Focalcool, Llc

EAST WINDSOR, NJ, United States

Focalcool, Llc

EAST WINDSOR, NJ, United States

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Merrill T.,Rowan University | Merrill T.,Focalcool, Llc
Mechanical Engineering | Year: 2010

Medivance Inc. offers the Arctic Sun system, which has two major components, a cooling console and a series of cooling pads called ArcticGel pads. The console ensures that coolant circulates at the correct temperature for the correct amount of time. An ArcticGel pad consists of three flexible layers so it can conform to the body. The outer layer, not in contact with the patient, insulates the pad so ambient thermal energy does not warm the coolant. The middle layer provides a leak-tight internal coolant flow pathway. Its design involves subtle enhancements or flow obstructions to promote coolant mixing and thin boundary layers - those regions where temperature gradients are greatest inside the coolant flow. The inner layer, in contact with the patient, is made of material that is thin, conductive, and gel-like. Heat transfer conduction rates are directly proportional to conductivity, area, and temperature differences, and inversely proportional to material thickness.


Merrill T.L.,Rowan University | Merrill T.L.,Focalcool, Llc | Merrill D.R.,Focalcool, Llc | Nilsen T.J.,Focalcool, Llc | Akers J.E.,Focalcool, Llc
Journal of Medical Devices, Transactions of the ASME | Year: 2010

Cardiovascular disease is the leading cause of death in the United States. Despite decades of care path improvements approximately 30% of heart attack victims die within 1 year after their first heart attack. Animal testing has shown that mild hypothermia, reducing tissue temperatures by 2-4°C, has the potential to save heart tissue that is not adequately perfused with blood. This paper describes the design of a cooling guide catheter that can provide rapid, local cooling to heart tissue during emergency angioplasty. Using standard materials and dimensions found in typical angioplasty guide catheters, a closed-loop cooling guide catheter was developed. Thermal fluid modeling guided the interior geometric design. After careful fabrication and leak testing, a mock circulatory system was used to measure catheter cooling capacity. At blood analog flow rates ranging from 20 ml/min to 70 ml/min, the corresponding cooling capacity varied almost linearly from 20 W to 45 W. Animal testing showed 18 W of cooling delivered by the catheter can reduce heart tissue temperatures rapidly, approximately 3° in 5 min in some locations. Future animal testing work is needed to investigate if this cooling effect can save heart tissue. Copyright © 2010 by ASME.


Merrill T.L.,Rowan University | Merrill T.L.,Focalcool, Llc | Mitchell J.E.,Focalcool, Llc | Merrill D.R.,Focalcool, Llc
Medical Engineering and Physics | Year: 2016

Recent revascularization success for ischemic stroke patients using stentrievers has created a new opportunity for therapeutic hypothermia. By using short term localized tissue cooling interventional catheters can be used to reduce reperfusion injury and improve neurological outcomes. Using experimental testing and a well-established heat exchanger design approach, the ɛ-NTU method, this paper examines the cooling performance of commercially available catheters as function of four practical parameters: (1) infusion flow rate, (2) catheter location in the body, (3) catheter configuration and design, and (4) cooling approach. While saline batch cooling outperformed closed-loop autologous blood cooling at all equivalent flow rates in terms of lower delivered temperatures and cooling capacity, hemodilution, systemic and local, remains a concern. For clinicians and engineers this paper provides insights for the selection, design, and operation of commercially available catheters used for localized tissue cooling. © 2016 IPEM


Merrill T.L.,Rowan University | Merrill T.L.,Focalcool, Llc | Merrill D.R.,Focalcool, Llc | Akers J.E.,Focalcool, Llc
Journal of Medical Devices, Transactions of the ASME | Year: 2012

Mild hypothermia has been shown to reduce heart tissue damage resulting from acute myocardial infarction (AMI). In previous work we developed a trilumen cooling catheter to deliver cooled blood rapidly to the heart during emergency angioplasty. This paper describes two alternative designs that seek to maintain tissue cooling capability and improve "ease of use." The first design was an autoperfusion design that uses the natural pressure difference between the aorta and the coronary arteries to move blood through the trilumen catheter. The second design used an external cooling system, where blood was cooled externally before being pumped to the heart through a commercially available guide catheter. Heat transfer and pressure drop analyses were performed on each design. Both designs were fabricated and tested in both in vitro and in vivo settings. The autoperfusion design did not meet a cooling capacity target of 20 W. Animal tests, using swine with healthy hearts, showed that the available pressure difference to move blood through the trilumen catheter was approximately 5-10 mmHg. This differential pressure was too low to motivate sufficient blood flow rates and achieve the required cooling capacity. The external cooling system, however, had sufficient cooling capacity and reasonable scalability. Cooling capacity values varied from 14 to 56 W over a flow range of 30-90 ml/min. 20 W and 30 W were achieved at 38 ml/min and 50 ml/min, respectively. Animal testing showed that a cooling capacity of 30 W delivered to the left anterior descending (LAD) and left circumflex arteries (LCX) of a healthy 70 kg swine can reduce heart tissue temperatures rapidly, approximately 3 °C in 5 min in some locations. Core temperatures dropped by less than 0.5 °C during this cooling period. An autoperfusion design was unable to meet the target cooling capacity of 20 W. An external cooling design met the target cooling capacity, providing rapid (1 °C/min) localized heart tissue cooling in a large swine model. Future animal testing work, involving a heart attack model, will investigate if this external cooling design can save heart tissue. © 2012 American Society of Mechanical Engineers.


Merrill T.L.,Rowan University | Merrill T.L.,Focalcool, Llc | Mingin T.,Rowan University | Merrill D.R.,Focalcool, Llc | And 2 more authors.
Perfusion (United Kingdom) | Year: 2013

Therapeutic hypothermia can reduce both ischemic and reperfusion injury arising after strokes and heart attacks. New localized organ cooling systems offer a way to reduce tissue damage more effectively with fewer side effects. To assess initial blood safety of our new organ cooling system, the CoolGuide Cooling System (CCS), we investigated safe operating conditions and configurations from a hemolysis perspective. The CCS consists of a peristaltic pump, a custom-built external heat exchanger, a chiller, biocompatible polyvinyl cellulose (PVC) tubing, and a control console. The CCS cools and circulates autologous blood externally and re-delivers cooled blood to the patient through a conventional catheter inserted directly into the organ at risk. Catheter configurations used included: a 7F guide catheter only, a 7F guide with a 0.038" wire inserted through the center and advanced 2 cm distal to the catheter distal tip, a 6F guide catheter only and a 6F guide with a 0.014" guidewire similarly inserted through the center. Using porcine blood, an in vitro test rig was used to measure the degree of hemolysis generation, defined as the percentage change in free hemoglobin, adjusted for total hemoglobin and hematocrit, between exiting and entering blood. The highest degree of hemolysis generation was 0.11±0.04%, based on the average behavior with a 6F catheter and a 0.014" guidewire configuration at a blood flow rate of approximately 130 mL/min. In terms of average percentage free hemoglobin exiting the system, based on total hemoglobin, the highest value measured was 0.17%±0.03%, using this 6F and 0.014" guidewire configuration. This result is significantly below the most stringent European guideline of 0.8% used for blood storage and transfusion. This study provides initial evidence showing hemolysis generation arising from the CoolGuide Cooling System is likely to be clinically insignificant. © The Author(s) 2012.


PubMed | Focalcool, Llc and Rowan University
Type: Journal Article | Journal: Medical engineering & physics | Year: 2016

Recent revascularization success for ischemic stroke patients using stentrievers has created a new opportunity for therapeutic hypothermia. By using short term localized tissue cooling interventional catheters can be used to reduce reperfusion injury and improve neurological outcomes. Using experimental testing and a well-established heat exchanger design approach, the -NTU method, this paper examines the cooling performance of commercially available catheters as function of four practical parameters: (1) infusion flow rate, (2) catheter location in the body, (3) catheter configuration and design, and (4) cooling approach. While saline batch cooling outperformed closed-loop autologous blood cooling at all equivalent flow rates in terms of lower delivered temperatures and cooling capacity, hemodilution, systemic and local, remains a concern. For clinicians and engineers this paper provides insights for the selection, design, and operation of commercially available catheters used for localized tissue cooling.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 477.47K | Year: 2016

Project Summary Stroke is the th leading cause of death and number one cause of adult disability in the United States The primary goal of ischemic stroke treatment is quickly restoring blood perfusion However studies have shown that this return of blood flow while necessary can also cause damage to local tissue Hypothermia has been shown to decrease this reperfusion injury The overall goal of our research is to couple therapeutic hypothermia to intracranial thrombectomy devices called stentrievers or stent retrievers Our device is a patented tissue cooling system that rapidly cools ischemic tissue at risk of reperfusion injury Our Phase I work will demonstrate ease of use and cooling effectiveness feasibility with a human scaled prototype rapid brain cooling during and after occlusion and brain tissue salvage and neurological benefit in a canine occlusion model Phase II will refine the design and prepare the technology for first in man studies Specific Aims Demonstrate ease of use and cooling effectiveness of FocalCoolandapos s CoolGuide cooling system with stent retrievers characterizing the cooling performance and ensuring safe operation in vitro Translate the human scaled prototype to a canine scaled version for in vivo testing Demonstrate safe cooling before and during reperfusion yielding infarct volume reduction and improved neurological outcome Cooling capability and stent retriever device integration will be determined using our in vitro circulatory system model To demonstrate the safety performance and efficacy of rapid localized brain tissue cooling in vivo studies will be conducted using an in vivo model of transient ischemic stroke Metrics of safety will include a decrease in core temperature no larger than C and safe maintenance of blood pressures and systemic hemodynamics during cooling Metrics for performance will include device ease of use with stent retrievers and tissue temperature reduction in at risk brain tissue regions during and after occlusion Metrics of efficacy will include reduction in infarct volume and neurological improvement compared to controls Relevance Effective recanalization with todayandapos s stent retrievers is a promising new standard of care for ischemic strokes Reperfusion injury however following recanalization continues to be an unmet problem in ischemic stroke care Approximately of stent retriever patients leave with modified Rankin Scores greater than indicating moderate disability to severe disability including death The technological innovation of combining stroke treatment therapies mechanical thrombectomy and precise well integrated reperfusion hypothermia may yield synergistic benefits resulting in reduced infarct size and improved long term neurological outcomes Both Medtronic and Stryker support this work Please see letters of Support Project Narrative Stroke is the th leading cause of death and number one cause of adult disability in the United States For stroke treatment quickly restoring blood flow has been shown to improve outcome yet some experts have found reperfusion injury reduces these benefits FocalCool LLC seeks to combine two technologies endovascular stentriever devices and therapeutic hypothermia using a novel localized tissue cooling system to maximize the benefit of blood flow restoration while minimizing the damaging effects of reperfusion injury


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 207.20K | Year: 2011

DESCRIPTION (provided by applicant): Stroke is the 3rd leading cause of death and number one cause of adult disability in the United States. The primary goal of ischemic stroke treatment is quickly restoring blood perfusion. However, studies have shown that this return of blood flow, while necessary to bettering patient outcome, can cause damage to local tissue. Hypothermia has been shown to decrease this reperfusion injury . The overall goal of this proposed research is to use therapeutic hypothermia to augment the tissue salvage capabilities of existing mechanical clot removal devices that restore perfusion by reducing reperfusion injury. Our proposed device is a cooling guide catheter which will function identically to conventional guide catheters but with blood cooling capabilities to save ischemic tissue at risk of reperfusion injury. Specific Aims: 1.) Design a cooling guide catheter that can be used with existing mechanical clot removal devices and that can quickly reduce target tissue temperatures, 2.) characterize device thermal-fluid performance in an in vitro brain model, and 3.) demonstrate that the cooling catheter can safely and effectively decrease target tissue temperature in a small animal pilot study. To achieve these aims the following willbe performed: thermal-fluid modeling, design input requirements and feasibility points, development of prototype designs, coolant pressure-flow behavior characterization, in vitro thermal-fluid performance testing for each prototype in system that mimicsintracranial blood flow, and in vivo testing demonstrating that rapid localized tissue cooling is feasible and that the catheter is hemocompatibile with no significant damage to vessels or tissue. Relevance: The technological innovation of combining stroketreatment therapies - mechanical clot removal and reperfusion hypothermia - may yield synergistic benefits, resulting in reduced infarct size and improved neurological outcomes compared to outcomes using either technology separately. If fast and safe cooling is shown feasible in Phase I, Phase II would investigate efficacy using an animal stroke model. PUBLIC HEALTH RELEVANCE: Stroke is the 3rd leading cause of death and number one cause of adult disability in the United States. For stroke treatment, quickly restoring blood flow has been shown to improve outcome, although some experts have found reperfusion injury mitigates these benefits. FocalCool, LLC seeks to combine two technologies, thrombectomy and therapeutic hypothermia using a novel coolingguide catheter potentially maximizing the benefit of blood flow restoration while minimizing damaging effects of reperfusion injury.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 299.76K | Year: 2013

DESCRIPTION (provided by applicant): The primary care goal during a heart attack is to quickly restore blood perfusion. Reperfusion, however, is paradoxical, while it enables organ survival; it also enables destructive biochemical processes. While numerousadjunctive therapies for acute myocardial infarctions (AMI) have been studied, innovative combination therapies are needed. Both hypothermia and gradual reperfusion have shown benefit in terms of saving heart tissue following ischemia-reperfusion. The overall goal of this work is to combine these two techniques for additive and perhaps synergistic benefits for improving AMI outcomes. Specific Aims: 1) Develop a combination therapy device that precisely controls reperfusion flow as well as tissue cooling and re-warming. 2) Demonstrate that the proposed combination therapy technology has the ability to carefully and safely control both reperfusion and tissue temperature and provides tissue salvage benefit in a large animal translational ischemia-reperfusion model. To achieve aim #1, a fixed set of design input requirements and feasibility points will be developed, five fully characterized and robust device prototypes will be created ready for in vivo testing, and an optimal operational protocol based on tissuecooling ability and potential efficacy for in vivo testing will be selected. For aim #2, the optimal operational protocl will be tested in a large animal ischemia-reperfusion model. These results will show that the protocol is safe and effective at reducing tissue damage, demonstrating that there is a potential for clinically relevant tissue salvage. Relevance: Approximately 110,000 people each year in the U.S. have an emergency angioplasty procedure. According to the AHA 2010 Statistics, 20% of first timeheart attack victims die within one year of the event. FocalCool, LLC's goal is to improve emergency angioplasty patient outcomes by reducing reperfusion injury through safe and effective use of controlled reperfusion hypothermia. If Phase I goals to demonstrate safety, cooling ability, and tissue salvage feasibility of the joint technology are successful, Phase II wok will freeze the design for GLP animal testing and an IDE application and demonstrate efficacy of tissue salvage in a translational preclinical model. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: While percutanous coronary intervention (PCI) is effective at re-establishing perfusion to formerly blocked areas of the heart, there are currently no approved therapeutic treatments ordevices on the market for myocardial reperfusion injury reduction. FocalCool, LLC seeks to develop an easy-to-use combination technology that carefully controls reperfusion blood flow as well as blood temperature to safely and quickly deliver cooled blooddirectly to the heart as an adjunctive treatment during PCI. If the proposed aims are achieved, a reperfusion injury reduction prototype device will be realized, with little change to today's care path, preserving more healthy heart tissue post PCI for improved patient outcomes.

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