Thermo-sensitive Hydrogel for Left Atrial Appendage Occlusion

This invention is nanostructured radiopaque, biomimetic, anti-coagulant, and thermo-sensitive hydrogel which is injected directly into the left atrial appendage (LAA) to occlude the space thereby preventing clot formation and subsequent atrial fibrillation and stroke. The thermo-sensitive properties of this hydrogel enable it to be delivered percutaneously at 4˚C and solidify at body temperature with adhesive properties. These properties allow the hydrogel to permanently attach to the LAA cavity and prevent atrial fibrillation related strokes. 

 

Stage of Development

 

In vitro data: Synthesis and characterization studies have been completed and consistently reproduced. Adhesion, erosion, and rheological studies in rabbit and pig hearts have successfully validated the hydrogel composition.

In vivo data: In vivo and ex vivo studies in rabbits revealed that the hydrogel can effectively adhere to and fill the LAA. Adult dogs have since been used to demonstrate the safety of the novel hydrogel composition by showing a complete lack of associated co-morbidities, as well as a lack of local or systemic toxicity 5 weeks after injection.

 

Competitive Landscape

 

Oral anti-coagulation therapy is the current standard of care for stroke-risk patients with atrial fibrillation. Unfortunately, this therapeutic strategy is often burdened with a risk of excessive bleeding and other adverse effects. Since the LAA is a common area for clot formation, medical devices that occlude the LAA have recently been under investigation for patients with a contraindication to anti-coagulation therapy. The Watchman device is currently the only FDA approved LAA occlusion device and while it has been considered safe and effective for patients with contraindications, there is still some level of risk and invasiveness associated with implanting a foreign object in the LAA. There are many similar umbrella-like devices under investigation to block clots from entering the LAA, but they are all limited by concerns of traumatic placement of the device, dislodgement of the device, and clot formation in front of the device. Alternatively, loop-based ligation devices have also been developed to prevent clots from entering the LAA, however, studies have indicated that these devices can sometimes lead to heavy bleeding and pericardial effusion.

 

Competitive Advantages

 

•       No foreign bodies inserted

•       Adhesive properties reduce risk of dislodgement

•       Thermo-sensitive properties allow for atraumatic delivery

•       Anti-coagulative properties eliminate the need for additional anti-coagulant therapy

•       Adaptive to individual LAA anatomies

 

Patent Information:
Licensing Contact
Paige Glumac
pglumac@houstonmethodist.org

Inventors:
Miguel Valderrabano
Ennio Tasciotti
Francesca Taraballi
Cristina Lupo