US20060129091A1

Movatterモバイル変換

Info

Publication number: US20060129091A1
Application number: US11/009,720
Authority: US
Inventors: Michael Bonnette; Eric Thor; Michael Schrom
Original assignee: Possis Medical Inc
Current assignee: Bayer Medical Care Inc
Priority date: 2004-12-10
Filing date: 2004-12-10
Publication date: 2006-06-15
Also published as: EP1824554A4; US20080300532A1; EP2520322A3; US20150196317A1; US9833257B2; US20140088610A1; US10314609B2; US8998843B2; EP1824554B1; US8162877B2; US8597238B2; WO2006065424A2; WO2006065424A3; EP1824554A2; US20120239065A1; EP2520322A2; US20180092658A1

Abstract

An enhanced cross stream mechanical thrombectomy catheter with backloading manifold having a distal end with outflow and inflow orifices at one side for producing concentrated cross stream jet flow for selective and concentrated thrombus ablation during thrombectomy procedures. The invention provides for suitable distancing of high powered ablation or suction forces from the near walls of the vasculature. Cross stream flow emanating from the one side of the distal end of the catheter resultantly urges the distal end of the catheter and thus the opposing non-orificed side of the distal end of the catheter toward and against the vascular wall to inhibit contact of the inflow orifice with the vascular wall. Features of the invention include a geometrically configured insert to facilitate the backloading or exchange of guidewires.

Description

CROSS REFERENCES TO RELATED APPLICATIONS

This patent application is related to patent application Ser. No. 10/455,096 filed Jun. 05, 2003, entitled “Thrombectomy Catheter Device Having a Self-Sealing Hemostatic Valve,” which is pending.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is for a thrombectomy catheter, and more particularly, relates to an enhanced cross stream mechanical thrombectomy catheter which accommodates interchanging of guidewires through rear loading of a guidewire, as well as loading of a guidewire in a conventional manner, and also provides for improved cross stream ablation at a thrombus site. The intended use of this invention is for the detachment and removal of unwanted tissues, such as thrombus, from within biological conduits.

2. Description of the Prior Art and Comparison to the Present Invention

In current cross stream catheters, vessel damage by the multiple inflow/outflow cross stream catheters involves the vessel wall being sucked into the catheter at the side inlet orifice of the catheter. The high velocity fluid jets nick the vessel that is sucked into the catheter side inflow orifice. With the design described by the present invention, the vessel is pushed away by a single side outflow. The side of the catheter with no orifices is pushed against the vessel and consequently no damage results. This new mechanical thrombectomy design is referred to as the Enhanced Cross Stream Mechanical Thrombectomy Catheter with Backloading Manifold. The design employs one set of inflow and outflow orifices instead of the symmetrical multiple orifice configuration. Generally speaking, the cross sectional area of multiple sets of outflow/inflow orifices of prior art devices are newly combined into one set having a larger but equal cross sectional outflow/inflow orifice area to substantially increase and concentrate the cross stream action on one side of the device, thereby increasing the localized flow intensity considerably. In the present invention, all the flow is concentrated to one set of orifices and, in addition, the area for recirculation is maximized since it is designed to have a guidewire removed or pulled back out of the flow zone while using the device. Removing the guidewire from the orifice area of the catheter removes a substantial fluid restriction between the single side inflow orifice and the single side outflow orifice. In theory, removing this fluid restriction in all cross stream catheter designs should increase catheter performance. However, in the multiple orifice pair arrangements of the prior art, internal turbulent eddies consumed the area and an increase in performance often did not accompany the retraction of the guidewire. The single inflow orifice and outflow orifice arrangement of the present invention simplifies the internal fluid pathway, and as a result, marked flow increase associated with guidewire removal is consistent and dramatic. The guidewire does not need to be pulled out completely to achieve substantial improvements in efficacy. In fact, even with the guidewire in place, it is much more effective than similarly sized cross stream thrombectomy catheters. Furthermore, retracting the guidewire to free the orifice area of the catheter results in an even greater increase in catheter performance. This removal of the guidewire from the region of cross stream action (i.e., from the ID of the catheter) greatly increases the flow volume and reduces flow resistance in which recirculation can more readily occur, thereby enhancing function. Furthermore, in existing designs, a guidewire cannot be reliably retracted from the catheter without the potential of the guidewire exiting the inflow orifices when the physician pushes it back through the tip of the device. The orifices of existing designs can be made smaller, but then a greater number of orifices must be provided to maintain suitable flow, resulting in limiting cross stream action since the resistance though smaller orifices is greater. Therefore, a new arrangement was created to solve the problem. Specifically, the high pressure tube is placed in the center of the large inflow and outflow orifice effectively creating two smaller orifices with the least amount of resistance to flow with minimized manufacturing cost. The high pressure tube further directs the guidewire up and out of the tip of the distal portion of the catheter due to its geometry (i.e., rounded surface, thickness keeps wire away from wall, etc.). In summary, by utilizing one set of large inflow and outflow orifices with the ability to remove and replace the guidewire when desired, the cross stream ablation action can be concentrated and enhanced. Furthermore, the ability of removing and replacing the guidewire at the flexible tip or at the proximal end of the manifold leads to further enhancement. The user may replace the same guidewire or may utilize another guidewire of his choice (“guidewire swapping”). This ability is favorable to physicians since they want as many choices to perform their job to the best of their ability as possible (i.e., beneficial so they do not lose wire position, or that they may want a stiffer or more floppy guidewire to cross a tight stenosis or traverse tortuous anatomy). This enhancement is achieved through simple changes to the manifold, whereby an insert is included for guidewire routing.

There is yet another benefit to the asymmetrical design of the present invention at the catheter distal end where all of the jet stream outflow is directed from one side of the catheter distal end resulting in a powerful concentration of directed force and increased flow caused by removal or proximal retardation of the guidewire. Such benefit results in the distal portion of the catheter reactingly being directed and forced against the vessel wall opposite to the cross stream action. This movement beneficially keeps the inflow and outflow orifices away from the vessel wall. It has been shown that vessel contact with the inflow or outflow orifices (interior jets, suction, or a combination of both) can cause vessel damage in various degrees. Therefore, this “naked catheter” (i.e., there are other designs having cages or balloons which would keep the jet flow from contacting the walls, but this design uses active jet flow to position the device) design is very safe with respect to vessel wall damage.

Some alternatives of this design would use differently shaped orifices, such as slots, instead of holes, etc. Round, oval, elliptical, obround, tapered, slotted, rectangular, triangular, rounded corner, protruding, or multiple-radius configurations can be utilized for the inflow and/or outflow orifices, where the orifices could be shaped such as to direct the flow in a preferred direction.

The catheter body could also be shaped to maximize the effectiveness of the flow. Also, the body of the catheter at the distal end may include a 180° reversal where the reversed distal end is utilized to aid in removing material from the vessel wall. The effectiveness of the catheter could also be increased by increasing the flow to the catheter tip, which would impart more energy to the system to do work.

There is an alternative design that is similar in principle to the first embodiments of the present invention but which uses a physical barrier to deflect the flow out the side outflow orifice. In the current cross stream designs, a static or slow moving column of fluid captures the energy from the high velocity fluid jets resulting in a recovered pressure near the side outflow orifices. This recovered pressure drives fluid out the side outflow orifices. The general principle is that the velocity fluid jets entrain surrounding fluid which enters the catheter from the side inlet orifices. This excess fluid must exit the catheter since the outflow rate of the catheter is balanced to equal the infused flow rate from a suction source, such as a pump. As a result, higher recovered pressure near the side outflow orifices, which generates the recirculating flow pattern at the catheter tip, is seen. There are a number of fluid mechanical inefficiencies associated with such a design. Primarily, the strong high velocity fluid jets end up traveling down past the side outflow orifices and eventually break up into large turbulent eddies. Guiding the flow out a side outflow orifice can preserve some of this energy rather than having it consumed by turbulence inside the catheter. Another alternative design is incorporated to implement waste flow removal by orienting most of the high velocity fluid jets forward and then deflecting them out the distal end of the catheter where a small number of proximal-facing high velocity fluid jets are utilized to drive outflow from the catheter. The other alternative is to apply a roller pump driven waste line to the guide catheter itself and use the roller pump negative pressure to evacuate the waste flow while the deflecting catheter is infusing flow into the patient.

SUMMARY OF THE INVENTION

The general purpose of the present invention is to provide an enhanced cross stream mechanical thrombectomy catheter with backloading manifold. The enhanced cross stream mechanical thrombectomy catheter with backloading manifold is capable of traditional loading over the proximal end of a guidewire or accommodational backloading of the distal end of a guidewire, such as would be useful during an exchange of guidewires whether during or prior to a thrombectomy procedure. Loading of a guidewire through the proximal end of the backloading manifold is accommodated and facilitated by a self-sealing arrangement including a hemostatic nut and a seal at the proximal end of the backloading manifold and by a tubular insert centrally located along the interior of the tubular central body of the backloading manifold. The insert includes a proximally-facing beveled surface entrance leading to an integral and distally located central passageway which extends along the greater portion of the length of the insert where such proximally-facing beveled surface entrance is useful for directing and loading a guidewire (i.e., a proximally loaded and distally directed guidewire) which is first directed in a central direction by the proximally-facing beveled surface entrance followed by passage through the central passageway. The distal and truncated portion of the insert central passageway connects to the proximal end of a catheter tube composed of a braided catheter tube successively connected to a plastic smooth catheter tube leading to an integral flexible and tapered distal tip at the distal portion of the smooth catheter tube. The geometry of a fluid jet emanator and related structure near the distal tip of the smooth catheter tube assists and promotes passage of a guidewire passing in either direction through the fluid jet emanator and related structure.

Cross stream flow at the distal portion of the smooth catheter tube as produced by a fluid jet emanator is enhanced by the use of one outflow orifice and one inflow orifice, thereby allowing concentration and intensity of the cross stream flow to provide only one localized region of thrombus ablation. Such ablation flow creates forces urging the distal portion of the plastic catheter tube away from the ablation area (i.e., away from the cross stream flow) in order that the vasculature walls are not blockingly engaged by the inflow orifice. Such distancing is also helpful in keeping the cross stream flow from being dangerously close to the vasculature wall, thereby minimizing the possibility of vasculature wall damage.

According to one or more embodiments of the present invention, there is provided an enhanced cross stream mechanical thrombectomy catheter with backloading manifold, including a backloading manifold having an exhaust branch and a high pressure connection branch extending from a tubular central body of the backloading manifold, a hemostatic nut threadingly secured to the proximal portion of a proximal cavity body of the backloading manifold, a tubular insert located in an insert cavity of the backloading manifold, a strain relief extending distally from a distal manifold extension of the backloading manifold, a catheter tube formed in part of a braided catheter tube being connected to the insert and extending through the strain relief and in part of a plastic smooth catheter tube successively connected to the braided catheter tube, an inflow and an outflow orifice spaced longitudinally along one side of and located near the proximal end of the plastic smooth catheter tube, an integral flexible tip at the distal end of the plastic smooth catheter tube, and a high pressure tube extending through the high pressure connection branch, through portions of the backloading manifold, partially through the insert, and through the catheter tube composed of the braided catheter tube and plastic smooth catheter tube to terminate as a fluid jet emanator near the distal portion of the plastic smooth catheter tube where such termination is distal of the inflow and the outflow orifices, as well as other components described herein.

One significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold with enhanced efficacy due to concentration of all the flow to one set of inflow and outflow orifices with a guidewire in place.

Another significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold with even greater enhanced efficacy due to concentration of all the flow to one set of inflow and outflow orifices with the removal, retarding or other positioning of a guidewire.

Yet another significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold that utilizes the position of the high pressure tube in relation to the outflow and inflow orifices to enable a guidewire to move freely in and out of the catheter tube without going out one of the orifices.

Still another significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold that has a specially designed insert that allows a guidewire to be completely removed and replaced or exchanged for another desired guidewire.

Another significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold that can be safer than other cross stream designs since the outflow orifice flow pushes the distal catheter end containing the inflow orifice and the outflow orifice away from the vessel wall (the region were damage can occur), thereby minimizing the possibility of blood vessel wall ingestion by the inflow orifice.

Another significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold that employs many of the above significant aspects and features plus additionally including a catheter having a reversed distal end incorporated to intimately contact and remove grumous material from a vessel wall by direct abrading contact and by cross stream flow ablation.

Another significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold that employs many of the above significant aspects and features and has inflow and outflow orifices shaped or sized to give optimal flow direction or performance.

Another significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold that employs many of the above significant aspects and features and wherein the efficacy can be increased by increasing flow to the jet orifices (i.e., currently 60 cc of fluid delivered per minute . . . increased to 100 cc/min).

Another significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold that employs deflection for concentrating and redirecting high velocity fluid jets to form cross stream jets with or without exhaust as an alternative design.

Another significant aspect and feature of the present invention includes an enhanced cross stream mechanical thrombectomy catheter with backloading manifold that can operate in a pressure range of 100 to 20,000 psi.

Yet another significant aspect and feature of the present invention is the use of additional outflow orifices and inflow orifices in angular off center opposition to the main outflow orifice and the inflow orifice.

Having thus described embodiments of the present invention and set forth significant aspects and features of the present invention, it is the principal object of the present invention to provide an enhanced cross stream mechanical thrombectomy catheter with backloading manifold.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the figures thereof and wherein:

FIG. 1 is an isometric view of an enhanced cross stream mechanical thrombectomy catheter with backloading manifold, the present invention;

FIG. 2 is an isometric exploded view of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold;

FIG. 3 is an exploded cross section side view of the components of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold;

FIG. 4 is an isometric view of the insert showing an elongated slot extending through the main body;

FIG. 5 is a cross section view of the assembled elements ofFIG. 3;

FIG. 6 is a cross section view of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold along line6-6 ofFIG. 5;

FIG. 7 is a bottom view of the distal end of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold showing the smooth catheter tube, the outflow orifice, and the inflow orifice, as well as the high pressure tube visible through the outflow orifice and the inflow orifice;

FIG. 8 is an isometric view of the fluid jet emanator;

FIG. 9 is a side view in cross section along line9-9 ofFIG. 8 of the fluid jet emanator;

FIG. 10 is a side view in cross section illustrating the elements ofFIG. 9 secured in the distal portion of the smooth catheter tube by a radiopaque marker band, as well as showing the cross stream flow;

FIG. 11 is a side view of the distal region of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold showing the distal end of a smooth catheter tube assembly positioned in a blood vessel (shown in cross section) at a site of a thrombotic deposit or lesion;

FIG. 12 is a side view in cross section illustrating the introduction of a guidewire into the enhanced cross stream mechanical thrombectomy catheter with backloading manifold;

FIG. 13, a first alternative embodiment, is an isometric view of an enhanced cross stream mechanical thrombectomy catheter with backloading manifold;

FIG. 14 is a partially exploded isometric view of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold illustrated inFIG. 13;

FIG. 15 is a cross section side view of the components of the distal region of the smooth catheter tube assembly along line15-15 ofFIG. 13;

FIG. 16 is a magnified cross section view along line16-16 ofFIG. 15;

FIG. 17 is a cross section view of the smooth catheter tube assembly along line17-17 ofFIG. 16;

FIG. 18 illustrates the distal portion of the smooth catheter tube assembly of the first alternative embodiment in cross section;

FIG. 19 is a side view of the distal region of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold constituting the first alternative embodiment showing the distal end of the smooth catheter tube assembly positioned in a blood vessel (shown in cross section) at a site of a thrombotic deposit or lesion;

FIG. 20, a second alternative embodiment, is an isometric view of an enhanced cross stream mechanical thrombectomy catheter with backloading manifold;

FIG. 21 is a partially exploded isometric view of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold illustrated inFIG. 20;

FIG. 22 is a cross section side view of the components of the distal region of the smooth catheter tube assembly along line22-22 ofFIG. 20;

FIG. 23 is a magnified cross section view along line23-23 ofFIG. 22;

FIG. 24 is a cross section view of the smooth catheter tube assembly along line24-24 ofFIG. 23;

FIG. 25 illustrates the distal portion of the smooth catheter tube assembly of the second alternative embodiment in cross section;

FIG. 26 is a side view of the distal region of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold constituting the second alternative embodiment showing the distal end of the smooth catheter tube assembly positioned in a blood vessel (shown in cross section) at a site of a thrombotic deposit or lesion;

FIG. 27, a third alternative embodiment, is an isometric view of an enhanced cross stream mechanical thrombectomy catheter with backloading manifold including a smooth catheter tube which is curved;

FIG. 28 is a partially exploded isometric view of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold illustrated inFIG. 27;

FIG. 29 is a cross section side view of the components of the distal region of the smooth catheter tube assembly along line29-29 ofFIG. 27;

FIG. 30 is a side view of the distal region of the enhanced cross stream mechanical thrombectomy catheter with backloading manifold constituting the third alternative embodiment at a thrombus site;

FIG. 31 is a cross section view along line31-31 ofFIG. 30;

FIG. 32, a fourth alternative embodiment, is a side view of a smooth catheter tube having an alternate shape outflow orifice;

FIG. 33, a fifth alternative embodiment, is a view of the distal portion of an alternatively provided smooth catheter assembly incorporating the components of the smooth catheter assembly shown in the first embodiment including additional outflow orifices and inflow orifices in angular off-center opposition to the main outflow orifice and the inflow orifice;

FIGS. 34aand34bare cross section views through the outflow orifices and inflow orifices of the smooth catheter assembly alonglines34a-34aand34b-34bofFIG. 33 showing cross stream jet flow regions;

FIG. 35 is likeFIG. 10 wherein the distal portion of the smooth catheter tube additionally includes an outflow orifice and an inflow orifice; and,

FIG. 36 is a cross section view of the distal region of the enhanced cross stream thrombectomy catheter with backloading manifold where the distal end of a smooth catheter tube is positioned in a blood vessel, artery or the like at the site of a thrombotic deposit or lesion.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 is an isometric view of an enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold10, the present invention. Externally visible major components of the invention include a centrally located backloadingmanifold12, ahemostatic nut14 threadingly secured to the backloadingmanifold12, anintroducer15, a flexible andtapered strain relief16 connected to and extending from the backloadingmanifold12, a catheter tube composed of abraided catheter tube18 of flexible or semi-flexible material, preferably polyimide or other such suitable composition, connected to the backloadingmanifold12 and extending through the tapered andflexible strain relief16 and a smoothcatheter tube assembly19 having asmooth catheter tube20 of plastic composition connected to and extending distally from thebraided catheter tube18, and anoutflow orifice22 and aninflow orifice24 located in longitudinal alignment along an imaginary line at the distal portion of thesmooth catheter tube20 near a flexible taperedtip26 located distally at the end of thesmooth catheter tube20. The components of the smoothcatheter tube assembly19 are depicted fully inFIGS. 2 and 3. For illustration purposes, theoutflow orifice22 and the inflow orifice2, which extend through thesmooth catheter tube20, are shown on the side of thesmooth catheter tube20, but can be located along any imaginary line extending longitudinally along a distal surface of thesmooth catheter tube20, such as is shown inFIGS. 3, 7,10 and11. Normally, thecatheter tube18 is formed as a braided construction for strength, as shown, but it can be effectively formed in other ways: for example, by using reinforcing components such as fibers, would strands, rings, wraps, or combinations thereof. Other externally visible major components of the invention include aradiopaque marker band28 located on thesmooth catheter tube20 in close proximity to and proximal to theoutflow orifice22, aradiopaque marker band30 located on thesmooth catheter tube20 in close proximity to and distal to theinflow orifice24, a highpressure connection branch32 extending from thecentral body34 of the backloadingmanifold12, anexhaust branch36 extending from the junction of thecentral body34 of the backloadingmanifold12 and the highpressure connection branch32, and ahigh pressure connector64 engaging with and extending from the highpressure connection branch32 of the backloadingmanifold12. Anorifice65 located in the highpressure connection branch32 allows for the introduction of adhesive43 to secure thehigh pressure connector64 in the highpressure connection branch32.

FIG. 2 is an isometric exploded view of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold10, the present invention, andFIG. 3 is an exploded cross section side view of the components of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold10. With reference toFIGS. 2 and 3, the present invention is now further described.

As also shown in the isometric view ofFIG. 4, theinsert50 includes a tubularmain body74 having a proximally locatedshoulder76 which can be tapered or of other suitable geometric configuration. Theshoulder76 engages an annular transition stop surface78 (FIG. 3) between the proximalinsert cavity portion48 and the distalinsert cavity portion46. One end of acentral passageway80 truncatingly intersects anelongated slot82; and such central passageway also intersects abore84 which is also truncated by intersecting theelongated slot82, i.e., thecentral passageway80 adjoins bore84 and each is truncated by intersection with theelongated slot82. Theelongated slot82 extends through themain body74 to intersect and align to a portion of the longitudinal axis of theinsert50. Theelongated slot82 accommodates passage of thehigh pressure tube71, as shown inFIG. 5. Thecentral passageway80 has a proximally locatedbeveled surface entrance86 resembling a cone. Thebeveled surface entrance86 is utilized for guidance and alignment for backloading of a guidewire through the backloadingmanifold12, as later described in detail.

Beneficial to the instant invention is the use of a self-sealinghemostatic valve88, flanking

washers

90 and92, and anintroducer15 which are related to a patent application entitled “Thrombectomy Catheter Device Having a Self-Sealing Hemostatic Valve,” application Ser. No. 10/455,096, filed Jun. 05, 2003. The self-sealinghemostatic valve88, which is slightly oversized with respect to theproximal manifold cavity52, and the

washers

90 and92 are aligned in and housed in theproximal manifold cavity52 at one end of the backloadingmanifold12. Thehemostatic nut14 includes a centrally locatedcylindrical boss94, acentral passageway96 having abeveled surface entrance97 extending through and in part forming thecylindrical boss94, andinternal threads98. Theinternal threads98 of thehemostatic nut14 can be made to engage the threadedsurface40 of the backloadingmanifold12, whereby thecylindrical boss94 is brought to bear against thewasher90 to resultantly bring pressure to bear as required against the self-sealinghemostatic valve88 andwasher92. The

washers

90 and92 and the self-sealinghemostatic valve88 are captured in theproximal manifold cavity52 by threaded engagement of thehemostatic nut14 to thecavity body38 of the backloadingmanifold12. Also included in thehemostatic nut14 is anannular lip100 which can be utilized for snap engagement of particular styles or types of introducers, as required, such asintroducer15 provided to aid in accommodation of a guidewire in either direction and to provide for venting for the interior of the backloadingmanifold12. Theintroducer15 includes a centrally locatedshaft102 with acentral passageway103 having abeveled surface entrance105, anactuating handle104, and

annular rings

106 and108 about theshaft102. Also shown inFIG. 3 is alumen110 central to thebraided catheter tube18 which joiningly connects to and communicates with alumen112 central to thesmooth catheter tube20. Acircular support ring114 is suitably attached to thehigh pressure tube71, such as by a weldment, and is located within thesmooth catheter tube20 in supporting alignment with theradiopaque marker band28. Afluid jet emanator116 including terminatedloop117 at the distal end of thehigh pressure tube71 and acircular support ring124 is located distal of theinflow orifice24 within the distal end of thesmooth catheter tube20 in alignment with theradiopaque marker band30, as later shown in detail inFIG. 10. The circular support rings114 and124 together with the respective associated

radiopaque marker bands

28 and30 constitute means for retaining thehigh pressure tube71 in alignment with the catheter tube composed ofbraided catheter tube18 and thesmooth catheter tube20.

FIG. 4 is an isometric view of theinsert50 showing theelongated slot82 extending through themain body74 in intersection with thecentral passageway80 and thebore84. Theelongated slot82 is beneficial for accommodation of thehigh pressure tube71, as well as for communication between the

combined lumens

110 and112 of thebraided catheter tube18 and thesmooth catheter tube20, respectively, and the high pressureconnection branch passageway62 and theexhaust branch passageway72, as shown inFIG. 5.

FIG. 5 is a cross section view of the assembled elements ofFIG. 3. Particularly shown is the relationship of thehigh pressure tube71, theinsert50, thelumen110 of thebraided catheter tube18, and the proximal end of thebraided catheter tube18. The proximal portion of thehigh pressure tube71 extends distally from theferrule66 through the high pressureconnection branch passageway62, through theelongated slot82 of theinsert50 while traversing the distal portion of thecentral passageway80 en route to and into thelumen110 of thebraided catheter tube18, and thence along thelumen110 and into thelumen112 of thesmooth catheter tube20 to terminate as part of thefluid jet emanator116 shown adjacent to the flexible taperedtip26 at the distal end of thesmooth catheter tube20. In addition to providing a passage for thehigh pressure tube71, theelongated slot82 allows communication between thelumen110 of thebraided catheter tube18 and thelumen112 of thesmooth catheter tube20, collectively, and the high pressureconnection branch passageway62 and theexhaust branch passageway72 for evacuation of effluence therefrom. Also shown is thejunction118 between thesmooth catheter tube20 and thebraided catheter tube18, such junction being suitably effected to provide for a smooth and continuous coupling of thesmooth catheter tube20 and thebraided catheter tube18.

FIG. 6 is a cross section view of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold12 along line6-6 ofFIG. 5. Shown in particular is theelongated slot82 through which thehigh pressure tube71 passes (passage ofhigh pressure tube71 not shown) and through which communication takes place between thelumen110 of thebraided catheter tube18 and the high pressureconnection branch passageway62 and theexhaust branch passageway72. Also shown is alumen120 central to thehigh pressure tube71.

FIG. 7 is a bottom view of the distal end of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold10 showing thesmooth catheter tube20 and theoutflow orifice22 and theinflow orifice24, as well as thehigh pressure tube71 visible through theoutflow orifice22 and theinflow orifice24.

FIG. 8 is an isometric view andFIG. 9 is a side view in cross section along line9-9 ofFIG. 8 of thefluid jet emanator116. Thefluid jet emanator116 includes a terminatedloop117 at the distal end of thehigh pressure tube71 and includes asupport ring124. The terminatedloop117 includes a plurality of proximally directed jet orifices122a-122n. Thesupport ring124 suitably secures to the distal surface of the terminatedloop117 such as by a weldment. Acenter void126 of the terminatedloop117 allows for passage of a guidewire or other suitable devices. Thesupport ring124, a tubular device, includes acentral passageway128 corresponding in use to that of thecenter void126 of the terminatedloop117 for passage of a guidewire or other suitable devices. A distally locatedannular shoulder130 on thesupport ring124 allows for the inclusion of a beveledannular surface132 juxtaposing thecentral passageway128 to aid in the guided accommodation of a guidewire or other suitable device at the distal portion of thecentral passageway128. A wideannular groove134 is formed between theannular shoulder130 and the distally facing surface of the terminatedloop117 and the smaller radiused body of thesupport ring124. The wideannular groove134 is utilized to secure thefluid jet emanator116 at a suitable location in the distal portion of thesmooth catheter tube20, as shown inFIG. 10.

Mode of Operation

FIG. 11 is a side view of the distal region of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold10 showing in particular the distal end of the smoothcatheter tube assembly19 positioned in a blood vessel142 (shown in cross section) at the site of a thrombotic deposit orlesion144. WhileFIG. 11 depicts the smoothcatheter tube assembly19 as being in a blood vessel in particular, it is to be understood that it is not limited to use in a blood vessel but has utility with respect to any body cavity in general. High velocity fluid jets136a-136n(shown inFIG. 10) of saline or other suitable solution are emanated or emitted in a proximal direction from thefluid jet emanator116 into thesmooth catheter tube20 and pass through theoutflow orifice22 creating cross stream jets140a-140ndirected toward the wall of theblood vessel142 having thrombotic deposits orlesions144 and thence are influenced by the low pressure at theinflow orifice24 to cause the cross stream jets140a-140nto be directed distally substantially parallel to the central axis of theblood vessel142 to impinge and break up thrombotic deposits orlesions144 and to, by entrainment, urge and carry along the dislodged and ablatedthrombotic particulates146 of the thrombotic deposits orlesions144 through theinflow orifice24, a relatively low pressure region, and into thelumen112, which functions as a recycling maceration lumen or chamber and also as an exhaust lumen. The entrainment through theinflow orifice24 is based on entrainment by the high velocity fluid jets136a-136n. The outflow is driven by internal pressure which is created by the high velocity fluid jets136a-136nand the fluid entrained through theinflow orifice24. The enhanced clot removal is enabled because of the recirculation pattern established between inflow and

outflow orifices

22 and24, which creates a flow field that maximizes drag force on wall-adhered thrombus, and because of impingement of the cross stream jets140a-140n. The cross stream jets140a-140n, whilst being forcefully directed outwardly and toward the wall of theblood vessel142, by opposite reaction urge the distal portion of thesmooth catheter tube20 in the direction opposite the outward flow direction and away from the impingement area of the cross stream jets140a-140nwith the immediate thrombotic deposit orlesion144 and/or the wall of theblood vessel142, thus distancing the highly concentrated high velocity cross stream jets140a-140nfrom the immediate thrombotic deposit orlesion144 and/or the wall of theblood vessel142 and thereby minimizing potential blood vessel wall damage. The cross stream jets140a-140ntraversing between theoutflow orifice22 and theinflow orifice24 combine to offer an enhanced broad cross section ablation area, such area having a breadth substantially larger and having more concentrated force than prior art devices using multiple inflow and outflow orifices where cross streams are of diminished force and breadth. Having a concentrated flow combining cross stream jets140a-140noffers selective and directed ablation to take place. Prior art devices using multiple inflow and outflow orifices and having multiple flow areas generate cross streams which are equally weak in all directions, as the flow force is divided between the multiple flow streams, whereby ablation forces cannot be concentrated where desired. The distal end of thesmooth catheter tube20 can be rotated axially to direct the cross stream jets140a-140nabout a longitudinal axis to have 360° coverage or can be rotated axially to offer coverage partially about the longitudinal axis, as required.

The placement of theguidewire141 within or the removal of theguidewire141 from the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold10 influences the operation of the invention. Suitably strong and well directed ablation flow can take place with aguidewire141 extending the full length of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold10 and/or additionally extending in a distal direction beyond the flexible taperedtip26 and along the vasculature. Such ablation flow can be further improved, enhanced, modified or otherwise influenced by varying the location of or by full removal of theguidewire141. With reference toFIG. 10, theguidewire141, as shown, allows suitable transition of the high velocity fluid jets136a-136nthrough theoutflow orifice22 to form cross stream jets140a-140nwhich return via theinflow orifice24. If, for example, theguidewire141 is urged proximally to aguidewire end position141abetween theinflow orifice24 and theoutflow orifice22, theinflow orifice24 is totally unrestricted and has less flow resistance, thereby allowing greater and more forceful ingress of the cross stream jets140a-140nladen with ablatedthrombotic particulates146, whereas the flow through theoutflow orifice22 remains substantially constant. Urging theguidewire141 further in a proximal direction to aguidewire end position141bdistal to theoutflow orifice22 causes theoutflow orifice22 and theinflow orifice24 both to be totally unrestricted and both to have less flow resistance, thereby allowing greater and more forceful flow from theoutflow orifice22, as well as resultantly increased ingress of the cross stream jets140a-140nladen with ablatedthrombotic particulates146 through theinflow orifice24. Each of the examples given above where theguidewire141 is not totally removed from thesmooth catheter tube20 or other proximally located regions promotes sustained maceration of the loitering entrained ablatedthrombotic particulates146 where the smaller ablatedthrombotic particulates146 are exhausted proximally through thesmooth catheter tube20, thebraided catheter tube18, and the associated and pertinent structure proximal thereto. In another example, urging of theguidewire141 to a position proximal of the proximal end of thebraided catheter tube18 or total removal of theguidewire141, in addition to allowing total unrestricted flow through theoutflow orifice22 and theinflow orifice24, allows unrestricted flow of ablatedthrombotic particulates146 along thesmooth catheter tube20, thebraided catheter tube18, and the associated and pertinent structure proximal thereto.

The preferred embodiment comprises asingle outflow orifice22, a corresponding cross stream jet which may be split in two by passage aroundhigh pressure tube71, and asingle inflow orifice24.

Although the preferred embodiment as illustrated incorporates aninflow orifice24 and anoutflow orifice22 aligned to thehigh pressure tube71, one or both of the inflow or outflow orifices may be located so that they do not align with the high pressure tube; in this case, other means for guiding a guidewire past the orifice(s) is provided to prevent the guidewire from inadvertently passing through the non-aligned orifice(s).

The invention also includes methods of treating a body vessel according to the aforementioned mode of operation.

FIG. 12 is a side view in cross section illustrating the introduction of theguidewire141 into the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold10. When it is desired to remove a guidewire, such asguidewire141, or exchange guidewires having different attributes, backloading is facilitated by the structure of theinsert50. Loading can be accomplished, if necessary, using theintroducer15 to gain entry through the self-sealinghemostatic valve88 where the introducer parts the sealing structure of the self-sealinghemostatic valve88 to allow entry of theguidewire141 therethrough. Otherwise the guidewire can pass unaided through the self-sealinghemostatic valve88. The tip of the guidewire may not be in proper alignment with thecentral passageway80, such as is shown by theguidewire141 shown in dashed lines. In such case, impingement of the tip of the distally urgedguidewire141 with the conically-shapedbeveled surface entrance86 ofcentral passageway80 directs the tip of theguidewire141 to align with and to be engaged within thecentral passageway80 of theinsert50 and to be in alignment, as shown, within thecentral passageway80 so as to align with and be subsequently engaged within the proximal portion of thebraided catheter tube18 for passage therethrough. Distal urging of theguidewire141 also positions the tip of theguidewire141 for passage through the distal region of thesmooth catheter tube20 where the geometry helpfully accommodates such passage by and along theoutflow orifice22 and theinflow orifice24 and through thefluid jet emanator116, thesupport ring124, and the flexible taperedtip26. Preferably, the tip of theguidewire141 is dome-shaped. Such a dome shape is easily guided by and accommodated by the proximally-facing rounded surface of the terminatedloop117 of thefluid jet emanator116. Use of theintroducer15 can also be utilized if front loading of a guidewire is required for passage through the self-sealinghemostatic valve88. Preferably, theguidewire141 exhibits sufficient size, flexibility and other attributes to navigate the tortuous vascular paths, but exhibits sufficient rigidity not to kink, bend or otherwise be permanently deformed and to stay within the appropriate confines of the distal portion of thesmooth catheter tube20 and not stray through theoutflow orifice22 or theinflow orifice24. The cross sections of theoutflow orifice22 and theinflow orifice24 are such that entry thereinto of the horizontally aligned guidewire of sufficient size and larger cross section profile is next to impossible. Notwithstanding, the use of one pair of inflow and outflow orifices further reduces the chance of inadvertent exiting of the guidewire tip through an orifice.

The present invention also includes methods of fabricating an enhanced cross stream mechanical thrombectomy catheter with backloading manifold including steps of providing components as disclosed herein and steps of aligning the provided components and steps of affixing the aligned provided components to retain the components in the aligned configuration as indicated inFIGS. 5, 7 and10.

FIG. 14 is a partially exploded isometric view of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold210;FIG. 15 is a cross section side view of the components of the distal region of the smoothcatheter tube assembly212 along line15-15 ofFIG. 13; andFIG. 16 is a magnified cross section view along line16-16 ofFIG. 15. With reference toFIGS. 14, 15 and16, the first alternative embodiment is now further described.

The smoothcatheter tube assembly212, the components of which are depicted fully inFIGS. 13 and 14, includes a centrally locatedsmooth catheter tube224, having

lumens

222aand222b, about which or in which other components are located, including aguidewire tube228 having alumen230 which aligns preferably in opposition to theoutflow orifice214, theinflow orifice216, and theevacuation orifice218 along the opposing outer surface of thesmooth catheter tube224 and which extends along thesmooth catheter tube224 from and including the flexibletapered tip220 to enter and pass within thelumen110 of thebraided catheter tube18 at or near thejunction118ato the interior of the backloadingmanifold12. A flexibleplastic sheath232, part of the smoothcatheter tube assembly212, encompasses thesmooth catheter tube224 and extends the length thereof from the flexibletapered tip220 until reaching thejunction118a. The proximal portion of thehigh pressure tube71 extends distally and through thelumen110 of thebraided catheter tube18, and thence along thelumen222aof and along thesmooth catheter tube224 to terminate as part of thefluid jet emanator116 shown inFIG. 15 adjacent to the flexibletapered tip220 at the distal end of thelumen222bof the smoothcatheter tube assembly212. Adeflector234 in the form of a truncated solid structure and including adeflector face236 suitably angled with respect to the longitudinal axis of thesmooth catheter tube224 is located between the

lumens

222aand222bof thesmooth catheter tube224 and defines the separation of the

lumens

222aand222bwherelumen222aextends proximally along the interior of thesmooth catheter tube224 from thedeflector234 in communication with theevacuation orifice218 and where thelumen222bextends distally from thedeflector234 in communication with theoutflow orifice214 and theinflow orifice216 until terminating at the flexibletapered tip220. Thedeflector234 is located in close proximity to theoutflow orifice214 and is oriented to cause the deflection of the highly pressurized fluid jets projected proximally from thefluid jet emanator116 to be reflectingly and deflectingly directed through theoutflow orifice214, as described later in detail. Thedeflector234 aids in structural integrity of the distal portion of thesmooth catheter tube224 as does the structure of thefluid jet emanator116. Also shown inFIG. 14 is thejunction118abetween the smoothcatheter tube assembly212 and thebraided catheter tube18, such junction being suitably effected to provide for a smooth and continuous coupling of the smoothcatheter tube assembly212 and thebraided catheter tube18.

FIG. 17 is a cross section view of the smoothcatheter tube assembly212 along line17-17 ofFIG. 16. Shown in particular is anelongated slot238 extending longitudinally through the upper surface of thedeflector234 through which thehigh pressure tube71 passes and secures such as by welding or other suitable means. Also shown is thesheath232 surroundingly encompassing thesmooth catheter tube224 and theguidewire tube228, thereby securing theguidewire tube228 to thesmooth catheter tube224.

Mode of Operation

The mode of operation of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold210 is explained with reference toFIGS. 18 and 19.FIG. 18 illustrates the distal portion of the smoothcatheter tube assembly212 in cross section and the use of a vacuum source, such as a vacuum pump orroller pump239, which connects through thelumen222aof thesmooth catheter tube224 to theexhaust branch36 of the backloadingmanifold12. High velocity fluid jets240a-240nare shown emanating proximally from the plurality of jet orifices122a-122nof the terminatedloop117 of thefluid jet emanator116 into thelumen222bof thesmooth catheter tube224 for subsequent creation of and culminating in cross stream jets242a-242n, shown by heavy lines, where the high velocity fluid jets240a-240nare concentratingly deflected and redirected by thedeflector face236 of thedeflector234 to flow as cross stream jets242a-242nfrom theoutflow orifice214 and return through theinflow orifice216 while accomplishing ablative action with adhered blood vessel thrombus foreign material and for maceration of foreign material in concert with the high velocity fluid jets240a-240n. A great preponderance of foreign material is introduced through theinflow orifice216 and into thelumen222bafter dislodging from a blood vessel wall for macerating impingement by the high velocity fluid jets240a-240n. Macerated small mass foreign material, i.e., thrombotic particulate, contained in the cross stream jets242a-242n, especially that foreign material near theoutflow orifice214, is drawn from the flow of the cross stream jets242a-242nby the relatively low pressure area presented at theevacuation orifice218 along an additional and proximally directedflow244 from theoutflow orifice214 to theevacuation orifice218 and thence proximally through and within thelumen222aof thesmooth catheter tube224, as also depicted by heavy lines. A previously placed guidewire (not shown) is incorporated to load the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold210 within the vasculature by first utilizing the distal end of thelumen230 of theguidewire tube228 followed by subsequent advancement by the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold210 along the guidewire in close proximity to a thrombus site. In the alternative, the first guidewire can be withdrawn completely from the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold210 and swapped by backloading with another guidewire of other properties and attributes if required. An advantage of the present invention is that the guidewire can be introduced by a front loading approach or by a backloading approach and, therefore, the guidewire can be removed and reintroduced or can be replaced by a different guidewire.

FIG. 19 is a side view of the distal region of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold210 showing in particular the distal end of the smoothcatheter tube assembly212 positioned in a blood vessel142 (shown in cross section) at a site of a thrombotic deposit orlesion144. WhileFIG. 19 depicts the smoothcatheter tube assembly212 as being in a blood vessel in particular, it is to be understood that it is not limited to use in a blood vessel, but has utility with respect to any body cavity in general. High velocity fluid jets240a-240n(shown inFIG. 18) of saline or other suitable solution are emanated or emitted in a proximal direction from thefluid jet emanator116 into thesmooth catheter tube224 and pass through theoutflow orifice214 creating cross stream jets242a-242ndirected toward the wall of theblood vessel142 having thrombotic deposits orlesions144 and thence are influenced by the low pressure at theinflow orifice216 to cause the cross stream jets242a-242nto be directed distally substantially parallel to the central axis of theblood vessel142 to impinge and break up thrombotic deposits orlesions144 and to, by entrainment, urge and carry along the dislodged and ablatedthrombotic particulate146 of the thrombotic deposits orlesions144 through theinflow orifice216, a relatively low pressure region, and into thelumen222b, which functions as a recycling maceration lumen or chamber or somethrombotic particulate146 may enter theevacuation orifice218. The entrainment through theinflow orifice216 is facilitated by a low pressure source presented by the high velocity fluid jets240a-240n. The outflow is driven in part by internal pressure which is created by the high velocity fluid jets240a-240n, but more generally, outflow drive is caused by the suction (low pressure region) at theevacuation orifice218 and proximally alonglumen222aas provided by the vacuum pump orroller pump239. The enhanced clot removal is enabled by of the recirculation pattern established between inflow and

outflow orifices

216 and214, which creates a flow field that maximizes drag force on wall-adhered thrombus, and because of impingement of the cross stream jets242a-242n. The cross stream jets242a-242n, while being forcefully directed outwardly and toward the wall of theblood vessel142 by opposite reaction urge the distal portion of thesmooth catheter tube224 in the direction opposite the outward flow direction and away from the impingement area of the cross stream jets242a-242nwith the immediate thrombotic deposit orlesion144 and/or the wall of theblood vessel142, thus distancing the highly concentrated cross stream jets242a-242nfrom the immediate thrombotic deposit orlesion144 and/or the wall of theblood vessel142, and thereby minimizing potential blood vessel wall damage. Such distancing also removes theinflow orifice216 from close proximity with and away from the opposed wall of theblood vessel142 thereby minimizing the chance of ingestion of theblood vessel142 wall structure by theinflow orifice216.

The cross stream jets242a-242ntraversing between theoutflow orifice214 and theinflow orifice216 combine to offer an enhanced broad cross section ablation area, such area having a breadth substantially larger and having more concentrated force than prior art devices using multiple inflow and outflow orifices where cross streams are of diminished force and breadth. Having a concentrated flow combining cross stream jets242a-242noffers selective and directed ablation to take place. Prior art devices using multiple inflow and outflow orifices and having multiple flow areas generate cross streams which are equally weak in all directions, as the flow force is divided between the multiple flow streams, whereby ablation forces cannot be concentrated where desired. The distal end of thesmooth catheter tube224 can be rotated axially to direct the cross stream jets242a-242nabout a longitudinal axis to have 360° coverage or can be rotated axially to offer coverage partially about the longitudinal axis or can be operated to and fro, as required.

FIG. 21 is a partially exploded isometric view of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold310;FIG. 22 is a cross section side view of the components of the distal region of the smoothcatheter tube assembly312 along line22-22 ofFIG. 20; andFIG. 23 is a magnified cross section view along line23-23 ofFIG. 22. With reference toFIGS. 21, 22 and23, the second alternate embodiment is now further described.

The smoothcatheter tube assembly312, the components of which are depicted fully inFIGS. 20 and 21, includes a centrally locatedsmooth catheter tube324 having

lumens

322aand322b, about which or in which other components are located, including aguidewire tube328 having alumen330 which aligns preferably in opposition to theoutflow orifice314, theinflow orifice316, and theevacuation orifice318 along the opposing outer surface of thesmooth catheter tube324 and which extends along thesmooth catheter tube324 from and including the flexibletapered tip320 to enter and pass within thelumen110 of thebraided catheter tube18 at or near thejunction118bto the interior of the backloadingmanifold12. A flexibleplastic sheath332, part of the smoothcatheter tube assembly312, encompasses thesmooth catheter tube324 and extends the length thereof from the flexibletapered tip320 until reaching thejunction118b. The proximal portion of thehigh pressure tube71 extends distally and through thelumen110 of thebraided catheter tube18, and thence along thelumen322aof and along thesmooth catheter tube324 to terminate as part of a multidirectionalfluid jet emanator116a shown inFIG. 22. In this embodiment, the multidirectionalfluid jet emanator116ais located between theinflow orifice316 and theevacuation orifice318 of thesmooth catheter tube324 and defines the separation of the

lumens

FIG. 24 is a cross section view of the smoothcatheter tube assembly312 along line24-24 ofFIG. 23. Shown in particular is theevacuation orifice318 which passes through both theplastic sheath332 and thesmooth catheter tube324.

Mode of Operation

The mode of operation of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold310 is explained with reference toFIGS. 25 and 26.FIG. 25 illustrates the distal portion of the smoothcatheter tube assembly312 in cross section and the use of an optional vacuum source, such as a vacuum pump orroller pump339, which connects through thelumen322aof thesmooth catheter tube324 to theexhaust branch36 of the backloadingmanifold12. High velocity fluid jets340a-340nare shown emanating distally from the plurality of jet orifices125a-125nin thedistal loop117bof thefluid jet emanator116 into thelumen322bof thesmooth catheter tube324 for subsequent creation of and culminating in cross stream jets342a-342n, as shown by heavy lines, where the high velocity fluid jets340a-340nare concentratingly deflected and redirected by thedeflector face336 of thedeflector334 to flow as cross stream jets342a-342nfrom theoutflow orifice314 and return through theinflow orifice316 while accomplishing ablative action with adhered blood vessel thrombus foreign material and for maceration of foreign material in concert with the high velocity fluid jets340a-340n. A great preponderance of foreign material is introduced through theinflow orifice316 and into thelumen322bafter dislodging from a blood vessel wall for macerating impingement by the high velocity fluid jets340a-340n. Macerated small mass foreign material, i.e., thrombotic particulate, contained in the cross stream jets342a-342n, especially that foreign material near theinflow orifice316, is drawn from the flow of the cross stream jets342a-342nby the relatively low pressure area presented at theevacuation orifice318 along an additional and proximally directedflow344 from near theinflow orifice316 to theevacuation orifice318 and thence proximally through and within thelumen322aof thesmooth catheter tube324, as also depicted by heavy lines. Proximally directed high velocity fluid jets346a-346nemanating proximally from the plurality of jet orifices123a-123nin theproximal loop117a into thelumen322aof thesmooth catheter tube324 create the relatively low pressure presented at theevacuation orifice318 to draw thrombotic particulate through theevacuation orifice318 and to provide a proximally directed driving force to urge the thrombotic particulate proximally along thelumen322a.

A previously placed guidewire (not shown) is incorporated to load the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold310 within the vasculature by first utilizing the distal end of thelumen330 of theguidewire tube328 followed by subsequent advancement by the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold310 along the guidewire in close proximity to a thrombus site. In the alternative, the first guidewire can be withdrawn completely from the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold310 and swapped by backloading with another guidewire of other properties and attributes, if required. An advantage of the present invention is that the guidewire can be introduced by a front loading approach or by a backloading approach and, therefore, the guidewire can be removed and reintroduced or can be replaced by a different guidewire.

FIG. 26 is a side view of the distal region of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold310 showing in particular the distal end of the smoothcatheter tube assembly312 positioned in a blood vessel142 (shown in cross section) at a site of a thrombotic deposit orlesion144. WhileFIG. 26 depicts the smoothcatheter tube assembly312 as being in a blood vessel in particular, it is to be understood that it is not limited to use in a blood vessel but has utility with respect to any body cavity in general. High velocity fluid jets340a-340n(shown inFIG. 25) of saline or other suitable solution are emanated or emitted in a distal direction from the multidirectionalfluid jet emanator116ainto thelumen322bof thesmooth catheter tube324 and are concentratingly deflected and redirected by thedeflector334 to pass through theoutflow orifice314 creating cross stream jets342a-342ndirected toward the wall of theblood vessel142 having thrombotic deposits orlesions144 and thence are influenced by the low pressure at theinflow orifice316 to cause the cross stream jets342a-342nto be directed proximally substantially parallel to the central axis of theblood vessel142 to impinge and break up thrombotic deposits orlesions144 and to, by entrainment, urge and carry along the dislodged and ablatedthrombotic particulate146 of the thrombotic deposits orlesions144 through theinflow orifice316, a relatively low pressure region, and into thelumen322b, which functions as a recycling maceration lumen or chamber, or somethrombotic particulate146 may enter theevacuation orifice318. The entrainment through theevacuation orifice318 is facilitated by a low pressure source presented by the high velocity fluid jets346a-346ndirected proximally along thelumen322afor entrainment ofthrombotic particulate146 along the path of the proximally directedflow344 for ingestion ofthrombotic particulate146 through theevacuation orifice318. The outflow is driven by internal pressure which is created by the high velocity fluid jets346a-346nproximally directed along thelumen322a, but alternatively, the outflow drive can be assisted by the suction (low pressure region) at thelumen322aas provided by the vacuum pump orroller pump339. The enhanced clot removal is enabled by the recirculation pattern established between inflow and

outflow orifices

316 and314, which creates a flow field that maximizes drag force on wall-adhered thrombus, and because of impingement of the cross stream jets342a-342n. The cross stream jets342a-342n, while being forcefully directed outwardly and toward the wall of theblood vessel142 by opposite reaction, urge the distal portion of thesmooth catheter tube324 in the direction opposite the outward flow direction and away from the impingement area of the cross stream jets342a-342nwith the immediate thrombotic deposit orlesion144 and/or the wall of theblood vessel142, thus distancing the highly concentrated cross stream jets342a-342nfrom the immediate thrombotic deposit orlesion144 and/or the wall of theblood vessel142, and thereby minimizing potential blood vessel wall damage. Such distancing also removes theinflow orifice316 from close proximity with and away from the opposed wall of theblood vessel142, thereby minimizing the chance of ingestion of theblood vessel142 wall structure by theinflow orifice316.

The cross stream jets342a-342ntraversing between theoutflow orifice314 and theinflow orifice316 combine to offer an enhanced broad cross section ablation area, such area having a breadth substantially larger and having more concentrated force than prior art devices using multiple inflow and outflow orifices where cross streams are of diminished force and breadth. Having a concentrated flow combining cross stream jets342a-342noffers selective and directed ablation to take place. Prior art devices using multiple inflow and outflow orifices and having multiple flow areas generate cross streams which are equally weak in all directions, as the flow force is divided between the multiple flow streams, whereby ablation forces cannot be concentrated where desired. The distal end of thesmooth catheter tube324 can be rotated axially to direct the cross stream jets342a-342nabout a longitudinal axis to have 360° coverage or can be rotated axially to offer coverage partially about the longitudinal axis or can be operated to and fro, as required.

FIG. 27, a third alternative embodiment, is an isometric view of an enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold410 incorporating much of the structure previously described, but differing by the substitution of a smoothcatheter tube assembly412, including asmooth catheter tube424, which is curved approximately 180°, and other components and structure housed in the smoothcatheter tube assembly412 for the straight smoothcatheter tube assembly19 and previously described components and structure housed in the straight smoothcatheter tube assembly19 of the first embodiment. Also, previously described components are utilized including the components of or components attached to or associated with the centrally located backloadingmanifold12 involving thehemostatic nut14, theintroducer15, the flexible andtapered strain relief16, and thebraided catheter tube18. Thesmooth catheter tube424, which is continuous, flexible and exhibits position memory, includes acurved section424alocated between a reversedsection424band astraight section424copposing the reversedsection424b. The smoothcatheter tube assembly412 is connected to and extends distally from thebraided catheter tube18 at ajunction118cand includes anoutflow orifice414 and aninflow orifice416 each extending through the wall of the reversedsection424bof thesmooth catheter tube424 and each located in longitudinal alignment along an imaginary line at the inwardly facingaspect418 of the reversedsection424bof thesmooth catheter tube424 and each opposingly facing thestraight section424cof thesmooth catheter tube424. Also included as part of the reversedsection424bis a distally located flexibletapered tip420.

Radiopaque marker bands

419 and421 are located on the reversedsection424bof thesmooth catheter tube424 flanking theoutflow orifice414 and theinflow orifice416.

FIG. 28 is a partially exploded isometric view of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold410; andFIG. 29 is a cross section side view of the components of the distal region of the smoothcatheter tube assembly412 along line29-29 ofFIG. 27. With reference toFIGS. 28 and 29, the third alternative embodiment is now further described.

The smoothcatheter tube assembly412, the components of which are depicted fully inFIGS. 27 and 28, includes alumen422 extending the length of the centrally locatedsmooth catheter tube424 including the flexibletapered tip420, the reversedsection424b, thecurved section424a, and thestraight section424cabout which and in which other components are located to connect with thelumen110 of thebraided catheter tube18 at or near thejunction118cto the interior of the backloadingmanifold12. The proximal portion of thehigh pressure tube71 extends distally and through thelumen110 of thebraided catheter tube18, and thence along thelumen422 of and along thesmooth catheter tube424 to terminate as part of thefluid jet emanator116, shown inFIG. 29, adjacent to the flexibletapered tip420 at the distal end of thelumen422 of thesmooth catheter tube424. In addition to the inwardly facingaspect418 along the reversedsection424b, outwardly facing aspects are incorporated into thesmooth catheter tube424, including an outwardly facingaspect426 along the outer portion of the reversedsection424band an outwardly facingaspect428 along the outer portion of thestraight section424c. Also shown inFIG. 27 is thejunction118cbetween the smoothcatheter tube assembly412 and thebraided catheter tube18, such junction being suitably effected to provide for a smooth and continuous coupling of the smoothcatheter tube assembly412 and thebraided catheter tube18.

Mode of Operation

FIG. 30 is a side view of the distal region of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold410 showing, in particular, the distal end of thesmooth catheter tube424 positioned in a blood vessel142 (shown in cross section) at a site of a thrombotic deposit orlesion144, andFIG. 31 is a cross section view along line31-31 ofFIG. 30 showing ablative action of the cross stream jets442a-442nwith the thrombotic deposit orlesion144, as previously described, and additionally shows abrading or scraping action of the distal end of thesmooth catheter tube424 by intimate contact with foreign matter, such asthrombus material144, in ablood vessel142 which could be a large blood vessel. WhileFIG. 30 depicts thesmooth catheter tube424 as being in a blood vessel in particular, it is to be understood that it is not limited to use in a blood vessel, but has utility with respect to any body cavity in general. High velocity fluid jets440a-440n(shown inFIG. 29) of saline or other suitable solution are emanated or emitted in a proximal direction from thefluid jet emanator116 into thesmooth catheter tube424 and pass through theoutflow orifice414 creating cross stream jets442a-442ndirected toward the wall of theblood vessel142 having thrombotic deposits orlesions144, and thence are influenced by the low pressure at theinflow orifice416 to cause the cross stream jets442a-442nto be directed distally substantially parallel to the central axis of theblood vessel142 to impinge and break up thrombotic deposits orlesions144 and to, by entrainment, urge and carry along the dislodged and ablatedthrombotic particulate146 of the thrombotic deposits orlesions144 through theinflow orifice416, a relatively low pressure region, and into thelumen422 which functions as a recycling maceration lumen or chamber. The entrainment through theinflow orifice416 is facilitated by a low pressure source presented by the high velocity fluid jets440a-440n. The outflow is driven by internal pressure which is created by the high velocity fluid jets440a-440n. The enhanced clot removal is enabled because of the recirculation pattern established between inflow and

outflow orifices

416 and414, which creates a flow field that maximizes drag force on wall-adhered thrombus and because of impingement of the cross stream jets442a-442n.

Intimate contact of or close proximity of the generally distal portion of thesmooth catheter tube424 to the inside wall of theblood vessel142, as shown best inFIG. 31, offers yet another innovative method of thrombotic deposit orlesion144 removal. The cross stream jets442a-442n, while being forcefully directed outwardly and toward the wall of theblood vessel142 during ablation activities by opposite reaction, urge the generally distal portion of thesmooth catheter tube424 in the direction opposite the outward flow direction and away from the impingement area of the cross stream jets442a-442nwith the immediate thrombotic deposit orlesion144 and/or the wall of theblood vessel142, thus distancing the cross stream jets442a-442nfrom the immediate thrombotic deposit orlesion144 and/or the wall of theblood vessel142, and thereby minimizing the danger or chance of potential blood vessel wall damage or ingestion. Thus, the reversedsection424b, particularly the outwardly facingaspect426 thereof, is forcibly maneuvered into intimate contact or into close proximity to the inside wall of theblood vessel142, as shown inFIG. 31. Such intimate contact or close proximity to the inside wall of theblood vessel142 is utilized to advantage by rotating the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold410, particularly thesmooth catheter tube424, within theblood vessel142, such as indicated byrotation arrows444. Such causes scraping and abrading impingement of the reversedsection424b, especially the outwardly facingaspect426 thereof, with the thrombotic deposit orlesion144 at or near the inner wall of theblood vessel142 to urge thrombotic (and lesion) particulate146ato part from the general structure of the thrombotic deposits orlesion144 and be entrained into the flow of the cross stream jets442a-442nfor maceration and/or evacuation through thelumen422, as shown inFIG. 31. To and fro operation of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold410 can also be incorporated into operation of the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold410 either singularly or in combination with rotation, as just described. Further, if the general distal end of thesmooth catheter tube424 is larger, or if the blood vessel is smaller, both thestraight section424cwith the outwardly facingaspect428 and the reversedsection424bwith the outwardly facingaspect426 can be utilized for rotational or for to and fro motion scraping and abrading impingement with the thrombotic deposits orlesions144 at or near the inner wall of theblood vessel142 to urge thrombotic (and lesion) particulate146ato part from the general structure of the thrombotic deposits orlesion144 to be entrained into the flow of the cross stream jets442a-442nfor maceration and/or evacuation through thelumen422. Even more vigorous scraping and abrading could be accomplished if the general distal end of thesmooth catheter tube424 were slightly oversized with respect to theblood vessel142.

A previously placed guidewire (not shown) is incorporated to load the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold410 within the vasculature by first utilizing the distal end of thelumen422 followed by subsequent advancement by the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold410 along the guidewire in close proximity to a thrombus site. In the alternative, the first guidewire can be withdrawn completely from the enhanced cross stream mechanical thrombectomy catheter with backloadingmanifold410 and swapped by backloading with another guidewire of other properties and attributes, if required. An advantage of the present invention is that the guidewire can be introduced by a front loading approach or by a backloading approach and, therefore, can be removed and reintroduced or can be replaced by a different guidewire.

The concentrated cross stream jets442a-442ntraversing between theoutflow orifice414 and theinflow orifice416 combine to offer an enhanced broad cross section ablation area, such area having a breadth substantially larger and having more concentrated force than prior art devices using multiple inflow and outflow orifices where cross streams are of diminished force and breadth. Having a concentrated flow combining cross stream jets442a-442noffers selective and directed ablation to take place. Prior art devices using multiple inflow and outflow orifices and having multiple flow areas generate cross streams which are equally weak in all directions, as the flow force is divided between the multiple flow streams, whereby ablation forces cannot be concentrated where desired. The distal end of thesmooth catheter tube424 can be rotated axially to direct the cross stream jets442a-442nabout a longitudinal axis to have 360° coverage or can be rotated axially to offer coverage partially about the longitudinal axis, as required.

FIG. 32, a fourth alternative embodiment, is a side view of asmooth catheter tube450 similar for the most part to and using components associated with thesmooth catheter tube20 of the first embodiment for use with an enhanced cross stream mechanical thrombectomy catheter with backloading manifold. Thesmooth catheter tube450 includes a flexibletapered tip452, aninflow orifice458, and anoutflow orifice460, each orifice extending through the wall of thesmooth catheter tube450 where the outflow orifice takes on an L-shape to influence and shape the pattern of the cross stream jets which pass therethrough. Theoutflow orifice460, as well as even the inflow orifice, could incorporate other shapes, such as, but not limited to, round, oval, elliptical, obround, tapered, slotted, rectangular, and rounded corner, or could be protruding.

Radiopaque marker bands

454 and456 are provided, as in the other embodiments.

FIG. 33, a fifth alternative embodiment, is a view of the distal portion of an alternatively providedsmooth catheter assembly19aincorporating the components of thesmooth catheter assembly19 shown in the first embodiment including additional outflow orifices and inflow orifices in equal and symmetric angular off-center opposition to themain outflow orifice22 and theinflow orifice24.

FIG. 35 is likeFIG. 10 wherein the distal portion of thesmooth catheter tube20 additionally shows theoutflow orifice504 and theinflow orifice506 in the structure thereof. In addition to the attributes, features and flow paths described inFIG. 10, high pressure jet streams136a-136nare shown emanating proximally from the plurality of jet orifices122a-122ninto thelumen112 of thesmooth catheter tube20 for subsequent creation of and culminating in cross stream jets508a-508nshown traveling from theoutflow orifice504 and returning through theinflow orifice506 for entry for maceration by the high pressure jet streams136a-136nand/or exhausting proximally with the flow within the distal portion of thesmooth catheter tube20 as generally depicted by arrowed lines. Theoutflow orifice500 and theinflow orifice502 are incorporated into use in the same manner culminating in symmetrically disposed cross stream jets510a-510nshown traveling from theoutflow orifice500 and returning through theinflow orifice502 shown inFIG. 36.

In addition to longitudinal alignment of theoutflow orifice500 andcorresponding inflow orifice502 and of theoutflow orifices504 andcorresponding inflow orifice506 with respect to each other and to theinflow orifice22 and of theoutflow orifices24 along imaginary lines, symmetrical alignment attributes and relationships are also addressed in the terms of cross stream jet flow region relationships as shown inFIGS. 34aand34b. A major cross streamjet flow region512 centers along and about the cross stream jets140a-140n, theoutflow orifice22 andinflow orifice24 and substantially along the center of thelumen112, such region being substantially perpendicular to theoutflow orifice22 andinflow orifice24. In a somewhat similar fashion, a minor cross streamjet flow region514 centers along and about the cross stream jets510a-510n(FIG. 36), theoutflow orifice500 andinflow orifice502 and substantially along the center of thelumen112 such region being substantially perpendicular to theoutflow orifice500 andinflow orifice502. Also in a somewhat similar fashion, a minor cross streamjet flow region516 centers along and about the cross stream jets508a-508n, theoutflow orifice504 andinflow orifice506 and substantially along the center of thelumen112, such region being substantially perpendicular to theoutflow orifice504 andinflow orifice506. Symmetrical angular relationships are maintained between major cross streamjet flow region512 and each of the minor cross stream

jet flow regions

514 and516. For purposes of example and illustration, an angle X between the major cross streamjet flow region512 and the minor cross streamjet flow region514 corresponds to and is the same value as an angle X between the major cross streamjet flow region512 and the minor cross streamjet flow region516, whereby symmetry exists. The value of the angle X can be unilaterally changed during manufacturing to maintain symmetry, as just previously described. The resultant combination of symmetric but lesser flow along and about the minor cross stream

jet flow regions

514 and516 opposes the stronger flow along and about the major cross streamjet flow region512 to assist in centering of thesmooth catheter assembly19awithin a blood vessel, as well as offering ablation services while still allowing urging of thesmooth catheter assembly19atoward the periphery of ablood vessel142.

FIG. 36 is likeFIG. 11 wherein a cross section view of the distal region of the enhanced cross stream thrombectomy catheter with backloadingmanifold10 incorporating the use of the smoothcatheter tube assembly19awith attention to the distal end of thesmooth catheter tube20 positioned in ablood vessel142, artery or the like at the site of a thrombotic deposit orlesion144 or other undesirable matter. In addition to and in cooperation with the mode of operation of the first embodiment, such as described inFIG. 11 and associated figures, the use and features of theoutflow orifice500 and theinflow orifice502 and of the similarly constructed and similarfunctioning outflow orifice504 and the inflow orifice506 (not shown) are also described, wherein the cross stream jets510a-510n, directly related to the minor cross streamjet flow region514, being similar to cross stream jets508a-508n, directly related to minor cross streamjet flow region516, are directed away from the main cross stream path, such as provided by the cross stream jets140a-140n, directly related to the major cross streamjet flow region512, to offer additional ablation and exhausting of thrombotic deposits orlesions144 to that region where thesmooth catheter tube20 is directed and urged toward theblood vessel144 by the more influential power of the relatively stronger cross stream jets140a-140n. Such positional urging of thesmooth catheter tube20, as described in the first embodiment, is the dominant factor in urging of thesmooth catheter tube20 away from the wall of theblood vessel142 near theoutflow orifice22 andinflow orifice24 as the flow and force therethrough is greater than that provided by such combined flow and force through theoutflow orifice500 to theinflow orifice502 and of theoutflow orifice504 to theinflow orifice506. The use of theorifice500 and theinflow orifice502 and of the similarly constructed and similarfunctioning outflow orifice504 and theinflow orifice506 provide for more complete ablation and exhausting while still allowing urging of thesmooth catheter tube20 towards the side of theblood vessel142 opposite the greater ablation activity. Symmetry of the cross stream jet flows are provided by the equiangular offset of theoutflow orifice500 and theinflow orifice502 and of the similarly constructed and similarfunctioning outflow orifice504 and theinflow orifice506 with respect to the cross stream jet flow provided by theoutflow orifice22 andinflow orifice24. Such symmetry ensures stability of the smoothcatheter tube assembly19aduring ablation procedures.

Various modifications can be made to the present invention without departing from the apparent scope thereof.

Parts List

10 enhanced cross stream mechanical thrombectomy catheter surface with backloading manifold cavity
12 backloading manifold mounting cavity
14 hemostatic nut
15 introducer
16 strain relief
18 braided catheter tube
19 smooth catheter tube assembly
19asmooth catheter tube assembly
20 smooth catheter tube
22 outflow orifice
24 inflow orifice
26 flexible tapered tip
28 radiopaque marker band
30 radiopaque marker band
32 high pressure connection branch
34 central body (of backloading manifold)
36 exhaust branch
38 cavity body
40 threaded surface
42 manifold extension
44 insert cavity
46 distal insert cavity portion
48 proximal insert cavity portion
50 insert
52 proximal manifold cavity
54 annular cavity wall
55 annular and planar su
56 distal manifold cavity
58 strain relief mounting cavity
60 passageway
62 high pressure connection branch passageway
63 threaded surface
64 high pressure connector
66 ferrule
67 lumen
70 central bore
71 high pressure tube
72 exhaust branch passageway
74 main body
76 shoulder
78 transition stop surface
80 central passageway
82 elongated slot
84 bore
86 beveled surface entrance
88 self-sealing hemostatic valve
90 washer
92 washer
94 cylindrical boss
96 central passageway
97 beveled surface entrance
98 interanl threads
100 annular lip
102 shaft
103 central passageway
104 actuating handle
105 beveled surface entrance
106 annular ring
108 annular ring
110 lumen
112 lumen
114 support ring
116 fluid jet emanator
116amultidirectional fluid jet emanator
117 terminated loop
117aproximal loop
117bdistal loop
118 junction
118a-cjunctions
120 lumen
1221-njet orifices
123a-njet orifices
124 support ring
124asupport ring
125a-njet orifices
126 center void
128 central passageway
130 annular shoulder
132 beveled annular surface
134 annular groove
136a-nhigh velocity fluid jets
140a-ncross stream jets
141 guidewire
141a-bguidewire end positions
142 blood vessel
144 thrombotic deposit or lesion
146 thrombotic particulate
146athrombotic particulate
210 enhanced cross stream mechanical thrombectomy catheter pump with backloading manifold
212 smooth catheter tube assembly
214 outflow orifice
216 inflow orifice
218 evacuation orifice
220 flexible tapered tip
222a-blumens
224 smooth catheter tube
228 guidewire tube
230 lumen (guidewire tube)
232 plastic sheath
234 deflector
236 deflector face
238 elongated slot
239 vacuum pump or roller pump
240a-nhigh velocity fluid jets
242a-ncross stream jets
244 proximally firected flow
310 enhanced cross stream mechanical thrombectomy catheter with backloading manifold
312 smooth catheter tube assembly
314 outflow orifice
316 inflow orifice
318 ecacuation orifice
320 flexible tapered tip
322a-blumens
324 smooth catheter tube
328 guidewire tube
330 lumen (guidewire tube)
332 plastic sheath
334 deflector
334 deflector
336 deflector face
339 vacuum pump or roller pump
340a-nhigh velocity fluid jets
342a-ncross stream jets
344 proximally directed flow
346a-nhigh velocity fluid jets
410 enhanced cross stream mechanical thrombectomy catheter with backloading manifold
412 smooth catheter tube assembly
414 outflow orifice
416 inflow orifice
418 inwardly facing aspect
419 radiopaque marker band
420 flexible tapered tip
421 radiopaque marker band
422 lumen
424 smooth catheter tube
424acurved section
424breversed section
424cstraight section
426 outwardly facing aspect (of424b)
428 outwardly facing aspect (of424c)
440a-nhigh velocity fluid jets
442a-ncross stream jets
444 rotation arrow
450 smooth catheter tube
452 flexible tapered tip
454 radiopaque marker band
456 radiopaque marker band
458 inflow orifice
460 outflow orifice
500 outflow orifice
502 inflow orifice
504 outflow orifice
506 inflow orifice
508a-ncross stream jets
510a-ncross stream jets
512 major cross stream jet flow region
514 minor cross stream jet flow region
516 minor cross stream jet flow region