Methods, agents, and devices for local neuromodulation of autonomic nerves
Inventors
Bright, Corinne • VENKATESWARA-RAO, Kondapavulur T. • STEIN, Emily
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Assignees
NORTHWIND MEDICAL Inc • Tulavi Therapeutics Inc
Member
Tulavi TherapeuticsTulavi Therapeutics is a medical device company specializing in solutions for peripheral nerve surgery. The company focuses on developing absorbable hydrogel-based technologies to optimize nerve recovery, reduce the risk of neuroma formation, and improve patient outcomes. Its platform leverages in situ forming, sutureless biomaterials suitable for a variety of nerve injuries, addressing critical gaps in current surgical care. Tulavi is committed to innovation, clinical evidence, and accessibility for both adult and pediatric populations.
Tulavi Therapeutics is a medical device company specializing in solutions for peripheral nerve surgery. The company focuses on developing absorbable hydrogel-based technologies to optimize nerve recovery, reduce the risk of neuroma formation, and improve patient outcomes. Its platform leverages in situ forming, sutureless biomaterials suitable for a variety of nerve injuries, addressing critical gaps in current surgical care. Tulavi is committed to innovation, clinical evidence, and accessibility for both adult and pediatric populations.
Publication Number
US-11918595-B2
Publication Date
2024-03-05
Expiration Date
Abstract
Methods, agents, and devices to treat medical conditions through local chemical neuromodulation of the autonomic nervous system are described. Drug formulations may be injected at or near ganglia, nerve plexi, ganglionated plexi, and nerves to treat different diseases. Target sites for the treatment of cardiac and other disease conditions may include extrinsic stellate (cervicothoracic) and cervical ganglia of the sympathetic chain, and intrinsic cardiac nerves and ganglionated plexi innervating the myocardium.
Core Innovation
The invention provides local chemical neuromodulation of a patient’s autonomic nervous system by delivering an agent locally at or near autonomic nerve targets. In particular, it focuses on delivery to a sympathetic nervous system target site, including the stellate ganglion and related cervical/thoracic ganglia, in an amount sufficient to affect function of the targeted nervous system tissue.
The invention specifies use of a tricyclic antidepressant as the local agent for treating disease conditions involving the sympathetic nervous system. By local delivery to the stellate ganglion, the method is described as alleviating one or more symptoms of the disease condition and modulating sympathetic nervous system function at the level of the autonomic target.
The invention also describes optional verification and monitoring of autonomic nervous system activity, including measuring electrical signal transmission associated with the stellate ganglion before and after administration. It further describes delivery concepts and supportive formulation elements, including small-volume drug formulations, sustained-release and hydrogel/polymeric carrier concepts, along with imaging/contrast and other additives as described in the document.
Claims Coverage
The independent claim covers one inventive combination for treating a sympathetic nervous system disease condition by local delivery of a specified drug class to the stellate ganglion, with an amount sufficient to affect stellate ganglion function and alleviate symptoms. Additional claim features refine the agent, carrier, access route, and monitoring.
Local tricyclic antidepressant delivery to the stellate ganglion
A method for treating a disease condition of a patient’s sympathetic nervous system by delivering an agent locally to a stellate ganglion in an amount sufficient to affect function of the stellate ganglion and alleviate one or more symptoms, wherein the agent comprises a tricyclic antidepressant.
Amitriptyline
The tricyclic antidepressant includes amitriptyline.
PEG carrier composition
Delivering the agent using a composition that includes a PEG carrier.
Hydrogel composition
Delivering the agent using a composition comprising a hydrogel.
Supraclavicular approach
Accessing the stellate ganglion using a supraclavicular approach.
Before and after electrical signal measurement
Measuring electrical signals transmitted from the stellate ganglion before and after delivering the agent to the stellate ganglion.
Claim coverage centers on local delivery of a tricyclic antidepressant to the stellate ganglion to affect its function and alleviate symptoms, with refinements that specify amitriptyline, PEG carrier and hydrogel compositions, a supraclavicular approach, and before and after electrical signal measurement.
Stated Advantages
Alleviates one or more symptoms of a sympathetic nervous system disease condition by affecting function of the stellate ganglion.
Documented Applications
Trigeminal neuralgia is described as an example disease condition for the method that delivers a tricyclic antidepressant to the stellate ganglion.
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