向に沿う頂辺を有する鋭角状で、単数または内腔軸心方向に所定間隔をあけて配置された複数個からなるものである。
The invention according to claim 3 is the structure according to claim 1,
Projections, at an acute angle with the top edge along the inner lumen axially to the distal end portion, is made of a plurality which are arranged at a predetermined interval in one or lumen axial direction.

請求項4記載の発明は、請求項1乃至3のいずれかに記載の構成において、
拡開翼は、前記アーム部に、翼形部上に当接する下方傾斜限と、上方に持ち上げられた上方傾斜限との間で、内腔軸心に平行なピンを介して回動自在に取り付けられたものである。
The invention according to claim 4 is the configuration according to any one of claims 1 to 3,
The spreading wing is rotatable on the arm part between a lower inclination limit that abuts on the airfoil part and an upper inclination limit that is lifted upward via a pin parallel to the lumen axis. It is attached.

請求項5記載の発明は、請求項1乃至4のいずれかに記載の構成において、The invention according to claim 5 is the configuration according to any one of claims 1 to 4,
拡開翼に、連結索を介して少なくとも保持部材に連結する連結用穴を形成したものである。  The expansion wing is formed with a connection hole that is connected to at least the holding member via a connection cable.

請求項6記載の発明は、請求項1乃至5のいずれかに記載の構成において、The invention according to claim 6 is the configuration according to any one of claims 1 to 5,
加圧部から側部外方に形成されたアーム部のアーム長さに対して、当該アーム部から外側に伸びる拡開翼の長さの比を、1.0以上、2.2以下としたものである。  The ratio of the length of the expanding blade extending outward from the arm portion to the arm length of the arm portion formed on the outer side of the pressurizing portion is set to 1.0 or more and 2.2 or less. Is.

請求項1記載の発明によれば、樹脂製の保持部材と樹脂製のクリップにより構成されるので、X線やMRI、CT検査時の取り外しも不要となる。また保持部材のホルダ部を包囲する嵌合体の加圧部に、保持部材のネック部に喰い込む突起を設けたので、突起を利用して嵌合体の加圧力を加圧部からホルダ部に効果的に伝達し、保持部材の内腔とチューブとの摩擦力を増大させてチューブを確実に固定することができ、また患者の体動や固定用テープの剥がし動作に対して、十分なグリップ力が得られ、保持部材からクリップが外れるの未然に防止することができる。さらに加圧部の両側部に設けられた拡開翼を、指で抓んで加圧部を拡開することにより、クリップを保持部材から容易に離脱させることができ、位置調整のためのチューブの移動を容易に行うことができる。
またネック部に、突起が嵌合する受圧溝を形成したので、保持部材に対するクリップのグリップ力を増大させることができ、体動や接触によるクリップの離脱を未然に防止することができる。
According to the first aspect of the present invention, since it is constituted by the resin-made holding member and the resin-made clip, it is not necessary to remove at the time of X-ray, MRI, or CT inspection. Moreover, since the protrusion which bites into the neck part of the holding member is provided in the pressurizing part of the fitting body that surrounds the holder part of the holding member, the pressing force of the fitting body is effectively applied from the pressing part to the holder part using the protrusion. The tube can be securely fixed by increasing the friction force between the lumen of the holding member and the tube, and sufficient grip force can be obtained for patient movement and peeling of the fixing tape. And the clip can be prevented from coming off from the holding member. In addition, the clip can be easily detached from the holding member by pinching the expanding blades provided on both sides of the pressing unit with fingers to expand the pressing unit. It can be easily moved.
Further, since the pressure receiving groove into which the protrusion is fitted is formed in the neck portion, the grip force of the clip with respect to the holding member can be increased, and the clip can be prevented from being detached due to body movement or contact.

請求項2および3記載の発明によれば、加圧部に、頂辺を有する複数の突起を所定間隔をあけて複数個配置したので、加圧力を各突起の頂辺周りでそれぞれ集中させることにより、保持部材の内腔とチューブとの摩擦力を効果的に増大させて、チューブを確実に把持し固定することができる。   According to the second and third aspects of the present invention, since the plurality of protrusions having apexes are arranged at predetermined intervals in the pressurizing portion, the applied pressure is concentrated around the apex of each protrusion. Thus, the frictional force between the lumen of the holding member and the tube can be effectively increased, and the tube can be reliably gripped and fixed.

請求項4記載の発明によれば、上方傾斜限で左右の拡開翼を指で抓んで加圧部を開き、クリップを保持部材から離脱させる。また、下方傾斜限で拡開翼を保持部材の翼形部上に重なるように密着させて隙間を少なくし、感染リスクを小さくするとともに、チューブ固定具を減容化することができ、チューブ固定具上に保護用テープを貼着してコンパクトに取り付け、使用することができる。 According to the fourth aspect of the present invention , the right and left spreading blades are pinched with fingers at the upper inclination limit to open the pressing portion, and the clip is detached from the holding member. In addition, the spreader blade is closely attached to the airfoil of the holding member at the lower inclination limit to reduce the gap, reduce the risk of infection, and reduce the volume of the tube fixing tool. A protective tape can be affixed on a tool and used compactly.

請求項5記載の発明によれば、拡開翼に形成した連結穴を使用して、連結索によりクリップと保持部材とを連結することができ、保持部材からクリップを分離した時に、クリップが落下して紛失するのを防止することができる。 According to the fifth aspect of the present invention, the clip and the holding member can be connected by the connecting rope using the connecting hole formed in the spreading blade, and the clip is dropped when the clip is separated from the holding member. Can be prevented from being lost.

請求項6記載の発明によれば、アーム部のアーム長さに対する拡開翼の長さを、1.0以上、2.2以下とすることにより、操作性がよく、嵩張ることなく誤って離脱させるおそれが無い装着性に優れた医療用チューブ固定具を提供することができる。 According to the sixth aspect of the present invention, the length of the expanding blade with respect to the arm length of the arm portion is set to 1.0 or more and 2.2 or less, so that the operability is good and it is accidentally detached without being bulky. Therefore, it is possible to provide a medical tube fixture that is excellent in wearability and can be prevented from being damaged.

本発明に係る医療用チューブ固定具の実施例を示し、クリップの底面側斜視図である。It is a bottom side perspective view of a clip, showing an embodiment of a medical tube fixture according to the present invention. 医療用チューブ固定具の分解斜視図である。It is a disassembled perspective view of a medical tube fixing tool. 医療用チューブ固定具の取り付け状態を示す斜視図である。It is a perspective view which shows the attachment state of a medical tube fixing tool. 医療用チューブ固定具の取り付け状態を示す全体平面図である。It is a whole top view which shows the attachment state of a medical tube fixing tool. 医療用チューブ固定具の分解状態を示す正面視の部分断面図である。It is a fragmentary sectional view of the front view which shows the decomposition | disassembly state of a medical tube fixing tool. クリップの平面図である。It is a top view of a clip. クリップの底面図である。It is a bottom view of a clip. 医療用チューブ固定具の装着状態を示す正面視の断面図である。It is sectional drawing of the front view which shows the mounting state of a medical tube fixing tool. (a)〜(c)は突起の種類を示す斜視図で、(a)はこの実施例のもの、(b)は変形例、(c)は他の実施例を示す。(A)-(c) is a perspective view which shows the kind of protrusion, (a) is a thing of this Example, (b) is a modification, (c) shows another Example. (a)および(b)は保持部材に対するクリップのグリップ力を増加させる他の構造を有する他の実施例1,2を示し、(a)は他の実施例1を示す分解状態の正面図、(b)は他の実施例2を示す分解状態の正面図である。(A) And (b) shows the other Examples 1 and 2 which have the other structure which increases the grip force of the clip with respect to a holding member, (a) is the front view of the decomposition | disassembly state which shows the other Example 1, (B) is the front view of the decomposition | disassembly state which shows other Example 2. FIG. 実験に使用した金属製クリップの斜視図である。It is a perspective view of the metal clip used for experiment. (a)および(b)は保持部材の他の実施例を示し、(a)は側面図、(b)は斜視図である。(A) And (b) shows the other Example of a holding member, (a) is a side view, (b) is a perspective view. (a)〜(c)はクリップの他の実施例を示し、(a)は平面図、(b)は底面図、(c)は(a)に示すA−A断面図である。(A)-(c) shows the other Example of a clip, (a) is a top view, (b) is a bottom view, (c) is AA sectional drawing shown to (a). (a)および(b)は他の実施例の保持部材とクリップの使用状態を示す斜視図で、(a)はクリップ装着前、(b)はクリップ装着後を示す。(A) And (b) is a perspective view which shows the use state of the holding member and clip of another Example, (a) is before clip mounting | wearing, (b) shows after clip mounting | wearing.

[実施例1]
以下、本発明の実施例を図面に基づいて説明する。
図1〜図4は、本発明に係るチューブ固定具10が使用されたカテーテルの一例を示すもので、カテーテル本体(チューブ)1は先端部から一定範囲が体内に挿入されており、チューブ固定具10は、カテーテル本体1で体外に位置する体外部に外嵌めされた保持部材11と、この保持部材11に離脱可能に装着されたクリップ21とで構成されている。
[Example 1]
Embodiments of the present invention will be described below with reference to the drawings.
1 to 4 show an example of a catheter in which a tube fixture 10 according to the present invention is used. A catheter body (tube) 1 is inserted into a body within a certain range from a distal end portion. Reference numeral 10 denotes a holding member 11 that is externally fitted to the outside of the body of the catheter body 1 and a clip 21 that is detachably attached to the holding member 11.

[保持部材]
このチューブ固定具10の保持部材11は、クリップ21より低硬度の樹脂材料により成形されている。ここで好ましくは、保持部材11がカテーテル本体1よりも低硬度な樹脂により形成されているほうがよく、これにより、保持部材11の取扱いの容易性が向上されるからである。この保持部材11は、図1,図2に示すように、カテーテル本体1が挿入される円形断面の内腔12aを有する円筒状のホルダ部12と、このホルダ部12の底部(人体に取り付けるときに皮膚に接触する部分)から両側方に向けて形成された一対の平板状の翼形部13とを一体に具備している。翼形部13は、例えば、ホルダ部12側で柔軟性を確保する薄肉部13aに、段部を介して強度を確保する厚肉部13bが形成され、厚肉部13bの中央部に、この保持部材11を縫合糸で人体の皮膚や固定部に縛り付けるための穴部14が形成されている(図3参照)。またホルダ部12の底部で、左右の翼形部13の付け根に、内腔12aに連通する所定幅のスリット15が内腔12aの軸心(内腔軸心)O方向に沿って形成されている。このため保持部材11は、スリット15を広げることによって、ホルダ部12を底部からカテーテル本体1に被せることができる。保持部材11の内腔12aの内径は、カテーテル本体1に容易に取り付けられ、かつ必要に応じてカテーテル本体1を回転方向、進退方向に容易に移動でき、またクリップ21を装着した状態ではカテーテル本体1が勝手に動かない大きさであればよい。具体的には、装着するカテーテル本体1の外径とほぼ同じ若しくはそれ以下の大きさであることが好ましい。
[Holding member]
The holding member 11 of the tube fixture 10 is formed of a resin material having a lower hardness than the clip 21. Here, it is preferable that the holding member 11 is made of a resin having a lower hardness than that of the catheter body 1, and this facilitates handling of the holding member 11. As shown in FIGS. 1 and 2, the holding member 11 includes a cylindrical holder portion 12 having a circular cross-section lumen 12a into which the catheter body 1 is inserted, and a bottom portion of the holder portion 12 (when attached to a human body). And a pair of flat airfoils 13 formed from both sides to the sides. The airfoil portion 13 is formed, for example, on a thin portion 13a that secures flexibility on the holder portion 12 side, and a thick portion 13b that secures strength through a stepped portion, and this central portion of the thick portion 13b A hole portion 14 is formed for binding the holding member 11 to the human skin or fixing portion with a suture (see FIG. 3). A slit 15 having a predetermined width communicating with the lumen 12a is formed at the bottom of the holder portion 12 at the base of the left and right airfoil portions 13 along the axial direction ( lumen axis ) O of the lumen 12a. Yes. For this reason, the holding member 11 can cover the catheter body 1 from the bottom portion by widening the slit 15. The inner diameter of the lumen 12a of the holding member 11 can be easily attached to the catheter body 1 and can be easily moved in the rotational direction and the forward / backward direction as required, and when the clip 21 is attached, the catheter body It is sufficient if 1 is a size that does not move freely. Specifically, it is preferable that the size is substantially the same as or smaller than the outer diameter of the catheter body 1 to be mounted.

翼形部13とホルダ部12との間のネック部16に、クリップ21によりカテーテル本体1を把持するとともに、クリップ21を外れ止めするための受圧溝17が内腔12aの軸心O方向に沿って形成されていることが好ましい。これら受圧溝17は角型断面で、底部が互いに平行な平坦面に形成されていることが好ましい。   The neck portion 16 between the airfoil portion 13 and the holder portion 12 holds the catheter body 1 with the clip 21 and a pressure receiving groove 17 for preventing the clip 21 from coming off along the direction of the axis O of the lumen 12a. It is preferable to be formed. These pressure receiving grooves 17 preferably have a square cross section and are formed on flat surfaces whose bottoms are parallel to each other.

またホルダ部12は、例えば、クリップ21が外嵌される円筒状の本体部12bと、この本体部12bの前方部および後方部で端部ほど縮径されたテーパ部12f,12rが形成され、これらテーパ部12f,12rの外周部に、本体部12bに装着されるクリップ21を位置決めするための鍔部18f,18rがそれぞれ形成されている。またホルダ部12の端部に、掛止穴19aが形成された掛止片19が突設されている。   In addition, the holder portion 12 is formed with, for example, a cylindrical main body portion 12b on which the clip 21 is fitted, and tapered portions 12f and 12r whose diameters are reduced toward the ends at the front and rear portions of the main body portion 12b. On the outer peripheral portions of the tapered portions 12f and 12r, flange portions 18f and 18r for positioning the clip 21 attached to the main body portion 12b are formed, respectively. In addition, a latching piece 19 having a latching hole 19 a is provided at the end of the holder 12.

この保持部材11の材質として、カテーテル本体1と密着し皮膚に接触しても抵抗感の少ない材質であるところの、常温付近でゴム弾性を有する軟質の高分子エラストマーが好ましい。また保持部材11には、常温付近でゴム弾性を有する他の合成高分子材料や天然ゴムなどの天然高分子材料も使用することができる。   The material of the holding member 11 is preferably a soft polymer elastomer having rubber elasticity near room temperature, which is a material that is in close contact with the catheter body 1 and has little resistance to contact with the skin. The holding member 11 can also be made of other synthetic polymer materials having rubber elasticity near normal temperature or natural polymer materials such as natural rubber.

[クリップ]
図2,図3には、カテーテル本体1が挿入された保持部材11と、この保持部材11に装着されるクリップ21が示されている。このクリップ21は、保持部材11のホルダ部12を把持して加圧しカテーテル本体1を固定可能な強度が必要なことから、材質として保持部材11よりも硬質の樹脂、たとえばポリアセタールやポリプロピレンなどが使用される。
[clip]
2 and 3 show a holding member 11 into which the catheter body 1 is inserted, and a clip 21 attached to the holding member 11. Since the clip 21 needs to be strong enough to hold and press the holder portion 12 of the holding member 11 and fix the catheter body 1, a material harder than the holding member 11, such as polyacetal or polypropylene, is used as the material. Is done.

クリップ21は、ホルダ部12を包囲するC形断面の嵌合体22と、この嵌合体22の開口端でネック部16に圧接する加圧部23と、これら加圧部23からそれぞれ両側方に伸びるアーム部24と、左右のアーム部24にそれぞれ取り付けられ「てこの原理」により嵌合体22の加圧部23を拡開してクリップ21を保持部材11から離脱可能な拡開翼25とを具備している。   The clip 21 has a C-shaped cross-section fitting body 22 that surrounds the holder portion 12, a pressure portion 23 that presses against the neck portion 16 at the opening end of the fitting body 22, and extends from the pressure portion 23 to both sides. Arm portions 24, and expansion blades 25 that are attached to the left and right arm portions 24, respectively, and are capable of expanding the pressurizing portion 23 of the fitting body 22 and separating the clip 21 from the holding member 11 according to the “lever principle”. doing.

加圧部23は、図1,図7,図9(a)に示すように、嵌合体22の開口部で軸心O方向に沿う平坦面23aに、軸心O方向に離間距離Lをあけて複数、たとえば3個の突起26が互いに対向して突設されている。これら突起26により、嵌合体22が押し広げられた時の弾性を利用した復元力により、受圧溝17の底面に3個の突起26が喰い込み、ネック部16を介してカテーテル本体1周囲を加圧し内腔12aとカテーテル本体1との摩擦力を増大させることにより、カテーテル本体1を把持固定することができる。   As shown in FIGS. 1, 7, and 9 (a), the pressurizing unit 23 opens a separation distance L in the axial center O direction on the flat surface 23 a along the axial center O direction at the opening of the fitting body 22. A plurality of, for example, three protrusions 26 are provided so as to face each other. With these protrusions 26, the three protrusions 26 bite into the bottom surface of the pressure receiving groove 17 by the restoring force using elasticity when the fitting body 22 is pushed and spread, and the circumference of the catheter body 1 is added via the neck portion 16. By increasing the frictional force between the pressing lumen 12a and the catheter body 1, the catheter body 1 can be grasped and fixed.

突起26の形状は、底面視で突出高さHの三角形状で、鋭角であることが好ましく、頂辺26aが軸心Oと直交する垂直方向となる三角柱形に形成されている。ここでこれら突起26が、四角錐や三角錐などの錐状に形成されていないのは、錐状では突起26の強度が低下して破損しやすいとともに、頂点にのみ加圧力が集中してしまい、カテーテル本体1を包囲した状態で強固な把持力が発生しにくいためである。   The shape of the protrusion 26 is a triangular shape with a protrusion height H as viewed from the bottom, and is preferably an acute angle, and is formed in a triangular prism shape in which the top side 26 a is perpendicular to the axis O. Here, these protrusions 26 are not formed in a pyramid shape such as a quadrangular pyramid or a triangular pyramid. In the conical shape, the strength of the protrusions 26 is reduced and easily damaged, and the pressure is concentrated only on the apex. This is because a strong gripping force is hardly generated in a state in which the catheter body 1 is surrounded.

ここで突起26の突出高さHは、カテーテル本体1の外径D(mm)に対して0.15×D以上で、0.23×D以下にて、好ましく形成される。これは、突起26の突出高さHが0.15×D未満では、保持部材11への喰い込みが浅くなって加圧力も小さくなり、またクリップ21がはずれやすくなる場合があるためである。また突起26の突出高さHが0.23×Dを超えると、クリップ21を離脱させる際にクリップ21を拡開する量が増大して操作性が低下する場合があるためである。たとえば外径が3.3mmのカテーテル本体1では、突起26の突出高さHが約0.50〜0.76mmが好ましく、外径が4.3mmのカテーテル本体1では、突起26の突出高さHが約0.65〜1.00mmが好ましい。   Here, the protrusion height H of the protrusion 26 is preferably 0.15 × D or more and 0.23 × D or less with respect to the outer diameter D (mm) of the catheter body 1. This is because when the protrusion height H of the protrusion 26 is less than 0.15 × D, the biting into the holding member 11 becomes shallow, the applied pressure becomes small, and the clip 21 may easily come off. Further, when the protrusion height H of the protrusion 26 exceeds 0.23 × D, when the clip 21 is released, the amount that the clip 21 is expanded increases and the operability may be lowered. For example, in the catheter body 1 having an outer diameter of 3.3 mm, the protrusion height H of the protrusion 26 is preferably about 0.50 to 0.76 mm, and in the catheter body 1 having an outer diameter of 4.3 mm, the protrusion height of the protrusion 26 is. H is preferably about 0.65 to 1.00 mm.

またこれら突起26は、例えば、等しい離間距離Lをあけて複数個が配置されているが、ネック部16の長さがたとえば10mmである場合、10mmに対して2個または3個が好ましい。これは突起26が1個以下では、喰い込みによる加圧力が小さくなるためであり、また突起26が4個を超えると、喰い込む力が分散されて均等化され、全体として把持力が減少されるからである。もちろん、嵌合体22の長さが10mm超えた場合には、突起26の個数を増加させればよい。   For example, a plurality of the protrusions 26 are arranged with an equal separation distance L. When the length of the neck portion 16 is 10 mm, for example, two or three are preferable for 10 mm. This is because when the number of the protrusions 26 is 1 or less, the pressure applied by the biting becomes small, and when the number of the protrusions 26 exceeds 4, the biting force is dispersed and equalized, and the gripping force is reduced as a whole. This is because that. Of course, when the length of the fitting body 22 exceeds 10 mm, the number of the protrusions 26 may be increased.

[突起の変形例]
さらに突起26に垂直方向の頂辺26aを形成したが、図9(b)に示すように、頂辺27aが軸心Oと平行な水平方向の三角柱形の突起27であっても、同様の把持力を発揮することができる。
[Modification of protrusion]
Further, although the vertical apex 26a is formed on the projection 26, the same applies even if the apex 27a is a horizontal triangular prism-shaped projection 27 parallel to the axis O as shown in FIG. A gripping force can be exhibited.

さらに図9(c)に示すように、頂辺28aが水平方向に一直線に連続する三角柱形の突起(突条)28では、喰い込みによる加圧力が幾分低下するものの、後述するように、保持部材11に対するクリップ21のグリップ力が極めて高くなるため、この突起(突条)28を加圧部23に形成する構造も有効である。   Furthermore, as shown in FIG. 9 (c), in the triangular prism-shaped protrusion (projection) 28 in which the top side 28a is continuous in a straight line in the horizontal direction, although the pressurizing force due to biting is somewhat reduced, as described later, Since the gripping force of the clip 21 with respect to the holding member 11 becomes extremely high, a structure in which the protrusion (projection) 28 is formed in the pressing portion 23 is also effective.

なお、各突起26〜28を先尖りの頂辺26a〜28aとしたが、頂辺26aを角丸形に形成しても、喰い込み力が少し低下するものの、効果的にグリップ力を発揮することができる。   In addition, although each protrusion 26-28 was made into the pointed apex side 26a-28a, even if it forms the apex side 26a in a rounded round shape, although a biting force will fall a little, it will exhibit grip power effectively. be able to.

(拡開翼)
嵌合体22の開口端から側部外方に伸びるアーム部24には、軸心Oに平行な前後一対のピン24bを介して拡開翼25を所定範囲で上下方向に揺動自在に支持するヒンジ29が設けられている。このヒンジ29は、アーム部24から外方に突出された前後一対の支持片24aにピン24bが前後外方にそれぞれ突設され、拡開翼25の基端側に突設された前後一対の被支持片25aの穴部にピン24bが回動自在に嵌合されている。そして、被支持片25aの下面がアーム部24に当接する位置が、拡開翼25の下方傾斜限となり、また被支持片25a間に設けられた加圧伝達部25bがアーム部24の受圧部24cに当接する位置が拡開翼25の上方傾斜限となる。これにより、拡開翼25がピン24bを中心に翼形部13上に重ねることができる下方傾斜限の下傾姿勢(図5の仮想線)と、上方に持ち上げられた上方傾斜限の上傾姿勢(図5の実線)の間で、上下回動角θu+θdの範囲で回動自在となっている。ここで図示された下回動角θdは60°で、この下回動角θdは、腕などの湾曲取付部にチューブ固定具10を取り付けた場合、皮膚に沿って湾曲する保持部材11の翼形部13に重なるようにするためである。これは、クリップ21によりカテーテル本体1を固定した後に、身体が引っ掛かって外れるのを防止するために保護用テープを貼着するが、拡開翼25と翼形部13との間に隙間があると、チューブ固定具10が嵩高くなって引っ掛けやすくなるとともに、空間部を介在する感染リスクが高くなるため、拡開翼25と翼形部13とを接するほうがより安全となるためである。また図示された上回動角θuは50°であるが、これは親指と人差し指で左右の拡開翼25を抓んで嵌合体22の加圧部23を拡開するためであり、指を閉じる力が入りやすく、十分な拡開角度が得られるのが好ましく、またホルダ部12からの離脱が可能な突起26間の間隔が得られる角度であればよい。
(Expanded wing)
The arm 24 that extends outward from the opening end of the fitting body 22 supports the expanding blade 25 in a predetermined range so as to be swingable in a vertical direction via a pair of front and rear pins 24b parallel to the axis O. A hinge 29 is provided. The hinge 29 has a pair of front and rear support pieces 24 a that protrude outward from the arm portion 24, and pins 24 b that protrude from the front and rear sides, respectively. A pin 24b is rotatably fitted in the hole of the supported piece 25a. The position where the lower surface of the supported piece 25a contacts the arm portion 24 is the downward inclination limit of the expanding blade 25, and the pressure transmission portion 25b provided between the supported pieces 25a is the pressure receiving portion of the arm portion 24. The position in contact with 24c is the upper inclination limit of the expanding blade 25. Thereby, the downward inclination posture (imaginary line in FIG. 5) in which the spreading blade 25 can be superimposed on the airfoil portion 13 around the pin 24b, and the upward inclination of the upward inclination limit lifted upward. Between the postures (solid line in FIG. 5), it is freely rotatable within the range of the vertical rotation angle θu + θd. The downward rotation angle θd shown here is 60 °, and this downward rotation angle θd is the wing of the holding member 11 that curves along the skin when the tube fixture 10 is attached to a curved attachment portion such as an arm. This is to overlap the shape portion 13. This is because, after the catheter body 1 is fixed by the clip 21, a protective tape is attached to prevent the body from being caught and removed, but there is a gap between the expanding blade 25 and the airfoil portion 13. This is because the tube fixture 10 becomes bulky and easily hooked, and the risk of infection through the space increases, so that it is safer to contact the spreader blade 25 and the airfoil portion 13. Further, the upper rotation angle θu shown in the figure is 50 °, which is to spread the pressurizing portion 23 of the fitting 22 by sandwiching the left and right expanding blades 25 with the thumb and forefinger, and closes the finger. It is preferable that a force is easily applied and a sufficiently widening angle is obtained, and any angle may be used as long as an interval between the protrusions 26 that can be detached from the holder portion 12 is obtained.

したがって、指に拡開翼25を摘んで上方回動限まで開き、さらに指に力を加え、「てこの原理」を利用して加圧伝達部25b、受圧部24cを介して左右のアーム部24を上方に押し上げることにより、C形の嵌合体22の開口端を開くことができ、加圧部23を開放し、嵌合体22をホルダ部12に対して嵌合、離脱させることができる。   Therefore, the left and right arm portions are opened via the pressurizing transmission portion 25b and the pressure receiving portion 24c using the “leverage principle” by applying the force to the finger by picking the spreading wing 25 on the finger and opening it to the upper rotation limit. By pushing up 24, the open end of the C-shaped fitting body 22 can be opened, the pressurizing portion 23 can be opened, and the fitting body 22 can be fitted to and detached from the holder portion 12.

[実験]
ところで、これら突起26は、ネック部16又は左右の受圧溝17を挟み込んで加圧しカテーテル本体1を固定する把持力を効果的に伝達するものであるが、突起26が、ネック部16又は受圧溝17に嵌まり込み喰い込むことにより、体動や衝撃などの外因によりクリップ21が保持部材11から外れないためのグリップ力を得る目的もある。
[Experiment]
By the way, these protrusions 26 effectively transmit a gripping force for fixing the catheter body 1 by sandwiching the neck portion 16 or the left and right pressure receiving grooves 17 and pressing the neck portion 16 or the left and right pressure receiving grooves 17. There is also an object of obtaining a grip force for preventing the clip 21 from being detached from the holding member 11 due to an external cause such as body movement or impact by being fitted into the bite 17.

ここで、このグリップ力を検証した実験結果を、表1を参照して説明する。
この実験は、クリップ21の嵌合体22をホルダ部12に把持させて、ホルダ部12内のカテーテル本体1を固定し、保持部材11を接着剤により固定基台に取り付ける。そして予め嵌合体22内に通した金属ワイヤを上方に引張り、保持部材11から嵌合体22を離脱させた。この時の抜け強度(引張り力)を計測することによりグリップ力を測定した。
Here, the experimental results of verifying the grip force will be described with reference to Table 1.
In this experiment, the fitting body 22 of the clip 21 is held by the holder portion 12, the catheter body 1 in the holder portion 12 is fixed, and the holding member 11 is attached to the fixed base with an adhesive. The metal wire previously passed through the fitting body 22 was pulled upward, and the fitting body 22 was detached from the holding member 11. The grip strength was measured by measuring the pull-out strength (tensile force) at this time.

クリップ21は、タイプA(従来品、図11のCR参照)乃至タイプDまで6種類を用意し、各タイプについてそれぞれ5回実験し、離脱時の引っ張り力の平均値を求めた。また保持部材11に受圧溝17を有しないものと、受圧溝17を有するものとをそれぞれ使用し、受圧溝17の有しない保持部材11を使用した平均値1と、受圧溝17を有する保持部材11を使用した平均値2とを求めた。   Six types of clips 21 of type A (conventional product, see CR in FIG. 11) to type D were prepared, and each type was tested five times to obtain an average value of the pulling force at the time of separation. Further, the holding member 11 having the pressure receiving groove 17 and the holding member 11 having the pressure receiving groove 17 are used, and the average value 1 using the holding member 11 having no pressure receiving groove 17 and the holding member having the pressure receiving groove 17 are used. An average value 2 using 11 was determined.

Figure 0006019608
Figure 0006019608

表1によれば、タイプC−1〜3で、垂直方向の頂辺26aを有する3つの突起26が形成されたクリップ21を使用した時に、嵌合体22の肉厚が0.91mmのタイプC−2で、従来の金属製クリップCR(タイプA)よりグリップ力が高くなり、タイプBで従来の金属製クリップCR(タイプA)とほぼ同等となることがわかった。また受圧溝17を形成した保持部材11を使用した実験では、「平均値2」および「平均値2/平均値1」に示すように、従来の金属製クリップCR(タイプA)に比較して、グリップ力が大幅に向上されており、受圧溝17の有効性が確認された。   According to Table 1, when the clip 21 in which the three projections 26 having the vertical side 26a are used in types C-1 to C-3, the thickness of the fitting body 22 is 0.91 mm. -2, the grip force was higher than that of the conventional metal clip CR (type A), and the type B was found to be almost equivalent to the conventional metal clip CR (type A). Further, in the experiment using the holding member 11 in which the pressure receiving groove 17 is formed, as shown in “average value 2” and “average value 2 / average value 1”, compared with the conventional metal clip CR (type A). The grip force was greatly improved, and the effectiveness of the pressure receiving groove 17 was confirmed.

またタイプDで使用したクリップ21は、図9(c)に示すように、加圧部23の全長にわたって軸心O方向に沿う頂辺28aを有する1本の突起28を形成したものであり、受圧溝17を有しない保持部材11では、従来の金属製クリップCR(タイプA)に比較して、グリップ力が幾分減少するものの、受圧溝17を形成した保持部材11では、タイプB乃至Cに比較してきわめて大きいグリップ力が確認され、受圧溝17を有しない保持部材11の約4.5倍に達した。   Further, as shown in FIG. 9C, the clip 21 used in the type D is formed with one protrusion 28 having a top side 28a along the axis O direction over the entire length of the pressurizing portion 23. The holding member 11 that does not have the pressure receiving groove 17 has a slightly reduced gripping force as compared with the conventional metal clip CR (type A), but the holding member 11 that has the pressure receiving groove 17 has types B to C. Compared to the above, a very large gripping force was confirmed, reaching about 4.5 times that of the holding member 11 having no pressure receiving groove 17.

以上のように、受圧溝17を形成した保持部材11を使用した場合、クリップ21に対するグリップ力が大幅に増大することが確認された。
[加圧部の他の実施例]
ところで、突起26が嵌まり込む受圧溝17を形成する以外に、グリップ力を増大させる構造を考えた場合、ネック部16を平坦面とし、図10(a)に示すように、互いに対向する保持部材11の外面でネック部16寄り(近傍)に、係止溝31を軸心O方向に沿って形成し、嵌合体22の内面の対向部で加圧部近傍に、係止溝31に嵌まり込む突条部32とを対向位置に形成することにより、大きいグリップ力を得ることができる。また反対に図10(b)に示すように、ホルダ部12外面に突条部32を、嵌合体22の内面に突条部32が嵌まり込む係止溝31をそれぞれ形成してもよい。
As described above, it has been confirmed that when the holding member 11 having the pressure receiving groove 17 is used, the gripping force on the clip 21 is significantly increased.
[Other Examples of Pressurizing Section]
By the way, in addition to forming the pressure receiving groove 17 into which the protrusion 26 is fitted, when considering a structure for increasing the grip force, the neck portion 16 is a flat surface, and as shown in FIG. A locking groove 31 is formed on the outer surface of the member 11 near (near) the neck portion 16 along the axial center O direction, and is fitted in the locking groove 31 near the pressurizing portion at the opposing portion of the inner surface of the fitting body 22. A large grip force can be obtained by forming the protruding protrusion 32 at the opposite position. On the other hand, as shown in FIG. 10B, the protruding portion 32 may be formed on the outer surface of the holder portion 12, and the locking groove 31 in which the protruding portion 32 is fitted on the inner surface of the fitting body 22.

上記実施例によれば、保持部材11と樹脂製のクリップ21により構成されるので、X線やMRI、CT検査時にクリップ21の取り外しが不要となる。また保持部材11のホルダ部12を包囲する嵌合体22の加圧部23に、保持部材11のネック部16に喰い込む突起26を設けたので、突起26を利用して嵌合体22の加圧力を効果的にホルダ部12に伝達して、保持部材11の内腔12aとカテーテル本体1との摩擦力を増大させ、カテーテル本体1を確実に固定することができるとともに、患者の体動や固定用テープの剥がし動作に対してクリップ21に十分なグリップ力が得られる。さらに、加圧部23の両側部にアーム部24を介して設けられた拡開翼25を、指で抓んで加圧部23を拡開することにより、クリップ21を保持部材11から容易に離脱させることができ、カテーテル本体1の位置調整のために移動を容易に行うことができる。   According to the above embodiment, since the holding member 11 and the resin clip 21 are used, it is not necessary to remove the clip 21 at the time of X-ray, MRI, or CT inspection. In addition, since the protrusion 26 that bites into the neck portion 16 of the holding member 11 is provided in the pressurizing portion 23 of the fitting body 22 that surrounds the holder portion 12 of the holding member 11, the pressure applied to the fitting body 22 using the protrusion 26. Can be effectively transmitted to the holder portion 12 to increase the frictional force between the lumen 12a of the holding member 11 and the catheter body 1, and the catheter body 1 can be securely fixed, and the patient's body movement and fixation can be fixed. A sufficient grip force can be obtained for the clip 21 with respect to the peeling operation of the tape. Furthermore, the clip 21 can be easily detached from the holding member 11 by spreading the pressure-applying portion 23 by holding the expanding blades 25 provided on both sides of the pressure-applying portion 23 via the arm portion 24 with fingers. And can be moved easily for adjusting the position of the catheter body 1.

また加圧部23に、頂辺26aを有する複数の突起26を所定間隔をあけて複数個配置したので、加圧力を各突起26の頂辺26a周りでそれぞれ集中させることができ、ホルダ部12の内腔12aとカテーテル本体1との摩擦力を効果的に増大させて、カテーテル本体1を確実に把持し固定することができる。   Further, since a plurality of projections 26 having apex sides 26a are arranged at predetermined intervals on the pressurizing unit 23, the applied pressure can be concentrated around the apex sides 26a of the respective projections 26, and the holder unit 12 can be concentrated. By effectively increasing the frictional force between the inner lumen 12a and the catheter body 1, the catheter body 1 can be securely grasped and fixed.

さらに、保持部材11のネック部16に、突起26が嵌合する受圧溝17を形成したので、保持部材11に対するクリップ21のグリップ力を増大させることができ、体動や接触によるクリップ21の離脱を未然に防止することができる。   Further, since the pressure receiving groove 17 into which the protrusion 26 is fitted is formed in the neck portion 16 of the holding member 11, the grip force of the clip 21 with respect to the holding member 11 can be increased, and the clip 21 is detached due to body movement or contact. Can be prevented in advance.

さらにまた、上傾姿勢で左右の拡開翼25を指で抓んで加圧部23を開き、嵌合体22を保持部材11から離脱させる。また下傾姿勢で保持部材11の翼形部13上に重なるように密着させて隙間を少なくし、感染リスクを小さくするとともに、チューブ固定具10を減容することができ、保護用テープなどを貼着することで、チューブ固定具10をコンパクトに取り付けて使用することができる。   Further, the left and right spreading blades 25 are pinched with fingers in the upward tilted posture to open the pressurizing unit 23, and the fitting body 22 is detached from the holding member 11. In addition, it is closely attached to the airfoil portion 13 of the holding member 11 in a downwardly inclined posture to reduce the gap, reduce the risk of infection, and reduce the volume of the tube fixture 10. By sticking, the tube fixture 10 can be compactly attached and used.

さらに、嵌合体22の内面とホルダ部12の外面に、互いに係合される係止溝31と突条部32とを軸心O方向に沿って形成することにより、保持部材11に対するクリップ21のグリップ力を増大させることができ、体動や接触によるクリップ21の離脱を未然に防止することができる。   Further, the engaging groove 31 and the protrusion 32 that are engaged with each other are formed on the inner surface of the fitting body 22 and the outer surface of the holder portion 12 along the axis O direction. The grip force can be increased, and the detachment of the clip 21 due to body movement or contact can be prevented in advance.

[保持部材の他の実施例]
図12は、保持部材の他の実施例を示し、実施例1と同一部材には同一符号を付して説明を省略する。
[Another Example of Holding Member]
FIG. 12 shows another embodiment of the holding member. The same members as those in the first embodiment are denoted by the same reference numerals, and description thereof is omitted.

この保持部材41は、カテーテル本体1の先端部ほど下位となるように翼形部13の底面13dに対して内腔12aの軸心Oが所定の傾斜角度αだけ傾斜されている。この傾斜角度αは、図12で3°で表されているが、好ましくは1°〜10°、より好ましくは1°〜5°、更に好ましくは2°〜4°に設定される。ここで傾斜角度αが1°未満であると、クリップ21による保持部分の角度と、カテーテル本体1の皮膚から体内挿入部分の角度との差から、カテーテル本体1に折れ曲がりが生じて、無理な力がかかり、カテーテル本体1に悪影響を与える恐れがある。また傾斜角度αが5°を越えると、皮膚から体内に挿入するテープなどで押さえる部分で、カテーテル本体1が折れ曲がって浮き上がり、テープの隙間からの汚染や感染を招くおそれがあるからである。   In this holding member 41, the axial center O of the lumen 12a is inclined by a predetermined inclination angle α with respect to the bottom surface 13d of the airfoil 13 so that the distal end portion of the catheter body 1 is lower. The inclination angle α is represented by 3 ° in FIG. 12, but is preferably set to 1 ° to 10 °, more preferably 1 ° to 5 °, and further preferably 2 ° to 4 °. If the inclination angle α is less than 1 °, the catheter body 1 is bent due to the difference between the angle of the holding portion by the clip 21 and the angle of the catheter body 1 from the skin to the body insertion portion. And may adversely affect the catheter body 1. In addition, when the inclination angle α exceeds 5 °, the catheter body 1 is bent and lifted at the portion pressed by the tape inserted into the body from the skin, which may cause contamination or infection from the gap between the tapes.

これにより内腔12aと同一軸心上に形成されるホルダ部12も翼形部13の底面13dに対して傾斜されており、ホルダ部12の上面に傾斜下位(カテーテル先端側)を示す矢印42が凸状に形成されている。なお、この矢印42の高さは僅かで、クリップ21のグリップ力に影響を与えるものではなく、もちろん、矢印を凹部状に形成したり、表面に印刷してもよい。   Accordingly, the holder portion 12 formed on the same axis as the lumen 12a is also inclined with respect to the bottom surface 13d of the airfoil portion 13, and an arrow 42 indicating an inclined lower side (catheter distal side) on the upper surface of the holder portion 12. Is formed in a convex shape. The height of the arrow 42 is slight and does not affect the gripping force of the clip 21. Of course, the arrow may be formed in a concave shape or printed on the surface.

また翼形部13とホルダ部12との間のネック部16に形成される受圧溝43は、上辺43aが内腔12aの軸心O方向に平行に傾斜され、下辺43bが翼形部13の底面13dに平行に形成されいる。これにより、受圧溝43が前部(カテーテル本体1の先端側)ほど幅の狭くなる側面視がテーパ状に形成されるが、これにより加圧部23の突起27による把持力が軽減されることはない。   Further, the pressure receiving groove 43 formed in the neck portion 16 between the airfoil portion 13 and the holder portion 12 has an upper side 43a inclined parallel to the direction of the axis O of the inner cavity 12a and a lower side 43b of the airfoil portion 13. It is formed parallel to the bottom surface 13d. As a result, the pressure receiving groove 43 is formed in a tapered shape in a side view in which the front portion (the distal end side of the catheter body 1) becomes narrower. This reduces the gripping force by the protrusion 27 of the pressurizing portion 23. There is no.

上記保持部材41によれば、この保持部材11をたとえばカテーテルに使用することにより、体内から導出されるカテーテル本体1を湾曲させることなくストレートな状態で保持することができる。また矢印42により、カテーテル本体1の装着方向を間違うことがない。   According to the holding member 41, by using the holding member 11 for a catheter, for example, the catheter body 1 led out from the body can be held in a straight state without being bent. The arrow 42 prevents the catheter body 1 from being attached in the wrong direction.

[クリップの他の実施例]
図13(a)〜(c)はクリップの他の実施例を示すもので、実施例1と同一部材には同一符号を付して説明を省略する。
[Other Examples of Clips]
FIGS. 13A to 13C show another embodiment of the clip, and the same members as those in Embodiment 1 are denoted by the same reference numerals and description thereof is omitted.

実施例1のクリップ21では、図5に示すように、嵌合体22の拡開端からピン24bまでのアーム部24のアーム長さAに対して、拡開翼25の長さF1を、A:F1≒1:1.2としていたが、この実施例のクリップ51の拡開翼52は、図13(c)に示すように、嵌合体22の拡開端からピン24bまでのアーム部24のアーム長さAに対して、拡開翼52の長さF2を、A:F2≒1:1.5とし、拡開翼52の長さF2を延長している。ここで、アーム部24のアーム長さAに対する拡開翼25の長さF2(F1)の適正値は、A:F2≒1:1.0〜2.2である。これは、A:F2≒1:1.0未満では、拡開するために力を必要とし操作性が悪くなるからであり、A:F2≒1:2.2を越える値とすると、嵩張るために、誤ってクリップ51を外すおそれがあり、装着性を低下させるからである。さらに、アーム部24のアーム長さAに対する拡開翼25の長さF2(F1)の好適値は、A:F2≒1:1.2〜1.8が好ましい。これにより、操作性が高く、嵩張らないコンパクトさを兼ね備えたものとなる。(実施品でカテーテル本体の外径4mmの場合、アーム長さA=5.5mmであり、拡開翼25の長さF2の適正値は、5.5〜12mmであり、好適値は、6.0〜10mmである。)
これにより、親指と人差し指(または中指)で左右の拡開翼52を挟み込み、小さい挟圧力で嵌合体22の加圧部23を広げることができ、クリップ21を保持部材41(11)のホルダ部12への着脱のための操作性を改善している。
In the clip 21 of the first embodiment, as shown in FIG. 5, the length F1 of the expanding blade 25 is set to A: with respect to the arm length A of the arm portion 24 from the expanded end of the fitting body 22 to the pin 24b. Although F1≈1: 1.2, the expanding blade 52 of the clip 51 of this embodiment has an arm of the arm portion 24 from the expanding end of the fitting 22 to the pin 24b as shown in FIG. 13 (c). With respect to the length A, the length F2 of the expanding blade 52 is set to A: F2≈1: 1.5, and the length F2 of the expanding blade 52 is extended. Here, an appropriate value of the length F2 (F1) of the spreading blade 25 with respect to the arm length A of the arm portion 24 is A: F2≈1: 1.0 to 2.2. This is because if A: F2≈1: 1.0, a force is required to expand and the operability deteriorates, and if A: F2≈1: 2.2, the value becomes bulky. In addition, there is a possibility that the clip 51 may be mistakenly removed, and the wearability is reduced. Further, the preferred value of the length F2 (F1) of the spreading blade 25 with respect to the arm length A of the arm portion 24 is preferably A: F2≈1: 1.2 to 1.8. As a result, the operability is high and the compactness is not bulky. (In the case where the outer diameter of the catheter body is 4 mm in the practical product, the arm length A is 5.5 mm, the appropriate value of the length F2 of the expanding blade 25 is 5.5 to 12 mm, and the preferred value is 6 .0 to 10 mm.)
Accordingly, the left and right spreading blades 52 can be sandwiched between the thumb and forefinger (or middle finger), and the pressurizing portion 23 of the fitting body 22 can be widened with a small clamping force, and the clip 21 is held by the holder portion of the holding member 41 (11). The operability for attaching / detaching to / from 12 is improved.

また左右の翼形部13の中央部に、連結用穴54がそれぞれ形成されている。これら連結用穴54は、図14(b)に示すように、たとえば連結索(ワンタッチクロス)53を、保持部材41(11)の掛止片19に形成された掛止穴19aと、カテーテル本体1の一方の分岐チューブ2に外嵌されたチューブクリップ3のチューブ挿通穴に通して環状に連結し、クリップ(51),21と保持部材41(11)とチューブクリップ3(カテーテル)とを自由度をもって互いに連結するためのものである。これにより、クリップ(51),21を保持部材41(11)から分離した時に、クリップ(51),21の落下や紛失を防止することができる。なお、図14(b)はクリップ(51),21の保持部材41(11)への装着前を示している。   In addition, connection holes 54 are respectively formed in the central portions of the left and right airfoil portions 13. As shown in FIG. 14 (b), these connecting holes 54 include, for example, a connecting cord (one-touch cross) 53, a hooking hole 19 a formed in the hooking piece 19 of the holding member 41 (11), and the catheter body. 1 through the tube insertion hole of the tube clip 3 fitted on one of the branch tubes 2 and connected in an annular shape, the clips (51) and 21, the holding member 41 (11) and the tube clip 3 (catheter) can be freely connected. It is for connecting with each other with a degree. Thereby, when the clips (51) and 21 are separated from the holding member 41 (11), it is possible to prevent the clips (51) and 21 from being dropped or lost. FIG. 14B shows the clips (51) and 21 before being attached to the holding member 41 (11).

O 内腔の軸心
A アーム長さ
F1,F2 拡開翼の長さ
1 カテーテル本体
10 チューブ固定具
11 保持部材
12 ホルダ部
12a 内腔
13 翼形部
14 穴部
15 スリット
16 ネック部
17 受圧溝
21 クリップ
22 嵌合体
23 加圧部
24 アーム部
25 拡開翼
29 ヒンジ
41 保持部材
43 受圧溝
51 クリップ
52 翼形部
54 連結用穴
O Axis of lumen A Arm length F1, F2 Length of expanding blade 1 Catheter body 10 Tube fixture 11 Holding member 12 Holder portion 12a Lumen 13 Airfoil portion 14 Hole portion 15 Slit 16 Neck portion 17 Pressure receiving groove 21 Clip 22 Fitting body 23 Pressure part 24 Arm part 25 Expanding blade 29 Hinge 41 Holding member 43 Pressure receiving groove 51 Clip 52 Airfoil part 54 Connection hole

Claims (6)

チューブを保持する保持部材と、当該保持部材を介してチューブを把持可能な樹脂製のクリップとを具備し、
前記保持部材が前記クリップより低硬度な樹脂により形成されるとともに、当該保持部材に、チューブが嵌合される内腔を有するホルダ部と、当該ホルダ部の底部からそれぞれ両側に伸びる翼形部と、前記ホルダ部の底部に内腔軸心方向に形成されて内腔に連通するスリットとを設け、
前記クリップに、C形断面に形成されて前記ホルダ部を包囲し開口端に形成された加圧部により、ホルダ部と翼形部との間のネック部を把持してチューブを固定可能な嵌合体と、前記加圧部からそれぞれ側方に伸びるアーム部と、前記アーム部に所定範囲で上下方向に揺動自在に支持され前記加圧部を前記アーム部を介して開放可能な拡開翼とを設け、
前記ネック部に受圧溝を内腔軸心方向に形成し、
前記加圧部に、前記受圧溝に喰い込む突起を突設した
ことを特徴とする医療用チューブ固定具。
A holding member that holds the tube, and a resin clip that can hold the tube via the holding member;
The holding member is formed of a resin having a hardness lower than that of the clip, and the holding member has a holder portion having a lumen into which a tube is fitted, and an airfoil portion extending from the bottom portion of the holder portion to both sides, respectively. The bottom of the holder portion is provided with a slit formed in the axial direction of the lumen and communicating with the lumen;
A fitting that can fix the tube by gripping the neck part between the holder part and the airfoil part by the pressurization part that is formed in a C-shaped cross section and surrounds the holder part and formed at the open end. A combined wing, an arm part extending laterally from the pressurizing part, and an expansion blade supported by the arm part so as to be swingable in a vertical direction within a predetermined range and capable of opening the pressurizing part via the arm part And
Forming a pressure receiving groove in the neck portion in the axial direction of the lumen;
A protrusion for biting into the pressure receiving groove protrudes from the pressurizing portion. A medical tube fixture.
突起は、内腔軸心と直角方向の頂辺を有する鋭角状に形成され、複数個が内腔軸心方向に所定間隔をあけて配置された
ことを特徴とする請求項1記載の医療用チューブ固定具。
2. The medical use according to claim 1, wherein the protrusions are formed in an acute angle shape having apexes perpendicular to the lumen axis, and a plurality of the protrusions are arranged at a predetermined interval in the lumen axis direction. Tube fixture.
突起は、先端部に内腔軸心方向に沿う頂辺を有する鋭角状で、単数または内腔軸心方向に所定間隔をあけて配置された複数個からなる
ことを特徴とする請求項1記載の医療用チューブ固定具。
The protrusion is formed of a single or a plurality of protrusions arranged at a predetermined interval in the lumen axis direction, having an apex along the lumen axis direction at the tip. Medical tube fixtures.
拡開翼は、前記アーム部に、翼形部上に当接する下方傾斜限と、上方に持ち上げられた上方傾斜限との間で、内腔軸心に平行なピンを介して回動自在に取り付けられた
ことを特徴とする請求項1乃至3のいずれかに記載の医療用チューブ固定具。
The spreading wing is rotatable on the arm part between a lower inclination limit that abuts on the airfoil part and an upper inclination limit that is lifted upward via a pin parallel to the lumen axis. The medical tube fixture according to any one of claims 1 to 3, wherein the medical tube fixture is attached.
拡開翼に、連結索を介して少なくとも保持部材に連結する連結用穴を形成した
ことを特徴とする請求項1乃至4のいずれかに記載の医療用チューブ固定具。
The medical tube fixture according to any one of claims 1 to 4, wherein a connecting hole that is connected to at least the holding member via a connecting rope is formed in the spreading wing.
アーム部のアーム長さに対して、当該アーム部から外側に伸びる拡開翼の長さの比を、1.0以上、2.2以下とした
ことを特徴とする請求項1乃至5いずれかに記載の医療用チューブ固定具。
The ratio of the length of the expanding blade extending outward from the arm portion to the arm length of the arm portion is set to 1.0 or more and 2.2 or less. The medical tube fixture described in 1.
JP2012031196A 2011-02-22 2012-02-16 Medical tube fixture Active JP6019608B2 (en)

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