[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Notices]
[Pages 31616-31617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13521]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: Public Health Service, National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Thrombolytic Temperature-Sensitive Liposomes

    Description of Technology: The subject technology discloses a novel 
method for inducing targeted thrombolysis in blood vessels. In this 
technology, a thrombolytic agent is encapsulated within temperature-
sensitive liposomes. This composition is administered into the 
patient's blood circulation. Certain clots and vulnerable 
atherosclerotic processes elicit an endogenous heat that facilitates 
local thrombolytic drug release. The thermosensitive liposome can also 
be exogenously heated to at least its phase transition temperature to 
induce the release the thrombolytic agent from the liposome at the 
thrombus for targeted thrombolysis. The temperature for activated 
release can be varied, depending on the specific composition of the 
liposome.
    Applications: Thrombolysis of blood clots formed in blood vessels, 
primarily in thromboemblic diseases such as myocardial infarction and 
stroke, venous thromboemblic diseases such as deep vein thrombosis 
(DVT), and pulmonary embolism (PE).
    Advantages:
     Due to the protection of the thrombolytic agent within the 
liposome structure until the time that release is induced, this 
technology provides for better stability and longer half-life of the 
agent.

--Enhanced efficacy compared to the currently used thrombolytic 
treatments.
--Decreased side effects compared to the currently used thrombolytic 
treatments.
--Potentially decreased immunogenicity.

     Lower treatment dose may be required compared to current 
methods using free thrombolytic agent.

--Increases safety profile and reduces the risk of dose-related 
intracranial hemorrhage in treated patients.

    Development Status: Proof of principle has been demonstrated in 
vitro.
    Inventors: Bradford Wood, Matt Dreher, et al. (NIHCC).
    Patent Status: U.S. Provisional Application No. 61/473,665 filed 08 
Apr 2011 (HHS Reference No. E-090-2011/0-US-01).
    Relevant Publications:
    1. Collen D. Staphylokinase: A potent, uniquely fibrin-selective 
thrombolytic agent. Nat Med. 1998 Mar;4(3):279-284. [PMID: 9500599]
    2. Elbayoumi TA, Torchilin VP. Liposomes for targeted delivery of 
antithrombotic drugs. Expert Opin Drug Deliv. 2008 Nov;5(11):1185-1198. 
[PMID: 18976130]
    3. Heeremans JL, Prevost R, Bekkers ME, et al. Thrombolytic 
treatment with tissue-type plasminogen activator (t-PA) containing 
liposomes in rabbits: A comparison with free t-PA. Thromb Haemost. 
1995;73(3):488-494. [PMID: 7667833]
    4. Tiukinhoy-Laing SD, Huang S, Klegerman M, Holland CK, McPherson 
DD. Ultrasound-facilitated thrombolysis using tissue-plasminogen 
activator-loaded echogenic liposomes. Thromb Res. 2007;119(6):777-784. 
[PMID: 16887172]
    5. Needham D, Dewhirst MW. The development and testing of a new 
temperature sensitive drug delivery

[[Page 31617]]

system for the treatment of solid tumors. Adv Drug Deliv Rev. 2001 Dec 
31;53(3):285-305. [PMID: 11744173]
    6. Frenkel V, Oberoi J, Stone MJ, et al. Pulsed-high intensity 
focused ultrasound enhances thrombolysis in an in vitro model. 
Radiology 2006 Apr;239(1);86-93. [PMID: 16493016]
    Licensing Status: Available for licensing.
    Licensing Contacts:
     Uri Reichman, PhD, MBA; 301-435-4616; [email protected].
     Michael Shmilovich, Esq.; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The NIH Clinical Center, 
Interventional Radiology Section & Center for Interventional Oncology 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize this novel approach to thrombolysis. Please contact Ken 
Rose, PhD at 301-435-3132 or [email protected] for more information.

Methods and Devices for Transcatheter Cerclage Annuloplasty

    Description of Technology: The invention relates to techniques and 
devices for cardiovascular valve repair, particularly annuloplasty 
techniques and devices in which tensioning elements are positioned to 
treat regurgitation of the mitral valve or tricuspid valve. More 
specifically, the technology pertains to a new device for myocardial 
septal traversal (``cerclage reentry'') that also serves to capture 
(ensnare) and externalize the traversing guidewire. The focus of the 
invention is to avoid a phenomenon in cardiac surgery known as 
``trabecular entrapment.'' The device features an expandable and 
collapsible mesh deployed in the right ventricle to simplify capture of 
a reentering guidewire during transcatheter cerclage annuloplasty. The 
wire mesh exerts pressure against trabecular-papillary elements of the 
tricuspid valve to displace them against the right ventricular septal 
wall. By abutting the right ventricular reentry site of the cercalge 
guidewire, trabecular entrapment is avoided. The device comprises a 
shaft having a distal loop which provides a target in the 
interventrical myocardial septum through which a catheter-delivered 
tensioning system is guided. The loop ensnares the catheter-delivered 
tensioning system as it reenters the right ventricle or right atrium. 
The expandable and collapsible mesh is disposed within the right 
ventricle such that the catheter-delivered tensioning system is 
directed from the ventricular septum into the right ventricular cavity 
through only a suitable opening in the mesh and such that the catheter 
delivered tensioning system is captured or ensnared within the mesh 
opening.
    Applications: Cardiovascular valve repair surgeries.
    Features and Advantages:
     The device avoids trabecular entrapment of the cerclage 
guidewire during septal-perforator-to-right-ventricular myocardial 
guidewire traversal
     The device allows ensnarement of reentering guidewire.
     The device provides an X-ray target for guidewire reentry 
from the septal perforator veins.
     Collapsible transcatheter device that can be introduced 
from a cephalad (typically transjugular or transaxillary) or caudad 
(typically transfemoral) approach.
     The device is intended to allow straightforward removal 
from the same vascular sheath as the cerclage retrograde traversal 
guidewire, to allow both free ends of the guidewire to be externalized 
through the same sheath.
    Development Status:
     Practical usefulness of the technology has been 
demonstrated.
     Preclinical testing of extant prototype is planned.
     Clinical development is planned.
    Inventors: Robert J. Lederman and Ozgur Kocaturk (NHLBI).
    Relevant Publication: Kim JH, et al. Mitral cerelage annuloplasty, 
a novel transcatheter treatment for secondary mitral valve 
regurgitation: initial results in swine. J Am Coll Cardiol. 2009 Aug 
11;54(7):638-651. [PMID: 19660696].
    Patent Status: U.S. Provisional Application No. 61/383,061 filed 15 
Sep 2010 (HHS Reference No. E-108-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contacts:
     Uri Reichman, PhD, MBA; 301-435-4616; [email protected].
     Michael Shmilovich, Esq.; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact Peg Koelble 
at [email protected] for more information.

    Dated: May 25, 2011
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-13521 Filed 5-31-11; 8:45 am]
BILLING CODE 4140-01-P