TE Connectivity Medical Heat Shrink Tubing

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THE ENGINEERS OF HEAT SHRINK TUBING
Presentation transcript:

TE Connectivity Medical Heat Shrink Tubing

Medical Heat Shrink Tubing Overview ISO 10993 and USP Class VI biocompatibility for most materials Master Files established with the FDA for select materials RoHS and REACH compliant materials and processes Manufacturing facility is ISO 13485 certified and FDA registered Customizable product lines to meet dimensional, mechanical, and cosmetic requirements of customers On site materials and process engineers to support design and development of new products Broad range of materials for wide range of medical applications Endoscopic and Laparoscopic shafts Balloon and stent bonding/welding Catheter shaft reflow/fusing Bonding of dissimilar materials Electrosurgical and trocar device protection Endoscopic and Laparoscopic shaft insulation Balloon and stent bonding process aids Catheter shaft reflow and bonding process aids Electrosurgical device protection Sheath for catheters and surgical instruments Protection and insulation of flexible and rigid joints Abrasion and chemical protection Sterilization compatibility Sealing within harsh environments Protection and insulation of flexible and rigid joints Abrasion and chemical protection

Portfolio highlights Materials Dimensions Options Polyethylene's / polyolefins HDPE LDPE EMA EVA Fluoropolymers PVDF FEP Others PEBA Custom compounding Recovered walls down to 0.001” (.025mm) Expanded walls down to 0.0005” (0.013mm) Expanded IDs up to 1.0” (25.4mm) Recovered IDs down to 0.005” (0.127mm) Longitudinal shrinkage <= 10% Shrink ratios up to 5:1 Single or dual wall Adhesive inner wall Custom colors Radio-opaque Peelable Sterilizable High pushability High flexibility High and low lubricity Spooled, cut to length, or cut and slit Double-bagged Pad printed

Identifying an opportunity Customer Needs Applications Substitutes Insulation or isolation Dielectric Chemical or abrasion protection Strain relief or flex relief Bonding, fusing, laser welding Lubricity Flexible or rigid jacket High temp / Temperature resistant Jacket Sterilization (reusable or reposable) Sealing Reflow layer Laparoscopy Surgical Electrosurgical Endoscopy Interventional Peripheral vascular Neurovascular Structural heart Trocar Bone shaver Hypotube Needle Tapes Mastics Adhesives Epoxies Conductive coatings Powder coatings Spray coatings PTFE coatings Laser welding Extrusions Catheter (ICE, IVUS, EP) Spinal Shaft/braided shaft Scope Guidewire Balloon Stent Angioplasty Minimally invasive procedure / surgery Stapler / suture

MT1000: PVDF-based fluoropolymer Features Performance Semi-rigid, good pushability High lubricity Recovered walls down to 0.005” and recovered ID’s down to 0.005” Full recovery at 175C Mechanically tough for increased device protection and sterilization compatibility Excellent insulation at high temperatures Excellent abrasion and chemical resistance USP Class VI Applications Electrosurgical and endoscopic instrument protection Increasing pushability and lubricity of otherwise flimsy components Rigid shaft outer layer to add lubricity and protection from chemicals and abrasion Reusable devices requiring sterilization

MT2000: HDPE-based polyolefin Features Performance Semi-rigid, good pushability Lubricity similar to FEP Recovered walls down to 0.005” and recovered ID’s down to 0.005” Full recovery at 140C Excellent electrical insulation Excellent abrasion and chemical resistance Shrink ratios up to 2.5:1 USP Class VI Applications Gamma-sterilizable replacement for FEP in non-process aid applications Protection from abrasion and chemicals Excellent electrical insulation Lubricious outer sheath Rigid and flexible surgical shaft applications

MT3000: Flexible PVDF-based fluoropolymer Features Performance Good flexibility Recovered walls down to 0.008” and recovered ID’s down to 0.007” Full recovery at 150C Excellent electrical insulation Excellent abrasion and chemical resistance in flexible applications USP Class VI Applications Electrosurgical and endoscopic instrument protection Flexible and rigid surgical shafts and trocars Protection of components in space-constrained critical environments where pliancy is desired Flex relief for material transitions

MT5000: Flexible LDPE-based polyolefin Features Performance High flexibility Recovered walls down to 0.006” and recovered ID’s down to 0.008” Full recovery at 110C Pad print friendly Easy to make in many colors Shrink ratio up to 4:1 Good mechanical toughness for flexible applications USP Class VI Applications Electrosurgical and endoscopic instrument protection Pad-print friendly for applications associated with device marking and labeling Flexible and rigid surgical shafts and trocars Cost effective protection and/or strain relief for critical components and joints

MT-FEP: 100% Fluorinated Ethylene Propylene Features Performance Good lubricity Good flexibility Recovered walls down to 0.006” and recovered ID’s down to 0.019” Full recovery at 210C Excellent electrical insulation Chemically inert with high chemical and abrasion resistance Longitudinal change <10% USP Class VI Custom samples available in < 3 weeks!! Applications Current industry standard for catheter shaft fusing sleeve to create braided shafts Skivable process aid for bonding applications Abrasion and chemical protection for flexible and rigid shafts and trocars Lubricious sheath for low friction applications

MT-LWA: Peelable LDPE-based polyolefin Peelable product for bond locations Features Performance Process aid Medical version of RNF-100 Recovered walls down to 0.006” and recovered ID’s down to 0.007” Full recovery at 110C Good axial tear propagation, remove while still warm Compatible with hot jaw and laser bonding processes Shrink ratios up to 4:1 USP Class VI Applications Easy peel process aid for balloon welding and bonding Bonding aid for shaft material transitions without the need to skive Catheter shaft fusing sleeve – particularly useful for tapered shafts due shrink ratios up to 4:1 Replacement of adhesives and mastics in bonding and joining applications Replacement of FEP as process aid

MT-PBX: PEBA-based heat shrink Features Performance 55D, 63D and 72D standard durometers Recovered walls down to 0.001” (0.0005” expanded wall) and recovered ID’s down to 0.005” Full recovery at 190C Option for dual wall with inner reflowable layer Same base material as most catheter jackets used in the medical industry today Flexible and semi-rigid options USP Class VI After Reflow Applications Outer sheath for catheter shafts without using FEP Protection of components and joints in space constrained areas Ultra-thin jacket for guidewires and other instruments Optional inner layer increase sealing and gripping during installation

TE Medical – Heat shrink family comparison Product Family Base Polymer Primary Market Full recovery Shrink Ratio Sterilization Radiopaque Option Adhesive Lining option Process Aid Abrasion Protection Pushability / Rigidity (Shaft) Strain Relief Insulation Lubricity <= 1.67:1 <= 2:1 <= 3:1 Up to > 4:1 Auto-Clave Gamma ETO Dry Heat MT1000 PVDF Surgical instruments and shafts 175°C (347°F) · N/A Better Best MT2000 HDPE 140°C (284°F) Average Good Limited MT3000 150°C (302°F) MT5000 LDPE 110°C (230°F) MT5510 EMA Standard MT-LWA Interventional shafts MT-FEP FEP Surgical & Interventional shafts 210°C (410°F) *MT-PBX PEBA 190°C (374°F) 72D – Better 63D – Good 55D – Limited 72D – Limited 63D – Better 55D - Better 55D - Good *Standard product available in 55D, 63D, and 72D shore hardness, as well as dual-wall .

TE Medical: One partner for all your heat shrink needs Heat Shrink Tubing FEP LWA (Peelable polyolefin) Custom Compounding PEBA PVDF HDPE LDPE EMA EVA TE Medical

Serving a wide range of applications Laparoscopic instruments, trocars, and electrosurgical device protection: MT1000, MT2000, MT3000, MT5000, MT-PBX and MT-FEP – TE’s heat shrink portfolio offers a full range of products that can be selected for sterilization versatility, flexibility or rigidity, lubricity, and chemical and abrasion resistance. From protective outer sheaths for laparoscopic and electrosurgical shafts, to lubricious layers between inner and out shafts in high RPM applications such as arthroscopic bone shaving. Manufacturing process aids: MT-LWA, MT5000 and MT-FEP: TE offers both fluoropolymer and polyolefin-based materials for process aid applications. MT-FEP – With shrink ratios up to 1.7:1, TE’s MT-FEP maintains longitudinal change <10% to reduce lot-to-lot variability and enable consistent shaft reflow processes. MT-LWA and MT5000 – With shrink ratios up to 4:1, TE’s MT-LWA is perfect for reflow applications where FEP shrink ratios are not suitable. MT-LWA and MT5000 have excellent tear propagation, allowing it to peel easily and without the use of blades. It’s optical clarity and optional controlled shrink force make it an exceptional process aid for hot jaw bonding and laser-weld application, such as balloon bonding. Interventional shaft encapsulation: MT-PBX and MT-PBX/PBX – Single and dual wall PEBA heat shrink with walls down to 0.001” and shrink ratios up to 4:1 MT-PBX – Single wall PEBA-based heat shrink. Recovered wall thickness down to 0.001” to provide thin wall protection of material transitions or entire catheter shafts; Adds rigidity to select sections of otherwise flimsy substrates MT-PBX/PBX – Dual wall PEBA; outer layer will heat shrink and inner layer will reflow to join with underlying braid to create a braided catheter shaft without the use of a process aid Protection and strain relief for joints and pivot points: MT1000, MT3000, MT5000, MT5510, MT-PBX, and MT-FEP – Provide durability and protection from temperature and chemicals through repeated flexure.

Medical Tubing: Capability Summary Medical Tubing reference EID RID Recovered WT Shrink Ratio Lower Limit Min Max Upper Limit High MT1000 0.010 0.014 0.500 1.000 0.005 0.007 0.250 0.022 N/A 3:1 4:1 MT2000 0.650 0.008 0.400 0.006 0.016 MT3000 0.054 1.250 0.023 0.625 MT5000 0.015 0.035 0.040 *MT5510 1.200 MT-LWA 0.375 0.011 0.187 0.028 MT-FEP 0.018 0.017 0.234 0.003 1.65:1 1.8:1 MT-PBX 72d 0.001 0.0015 0.020 63d 0.002 55d 0.626 Min and Max Lower and Upper limits Current range of established (higher confidence) process capabilities – high probability of success Theoretical min and max based on equipment capabilities – may or may not be achievable Usually no need for added tooling or NRE High probability for new tooling and increased development work Shorter sample and project lead times, generally speaking Longer sample and project lead times, generally speaking Can be quoted with standard sample lot charge Quote will likely include sample charge + NRE + NRT *Standard product line still in development but manufacturing capability has been established