Περικλής Α. Νταβλούρος, Επίκουρος Καθηγητής Καρδιολογίας. Επεμβατική Καρδιολογία & Συγγενείς. Καρδιοπάθειες. Patras University Hospital

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1 Περικλής Α. Νταβλούρος, Επίκουρος Καθηγητής Καρδιολογίας None Επεμβατική Καρδιολογία & Συγγενείς Καρδιοπάθειες

2 Χαρακτηριστικά μπαλονιών που μπορούν να χρησιμοποιηθούν σε προδιαγραφές

3 Equipment Selection PCI devices are commodity items in most situations Similar performance in >90% of cases Differences in engineering Device anatomy design, construction, specifications Differences in applications General Principles Device physiology performance, specialty situations

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5 Balloon Parts Shaft Balloon Tip

6 Balloon Parts Shaft: Delivery (pushability, trackability, torqueability), kink resistance, deflation time Balloon: (compliance, burst, cutting, DE) Tip: Crossability

7 Shaft Deliverability Pushability Trackability Torqueability Kink resistance Deflation time

8 Balloon Characteristics Ένδειξη: π.χ. χρόνιες αποφράξεις, ελικωμένες, ασβεστωμένες βλάβες, μεταδιάταση (υπερδιάταση) κτλ

9 Shaft Κατασκευή: monorail και οver the wire Μήκος καθετήρα π.χ. 140 cm - 160cm OtW: Allow contrast wire exchange, but are more difficult to use

10 Dilation Catheters Product Engineering Balloon material, size, physics Size: diameter & length

11 Diameter and Length The balloon diameter is the nominal inflated balloon diameter measured at a specified pressure The balloon length typically refers to the working length of the balloon, or the length of the straight body section

12 Dilation Catheters Product Engineering Characteristics Size: diameter & length Material

13 Balloon Characteristics Εύρος διαμέτρων και μήκους Κατασκευασμένοι από κράμα. Π.χ. Πολυαμιδίου

14 Dilation Catheters Product Engineering Characteristics Size: diameter & length Material Profile

15 Balloon Profile Max diameter of a balloon mounted on a catheter when: Deflated Wrapped

16 Balloon Profile Balloon profile is the maximum diameter of the balloon when mounted on a catheter in its deflated and wrapped condition or the smallest hole through which the deflated wrapped balloon can pass

17 Balloon Profile Profile: Maximum cross sectional area or diameter (F) 5F catheter with balloon mounted => 5.7 F A 5.7 F balloon catheter necessitates 6 F catheter Low profile: material, wrapping, etc Low profile: smaller crossability

18 Crossability Balloon profile Friction forces: Hydrophilic coating (e.g LFC) Pushability

19 Dilation Catheters Product Engineering Characteristics Size: diameter & length Material Profile Coating

20 Dilation Catheters Product Engineering Characteristics Size: diameter & length Material Profile Coating Pushability

21 Pushability Maximize the cross-sectional area of the hypotube Maximize the elasticity modulus by increasing the material stiffness (Stiff shaft with long and smooth transition) Maximize the tensile strength of the material Minimize the device length as much as possible OtW vs. Rex Low profile Floppy catheter at the balloon end (leading end)

22 Size: diameter & length Material Profile Coating Pushability Dilation Catheters Balloon shaft, neck & tip (cross section, stiffness, length, OtW, profile, floppy end) Product Engineering

23 Trackability Using a low friction outer surface (higher lubricity) PTFE and Hydrophilic coatings applied to the hypotube outer surface to maximize lubricity properties Reducing the elasticity modulus Reducing wall thickness Reducing outer diameter

24 Dilation Catheters Size: diameter & length Material Profile Coating Pushability Balloon shaft, neck & tip ( cross section, stiffness, length, OtW, profile, floppy end) Trackability Product Engineering Shaft: wall thickness, outer diameter, elasticity, lubricant

25 Torqueability Increasing the tube wall thickness Using a stiffer material Reducing the device length (minimal length possible) Stiffness transition Increasing the shaft flexibility gradually towards the distal end Kink Resistance Increasing the shaft wall thickness Increasing the elasticity of the material Deflation time Increasing the shaft inner diameter (and overall device inflation channel)

26 Dilation Catheters Size: diameter & length Material Profile Coating Product Engineering Torqueability Shaft: Wall thickness, length, stifness, transition Kink resistance Pushability Shaft: Wall thickness, elasticity Balloon shaft, neck & tip ( cross section, stiffness, length, OtW, profile, floppy end) Trackability Shaft: wall thickness, outer diameter, elasticity, lubricant Deflation time hypotube diameter, double lumen

27 Balloon catheter design Coaxial Double lumen Balloon on a wire

28 Crossability Low Profile: it is not enough to produce thinwalled balloons Wall thickness or thinness in the balloon cone and neck area is just as important as a thin body Critical for achieving low profile and flexibility (trackability)

29 Balloon Characteristics Xαμηλό προφίλ εισόδου (size tip) π.χ. 0,016 και 0,019 προφίλ προσπέλασης Να είναι συμβατά με οδηγό καθετήρα 5 Fr. Σημείο ένωσης καθετήρα με μπαλόνι στο άπω άκρο του: ειδική επεξεργασία-λείανση με laser (laser bonded) για ανεμπόδιστη καθοδήγηση σε κάθε τύπου ανατομίες.

30 Balloon Characteristics: Trackability Crossability Να διαθέτει ειδική σχεδίαση μικρού ρύγχους (tip) για προσπέλαση σε ασβεστωμένα, αποφραγμένα αγγεία με ιδιαίτερα χαμηλό προφίλ (0.42mm) Tip σταδιακά λεπτυνόμενο που να ακολουθεί πιστά τον συρμάτινο οδηγό χωρίς να δημιουργεί προεξοχές

31 Balloon Characteristics: Pushability, Trackability Προωθητικότητα: O καθετήρας να διαθέτει βαθμιαία κλιμακούμενη σκληρότητα ώστε να επιτυγχάνεται μεγάλη προωθητικότητα αλλά και ισχυρή αντίσταση κατά των τσακισμάτων Στο άνω τμήμα να υπάρχει σπειροειδές μεταλλικό έλασμα εντός του καθετήρα έτσι ώστε να επιτυγχάνεται ιδανική ισορροπία σκληρότητας και κυρίως άριστη προωθητικότητα

32 Tip design Cross Tapered Tip Design Tapered tip with.017" tip entry profile designed to cross tight lesions Improved tip-to-wire conformability for confident track and cross Polyurethane tip material is flexible yet durable for tough lesions

33 Dilation Catheters Product Engineering Size: diameter & length Torqueability Material Profile Coating Pushability Balloon shaft, neck & tip ( cross section, stiffness, length, OtW, profile, floppy end) Shaft: Wall thickness, length, stifness, transition Kink resistance Shaft: Wall thickness, elasticity Deflation time hypotube diameter, double lumen Crossability Trackability Profile, coating, tip Shaft: wall thickness, outer diameter, elasticity, lubricant

34 Balloon Characteristics: ΕΠΥ Να έχουν χαμηλή τριβή Υψηλή ευελιξία Προωθητικότητα Ειδικά σχεδιασμένα στο άκρο για να παρέχουν μέγιστη ασφάλεια και προσπελασιμότητα.

35 Dilation Catheters Size: diameter & length Material Profile Coating Pushability Balloon shaft, neck & tip ( cross section, stiffness, length, OtW, profile, floppy end) Trackability Shaft: wall thickness, outer diameter, elasticity, lubricant Product Engineering Torqueability Shaft: Wall thickness, length, stifness, transition Kink resistance Shaft: Wall thickness, elasticity Deflation time hypotube diameter, double lumen Crossability Profile, coating, tip Compliance

36 Compliance Compliance: Change in volume per unit change in pressure Change in length negligible

37 Compliance What it means to you! Compliant balloon Ca ++ Ca ++ Noncompliant balloon

38 Compliance Early balloons: PVC (compliant) increase significantly their diameter Unpredictable diameters Overstretching normal vessel Decreased dilating force in stenotic site

39 Compliance Non compliant: No vessel rupture Vessel Rupture: Compliance Diameter Temperature Number of inflations

40 Compliance Nylon=> Polyurethane => Polyethylene (PE) => Polyethylene terephthalate (PET) PE most compliant

41 Compliance 3,5 mm 3 2, Atm Least compliant Maverick Ninja Fx Voyager Sprinter Raptor NC Stormer Highsail Q Maverick NC Raptor NC Monorail Complia nt Semi

42 Linear vs Hinged Compliance 3,5 Q Maverick mm 3 NC Monorail 2, Atm

43 Hinged Compliance 3,5 Don t confuse hinged compliance with semi compliant Compliant Coyote mm 3 Charger Solaris Semi 2, Atm Patras University Hospital Quantum Least

44 Hinged Compliance mm 3,5 3,0 2,5 NC Stormer Highsail Q Maverick Most are now also in the least compliant category Atm

45 Compliance 3,5 Stent Delivery Balloons Cypher Taxus mm 3,0 2, Atm

46 Compliance 8 mm nominal diameter balloons: PVC=>PE=>PET Asterisk: burst point

47 Burst Pressure Average pressure to failure of a balloon, usually measured at body temperature. Rated burst pressure: max statistically guaranteed pressure to which a balloon can be inflated without failing For PTCA and PTA catheters, this is normally 95% confidence / 99% guarantee.

48 Hoop Strength Non radial circumferential force leading to burst Depends on surface T=P x D Large balloons burst at lower pressures than small balloons of the same material High pressure balloons

49 Compliance mm 3,5 3,0 2,5 Opensail Raptor NC Mono Atm Don t confuse burst pressure with compliance ( high pressure vs noncompliant )

50 Balloon Characteristics: Safety Rated burst pressure Υψηλών πιέσεων π.χ. ως 22 atm Κωνικό σχεδιασμό μπαλονιού ώστε να αποφεύγεται ο τραυματισμός υγιούς αγγείου ιαφοροποιήσιμη διατασιμότητα για επίτευξη ατραυματικά μεγαλύτερου υπολειπόμενου αυλού στα stents με την μεταδιάταση τους και διατήρηση του αρχικού profile του μπαλονιού.

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52 Dilation Catheters Product Engineering Size: diameter & length Torqueability Material Profile Coating Pushability Balloon shaft, neck & tip ( cross section, stiffness, length, OtW, profile, floppy end) Shaft: Wall thickness, length, stifness, transition Kink resistance Shaft: Wall thickness, elasticity Deflation time hypotube diameter, double lumen Crossability Trackability Profile, coating, tip Shaft: wall thickness, outer Compliance diameter, elasticity, lubricant Burst pressure High pressure

53 Balloon Characteristics Guidewire compatibility (size) Markers: 1 vs. 2, material e.g. platinum iridium

54 Flexibility with Visibility Proprietary Tungsten Marker Marker material comprised of tungsten polymer Flexible marker design allows the catheter to conform easily in tortuous anatomy Marker flexibility helps to reduce resistance when crossing tight lesions

55 Dilating efficiency Dilation Catheters Product Engineering Balloon material Compliance Burst pressure Rewrap (i.e. Cutting balloon) Tip transition Entry profile Balloon transition Crossing profile Distal balloon / tip length / flexibility Force transmission (push) OTW vs Rx Crossing efficiency

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60 Designed for Complex Lesions The Cutting Balloon Device is a proven tool for the mechanical challenges of complex lesions that are often resistant to conventional balloon angioplasty. Treat challenging lesions with the flexible, deliverable and predictable Flextome Cutting Balloon Device.

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62 Cutting Balloon

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64 Cutting Balloon Kαθετήρες Μπαλόνια αγγειοπλαστικής στεφανιαίων αγγείων όλων των τύπων και μεγεθών (διάμετρος και μήκος μπαλονιού), με μαχαιρίδια στην επιφάνεια του μπαλονιού.

65 Drug Eluting Balloons Καθετήρες μπαλόνια αγγειοπλαστικής στεφανιαίων αγγείων Μπαλόνι επικαλυμμένο με paclitaxel εγκαταστημένο σε αναλογία. Π.χ. 3mg/mm2

66 Γ1. ΜΠΑΛΟΝΙΑ ΑΓΓΕΙΟΠΛΑΣΤΙΚΗΣ στεφανιαίων αρτηριών ημιδιατατά (semi-compliant), Γ2. ΜΠΑΛΟΝΙΑ ΑΓΓΕΙΟΠΛΑΣΤΙΚΗΣ στεφανιαίων αρτηριών μη-διατατά (non-compliant) Τεχνικές προδιαγραφές Γ1. ΜΠΑΛΟΝΙΑ ΑΓΓΕΙΟΠΛΑΣΤΙΚΗΣ στεφανιαίων αρτηριών ημιδιατατά (semi-compliant), μέσης ενδοτικότητας. Να προσφέρονται σε ποικιλία μεγέθους διαμέτρου και Να εξασφαλίζουν χαμηλό προφίλ (profile) εισόδου Γ2. ΜΠΑΛΟΝΙΑ ΑΓΓΕΙΟΠΛΑΣΤΙΚΗΣ στεφανιαίων αρτηριών χαμηλής ενδοτικότητας, αντοχής σε υψηλές πιέσεις, ειδικά για χρόνιες αποφράξεις. Να προσφέρονται σε ποικιλία μεγέθους διαμέτρου και Να εξασφαλίζουν ιδιαίτερα χαμηλό προφίλ (profile) εισόδου

67 How to Evaluate a New Balloon Graph compliance Check rated burst Tests to perform (outside the body) tip bend finger drag Tests to perform (inside the body) 3,5 3,0 2,5 Opensail Voyager When will not cross, try same size and length balloon of another company with similar compliance using same guide and wire mm Atm

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