System for treating, preventing and/or replacing a heart valve, in particular an inflamed, infected, thrombosed or degenerated heart valve
Inventors
Figulla, Hans-Reiner • Seidel, Raphael Andreas • Chavalla, Sharath Chandra
Assignees
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Publication Number
US-12257147-B2
Publication Date
2025-03-25
Expiration Date
Abstract
An anchoring for heart valve prostheses includes a stent framework, for attaching heart valve leaflets to an inner side, and compartmentalization clips, connected with the stent framework at a first end region and having a free second end region. The anchoring exhibits a primary form and reversibly transformable into a delivery form for the minimally invasive introduction into the body of the patient by elastic deformation and/or compression of certain regions or elements. The compartmentalization clips are arcuately shaped between the first and second end regions in the primary form and are elastically foldable such that the compartmentalization clips extend in a flat manner between the first and second end regions in the delivery form. The anchoring has a separation structure connected with the stent framework and the compartmentalization clips to separate the areas of the native leaflets to be treated from the bloodstream when the anchoring implanted.
Core Innovation
An anchoring for a heart valve prosthesis is described for one of treatment, prevention, and replacement of a heart valve, in particular for an inflamed, infected, thrombosed, and degenerated heart valve. The anchoring includes a stent framework configured for attaching at least two heart valve leaflets to an inner side, with a proximal end and a distal end, and at least two compartmentalization clips connected with the stent framework at a first end region and having a free second end region.
The anchoring exhibits a primary form and is reversibly transformable into a delivery form for minimally invasive introduction into a body by elastic deformation and compression of regions and elements of the anchoring. In the primary form, the compartmentalization clips are arcuately shaped and comprise arms having at least partial twisting, and the compartmentalization clips are configured to elastically fold over such that the clips extend in a substantially flat manner between the first and second end regions in the delivery form.
A separation structure connected with the stent framework and the compartmentalization clips separates areas of native heart valve leaflets to be treated from a bloodstream when the anchoring is in an implanted state. The clips can hold and clamp native heart valve leaflets and infectious deposits including infectious vegetation, and thrombotic deposits including thrombotic vegetation, between the stent framework and at least one compartmentalization clip.
The separation structure includes a matrix releasably containing at least one of an antibiotic, an antithrombotic, and a thrombolytic agent, and the matrix is bioresorbable. The disclosure emphasizes one-piece anchoring with compartmentalization clips and a separation structure, and states improved local drug concentration, reduced embolization risk, and reduced need for complex part alignment during catheter implantation.
Claims Coverage
The partial content includes four independent claims. Across these independent claims, the inventive features are centered on a stent-framework-based anchoring with arcuately shaped, elastically foldable compartmentalization clips that reversibly transform from a primary form to a substantially flat delivery form, together with a separation structure that isolates leaflet treatment areas from bloodstream and supports releasably contained therapeutic agents.
Reversibly transformable stent-and-clips anchoring for minimally invasive introduction
The anchoring comprises a stent framework configured for attaching at least two heart valve leaflets to an inner side, and at least two compartmentalization clips connected with the stent framework, wherein the anchoring exhibits a primary form and is able to be reversibly transformed into a delivery form for minimally invasive introduction into a body by elastic deformation and compression of regions and elements of the anchoring.
Arcuately shaped clips folded into substantially flat delivery form
The compartmentalization clips are arcuately shaped between the first and second end regions in the primary form, and the compartmentalization clips are configured to be elastically folded over such that the compartmentalization clips extend in a substantially flat manner between the first and second end regions in the delivery form.
Separation structure isolating leaflet treatment from bloodstream
The anchoring further comprises a separation structure connected with the stent framework and the compartmentalization clips such that the separation structure separates areas of native heart valve leaflets to be treated from a bloodstream when the anchoring is in an implanted state.
Clamping of native leaflets and infectious or thrombotic deposits between stent and clips
Each compartmentalization clip is configured to at least partially overlap the stent framework in a primary form of the anchoring to hold and clamp at least one of native heart valve leaflets and infectious deposits, infectious vegetation, thrombotic deposits, and thrombotic vegetation of the native heart valve between the stent framework and at least one compartmentalization clip.
Bioresorbable releasably contained drug matrix on separation structure
The separation structure includes a matrix releasably containing at least one of an antibiotic, antithrombotic, and thrombolytic agents, and the matrix is bioresorbable.
Clip-surface orientation and twisting
The compartmentalization clips comprise arms having an at least partial twisting in the primary form, and include a first clip surface and a second clip surface oppositely disposed from the first clip surface, with the first clip surface directed outward in the primary form and inward in the delivery form.
Across the independent claims, the coverage centers on an anchoring device using a stent framework and arcuately shaped compartmentalization clips that elastically fold into a substantially flat delivery form while the implanted configuration includes a separation structure isolating leaflet-treatment areas from bloodstream. The independent claims further include clamping of native leaflets and infectious or thrombotic deposits between the stent framework and clips, and a bioresorbable matrix on the separation structure that releasably contains antibiotic, antithrombotic, and/or thrombolytic agents, together with clip geometry and clip-surface orientation features between primary and delivery forms.
Stated Advantages
Improved local drug concentration.
Reduced embolization risk.
Reduced need for complex part alignment during catheter implantation.
Documented Applications
Treatment, prevention, and replacement of a heart valve, in particular of an inflamed, infected, thrombosed, and degenerated heart valve (including bacterial endocarditis context in the disclosure).
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