Abstract: An elongated medical sheath is configured to be movable and positionable proximate to a biological feature of a patient. An expandable-and-collapsible support structure is configured to be selectively movable, at least in part, between an interior of the elongated medical sheath and an exterior of the elongated medical sheath. An energy-emitting assembly is supported by the expandable-and-collapsible support structure.

Abstract: Methods and apparatus are disclosed for puncturing tissue, including a surgical introducer with a stiff main body and a flexible tip which can be used with a puncture device to gain epicardial access. The surgical introducer comprises an introducer shaft having a rigid portion and a flexible tip portion. The rigid portion has a metal tube extending to the rigid portion distal end. The flexible tip portion is distal of the metal tube distal end. The flexible tip portion includes a first polymer and a second polymer, wherein the second polymer is more flexible than the first polymer. The second polymer extends distally from the metal tube distal end to define a second polymer flexible tip segment. The first polymer extends distally from the second polymer flexible tip segment end to define a flexible tip portion cap.

Abstract: A guidewire for performing a transseptal puncture, the guidewire having a distal end and a proximal end with an elongated length therebetween. The guidewire has at least one recess along its elongated length. The distal end of the guidewire is configured to puncture tissue. At least one guidewire marker is configured to be securely positioned, respectively at said at least one recess of the elongated length of the guidewire.

Abstract: A catheter includes an elongate shaft extending longitudinally between a proximal portion defining a proximal end and a distal portion defining a distal end. A lumen extends through the shaft from the proximal end to the distal end. The shaft includes a heat-shielding layer and an outer layer adjacent the heat-shielding layer. The heat-shielding layer includes an inner liner layer adjacent the lumen and a heat-shielding layer adjacent the inner liner layer. In the distal portion, at least a section of the outer layer is radiopaque.

Abstract: Methods and devices are disclosed for puncturing tissue, comprising an assembly for puncturing a target tissue. The puncture device of the assembly has a distal tip configured to puncture the target tissue and at least one proximal marker, formed on the proximal portion of the puncture device. The supporting member of the assembly includes a proximal end, a distal end, and a lumen for receiving the puncture device. The puncture device is configured to enable advancement and withdrawal of the supporting member overtop of the puncture device. Alignment of the proximal end of the supporting member and the at least one proximal marker of the puncture device occurs when the distal tip of the puncture device protrudes from the distal end of the supporting member.

Abstract: Methods and devices are disclosed for puncturing tissue, comprising a puncture device for puncturing tissue and a supporting member for supporting the puncture device. The puncture device is capable of being insertable within the supporting member and being selectively usable in co-operation therewith during a portion of a procedure for puncturing tissue and wherein the puncture device is usable independently therefrom during another portion of the procedure. The puncture device comprises visual or tactile markers for determining the relative positioning between puncture device and supporting member.

Abstract: A method and apparatus are disclosed for an RF guidewire for applying RF energy to create a channel through a region of tissue within a patient's body. The RF guidewire is configured to have a hydrophilic coating disposed thereon to reduce friction to facilitate traversal through vasculature while maintaining its mechanical, electrical and thermal properties. The RF guidewire includes an electrode tip at a distal end of the guidewire for delivering the energy and an electrically insulative thermal shield between the electrode tip and electrical insulation for thermally protecting the electrical insulation from heat produced by delivering the energy. Some embodiments include electrical insulation inside of the electrically insulative thermal shield.

Abstract: A method and apparatus are disclosed for an RF guidewire for applying RF energy to create a channel through a region of tissue within a patient's body. The RF guidewire is configured to have a hydrophilic coating disposed thereon to reduce friction to facilitate traversal through vasculature while maintaining its mechanical, electrical and thermal properties.

Abstract: Methods and devices are disclosed for puncturing tissue, comprising a puncture device for puncturing tissue and a supporting member for supporting the puncture device. The puncture device is capable of being insertable within the supporting member and being selectively usable in co-operation therewith during a portion of a procedure for puncturing tissue and wherein the puncture device is usable independently therefrom during another portion of the procedure. The puncture device comprises visual or tactile markers for determining the relative positioning between puncture device and supporting member.

Abstract: Methods and apparatus are disclosed for puncturing tissue, including a surgical introducer with a stiff main body and a flexible tip which can be used with a puncture device to gain epicardial access. The surgical introducer comprises an introducer shaft having a rigid portion and a flexible tip portion. The rigid portion has a metal tube extending to the rigid portion distal end. The flexible tip portion is distal of the metal tube distal end. The flexible tip portion includes a first polymer and a second polymer, wherein the second polymer is more flexible than the first polymer. The second polymer extends distally from the metal tube distal end to define a second polymer flexible tip segment. The first polymer extends distally from the second polymer flexible tip segment end to define a flexible tip portion cap.

Abstract: A method and apparatus are disclosed for puncturing a target tissue. Apparatus includes an elongate puncture device having a tip electrode that is configured for collecting EGMs and for delivering energy for puncturing the target tissue. The method comprising collecting EGMs to indirectly measure and monitor a pressure applied against the target tissue by the elongate puncture device, thereby confirming a position of the tip electrode of the elongate puncture device relative to the target tissue.

Abstract: A method and apparatus are disclosed for an RF guidewire for applying RF energy to create a channel through a region of tissue within a patient's body. The RF guidewire is configured to have a hydrophilic coating disposed thereon to reduce friction to facilitate traversal through vasculature while maintaining its mechanical, electrical and thermal properties.

Abstract: An electrosurgical device and methods are disclosed for creating a channel through a region of tissue. The device comprises an elongate member for receiving the energy from an electrical energy source. An electrical insulation layer surrounds the elongate member along the device proximal region. An electrode tip is coupled to the distal end of the elongate member for delivering the energy, the electrode tip being configured and sized for delivering the energy in a manner such that electrical arcing is generated in the region of tissue in order to create a channel through at least a portion of the region of tissue. An electrically insulative thermal shield is disposed between the electrode tip and the device proximal region for preventing arcing therebetween during the delivery of the energy and for thermally protecting the device proximal region from heat produced by the delivery of the energy through the electrode tip.

Abstract: Devices and methods are disclosed for widening a channel in a treatment site, the channel containing a guide-wire. The channel is widened by advancing an elongated dilation device, which is configured to fit tightly over the guide-wire at the distal tip of the dilation device and to provide a distal dilating surface, over the guide-wire and at least partially through the treatment site. The dilation device comprises a tubular metallic shaft, typically a metal inner tube, for providing sufficient stiffness and column strength for the dilator to be advanced at least partially through the channel, and a flexible sleeve providing a tapered distal tip. The distal end of the dilator defines a leading surface that is shaped to force away portions of a lesion surrounding the guide-wire away from the guide-wire as the distal end is advanced over the guide-wire through the lesion, whereby a channel through the lesion is at least partially dilated.

Abstract: Devices and methods are disclosed for widening a channel in a treatment site, the channel containing a guide-wire. The channel is widened by advancing an elongated dilation device, which is configured to fit tightly over the guide-wire at the distal tip of the dilation device and to provide a distal dilating surface, over the guide-wire and at least partially through the treatment site. The dilation device comprises a tubular metallic shaft, typically a metal inner tube, for providing sufficient stiffness and column strength for the dilator to be advanced at least partially through the channel, and a flexible sleeve providing a tapered distal tip. The distal end of the dilator defines a leading surface that is shaped to force away portions of a lesion surrounding the guide-wire away from the guide-wire as the distal end is advanced over the guide-wire through the lesion, whereby a channel through the lesion is at least partially dilated.

Abstract: An electrosurgical device and methods are disclosed for creating a channel through a region of tissue. The device comprises an elongate member for receiving the energy from an electrical energy source. An electrical insulation layer surrounds the elongate member along the device proximal region. An electrode tip is coupled to the distal end of the elongate member for delivering the energy, the electrode tip being configured and sized for delivering the energy in a manner such that electrical arcing is generated in the region of tissue in order to create a channel through at least a portion of the region of tissue. An electrically insulative thermal shield is disposed between the electrode tip and the device proximal region for preventing arcing therebetween during the delivery of the energy and for thermally protecting the device proximal region from heat produced by the delivery of the energy through the electrode tip.