Devices, methods and kits for delivery of therapeutic materials to a target artery
Inventors
Agah, Ramtin • Najmabadi, Kamran • Zanchi, Marta Gaia
Assignees
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Publication Number
US-9457171-B2
Publication Date
2016-10-04
Expiration Date
Abstract
An apparatus includes an inner catheter that is coupled to a handle and defines a lumen configured to receive a guidewire. An outer catheter is movably coupled to the handle and defines a first lumen in fluid communication with a distal opening and that is configured to introduce a therapeutic agent through the distal opening and into a target pancreatic artery(ies). The outer catheter defines a second lumen configured to receive at least a portion of the inner catheter. An actuator is coupled to the handle and configured to move the outer catheter relative to the handle. A first occlusion element is coupled to the inner catheter and a second occlusion element is coupled to the outer catheter and disposed proximal to the first occlusion element. A distance between the first occlusion element and the second occlusion element is adjustable when the outer catheter is moved relative to the handle.
Core Innovation
The invention relates to a multi-occlusion endovascular catheter system and kit for pancreas-targeted delivery of therapeutic agent(s) into one or more target arteries. The system includes an inner catheter configured to receive a guidewire and having a first occlusion element, and an outer catheter defining a first lumen with an opening in a side wall at a distal end portion. The opening introduces a therapeutic agent through the outer catheter and into one or more target arteries while the inner catheter is received via a second lumen in the outer catheter.
The system uses a second occlusion element disposed proximal to the first occlusion element to define an isolated arterial segment or isolated region in the target artery. A distance between the first occlusion element and the second occlusion element is adjustable when at least one of the outer catheter and the inner catheter is moved relative to the other. An actuator and relative catheter movement define and adjust the isolated region so that therapeutic agent delivery is confined to the isolated area.
Embodiments further include sealing to prevent therapeutic agent from entering the second lumen of the outer catheter. The disclosure includes ports arranged to communicate therapeutic agent and inflation medium(s) to the relevant lumen(s) and occlusion elements, and it describes single-handed manipulation and visualization via contrast injection. Documented uses include local delivery of therapeutic materials for stem-cell engraftment and locally delivered chemotherapy for pancreatic cancer, including delivery into pancreatic artery and/or splenic artery configurations.
Claims Coverage
The independent claims are directed to three inventive features: an apparatus with inner and outer catheters and first/second occlusion elements with adjustable spacing, a handle-coupled apparatus with defined spacing relationships between occlusion elements, and a catheter delivery kit with sealing and optional components for slidably receiving within the inner catheter lumen. The claims center on occlusion-based isolation of a target arterial region combined with therapeutic agent delivery through a side-wall opening.
Inner and outer catheters with side-wall therapeutic-agent opening
The apparatus includes an inner catheter defining an inner catheter lumen configured to receive a guidewire, and an outer catheter defining a first lumen in fluid communication with an opening defined in a side wall at a distal end portion of the outer catheter and configured to introduce a therapeutic agent through the opening and into one or more target arteries, and a second lumen configured to receive at least a portion of the inner catheter.
Adjustable first and second occlusion elements to define isolated region
The apparatus includes a first occlusion element coupled to the inner catheter and a second occlusion element coupled to the outer catheter, the second occlusion element disposed proximal to the first occlusion element, a distance between the first occlusion element and the second occlusion element being adjustable when at least one of the outer catheter and the inner catheter is moved relative to the other.
Handle-coupled catheter system with first and second distance relationship
The apparatus includes a handle, an inner catheter coupled to the handle, and an outer catheter coupled to the handle, with first and second occlusion elements disposed such that at least one of the inner catheter and the outer catheter is moved relative to the other between a first position in which the second occlusion element is at a first distance from the first occlusion element and a second position in which the second occlusion element is at a second distance from the first occlusion element, the second distance being greater than the first distance.
Kit including catheter device, ports, sealing, and optional insertion components
A kit includes a catheter device including a handle, an outer catheter coupled to the handle, an inner catheter movably coupled to the outer catheter, a distal occlusion element coupled to the inner catheter, a proximal occlusion element coupled to the outer catheter, the outer catheter defining a first lumen in fluid communication with an opening defined in a side wall of the outer catheter and configured to introduce one or more therapeutic agent to one or more target arteries, and a second lumen configured to receive at least a portion of the inner catheter, wherein the handle includes a first port and a second port, one or more therapeutic agent for delivery, and a sealing element coupled to the outer catheter and configured to seal the second lumen of the outer catheter and prevent a therapeutic agent from entering into the second lumen, and wherein the kit further comprises at least one of a stylet, a dilator, a guidewire, or a guide catheter configured to be slidably received within the lumen of the inner catheter.
Across the independent claims, the coverage centers on occlusion-based isolation created by first and second occlusion elements on inner and outer catheters, with therapeutic agent introduction through a distal side-wall opening in the outer catheter into one or more target arteries. The claims further require adjustable or relative positioning to vary the spacing between occlusion elements, including a handle-coupled distance relationship, and for the kit, a sealing element configured to seal a second lumen to prevent therapeutic agent entry, along with optional stylet, dilator, guidewire, or guide catheter components slidably received within the inner catheter lumen.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Stem-cell engraftment using locally delivered therapeutic materials to a pancreas-targeted region.
Locally delivered chemotherapy for pancreatic cancer using the pancreas-targeted catheter system.
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