Occlusion perfusion catheter

Inventors

TEESLINK, C. Rex • Hoyns, Dirk V.

Assignees

Advanced Catheter Therapies Inc

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Publication Number

US-8398589-B2

Patent

Publication Date

2013-03-19

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

An occlusion perfusion catheter includes a catheter shaft carrying proximal and distal occlusion balloons and a longitudinal arrangement of lumens and ports. The catheter includes an agent delivery lumen configured for therapeutic agent perfusion and a separate evacuation/aspiration lumen configured for evacuation and aspiration, with an aspiration option that can include fluid exchange. Between the occlusion balloons, the catheter provides an isolated treatment region for controlled delivery and removal of therapeutic agents into or toward a vessel treatment region.

The catheter further includes separate skive ports and lumens for guidewire and for therapeutic agent perfusion and evacuation and aspiration. Optional pressure-sensing means are positioned near delivery or aspiration regions to detect pressure at or within the delivery skive port or agent delivery lumen during introducing of at least one agent into the isolated treatment region. The lumens and hubs are arranged so that the catheter supports isolating the treatment region with balloon inflation while enabling perfusion of therapeutic agents and optionally evacuation, aspiration, and flushing.

An occlusion visualization catheter includes visualization means between the occlusion balloons for visualizing the isolated treatment region. The visualization means may turn about the catheter longitudinal axis via torque applied to the visualization means, and the isolated region can be optionally evacuating and or flushing before introducing agents. The document describes catheter-based workflows for delivering and aspirating agents into a vessel treatment region while minimizing agent volume, with optional pressure monitoring and visualization.

Claims Coverage

The independent claims include three inventive methods: accessing a lumen with pressure-detected agent introduction, visualizing a lumen with torque-turnable visualization means, and introducing at least one agent into the media of a vessel wall with pressure-detected agent introduction. Across these, the document emphasizes four core inventive features: isolation of a treatment region, delivery via an agent delivery lumen and delivery skive port, optional evacuation and flushing, and, for the first and third methods, selecting and detecting a pressure associated with the delivery skive port or agent delivery lumen. The visualization method additionally adds torque-driven visualization means introduced into the isolated treatment region.

Catheter-based lumen access with pressure-detected agent introduction via a delivery skive port

A method of accessing a lumen by inserting a catheter comprising an agent delivery lumen with a delivery skive port, isolating a treatment region within the lumen, optionally evacuating and optionally flushing the isolated treatment region, and introducing at least one agent via the agent delivery lumen into the isolated treatment region by selecting a pressure to be detected within the delivery skive port or within the agent delivery lumen and detecting the pressure.

Torque-turnable visualization means introduced into an isolated treatment region

A method of visualizing a lumen by inserting a catheter comprising a longitudinal axis, isolating a treatment region within the lumen, optionally evacuating and optionally flushing the isolated treatment region, and introducing visualization means into the isolated treatment region via the catheter wherein the visualization means may turn about the longitudinal axis via torque applied to the visualization means.

Vessel wall media agent introduction with pressure-detected delivery via a delivery skive port

A method of introducing at least one agent into the media of a vessel wall by inserting a catheter comprising an agent delivery lumen with a delivery skive port, isolating a treatment region within the lumen, optionally evacuating and optionally flushing the isolated treatment region, and introducing via the agent delivery lumen at least one agent into the isolated treatment region by selecting a pressure to be detected within the delivery skive port or within the agent delivery lumen and detecting the pressure.

Across the independent claims, the claimed coverage centers on isolating a treatment region within a lumen using a catheter, delivering introduced agents via an agent delivery lumen and delivery skive port, and optionally evacuating and flushing the isolated region. For the accessing and vessel-wall media introduction methods, introducing is defined by selecting a pressure associated with the delivery skive port or agent delivery lumen and detecting that pressure. For lumen visualization, the claims add introduction of visualization means into the isolated treatment region, with the visualization means being rotatable about the catheter longitudinal axis via torque.

Stated Advantages

Minimizing agent volume.

Enabling optional visualization and optional pressure monitoring during delivery and aspiration workflows.

Documented Applications

Delivering and aspirating therapeutic agents to a vessel treatment region within an isolated treatment region.

Introducing at least one agent into the media of a vessel wall.

Visualizing a lumen, including visualizing the isolated treatment region.

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