Subintimal re-entry catheter with shape controlled balloon
First Claim
1. A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space, comprising:
- an inflatable balloon having a deflated state, a first inflation state, and a second inflation state having a different cross-sectional profile from the first inflation state, wherein in the first inflation state the inflatable balloon has a flattened cross-sectional profile, and in the second inflation state the inflatable balloon has a circular cross-sectional profile; and
an elongate shaft extending distally from a hub assembly along a longitudinal axis to the inflatable balloon, the elongate shaft including;
a guidewire lumen having a proximal opening, a distal opening, and a lateral opening in a distal region of the elongate shaft proximal of the distal opening; and
an inflation lumen in fluid communication with the inflatable balloon;
wherein the inflatable balloon is configured to be inflated in the subintimal space from the deflated state to the first inflation state at inflation pressures below a threshold inflation pressure and inflated to the second inflation state at inflation pressures above the threshold inflation pressure; and
wherein the inflatable balloon is configured to orient the lateral opening toward the lumen of the blood vessel when the inflatable balloon is inflated to the first inflation state;
wherein the inflatable balloon includes a first segment configured to be oriented radially toward the lumen of the blood vessel from the longitudinal axis in the first inflation state, a second segment configured to be oriented radially away from the lumen of the blood vessel from the longitudinal axis, and third and fourth segments interposed between the first and second segments;
wherein in the first inflation state the third and fourth segments are located further from the longitudinal axis than the first and second segments;
wherein, in the first inflation state, the first and second segments are affixed to a guidewire tube of the elongate shaft extending through the inflatable balloon at one or more attachment points; and
wherein, in the second inflation state, the one or more attachment points are broken such that the first and second segments are detached from the guidewire tube of the elongate shaft extending through the inflatable balloon.
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Accused Products
Abstract
A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The catheter includes an inflatable balloon mounted on a distal end region of the catheter shaft of the catheter. The catheter shaft includes a guidewire lumen having a distal opening and a lateral opening in a distal region of the catheter shaft proximal of the distal opening, and an inflation lumen in fluid communication with the balloon. The balloon is configured to be inflated in the subintimal space to a first inflation state at inflation pressures below a threshold inflation pressure to orient the lateral opening toward the lumen of the blood vessel, and inflated to a second inflation state at inflation pressures above the threshold inflation pressure. The catheter includes means for retaining the balloon in the first inflation state at pressures below the threshold inflation pressure.
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Citations
19 Claims
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1. A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space, comprising:
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an inflatable balloon having a deflated state, a first inflation state, and a second inflation state having a different cross-sectional profile from the first inflation state, wherein in the first inflation state the inflatable balloon has a flattened cross-sectional profile, and in the second inflation state the inflatable balloon has a circular cross-sectional profile; and an elongate shaft extending distally from a hub assembly along a longitudinal axis to the inflatable balloon, the elongate shaft including; a guidewire lumen having a proximal opening, a distal opening, and a lateral opening in a distal region of the elongate shaft proximal of the distal opening; and an inflation lumen in fluid communication with the inflatable balloon; wherein the inflatable balloon is configured to be inflated in the subintimal space from the deflated state to the first inflation state at inflation pressures below a threshold inflation pressure and inflated to the second inflation state at inflation pressures above the threshold inflation pressure; and wherein the inflatable balloon is configured to orient the lateral opening toward the lumen of the blood vessel when the inflatable balloon is inflated to the first inflation state; wherein the inflatable balloon includes a first segment configured to be oriented radially toward the lumen of the blood vessel from the longitudinal axis in the first inflation state, a second segment configured to be oriented radially away from the lumen of the blood vessel from the longitudinal axis, and third and fourth segments interposed between the first and second segments; wherein in the first inflation state the third and fourth segments are located further from the longitudinal axis than the first and second segments; wherein, in the first inflation state, the first and second segments are affixed to a guidewire tube of the elongate shaft extending through the inflatable balloon at one or more attachment points; and wherein, in the second inflation state, the one or more attachment points are broken such that the first and second segments are detached from the guidewire tube of the elongate shaft extending through the inflatable balloon. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space, comprising:
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an elongate shaft extending distally from a hub assembly; an inflatable balloon mounted on a distal region of the elongate shaft, the inflatable balloon configured to be inflated in the subintimal space from a deflated state to a first inflation state at inflation pressures below a threshold inflation pressure and inflated to a second inflation state at inflation pressures above the threshold inflation pressure, wherein in the first inflation state the inflatable balloon has a flattened cross-sectional profile and in the second inflation state the inflatable balloon has a circular cross-sectional profile; and means for retaining the inflatable balloon in the first inflation state until the inflatable balloon is inflated to an inflation pressure above the threshold inflation pressure. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15)
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16. A method of recanalizing a blood vessel having an occlusion therein, the method comprising:
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advancing a distal region of a catheter shaft including an inflatable balloon mounted thereon into a subintimal space between a first tissue layer and a second tissue layer of a wall of a blood vessel, the inflatable balloon having a deflated state, a first inflation state, and a second inflation state having a different cross-sectional profile from the first inflation state, wherein in the first inflation state the inflatable balloon has a flattened cross-sectional profile, and in the second inflation state the inflatable balloon has a circular cross-sectional profile; inflating the inflatable balloon from the deflated state to the first inflation state in the subintimal space by inflating the inflatable balloon to a first inflation pressure below a threshold inflation pressure to orient a lateral port in the distal region of the catheter shaft toward a lumen of the blood vessel distal of the occlusion; advancing a penetration member from the lateral port of the catheter shaft to penetrate through the first tissue layer into the lumen of the blood vessel; and thereafter, inflating the inflatable balloon to the second inflation state different from the first inflation state by inflating the inflatable balloon to a second inflation pressure above the threshold inflation pressure to expand the subintimal space. - View Dependent Claims (17, 18, 19)
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Specification