Treatment of sepsis and related inflammatory conditions by local neuromodulation of the autonomic nervous system
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-11154547-B2
Publication Date
2021-10-26
Expiration Date
Abstract
Methods of use, formulations, and devices for delivering therapeutic drugs locally to the region of the spleen are described herein. A method for treating sepsis and other inflammatory disease conditions can include inserting a drug delivery system inside the body, advancing the device to the spleen through the splenic artery, splenic vein or other blood vessel adjacent to the splenic nerves, or within a ligament associated with the spleen, such as the splenorenal or gastrosplenic ligaments.
Core Innovation
The invention relates to modulating inflammation in a patient by delivering a therapeutic agent delivery system between one or more folds of one or more ligaments directly connected to a splenic hilum. The therapeutic agent delivery system comprises at least one therapeutic agent configured to provide an anti-inflammatory effect, and the one or more ligaments comprise at least one of a splenorenal ligament or a gastrosplenic ligament.
A key aspect is the use of an injectable in situ forming hydrogel slurry that includes the therapeutic agent and is configured to limit a spread of the hydrogel beyond the one or more folds of the one or more ligaments. The delivery site is defined by accessing between the folds of the ligaments, with catheter-based access described for positioning at the target site.
In one approach, a catheter is inserted into a first blood vessel, advanced into a second blood vessel, and a wall of the second blood vessel is penetrated to position the catheter between the ligament folds. In another approach, the catheter is inserted percutaneously and positioned between the one or more folds of the one or more ligaments with a portion of the catheter.
The anti-inflammatory modulation is tied to the cholinergic anti-inflammatory pathway (CAP) and to sympathetic signaling mechanisms, including nicotinic acetylcholine receptor (α7 nAChR) mechanisms and adrenergic receptor pathways, with suppression of pro-inflammatory cytokines described in the provided content.
Claims Coverage
The provided set includes four independent claims that all cover methods of modulating inflammation by delivering an anti-inflammatory therapeutic agent delivery system between folds of ligaments connected to a splenic hilum, using an injectable in situ forming hydrogel slurry configured to limit spread beyond the folds. The claims differ mainly by the access and positioning approach at the ligament-fold target site.
Ligament-fold delivery site at splenic hilum with anti-inflammatory hydrogel
Accessing between one or more folds of one or more ligaments directly connected to a splenic hilum, where the one or more ligaments comprises at least one of a splenorenal ligament or a gastrosplenic ligament; and delivering a therapeutic agent delivery system between the one or more folds, the therapeutic agent delivery system comprising a hydrogel comprising at least one therapeutic agent configured to provide an anti-inflammatory effect, wherein the hydrogel comprises an injectable in situ forming hydrogel slurry configured to limit a spread beyond the one or more folds.
Catheter placement via two-vessel access and hydrogel delivery between ligament folds
Providing a therapeutic agent delivery system comprising at least one therapeutic agent configured to provide an anti-inflammatory effect; inserting a catheter into a first blood vessel, advancing the catheter into a second blood vessel, and penetrating a wall of the second blood vessel with a portion of the catheter to a position between the one or more folds of the one or more ligaments, where the one or more ligaments comprises at least one of a splenorenal ligament or a gastrosplenic ligament; and delivering the therapeutic agent delivery system between the one or more folds of the one or more ligaments with an injectable in situ forming hydrogel slurry configured to limit spread beyond the one or more folds.
Gel flowing between ligament folds using folds as a boundary
Accessing between one or more folds of one or more ligaments directly connected to a splenic hilum, where the one or more ligaments comprises at least one of a splenorenal ligament or a gastrosplenic ligament; and flowing a gel comprising a therapeutic agent between the one or more folds such that the one or more folds serves as a boundary and limits a spread of the gel to between the one or more folds, where the therapeutic agent is configured to provide an anti-inflammatory effect; wherein the gel comprises an injectable in situ forming hydrogel slurry configured to limit the spread of the gel beyond the one or more folds.
Percutaneous catheter positioning between ligament folds with anti-inflammatory hydrogel
Providing a therapeutic agent delivery system comprising at least one therapeutic agent configured to provide an anti-inflammatory effect; accessing between one or more folds of one or more ligaments directly connected to a splenic hilum, inserting a catheter percutaneously, and positioning the catheter between the one or more folds of the one or more ligaments with a portion of the catheter, where the one or more ligaments comprises at least one of a splenorenal ligament or a gastrosplenic ligament; and delivering the therapeutic agent delivery system between the one or more folds with an injectable in situ forming hydrogel slurry configured to limit spread of the hydrogel beyond the one or more folds.
Across the independent claims, the inventive focus is delivering an anti-inflammatory therapeutic agent via an injectable in situ forming hydrogel slurry that is constrained by delivering between folds of ligaments directly connected to the splenic hilum. The distinct claim coverage is the mode of access and positioning of the delivery at the ligament-fold target site.
Stated Advantages
The injectable in situ forming hydrogel slurry is configured to limit spread beyond the one or more folds of the ligaments.
Suppression of pro-inflammatory cytokines is described in the provided content.
Documented Applications
Modulating inflammation in a patient.
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