Inflatable sheath for introduction of ultrasonic catheter through the lumen of a fiber optic endoscope
First Claim
1. An ultrasound imaging apparatus for use with an endoscope for imaging a bodily passageway or cavity area of interest, the endoscope being of the type having proximal and distal ends and an open lumen therein, the ultrasound imaging apparatus comprising an elongated ultrasound transducer-bearing catheter or guide wire adapted to be disposed within the open lumen of the endoscope, the ultrasound catheter or guide wire having proximal and distal ends, wherein the improvement comprises:
- an inflatable, substantially readily distensible, distally closed sheath being of a sufficient length to cover substantially the entire length of the ultrasound catheter or guide wire, the sheath being adapted to be advanced through the open lumen of the endoscope so that a distal end portion of the sheath may be positioned distally of the endoscope;
the ultrasound catheter or guide wire being adapted to be disposed within the sheath so that the ultrasound transducer is disposed in the sheath'"'"'s distal end portion positioned distally of the endoscope; and
means for selectively inflating the sheath to expand it against the open lumen of the endoscope and to form an expanded, substantially readily distensible balloon distally of the endoscope to engage a wall of the bodily passageway or cavity area of interest;
whereby an ultrasound image of the area of interest may be obtained through the sheath in its inflated, distended condition.
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Accused Products
Abstract
A inflatable sheath for ultrasonic imaging, with a fiber optic endoscope, of a bodily passageway or cavity area of interest. The inflatable sheath, having an ultrasound transducer therein, is introduced into the distal end of an endoscope. Typically the endoscope comprises an elongated shaft that has at least a pair of fiber optic bundles and an open lumen extending therethrough. Fiber optic illumination of the area just distal to the distal end of the endoscope is provided through one of the fiber optic bundles, and observation of the lit area is provided through the other bundle. The open lumen is provided for introducing an inflatable sheath, guided by a pushing shaft, into the illuminated area. Once inserted, the sheath can be inflated with a fluid sonolucent ultrasound coupling medium, and the pushing shaft can then be removed, the distal portion of the inflated sheath holding the sheath in place (with respect to the lumen of the endoscope) as the pushing shaft is removed. An ultrasonic imaging device bearing one or more ultrasonic transducer elements is then introduced through the lumen of the inflatable sheath so that the transducer elements are positioned within the sheath. The inflatable sheath is fully inflated thereafter with a fluid sonolucent ultrasound coupling medium so that the walls of the sheath engage the walls of the bodily pasageway or cavity, thus permitting ultrasonic imaging of the adjacent body tissue. In certain applications, the ultrasound catheter may be preferably curved at its distal end so that the transducer elements are brought closer to or immediately adjacent to the interior surface of the inflated sheath and hence closer to the body tissue of interest. In other aspects of the disclosure, alternate apparatus and methods are provided for advancing the inflatable sheath, inflating the inflatable sheath and combining the ultrasound catheter with the pushing shaft and/or inflating catheter.
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Citations
17 Claims
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1. An ultrasound imaging apparatus for use with an endoscope for imaging a bodily passageway or cavity area of interest, the endoscope being of the type having proximal and distal ends and an open lumen therein, the ultrasound imaging apparatus comprising an elongated ultrasound transducer-bearing catheter or guide wire adapted to be disposed within the open lumen of the endoscope, the ultrasound catheter or guide wire having proximal and distal ends, wherein the improvement comprises:
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an inflatable, substantially readily distensible, distally closed sheath being of a sufficient length to cover substantially the entire length of the ultrasound catheter or guide wire, the sheath being adapted to be advanced through the open lumen of the endoscope so that a distal end portion of the sheath may be positioned distally of the endoscope; the ultrasound catheter or guide wire being adapted to be disposed within the sheath so that the ultrasound transducer is disposed in the sheath'"'"'s distal end portion positioned distally of the endoscope; and means for selectively inflating the sheath to expand it against the open lumen of the endoscope and to form an expanded, substantially readily distensible balloon distally of the endoscope to engage a wall of the bodily passageway or cavity area of interest; whereby an ultrasound image of the area of interest may be obtained through the sheath in its inflated, distended condition. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 12)
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11. An ultrasound imaging apparatus for use with an endoscope for imaging a bodily passageway or cavity area of interest, the endoscope being of the type having proximal and distal ends and an open lumen therein, the ultrasound imaging apparatus comprising an elongated ultrasound transducer-bearing catheter adapted to be disposed within the open lumen of the endoscope, the ultrasound catheter having proximal and distal ends, wherein the improvement comprises:
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an inflatable, substantially readily distensible sheath comprising an elongated distensible tube having a proximal end and having a distal end sealed with a plug, the tube being of a sufficient length to cover substantially the entire length of the ultrasound catheter, the sheath being adapted to be advanced through the open lumen of the endoscope so that a distal end portion of the sheath may be positioned distally of the endoscope; the ultrasound catheter being adapted to be disposed within the sheath and movable longitudinally along the inflatable sheath when the sheath is inflated so that the ultrasound transducer may be disposed in the sheath'"'"'s distal end portion positioned distally of the endoscope, the ultrasound catheter including a lumen through which sheath inflation sonolucent fluid ultrasound coupling medium can be injected; scalable fitting means for scaling the proximal end of the sheath to the ultrasound catheter and for permitting the ultrasound catheter to be advanced into or withdrawn from the inflatable sheath; and means for selectively inflating the sheath to expand it against the open lumen of the endoscope and to form an expanded, substantially readily distensible balloon distally of the endoscope to engage a wall of the bodily passageway or cavity area of interest; whereby an ultrasound image of the area of interest may be obtained through the sheath in its inflated, distended condition.
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13. A combination ultrasound and fiber optic endoscope for imaging a bodily passageway or cavity area of interest, comprising:
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an elongated, flexible fiber optic endoscope having proximal and distal ends and an open lumen therein, such open lumen having an inner wall; an elongated flexible optical fiber extending through the endoscope from the proximal to the distal end thereof and illumination meant associated therewith for providing light through the fiber to visually illuminate the area of interest, and a separate optical fiber extending through the endoscope from the distal to the proximal end thereof and imaging means associated therewith for transmitting a visual image from the area of interest to the proximal end of the endoscope; an inflatable, substantially readily distensible, distally closed sheath adapted to be advanced through the open lumen of the endoscope so that a distal end portion of the sheath may be positioned distally of the endoscope'"'"'s open lumen; means for selectively inflating the sheath to expand the portion of the sheath disposed in the endoscope'"'"'s open lumen against the lumen'"'"'s inner wall, and to form an expanded, substantially readily distensible balloon distally of the endoscope to engage a wall of the bodily passageway or cavity area of interest; an elongated ultrasound transducer-bearing catheter or guide wire adapted to be disposed within the inflatable sheath within the open lumen of the endoscope, the ultrasound catheter or guide wire having proximal and distal ends and ultrasound transducer means carried near its distal end for providing an ultrasound image of the area of interest; the sheath being of a sufficient length to cover substantially the entire length of the ultrasound catheter or guide wire, and the ultrasound catheter or guide wire being adapted to be disposed within the sheath and movable longitudinally with respect thereto when the sheath is inflated so that the ultrasound transducer may be selectively disposed in the sheath'"'"'s distal end portion positioned distally of the endoscope; whereby an ultrasound image of the area of interest may be obtained through the sheath in its inflated, distended condition.
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14. A method of transluminal ultrasound imaging of body tissue of interest adjacent to a bodily passageway or cavity employing an ultrasound catheter or guide wire having one or more ultrasound transducer elements on the distal portion thereof and an endoscope which has proximal and distal ends and an open lumen therethrough, comprising the steps of:
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introducing the endoscope into a desired position in a body passageway or cavity area of interest; introducing an elongated, inflatable, substantially readily distensible, distally closed sheath having proximal and distal ends through the open lumen of the endoscope until a distal end portion thereof is positioned distally of the endoscope and adjacent the tissue of interest; inflating the elongated inflatable sheath with a fluid sonolucent ultrasound coupling medium so that the portion of the sheath disposed in the endoscope lumen is distended against the lumen inner wall and the portion of the sheath extending distally of the endoscope is distended to substantially fill the bodily passageway or cavity area adjacent the tissue of interest; inserting the ultrasound catheter or guide wire into the sheath so that substantially the entire length of the ultrasound catheter or guide wire is disposed within the inflatable sheath with the ultrasound transducer element(s) positioned near the tissue of interest; and ultrasonically imaging the tissue of interest through the expanded sheath filled with fluid sonolucent ultrasound coupling medium. - View Dependent Claims (15, 16, 17)
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Specification