Abstract: A drug delivery particle including a reservoir region having primarily large pores and a metering region. The particle can be highly spherical.

Abstract: Method and apparatus to modify a fluid by passing a compound through a selectively permeable membrane is provided. In one embodiment a fluid moving through a vessel is modified prior to its ejection from the vessel. This may be accomplished by urging the fluid into a mixing chamber wherein the mixing chamber is in fluid communication with an exit orifice and a passageway. This passageway may be in communication with a second chamber through a selectively permeable membrane. The fluid may then be altered by passing a compound between the mixing chamber and the second chamber through the passageway and the selectively permeable membrane. A device for modifying a fluid moving through a vessel may contain a first lumen, a second lumen, an exit orifice, and a mixing chamber in communication with the first lumen and the exit orifice.

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 regards the delivery of therapeutic at a target site. Systems that employ the present invention may employ a medical device sized to be inserted into a target site, a driving layer covering at least a portion of an accessible surface of the medical device, and a therapeutic interfaced with at least a portion of the driving layer. In this system, the driving layer may have a material characteristic that serves to release the therapeutic from the medical device when the medical device is at the target site. Other systems that employ the invention may also have properties that include having a driving layer with a higher solubility than the therapeutic at the target site, a medical device that is hydrophobic while the therapeutic is hydrophilic, and a coating covering at least a portion of the therapeutic.

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 method for furnishing a therapeutic-agent-containing medical device is provided. The method comprises: (a) providing a reactive layer comprising a cross-linking agent on a medical device surface; and (b) subsequently applying a polymer-containing layer, which comprises a polymer and a therapeutic agent, over the reactive layer. The cross-linking agent interacts with the polymer to form a cross-linked polymeric region that comprises the therapeutic agent. Moreover, in certain embodiments, the polymer-containing layer does not comprise the cross-linking agent at the time the polymer-containing layer is applied over the reactive layer. Examples of medical devices include implantable or insertable medical devices, for example, catheters, balloon, cerebral aneurysm filler coils, arterio-venous shunts and stents.

Abstract: A medical device with a therapeutic agent-releasing polymer coating. The medical device is provided by a method that comprises: (a) attaching at least one reactive species to a medical device surface, which reactive species leads to chain growth polymerization in the presence of monomer; (b) contacting the reactive species with at least one monomer species, thereby forming a polymer coating on the surface of the medical device; and (c) providing at least one therapeutic agent within the polymer coating. The therapeutic agent may be incorporated during formation of the polymer coating or after formation of the polymer coating. The at least one reactive species can comprise, for example, a free radical species, a carbanion species. a carbocation species, a Ziegler-Natta polymerization complex, a metallocene complex, and/or an atom transfer radical polymerization initiator.

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.

Abstract: A medical device having a coating of cell adhesion polypeptides to enhance endothelial cell adhesion onto the medical device. The cell adhesion polypeptides may be any of the proteins of the extracellular matrix which are known to play a role in cell adhesion or derivative peptides such as RGD or YIGSR. The polypeptides may be incorporated into the backbone of a polymer such as polyurethane, or grafted onto a polymer such polybisphosphonate. The polypeptides may also be carried on antibodies or displayed on bacteriophages. The polypeptides may also be modified to have adhesive amino acid sequences. In certain embodiments, the medical device further comprises a temporary barrier that protects the polypeptides from biofouling. The temporary barrier may be formed of a biodegradable polymer and be constructed as a coating over the polypeptides or as a plurality of micelles encapsulating the polypeptides.

Abstract: Methods for the treatment of asthma are provided, which comprise: (a) providing an implantable or insertable medical device that comprises an asthma treatment agent; and (b) inserting or implanting the medical device within the lungs (e.g., the trachea or the bronchial tree) of a patient, whereupon the therapeutic agent is delivered to the patient in an amount effective to reduce or eliminate the symptoms of asthma. Also disclosed herein are medical devices and kits for carrying out such methods.

Abstract: The present invention relates to medical devices that are to be implanted or inserted into the body of a patient for the purpose of removing undesired body tissues. In one embodiment of the invention the medical device comprises a body tissue removal agent for removing undesired body tissue simultaneously with or prior to treatment of body tissue that is in proximity to the undesired body tissue with a biologically active material. Such biologically active material may facilitate regeneration of the body tissue that was removed or may prevent the recurrence of the undesired body tissue.

Abstract: A medical device includes a carrier and an agent. The agent is formulated to control inflammation of biological tissue, such as heart tissue, and is releasably coupled to the carrier. The carrier is configured to be disposed in operative proximity to the biological tissue to be treated by the agent. In one embodiment, the carrier is configured to release the agent or otherwise deliver the agent to the biological tissue, thus controlling inflammation of the tissue. Also, a method to improve healing of biological tissue includes placing a medical device proximate to the heart of a patient, where the medical device has a carrier and an agent configured to control inflammation, the agent is releasably coupled to the carrier. In one embodiment, the method includes causing the agent to be released from the carrier.

Abstract: The present invention relates to the direct delivery of therapeutic to a target tissue. In one embodiment a method for direct injection of plug forming material into a body tissue is provided. The method may comprise providing a catheter including a injection tube having a first channel, a second channel and a piercing tip. The first and second channels can be in fluid communication with a pressure source and a plug forming material. The injection tube may be slidably positioned in a pressure apron and moved from a first position to a second position so that the piercing tip extends beyond the tissue-mating surface in the second position to deliver the plug forming material.

Abstract: The present invention provides a method comprising administering cells by infusion through a blood vessel and administering a vasodilator, a vascular enhancer, or both. In accordance with one embodiment, the delivery of stem cells to the myocardium by intracoronary infusion is improved by administration of one or more vasodilators and/or vascular permeability enhancers prior to or at the time of cell therapy.

Abstract: A medical device for: delivering a therapeutic agent to a body lumen is described. The device may generally be a stent with an inner sidewall surface and an outer sidewall surface, with a plurality of struts having a plurality of openings therein. An inner and outer layer may be applied to the stent, forming pockets within at least a portion of the openings. The pockets may be filled with at least one therapeutic agent. The pockets may take a variety of shapes and sizes, and may be designed for release or rupture in variety of ways.

Abstract: A pressure apron for insitu plug formation is provided. In one embodiment an injection tube having a first channel and a piercing tip is provided, the first channel in fluid communication with a pressure source. In this embodiment, the injection catheter may also include a pressure apron with a tissue-mating surface. In another embodiment a medical kit for delivering a therapeutic is provided. This medical kit may include a catheter having a channel and a piercing tip, the piercing tip in fluid communication with a pressure source and slidably placed in the channel. The catheter in this embodiment may include a pressure apron with a tissue-mating source while a therapeutic may be included with the kit.

Abstract: A medical device and system capable of providing on-demand delivery of biologically active material to a body lumen patient, and a method of making such medical device. A first coating layer comprising a biologically active material and optionally a polymeric material is disposed on the surface of the medical device. A second coating layer comprising magnetic particles and a polymeric material is disposed on the first coating layer. The second coating layer, which is substantially free of a biologically active material, protects the biologically active material prior to delivery. The system includes the medical device and a source of energy, such as an electromagnetic or mechanical vibrational energy. When the patient is exposed to the energy source, the magnetic particles move out of the second coating layer and create channels therein through which the biologically active material can be released.

Abstract: This invention provides a high-solids therapeutic composition for coating a medical device comprising: (a) a first material which is a hydrophilic therapeutic agent; and (b) a second material which includes a hydrophobic polymer and an emulsifying surfactant, wherein the composition is in a singular stable phase. Also provided is a mold-cast medical device, said medical device comprising a cured mixture of: (a) a first material which is a hydrophilic therapeutic agent; and (b) a second material which includes a hydrophobic polymer and an emulsifying surfactant, wherein the mixture forms a high-solids device. Further provided is an injectable polymer comprising: (a) a first material which is a hydrophilic therapeutic agent; and (b) a second material which includes a hydrophobic polymer and an emulsifying surfactant, wherein the polymer is in a singular stable phase.

Abstract: Apparatus and method utilizing fluid to deliver a bolus of therapeutic material through a lumen to a delivery or discharge control portion of the apparatus, where the bolus may be discharged or delivered to a desired location.

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.