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Publication Number
US-9526874-B2
Publication Date
2016-12-27
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 system for accessing and treating a biological space by inserting a catheter that isolates a treatment region. The catheter includes a catheter shaft with a first balloon positioned proximal to a distal tip and a second balloon positioned proximal to the first balloon, thereby defining an isolated treatment region between the balloons.
The catheter provides an agent delivery orifice positioned between the first and second balloons and an agent aspiration orifice positioned between the first and second balloons, with the delivery and aspiration orifices lying on opposite sides of the longitudinal axis. At the agent delivery orifice, the catheter includes at least one pressure sensing means to sense pressure at the delivery orifice.
In the method aspect, isolating the treatment region enables optionally evacuating and/or flushing the isolated treatment region and introducing at least one agent into the isolated treatment region via the agent delivery orifice. A further aspect includes a catheter configuration with two balloons and the same combination of delivery and aspiration orifices positioned between the balloons on opposite sides of the longitudinal axis, together with at least one pressure sensing means at the delivery orifice.
The dependent refinements include adding a third balloon between the first and second balloons and between the agent delivery orifice and the aspiration orifice, as well as method refinements that optionally introduce at least one second agent via an aspiration orifice, including chemical interaction between agents.
Claims Coverage
The document includes two independent claims. Across these independent claims, the core inventive features are the two-balloon catheter that isolates a treatment region, the delivery and aspiration orifice pair arranged on opposite sides of the catheter longitudinal axis, and pressure sensing at the agent delivery orifice; one independent claim focuses on a method of accessing a biological space and one focuses on the catheter structure.
Two-balloon isolation of a treatment region for biological space access
A catheter shaft having a distal end and a proximal end with a first balloon positioned proximal to the shaft distal tip and a second balloon positioned proximal to the first balloon, where isolating a treatment region between the first and second balloons occurs in the biological space.
Agent delivery orifice and aspiration orifice between balloons on opposite sides of the longitudinal axis
An agent delivery orifice positioned between the first and second balloons and an agent aspiration orifice positioned between the first and second balloons, wherein the agent delivery orifice and the aspiration orifice lie on opposite sides of the longitudinal axis.
Pressure sensing means at the agent delivery orifice
At least one pressure sensing means positioned at the agent delivery orifice, where the pressure sensing means is at said agent delivery orifice.
Optional evacuation and/or flushing of the isolated treatment region
Optionally evacuating the isolated treatment region and/or flushing the isolated treatment region after isolating the treatment region between the first and second balloons in the biological space.
Delivery of at least one agent into the isolated treatment region
Introducing, via the agent delivery orifice, at least one agent into the isolated treatment region.
Catheter structure with two balloons, delivery/aspiration orifices, and pressure sensing
A catheter comprising a catheter shaft with a longitudinal axis, a first balloon positioned proximal to the shaft distal tip, a second balloon positioned proximal to the first balloon, an agent delivery orifice between the first and second balloons, at least one pressure sensing means at said delivery orifice, and an aspiration orifice between the first and second balloons, wherein said agent delivery orifice and said aspiration orifice lie on opposite sides of said longitudinal axis.
Overall claim coverage centers on isolating an in vivo or in-body space using first and second balloons, while arranging an agent delivery orifice and an agent aspiration orifice between the balloons on opposite sides of the longitudinal axis. Pressure sensing means is required at the agent delivery orifice, and the method claim additionally requires introducing at least one agent into the isolated treatment region, with optional evacuating and/or flushing.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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