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Fully absorbable intraluminal device and method of manufacture

A technology of equipment and lumen, applied in the field of intraluminal equipment, can solve problems such as problems

Active Publication Date: 2018-03-27
ZORION MEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This approach gives more control over the disintegration process, but suffers from the low radial stiffness required to open the artery (i.e., so-called acute growth), and the limited ductility that makes stent-arterial sizing cost-effective. problematic, especially for tapered vessels)
Furthermore, the effect of the long absorption time of PLLA's crystalline domain of more than 2 years on the duration of antiplatelet therapy required to prevent life-threatening blood clots is unknown

Method used

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  • Fully absorbable intraluminal device and method of manufacture
  • Fully absorbable intraluminal device and method of manufacture
  • Fully absorbable intraluminal device and method of manufacture

Examples

Experimental program
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Effect test

Embodiment 1

[0052] High purity alloy Mg-4%Li rods were cast and subsequently drawn into fine wires with a diameter of 125 microns by conventional cold drawing through progressively smaller dies with intermediate annealing treatments. The wire was then formed into a sinusoidal waveform (1.5 mm amplitude) around a 350 micron diameter needle on a hand bending jig. The continuous sine wave was wound around a 1.05 mm mandrel and annealed to form a cylindrical Mg-Li scaffold wire form with a length of 12 mm. Mg-Li wire forms were cleaned in isopropanol, dried, and then spray coated with PGLA 50-50 copolymer (Mn = 70000 Da). Separately, 1.3 mm diameter tubes were extruded from PLLA and longitudinal slits were laser cut to enable expansion. The PLLA tube with a 14mm long slit was then slightly unrolled by heating to 60°C and drawn over a 1.8mm inner diameter conical mandrel and cooled. The hybrid scaffold was then assembled by sliding a PLLA-extruded tubular sleeve onto the Mg-Li wire form, fol...

Embodiment 2

[0054] The same hybrid fully resorbable scaffold as in Example 1 was fabricated with Mg-Li wire form and 5050 PLGA coating, except that Mg-Li 'sandwiched' between the inner and outer layers of the laser-cut PLLA tube Li wire form forms a 3-layer hybrid scaffold (see, e.g. Figure 6 and 7 , which shows an exemplary helical tubular wire structure 600 sandwiched between two expandable polymer mesh tubular sleeves 602a, 602b). Assemblies were fabricated in silicone split tank molds. The hybrid stent was assembled on 1 mm length of OD silicone tubing, loaded first with the PLLA tube, then in the form of Mg-Li wires, then another, larger diameter (approx. 1.7 mm) PLLA tube. The mold was clamped together by placing the entire assembly in a vacuum oven at 65°C for 10 minutes while the combination of heat and pressure bonded the polymers within the 3 layers together. The assembly was crimped onto a 3.0 mm balloon catheter stent delivery system, packaged and sterilized. When unfolde...

Embodiment 3

[0056] Fine-grain, high-purity Mg-1.0Ca was cast and drawn into 95μ wires using conventional drawing dies. The wire was formed into a continuous sinusoidal shape (1.0 mm amplitude) around a hardened 0.27 mm needle on a programmable, automated wire forming machine. The wire form was wound around a 0.9 mm stainless steel mandrel and annealed to produce a cylindrical wire form of approximately 1.1 mm ID which was rinsed in acetone, air dried and spray coated with 50-50 PLGA and paclitaxel in dichloromethane solvent. solution to a thickness of approximately 3-5 µ. The formulation has a dry weight of 5% paclitaxel and 95% PLGA and results in about 1 microgram drug / mm stent length or less. Separately, 90-10 PGLA tubing was extruded to have a 1.0 mm OD and laser cut into a zigzag fine mesh capable of expansion. The laser-cut PLGA tube was then loaded onto a 0.9 mm silicone tube connected to an inflatable device, and the Mg-Ca wire form was loaded onto the PLGA tube (see e.g. Figu...

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Abstract

The present invention provides a fully absorbable intraluminal device comprising: a magnesium alloy structure with a polymer surface coating, the magnesium alloy structure being substantially free of rare earth metals; and an expandable polymer mesh sleeve, the An expandable polymer mesh sleeve can be at least partially bonded to the polymer surface coating to form a mechanical coupling with the magnesium alloy structure.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 61 / 795,695, filed October 23, 2012, entitled "Methods of Fabrication and Design of Multilayer Fully Absorbable Tubular Medical Devices," the disclosure of which is adopted herein Such references in are hereby incorporated in their entirety. technical field [0003] The present teachings relate generally to intraluminal devices, and more specifically to fully absorbable intraluminal implants. Background technique [0004] The fields of coronary angioplasty and stenting have made remarkable progress in the treatment of coronary heart disease through at least three generations of product technologies. However, as these generational advances are achieved, new challenges or failing treatment modalities also typically exist. For example, although balloon angioplasty therapy improves short-term luminal flow, the associated vascular recoil ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/02A61L31/10A61L31/14
CPCA61L31/022A61L31/10A61L31/148A61F2210/0004C08L67/04A61F2/90
Inventor 马克·斯特克尔扬尼斯·O·潘代利迪斯
Owner ZORION MEDICAL
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