Low profile occlusion catheter
Inventors
Assignees
Publication Number
US-10569062-B2
Publication Date
2020-02-25
Expiration Date
2034-09-09
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Abstract
A low profile occlusion catheter having a guiding atraumatic tip that prevents entry of the balloon into collateral vessels. The occlusion catheter system is particularly well suited for use in vascular occlusion and includes a pressure monitoring line to monitor the degree and state of occlusion.
Core Innovation
The invention provides a low profile occlusion catheter system that includes a guiding atraumatic tip designed to prevent balloon entry into collateral vessels. The system incorporates multiple catheter members and lumens configured for improved navigation through vasculature and features a pressure monitoring line to monitor the degree and state of occlusion. The system may include three catheter members arranged to create an annular space, with an expandable occlusion member—such as a balloon—coupled between various catheter members for targeted vascular occlusion.
This catheter system is designed to address the critical challenge faced by conventional occlusion balloon catheters, which do not adequately balance the need for a stiff, high-strength proximal segment with a flexible, low-profile distal segment capable of tracking tortuous vascular pathways without entry into collateral vessels. By providing an atraumatic tip formed from elastic, shape memory, or superelastic materials, and allowing for a graduated reduction in durometer along the distal section, the invention provides improved flexibility and trackability while minimizing the risk of trauma or perforation during placement.
Additionally, the design features fluid pathways and ports for introducing or withdrawing fluids and for pressure or flow sensing within the body. The modular assembly supports advanced intervention functions, such as inflation and deflation of the balloon via external fluid sources, and may include radio opaque markers for visualization under imaging modalities. Construction materials may include metals, polymers, or metal-reinforced polymers, tailored to provide the necessary strength, flexibility, and biocompatibility for safe vascular insertion and use.
Claims Coverage
The claim coverage is centered on one independent claim outlining six main inventive features integral to the described occlusion catheter system.
Coaxial multi-member catheter configuration with backbone
The system comprises a first catheter member with a longitudinal lumen, a second catheter member with a second lumen positioned concentrically and spaced apart over a proximal section of the first member to form an annular space and port, and a third catheter member positioned over a distal section of the first member. The first member extends beyond the second member and into the third, providing a backbone of higher stiffness for the system. This creates dedicated regions for occlusion, pressure monitoring, and fluid flow communication.
Atraumatic tip member
An atraumatic tip member is co-axially coupled proximate to the distal end of the third catheter member. The tip is designed to provide a soft, atraumatic interface, suppressing vessel trauma and preventing inadvertent entry into collateral vessels during deployment.
Separate expandable occlusion member
A separate occlusion member, such as a balloon, is fixed near the distal end of the second catheter member and the proximal end of the third catheter member. The occlusion member encloses the region between these two catheter members, and the distal end of the first catheter member extends beyond the occlusion member into the third catheter member.
Backbone with defined stiffness hierarchy
The first catheter member—the backbone—possesses greater stiffness than both the second and third catheter members. This arrangement lends required column strength and supports tracking and passage through tortuous vascular pathways while supporting flexible distal segments.
Annular port and fluid flow communication
An annular port is defined at the distal end of the second catheter member where it overlaps with the first catheter member, enabling fluid delivery or withdrawal, balloon inflation, or other vascular interventions. The configuration allows for the first and third lumens to be in fluid flow communication.
Gradient flexibility via material or structural variation
The third catheter member may incorporate segments of progressively decreasing stiffness toward the atraumatic tip, creating a step-down transition and supporting both control and flexibility for navigation within vasculature.
The inventive features collectively allow for a low-profile, multi-lumen occlusion catheter system with a highly flexible, atraumatic distal tip and a strong, supportive proximal backbone, configured to facilitate safe and effective vascular occlusion and associated interventions while minimizing the risk of vessel trauma and misplacement.
Stated Advantages
Provides a low-profile catheter system capable of passing through small diameter introducer sheaths for easier vascular access and navigation.
The combination of a stiff backbone and highly flexible distal segments enables optimal trackability through tortuous anatomy while minimizing trauma or risk of vessel perforation.
The atraumatic tip design helps prevent entry into collateral vessels and reduces the likelihood of vascular injury during placement.
The system allows for monitoring of vascular pressure or flow and for the introduction or withdrawal of fluids at precise locations.
Radio opaque markers facilitate visualization of the catheter and balloon position during deployment using imaging techniques.
Documented Applications
Vascular occlusion, including use as an aortic occlusion balloon catheter.
Angioplasty procedures.
Stent delivery interventions.
Atherectomy procedures.
Drug delivery within the vasculature.
Imaging procedures in vascular intervention.
Use in any suitable arterial or venous access site, such as the femoral, brachial, or subclavian arteries.
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