College Station, TX, United States
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Patent
Texas A&M University and CorInnova Incorporated | Date: 2016-11-30

The present invention provides methods, systems, kits, and cardiac compression devices that have both passive chambers and active chambers to improve heart function.


Moreno M.R.,Texas A&M University | Moreno M.R.,CorInnova Incorporated | Biswas S.,Texas A&M University | Harrison L.D.,CorInnova Incorporated | And 6 more authors.
Journal of Medical Devices, Transactions of the ASME | Year: 2011

One of the major maladaptive changes after a major heart attack or cardiac event is an initial decline in pumping capacity of the heart leading to activation of a variety of compensatory mechanisms, and subsequently a phenomenon known as cardiac or left ventricular remodeling, i.e., a geometrical change in the architecture of the left ventricle. Evidence suggests that the local mechanical environment governs remodeling processes. Thus, in order to control two important mechanical parameters, cardiac size and cardiac output, we have developed a minimally invasive direct cardiac contact device capable of providing two actions simultaneously: (1) adjustable cardiac support to modulate cardiac size and (2) synchronous active assist to modulate cardiac output. As a means of enabling experiments to determine the role of these mechanical parameters in reverse remodeling or ventricular recovery, the device was further designed to (1) be deployed via minimally invasive surgical procedures, (2) allow uninhibited motion of the heart, (3) remain in place about the heart via an intrinsic pneumatic attachment, and (4) provide direct cardiac compression without aberrantly inverting the curvature of the heart. These actions and features are mapped to particular design solutions and assessed in an acute implantation in an ovine model of acute heart failure (esmolol overdose). The passive support component was used to effectively shift the EDPVR leftward, i.e., counter to the effects of disease. The active assist component was used to effectively decompress the constrained heart and restore lost cardiac output and stroke work in the esmolol failure model. It is expected that such a device will provide better control of the mechanical environment and thereby provide cardiac surgeons a broader range of therapeutic options and unique intervention possibilities. © 2011 American Society of Mechanical Engineers.


Moreno M.R.,Texas A&M University | Moreno M.R.,CorInnova Incorporated | Biswas S.,Texas A&M University | Harrison L.D.,CorInnova Incorporated | And 6 more authors.
Journal of Medical Devices, Transactions of the ASME | Year: 2011

One of the maladaptive changes following a heart attack is an initial decline in pumping capacity, which leads to activation of compensatory mechanisms, and subsequently, a phenomenon known as cardiac or left ventricular remodeling. Evidence suggests that mechanical cues are critical in the progression of congestive heart failure. In order to mediate two important mechanical parameters, cardiac size and cardiac output, we have developed a direct cardiac contact device capable of two actions: (1) adjustable cardiac support to modulate cardiac size and (2) synchronous active assist to modulate cardiac output. In addition, the device was designed to (1) remain in place about the heart without tethering, (2) allow free normal motion of the heart, and (3) provide assist via direct cardiac compression without abnormally inverting the curvature of the heart. The actions and features described above were mapped to particular design solutions and assessed in an acute implantation in an ovine model of acute heart failure (esmolol overdose). A balloon catheter was inflated in the vena cava to reduce preload and determine the end-diastolic pressure-volume relationship with and without passive support. A Millar PV Loop catheter was inserted in the left ventricle to acquire pressure-volume data throughout the experiments. Fluoroscopic imaging was used to investigate effects on cardiac motion. Implementation of the adjustable passive support function of the device successfully modulated the end-diastolic pressure-volume relationship toward normal. The active assist function successfully restored cardiac output and stroke work to healthy baseline levels in the esmolol induced failure model. The device remained in place throughout the experiment and when de-activated, did not inhibit cardiac motion. In this in vivo proof of concept study, we have demonstrated that a single device can be used to provide both passive constraint/support and active assist. Such a device may allow for controlled, disease specific, flexible intervention. Ultimately, it is hypothesized that the combination of support and assist could be used to facilitate cardiac rehabilitation therapy. The principles guiding this approach involve simply creating the conditions under which natural growth and remodeling processes are guided in a therapeutic manner. For example, the passive support function could be incrementally adjusted to gradually reduce the size of the dilated myocardium, while the active assist function can be implemented as necessary to maintain cardiac output and decompress the heart. © 2011 American Society of Mechanical Engineers.


The present invention an implantable, sub-cutaneous, bellows-like device with one plate proximal (or superficial) to the skin surface and the other plate distal (or deep) to the skin surface having a component of a pneumatic/hydrulic driver for an implantable medical device such as a cardiac assist, cardiac support, or combined cardiac assist and support device and inducible magnet material on the distal plate of the bellows that can be magnetically drawn towards the proximal plate by the action of a magnet outside the body to contract the bellows or pressurize the fluid in the bellows.


Patent
Texas A&M University and CorInnova Incorporated | Date: 2016-07-15

The present invention includes a device and method for a self-expanding framework device adapted to facilitate the deployment of an extra-cardiac device. The device includes a deployment tube and a self-expanding wire framework having a structure that results in the self-expanding wire framework circumferential flaring motion and bending outwardly to advance around the heart.


The present invention provides a biphasic and dynamic direct cardiac contact device adapted to be implanted in a patient suffering from congestive heart failure and related cardiac pathologies, said cardiac device having means for providing ventricular assist, ventricular support and diastolic recoil, or for providing ventricular support and diastolic recoil only.


Patent
Corinnova Incorporated and Texas A&M University | Date: 2012-10-17

The present invention provides methods, systems, kits, and devices that aid in the positioning of a direct cardiac compression device about the heart.


Patent
Texas A&M University and CorInnova Incorporated | Date: 2016-04-27

The present invention provides a combined direct cardiac compression and aortic counterpulsation device comprising: an inflatable direct cardiac compression jacket configured when inflated to directly compress a heart and assist in displacing blood therefrom, an aortic counterpulsation chamber configured when inflated to displace aortic volume for the purposes of causing a counterpulsation effect, and a driver operably connected to said inflatable direct cardiac compression jacket and to said aortic counterpulsation chamber, said driver is configured to inflate said direct cardiac compression jacket and to deflate said aortic counterpulsation chamber during systole of the heart; said driver is further configured to deflate said direct cardiac compression jacket and to inflate said aortic counterpulsation chamber during diastole of the heart.


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 100.00K | Year: 2009

This Small Business Innovation Research (SBIR) Phase I project is focused on a novel therapy for heart failure that employs device mediated intervention to guide cardiac growth, remodeling, and recovery. The CorInnova device is the first to combine active cardiac assist and passive cardiac support. It is non-blood contacting, adjustable post-implantation, and can be delivered via minimally invasive surgical procedures. Hence, CorInnova's technology represents a substantial advancement from both, existing cardiac assist and existing cardiac support technologies. While the device has shown potential in limited short-term animal studies, the full capabilities and limitations of the design are as yet unknown. The research plan is aimed at determining these capabilities and limitations. The broader impacts of this research are important in the treatment of Congestive Heart Failure (CHF). CHF is a debilitating condition that currently afflicts nearly 5 million Americans. Treatment costs are estimated to be in excess of $50 billion per year. For the 300,000 Americans in ""end-stage heart failure"", transplant is the preferred treatment option. However, the lack of donor hearts renders this treatment option ""epidemiologically trivial"". For most of these patients, the potential for cardiac rehabilitation is neglected. Thus, the proposed technology represents a shift in the treatment paradigm - an intervention conceived to stimulate restorative growth and remodeling processes - essentially providing rehabilitative physical therapy for the heart muscle. The versatility of the device empowers the cardiologist, providing the means for tactical intervention via adjustments to the passive support component and application of active cardiac assist. This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).

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