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  Medical device for intra-lumenal delivery of pharmaceutical agentsUSPTO Application #: 20080051882Title: Medical device for intra-lumenal delivery of pharmaceutical agents Abstract: The present invention relates to intra-lumenal drug delivery devices. The device, such as a stent, is coated or impregnated with a pharmaceutical agent suitable for use in treatment of restenosis, pulmonary hypertension, and cancer. Suitable pharmaceutical agents include vasodilators and chemotherapeutics. (end of abstract) Agent: John Richard Merkling - Lakewood, CO, US Inventor: Leo Rubin USPTO Applicaton #: 20080051882 - Class: 623 142 (USPTO) The Patent Description & Claims data below is from USPTO Patent Application 20080051882. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001]This application claims priority to U.S. patent applications Ser. Nos. 60/296,896; 60/299,867; and 10/518,109, filed Jun. 8, 2001; Jun. 21, 2001 and Oct. 12, 2004, respectively. FIELD OF THE INVENTION [0002]The present invention relates to devices for intra-lumenal drug delivery. The devices are particularly useful for local delivery of therapeutic substances such as chemotherapeutics, platelet inhibitors, smooth muscle inhibitors and vasodilators. Such therapeutic substances can be used in treating restenosis, pulmonary hypertension and other circulatory disorders. The device is coated or impregnated with the pharmaceutical substance and can be permanent or biodegradable. BACKGROUND OF THE INVENTION Restenosis [0003]Stenosis is the narrowing of the blood vessel lumen. In the case of the heart, stenosis of cardiac circulation can lead to acute infarction with subsequent ischemia. Stenosis is frequently treated with angioplasty. Neointimal formation after stent implantation can cause luminal narrowing called restenosis. Restenosis is induced by initial platelet adhesion and thrombus formation followed by immunocytic adhesion on the stent surface and injured vessel wall. The thrombus then releases factors that activate the proliferation of smooth muscle cells. [0004]While percutaneous transluminal angioplasty (PTA), a method of expanding a blood vessel blocked by plaque, presently enjoys wide use, it suffers from two major problems. First, the blood vessel may suffer acute occlusion immediately after or within the initial hours after the dilation procedure. The second major problem encountered in PTA is the re-narrowing of an artery after an initially successful angioplasty. This re-narrowing is referred to as "restenosis" and typically occurs within the first six months after angioplasty. Restenosis is believed to arise through the proliferation and migration of smooth muscle cells arterial wall, as well as through geometric changes in the arterial wall referred to as "remodeling." It has similarly been postulated that the delivery of appropriate agents directly into the arterial wall could interrupt the cellular and/or remodeling events leading to restenosis. However, the results of attempts to prevent restenosis in this manner have been mixed. [0005]A device such as an intravascular stent can be a useful adjunct to PTA, particularly in the case of either acute or threatened closure after angioplasty. The stent is placed in the dilated segment of the artery to mechanically prevent abrupt closure and restenosis. Unfortunately, even when the implantation of the stent is accompanied by aggressive and precise antiplatelet and anticoagulation therapy (typically by systemic administration), the incidence of thrombotic vessel closure or other thrombotic complication remains significant, and the prevention of restenosis is not as successful as desired. An undesirable side effect of the systemic antiplatelet and anticoagulation therapy is an increased incidence of bleeding complications, limiting its use. A suitable device would work locally to deliver a therapeutic agent that would prevent thrombus formation and inhibit smooth muscle cell proliferation without undesirable side-effects. Stents [0006]Recent major breakthroughs have made new materials available for percutaneous peripheral arterial and coronary artery intervention procedures. Typically, a stent is an inserted mesh of wires that stretch and mold to the arterial wall to prevent reocclusion. The arterial and coronary artery stents have made progressive structural improvements leading to the evolution of third generation stents or coated stents. Stents are described for instance in U.S. Pat. Nos. 6,235,053; 6,165,209; 6,129,725; 6,241,760; and 6,197,047. [0007]Implantable medical devices capable of delivering medicinal agents have been described. Several patents are directed to devices utilizing biodegradable or bioresorbable polymers as drug containing and releasing coatings, including U.S. Pat. Nos. 4,916,193; 4,994,071; and 6,096,070. Other patents are directed to the formation of a drug containing hydrogel on the surface of an implantable medical device, these include U.S. Pat. Nos. 5,221,698; and 5,304,121. Still other patents describe methods for preparing coated intravascular stents. U.S. Pat. No. 5,464,650 describes coating stents via application of polymer solutions containing dispersed therapeutic material to the stent surface followed by evaporation of the solvent. U.S. Pat. No. 6,099,561 describes stents with ceramic-like coatings. U.S. Pat. No. 6,231,600 describes stents with hybrid coatings including a time released restenosis inhibiting coating and a non-thrombogenic coating to prevent clotting on the device. U.S. Pat. No. 6,214,901 describes a biocompatible polymer suitable for coating implantable medical devices and delivering therapeutics suspended therein. Additional coatings for medical devices are described for instance in U.S. Pat. Nos. 6,071,305; 6,179,817; and 6,218,016. [0008]Several therapeutic agents have been proposed for treating or preventing restenosis. U.S. Pat. No. 6,214,868 describes preventing or treating coronary restenosis which comprises administering an effective amount of a catechin, derived from a green tea extract. US Patent No. describes inhibiting restenosis with a peptide abundant in basic amino acid residues linked via its C-terminus to a peptide of at least two consecutive hydrophobic amino acid residues. U.S. Pat. No. 6,239,118 describes inhibiting restenosis with a substituted adenine derivative such as 2-chloro-deoxyadenisine. U.S. Pat. No. 6,171,609 describes inhibiting restenosis with an inhibitor of vascular smooth muscle cell contraction. U.S. Pat. No. 6,241,718 describes inhibiting restenosis by applying cryogenic energy to a treatment site. U.S. Pat. No. 6,156,350 describes inhibiting restenosis by flushing with a solution with a pH below 4.0 such as a hydrochloric acid. Pulmonary Hypertension [0009]Pulmonary hypertension has been an enigma to the medical profession both diagnostically and therapeutically. Its well known "mirror image cousin," arterial hypertension is probably the most diagnosed and treated medical condition, while this poor relation remains undiagnosed, untreated and quietly deadly. Unlike arterial hypertension, pulmonary hypertension can not be readily diagnosed such as by a sphygmomanometer. [0010]Pulmonary hypertension is defined when the pressure in the pulmonary artery exceeds 25 mm of mercury at rest or 30 mm of mercury during exercise. There are two forms of pulmonary hypertension. One is known as primary pulmonary hypertension where the cause is unknown and second form is referred to as secondary pulmonary hyertension, meaning that it is secondary to another identifiable underlying cause. [0011]Pulmonary hypertension usually occurs in young adults, with a mean age of 45, varying from 15 to 66 years of age. Approximately 62% are female. The median survival time after diagnosis is approximately 2.5 years. Secondary pulmonary hypertension can result from a multitude of diseases including cardiac problems such as sever mitral stenosis, severe aortic stenosis, left to right shunts (VSD), congestive heart failure, diastolic dysfunction, to list a few of the cardiac causes. Other causes are obstructive sleep apnea, chronic pulmonary emboli, pulmonary parenchymal disease such as emphysema, pulmonary fibrosis or chest wall deformities. It also occurs in connective tissue disease e.g. lupus erythematosus, polymiositis, rheumatoid arthritis, scleroderma and with the CREST syndrome. Secondary pulmonary hypertension has been associated with portal hypotension, and with the use of appetite suppressants. [0012]Elevated pulmonary artery pressure has been found to be a specifically significant prognostic factor in chronic obstructive pulmonary disease patients receiving long term oxygen therapy. In a recent study at the University Hospital in Strasbourg France, Oswald-Mammosser and co-workers found that the five year survival in patient's with severe COPD with normal resting pulmonary artery pressure was 62% and in patients with elevated pulmonary artery pressure the survival was only 36%. The means of treatment for primary or secondary pulmonary hypertension are medical or surgical. At present, most of the medical treatments are experiment and are primarily related to prostacyclin analogues given either orally, inhaled or by infusion. There have also been several studies with inhaled nitrate oxide and oral endothelin receptor antagonists. None of these produced any dramatic results. WO 01/34088 discusses the use of vasoactive intestinal peptide (VIP) for treatment of pulmonary hypertension. [0013]Surgery for treatment of pulmonary hypertension usually consists of lung transplantation, single, bilateral or heart with bilateral lung. Most patients have a waiting period of two to three years for an appropriate donor, obviating the need for many patients who succumb to pulmonary hypertension within that time. Survival at five years post-transplantation is 37-44%. At present it does not appear to be a viable treatment. The lung volume reduction procedure remains a questionable option for COPD. Cancer [0014]In spite of numerous advances in medical research, cancer remains the second leading cause of death in the United States. In the industrialized nations, roughly one in five persons will die of cancer. Traditional modes of clinical care, such as surgical resection, radiotherapy and chemotherapy, have a significant failure rate, especially for solid tumors. Failure occurs either because the initial tumor is unresponsive, or because of recurrence due to regrowth at the original site and/or metastases. Even in cancers such as breast cancer where the mortality rate has decreased, successful intervention relies on early detection of the cancerous cells. The etiology, diagnosis and ablation of cancer remain a central focus for medical research and development. [0015]Neoplasia resulting in benign tumors can usually be completely cured by removing the mass surgically. If a tumor becomes malignant, as manifested by invasion of surrounding tissue, it becomes much more difficult to eradicate. Once a malignant tumor metastasizes, it is much less likely to be eradicated. [0016]The three major cancers, in terms of morbidity and mortality, are colon, breast and lung. New surgical procedures offer an increased survival rate for colon cancer. Improved screening methods increase the detection of breast cancer, allowing earlier, less aggressive therapy. Numerous studies have shown that early detection increases survival and treatment options. Lung cancer remains largely refractory to treatment. [0017]Excluding basal cell carcinoma, there are over one million new cases of cancer per year in the United States alone, and cancer accounts for over one half million deaths per year in this country. In the world as a whole, the five most common cancers are those of lung, stomach, breast, colon/rectum, and uterine cervix, and the total number of new cases per year is over 6 million. Only about half the number of people who develop cancer die of it. Continue reading... Full patent description for Medical device for intra-lumenal delivery of pharmaceutical agents Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Medical device for intra-lumenal delivery of pharmaceutical agents patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. 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