摘要:
A helical element for insertion into tissue comprises a helical element having an insertion end, a protruding end and an open central area within the wire, rods, filaments, cables or the like that form the helix. The helical element has at least its insertion end covered by a cap of a water-soluble or water-dispersible composition. The composition of the cap comprises a water-soluble or water dispersible component having a hydrogel mixed therein. In one embodiment, there is either a hollow area within the composition within the open central area or the material is more porous than the remaining material. The helical element preferably comprises an electrical lead, such as a positive endocardial lead, with an electrode at the protruding or distal end of the lead. The helical element may comprise any biocompatable material with sufficient structural integrity to provide a secure attachment to tissue in a patient. Where the helical element is also to provide an active (electrically active) function, the composition of the helical element should also be electrically conductive.
摘要:
A medical device is insertable and/or implantable into a body of a patient. The medical device includes a plurality of hollow and/or collapsible tines which are adapted to assist in deployment of the medical device into the body and in preventing inadvertent removal or dislodging of the medical device from the body. The tines are coupled to the medical device body at a coupling end and extend away from the device to a free end. The tines can have a number of configurations such as cylindrical or cone shaped. In addition, the cross section of the free end of the tines can be elliptical, where the free end extends to a tip. Another cross section includes a semi-circle including an open portion which can face towards or away from the medical device body. The tines also include coiled structures which can have a radial axis perpendicular to the radial axis of the medical device.
摘要:
A seal adapted for use with medical devices is provided with a lead having a distal tip electrode. The distal tip of the lead is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead can include a fixation helix for securing the electrode to cardiac tissue. The lead assembly can alternatively include an open lumen lead tip. A seal is provided within the lead tip assembly such that the seal is expanded to prevent or limit further entry of fluids through the lead tip. The seal includes an expandable matrix, such as a hydrogel. The seal is formed on or within the lead when the lead and the seal comes into contact with a fluid and expands. The seal is also formed as a plug which is deployed through the medical device, and expands as the plug absorbs fluid. A housing incorporating the seal can also be attached to a portion of the medical device to provide the seal.
摘要:
A medical electrical lead body having an outer surface and including at least one lumen having an inner surface treated with a silane surface modifying agent to form a three-dimensional, densely cross-linked lubricious coating over at least a portion of the inner surface of the lumen. The outer surface of the lead body also may be similarly treated. The lubricious silane coating may reduce the coefficient of friction of the coated surface of the lead body by as much as 80% when compared to an uncoated surface. A reduction in the coefficient of friction may enhance the stringing efficiency of a conductor through the lead body lumen and may enhance its abrasion resistance.
摘要:
A solventless method for forming a coating on a medical electrical lead is described. The method includes combining particles of a therapeutic agent with a polymeric material in a flowable form in the absence of a solvent to form a uniform suspension. A predetermined amount of the suspension is dispensed onto a portion of the lead and is then cured to form the therapeutic agent eluting layer. Additional layers such as a primer layer, fluoro-opaque layer and/or a topcoat layer can be formed using the solventless method. Employing a solventless method may avoid contraction of the layer being formed due to solvent evaporation during the curing process, and may facilitate greater control over the thickness of the therapeutic agent eluting coating.
摘要:
A lead having an extendable and retractable fixation mechanism has a rotating terminal pin at the terminal end which rotates the fixation mechanism at the distal end. As the terminal pin is rotated, the fixation mechanism is extended or retracted from the distal end of the lead. A threaded collar allows for the fixation mechanism to smoothly extend and retract from the lead, and allows for a 1:1 turn ratio between the terminal pin and the fixation mechanism. A fluoroscopic ring disposed at the distal end of the lead provides information during the implantation process.
摘要:
A lead having an extendable and retractable fixation mechanism has a rotating terminal pin at the terminal end which rotates the fixation mechanism at the distal end. As the terminal pin is rotated, the fixation mechanism is extended or retracted from the distal end of the lead. A threaded collar allows for the fixation mechanism to smoothly extend and retract from the lead, and allows for a 1:1 turn ratio between the terminal pin and the fixation mechanism. A fluoroscopic ring disposed at the distal end of the lead provides information during the implantation process.
摘要:
A seal adapted for use with medical devices is provided with a lead having a distal tip electrode. The distal tip of the lead is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead can include a fixation helix for securing the electrode to cardiac tissue. The lead assembly can alternatively include an open lumen lead tip. A seal is provided within the lead tip assembly such that the seal is expanded to prevent or limit further entry of fluids through the lead tip. The seal includes an expandable matrix, such as a hydrogel. The seal is formed on or within the lead when the lead and the seal comes into contact with a fluid and expands. The seal is also formed as a plug which is deployed through the medical device, and expands as the plug absorbs fluid. A housing incorporating the seal can also be attached to a portion of the medical device to provide the seal.
摘要:
The present methods provide an amorphous, conformal, protective, abrasion-resistant, lubricious fluoropolymer coating on to a polymer substrate via a gas plasma deposition method. The coating method, according to one embodiment of the method, involves generating a gas plasma by introducing a mixture of a fluorinated gas monomer and a hydrocarbon gas into an energetic ion field, such as an ion beam or the field produced by a radio-frequency source. The fluorinated gas monomer is selected from the group consisting of CF.sub.4, C.sub.2 F.sub.4, C.sub.2 F.sub.6, CF.sub.3.sub.2CO, CH.sub.2 CF.sub.2 and mixtures of the foregoing. The hydrocarbon gas is selected from the group consisting of C.sub.2 H.sub.2, C.sub.2 H.sub.4, C.sub.2 H.sub.6, and H.sub.2 and mixtures of the foregoing. The polymer substrate is exposed to the foregoing gas plasma for sufficient time to achieve the desired coating thickness.
摘要:
A lead having an extendable and retractable fixation mechanism has a rotating terminal pin at the terminal end which rotates the fixation mechanism at the distal end. As the terminal pin is rotated, the fixation mechanism is extended or retracted from the distal end of the lead. A threaded collar allows for the fixation mechanism to smoothly extend and retract from the lead, and allows for a 1:1 turn ratio between the terminal pin and the fixation mechanism. A fluoroscopic ring disposed at the distal end of the lead provides information during the implantation process.