WO1997029801A1 - Reduced stiffness, bidirectionally deflecting catheter assembly - Google Patents
Reduced stiffness, bidirectionally deflecting catheter assembly Download PDFInfo
- Publication number
- WO1997029801A1 WO1997029801A1 PCT/US1997/002357 US9702357W WO9729801A1 WO 1997029801 A1 WO1997029801 A1 WO 1997029801A1 US 9702357 W US9702357 W US 9702357W WO 9729801 A1 WO9729801 A1 WO 9729801A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tip section
- core wire
- medium
- catheter
- handle
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/283—Invasive
- A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/04—Arrangements of multiple sensors of the same type
- A61B2562/043—Arrangements of multiple sensors of the same type in a linear array
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
- A61B2562/17—Comprising radiolucent components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
- A61M2025/015—Details of the distal fixation of the movable mechanical means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M2025/0161—Tip steering devices wherein the distal tips have two or more deflection regions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
Definitions
- electrophysiology catheters used for cardiac mapping and ablation, is always in result of certain compromises and tradeoffs.
- Such catheters commonly employ a handle to which a flexible hollow catheter shaft extends.
- a tip section extends from the distal end of the catheter shaft and is typically more flexible than the catheter shaft.
- One or more electrodes are carried by the tip section to provide the desired mapping, pacing, ablation or catheterization.
- One common type of electrophysiology catheter permits the tip section to be axially deflected by pulling on a relatively thin, flexible manipulator wire.
- the distal end of the manipulator wire is typically connected near the tip of the tip section while at the proximal end of the manipulator wire is typically connected to some type of slider carried by the handle.
- Pulling on the manipulator wire causes the tip of the tip section to deflect axially to the desired shape. (Pulling on the manipulator wire moves the tip both radially and axially to create the curve in the tip. This complex movement is termed axial deflection for ease of reference.) Since the catheter shaft and tip section are typically radiopaque, this movement can be observed by the physician.
- the catheter shown in U.S. Patent No. 5,487,757 shows a catheter in which the tip section can be deflected axially by pulling on a manipulator wire, the size of the curved tip section can be changed by sliding a stiffener wire to different positions along the tip section, and the tip section can be deflected laterally by rotating a core wire extending from a rotatable ring carried by the handle to the tip section. While this catheter assembly provides a great deal of control for the user, in some situations the catheter is not as flexible as is desired.
- the present invention is directed to an electrophysiology catheter assembly which uses a single core wire to achieve one or more of the following: (1) tip deflection in two, opposite directions in the same plane;
- the catheter assembly includes a handle, a hollow, flexible catheter shaft and a tip section secured to the distal end of the catheter shaft.
- the tip section has a radially offset, longitudinally extending core wire lumen through which a core wire, extending from the handle at its proximal end to the tip section at its distal end, passes.
- the core wire is secured to a core wire manipulator carried by the handle.
- the core wire manipulator can be moved, preferably in two different directions, to pull or push on the core wire to cause the tip section to deflect axially in opposite directions in the same plane.
- the proximal and distal ends of the core wire are preferably non-rotatably secured to the handle and the tip section so that rotating the handle about its longitudinal axis causes the axially deflected tip section to deflect laterally due to torsional forces exerted on the tip section by both the catheter shaft and the core wire.
- the tip section can include a stiffener element, such as a hypotube, along a portion of its length so that, for example, the distal end of the tip section remains essentially straight when the remainder of the tip section is curved in its axially deflected condition. This can be very useful for certain electrophysiology procedures.
- a spring coil can be used along at least a portion of, and preferably the entire length of, the proximal shaft to increase the columnar strength. This substantially increased columnar strength reduces undulation and waviness in the catheter shaft while allowing the catheter shaft to remain flexible.
- Another feature of the invention is the use of a taper on the same core wire to determine the size and shape of the axially deflected tip.
- the physician may be provided with a selection of, for example, four different electrophysiology catheter assemblies depending on the particular size and shape desired for the tip section when axially deflected.
- the tip section can be provided with different size curves by using a longitudinally sliding stiffener wire which can be extended by the user different distances into the tip section.
- a range of material stiffness can be provided in the tip section and shaft to optimize performance for different anatomical sites.
- a stiff tip and shaft plus large curve can be used for mapping and ablation of the right atrial free wall
- a soft tip and shaft plus smaller curve can be used for traversing the aortic arch and positioning the tip at the septal portion of the mitral valve annulus.
- Fig. 1 is a simplified overall view of an electrophysiology catheter assembly made according to the invention
- Fig. IA is a simplified view of the tip section of
- Fig. 1 illustrating, in dashed lines, the curvatures of the tip section after having pulled and pushed the core wire of Figs. 2-4 by pulling and pushing of the core wire slider of Fig. 1;
- Fig. IB is a view of the tip section of the catheter assembly of Fig. 1 illustrating, in dashed lines, a axially deflected tip portion with the distal end of the tip portion being substantially straight due to the use of the hypotube in Fig. 4;
- Figs. 2 and 3 are cross-sectiona ⁇ views taken along lines 2-2 and 3-3 of Fig. 1;
- Fig. 4 is an enlarged cross-sectional view of the tip of the tip section of the catheter assembly of Fig. 1;
- Fig. 5 is a view similar to that of Fig. 1, of an alternative embodiment of an electrophysiology catheter assembly including a slidable stiffener wire;
- Figs. 6 and 7 are cross-sectional views taken along lines 6-6 and 7-7 of Fig. 5;
- Fig. 8 is a cross-sectional view similar to Fig. 6, but of a catheter assembly including a spring coil along the catheter shaft;
- Fig. 9 is a schematic illustration of various anatomical sites within the heart and the different shaft stiffness, tip stiffness and size of curved tip appropriate for the different sites.
- Fig. 1 illustrates an electrophysiology catheter assembly 2 including a handle 4 from which a catheter shaft 6 extends.
- Catheter shaft 6 has a proximal end 8 extending from a end cap 10 of handle 4.
- Catheter assembly 2 also includes a tip section 12 extending from the distal end 14 of catheter shaft 6.
- Handle 4 is preferably a simplified version of one of the handles shown in U.S. Patent Application No. 08/343,310, the disclosure of which is incorporated by reference.
- catheter shaft 6 includes a jacket 16 surrounding a polyetherimide tubing 18.
- Jacket 16 is made of Pebax®, a polyamide polyether block copolymer of Elf Atochem, Inc. of Philadelphia, PA.
- Stainless steel braiding wire 20 is embedded within jacket 16.
- the construction of catheter shaft 6 provides catheter assembly 2 with reasonable torque transmitting ability.
- the combination of catheter shaft 6 and tip section 12 has a torsional stiffness of about .50 to 1.5 inch-ounce per 120 cm, and more preferably about .80 inch-ounce per 120 cm, when the proximal end of the catheter shaft is rotated about 3 turns about the longitudinal axis 21 of handle 4.
- Catheter shaft 6 defines a hollow interior 22 through which a stainless steel core wire 24 passes.
- various electrical wires pass through hollow interior 22, the number and composition depending upon the use to which catheter assembly is to be put.
- tip section 12 includes a higher power, ablation capable tip electrode 26 and three lower power, mapping electrodes 28. These various electrodes are connected to insulated mapping electrode wires 30 and an ablation electrode wire 32. RF ablation energy is typically conducted through wire 32 to electrode 26. (Wires 30, 32 can be of different sizes or identical.)
- a pair of thermocouple wires 34 also pass through hollow interior 22 and terminate within a cavity 36 formed in tip electrode 26 as shown in Fig. 4. Tip section 12 is secured to distal end 14 of catheter shaft 6 at a junction 38 typically by RF energy or hot air ther o-welding techniques.
- Tip section 12 includes a tip tubing body 40 made of Pebax®.
- Body 40 has a pair of longitudinally extending lumens 42, 44.
- Core wire 24 passes through lumen 42 while the remainder of the wires pass through lumen 44.
- the doubled- over end of core wire 24 passes into and is secured to insulator 46, see Fig. 4.
- Lumen 42 is radially offset so that pulling or pushing core wire 24 exerts a radially offset force on tip section 12.
- Insulator 46 typically made of PEEK (poly-ether- ether-keytone) , is thermally or adhesively bonded to the distal end 48 of body 40.
- ablation electrode wire 32 is welded, brazed, or otherwise secured to tip electrode 26, as is conventional.
- a poiyimide tubing 54 is used to surround and electrically insulate thermocouple wires 34 from tip electrode 26.
- proximal end, not shown, of core wire 24 is secured to a core wire slider 56 carried by handle 4.
- slider 12 With tip section 12 in the straight condition as shown in Fig. 1, slider 12 can be moved in a distal direction 58, pushing on core wire 24, or a proximal direction 60, pulling on core wire 24. Doing so causes tip section 12 to deflect axially in two different directions in the same plane; this is illustrated in Fig. IA.
- core wire 24 has sufficient columnar strength so as not to buckle when slider 12 is moved in distal direction 58.
- catheter assembly 2 provides the user with a bidirectional deflectable catheter assembly using slider 56 by moving slider 56 in either distal direction 58 or proximal direction 60.
- Handle 4 also includes an electrical connector 62 to which wires 30, 32, 34 are connected.
- Core wire 24 is also used to cause axially deflected tip section 12 to deflect laterally. Lateral deflection occurs when handle 4 is rotated about its longitudinal axis 21.
- Core wire 24 has a torsional stiffness of about .1-.5 inch-ounce per 120 cm, and preferably about .20 inch-ounce per 120 cm, when the proximal end of the core wire is rotated about 3 turns about longitudinal axis 21.
- the combination of tip section 12 and catheter shaft 6 has a torsional stiffness of about .50 to 2.0 inch-ounce, and preferably at least about .80 inch-ounce, per 120 cm of length, when handle 4 is rotated about 3 turns around axis 21. Therefore, torsional stiffness for lateral deflection of tip 12 is provided in substantial part by both catheter shaft 6 and core wire 24.
- a stiffener element such as a hypotube 64 shown in Fig. 4, can be used.
- Hypotube 64 is positioned within a distal section of lumen 42 and, in the preferred embodiment is about 8 to 15 mm long.
- the difference between deflecting tip section 12 with and without hypotube can be seen by comparing Fig. IA (without hypotube 64) and Fig. IB (with hypotube 64) .
- Fig. IA without hypotube 64
- Fig. IB with hypotube 64
- Figs. 5-7 illustrate an alternative embodiment of the invention with like reference numerals referring to like elements.
- the primary difference between catheter assembly 2A of Figs. 5-7 and catheter assembly 2 of Figs. 1-4 is the addition of a stiffener wire 68 which extends from a stiffener wire slider 70 carried by handle 4 into various positions along tip section 12 depending on the particular location of slider 70.
- Advancing slider 70 in the direction of arrow 58 extends stiffener wire 68 further into tip section 12; thus tip section 12, when axially deflected by the manipulation of slider 56, should have a smaller radius of curvature because of the additional stiffness imparted to tip section 12 , especially along the proximal portion of the tip section.
- Fig. 8 illustrates a cross-sectional view similar to that of Fig. 6 of a further alternative embodiment of the invention.
- a spring coil 66 extends along the entire length of catheter shaft 6.
- Spring coil 72 is preferably made of tightly wound .007 inch (.18mm) diameter stainless steel. Spring coil 66 is anchored at each end to catheter shaft 6 so that a slight compression is built into the spring coil. Use of spring coil 72 increases the columnar strength of catheter shaft 6 to prevent waviness of the catheter shaft during use and to reduce catheter shaft undulation when tip section 12 is deflected.
- One of the key features of the invention is to provide a family of catheters which, as a group, offer all the performance characteristics which are needed for ablation.
- SVT supraventricular tachycardia
- a large curve, relatively stiff shaft, and relatively stiff tip are commonly required for the best results.
- the large curve is required so that the catheter tip will span the large distance from the inferior vena cava (entry point for the catheter) to the right atrial free wall.
- the stiff shaft and stiff tip are required to provide good stability of the tip against the beating free wall, and to permit maximum tip- to-tissue pressure to be generated.
- the high blood flow rates in this area of the heart make it essential that the tip contact be excellent to insure efficient delivery of RF energy to the tissue.
- a small curve, relatively soft tip and relatively soft shaft are often optimal.
- the soft shaft allows the catheter to negotiate the 180° bend of the aortic arch.
- the soft tip allows the device to pass though the aortic valve without causing damage.
- the small curve allows access to septal sites which are very close to the catheter shaft when the tip is deflected to approximately 180°.
- a catheter with a "medium" curve size and an intermediate value for tip and shaft stiffness is useful for many other locations around the tricuspid annulus on the right side of the heart, and similar intermediate qualities of stiffness and size are usually appropriate for left lateral (and some septal) sites on the mitral valve annulus.
- AV atrial tachycardias
- AV junction ablation AV nodal reentrant tachycardia, AV junction ablation, atrial flutter, atrial fibrillation
- ventricular tachycardias AV nodal reentrant tachycardia, AV junction ablation, atrial flutter, atrial fibrillation
- each refers to the radial distance the tip of the tip section moves from the central axis when deflected 90°; a "short reach”, such as 35 mm, refers to a smaller radius while a “long reach”, such as 65 mm, refers to a longer radius. "R” and “L” stand for right and left.
- Posterior Medium Medium Med. to Long Accessory Shaft bending stiffness preferably ranges from .052 lb to .170 lb, and more preferably .063 lb to .161 lb.
- the bending stiffness of the tip section preferably ranges from .032 lb to .117 lb, and more preferably from .066 lb to .088 lb.
- the terms soft, medium and stiff refer to values at the lower range (typically lower 1/3) , middle range (typically middle 1/3) , and upper range (typically upper 1/3) of these values.
- These stiffness values are for forces measured as follows. For shaft stiffness, immerse the catheter shaft into a 37°C water bath. Clamp the catheter near the center of the shaft. Place a universal force gauge in contact with the shaft, approximately 4 cm from the clamp. Zero the gauge. Lower the gauge 15 mm to deflect the shaft. Record the maximum force as the shaft bending stiffness value.
- a compression tester is used above a block covered with 600 grit sandpaper.
- the catheter shaft is gripped by the tester at the shaft's distal end.
- the tip of the tip section is placed against the sandpaper at an angle of between about 10° - 20° from a perpendicular to the sandpaper.
- the compression tester is moved towards the sandpaper a distance of one inch, or until the tip of the tip section slips, whichever first occurs.
- the maximum axial force exerted on the tip section by the compression tester is recorded as the tip section bending stiffness value.
- a catheter assembly 2 or 2A In use, the user first selects a catheter assembly 2 or 2A. If a catheter assembly 2 is selected, a catheter assembly having a core wire 24 with a particular taper (or other cross-sectional profile) along tip section 12 to produce the desired shape when axially deflected is selected for the particular procedure. A particular combination of tip and shaft stiffness is also selected, appropriate for the anatomical site. If a catheter assembly 2A is selected, the shape of the axially deflected tip section 12 can be adjusted during use utilizing stiffener wire slider 70 to move stiffener wire 68 axially through lumen 44. In either case, tip section 12 is axially deflected in one of two opposite directions lying in the same plane as suggested in Fig.
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Abstract
Description
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Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE69727371T DE69727371T2 (en) | 1996-02-16 | 1997-02-16 | TWO-WAY DIRECTABLE CATHETER WITH REDUCED STIFFNESS |
EP97907636A EP0889744B1 (en) | 1996-02-16 | 1997-02-16 | Reduced stiffness, bidirectionally deflecting catheter assembly |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US1180796P | 1996-02-16 | 1996-02-16 | |
US60/011,807 | 1996-02-16 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1997029801A1 true WO1997029801A1 (en) | 1997-08-21 |
Family
ID=21752056
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/002357 WO1997029801A1 (en) | 1996-02-16 | 1997-02-16 | Reduced stiffness, bidirectionally deflecting catheter assembly |
Country Status (4)
Country | Link |
---|---|
US (1) | US5807249A (en) |
EP (1) | EP0889744B1 (en) |
DE (1) | DE69727371T2 (en) |
WO (1) | WO1997029801A1 (en) |
Cited By (4)
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DE19933278A1 (en) * | 1999-07-14 | 2001-01-18 | Biotronik Mess & Therapieg | Catheter, in particular, ablation catheter with deflectable end section comprises handle unit with manual control wheel joined to gearwheel which drives toothed belt with attached control wires |
WO2009086099A2 (en) * | 2007-12-20 | 2009-07-09 | Bayer Schering Pharma Ag | Catheter having a core wire and low profile bond |
EP2190515A1 (en) * | 2007-12-21 | 2010-06-02 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Medical catheter assembly with deflection pull ring and distal tip interlock |
WO2015096740A1 (en) * | 2013-12-27 | 2015-07-02 | 先健科技(深圳)有限公司 | Adjustable bent sheath tube |
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US5971983A (en) * | 1997-05-09 | 1999-10-26 | The Regents Of The University Of California | Tissue ablation device and method of use |
US20030109778A1 (en) * | 1997-06-20 | 2003-06-12 | Cardiac Assist Devices, Inc. | Electrophysiology/ablation catheter and remote actuator therefor |
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US6245064B1 (en) | 1997-07-08 | 2001-06-12 | Atrionix, Inc. | Circumferential ablation device assembly |
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US20050137661A1 (en) * | 2003-12-19 | 2005-06-23 | Sra Jasbir S. | Method and system of treatment of cardiac arrhythmias using 4D imaging |
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DE19933278A1 (en) * | 1999-07-14 | 2001-01-18 | Biotronik Mess & Therapieg | Catheter, in particular, ablation catheter with deflectable end section comprises handle unit with manual control wheel joined to gearwheel which drives toothed belt with attached control wires |
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US8267886B2 (en) | 2007-12-20 | 2012-09-18 | Medrad, Inc. | Catheter having a core wire and a low profile bond |
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JP2011507606A (en) * | 2007-12-21 | 2011-03-10 | セント・ジュード・メディカル・エイトリアル・フィブリレーション・ディヴィジョン・インコーポレーテッド | Medical catheter assembly with flexible pull ring and distal tip coupling mechanism |
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US8162934B2 (en) | 2007-12-21 | 2012-04-24 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Medical catheter assembly with deflection pull ring and distal tip interlock |
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WO2015096740A1 (en) * | 2013-12-27 | 2015-07-02 | 先健科技(深圳)有限公司 | Adjustable bent sheath tube |
EP3088034A4 (en) * | 2013-12-27 | 2017-08-30 | Lifetech Scientific (Shenzhen) Co., Ltd. | Adjustable bent sheath tube |
US10188834B2 (en) | 2013-12-27 | 2019-01-29 | Lifetech Scientific (Shenzhen) Co. Ltd. | Adjustable bent sheath tube |
Also Published As
Publication number | Publication date |
---|---|
EP0889744A1 (en) | 1999-01-13 |
US5807249A (en) | 1998-09-15 |
DE69727371D1 (en) | 2004-03-04 |
DE69727371T2 (en) | 2004-12-09 |
EP0889744B1 (en) | 2004-01-28 |
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