3d printed totally bioresorbable stents · 2018-01-12 · 3d printing technology laser cut...
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Add:5 Kaituo Road, Suite A101 Haidian District Tel:010-62977955 Fax:010-62976827
北京阿迈特医疗器械有限公司
Beijing Advanced Medical Technologies Co., Ltd
Qing Liu, PhDBeijing Advanced Medical Technologies Co., Ltd
Adjunct professor, Institute of advanced material and nanomedicine, Tongji University
Tallinn And Helsinki Feb. 05-11, 2018.
北 京 阿 迈 特 医 疗 器 械 有 限 公 司
Beijing Advanced Medical Technologies Co., Ltd
3D Printed Totally Bioresorbable Stents
CONTENTS
Introduction to AMT
Novel 3D Printing Technology
Totally Bioresorbable Stents
Stent Delivery System
Proposals
北 京 阿 迈 特 医 疗 器 械 有 限 公 司
CONTENTS
Introduction to AMT
Novel 3D Printing Technology
Totally Bioresorbable Stents
Stent Delivery System
Proposals
北 京 阿 迈 特 医 疗 器 械 有 限 公 司
• A leading company specialized in commercialization of 3D
printed bioresorbable stents
• Found in 2011 in Beijing, China
• 3800m2 of Class 10K GMP Manufacturing facility and lab space
• With 43 employees
Add:5 Kaituo Road, Suite A101 Haidian District Tel:010-62977955 Fax:010-62976827
Stent Printing Stent Crimping
Radial Force Testing Analytical Lab In-process Stent Inspection
Drug Eluting Coating
GMP Complained Manufacture facility
Add:5 Kaituo Road, Suite A101 Haidian District Tel:010-62977955 Fax:010-62976827
• Technology originally developed in 3D Biotek, NJ ,
US, and transferred to AMT in Beijing, China
Add:5 Kaituo Road, Suite A101 Haidian District Tel:010-62977955 Fax:010-62976827
2015 Cardiovascular Disease Report of China
# of Cardiovascular patients is expected to grow in the next 10 years
Cardiovascular Disease is the #1 Cause of Death in ChinaRural Region Metropolitan Region
Add:5 Kaituo Road, Suite A101 Haidian District Tel:010-62977955 Fax:010-62976827
Coronary Stent Market and PCI Procedures
Annual PCI Procedure Growth Rate
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
Cardiovascular Disease is the #1 Cause of Death in China
Annual # of PCI Procedures
Target Market II: Peripheral Artery Disease (PAD)
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
Diabetic Patients in China:~ 113 millionPAD patients:~22 millionAmputation:> 1 million
Diabetic patients are often having PAD
Stenting is an effective way of treating PAD
CONTENTS
Introduction to AMT
Novel 3D Printing Technology
Totally Bioresorbable Stents
Stent Delivery System
Proposals
北 京 阿 迈 特 医 疗 器 械 有 限 公 司
激光切割
• 多步成型,加工繁琐
• 每步成品率低,成本高
• 材料利用率低(﹤10%)
• 关键技术被大量专利覆盖
Polymer Tubing Extrusion Laser Cutting
Laser Cut Technology
• Multi-step process• 80-90% material wasted• Patent protected, no freedom to
operate (FTO)
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
Horizontal type
Vertical type
BVS
Reference standard
Abbott’s Absorb BVS
feasibility:traditional 3D printing
Vascular Bioresorbable Scaffold Using 3D Printing?
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
˂5 min
1 step process
• Multi-step process
• Lower yields, high cost
• Most material wasted(>90%)
• No FTO
• One step process (﹤5 min)
• Highly efficient in using materials
• Capable producing complicated structure
• Proprietary Technology, FTO
Laser Cut Technology3D Printing Technology
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
BRS using 3D printing
Traditional 3DP
Novel 3DP
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
A. Polyglycolide (PGA) stents; B. Poly(lactide –co –glycolide) 50/50 stents; C. Polyurethane stents.
PCL stents
Stents With Various Materials
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
PLLA stents: (A) helical; (B) closed-cell; (C) zig-zag; (D) complex。
PCL stents
Stent with various structures
Stents with Various Designs
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
CONTENTS
Introduction to AMT
Novel 3D Printing Technology
Totally Bioresorbable Stents
Stent Delivery System
Proposals
北 京 阿 迈 特 医 疗 器 械 有 限 公 司
AMSorb
AMSorbTM, 3D Printed Coronary Stents With An Innovative Design
Ability To Adapt To Anatomic Shape Of The Vessels
Sirolimus Drug Eluting PLLA Stents from AMT
Strut Thickness: ~0.14 mmStrut Cross-Section: Round (~0.015 mm2)
Add:5 Kaituo Road, Suite A101 Haidian District Tel:010-62977955 Fax:010-62976827
支架 生产商 材料
AMT 北京阿迈特 聚乳酸
BVS 美国雅培 聚乳酸
Manufacture Abbott AMT
BRS Design
Structure Open Cell, Multi-Link Closed Cell
Material PLLA PLLA
Processing Laser Tube Cutting 3D Multi-Axial Fabrication
Strut
Thickness0.15~0.17 mm 0.13~0.15 mm
AMSorbBVS
Comparison Between BRS and Metallic Stent (Coronary)
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
Cross section reduced 41%.
Advantages:
1. Less blood flow disturbance 2. Fast endothelization3. Reduced total resorption time.
Comparison of cross sections of struts of the two types of stents
0.03 mm2
0.0154 mm2
0.00 0.01 0.02 0.03 0.04
激光切割BVS
矩形横截面
3D打印BRS
圆形横截面
支架杆横截面积比较
Add:5 Kaituo Road, Suite A101 Haidian District Tel:010-62977955 Fax:010-62976827
PerisorbTM, 3D Printed Peripheral Stents With An Innovative Design
Paclitaxol Drug Eluting PLA based Stents
Modified PLLA polymer with better fatigue resistant propertiesAsymmetric Drug Eluting Coating for Targeted Drug DeliverySuper Flexible Structure design
Add:5 Kaituo Road, Suite A101 Haidian District Tel:010-62977955 Fax:010-62976827
CONTENTS
Introduction to AMT
Novel 3D Printing Technology
Totally Bioresorbable Stents
Stent Delivery System
Proposals
北 京 阿 迈 特 医 疗 器 械 有 限 公 司
Peripheral BRS System (6.0x36mm) Coronary BRS System (3.0x15mm)
AMT BRS Delivery Systems
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
AMT Stent Delivery Systems
-Atraumatic tip- Sturdy, pushable proximal shaft- Soft distal shaft- Low crossing profile- High pressure rating- Durable, rugged balloon material- Optimal compliance-Three balloon winging-Small tip entry profile
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
CONTENTS
Introduction to AMT
Novel 3D Printing Technology
Totally Bioresorbable Stents
Stent Delivery System
Proposals
北 京 阿 迈 特 医 疗 器 械 有 限 公 司
北京阿迈特医疗器械有限公司Beijing Advanced Medical Technologies Co., Ltd北 京 阿 迈 特 医 疗 器 械 有 限 公 司
Beijing Advanced Medical Technologies Co., Ltd
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827
Proposals:
1. Marketing and Sales of AMT Products
2. Collaboration in New Product Development
3. OEM of Balloon Catheters
Thank you!
北京阿迈特医疗器械有限公司Beijing Advanced Medical Technologies Co., Ltd北 京 阿 迈 特 医 疗 器 械 有 限 公 司
Beijing Advanced Medical Technologies Co., Ltd
北 京 阿 迈 特 医 疗 器 械 有 限 公 司北 京 阿 迈 特 医 疗 器 械 有 限 公 司Add:5 Kaituo Road, Suite A101, Haidian District Tel:010-62977955 Fax:010-62976827