Cook Medical Technologies LLC

University of Limerick

James Butler

John Neilan

David Murray

Sean Cummins

Joe Hayes

Olivia Ryan

James M Carlson

Abbasi A Gandhi

Darach McGrath

Shay Joseph Lavelle

Fionan Keady

Peter Tiernan

Syed Ansar Md Tofail

Syed A M Tofail

Lisa O'Donoghue

Fionán Keady

Donagh O'Sullivan

Garry Warren

Tofail Ansar Md Syed

Shane Holland

A medical device such as a stent () or medical balloon () is at least partially coated with a saturated carboxylic acid layer in order to enhance biocompatibility, reduce thrombogenesis and increase endothelialisation. The coating is preferably of citric acid in non-crosslinked form and preferably non-porous so as to mask the underlying structure of the medical device. The acid coating forms an outer surface of at least a part of the medical device, that is has no other layer or material overlying it, save for in some embodiments a partial coating of a bioactive material.

Coated medical device and method of coating such a device

A method of modifying a surface of a medical device for implantation or disposition inside a patient is described. The medical device comprises a structure having at least one surface. The method includes the steps of: placing the medical device into a plasma chamber substantially free from contaminants and substantially sealing the plasma chamber from the atmosphere; removing at least an outermost layer of any oxide layer from the at least one surface of the structure by a plasma oxide-removal process, whilst maintaining the plasma chamber under seal from the atmosphere; and subsequently forming a new oxide layer at the least one surface of the structure by introducing at least one gas into the plasma chamber, whilst maintaining the plasma chamber under seal from the atmosphere. A medical device including a bulk material and an oxide layer disposed over at least one surface of the medical device. The oxide layer is substantially pure and free from contaminants.

Medical device with plasma modified oxide layer and method of forming such a device

There is disclosed a method of improving the reliability of coating an implantable medical device, such as a stent, with bioactive material in the absence of a carrier material such as a matrix or polymer layer. The method involves cleaning volatile components from the exposed surfaces of the medical device, removing carbon deposits and then applying a uniform carbon layer in a controlled environment. The deliberately applied carbon layer masks impurities of the underlying native oxide layer and leads to more uniform bioactive material coating not only a over the surfaces of a single medical device but also from device to device within a batch and between batches of devices. This improves production as well as optimising the amount and release of drug on the medical device without the need for a carrier material.

Regulation/modification of stent contact surface for polymer free drug coating

A medical device such as a stent or medical balloon is functionalised prior to coating with a bioactive material, specifically by carboxylic acidification of the contact surface or surfaces of the medical device. The preferred process involves washing a stent or other medical device in a washing solution which may be sodium hydroxide, soaking in a carboxylic acid solution, rinsing in water to remove excess carboxylic acid, allowing to dry before applying a bioactive agent layer. It has been found that washing after functionalisation removes excess carboxylic acid and enhances the retention of bioactive agent on the contact surface or surfaces of the medical device leading to a more uniform and consistent layer of bioactive agent.

Bioactive agent coated medical device and method of coating such a device

A vascular intervention device delivery system includes a catheter with a proximal end attached to a handle, and a distal carrier segment for mounting a vascular intervention device thereon. A retractable sheath is movable from a first position covering the distal carrier segment to a second position retracted proximally uncovering the distal carrier segment. A pull is attached to the retractable sheath and extends proximally from the retractable sheath toward the handle. A majority of the length of the pull has a cross sectional shape with a concave side that faces the longitudinal axis and is opposite to a convex side that faces away from the longitudinal axis. The cross sectional shape has a width that is greater than a thickness.

Pull wire for vascular intervention device delivery system

A vascular intervention device delivery system, such as for implanting a self expanding stent, includes a thumbwheel rotatably mounted in a handle. A catheter has a proximal end attached to the handle and a distal carrier segment for mounting a stent thereon. A retractable sheath is movable to a position retracted proximally to uncover the distal carrier segment. A pull with a curved cross section extends between the thumbwheel and the retractable sheath. An idler wheel with a perimeter notch is rotatably mounted in the handle proximal to the thumbwheel. A pin is movably in the handle between a first position received in the perimeter notch to block rotation of the idler wheel, and a second position outside of the perimeter notch to permit rotation of the idler wheel. The pull wraps around the idler wheel to return in a direction for being wound onto a spool of the thumbwheel.

Thumbwheel actuated vascular intervention device delivery system

A single-wire stylet may be constructed as an elongate single-wire, memory-metal alloy body with a generally cylindrical body profile, extending distally from a proximal end terminus, where embodiments include a polymeric distal tip member fixedly attached directly at a distal end of the single-wire body. At least one lengthwise portion of the single-wire body is at least partially in martensitic phase at operating temperatures at and below about 37&#xb0; C. Where present, the polymeric distal tip member has a generally cylindrical body profile circumferentially bounded by an outer circumference substantially equal to or greater than that of the metal body. The polymeric distal tip member may be overmolded upon a distal-end tip length of an elongate single-wire, memory-metal alloy stylet body, where the distal end and/or discrete intermediate distal-portion length(s) that include martensitic-phase alloy and any polymeric member have greater flexibility than a proximal-most length of the alloy stylet body.

Endoscopic needle stylet with enhanced-flexibility lengths

There are disclosed implantable medical devices and apparatus for treating implantable medical devices during production, so as to cause the implantable medical devices to have abluminal surfaces and luminal surfaces with different functional characteristics and in particular surface energies. The luminal surfaces of the medical device are preferably coated with carbon, so as to have a low surface energy, which reduces the risk of thrombi forming when implanted into a patient's vessels. The abluminal surfaces are treated so as to have a high surface energy, such that a therapeutic, preferably bioactive, material, such as a drug, can adhere to the abluminal surfaces and preferably without any need for a containment layer such as polymer or other matrix material. Once the therapeutic material has been delivered into the tissue wall, the stent can remain within the patient's vessel without leaving any delivery artefacts, as occurs with some prior art drug eluting medical devices.

Implantable medical device with differentiated luminal and abluminal characteristics

A medical device such as a stent () or medical balloon () is at least partially coated with a carboxylic acid layer in order to enhance biocompatibility, reduce thrombogenesis and increase endothelialisation. The coating is preferably of citric acid in non-crosslinked form and preferably non-porous so as to mask the underlying structure of the medical device. The acid coating forms an outer surface of at least a part of the medical device, that is has no other layer or material overlying it, save for in some embodiments a partial coating of a bioactive material.

A medical device such as a stent () or medical balloon () is functionalised prior to coating with a bioactive material (), specifically by acidification or basification of the contact surface or surfaces () of the medical device. Functionalisation with subsequent coating of bioactive agent directly onto the functionalised surface provides a significantly more consistent and reliable coating of bioactive agent on a medical device without requiring containment or time release devices.

A method of forming a sintered nickel-titanium-rare earth (Ni&#x2014;Ti-RE) alloy includes adding one or more powders comprising Ni, Ti, and a rare earth constituent to a powder consolidation unit comprising an electrically conductive die and punch connectable to a power supply. The one or more powders are heated at a ramp rate of about 35&#xb0; C./min or less to a sintering temperature, and pressure is applied to the powders at the sintering temperature, thereby forming a sintered Ni&#x2014;Ti-RE alloy.

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Aherlow, Ireland

James Butler