Devices and methods of treating or ameliorating diastolic heart failure through pulmonary valve intervention
Inventors
Sugimoto, Hiroatsu • Magnin, Christopher J.
Assignees
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Publication Number
US-9649480-B2
Publication Date
2017-05-16
Expiration Date
Abstract
The present teachings provide a device and methods of making and use thereof. Specifically, one aspect of the present teachings provides a device for restricting blood flow entering the lung after each right bean systole. Certain embodiments of the present teachings provide a device that prevents a complete closure of the pulmonary valve leaflets so that a certain amount of blood is allowed to flow from the pulmonary artery to the right ventricle at the end of a right ventricle systole. Other embodiments of the present teachings provide a device that restricts the amount of blood outflowing from the right ventricle to the pulmonary artery. In addition, the present teachings also provide a delivery system for implanting such a device approximately to or at the pulmonary valve.
Core Innovation
The invention relates to a pulmonary valve intervention system for treating diastolic heart failure by restricting blood flow from the right ventricle to the pulmonary artery. The disclosed approach allows blood back-flow from the pulmonary artery to the right ventricle while restricting right-ventricle-to-pulmonary-artery blood flow after right-ventricular systole. A delivery system and an implantable device are provided, with deployment at and through the pulmonary valve annulus to position the implant where the restriction and back-flow relationship is established.
The implantable device has an elongated profile in a delivery configuration and an expanded profile in a deployed configuration. The device includes a hollow body portion, and the hollowed/open structure is positioned through the pulmonary valve such that blood is allowed to back-flow from the pulmonary artery to the right ventricle. The device is deployed with a distal end at a location distal to the pulmonary valve annulus and a proximal end at or near the pulmonary valve annulus.
A distal portion can be radially expandable to change restriction based on right-heart pressure conditions. The radially expandable distal portion transitions between a first configuration and a second configuration when the right ventricle reaches a set pressure, and it can expand further as right pressure increases beyond the set pressure until it reaches a maximum radial profile, including up to no restriction. The partial content further describes tissue-securement features such as tissue anchors and radial interference and notes optional pressure-responsive behavior for tailoring restriction to physiologic parameters.
Claims Coverage
The partial content provides two independent method claims. Both independent claims share the same core concept: treating diastolic heart failure by restricting right ventricle-to-pulmonary artery blood flow using an implantable device deployed near and through the pulmonary valve, while allowing blood back-flow from the pulmonary artery to the right ventricle. Across the families, the inventive features include an elongated-to-expanded device configuration for deployment and, in dependent claims, optional pressure-responsive distal expansion and optional tissue-anchor engagement at the pulmonary valve annulus.
Elongated delivery profile to expanded deployed configuration with hollow body
Providing a delivery system and an implantable device, wherein the delivery system comprises a proximal end, a distal end, and an axial lumen, wherein the implantable device comprises a distal end, a proximal end, and a hollow body portion, and wherein the implantable device has a first elongated profile when slidably disposed within the axial lumen of the delivery system, and a second expanded profile when the device is outside of the delivery system.
Pulmonary valve annulus-positioned deployment through the pulmonary valve
Advancing the delivery system and the implantable device in its first elongated profile at or near the pulmonary valve, deploying the distal end of the device at a location distal to the pulmonary valve annulus, the proximal end of the device at or near the pulmonary valve annulus, and the hollow body portion of the device through the pulmonary valve.
Allowing pulmonary-artery-to-right-ventricle back-flow while restricting right ventricle to pulmonary artery
Allowing blood back-flow from the pulmonary artery to the right ventricle as part of restricting blood flow from the right ventricle to the pulmonary artery for treating a patient with diastolic heart failure.
Elongated delivery configuration to expanded deployed configuration without axial-lumen delivery system limitation
Providing an implantable medical device having a hollowed body portion with a distal end and a proximal end, wherein the device has an elongated delivery configuration and an expanded deployed configuration.
Deployment distal/proximal placement relative to pulmonary valve annulus and hollowed body through the pulmonary valve
Advancing the implantable device in its elongated delivery profile at or near the pulmonary valve, deploying the distal end of the device at a location distal to the pulmonary valve annulus, the proximal end of the device at or near the pulmonary valve annulus, and the hollowed body portion of the device through the pulmonary valve.
Both independent claims cover methods that deploy an implantable device having a hollow body portion through the pulmonary valve with an elongated-to-expanded configuration, to treat diastolic heart failure by restricting blood flow from the right ventricle to the pulmonary artery while allowing blood back-flow from the pulmonary artery to the right ventricle.
Stated Advantages
Documented Applications
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