EXPANDABLE TRANS-SEPTAL SHEATH
First Claim
1. An expandable endovascular access sheath adapted for providing minimally invasive access to the left atrium, comprising:
- an axially elongate sheath tube with a proximal end, a distal end, and a central through lumen;
a distal region of the sheath which is expandable in circumference in response to outward pressure applied therein;
a hub affixed to the proximal end of the sheath tube, the hub adapted to facilitate the passage of instrumentation;
a central obturator, which serves to occlude the central lumen of the sheath during insertion further comprising a hub that releasably locks to the hub of the sheath; and
a guidewire lumen within the obturator, capable of passing over standard medical guidewires and which will allow the obturator and sheath to track over said guidewires through tortuosity such as that found tracking into the right and left atria, and any transitions therebetween;
wherein the obturator is a balloon dilator capable of expanding the distal region of the sheath from a collapsed configuration to an expanded configuration.
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Accused Products
Abstract
Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the performance of procedures in the left atrium. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the right atrium and through the atrial septum into the left atrium. The distal end of the sheath is subsequently expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as electrophysiological mapping of the heart, radio-frequency ablation of left atrial tissue, placement of left atrial implants, mitral valve repair, or the like.
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Citations
24 Claims
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1. An expandable endovascular access sheath adapted for providing minimally invasive access to the left atrium, comprising:
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an axially elongate sheath tube with a proximal end, a distal end, and a central through lumen; a distal region of the sheath which is expandable in circumference in response to outward pressure applied therein; a hub affixed to the proximal end of the sheath tube, the hub adapted to facilitate the passage of instrumentation; a central obturator, which serves to occlude the central lumen of the sheath during insertion further comprising a hub that releasably locks to the hub of the sheath; and a guidewire lumen within the obturator, capable of passing over standard medical guidewires and which will allow the obturator and sheath to track over said guidewires through tortuosity such as that found tracking into the right and left atria, and any transitions therebetween; wherein the obturator is a balloon dilator capable of expanding the distal region of the sheath from a collapsed configuration to an expanded configuration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method of instrumenting the left atrium comprising the steps of:
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routing a guidewire into the right atrium from a peripheral vein; inserting a sheath with a pre-inserted dilator into the patient over the guidewire, and advancing the sheath to a treatment or diagnostic site within the right atrium of the heart, wherein the sheath comprises a distal region which is collapsed in diameter; performing a trans-septal puncture between the right and left atrium and advancing the collapsed sheath through the puncture into the left atrium; dilating the distal region of the sheath so that the distal region of the sheath is expanded, wherein a full-size lumen exists within the sheath and extending from the proximal end to the distal end; collapsing the dilator by an action applied at the proximal end of said dilator; removing the dilator from the sheath; Inserting instrumentation through the lumen of the sheath into the left atrium; performing therapy or diagnosis with the instrumentation; and removing the sheath from the patient. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 23, 24)
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20. A sheath adapted for insertion into the right or left atrium of the heart comprising:
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a means for tracking a sheath over an already placed guidewire to a target treatment site in the right or left atrium of the heart; a means for articulating the distal end of the sheath, wherein the sheath is diametrically collapsed along at least a portion of its distal length; a means for dilating at least a portion of the distal end of the sheath, wherein the dilating means is operable from the proximal end of the sheath; and a means for removal of the sheath from the patient. - View Dependent Claims (21, 22)
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Specification