JP2016209090A - Catheter hub, connection structure, and pressure proof inspection device - Google Patents

Catheter hub, connection structure, and pressure proof inspection device Download PDF

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JP2016209090A
JP2016209090A JP2015093068A JP2015093068A JP2016209090A JP 2016209090 A JP2016209090 A JP 2016209090A JP 2015093068 A JP2015093068 A JP 2015093068A JP 2015093068 A JP2015093068 A JP 2015093068A JP 2016209090 A JP2016209090 A JP 2016209090A
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catheter hub
connector
catheter
sealing surface
end opening
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JP6459760B2 (en
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広梓 永井
Koji Nagai
広梓 永井
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Kaneka Corp
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Abstract

PROBLEM TO BE SOLVED: To provide a catheter hub, a connection structure, and a pressure proof inspection device capable of reducing the possibility of generating shavings or fragments due to abrasion in performing pressure proof inspection of a catheter, and performing connection while keeping airtightness with the catheter.SOLUTION: A pressure proof inspection device includes a catheter hub holding part for detachably holding a catheter hub, a connector connected to the catheter hub so as to receive its proximal side capable of injecting fluid into a lumen part of a catheter, and a connector holding part for closely connecting the connector and the catheter hub by holding the catheter hub to which the connector is connected, with the catheter hub holding part. An annular sealing face formed in a step part provided over the whole circumference of the outer periphery of the catheter hub, and a sealing face of the connector provided so as to correspond to the above sealing face are brought into contact with each other when holding the catheter hub to which the connector is connected by the catheter hub holding part and the connector holding part, thereby sealing the two sealing faces.SELECTED DRAWING: Figure 1

Description

本発明は、カテーテルハブ、接続構造及び耐圧検査装置に関するものである。   The present invention relates to a catheter hub, a connection structure, and a pressure test apparatus.

近年、心筋梗塞や脳梗塞の治療において開胸・開脳して血管にバイパス処理を施すような外科的治療法とは別に、バルーンカテーテルを用いた血管内治療(IVR:Interventional Radiology)という低侵襲性型治療法が盛んに行われている。心臓や脳血管だけでなく手や足といった末梢の血管に適用されることもあり、その症例数は年々増加傾向にある。前述したバルーンカテーテルによる処置方法の一つとして、以下の流れで狭窄部を物理的に拡張治療する方法がある。その方法は、(1)狭窄部位にカテーテル先端部のバルーン部を配置、(2)カテーテル手元側のハブから流体をバルーン内に注入し加圧、(3)バルーン部拡張により狭窄部拡張という順序となる。   In recent years, in the treatment of myocardial infarction and cerebral infarction, apart from surgical treatment such as performing thoracotomy and brain opening and bypassing the blood vessel, minimally invasive treatment called intravascular treatment (IVR) using balloon catheter Sexual type treatment is actively performed. It may be applied not only to the heart and cerebral blood vessels but also to peripheral blood vessels such as hands and feet, and the number of cases is increasing year by year. As one of the treatment methods using the above-described balloon catheter, there is a method of physically expanding and treating a stenosis part according to the following flow. The method is as follows: (1) placing the balloon portion at the distal end of the catheter at the stenosis site, (2) injecting fluid into the balloon from the hub on the proximal side of the catheter, and pressurizing. It becomes.

上記治療を行う際にカテーテル手元側にあるカテーテルハブにインデフレーターを接続し、バルーン部を加圧することにより、カテーテル先端側のバルーン部の拡張を行う。印加する圧力は用途に応じてMPaオーダーにわたる。前述したカテーテルハブにおけるインデフレーターとの接続部の形状に関してはISO規格などで定める簡易な差し込みで気密性を確保することが可能なルアーテーパー方式の雌ハブであること等が薬事法承認基準により定められている。   When performing the above treatment, an indeflator is connected to the catheter hub on the proximal side of the catheter and the balloon portion is pressurized to expand the balloon portion on the distal end side of the catheter. The applied pressure is on the order of MPa depending on the application. Regarding the shape of the connecting portion with the indeflator in the catheter hub described above, it is determined by the Pharmaceutical Affairs Law approval standards that it is a luer taper type female hub that can ensure airtightness with a simple insertion determined by ISO standards and the like. It has been.

インデフレーターの先端側は前述したテーパー形状の雌ハブと気密性保持が可能なように、対応するテーパー形状の雄ハブとなっている。このようなカテーテルハブとしての雌ハブと、インデフレーターの先端側の雄ハブとの接続状態は、例えば、図9に示すような接続構造を有する。簡単に説明すると以下の通りである。図9に示すようにインデフレーター61とカテーテル70とは、雄ハブ62とカテーテルハブとしての雌ハブ71を介して接続されている。インデフレーター61は、圧力ゲージ63を有するシリンジ部64と、シリンジ部64に接続された接続チューブ65と、接続チューブ65に接続された雄ハブ62を有する。雄ハブ62は、雌ハブ71の雌型テーパー部72に嵌合する雄型テーパー部66と雌ネジ部67を有するルアーロック方式のコネクタである。雌ネジ部67は、雄型テーパー部66に面するように雌ネジとしてのねじ山68が形成される。雌ハブ71の近位側端部のフランジ部73がねじ山68と係合し、両者のねじ固定が可能になっている。そして、フランジ部73をねじ山68に沿って回動させることで、雌ハブ71の雌型テーパー部72のテーパー面と雄ハブ62の雄型テーパー部66のテーパー面とが密着するように面接触する。また、ねじ固定により雌ハブ71と雄ハブ62との接続状態を保持する。このような構成により、カテーテル70の雌ハブ71及びインデフレーター61の雄ハブ62のテーパー部66、72は面同士の締め付けにより気密性が得られかつねじ固定により気密性を保持することが可能になる。   The tip end side of the indeflator is a corresponding tapered male hub so as to maintain airtightness with the tapered female hub described above. The connection state between the female hub as the catheter hub and the male hub on the distal end side of the indeflator has, for example, a connection structure as shown in FIG. The following is a brief description. As shown in FIG. 9, the indeflator 61 and the catheter 70 are connected via a male hub 62 and a female hub 71 as a catheter hub. The indeflator 61 includes a syringe part 64 having a pressure gauge 63, a connection tube 65 connected to the syringe part 64, and a male hub 62 connected to the connection tube 65. The male hub 62 is a luer lock type connector having a male tapered portion 66 and a female threaded portion 67 that are fitted to the female tapered portion 72 of the female hub 71. The female screw portion 67 is formed with a screw thread 68 as a female screw so as to face the male tapered portion 66. The flange 73 at the proximal end of the female hub 71 is engaged with the screw thread 68 so that both screws can be fixed. Then, by rotating the flange portion 73 along the screw thread 68, the taper surface of the female taper portion 72 of the female hub 71 and the taper surface of the male taper portion 66 of the male hub 62 are brought into close contact with each other. Contact. Further, the connection state between the female hub 71 and the male hub 62 is maintained by screw fixing. With such a configuration, the taper portions 66 and 72 of the female hub 71 of the catheter 70 and the male hub 62 of the indeflator 61 can be hermetically sealed by tightening the surfaces and can be kept airtight by screw fixing. Become.

ところで、例えば、バルーンカテーテルの生産時には施術時に加圧した際にバルーン部の破裂などが生じないよう耐圧検査を実施する。この耐圧検査時には、一般にカテーテルハブに耐圧検査機に設けられているルアーロック方式のコネクタを接続し、検査を実施する。この際、カテーテルハブとコネクタとの接続部分の気密性は、前述した治療時にインデフレーターを使用する場合と同様にカテーテルハブとコネクタのテーパー面同士の締め付けにより確保される。   By the way, for example, when a balloon catheter is produced, a pressure resistance test is performed so that the balloon portion is not ruptured when the pressure is applied during the operation. At the time of this pressure test, generally, a luer lock type connector provided in the pressure tester is connected to the catheter hub to perform the test. At this time, the airtightness of the connection portion between the catheter hub and the connector is ensured by tightening the tapered surfaces of the catheter hub and the connector as in the case of using the indeflator during the above-described treatment.

このような耐圧検査機にて大量に処理する場合、テーパー面同士を密着させるとともに、ねじ固定を行うため、接触面やねじ部分での摩擦等の作用により耐圧検査機側のコネクタから摩耗による削りカスあるいは欠片が生じる場合がある。その結果、それらが、カテーテル内に入り込む可能性が高まる。カテーテル内にこのような削りカスあるいは欠片が残留した状態で施術し、加圧時にバルーン部が何らかの拍子で破裂した場合、患者の体内にそれらが入り込む可能性がある。   When processing a large amount with such a pressure tester, the taper surfaces are brought into close contact with each other, and screws are fixed. Waste or fragments may occur. As a result, they are more likely to enter the catheter. When the operation is performed with such scraps or fragments remaining in the catheter and the balloon portion bursts at some time during pressurization, they may enter the patient's body.

カテーテルハブに対するその他の接合手段としては、(i)特許文献1に記載の発明のように係合を用いたロック機構、(ii)特許文献2に記載の発明のような弾性材料を用いる手段が存在する。
特許文献1には、先端ガードをカテーテルハブに係合させるロック機構が記載されている。そのカテーテルハブの内腔部には凹部が設けられ、先端ガードには、その径方向外側に撓むように複数のフィンガーが形成され、フィンガーには、その径方向外側に伸びるつめが形成される。そして、カテーテルハブの凹部にフィンガーのつめが収まること等により、先端ガードがカテーテルハブ内でロックされる。
特許文献2には、内針ハブを収納部材に収納し、内針ハブの中央部付近に設けられている弾性材料からなる保持部材12により、収納部材8内に保持部材12と内針ハブ6と収納部材8の内面により形成される密閉された減圧空間を形成することが記載されている。
しかしながら、特許文献1に記載の(i)の手段では高圧に耐え得る気密性を確保することが難しく、特許文献2に記載の(ii)の手段でも弾性材料を使用するため削りカスあるいは欠片が生じる可能性がある。
As other joining means to the catheter hub, (i) a locking mechanism using engagement as in the invention described in Patent Document 1, and (ii) means using an elastic material as in the invention described in Patent Document 2. Exists.
Patent Document 1 describes a lock mechanism for engaging a tip guard with a catheter hub. A concave portion is provided in the lumen portion of the catheter hub, a plurality of fingers are formed on the distal end guard so as to bend outward in the radial direction, and pawls extending outward in the radial direction are formed on the fingers. The tip guard is locked in the catheter hub, for example, by the finger pawls being received in the recesses of the catheter hub.
In Patent Document 2, an inner needle hub is housed in a housing member, and the holding member 12 and the inner needle hub 6 are placed in the housing member 8 by a holding member 12 made of an elastic material provided near the center of the inner needle hub. And forming a sealed decompression space formed by the inner surface of the storage member 8.
However, it is difficult for the means (i) described in Patent Document 1 to ensure airtightness that can withstand high pressure, and the means (ii) described in Patent Document 2 uses an elastic material, so that scraps or fragments are not formed. It can happen.

特開平09−099073号公報Japanese Patent Laid-Open No. 09-099073 特開平10−201852号公報Japanese Patent Laid-Open No. 10-201852

前述の問題点に鑑みて、本発明の目的とするところは、カテーテルの耐圧検査時に摩耗による削りカスあるいは欠片を生じさせる可能性を低減し、カテーテルとの気密性を保持しつつ接続することが可能なカテーテルハブ、接続構造および耐圧検査装置を提供することにある。   In view of the above-mentioned problems, the object of the present invention is to reduce the possibility of causing scraps or fragments due to wear during pressure resistance inspection of the catheter, and to connect while maintaining airtightness with the catheter. It is an object of the present invention to provide a possible catheter hub, connection structure, and pressure test apparatus.

本発明者が鋭意検討したところ、所定の封止面が形成された所定の段部を有するカテーテルハブ、当該カテーテルハブの封止面に対応する所定の封止面を有するコネクタが接続されたカテーテルハブをカテーテルハブ把持部とコネクタ把持部とで挟み込み両者を密封することが可能な耐圧検査装置により、前述の課題を解決可能なことを見出し、本発明を完成するに至った。   As a result of intensive studies by the present inventors, a catheter hub having a predetermined step portion on which a predetermined sealing surface is formed, and a catheter to which a connector having a predetermined sealing surface corresponding to the sealing surface of the catheter hub is connected. It has been found that the above-mentioned problems can be solved by a pressure-resistant inspection device capable of sandwiching a hub between a catheter hub gripping portion and a connector gripping portion and sealing both, and has completed the present invention.

(1)本発明の第一は、カテーテルハブを着脱可能に把持するカテーテルハブ把持部と、
カテーテルハブの近位側を受け入れるように接続してカテーテルの内腔部に流体を注入可能なコネクタと、
前記コネクタが接続された前記カテーテルハブを前記カテーテルハブ把持部とで挟み込むことでコネクタとカテーテルハブとを密着させるコネクタ把持部とを有し、
コネクタが接続されたカテーテルハブをカテーテルハブ把持部とコネクタ把持部とで挟み込んだ時に、カテーテルハブの外周部の全周に亘り設けられた段部に形成された環状の封止面と、該封止面に対応するように設けられたコネクタの封止面とが当接することで両者が密封される耐圧検査装置に関する。
(2)本発明では、カテーテルハブの前記段部が鍔形状の中間突起部により形成され、前記カテーテルハブ把持部が、カテーテルハブの中間突起部に形成されている封止面とは反対側の面に面する位置に中間突起部を支持する機構を有することが好ましい。
(1) A first aspect of the present invention is a catheter hub gripping part that detachably grips a catheter hub;
A connector connected to receive the proximal side of the catheter hub and injecting fluid into the lumen of the catheter;
A connector gripping part that tightly attaches the connector and the catheter hub by sandwiching the catheter hub to which the connector is connected with the catheter hub gripping part;
When the catheter hub to which the connector is connected is sandwiched between the catheter hub gripping part and the connector gripping part, an annular sealing surface formed on a step provided over the entire circumference of the catheter hub, and the sealing The present invention relates to a pressure-resistant inspection device in which both are sealed by contact with a sealing surface of a connector provided so as to correspond to a stop surface.
(2) In the present invention, the step portion of the catheter hub is formed by a saddle-shaped intermediate projection portion, and the catheter hub gripping portion is opposite to the sealing surface formed on the intermediate projection portion of the catheter hub. It is preferable to have a mechanism for supporting the intermediate protrusion at a position facing the surface.

(3)本発明の第二は、カテーテルを構成するカテーテル本体の内腔に連通可能な内腔を有するカテーテルハブと、当該カテーテルハブの内腔に連通可能な内腔を有するコネクタとを接続するための接続構造において、
前記カテーテルハブは遠位端開口部から近位端開口部に亘る前記内腔を有し、前記遠位端開口部と前記近位端開口部との間に位置する外周部には、その全周に亘る段部が形成されるとともに、該段部には環状の封止面が形成され、
前記コネクタは、遠位端開口部から近位側開口部に亘る前記内腔を有し、当該内腔は、前記遠位端開口部から前記カテーテルハブの近位側を受け入れ可能であり、前記遠位端開口部の近傍には、当該遠位端開口部を囲むようにカテーテルハブの前記封止面に対応する封止面が形成され、
外部応力によりカテーテルハブの封止面とコネクタの封止面とを当接させ、密着させることで両者の密封を保持しつつ両者を接続する接続構造に関する。
(4)本発明では、前記カテーテルハブの封止面及び/又は前記コネクタの封止面に弾性材料が設けられていることが好ましい。
(3) In the second aspect of the present invention, a catheter hub having a lumen that can communicate with the lumen of the catheter main body constituting the catheter and a connector having a lumen that can communicate with the lumen of the catheter hub are connected. In the connection structure for
The catheter hub has the lumen extending from the distal end opening to the proximal end opening, and the outer peripheral portion located between the distal end opening and the proximal end opening has a whole thereof. A step is formed over the circumference, and an annular sealing surface is formed on the step,
The connector has the lumen from a distal end opening to a proximal opening, the lumen being receivable from the distal end opening to the proximal side of the catheter hub; In the vicinity of the distal end opening, a sealing surface corresponding to the sealing surface of the catheter hub is formed so as to surround the distal end opening,
The present invention relates to a connection structure in which a sealing surface of a catheter hub and a sealing surface of a connector are brought into contact with each other by an external stress and are brought into close contact with each other while maintaining a seal between the two.
(4) In the present invention, it is preferable that an elastic material is provided on the sealing surface of the catheter hub and / or the sealing surface of the connector.

(5)本発明の第三は、カテーテルを構成するカテーテル本体の内腔に連通可能な内腔を有するカテーテルハブにおいて、
前記カテーテルハブの内腔は、前記カテーテルハブの遠位端開口部から近位端開口部に亘り形成されており、前記遠位端開口部と前記近位端開口部との間に位置する外周部には、その全周に亘る段部が形成されるとともに、該段部には環状の封止面が形成されるカテーテルハブに関する。
(6)本発明では、カテーテルハブの前記段部が鍔形状の中間突起部により形成されることが好ましい。
(7)本発明では、前記封止面は、前記近位端開口部側に面するように設けられることが好ましい。
(8)本発明では、前記封止面に弾性材料が設けられていることが好ましい。
(9)本発明では、前記近位端開口部の近傍には、その外周部に雄ネジ部及び/又はその内周部にテーパーが形成されていることが好ましい。
(5) A third aspect of the present invention is a catheter hub having a lumen that can communicate with a lumen of a catheter body constituting the catheter.
The lumen of the catheter hub is formed from the distal end opening to the proximal end opening of the catheter hub, and is an outer periphery located between the distal end opening and the proximal end opening. The step is formed with a stepped portion over the entire circumference, and the stepped portion relates to a catheter hub in which an annular sealing surface is formed.
(6) In this invention, it is preferable that the said step part of a catheter hub is formed with a hook-shaped intermediate protrusion part.
(7) In this invention, it is preferable that the said sealing surface is provided so that the said proximal end opening part side may be faced.
(8) In the present invention, it is preferable that an elastic material is provided on the sealing surface.
(9) In the present invention, in the vicinity of the proximal end opening, it is preferable that a male screw part and / or a taper is formed in the inner peripheral part in the outer peripheral part.

(10)本発明の第四は、前記(5)〜(9)の何れかに記載のカテーテルハブに接続可能なコネクタであって、
該コネクタは、遠位端開口部から近位側開口部に亘る前記内腔を有し、当該内腔は、前記遠位端開口部から前記カテーテルハブの近位側を受け入れ可能であり、
前記遠位端開口部の近傍には、当該遠位端開口部を囲むようにカテーテルハブの封止面に当接可能で当該カテーテルハブの封止面に対応する封止面が形成されているコネクタに関する。
(11)本発明では、前記内腔は、前記カテーテルハブの近位端開口部から段部に形成された封止面に亘る部分を受け入れ可能であることが好ましい。
(10) A fourth aspect of the present invention is a connector connectable to the catheter hub according to any one of (5) to (9),
The connector has the lumen from a distal end opening to a proximal opening, the lumen being receivable from the distal end opening to the proximal side of the catheter hub;
A sealing surface corresponding to the sealing surface of the catheter hub is formed in the vicinity of the distal end opening so as to be able to contact the sealing surface of the catheter hub so as to surround the distal end opening. Concerning connectors.
(11) In this invention, it is preferable that the said lumen | bore can receive the part ranging from the proximal end opening part of the said catheter hub to the sealing surface formed in the step part.

本発明によれば、カテーテルの耐圧検査時に摩耗による削りカスあるいは欠片を生じさせる可能性を低減し、カテーテルとの気密性を保持しつつ接続することが可能である。   According to the present invention, it is possible to reduce the possibility of generating scraps or fragments due to wear during pressure resistance testing of a catheter, and to connect the catheter while maintaining airtightness.

本発明に係るカテーテルハブの第一実施形態を用いたカテーテルの近位側を模式的に表す部分斜視図である。It is a fragmentary perspective view which represents typically the proximal side of the catheter using 1st embodiment of the catheter hub which concerns on this invention. (a)本発明に係るカテーテルハブの第一実施形態を模式的に示した正面図である。(b)図2(a)の右側面図である。(A) It is the front view which showed typically 1st embodiment of the catheter hub which concerns on this invention. (B) It is a right view of Fig.2 (a). (a)本発明に係るカテーテルハブの第二実施形態を模式的に示した正面図である。(b)図3(a)の右側面図である。(A) It is the front view which showed typically 2nd embodiment of the catheter hub which concerns on this invention. (B) It is a right view of Fig.3 (a). (a)本発明に係るカテーテルハブの第三実施形態を模式的に示した正面図である。(b)図4(a)の右側面図である。(A) It is the front view which showed typically 3rd embodiment of the catheter hub which concerns on this invention. (B) It is a right view of Fig.4 (a). (a)本発明に係るコネクタの第一実施形態を模式的に示した斜視図である。(b)本発明に係るコネクタの第二実施形態を模式的に示した斜視図である。(A) It is the perspective view which showed typically 1st embodiment of the connector which concerns on this invention. (B) It is the perspective view which showed typically 2nd embodiment of the connector which concerns on this invention. 本発明に係るカテーテルハブの第二実施形態とコネクタの第二実施形態とを接続する際の状態を模式的に示した部分拡大断面図である。It is the partial expanded sectional view which showed typically the state at the time of connecting 2nd embodiment of the catheter hub which concerns on this invention, and 2nd embodiment of a connector. 本発明に係る耐圧検査装置の使用状態を模式的に示した斜視図である。It is the perspective view which showed typically the use condition of the pressure | voltage resistant test | inspection apparatus which concerns on this invention. 図7における1つのカテーテルの耐圧試験装置に対する設置状態を模式的に示した切り欠き拡大断面図である。It is the notch expanded sectional view which showed typically the installation state with respect to the pressure | voltage resistant test apparatus of one catheter in FIG. 一般的なカテーテルハブとインデフレーターとの接続状態を模式的に示した説明図である。It is explanatory drawing which showed typically the connection state of a general catheter hub and an indeflator.

以下、本発明に係る耐圧検査装置、接続構造、カテーテルハブ及びコネクタの実施形態について図面を参照しつつ説明する。なお、便宜上、図面において符号を省略する場合もあるが、かかる場合、他の図面を参照するものとする。また、図面における種々部材の寸法は、便宜上、見やすいように調整されていることもある。   Hereinafter, embodiments of a pressure resistance testing device, a connection structure, a catheter hub, and a connector according to the present invention will be described with reference to the drawings. For convenience, reference numerals may be omitted in the drawings, but in such a case, other drawings are referred to. Moreover, the dimension of the various members in drawing may be adjusted so that it may be easy to see for convenience.

本発明に係る耐圧検査装置は、カテーテルハブを着脱可能に把持するカテーテルハブ把持部と、カテーテルハブの近位側を受け入れるように接続してカテーテルの内腔部に流体を注入可能なコネクタと、このコネクタが接続されたカテーテルハブをカテーテルハブ把持部とで挟み込むことでコネクタとカテーテルハブとを密着させるコネクタ把持部とを有する。そして、コネクタが接続されたカテーテルハブをカテーテルハブ把持部とコネクタ把持部とで挟み込んだ時に、カテーテルハブの外周部の全周に亘り設けられた段部に形成された環状の封止面と、該封止面に対応するように設けられたコネクタの封止面とが当接することで両者が密封されるように構成される。
このように本発明に係る耐圧検査装置では、コネクタが、カテーテルの構成部材であるカテーテルハブの近位側を受け入れるようにカテーテルハブと接続する。そして、コネクタが接続されたカテーテルハブをカテーテルハブ把持部とコネクタ把持部とで挟み込んだ時に、コネクタとカテーテルハブの所定の封止面同士が当接し、両者が密封されるようになっている。即ち、コネクタは、例えばカテーテルハブの近位側に設けられているインデフレーター等との接続部分を覆うようにカテーテルハブと接続し、コネクタの封止面は、カテーテルハブの封止面と突き当てた状態に接するように構成されて、両者の気密性が確保されるようになっている。そのため、従来のように例えばテーパー面同士を接触させつつねじ固定する必要がない。その結果、摩耗による削りカスあるいは欠片(以下、「カス等」と称する。)を生じさせる可能性を低減し、カテーテルとの気密性を保持しつつ接続することが可能となる。また、両者の封止面同士の当接位置はカテーテルハブの近位側のインデフレーター等との接続部分と離れることになるため、仮にカス等が生じたとしても、それらがカテーテル内に混入する可能性を低減することができる。
A pressure-resistant test device according to the present invention includes a catheter hub gripping part that detachably grips the catheter hub, a connector that can be connected to receive the proximal side of the catheter hub and can inject fluid into the lumen of the catheter, The connector hub has a connector gripping portion that brings the connector and the catheter hub into close contact with each other by sandwiching the catheter hub to which the connector is connected with the catheter hub gripping portion. And, when the catheter hub to which the connector is connected is sandwiched between the catheter hub gripping portion and the connector gripping portion, an annular sealing surface formed on the stepped portion provided over the entire circumference of the catheter hub, It is configured such that both of them are sealed by contacting with a sealing surface of a connector provided so as to correspond to the sealing surface.
As described above, in the pressure test apparatus according to the present invention, the connector is connected to the catheter hub so as to receive the proximal side of the catheter hub, which is a constituent member of the catheter. When the catheter hub to which the connector is connected is sandwiched between the catheter hub gripping portion and the connector gripping portion, predetermined sealing surfaces of the connector and the catheter hub come into contact with each other so that both are sealed. That is, for example, the connector is connected to the catheter hub so as to cover a connecting portion with an indeflator provided on the proximal side of the catheter hub, and the sealing surface of the connector abuts against the sealing surface of the catheter hub. It is configured so as to be in contact with the above-mentioned state, and the airtightness of both is ensured. Therefore, it is not necessary to fix the screws while bringing the tapered surfaces into contact with each other, for example. As a result, it is possible to reduce the possibility of generating scraped scraps or pieces (hereinafter referred to as “scraps”) due to wear, and to connect the catheter while maintaining airtightness. In addition, since the contact position between the sealing surfaces of the two is separated from the connection portion with the inflator and the like on the proximal side of the catheter hub, even if debris or the like is generated, they are mixed in the catheter. The possibility can be reduced.

本発明に係る耐圧検査装置は、上述した所定構造のコネクタを介してカテーテルに接着固定されている特定構造を有する本発明のカテーテルハブと着脱可能に接続され、カテーテルの耐圧検査が可能なように構成される。そこで、先ず、本発明のカテーテルハブ及びコネクタの実施形態について説明する。   The pressure resistance test apparatus according to the present invention is detachably connected to the catheter hub of the present invention having a specific structure bonded and fixed to the catheter via the connector having the predetermined structure described above so that the pressure resistance test of the catheter can be performed. Composed. First, an embodiment of the catheter hub and connector of the present invention will be described.

本発明のカテーテルハブは、カテーテルを構成するカテーテル本体の内腔に連通可能な内腔を有する。そして、その内腔は、カテーテルハブの遠位端開口部から近位端開口部に亘り形成されている。また、遠位端開口部と近位端開口部との間に位置する外周部には、その全周に亘る段部が形成されるとともに、この段部には環状の封止面が形成されている。
このように、内腔の両端の開口部間に位置する外周部の全周に亘る段部に環状の封止面を有することで、前述したように、耐圧検査装置のコネクタの封止面との当接によって、本発明の耐圧試験装置と気密性を確保しつつ接続できる。また、カテーテルハブには、このような位置に封止面が形成されているため、カテーテルハブの近位端側が、耐圧検査装置のコネクタの内腔に受け入れられ、コネクタに覆われるようにコネクタと接続可能になっている。そのため、近位端開口部に設けられるインデフレーター等との接続部分とは別の部分で、カテーテルハブの封止面と耐圧検査装置のコネクタの封止面とが当接するように構成し得る。その結果、耐圧検査装置との接続時において、従来のねじ固定等の場合とは異なり、気密性を確保しつつカス等の発生を低減することができる。また、カス等がカテーテル内に混入する可能性を低減し得る。さらに、検査時に、カテーテルハブの封止面が耐圧検査装置のコネクタの封止面に当接する、即ち、突き当てた状態に接するように構成し得るため、例えば従来のねじ固定の場合と異なり、カテーテルハブを耐圧検査装置に設置し易くし得る。その結果、検査効率を向上させ得る。また、耐圧検査装置へ設置可能なカテーテルハブの数を多くすることやその装置化も容易であり、一度に多数の耐圧検査を行うことも可能になり、より一層の検査効率の向上を図り得る。
The catheter hub of the present invention has a lumen that can communicate with the lumen of the catheter body constituting the catheter. The lumen is formed from the distal end opening of the catheter hub to the proximal end opening. In addition, a stepped portion is formed on the outer peripheral portion located between the distal end opening portion and the proximal end opening portion, and an annular sealing surface is formed on the stepped portion. ing.
Thus, by having an annular sealing surface on the entire step of the outer periphery located between the openings at both ends of the lumen, as described above, the sealing surface of the connector of the pressure-resistant testing device By the contact, it can be connected to the pressure test apparatus of the present invention while ensuring airtightness. In addition, since the sealing surface is formed at such a position in the catheter hub, the proximal end side of the catheter hub is received in the lumen of the connector of the pressure-resistant testing device, and the connector hub is covered with the connector. Connection is possible. Therefore, it can be configured such that the sealing surface of the catheter hub and the sealing surface of the connector of the pressure-resistant testing device are in contact with each other at a portion different from the connection portion with the indeflator provided in the proximal end opening. As a result, at the time of connection with the pressure-resistant inspection device, unlike the conventional screw fixing or the like, it is possible to reduce the occurrence of debris and the like while ensuring airtightness. Moreover, the possibility that debris and the like are mixed in the catheter can be reduced. Furthermore, at the time of inspection, since the sealing surface of the catheter hub abuts on the sealing surface of the connector of the pressure-resistant inspection device, that is, it can be configured to contact the abutted state, for example, unlike the case of conventional screw fixing, The catheter hub can be easily installed in the pressure test apparatus. As a result, inspection efficiency can be improved. In addition, it is easy to increase the number of catheter hubs that can be installed in the pressure-resistant testing device and to implement the device, and it is possible to perform a large number of pressure-resistant tests at once, thereby further improving the inspection efficiency. .

図1は、本発明に係るカテーテルハブの第一実施形態を用いたカテーテルの近位側を模式的に示した部分斜視図である。図2(a)はカテーテルハブの第一実施形態の正面図であり、図2(b)は図2(a)の右側面図である。図1、2に示すカテーテル1は、カテーテルハブ10とカテーテル本体12とを有する。カテーテルハブ10は、遠位端に遠位端開口部18と近位端に近位端開口部19とを有し、遠位端開口部18から近位端開口部19に亘り、内腔部16が形成されている。本実施形態ではカテーテルハブ10の近位側で近位端開口部19の近傍には、インデフレーターやシリンジ等を接続するための接続部14が設けられており、接続部14の外周部には雄ねじ部13が設けられるとともに、接続部14における内腔部16を形成する壁面(内周部)は、シリンジ等の先端部分の雄型テーパー形状に対応した雌型テーパー形状を有している。カテーテルハブ10の接続部14の遠位側の外周部にはカテーテルハブ10を術者等が把持して操作するための操作部11が形成されている。カテーテルハブ10の遠位端には、カテーテル本体12が接合されており、カテーテル本体12の内腔部17はカテーテルハブ10の内腔部16に連通している。遠位端開口部18と近位端開口部19の間に位置する外周部には、その全周に亘る段部15が設けられている。段部15には、環状の封止面15aが形成されている。   FIG. 1 is a partial perspective view schematically showing the proximal side of a catheter using the first embodiment of the catheter hub according to the present invention. Fig.2 (a) is a front view of 1st embodiment of a catheter hub, FIG.2 (b) is a right view of Fig.2 (a). The catheter 1 shown in FIGS. 1 and 2 has a catheter hub 10 and a catheter body 12. The catheter hub 10 has a distal end opening 18 at the distal end and a proximal end opening 19 at the proximal end, and extends from the distal end opening 18 to the proximal end opening 19. 16 is formed. In the present embodiment, a connection portion 14 for connecting an inflator, a syringe, and the like is provided on the proximal side of the catheter hub 10 and in the vicinity of the proximal end opening portion 19. While the male screw part 13 is provided, the wall surface (inner peripheral part) which forms the inner cavity part 16 in the connection part 14 has a female taper shape corresponding to the male taper shape of the tip portion of a syringe or the like. On the outer peripheral portion on the distal side of the connection portion 14 of the catheter hub 10, an operation portion 11 is formed for the operator or the like to hold and operate the catheter hub 10. A catheter body 12 is joined to the distal end of the catheter hub 10, and the lumen 17 of the catheter body 12 communicates with the lumen 16 of the catheter hub 10. A step portion 15 is provided on the outer periphery located between the distal end opening 18 and the proximal end opening 19 over the entire periphery. An annular sealing surface 15 a is formed on the step portion 15.

カテーテルハブ10の段部15の位置は、後述する耐圧検査装置101のコネクタ50によりカテーテルハブ10の近位側を受け入れることが可能であれば、遠位端開口部18と近位端開口部19の間の外周部のうちの何れでもよい。コネクタ50におけるカテーテルハブ10の近位側を受け入れる部分の構造等に応じて、適宜決定することができる。本例では、接続部14の遠位端より遠位側でその近傍に封止面15aが位置するように段部15が設けられている。   If the position of the step portion 15 of the catheter hub 10 can receive the proximal side of the catheter hub 10 by a connector 50 of the pressure test apparatus 101 described later, the distal end opening 18 and the proximal end opening 19 are provided. Any of the outer peripheral parts may be used. It can be determined as appropriate according to the structure of the portion of the connector 50 that receives the proximal side of the catheter hub 10. In this example, the step portion 15 is provided so that the sealing surface 15a is positioned in the vicinity of the distal end of the connection portion 14 on the distal side.

段部15の構造としては、カテーテルハブ10の外周部の全周に亘るとともに、環状の封止面15aを形成可能であれば、特に限定はない。例えば、(a)カテーテルハブ10の長軸方向の中心軸に直交する2つの環状面を有する鍔形状、(b)同中心軸に直交する1つの環状面とこの環状面の外縁部からカテーテルハブ10の遠位側に向かって段階的及び/又は連続的に環状面の外縁部より減縮する階段状及び/又はテーパー状の減縮部とを有する形状、(c)カテーテルハブ10の近位側から遠位側に向かって段階的及び/又は連続的に拡大する階段状及び/又はテーパー状の拡大部とこの拡大部から連続しカテーテルハブ10の遠位側に向かって段階的及び/又は連続的に減縮する階段状及び/又はテーパー状の減縮部とを有する形状等の中間突起部が挙げられる。図1、2では、段部15は前述の(a)の鍔形状の中間突起部(15)により形成されている。鍔形状の中間突起部(15)の近位側の環状面には環状の封止面15aが形成される。また、鍔形状の中間突起部(15)の周縁部は、術者が施術時に邪魔、あるいは怪我などリスクが生じないように面取りなどの処理が施されていることが好ましい。また、図2(b)に示すように本例では、鍔形状の中間突起部(15)の形状は、右側面視において、後述するコネクタ50の形状を考慮して円環形状としているが、検査時に気密性が保持できれば特に限定はなく、楕円環形状、多角環形状等でもよい。また、環状面と減縮部とを有する形状の中間突起部の場合における環状面も同様の形状とすることができる。この時、減縮部は環状面の形状に応じて適宜決定することができる。   The structure of the stepped portion 15 is not particularly limited as long as it extends over the entire outer periphery of the catheter hub 10 and can form the annular sealing surface 15a. For example, (a) a saddle shape having two annular surfaces orthogonal to the central axis in the longitudinal direction of the catheter hub 10, and (b) one annular surface orthogonal to the central axis and an outer edge portion of the annular surface from the catheter hub (C) a shape having a stepped and / or tapered reduced portion that gradually and / or continuously decreases toward the distal side of the annular surface from the outer edge of the annular surface, (c) from the proximal side of the catheter hub 10 A stepped and / or tapered enlarged portion that expands stepwise and / or continuously toward the distal side, and a stepwise and / or continuous portion extending from the enlarged portion toward the distal side of the catheter hub 10 An intermediate protrusion such as a shape having a stepped and / or tapered reduced portion that is reduced in size. In FIGS. 1 and 2, the step portion 15 is formed by the hook-shaped intermediate projection portion (15) described above (a). An annular sealing surface 15a is formed on the annular surface on the proximal side of the bowl-shaped intermediate protrusion (15). Moreover, it is preferable that the peripheral edge part of the saddle-shaped intermediate projection part (15) is subjected to a process such as chamfering so that the operator does not have a risk of obstruction or injury during the operation. Further, as shown in FIG. 2B, in this example, the shape of the hook-shaped intermediate protrusion (15) is an annular shape in consideration of the shape of the connector 50 described later in the right side view. There is no particular limitation as long as airtightness can be maintained during inspection, and an elliptical ring shape, a polygonal ring shape, or the like may be used. In addition, the annular surface in the case of the intermediate projection having the shape having the annular surface and the reduced portion can also have the same shape. At this time, the reduced portion can be appropriately determined according to the shape of the annular surface.

封止面15aは、後述するようなコネクタ40、50の封止面42、52と当接可能であれば、その構造に、特に限定はない。本実施形態では、カテーテルハブ10の長軸方向に直交する環状の平面としている。即ち、封止面15aは近位端開口部19側に面するように設けられている。この場合、コネクタ40、50をカテーテルハブ10の長軸方向に沿って移動させ、封止面15aをコネクタ40、50の封止面42、52に突き当てた状態で気密性を確保するのが容易である点で好適である。   If the sealing surface 15a can contact | abut with the sealing surfaces 42 and 52 of the connectors 40 and 50 which are mentioned later, there will be no limitation in the structure. In the present embodiment, an annular plane orthogonal to the major axis direction of the catheter hub 10 is used. That is, the sealing surface 15a is provided so as to face the proximal end opening 19 side. In this case, the connectors 40 and 50 are moved along the long axis direction of the catheter hub 10 to ensure airtightness in a state where the sealing surface 15a is abutted against the sealing surfaces 42 and 52 of the connectors 40 and 50. This is preferable because it is easy.

封止面15aの表面状態は、特に限定はなく、カテーテルハブ10の封止面15aとコネクタの封止面とで密封する構成に応じて、適宜決定すればよい。例えば、図1、2に示すカテーテルハブ10の封止面15aを硬質材料で形成し、コネクタの封止面も同程度の硬質材料で形成し、両封止面同士を突き当てた状態で気密性を確保する場合は、封止面同士の接触部分で密着性を向上させる観点から、封止面の表面は鏡面状の平滑面であるのが好ましい。   The surface state of the sealing surface 15a is not particularly limited, and may be appropriately determined according to the configuration in which the sealing surface 15a of the catheter hub 10 and the sealing surface of the connector are sealed. For example, the sealing surface 15a of the catheter hub 10 shown in FIGS. 1 and 2 is formed of a hard material, the sealing surface of the connector is also formed of the same level of hard material, and the two sealing surfaces are in contact with each other and are airtight. In order to ensure the property, the surface of the sealing surface is preferably a mirror-like smooth surface from the viewpoint of improving the adhesion at the contact portion between the sealing surfaces.

図1、2に示すような鍔形状の中間突起部15の遠位端開口部18側の構造については特に限定しないが、耐圧検査時に近位端開口部19側からコネクタの封止面をカテーテルハブ10の封止面15aに当接させた時の押圧力に抗する観点から、中間突起部15の遠位端開口部18側の環状面15bの内縁部分近傍部に、アール形状やテーパー形状など肉厚部分を形成してもよい(図示せず。)。同様の理由で、この肉厚部分は封止面15aの内縁部分近傍部にも形成してもよい。また、より押圧力に対する強度を確保する観点からは、図1、2に示すような環状面15bを有する中間突起部15の構造に替えて、前述の(b)のように、カテーテルハブ10の中心軸に直交する1つの環状面である封止面15aの外縁部からカテーテルハブ10の遠位側に向かって段階的及び/又は連続的に封止面15aの外縁部より減縮する階段状及び/又はテーパー状の減縮部を形成してもよい。   Although the structure on the distal end opening 18 side of the saddle-shaped intermediate projection 15 as shown in FIGS. 1 and 2 is not particularly limited, the sealing surface of the connector is connected to the catheter from the proximal end opening 19 side during pressure resistance testing. From the viewpoint of resisting the pressing force when being brought into contact with the sealing surface 15 a of the hub 10, a round shape or a tapered shape is formed in the vicinity of the inner edge portion of the annular surface 15 b on the distal end opening 18 side of the intermediate protrusion 15. A thick portion may be formed (not shown). For the same reason, this thick portion may also be formed near the inner edge portion of the sealing surface 15a. Further, from the viewpoint of securing the strength against the pressing force, instead of the structure of the intermediate projection 15 having the annular surface 15b as shown in FIGS. A stepped shape that is gradually and / or continuously reduced from the outer edge of the sealing surface 15a toward the distal side of the catheter hub 10 from the outer edge of the sealing surface 15a, which is one annular surface orthogonal to the central axis, and A tapered reduced portion may be formed.

中間突起部15のカテーテルハブ10の中心軸に直交する方向の大きさについては、カテーテルハブ10の近位側を受け入れるコネクタの封止面と当接可能な封止面15aを形成可能であれば、特に限定はない。図1、2に示す実施形態では、カテーテルハブ10の近位側に形成されている接続部14の雄ねじ部13を受け入れて、接続部14の全体をその外側から覆うコネクタ(例えば図5参照。)の封止面と当接し、密封可能なような大きさであればよい。したがって、本実施形態での中間突起部15の中心軸に直交する方向(径方向)の大きさは、ねじ部13より大きければよい。また、カテーテルとして使用する際に術者等の作業に支障がない程度の大きさにする観点からは、コネクタの封止面と同程度か、それより若干大きい程度の大きさにするのが好ましい。   With respect to the size of the intermediate protrusion 15 in the direction perpendicular to the central axis of the catheter hub 10, it is possible to form a sealing surface 15 a that can contact the sealing surface of the connector that receives the proximal side of the catheter hub 10. There is no particular limitation. In the embodiment shown in FIGS. 1 and 2, a connector (see, for example, FIG. 5) that receives the male screw portion 13 of the connection portion 14 formed on the proximal side of the catheter hub 10 and covers the entire connection portion 14 from the outside. It is sufficient if the size is such that it can contact and seal the sealing surface. Therefore, the size in the direction (radial direction) orthogonal to the central axis of the intermediate protrusion 15 in this embodiment may be larger than that of the screw portion 13. Also, from the viewpoint of making the size that does not hinder the operator's work when used as a catheter, it is preferable that the size be the same as or slightly larger than the sealing surface of the connector. .

操作部11の形状は、本実施形態では、図2(b)に示すように右側面の正面視で外部形状が菱形状で、カテーテルハブ10の長軸方向に沿って同形状が連続する偏平な形状に形成されているが、これに限定されない。術者の作業性を考慮して他の偏平な形状等の把持し易い形状を採用することができる。
また、接続部14の構成は、図1等に示すように外周部に雄ねじ部が形成され内周部にテーパー形状が形成されているが、カテーテルハブの用途に応じて外周部の雄ねじ部及び/又は内周部にテーパー形状を設けるとよい。前述のように拡張治療に用いるバルーンカテーテルの場合は、気密性と接続性の観点から、外周部の雄ねじ部及び内周部にテーパー形状を設けるのが好ましい。
In the present embodiment, as shown in FIG. 2B, the shape of the operation portion 11 is a flat shape in which the external shape is a rhombus shape in front view of the right side surface, and the same shape continues along the major axis direction of the catheter hub 10. However, the present invention is not limited to this. Considering the operator's workability, it is possible to adopt a shape that is easy to grip, such as another flat shape.
In addition, as shown in FIG. 1 or the like, the connection portion 14 has a male screw portion formed on the outer peripheral portion and a tapered shape formed on the inner peripheral portion. It is preferable to provide a taper shape on the inner periphery. As described above, in the case of a balloon catheter used for dilatation treatment, it is preferable to provide a tapered shape on the male screw portion and the inner peripheral portion of the outer peripheral portion from the viewpoint of airtightness and connectivity.

次に、本発明に係るカテーテルハブの第二実施形態について図3を参照しつつ説明する。
本発明に係るカテーテルハブでは、例えば、第一実施形態のように、段部15に形成されている環状の封止面15aが平面であってもよいが、カテーテルハブの封止面に、コネクタの封止面との当接状態をより良好に維持する観点から、コネクタと相補的な構造の係止部を設けてもよい。このような係止部を設けることで、耐圧検査時に長手方向に対して交差する方向からの予期せぬ衝撃に対して封止面同士の接続ズレ等の障害が生じにくくなる点で好適である。
このような係止部としては、例えば、カテーテルハブの封止面に凹部を設けたもの、封止面を平滑な凹面状にしたもの、凸部を設けたもの、封止面を平滑な凸面状にしたもの等が挙げられるが、これに限定されるわけではない。また、係止部は、接続ズレを防止できれば特に限定はなく、環状の封止面に沿って環状に連続して形成されてもよいし、任意の位置に不連続に形成されてもよい。もっとも、カテーテルハブの係止部に相補的な構造の係止部がコネクタの封止面に形成されている場合に有効であるため、コネクタとの当接を容易に行う観点から、係止部は、カテーテルハブの封止面とコネクタの封止面の環状の面方向に沿って均等な形状であることが好ましく、円形がより好ましい。
Next, a second embodiment of the catheter hub according to the present invention will be described with reference to FIG.
In the catheter hub according to the present invention, for example, as in the first embodiment, the annular sealing surface 15a formed on the step portion 15 may be a flat surface. From the viewpoint of better maintaining the contact state with the sealing surface, a locking portion complementary to the connector may be provided. By providing such a locking portion, it is preferable in that a failure such as a displacement of the sealing surfaces is less likely to occur due to an unexpected impact from a direction intersecting the longitudinal direction at the time of pressure resistance inspection. .
As such a locking part, for example, a concave part on the sealing surface of the catheter hub, a smooth concave surface of the sealing surface, a convex part, a smooth convex surface of the sealing surface However, the present invention is not limited to this. Further, the locking portion is not particularly limited as long as it can prevent connection displacement, and may be formed continuously in an annular shape along the annular sealing surface, or may be formed discontinuously at an arbitrary position. However, since it is effective when a locking portion having a structure complementary to the locking portion of the catheter hub is formed on the sealing surface of the connector, the locking portion is used from the viewpoint of easily contacting the connector. Are preferably uniform in shape along the annular surface direction of the sealing surface of the catheter hub and the sealing surface of the connector, and more preferably circular.

図3は、本発明に係るカテーテルハブの第二実施形態を用いたカテーテルの近位側を模式的に示した部分説明図であり、図3(a)は、その正面図であり、図3(b)は、図3(a)の右側面図である。図3に示す第二実施形態は、第一実施形態の段部15に形成された封止面15aに係止部として凹部を設けたものである。そこで、図3には第一実施形態と同じ構成については同じ符号を付し、第一実施形態と異なる点について以下に説明する。
第二実施形態に係るカテーテルハブ20は、第一実施形態のカテーテルハブ10の段部15の封止面15aに凹部26を設けたものである。即ち、第二実施形態に係るカテーテルハブ20は、遠位端開口部18と近位端開口部19の間に位置する外周部に、その全周に亘る段部25として鍔形状の中間突起部(25)が設けられている。中間突起部(25)は、カテーテルハブ20の長軸方向の中心軸に直交する2つの環状面25a、25bを有する鍔形状である。環状面25aは、封止面(25a)として機能する。封止面25aには環状の凹部26が形成されている。凹部26は、図3(b)に示すように、側面視で円形である。もっとも、本発明では、凹部26は、封止面に沿って形成された、楕円形、多角形などの連続した凹部でもよいし、全体として円形、楕円形、多角形等となるような不連続な凹部でもよいし、その他の構造でもよい。
FIG. 3 is a partial explanatory view schematically showing a proximal side of a catheter using the second embodiment of the catheter hub according to the present invention, and FIG. 3 (a) is a front view thereof, FIG. FIG. 3B is a right side view of FIG. In the second embodiment shown in FIG. 3, a concave portion is provided as a locking portion on the sealing surface 15a formed in the step portion 15 of the first embodiment. Therefore, in FIG. 3, the same components as those in the first embodiment are denoted by the same reference numerals, and differences from the first embodiment will be described below.
The catheter hub 20 according to the second embodiment has a concave portion 26 provided on the sealing surface 15a of the step portion 15 of the catheter hub 10 of the first embodiment. That is, the catheter hub 20 according to the second embodiment has a saddle-shaped intermediate protrusion as a step portion 25 over the entire circumference on the outer circumference located between the distal end opening 18 and the proximal end opening 19. (25) is provided. The intermediate protrusion (25) has a bowl shape having two annular surfaces 25a and 25b orthogonal to the central axis of the catheter hub 20 in the long axis direction. The annular surface 25a functions as a sealing surface (25a). An annular recess 26 is formed in the sealing surface 25a. As shown in FIG. 3B, the recess 26 is circular in a side view. However, in the present invention, the recess 26 may be a continuous recess such as an ellipse or a polygon formed along the sealing surface, or a discontinuity such as a circle, an ellipse, or a polygon as a whole. A concave portion or other structure may be used.

凹部26の断面形状は、図3では断面V字形状の溝で示しているが、半円形状、楕円形状あるいは多角形状等でもよい。   The cross-sectional shape of the recess 26 is shown by a V-shaped groove in FIG. 3, but may be a semicircular shape, an elliptical shape, a polygonal shape, or the like.

次に、本発明に係るカテーテルハブの第三実施形態について図4を参照しつつ説明する。
本発明に係るカテーテルハブでは、封止面に弾性材料が設けられてもよい。これにより、コネクタの封止面と当接した時の密着性が向上し、密封の保持がより容易になる。また、耐圧検査時に、カテーテルハブとコネクタの封止面同士を当接させて密着させる際に、弾性材料を用いない場合に比べて小さい押圧力により密着性、密封性を保持できる。そのため、段部が、例えば図4に示すような鍔形状の中間突起部である場合に、中間突起部が押圧力により損傷する可能性を低減できる。
Next, a third embodiment of the catheter hub according to the present invention will be described with reference to FIG.
In the catheter hub according to the present invention, an elastic material may be provided on the sealing surface. Thereby, the adhesiveness when contacting with the sealing surface of the connector is improved, and the sealing is more easily maintained. Further, at the time of pressure resistance inspection, when the sealing surfaces of the catheter hub and the connector are brought into contact with each other and brought into close contact with each other, adhesion and sealability can be maintained with a smaller pressing force than when no elastic material is used. Therefore, when a step part is a saddle-shaped intermediate protrusion part as shown, for example in FIG. 4, possibility that an intermediate protrusion part will be damaged by pressing force can be reduced.

本発明で用いることができる弾性材料としては、コネクタの封止面との密着性を向上させ、両者の密封性を容易に保持させることができれば特に限定はなく、例えば、ウレタンゴム、ニトリルゴム、ブチルゴム、シリコーンゴムなどのゴム系材料でもよいし、ポリアミド系エラストマー等の熱可塑性エラストマーでもよい。   The elastic material that can be used in the present invention is not particularly limited as long as it can improve the adhesion with the sealing surface of the connector and easily maintain the sealing performance of both, for example, urethane rubber, nitrile rubber, It may be a rubber material such as butyl rubber or silicone rubber, or may be a thermoplastic elastomer such as a polyamide elastomer.

図4は、本発明に係るカテーテルハブの第三実施形態を用いたカテーテルの近位側を模式的に示した部分説明図であり、図4(a)は、その正面図であり、図4(b)は、図4(a)の右側面図である。図4に示す第三実施形態は、第一実施形態の段部15に形成された封止面15aに弾性材料を設けたものである。そこで、図4には第一実施形態と同じ構成については同じ符号を付し、第一実施形態と異なる点について以下に説明する。
第三実施形態に係るカテーテルハブ30は、第一実施形態のカテーテルハブ10の段部15の封止面15aに弾性材料36を設けたものである。即ち、第三実施形態に係るカテーテルハブ30は、遠位端開口部18と近位端開口部19の間に位置する外周部に、その全周に亘る段部35として鍔形状の中間突起部(35)が設けられている。中間突起部(35)は、カテーテルハブ30の長軸方向の中心軸に直交する2つの環状面35a、35bを有する鍔形状である。環状面35aは、平滑な平面で、封止面(35a)として機能する。封止面35aには環状の弾性部材36が設けられている。
4 is a partial explanatory view schematically showing the proximal side of a catheter using the third embodiment of the catheter hub according to the present invention, and FIG. 4 (a) is a front view thereof, FIG. FIG. 4B is a right side view of FIG. In the third embodiment shown in FIG. 4, an elastic material is provided on the sealing surface 15a formed in the step portion 15 of the first embodiment. Therefore, in FIG. 4, the same components as those in the first embodiment are denoted by the same reference numerals, and differences from the first embodiment will be described below.
The catheter hub 30 according to the third embodiment is obtained by providing an elastic material 36 on the sealing surface 15a of the step portion 15 of the catheter hub 10 of the first embodiment. That is, the catheter hub 30 according to the third embodiment has a saddle-shaped intermediate projection as a step 35 extending over the entire circumference of the outer circumference located between the distal end opening 18 and the proximal end opening 19. (35) is provided. The intermediate protrusion (35) has a bowl shape having two annular surfaces 35a and 35b orthogonal to the central axis of the catheter hub 30 in the long axis direction. The annular surface 35a is a smooth flat surface and functions as a sealing surface (35a). An annular elastic member 36 is provided on the sealing surface 35a.

弾性材料36の封止面35aに対する配置は、図4に示す例では、中間突起部35の封止面35aのほぼ全体を覆うように配置されている。もっとも、図示しないが、コネクタの封止面と当接した時の密着性を向上し、密封を保持する観点からは、コネクタの封止面が接触する部分の環状の全周に亘って弾性材料を配置すればよいため、カテーテルハブ30の封止面35aに、コネクタの封止面に対応する環形状としてもよい。このような環形状としては、例えば図3(b)に示す係止部としての凹部26の側面視で円形状となるものが挙げられるが、これに限らず、楕円形状、多角形状等であってもよい。また、弾性材料36のカテーテルハブとの当接する側の表面は、平滑な平面でもよいし、環状に連続する1つの凸部が形成されていてもよいし、このような凸部が2つ以上同心状に形成されていてもよい。凸部の断面形状は、例えば、半円形状、半楕円形状、多角形状等が挙げられるが特に限定はない。
また、図示しないが、第二実施形態における係止部としての凹部26に沿って弾性材料36を配置してもよい。
In the example illustrated in FIG. 4, the elastic material 36 is disposed so as to cover substantially the entire sealing surface 35 a of the intermediate protrusion 35 in the example illustrated in FIG. 4. However, although not shown in the drawings, from the viewpoint of improving the adhesion when contacting the sealing surface of the connector and maintaining the sealing, an elastic material is formed over the entire circumference of the annular portion of the portion where the sealing surface of the connector contacts. Therefore, the sealing surface 35a of the catheter hub 30 may have a ring shape corresponding to the sealing surface of the connector. Examples of such an annular shape include a circular shape in a side view of the concave portion 26 as the locking portion shown in FIG. 3B, but are not limited to this, and may be an elliptical shape, a polygonal shape, or the like. May be. Further, the surface of the elastic material 36 on the side in contact with the catheter hub may be a smooth flat surface, or may be formed with one convex portion that is continuous in an annular shape, or two or more such convex portions. It may be formed concentrically. Examples of the cross-sectional shape of the protrusion include a semicircular shape, a semi-elliptical shape, and a polygonal shape, but are not particularly limited.
Moreover, although not shown in figure, you may arrange | position the elastic material 36 along the recessed part 26 as a latching | locking part in 2nd embodiment.

次に、本発明に係るコネクタの実施形態について図5を参照しつつ説明する。
本発明に係るコネクタは、前述したような本発明に係るカテーテルハブと接続可能である。そして、遠位端開口部から近位側開口部に亘る前記内腔を有する。この内腔は、遠位端開口部からカテーテルハブの近位側を受け入れ可能である。また、コネクタの遠位端開口部の近傍には、当該遠位端開口部を囲むようにカテーテルハブの封止面に当接可能で当該カテーテルハブの封止面に対応する封止面が形成されている。このように、遠位端開口部からカテーテルハブの近位側を受け入れ可能な内腔を有するため、カテーテルハブの近位側を覆うようにカテーテルハブと接続可能になっている。即ち、カテーテルハブの近位端開口部に設けられるインデフレーター等との接続部分とは別の部分で、カテーテルハブの封止面と当接し、密封するように構成し得る。そのため、従来のねじ固定等の場合とは異なり、気密性を確保しつつカス等の発生を低減することができる。また、コネクタの封止面がカテーテルハブの封止面に突き当てた状態に接するように構成し得るため、例えば従来のねじ固定の場合と異なり、カテーテルハブとの接続を容易に行い得る。その結果、検査効率を向上させ得る。また、耐圧検査装置へ設置可能なカテーテルハブの数を多くすることやその装置化も容易であり、一度に多数の耐圧検査を行うことも可能になり、より一層の検査効率の向上を図り得る。
Next, an embodiment of a connector according to the present invention will be described with reference to FIG.
The connector according to the present invention can be connected to the catheter hub according to the present invention as described above. And it has the said lumen from a distal end opening part to a proximal side opening part. The lumen can receive the proximal side of the catheter hub from the distal end opening. In addition, a sealing surface corresponding to the sealing surface of the catheter hub is formed in the vicinity of the distal end opening of the connector so as to be able to contact the sealing surface of the catheter hub so as to surround the distal end opening. Has been. Thus, since it has the lumen | bore which can receive the proximal side of a catheter hub from a distal end opening part, it can connect with a catheter hub so that the proximal side of a catheter hub may be covered. That is, it may be configured to contact and seal the sealing surface of the catheter hub at a portion different from a connection portion with an indeflator or the like provided at the proximal end opening of the catheter hub. Therefore, unlike conventional screw fixing, it is possible to reduce the occurrence of debris and the like while ensuring airtightness. Moreover, since the sealing surface of the connector can be configured to come into contact with the sealing surface of the catheter hub, for example, unlike the case of conventional screw fixing, the connection with the catheter hub can be easily performed. As a result, inspection efficiency can be improved. In addition, it is easy to increase the number of catheter hubs that can be installed in the pressure-resistant testing device and to implement the device, and it is possible to perform a large number of pressure-resistant tests at once, thereby further improving the inspection efficiency. .

図5は、本発明に係るコネクタの実施形態を模式的に示した斜視図であり、図5(a)は第一実施形態を、図5(b)は第二実施形態を示したものである。   FIG. 5 is a perspective view schematically showing an embodiment of the connector according to the present invention. FIG. 5 (a) shows the first embodiment, and FIG. 5 (b) shows the second embodiment. is there.

図5(a)に示す第一実施形態に係るコネクタ40は、カテーテルハブの近位側を受け入れ可能なハウジング部41と、耐圧検査装置に着脱可能に接続可能な連結部46とを備える。また、コネクタ40は、遠位端開口部43と近位端開口部44を有し、遠位端開口部43から近位側開口部44に亘る内腔45を有する。内腔45は、ハウジング部41に形成される内腔45aと連結部46に形成される内腔45bとで構成される。ハウジング部41の遠位端には、遠位端開口部43を囲むようにカテーテルハブの封止面に当接可能で当該カテーテルハブの封止面に対応する封止面42が形成されている。   The connector 40 according to the first embodiment shown in FIG. 5A includes a housing portion 41 that can receive the proximal side of the catheter hub, and a connecting portion 46 that can be detachably connected to the pressure-resistant testing device. The connector 40 has a distal end opening 43 and a proximal end opening 44, and has a lumen 45 extending from the distal end opening 43 to the proximal opening 44. The lumen 45 includes a lumen 45 a formed in the housing portion 41 and a lumen 45 b formed in the connecting portion 46. At the distal end of the housing portion 41, a sealing surface 42 that can contact the sealing surface of the catheter hub so as to surround the distal end opening 43 and that corresponds to the sealing surface of the catheter hub is formed. .

ハウジング部41に形成される内腔45の形状、大きさは、前述したカテーテルハブの近位側を受け入れ可能な形状、大きさであれば特に限定はない。本実施形態では、ハウジング部41は径が長軸方向沿って一定の円筒状で、その内径は、カテーテルハブの近位側の最大幅より大きくなっている(例えば図6、8参照。)。内腔45aの長軸方向長さは、カテーテルハブの封止面から近位側の長軸方向長さ以上で、好ましくはその長さより大きい長さである。
封止面42は、前述したカテーテルハブの封止面に対応する形状を有していればよい。本実施形態では、封止面42は、例えば図1に示すような封止面15aに対応する形状を有する。したがって、封止面42は、コネクタ40の長手方向の中心軸に直交する平面上で遠位端開口部43を囲むように形成された円環状の平滑な平面である。
連結部46の構造は、耐圧検査装置との接続構造に応じて適宜変更可能である。本実施形態では、ハウジング51より径の小さい円筒状であるが、これに限定されない。
The shape and size of the lumen 45 formed in the housing part 41 are not particularly limited as long as the shape and size can receive the proximal side of the catheter hub described above. In the present embodiment, the housing portion 41 has a cylindrical shape whose diameter is constant along the major axis direction, and the inner diameter thereof is larger than the maximum width on the proximal side of the catheter hub (see, for example, FIGS. 6 and 8). The length in the long axis direction of the lumen 45a is not less than the length in the long axis direction on the proximal side from the sealing surface of the catheter hub, and is preferably longer than that length.
The sealing surface 42 should just have the shape corresponding to the sealing surface of the catheter hub mentioned above. In the present embodiment, the sealing surface 42 has a shape corresponding to the sealing surface 15a as shown in FIG. 1, for example. Therefore, the sealing surface 42 is an annular smooth flat surface formed so as to surround the distal end opening 43 on a plane orthogonal to the longitudinal central axis of the connector 40.
The structure of the connecting portion 46 can be changed as appropriate according to the connection structure with the pressure-resistant inspection device. In the present embodiment, the cylindrical shape is smaller in diameter than the housing 51, but the present invention is not limited to this.

図5(b)に示す第二実施形態に係るコネクタ50は、第一実施形態に係るコネクタ40の封止面42に係止部又は弾性材料を設けたものである。そこで、図5(b)には第一実施形態と同じ構成については同じ符号を付し、第一実施形態と異なる点について以下に説明する。
第二実施形態に係るコネクタ50は、第一実施形態のコネクタ40の封止面42に係止部又は弾性材料を設けたものである。コネクタ50のハウジング部41の遠位端には、遠位端開口部43を囲むようにカテーテルハブの封止面に当接可能で当該カテーテルハブの封止面に対応する封止面52が形成されている。そして、封止面52には、係止部又は弾性材料53が設けられている。係止部又は弾性材料53の形状は、封止面52に沿って連続する環状の構造を有していれば特に限定はない。もっとも、封止面同士の当接により密封するため、カテーテルハブの封止面に対応した相補的な構造を有するのが好ましい。そのため、係止部53を設けた場合は、カテーテルハブの封止面に形成された係止部に対応した形状であることが好ましい。特に両者が硬質材料である場合は両係止部が対応した形状である必要がある。例えば、図5(b)に示す構造の係止部53の場合は、図3に示すカテーテルハブの係止部26の断面形状を図5(b)に示す断面形状(半円形状)に対応した断面形状にした係止部(凹部)のカテーテルハブに対して好適である。一方、弾性材料53を設けた場合は、必ずしも断面形状を対応させる必要はない。例えば図6に示すように、断面V字形状の凹部26に対して断面半円形状の弾性材料53が圧接されるように嵌りこむようにしてもよい。
前述のように、係止部は、予期せぬ衝撃に対して封止面同士の接続ズレ等の障害が生じにくくする意義を有し、弾性材料は、封止面同士が当接した時の密着性を向上させ、密封の保持をより容易にする意義を有する。そのため、これらの意義に応じてカテーテルハブの封止面の構造に対応した係止部又は弾性材料を設けるとよい。尚、図6に示すカテーテルハブとコネクタの封止面の組み合わせの場合は、コネクタ50の弾性材料53は係止部としての意義をも有する。
The connector 50 according to the second embodiment shown in FIG. 5B is obtained by providing a locking portion or an elastic material on the sealing surface 42 of the connector 40 according to the first embodiment. Therefore, in FIG. 5B, the same components as those in the first embodiment are denoted by the same reference numerals, and differences from the first embodiment will be described below.
The connector 50 which concerns on 2nd embodiment provides the latching | locking part or the elastic material in the sealing surface 42 of the connector 40 of 1st embodiment. A sealing surface 52 corresponding to the sealing surface of the catheter hub is formed at the distal end of the housing portion 41 of the connector 50 so as to be able to contact the sealing surface of the catheter hub so as to surround the distal end opening 43. Has been. The sealing surface 52 is provided with a locking portion or an elastic material 53. The shape of the locking portion or the elastic material 53 is not particularly limited as long as it has an annular structure that continues along the sealing surface 52. However, it is preferable to have a complementary structure corresponding to the sealing surface of the catheter hub in order to seal the sealing surface by abutment. Therefore, when the latching | locking part 53 is provided, it is preferable that it is a shape corresponding to the latching | locking part formed in the sealing surface of a catheter hub. In particular, when both are hard materials, both locking portions need to have corresponding shapes. For example, in the case of the locking portion 53 having the structure shown in FIG. 5B, the cross-sectional shape of the locking portion 26 of the catheter hub shown in FIG. 3 corresponds to the cross-sectional shape (semicircular shape) shown in FIG. This is suitable for a catheter hub having a locking portion (concave portion) having a cross-sectional shape. On the other hand, when the elastic material 53 is provided, it is not always necessary to correspond to the cross-sectional shape. For example, as shown in FIG. 6, an elastic material 53 having a semicircular cross section may be fitted into the concave portion 26 having a V shape cross section so as to be pressed.
As described above, the locking portion has a significance of making it difficult to cause a failure such as a connection gap between the sealing surfaces against an unexpected impact, and the elastic material is used when the sealing surfaces are in contact with each other. It has the significance of improving adhesion and making sealing easier. Therefore, it is good to provide the latching | locking part or elastic material corresponding to the structure of the sealing surface of a catheter hub according to these meanings. In the case of the combination of the catheter hub and the sealing surface of the connector shown in FIG. 6, the elastic material 53 of the connector 50 also has significance as a locking portion.

係止部53の構造は、前述したカテーテルハブの係止部に対応した相補的な構造であればよい。弾性材料53の構造は、カテーテルハブの封止面と当接して密着し、両者が密封されれば特に限定はなく、コネクタ50の封止面52に沿って連続する環状であればよい。例えば、円形状、楕円形状、多角形状等が挙げられるが、これらに限定されない。このような環状の凸部は1つでもよいし、2つ以上同心状に形成されていてもよい。また、断面形状も特に限定はなく、例えば、半円形状、半楕円形状、多角形状等が挙げられるが特に限定はない。弾性材料は、カテーテルハブの場合と同様の材料を採用することができる。   The structure of the locking portion 53 may be a complementary structure corresponding to the locking portion of the catheter hub described above. The structure of the elastic material 53 is not particularly limited as long as the elastic material 53 comes into contact with and closely adheres to the sealing surface of the catheter hub, and both are sealed, and may be an annular shape that is continuous along the sealing surface 52 of the connector 50. For example, a circular shape, an elliptical shape, a polygonal shape, and the like can be given, but the invention is not limited to these. There may be one such annular convex portion, or two or more may be formed concentrically. Also, the cross-sectional shape is not particularly limited, and examples thereof include a semicircular shape, a semi-elliptical shape, and a polygonal shape, but are not particularly limited. As the elastic material, the same material as that of the catheter hub can be adopted.

次に、本発明に係るカテーテルハブとコネクタとの接続構造の実施形態について図6、8を参照しつつ説明する。
本発明に係る接続構造は、カテーテルを構成するカテーテル本体の内腔に連通可能な内腔を有するカテーテルハブと、当該カテーテルハブの内腔に連通可能な内腔を有するコネクタとを接続するためのものである。
ここで、カテーテルハブは遠位端開口部から近位端開口部に亘る内腔を有している。その遠位端開口部と近位端開口部との間に位置する外周部には、その全周に亘る段部が形成されるとともに、この段部には環状の封止面が形成されている。
また、コネクタは、遠位端開口部から近位側開口部に亘る内腔を有している。この内腔は、その遠位端開口部からカテーテルハブの近位側を受け入れ可能であり、遠位端開口部の近傍には、当該遠位端開口部を囲むようにカテーテルハブの前記封止面に対応する封止面が形成されている。
そして、外部応力によりカテーテルハブの封止面とコネクタの封止面とを当接させ、密着させることで両者の密封を保持しつつ両者を接続する。
Next, an embodiment of a connection structure between a catheter hub and a connector according to the present invention will be described with reference to FIGS.
A connection structure according to the present invention is for connecting a catheter hub having a lumen that can communicate with the lumen of a catheter body constituting the catheter and a connector having a lumen that can communicate with the lumen of the catheter hub. Is.
Here, the catheter hub has a lumen extending from the distal end opening to the proximal end opening. At the outer periphery located between the distal end opening and the proximal end opening, a step is formed over the entire periphery, and an annular sealing surface is formed at the step. Yes.
The connector also has a lumen extending from the distal end opening to the proximal opening. The lumen can receive the proximal side of the catheter hub from its distal end opening, and in the vicinity of the distal end opening, the sealing of the catheter hub so as to surround the distal end opening. A sealing surface corresponding to the surface is formed.
Then, the sealing surface of the catheter hub and the sealing surface of the connector are brought into contact with each other by an external stress and are brought into close contact with each other, so that the both are connected while maintaining the sealing therebetween.

このように本発明に係る接続構造では、コネクタが、カテーテルの構成部材であるカテーテルハブの近位側を受け入れるようにカテーテルハブと接続する。そして、外部応力によりカテーテルハブの封止面とコネクタの封止面とを当接させ、密着させることで両者の密封を保持するようになっている。コネクタは、例えばカテーテルハブの近位側に設けられているインデフレーター等との接続部分を覆うようにカテーテルハブと接続し、コネクタの封止面は、カテーテルハブの封止面と突き当てた状態に接するように構成されて、両者の気密性が確保されるようになっている。そのため、従来のように例えばテーパー面同士を接触させつつねじ固定する必要がない。その結果、カス等を生じさせる可能性を低減し、カテーテルとの気密性を保持しつつ接続することが可能となる。また、両者の封止面同士の当接位置はカテーテルハブの近位側のインデフレーター等との接続部分と離れることになるため、仮にカス等が生じたとしても、それらがカテーテル内に混入する可能性を低減することができる。   Thus, in the connection structure according to the present invention, the connector is connected to the catheter hub so as to receive the proximal side of the catheter hub that is a component of the catheter. And the sealing surface of a catheter hub and the sealing surface of a connector are contact | abutted by external stress, and the sealing of both is hold | maintained by making it closely_contact | adhere. The connector is connected to the catheter hub so as to cover, for example, a connection portion with an indeflator provided on the proximal side of the catheter hub, and the sealing surface of the connector is in contact with the sealing surface of the catheter hub It is comprised so that it may touch, and the airtightness of both is ensured. Therefore, it is not necessary to fix the screws while bringing the tapered surfaces into contact with each other, for example. As a result, it is possible to reduce the possibility of causing debris or the like and to connect the catheter while maintaining airtightness. In addition, since the contact position between the sealing surfaces of the two is separated from the connection portion with the inflator and the like on the proximal side of the catheter hub, even if debris or the like is generated, they are mixed in the catheter. The possibility can be reduced.

図6は、図3に示す第二実施形態に係るカテーテルハブ20と図5(b)に示す第二実施形態に係るコネクタ50とを接続する際の状態を模式的に示した部分拡大図である。図8は、図1、2に示す第一実施形態に係るカテーテルハブ10と図5(a)に示す第一実施形態に係るコネクタ40との接続構造4の実施形態を模式的に示した切り欠き断面図である。   6 is a partially enlarged view schematically showing a state when the catheter hub 20 according to the second embodiment shown in FIG. 3 and the connector 50 according to the second embodiment shown in FIG. 5B are connected. is there. FIG. 8 is a schematic view showing an embodiment of the connection structure 4 between the catheter hub 10 according to the first embodiment shown in FIGS. 1 and 2 and the connector 40 according to the first embodiment shown in FIG. FIG.

図6、8に示すように、カテーテルハブ20、10とコネクタ50、40とは、カテーテルハブ20、10の近位側の接続部14が、コネクタ50、40のハウジング部41により覆われるように接続される。この時、カテーテルハブ20、10の段部25、15である鍔形状の中間突起部(25、15)の封止面25a、15aは、コネクタ50、40の封止面52、42と当接する。
この時、図6に示す実施形態では、カテーテルハブ20の封止面25aに形成された係止部としての凹部26に、コネクタ50の封止面52に形成された弾性部材53で形成された係止部としての凸部(53)が嵌まり込む。また、この時、凹部26と凸部(53)以外の部分の封止面25a、52同士も当接し得る。
また、図8に示す実施形態では、カテーテルハブ10の中間突起部15の封止面15aの平滑な平面と、コネクタ40の封止面42の平滑な平面とが当接する。
そして、コネクタ50、40の封止面52、42とカテーテルハブ20、10の封止面25a、15aとを当接させるように、外部応力を負荷する。つまり、図6、8に示す実施形態では、カテーテルハブ20、10及びコネクタ50、40の長手方向の中心軸に平行な方向で、カテーテルハブ20、10の遠位端側とコネクタ50、40の近位側とから、両者を挟み込むように外部応力を負荷する。負荷方向は、コネクタハブ20、10の当接面25a、15aとコネクタ50、40の封止面52、42とに対して直交する方向である。これにより、図6に示す実施形態では、コネクタ50の弾性材料53がカテーテルハブ20の凹部26に圧接されるように嵌まり込み、弾性部材53と凹部26とが密着して、密封性が向上するとともに、予期せぬ衝撃に対して封止面同士の接続ズレ等の障害が生じにくくなるように両者が接続される。図8に示す実施形態では、コネクタハブ10の封止面15aとコネクタ40の封止面42とが密着して密封されるように、両者が接続される。この時の外部応力の負荷の仕方としては、両者の封止面同士が当接し密着できれは、特に限定はない。
As shown in FIGS. 6 and 8, the catheter hubs 20, 10 and the connectors 50, 40 are arranged such that the proximal connection part 14 of the catheter hubs 20, 10 is covered by the housing part 41 of the connectors 50, 40. Connected. At this time, the sealing surfaces 25a and 15a of the hook-shaped intermediate protrusions (25 and 15) which are the step portions 25 and 15 of the catheter hubs 20 and 10 come into contact with the sealing surfaces 52 and 42 of the connectors 50 and 40, respectively. .
At this time, in the embodiment shown in FIG. 6, the recess 26 as the locking portion formed on the sealing surface 25 a of the catheter hub 20 is formed by the elastic member 53 formed on the sealing surface 52 of the connector 50. The convex part (53) as a latching part fits. At this time, the sealing surfaces 25a and 52 other than the concave portion 26 and the convex portion (53) can also come into contact with each other.
In the embodiment shown in FIG. 8, the smooth flat surface of the sealing surface 15 a of the intermediate protrusion 15 of the catheter hub 10 and the smooth flat surface of the sealing surface 42 of the connector 40 abut.
Then, external stress is applied so that the sealing surfaces 52 and 42 of the connectors 50 and 40 and the sealing surfaces 25a and 15a of the catheter hubs 20 and 10 are brought into contact with each other. That is, in the embodiment shown in FIGS. 6 and 8, the distal end side of the catheter hub 20, 10 and the connectors 50, 40 are arranged in a direction parallel to the longitudinal central axis of the catheter hub 20, 10 and the connectors 50, 40. External stress is applied from the proximal side so as to sandwich both of them. The load direction is a direction orthogonal to the contact surfaces 25a and 15a of the connector hubs 20 and 10 and the sealing surfaces 52 and 42 of the connectors 50 and 40. Accordingly, in the embodiment shown in FIG. 6, the elastic material 53 of the connector 50 is fitted so as to be pressed against the concave portion 26 of the catheter hub 20, and the elastic member 53 and the concave portion 26 are brought into close contact with each other, thereby improving the sealing performance. At the same time, the two are connected so that a failure such as a connection shift between the sealing surfaces is less likely to occur due to an unexpected impact. In the embodiment shown in FIG. 8, both are connected such that the sealing surface 15 a of the connector hub 10 and the sealing surface 42 of the connector 40 are tightly sealed. The method of applying external stress at this time is not particularly limited as long as the sealing surfaces of the two come into contact with each other and can be brought into close contact with each other.

次に、本発明に係る耐圧検査装置の実施形態について図7、8を参照しつつ説明する。
図7は、本発明に係る耐圧検査装置の実施形態の使用状態を模式的に示した斜視図である。図8は、図7に示した耐圧検査装置に設置されているカテーテルにおけるカテーテルハブの設置状態を模式的に示した切り欠き拡大断面図である。
図7、8では、図1、2に示すカテーテル1の耐圧検査を行う場合を例にして、図5(a)に示すコネクタ40を有する耐圧検査装置101にカテーテル1のカテーテルハブ10を設置した状態を示しているが、前述したような各種のカテーテルハブを有するカテーテルの耐圧検査に適用可能である。また、前述したような各種のコネクタを有する耐圧検査装置についても同様である。
Next, an embodiment of a pressure test apparatus according to the present invention will be described with reference to FIGS.
FIG. 7 is a perspective view schematically showing a usage state of the embodiment of the pressure resistance testing apparatus according to the present invention. FIG. 8 is a cutaway enlarged cross-sectional view schematically showing the installation state of the catheter hub in the catheter installed in the pressure test apparatus shown in FIG.
7 and 8, the catheter hub 10 of the catheter 1 is installed in the pressure test apparatus 101 having the connector 40 shown in FIG. 5 (a), taking as an example the case of performing the pressure test of the catheter 1 shown in FIGS. Although the state is shown, it is applicable to the pressure resistance test of the catheter having various catheter hubs as described above. The same applies to a pressure-resistant inspection apparatus having various connectors as described above.

図7に示す耐圧検査装置101は、カテーテル把持部106、107、コネクタ40、コネクタ把持部104を有する。カテーテル把持部106、107は、架台105の上面に設けられている。コネクタ40は、コネクタ把持部104に着脱可能に設置されている。コネクタ把持部104は、コネクタ40とカテーテル把持部106、107との間の間隔を調整し、カテーテルハブの封止面とコネクタ40の封止面42とを密着させることが可能なように、コネクタ40を架台105に対して相対移動可能なように構成されている。また、コネクタ把持部104には、配管103を介してカテーテル1の内腔部16、17に流体を注入するための流体注入装置102が接続されている。コネクタ把持部104の内部には、コネクタ40の内腔45に連通する流体の流路が形成されている(図示せず。)。検査用の流体は、特に限定はないが、検査の簡便性の観点から、気体が好ましい。   The pressure resistance test apparatus 101 illustrated in FIG. 7 includes catheter gripping portions 106 and 107, a connector 40, and a connector gripping portion 104. The catheter gripping portions 106 and 107 are provided on the upper surface of the gantry 105. The connector 40 is detachably installed on the connector grip 104. The connector grip 104 adjusts the distance between the connector 40 and the catheter grips 106 and 107 so that the sealing surface of the catheter hub and the sealing surface 42 of the connector 40 can be brought into close contact with each other. 40 is configured to be movable relative to the gantry 105. In addition, a fluid injection device 102 for injecting fluid into the lumens 16 and 17 of the catheter 1 is connected to the connector grip 104 via a pipe 103. A fluid flow path communicating with the inner cavity 45 of the connector 40 is formed inside the connector grip 104 (not shown). The fluid for inspection is not particularly limited, but gas is preferable from the viewpoint of simplicity of inspection.

図7、8に示すように、カテーテルハブ把持部106、107は、カテーテル1のカテーテルハブ10を着脱可能に把持するように構成されている。カテーテルハブ把持部106は、カテーテルハブ10の遠位側の端部近傍において、架台105の上面に突設された2組の支持体106a、106bを備え、カテーテルハブ10の遠位側部分の側面を挟み込むようになっている。また、支持体106a、106bのカテーテルハブ10に面する側の壁面は、架台105の上面側からの平面視で、カテーテルハブ10の対応する外周部の形状に対応する形状になっている(図8参照。)。これにより、カテーテルハブ10を安定して把持し易くなる。また、カテーテルハブ10の長軸方向の中心軸に平行にカテーテル把持部104を架台105に対して相対移動させカテーテルハブ10とコネクタ40との封止面同士を当接させる時に、その押圧力を受け止めるため、本実施形態では、支持体106a、106bのカテーテルハブ10に面する側の壁面間距離は、押圧力の負荷方向に沿って減縮するようになっている。尚、同様の機能を発揮する他の構造であってもよい。
本発明では、このような押圧力をより効果的に受け止める観点から、カテーテルハブ把持部が、カテーテルハブの中間突起部に形成されている封止面とは反対側の面に面する位置に中間突起部を支持する機構を有するのが好ましい。このような機構として、本実施形態では、カテーテルハブ10の鍔形状の中間突起部15におけるカテーテルハブ10の遠位側に面する環状面15bの側に、さらに、カテーテル把持部107を設けている。カテーテル把持部107も、前述の他のカテーテル把持部106と同様に、架台105の上面に突設された2組の支持体107a、107bを備え、カテーテルハブ10の中間突起部15の環状面bの遠位側部分の側面を挟み込むようになっている。本実施形態では、支持体107a、107bは角柱状としているが、コネクタ10の環状の封止面42による押圧力を環状面15bの側から環状面15b全体で支持する観点から、カテーテルハブ10の着脱性を考慮しつつ、環状面15bに対応した分割可能な環状の構造にしてもよい。これらの支持体は、図7に示すような状態で移動不可の状態で設置してもよいし、移動可能にしてもよい。また、本実施形態では、カテーテルハブ10の段部15が鍔形状の中間突起部15である場合を例にしているが、それ以外の場合でも、同様の機能を発揮可能な形状の支持体を設けることができることは勿論のことである。
As shown in FIGS. 7 and 8, the catheter hub gripping portions 106 and 107 are configured to detachably hold the catheter hub 10 of the catheter 1. The catheter hub grip 106 includes two sets of supports 106 a and 106 b protruding from the upper surface of the gantry 105 in the vicinity of the distal end of the catheter hub 10, and the side surface of the distal portion of the catheter hub 10. Is to be inserted. Further, the wall surfaces of the supports 106a and 106b on the side facing the catheter hub 10 have a shape corresponding to the shape of the corresponding outer peripheral portion of the catheter hub 10 in plan view from the upper surface side of the gantry 105 (FIG. 8). Thereby, it becomes easy to grasp the catheter hub 10 stably. Further, when the catheter gripping portion 104 is moved relative to the gantry 105 in parallel with the central axis in the longitudinal direction of the catheter hub 10, the pressing force is applied when the sealing surfaces of the catheter hub 10 and the connector 40 are brought into contact with each other. In order to accept, in this embodiment, the distance between the wall surfaces of the supports 106a and 106b on the side facing the catheter hub 10 is reduced along the load direction of the pressing force. Other structures that exhibit the same function may be used.
In the present invention, from the viewpoint of more effectively receiving such a pressing force, the catheter hub gripping portion is intermediate at a position facing the surface opposite to the sealing surface formed on the intermediate projection of the catheter hub. It is preferable to have a mechanism for supporting the protrusion. As such a mechanism, in this embodiment, a catheter gripping portion 107 is further provided on the side of the annular surface 15b facing the distal side of the catheter hub 10 in the saddle-shaped intermediate projection portion 15 of the catheter hub 10. . Similarly to the other catheter gripping portions 106 described above, the catheter gripping portion 107 also includes two sets of supports 107a and 107b protruding from the upper surface of the gantry 105, and the annular surface b of the intermediate projection portion 15 of the catheter hub 10 is provided. The side surface of the distal portion of the device is sandwiched. In the present embodiment, the supports 107a and 107b are prismatic, but from the viewpoint of supporting the pressing force by the annular sealing surface 42 of the connector 10 on the entire annular surface 15b from the annular surface 15b side, A splittable annular structure corresponding to the annular surface 15b may be used in consideration of detachability. These supports may be installed in a state where they cannot move in the state shown in FIG. 7 or may be movable. Further, in this embodiment, the case where the step portion 15 of the catheter hub 10 is a saddle-shaped intermediate projection portion 15 is taken as an example. However, in other cases, a support body having a shape capable of performing the same function is used. Of course, it can be provided.

図7に示す耐圧検査装置101では、6個のカテーテルを設置して1〜6個のカテーテルの耐圧検査を一度に行えるようにしているが、1つのカテーテルのみ設置可能な構造でもよいし、2つ以上設置可能な構造でもよい。   In the pressure resistance test apparatus 101 shown in FIG. 7, six catheters are installed so that pressure resistance tests of one to six catheters can be performed at one time. It may be a structure where two or more can be installed.

耐圧検査装置101の使用方法について以下に説明する。
耐圧検査装置101のコネクタ把持部104により、カテーテル1のカテーテルハブ10の接続部14をコネクタ40のハウジング部41の内腔45aに挿入可能になるように、コネクタ40を架台105に対して相対移動させる、又は、コネクタ把持部104からコネクタ40を取り外す。その後、カテーテルハブ10の遠位側の端部近傍部分をカテーテルハブ把持部106の2組の支持体106a、106bの間に嵌め込む。それと同時に、カテーテルハブ10の中間突起部15の環状面15bの遠位側をカテーテルハブ107の2組の支持体107a、107bの間に嵌め込む。この時、コネクタ40の内腔45aにカテーテルハブ107の接続部14を挿入した状態で、コネクタ40がコネクタ把持部104に接続された状態にする。
そして、コネクタ把持部40により、コネクタ40とカテーテル把持部106、107との間の間隔を調整することで、コネクタ40が接続されたカテーテルハブ10がカテーテルハブ把持部106、107とコネクタ把持部104とで挟み込まれ、カテーテルハブ10の封止面14と、コネクタ40の封止面42とが当接するように外部応力が負荷され、カテーテルハブ10とコネクタ40が密封される。この状態を保持しながら、流体注入装置102から配管103を介して流体が注入され、カテーテル1の内腔が所望の圧力になるように加圧される。この時、圧力が所定値に至らない場合は密封性が低い可能性があるため、耐圧検査が不合格となり、所望の圧力に至った場合は、耐圧検査合格となる。
検査終了後は、コネクタ把持部40により、コネクタ40とカテーテル把持部106、107との間の間隔を調整して、カテーテルハブ10(カテーテル1)を取り外す。
The usage method of the pressure | voltage resistant test | inspection apparatus 101 is demonstrated below.
Relative movement of the connector 40 relative to the gantry 105 so that the connector gripping portion 104 of the pressure-resistant testing device 101 can insert the connecting portion 14 of the catheter hub 10 of the catheter 1 into the lumen 45a of the housing portion 41 of the connector 40. Or the connector 40 is removed from the connector grip 104. Thereafter, the vicinity of the distal end of the catheter hub 10 is fitted between the two sets of supports 106 a and 106 b of the catheter hub gripping portion 106. At the same time, the distal side of the annular surface 15 b of the intermediate projection 15 of the catheter hub 10 is fitted between the two sets of supports 107 a and 107 b of the catheter hub 107. At this time, the connector 40 is connected to the connector gripping portion 104 while the connection portion 14 of the catheter hub 107 is inserted into the lumen 45 a of the connector 40.
Then, by adjusting the distance between the connector 40 and the catheter gripping portions 106 and 107 by the connector gripping portion 40, the catheter hub 10 to which the connector 40 is connected becomes the catheter hub gripping portions 106 and 107 and the connector gripping portion 104. The external stress is applied so that the sealing surface 14 of the catheter hub 10 and the sealing surface 42 of the connector 40 are in contact with each other, and the catheter hub 10 and the connector 40 are sealed. While maintaining this state, fluid is injected from the fluid injection device 102 through the pipe 103, and the lumen of the catheter 1 is pressurized to a desired pressure. At this time, if the pressure does not reach a predetermined value, the sealing performance may be low, so the pressure resistance test is rejected, and if the pressure is reached, the pressure resistance test is passed.
After completion of the test, the distance between the connector 40 and the catheter gripping portions 106 and 107 is adjusted by the connector gripping portion 40, and the catheter hub 10 (catheter 1) is removed.

以上のように、本発明によれば、カテーテルハブの接続部を覆うようにコネクタとカテーテルハブとを接続し、両者の封止面同士を突き当てた状態で接触させるだけで両者を密封可能である。そのため、カテーテルの耐圧検査時にカス等を生じさせる可能性やカテーテル内腔への混入の可能性を低減できる。耐圧検査装置へのカテーテルの着脱が容易であるため、検査効率を向上させることができる。   As described above, according to the present invention, the connector and the catheter hub can be connected so as to cover the connecting portion of the catheter hub, and both can be sealed simply by bringing the sealing surfaces into contact with each other. is there. Therefore, it is possible to reduce the possibility of causing debris or the like during the pressure resistance test of the catheter and the possibility of mixing into the catheter lumen. Since the catheter can be easily attached to and detached from the pressure-resistant inspection device, the inspection efficiency can be improved.

1、2、3 カテーテル
4 接続構造
10、20、30 カテーテルハブ
11 操作部
12 カテーテル本体
13 雄ねじ部
14 接続部
15、25、35 中間突起部
15a、25a、35a 封止面
15b、25b、35b 環状面
16、17 内腔部
18 遠位端開口部
19 近位端開口部
26 係止部(凹部)
36 弾性材料
40、50 コネクタ
41 ハウジング部
42、52 封止面
43 遠位端開口部
44 近位側開口部
45、45a、45b 内腔
46 連結部
53 係止部/弾性材料
101 耐圧検査装置
102 流体注入装置
103 配管
104 コネクタ把持部
105 架台
106、107 カテーテルハブ把持部
106a、106b、107a、107b 支持体

1, 2, 3 Catheter 4 connection structure 10, 20, 30 Catheter hub 11 Operation part 12 Catheter body 13 Male thread part 14 Connection part 15, 25, 35 Intermediate projection part 15a, 25a, 35a Sealing surface 15b, 25b, 35b Annular Surface 16, 17 Lumen 18 Distal end opening 19 Proximal end opening 26 Locking portion (concave portion)
36 Elastic material 40, 50 Connector 41 Housing portion 42, 52 Sealing surface 43 Distal end opening 44 Proximal opening 45, 45a, 45b Lumen 46 Connection portion 53 Locking portion / elastic material 101 Pressure test device 102 Fluid injection device 103 Piping 104 Connector gripping part 105 Base 106, 107 Catheter hub gripping part 106a, 106b, 107a, 107b Support

Claims (11)

カテーテルハブを有するカテーテルの内腔部に流体を注入して耐圧性を検査するための耐圧検査装置において、
カテーテルハブを着脱可能に把持するカテーテルハブ把持部と、
カテーテルハブの近位側を受け入れるように接続してカテーテルの内腔部に流体を注入可能なコネクタと、
前記コネクタが接続された前記カテーテルハブを前記カテーテルハブ把持部とで挟み込むことでコネクタとカテーテルハブとを密着させるコネクタ把持部とを有し、
コネクタが接続されたカテーテルハブをカテーテルハブ把持部とコネクタ把持部とで挟み込んだ時に、カテーテルハブの外周部の全周に亘り設けられた段部に形成された環状の封止面と、該封止面に対応するように設けられたコネクタの封止面とが当接することで両者が密封される耐圧検査装置。
In a pressure test apparatus for inspecting pressure resistance by injecting fluid into the lumen of a catheter having a catheter hub,
A catheter hub gripping part for detachably gripping the catheter hub;
A connector connected to receive the proximal side of the catheter hub and injecting fluid into the lumen of the catheter;
A connector gripping part that tightly attaches the connector and the catheter hub by sandwiching the catheter hub to which the connector is connected with the catheter hub gripping part;
When the catheter hub to which the connector is connected is sandwiched between the catheter hub gripping part and the connector gripping part, an annular sealing surface formed on a step provided over the entire circumference of the catheter hub, and the sealing A pressure-resistant inspection device in which a sealing surface of a connector provided so as to correspond to a stop surface comes into contact with each other to be sealed.
カテーテルハブの前記段部が鍔形状の中間突起部により形成され、前記カテーテルハブ把持部が、カテーテルハブの中間突起部に形成されている封止面とは反対側の面に面する位置に中間突起部を支持する機構を有する請求項1記載の耐圧検査装置。   The step portion of the catheter hub is formed by a saddle-shaped intermediate projection, and the catheter hub gripping portion is intermediate at a position facing the surface opposite to the sealing surface formed on the intermediate projection of the catheter hub. The pressure | voltage resistant test | inspection apparatus of Claim 1 which has a mechanism which supports a projection part. カテーテルを構成するカテーテル本体の内腔に連通可能な内腔を有するカテーテルハブと、当該カテーテルハブの内腔に連通可能な内腔を有するコネクタとを接続するための接続構造において、
前記カテーテルハブは遠位端開口部から近位端開口部に亘る前記内腔を有し、前記遠位端開口部と前記近位端開口部との間に位置する外周部には、その全周に亘る段部が形成されるとともに、該段部には環状の封止面が形成され、
前記コネクタは、遠位端開口部から近位側開口部に亘る前記内腔を有し、当該内腔は、前記遠位端開口部から前記カテーテルハブの近位側を受け入れ可能であり、前記遠位端開口部の近傍には、当該遠位端開口部を囲むようにカテーテルハブの前記封止面に対応する封止面が形成され、
外部応力によりカテーテルハブの封止面とコネクタの封止面とを当接させ、密着させることで両者の密封を保持しつつ両者を接続する接続構造。
In a connection structure for connecting a catheter hub having a lumen communicable with the lumen of the catheter body constituting the catheter and a connector having a lumen communicable with the lumen of the catheter hub,
The catheter hub has the lumen extending from the distal end opening to the proximal end opening, and the outer peripheral portion located between the distal end opening and the proximal end opening has a whole thereof. A step is formed over the circumference, and an annular sealing surface is formed on the step,
The connector has the lumen from a distal end opening to a proximal opening, the lumen being receivable from the distal end opening to the proximal side of the catheter hub; In the vicinity of the distal end opening, a sealing surface corresponding to the sealing surface of the catheter hub is formed so as to surround the distal end opening,
A connection structure in which the sealing surface of the catheter hub and the sealing surface of the connector are brought into contact with each other by an external stress and are brought into close contact with each other while maintaining the sealing therebetween.
前記カテーテルハブの封止面及び/又は前記コネクタの封止面に弾性材料が設けられている請求項3記載の接続構造。   The connection structure according to claim 3, wherein an elastic material is provided on a sealing surface of the catheter hub and / or a sealing surface of the connector. カテーテルを構成するカテーテル本体の内腔に連通可能な内腔を有するカテーテルハブにおいて、
前記カテーテルハブの内腔は、前記カテーテルハブの遠位端開口部から近位端開口部に亘り形成されており、前記遠位端開口部と前記近位端開口部との間に位置する外周部には、その全周に亘る段部が形成されるとともに、該段部には環状の封止面が形成されるカテーテルハブ。
In a catheter hub having a lumen capable of communicating with a lumen of a catheter body constituting the catheter,
The lumen of the catheter hub is formed from the distal end opening to the proximal end opening of the catheter hub, and is an outer periphery located between the distal end opening and the proximal end opening. A catheter hub in which a step portion is formed on the entire portion, and an annular sealing surface is formed on the step portion.
カテーテルハブの前記段部が鍔形状の中間突起部により形成される請求項5記載のカテーテルハブ。   The catheter hub according to claim 5, wherein the step portion of the catheter hub is formed by a hook-shaped intermediate protrusion. 前記封止面は、前記近位端開口部側に面するように設けられる請求項5又は6に記載のカテーテルハブ。   The catheter hub according to claim 5 or 6, wherein the sealing surface is provided so as to face the proximal end opening side. 前記封止面に弾性材料が設けられている請求項5〜7の何れかに記載のカテーテルハブ。   The catheter hub according to claim 5, wherein an elastic material is provided on the sealing surface. 前記近位端開口部の近傍には、その外周部に雄ネジ部及び/又はその内周部にテーパーが形成されている請求項5〜8の何れかに記載のカテーテルハブ。   The catheter hub according to any one of claims 5 to 8, wherein a male screw portion and / or a taper is formed in an inner peripheral portion in the vicinity of the proximal end opening. 請求項5〜9の何れかに記載のカテーテルハブに接続可能なコネクタであって、
該コネクタは、遠位端開口部から近位側開口部に亘る前記内腔を有し、当該内腔は、前記遠位端開口部から前記カテーテルハブの近位側を受け入れ可能であり、
前記遠位端開口部の近傍には、当該遠位端開口部を囲むようにカテーテルハブの封止面に当接可能で当該カテーテルハブの封止面に対応する封止面が形成されているコネクタ。
A connector connectable to the catheter hub according to any one of claims 5 to 9,
The connector has the lumen from a distal end opening to a proximal opening, the lumen being receivable from the distal end opening to the proximal side of the catheter hub;
A sealing surface corresponding to the sealing surface of the catheter hub is formed in the vicinity of the distal end opening so as to be able to contact the sealing surface of the catheter hub so as to surround the distal end opening. connector.
前記内腔は、前記カテーテルハブの近位端開口部から段部に形成された封止面に亘る部分を受け入れ可能である請求項10記載のコネクタ。

The connector according to claim 10, wherein the lumen can receive a portion extending from a proximal end opening of the catheter hub to a sealing surface formed in a stepped portion.

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