Patent Description:
This document pertains generally, but not by way of limitation, to atherectomy and thrombectomy systems and catheters.

Atherectomy and thrombectomy are procedures for removing plaques and thrombus from the vasculature. Plaques are more robust and anchored to the vessel walls relative to thrombus, which has a softer consistency and is more easily removed from the vessel.

In some examples, atherectomy catheters remove plaques from vessel walls through mechanical engagement and abrasion of plaques. The mechanical removal of plaques generates loose particulate matter within the vessel wall that increases the risk of emboli within the blood stream.

Similarly, in some examples, thrombectomy procedures remove thrombus from vessel walls through mechanical systems that mechanically engage and remove thrombus, for instance by cutting of the thrombus with one or more features at the end of a catheter. In still other examples, catheters include hydrodynamic features that generate streams of solution, such as saline, that engage with thrombus and hydrodynamically remove thrombus from the vessel walls. In yet other examples, solutions such as lytic medicants are delivered to thrombus within the vasculature, and the medicanis breakdown the thrombus.

In some examples, atherectomy catheters include cutters coupled with a drive shaft to mechanically abrade plaques. The drive shaft extends through an aspiration lumen. Effluent (infusion fluid including entrained particulate) flows around the drive shaft during use of the catheter including rotation of the drive shaft to accordingly rotate the cutters. In still other examples, guide wires are delivered through the drive shaft to a distal portion of the catheter and into the vasculature. The catheter is translated through the vasculature according to the track of the guide wire. Because the drive shaft is within the aspiration lumen the guide wire is also positioned within the aspiration lumen with the effluent during operation.

In this specification the non-SI unit 'psi' is used, which may be converted to the SI or metric unit according to the following conversions: <NUM> psi = <NUM>,<NUM> Kilopascal, <NUM> inch = <NUM>. Infusion fluid is delivered through an infusion lumen extending through the catheter body. The aspiration lumen also extends through the catheter body and is adjacent to the infusion lumen. The infusion fluid is delivered through the infusion lumen at an elevated pressure, for instance from <NUM> to <NUM> psi. The elevated pressure ensures the infusion fluid is delivered under pressure to the catheter distal portion for entrainment of particulate for eventual aspiration through the aspiration lumen and/or to provide for balanced inflows and outflows, as well as lubrication of moving components. <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT> disclose atherectomy devices of the prior art.

Claim <NUM> defines the invention and dependent claims disclose embodiments. No surgical methods are claimed. The disclosure is directed to several alternative designs, materials and methods of manufacturing medical device structures and assemblies, and uses thereof.

In one example, a matter elimination catheter is disclosed. The catheter includes a catheter body extending from a catheter proximal portion to a catheter distal portion. The catheter body includes an infusion lumen, an aspiration lumen fluidly isolated from the infusion lumen, and a septum of the catheter body interposed between the infusion and aspiration lumens. The catheter also includes a drive shaft within the infusion lumen and a guide wire lumen within the drive shaft. The drive shaft is configured to provide rotation near the catheter distal portion. The infusion lumen, the drive shaft and the guide wire lumen are fluidly separated from the aspiration lumen with the septum.

Additionally or alternatively, in another example, the septum spans the catheter body from a first portion of a catheter body side wall to a second portion of the catheter body side wall.

Additionally or alternatively, in another example, the catheter includes an outflow port near the catheter distal portion in communication with the infusion lumen near the catheter distal portion and an inflow port near the catheter distal portion in communication with the aspiration lumen near the catheter distal portion.

Additionally or alternatively, in another example, the catheter includes an infusion fluid source in communication with the infusion lumen and configured to provide a source of pressurized infusion fluid through the infusion lumen and the outflow port; and an aspiration source in communication with the aspiration lumen and configured to aspirate the infusion fluid with entrained matter and/or with blood as an aspirant dilutant through the inflow port and the aspiration lumen. In an operational mode the infusion fluid entrains matter from a vessel between the at least one outflow port and the inflow port, and the entrained matter and infusion fluid are delivered to the catheter proximal portion through the aspiration lumen. The infusion fluid may also maintain an isovolumetric treatment site so the vessel does not have a tendency to suck down or collapse with vacuum pressure, as well as provide lubrication to lubricate the cutter and the drive shaft, bearings, and other moving components.

Additionally or alternatively, in another example, in a pressurized configuration pressure of the infusion fluid within the infusion lumen is greater than pressure of the infusion fluid with entrained matter exterior of the aspiration lumen, and the infusion fluid with entrained matter is directed away from the drive shaft within the infusion lumen according to the pressure difference.

Additionally or alternatively, in another example, the catheter includes a guide wire liner within the guide wire lumen of the drive shaft, wherein the drive shaft is rotatable relative to the guide wire liner.

Additionally or alternatively, in another example, the catheter includes one or more fluid bearings isolated from the aspiration lumen and generated with pressurized infusion fluid delivered through the infusion lumen.

Additionally or alternatively, in another example, the one or more fluid bearings include one or more of fluid dynamic bearings or hydrostatic bearings.

Additionally or alternatively, in another example, the catheter includes at least one shaft fluid bearing interposed between the catheter body and the drive shaft in the infusion lumen, and the at least one shaft fluid bearing is generated with pressurized infusion fluid delivered through the infusion lumen.

Additionally or alternatively, in another example, the at least one shaft fluid bearing extends from the catheter proximal portion to the catheter distal portion.

Additionally or alternatively, in another example, the at least one shaft fluid bearing extends the length of the drive shaft.

Additionally or alternatively, in another example, the catheter includes at least one guide wire fluid bearing interposed between the drive shaft and at least one of a guide wire or a guide wire liner in the guide wire lumen, wherein the at least one guide wire fluid bearing is generated with pressurized infusion fluid delivered through the infusion lumen and penetrating the drive shaft.

Additionally or alternatively, in another example, the drive shaft is coupled to at least one rotatable cutter near the catheter distal portion, and the drive shaft and the at least one rotatable cutter are rotatable relative to the catheter body.

Additionally or alternatively, in another example, the catheter includes at least one cutter fluid bearing interposed between the rotatable cutter and the catheter body, wherein the at least one cutter fluid bearing is formed between a cutter interface and a catheter body interface with pressurized infusion fluid delivered from the infusion lumen.

Another example is a matter elimination catheter including a catheter body extending from a catheter proximal portion to a catheter distal portion. The catheter body includes an infusion lumen in fluid communication with at least one outflow port near the catheter distal portion, an aspiration lumen isolated from the infusion lumen, and a septum of the catheter body interposed between the infusion and aspiration lumens. The catheter also includes a drive shaft within the infusion lumen. The drive shaft is configured to provide rotation near the catheter distal portion. In an infusion configuration, an infusion fluid is delivered through the infusion lumen to the at least one outflow port and/or along the bearings, cutters, drive shaft or other rotatable catheter components in juxtaposition with static components. The drive shaft and a portion of the catheter body associated with the infusion lumen are configured to provide at least one shaft fluid bearing therebetween with the infusion fluid. The at least one outflow port is configured to provide a fluid barrier with the infusion fluid to prevent ingress of infusion fluid with entrained matter into the infusion lumen.

Additionally or alternatively, in another example, the catheter includes a manifold coupled to the catheter proximal portion. The manifold includes an infusion port configured to deliver infusion fluid to the infusion lumen and a diversion sleeve extending proximally relative to the infusion port, the drive shaft rotatably extending through the diversion sleeve.

Additionally or alternatively, in another example, in the infusion configuration the infusion fluid is directed distally over an exterior perimeter of the diversion sleeve, and at a distal end of the diversion sleeve a first portion of the infusion fluid flows distally through the infusion lumen toward the catheter distal portion and a second portion of the infusion fluid flows proximally along an interior perimeter of the diversion sleeve. The first and second portions are controlled by the dimensions between an inner diameter of the diversion sleeve and an outer diameter of the drive shaft.

Additionally or alternatively, in another example, the second portion of the infusion fluid forms a shaft fluid bearing between the diversion sleeve and the drive shaft.

Additionally or alternatively, in another example, the catheter includes a guide wire extending through the drive shaft, wherein the first portion of the infusion fluid forms a guide wire fluid bearing between the drive shaft and the guide wire extending through the drive shaft.

Additionally or alternatively, in another example, the catheter includes a guide wire liner extending through the drive shaft, wherein the first portion of the infusion fluid forms a guide wire fluid bearing between the drive shaft and the guide wire liner extending through the drive shaft.

The above summary of some example embodiments is not intended to describe each disclosed embodiment or every implementation of the aspects of the disclosure.

The aspects of the disclosure may be further understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:.

While the aspects of the disclosure are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

Definitions of certain terms are provided below and shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

Although some suitable dimensions, ranges and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.

As used in this specification and the appended claims, the singular forms "a," "an," and "the" include or otherwise refer to singular as well as plural referents, unless the content clearly dictates otherwise. Accordingly, the terms "a" or "an" are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of "at least one" or "one or more". As used in this specification and the appended claims, the term "or" is generally employed to include "and/or," unless the content clearly dictates otherwise. Accordingly, the term "or" is used to refer to a nonexclusive or, such that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise indicated. As used in this specification and the appending claims, the terms "including" and "comprising" are openended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim.

The present inventors have recognized, among other things, that a problem to be solved can include the fouling of the aspiration lumen with particulate matter including fibrin, plaques and thrombus. Fouling is particularly problematic with a drive shaft in the aspiration lumen as rotation of the drive shaft may be prevented. Still further, fouling may not prevent rotation of the drive shaft, but it may cause seizing of a guide wire by the drive shaft with the guide wire positioned in vasculature. Rotation of the seized guide wire within vasculature should be avoided.

In an example, the present subject matter can provide a solution to these and other problems, such as by isolating the drive shaft and a guide wire or guide wire liner within the drive shaft from the effluent within the aspiration lumen. In one example, the drive shaft and the guide wire lumen interior to the drive shaft extend through an infusion lumen that is isolated from the aspiration lumen where the effluent is directed during operation of a catheter. A septum between the aspiration and infusion lumens isolates the drive shaft. Infusion fluid delivered along the infusion lumen is clean (e.g., without particulate, such as fibrin, that may cause seizing of the drive shaft) and lubricates the drive shaft to facilitate rotation without the risk of fouling. Suitable infusion fluids include, but are not limited to, saline. Other suitable infusion fluids which are lubricants made for rotational atherectomy devices include Rotaglide® and Viperslide®. In certain embodiments, the infusion includes a medicament, such as, but not limited to, anti-restenosis or anti-thrombosis medicaments. Similarly, by isolating the guide wire and a guide wire lumen from the effluent the seizing of the guide wire by the drive shaft is substantially prevented. Further, the clean infusion fluid provides a lubricant to facilitate the movement of the catheter relative to the guide wire.

Further still, the infusion fluid is delivered at an elevated pressure, for instance <NUM> to <NUM> psi (<NUM> to <NUM> psi or <NUM> to <NUM> psi). The pressurized and clean infusion fluid is delivered along the length of the drive shaft within the infusion lumen. The infusion fluid is eventually delivered through one or more outflow ports near a catheter distal portion. In one example, the outflow ports are dedicated ports that provide a cyclical flow of fluid configured to entrain loose particulate for eventual delivery to an inflow port of the aspiration lumen. In another example, the outflow ports include virtual ports provided between rotating features of the catheter, such as the interfaces of the catheter body (e.g., between one or more of catheter body material, saddle or a fitting) and the rotatable cutters. As described herein the infusion fluid provides a fluid barrier at these outflow ports. The outflow of infusion fluid from the outflow ports generates a fluid barrier that substantially prevents the ingress of particulate (e.g., thrombus or plaques) into the infusion lumen. In one example, the fluid barriers are generated by a pressure differential between the infusion fluid in the infusion lumen and the effluent outside of the infusion lumen. Accordingly, in another example, the drive shaft and a guide wire therein are substantially protected from fouling through a combination of the isolation of the infusion lumen from the aspiration lumen and the fluid barrier at each of the outflow ports. Furthermore, in some instances the cutting action may be enhanced by the action of displacing particles and reducing heat friction with the infusion fluid.

The present inventors have further recognized, among other things, that a problem to be solved can include minimization of rotational friction between a rotating drive shaft of a catheter and one or more of the catheter body and a guide wire. As described above, translational and rotational friction, including seizing of a guide wire is a negative outcome. Accordingly, minimizing translational and rotational friction for both the drive shaft and the guide wire caused by one or more of mechanical engagement of features (e.g., drive shaft to guide wire or catheter body) or effluent including particulate is desired.

In an example, the present subject matter can provide a solution to this problem, such as by isolating the drive shaft and a guide wire or guide wire liner within the drive shaft from the effluent and providing a flow of clean infusion fluid that may also act as a lubricant. As described herein, the drive shaft and guide wire lumen within the drive shaft are isolated from an aspiration lumen by placement within an infusion lumen. The pressurized flow of "clean" infusion fluid along the length of the drive shaft and the guide wire lubricates both the drive shaft and the guide wire and facilitates translation and/or rotation of both (e.g., relative to each other and the catheter body).

In addition to the provision of a clean lubricant, the drive shaft and the guide wire (or guide wire lumen liner) are both subject to pressurized infusion fluid that forms at least one fluid bearing (e.g., fluid dynamic bearings or hydrostatic bearings) extending between and optionally including moving portions of the catheter distal end, such as a rotating cutter (e.g., a one or more of a first cutter and a second cutter); or locations where prevention of ingress of effluent is desired. For instance, a fluid bearing of the drive shaft extends from the catheter proximal portion to the termination of the drive shaft near the catheter distal portion. The infusion fluid is positioned between the drive shaft and the catheter body, and penetrates the drive shaft under pressure to provide a fluid bearing between the drive shaft interior and a guide wire and/or guide wire liner. The resulting at least one fluid bearing facilitates rotation and/or translation of the drive shaft and the guide wire even in the most tortuous of vasculature. Further, the at least one fluid bearing facilitates the easy translation of the catheter over the guide wire or the converse. Additionally, at least one fluid bearing prevents the transmission of rotation from the drive shaft to the guide wire and thereby minimizes rotation of the guide wire within vasculature. The fluid bearings reduce the need for precise machining and maintenance of mechanical bearings needed with rotational features, such as cutters, in other designs.

Moreover, as described above, the high pressure infusion fluid used to infuse and lubricate is delivered to one or more rotatable cutters near the catheter distal portion. The infusion fluid is directed between interfaces of the cutters and the catheter body (e.g., catheter body material, fittings, or the like). The infusion fluid provides a lubricant layer and fluid bearing at these interfaces to facilitate the rotation of the cutters and substantially prevent the transmission of rotation or seizing of the cutters by engagement with the catheter tube, sleeves, or the like with the cutters.

The lubrication of the interfaces between the drive shaft, the catheter body and one or more of a guide wire or guide wire liner facilitates a minimized construction for the proximal manifold of the system including the infusion and aspiration ports and the motor coupled with the drive shaft. For instance, multiple speed configurations and controls for the same can be removed as seizing of the drive shaft on the guide wire is eliminated (minimized or eliminated) in favor of reliable operation of the drive shaft to rotate the cutters at a desired speed. Additionally, anchoring features including, but not limited to, clamps, septums and the like used to grasp a guide wire and prevent movement, such as rotation, of the guide wire are obviated with the isolation of the drive shaft and the guide wire in the infusion lumen and the provision of one or more fluid bearings as provided herein. In one example, the manifold of the system includes the infusion and aspiration ports coupled with the corresponding infusion fluid and aspiration sources, a motor coupled with the drive shaft (e.g., by a pinion gear), and an optional Tuohy-Borst adapter for the introduction of the guide wire to the infusion lumen and the guide wire lumen of the drive shaft.

The optional Tuohy-Borst adapter assists in priming the guide wire lumen (e.g., within the drive shaft) in a construction using the guide wire liner (described herein). The need for rotational guide wire exchange (REX), an exchange technique using a lower rotation speed when a physician wants to move an atherectomy catheter on a guide wire (e.g., to prevent disturbance or damage to tissue), is eliminated with the fluid bearings as described herein. The fluid bearings provide a fluid interface between the guide wire lumen of the drive shaft and the liner (or alternatively between the drive shaft and the guide wire if no liner is present) to accordingly facilitate the sliding exchange of a guide wire relative to the catheter. In another example, a dedicated guide wire liner is self-priming with the guide wire by penetrating an orifice at a point along the guide wire liner so high pressure fluid (e.g., saline, lubricant, and/or medicament) bleeds through the orifice to continually fill the ID of the guide wire liner with saline and/or lubricant, such as Rotaglide® or Viperslide®, The orifice is optionally located near a distal portion of the catheter (e.g., distal to the drive shaft) to minimize risk of a structural failure of a non-rotatable feature. In other words, any failure would occur distally of the drive shaft and accordingly not result in seizing and transmission of rotation to the guide wire.

Further still, a catheter including a septum in the catheter body that divides the infusion and aspiration lumens is more efficient with regard to infusion aspiration capacities because the resulting dual lumens (divided by the septum) provide additional cross sectional area for each lumen relative to a corresponding catheter having coaxial lumens (e.g., an infusion tube within an aspiration lumen or the converse). Additional efficiencies are realized because movement of the higher viscosity particulate entrained effluent (relative to just the infusion fluid) is not resisted by rotation of the drive shaft. Instead, the effluent is isolated from the rotating drive shaft and accordingly free to move along the catheter body without rotational resistance from the drive shaft. Similarly, the drive shaft is not slowed by passage of the effluent including the entrained particulate. Instead, the drive shaft is bathed by the infusion fluid in the infusion lumen, and the infusion fluid has a lower viscosity and that accordingly minimizes rotational resistance for the drive shaft. In this manner the energy supplied and consumed by a catheter incorporating these features is conserved and optimally used (e.g., for the provision of rotation, infusion and aspiration).

In another example, the dual lumen catheter body includes the septum spanning the catheter body. The catheter body including the septum provides greater structural integrity provides enhanced pushability. Furthermore, the structural integrity is realized in a cost effective fashion as the catheter body is extruded from polymer and optionally includes a braid, as opposed to a laser cut tube. Expensive and labor intensive inner and outer sheaths are accordingly avoided.

Furthermore, providing a dual lumen tube negates the possible pinching effect encountered with sheaths in existing devices which can close off infusion fluid being delivered to the distal tip of the device, and in certain circumstances may lead to ballooning of the outer sheath and possible burst of the weakened area.

Now referring to <FIG> and the associated cross-sectional view of <FIG>, there is illustrated a proximal end region of an exemplary matter elimination catheter <NUM>. The proximal end region of the catheter <NUM> may include a manifold <NUM> attached to a proximal end of an elongate shaft <NUM>, with the elongate shaft <NUM> extending distally therefrom.

The elongate shaft <NUM> may include a catheter body <NUM> having a proximal end extending into and secured to the manifold <NUM>. For example, a bond region <NUM> between the catheter body <NUM> and the manifold <NUM>, shown in <FIG>, may secure the catheter body <NUM> to the manifold <NUM>. For example, proximal end of the catheter body <NUM> may be adhesively bonded, thermally bonded, mechanically coupled or otherwise secured to the manifold at the bond region <NUM>.

The catheter body <NUM> may include one or more, or a plurality of lumens extending therethrough. For example, the catheter body <NUM> may include an infusion lumen and an aspiration lumen fluidly isolated from the infusion lumen, as well as one or more additional lumens, if desired. As shown in <FIG>, in some instances the catheter body <NUM> may be a dual lumen extruded tubular member defining an infusion lumen <NUM> and an aspiration lumen <NUM> fluidly isolated from the infusion lumen <NUM>. Thus, the catheter body <NUM> may be a monolithic structure including both an infusion lumen <NUM> and an aspiration lumen <NUM> extending therethrough.

The catheter body <NUM> may include a septum <NUM> spanning across the catheter body <NUM> to divide the interior space of the catheter body <NUM> into infusion lumen <NUM> and the aspiration lumen <NUM>. For example, the septum <NUM> may span from the annular outer wall of the catheter body <NUM> on one side of the catheter body <NUM> to the annular outer wall of the catheter body <NUM> on an opposite side of the catheter body <NUM>. Thus, a first surface <NUM> of the septum <NUM> may partially define the infusion lumen <NUM> along with a first portion of the inner surface of the annular outer wall of the catheter body <NUM>, while a second surface <NUM> of the septum <NUM> may partially define the aspiration lumen <NUM> along with a second portion of the inner surface of the annular outer wall of the catheter body <NUM>.

In some instances, as shown in <FIG>, the septum <NUM> may have a bowed or arcuate configuration such that one of the first and second surfaces <NUM>, <NUM> of the septum <NUM> is convex while the other of the first and second surfaces <NUM>, <NUM> of the septum <NUM> is concave. For example, the first surface <NUM> of the septum <NUM> may be concave such that the infusion lumen <NUM> may have a generally elliptical or oval shape, while the second surface <NUM> of the septum <NUM> may be convex such that the aspiration lumen <NUM> may have a generally crescent shape. In other embodiments, the curvature of the septum <NUM> may be reversed, in which case the shapes of the infusion lumen <NUM> and the aspiration lumen <NUM> may also be reversed. In yet other embodiments, the septum <NUM> may be planar, with opposing flat surfaces.

Referring to <FIG> and <FIG>, the manifold <NUM> may include an infusion port <NUM> in fluid communication with the infusion lumen <NUM> for delivering an infusion fluid through the infusion lumen <NUM> to the distal end of the elongate shaft <NUM>. In some instances, a first Y-adapter may provide the infusion port <NUM>. A source of infusion fluid may be coupled to the infusion port <NUM> during operation of the catheter <NUM>.

Referring to <FIG> and <FIG>, the manifold <NUM> may also include an aspiration port <NUM> in fluid communication with the aspiration lumen <NUM> for withdrawing effluent through the aspiration lumen <NUM> from the distal end of the elongate shaft <NUM>. For example, a proximal portion of the catheter body <NUM> within the manifold <NUM> may be skived to provide a fluid pathway between the aspiration lumen <NUM> and the aspiration port <NUM>, leaving the septum <NUM> and portion of the catheter body <NUM> defining the infusion lumen <NUM> extending further proximal of the aspiration port <NUM>. The septum <NUM> and portion of the catheter body <NUM> defining the infusion lumen <NUM> proximal of the aspiration port <NUM> may be secured to the manifold <NUM> at a bond location <NUM> proximal of the aspiration port <NUM> and the aspiration lumen <NUM>. The bond location <NUM> may isolate infusion fluid entering the infusion lumen <NUM> of the catheter body <NUM> through the infusion port <NUM> from effluent exiting the aspiration lumen <NUM> of the catheter body <NUM> through the aspiration port <NUM>. In some instances, a second Y-adapter may provide the aspiration port <NUM>. A vacuum source may be coupled to the aspiration port <NUM> during operation of the catheter <NUM> to draw a vacuum through the aspiration lumen <NUM>.

As shown in <FIG>, <FIG> and <FIG>, the elongate shaft <NUM> may also include a drive shaft <NUM> extending through a lumen of the catheter body <NUM>. For example, the drive shaft <NUM> may extend through the infusion lumen <NUM>, and thus be isolated from the aspiration lumen <NUM> and effluent passing through the aspiration lumen <NUM>. In some instances, the drive shaft <NUM>, or a portion thereof, may include a coiled member formed of one or more tight wound filaments and/or a solid-walled tubular member. In some instances, a proximal portion of the drive shaft <NUM> may be formed of a solid-walled tubular member <NUM> and a distal portion of the drive shaft <NUM> may be formed of a coiled member <NUM> secured to the solid-walled tubular member <NUM>, as shown in <FIG>. For instance, a proximal end of the coiled member <NUM> may be secured to a distal end of the solid-walled tubular member <NUM> at a joint, such as a butt joint, or a lap joint (e.g., the proximal end of the coiled member <NUM> may extend into the lumen of the solid-walled tubular member <NUM>, or vice versa). In some instances, a sleeve <NUM> may extend across the joint, surrounding both the proximal end of the coiled member <NUM> and the distal end of the solid-walled tubular member <NUM>, and secured thereto. The sleeve <NUM> may extend along any length of the coiled member <NUM> and/or the solid-walled tubular member <NUM>, as desired.

The drive shaft <NUM> may be rotatable and/or axially translatable within the infusion lumen <NUM> of the catheter body <NUM>. For example, the matter elimination catheter <NUM> may include a prime mover (not shown) to provide rotational motion to the drive shaft <NUM> to rotate a cutting member positioned at the distal end of the elongate shaft <NUM>. For example, in some instances the prime mover may be an electrical motor, a fluid turbine, or the like. A controller (not shown) may be used to control the prime mover. For example, the user may provide power to the prime mover and/or control the speed of rotation of the drive shaft <NUM> via a controller. In the illustrated embodiment, a pinion gear <NUM> may be secured to the drive shaft <NUM> to transfer rotational motion from the prime mover to the drive shaft <NUM>. For example, the pinion gear <NUM> may be secured to a pinion shaft <NUM>, which is secured to the drive shaft <NUM> such that rotation of the pinion gear <NUM> and pinion shaft <NUM> causes rotation of the drive shaft <NUM> within the catheter body <NUM>.

In some embodiments, the lumen of the drive shaft <NUM> may define the guide wire lumen <NUM> extending through the drive shaft <NUM>. However, in other embodiments, a guide wire liner <NUM> may extend through the lumen of the drive shaft <NUM> to define the guide wire lumen <NUM>, as shown in the illustrated embodiment. The guide wire liner <NUM> may be a thin walled tubular member creating an interface between the inner surface of the drive shaft <NUM> and the guide wire extending through the guide wire lumen <NUM>. The guide wire liner <NUM> may be positioned with the lumen of the drive shaft <NUM> such that the guide wire liner <NUM> remains stationary as the drive shaft <NUM> rotates during operation of the catheter <NUM>. Accordingly, there is no relative rotational movement between the guide wire and the component directly surrounding the guide wire (e.g., the guide wire liner <NUM>) during operation of the catheter <NUM>. As shown in the illustrated embodiment, the guide wire liner <NUM> may extend the entire length of the drive shaft <NUM>, and may extend proximal of the proximal end of the drive shaft <NUM> and/or may extend distal of the distal end of the drive shaft <NUM>.

The drive shaft <NUM>, such as the solid-walled tubular member <NUM> (e.g., a stainless steel hypotube), may extend into and/or through a distal seal tube <NUM>, shown in <FIG>, <FIG> and <FIG>. The distal seal tube <NUM> may be a polymeric tubular member, such as a polyimide tubular member, in some instances. The distal seal tube <NUM> may be secured to the manifold <NUM> at a bond location <NUM>. Accordingly, the drive shaft <NUM> may be rotatable relative to the distal seal tube <NUM> and the manifold <NUM>. A tight tolerance may be maintained between the outer surface of the drive shaft <NUM> and the inner surface of the distal seal tube <NUM> to provide a hydraulic seal therebetween. Thus, infusion fluid introduced through the infusion port <NUM> may not escape and/or air may not enter through the clearance between the drive shaft <NUM> and the distal seal tube <NUM>.

As shown in <FIG>, the catheter <NUM> may also include an adapter <NUM>, such as a Tuohy-Borst adapter, coupled to a proximal end of the drive shaft <NUM> and/or guide wire liner <NUM>, if present. For instance, the proximal end of the drive shaft <NUM> and/or the proximal end of the guide wire liner <NUM> may extend into the adapter <NUM>. As shown, the guide wire liner <NUM> may extend proximal of the proximal end of the drive shaft <NUM> and be secured to the adapter <NUM> at a bond location <NUM>. The adapter <NUM> may include a guide wire port <NUM> providing guide wire access to the guide wire lumen <NUM>. The adapter <NUM> may also include a side or auxiliary access port <NUM> for access to the guide wire lumen <NUM>.

The adapter <NUM> may include a guide wire director <NUM> to facilitate positioning a guide wire into the guide wire lumen <NUM>. For example, the guide wire director <NUM> may include a tapered or conical bore arranged to direct a guide wire into the guide wire lumen <NUM>. Although not shown, the adapter <NUM> may include a hemostasis valve to create a fluid seal around a guide wire inserted into the guide wire lumen <NUM>.

Furthermore, the drive shaft <NUM>, such as the solid-walled tubular member <NUM>, may extend into and/or through a proximal seal tube <NUM>, shown in <FIG>. The proximal seal tube <NUM> may be a polymeric tubular member, such as a polyimide tubular member, in some instances. The proximal seal tube <NUM> may be secured to the adapter <NUM> at a bond location <NUM>. Accordingly, the drive shaft <NUM> may be rotatable relative to the proximal seal tube <NUM> and the adapter <NUM>. A tight tolerance may be maintained between the outer surface of the drive shaft <NUM> and the inner surface of the proximal seal tube <NUM> to provide a hydraulic seal therebetween.

In some instances, the proximal seal tube <NUM>, or another tubular member surrounding the drive shaft <NUM>, may serve as a diversion sleeve for diverting infusion fluid distally along the drive shaft <NUM>. The proximal seal tube <NUM> (or other tubular member), which may extend proximally relative to the infusion port <NUM>, may extend along the drive shaft <NUM> for a distance distal of the infusion port <NUM>. In some instances, the proximal seal tube <NUM> (or other tubular member) serving as a diversion sleeve may extend along the drive shaft <NUM> distal of the infusion port <NUM> any desired length, such as about <NUM> inch (<NUM>) or less, about <NUM> inches (<NUM>) or less, about <NUM> inches (<NUM>) or less, or about <NUM> inches (<NUM>) or less, although other lengths may also be used. Accordingly, infusion fluid introduced through the infusion port <NUM> may be directed distally over an exterior perimeter of the diversion sleeve (e.g., the proximal seal tube <NUM>) up to the distal end of the diversion sleeve, at which point a first portion of the infusion fluid flows distally through the infusion lumen <NUM> toward the distal end region of the catheter <NUM> and a second portion of the infusion fluid flows proximally along an interior perimeter of the diversion sleeve (e.g., the proximal seal tube <NUM>) between the drive shaft <NUM> and the diversion sleeve (e.g., the proximal seal tube <NUM>). The distribution of infusion fluid between the first and second portions may be controlled by the length of the diversion sleeve distal of the infusion port <NUM> and/or the dimensions (e.g., tolerance) between the inner diameter of the diversion sleeve and the outer diameter of the drive shaft <NUM>. The first portion of the infusion fluid may provide a fluid bearing between a guide wire or the guide wire liner <NUM> and the drive shaft <NUM>, while the second portion of infusion fluid may provide a fluid bearing between the drive shaft <NUM> and the diversion sleeve (e.g., the proximal seal tube <NUM>).

In some instances, the manifold <NUM>, including the infusion port <NUM> and the aspiration port <NUM>, may be considered a distal manifold assembly and the adapter <NUM>, providing the guide wire port <NUM>, may be considered a proximal manifold assembly. The pinion gear <NUM> and pinion shaft <NUM> may be positioned between the distal manifold assembly (e.g., manifold <NUM>) and the proximal manifold assembly (e.g., adapter <NUM>), and rotatable relative to both the manifold <NUM> and the adapter <NUM>.

An exemplary distal end region of the catheter <NUM> is illustrated at <FIG> and <FIG>. The distal end region of the catheter <NUM> may include a rotatable cutting member <NUM> positioned at the distal end of the elongate shaft <NUM>. The cutting member <NUM> may be secured to the distal end of the drive shaft <NUM>, and thus rotated through rotation of the drive shaft <NUM>. For example, the distal end of the drive shaft <NUM> may extend into a bore of a proximal neck <NUM> of the cutting member <NUM> and be fixedly secured thereto, such as by welding, adhesive, interference fit, or the like. The cutting member <NUM> may include one or more flutes having a cutting edge for removing occlusive material from a body lumen. In other instances, the cutting member <NUM> may be a burr having an abrasive surface, such as a diamond coated abrasive surface, or the cutting member <NUM> may be of another construction for abrading or cutting occlusive material. In some instances, the cutting member <NUM> may be positioned distal of the catheter body <NUM>. In other instances, the cutting member <NUM>, or a portion thereof, may be positioned within the distal end region of the catheter body <NUM>, if desired.

In some instances, the cutting member <NUM> may be rotatably coupled to the catheter body <NUM>. For example, as shown in <FIG> and <FIG>, a coupling assembly may be provided at the distal end region of the elongate shaft <NUM> to permit rotation between the cutting member <NUM>/drive shaft <NUM> and the catheter body <NUM>. For example, the coupling assembly may include a saddle <NUM> at the distal end of the catheter body <NUM> and a retaining ring <NUM> secured to the drive shaft <NUM>. The saddle <NUM> may be an integral portion of the catheter body <NUM>, or a separate component secured thereto. The saddle <NUM> may be fixedly secured to the distal end of the catheter body <NUM> by welding, crimping, adhesive, interference fit, or the lit. Similarly, the retaining ring <NUM> may be fixedly secured to the drive shaft <NUM>, such as the outer surface of the drive shaft <NUM>, by welding, crimping, adhesive, interference fit, or the like. The saddle <NUM> and the retaining ring <NUM> may be formed of any desired material, such as stainless steel, titanium, tungsten, or other metallic material, although polymeric or ceramic materials, as well as other materials may also be used if desired. The saddle <NUM> may be configured to constrain proximal and distal movement of the cutting member <NUM> relative to the catheter body <NUM> while permitting rotational movement of the cutting member <NUM> relative to the catheter body <NUM>. For example, the neck portion <NUM> of the cutting member <NUM> may extend into the saddle <NUM> such that a stop surface of the neck portion <NUM> engages with a stop surface (e.g., distal flange) of the saddle <NUM> to inhibit proximal movement of the cutting member <NUM> relative to the catheter body <NUM>. In some instances, the saddle <NUM> may serve as a guide or bearing to maintain alignment between the cutting member <NUM> and the catheter body <NUM>. Furthermore, the retaining ring <NUM> may be fixedly secured to the drive shaft <NUM> proximal of the saddle <NUM> such that a stop surface of the retaining ring <NUM> engages with a stop surface (e.g., proximal flange) of the saddle <NUM> to inhibit distal movement of the drive shaft <NUM>, and thus the cutting member <NUM>, relative to the catheter body <NUM>.

The saddle <NUM> may be fixedly secured to the catheter body <NUM> in any desired way. For example, the saddle <NUM> may be adhesively bonded and/or mechanically engaged to the catheter body <NUM>. In the illustrative embodiment, a radiopaque marker ring <NUM> may be crimped around a portion of the catheter body <NUM> overlaying a reduced diameter portion (e.g., an annular groove) of the saddle <NUM> to secure the catheter body <NUM> to the saddle <NUM>.

The cutting member <NUM> may include a distal opening <NUM> aligned with the guide wire lumen <NUM> to permit a guide wire to pass therethrough into the guide wire lumen <NUM>. The guide wire liner <NUM>, if present, may extend through the drive shaft <NUM> to define the guide wire lumen <NUM>. The guide wire liner <NUM> may extend distal of the distal end of the drive shaft <NUM> into the bore of the cutting member <NUM> to form an interface between the cutting member <NUM> and a guide wire extending through the guide wire lumen <NUM>. The bore of the cutting member <NUM> may have a diameter slightly larger than the outer diameter of the guide wire liner <NUM> to provide a clearance for infusion fluid to pass therebetween to lubricate the guide wire, as will be further discussed herein. The guide wire liner <NUM> may remain stationary as the cutting member <NUM> is rotated. Thus, the cutting member <NUM> is rotatable relative to the guide wire liner <NUM> during operation, such that the guide wire is isolated from direct contact with the rotating cutting member <NUM> except at the distal opening <NUM> of the cutting member <NUM>.

The distal end region of the elongate shaft <NUM> may include one or more, or a plurality of aspiration or inflow ports for aspirating effluent into the aspiration lumen <NUM> of the catheter body <NUM>. For example, the distal end region of the catheter body <NUM> may include an inflow port <NUM> opening into the aspiration lumen <NUM>. As shown in <FIG>, the inflow port <NUM> may open into the aspiration lumen <NUM> through a sidewall of the catheter body <NUM>. The septum <NUM> may isolate the drive shaft <NUM>, extending through the infusion lumen <NUM> from effluent passing into the aspiration lumen <NUM>. Furthermore, <FIG> illustrates that within the distal end region, the septum <NUM> may have a bowed or arcuate configuration such that one of the first and second surfaces <NUM>, <NUM> of the septum <NUM> is convex while the other of the first and second surfaces <NUM>, <NUM> of the septum <NUM> is concave. For example, the first surface <NUM> of the septum <NUM> may be concave such that the infusion lumen <NUM> may have a generally elliptical or oval shape, while the second surface <NUM> of the septum <NUM> may be convex such that the aspiration lumen <NUM> may have a generally crescent shape. In other embodiments, the curvature of the septum <NUM> may be reversed, in which case the shapes of the infusion lumen <NUM> and the aspiration lumen <NUM> may also be reversed. In yet other embodiments, the septum <NUM> may be planar, with opposing flat surfaces.

<FIG> illustrates exemplary flow paths of an infusion fluid and an effluent at the distal end region of the catheter <NUM> shown in <FIG>. A pressurized infusion fluid (e.g., saline, Rotoglide, etc.), from an infusion fluid source (e.g., saline bag, etc.) in fluid communication with the infusion lumen <NUM>, may pass through the infusion lumen <NUM> and be in direct contact with the drive shaft <NUM>. In some instances, the infusion fluid may penetrate between adjacent coils of the drive shaft <NUM> such that infusion fluid is located within the lumen of the drive shaft <NUM>, such as between the outer surface of the guide wire liner <NUM> and the inner surface of the drive shaft <NUM>, or between the outer surface of a guide wire and the inner surface of the drive shaft <NUM> (when no guide wire liner <NUM> is present), as well as along an exterior of the drive shaft <NUM> (i.e., between the outer surface of the drive shaft <NUM> and the inner surface of the infusion lumen <NUM>. In some instances, the infusion fluid may provide one or more fluid bearings between components of the catheter <NUM>. The fluid bearings may be fluid dynamic bearings or hydrostatic bearings, for example.

The pressurized infusion fluid through the infusion lumen <NUM> interposed between the drive shaft <NUM> and the catheter body <NUM> may form a shaft fluid bearing between the drive shaft <NUM> and the catheter body <NUM> (i.e., between the outer surface of the drive shaft <NUM> and the inner surface of the infusion lumen <NUM>). The shaft fluid bearing may extend from the catheter proximal portion near the manifold <NUM> to the catheter distal portion near the distal end of the drive shaft <NUM>. For example, the shaft fluid bearing may extend along the length of the drive shaft <NUM>.

The pressurized infusion fluid through the infusion lumen <NUM> interposed between the guide wire liner <NUM> or a guide wire in the guide wire lumen <NUM> and the drive shaft <NUM> may form a guide wire fluid bearing between the outer surface of the guide wire liner <NUM> or a guide wire and the inner surface of the drive shaft <NUM>. The guide wire fluid bearing may extend from the catheter proximal portion near the manifold <NUM> to the catheter distal portion near the distal end of the drive shaft <NUM>. For example, the guide wire fluid bearing may extend along the length of the drive shaft <NUM>.

The infusion fluid may exit the distal end region of the catheter <NUM> at one or more outflow ports. For example, as shown with the arrows in <FIG>, infusion fluid may pass through a clearance gap between the outer surface of the guide wire liner <NUM> and the inner surface of the bore through the cutting member <NUM> and out the distal opening <NUM>. Additionally or alternatively, infusion fluid may pass between the retaining ring <NUM> and the catheter body <NUM>, between the retaining ring <NUM> and the saddle <NUM>, between the saddle <NUM> and the drive shaft <NUM> and/or between the cutting member <NUM> (e.g., the neck <NUM>) and the saddle <NUM>, and exit through a clearance gap between the cutting member <NUM> and the saddle <NUM>. The pressurized infusion fluid may form a fluid bearing between one or more of these structures, such as between one or more of the guide wire liner <NUM>, guide wire, cutting member <NUM>, saddle <NUM>, retaining ring <NUM>, drive shaft <NUM>, and catheter body <NUM>. For example, pressurized fluid through the infusion lumen <NUM> interposed between the cutting member <NUM> and the catheter body <NUM> (e.g., saddle <NUM>) may form a cutter fluid bearing between the cutting member <NUM> (e.g., neck <NUM>) and the catheter body <NUM> (e.g., saddle <NUM>) ), and/or pressurized fluid through the infusion lumen <NUM> interposed between the cutting member <NUM> and the guide wire liner <NUM> or guide wire may form a cutter fluid bearing between the cutting member <NUM> and the guide wire liner <NUM> or guide wire extending through the bore of the cutting member <NUM>.

In some instances, such as shown in <FIG>, the guide wire liner <NUM> may include one or more, or a plurality of orifices <NUM> extending through the sidewall of the guidewire liner <NUM>. Although three orifices <NUM> are shown, in other embodiments the guide wire liner <NUM> may include one, two, four, five, or more orifices arranged at any desired location along the guide wire liner <NUM>. The orifice(s) may be provided so high pressure fluid (e.g., saline, lubricant, and/or medicament) within the infusion lumen <NUM> passes (e.g., weeps, oozes, drips, sprays, bleeds, etc.) through the orifice <NUM> to continually fill the lumen of the guide wire liner <NUM> with saline and/or lubricant, such as Rotoglide. Arrows shown in <FIG> illustrate infusion fluid passing through the orifices <NUM> into the guide wire lumen <NUM> defined by the guide wire liner <NUM>. Infusion fluid passing into the lumen of the guide wire liner <NUM> may help lubricate the guide wire extending therethrough, for example. One or more of the orifices <NUM> may optionally be located near a distal portion of the catheter <NUM> (e.g., distal to the drive shaft <NUM> and/or within the bore of the cutting member <NUM>).

Furthermore, the pressurized infusion fluid may provide a fluid barrier to prevent ingress of effluent, including particulates such as fibrin, from entering the distal end region of the catheter <NUM> through the distal opening <NUM>, between the outer surface of the guide wire liner <NUM> and the inner surface of the bore through the cutting member <NUM>, between the cutting member <NUM> (e.g., the neck <NUM>) and the saddle <NUM> or other clearance gap between one or more of the guide wire liner <NUM>, guide wire, cutting member <NUM>, saddle <NUM>, retaining ring <NUM>, drive shaft <NUM>, and catheter body <NUM>. In other words, the pressure gradient between the pressurized infusion fluid within the distal end region of the catheter <NUM> and the pressure within the body lumen may permit infusion fluid to exit through one or more of these pathways, while preventing effluent to enter the distal end region of the catheter <NUM> through one or more of these pathways.

Also shown in <FIG>, a vacuum may be drawn through the aspiration lumen <NUM> via an aspiration source (e.g., pump) in communication with the aspiration lumen <NUM> to draw effluent (e.g., infusion fluid and entrained particulates) into the aspiration lumen <NUM> through the aspiration or inflow port <NUM>. The effluent is isolated from the drive shaft <NUM> via the septum <NUM>. Therefore, the drive shaft <NUM> may be continuously covered with the infusion fluid, while not being fouled with particulates from the effluent.

An alternative distal end region of the catheter <NUM> is illustrated at <FIG> and <FIG>. The distal end region shown in <FIG> and <FIG> may be similar to the distal end region of the catheter <NUM> shown in <FIG> and <FIG> in many respects, with the exception of features noted below. For instance, the cutting member <NUM> may be rotatably coupled to the catheter body <NUM> via a coupling assembly provided at the distal end region of the elongate shaft <NUM> to permit rotation between the cutting member <NUM>/drive shaft <NUM> and the catheter body <NUM>. For example, the coupling assembly may include a saddle <NUM> at the distal end of the catheter body <NUM> and a retaining ring <NUM> secured to the drive shaft <NUM>. Additionally, the cutting member <NUM> may include a distal opening <NUM> aligned with the guide wire lumen <NUM> to permit a guide wire to pass therethrough into the guide wire lumen <NUM>. The guide wire liner <NUM>, if present, may extend through the drive shaft <NUM> to define the guide wire lumen <NUM>. The guide wire liner <NUM> may extend distal of the distal end of the drive shaft <NUM> into the bore of the cutting member <NUM> to form an interface between the cutting member <NUM> and a guide wire extending through the guide wire lumen <NUM>. The bore of the cutting member <NUM> may have a diameter slightly larger than the outer diameter of the guide wire liner <NUM> to provide a clearance for infusion fluid to pass therebetween to lubricate the guide wire, as will be further discussed herein. The guide wire liner <NUM> may remain stationary as the cutting member <NUM> is rotated. Thus, the cutting member <NUM> is rotatable relative to the guide wire liner <NUM> during operation, such that the guide wire is isolated from direct contact with the rotating cutting member <NUM> except at the distal opening <NUM> of the cutting member <NUM>. Further discussion of the similar features, and their interaction with other components has been described above, and thus will not be repeated.

The distal end region of the catheter <NUM> shown in <FIG> and <FIG> may include a rotatable cutting member <NUM> having a distal cutter 60a and a proximal cutter 60b. Both the distal cutter 60a and the proximal cutter 60b may be rotated through rotation of the drive shaft <NUM>. The distal cutter 60a may include one or more flutes having a cutting edge for removing occlusive material from a body lumen. In other instances, the distal cutter 60a may be a burr having an abrasive surface, such as a diamond coated abrasive surface, or the distal cutter 60a may be of another construction for abrading or cutting occlusive material. The proximal cutter 60b may be an expandable cutter including one or more expandable blades, or the proximal cutter 60b may be a morcellator or macerator for morcellating or macerating excised tissue, for example. In some instances, the proximal cutter 60b may have a first cutting diameter when the drive shaft <NUM> is rotated in a first rotational direction (e.g., clockwise) and a second cutting diameter when the drive shaft <NUM> is rotated in an opposite, second rotational direction (e.g., counter-clockwise. The first cutting diameter may be different than the second cutting diameter, for example, the first cutting diameter may be less than the second cutting diameter. For instances, the blades of the proximal cutter 60b may expand to the second cutting diameter or beyond from the first cutting diameter when the drive shaft <NUM> is rotated in the second rotational direction.

Similar to the embodiment discussed above, as shown in <FIG>, the inflow port <NUM> may open into the aspiration lumen <NUM> through a sidewall of the catheter body <NUM>. The septum <NUM> may isolate the drive shaft <NUM>, extending through the infusion lumen <NUM> from effluent passing into the aspiration lumen <NUM>. Furthermore, <FIG> illustrates that within the distal end region, the septum <NUM> may have a bowed or arcuate configuration such that one of the first and second surfaces <NUM>, <NUM> of the septum <NUM> is convex while the other of the first and second surfaces <NUM>, <NUM> of the septum <NUM> is concave. For example, the first surface <NUM> of the septum <NUM> may be concave such that the infusion lumen <NUM> may have a generally elliptical or oval shape, while the second surface <NUM> of the septum <NUM> may be convex such that the aspiration lumen <NUM> may have a generally crescent shape. In other embodiments, the curvature of the septum <NUM> may be reversed, in which case the shapes of the infusion lumen <NUM> and the aspiration lumen <NUM> may also be reversed. In yet other embodiments, the septum <NUM> may be planar, with opposing flat surfaces.

The infusion fluid may exit the distal end region of the catheter <NUM> at one or more outflow ports. For example, as shown with the arrows in <FIG>, infusion fluid may pass through a clearance gap between the outer surface of the guide wire liner <NUM> and the inner surface of the bore through the cutting member <NUM> and out the distal opening <NUM>. Additionally or alternatively, infusion fluid may pass between the retaining ring <NUM> and the catheter body <NUM>, between the retaining ring <NUM> and the saddle <NUM>, between the saddle <NUM> and the drive shaft <NUM> and/or between the cutting member <NUM> (e.g., the neck <NUM>) and the saddle <NUM>, and exit through a clearance gap between the cutting member <NUM> and the saddle <NUM>. In some instances infusion fluid may also exit through gaps in the proximal, expandable cutter 60b. The pressurized infusion fluid may form a fluid bearing between one or more of these structures, such as between one or more of the guide wire liner <NUM>, guide wire, cutting member <NUM>, saddle <NUM>, retaining ring <NUM>, drive shaft <NUM>, and catheter body <NUM>. For example, pressurized fluid through the infusion lumen <NUM> interposed between the cutting member <NUM> and the catheter body <NUM> (e.g., saddle <NUM>) may form a cutter fluid bearing between the cutting member <NUM> (e.g., neck <NUM>) and the catheter body <NUM> (e.g., saddle <NUM>), and/or pressurized fluid through the infusion lumen <NUM> interposed between the cutting member <NUM> and the guide wire liner <NUM> or guide wire may form a cutter fluid bearing between the cutting member <NUM> and the guide wire liner <NUM> or guide wire extending through the bore of the cutting member <NUM>.

Furthermore, the pressurized infusion fluid may provide a fluid barrier to prevent ingress of effluent, including particulates such as fibrin, from entering the distal end region of the catheter <NUM> through the distal opening <NUM>, between the outer surface of the guide wire liner <NUM> and the inner surface of the bore through the cutting member <NUM>, between the cutting member <NUM> (e.g., the neck <NUM>) and the saddle <NUM>, between blades or other structure of the proximal, expandable cutter 60b, or other clearance gap between one or more of the guide wire liner <NUM>, guide wire, cutting member <NUM>, saddle <NUM>, retaining ring <NUM>, drive shaft <NUM>, and catheter body <NUM>. In other words, the pressure gradient between the pressurized infusion fluid within the distal end region of the catheter <NUM> and the pressure within the body lumen may permit infusion fluid to exit through one or more of these pathways, while preventing effluent to enter the distal end region of the catheter <NUM> through one or more of these pathways.

The drawings show, by way of illustration, specific embodiments. However, one can also contemplate examples in which only those elements shown or described are provided. Moreover, one can also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

Claim 1:
A matter elimination catheter, comprising:
a catheter body (<NUM>) extending from a catheter proximal portion to a catheter distal portion, the catheter body (<NUM>) including an infusion lumen (<NUM>);
a drive shaft (<NUM>) disposed within the infusion lumen (<NUM>);
a rotatable cutting member (<NUM>) secured to a distal end of the drive shaft (<NUM>) and rotatable through rotation of the drive shaft (<NUM>); and characterised by
a guide wire liner (<NUM>) extending through the drive shaft (<NUM>) to define a guide wire lumen (<NUM>) therein,
wherein the guide wire liner (<NUM>) extends distal of the distal end of the drive shaft (<NUM>) into a bore of the cutting member (<NUM>).