Catheter system for implantation of prosthetic heart valves
Inventors
Ottma, Rüdiger • Moszner, Robert • Figulla, Hans-Reiner • Ferrari, Markus • Damm, Christoph
Assignees
JEN meditec GmbH • Jenavalve Technology GmbH • Jenavalve Technology Inc
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Publication Number
US-11517431-B2
Publication Date
2022-12-06
Expiration Date
Abstract
The invention relates to a catheter for the transvascular implantation of prosthetic heart valves, in particular including self-expanding anchorage supports (10), which allow a minimally invasive implantation of prosthetic heart valves. The aim of the invention is to reduce the risk to the patient during the implantation. To achieve this, according to the invention a prosthetic heart valve with anchorage supports is temporarily housed in a folded form in a cartridge-type unit (4) during the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system (1), which includes a flexible region (9) that can be guided through the aorta. Actuating elements (2, 3) run through the interior of the hollow guide system, said elements permitting sections of the cartridge-type unit to be displaced radially about their longitudinal axis and/or laterally in a proximal direction, thus allowing individual sections of the anchorage support and the associated prosthetic heart valve to be sequentially released.
Core Innovation
The invention provides a transvascular catheter system for implanting a prosthetic heart valve in a patient. A guide system extends between a proximal end and a distal end and carries a cartridge unit disposed at the distal end. The cartridge unit retains the prosthetic heart valve in a collapsed state using a first sleeve, a second sleeve movable with respect to the first sleeve, and a third sleeve comprising at least one anchoring configured to engage the prosthetic heart valve and disposed within and movable with respect to the first sleeve.
A handle positioned at the proximal end is manipulated to cause sequential movement of the second sleeve and the third sleeve. This sequential movement transitions the prosthetic heart valve from a collapsed state to a partially expanded state and subsequently from the partially expanded state to a fully expanded state. The cartridge arrangement enables sequential release by displacing cartridge sleeves such that different anchoring support sections are released in a defined order during transition from partially expanded to fully expanded.
The invention further includes a flexible bendable region in the guide system configured to be guided through the aorta. It also discloses actuating elements operating through the hollow guide system to sequentially displace the cartridge sleeves, allow function checking after partial unfolding, and permit retraction of the valve back into the cartridge if positioning or function is unsatisfactory.
Claims Coverage
The document contains two independent claims, covering a catheter system and a method for implanting the prosthetic heart valve. The independent claims share a core inventive structure: a distal cartridge with first, second, and third sleeves, at least one anchoring portion on the third sleeve, and handle manipulation that drives sequential transitions from collapsed to partially expanded to fully expanded.
Sequential sleeve-driven transition of prosthetic heart valve states
A handle positioned at a proximal end of the guide system is manipulated to cause sequential movement of the second sleeve and the third sleeve to sequentially transition the prosthetic heart valve from the collapsed state to a partially expanded state and then to a fully expanded state.
Distal cartridge unit with first, second, and anchoring third sleeve
A cartridge unit disposed at a distal end of the guide system retains the prosthetic heart valve in a collapsed state. The cartridge unit comprises a first sleeve, a second sleeve movable with respect to the first sleeve, and a third sleeve comprising at least one anchoring configured to engage the prosthetic heart valve and disposed within and movable with respect to the first sleeve.
Guiding through aorta with a flexible region
The catheter system comprises a guide system with a flexible region configured to be guided through a patient’s aorta.
Method of implanting by delivering valve and manipulating handle for sequential expansion
A method for implanting a prosthetic heart valve comprises delivering the prosthetic heart valve to an implantation site of a patient using a catheter system with a guide system, a handle positioned at a proximal end, and a cartridge unit disposed at a distal end; manipulating the handle to cause sequential movement of the second sleeve and the third sleeve to sequentially transition the prosthetic heart valve from the collapsed state to a partially expanded state and then to a fully expanded state.
Across the independent claim set, inventive coverage centers on a nested sleeve cartridge at the distal end that retains the prosthetic heart valve in a collapsed state, and a proximal handle whose manipulation sequentially moves the second and third sleeves to drive the valve through collapsed-to-partially-expanded-to-fully-expanded states. Dependent claim features further ground the guide system routing through an aorta using a flexible region.
Stated Advantages
Documented Applications
No documented applications found
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