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Autologous platelet gel on a stent graft

a technology stent, which is applied in the field of autologous platelet gel on stent graft, can solve the problems of approximately 14,000 u.s. deaths per year, aneurysms are asymptomatic, and aneurysm deaths are suspected of being underreported, so as to promote endothelialization of stent graft, promote stent graft strengthening and fixation, and enhance the proliferation of smooth muscl

Inactive Publication Date: 2006-05-04
MEDTRONIC VASCULAR INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[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.
[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.

Problems solved by technology

Aneurysms are asymptomatic and they often burst before the patient reaches the hospital.
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.
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.
Additionally, patients whose multiple medical comorbidities make them excessively high risk for conventional aneurysm repair are candidates for stent grafting.
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.
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.
Endoleaks present a risk factor for post-surgical rupture of the aneurysm due to increased blood pressure within the aneurysm sac.
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.
The magnetic fields used in this imaging process, when moving across the body, may cause insufficiently endothelialized metal-containing stents to migrate.

Method used

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  • Autologous platelet gel on a stent graft
  • Autologous platelet gel on a stent graft
  • Autologous platelet gel on a stent graft

Examples

Experimental program
Comparison scheme
Effect test

example 1

Properties of Platelet Rich Plasma

[0066] Aliquots of human peripheral blood (30-60 mL) are passed through the Magellan™ Autologous Platelet Separation System (the Magellan™ system) and the concentrated, platelet-rich plasma fraction (PRP) assayed for platelets (PLT), white blood cells (WBC) and hematocrit (Hct) (Table 1). The Magellan™ system concentrated platelets and white blood cells six-fold and three-fold respectively.

TABLE 1Blood cell yields after passing through the Magellan ™ system.Mean ± SDn = 19Initial BloodPRPYieldPLT (× 1000 / μL)220.03 ± 48.581344.89 ± 302.006.14 ± 0.73WBC (× 1000 μ / L) 5.43 ± 1.4317.04 ± 7.013.12 ± 0.90Hct (%)38.47 ± 2.95 6.81 ± 1.59

Cell Yield = cell count in PRP / cell count in initial blood = [times baseline]

[0067] Additionally, PRP was assayed for levels of the endogenous growth factors platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), and ...

example 2

Autologous Platelet Gel Generation

[0068] Autologous Platelet Gel (APG) is generated from the PRP fraction produced in the Magellan system by adding thrombin and calcium to activate the fibrinogen present in the PRP. For each approximately 7-8 mL of PRP, approximately 5000 units of thrombin in 5 mL 10% calcium chloride are required for activation. The APG is formed immediately upon mixing of the activator solution with the PRP. The concentration of thrombin can be varied from approximately 1-1,000 U / mL, depending on the speed required for setting to occur. The lower concentrations of thrombin will provide slower gelling times.

example 3

Effects of APG on Cell Proliferation

[0069] A series of in vitro experiments were conducted evaluating the effect of released factors from APG on the proliferation of the human microvascular endothelial cells, human coronary artery smooth muscle cells and human dermal fibroblasts. Primary cell cultures of the three cell types were established according to protocols well known to those skilled in the art of cell culture. For each cell type, three culture conditions were evaluated. For APG cultures, APG was added to cells in basal medium. A second group of cells were cultured in growth medium. Growth medium is the standard culture medium for the cell type and contains optimal growth factors and supplements. The control cultures contain cells cultured only in basal medium which contains no growth factors.

[0070] Autologous platelet gel had a significant growth effect on human coronary artery smooth muscle cells after five days of culture (FIG. 7), human microvascular endothelial cells ...

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PUM

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Abstract

Methods for ameliorating stent graft migration and endoleak using treatment site-specific cell growth promoting compositions in combination with stent grafts are disclosed. Also disclosed are application of 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. Additional embodiments include medical devices having autologous platelet gel coatings and / or autologous platelet gel delivery devices useful for treating aneurysms.

Description

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 ...

Claims

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Application Information

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IPC IPC(8): A61F2/06
CPCA61L27/3616A61L27/3641A61L2300/414A61L27/54A61L27/3645
Inventor FERNANDES, BRIANCHU, JACK
Owner MEDTRONIC VASCULAR INC
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