Patent Description:
Catheters may be used for a variety of procedures. Some catheters, typically referred to as thrombectomy catheters, may be used to perform procedures in which thrombotic material is removed from a blood vessel (or other body lumen). The removed material may preferably be removed from the body through the thrombectomy catheter.

Examples of some thrombectomy catheters are described in, e.g., U. Patent Application Publication <CIT>); <CIT>); <CIT>); <CIT>); U. Patent Application Publication <CIT>); and U. Patent Application Publication No. <CIT>.

<CIT> discloses a cross stream thrombectomy catheter and system for fragmentation and removal of thrombus or other material from blood vessels or other body cavities. High velocity saline jets emitted from a toroidal loop jet emanator or other jet emanator in a catheter distal end entrain fluid through inflow orifices, and with flow resistances create a back-pressure which drives cross stream streams through outflow orifices in a radial direction and thence radially and circumferentially to apply normal and drag forces on thrombotic deposits or lesions in the blood vessel or other body cavity, thereby breaking apart and transporting thrombus particles to be entrained through the inflow orifices, whereupon the high velocity jets macerate the thrombus particles which then transit an exhaust lumen or recirculate again via the outflow orifices.

<CIT> discloses a catheter comprising: a catheter body with a catheter lumen extending from a proximal catheter portion to a distal catheter portion; a manifold assembly coupled with the proximal catheter portion, a manifold lumen extends through the manifold assembly from a proximal manifold portion to a distal manifold portion, the manifold lumen is in communication with the catheter lumen, and the manifold lumen includes an assembly cavity extending around the proximal catheter portion; a fluid jet loop coupled with a high pressure tube at the distal catheter portion, the fluid jet loop extends around a fluid jet loop lumen, the fluid jet loop includes fluid jet orifices along a tapered loop guide surface, and the tapered loop guide surface tapers from a fluid jet loop outer perimeter toward a fluid jet loop inner perimeter and the fluid jet loop lumen; a composite guide including: a proximal guide insert positioned within the assembly cavity, the proximal guide insert includes a guide insert surface substantially flush with a catheter body interior wall, and the proximal guide insert is configured to guide an instrument past the assembly cavity and into the catheter lumen, and a distal guide including the tapered loop guide surface and an intermediate guide surface of the catheter lumen flushly engaged with a leading edge of the tapered loop guide surface, wherein the distal guide is configured to guide the instrument over the intermediate guide surface, the tapered loop guide surface and through the fluid jet loop.

The invention is defined by the features of the claims. Embodiments not falling within the scope of the claims are not part of the invention.

Thrombectomy catheters having at least one outflow orifice and one or more inflow orifices, systems including the thrombectomy catheters, and methods of using the thrombectomy catheters are described herein.

In one or more embodiments, the thrombectomy catheters described herein may include one or more of the protective features described herein that may limit potential hazards to vessel walls in which the thrombectomy catheters are used.

Among the protective features that may be used in one or more embodiments of the thrombectomy catheters described herein is the use of radiopaque markers on the high-pressure tube which is, itself, located off center within the catheter lumen such that the rotational orientation of the inflow orifice or orifices can be monitored during use of the thrombectomy catheter.

Another protective feature that may be used in one or more embodiments of the thrombectomy catheters described herein is in the location of fluid jet openings in a fluid jet emanator from which fluid jets emanate relative to an inflow orifice in the catheter. In particular, the inflow orifice (or orifices) may extend about a portion of the circumference of the wall of the catheter that is defined by an orifice arc having a center at the center of the catheter lumen. In one or more embodiments, the openings in the fluid jet emanator are located outside of that orifice arc such that fluid jets emanating from those openings are located a distance away from the inflow orifice. As a result, fluid jets emanating from the fluid jet openings are less likely to come into direct contact with tissue that may be drawn into the inflow orifice or orifices of the thrombectomy catheter.

Another protective feature that may be used in one or more embodiments of the thrombectomy catheters described herein is the use of a high-pressure tube located off center within the catheter lumen and which extends across the opening of an inflow orifice in the thrombectomy catheter. In addition, the high-pressure tube may include an arcuate portion which arcs away from a center of the catheter lumen within the inflow orifice. As a result, the high-pressure tube may limit the entry of tissue into the inflow orifice during use of the thrombectomy catheter.

In a first aspect, one or more embodiments of a thrombectomy catheter as described herein may include: a catheter body extending from a distal portion toward a proximal portion along a longitudinal axis: a high pressure tube extending through a lumen of the catheter body from the proximal portion toward the distal portion, the high pressure tube configured for coupling with a fluid source near the proximal portion and terminating in a fluid jet emanator located in the catheter lumen, the fluid jet emanator comprising a plurality of fluid jet openings configured to direct a plurality of fluid jets through the catheter lumen toward the proximal portion, wherein the high pressure tube extends along one side of the catheter lumen such that the high pressure tube is off-center within the catheter lumen; an inflow orifice formed through a wall of the catheter body in the distal portion, wherein the inflow orifice is located proximally from the fluid jet emanator; a radiopaque marker attached to the high pressure tube within an axial length of the inflow orifice as measured along the longitudinal axis, wherein the radiopaque marker is off-center within the catheter lumen; and an outflow orifice in the distal portion, wherein the outflow orifice is located proximally of the inflow orifice such that the inflow orifice is located between the outflow orifice and the fluid jet emanator.

In one or more embodiments of the thrombectomy catheters described herein, the inflow orifice extends about a portion of the circumference of the wall defined by an orifice arc having a center at a center of the catheter lumen within the inflow orifice, and wherein the plurality of fluid jet openings in the fluid jet emanator are located outside of the orifice arc. In one or more embodiments, a portion of the fluid jet emanator within the orifice arc is free of any fluid jet openings.

In one or more embodiments of the thrombectomy catheters described herein, the high pressure tube extends across the inflow orifice. In one or more embodiments, the high pressure tube comprises an arcuate portion located in the inflow orifice, wherein the arcuate portion arcs away from a center of the cadieter lumen within the inflow orifice. In one or more embodiments, the radiopaque marker is attached to the arcuate portion of the high pressure tube.

In one or more embodiments of the thrombectomy catheters described herein, the distal portion of the catheter body between the inflow orifice and the outflow orifice forms an arc when unrestrained, and wherein the inflow orifice and the outflow orifice face a center of the arc.

In a second aspect, one or more embodiments of the thrombectomy catheters described herein may include: a catheter body extending from a distal portion toward a proximal portion along a longitudinal axis; a high pressure tube extending through a lumen of the catheter body from the proximal portion toward the distal portion, the high pressure tube configured for coupling with a fluid source near the proximal portion and terminating in a fluid jet emanator located in the catheter lumen, the fluid jet emanator comprising a plurality of fluid jet openings configured to direct a plurality of fluid jets through the catheter lumen toward the proximal portion: an inflow orifice formed through a wall of the catheter body in the distal portion, wherein the inflow orifice is located proximally from the fluid jet emanator, and wherein the inflow orifice extends about a portion of the circumference of the wall defined by an orifice arc having a center at a center of the catheter lumen within the inflow orifice, and wherein the plurality of fluid jets emanating from the fluid jet emanator are located outside of the orifice arc; and an outflow orifice in the distal portion, wherein the outflow orifice is located proximally of the inflow orifice such that the inflow orifice is located between the outflow orifice and the fluid jet emanator.

In one or more embodiments of the thrombectomy catheters described herein, a portion of the fluid jet emanator within the orifice arc is free of any fluid jet openings.

In one or more embodiments of the thrombectomy catheters described herein, the high pressure tube is located off-center within the catheter lumen and extends across the inflow orifice. In one or more embodiments, the high pressure tube comprises an arcuate portion located in the inflow orifice, wherein the arcuate portion arcs away from a center of the catheter lumen within the inflow orifice. In one or more embodiments, a radiopaque marker is attached to the arcuate portion of the high pressure tube.

In a third aspect, one or more embodiments of a thrombectomy catheter as described herein may include: a catheter body extending from a distal portion toward a proximal portion along a longitudinal axis; an inflow orifice formed through a wall of the catheter body in the distal portion; a high pressure tube extending through a lumen of the catheter body from the proximal portion toward the distal portion, the high pressure tube configured for coupling with a fluid source near the proximal portion and terminating in a fluid jet emanator located in the catheter lumen, the fluid jet emanator comprising a plurality of fluid jet openings configured to direct a plurality of fluid jets through the catheter lumen toward the proximal portion, wherein the fluid jet emanator is located distal from the inflow orifice, and wherein the high pressure tube is located off center within the catheter lumen and extends across the inflow orifice, and further wherein the high pressure tube comprises an arcuate portion located in the inflow orifice, wherein the arcuate portion arcs away from a center of the catheter lumen within the inflow orifice; and an outflow orifice in the distal portion, wherein the outflow orifice is located proximally of the inflow orifice such that the inflow orifice is located between the outflow orifice and the fluid jet emanator.

In one or more embodiments of the thrombectomy catheters described herein, the distal portion of the catheter body between the inflow orifice and the outflow orifice forms an arc when unrestrained, and wherein the inflow orifice and the outflow orifice face a center of the arc. In one or more embodiments, a radiopaque marker is attached to the arcuate portion of the high pressure tube.

In a fourth aspect, one or more embodiments of the thrombectomy catheters described herein may include: a catheter body extending from a distal portion toward a proximal portion along a longitudinal axis; a high pressure tube extending through a lumen of the catheter body from the proximal portion toward the distal portion, the high pressure tube configured for coupling with a fluid source near the proximal portion and terminating in a fluid jet emanator located in the catheter lumen, the fluid jet emanator comprising a plurality of fluid jet openings configured to direct a plurality of fluid jets through the catheter lumen toward the proximal portion: an inflow orifice formed through a wall of the catheter body in the distal portion, wherein the inflow orifice is located proximally from the fluid jet emanator; and an outflow orifice in the distal portion, wherein the outflow orifice is located proximally of the inflow orifice such that the inflow orifice is located between the outflow orifice and die fluid jet emanator; wherein the distal portion of the catheter body between the inflow orifice and the outflow orifice forms an arc when unrestrained, and wherein the inflow orifice and the outflow orifice face a center of the arc.

In one or more embodiments of the thrombectomy catheters described herein, the high pressure tube is located off-center within the catheter lumen and extends across the inflow orifice, wherein the high pressure tube comprises an arcuate portion located in the inflow orifice, wherein the arcuate portion arcs away from a center of the catheter lumen within the inflow orifice, and wherein a radiopaque marker is attached to the arcuate portion of the high pressure tube.

In a fifth aspect, one or more embodiments of a thrombectomy catheter system as described herein may include: a manifold comprising a high pressure connection branch, an exhaust branch, and a catheter branch, wherein the manifold comprises visible reference indicia proximate the catheter branch and a thrombectomy catheter. The thrombectomy catheter may include: a rotating fitting configured for rotatable connection to the catheter connection branch of the manifold such that rotation of the rotating fitting rotates the thrombectomy catheter relative to the visible reference indicia on the manifold, wherein the rotating fitting comprises visible indicia proximate the visible reference indicia on the manifold when the rotating fitting is connected to the catheter connection branch, and wherein the visible indicia on the rotating fitting is configured to provide an indication of rotational orientation of the thrombectomy catheter relative to the visible reference indicia on the manifold; a catheter body attached to rotating fitting, the catheter body comprising a proximal portion extending away from the rotating fitting towards a distal portion along a longitudinal axis; a high pressure tube extending through the high pressure connection branch and into a lumen of the catheter body from the proximal portion toward the distal portion, the high pressure tube configured for coupling with a fluid source and terminating in a fluid jet emanator located in the catheter lumen, the fluid jet emanator comprising a plurality of fluid jet openings configured to direct a plurality of fluid jets through the catheter lumen toward the proximal portion; an inflow orifice formed through a wall of the catheter body in the distal portion, wherein the inflow orifice is located proximally from the fluid jet emanator; and an outflow orifice in the distal portion, wherein the outflow orifice is located proximally of the inflow orifice such that the inflow orifice is located between the outflow orifice and the fluid jet emanator.

In one or more embodiments of the thrombectomy catheter systems described herein, the thrombectomy catheter comprises a radiopaque marker attached to the high pressure tube within an axial length of the inflow orifice as measured along the longitudinal axis. In one or more embodiments, the radiopaque marker is off-center within the catheter lumen.

In one or more embodiments of the thrombectomy catheter systems described herein, the inflow orifice extends about a portion of the circumference of the wall defined by an orifice arc having a center at a center of the catheter lumen within the inflow orifice, and wherein the plurality of fluid jet openings in the fluid jet emanator are located outside of the orifice arc. In one or more embodiments, a portion of the fluid jet emanator within the orifice arc is free of any fluid jet openings.

In one or more embodiments of the thrombectomy catheter systems described herein, the high pressure tube extends across the inflow orifice. In one or more embodiments, the thrombectomy catheter comprises a radiopaque marker attached to the high pressure tube within an axial length of the inflow orifice as measured along the longitudinal axis. In one or more embodiments, the high pressure tube comprises an arcuate portion located in the inflow orifice, wherein the arcuate portion arcs away from a center of the catheter lumen within the inflow orifice. In one or more embodiments, the thrombectomy catheter comprises a radiopaque marker attached to the high pressure tube within an axial length of the inflow orifice as measured along the longitudinal axis.

In one or more embodiments of the thrombectomy catheter systems described herein, the distal portion of the catheter body between the inflow orifice and the outflow orifice forms an arc when unrestrained, and wherein the inflow orifice and the outflow orifice face a center of the arc.

If used herein, the words "preferred" and "preferably" refer to embodiments described herein that may afford certain benefits, under certain circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the invention.

As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a" or "the" component may include one or more of the components and equivalents thereof known to those skilled in the art. Further, the term "and/or" means one or all of the listed elements or a combination of any two or more of the listed elements.

It is noted that the terms "comprises" and variations thereof do not have a limiting meaning where these terms appear in the accompanying description. Moreover, "a," "an," "the," "at least one," and "one or more" are used interchangeably herein.

Relative terms such as above, below, left, right, forward, rearward, top, bottom, side, upper, lower, horizontal, vertical, and the like may be used herein and, if so, are from the perspective observed in the particular figure. Any such terms should not be used to limit the scope of the inventions described herein unless explicitly indicated otherwise.

The above summary is not intended to describe each embodiment or every implementation of the dust collectors and related methods as described herein. Rather, a more complete understanding of the invention will become apparent and appreciated by reference to the following Description of Illustrative Embodiments and claims in view of the accompanying figures of the drawing.

In the following description of illustrative embodiments, reference is made to the accompanying figures of the drawing which form a part hereof, and in which are shown, by way of illustration, specific embodiments. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.

<FIG> is a perspective view of components that may be provided in a system that includes a catheter <NUM> as described herein. Illustrative embodiments of many of these system components may be described in, e.g., <CIT>. Patent Application Publication No. <CIT>).

Among the components in the illustrative embodiment depicted in <FIG> is a manifold <NUM> that is attached to a proximal end <NUM> of a catheter <NUM>. The manifold <NUM> may, in one or more embodiments, include a catheter connection branch <NUM>, a high pressure connection branch <NUM>, an exhaust branch <NUM>, and a guidewire port <NUM>, with a hemostatic nut <NUM> connected to the manifold <NUM> over the guidewire port <NUM> and an introducer <NUM> extending through the nut <NUM> to secure, e.g., a guidewire (not shown) that may pass into the guidewire port <NUM>.

Although not depicted in <FIG>, a high pressure fluid source and a high pressure fluid pump may be connected to the manifold <NUM> via the high pressure connection branch <NUM> to supply high pressure saline or other suitable fluid to a high pressure tube that extends from the high pressure connection branch <NUM> into the catheter <NUM>. Examples of some suitable systems including high pressure fluid sources and/or exhaust collection systems may be described in, e.g., <CIT>); <CIT>); <CIT>); etc..

The catheter <NUM> may, in one or more embodiments, be constructed of tubular components located between the proximal end <NUM> and the distal end <NUM> of the catheter <NUM>. The catheter <NUM> may, in one or more embodiments, include a proximal portion <NUM> extending from the proximal end <NUM> towards the distal end <NUM> and a distal portion <NUM> extending from the distal end <NUM> towards the proximal end <NUM>. The particular location of the junction between the proximal portion <NUM> and the distal portion <NUM> may vary between embodiments of catheters as described herein. In one or more embodiments, the proximal portion <NUM> of the catheter <NUM> and/or the distal portion <NUM> of the catheter <NUM> may be constructed so as to be flexible enough to facilitate advancement of the catheter along a curved passageway such as, e.g., a blood vessel. In one or more embodiments, the distal portion <NUM> may be, but is not necessarily, shorter than the proximal portion <NUM>. Either or both of the proximal portion <NUM> and distal portion <NUM> may include multiple sub-sections having different external sizes. In one or more embodiments, however, the distal portion <NUM> may have a uniform external size (e.g., diameter for a circular body) over a length between the inflow and outflow orifices in the catheters as described herein.

The tubular components used to manufacture catheters as described herein may, in one or more embodiments, be constructed of materials which promote pushability, torqueability, and which provide for operator feel. In one or more embodiments, the proximal portion <NUM> may, for example, be constructed of braided polyimide, a synthetic polymeric resin, metal (e.g., stainless steel, Nitinol, etc.) or any other suitable flexible material(s), and the distal portion <NUM> may be constructed of Pebax, a thermoplastic elastomer, metal (e.g., stainless steel, Nitinol, etc.) or any other suitable material(s). The catheters described herein may, in one or more embodiments, include an external hydrophilic coating to enhance deliverability along the vasculature or other structure. In one or more embodiments, e.g., those including metallic tubing, the tubing may include spiral cuts to improve flexibility.

The external body dimensions of one or more embodiments of the proximal portion <NUM> and the distal portion <NUM> may be selected such that the distal portion <NUM> has smaller external dimensions than the proximal portion <NUM> which may potentially facilitate advancement of the distal portion <NUM> into smaller passageways. In one or more embodiments, the proximal portion <NUM> may have an external dimension of about <NUM> French (Fr) as measured with reference to the French catheter scale (wherein <NUM> Fr = <NUM>/<NUM>, and <NUM> Fr = <NUM>). The distal portion <NUM> may include sub-sections that have different external dimensions. In one or more embodiments, for example, a proximal end of the distal portion <NUM> can be sized to mate with a distal end of the proximal portion <NUM> that also has the same diameter. The more distally located subsections of the distal portion <NUM> may, in one or more embodiments, be drawn and reduced or otherwise processed to reduce their external dimensions relative to the proximal portion to facilitate advancement of the distal portion <NUM> into smaller passageways. In one or more embodiments, different portions of the thrombectomy catheters described herein may have external dimensions that range from, e.g., <NUM> French to <NUM> French, although thrombectomy catheters having external dimensions outside of that range may also be provided.

In one or more embodiments, the proximal portion <NUM> and the distal portion <NUM> may be constructed of separate members that are attached to each other by any suitable technique, e.g., the proximal portion <NUM> and the distal portion <NUM> can be attached together by adhesive, welding, swaging, or by any other suitable method. In one or more alternative embodiments, the proximal portion <NUM> and the distal portion <NUM> may be formed of one continuous member that may be tapered or otherwise reduced in size at one or more transition sections such that joints between separate members may not be required.

Regardless of the specific construction details, the proximal portion <NUM> and the distal portion <NUM> may, in one or more embodiments, function together as an exhaust tube for evacuation of material, e.g., macerated effluence from a thrombus or lesion site as described in one or more of the issued patents and/or patent application publications identified herein. To do so, the distal portion <NUM> includes one or more outflow orifices <NUM> and one or more inflow orifices <NUM>, the arrangement, construction, and/or use of which are described in more detail herein with respect to various illustrative embodiments.

One illustrative embodiment of a distal portion <NUM> of a catheter as described herein is depicted in <FIG>. A perspective view of the distal portion <NUM> of the catheter is provided in <FIG>, while <FIG> is a cross-sectional view of <FIG> taken along line <NUM>-<NUM> in <FIG> (that is, in the illustrated embodiment, located on the longitudinal axis <NUM> of the catheter), and <FIG> is a cross-sectional view taken along line <NUM>-<NUM> in <FIG>. In one or more embodiments, the longitudinal axis <NUM> extends through the catheter from the proximal end (which may, for example, be located in a manifold) to the distal end <NUM>. In the case of a catheter having a circular or generally circular body, the longitudinal axis <NUM> may be located at the center of the catheter lumen <NUM>.

The distal portion <NUM> of the catheter as depicted in <FIG> includes a distal end <NUM>, along with an outflow orifice <NUM> and an inflow orifice <NUM>. The outflow orifice <NUM> and the inflow orifice <NUM> open into the lumen <NUM> formed within the catheter, with that lumen <NUM> preferably extending proximally towards a proximal end of the catheter. In one or more embodiments such as the illustrative embodiment of <FIG>, the outflow orifice <NUM> and the inflow orifice <NUM> are aligned with each other along the longitudinal axis <NUM>, i.e., the outflow orifice <NUM> and the inflow orifice <NUM> face in the same direction. In one or more alternative embodiments, the outflow orifice <NUM> and the inflow orifice <NUM> may not be aligned with each other along the longitudinal axis <NUM>, i.e., the orifices may face in different directions.

The distal portion <NUM> of the catheter includes optional radiopaque markers <NUM> and <NUM> that, in the illustrative embodiment may be positioned such that radiopaque marker <NUM> is proximal from the outflow orifice <NUM> and radiopaque marker <NUM> is located distal from the inflow orifice <NUM>. The radiopaque markers <NUM> and <NUM> may be used to assist with monitoring the longitudinal location of the distal portion <NUM> of the catheter when it is positioned within a vessel or other location using, e.g., fluoroscopic imaging, etc. In particular, placement of the outflow orifice <NUM> and the inflow orifice <NUM> may be monitored using the radiopaque markers <NUM> and <NUM>.

The illustrative embodiment of distal portion <NUM> of the catheter depicted <FIG> includes a fluid jet emanator <NUM> located at the end of a high pressure tube <NUM> that, in one or more embodiments, extends proximally through the lumen <NUM> of the catheter. The depicted illustrative embodiment of fluid jet emanator <NUM> includes proximally directed fluid jet openings <NUM> located on the proximal side of the fluid jet emanator <NUM> for the creation of one or more cross-stream jets outside of the distal portion <NUM> of the catheter using outflow orifice <NUM> and inflow orifice <NUM>.

The illustrative embodiment of fluid jet emanator <NUM> is in the form of an arcuate loop that at least partially defines an opening <NUM> that may, in one or more embodiments, allow for the passage of a guidewire or other elongate structure through the loop and the lumen <NUM> to the distal end <NUM> of the catheter. The fluid jet emanators used in connection with the catheters described herein may take a variety of forms other than a loop in one or more alternative embodiments (i.e., they are not limited to the arcuate loop depicted in <FIG>). For example, the fluid jet emanators may be in the form of a shorter loop (e.g., a loop that does not extend as far around the interior of the catheter as does loop <NUM>) or other bodies/structures that do not include arcuate tubing (such as, e.g., the fluid jet emanators described in, e.g., U. Patent Application Publication <CIT>)).

The fluid jet emanator <NUM> depicted in <FIG> may rest against or otherwise be supported by a support ring <NUM> located on the distal side of the fluid jet emanator <NUM>. The support ring <NUM> may, in one or more embodiments, define an opening <NUM> aligned with the opening <NUM> in the loop of fluid jet emanator <NUM> to, e.g., allow a guidewire that is inserted into the distal end <NUM> of the catheter to pass through the support ring <NUM>.

Although not depicted in <FIG>, one or more alternative embodiments of catheters as described herein may include a guidewire tube located in the lumen <NUM>, with the guidewire tube extending through one or both of the opening <NUM> in the fluid jet emanator <NUM> and opening <NUM> in the support ring <NUM>. Such a guidewire tube may be used to isolate a guidewire from the fluids within the lumen <NUM> if such isolation is desired.

Fluid is delivered to the fluid jet emanator <NUM> through a high-pressure tube <NUM> that, in the depicted embodiment, passes through lumen <NUM>. In one or more alternative embodiments, the high-pressure tube <NUM> may be located in a separate lumen that is not a part of the catheter lumen <NUM>. The high-pressure tube <NUM> extends, in one or more embodiments, from the proximal portion of the catheter to the distal portion <NUM> of the catheter as seen in <FIG>. As discussed in the patents identified herein, the high-pressure tube <NUM> is configured for coupling with a fluid source somewhere within the proximal portion of the catheter. Examples of some potentially suitable connections between a high pressure tube and a fluid source/pump may be found in the patents identified herein.

Also depicted in connection with the illustrative embodiment of <FIG> is a radiopaque marker <NUM> attached to the high-pressure tube <NUM>. The radiopaque marker <NUM> is, in one or more embodiments, located within the axial length of the inflow orifice <NUM> as measured along the longitudinal axis <NUM>. As a result, monitoring the position of the radiopaque marker <NUM> may, in one or more embodiments, provide a user with an indication of the location of the inflow orifice <NUM> along the longitudinal axis <NUM> during use of the catheter.

In one or more embodiments, the radiopaque marker <NUM> is located off-center within the catheter lumen <NUM>. Because the radiopaque marker <NUM> is located off-center within the catheter lumen <NUM>, monitoring the position of the radiopaque marker <NUM> also may provide a user with an indication of the rotational orientation of the distal portion <NUM> of the catheter with respect to the longitudinal axis <NUM>. In one or more embodiments, such as that depicted in <FIG>, the high-pressure tube <NUM> is located off-center within the catheter lumen <NUM> as well (as best seen in, e.g., <FIG>).

By providing an indication of the rotational orientation of the distal portion <NUM> of the catheter, the radiopaque marker <NUM> also provides an indication of the rotational orientation of the inflow orifice <NUM>. As a result, a user may, in one or more embodiments, be able to monitor the direction in which the inflow orifice <NUM> opens within a vessel as the catheter is being used.

In addition to the features described above which are depicted in connection with the illustrative embodiment of <FIG>, another feature that may be provided in one or more embodiments of the catheters as described herein may be discussed best with respect to the cross-sectional view of <FIG>. As seen there, the inflow orifice <NUM> may extend about an arcuate portion of the circumference of the wall <NUM> of the catheter between edges <NUM> and <NUM> of the inflow orifice <NUM>. The inflow orifice <NUM> may be described as defining an orifice arc between edges <NUM> and <NUM> that which has a center at the center of the catheter lumen <NUM>. The orifice arc as seen in <FIG> as an angle α (alpha), which may, in one or more embodiments, occupy a selected portion of the circumference of the catheter. In one or more embodiments, the angle α may have an upper limit of, e.g., about <NUM> degrees or less. In one or more embodiments, the angle α may have a lower limit of, e.g., about <NUM> degrees or more. In one or more alternative embodiments, the angle α may have an upper limit of, e.g., about <NUM> degrees or less, about <NUM> degrees or less, about <NUM> degrees or less, or about <NUM> degrees or less. In one or more alternative embodiments, the angle α may have a lower limit of, e.g., about <NUM> degrees or more or about <NUM> degrees or more.

In the illustrative embodiment depicted in <FIG>, the fluid jet openings <NUM> in the fluid jet emanator <NUM> may be located outside of the orifice arc defined by angle α (alpha). Positioning the fluid jet openings <NUM> in the fluid jet emanator <NUM> outside of the orifice arc may, in one or more embodiments, reduce the likelihood that a fluid jets emanating from the fluid jet openings <NUM> will come into direct contact with tissue that may be drawn into the catheter lumen <NUM> through inflow orifice <NUM>. In another manner of describing the arrangement of fluid jet openings <NUM> relative to the orifice arc defined by angle α (alpha), the portion of the fluid jet emanator <NUM> located within the orifice arc may be described as being free of any fluid jet openings <NUM> provided in the fluid jet emanator <NUM>. In one or more alternative embodiments, however, the fluid jet openings <NUM> in the fluid jet emanator <NUM> may be located within the orifice arc.

The arrangement of the features in the distal portion <NUM> of the catheter as depicted in <FIG>, including, e.g., the outflow orifice <NUM>, inflow orifice <NUM>, fluid jet emanator <NUM>, and catheter lumen <NUM>, may provide a catheter that, in one or more embodiments, produces non-hemolyzing cross-stream jets of saline or other suitable fluids which exit from the outflow orifice <NUM> to accomplish thrombectomy functions as described in, e.g., <CIT>) (see, e.g., <FIG> and the corresponding description of that document) and at least some of the other patents identified herein. As discussed there, cross stream jets emanating from one or more outflow orifices may provide for the fluid jet impingement on the deposits of thrombus or lesions on the inner wall of a blood vessel adjacent to or in close proximity to the outflow orifices to impinge, ablate and loosen deposits of thrombus or lesions, whereby such thrombus or lesion particulate and fluids can be drawn into the catheter lumen through one or more inflow orifices for removal proximally through the catheter.

Although the illustrative embodiment depicted in <FIG> includes only a single inflow orifice <NUM>, one or more alternative embodiments may include two or more inflow orifices. One illustrative embodiment of a catheter including two inflow orifices is dictated in the perspective view of <FIG>, wherein the distal portion <NUM> of the depicted catheter includes a first inflow orifice <NUM> and a second inflow orifice <NUM> which are separated from each other by a saddle <NUM>. The distal portion <NUM> of the depicted catheter also includes a single outflow orifice <NUM> that may be paired with the two or more inflow orifices of this illustrative embodiment.

Although the catheter depicted in <FIG> includes a single inflow orifice <NUM>, an orifice arc may also be defined by two or more circumferentially arranged inflow orifices such as, e.g., orifices <NUM> and <NUM> in the distal portion <NUM> of the catheter as depicted in <FIG>. In such an embodiment, the orifice arc may be defined between the outermost edges of the inflow orifices <NUM> and <NUM>.

In one or more embodiments, drugs for treatment or for lysing of the thrombus or lesions on a vessel wall may be delivered via one or more outflow orifices to, e.g., soften the deposits of thrombus or lesions in the region of the blood vessel adjacent to or in close proximity to the outflow orifices. Any such drugs may, in one or more embodiments, be delivered through a high-pressure tube delivering fluid to a fluid jet emanator, through a separate lumen, using a different fluid delivery device (e.g., catheter, etc.).

The sizing of the various components used in connection with one or more embodiments of the systems and methods described herein may vary based on a number of factors such as, e.g., size of the catheter, materials to be removed using the catheter, fluid flow rates desired, etc. In general, however, fluid jet openings in the fluid jet emanators used in one or more embodiments of the catheters described herein can range in size, e.g., from about <NUM> to about <NUM> (<NUM> inch to about <NUM> inch) for emanation of saline or other suitable fluid therefrom in a velocity range of about <NUM> to about <NUM>/s. By sizing the fluid jet openings and adjusting the high pressure fluid pump, the velocity and strength of the cross stream fluid flow in one or more embodiments can be controlled. The general operating pressures of the catheter systems described herein may, in one or more embodiments, for example, range from about <NUM> psi to about <NUM>,<NUM> psi (<NUM> psi is approximately <NUM>,<NUM> pascals).

The high pressure tubes used in one or more embodiments of catheters as described herein may, in one embodiment, be circular tubes with an outside diameter of about <NUM> (about <NUM> inch) and in inside diameter of about <NUM> (about <NUM> inch) over a proximal portion, and an outside diameter of about <NUM> (about <NUM> inch) and an inside diameter of about <NUM> (about <NUM> inch) over an intermediate portion, and an outside diameter of about <NUM> (about <NUM> inch) and an inside diameter of about <NUM> (about <NUM> inch) over a distal portion, although other tube profiles and/or dimensions may be used.

The different portions of the catheters described herein may have a variety of different tubular profiles and/or dimensions, although in one or more embodiments, the proximal and distal portions may be circular in profile and have an outside diameter ranging from an upper limit of, e.g., about <NUM> French to a lower limit of about <NUM> French, although catheters having different profiles and/or dimensions outside of these upper and/or lower limits may also be provided in one or more alternative embodiments.

Another illustrative embodiment of a catheter as described herein is depicted in connection with <FIG>. A perspective view of the distal portion <NUM> of the catheter is provided in <FIG>, while <FIG> is a cross-sectional view of <FIG> taken along line <NUM>-<NUM> in <FIG> (that is, in the illustrated embodiment, located on the longitudinal axis <NUM> of the catheter), and <FIG> is a cross-sectional view taken along line <NUM>-<NUM> in <FIG>. In one or more embodiments, the longitudinal axis <NUM> extends through the catheter from the proximal end (which may, for example, be located in a manifold) to the distal end <NUM>. In the case of a catheter having a circular or generally circular body, the longitudinal axis <NUM> may be located at the center of the catheter lumen <NUM>.

The distal portion <NUM> of the catheter as depicted in <FIG> includes a distal end <NUM>, along with an outflow orifice <NUM> and an inflow orifice <NUM>. The inflow orifice <NUM> and the outflow orifice <NUM> open into the lumen <NUM> formed within the catheter, with that lumen <NUM> preferably extending proximally towards a proximal end of the catheter.

The distal portion <NUM> of the catheter includes optional radiopaque markers <NUM> and <NUM> that, in the illustrative embodiment may be positions such that radiopaque marker <NUM> is proximal from the outflow orifice <NUM> and radiopaque marker <NUM> is located distal from the inflow orifice <NUM>. The radiopaque markers <NUM> and <NUM> may be used to assist with monitoring the longitudinal location of the distal portion <NUM> of the catheter when it is positioned within a vessel or other location using, e.g., fluoroscopic imaging, etc. In particular, placement of the outflow orifice <NUM> and the inflow orifice <NUM> may be monitored using the radiopaque markers <NUM> and <NUM>.

The illustrative embodiment of distal portion <NUM> of the catheter depicted <FIG> includes a fluid jet emanator <NUM> located at the end of a high pressure tube <NUM> that, in one or more embodiments, extends proximally through the catheter. The depicted illustrative embodiment of fluid jet emanator <NUM> includes proximally directed fluid jet openings <NUM> located on the proximal side of the fluid jet emanator <NUM> for the creation of a cross-stream jet outside of the distal portion <NUM> of the catheter using outflow orifice <NUM> and inflow orifice <NUM>. The fluid jet emanator <NUM> depicted in <FIG> may rest against or otherwise be supported by a support ring <NUM> located on the distal side of the fluid jet emanator <NUM>.

Fluid is delivered to the fluid jet emanator <NUM> through a high-pressure tube <NUM> that, in the depicted embodiment, passes through lumen <NUM>. The high-pressure tube <NUM> extends, in one or more embodiments, from the proximal portion of the catheter to the distal portion <NUM> of the catheter as seen in <FIG>. As discussed in the patents identified herein, the high-pressure tube <NUM> is configured for coupling with a fluid source near the proximal portion located near the proximal end of the catheter.

Unlike the high-pressure tube <NUM> depicted in connection with the illustrative embodiment of <FIG>, the high-pressure tube <NUM> is positioned within the catheter lumen <NUM> such that a portion of the high-pressure tube <NUM> extends across the inflow orifice <NUM> in the distal portion <NUM>. Although the portion of the high-pressure tube <NUM> extending across the inflow orifice <NUM> is depicted as generally bisecting the inflow orifice <NUM> over its circumferential direction (i.e., from edge <NUM> to edge <NUM> as seen in the cross-sectional view of <FIG>), such an arrangement is not necessarily required. For example, the portion of the high-pressure tube <NUM> extending across the inflow orifice <NUM> may, in one or more embodiments, be closer to one edge <NUM> than the opposite edge <NUM> (or vice versa).

The portion of high-pressure tube <NUM> extending across the inflow orifice <NUM> is, in the depicted embodiment, generally aligned with the longitudinal axis <NUM>, although it should be understood that such an alignment is not necessarily required and that, for example, in one or more alternative embodiments the portion of high-pressure tube <NUM> extending across the inflow orifice <NUM> may be oriented in a direction that is not aligned with the longitudinal axis <NUM>.

As best seen in, e.g., the cross-sectional view of <FIG>, the portion of the high-pressure tube <NUM> extending across the inflow orifice <NUM> may include an arcuate portion <NUM> which arcs away from a center of the catheter lumen <NUM> within the boundaries of the inflow orifice <NUM>. In one or more embodiments, the center <NUM> of the arc <NUM> formed by the arcuate portion <NUM> of the high-pressure tube <NUM> may be located on the longitudinal axis <NUM> where the longitudinal axis extends along the center of the catheter lumen <NUM>, although such an arrangement is not necessarily required. In one or more embodiments in which a high-pressure tube <NUM> includes an arcuate portion <NUM> extending across the inflow orifice <NUM>, the arcuate portion <NUM> of the high-pressure tube <NUM> may help to limit the entry of tissue into the inflow orifice <NUM> during operation of the catheter.

Also depicted in connection with the illustrative embodiment of <FIG> is a radiopaque marker <NUM> attached to the high-pressure tube <NUM>. The radiopaque marker <NUM> may, in one or more embodiments, be located within the arcuate portion <NUM> of the high-pressure tube <NUM> which, in the depicted embodiment is also within the axial length of the inflow orifice <NUM> as measured along the longitudinal axis <NUM>. As a result, monitoring the position of the radiopaque marker <NUM> may, in one or more embodiments, provide a user with an indication of the location of the inflow orifice <NUM> along the longitudinal axis <NUM> during use of the catheter.

In one or more embodiments, the radiopaque marker <NUM> may also be described as being located off-center within the catheter lumen <NUM>. Because the radiopaque marker <NUM> is located off-center within the catheter lumen <NUM>, monitoring the position of the radiopaque marker <NUM> also may provide a user with an indication of the rotational orientation of the distal portion <NUM> of the catheter with respect to the longitudinal axis <NUM>. By providing an indication of the rotational orientation of the distal portion <NUM> of the catheter, the radiopaque marker <NUM> also provides an indication of the rotational orientation of the inflow orifice <NUM>. As a result, a user may, in one or more embodiments, be able to monitor the direction in which the inflow orifice <NUM> opens within a vessel as the catheter is being used.

In addition to the features described above which are depicted in connection with the illustrative embodiment of <FIG>, another feature that may be provided in one or more embodiments of the catheters as described herein may be discussed best with respect to the cross-sectional view of <FIG>. As seen there, the inflow orifice <NUM> may extend about a portion of the circumference of the wall <NUM> of the catheter from edge <NUM> to edge <NUM>. The inflow orifice <NUM> may be described as defining an orifice arc which has a center at the center of the catheter lumen <NUM>. The orifice arc as seen in <FIG> as an angle β (beta), which may, in one or more embodiments, occupy a selected portion of the circumference of the catheter. In one or more embodiments, the angle β (beta) may have an upper limit of less than <NUM> degrees. In one or more embodiments, the angle β (beta) may have an upper limit of about <NUM> degrees or less. In one or more embodiments, the angle β (beta) may have a lower limit of about <NUM> degrees or more. In one or more embodiments, the angle β (beta) may have a lower limit of about <NUM> degrees or more. In one or more embodiments, the angle β (beta) may have a range of about <NUM> degrees to less than <NUM> degrees. In one or more embodiments, the angle β (beta) may have a range of about <NUM> degrees to about <NUM> degrees. In one or more embodiments, the angle β (beta) may have a range of about <NUM> degrees to less than <NUM> degrees. In one or more embodiments, catheters as described herein may have one or more inflow orifices with an angle β (beta) of about <NUM> degrees to about <NUM> degrees in combination with one or more inflow orifices with an angle β (beta) of about <NUM> degrees to less than <NUM> degrees. Limiting inflow orifice size to the smaller of those angular ranges (i.e., about <NUM> degrees to about <NUM> degrees) may, in one or more embodiments, limit the inflow area which may improve safety. Providing inflow orifice sizes in the larger of those angular ranges (i.e., about <NUM> degrees to less than <NUM> degrees) may, in one or more embodiments, limit the inflow velocity and/or suction force which may improve safety.

In one or more embodiments, such as that depicted in <FIG>, the orifice arc defined by angle β (beta) of the inflow orifice <NUM> may be greater than about <NUM> degrees at least due in part to the location of the arcuate portion of the high-pressure tube <NUM> extending across the inflow orifice <NUM>. As discussed herein, location of the high-pressure tube <NUM> across the inflow orifice <NUM> may reduce tissue entry into the inflow orifice <NUM> that would otherwise occur if the high-pressure tube <NUM> did not extend across the inflow orifice <NUM>.

As with the embodiment depicted in connection with <FIG>, the arrangement of the features in the distal portion <NUM> of the catheter as depicted in <FIG>, including, e.g., the outflow orifice <NUM>, inflow orifice <NUM>, fluid jet emanator <NUM>, and catheter lumen <NUM>, may provide a catheter that, in one or more embodiments, produces non-hemolyzing cross-stream jets of saline or other suitable fluids which exit from the outflow orifices to accomplish thrombectomy functions as described in, e.g., <CIT>) (see, e.g., <FIG> and the corresponding description of that document) and at least some of the other patents identified herein. As discussed there, cross stream jets emanating from outflow orifices may provide for the fluid jet impingement on the deposits of thrombus or lesions on the inner wall of a blood vessel adjacent to or in close proximity to the outflow orifices to impinge, ablate and loosen deposits of thrombus or lesions, whereby such thrombus or lesion particulate and fluids can be drawn into catheter lumen through one or more inflow orifices for removal proximally through the catheter.

With reference to <FIG>, another feature that may be included in one or more embodiments of the catheters as described herein is depicted. The distal portion <NUM> of the catheter as seen in <FIG> includes, in a manner similar to the other illustrative embodiments described herein, an outflow orifice <NUM> and an inflow orifice <NUM>. Other features not depicted in <FIG> but described in connection with the other embodiments described herein may be included, such as, e.g., fluid jet emanators, etc. The distal portion <NUM> of the catheter forms, in the depicted embodiment, an arc <NUM> between the outflow orifice <NUM> and the inflow orifice <NUM> when the distal portion <NUM> of the catheter is unrestrained. In other words, in the absence of external forces acting on the distal portion <NUM> of the catheter, the distal portion <NUM> will form an arc <NUM> as described herein. The tendency of the distal portion <NUM> of the catheter to form such an arc may, in one or more embodiments, be overcome through the use of a stylet or other structure, but in the absence of such a structure, the distal portion <NUM> may take on and arcuate shape between the outflow orifice <NUM> and the inflow orifice <NUM>.

In one or more embodiments, the outflow orifice <NUM> and the inflow orifice <NUM> may face the center <NUM> of the arc <NUM> formed by the distal portion <NUM> of the catheter, an example of which is depicted in <FIG>. By including a distal portion <NUM> that forms an arc having a center <NUM> that is faced by the inflow orifice <NUM>, the likelihood of drawing tissue into the inflow orifice <NUM> during operation of the catheter may be reduced.

As discussed herein, the distal portions of the catheters described herein may be advantageously used in one or more rotational orientations with respect to a longitudinal axis extending through the catheter. Because the rotational orientation of the distal portions of the catheters may be useful in one or more embodiments, the use of a manifold at the proximal end of the catheter that is capable of providing an indication of the rotational orientation of the distal portion of the catheters may, in one or more embodiments, also be useful.

One illustrative embodiment of a manifold that may be used with the catheters described herein to provide such rotational orientation indications to a user is depicted in <FIG>. The manifold <NUM> is, in the depicted embodiment, attached to a proximal end of a catheter <NUM>. The manifold <NUM> may, in one or more embodiments, include a catheter connection branch <NUM>, a high pressure connection branch <NUM>, and an exhaust branch <NUM>. A guidewire lumen <NUM> extends through the manifold <NUM> to a guidewire port <NUM>, with a hemostatic nut <NUM> connected to the manifold <NUM> over the guidewire port <NUM> and an introducer <NUM> extending through the nut <NUM> to secure, e.g., a guidewire (not shown) that may be inserted into the guidewire lumen <NUM> through the guidewire port <NUM>.

Although not depicted in <FIG>, a high pressure fluid source and a high pressure fluid pump may be connected to the manifold <NUM> via the high pressure connection branch <NUM> to supply high pressure saline or other suitable fluid to a high pressure tube <NUM> that extends from the high pressure connection branch <NUM> into the catheter <NUM>. In one or more embodiments, the exhaust branch <NUM> may include a stopcock or other fluid control device to control the flow of fluid out of the manifold <NUM> through the exhaust branch <NUM>. Examples of some suitable systems including high pressure fluid sources and/or exhaust collection systems may be described in, e.g., <CIT>); <CIT>); U. Patent Application Publication No. <CIT>); etc..

In one or more embodiments such as the illustrative embodiment depicted in <FIG>, the proximal end <NUM> of the catheter <NUM> is attached to the manifold <NUM> by the use of a rotating fitting <NUM> on the catheter branch <NUM> that allows rotation of the catheter <NUM> relative to the manifold <NUM> about a longitudinal axis <NUM> extending through the catheter <NUM> while the catheter <NUM> remains sealed to the manifold <NUM>. That rotation may, in one or more embodiments, be useful in positioning the distal portion (not shown) of the catheter <NUM> in a desired rotational orientation as described herein. A strain relief tube <NUM> may, in one or more embodiments, extend distally from the rotating fitting <NUM> to provide support to the catheter <NUM> during use of the manifold <NUM> and attached catheter <NUM>.

In the illustrative embodiment depicted in <FIG>, the rotating fitting <NUM> forms a sleeve that is configured to be attached to the catheter branch <NUM>. The fitting <NUM> is, in one or more embodiments, retained on the catheter branch <NUM> by a flange <NUM> that fits within a channel <NUM> formed in the catheter branch <NUM>. A seal <NUM> may be provided within the junction between the catheter branch <NUM> and the fitting to prevent or at least limit leakage out of the manifold <NUM> through the interface between the catheter branch <NUM> and the fitting <NUM>. In the depicted illustrative embodiment, the seal <NUM> is in the form of an O-ring although many other seal constructions may be used in place of an O-ring.

In one or more embodiments, the fitting <NUM> (which, for the purposes of the discussion herein includes the strain relief tube <NUM>) may include visible markings or some other indicia that indicated the rotational position of features on the catheter <NUM> (relative to the longitudinal axis <NUM>) that may, themselves, not be visible during use of the catheter <NUM>. Those catheter features may include, e.g., inflow and/or outflow orifices provided in the distal portion of the catheters as described herein. The catheter <NUM> may, in one or more embodiments, be fixedly attached to the rotating fitting <NUM> such that rotating of the fitting <NUM> about the catheter branch <NUM> causes corresponding rotation of the catheter <NUM>.

<FIG> depicts one illustrative embodiment of visible indicia that may be provided on a manifold body <NUM> (see, e.g., <FIG>) from which the catheter branch <NUM> extends and the fitting <NUM>. In particular, fitting <NUM> may include one or more visible indicia <NUM> indicative of the rotational orientation of features on the catheter <NUM> such as, e.g., the inflow and/or outflow orifices in the distal portion of the catheter <NUM> connected to the fitting <NUM>. A set of reference indicia <NUM> may be provided on the manifold body <NUM>. Rotation of the fitting <NUM> about a longitudinal axis extending through the catheter fitting <NUM> and the attached catheter <NUM> will move the visible indicia <NUM> on the fitting <NUM> in either direction along bidirectional arrow <NUM> relative to the reference indicia <NUM> on the manifold body <NUM>, thereby providing a user with an indication of the rotational orientation of the catheter <NUM> (and features of the catheter <NUM>) relative to the manifold <NUM>. The depicted indicia are illustrative only, i.e., many other indicia may be used in place of those depicted in <FIG>.

Claim 1:
A thrombectomy catheter (<NUM>; <NUM>) comprising:
a catheter body extending from a distal portion (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) toward a proximal portion (<NUM>) along a longitudinal axis (<NUM>; <NUM>; <NUM>);
a high pressure tube (<NUM>; <NUM>; <NUM>) extending through a lumen of the catheter body from the proximal portion (<NUM>) toward the distal portion (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>), the high pressure tube (<NUM>; <NUM>; <NUM>) configured for coupling with a fluid source near the proximal portion (<NUM>) and terminating in a fluid jet emanator (<NUM>; <NUM>) located in the catheter lumen (<NUM>; <NUM>), the fluid jet emanator (<NUM>; <NUM>) comprising a plurality of fluid jet openings (<NUM>; <NUM>) configured to direct a plurality of fluid jets through the catheter lumen (<NUM>; <NUM>) toward the proximal portion (<NUM>), wherein the high pressure tube (<NUM>; <NUM>; <NUM>) extends along one side of the catheter lumen (<NUM>; <NUM>) such that the high pressure tube (<NUM>; <NUM>; <NUM>) is off-center within the catheter lumen (<NUM>; <NUM>);
an inflow orifice (<NUM>; <NUM>; <NUM>, <NUM>; <NUM>; <NUM>) formed through a wall of the catheter body in the distal portion, wherein the inflow orifice (<NUM>; <NUM>; <NUM>, <NUM>; <NUM>; <NUM>) is located proximally from the fluid jet emanator (<NUM>; <NUM>);
a radiopaque marker (<NUM>; <NUM>) attached to the high pressure tube (<NUM>; <NUM>; <NUM>) within an axial length of the inflow orifice (<NUM>; <NUM>; <NUM>, <NUM>; <NUM>; <NUM>) as measured along the longitudinal axis, wherein the radiopaque marker (<NUM>; <NUM>) is off-center within the catheter lumen (<NUM>; <NUM>); and
an outflow orifice (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) in the distal portion, wherein the outflow orifice (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) is located proximally of the inflow orifice (<NUM>; <NUM>; <NUM>, <NUM>; <NUM>; <NUM>) such that the inflow orifice (<NUM>; <NUM>; <NUM>, <NUM>; <NUM>; <NUM>) is located between the outflow orifice (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) and the fluid jet emanator (<NUM>; <NUM>).