US20090182271A1 - Dual Balloon Telescoping Guiding Catheter - Google Patents
Dual Balloon Telescoping Guiding Catheter Download PDFInfo
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- US20090182271A1 US20090182271A1 US12/405,908 US40590809A US2009182271A1 US 20090182271 A1 US20090182271 A1 US 20090182271A1 US 40590809 A US40590809 A US 40590809A US 2009182271 A1 US2009182271 A1 US 2009182271A1
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- Prior art keywords
- guide
- inner guide
- balloon
- distal
- coronary sinus
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- 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
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
-
- 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
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
- A61M2025/1015—Multiple balloon catheters having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
-
- 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
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biophysics (AREA)
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- Child & Adolescent Psychology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
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- Media Introduction/Drainage Providing Device (AREA)
Abstract
A guiding catheter includes an inner guide movably disposed within an outer guide. Both inner and outer guides include inner and outer balloons, respectively, located at the distal tip of the guides. The inner guide balloon is fluted, thereby allowing blood to flow past the implanted balloon when inflated. The outer balloon is substantially annular in shape and is deployable as an occlusion balloon. Various sensors can be provided at the distal end of the guiding catheter to assist in locating a destination vessel or structure of interest.
Description
- This application is a continuation of U.S. patent application Ser. No. 10/132,093 filed on Apr. 25, 2002, to which Applicant claims priority under 35 U.S.C. §120, and which is incorporated herein by reference in its entirety.
- The invention relates generally to surgical catheters, and more particularly to guiding catheters using balloons affixed to the distal tips of telescoping inner and outer guides.
- Catheters are used in a variety of medical procedures. In some applications, these devices provide physicians the ability to explore, operate, and insert drugs/medical devices in various reaches of the anatomy without invasive surgery. Oftentimes, the catheters have medical devices mounted on the catheter shaft. For example, an electrophysiological (EP) ablation catheter has an ablation electrode mounted at a distal tip of the catheter. In another application, guiding catheters are used to create an easily navigable pathway to be used for delivery of various payloads such as drugs, therapeutic/diagnostic devices (e.g., EP mapping and ablation electrodes), and implantable devices (e.g., cardiac pacing/defibrillation leads).
- Guiding catheter systems are typically configured with a profile that is optimized for the intended method of access. For example, when trying to access the coronary sinus of a patient's heart, one method is to enter the venous system through an incision at a large vein such as the subclavian vein near the shoulder. A guiding catheter is inserted through this incision and is sent in an arced path through the superior vena cava into the right atrium of the heart. From the right atrium, the ostium of the coronary sinus must be located. A catheter with a distal contour including a relatively sharp bend will point the catheter towards the likely location of the coronary sinus once the right atrium is reached. The contours of pre-shaped guiding catheters are often fixed during manufacture.
- A pre-shaped guiding catheter is sometimes used to blindly locate the coronary sinus ostium. This endeavor, however, is complicated by the fact that the location of the coronary sinus ostium may vary appreciably from one patient to another, especially among patients with diseased hearts. If the pre-shaped catheter is introduced and found to be not well adapted to the patient's anatomy, the catheter must be removed and a replaced with a catheter having a different shape. Replacing a catheter in this manner is time consuming, expensive, and can cause unnecessary trauma to the patient.
- Even when the catheter has an ideal shape for a given application, the size and flexibility of the catheter that provides maneuverability through a convoluted access path becomes a disadvantage when trying to manipulate the distal end of the catheter in the right atrium. Further, once the catheter has cannulated the destination vessel, the flexible distal tip may be dislodged from the destination vessel due to shape distortions caused by introducing a payload through the catheter.
- The primary objective of a typical guiding catheter procedure is to locate and cannulate a vessel of interest in the least amount of time. Finding and cannulating the coronary sinus, for example, can become a time consuming, trial and error procedure even in a healthy patient. Patients exhibiting symptoms of advanced heart disease can have blockages or deformations of heart structure, further complicating the task of locating the ostium of the coronary sinus.
- There is a need for an improved guiding catheter that provides for more efficient access to vessels of interest, such as the coronary sinus. There is a further need for a catheter that can be positively secured in a cannulated destination vessel. The present invention fulfills these and other needs, and addresses other deficiencies of prior art implementations and techniques.
- The invention relates to a guiding catheter for use in accessing various anatomical regions, particularly the heart. In particular, a guiding catheter of the present invention employs a telescopic arrangement of inner and outer guides, with each guide provided with a controllably inflatable balloon.
- According to one embodiment, a guiding catheter of the present invention includes an outer guide having a pre-formed distal curve, a guide lumen, and an inflation lumen. The guiding catheter also includes an inner guide movably disposed within the guide lumen of the outer guide. The inner guide includes an inflation lumen and can further include a pre-formed distal curve. An annular balloon is fixably mounted to a distal end of the outer guide and in fluid connection with the inflation lumen of the outer guide. A fluted balloon is fixably mounted to a distal end of the inner guide and in fluid connection with the inflation lumen of the inner guide. At least two inflation mechanisms are provided, each independently in fluid connection with the inflation lumens of the inner and outer guides. The inflation mechanisms are used to selectively pressurize and depressurize a fluid within the inflation lumens to respectively inflate and deflate the annular and fluted balloons.
- One or more sensors can be provided at a distal end of the guiding catheter to assist in locating a destination vessel or structure of interest. A sensor can be mounted to the outer guide, the inner guide, or both the outer and inner guides. Useful sensor arrangements can include one or more of an optical sensor, infrared sensor, ultrasound sensor, pressure sensor, temperature sensor, flow sensor, and oxygen sensor.
- According to another embodiment, a method for accessing a destination vessel in a patient's heart according to the present invention involves introducing a distal end of a guiding catheter into a patient's access vessel. The guiding catheter according to this embodiment includes an outer guide having a guide lumen and an annular balloon mounted to a distal end of the outer guide. The guiding catheter further includes an inner guide movably disposed within the guide lumen of the outer guide. The inner guide includes a fluted balloon mounted to a distal end of the inner guide.
- The method further involves advancing the distal end of the guiding catheter through a circulatory pathway, and distally extending the inner guide to engage the destination vessel with the distal end of the inner guide. The inner guide is distally extended to seat the inner guide in the destination vessel. The fluted balloon is inflated to anchor the inner guide in the destination vessel.
- According to a further aspect, after engaging the destination vessel with the inner guide, the outer guide is distally advanced over the inner guide to engage the destination vessel with the outer guide. The annular balloon is inflated to occlude blood flow. A contrast media is injected into the guiding catheter for mapping blood vessels. Various types of sensing can be employed at the distal end of the guiding catheter to assist in locating a destination vessel or structure of interest.
- The above summary of the present invention is not intended to describe each embodiment or every implementation of the present invention. Advantages and attainments, together with a more complete understanding of the invention, will become apparent and appreciated by referring to the following detailed description and claims taken in conjunction with the accompanying drawings.
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FIG. 1 is a perspective view of a catheter according to an embodiment of the present invention; -
FIG. 2 is a side view of a distal end of the catheter according to an embodiment of the present invention; -
FIG. 3 is a cross sectional view of an inner guide corresponding to section 1-1 inFIG. 2 ; -
FIG. 4 is a cross sectional view of an outer guide corresponding to section 2-2 inFIG. 2 ; -
FIG. 5 is a perspective view of the distal end of the outer guide according to an embodiment of the present invention; -
FIG. 6 is a side view of proximal inflation mechanisms according to the present invention; and -
FIG. 7 is a perspective cutaway view of a heart, illustrating a catheter according to the present invention cannulating the coronary sinus. - While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail herein. It is to be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
- In the following description of the illustrated embodiments, references are made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration, various embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized, and structural and functional changes may be made without departing from the scope of the present invention.
- In
FIG. 1 , a catheter according to the present invention, generally indicated byreference numeral 100, is illustrated. Thecatheter 100 utilizes a telescoping guide configuration that includes aninner guide 102 movably disposed within anouter guide 104. Theouter guide 104 has apre-formed curve 106 near a distal end. Thepre-formed curve 106 typically includes a shape optimized for the intended access path and destination vessel. Fluted andannular balloons outer guides - The
fluted balloon 108 includes flutedgrooves 112 adjacent toinflatable sections 114. Thefluted balloon 108 is inflated via an inflation lumen within theinner guide 102. Thefluted balloon 108 is configured such that theinflatable sections 114 are enlarged upon inflation, the enlargedinflatable sections 114 gripping an interior surface of a blood vessel. Thefluted grooves 112 allow some blood to flow past theinflated balloon 108, thereby preventing complete occlusion of the blood vessel. In this way, thefluted balloon 108 can advantageously be used to secure the distal tip of theinner guide 102 for a relatively long period of time without introducing problems caused by full blood flow occlusion. - The
fluted balloon 108 may be formed similar to a standard latex occlusion balloon, with the additional application of longitudinal adhesive sections to the inside of theballoon 108. The adhesive sections bond an outer, inflatable member of theballoon 108 to theguide 102 to form thefluted grooves 112. The adhesive sections prevent an area encompassed by thefluted grooves 112 from inflating when pressurizing theballoon 108. The areas between adhesive sections serve as theinflatable sections 114. - An alternate configuration of the
fluted balloon 108 may include bonding a plurality of elongated balloon sections lengthwise along theinner guide 102, each balloon section forming aninflatable section 114. The spaces between balloon sections form thefluted grooves 112. The elongated balloons can include a common fluid connection for inflation, such as a ring shaped manifold. - The outer guide balloon 110 (i.e., annular balloon) can be constructed similarly to occlusion balloons known in the art. The
annular balloon 110 is controllably expandable to substantially block the vessel in which theouter guide 104 is located, thereby occluding blood flow in the vessel. For bothballoons - The inner and
outer guides guides guides guides guides - As shown in
FIG. 1 , thepre-formed curve 106 is typically located proximal to theannular balloon 110. Various curve shapes are possible, the shapes being dictated by the destination vessel and access path of interest. Thepre-formed curve 106 is made flexible such that theouter guide 104 straightens while being guided through the vasculature, yet resumes the pre-formed shape when a wider cavity, such as a heart chamber, is reached. - The
inner guide 102 may also include apre-formed shape 202 at a distal end, as seen inFIG. 2 . Theinner guide 102 can be made retractable within theouter guide 104 such that the inner guide's distal end substantially takes the shape of theouter guide 104 when retracted. When theinner guide 102 is extended such that thepre-formed curve 202 extends beyond the outer guide's distal tip, thepre-formed curve 202 resumes its original, pre-formed shape. - The
pre-formed curves guides guides pre-formed curve - Alternatively, a
stylet FIGS. 3 and 4 , made of Nitonol or other superelastic material can be affixed (e.g., bonded or enclosed) within a distal portion of one or both of theguides stylet - The
guides braid 304, 404 as seen inFIGS. 4 and 5 . Thebraids 304, 404 are typically formed of fine stainless steel wires, although stainless steel ribbon and/or artificial fibers can also be used to form thebraids 304, 404. Thebraids 304, 404 may cover all or part of theguides braids 304, 404 can be bonded or otherwise affixed to an exterior surface of theguides braids 304, 404 can be molded within the walls of theguides - The inner and
outer guides guide lumens outer guide lumen 406 is open throughout the length of theouter guide 104. Theinner guide lumen 306 is typically open for guiding applications, although an openinner guide lumen 306 may not be required if theinner guide 102 is not used to carry a payload. A lubricious liner made from a material such as PTFE can be applied to an interior surface of thelumens inner guide 102 within theouter guide 104. - The inner and
outer guides guides inflation lumens distal balloons inflation lumens guides guides balloons inflation lumens balloons guides lumens balloons balloons guides -
FIG. 5 illustrates proximal inflation mechanisms for the inner andouter guides guides valves 502, 504 (e.g., hemostatic valves). Thevalves guide lumens catheter 100 from introducing an air embolism in the blood vessels. Thevalve 502 seals theinner guide 102 within theouter guide 104. Thevalve 504 seals any payloads that may be introduced through theinner guide lumen 306. - The
valves inflation lumens proximal inflation mechanisms proximal inflation mechanisms inflation mechanisms - Turning back to
FIG. 4 , anaccessory lumen 410 is shown in theouter guide 104. Theaccessory lumen 410 is preferably extruded into the wall of theouter guide 104. Theaccessory lumen 410 can be used for carrying accessory payloads such as injections and guide wires. Theaccessory lumen 410 can also be used to carry conductors or other communication media coupled to a sensor attached to the outer guide's distal end. - Referring now to
FIG. 6 , an exemplary sensor configuration is illustrated on anouter guide 104. Thesensor 602 can include a sensor/transducer that measures pressure, temperature, flow, oxygen, infrared, and ultrasound. Miniature sensor assemblies are available in the form of Micro-Electro-Mechanical Systems (MEMS) that are particularly suited to this application. Such MEMS sensors/transducers are commercially available and adaptable to medical devices. Acommunication medium 604 is coupled to thesensor 602 and communicates sensor signals to measuring/processing equipment at the proximal end of thecatheter 100. Thecommunication medium 604 typically includes at least one electrical conductor and can be disposed within theaccessory lumen 410 of theouter guide 104. - An
alternate sensor 602 includes a fiber optical sensor (e.g., lens) for such applications as thermal, visual, or laser-Doppler velocimetry sensing. Thecommunication medium 604 in an optical sensor includes an optical fiber that can be disposed within theaccessory lumen 410. It is understood that a similar sensor and communication medium arrangement can be provided for theinner guide 102, exclusive of, or in addition to, such an arrangement provided for theouter guide 104. - A
catheter 100 according to the present invention has features particularly useful in accessing anatomical features within the heart. An exemplary use of thecatheter 100 is described hereinbelow relating to accessing the coronary sinus, it being understood that other vessels of interest can be similarly accessed in accordance with the principles of the present invention. Coronary sinus access is often required in pacing/defibrillation lead implant procedures. Since the opening (ostium) of the coronary sinus into the right atrium is relatively small compared to the size of the right atrium, the coronary sinus is a challenging target vessel for cannulation. - Aspects of a coronary sinus access procedure are shown in
FIG. 7 . Catheterizing thecoronary sinus 702 involves introducing the distal tip of thecatheter 100 through anincision 704 into apercutaneous access vessel 706. Common access vessels include the right cephalic vein and the subclavian vein. Thecatheter 100 is advanced throughaccess vessel 706 into thesuperior vena cava 708, thereby entering into theright atrium 710. From theright atrium 710, thecatheter 100 can then locate the coronary sinus ostium 712, thereby readying thecatheter 100 for introduction into thecoronary sinus 702. - The clinician may utilize a
sensor 602 in theouter guide 104 to assist in locating the coronary sinus ostium 712. For example, a flow sensor or Doppler sensor can sense the stream of blood exiting the coronary sinus based on flow rate or flow velocity. A thermal or infrared sensor can look for a higher temperature region indicative of the typically higher temperature blood leaving thecoronary sinus 702. Other devices, such as a fiber optic camera or ultrasound transducer, can provide a visual representation of the heart structure to aid in guiding thecatheter 100. - The
catheter 100 can be maneuvered by extending and/or torquing a proximal end of theouter guide 104, thereby directing the guide's pre-formeddistal end 106. Theinner guide 102 can also be extended and torqued to probe for the ostium at a distal end. By using thesensor 602 and/or other means of visualizing the catheter 100 (e.g., angiography/venography), a distal tip of the inner orouter guides - The
outer guide 104 may include an accessory lumen 410 (as shown inFIG. 4 ) that can accept a probing wire. The probing wire can be extended through theouter guide 104 to assist in locating the ostium. The probing wire can include a distal curve that assumes a pre-set shape upon extension from theouter guide 104, thereby providing an alternate shape to search for the ostium. - After the ostium is located, the
outer guide 104 may be inserted into the ostium. Alternatively, theinner guide 102 may be extended from theouter guide 104 into the ostium, thereby providing an extension of theouter guide 104. Once the coronary sinus is cannulated, theouter guide 104 may be distally extended so that theannular balloon 110 is enclosed within the coronary sinus. Theannular balloon 110 can then be inflated to provide occlusion for a contrast injection. The contrast injection can be introduced through the inner orouter guides - After the contrast mapping is complete, the
inner guide 102 is advanced into position, theouter guide 104 is at least partially retracted, and thefluted balloon 108 is inflated. As seen inFIG. 7 , the inflatedfluted balloon 108 secures theinner guide 102 within the coronary sinus so as to prevent dislodgment, while advantageously allowing perfusion of blood through the coronary sinus. After securing theinner guide 102, a payload can be introduced through theinner guide lumen 306 and into thecoronary sinus 702. After delivery of the payload (e.g., a pacing or defibrillation lead implanted at a desired location), thecatheter 100 is properly retracted and removed from the patient's body. - It will, of course, be understood that various modifications and additions can be made to the preferred embodiments discussed hereinabove without departing from the scope of the present invention. Accordingly, the scope of the present invention should not be limited by the particular embodiments described above, but should be defined only by the claims set forth below and equivalents thereof.
Claims (1)
1. A guiding catheter, comprising:
an outer guide, comprising:
an outer surface having a circumference dimensioned to navigate into the coronary sinus and engage a destination vessel distal to, and smaller than, the coronary sinus;
a pre-formed distal curve configured to facilitate cannulation of the coronary sinus from the right ventricle and cannulation of the destination vessel by the outer guide;
a guide lumen dimensioned to receive an implantable cardiac lead;
a distal region flexible relative to a proximal region; and
an inflation lumen;
an inner guide movably disposed within the guide lumen of the outer guide, the inner guide comprising:
an inflation lumen;
a distal region flexible relative to a proximal region;
a pre-formed curve on a distal end of the inner guide, the distal end of the inner guide having a circumference; and
the inner and outer guides each configured such that the pre-formed curve of the inner guide substantially takes the shape of the outer guide when the pre-formed curve of the inner guide is retracted within the outer guide and the pre-formed curve of the inner guide assumes its pre-formed shape when extended beyond a distal end of the outer guide;
an annular balloon fixably mounted on the outer guide distal of the pre-formed distal curve of the outer guide and in fluid connection with the inflation lumen of the outer guide, the annular balloon configured to seal the coronary sinus and stabilize the inner guide in the coronary sinus in an inflated configuration by engagement with the coronary sinus;
a fluted perfusion balloon fixably mounted to the inner guide distal of the pre-formed curve of the inner guide, the fluted balloon in fluid connection with the inflation lumen of the inner guide and comprising:
a plurality of flutes arranged generally parallel to a longitudinal axis of the inner guide and configured to retain a fluted configuration sufficient to permit perfusion of fluid flow relative to the fluted balloon when pressurized, and
the fluted perfusion balloon configured to secure the inner guide within the destination vessel in an inflated configuration by engagement of the plurality of flutes with the destination vessel sufficient to facilitate advancement of the outer guide over the inner guide to engage the destination vessel with the outer guide; and
at least two inflation mechanisms each independently in fluid connection with the inflation lumens of the inner and outer guides, the inflation mechanisms facilitating pressurization and depressurization of a fluid within the inflation lumens to respectively inflate and deflate the annular and fluted balloons.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US12/405,908 US20090182271A1 (en) | 2002-04-25 | 2009-03-17 | Dual Balloon Telescoping Guiding Catheter |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/132,093 US7503904B2 (en) | 2002-04-25 | 2002-04-25 | Dual balloon telescoping guiding catheter |
US12/405,908 US20090182271A1 (en) | 2002-04-25 | 2009-03-17 | Dual Balloon Telescoping Guiding Catheter |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US10/132,093 Continuation US7503904B2 (en) | 2002-04-25 | 2002-04-25 | Dual balloon telescoping guiding catheter |
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US20090182271A1 true US20090182271A1 (en) | 2009-07-16 |
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US10/132,093 Expired - Fee Related US7503904B2 (en) | 2002-04-25 | 2002-04-25 | Dual balloon telescoping guiding catheter |
US11/027,092 Abandoned US20050119567A1 (en) | 2002-04-25 | 2004-12-30 | Methods using a dual balloon telescoping guiding catheter |
US12/405,908 Abandoned US20090182271A1 (en) | 2002-04-25 | 2009-03-17 | Dual Balloon Telescoping Guiding Catheter |
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US10/132,093 Expired - Fee Related US7503904B2 (en) | 2002-04-25 | 2002-04-25 | Dual balloon telescoping guiding catheter |
US11/027,092 Abandoned US20050119567A1 (en) | 2002-04-25 | 2004-12-30 | Methods using a dual balloon telescoping guiding catheter |
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Also Published As
Publication number | Publication date |
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US20030204138A1 (en) | 2003-10-30 |
US20050119567A1 (en) | 2005-06-02 |
US7503904B2 (en) | 2009-03-17 |
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