Method of local antibiotic treatment of infective endocarditis
Inventors
Seidel, Raphael A. • Figulla, Hans R. • Tramm, Kristina M.
Assignees
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Publication Number
US-11759460-B2
Publication Date
2023-09-19
Expiration Date
Abstract
A method of treating or preventing endocarditis in a human patient in need of therapy is disclosed. The method comprises identifying a patient inflicted with or being at risk of contracting Staphylococcus aureus, Enterococcus faecalis, or Enterococcus faecium; and locally delivering to or in the vicinity of a heart valve a therapeutically or prophylactically effective amount of rifampicin, daptomycin, dalbavancin, vancomycin, or gentamycin, or a combination of rifampicin, daptomycin, dalbavancin, vancomycin, and gentamycin. The method comprises treatment or prevention of a bacterial biofilms on the endocardium caused by Staphylococcus aureus, Enterococcus faecalis, or Enterococcus faecium.
Core Innovation
The invention relates to treating or preventing endocarditis in a human patient in need of therapy by identifying a patient inflicted with or at risk of contracting Staphylococcus aureus, Enterococcus faecalis, or Enterococcus faecium at or about a heart valve. The approach targets the local environment at or near the heart valve to control infective endocarditis associated with bacterial biofilms and vegetations.
After identifying the patient, the invention provides a method that locally applies to or in the vicinity of the heart valve a therapeutically or prophylactically effective amount of an agent. The agent consists of rifampicin, daptomycin, dalbavancin, vancomycin, or gentamycin, or any combination of 2 or more of these agents, for direct local application at or about the heart valve.
Local application is performed using an implantable medical device with a coating that includes an impermeable polymeric inner layer. An outer layer of the agent is disposed such that the impermeable layer is configured to prevent washout of the agent into the blood stream for direct local application of the agent at or about the heart valve.
Claims Coverage
The independent claim covers one method framework with three inventive elements, including patient identification at risk of specific pathogens, locally applying one or more specified antibiotics at or about a heart valve, and using an implantable device with a coating architecture that prevents washout into the blood stream.
Patient identification at or about a heart valve
Identifying a patient inflicted with or being at risk of contracting Staphylococcus aureus, Enterococcus faecalis, or Enterococcus faecium at or about a heart valve.
Local application of a specified rifampicin/daptomycin/dalbavancin/vancomycin/gentamycin agent
Locally applying to or in the vicinity of the heart valve a therapeutically or prophylactically effective amount of an agent consisting of rifampicin, daptomycin, dalbavancin, vancomycin, or gentamycin, or any combination of 2 or more of rifampicin, daptomycin, dalbavancin, vancomycin, and gentamycin.
Implantable device coating with impermeable polymeric inner layer to prevent washout
Applying the local application of the agent by an implantable medical device having a coating including an impermeable polymeric inner layer over which an outer layer of the agent is disposed such that the impermeable layer is configured to prevent washout of the agent into the blood stream for direct local application of the agent at or about the heart valve.
The claim coverage combines risk-based identification for Staphylococcus aureus or Enterococcus faecalis/faecium at or about a heart valve, local administration of rifampicin, daptomycin, dalbavancin, vancomycin, or gentamycin, and a coated implantable medical device architecture with an impermeable polymeric inner layer configured to prevent washout into the blood stream.
Stated Advantages
Prevents washout of the agent into the blood stream for direct local application at or about the heart valve.
Documented Applications
Local treatment or prevention of infective endocarditis in a human patient by applying specified antibiotics at or about a heart valve using an implantable medical device with a washout-preventing impermeable inner layer.
Use with replacement heart valve contexts including an aortic valve replacement device.
Local delivery and prophylactically or therapeutically targeted control of bacterial biofilms and vegetations associated with endocarditis.
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