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Publication Number
US-11938284-B2
Publication Date
2024-03-26
Expiration Date
Abstract
Some embodiments are directed to a catheter system comprising an introducer having a main body, an introducer sheath projecting from the main body, and a first seal supported within the introducer and a catheter having a main body, an outer sheath projecting from the main body, a second seal supported within the catheter, and an inner core configured to be advanced axially through the main body, the second seal, and the outer sheath. The introducer can be configured to be selectively engageable with the catheter so that the catheter can be selectively and removably linked with the introducer in the axial direction. The catheter system can also be configured such that, when the introducer and the catheter are linked, the catheter can be rotatable relative to the introducer. The introducer can be configured to radially restrain an endoluminal prosthesis.
Core Innovation
The invention relates to a catheter system for endoluminal delivery that includes an introducer comprising a main body and a tubular introducer sheath projecting from the main body. The system further includes a catheter comprising a main body and an outer sheath projecting from the main body, where the outer sheath is configured to be at least partially advanced through the main body of the introducer.
The catheter is configured to engage with the introducer and includes an inner core configured to be advanceable through the main body of the catheter and the outer sheath while being advanceable over a guidewire. The introducer comprises a first seal portion, where the first seal comprises a hemostasis valve and an annular rubber seal, and in embodiments the first seal portion is configured to operate during catheter docking.
The docking mechanism provides selective removable axial engagement between the introducer and the catheter, axially fixes the catheter as a single unit for handling, and permits catheter and inner-core rotation relative to the introducer, optionally with rotational locking. The system is configured to support endoluminal prosthesis delivery, including stent, stent graft, fenestrated stent, and bifurcated stent or stent graft, using an outer sheath and/or an introducer sheath configured to radially restrain the prosthesis.
Claims Coverage
The provided independent claims cover three inventive categories: a catheter system with a hemostasis seal portion and guidewire-advanceable inner core, a system-level seal portion defined by interference or close-tolerance fit between specified adjacent components, and a method of placing the catheter into a patient's blood vessel using the introducer seal portion and guidewire-advanceable inner core. Across the independent claims, the main inventive features include an introducer/catheter engagement with a tubular introducer sheath and outer sheath advancement, an inner core advanceable over a guidewire, and a first seal portion that includes a hemostasis valve and an annular rubber seal or an interference/close-tolerance fit seal portion defined by adjacent components.
Introducer with tubular introducer sheath and catheter with outer sheath advanced through introducer
An introducer comprising a main body and a tubular introducer sheath projecting from the main body; and a catheter comprising a main body and an outer sheath projecting from the main body, the outer sheath configured to be at least partially advanced through the main body of the introducer.
Inner core advanceable through catheter and outer sheath over a guidewire
A catheter further comprising an inner core that is configured to be advanceable through the main body of the catheter and the outer sheath, wherein the inner core is configured to be advanceable over a guidewire.
First seal portion with hemostasis valve and annular rubber seal
The introducer comprises a first seal portion, wherein the first seal comprises a hemostasis valve and an annular rubber seal.
Removably engaged catheter with interference or close-tolerance fit seal between adjacent components
The catheter is configured to engage with the introducer, wherein the introducer comprises a first seal portion, and wherein the seal portion comprises an interference or close tolerance fit between adjacent components, wherein the adjacent components comprise at least two of the outer sheath, one or more inside surfaces of the main body, one or more inside surfaces of a hub portion of the introducer and the inner core.
Overall, the independent claims require an introducer with a tubular introducer sheath and a catheter with an outer sheath advanced through the introducer, an inner core advanceable through the catheter and outer sheath and over a guidewire, and a first seal portion. The second system claim further specifies the seal portion as an interference or close-tolerance fit between adjacent components comprising at least two of the outer sheath, inner surfaces of the introducer main body, hub portion surfaces, and the inner core.
Stated Advantages
Supports endoluminal delivery while providing a first seal portion comprising a hemostasis valve and an annular rubber seal.
Permits selective removable axial engagement and axially fixes the catheter as a single unit for handling.
Permits catheter and inner-core rotation relative to the introducer while optionally locking rotation.
Outer sheath and introducer sheath configuration provides a lumen that is substantially continuous with limited gaps to avoid snagging.
Allows single-operator use and reduced rotational torque via containment of the outer sheath within the introducer.
Seal operation during catheter docking using a handle-adjustable hemostasis valve.
Documented Applications
Endoluminal delivery including delivery of a stent, stent graft, fenestrated stent, and bifurcated stent or stent graft.
Placing a catheter into a patient's blood vessel using an introducer with a tubular introducer sheath and passing the catheter through the introducer sheath.
Placing multiple stents or stent grafts in the patient's vessel.
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