Abstract:
The disclosure provides macrolide particulates including a macrolide therapeutic agent such as rapamycin at high concentration in the particulate. In one method the particulates are made by adding a composition containing an polyoxyethylene sorbitan n-acyl ester, poly(ethyleneimine), or alkylated quaternary ammonium salt to a composition including macrolide dissolved in an alcohol such as ethanol. In another method the particulates are made by adding a non-solvent composition to a composition including macrolide and an alkyl-substituted chromanol dissolved in an alcohol such as ethanol. The formed macrolide particulates have one or more desirable properties including sizes in the range of 0.1 μm to 10 μm, spherical or near spherical shapes, low polydispersity, and/or stability. The macrolide particulates can be used for therapeutic compositions, or in association with an implantable or insertable medical device, such as associated with a polymeric coating on a device.
Abstract:
A hemodialysis vascular access device includes a proximal end sized and shaped to sealably couple to a hemodialysis catheter, a movable structure coupled to the proximal end, a fixation structure coupled to the movable region and sized and shaped for fixation on a patient, an elongated sleeve coupled to the fixation structure and sized and shaped for insertion into a patient's vasculature, and a valve at a distal end of the internal lumen. When a hemodialysis catheter is inserted into the device and coupled to the proximal end, distal movement of the proximal end relative to the fixation structure biases a distal end of the hemodialysis catheter from a position inside the elongated sleeve through a valve out of the device and into the patient's blood.
Abstract:
Drug delivery coatings and devices including the same are described herein. The drug delivery coating has a first coated layer with non-ionic polymer and photogroups, a second coated layer with acid polymer in contact and hydrogen bonded with the first layer, particles with hydrophobic therapeutic agent, and cationic agent. The coating can be provided on a balloon catheter, and the particles and cationic agent can be transferred to tissue during a medical procedure, such as an angioplasty procedure, for a therapeutic effect.
Abstract:
Embodiments herein include high-pressure balloon catheters and methods for making the same. In an embodiment, a balloon catheter is included. The balloon catheter can include a catheter shaft and a balloon disposed on the catheter shaft. The balloon can include a wall member including an extruded material layer, a fibrous layer disposed to the outside of the extruded material layer, and at least one of a polyurethane composition and an epoxy composition contacting the fibrous layer. Other embodiments are also included herein.
Abstract:
A balloon catheter includes a catheter shaft extending between proximal and distal end portions along a shaft axis. The catheter shaft includes an inflation lumen, and at least one inflation port in communication with the inflation lumen. A balloon assembly is coupled with the catheter shaft and in communication with the at least one inflation port. The balloon assembly includes a balloon membrane having a balloon body, a balloon proximal nose and a balloon distal nose coupled with the catheter shaft. An interlaced jacket is coupled with the balloon membrane, the interlaced jacket includes interlaced filaments extending at diverging angles relative to the shaft axis.
Abstract:
The disclosure provides macrolide particulates including a macrolide therapeutic agent such as rapamycin at high concentration in the particulate. In one method the particulates are made by adding a composition containing an polyoxyethylene sorbitan n-acyl ester, poly(ethyleneimine), or alkylated quaternary ammonium salt to a composition including macrolide dissolved in an alcohol such as ethanol. In another method the particulates are made by adding a non-solvent composition to a composition including macrolide and an alkyl-substituted chromanol dissolved in an alcohol such as ethanol. The formed macrolide particulates have one or more desirable properties including sizes in the range of 0.1 μm to 10 μm, spherical or near spherical shapes, low polydispersity, and/or stability. The macrolide particulates can be used for therapeutic compositions, or in association with an implantable or insertable medical device, such as associated with a polymeric coating on a device.
Abstract:
Embodiments of the invention include devices and coatings for devices including coated hydrophobic active agent particles. In an embodiment, the invention includes a drug delivery device including a substrate; and coated therapeutic agent particles disposed on the substrate, the coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent; and a cationic agent in contact with the particulate hydrophobic therapeutic agent. Other embodiments are also included herein.
Abstract:
Embodiments of the invention include wound packing devices and methods of making and using the same. In an embodiment, the invention includes a wound packing device including a plurality of spacing elements capable of absorbing exudate, wherein the surface of the spacing elements resist colonization by microorganisms. The wound packing device can also include a connector connecting the plurality of spacing elements to one another. Other embodiments are also included herein.
Abstract:
Disclosed herein is a delivery composition for administering a hydrophobic active agent. In one embodiment, a delivery composition for local administration of a hydrophobic active agent to a tissue or organ of a patient is disclosed. In one embodiment, the delivery composition includes a cationic delivery agent, a therapeutically effective amount of a hydrophobic active agent and a pharmaceutically acceptable aqueous carrier. In one embodiment, the cationic delivery agent includes polyethyleneimine (PEI). In a more specific embodiment, the cationic delivery agent includes branched PEI. Methods of making the delivery composition, as well as kits and methods of use are also disclosed.
Abstract:
The invention provides therapeutic particulates including a macrolide, such as rapamycin, in solid state crystalline form, having a size of 20 μm or less, or 10 μm or less. The particulates are formed in one method by preparing a composition with a macrolide and first (e.g., xylene) and second (e.g., an alcohol, acetone, or acetonitrile) solvents. In the composition a maximum solubility for the macrolide that is greater than a maximum solubility of the macrolide dissolved in either the first or second solvent individually. The first and second solvents are then evaporated from the composition to provide the macrolide particulates. In another method, the particulates can be formed by a method including sonication and stirring/evaporation steps, and the particulates can be obtained from a supersaturated solution, formed during the process. Particulates display desirable low polydispersity, and can be used in therapeutic compositions, or can be associated with an implantable or insertable medical device for the treatment of a subject.