System and method for controlled delivery of medical devices into patient bodies
Inventors
Assignees
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Publication Number
US-10980653-B2
Publication Date
2021-04-20
Expiration Date
Abstract
Intravascular delivery system for deployment of a therapeutic device, such as a stent, in a controlled and robust manner is supported by a lockable balloon catheter equipped with a locking mechanism configured to lock in vivo to a delivery component, such as a guidewire. The lockable balloon catheter can be controllably transitioned between a locked and an unlocked modes of operation by inflation/deflation of the balloon of the lockable balloon catheter. Being in the locked mode of operation, the lockable balloon catheter facilitates delivery of the therapeutic element along the delivery component to a target site while enhancing the stability of the delivery component, especially near the target site.
Core Innovation
The invention relates to an intravascular minimally invasive delivery system using at least a lockable balloon catheter having an elongated catheter shaft with a rapid-exchange (RX) port and an inflation lumen. The balloon is secured to the elongated catheter shaft at a distal region, with a proximal end of the balloon displaced from the RX port a predetermined distance. The elongated catheter shaft includes a guidewire lumen extending distally from the RX port to and along the distal region.
A locking mechanism is operatively coupled between the balloon and the elongated catheter shaft, the locking mechanism including the balloon, walls of the elongated catheter shaft, and the inflation lumen. The locking mechanism transitions the elongated catheter shaft between an unlocked configuration, when a diameter of the guidewire lumen permits slidable movement of the guidewire, and a locked configuration, when inflation of the balloon compresses the walls to reduce the diameter of the guidewire lumen so the guidewire is circumferentially contacted to prevent displacement.
When the guidewire is anchored or stabilized near a target site, the system enables advancement of a therapeutic delivery catheter carrying a therapeutic device to the target site. The documented embodiments include radiopaque markers disposed along the elongated catheter shaft and a radiopaque marker positioned adjacent to the RX port, as well as a locking portion formed from flexible or braided material, optionally polymer-coated, and a kink resistant reinforcement mechanism between the RX port and the balloon using wire-like members.
Claims Coverage
The partial content provides three independent claims describing lockable balloon catheter delivery systems with an RX port and inflation-lumen driven transitions between unlocked and locked configurations. Across the independent claims, there are five main inventive feature themes.
Lockable balloon catheter with rapid-exchange (RX) port
A lockable balloon catheter includes an elongated catheter shaft having a proximal region, a distal region, and a rapid-exchange (RX) port formed in walls between the proximal and distal regions, together with an inflation lumen configured within the elongated body and extending in the longitudinal direction.
Inflation-lumen driven locking by lumen diameter reduction
A locking mechanism operatively coupled between the balloon and the elongated catheter shaft transitions the elongated catheter shaft between an unlocked configuration and a locked configuration, where responsive to inflation through the inflation lumen the walls are compressed by pressure inside the balloon to reduce the diameter of the guidewire lumen or delivery component lumen to circumferentially contact the guidewire or delivery component to prevent displacement.
Predetermined spacing between RX port and balloon proximal end
The balloon has a proximal end and a distal end secured to the elongated catheter shaft at the distal region, with the proximal end of the balloon displaced from the RX port a predetermined distance.
Secure advancement by anchored balloon near target site
A therapeutic device delivery catheter carrying a therapeutic device is operatively coupled to a delivery component for displacement to a target site within a body lumen along the delivery component, whereby the therapeutic element is advanced along the delivery component in proximity to the RX port while the balloon is inflated and anchored within the body lumen.
Application to internal passages including blood vessel, bile duct, and ureteric duct
A delivery system advances a stent along a guidewire to a lesion site within an internal passage in a patient's body, where the internal passage includes at least one of a blood vessel, a bile duct, and an ureteric duct, using the lockable balloon catheter structure to securely advance the stent.
Across the independent claims, coverage centers on a lockable balloon catheter with an RX port and inflation lumen, where inflation compresses catheter shaft walls to reduce a guidewire or delivery-component lumen diameter for circumferential contact and preventing displacement. The claims also require a predetermined RX-port-to-balloon spacing and, in one formulation, advancement of a therapeutic device along a delivery component while the balloon is inflated and anchored near the RX port, including stent delivery to lesion sites in specified internal passages.
Stated Advantages
Prevents displacement of the guidewire within the guidewire lumen by circumferential contact in the locked configuration.
Prevents displacement of the delivery component within the delivery component lumen by circumferential contact in the locked configuration.
Enables advancement of a stent along a guidewire to a lesion site within a blood vessel, and in an internal passage formulation within at least one of a blood vessel, a bile duct, and an ureteric duct.
Advances a therapeutic element along a delivery component to a target site in proximity to the RX port while the balloon is inflated and anchored.
Documented Applications
Intravascular delivery of a stent along a guidewire to a lesion site within a blood vessel of a patient.
Delivery of a therapeutic device along a delivery component to a target site within a body lumen, with the therapeutic element advanced in proximity to an RX port while the balloon is inflated and anchored.
Secure stent delivery along a guidewire to a lesion site within an internal passage including at least one of a blood vessel, a bile duct, and an ureteric duct.
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