CST Platform 원형 문합기 by Lane Foo is a highly esteemed winner of the very prestigious 2020 A' Design Award 철상 in 의료 기기 및 의료 장비 디자인 Competition Category.

철의료 제품· 2020

CST Platform 원형 문합기

by Lane Foo

Client: Touchstone

A' Design Award 철상 Winner in 의료 제품 Category

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Verified Award Winner
Verify Award Status for #93518

Visit Site View at A' Design Award Press Release Award Badge

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The Design

About CST Platform 원형 문합기

CST 플랫폼은 소화기 외과 수술을 위해 설계된 원형 문합기입니다. 원형 문합기는 장기의 일부를 절제한 후 조직을 접합하여 소화관의 연속성을 복원합니다. 하우징 내부의 지지 구조물을 제거해 장애물이 없는 헤드를 구현함으로써, 피스톤 효과로 인한 스테이플 변형을 감소시켰습니다. 확대된 관형 케이싱은 한 번의 조작으로 더 많은 조직을 절제할 수 있게 합니다. 자동 안전 잠금 장치는 기기가 격발 준비를 완료했을 때만 해제되며, 명료한 벨 소리로 격발이 완료되었음을 확인시켜 줍니다.

The Recognition

About the A' Design Award 철상

CST Platform 원형 문합기, 이 작품은 A' Design Award 철상 수상작으로, 잘 디자인된 창작물에 기대되는 전문적·산업적 요건을 충족하는 좋은 디자인에 수여되는 권위 있는 인정입니다. 철상 수상작은 창작자의 뛰어난 기술, 높은 전문성, 전문가다운 이해, 창의적 역량을 보여 줍니다. CST Platform 원형 문합기, 이 작품은 높이 평가받고 감탄과 사랑을 받는 창작물로서 실용적이고 혁신적일 것으로 기대됩니다. 이 철상 수상 디자인은 업계 모범 사례를 통합하며 노하우와 재능으로 연결된 유능한 기술적 특성을 갖추고 있습니다. CST Platform 원형 문합기, 이 작품은 철저함으로 존중받으며 삶의 질을 개선하여 세상을 더 나은 곳으로 만들도록 디자인되었습니다.

Behind the Design

Press Kit

Credits, team members and technical details provided by the designer.

Unique Properties: The most important thing that surgeons can focus on their patients and the life-saving procedures. Medical devices can help surgeons achieve their goals.
CST platform is an advanced circular stapler platform. A build-in barrier-free structure helps to solve the problem of malformation which caused by the piston effect. Engineer removed the problem maker—internal supporting structure, increased the head volume, to get flat and even tissue condition. This will ensure the tissue won’t milk out from the head part of circular stapler while it is fired.
Safety lock of a circular stapler plays an important role in the surgery. When the indicator is not fully within the green range while tissue is being compressed, attempting to fire may cause a disaster. After firing, re-squeeze the firing handle will also damage the anastomosis ring. That’s why all other circular stapler set a manual safety lock to avoid problems. Nonetheless, surgeons forget to release or reset the safety lock that still occurs. The designer created the 4th generation automatic safety lock. It is smart, will engage driven members only when the instrument is in the correct firing status. This solves problems fundamentally.
CST platform also provides audible feedback to remind the surgeon that she/he has completed the firing successfully.
Dimensions & Packaging: Product dimensions differs in different models. General dimension, height: 501mm, width: 186mm, depth: 34.5mm. Weight: 470g. Firing force: nearly 200N
e.g. CST29: the diameter of the stapler housing is 29mm, the volume of tubular casing is 13.2 cubic millimeter, the area of opening windows: 1332 square millimeter
Tags: Medical device, Surgery, Surgical stapler, Circular stapler, Anastomosis, Barrier-Free, Piston effect, Leverage-Control, Automatic safety lock
Production Technology: We care about all aspects of product experience. We hope that during the firing, the surgeon can not only feel but also hear the feedback from the device. A clear and distinctive bell tone can be heard after firing, which reminds surgeon to avoid re-squeeze the firing trigger. It increases the safety level of an operation.
Design Challenge: Engineer should be balanced by many factors, such as process, material, cost, etc. Engineering validation brings us the great challenges to remove the support structure of stapler housing, the rigidity of the tubular casing is reduced to cause the yaw of the anvil. Engineers work on design, materials, and processes to resolve this contradiction.
Firstly, improve the design. After removing the support structure, engineers insert a stainless steel sleeve in the anti-expansion tube to reduce the gap between the anvil shaft and the anti-expansion tube, increase the precision and coaxial.
Secondly, search for higher strength and biosafety materials to meet new design demands.
Thirdly, in terms of processing and manufacturing processes, machining accuracy must reach the micron level to meet our design expectations. Nonetheless, higher design standards and assembly accuracy have also brought huge challenges to the product percent of pass and cost.
Research: To provide excellent products, engineers had analyzed the main technical indicators such as the stress analysis of the core components, staple formation, etc.
While the instrument is being closed, the head part has to bear up to 90kgf force to compress the tissue. During the firing, it needs another 48kgf force to cut through the washer and 50kgf force to ensure proper staple formation. We have reinforced the structure of the stressed components and selected heavy strength materials to bear the huge force.
The yaw of the anvil is a very important index, which directly affects whether the staple leg can be aligned with the forming notch or not. Engineers designed a yaw test scheme: apply 10kgf lateral force to the anvil to measure its yaw. In this test, the actual swing of CST is less than 0.2 mm, which is 60% less than the average value 0.53mm.
Inspiration: Surgical staples for internal use are medical devices used to deliver compatible staples to internal tissues during surgery. In 1978, the first circular stapler was invented, mainly used in gastrointestinal, gynecological, and thoracic surgery. More than 15 million surgical procedures were done with staplers in 2018 with an increasing rate of 7.2% year by year. For more than 40 years, no breakthrough development of circular staplers’ structure and performance. Problems such as the limited volume of the tubular casing and poor consistency of staple formation have plagued surgeons and manufacturers. In the United States only, annual adverse events due to staples malformation accounted for 32.1% of the overall reports, and almost 1% of patients died accordingly. According to our research，the malformation is caused by the piston effect in the head part of circular stapler. It will challenge us to rethink and redefine what is possible and how we can improve circular staplers to our surgeons and benefit to patients.
Project Duration: Nearly eleven years in development, the project began in January 2008 and released in Suzhou, Milano, New York, and Sydney in August 2018.
Operation Flow: CST platform is used in digestive surgery. It has the same indication as the conventional circular stapler. The main difference is product performance and user experience.
The most clinical benefit of CST platform is that with barrier-free, the occurrence of surgical leakage caused by staple malformation, which is the severe postoperative complication, will decrease remarkably.
Thanks to the enlarged volume of the tubular casing, now with one CST stapler,the surgeon is able to resect the amount of tissue in which conventionally needs two. This helps to reduce the cost of medical treatment for patients.
With the adoption of the 4th generation automatic safety lock, it changes the complicated operation of instruments into simple, shortens the learning curve of surgeons, let them concentrate on the surgery itself.
Patents: Patent No.:
PCT/CN2018/121973, PCT/CN2018/120698, PCT/CN2018/120697, PCT/CN2018/118111, PCT/CN2018/120699, PCT/CN2018/122049, PCT/CN2018/120122
CN201711434954.3, CN201711431490.0, CN201711434138.2, CN201711435672.5, CN201711435644.3, CN201711434086.9, CN201711451948.9, CN201711472884.0, CN201711473924.3, CN201711473925.8, CN201711478115.1, CN201711472892.5, CN201711473891.2
Team Members: Designer：Lane Foo,
Engineer：Terry Lin, Alex Guo, Chris Chen, Jackel Ding, Tom Liu