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Publication Number
US-8262611-B2
Publication Date
2012-09-11
Expiration Date
Abstract
Catheters for occluding, visualizing, irrigating, evacuating, and delivering agents to a treatment area are disclosed. The catheters comprise a catheter body comprising five lumens, first and second occlusion balloons coupled to the catheter body, an optional space-occupying balloon coupled to the catheter body and disposed between the first and second occlusion balloons, and an optional visualization means that enables visualization between the first and second occlusion balloons. Methods for using these catheters are also disclosed. A method comprises inflating the first and second occlusion balloons, inflating the space-occupying balloon, allowing fluid to exit via an evacuation lumen, optionally irrigating or aspirating to facilitate fluid exit via said lumen, and delivering an agent to a treatment area via the agent lumen.
Core Innovation
The invention relates to an occlusion perfusion catheter (OPC) and an occlusion visualization catheter (OVC). The catheter includes a catheter shaft having a longitudinal axis with a first balloon and a second balloon positioned on the shaft such that the balloons define a treatment region. The catheter can include a third balloon and a space-occupying balloon to reduce treatment volume and increase agent effectiveness within the treatment region.
The catheter architecture provides separate agent-delivery and aspiration functions using distinct segments located between the balloons. An agent delivery segment is formed with an agent delivery segment orifice, and an aspiration segment is formed with an aspiration segment orifice. The agent delivery segment orifice and the aspiration segment orifice lie on opposite sides of the longitudinal axis, and the catheter further includes an agent delivery lumen and an aspiration lumen in communication with the corresponding orifices.
The device further integrates guidewire lumen functionality and pressure-sensing means. A guidewire lumen is formed within the shaft and communicates with an opening at the proximal end and an opening at the distal end of the catheter for over-the-wire positioning. Pressure-sensing means extend through the agent delivery lumen and have a distal end at the agent delivery segment orifice or within the agent delivery lumen. Optional valves and an optional visualization arrangement use a visualization means between the occlusion balloons with a visualization slot for 360° lumen viewing, including a visualization means that may turn about the longitudinal axis via torque.
Claims Coverage
The partial content includes three independent claims that share the same overall catheter concept and positioning constraint, while varying the balloon/lumen architecture and whether visualization and multi-balloon inflation pathways are explicitly required. Across the independent claims, there are distinct inventive features involving balloon placement and material, separate agent delivery and aspiration segments with opposite-side orifices, guidewire lumen communication, pressure-sensing means, and optionally visualization means with a turnable visualization element.
Opposing balloons defining a treatment region with separate agent delivery and aspiration orifices
A catheter having a first balloon and a second balloon positioned on the shaft proximal to the shaft distal tip with the second balloon constructed of a non-compliant material, and a third balloon positioned proximal to the second balloon, wherein an agent delivery segment positioned between the first and third balloons includes one agent delivery segment orifice and an aspiration segment positioned between the first and third balloons includes one aspiration segment orifice, and wherein the agent delivery segment orifice and the aspiration segment orifice lie on opposite sides of the longitudinal axis.
Guidewire lumen communicating with proximal and distal catheter openings
A guidewire lumen formed within the shaft and in communication with an opening formed in a proximal end of the catheter and an opening formed in a distal end of the catheter.
Pressure-sensing means extending through the agent delivery lumen
A first pressure-sensing means having proximal and distal ends and a length therebetween extending through the agent delivery lumen, wherein the first pressure sensing means distal end is at the agent delivery segment orifice or within the agent delivery lumen.
Three-balloon catheter with separate inflation lumens and ports
A catheter having a first balloon, a second balloon constructed of a non-compliant material, and a third balloon arranged axially, wherein a first inflation lumen is in communication with the first and third balloons and further in communication with a first balloon inflation port on the proximal end of the catheter shaft, and wherein a second inflation lumen is in communication with the second balloon and further in communication with a second balloon inflation port on the proximal end of the catheter shaft.
Dedicated agent-delivery and aspiration lumens with proximal ports
An agent delivery lumen and an agent delivery segment positioned between the second and third balloons with one agent delivery segment orifice, wherein the agent delivery lumen is in communication with the agent delivery segment orifice and an agent delivery port formed on the proximal end of the catheter shaft, and an aspiration lumen and an aspiration segment positioned between the first and second balloons with one aspiration segment orifice, wherein the aspiration lumen is in communication with the aspiration segment orifice and an aspiration port formed on the proximal end of the catheter shaft, and wherein the agent delivery segment orifice and the aspiration segment orifice lie on opposite sides of the longitudinal axis.
Two pressure-sensing means routed through the agent delivery lumen
A first pressure-sensing means extending through the agent delivery lumen with the first pressure-sensing means proximal end in communication with a connector formed on the proximal end of the catheter shaft and the first pressure-sensing means distal end at the agent delivery segment orifice or within the agent delivery lumen, and a second pressure-sensing means extending through the agent delivery lumen with the second pressure-sensing means proximal end in communication with the connector and the second pressure-sensing means distal end located within the agent delivery lumen.
Visualization catheter with a lumen/slot visualization path and a turnable visualization means
A catheter having a first balloon and a second balloon, an agent delivery segment positioned between the first and second balloons with one agent delivery segment orifice, and an aspiration segment positioned between the first and second balloons with one aspiration segment orifice, and a visualization means lumen in communication with a visualization means slot, wherein the visualization means extends through the visualization means lumen at least to the visualization means slot and may turn about the longitudinal axis via torque applied to the visualization means, and wherein the agent delivery segment orifice and the aspiration segment orifice lie on opposite sides of the longitudinal axis.
Across the independent claims, the main claim coverage is directed to a multi-lumen catheter combining opposing or axially arranged balloons, separate agent delivery and aspiration segments whose orifices lie on opposite sides of the longitudinal axis, and a guidewire lumen that communicates with proximal and distal openings. The claims also include pressure-sensing means routed through the agent delivery lumen with specified distal placement, and optionally include a visualization means lumen and slot arrangement with a visualization element that can turn about the longitudinal axis via applied torque.
Stated Advantages
increase agent effectiveness
reduce treatment volume
Documented Applications
Occlusion visualization catheter (OVC) operation using a visualization lumen and visualization means with a visualization slot for lumen viewing.
Occlusion perfusion catheter (OPC) use using separate agent-delivery and aspiration segments for agent perfusion and aspiration.
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