Abstract:
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° 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.
Abstract:
A nickel-titanium-rare earth (Ni—Ti-RE) alloy comprises nickel at a concentration of from about 35 at. % to about 65 at. %, a rare earth element at a concentration of from about 1.5 at. % to about 15 at. %, boron at a concentration of up to about 0.1 at. %, with the balance of the alloy being titanium. In addition to enhanced radiopacity compared to binary Ni—Ti alloys and improved workability, the Ni—Ti-RE alloy preferably exhibits superelastic behavior. A method of processing a Ni—Ti-RE alloy includes providing a nickel-titanium-rare earth alloy comprising nickel at a concentration of from about 35 at. % to about 65 at. %, a rare earth element at a concentration of from about 1.5 at. % to about 15 at. %, the balance being titanium; heating the alloy in a homogenization temperature range below a critical temperature; and forming spheroids of a rare earth-rich second phase in the alloy while in the homogenization temperature range.
Abstract:
A medical device such as a stent (10) or medical balloon (40) 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.
Abstract:
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.
Abstract:
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.
Abstract:
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.
Abstract:
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.
Abstract:
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.
Abstract:
A medical device assembly including a catheter having a proximal end, a distal end, and a lumen therethrough. A medical device is disposed about a distal portion of the catheter. A removable loading tool and protector is disposed about the catheter and the medical device, and includes a body having a generally tubular configuration and having a proximal end, a distal end, an intermediate region disposed between the proximal end and the distal end, and a lumen disposed therethrough; and a proximal region having a length and extending from the proximal end of the body, the proximal region having at least one slit positioned adjacent to the proximal end of the body. The proximal region has a first inner diameter and the intermediate region has a second inner diameter, the first inner diameter of the proximal region being greater than the second inner diameter of the intermediate region.
Abstract:
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.