Detachable-tip balloon microcatheter for embolization of vascular pathology
Inventors
Backeris, Peter • YAEGER, Kurt • Costa, Anthony • Oxley, Thomas • Berenstein, Alejandro • KWON, Young Joon • BORRELLO, Joe
Assignees
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Abstract
A detachable tip sheathed balloon microcatheter is provided for delivering an embolic agent to a target location for the embolization of an arteriovenous malformation (AVM). The detachable tip sheathed balloon microcatheter including a balloon microcatheter including a first shaft and an inflatable balloon that is coupled to a distal end portion of the first shaft; and a detachable tip assembly that is configured to be detachably coupled to the first shaft of the balloon microcatheter. The detachable tip assembly includes a protective balloon sheath that is coupled to a proximal end portion of the second shaft, wherein when the detachable tip assembly is coupled to the balloon microcatheter, the protective balloon sheath surrounds at least a portion of the inflatable balloon.
Core Innovation
The disclosed invention provides a detachable tip sheathed balloon microcatheter for delivering an embolic agent to a target location. The system includes a balloon microcatheter with a first shaft and an inflatable balloon coupled to a distal end portion of the first shaft, and a detachable tip assembly detachably coupled to the first shaft. The detachable tip assembly includes a protective balloon sheath that is coupled to a proximal end portion of a second shaft.
When the detachable tip assembly is coupled to the balloon microcatheter, the protective balloon sheath surrounds at least a portion of the inflatable balloon. The protective balloon sheath is described as protecting the balloon and the detachment interface from contact with an embolic agent to enable formation of an embolic cast and to facilitate controlled, atraumatic tip release.
The disclosure also specifies structural relationships between catheter shafts to support the detachable coupling and a controlled detachment configuration. The first shaft includes an outer catheter tube and an inner catheter tube received within a central lumen of the outer catheter tube, the second shaft comprises a tubular structure configured to be received into and securely held within the outer catheter tube, and the protective balloon sheath extends proximally beyond a proximal end of the second shaft.
Claims Coverage
The claim content contains four inventive features. Across the claims, the inventive features center on the detachable tip assembly with a protective balloon sheath that surrounds the inflatable balloon when coupled, plus specific coupling, detachment, and sheath behavior.
Detachable tip assembly with protective balloon sheath surrounding inflatable balloon
A detachable tip sheathed balloon microcatheter includes a balloon microcatheter with a first shaft and an inflatable balloon coupled to a distal end portion of the first shaft, and a detachable tip assembly configured to be detachably coupled to the first shaft, the detachable tip assembly including a protective balloon sheath coupled to a proximal end portion of a second shaft, wherein when the detachable tip assembly is coupled to the balloon microcatheter, the protective balloon sheath surrounds at least a portion of the inflatable balloon.
Protective balloon sheath extending and shaft abutting to define surrounding relationship
The first shaft includes an outer catheter tube and an inner catheter tube received within a central lumen of the outer catheter tube, the second shaft comprises a tubular structure configured to be received into and securely held within the outer catheter tube, the protective balloon sheath extends proximally beyond a proximal end of the second shaft, and the proximal end of the second shaft abuts a distal end of the inner catheter tube at a location at which the inflatable balloon is in a surrounding relationship.
Sliding catheter-detachment mechanism releasing detachable tip assembly after limit of motion
A detachment mechanism for controllably detaching the balloon microcatheter from the detachable tip assembly comprises a sliding catheter-detachment mechanism configured, when actuated, to retract the outer catheter tube relative to the inner catheter tube, thereby releasing the detachable tip assembly after a limit of motion is reached.
Proximal end region of sheath with less elasticity resisting expansion to prevent premature detachment
A proximal end region of the protective balloon sheath comprises a section having less elasticity relative to other regions including a distal end of the protective balloon sheath such that the proximal end region resists expansion, thereby preventing the inflatable balloon from pushing the protective balloon sheath forward and detaching the tip assembly prematurely.
The claims emphasize a detachable tip assembly for a balloon microcatheter where a protective balloon sheath surrounds the inflatable balloon when coupled, with additional structural relationships between outer and inner catheter tubes and a second shaft, and with detachment control defined by a sliding catheter-detachment mechanism or by a proximal sheath region with reduced elasticity to prevent premature detachment.
Stated Advantages
Facilitates controlled, atraumatic tip release.
Reduces reflux.
Reduces catheter entrapment force.
Enables formation of an embolic cast.
Shorter procedures and reduced radiation-reduced procedures.
Documented Applications
Transarterial or transvenous embolization of arteriovenous malformations (AVMs).
Embolization of arteriovenous fistulas (DAVFs).
Replacing dual-microcatheter techniques with a single device.
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