Intravascular device such as introducer sheath or balloon catheter or the like and methods for use thereof

Claim 1

A method for sequentially imaging and dilating a region of a subject: using an ultrasound probe, a guidewire, and a catheter, wherein the catheter comprises an elongate, flexible member having a lumen in its distal length; a dilation balloon attached to the distal length, the outside of the distal length and the balloon being sized for passage into the region of the subject and the lumen having a diameter sized to accept either the guidewire or the ultrasound probe, wherein the lumen splits into a dual lumen proximal of said balloon, the dual lumen comprising a guidewire lumen sized to accept the guidewire and a probe lumen sized to accept the ultrasound probe, the flexible member further comprising a third lumen wherein the third lumen communicates with the balloon, the method comprising the steps of: advancing the guidewire through the subject until a distal tip of the guidewire is distal of the region of the subject to be imaged; advancing the catheter along the guidewire until the distal portion has passed into the region to be imaged; pulling the guidewire proximally while holding the catheter relatively stationary in the distal and proximal directions within the subject, and leaving the distal tip of the guidewire within the wire lumen; advancing the ultrasound probe tip into the distal lumen portion of the catheter; preventing the ultrasound probe from extending distally beyond the catheter; activating the probe to obtain pre-dilation ultrasound images of the region; retracting the probe into the probe lumen; advancing the guidewire distally of the catheter tip; moving the catheter distally until the balloon passes into said region of the subject; and inflating and then deflating the balloon.

Claim 2

A method for sequentially imaging and dilating a region of a subject: using an ultrasound probe, a guidewire, and a catheter, wherein the catheter comprises an elongate, flexible member having a lumen in its distal length; a dilation balloon attached to the distal length, the outside of the distal length and the balloon being sized for passage into the region of the subject and the lumen having a diameter sized to accept either the guidewire or the ultrasound probe, wherein the lumen splits into a dual lumen proximal of said balloon, the dual lumen comprising a guidewire lumen sized to accept the guidewire and a probe lumen sized to accept the ultrasound probe, the flexible member further comprising a third lumen wherein the third lumen communicates with the balloon, the method comprising the steps of: advancing the guidewire through the subject until a distal tip of the guidewire is distal of the region of the subject to be imaged; advancing the catheter along the guidewire until the distal portion has passed into the region to be imaged; pulling the guidewire proximally while holding the catheter relatively stationary in the distal and proximal directions within the subject, and leaving the distal tip of the guidewire within the wire lumen; advancing the ultrasound probe tip into the distal lumen portion of the catheter; preventing the ultrasound probe from extending distally beyond the catheter; activating the probe to obtain pre-dilation ultrasound images of the region; retracting the probe into the probe lumen; advancing the guidewire distally of the catheter tip; moving the catheter distally until the balloon passes into said region of the subject; and inflating and then deflating the balloon.

Claim 5

A method for sequentially dilating and then imaging a region of a subject: using an ultrasound probe, a guidewire, and a catheter, wherein the catheter comprises an elongate flexible member having a lumen in its distal length, a dilation balloon attached to the distal length, the outside of the distal length and balloon being sized for passage into the region of the subject and the lumen having a diameter sized to accept either the guidewire or the ultrasound probe, wherein the lumen splits into a dual lumen proximal of said balloon, the dual lumen comprising a guidewire lumen sized to accept the guidewire and a probe lumen sized to accept the ultrasound probe, the flexible member further comprising a third lumen wherein the third lumen communicates with the balloon, the method comprising the steps of: advancing the guidewire through the subject until a distal tip of the guidewire is distal of the region of the subject to be imaged; advancing the catheter through the distal lumen and the guidewire lumen, until the balloon has passed into the region to be dilated; inflating and then deflating the balloon by flowing a fluid through the third lumen; pulling the guidewire proximally, and leaving the distal tip of the guidewire within the wire lumen; advancing the ultrasound probe tip into the distal lumen portion of the catheter; preventing the ultrasound probe from extending distally beyond the catheter; and activating the probe to obtain post-dilation ultrasound images of the region.

Claim 6

A method for sequentially dilating and then imaging a region of a subject: using an ultrasound probe, a guidewire, and a catheter, wherein the catheter comprises an elongate flexible member having a lumen in its distal length, a dilation balloon attached to the distal length, the outside of the distal length and balloon being sized for passage into the region of the subject and the lumen having a diameter sized to accept either the guidewire or the ultrasound probe, wherein the lumen splits into a dual lumen proximal of said balloon, the dual lumen comprising a guidewire lumen sized to accept the guidewire and a probe lumen sized to accept the ultrasound probe, the flexible member further comprising a third lumen wherein the third lumen communicates with the balloon, the method comprising the steps of: advancing the guidewire through the subject until a distal tip of the guidewire is distal of the region of the subject to be imaged; advancing the catheter through the distal lumen and the guidewire lumen, until the balloon has passed into the region to be dilated; inflating and then deflating the balloon by flowing a fluid through the third lumen; pulling the guidewire proximally, and leaving the distal tip of the guidewire within the wire lumen; advancing the ultrasound probe tip into the distal lumen portion of the catheter; preventing the ultrasound probe from extending distally beyond the catheter; and activating the probe to obtain post-dilation ultrasound images of the region.

Claim 8

A method of imaging and dilating a region of a lumen in a subject comprising the steps of: positioning a guidewire so that the distal tip of the guidewire is within the lumen and distal of a region of the lumen to be imaged and dilated; advancing a catheter using the guidewire as a guidance device until a distal end of the catheter is within the lumen, and distal of the region of the lumen to be imaged and dilated; retracting the guidewire until it becomes proximal of the region of the lumen to be imaged and dilated; advancing an ultrasound probe within the catheter until the tip is within the region of the lumen to be imaged and dilated; preventing the ultrasound probe from extending distally beyond the catheter; activating the probe to obtain images; advancing the catheter using a method comprising the steps of: retracting the probe, advancing the guidewire, and moving the catheter distally using the guidewire as a guidance device until a balloon dilation portion of the catheter is within the region to be imaged and dilated; and dilating the region of the lumen in the subject by temporarily inflating the balloon through a catheter lumen.

Claim 9

A method of imaging and dilating a region of a lumen in a subject comprising the steps of: positioning a guidewire so that the distal tip of the guidewire is within the lumen and distal of a region of the lumen to be imaged and dilated; advancing a catheter using the guidewire as a guidance device until a distal end of the catheter is within the lumen, and distal of the region of the lumen to be imaged and dilated; retracting the guidewire until it becomes proximal of the region of the lumen to be imaged and dilated; advancing an ultrasound probe within the catheter until the tip is within the region of the lumen to be imaged and dilated; preventing the ultrasound probe from extending distally beyond the catheter; activating the probe to obtain images; advancing the catheter using a method comprising the steps of: retracting the probe, advancing the guidewire, and moving the catheter distally using the guidewire as a guidance device until a balloon dilation portion of the catheter is within the region to be imaged and dilated; and dilating the region of the lumen in the subject by temporarily inflating the balloon through a catheter lumen.