Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 356.98K | Year: 2016
Abstract This Phase I STTR application proposes development of an innovative low cost magnetic levitation motor specifically designed for pediatric extracorporeal cardiac and cardiopulmonary therapies Magnetic levitation enables contact free impeller operation thereby eliminating critical areas of wear and heat generation that can contribute to hemolysis and thrombosis The extracorporeal pediatric market is currently served by a single magnetically levitated blood pump St Jude Medicalandapos s PediMag formerly Thoratec As with many pediatric medical products the PediMag is a scaled down version of a prior adult device originally designed for post cardiotomy support CentriMag While PediMag has been used successfully in a range of post cardiotomy support applications broader usage is complicated by several factors including lack of ancillary componentry designed specifically for the pump system e g pediatric blood oxygenator and heat exchanger complex control algorithms and a high disposable cost approximately $ per disposable PediMag pump head To address these shortcomings we propose an innovative magnetic levitation system based on a hysteresis motor concept that permits a smaller overall configuration eliminates magnetic field safety concerns reduces vibration and relocates the costly rare earth magnetic elements from the disposable blood contacting component to the reusable motor stator The hysteresis motor design also permits simplified control algorithms for enhanced robustness and reduced power requirements enhancing patient transport and mobility The rotor impeller portion of the proposed hysteresis motor will be based on the same impeller geometry as is currently used in the existing pCAS pump oxygenator replacing the current mechanical bearings rotating shaft and blood contacting seal This strategy will lower overall development costs and permit the use of existing comprehensive in vitro and in vivo test data to allow direct and efficient comparison of the performance of the new magnetically levitated prototype to the existing blood seal based pCAS pump oxygenator In Phase I we will perform two acute and one day chronic animal study This permits us to demonstrate basic feasibility while simultaneously minimizing costs and the Phase I project timeline However as part of a subsequent Phase II effort we plan to significantly expand our chronic in vivo studies to include multiple evaluations of at least days !Narrative Many pediatric medical products are simply scaled down versions of adult products Currently the only magnetically levitated blood pump available for pediatric support is similarly a scaled down version of its adult counterpart This project intends to develop improved technology specifically for the pediatric cardiac and cardiopulmonary life support patient populations and test it using an integrated pump oxygenator
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 257.84K | Year: 2016
DESCRIPTION provided by applicant To date blood compatibility testing of biomaterials and medical devices has not led to a consensus on what materials are non thrombogenic nor has it advanced understanding of what and how variables and responses can be measured in vitro to begin to predict in vivo performance While ISO identifies five categories of responses that should be considered thrombosis coagulation platelets leukocyte activation and complement the scientific and regulatory communities continue to focus on coagulation and platelets The other ISO categories dealing with inflammation are typically dealt with early and separately as part of biomaterial development This current approach all but guarantees missing interactions of coagulation and inflammation necessary to predict in vivo performance Current testing methodologies also fail to evaluate the categorical responses under physiological limits of the key Virchow variables of blood flow condition of the blood e g coagulopathies and the influence of the blood contacting surface These uncertainties and the current cost of comprehensive testing stifle development of new materials or surface coatings In fact the FDA has repeatedly acknowledged these shortcomings and encouraged development of new test methods Most recently the FDA announced the Medical Device Development Tool program to address this matter Therefore Ension proposes development of a system Ension Triad System or ETS to provide effective positive and negative control ranges for each of the Virchow variables ETS will enable designed experiments capable of generating quantitative analysis of variance and identify conditions for optimal performance in all five ISO categories Preliminary Data Ension has developed the Ension Bioactive Surface EBS that was inspired by the endothelial glycocalyx We have published on critical interactions between the variables of blood condition levels of anticoagulant and bioactivity of the EBS ATIII adsorption and FIIa deactivation and we have demonstrated statistically significant categorical responses that identify known clinical mediators not revealed in current testing protocols Specific Aims This Phase I project proposes design and fabrication of the ETS system and assesses the feasibility of this tool for standardizing blood compatibility testing and enabling improved medical device development In Specific Aim we will fabricate a functional ETS prototype and optimize the EBS treatment on all of the ETS prototypeandapos s blood contacting materials Specific Aim focuses on in vitro characterization of the ETS prototype to identify mechanical and chemical properties in human blood Finally in Specific Aim we will utilize ETS systems with catheter test articles and vary the three Virchow variables to generate statistical correlations to both evaluate Phase I feasibility and provide a basis for extensive animal model testing planned for our Phase II effort This Phase I effort will demonstrate a heretofore unattainable and reproducible rank ordering of blood compatible materials as well as identifying how category response vary within meaningful ranges of flow blood condition and surface properties PUBLIC HEALTH RELEVANCE Current in vitro systems and methods to assess blood compatibility of biomaterials and medical products have been unable to achieve a comprehensive understanding of the blood biomaterial interaction to predict in vivo performance This Phase I proposes development of a standardized cost effective bench top blood circulation loop and accompanying testing protocols that can comprehensively address all five categories of blood compatibility and account for each Virchow variable in a single highly controlled test
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 880.73K | Year: 2014
DESCRIPTION (provided by applicant): Infection is a common and frequently very serious complication associated with medical implants. Man-made materials, including those used to fabricate ventricular assist devices (VADs), compromise the body's ability tofight infection in tw ways. First, by breaching skin with transcutaneous cannulae and drivelines, and second, by eliciting a foreign body reaction which results in scarring near the implant surface that creates an environment where bacteria can thrive outside the reach of the body's immune system. Currently available infection resistant materials typically rely on the release of antimicrobial substances. Though effective over the short-term, the released drugs can compromise normal healing and exacerbate the problem of isolating the implant surface from the body's immune defenses. Ension proposes development of an infection resistant surface designed to promote normal healing for application to the transcutaneous drivelines of ventricular assist devices. The
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 224.97K | Year: 2015
DESCRIPTION provided by applicant The objective of the proposed Phase I SBIR is to develop and evaluate the ability of a novel regenerative collagen matrix RCM to prevent scarring and contracture while promoting regeneration in burn wounds Scarring and contracture of burn wounds are very common and can lead to loss of tissue functionality and severely compromised tissue aesthetics Current dermal substitutes have not been significantly effective in minimizing scarring and contracture in burn wounds The standard of care includes massage pressure therapies steroids silicone dressings and additional surgeries to manage the scar and contracture burden All current therapies aim to manage scarring and contracture after healing The critical barrier to progress in the field is the lack of a wound dressing capable of intervening at the cellular level from the beginning of the healing process to prevent scarring and contracture To this end the proposed RCM incorporates enhanced architectural features and reinforced physical chemical and biological parameters to achieve a wound dressing suitable for application early in the treatment process and with the ability to prevent scarring an contracture while promoting regeneration in burn wounds Physical reinforcement will provide stress shielding to the cells that minimizes unchecked wound firboproliferation that leads to scarring and contracture This is achieved by combining two physical forms of collagens within the RCM Chemical reinforcement through crosslinking of the collagen will increase in vivo half life by making the collagen more resistant to enzymatic degradation in the wound milieu Biological reinforcement through heparin immobilization will induce regeneration because of heparinandapos s ability to sequester growth factors within the RCM and optimally present them to the cells that potentiates their effects The proposed RCMandapos s novel bi modal architecture will exhibit a random open pore scaffold to facilitate cellular migration and intercellular interaction withn the matrix and oriented micro channels to provide a micro niche topography for keratinocytes to enhance their proliferative phenotype and synthesis of the basement membrane proteins This bi modal architecture of the proposed RCM plays a vital role in providing the necessary stimuli for the wound invading cells to promote regeneration rather than scarring RCM will undergo extensive in vitro characterization to ensure that all Phase I design specifications are satisfied after sterilization In vitro feasibility assessments will include colagen denaturation temperature degradation time heparin bioactivity and pore size distribution In vivo testing will be performed using a standard swine burn model to determine initial efficacy and preliminary biocompatibility of RCM over the course of one and three months with biopsies collected at specified time points for histological wound evaluations If the proposed Phase I is successful then a Phase II SBIR proposal will be submitted with the objective to realize a commercialization path by conducting pre clinical studies aimed to determine efficacy and safety as described in the FDAandapos s andquot Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds Developing Products for Treatmentandquot PUBLIC HEALTH RELEVANCE The objective of the proposed Phase I SBIR is to develop and evaluate the ability of a novel regenerative collagen matrix RCM to prevent scarring and contracture while promoting regeneration in burn wounds Scars and contracture compromise the regeneration of the burn wound tissue to its original functionality and aesthetics The current standard of care is to largely manage scars and contractures only after healing has occurred In contrast the proposed RCM incorporates enhanced novel architectural features and reinforced physical chemical and biological parameters to prevent scarring and contracture before healing has occurred to enable optimal functional and aesthetic recovery of the wounded tissue
Ension, Inc. | Date: 2012-04-06
The integrated medical apparatus includes an operator handle end and a multi-prong grasping member positioned within and movable relative to a grasper lumen that extends from the handle end, wherein the grasping prongs are moved between an open and closed position by relative axial movement between the prongs of the grasping member and the grasper lumen. The medical apparatus includes a contractible snare and a plurality of axially moveable snare pushing arms. At least two of the snare pushing arms include a snare holding and release mechanism, wherein the snare pushing arms are configured to advance the snare in an open, encircling position to a final deployed position where the snare can be released through the activation of the holding and release mechanism of the pushing arms, and finally tightened in a conventional fashion, such as pulling on an end of the snare at the handle end.
Ension, Inc. | Date: 2014-08-05
A method for stimulation of collateral development in ischemic cardiac regions comprises the fluid coupling of the left ventricle of the heart to the anterior interventricular vein to stimulate collateral development in ischemic regions. The fluid coupling of the left ventricle of the heart to the anterior interventricular vein includes a control of the diastolic/systolic pressure in the venous system to be within about 20-50 mmHg. The fluid coupling of the left ventricle of the heart to the anterior interventricular vein includes inserting a transmyocardial conduit into the left ventricle and a tri-directional coupler attached to the anterior interventricular vein. An associated apparatus for stimulation of collateral development in ischemic cardiac regions via the fluid coupling of the left ventricle of the heart to the anterior interventricular vein is disclosed.
Ension, Inc. | Date: 2014-03-14
A variety of medical devices including staples sutures and dental floss with surface treatment on at least one tissue-facing surface to improve biologic function such as to control tissue adhesion are disclosed including heparin surface treatment which provides heparin present in an amount to yield heparin bioactivity of at least one of i) an ATIII binding of at least 2 pmol/cm^(2), and ii) a thrombin deactivation of at least 0.2 IU/cm^(2); an acrylic surface treatment for coupling thereto of a heparin surface treatment, a collagen surface treatment or both; and an amino-functional polysiloxane surface treatment for coupling thereto of a heparin surface treatment.
Ension, Inc. | Date: 2012-01-09
A method of treating the surface of a medical device with a biomolecule comprising the steps of: providing a polyolefin substrate forming a medical device; cleaning the polyolefin substrate; exposing the polyolefin substrate to a reactive gas containing acrylic acid and to plasma energy to yield a plasma-deposited polyacrylic acid coating on the polyolefin substrate; and attaching a biomolecule, such as heparin, to the polyolefin substrate following formation of the plasma-deposited polyacrylic acid coating on the polyolefin substrate.
Ension, Inc. | Date: 2013-09-30
A method of preparing a crosslinked, collagen-based medical scaffold is provided, comprising: (a) immersing a sample of fibrous and/or non-fibrous collagen in a buffered acidic, aqueous solution comprising an alcohol; (b) contacting the collagen in solution with a catalytic component comprising 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride for a time at least sufficient to effect reaction between amino and carboxyl groups present on the collagen and to yield crosslinked collagen that is resistant to pronase degradation; and (c) drying the crosslinked collagen to yield a porous, crosslinked collagen article wherein the porous, crosslinked collagen article demonstrates a pore size of 10-500 microns. Also provided are bioactive collagen medical scaffolds for wound care dressings, hernia repair prosthetics, and surgical incision closure members, prepared using the method above.
Ension, Inc. | Date: 2013-06-13
An integrated blood pump oxygenator comprises an an impeller housing supporting an impeller; with an annular hydrogel impeller packing material adjacent the bearings and around the shaft of the impeller. The oxygenator including a rollover outlet in the form of an annular chamber extending around a center pump housing member; and further including an annular chamber within an annular array of hollow fiber membranes in fluid communication with the annular chamber extending from the impeller around the center pump housing; wherein the annular chamber provides substantially perpendicular radial outward cross flow across the membranes.