JP2018149038A - Method for manufacturing prior check tool for catheter indwelling position - Google Patents
Method for manufacturing prior check tool for catheter indwelling position Download PDFInfo
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- JP2018149038A JP2018149038A JP2017046795A JP2017046795A JP2018149038A JP 2018149038 A JP2018149038 A JP 2018149038A JP 2017046795 A JP2017046795 A JP 2017046795A JP 2017046795 A JP2017046795 A JP 2017046795A JP 2018149038 A JP2018149038 A JP 2018149038A
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 14
- 238000000034 method Methods 0.000 title abstract description 18
- 238000003825 pressing Methods 0.000 claims abstract description 42
- 239000000758 substrate Substances 0.000 claims abstract description 33
- 239000008280 blood Substances 0.000 claims abstract description 27
- 210000004369 blood Anatomy 0.000 claims abstract description 27
- 238000001631 haemodialysis Methods 0.000 claims abstract description 7
- 238000010438 heat treatment Methods 0.000 claims abstract description 7
- 230000000322 hemodialysis Effects 0.000 claims abstract description 7
- 238000012790 confirmation Methods 0.000 claims description 28
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 15
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 15
- -1 polytetrafluoroethylene Polymers 0.000 claims description 4
- 230000001954 sterilising effect Effects 0.000 abstract description 10
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 10
- 230000008602 contraction Effects 0.000 abstract description 5
- 230000005540 biological transmission Effects 0.000 abstract 1
- 210000004204 blood vessel Anatomy 0.000 description 4
- 229910052751 metal Inorganic materials 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 210000002620 vena cava superior Anatomy 0.000 description 3
- 230000000149 penetrating effect Effects 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 210000003129 brachiocephalic vein Anatomy 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000000502 dialysis Methods 0.000 description 1
- 210000004731 jugular vein Anatomy 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 239000000565 sealant Substances 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
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Abstract
Description
本発明は、血液透析用のカフ型カテーテルの留置を行う際に、事前にカテーテルの留置位置を確認するために用いる事前確認具の製造方法に関する。 The present invention relates to a method for manufacturing a prior confirmation tool used for confirming a catheter placement position in advance when placing a cuff catheter for hemodialysis.
日本で血液透析を受けている患者のうち、約90％の患者は自己血管を用いた動静脈シャントにより透析が行われているが、２〜３％程度の患者は、血液透析用カテーテルを用いて透析が行われている。 About 90% of patients undergoing hemodialysis in Japan are dialyzed with an arteriovenous shunt using autologous blood vessels, while about 2-3% of patients use a hemodialysis catheter. Dialysis is performed.
血液透析用カテーテルには２種類あり、カフ型と非カフ型に分類される。このうち、カフ型カテーテルは、血管内から直接体外へ誘導される非カフ型カテーテルと比較して、皮下トンネルを経由して対外に誘導されるために感染予防となり、長期的に使用できるカテーテルとして知られている。 There are two types of hemodialysis catheters, which are classified into cuff type and non-cuff type. Among these, the cuff type catheter is used as a catheter that can be used for a long period of time because it is guided to the outside through a subcutaneous tunnel compared to a non-cuff type catheter that is directly guided from the blood vessel to the outside of the body. Are known.
カフ型カテーテルでは、先端が送血用と脱血用の２つに枝分かれしており、脱血用カテーテルの方が数センチ短く設定されている。このカフ型カテーテルを患者の体内に留置する場合には、右内頚静脈に穿刺を行い、気管分岐部よりもやや足側に送血カテーテル先端を留置するとともに、気管分岐部付近に脱血用カテーテル先端を留置している。 In the cuff type catheter, the tip is branched into two for blood sending and blood removal, and the blood removal catheter is set to be several centimeters shorter. When placing this cuff catheter in the patient's body, puncture the right internal jugular vein, place the tip of the blood-feeding catheter slightly on the foot side of the tracheal bifurcation, and remove blood near the tracheal bifurcation. The catheter tip is indwelling.
特に、患者の体内にカフ型カテーテルを留置する際には、脱血用カテーテルに設けられている脱血穴が十分に脱血可能な上大静脈に位置させることが望ましい。例えば脱血穴が上大静脈よりも径が細い腕頭静脈内に留置された場合には、脱血不良を生じるおそれがあるためである。 In particular, when a cuff catheter is placed in a patient's body, it is desirable that the blood removal hole provided in the blood removal catheter is located in the superior vena cava where blood can be sufficiently removed. For example, if the blood removal hole is placed in the brachiocephalic vein having a diameter smaller than that of the superior vena cava, there is a risk of poor blood removal.
このように、カフ型カテーテルを患者の体内に留置する際には、細心の配慮が必要である一方で、留置する前に脱血穴や送血穴の位置設定を行うことはなく、術者の経験に基づいて留置が行われているという状況であった。 As described above, when placing a cuff catheter in a patient's body, careful consideration is necessary. On the other hand, the position of the blood removal hole and blood feeding hole is not set before placement. It was the situation that detention was carried out based on experience.
本発明者らは、このような現状に鑑みて、カフ型カテーテルを体内に留置する前に、放射線透視下で血管の位置を確認しながら脱血穴及び送血穴の位置をあらかじめ設定しておくことで、上記の問題点を解決できると考えて、放射線透視下での脱血穴及び送血穴の位置設定を行いやすくするための事前確認具を発明した（例えば、特許文献１参照。）。 In view of the current situation, the present inventors set the positions of blood removal holes and blood feeding holes in advance while confirming the positions of blood vessels under radioscopy before placing the cuff catheter in the body. In view of the above, it is considered that the above-mentioned problems can be solved, and a prior confirmation tool for facilitating the position setting of the blood removal hole and blood feeding hole under radioscopy has been invented (see, for example, Patent Document 1). ).
このカテーテルの留置位置の事前確認具は、患者の体表面に載置して使用するものであり、血管に沿わせて配置される所定長さの長手状基体で構成している。 The catheter indwelling position prior confirmation tool is used by being placed on the body surface of a patient, and is composed of a longitudinal base having a predetermined length arranged along a blood vessel.
そして、長手状基体には、カフ型カテーテルの送血穴、脱血穴、及びカフと対応する位置、さらにはカフ型カテーテルを体外に誘導する出口に対応する位置に、放射線に対して不透過な金属材料で送血穴部マーク、脱血穴部マーク、カフ部マーク、出口部マークをそれぞれ設けている。 The longitudinal substrate is opaque to radiation at a position corresponding to the blood feeding hole, blood removal hole, and cuff of the cuff catheter, and further to a position corresponding to the outlet for guiding the cuff catheter out of the body. A blood-feeding hole mark, a blood removal hole mark, a cuff mark, and an outlet mark are each formed of a metal material.
特に、カフ部マークの部分には長手状基体を貫通するカフ部貫通孔を設け、出口部マークの部分には長手状基体を貫通する出口部貫通孔を設けており、このカフ部貫通孔及び出口部貫通孔に油性ペン等のマーキングに用いるペンのペン先を挿入することで、患者の体表面に目印となるマーキングを可能としている。 In particular, the cuff portion mark portion is provided with a cuff portion through hole penetrating the longitudinal base body, and the outlet portion mark portion is provided with an outlet portion through hole penetrating the longitudinal base body. By inserting a pen tip of a pen used for marking of an oil-based pen or the like into the outlet portion through-hole, marking as a mark on the patient's body surface is made possible.
この事前確認具を用いることで、カフ型カテーテルの脱血穴を上大静脈に適正に留置させた状態で、カフ及びカフ型カテーテルを体外に誘導する出口を適正に配置でき、脱血不良の発生を防止できるだけでなく、比較的経験の浅い術者であっても安心してカフ型カテーテルの留置作業を行うことができる。 By using this prior confirmation tool, the cuff and the cuff catheter can be properly placed at the outlet for guiding the cuff and the cuff catheter outside the body with the blood removal hole of the cuff catheter properly placed in the superior vena cava. Not only can this be prevented, but even a relatively inexperienced operator can safely place the cuff catheter.
カテーテルの留置位置の事前確認具は、使用する前に滅菌処理する必要があるが、オートクレーブを用いた滅菌処理を行った場合に、長手状基体に熱収縮が生じることで、送血穴部マーク、脱血穴部マーク、カフ部マーク、出口部マークの各マーク間の距離が短くなるという問題があることがわかった。 Prior to using the catheter indwelling position confirmation tool, it is necessary to sterilize it, but when sterilization using an autoclave is performed, heat shrinkage occurs in the elongated substrate, so that the blood feed hole mark It has been found that there is a problem that the distance between the blood removal hole mark, the cuff mark, and the exit mark is shortened.
本発明のカテーテルの留置位置の事前確認具の製造方法では、血液透析に用いるカフ型カテーテルを体内に留置する前に、放射線透視下でカフ型カテーテルの脱血穴及び送血穴の留置位置を設定するために用いる所定長さの長手状基体からなる事前確認具の製造方法において、長手状基体をプレスするプレス工程と、長手状基体を加熱して熱収縮を生じさせる加熱工程とを有し、特に、プレス工程において、プレスされた長手状基体の表面にプレス痕による起伏を形成しているものである。 In the manufacturing method of the prior confirmation device for the indwelling position of the catheter according to the present invention, the indwelling positions of the blood removal hole and blood feeding hole of the cuff type catheter are placed under radioscopy before placing the cuff type catheter used for hemodialysis in the body. In the manufacturing method of the prior confirmation tool which consists of the longitudinal base of predetermined length used for setting, it has the press process which presses a longitudinal base, and the heating process which heats a longitudinal base and produces heat shrink In particular, in the pressing step, undulations due to press marks are formed on the surface of the pressed longitudinal base.
さらに、本発明のカテーテルの留置位置の事前確認具の製造方法では、以下の点にも特徴を有するものである。
（１）起伏は複数の線状の隆起部を有するとともに、この隆起部同士を交差させていること。
（２）長手状基体がポリテトラフルオロエチレン製であること。
（３）プレス工程では、長手状基体の長手方向と平行な一方の側縁を挟みながらプレスする第１プレス工程と、他方の側縁を挟みながらプレスする第２プレス工程とを有し、長手状基体の中央部分を、第１プレス工程と第２プレス工程とで二重にプレスしていること。
Furthermore, the manufacturing method of the prior confirmation tool for the indwelling position of the catheter of the present invention is also characterized by the following points.
(1) The undulation has a plurality of linear ridges, and the ridges cross each other.
(2) The longitudinal substrate is made of polytetrafluoroethylene.
(3) The pressing step includes a first pressing step for pressing while sandwiching one side edge parallel to the longitudinal direction of the longitudinal substrate, and a second pressing step for pressing while sandwiching the other side edge. The central portion of the substrate is pressed twice in the first press step and the second press step.
本発明によれば、長手状基体の表面にプレス痕による起伏を形成した状態で、長手状基体に熱収縮を生じさせることで、ある一定量の収縮が生じた後に、さらなる熱収縮が生じることを抑制でき、滅菌処理によって所定のマーク館の間隔寸法が縮小することを防止できる。 According to the present invention, the thermal contraction of the longitudinal base body is caused by the occurrence of press shrinkage on the surface of the longitudinal base body, so that a certain amount of shrinkage occurs and then further thermal contraction occurs. It is possible to prevent the distance between the predetermined mark halls from being reduced by sterilization.
まず、本発明におけるカテーテルの留置位置の事前確認具の形態について、図面を用いながら説明する。図１（ａ）は、事前確認具の平面図であり、底面図も平面図と対称に表れる。図１（ｂ）は、事前確認具の正面図であり、背面図も正面図と対称に表れる。図１（ｃ）は、図１（ａ）のＡ−Ａ断面図である。図１（ｄ）は、事前確認具の右側面図であり、左側面図も右側面図と対称に表れる。図２は、図１（ｃ）のＢ−Ｂ断面図である。図３は、事前確認具の参考図である。図１〜３では、事前確認具の形態に特化して説明するために、後述するように事前確認具の表面に形成するプレス痕は省略している。 First, the form of the prior confirmation tool for the indwelling position of the catheter in the present invention will be described with reference to the drawings. Fig.1 (a) is a top view of a prior confirmation tool, and a bottom view also appears symmetrically with a top view. FIG.1 (b) is a front view of a prior confirmation tool, and a rear view also appears symmetrically with the front view. FIG.1 (c) is AA sectional drawing of Fig.1 (a). FIG.1 (d) is a right view of a prior confirmation tool, and a left view also appears symmetrically with a right view. FIG. 2 is a cross-sectional view taken along the line BB in FIG. FIG. 3 is a reference diagram of the prior confirmation tool. In FIGS. 1 to 3, in order to specifically explain the form of the prior confirmation tool, the press marks formed on the surface of the prior confirmation tool are omitted as will be described later.
カテーテルの留置位置の事前確認具は、図１（ａ）及び図３に示すように、一方向に延伸した長手状基体11であって、所定位置にハトメ金具12を装着して貫通孔13を形成しているものである。さらに、長手状基体11には、長手状基体11の長手方向と平行な左右の側縁に凹状に切り欠いた切欠凹部14を設けている。切欠凹部14は、隣り合った２つのハトメ金具12の間に設けることで長手状基体11の幅寸法を小さくしており、長手状基体11を大きい曲率で湾曲可能としている。また、長手状基体11の両端は、中央部分よりも太幅とすることでハンドリング性を向上させている。 As shown in FIGS. 1 (a) and 3, the catheter indwelling position pre-checking tool is a longitudinal base 11 extending in one direction, and is fitted with a grommet 12 at a predetermined position so that a through hole 13 is formed. It is what is formed. Further, the longitudinal base 11 is provided with notched recesses 14 that are notched in the left and right side edges parallel to the longitudinal direction of the longitudinal base 11. The notch recess 14 is provided between two adjacent eyelet fittings 12 to reduce the width of the longitudinal base 11 so that the longitudinal base 11 can be bent with a large curvature. Further, the handling properties are improved by making the both ends of the elongated substrate 11 wider than the center portion.
長手状基体11は、ポリテトラフルオロエチレン製としており、滅菌処理において変質しない材料を用いることが望ましい。ハトメ金具12は、放射線不透視の金属製であれば何であってもよい。本実施形態では、アルミニウム製のハトメ金具12を用いている。ハトメ金具12は、中央が貫通孔13となっていることで、この貫通孔13を利用して油性ペン等のマーキングに用いるペンのペン先を挿入して、患者の体表面へのマーキングを可能としている。ハトメ金具12の替わりに放射線不透視の金属片を長手状基体11に埋め込んでもよく、必要に応じて金属片に貫通孔を形成してもよい。 The elongated substrate 11 is made of polytetrafluoroethylene, and it is desirable to use a material that does not change in sterilization. The eyelet fitting 12 may be anything as long as it is made of radiopaque metal. In this embodiment, an aluminum eyelet fitting 12 is used. The eyelet bracket 12 has a through-hole 13 at the center, so that the pen tip of the pen used for marking oil-based pens can be inserted using this through-hole 13 to mark the patient's body It is said. Instead of the eyelet fitting 12, a radiopaque metal piece may be embedded in the longitudinal base 11, and a through hole may be formed in the metal piece as necessary.
本実施形態の事前確認具では、長手状基体11に複数のハトメ金具12のみを取り付けているが、マーキングの必要のない部分ではハトメ金具12ではなく、適宜の形状の金具を装着して、位置あるいは距離の識別性を向上させてもよい。 In the prior confirmation tool of the present embodiment, only a plurality of eyelet fittings 12 are attached to the longitudinal base body 11, but in a portion that does not require marking, a fitting of an appropriate shape is attached instead of the eyelet fitting 12, Alternatively, distance discrimination may be improved.
以下において、本発明のカテーテルの留置位置の事前確認具の製造方法について説明する。 Below, the manufacturing method of the prior confirmation tool of the indwelling position of the catheter of this invention is demonstrated.
長手状基体11には、日本ゴア株式会社のジョイントシーラントとして販売されているポリテトラフルオロエチレン(PTFE)を用いており、特に、延伸PTFE（ePTFE）であって、太径の一本線状として提供されている。説明の便宜上、太径の一本線状の延伸PTFEを「太径PTFE」と呼ぶこととする。 Polytetrafluoroethylene (PTFE) sold as a joint sealant of Nippon Gore Co., Ltd. is used for the elongated substrate 11, and in particular, it is expanded PTFE (ePTFE) and is provided as a single wire with a large diameter. Has been. For convenience of explanation, the large-diameter single-line expanded PTFE will be referred to as “large-diameter PTFE”.
図４（ａ）及び図（ｂ）に示すように、太径PTFE10をプレスすることで所定厚みの扁平形状として長手状基体11としている。 As shown in FIGS. 4A and 4B, the long base 11 is formed into a flat shape having a predetermined thickness by pressing a large diameter PTFE 10.
特に、本実施形態では、図４（ａ）に示すように、はじめに長手状基体11の長手方向と平行な一方の側縁を挟みながらプレスを行い、次いで他方の側縁を挟みながらプレスを行う２段階でのプレスを行っている。ここで、先に行うプレス工程を「第１プレス工程」と呼び、後に行うプレス工程を「第２プレス工程」と呼ぶこととする。 In particular, in this embodiment, as shown in FIG. 4A, first, pressing is performed while sandwiching one side edge parallel to the longitudinal direction of the longitudinal substrate 11, and then pressing is performed while sandwiching the other side edge. Pressing in two stages. Here, the first pressing step is referred to as a “first pressing step”, and the subsequent pressing step is referred to as a “second pressing step”.
しかも、本実施形態では、第１プレス工程及び第２プレス工程での太径PTFE10のプレスを、図４（ａ）に示すように、ペンチＰを用いて行っている。すなわち、ペンチＰで太径PTFE10を挟んで潰すことで扁平な長手状基体11としている。 Moreover, in the present embodiment, the large diameter PTFE 10 is pressed in the first press process and the second press process using the pliers P as shown in FIG. In other words, the flat longitudinal base 11 is formed by crushing the large-diameter PTFE 10 with the pliers P.
特に、長手状基体11と接触するペンチＰの接触面には、滑り止めとしての凹凸形状が形成されていることで、この凹凸形状が長手状基体11の表面にプレス痕として転写されて、長手状基体11の表面に起伏を形成することとなっている。すなわち、長手状基体11では、表面に起伏を形成することで均一な厚みとしているのではなく、不均一な厚みを有することとしている。 In particular, the contact surface of the pliers P that comes into contact with the longitudinal substrate 11 is provided with an uneven shape as a slip stopper, and this uneven shape is transferred as a press mark on the surface of the longitudinal substrate 11 to form a longitudinal shape. The undulations are formed on the surface of the substrate 11. In other words, the longitudinal substrate 11 does not have a uniform thickness by forming undulations on the surface, but has a non-uniform thickness.
ペンチＰの接触面に形成されている凹凸形状は、具体的には凹条の溝を複数形成することで凹凸形状としているものであることから、長手状基体11の表面の起伏における突出部分は、ペンチＰの接触面の各溝に対応した線状の隆起部15で構成されることとなっている。隆起部15は、直線状となっている場合に限定されず、適宜の曲線状となっていてもよい。また、隆起部15は、隆起部15の延伸方向に一様な高さあるいは一様な幅となっている必要はなく、高さが変動していてもよいし、幅寸法が変動していてもよい。 Since the concavo-convex shape formed on the contact surface of the pliers P is specifically a concavo-convex shape by forming a plurality of concave grooves, the protruding portion in the undulation of the surface of the longitudinal substrate 11 is The linear ridges 15 corresponding to the grooves on the contact surface of the pliers P are formed. The raised portion 15 is not limited to a linear shape, and may be an appropriate curved shape. Further, the raised portion 15 does not need to have a uniform height or a uniform width in the extending direction of the raised portion 15, and the height may vary, and the width dimension may vary. Also good.
隆起部15は、個々に孤立しているよりも、隆起部15同士が交差していることが望ましい。本発明者らは、隆起部15同士が交差したプレス痕が形成されるプレス形態を「クロスプレス」と呼んでいる。 It is desirable that the ridges 15 intersect each other rather than being individually isolated. The present inventors call a press form in which a press mark in which the raised portions 15 intersect each other is formed as a “cross press”.
本実施形態では、第１プレス工程において、図４（ａ）に示すように、太径PTFE10の長手方向と平行な一方の側縁に沿ってペンチＰで繰り返しプレスを行っているが、金型を用いたプレス工程としてもよい。この場合、金型における太径PTFE10との接触面には、隆起部15を形成するための凹凸形状を形成しておくことが望ましい。また、第２プレス工程においても、図４（ｂ）に示すように、太径PTFE10の長手方向と平行な他方の側縁に沿ってペンチＰで繰り返しプレスを行っているが、金型を用いたプレス工程としてもよい。この場合も、金型における太径PTFE10との接触面には、隆起部15を形成するための凹凸形状を形成しておくことが望ましい。 In the present embodiment, in the first pressing step, as shown in FIG. 4A, the pressing is repeatedly performed with the pliers P along one side edge parallel to the longitudinal direction of the large diameter PTFE10. It is good also as a press process using. In this case, it is desirable to form an uneven shape for forming the raised portion 15 on the contact surface of the mold with the large diameter PTFE 10. Also in the second pressing step, as shown in FIG. 4B, pressing is repeatedly performed with pliers P along the other side edge parallel to the longitudinal direction of the large-diameter PTFE10. It may be a pressing process. Also in this case, it is desirable to form an uneven shape for forming the raised portion 15 on the contact surface of the mold with the large diameter PTFE 10.
さらに、第２プレス工程では、第１プレス工程において一度プレスされている長手状基体11の中央部分を再度プレスすることで、長手状基体11の中央部分を第１プレス工程と第２プレス工程とで二重にプレスしている。 Further, in the second pressing step, the central portion of the longitudinal base 11 that has been pressed once in the first pressing step is pressed again, so that the central portion of the longitudinal base 11 is replaced with the first pressing step and the second pressing step. Double press.
このように、長手状基体11の中央部分を第１プレス工程と第２プレス工程とで二重にプレスすることによっても、長手状基体11が不均一な厚みを有することとしている。 As described above, the longitudinal base 11 has a non-uniform thickness even when the central portion of the longitudinal base 11 is pressed twice in the first pressing step and the second pressing step.
第１プレス工程と第２プレス工程によるプレス工程の後に、長手状基体11をオートクレーブによる滅菌処理の温度条件で加熱して、長手状基体11に熱収縮を生じさせている。これが加熱工程である。 After the pressing process by the first pressing process and the second pressing process, the elongated substrate 11 is heated under the temperature condition of the sterilization treatment by the autoclave to cause the elongated substrate 11 to undergo thermal shrinkage. This is the heating process.
図５は、プレス工程後の長手状基体11に対して、オートクレーブによる滅菌処理を繰り返し行った場合の、長手状基体11の長手方向の収縮状態を計測した結果を示すグラフである。図５のグラフの左側のグラフは、長手状基体11の長さの実測値であり、図５のグラフの右のグラフは、プレス工程後の長手状基体11の長さを100%として示したグラフである。図５において、クロスプレスではない長手状基体は、圧延ローラーを使用して太径PTFEを長手状基体11と同様の厚さにまでプレスしたものである。 FIG. 5 is a graph showing the results of measuring the contraction state in the longitudinal direction of the longitudinal substrate 11 when the sterilization treatment by the autoclave is repeatedly performed on the longitudinal substrate 11 after the pressing step. The graph on the left side of the graph of FIG. 5 is an actual measurement value of the length of the longitudinal substrate 11, and the graph on the right side of the graph of FIG. 5 shows the length of the longitudinal substrate 11 after the pressing process as 100%. It is a graph. In FIG. 5, the longitudinal substrate that is not a cross press is obtained by pressing a large diameter PTFE to the same thickness as the longitudinal substrate 11 using a rolling roller.
図５に示すように、クロスプレスを施された長手状基体11では、オートクレーブによる滅菌処理を５回以上実施することで熱収縮が抑制されるが、クロスプレスを施されていない長手状基体では、オートクレーブによる滅菌処理のたびに熱収縮が生じることが明らかである。 As shown in FIG. 5, in the longitudinal substrate 11 subjected to the cross press, the heat shrinkage is suppressed by performing sterilization by autoclave five times or more. However, in the longitudinal substrate not subjected to the cross press, It is clear that heat shrinkage occurs every time sterilization by autoclave.
以上のことから、本実施形態では、加熱工程においてオートクレーブによる滅菌処理を10回実施することとしている。 From the above, in this embodiment, the sterilization process by the autoclave is performed 10 times in the heating process.
加熱工程後、図４（ｃ）に示すように、長手状基体11の所定位置に貫通孔13を形成し、次いで、図４（ｄ）に示すように、貫通孔13にハトメ金具12を装着している。 After the heating step, as shown in FIG. 4 (c), a through hole 13 is formed at a predetermined position of the longitudinal base 11, and then, as shown in FIG. 4 (d), a fitting 12 is attached to the through hole 13. doing.
ハトメ金具12の装着後、図４（ｅ）に示すように、長手状基体11の両端を除いて、長手状基体11の長手方向と平行な左右の側縁をそれぞれ切り落とすことで長手状基体11を細幅とし、さらに細幅とした長手状基体11の長手方向と平行な左右の側縁であって、隣り合った２つのハトメ金具12の間を凹状に切り欠いて切欠凹部14を形成している。 After the attachment of the eyelet fitting 12, as shown in FIG. 4 (e), the left and right side edges parallel to the longitudinal direction of the longitudinal base 11 are cut off, except for both ends of the longitudinal base 11, so that the longitudinal base 11 is cut off. The left and right side edges parallel to the longitudinal direction of the elongated base body 11 are further narrowed, and a notch recess 14 is formed by notching the gap between two adjacent eyelet fittings 12. ing.
切欠凹部14を形成することで、カテーテルの留置位置の事前確認具は完成となる。 By forming the notch recess 14, the prior confirmation tool for the indwelling position of the catheter is completed.
10 太径PTFE
11 長手状基体
12 ハトメ金具
13 貫通孔
14 切欠凹部
15 隆起部
Ｐ ペンチ
10 Large diameter PTFE
11 Long substrate
12 Eyelet bracket
13 Through hole
14 Notch recess
15 ridge P pliers
Claims (4)
前記長手状基体をプレスするプレス工程と、
前記長手状基体を加熱して熱収縮を生じさせる加熱工程と
を有し、
前記プレス工程では、プレスされた前記長手状基体の表面にプレス痕による起伏を形成するカテーテルの留置位置の事前確認具の製造方法。 Before placing a cuff catheter used for hemodialysis in the body, a catheter comprising a longitudinal base body of a predetermined length used for setting the placement position of the blood removal hole and blood feed hole of the cuff catheter under radioscopy In the manufacturing method of the prior confirmation tool of the detention position of
A pressing step of pressing the elongated substrate;
Heating the longitudinal substrate to cause heat shrinkage,
In the pressing step, a method for producing a prior confirmation tool for an indwelling position of a catheter that forms undulations due to a press mark on the surface of the pressed long base.
前記長手状基体の中央部分は、前記第１プレス工程と前記第２プレス工程とで二重にプレスしている請求項１〜３のいずれか１項に記載のカテーテルの留置位置の事前確認具の製造方法。 The pressing step includes a first pressing step for pressing while sandwiching one side edge parallel to the longitudinal direction of the longitudinal substrate, and a second pressing step for pressing while sandwiching the other side edge,
The prior confirmation tool for the indwelling position of the catheter according to any one of claims 1 to 3, wherein the central portion of the longitudinal base is pressed twice in the first pressing step and the second pressing step. Manufacturing method.
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|---|---|---|---|---|
| JP2012214788A (en) * | 2011-03-31 | 2012-11-08 | Toray Ind Inc | Solar cell sealing material sheet and solar cell module |
| JP2015009221A (en) * | 2013-07-01 | 2015-01-19 | 住友電工ファインポリマー株式会社 | Method for producing porous polytetrafluoroethylene membrane |
| JP2015084971A (en) * | 2013-10-31 | 2015-05-07 | 国立大学法人 岡山大学 | Prior check tool of placement position of catheter |
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| JP2012214788A (en) * | 2011-03-31 | 2012-11-08 | Toray Ind Inc | Solar cell sealing material sheet and solar cell module |
| JP2015009221A (en) * | 2013-07-01 | 2015-01-19 | 住友電工ファインポリマー株式会社 | Method for producing porous polytetrafluoroethylene membrane |
| JP2015084971A (en) * | 2013-10-31 | 2015-05-07 | 国立大学法人 岡山大学 | Prior check tool of placement position of catheter |
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