Patch stabilization of rods for treatment of cardiac muscle

#The present invention regards delivery of therapeutic agents, such as therapeutic drugs or genetic material, into a muscle or other tissue.

#The delivery of therapeutic agents to diseased muscle or other tissue is an important, often repeated, procedure in the practice of modem medicine. Therapeutic agents, including therapeutic drugs and genetic material, may be used to treat, regenerate, or otherwise affect the muscle surface or the interior of the muscle itself. Such therapy can promote revascularization and create new formation of muscle, such as the myocardium of the heart. For example, many of the treatments for a failing heart due to congestive heart failure entail the delivery of therapeutic agents, growth factors, nucleic acids, gene transfection agents, or cellular transplants, e.g. fetal cardiomyocytes, allogeneic cardiomyocytes, allogeneic or autologous myocytes, and other potentially pluripotential cells from autologous or allogeneic bone marrow or stem cells.

#Current methods for delivering therapeutic agents to muscle, such as the heart muscle, entail injecting directly into the muscle a genetic cell or therapeutic drug. Delivery of therapeutic agents has been proposed or achieved using medical devices such as catheters, needle devices and various coated implantable devices such as stents. The cells and agents can be injected directly or can be formulated into gels, sealants, or microparticles for injection.

#FIG. 1 is a perspective view of a therapeutic agent delivery implant in accordance with the present invention.

#FIG. 2 is a side view of the implant of FIG. 1.

#FIG. 3 is an end view of the implant of FIG. 1 taken along line 3-3 of FIG. 2.

#In FIG. 1, an implant in accordance with the present invention for delivering therapeutic agents into a muscle that minimizes the loss of therapeutic agent due to the contraction of the muscle is shown and generally designated as 10. As seen in FIG. 1, the implant 10 includes at least one rod 11 for insertion and delivery of therapeutic agent into the muscle and a patch 12. Rod 11, having a first end 13 and a second end 14, contains for example a therapeutic drug for delivery into the muscle upon insertion into a treatment site of the muscle. When the rod 11 is inserted into the muscle, therapeutic drug delivery may be initiated.

#After insertion of the rod 11, patch 12 is attached to the exterior surface of the muscle to minimize or preclude the loss of therapeutic agent as the muscle contracts, such as in the beating of a heart. Thus, stability and long term delivery of the therapeutic agent can be obtained if the patch 12 is mounted to rod 11 at the first end 13 of rod 11. A person skilled in the art would appreciate that the patch 12 can be mounted on rod 11 in any manner well known in the pertinent art, such as by bonding or other mechanical attachment means. Alternatively, rod 11 and patch 12 may be separate components, wherein the patch 12 is attached to the surface of the muscle after the rod is inserted.

#One skilled in the pertinent art would appreciate that the patch can be secured to the surface of the muscle in a variety of methods. For example, the patch 12 can be stabilized to the heart surface by sewing or stapling the patch 12 to the heart. Alternatively, tissue adhesives, e.g. cyanoacrylates, fibrin sealant, albumin sealants, PEG sealants, or collagen/gelatin sealants, can be used to keep the rod 11 in place for the duration of the delivery. Also, a skilled artisan would appreciate that barbs may be used to attach patch 12 to the muscle surface. Barbs can be mounted to the surface of patch 12 that contacts the muscle surface.