Abstract: An atherectomy device includes a catheter that is coupled to a handle. The catheter includes an outer sheath and a drive shaft carried within and rotatable relative to the outer sheath. A cutter assembly is coupled to and extends distally relative to the outer sheath. The cutter assembly includes a housing coupled to and extending distally from the outer sheath. A proximal cutting element is rotatably carried by the housing, and the proximal cutting element is coupled to and extends distally from the drive shaft. The proximal cutting element includes at least one proximal cutting blade, and the at least one proximal cutting blade has a negative rake angle. A distal cutting element is rotatable with the proximal cutting element relative to the housing. The distal cutting element includes at least one distal cutting blade, and the at least one distal cutting blade has a positive rake angle.

Abstract: An exemplary catheter includes a housing having the distal catheter region configured to be at least partially disposed in a body and the proximal catheter region configured to remain at least partially outside of the body. The catheter may define an imaging lumen configured to receive an imaging device, a guidewire lumen, an off-ramp, and an indicator lumen configured to receive an indicator that is detectable by the imaging device. The guidewire lumen is configured to receive a guidewire and includes a distal region and a proximal region. The off-ramp extends from the guidewire lumen at or near an intersection of the distal and proximal regions of the guidewire lumen. The catheter may also include one or more guidewire feeders configured to cause the guidewire to move from the proximal section to the off-ramp.

Abstract: An atherectomy device including a handle configured to be manipulated by a user. The device further includes a catheter comprising an outer sheath and a drive shaft carried within and rotatable relative to the outer sheath. A cutter assembly is coupled to and extends distally relative to the outer sheath. The cutter assembly includes a housing coupled to and extending distally from the outer sheath. A proximal cutting element is rotatably carried by the housing, and the proximal cutting element is coupled to and extends distally from the drive shaft. The proximal cutting element includes a cutting stem having at least one cutting feature and at least one cutting blade coupled to the cutting stem. A distal cutting element is carried by the cutting stem and is rotatable with the proximal cutting element relative to the housing. The distal cutting element includes at least one cutting blade.

Abstract: An atherectomy device (100) for removing occlusive material from the vasculature of a subject includes a sheath (116) and a drive shaft (216) disposed within the sheath. The drive shaft (216) couples to a cutting element (118). The drive shaft (216) is rotatable relative to the sheath (116) to rotate the cutting element (118). The drive shaft (216) and the sheath (116) define therebetween a material removal passageway (218) for receiving the occlusive material. The drive shaft (216) includes a coil (504) having an inner lumen (512). A jacket (516) is disposed outwardly of the coil (504), and the jacket (516) inhibits the occlusive material in the material removal passageway (218) from passing through the coil and entering the inner lumen (512).

Abstract: An atherectomy device including a handle configured to be manipulated by a user. The device further includes a catheter comprising an outer sheath and a drive shaft carried within and rotatable relative to the outer sheath. A cutter assembly is coupled to and extends distally relative to the outer sheath. The cutter assembly includes a housing coupled to and extending distally from the outer sheath. A proximal cutting element is rotatably carried by the housing, and the proximal cutting element is coupled to and extends distally from the drive shaft. The proximal cutting element includes a cutting stem having at least one cutting feature and at least one cutting blade coupled to the cutting stem. A distal cutting element is carried by the cutting stem and is rotatable with the proximal cutting element relative to the housing. The distal cutting element includes at least one cutting blade.

Abstract: An atherectomy device includes a cutter assembly. The cutter assembly includes a housing, and the housing includes a housing bearing surface. The cutter assembly also includes a cutting element rotatably and translatably carried by the housing. The cutting element includes at least one cutting blade configured to cut occlusive material upon rotation of the cutting element relative to the housing. The cutting element also includes a cutter bearing surface configured to engage the housing bearing surface. Upon the cutting element rotating relative to the housing and the at least one cutting blade cutting occlusive material, the cutting element translates distally relative to the housing until the cutter bearing surface engages the housing bearing surface.

Abstract: An atherectomy device includes an outer sheath and a drive shaft. The drive shaft is disposed within and rotatable relative to the outer sheath. The atherectomy device further includes a cutter assembly including a housing coupled to and extending distally from the outer sheath. The cutter assembly further includes a proximal cutting element rotatably carried by the housing. The proximal cutting element is coupled to and extends distally from the drive shaft, and the proximal cutting element includes at least one proximal cutting blade. The cutter assembly further includes a distal cutting element that is rotatable with the proximal cutting element relative to the housing. The distal cutting element includes a first distal cutting blade that has a first cutting edge and a second distal cutting blade that has a second cutting edge. The first and second cutting edges have different shapes.

Abstract: An atherectomy device includes a catheter that is coupled to a handle. The catheter includes an outer sheath and a drive shaft carried within and rotatable relative to the outer sheath. A cutter assembly is coupled to and extends distally relative to the outer sheath. The cutter assembly includes a housing coupled to and extending distally from the outer sheath. A proximal cutting element is rotatably carried by the housing, and the proximal cutting element is coupled to and extends distally from the drive shaft. The proximal cutting element includes at least one proximal cutting blade, and the at least one proximal cutting blade has a negative rake angle. A distal cutting element is rotatable with the proximal cutting element relative to the housing. The distal cutting element includes at least one distal cutting blade, and the at least one distal cutting blade has a positive rake angle.

Abstract: An atherectomy device includes a catheter, and the catheter includes an outer sheath. The outer sheath includes a proximal portion coupled to and extending distally relative to a handle, and the proximal portion defines a longitudinal axis of the catheter. The outer sheath also includes a distal portion coupled to and extending distally relative to the proximal portion, and the distal portion normally has a curved configuration and is offset from the longitudinal axis. The catheter further includes a drive shaft carried within and rotatable relative to the outer sheath. A cutter assembly is coupled to and extends distally relative to the distal portion of the outer sheath. A cutter is coupled to the drive shaft and rotates about a cutter rotation axis upon rotation of the drive shaft relative to the outer sheath. The cutter rotation axis is normally disposed at an acute angle relative to the longitudinal axis.

Abstract: In accordance with the present disclosure there is provided exemplary embodiments of an introducer sheath having a hub with an elongated tubular member extending from the hub. Disposed within the hub is a flexible valve member with a proximal surface and a distance surface and an aperture extending between the proximal surface and the distal surface. Both surfaces of the flexible valve member being parallel in a non-planar, retracted state and in a planar, relaxed state.

Abstract: In accordance with the present disclosure there is provided exemplary embodiments of an introducer sheath, wherein the introducer sheath may be formed of multiple components at least one of which may be integrally formed or resiliently assembled to form a single introducer sheath. One embodiment of the introducer sheath includes a hub and a flexible valve. The flexible valve member may be non-planar in a relaxed state.

Abstract: In accordance with the present invention there is provided exemplary embodiments of an introducer sheath in accordance with the present invention, wherein the introducer sheath of the present invention is formed of multiple components which are resiliently assembled to form a single introducer sheath. One embodiment of the introducer sheath includes a hub, a retaining member and an elongated tubular member. The hub has a lumen that has a groove. The elongated tubular member has a proximal end that includes a flared portion. The distal end of the retaining member is configured to be received in the groove formed in the lumen of the hub. The distal end of the retaining member contacts the flared portion of the tubular member when distal end of the retaining member is disposed in the groove such that the tubular member is retained within the lumen of the hub in a sealed engagement.

Abstract: In accordance with the present disclosure there is provided exemplary embodiments of an introducer sheath, wherein the introducer sheath may be formed of multiple components at least one of which may be integrally formed or resiliently assembled to form a single introducer sheath. One embodiment of the introducer sheath includes a hub and a flexible valve. The flexible valve member may be non-planar in a relaxed state.

Abstract: In accordance with the present invention there is provided exemplary embodiments of an introducer sheath in accordance with the present invention, wherein the introducer sheath of the present invention is formed of multiple components which are resiliently assembled to form a single introducer sheath. One embodiment of the introducer sheath includes a hub, a retaining member and an elongated tubular member. The hub has a lumen that has a groove. The elongated tubular member has a proximal end that includes a flared portion. The distal end of the retaining member is configured to be received in the groove formed in the lumen of the hub. The distal end of the retaining member contacts the flared portion of the tubular member when distal end of the retaining member is disposed in the groove such that the tubular member is retained within the lumen of the hub in a sealed engagement.

Abstract: A carrier strip is provided having at least one void therein adapted to firmly and releasably hold a tubular structure therein. The carrier strip is preferably formed of a flexible or resilient plastic and includes a surface for permanent labeling thereof. The voids may be formed in a variety of sizes in the same strip or, alternatively, strips having voids of uniform sizes can be joined together. Carrier strips may also be color coded and formed with a plurality of voids sized to accommodate several popular test tube sizes and configurations. Labeling surfaces are provided adjacent each void to facilitate individual identification of the test tube held therein. The carrier strip portion defining the voids may also be formed to completely or only partially encircle the tubular structure.