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금형 내 도금특성에 따른 카테터 팁 성형 공정 개선

이한창1,2, 정진혁3, 이규익1,2, 김우진1, 김규만2, 이봉구4,#orcid

Study on Improvement of Catheter Tip Forming Process according to Plating Characteristics in Mold

Han Chang Lee1,2, Jinhyuk Jung3, Gyu Ik Lee1,2, Woojin Kim1, Gyu Man Kim2, Bong Gu Lee4,#orcid
Journal of the Korean Society for Precision Engineering 2022;39(9):711-721.
Published online: September 1, 2022

1 한국생산기술연구원 첨단메카트로닉스연구그룹

2 경북대학교 기계공학부

3 ㈜바스플렉스

4 대림대학교 기계공학과

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#E-mail: positivethink@daelim.ac.kr, TEL: +82-31-467-4804
• Received: May 16, 2022   • Revised: July 14, 2022   • Accepted: July 19, 2022

Copyright © The Korean Society for Precision Engineering

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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  • Catheter tip forming is processing the tip at the distal end so that catheter can move smoothly through the geometrically complex vascular structure. This thermoforming process has a problem in that the polymer tube adheres to the outer surface of the mold. To resolve this problem, previous researchers have coated the outer surface of the mold with PTFE (Polytetrafluoroethylene), which has a low coefficient of friction. However, due to repeated use, the coating is detached and the polymer tube adheres to the mandrels again, and the mold is frequently replaced. Thus, in this study, three types of metal were electroplated on the surface of the mold in to realize the performance of the PTFE coating. To select the optimal plating material, Cr, Zn, and Ni were selected as candidate groups. Surface energy, adhesion force, and abrasion depth & volume were measured for performance comparison. As a result, Ni, which has similar surface properties to PTFE, and the best durability, was selected as the optimal material. Based on these results, we present Ni-plated mold that can replace PTFE.
  • KEYWORDS: Adhesion, Catheter, Durability, Plating, Surface energy, Tip forming
  • KEYWORDS: 접착, 카테터, 내구성, 도금, 표면에너지, 팁 성형

W

Work of Adhesion

γ

Surface Tension

r

Roughness Factor
1.1 카테터 팁 성형 공정
최소 침습 시술이란 카테터를 이용하여 환자의 병변을 진단하거나, 치료 시 개복을 하지 않고 최소 절개로 시술하는 형태로서 2000년대 초반부터 전 세계적으로 급증하고 있는 대표적인 술기이다. 개복 시술의 경우 장기를 절제하여 시술함으로 절제된 장기 조직에 손상을 일으켜 수술 후 통증을 유발하고 합병증의 원인이 된다. 그에 비해 최소 침습 시술은 개복하지 않고 국부적으로 시술하기 때문에 환자의 고통을 줄일 수 있고, 시술 후 회복도 빠르며, 시술 시에 발생하는 세균 감염률을 줄일 수 있다. 또한 종래의 개복수술에 비해 시술 시간을 단축할 수 있어 시술자들의 집중도를 높일 수 있으며 시술 과정이 간편하여 치료 성공 확률이 높으며, 피부를 최소 절개함으로 미용 효과가 뛰어나다[1-4].
카테터는 도관 형태의 소모성 의료기기로서 환자 신체 내부에 삽입하여 병변을 진단하거나 치료할 때 사용되는 중재 시술 의료분야의 대표적인 의료기기이다[5]. 이중 Introducer Sheath & Dilator는 혈관 내 병변을 진단 또는 치료에 필요한 카테터의 경피적 진입을 도와주는 카테터이다. Introducer Sheath & Dilator의 구성은 Fig. 1과 같이 피부 조직을 천공하는 니들(Needle), 피부에서 피하 조직을 통해 혈관으로 비외상성 전이를 형성하는 혈관 확장기(Vessel Dilator), 진단 및 카테터의 부드러운 삽입을 유도하는 외피(Sheath)로 이루어져 있다[6].
Fig. 1

Schematic diagram of introducer sheath & dilator procedure

KSPE_2022_v39n9_711_f001.jpg
Introducer Sheath & Dilator 제조에 필요한 공정은 크게 네 가지로 나뉘는데 의료용 고분자로 형태와 사이즈를 성형하는 압출 공정과 압출된 튜브를 사양에 맞게 절단하는 공정, 튜브 끝단 형상을 Taper 또는 Round 형상으로 성형하는 팁 성형 공정, 허브를 부착하기 위한 인서트 사출성형 공정으로 이루어져 있다. 그중 팁 성형 공정은 카테터 말단부를 원하는 형상으로 성형하여 구불구불한 혈관 구조를 이동하면서 혈관 내에 손상을 일으키지 않게 하는 공정을 말한다. 따라서 인체 조직에 대한 외상을 최소화하여 혈관 내에 안전하게 삽입하기 위해서는 팁 성형 공정이 필수적으로 요구된다[7].
1.2 기존 공정법의 문제점
카테터 팁 성형 공정은 금형에 열에너지를 공급한 후 고분자 튜브에 연화점 이상의 열을 전달하여 원하는 형상을 성형하는 공정이다. 하지만 금형과 Mandrel이 가열과 냉각과정에 반복적으로 노출되면 Mandrel 외면에 카테터 튜브가 용착되는 현상이 발생하게 되고, 이를 해결하기 위해 기존 산업에서는 금형 표면에 상대적으로 표면에너지가 낮은 불소계 고분자 소재인 PTFE (Poly-Tetrafluoroethylene)를 코팅하여 해결하였다. 하지만 Fig. 2와 같이 PTFE 코팅된 Mandrel의 경우 열 성형 작업 횟수가 많아질수록 코팅이 벗겨져 이를 재차 코팅하거나 새로 제작해야 하기 때문에 제품의 단가 상승, 제조 시간 증가로 이어질 수 있다.
Fig. 2

Limitation of current tip forming process

KSPE_2022_v39n9_711_f002.jpg
1.3 문제점 정의 및 연구 동향
앞서 언급한 바와 같이 폴리머 튜브의 응착 현상을 방지하기 위해 PTFE를 코팅하여 사용해 왔다. 이는 PTFE의 표면 특성에 기인한 문제 해결 방식으로 볼 수 있는데, 통상 접착력은 물질 간 표면 특성에 의해 좌우된다. 이러한 표면 특성에 대한 문제점을 해결하기 위한 선행 연구사례에서는 물질의 표면 상태 및 특성을 파악하는 연구가 활발히 진행되었다.
이 중 2006년 Rha, et al.은 여러 시편들의 표면에너지와 응착력을 측정하여 비교하였다. 특히, 표면 거칠기가 표면에너지와 응착력에 미치는 영향에 대해 연구하였다[8]. 2017년 Alam, et al.은 다양한 소재들의 표면 특성에 따른 바이오 소재의 접합 특성을 알아보고자 소재들의 표면에너지, 거칠기 및 습윤성을 분석하여 이를 평가하였다[9]. 2007년 Kim, et al.은 RG 모델을 기초로 거칠기 돌기가 입자의 하중을 받음에 따라 높이가 변형되는 상호작용을 고려하여 RG 모델과 비교하여 시뮬레이션하였고, AFM을 이용해 시편의 표면 형상 관련 데이터를 계측하였다. 또한 팁과 시편 사이의 분리력(Pull-Off Force)을 계측하여 형상 관련 데이터를 이용해서 계산된 값과 비교하여 상호작용을 고려한 경우의 유효성을 입증하였다[10].
또한 PTFE 코팅 마모의 경우 재료 자체의 강도 및 경도와 같은 기계적 특성에 기인하는 결과로, 이를 공학적으로 정의하기 위한 연구 또한 많이 수행되어왔다. 2010년 Kim, et al.은 피스톤 재료로 사용되고 있는 SACM645 소재를 다양한 방법으로 열처리를 실시하고, DLC 코팅한 시험편으로 건조 상태에서 코팅 마모 특성을 조사하였다[11]. 2017년 Kim, et al.은 고부하 롱피치 롤러 체인의 부품간 마모 거동을 분석하고, 마모 시험을 통해 마모 특성을 평가하였다[12].
이와 같은 접착력과 물질간 표면 특성에 대한 연구가 많이 이루어졌으나, 카테터 팁 성형에 적용할 수 있는 표면 특성 연구와 실험이 부족한 실정이다. 따라서 본 연구에서는 상기에 언급한 선행 연구 자료에서 고찰할 수 있는 기계 재료의 표면 특성과 기계적 특성에 대한 자료를 바탕으로 카테터 팁 성형 공정에 이형성과 내구성이 좋은 금속소재를 적용함으로써 기존 PTFE 코팅 방식의 문제점을 개선하고자 한다.
2.1 접착성(Work of Adhesion) 분석법
접착력은 두 물체의 평형 상태에서 무한의 거리까지 분리하는데 필요한 가역적 열에너지로 정의된다. 식(1)에 액체, 고체 조합에 대한 Work of Adhesion을 나타내었다[13].
(1)
Wa=γL+γS-γSL
여기서 γL mJ/m2은 액상의 표면장력, γS mJ/m2는 고체상의 표면장력, γSL mJ/m2은 고체와 액체 사이의 표면장력, Wa mJ/m2는 접착에너지를 나타낸 것으로 고체의 표면에너지가 증가하면 접착에너지가 증가함을 알 수 있다. 식(1)에서 알 수 있듯 고체 표면의 접착성은 습윤성에 영향을 받는 것을 알 수 있으며 이는 액체/고체/기체 3상이 이루는 접촉각을 통해 직접 계산할 수 있다. 이에 대해 영향을 주는 요소로서는 고체 표면에서의 접촉각, 표면의 거칠기, 재료의 극성 등이 있다. 이러한 요소들을 고려하여 측정된 접촉각을 Lewis Acid/Base 식에 적용하였고, 분석 시편 표면에 작용하는 표면장력을 Lifshitz Van Der Walls 성분과 Lewis Acid/Base 성분으로 나누어 식(2)와 같이 표현하였다.
(2)
γS=γSLW+γSAB
여기서 γS는 앞서 언급한 고체의 표면장력이고, γSLW mJ/m2는 Lifshitz Van Der Walls 성분의 표면장력, γSAB mJ/m2는 Lewis Acid/Base 성분의 표면장력이다. 그리고 Lewis Acid/Base 성분을 아래의 식(3)과 같이 Acid 성분의 표면장력(γSA), Base 성분의 표면장력(γSB)으로 나눌 수 있다.
(3)
γSAB=2γSAγSB
이를 통해 앞서 기술한 Work of Adhesion 계산에 필요한 물성치를 확보하였다. 이후 Young의 방정식을 통해 표면에너지를 직접 계산하여 접착에너지를 비교하고자 이에 대한 분석 순서도를 Fig. 3과 같이 설정하였다.
Fig. 3

Flow chart of analysis conditions required for optimal plating material selection

KSPE_2022_v39n9_711_f003.jpg
먼저 분석에 필요한 시편을 제작하고, 제작된 시편은 통상 친수성의 금속소재이므로 표면 거칠기를 고려할 때 Wenzel 모델을 적용할 수 있다. 따라서 실험을 통해 얻을 수 있는 접촉각은 식(4)와 같이 정의된다[14-16].
(4)
cos θm=r⋅cos θy
여기서 θm degree는 거친 표면에 대한 접촉각을 나타내고, θy degree는 이상적인 평평한 표면에 대한 Young의 방정식의 접촉각 값이며, r은 Roughness Factor를 나타낸다. 여기서 r을 계산하는 식(5)는 아래와 같다. 일반적으로 표면의 값이 1이면 이상적인 평면이고 값이 1보다 크면 거친 평면으로 구분할 수 있다.
(5)
r=1+Sdr100
여기서 Sdr (%)은 표면 면적에 대한 거칠기 비율로서 접촉각 측정을 위한 용액 방울이 증착되는 고체 표면의 투영 영역과 거친 영역 사이의 비율을 말한다[17]. Sdr은 AFM (Atomic Force Microscope)을 사용하여 측정하였으며 결과를 기반으로 얻어진 표면 거칠기의 정량적 수치를 식(6)에 대입하여 계산하였다.
(6)
Sdr=1A∬1+∂zx,y∂x2+∂zx,y∂y2dxdy
이후 계산값을 표면에너지 계산에 대입하여 접착력을 예측하고, 실제 접착력을 AFM을 통해 측정함으로써 습윤성과 접착력의 관계를 검증하였다[18,19].
2.2 도금 소재 선정 및 시편
도금 소재를 선정하기에 앞서 소재 특성을 파악하기 위한 시편을 가로 43.2, 세로 30.5, 두께 5 mm로 제작하였다. 또한 시편의 표면에 두께 7-10 μm 수준의 도금층을 Fig. 4와 같이 증착하였다. 이 중 Figs. 4(a)와 4(c)인 Cr, Zn를 전기적 방법, 4(b)인 Ni를 전류를 사용하지 않고 용액에서 화학적인 환원을 통해 증착하였다[20-22]. 또한 기존 팁포밍 공정 개선을 위해 SUS420으로 가공된 핀에도 동일한 소재의 도금을 진행하였다.
Fig. 4

Check the surface plating elements of the specimens

KSPE_2022_v39n9_711_f004.jpg
준비된 시편들의 원소를 EDS (Energy Dispersive X-Ray Spectrometer)를 활용하여 분석하였다. 그 결과를 Fig. 4에 도시하였다. 해당 결과를 보았을 때 SEM 측정을 위한 백금(PT), 지르코늄(Zr)이 일부 검출되었으나 표면상에서 도금 소재가 주를 이루는 것을 확인할 수 있으며 PTFE의 경우 불소계 고분자 유기물이므로 플루오린(F), 탄소(C)가 주성분임을 확인하였다. 이를 보아 제작된 시편의 도금이 양호하게 이루어졌음을 확인할 수 있다.
3.1 접촉각 분석 결과
측정을 위해 고체 표면 위에 용액을 떨어뜨려 측정하는 방법인 Sessile Drop 방법을 사용하여 접촉각을 측정하였으며 SEO사의 Phoenix 300 Touch 장비에서 ASTM D5946에 의거하여 측정하였다[23]. 또한, 각 측정에 사용한 용액은 극성 용액인 Di-water와 Glycerol을 사용하였고, 비극성 용액으로 Diiodomethane을 사용하였다. 각 용액에 대한 표면장력을 Table 1에 정리하였다[24]. 측정에 사용된 용액 양은 0.003-0.004 ml이고, 모든 접촉각 측정은 5회 반복 측정하여 편차를 구하였다. Table 2에 용액에 따른 접촉각 측정 결과를 정리하였다.
Table 1

Surface tension data of various solutions

Table 1
Test
liquid		 Surface tension [mJ/m2]
γs γSLW γSAB γSA γSB
Di-water 72.8 21.8 51 25.5 25.5
Diiodomethane 63.4 34 29.4 3.92 57.4
Glycerol 50.8 50.8 0 0.72 0
Table 2

Comparison of contact angle data

Table 2
Specimen
liquid		 Cr Ni Zn PTFE
Di-water [o] 89.2 96.7 65.6 109.1
Diiodomethane [o] 48.1 53.4 46.2 58.3
Glycerol [o] 81.2 102.3 88.6 95.9
앞서 제시한 측정법을 통해 각 시편들의 접촉각을 측정하였고 그 결과를 Table 2에 정리하였다. 기존에 연구된 사례들과 마찬가지로 Cr, Zn의 경우 90o 또는 이하의 접촉각을 나타냈으며 이는 친수성을 띤다는 것을 나타낸다. 반면 Ni의 경우 금속소재임에도 불구하고 접촉각이 96.7o로 소수성을 나타냈다. 또한 폴리머 소재인 PTFE는 109.1o의 접촉각이 측정되어 소수성임을 확인하였다.
3.2 표면 거칠기 측정 결과
거친 표면을 고려한 Wenzel 모델을 적용하여 표면에너지를 계산하고자 한다. 그에 앞서 고체 표면의 값(Roughness Factor)을 계산하기 위해 각 시편의 값을 AFM (Atomic Force Microscopy) 장비의 Non-Contact Mode를 사용하여 측정하였다. Non-Contact Mode는 실리콘 또는 실리콘 질화물로 만든 표준 캔틸레버를 사용하여 공기 또는 액체에 접촉식으로 적용되는 Tapping 또는 AM Mode와 달리 캔틸레버 편향 자체를 구동 신호로 사용하여 캔틸레버가 공진 주파수의 변화에 즉시 반응하여 측정하는 방식이다. 해당 분석법에서 얻어진 결과를 분석 Software인 XEI를 활용하여 시편의 Ra (Average Roughness), Sdr, r 값을 계산하여 그 결과를 Fig. 5에 정리하여 나타냈다.
Fig. 5

Graph of surface roughness measurement result

KSPE_2022_v39n9_711_f005.jpg
3.3 표면에너지 계산 결과
앞서 측정된 접촉각을 Young의 방정식과 결합하여 액체와 고체 사이의 Work of Adhesion을 식(1)과 같이 나타냈다.
(1)
γS1+cos θrr=2γSLWγLLW+γSAγLB+γSBγLA
여기서, θr은 각 시편에서 얻어진 접촉각이며 Wenzel 모델을 적용한 표면 거칠기 상수 r을 계산에 반영하였다.
또한 앞서 언급한 고체의 Lifshitz Van Der Walls 성분의 표면장력, Lewis Acid/Base 성분의 표면장력 값을 계산하고자 접촉각 측정에 사용한 용액의 표면장력 값을 대입하였다. 이를 통해 정리된 행렬식(2)을 통해 시험용액에 따른 표면에너지를 계산하여 그 결과를 Fig. 6에 나타냈다.
(2)
γWLWγWBγWAγDMLWγDMBγDMAγGLWγGBγGAγSLWγSAγSB=γW1+cos θrr2γDM1+cos θrr2γG1+cos θrr2
Fig. 6

Graph of summaries of the contact angle measurement results and surface energy calculation results

KSPE_2022_v39n9_711_f006.jpg
표면에너지 계산 결과 Di-water 기준 Cr은 39.27이었고, Ni는 35.23, Zn은 42.92, PTFE는 31.43 mJ/m2로 Ni 도금된 시편이 금속소재 중 표면에너지가 가장 낮음을 알 수 있다. 이는 동일한 극성 용액인 Glycerol에서도 유사한 경향을 나타냈으며 비극성 용액인 Diiodomethane에서도 Ni의 표면에너지가 가장 낮았다. 이는 앞선 이론적 배경에서 언급한 고체 표면과 액체가 이루는 접촉각에 기인한 결과라고 볼 수 있으며 Ni와 PTFE 간의 표면에너지 차이가 가장 적으므로 이형성 면에서 Ni가 가장 적합함을 확인하였다.
3.4 접착력 분석 결과
본 연구에서 사용된 시편들의 접착력을 측정하여 비교하기 위해 AFM의 Contact Mode를 사용하였다. 접착력을 측정하는 원리는 AFM의 켄틸레버 팁이 시편의 표면에서 접촉 후 이탈하면서 발생하는 접착력과 접착에너지를 측정하는 방법으로서 캔틸레버 팁의 접촉은 탄성체의 접촉을 고려한 Johnson, Kendall 및 Roberts (JKR)의 모델에 의해 정의할 수 있다. 따라서 본 연구에서는 캔틸레버 팁이 시편 표면에 분리될 때의 거리(Adhesion Distance)와 힘(Adhesion Force)을 측정하였고, 측정결과를 Fig. 7에 도시하였다.
Fig. 7

Results of adhesion force & distance

KSPE_2022_v39n9_711_f007.jpg
해당 측정 결과를 살펴보면 도금이 되지 않은 PTFE를 제외한 도금 소재 중 Ni 시편의 접착력과 접착 거리가 각각, 1.59 nN, 181.66 nm으로 Cr(1.97 nN, 210.79 nm), Zn(2.05 nN, 226.19 nm)에 비해 상대적으로 낮은 접착력을 가지는 것을 확인하였다. 이는 앞서 측정한 표면에너지 측정 결과에서 예측한 바와 같이 니켈 도금이 가장 낮은 표면에너지를 가진 데에 기인한 결과로 사료되며, 마찬가지로 상대적으로 높은 표면에너지 값을 가진 Cr, Zn이 예측한 바와 같이 접착에너지가 높은 것을 확인할 수 있었다. 표면에너지가 가장 낮은 PTFE가 접착력이 낮을 것으로 예상하였지만 접착력이 높게 측정됨을 알 수 있다. 이는 Kim의 연구에서도 동일하게 발생한 현상인데, 해당 연구에 따르면 PTFE 소재 본연의 탄성계수와 경도가 매우 낮아 AFM 캔틸레버 팁의 선단이 시편의 표면과 접촉할 시 변형이 일어남에 따라 접촉 면적이 커져 접착력이 크게 나타나는 것이라 정의하였다. 이와 마찬가지로 상기의 측정 결과에서도 동일한 현상이 발생한 것으로 사료된다[8].
3.5 마모시험 결과
앞서 수행된 도금 소재의 내구성을 검증하고자 마모시험을 진행하였으며 Bruker 사의 UMT-Tribolab 장비를 사용하였다. 시험기 베드에 측정 시편을 고정한 후 핀에 장착된 강구를 시편 표면에 위치시키고 15 N의 하중과 0.5 mm/s 속도의 직선왕복운동을 진행한다. 이때 발생된 반력 값을 Friction/Load Sensor를 통해 읽어드림으로써 시편의 내마모성을 평가하게 된다. 마모시험이 완료된 시편들의 마모 상태를 확인하기 위해 ZEISS 사의 공초점 현미경(Confocal Laser Scanning Microscopy)을 사용하였으며 각 시편의 마모 상태를 Fig. 8에 도시하였다. 네 종류의 시편 모두 강구의 왕복운동에 의해 표면에 압흔이 남은 것을 확인할 수 있으며 그 크기를 정성적으로 비교하였을 때 PTFE의 마모가 가장 두드러지게 큰 것을 확인할 수 있다. 또한 Fig. 9와 같이 측정 결과를 정량적으로 비교하였을 때 Ni 도금된 시편의 마모된 체적이 가장 낮았으며, Cr, Zn 순으로 높은 결과 값을 나타냈다.
Fig. 8

Results of wear test

KSPE_2022_v39n9_711_f008.jpg
Fig. 9

Quantitative comparison results of wear amount and maximum depth for various specimens

KSPE_2022_v39n9_711_f009.jpg
이를 보아 내마모성이 가장 좋은 도금 소재는 Ni임을 알 수 있었다. 이러한 결과는 소재 고유의 경도에 기인한 결과로 생각할 수 있으며, 선행 연구자료를 참고하였을 때 Ni의 비커스 경도는 32.3, Cr은 29.2, Zn은 18.4 Hv로, 본 연구 결과에서 측정한 마모량과 반비례 관계에 있음을 확인할 수 있다. 또한 PTFE 코팅된 시편은 앞선 금속소재에 비해 매우 낮은 내구성을 보였다.
4.1 프로토타입 제작 및 성능평가 방법
Fig. 10은 PTFE가 코팅된 Mandrel과 분석 결과를 바탕으로 최적 도금 소재로 채택한 Ni 소재가 도금된 Mandrel의 모습을 나타낸 사진이다. 해당 Mandrel의 성형 정밀도와 내구성을 평가하기 위해 각각 100회 반복 사용하여 팁 성형 실험을 진행하였다. 앞서 언급한 성형 정밀도 평가의 경우 실험에서 나온 결과물을 Micro CT Scanner 장비를 사용하여 팁 성형부의 치수를 정밀 측정하였다. 또한 내마모성 평가의 경우 Mandrel들의 표면 상태를 정성적으로 평가하기 위해 SEM을 활용한 실험 전과 후의 표면 상태를 비교하였고, AFM을 이용한 표면 거칠기 값을 정량적으로 측정하여 비교하였다.
Fig. 10

Ni applied prototype for performance evaluation

KSPE_2022_v39n9_711_f010.jpg
성형 정밀도 평가를 위한 목표 형상과 실험장비를 Fig. 11에 도시하였다. 튜브 외경은 시중에 판매되는 Introducer Sheath & Dilator에 주로 사용되는 5 Fr(1.67 mm)로, 내경은 1.2 mm로 결정하였다. 또한 튜브의 팁 내경의 경우 5 Fr 카테터 시술에 주로 사용되는 1 직경의 가이드와이어가 원활히 삽입될 수 있도록 1.04 mm로 설계하였고, 말단부의 Round를 1 mm 반경으로 설정했으며, 경피적 삽입을 원활히 할 수 있게 3o의 Taper 구간을 5 mm 길이로 결정하였다. 또한 실험에 사용된 카테터 팁 성형기는 Plastic Weld Systems Inc.의 HPS10-MXP을 사용하였다. 해당 성형 장비의 경우 튜브를 고정하는 그리퍼와 금형 내부로 진입시켜주는 공압 실린더로 이루어진 이송계가 존재하며, 공정 진행 방향을 따라 최종 카테터 팁 형상을 가공하는 금형과 열에너지를 공급하는 코일, 성형이 마무리된 후 금형을 냉각할 수 있는 공압 노즐로 이루어진 성형부가 위치한다. 개선된 금형의 성능평가를 위해 최적의 공정 조건을 설정할 필요가 있다. 따라서 열화상 카메라를 통해 설정한 공정 조건에서의 금형의 온도 변화 양상을 살펴보았다. 측정 결과 금형 외부 온도가 최대 83.8oC까지 상승하는 것으로 나타났으며 이는 실험에 사용될 고분자 소재인 LDPE (Low Density Polyethylene)의 유리전이온(Tg) 이상, 용융온도(Tm) 이하로 가열, 유지되고 있음을 시사한다. 반면 냉각 시 금형 온도가 최대 24.3oC까지 하강됨을 확인하였다. 실험실 온도가 평균 24-26oC인 것을 감안하면 공정 후 금형의 냉각이 양호하게 이루어짐을 알 수 있다.
Fig. 11

Preparation of target and equipment for performance evaluation

KSPE_2022_v39n9_711_f011.jpg
앞선 성형 정밀도 평가와 더불어 금형의 내구성을 정량적으로 검증할 필요가 있다. 따라서 본 연구에서는 사용하기 전, 50회 사용 후, 100회 사용 후로 실험군을 나누었으며 이때의 표면 상태를 SEM과 AFM으로 분석하여 평가하였다.
4.2 카테터 팁 성형 실험 결과
카테터 팁 성형 결과물의 치수 정밀도를 확인하기 위해 팁 성형된 튜브를 성형부 끝단부터 약 10 mm로 잘라 측정 시편을 구성하였다. 측정에 사용된 Micro CT Scanner 장비에서 튜브에 방사선을 조사하여 3D 모델로 재구성하였고, 1/2 지점상의 단면 형상을 Fig. 12와 같이 주요 형상 치수를 측정하였고, 그 결과를 Table 3에 정리하였다.
Fig. 12

Result of dimensional precision test for performance evaluation of Ni applied mold

KSPE_2022_v39n9_711_f012.jpg
Table 3

Comparison of target dimensions and experiment result

Table 3
Target PTFE Ni
Angle [o] 3 3.08 3.07
Length [mm] 5 4.95 4.92
Tip hole [mm] 1.04 1.04 1.03
Round [mm] 1 0.97 0.99
측정 결과에 따르면 혈관에 원활히 삽입될 수 있도록 도와주는 Taper부의 각도와 길이는 3.07o 와 4.92 mm로 측정되었다. 또한 말단부의 라운드는 0.99로 측정되었고, 가이드와이어가 삽입되는 카테터 팁 내경은 1.03 mm로 측정되었다. 이를 통해 본 연구에서 개발한 프로토타입이 기존에 사용되어오던 PTFE가 적용된 금형과 동일한 수준의 성형 성능을 보인다는 것을 확인할 수 있다.
Fig. 13

Qualitative comparison results of the surface of two specimens according to the number of cycles

KSPE_2022_v39n9_711_f013.jpg
4.3 프로토타입 내마모성 평가
실험에서 사용된 프로토타입의 내마모성을 정성적으로 평가하기 위해 사용하기 전과 50번 사용했을 때와 100번 사용했을 때의 표면 상태를 SEM을 통해 확인하였다.
앞선 실험 결과에서 알 수 있듯 프로토타입에서는 PTFE와 같은 마모가 발생하지 않았다. 이를 정량적으로 분석하기 위해 3개의 구간을 설정하여 해당 영역의 표면 거칠기를 측정하였고, 그 결과를 Fig. 14에 나타냈다.
Fig. 14

Comparison of surface roughness before and after experiment of Ni pleated prototype

KSPE_2022_v39n9_711_f014.jpg
분석 결과 사용 전의 Roughness는 Figs. 14(1)부터 14(3) 지점에서 각각 80.45, 81.56, 79.44 nm로 나타났으며 사용 후 79.32, 80.20, 81.28 nm로 사용 횟수가 증가하였음에도 불구하고 표면 거칠기에 큰 영향이 없는 것을 확인하였다. 이를 통해 본 연구에서 제안한 금속 도금법이 반복적인 카테터 생산에 적합함을 알 수 있으며 종래의 PTFE 코팅보다 월등한 내구성을 가진다는 것을 알 수 있다.
본 연구는 종래의 카테터 팁 성형 공정에 적용되어오던 PTFE 코팅을 대체하고자 상대적으로 내구성이 뛰어나고, 접착 성능이 비슷한 최적의 도금 소재를 선정하고자 Cr, Ni, Zn의 접촉각에 따른 표면에너지 및 접착력, 마모시험을 수행하였다. 정밀한 분석을 위해 시편의 표면 상태를 정의하고자 AFM의 Non-Contact Mode를 사용하여 시편의 표면 거칠기를 알아보았다. 측정 결과에서 얻어진 표면 거칠기 값을 바탕으로 표면 거칠기 상수를 계산하였고, 그 결과를 Lewis Acid/Base에 적용하여 표면에너지를 계산하였을 때 PTFE를 제외한 3개의 시편 중 Ni의 표면에너지 값이 가장 낮은 것을 확인하였다. 이후 시편의 접착력을 측정하기 위해 AFM의 Contact Mode를 사용하였으며, 그 결과 앞선 표면에너지 측정 결과에서 예측한 바와 같이 Ni의 접착력이 가장 낮은 것을 확인할 수 있었다. 또한 내마모성을 평가하고자 마모시험을 진행하여 시편의 내구성을 평가하였을 때 Ni 도금 시편이 내마모성 또한 가장 뛰어남을 확인할 수 있었으며 이는 소재 자체의 경도에 기인한 결과임을 확인하였다.
앞선 분석 결과를 바탕으로 Ni를 최적의 도금 소재로 선정하였고, 카테터 팁 성형 공정에 적용되었을 때의 성능을 평가하고자 목표 형상을 정의하여 실험을 진행한 후 성형성, 내마모성의 정성적/정량적 평가를 진행하였다. 성형성의 경우 PTFE 코팅된 Mandrel의 성형 결과와 동일한 성능을 내는 것을 확인하였으며, 내마모성의 경우 사용하기 전, 50회 사용 후, 100회 사용 후의 표면 상태를 SEM을 통해 정성적 평가를 진행하였는데, 그 결과 PTFE의 경우 50회 사용 시점부터 표면이 손상되기 시작하였고, 100회 사용에 이르렀을 때 대부분 벗겨지는 것을 확인할 수 있었다. 반면, Ni 도금의 경우 사용 전과 50회 사용 후, 100회 사용 후의 표면 상태가 일정하게 유지되는 것을 확인하였으며, 별다른 손상이나 이물질 등이 발견되지 않음을 확인하였다. 이를 더욱 정량적으로 평가하고자 사용 전과 사용 후 Mandrel을 3개의 구간으로 나누어 AFM 측정을 진행한 결과, 표면 거칠기 값이 일정하게 유지되는 것을 확인하였다. 이를 보아 Ni로 Mandrel를 도금하는 것이 PTFE의 성형 능력을 구현함과 동시에, 내마모성을 획기적으로 개선할 수 있다고 말할 수 있으며, 이러한 결과는 카테터 제조 공정의 개선 및 생산성 향상을 유도할 수 있을 것으로 기대한다.
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Han Chang Lee
KSPE_2022_v39n9_711_bf001.jpg
Ph.D. candidate in the School of Mechanical Engineering, Kyungpook National University and Korea Institute of Industrial Technology. His research interest is minimally invasive medical device.
Jinhyuk Jung
KSPE_2022_v39n9_711_bf002.jpg
He received his M.S. degrees in Mechanical Engineering from Kyungpook National University, Korea in 2021. He is currently a researcher in VASFLEX Co., Ltd.. His research interest is medical device.
Gyu Ik Lee
KSPE_2022_v39n9_711_bf003.jpg
M.S. candidate in the School of Mechanical Engineering, Kyungpook National University and Korea Institute of Industrial Technology. His research interest is minimally invasive medical device.
Woojin Kim
KSPE_2022_v39n9_711_bf004.jpg
Principal researcher in the Korea Institute of Industrial Technology. His research interests are minimally invasive medical device, polymer extrusion, aerosol control and electrospray.
Gyu Man Kim
KSPE_2022_v39n9_711_bf005.jpg
Professor in the School of Mechanical Engineering, Kyungpook National University. His research interest is MEMS and its applications.
Bong Gu Lee
KSPE_2022_v39n9_711_bf006.jpg
Professor in the Department of Mechanical Engineering, Daelim University Collage. His research interests are precision machining, CAD/CAM and 3D printing.

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Study on Improvement of Catheter Tip Forming Process according to Plating Characteristics in Mold
J. Korean Soc. Precis. Eng.. 2022;39(9):711-721.   Published online September 1, 2022
DOI: https://doi.org/10.7736/JKSPE.022.065
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Study on Improvement of Catheter Tip Forming Process according to Plating Characteristics in Mold
J. Korean Soc. Precis. Eng.. 2022;39(9):711-721.   Published online September 1, 2022
DOI: https://doi.org/10.7736/JKSPE.022.065
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Study on Improvement of Catheter Tip Forming Process according to Plating Characteristics in Mold
Image Image Image Image Image Image Image Image Image Image Image Image Image Image
Fig. 1 Schematic diagram of introducer sheath & dilator procedure
Fig. 2 Limitation of current tip forming process
Fig. 3 Flow chart of analysis conditions required for optimal plating material selection
Fig. 4 Check the surface plating elements of the specimens
Fig. 5 Graph of surface roughness measurement result
Fig. 6 Graph of summaries of the contact angle measurement results and surface energy calculation results
Fig. 7 Results of adhesion force & distance
Fig. 8 Results of wear test
Fig. 9 Quantitative comparison results of wear amount and maximum depth for various specimens
Fig. 10 Ni applied prototype for performance evaluation
Fig. 11 Preparation of target and equipment for performance evaluation
Fig. 12 Result of dimensional precision test for performance evaluation of Ni applied mold
Fig. 13 Qualitative comparison results of the surface of two specimens according to the number of cycles
Fig. 14 Comparison of surface roughness before and after experiment of Ni pleated prototype

Fig. 1

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Fig. 14

Study on Improvement of Catheter Tip Forming Process according to Plating Characteristics in Mold
Test
liquid		 Surface tension [mJ/m2]
γs γ S L W γ S A B γ S A γ S B
Di-water 72.8 21.8 51 25.5 25.5
Diiodomethane 63.4 34 29.4 3.92 57.4
Glycerol 50.8 50.8 0 0.72 0
Specimen
liquid		 Cr Ni Zn PTFE
Di-water [o] 89.2 96.7 65.6 109.1
Diiodomethane [o] 48.1 53.4 46.2 58.3
Glycerol [o] 81.2 102.3 88.6 95.9
Target PTFE Ni
Angle [o] 3 3.08 3.07
Length [mm] 5 4.95 4.92
Tip hole [mm] 1.04 1.04 1.03
Round [mm] 1 0.97 0.99
Table 1 Surface tension data of various solutions
Table 2 Comparison of contact angle data
Table 3 Comparison of target dimensions and experiment result

Table 1

Table 2

Table 3

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