A device for crossing a lesion in a tissue lumen includes a crossing wire configured to pass through a lumen of a catheter, the crossing wire including a loop at a distal end of the crossing wire. The loop can have a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a pair of lateral opposing portions configured for alignment with a wall of the tissue lumen and a leading portion interconnecting the pair of lateral opposing portions, the leading portion being configured to interrogate the lesion. The loop has a length in an axial direction of the crossing wire extending from the leading portion to proximal ends of the pair of lateral opposing portions, the length being perpendicular to the width, and the length of the loop is at least twice the width of the loop.

A catheter for actively scoring or slicing a lesion. A catheter body includes first and second lateral openings. A selectively deployable cutter is connected to the catheter body. The cutter has a retracted configuration in which it does not perform a slicing or scoring function, such as while tracking through the vasculature, and a deployed configuration for slicing or scoring an obstruction. The cutter may include a plurality of retractable blades, such that when deployed, each blade projects in a different direction, such as from one of the lateral openings. Related methods are also disclosed.

A tissue-removing catheter includes a cutting element. A radially innermost portion of the leading radial wall of a raised element of the cutting element may be spaced a radial distance from the longitudinal axis that is less than 66% of the radius of the annular cutting edge. The cutting element may be extendable through the window during operation such that as the cutting element is being rotated about its longitudinal axis, less than an entire radial portion of the leading radial wall passes through the window. A plurality of abrading members may be formed on at least the central portion of the inner surface of the cutting element to abrade hardened tissue as the cutting element is rotating about its longitudinal axis. A radially outermost portion of the leading radial edge of the raised element may be spaced apart radially from an inner surface of the cutting element.

A tissue-removing catheter includes a tissue-removing element operatively connected to a drive shaft for rotation of the tissue-removing element about an axis of rotation in a cutting direction. A tissue-removing head of the tissue-removing element defines an annular cutting blade. In some embodiments, angularly spaced cutting teeth form the cutting blade. Inner shearing members extend radially inward from the cutting blade. As the tissue-removing element rotates in the cutting direction and advances axially through a body lumen, the annular cutting edge separates the tissue from the body lumen wall. Leading surfaces of the inner shearing members shear the separated tissue radially inwardly. In some embodiments, the tissue-removing element is an integrally formed, one-piece body made by removing material from a blank to form the cutting blade and inner shearing members.

A tissue-removing catheter includes a tissue-removing element operably connected to a drive shaft for rotation of the tissue-removing element about an axis of rotation in a cutting direction. The tissue-removing element is an integrally formed, one-piece body and has an annular tissue-removing head at the distal end of a tissue-removing element body. In some embodiments, primary tissue-removing components include an integrally formed cutting tooth and inner shearing member and are spaced angularly around the tissue-removing blade. Secondary tissue-removing components include cutting teeth and are interposed between the primary tissue-removing components around the tissue-removing blade. The tissue-removing element is made by removing material from a blank to form the primary and secondary tissue-removing components.

A device for crossing a lesion in a tissue lumen includes a crossing wire configured to pass through a lumen of a catheter, the crossing wire including a loop at a distal end of the crossing wire. The loop can have a configuration that prevents a width of the loop from exceeding a width of the tissue lumen, and the loop having a pair of lateral opposing portions configured for alignment with a wall of the tissue lumen and a leading portion interconnecting the pair of lateral opposing portions, the leading portion being configured to interrogate the lesion. The loop has a length in an axial direction of the crossing wire extending from the leading portion to proximal ends of the pair of lateral opposing portions, the length being perpendicular to the width, and the length of the loop is at least twice the width of the loop.

A tissue-removing catheter includes an elongate catheter body. The catheter body has a jogged portion that applies an urge force against a body lumen wall and urges a portion of the catheter body toward a portion of the body lumen wall. A tissue-removing element removes tissue from the body lumen during the cutting operation. The tissue-removing element is located generally adjacent the portion of the catheter body that is urged toward the body lumen wall by the logged portion. An urging mechanism selectively applies a compressive load to the catheter body to adjust the bending stiffness of the jogged portion and the urge force applied by the jogged portion.

A medical device is disclosed for cutting an object in a living body lumen. The medical device includes a rotatable elongate member, rotating member having a cutting portion cutting the object and disposed on the distal end side of the elongate member for rotating together with rotation of the elongate member; and a distal member having a guide portion disposed on the distal end side of the rotating member with a space left from the rotating member and a supporting portion which supports the guide portion and defines a dimension of the space in an axial direction of the elongate member. The guide portion is disposed at a position at which the guide portion overlaps with part of the cutting portion and exposes part of the cutting portion as viewed from the distal end side of the distal member.

A method and apparatus are disclosed for a needle for gaining access to the pericardial cavity of a heart. The needle includes an elongate member (e.g. a main shaft) defining a lumen and a side-port in fluid communication with the lumen; a blunt atraumatic tip for delivering energy for puncturing tissue; and a guiding surface (e.g. a ramp) for directing a device (e.g. a guidewire) through the side-port. The method includes using the needle for tenting a pericardium and delivering energy for puncturing the pericardium, and advancing a guidewire or other device through the needle and into the pericardial cavity.

An endoluminal punch system including a sheath and dilator. The endoluminal punch may include energy delivery system capable of being transmitted from the proximal end to the distal end of the endoluminal punch to assist with tissue crossing and incisions. The dilator may include selectively deployable cutting mechanism to create incisions in tissue that are larger than their basic external diameter. The system may also be configured to reduce the risk of generating plastic emboli during insertion of the endoluminal punch.