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Bioactive bracket for type II diabetics and methods for use thereof

A bioactive, bioactive agent technology for use in the field of implantable stents coated with biodegradable polymers

Inactive Publication Date: 2007-06-20
MEDIVAS LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although patients with type 2 diabetes represent a major proportion of patients who experience this treatment failure, not all patients with type 2 diabetes experience stenting failure, and why some patients experience failure and some do not experience failure has not been studied to date

Method used

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  • Bioactive bracket for type II diabetics and methods for use thereof
  • Bioactive bracket for type II diabetics and methods for use thereof
  • Bioactive bracket for type II diabetics and methods for use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0207] Amide Bond Formation - This example illustrates the coupling of a carboxyl group of a polymer to an amino functional group of a bioactive agent, or equivalently, a carboxyl group of a bioactive agent and an amino functional group of a polymer.

[0208]Coupling via preformed active ester; carbodiimide-mediated coupling - coupling of 4-amino-Tempo to polymer. The PEA polymer in the free carboxylic acid form was first converted to its active succinimide ester (PEA-OSu) or benzotriazole ester (PEA-OBt). This transformation can be achieved by reacting dry PEA-H polymer with N-hydroxysuccinimide (NHS) or 1-hydroxybenzotriazole (HOBt) and a suitable dehydrating agent such as dicyclohexylcarbodiimide (DCC ) in anhydrous CH 2 Cl 2 The reaction was completed at room temperature for 16 hours. After filtering off the precipitated dicyclohexylurea (DCU), the PEA-OSu product can be isolated by precipitation, or used without further purification, in which case the PEA-OSu solution ...

Embodiment 2

[0210] Ester Bond Formation - This example illustrates the coupling of carboxyl groups of a polymer to hydroxyl functional groups of a bioactive agent, or equivalently, the coupling of carboxyl groups of a bioactive agent to hydroxyl functional groups of a polymer.

[0211] Carbodiimide-mediated esterification. For coupling, samples of carboxyl-containing polymers were dissolved in DCM. To this slightly viscous solution was added a solution of hydroxyl-containing drug / biological material and DMAP in DCM. The flask was then placed in an ice bath and cooled to 0 °C. Subsequently, a solution of 1,3-diisopropylcarbodiimide (DIPC) in DCM was added, the ice bath was removed and the reaction was allowed to warm to room temperature. The coupling reaction was stirred at room temperature for 16 hours, during which time TLC was performed periodically to monitor the consumption of the hydroxyl functionality of the bioactive agent. After the indicated times, the reaction mixture was pre...

Embodiment 3

[0212] PEC isolation. To establish a protocol for isolation of endothelial progenitor cells (PECs) from peripheral blood, blood from healthy normal donors was used. Literature review lists various PEC separation schemes (J.C.I. (2000) 105: 71-77; Circ. (2003) 107: 143-149; Circ. (2003) 107: 1164-1169; Plast.Reconstruc.Surgr.( 2004) 113:284; and Am. J. Physiol. Heart Circ. Physiol. (2004) 286: H1985-H1993). Surprisingly, however, initial attempts required modification of known protocols to ensure successful separation. The flowchart in Figure 2 shows the modified protocol followed in the isolation of PECs.

[0213] It was determined from experimental PEC isolations that cells will attach and grow better on fibronectin-coated plates than on gel-coated plates. Cells were isolated from ~120 mL of peripheral blood and an aliquot was plated on Endothelial Basal Medium and 5% FBS (Cambrex). Medium was changed every 4-5 days. The total number of cells obtained from the isolate is...

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Abstract

The present invention is based on the discovery that a vascular stent or other implantable medical device can be coated with a biodegradable biocompatible polymer to which is attached a bioligand that specifically captures progenitors of endothelial cells (PECs) from the circulating blood to promote endogenous formation of healthy endothelium in Type II diabetics. In one embodiment, the bioligand is a peptide that specifically binds to an integrin receptor on PECs. The invention also provides methods for using such vascular stents and other implantable devices to promote vascular healing in Type II diabetics, for example following mechanical intervention.

Description

[0001] related application [0001] This application relies on priority to US Provisional Application Serial No. 60 / 559,937, filed April 5, 2004, under 35 U.S.C. §119(e). technical field [0002] The present invention relates generally to implantable medical devices and, in particular, to implantable stents coated with biodegradable polymers to promote vascular healing in diabetic patients. Background technique [0003] The normal endothelium that covers the lining of blood vessels is uniquely and completely compatible with blood. Endothelial cells trigger metabolic processes, such as the secretion of prostacyclin and endothelium-derived relaxing factor (EDRF), which effectively hinder the deposition of platelets on the vessel wall and thrombus formation in the vessel wall. However, damaged arterial surfaces in the vasculature are highly susceptible to thrombus formation. Abnormal platelet deposition leading to thrombus formation is more likely to occur in vessels where en...

Claims

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Application Information

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IPC IPC(8): A61F2/00A61F2/02A61F2/04A61F2/06A61F2/82A61K9/00A61K39/395A61L31/10A61L31/16
CPCA61L31/10A61L31/16A61L2300/114A61L2300/25A61L2300/256A61L2300/416A61L2300/604A61L2300/608
Inventor K·W·卡彭特W·G·图内尔K·M·德菲费K·A·格拉科
Owner MEDIVAS LLC
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