Balloon catheter systems and methods for bypassing an occlusion in a blood vessel
Inventors
Assignees
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Publication Number
US-9364642-B2
Publication Date
2016-06-14
Expiration Date
Abstract
A catheter for subintimally bypassing an occlusion in a vessel includes a catheter shaft including a guidewire lumen disposed therethrough and having a shaft longitudinal axis, at least two balloons coupled to an exterior of the catheter shaft such that longitudinal axes of the balloons are in a common plane with the shaft longitudinal axis when uninflated and with no external forces on the catheter. The balloons are configured such that when the catheter is disposed in the subintima of a vessel and the balloons are inflated, a tip of the catheter shaft is oriented towards a true lumen of the vessel distal of the occlusion.
Core Innovation
The invention relates to balloon catheter systems and methods for bypassing an occlusion via a subintimal approach. A catheter is advanced into a subintimal space between layers of the vessel wall proximal to the occlusion so that a distal end of the catheter is distal of the occlusion, including chronic total occlusion (CTO). The catheter shaft includes a guidewire lumen and at least one inflation lumen, and the catheter further includes a first balloon and a second balloon coupled to opposite exterior sides of the catheter shaft.
The balloons are coupled to the catheter shaft at proximal and distal balloon bonds, and the catheter shaft is external to each balloon between the respective proximal and distal bonds. When the first balloon and the second balloon are inflated while the catheter is disposed in the subintima, the catheter shaft bends such that a tip of the catheter shaft distal of the first and second balloons is oriented towards a true lumen of the vessel distal of the occlusion.
In a three-balloon embodiment, a third balloon having a third balloon longitudinal axis is coupled along the exterior of the catheter shaft, disposed between the first balloon and the catheter shaft. When the first, second, and third balloons are uninflated and without external forces acting upon them, the first balloon longitudinal axis, the second balloon longitudinal axis, the third balloon longitudinal axis, and the shaft longitudinal axis are substantially aligned along a common plane.
When the first, second, and third balloons are inflated, the distal end of the catheter shaft is rotated to be directed towards the true lumen distal of the occlusion. The disclosed construction includes catheter shaft geometry with inner and outer shafts and bonding regions configured such that balloon coupling does not occur between the proximal and distal bonds.
Claims Coverage
The independent claims cover four closely related inventive features across two catheter embodiments and two corresponding methods. The key inventive features are balloon coupling at proximal and distal bonds with the shaft external between bonds, and shaft bending or rotation toward the true lumen upon balloon inflation in the subintimal space.
Two opposite exterior balloons uncoupled between proximal and distal bonds for shaft bending toward true lumen
A catheter for bypassing an occlusion via a subintimal approach includes a catheter shaft having a guidewire lumen disposed therethrough and a first balloon coupled to an exterior of the catheter shaft with a proximal portion coupled at a first balloon proximal bond and a distal portion coupled at a first balloon distal bond, wherein the first balloon is not coupled to the catheter shaft between the first balloon proximal bond and the first balloon distal bond and wherein the catheter shaft is external to the first balloon between the first balloon proximal bond and the first balloon distal bond; and a second balloon coupled to an exterior of the catheter shaft opposite the first balloon with analogous proximal and distal bonds and with the catheter shaft external to the second balloon between those bonds; wherein when disposed in the subintima and inflated, the catheter shaft bends such that a distal tip distal of the first and second balloons is oriented towards a true lumen distal of the occlusion.
Subintimal advancement with inflation-bent distal tip directed toward true lumen distal of occlusion
A method of bypassing an occlusion in a true lumen of a vessel advances a catheter in the true lumen proximal to the occlusion into a subintimal space between layers of the vessel wall proximal to the occlusion such that a distal end of the catheter is distal of the occlusion, wherein the catheter includes a catheter shaft, a first balloon and a second balloon coupled with proximal and distal balloon bonds and uncoupled between the proximal and distal bonds such that the catheter shaft is external to each balloon between those bonds; and inflates the first balloon and the second balloon such that the catheter shaft is bent and the distal tip of the catheter shaft is directed towards the true lumen distal of the occlusion.
Three-balloon catheter configured for common-plane alignment when uninflated and distal rotation toward true lumen
A catheter for bypassing an occlusion via a subintimal approach includes a catheter shaft including a guidewire lumen disposed therethrough, a first balloon and a second balloon coupled to opposite exterior sides of the catheter shaft with proximal and distal balloon bonds and with the catheter shaft external to each balloon between those bonds; and a third balloon coupled to an exterior of the catheter shaft along the third balloon with the catheter shaft external to the third balloon and the third balloon disposed between the first balloon and the catheter shaft; wherein when the first, second, and third balloons are uninflated and without external forces acting upon them, the first, second, third, and shaft longitudinal axes are substantially aligned along a common plane.
Three-balloon inflation to rotate distal catheter end toward true lumen distal of occlusion
A method of bypassing an occlusion in a true lumen of a vessel advances a catheter in the true lumen proximal to the occlusion into a subintimal space between layers of the vessel wall proximal to the occlusion such that a distal end of the catheter is distal of the occlusion, wherein the catheter includes a catheter shaft, a first balloon and a second balloon coupled to opposite exterior sides with proximal and distal balloon bonds and uncoupled between those bonds such that the catheter shaft is external to each balloon between those bonds, and a third balloon coupled along the third balloon with the catheter shaft external to the third balloon and disposed between the first balloon and the catheter shaft; and inflates the first, second, and third balloons such that a distal end of the catheter shaft is rotated to be directed towards the true lumen distal of the occlusion.
Across the independent claims, the inventive concept centers on balloon-coupled catheter shafts where each balloon is coupled at proximal and distal bonds but the catheter shaft is external to the balloon between those bonds, enabling the shaft to bend or rotate when balloons are inflated in the subintimal space so the distal tip or end is directed toward the true lumen distal of the occlusion.
Stated Advantages
Documented Applications
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