Abstract: The invention is directed to a method for treating a tissue or organ in a subject by directly administering an effective amount of an exogenous, decellularized extracellular matrix or a mixture of extracellular matrix and mesenchymal stem cells into the intended site of activity, such as bone marrow cavity. In one embodiment, the invention provides methods of treating bone marrow to increase the number of circulating progenitor and stem cells. In some other embodiments of the invention, the decellularized extracellular matrix to be directly administered is configured to be a time released therapeutic.

Abstract: The invention is directed to an apparatus, such as a medical device, having a surface coated or covered with a decellularized extracellular matrix or having a component comprising the decellularized extracellular matrix for implantation into a subject, preferably a human. In one embodiment of the invention, a decellularized extracellular matrix is used to form a bodily implant such as a vein, an artery, an esophagus, or a ventricular restraining device. In some embodiments of the invention, the decellularized extracellular matrix is configured to be a time released therapeutic. In another embodiment of the invention, a decellularized extracellular matrix forms an aneurysm treatment device, such as an aneurysm coil, a seal, a pouch, or a filler. In a further embodiment of the invention, decellularized extracellular matrix is used to embolize lesions, tumors, or vessels.

Abstract: The present invention is generally directed to medical devices, and more specifically to medical devices that are at least partially insertable or implantable into the body of a patient. The medical devices generally comprise (a) a therapeutic agent, more typically, a high-molecular-weight therapeutic agent, and (b) at least one polymeric layer, which typically acts to control the release of the therapeutic agent from the medical device. Also disclosed herein are methods of making such medical devices.

Abstract: A device and method for delivering and injecting fluid into heart tissue utilizing a laterally directed needle to increase injectate (fluid) retention in the heart tissue. The device may comprise a catheter having a shaft wherein the distal end of the shaft includes a primary penetrating member and a secondary penetrating member. The secondary penetrating member includes an injection lumen in fluid communication with a pressurized fluid source. The primary penetrating member penetrates the heart tissue at the injection site in a first direction, and the secondary penetrating member penetrates the heart tissue in a second direction different from the first direction such that fluid leakage from the injection site is reduced and the volume of treated tissue is increased.

Abstract: A therapeutic delivery catheter system method or kit for delivery of therapeutic to a target location is provided. In various embodiments of the present invention the invention may include a catheter with a therapeutic delivery lumen and a therapeutic delivery orifice. The lumen and the orifice may be in fluid communication with each other and may be configured such that therapeutic delivered therethrough may be done at pressures mimicking pressures existing or otherwise normal at the target locations receiving the therapeutic. In some embodiments the catheter may be part of a kit that may include instructions regarding the proper manner of operation of the catheter. These instructions may include suggested target pressures for therapeutic delivery as well as delivery times, and suggested lengths of time for the device to reside at the target area after delivery to allow for proper uptake of the therapeutic.

Abstract: The present invention relates to a medical device and method for treating the body tissue of a patient. The present invention is also directed to a method of making the medical device and a method of using the medical device. More particularly, the invention relates to a medical device which is inserted into the body for delivery of therapeutic patches to the surface of a body lumen, organ or cavity. Specifically, the medical device has an umbrella-like or a basket-like expandable assembly; and a therapeutic patch. The expandable assembly is capable of changing from a retracted position to an expanded position. The expandable assembly can be self-expanding or non-self-expanding. In one embodiment, the medical device comprises an elongated member; an umbrella-like expandable assembly which has a plurality of wire elements; and a therapeutic patch.

Abstract: A therapeutic delivery device is provided wherein a delivery body is supported by an elongate member such that the body may rotate as it delivers therapeutic to a target site. Therapeutic may be delivered by deploying delivery heads into a target site as well as by dispensing therapeutic from the delivery head. The delivery body may be cylindrically shaped, spherically shaped or shaped in various other configurations. In one embodiment the delivery body contains tracks that may roll back and forth over a target site to dispense therapeutic. In another embodiment, the delivery heads of the delivery body have internal valves that open and close in order to dispense therapeutic.

Abstract: Embodiments of the present invention regard the delivery of therapeutic. One such apparatus may comprise multiple, independently-activated, injection devices for the delivery of therapeutic or other substances. This apparatus may include a first catheter; a second catheter in the first catheter and a multiple delivery member injection device. This multiple delivery member may include an expandable member and a plurality of injection elements. A third catheter may be positioned in the second catheter. This third catheter may have a distal end connected to a wall of the expandable member and a plurality of filling tubes connected to an distal end of the third catheter. In some of the embodiments each of the injection elements may hold a pressurized therapeutic prior to release of the therapeutic.

Abstract: The present invention is generally directed to medical devices, and more specifically to medical devices that are at least partially insertable or implantable into the body of a patient. The medical devices generally comprise (a) a therapeutic agent, more typically, a high-molecular-weight therapeutic agent, and (b) at least one polymeric layer, which typically acts to control the release of the therapeutic agent from the medical device. Also disclosed herein are methods of making such medical devices.

Abstract: The present invention relates to a medical device and method for treating the body tissue of a patient. The present invention is also directed to a method of making the medical device and a method of using the medical device. More particularly, the invention relates to a medical device which is inserted into the body for delivery of therapeutic patches to the surface of a body lumen, organ or cavity. In one embodiment, the medical device comprises an elongated member; an umbrella-like expandable assembly which has a plurality of wire elements; and a therapeutic patch. In another embodiment, the medical device comprises an elongated member, a basket-like expandable assembly having a plurality of wire elements; and a therapeutic patch.

Abstract: The present invention provides a systems that delivers therapeutic to the inner lumens, chambers, cavities, and vessels of the body. A therapeutic delivery device for delivery of therapeutic to a target site within the body of a patient is provided. This device may include a catheter, an expandable multi-port housing fluidly coupled to the catheter and a sheath. The multi-port housing in this device may be sized to travel within a lumen of a patient and may be adapted to expand from a first configuration to a second configuration. The multi-port housing may also contain at least two ejection ports coupled to an internal lumen of the multi-port housing.

Abstract: Embodiments of the present invention relate to multiple needle catheter-based injection systems to deliver a plug of a therapeutic or other agent. A medical device may include a catheter with a distal end, a proximal end and a catheter lumen extending therebetween and an outer needle disposed in the catheter lumen with a distal end and a proximal end and an outer needle lumen extending therebetween. The medical device may include an inner needle with a distal end and a proximal end, the inner needle being disposed in the outer needle lumen and the distal end of the inner needle to receive and hold a therapeutic plug, and a needle control mechanism coupled to the proximal ends of the outer needle and the inner needle, the needle control mechanism to independently and jointly control ejection and retraction of the outer and inner needles to deliver the therapeutic plug into a target tissue site.

Abstract: The present invention relates to a biocompatible, three-dimensional scaffold useful to grow cells and to regenerate or repair tissue in predetermined orientations. The scaffold is particularly useful for regeneration and repair of cardiac tissue. The scaffold contains layers of alternating A-strips and S-strips, wherein the A-strips within each layer are aligned parallel to each other and preferentially promote cellular attachment over attachment to the S-strips. Methods of producing and implanting the scaffold are also provided.

Abstract: This invention relates to a method of treating ischemic or diseased myocardium by injecting a therapeutic agent, such as a gene, protein, cell or drug, into normal myocardium, preferably adjacent to an ischemic zone in the heart of a subject. The method is useful for inducing angiogenesis and collateral blood vessel formation to improve cardiac function in subjects with ischemic heart disease. The method can also be used to promote tissue regeneration in such subjects.

Abstract: The present invention relates to implantable medical devices and methods that employ these medical devices to treat heart valves. In one embodiment, a medical device is provided comprising a body. The body may have a portion thereof including therapeutic agent and can be configured to support the device proximate a heart valve. Methods in accordance with embodiments of the present invention may also include providing a medical device having a body with at least a portion thereof including a therapeutic agent. These methods may also include positioning the medical device in a location proximate to a downstream surface of the heart valve and securing the device. The therapeutic agent released may then be delivered to the heart valve.

Abstract: A catheter for delivering therapeutic to an injection site within the body is provided. This catheter can include a shaft having a proximal end, a distal end, and an infusion lumen extending therein; a penetrating member coupled to the shaft and extendable from the distal end of the shaft, and a stabilizer positioned towards the distal end of the shaft. The catheter could also include a delivery system, able to be calibrated to deliver therapeutic through an injection port at a rate less than the therapeutic absorption rate of the injection site.

Abstract: An apparatus and method for delivering a viscous liquid therapeutic material fluid through a lumen in a catheter that selectively narrows the lumen at a plurality of axial locations along the lumen.

Abstract: The present invention relates to a biocompatible, three-dimensional scaffold useful to grow cells and to regenerate or repair tissue in predetermined orientations. The scaffold is particularly useful for regeneration and repair of cardiac tissue. The scaffold contains layers of alternating A-strips and S-strips, wherein the A-strips within each layer are aligned parallel to each other and preferentially promote cellular attachment over attachment to the S-strips. Methods of producing and implanting the scaffold are also provided.

Abstract: The invention features a catheter assembly and methods for delivering a hydrogel-lined stent to a body lumen, and methods for lining a stent with a hydrogel. The assembly includes a catheter which has a balloon at least a portion of which is coated with a hydrogel and an expansible stent mounted on the balloon in a contracted condition for passage with the catheter to a site of a body. Expansion of the balloon lodges the stent in the body with hydrogel coated on the inner surfaces of the stent as a lining.

Abstract: This invention comprises an apparatus for treating an atherosclerotic plaque in a coronary artery of a mammal by placing at or proximate to an entrance to the coronary artery and upstream of the vulnerable plaque, and an effective amount of a therapeutic agent for the treatment of the plaque. This invention comprises delivering a deposition of a therapeutic drug high in the coronary arterial tree for treatment of downstream vulnerable plaques. The invention also comprises slow release formulation and delivery of an apparatus that is totally degradable or removed and/or replaced.