| Autologous platelet gel on a stent graft -> Monitor Keywords |
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  Autologous platelet gel on a stent graftRelated Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Arterial Prosthesis (i.e., Blood Vessel), Having Plural Layers, CoatingThe Patent Description & Claims data below is from USPTO Patent Application 20060095121. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] Methods for preventing stent graft migration and endoleak using treatment site-specific cell growth promoting factor application devices and related methods are disclosed. Specifically, methods for applying cell growth promoting compositions such as, but not limited to, autologous platelet gel compositions directly to treatment sites before, during or after stent graft implantation are provided. More specifically, medical devices having autologous platelet gel coatings and/or autologous platelet gel delivery devices useful for treating aneurysms are provided. BACKGROUND OF THE INVENTION [0002] Aneurysms arise when a thinning, weakening section of an artery wall balloons out to more than 150% of the artery's normal diameter. The most common and deadly of these occur in the aorta, the large blood vessel stretching from the heart to the lower abdomen. A normal aorta is between 1.6 to 2.8 centimeters wide; if an area reaches as wide as 5.5 centimeters, the risk of rupture increases such that surgery is recommended. Aneurysms are asymptomatic and they often burst before the patient reaches the hospital. [0003] Aneurysms are estimated to cause approximately 32,000 deaths each year in the United States. Additionally, aneurysm deaths are suspected of being underreported because sudden unexplained deaths, about 450,000 in the United States alone, are often simply misdiagnosed as heart attacks or strokes while many of them may be due to aneurysms. Aneurysms most often occur in the aorta, the largest artery in the body. Most aortic aneurysms, approximately 15,000/year, involve the abdominal aorta while approximately 2,500 occur in the chest. Cerebral aneurysms occur in the brain and present a more complicated case because they are more difficult to detect and treat, causing approximately 14,000 U.S. deaths per year. Aortic aneurysms are detected by standard ultrasound, computerized tomography (CT) and magnetic resonance imaging (MRI) scans and the increased use of these scanning techniques for other diseases has produced an estimated 200% increase in the diagnosis of intact aortic aneurysms. Approximately 200,000 intact aortic aneurysms are diagnosed each year due to this increased screening alone. [0004] U.S. surgeons treat approximately 50,000 abdominal aortic aneurysms each year, typically replacing the abnormal section with a plastic or fabric graft in an open surgical procedure. A less-invasive procedure that has more recently been used is the stent graft which threads a compressed tubular device to the aneurysm and is expected to span the aneurysm to provide support without replacing a section of the aorta. A vascular graft containing a stent (stent graft) is placed within the artery at the site of the aneurysm and acts as a barrier between the blood and the weakened wall of the artery, thereby decreasing pressure on artery. The less invasive approach of stent grafting aneurysms decreases the morbidity seen with conventional aneurysm repair. Additionally, patients whose multiple medical comorbidities make them excessively high risk for conventional aneurysm repair are candidates for stent grafting. Stent grafts have also emerged as a new treatment for a related condition, acute blunt aortic injury, where trauma causes damage to the artery. There are, however, risks associated with endovascular repair of abdominal aortic aneurysms. The most common of these risks is migration of the stent graft due to hemodynamic forces within the artery. Graft migrations lead to endoleaks, a leaking of blood into the aneurysm sac between the outer surface of the graft and the inner lumen of the blood vessel. [0005] The abdominal aorta between the renal artery and the iliac branch is the most susceptible arterial site to aneurysms. While this area of the aorta is ideally straight, in many patients the aorta is curved leading to asymmetrical hemodynamic forces. When a stent graft is deployed in this curved portion of the aorta, hemodynamics place uneven forces on the graft, leading to graft migration. Additionally, the asymmetrical hemodynamic forces can cause remodeling of the aneurysm sac which leads to increased risk of aneurysm rupture and increased endoleaks. [0006] The goal of endovascular repair of aorta aneurysms is to provide a graft which comes in close contact with the vessel wall, in fact sealed to the vessel wall. The greater the area of the stent graft in contact with the artery wall, the better graft fixation, and the tighter seal leads to a decreased risk of migration and endoleak. Endoleaks present a risk factor for post-surgical rupture of the aneurysm due to increased blood pressure within the aneurysm sac. [0007] Stent grafts have been designed with stainless steel anchoring barbs that engage the aortic wall directly to prevent migration. Additionally, endostaples have been developed to fix the graft more readily to the treatment site. These physical anchoring have proven to be effective in some patients however they have not sufficiently ameliorated the graft migration and endoleak problems associated with current stent-grafting methods and devices in all cases. [0008] The combination of the metal scaffolding of most stent grafts and a predilection to graft migration has led to the contraindication of magnetic resonance imaging (MRI) in some patients having stent grafts. The magnetic fields used in this imaging process, when moving across the body, may cause insufficiently endothelialized metal-containing stents to migrate. Anchoring the stent graft into the vessel wall may be expected to ameliorate this problem to the extent that sufficient tissue in-growth occurs. Inducing significant endothelialization of the stent graft may allow patients access to this vital medical diagnostic procedure. [0009] Therefore there exists a medical need for compositions useful for coating stent grafts or direct application to the aneurysm wall at the time of stent implantation that promote healing, reduce endoleaks and minimize device migration by promoting endothelial tissue in-growth. SUMMARY OF THE INVENTION [0010] Compositions are provided in combination with vascular stent grafts for the treatment of aneurysms. Additionally, devices are described which provide structural support for weakened arterial walls while the accompanying compositions seal the support to the tissue wall and promote tissue in-growth to reduce graft migration and prevent endoleaks. [0011] In one embodiment according to the present invention, a stent graft is provided comprising a luminal wall contacting surface; a blood flow contacting surface; and a cell growth promoting composition on the luminal wall contacting surface. The stent graft can optionally have a metal scaffold attached to the luminal wall contacting surface of the stent graft. The cell growth promoting compositions may be applied directly to the exterior of the stent graft either alone or dispersed in a biocompatible polymer by spraying, dipping or rolling. [0012] In another embodiment according to the present invention, the cell growth promoting composition is autologous platelet gel (APG). [0013] In yet another embodiment according to the present invention, the stent graft is coated with APG prior to deployment by depositing platelet poor plasma and thrombin on the stent graft in the stent graft chamber of a stent deployment catheter. [0014] In an embodiment according to the present invention, the cell growth promoting composition is an endothelial cell promoting factor, a smooth muscle cell promoting factor or a fibroblast promoting factor such as a vascular growth factor or a heparin binding growth factor. [0015] In another embodiment according to the present invention, the cell growth promoting factors is selected from the group including vascular endothelial growth factor A, vascular endothelial growth factor B, vascular endothelial growth factor C, vascular endothelial growth factor D, placental growth factor, fibroblast growth factor 1, fibroblast growth factor 2 and insulin-like growth factor. [0016] In an embodiment according to the present invention, a method is claimed for providing a stent graft and a cell growth promoting composition comprises administering a cell growth promoting composition directly to a lumen of a blood vessel wall adjacent to a treatment site; and contacting the cell growth promoting composition with the luminal wall contacting surface of the stent graft and the blood vessel luminal wall at the treatment site. The cell growth promoting composition may be autologous platelet gel. [0017] In another embodiment according to the present invention, a further step is included wherein a drug is delivered in combination with the autologous platelet gel. The drug can be selected from the group consisting of small molecules, peptides, proteins, hormones, DNA or RNA fragments, cells, genetically engineered cells, genes, cell growth promoting compositions and matrix metalloproteinase inhibitors. [0018] In yet another embodiment according to the present invention includes a method for providing a stent graft and a cell growth promoting composition comprising advancing a stent deploying catheter containing a vascular stent to a treatment site; advancing at least one injection catheter containing the cell growth promoting composition to the treatment site; deploying the stent graft at the treatment site; and applying the cell growth promoting composition from the injection catheter to the inner lumen of the blood vessel at the treatment site; such that the luminal wall contacting surface of the stent graft engages the cell growth promoting composition at the treatment site. The stent deployment catheter and the injection catheter can be deployed to the treatment site via the same or a different route. Additionally, the injection catheter can reach the treatment site via a blood vessel which bisects the treatment site. The injection catheter can be a single lumen injection catheter or a multilumen injection catheter. [0019] In an embodiment according to the present invention, the treatment site is the area where the distal end of the stent graft contacts the vessel lumen wall. In another embodiment according to the present invention, the treatment site is the junction between a stent graft and an iliac limb section. In yet another embodiment according to the present invention, the treatment site is the aneurysm sac. [0020] In one embodiment according to the present invention, a delivery catheter is provided for delivering a stent and a cell growth promoting composition to an aneurysm site which comprises a stent graft chamber in which the stent graft is radially compressed; an injection catheter disposed within the delivery catheter; and at least one injection port at the distal end of the injection catheter capable of delivering a cell growth promoting composition. The injection catheter can be a single lumen injection catheter or a multilumen injection catheter. The injection catheter may further comprise a vent for expressing air or excess cell growth promoting composition. [0021] In an embodiment according to the present invention, a method is provided for treating abdominal aortic aneurysms comprising delivering a stent graft to a treatment site; promoting endothelialization of the stent graft by depositing a cell growth promoting composition on the inner lumen of the blood vessel contacting the luminal wall contacting surface of the stent graft and the inner lumen of the blood vessel; and promoting strengthening and fixation of stent graft by enhancing proliferation of smooth muscle cells and fibroblasts. The cell growth promoting composition for treating abdominal aortic aneurysms may be autologous platelet gel. Continue reading... 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