Deployment methods and mechanisms for minimally invasive implantation of heart contacting cardiac devices
Inventors
Criscione, John C. • Harrison, Lewis D. • Moreno, Michael R. • Bolch, Christina M. • Robbins, Dennis I. • Biswas, Saurabh
Assignees
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Publication Number
US-9510746-B2
Publication Date
2016-12-06
Expiration Date
Abstract
The present invention provides methods, systems, kits, and devices that aid in the positioning of a direct cardiac compression device about the heart.
Core Innovation
The invention provides a minimally invasive implantation and deployment framework for a direct cardiac compression device (DCCD) about the heart apex. It obtains pericardial access to a pericardial sac, separates the pericardial sac from an apex of a heart, and creates a space for deployment between the pericardial sac and the heart.
A deployable interface includes an insertion device with a series of interlocked retractable loops. The loops extend from the insertion device to position the DCCD around the heart apex, where one or more pockets on the DCCD exterior or interior removably mate to an apex eyelet of the interlocking loops, and the loops expand the DCCD around the apex.
After deployment, the interlocking loops retract into the insertion device so that the eyelets are removed from the pockets, and the insertion device is dissociated from the DCCD and removed. The disclosed system further includes additional deployment mechanisms and pericardial stabilization concepts that maintain deployment about the heart apex, and an overall DCCD system/device architecture that uses passive adjustable support chambers and synchronous active assist inflatable chambers.
Claims Coverage
The document includes two independent claims. Each independent claim centers on deploying a direct cardiac compression device around the heart apex using an insertion device with a series of interlocked retractable loops whose apex forms eyelets that removably mate with complementary pockets or eyelet receivers on the DCCD exterior or interior.
Pericardial access and deployment space creation
Obtaining pericardial access to a pericardial sac; separating the pericardial sac from an apex of a heart; and creating a space for the deployment of a direct cardiac compression device.
Removable mating between DCCD pockets and loop apex eyelets
Providing the direct cardiac compression device having one or more pockets on the exterior or interior of the direct cardiac compression device, wherein the one or more pockets are adapted to removably mate to the eyelet at the apex of the series of interlocking loops.
Interlocked retractable loop insertion device with eyelets
Providing an insertion device comprising a series of interlocked retractable loops, wherein each interlocked retractable loop has a left side and a right side connected by an apex which forms an eyelet at the apex, wherein each interlocked retractable loop is connected to the adjacent interlocked retractable loop by connecting the left side to an adjacent right side.
Flaring and expanding deployment around the apex
Extending the series of interlocking loops from the insertion device to extend the one or more pockets and the direct cardiac compression device around the heart; and extending the series of interlocking loops to expand the direct cardiac compression device around the heart apex.
Loop retraction and insertion device dissociation and removal
Retracting the series of interlocking loops into the insertion device to remove the eyelets apex from the one or more pockets of the direct cardiac compression device; dissociating the insertion device from the direct cardiac compression device and removing the insertion device.
Deployment between pericardial sac and heart using eyelet receivers
Providing a direct cardiac compression device comprising a set of eyelet receivers positioned on about an outer surface; placing the direct cardiac compression device into the insertion device, wherein the set of eyelet receivers contact the one or more eyelets; extending the retractable framework from the insertion device into the space for the deployment of the direct cardiac compression device; extending the retractable framework into the pericardial sac to position the direct cardiac compression device around the heart; wherein the series of interlocking loops move the set of eyelet receivers contact and thus the direct cardiac compression device around the heart.
Partial framework retraction and dissociation sequence for removal
Retracting partially the retractable framework of the insertion device; dissociating the one or more retractable loops from the set of eyelet receivers contact; dissociating the insertion device from the direct cardiac compression device; retracting the retractable framework into the insertion device and removing the insertion device.
Across the independent claims, the core claim coverage is the coordinated use of a retractable insertion device with interlocked loops whose apex forms eyelets, and a DCCD having pockets or eyelet receivers that contact and removably mate with those eyelets to enable expansion and positioning around the heart apex, followed by loop retraction, dissociation, and insertion device removal.
Stated Advantages
A leftward shift of EDPVR with passive support.
Increased stroke work and cardiac output with active assist.
Maintained cardiac curvature without inversion.
The device does not significantly impair function when inactive.
Documented Applications
Minimally invasive implantation and deployment of a direct cardiac compression device (DCCD) around the heart apex using pericardial access.
Acute ovine failure-model evaluation of the DCCD, including passive support and active assist.
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