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Publication Number
US-10850065-B2
Publication Date
2020-12-01
Expiration Date
Abstract
A catheter tip that provides longitudinal flexibility, pushability and radial rigidity thereby improving deliverability is provided. The catheter tip includes a spring-like element to provide longitudinal flexibility and pushability to the catheter tip. The spring-like element may also provide radial support to the distal edge of the catheter tip. Alternatively, a radially rigid distal end may also be included distal of the spring-like element. The apparatus may be used with any interventional catheter system, but is particularly suitable for use with balloon-expandable stent systems and balloon-angioplasty systems, where flexibility of the catheter tip and minimal flaring of the distal edge of the catheter tip is desirable.
Core Innovation
The invention provides a catheter tip architecture that combines a longitudinally flexible tube and a spring-like element to achieve pushability while maintaining longitudinal flexibility. The spring-like element is attached to the longitudinally flexible tube and is located either inside or outside the flexible tube. The spring-like element extends to a distal edge in some embodiments, while in other embodiments it has a distal end that does not extend to a distal edge.
The distal end portion of the catheter tip is configured with radial rigidity and a rounded/tapered distal end to reduce distal edge flaring or protrusion and to avoid catching on vessel walls or previously deployed stent struts. In embodiments, a radially rigid distal end section is located distal of the spring-like element and is contiguous with selected structures including the longitudinally flexible tube and spring-like element. Tapering of the radially rigid distal end section is described as a feature.
A spring constant for the spring-like element is limited to a range of 0.3 to 25 gF/mm. The described embodiments include spring-like structures such as an extension spring and accordion/braided-accordion configurations, and include placing the spring near a balloon with an optional spacer portion and a flexible spacer tube. Radiopacity benefits are also described, including the use of radiopaque markers.
In disclosed performance comparisons, the radially rigid and rounded/tapered distal end reduces distal edge protrusion and helps eliminate kinking or buckling in stenosis, including in curved vessels. The catheter tip is described as improving deliverability through tortuous and stenotic vessels relative to conventional tapered plastic tips.
Claims Coverage
The independent claims cover multiple catheter-tip and catheter-system configurations that each use a longitudinally flexible tube together with a spring-like element to provide pushability, with a defined spring-constant range of 0.3 to 25 gF/mm. Across the independent claims, the main inventive features include the placement of the spring-like element inside or outside the flexible tube, whether it extends to or stops short of the distal edge, the presence of a radially rigid distal end section, and maintaining distal edge longitudinal flexibility relative to a guide wire.
Longitudinally flexible tube with attached spring-like element providing pushability to distal edge
A flexible and pushable catheter tip comprising a longitudinally flexible tube and a spring-like element attached to the flexible tube, the spring-like element located inside or outside the flexible tube, wherein the spring-like element provides pushability, and wherein a spring constant is in a range of 0.3 to 25 gF/mm.
Luminal-side spring-like element with radially rigid distal end section contiguous with tube or spring region
A flexible and pushable catheter tip comprising a longitudinally flexible tube and a spring-like element having a distal end coupled to the flexible tube with the spring located on the luminal side, and a radially rigid distal end section located distal of the spring-like element and contiguous with a structure selected from the longitudinally flexible tube and the spring-like element, wherein the spring-like element provides pushability and wherein a spring constant is in a range of 0.3 to 25 gF/mm.
Non-compressible wire coil spring-like element with proximal spacer portion
A flexible and pushable catheter tip comprising a non-compressible spring-like element and a spacer portion located at a proximal end of the spring-like element, wherein the spring-like element provides pushability, wherein the spring-like element is a wire coil, and wherein a spring constant is in a range of 0.3 to 25 gF/mm.
Balloon-mounted catheter tip with spring-like element covered by longitudinally flexible tube and open distal end
A catheter comprising a balloon mounted proximal of the catheter tip, and a catheter tip including a spring-like element having a length and a longitudinally flexible tube extending with the entire length of the spring-like element, wherein the spring-like element provides pushability, wherein the spring-like element has a distal end and does not extend to a distal edge of the catheter tip, wherein a distal end of the catheter tip is open, and wherein a spring constant is in a range of 0.3 to 25 gF/mm.
Balloon-mounted catheter tip with longitudinally flexible tube and radially rigid distal section
A catheter comprising a balloon mounted proximal of the catheter tip, and a catheter tip including a spring-like element having a distal end, a longitudinally flexible tube coupled with the spring-like element, and a radially rigid distal end section located distal of the spring-like element, wherein the spring-like element provides pushability and wherein a spring constant is in a range of 0.3 to 25 gF/mm.
Catheter system with spring-like element extending to distal edge and distal edge flexibility not less than guide wire
A catheter system comprising a catheter, a balloon, a guide wire, and a catheter tip, the catheter tip including a longitudinally flexible tube having a luminal side and a vessel wall side, and a spring-like element having a length, with the spring-like element located inside or outside the longitudinally flexible tube, wherein the spring-like element provides pushability, wherein the spring-like element extends to a distal edge of the catheter tip, wherein the distal edge of the catheter tip does not have less longitudinal flexibility than the guide wire slidably extending therethrough, and wherein a spring constant is in a range of 0.3 to 25 gF/mm.
Catheter system with non-compressible wire coil spring-like element plus proximal spacer portion and distal edge flexibility not less than guide wire
A catheter system comprising a catheter, a balloon, a guide wire, and a catheter tip, the catheter tip including a non-compressible spring-like element and a spacer portion located at a proximal end of the spring-like element, wherein the spring-like element provides pushability, wherein the spring-like element is a wire coil, wherein a distal edge of the catheter tip does not have less longitudinal flexibility than the guide wire slidably extending therethrough, and wherein a spring constant is in a range of 0.3 to 25 gF/mm.
Spring-like element not extending to distal edge while attached to longitudinally flexible tube
A flexible and pushable catheter tip comprising a longitudinally flexible tube having a luminal side and a vessel wall side, and a spring-like element having a distal end attached to the flexible tube and located inside or outside the flexible tube, wherein the spring-like element does not extend to a distal edge of the catheter tip, and wherein a spring constant is in a range of 0.3 to 25 gF/mm.
Catheter system with spring-like element extending with longitudinally flexible tube but not to distal edge
A catheter system comprising a catheter, a balloon, a guide wire, and a catheter tip, the catheter tip including a longitudinally flexible tube having a luminal side and a vessel wall side, and a spring-like element having a length, wherein the entire length of the spring-like element extends with the longitudinally flexible tube and the spring-like element is located inside or outside the longitudinally flexible tube, wherein the spring-like element has a distal end and does not extend to a distal edge of the catheter tip, wherein the distal edge of the catheter tip does not have less longitudinal flexibility than the guide wire slidably extending therethrough, and wherein a spring constant is in a range of 0.3 to 25 gF/mm.
Across the independent claims, the inventive coverage is centered on a flexible and pushable catheter tip where a spring-like element attached to a longitudinally flexible tube provides pushability with a defined spring-constant range of 0.3 to 25 gF/mm. The claims further differentiate configurations by whether the spring-like element extends to or stops short of the distal edge, whether a radially rigid distal end section is provided distal to the spring-like element, and, in catheter systems, whether the distal edge longitudinal flexibility is not less than the guide wire.
Stated Advantages
Improves deliverability through tortuous or stenotic vessels.
Reduces distal edge protrusion by using a radially rigid and rounded/tapered distal end.
Helps prevent distal edge flaring or protrusion and catching on vessel walls or previously deployed stent struts.
Eliminates kinking or buckling in stenosis.
Improves performance relative to conventional tapered plastic tips in curved vessels.
Provides radiopacity benefits.
Documented Applications
Balloon-expandable stent delivery and balloon angioplasty contexts with guide wire use in tortuous and stenotic vessels, including situations involving previously deployed stent struts.
Use in curved vessels and in stenosis where distal edge protrusion and kinking or buckling are addressed.
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