Therapeutic delivery devices, systems, and methods
Inventors
Chamberlain, Dean • Novokhatny, Valery • Fineberg, David
Assignees
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Publication Number
US-9028465-B2
Publication Date
2015-05-12
Expiration Date
Abstract
Devices, systems, and methods for delivery of therapeutics, in particular thrombolytic agents, in particular plasmin, are provided. The devices, systems, and methods also provide for occlusion of a vessel or graft distal and/or proximal to a treatment zone. Also provided are devices, systems, and methods that trap emboli.
Core Innovation
The disclosed invention provides methods and coaxial occlusion/infusion catheter systems for treating thrombosis in a vessel or graft by administering a plasmin-containing composition into an infusion zone within a thrombus. A distal tip of the catheter system is positioned distal to a thrombus so that the thrombus length corresponds to the infusion zone, and the composition exits pressure responsive slits or side holes to provide plasmin within the thrombus.
To reduce plasmin escape and inactivation outside the targeted treatment zone, the catheter system includes occlusion features that block flow distal to the infusion zone and, in some embodiments, proximal to the infusion zone. The occlusion catheter component provides occlusion of the vessel or graft distal to the infusion zone, and the sheath component provides occlusion of the vessel or graft proximal to the infusion zone.
The method includes incubating the plasmin-containing composition in the infusion zone to dissolve the thrombus. In some embodiments, occlusion chamber activation is followed by inactivation to permit normal blood flow through the vessel or graft and removal of the catheter system. In further embodiments, the infusion zone is aligned to a treatment zone defined by thrombus length and/or the infusion zone is maximized.
Claims Coverage
The independent claims are clm-00001, clm-00006, and clm-00011. Across these claims, the same main inventive theme is repeated: a coaxial occlusion/infusion catheter system with pressure responsive slits or side holes and occlusion chambers positioned relative to an infusion zone, combined with administering and incubating a plasmin-containing composition to dissolve a thrombus.
Coaxial occlusion/infusion catheter positioning relative to thrombus length
Inserting a coaxial occlusion/infusion catheter system into a subject's vessel or graft and advancing the catheter so that a distal tip lies distal to a thrombus, with the thrombus length corresponding to the infusion zone, wherein the thrombus defines a treatment zone for the infusion zone.
Pressure responsive slits or side holes with detectable markers positioned within thrombus
An infusion catheter component comprising 1 to 40 pressure responsive slits or side holes and one or more detectable markers for positioning all of said pressure responsive slits or side holes within the thrombus, wherein the composition comprising plasmin exits said pressure responsive slits or side holes thereby providing the composition comprising plasmin within the thrombus.
Occlusion chambers activated by inflation to block distal and proximal flow
Occlusion of the vessel or graft distal to the infusion zone using an occlusion catheter component having an occlusion chamber, with occlusion chamber activation by inflation through an inflation lumen, and in embodiments also occlusion of the vessel or graft proximal to the infusion zone using an outer sheath component having an occlusion chamber activated by inflation through an inflation lumen.
Administering plasmin via an annular fluid passageway and incubating to dissolve thrombus
Administering a composition comprising plasmin by infusion into an annular fluid passageway between an outer wall of the occlusion catheter and an inner wall of the infusion catheter (or administering the plasmin composition into the infusion catheter), and incubating the composition in the infusion zone, thereby dissolving the thrombus.
Occlusion chamber inactivation to permit normal blood flow and removal of catheter system
Inactivating an occlusion chamber to permit normal blood flow through the vessel or graft and then removing the catheter system from the subject's vessel or graft.
The independent claims cover plasmin infusion into a thrombus using pressure responsive slits or side holes positioned by detectable markers, while occlusion chambers activated by inflation block flow distal and, in some embodiments, proximal to an infusion zone. Incubating the plasmin-containing composition in the infusion zone dissolves the thrombus, with embodiments further including inactivation of occlusion and removal of the catheter system.
Stated Advantages
Reduces embolization risk by trapping emboli and restoring flow after treatment.
Reduces plasmin escape and inactivation outside the intended infusion zone.
Documented Applications
Treating acute peripheral arterial occlusion (aPAO) by delivering a plasmin-containing composition into a thrombus using a coaxial infusion catheter system with occlusion distal and/or proximal to an infusion treatment zone.
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