Hydrodynamic direct-flow catheter system

Abstract

A hydrodynamic direct flow catheter system (10a-e) comprising a manifold (14) having a central elongated tubular body (16) with a proximal end and a distal end, an elongated flexible catheter tube (12a-e) having a proximal end and a distal end, the proximal end of the catheter tube (12a-e) extending into and distally out of the distal end of the central tubular body (16) of the manifold (14), a tapered flexible tip (40) having a proximal end and a distal end, the tapered flexible tip (40) having a central passageway (88) extending therethrough, the elongated flexible catheter tube (12a-e) having an elongated distal portion, the elongated distal portion of the catheter tube (12a-e) having a proximal end and a distal end,wherein the distal end of the elongated distal section is connected to the proximal end of the tapered flexible tip (40), a tubular fluid jet ejector (52) disposed in the elongated distal section proximal to the proximal end of the tapered flexible tip (40), one or more inflow openings (38) in the distal section proximal to the tubular fluid jet ejector, the tubular fluid jet ejector (52) having a proximal end and a distal end, a plurality of spaced radially aligned fluid jet openings (90a-n) around a peripheral surface of the tubular fluid jet ejector, the spaced radially aligned fluid jet openings (90a-n) opposite the proximal end of the tubular fluid jet ejector,a plurality of holes (94a-n) in the elongated distal portion and in corresponding alignment with the plurality of spaced radially directed fluid jet orifices (90a-n), an elongated flexible high-pressure tube (50) having a proximal end and a distal end, the elongated flexible high-pressure tube (50) extending from the manifold (14) through the elongated flexible catheter tube (12a-e) and terminating in the tubular fluid jet emitter (52), and a high-pressure fluid source (42) delivering pressurized fluid into the proximal end of the elongated flexible high-pressure tube, the radially directed fluid jet orifices (90a-n) having diameters between 0.0254 mm (0.001 in.) to 1.016 mm (0.040 in.).

Description

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application claims priority to previously filed U.S. Provisional Application No. 61 / 070,095, filed March 20, 2008, entitled "Direct Spray Disruption and Removal Catheter," and is hereby incorporated by reference into this application as if fully set forth herein.

[0002] This patent application relates to patent application No. 10 / 455,096, filed on June 5, 2003, entitled "Thrombectomy Catheter Device Having a Self-Sealing Hemostasis Valve", now US Patent No. US 7,226,433 B2, which is a continuation-in-part (CIP) of application No. 10 / 198,264, filed on July 16, 2002, entitled "Rapid Exchange Fluid Jet Thrombectomy Device and Method", now US Patent No. US 6,875,193 B1, which is a continuation-in-part (CIP) of application No. 09 / 888,455, filed on June 25, 2001, now US Patent No. US 6,755,803 B1, which is a continuation-in-part (CIP) of application No. 09,356,783 filed on July 16, 1999, now withdrawn, which is a branch of application No. 09 / 019,728, filed on February 6, 1998, now U.S. Patent No. US 5,989,210 A, and is hereby incorporated by reference into this application as if fully set forth herein.

[0003] This patent application also relates to patent application No. 11 / 096,592, filed April 1, 2005, entitled "Rapid Exchange Fluid Jet Thrombectomy Device and Method," which is pending patent application and which is a continuation-in-part (CIP) of application No. 10 / 198,264, filed July 16, 2002, entitled "Rapid Exchange Fluid Jet Thrombectomy Device and Method," now US Patent No. US 6,875,193 B1, which is a continuation-in-part (CIP) of application No. 09 / 888,455, filed June 25, 2001, now US Patent No. US 6,755,803 B1, which is a continuation-in-part (CIP) of application No. 09,356,783, filed July 16, 1999, now withdrawn, which is a Branch of application No. 09 / 019,728, filed February 6, 1998, now U.S. Patent No. US 5,989,210 A, and is hereby incorporated by reference into this application as if fully set forth herein. BACKGROUND OF THE INVENTION FIELD OF THE INVENTION

[0004] The general purpose of this disclosure is to provide a direct-flow hydrodynamic catheter system for use in thrombectomies and related procedures. More specifically, a direct-flow hydrodynamic catheter system is disclosed, preferably in the form of radially directed fluid jet streams, which utilizes controlled fluid jet streams to perform thrombectomy of highly organized material or to achieve the infusion of drugs to a conduit wall, or, as shown in alternative embodiments, to accomplish cellular sampling from the conduit wall. The device is primarily intended for use as an improved thrombectomy device, which may be advantageous for the robust and aggressive removal of thrombus, lesions, and the like from coronary arteries, peripheral arteries or veins, neurological arteries or veins, or arterial-venous lines. DESCRIPTION OF PREVIOUS TECHNOLOGY

[0005] Prior art thrombectomy devices provide structures for the removal of thrombus, lesions, gum-like material, and the like from the vasculature, but do little to address the control of fluid jet streams, which are critical in performing interventional procedures. Some prior art thrombectomy devices utilize indirect, cross-path fluid jet streams whose axial path may be reduced and of insufficient strength, not employing the full force intended by the radially directed fluid jet streams disclosed herein. The fluid jet streams generated by prior art devices, unless effectively controlled, may fail to satisfactorily perform thrombectomy or may cause undesirable harm.If the strength of the fluid jet streams is excessive, damage to a blood vessel wall may occur, and if the strength of the fluid jet stream is insufficient, satisfactory thrombectomy cannot be performed. As presented in this disclosure, it is contemplated to provide a catheter system for aggressive and robust thrombectomy by controlling the volumetric flow rate, which can be influenced by its structure and controlled by a physician in its application. US 2006 / 0129091 A1 discloses an improved mechanical crossflow thrombectomy catheter with a backloading manifold having a distal end with outlet and inlet ports on one side to produce a concentrated crossflow jet flow for selective and concentrated thrombus ablation during thrombectomy procedures. The disclosure provides for appropriate distancing of the high-power ablation or suction forces from the near walls of the vessel. The crossflow emanating from one side of the distal end of the catheter pushes the distal end of the catheter, and thus the opposite, non-perforated side of the distal end of the catheter, toward and against the vessel wall to prevent contact of the inflow port with the vessel wall. Features of the disclosure include a geometrically configured insert to facilitate backloading or exchange of guidewires. US 2002 / 0120226 A1 discloses a catheter for injecting and extracting fluids to interact with material at a treatment site in the body. EP 1 382 366 A1 discloses a quick-change liquid jet thrombectomy device for removing thrombi or unwanted tissue debris from a vein, artery, or the like. The device comprises a semi-rigid intermediate tube between a proximal and a distal outlet tube, which receives a guidewire tube exit located along the catheter at less than half the length of the catheter, measured from the distalmost point of the catheter. Such a guidewire position is convenient for maneuvering and advancing the guidewire longitudinally, as well as for maneuvering and advancing the catheter longitudinally by a physician. SUMMARY OF THE INVENTION

[0006] The invention is defined by the independent claims. Optional aspects are contained in the dependent claims.

[0007] The general purpose of this disclosure is to provide a hydrodynamic direct-flow catheter system, also referred to herein as the catheter system. This disclosure describes the use of a direct spray in the form of radially directed fluid jet streams emanating from an ejector at the distal end of a hydrodynamic direct-flow catheter tube, synonymously referred to as a catheter tube, for the purposes of, but not limited to, thrombectomy of a highly organized material or the infusion of drugs into a vascular conduit.The hydrodynamic direct-flow catheter system requires a physician to control a high-pressure fluid pump and a high-pressure fluid source for the purpose of delivering pressurized saline solution, with or without medication, to an ejector at the distal end of a catheter tube tip to provide the outflow of radially directed fluid jets and to provide a hydrodynamic effect upon direct impingement of debris in the vascular conduit. An inflow port is included near the distal end of the catheter tube, proximal to a fluid flow ejector, to collect dislodged thrombus or lesion particles that are evacuated through the catheter tube. A collection chamber and outflow regulator in the form of a physician-operated roller pump are also provided for evacuation and control of the evacuation rate, i.e., aspiration, of the catheter tube.The present disclosure provides the structure and use of a catheter tube whereby fluid jet streams from a fluid jet ejector are directed radially and outwardly, or optionally at any other convenient angle, in a distal or proximal direction to directly impinge upon the vascular conduit, unobstructed by any device structure. The inflow port is provided proximal to the fluid jet ejector to provide for the ingestion and entrainment of thrombus or lesion particles released from within the vasculature by radially directed fluid jet streams. The outflow roller pump can be operated by a physician to control the speed to aspirate released thrombus or lesions, or, as shown in an alternative embodiment, can be used to assist in the aspiration of conduit wall cell samples.

[0008] The desired velocity and strength of the radially directed fluid jet streams can be controlled using the fluid jet ejector in the distal end of the catheter tube, the jet ejector having appropriately sized radially directed jet orifices, and the outflow regulator for aspiration in coordination with manipulation of the high-pressure fluid pump to provide a desired operating pressure, volume, and outflow. As disclosed herein, the catheter system is more robust and aggressive than traditional thrombectomy catheters and is preferably used in situations and in vessel segments that can withstand aggressive hydrodynamic direct flow action. Another application of the disclosed catheter system is the treatment of venous valves that lose function when embedded in an organized thrombus.The devices of the present disclosure are intended to free these venous valves of adherent thrombus using radially directed fluid jet streams to prevent postphlebitic (postthrombotic) syndrome. Another potential application is to provide more robust thrombectomy of adherent and organized mural thrombus. The devices of the present disclosure can also utilize the powerful radially directed jet streams to deliver drugs into the vessel wall.

[0009] The preferred embodiment includes the use of setpoint, high-power, radially directed fluid jet streams emanating from a fluid jet ejector to ablate thrombus and lesions and utilizes aspiration to provide outflow.

[0010] A first alternative embodiment involves the use of target-value, high-power, radially directed fluid jets emanating from a fluid jet ejector and the use of a proximally located balloon used to center the distal end of the catheter tube. Proximally directed fluid jets emanating from a fluid jet ejector are used to supplement the evacuation of effluent and supplement the inflation of the proximally located balloon.

[0011] A second alternative embodiment includes the use of small-sized, high-power, radially directed fluid jets emanating from a fluid jet ejector, and also includes proximally directed fluid jets emanating from a fluid jet ejector, the jets being used to supplement the aspiration of effluent through the catheter tube.

[0012] A third alternative embodiment that can be used for cell harvesting involves the use of small, high-power, radially directed fluid jets emanating from a fluid jet ejector, and also includes a distally located balloon used to center the distal end of the catheter tube. Distally directed fluid jets emanating from a fluid jet ejector are used to inflate the distally located balloon. Proximally directed fluid jets emanating from a fluid jet ejector are used to supplement the aspiration of the effluent, if necessary.

[0013] A fourth alternative embodiment involves the use of distally directed fluid jet streams emanating from the distally directed jet orifices of a fluid jet ejector and thence through one or more distally located small-diameter outflow orifices in the distal end of the catheter tube when low-power crossflow jets are used for thrombus ablation. Proximally directed fluid jet streams emanating from a fluid jet ejector are used to supplement the aspiration of the effluent through the catheter tube.

[0014] A fifth alternative embodiment provides for the use of setpoint, high-power, distally directed fluid jet streams emanating from a fluid jet ejector and proximally directed fluid jet streams emanating from a fluid jet ejector to supplement the aspiration of the effluent through the catheter tube.

[0015] According to one embodiment of the disclosure, a hydrodynamic direct-flow catheter system for removing thrombus, lesions, and the like is provided, including means for infusing drugs, lysis fluids, and the like into the vasculature. A catheter tube with a coaxial high-pressure tube and a coaxial distally positioned fluid jet emitter is provided for invasive use and treatment in the vasculature. The proximal end of the catheter tube, including the high-pressure tube, is connected to and aligned with the distal end of a centrally located manifold.The manifold and other connected control components include, but are not limited to, a physician-controlled high-pressure pump and high-pressure fluid source, a physician-controlled outflow regulator and collection chamber provided for operating the catheter tubing system, a high-pressure tube, and a fluid jet ejector provided for discharging radially directed fluid jet streams to effect loosening and evacuation of loosened thrombus, lesions, and fluid from the vasculature, or for delivering lysing agents or drugs into the vasculature.

[0016] A key aspect and feature of the devices of the present disclosure is the use of radially directed fluid jet streams for the purpose of improved thrombectomy of mural thrombus.

[0017] Another essential aspect and feature of the devices of the present disclosure is the use of direct fluid jet streams that can operate in any desired direction and in multiple rows, i.e., different outflow points that can then also operate in any desired direction.

[0018] Another essential aspect and feature of the devices of the present disclosure is the use of proximally directed fluid jet streams with radially directed fluid jet streams for the purpose of cellular waste maceration in conjunction with energy delivery.

[0019] Another essential aspect and feature of the devices of the present disclosure is the use of radially directed fluid jet streams for the purpose of cell sampling.

[0020] Another essential aspect and feature of the devices of the present disclosure is the use of direct fluid jet streams having velocities that do not cause hemolysis.

[0021] Another essential aspect and feature of the devices of the present disclosure is the use of fluid jet streams having sufficient momentum that can be delivered by a large non-hemolyzing fluid jet stream that, via an increased flow rate, is equivalent in energy to a smaller high-speed fluid jet stream.

[0022] Yet another significant aspect and feature of the devices of the present disclosure is the use of direct radially directed fluid jet streams that can be physician-controlled by means of a high pressure fuel pump.

[0023] Yet another essential aspect and feature of the devices of the present disclosure is direct fluid jet flow disruption, i.e., erosion, fragmentation, and reduction of thrombus or unwanted cellular matter to particulate matter by fluid jet flows of saline solution, wherein outflow consisting of thrombus and / or cellular particulate matter and fluid saline solution is enhanced and advanced, evacuated, and removed by aspiration using a physician-controlled outflow regulator in the form of a roller pump.

[0024] Another essential aspect and feature of the devices of the present disclosure is direct fluid jet flow disruption, i.e., the erosion, fragmentation, and reduction of thrombus or unwanted cellular matter to particulate matter by fluid jet flows of saline solution, whereby the outflow consisting of thrombus and / or cellular particulate matter and the fluid saline solution is enhanced and advanced, evacuated, and removed through the use of directed fluid jet flows.

[0025] Another essential aspect and feature of the devices of the present disclosure is direct fluid jet flow disruption, i.e., the erosion, fragmentation, and reduction of thrombus or unwanted cellular matter to particulate matter by fluid jet flows of saline solution, thereby enhancing the outflow consisting of thrombus and / or cellular particulate matter and the fluid saline solution, and advancing, evacuating, and removing it by manual aspiration using a syringe.

[0026] Another essential aspect and feature of the devices of the present disclosure is direct fluid jet flow disruption, i.e., the erosion, fragmentation, and reduction of thrombus or unwanted cellular matter to particulate matter by fluid jet flows of saline solution, thereby enhancing and advancing, evacuating, and removing the effluent consisting of thrombus and / or cellular particulate matter and the fluid saline solution, and whereby the vacuum associated with the devices of the present disclosure is controlled by varying the relationship between the input fluid jet flow pressure and the effluent regulator, e.g., a bottle vacuum.

[0027] Another essential aspect and feature of the devices of the present disclosure is the use of proximal or distal balloons inflated by proximally or distally directed fluid jet streams, respectively, for the purpose of centering the distal portion, including the inflow port(s), of a catheter tube.

[0028] Another significant aspect and feature of the devices of the present disclosure is the use of a cross-flow catheter tube that utilizes direct fluid jet streams as the downstream component.

[0029] Another essential aspect and feature of the devices of the present disclosure is the use of direct fluid jet flow devices operating with or without evacuation capabilities.

[0030] Another important aspect and feature of the devices of the present disclosure is the use of a catheter tube and manifold that can be used with any size guidewire.

[0031] Another essential aspect and feature of the devices of the present disclosure is the use of direct fluid jet stream velocities in the range of 1 to 250 m / s.

[0032] Another significant aspect and feature of the devices of the present disclosure is the use of direct fluid jet streams emanating from orifices of 0.001 in. to 0.040 in. in diameter.

[0033] Having thus briefly described one or more embodiments of this disclosure and having noted some significant aspects and features, the primary object of this disclosure is to provide a hydrodynamic direct flow catheter system. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Further objects of the disclosure and many of its attendant advantages will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which like reference numerals designate like parts throughout the figures. In the drawings: Fig. 1 a plan view of the visible components of a hydrodynamic direct flow catheter system; Fig. 2 generally an isometric exploded and segmental view of a catheter tube and a manifold, which are connected to Fig. 1 shown control components can be used. Fig. 3 is an assembled view in partial cross-section of the components of the distributor and the closely related components and features thereof; Fig. 4 the distal part of the catheter tube and the relationships of radiopaque marker bands, a support ring, a high-pressure tube and a fluid jet outlet to each other and to the catheter tube; Fig. 5 is an isometric view of the fluid jet ejector shown connected to and communicating with a high pressure pipe; Fig. 6 is a side view in partial cross-section of the distal part of the catheter tube during the implementation of the method and the use thereof, wherein the implementation of control connections and functions of the accompanying components is carried out in a manner as shown in Fig. 1 used in the manner shown; Fig. 7, a first alternative embodiment, generally an isometric exploded and segmented view of a catheter tube and a manifold, which are connected to in Fig. 1 shown control components are used; Fig. 8 an explanation that in many respects Fig. 4, showing the distal part of the catheter tube and the relationships of radiopaque marker bands, a support ring of a high pressure tube, a fluid jet emitter and a balloon to each other and to the catheter tube; Fig. 9, one in many ways Fig. 5 corresponding explanation, an isometric view of another fluid jet emanator shown in connection and in communication with a high pressure pipe; Fig. 10, in many ways Fig. 6, a side view in partial cross-section of the distal part of the catheter tube in the performance of the method and the use thereof, wherein the implementation of control connections and functions of the accompanying components is carried out in a manner as in Fig. 1 used in the manner shown; Fig. 11, a second alternative embodiment, an isometric exploded and segmented view of a catheter tube and a manifold, which are connected to Fig. 1 shown control components are used; Fig. 12, one in many ways Fig. 4 corresponding explanation, the distal part of the catheter tube and the relationships of radiopaque marker bands, a support ring, a high-pressure tube and a fluid jet outlet to each other and to the catheter tube; Fig. 13, one in many ways Fig. 5 corresponding explanation, an isometric view of another fluid jet emanator shown in connection and in communication with a high pressure pipe; Fig. 14, in many ways Fig. 6, a side view in partial cross-section of the distal part of the catheter tube in the performance of the method and the use thereof, wherein the implementation of control connections and functions of the accompanying components is carried out in a manner as in Fig. 1 used in the manner shown; Fig. 15, a third alternative embodiment, an isometric exploded and segmented view of a catheter tube and a manifold, which are connected to Fig. 1 shown control components are used; Fig. 16, one in many ways Fig. 4 corresponding explanation, the distal part of the catheter tube and the relationships of radiopaque marker bands, a support ring, a high-pressure tube, a fluid jet emitter and a balloon to each other and to the catheter tube; Fig. 17, one in many ways Fig. 13 corresponding explanation, an isometric view of another fluid jet ejector shown in connection and in communication with a high pressure pipe; Fig. 18, in many ways Fig. 6, a side view in partial cross-section of the distal part of the catheter tube in the performance of the method and the use thereof, wherein the implementation of control connections and functions of the accompanying components is carried out in a manner as in Fig. 1 used in the manner shown; Fig. 19, a fourth alternative embodiment, an isometric exploded and segmented view of a catheter tube and a manifold, which are provided with the Fig. 1 shown control components are used; Fig. 20, one in many ways Fig. 4 corresponding explanation, the distal part of the catheter tube and the relationships of radiopaque marker bands, a support ring, a high-pressure tube and a fluid jet outlet to each other and to the catheter tube; Fig. 21, one in many ways Fig. 5 corresponding explanation, an isometric view of another fluid jet ejector shown in connection and in communication with a high pressure pipe; Fig. 22, in many ways Fig. 6, a side view in partial cross-section of the distal part of the catheter tube in the performance of the method and use thereof, wherein the implementation of control connections and functions of the accompanying components is carried out in a manner as in Fig. 1 used in the manner shown; Fig. 23, a fifth alternative embodiment, an isometric exploded and segmented view of a catheter tube and a manifold, which are provided with the Fig. 1 shown control components are used; Fig. 24, one in many ways Fig. 4 corresponding explanation, the distal part of the catheter tube and the relationships of radiopaque marker bands, a support ring, a high-pressure tube and a fluid jet outlet to each other and to the catheter tube; Fig. 25, one in many ways Fig. 5 corresponding explanation, an isometric view of another fluid jet ejector shown in connection and in communication with a high-pressure pipe; and Fig. 26, in many ways Fig. 6, a side view in partial cross-section of the distal part of the catheter tube in the performance of the method and the use thereof, wherein the implementation of control connections and functions of the accompanying components is carried out in a manner as in Fig. 1 shown manner. DETAILED DESCRIPTION

[0035] Fig. 1 is a plan view of the visible components of a hydrodynamic direct-flow catheter system 10, which for purposes of brevity may also be referred to as the catheter system 10. The system includes a hydrodynamic direct-flow catheter tube 12, also referred to as the catheter tube 12, in conjunction with a one-piece manifold 14, the latter having a plurality of structures extending therefrom or connected thereto, including, but not limited to, the flexible, versatile catheter tube 12.The visible portion of the one-piece manifold 14 includes a central tubular body 16, a threaded outlet branch 18 and a high-pressure connection branch 20 extending at an angle from the central tubular body 16, a partially shown hollow body 22 extending proximally from the central tubular body 16, and a threaded connector portion 24 extending distally from the central tubular body 16. The proximal end of the catheter tube 12 is attached to the manifold 14 through the use of a Luer-lock connector 26 received by the threaded connector portion 24. The proximal end of the catheter tube 12 passes through a strain relief tube 28 and through the Luer-lock connector 26 to communicate with the manifold 14. Also shown is a hemostasis nut 30 aligned with the proximal region of the hollow body 22 and screwed thereto during engagement.A threaded high-pressure connection port 32 is attached to the high-pressure connection branch 20 via a Luer-Lock connector 34. In . Fig. 2 shows an insertion device 36. In Fig. 3, in connection with the disclosure, a guide wire 37 is shown.

[0036] The catheter tube 12 extends distally from the manifold 14 and includes an inflow port 38 at the distal portion of the catheter tube 12. In the alternative, an inflow gap could be provided in place of the inflow port 38. A tapered flexible tip 40 extends distally from and is attached to the distal portion of the catheter tube 12. The catheter tube 12 functions as an outlet tube for evacuating thrombus or lesion particulate material, fluids, or other cellular debris or drainage from the thrombus or lesion site. Preferably, the catheter tube 12 includes a hydrophilic coating to enhance delivery capability along the vasculature or other structure.

[0037] Control components provide for the operation and use of the catheter tube 12, the manifold 14, and closely associated components, and include a high-pressure fluid source 42 and a high-pressure fluid pump 44 connected to the manifold 14 via the threaded high-pressure connection port 32 and the connector 46. Also included are a drain regulator 47 in the form of a roller pump or other suitable device and a collection chamber 48 connected to the threaded outlet branch 18 via a connector 49, as shown.

[0038] The Fig. 2 and Fig. 3 show parts of Revelation. Fig. Figure 2 is generally an isometric exploded and segmented view of the catheter tube 12 and manifold 14, which are shown in Fig. 1 shown control components can be used. Fig. Figure 3 is an assembled view in partial cross-section of the components of the manifold 14 and closely related components and features thereof. Also included is a guide wire 37 incorporated in the use thereof.

[0039] A group of assembled components, including a high-pressure tube 50 and a fluid jet ejector 52, deliver a pressurized saline solution or other suitable fluid to the distal portion of the catheter tube 12 to generate fluid jet streams radially directed from the fluid jet ejector 52, as described in detail later. The high-pressure tube 50, preferably made of flexible stainless steel or other suitable material, extends within and through closely associated features or components connected to the manifold 14 and is aligned with and distal to the strain relief tube 28. The high-pressure tube 50 extends along a major portion of and within a lumen 53 of the catheter tube 12 to terminate at the fluid jet ejector 52. The distal end of the high-pressure tube 50, including the fluid stream ejector 52, is in the Fig. 4 and Fig. 5 is also shown in greater detail.

[0040] As in the Fig. 2 and Fig. 3, the manifold 14, which is also used with reference to the alternative embodiments, has connected and communicating passageways and cavities ( Fig. 3), including a high-pressure connection branch path 54, an outlet branch path 56, a tapered central passageway 58 extending from and through the threaded connection opening 24 and through the central tubular body 16 to and communicating with a multi-radius cavity 16, which is preferably cylindrical and located centrally of the hollow body 22. External threads 62 are disposed around the proximal portion of the hollow body 22 in the proximal region of the manifold 14 for receiving the internal threads 64 of the hemostasis nut 30.

[0041] Convenient for the devices of the disclosure is the use of a flexible self-sealing hemostasis valve 66 and the use of a sealing ring 68 located distal to the self-sealing hemostasis valve 66, the form and function of which are described in the cited U.S. Patent No. 7,226,433, which is incorporated herein in its entirety. The self-sealing hemostasis valve 66 and the sealing ring 68 are aligned within the larger radius portion of the multi-radius cavity 66 of the hollow body 22. The hemostasis nut 30 includes a centrally located cylindrical boss 70. The sealing ring 68 and the self-sealing hemostasis valve 66 are retained within the larger radius portion of the multi-radius cavity 60 by the threaded engagement of the hemostasis nut 30 with the threads 62 at the proximal end of the manifold 14.The cylindrical boss 70 is urged against the collective of the self-sealing hemostasis valve 66 and the sealing ring 68, thereby applying pressure, if necessary, to the self-sealing hemostasis valve 66, which pressure culminates in a tight seal of the self-sealing hemostasis valve 66 around the guidewire 37. Although one method of sealing against a guidewire is briefly shown and described herein, it is contemplated that other methods may be incorporated into this and other forms of the present disclosure, such as the methods referred to in U.S. Patent No. 7,226,433.

[0042] Also shown is a ferrule 72 aligned in a passageway 74 of the threaded high pressure connection port 32, this combination being partially aligned in an internal passageway 76 of the Luer lock connector 34. The proximal end of the flexible high pressure tube 50, which is in segmented form in Fig. 2, is used for delivering set pressure or high pressure ablation fluids or for delivering drugs or other fluids and is conveniently mounted in a central passageway of the ferrule 72 for communication with the inner passageway 74 of the threaded high pressure connection port 32, as shown in Fig. 3. The proximal end of the high-pressure tube 50 also extends through the passage of the high-pressure connection branch 54, through a portion of the tapered central passageway 58, through the strain relief tube 28 and the Luer lock connector 26, and through the lumen 53 of the catheter tube 12.

[0043] As in Fig. 4, the high-pressure tube 50 extends through and is conveniently connected to a support ring 78 to provide an anchoring and alignment structure for the high-pressure tube 50, thereby securing the distal portion of the high-pressure tube 50 within the distal end of the catheter tube 12. In addition, the high-pressure tube 50 also extends indirectly through the radiopaque marker band 80. The concentrically aligned radiopaque marker band 80 and the support ring 78 are shown in tight contact with the full wall thickness of the catheter tube 12 at the distal end of the catheter tube 12. The high-pressure tube 50 is preferably connected to the support ring 78, such as by welding or by other suitable means, where the support ring 78 acts as a support for the catheter tube 12 in the region beneath the radiopaque marker band 80.The high-pressure tube 50 extends beyond the inlet opening 38 and terminates in an internal annular manifold (not shown) of the fluid jet ejector 52 and is conveniently connected thereto where the internal cavity (not shown) of the fluid jet ejector 52 communicates with the lumen of the high-pressure tube 50, as in the closely related fluid jet ejector described in the aforementioned patent application No. 11 / 096,592 or in other applications or patents assigned to the assignee. The fluid jet ejector 52, which is also described in . Fig. 5 as an isometric view, includes an annular groove 84 in coordinated use with a radiopaque marker band 82 to secure the fluid jet emitter 52 within the distal portion of the catheter tube 12. The distally located radiopaque marker band 82 is fixedly mounted around the distal end of the catheter tube 12 to effect an annular frictional engagement with all or a portion of the annular groove 84 of the fluid jet emitter 52.Such frictional engagement is sufficient to place the outer radial surface of the radiopaque marker band 82 (also 80) in a position smaller than the general and larger outer radial surface of the catheter tube 12, thereby providing, in part, a catheter tube 12 having no elements projecting above the general outer radial surface thereof for unobstructed and smooth distal or proximal transition of the catheter tube 12 in a vein, artery, or the like. A passageway 86 (. Fig. 5) is central to the fluid jet outlet 52 for receiving the passage of a guide wire 37 (in Fig. 3). The tapered flexible tip 40 is shown in a convenient attachment to the distal end of the distal portion of the catheter tube 12. The tapered flexible tip 40 includes an internal multi-radius passage 88 for receiving a guidewire 37. In Fig. 2, the radiopaque marker band 80 is shown displaced a short distance distal to the support ring 78, and the fluid jet emitter 52 is shown displaced proximally a short distance from the radiopaque marker band 82 for the purpose of clarity, but they are in Fig. 4 in frictional engagement in their actual positions along and relative to the distal end of the catheter tube 12. The relationships of the radiopaque marker bands 80 and 82, the support ring 78, and the fluid jet emitter 52 to each other and to the catheter tube 12 are best seen in Fig. 4 shown.

[0044] The structure is provided to promote and assist the insertion and passage of the distal portion of the catheter tube 12 through blood vessels, arteries, and the like to the sites of thrombus or lesion deposits. The tapered flexible tip 40, unlike a rounded and non-tapered flexible tip, can divide thrombus or lesion deposits and more easily penetrate thrombus or lesion deposits during its distal insertion path, rather than advancing or pushing such thrombus or lesion deposits distally. The decreasing diameter in a distal direction of the tapered flexible tip 40 also allows for increased flexibility in negotiating and passing through tortuous paths.

[0045] The outlet tube support ring 78 in use with the radiopaque marker band 80 and the use of the fluid jet ejector 52 with the marker band 82 in and around the proximal and distal portions of the catheter tube 12, respectively, are examples of structures that provide support or reinforcement along the catheter tube 12. Such a support ring 78, marker bands 80 and 82, and the external structure of the fluid jet ejector 52 provide for the use of a thinner wall thickness for the catheter tube 12 and enable a larger and more effective and efficiently sized lumen 53 of the catheter tube 12, as well as contributing to a reduced outer diameter.Such support rings and such outer structure of the fluid jet emitter 52 also help to supportively maintain the diameter and overall shape of the catheter tube 12 as the catheter tube 12 is advanced or pushed along a vein or artery, as well as providing torsional support.

[0046] Fig. 5 is an isometric view of the fluid jet ejector 52, shown connected to and in communication with the high-pressure tube 50. The fluid jet ejector 52 includes a plurality of similar and desired radially aligned jet orifices 90a-90n located around the periphery of the fluid jet ejector, also including the previously described annular groove 84 and passageway 86. The plurality of radially aligned jet orifices 90a-90n are a unit and are collectively pressurized by a pressurized saline solution provided through the high-pressure tube 50.

[0047] This high-pressure tube 50 delivers high-pressure saline solution or other suitable fluid to the fluid jet ejector 52 for generating and distributing high-pressure, desired-value, radially directed fluid streams 92 of saline solution or other suitable fluids that flow from the radially directed jet orifices 90a-90n of the fluid jet ejector 52 to perform functions as described herein. A plurality of holes 94a-94n, corresponding to and in alignment with the radially directed jet orifices 90a-90n, are provided in the distal end of the catheter tube 12, as shown in Fig. 4, or in alternative embodiments, to allow the passage of the radially directed fluid jet streams 92 therethrough. Although the use of the particular type of fluid jet ejector 52 is shown, other fluid jet ejectors with other configurations that discharge radially directed fluid jet streams 92 may also be used instead of the fluid jet ejector shown in Fig. 5, and the use of other fluid jet ejectors should not be considered as limiting the scope of the disclosure. OPERATION

[0048] Generally, a standard guidewire is deployed into a blood vessel 96 requiring treatment, or, alternatively, a filter guidewire or balloon occlusion guidewire could be used. The catheter tube 12 and other closely connected and aligned components directly associated with it, consisting primarily of the high-pressure tube 50 and the fluid jet ejector 52, are advanced over and along a guidewire (37) aligned within the blood vessel 96 for the purpose of debris / thrombus / lesion removal, drug infusion, or other procedures, and maneuvered into an appropriate position for treatment.A typical guiding catheter or sheath may be inserted, if necessary, to assist in the placement of the catheter tube 12 and the closely aligned, in direct combination, components of the direct-stream hydrodynamic catheter system 10 at the desired location of the blood vessel 96 to allow the tapered tip 40 of the catheter tube 12 to be expanded through the thrombus or lesions 98 to position the fluid jet emitter in close proximity to the thrombus or lesions 98. The catheter tube 12 may be moved proximally or distally during the procedure to maximize the effect of the catheter system. Further interventions can usually be performed via the retained guidewire or guidewire assembly.

[0049] In addition, Fig. 6 a side view in partial cross-section of the catheter tube 12 during the performance of the method and during use thereof, which control connections and functions of the accompanying components in a manner as in Fig. 1, with particular attention being paid to the distal portion of the catheter tube 12, the flexible tapered tip 40, the fluid jet ejector 52, the inflow opening 38, and other closely related components positioned within the blood vessel 96 containing deposits of thrombus or lesions 98. More specifically, and with reference to Fig. 1 and Fig. 6 further describes the operation in use. The hydrodynamic direct-flow catheter tube 12 is engaged over and around a guidewire 37, wherein the guidewire 37 (previously inserted into a vein or artery) can first slidably pass through the passageway 88 of the tapered, flexible tip 40, into and through the lumen 53 of the catheter tube 12, followed by traversing the passageway 86 of the fluid jet emitter 52, beyond the inflow opening 38, followed by traversing the lumen 53 of the catheter tube 12, the strain relief tube 28, the tapered central passageway 58 of the manifold 14 ( Fig. 3) and slidably in and tightly engaged with the hemostasis valve 66 ( Fig. 3) to finally exit the hemostasis nut 30.

[0050] The distal portion of the high-pressure tube 50 delivers pressurized saline or other suitable fluid to the fluid jet ejector 52 to generate and distribute preferably non-hemolytic, radially directed fluid jet streams 92 of saline or other suitable fluids that flow as direct fluid jet streams from the radially directed jet orifices 90a-90n of the fluid jet ejector 52 to perform thrombectomy functions as described herein. Carefully generated operating pressure and fluid flows at low-hemolysis levels can be provided primarily by controlling the inlet fluid pressure at the high-pressure fluid pump 44 and / or by controlling the outlet rate at the outflow regulator 47, with the outflow regulator 47 operating to provide negative pressure for outflow aspiration.Additional fluid jet emitters of suitable size and / or configuration may also be incorporated into the distal portion of the catheter tube 12 in place of the fluid jet emitter 52 to emit or discharge one or more radially directed fluid jet streams 92.

[0051] The use of the radially directed fluid jet streams 92 from the radially directed jet orifices 90a-90n provides fluid jet impingement of the deposits of thrombus or lesions 98 on the inner wall of the blood vessels 96 opposite or in close proximity to the radially directed jet orifices 90a-90n to act upon, ablate, and loosen deposits of thrombus or lesions 98. Such thrombus or lesion particulate material and fluids may be entrained through one or more inflow orifices 38 by aspiration, including the use of an outflow regulator 47 to drain proximally through the catheter tube 12. Alternatively, manual aspiration techniques, as well known in the art, may be used.In addition, drugs for treating or lysing the thrombus or lesions 98 can also be delivered via the radially directed jet orifices 90a-90n and the radially directed fluid jet streams 92 to soften the deposits of thrombus or lesions 98 in the region of the blood vessel 96 opposite or in close proximity to the radial jet orifices 90a-90n, thereby more efficiently and profitably utilizing the radially directed fluid jet streams 92. The drugs are delivered to the sites of the deposits of thrombus or lesions 98 through the high-pressure tube 50 using the fluid jet emitter 52.

[0052] One or more inflow ports 38 receive, ingest, and entrain thrombus or lesions 98 in the form of particulate material and / or cellular debris by a fluid flow therethrough to be advanced and conveyed along the lumen 53 of the catheter tube 12 by aspiration comprising the outflow regulator 47, wherein the entrainment of particulate thrombus or lesions 98 and / or cellular debris through the inflow port(s) 38 is influenced by and relies upon entrainment in conjunction with aspiration in coordination with the outflow regulator 47 through the catheter 12. In such a device, the inflow port 38 is sufficiently sized for aspiration, or multiple inflow ports may be used to achieve a desired fluid inflow and aspiration.The outflow of fluid and thrombus or lesions is driven proximally through the catheter tube 12 by internal pressure resulting from the radially directed fluid jet streams 92 and the fluid entrained through the inflow port 38, and is assisted by aspiration through the use of the outflow regulator 47.

[0053] As disclosed herein, the radially directed fluid jet streams 92 are driven by the same pressure source, where the velocity is controlled by the high-pressure pump 44 and the entire range of all radially directed jet orifices 90a-90n. By sizing the radially directed jet orifices 90a-90n and operating the high-pressure pump 44 within appropriate parameters, the velocity and strength of the radially directed jet streams 92 can be influenced and controlled. The use of desired, radially directed jet orifices 90a-90n provides fluid jet streams with sufficient momentum to be delivered by large, non-hemolytic fluid jet streams (92) that are equivalent in energy, via an increased flow rate, to a smaller, high-speed fluid jet stream to be described later.The principle for aggressive cellular debris removal depends on the velocity of the radially directed jet streams 92. It should be noted that there is a critical velocity for cellular debris release. As the radially directed jet streams 92 travel through a fluid environment, the jet streams entrain surrounding fluid, thereby slowing the velocity of the fluid jet streams. Empirical relationships exist for turbulent jet streams that show that the velocity is proportional to the diameter of the jet streams and to the initial velocity of the jet streams. Thus, the velocity for a given distance would be increased by either increasing the initial jet stream velocity or increasing the jet orifice diameter.It should be noted that if the jet orifice diameter is increased, the pumping speed of the high-pressure pump 44 would need to be increased to maintain the fluid jet flow velocity. In practice, the catheter system is designed with a given series of jet orifice diameters and with the pumping speed of the high-pressure pump 44 adjusted to achieve the appropriate efficiency.

[0054] In general, the structure and operation of the embodiments disclosed herein provide radially directed jet orifices ranging in size from 0.001 in. to 0.040 in. for discharging saline or other suitable fluid therefrom at a velocity range of 1 to 250 m / s. Proximally directed jet orifices may range in size from 0.001 in. to 0.040 in. for discharging saline or other suitable fluid therefrom at a velocity range of 1 to 250 m / s. Distally directed jet orifices, where used, may range in size from 0.001 in. to 0.040 in. for discharging saline or other suitable fluid therefrom at a velocity range of 1 to 250 m / s. By sizing the radially directed jet orifices and adjusting the high-pressure fluid pump, the velocity and strength of the radially directed jet stream can be controlled.Also, the radially directed jet orifices can be sized so that the velocity of the jet streams decreases to a point where no red blood cells are hemolyzed, but the momentum of the jet streams can then be increased by means of an infused volume such that the effectiveness of the catheter system is as high as that of the high-velocity flow bectomy catheters disclosed in applicant's related documents, as discussed above. The general operating pressure of the catheter system can range from 50 psi to 20,000 psi. In general, the catheter systems of the embodiments disclosed herein utilize nominally sized, radially directed jet orifices 90a-90n to discharge radially directed fluid jet streams 92, and the fourth alternative embodiment utilizes crossflow jets 132 where the occurrence of hemolysis is not desired or is to be minimized. Fig. 22). Other embodiments may utilize smaller sized, radially directed jet orifices 112a-112n (shown later) to discharge radially directed fluid jet streams 92 of greater strength and effectiveness.

[0055] Fig. 7, a first alternative embodiment, is in many respects a Fig. 2 similar explanation and shows a hydrodynamic direct flow catheter tube 12a, also referred to as the catheter tube 12a, and the manifold 14 and associated components, and each being connected to accompanying control components and controlling the functions of the accompanying control components in a manner corresponding to that shown in Fig. 1, wherein all numerals correspond to the elements already described or otherwise described herein. The catheter tube 12 is reconfigured as a catheter tube 12a to additionally include a balloon 100 that is self-inflating, located at the distal end thereof and in a position proximal to the inflow opening 38. A support ring 102 is additionally included and is attached to the high pressure tube 50. A marker band 104 is also additionally included and is coaxially and indirectly aligned with the support ring 102, as described in detail later. The components of Fig. 7 are used with the control components referred to in Fig. 1 is referred to and which is Fig. 1, such control components consisting of the high-pressure fluid source 42, the high-pressure fluid pump 44, the threaded high-pressure connection port 32 and the connecting element 46, the outflow regulator 47, the collection chamber 48, and the connecting element 49, which are used in much the same manner as already described. Together, said control elements, in combination with the catheter tube 12a and the manifold 14 and the closely related components thereof, comprise a hydrodynamic direct-flow catheter system 10a, which is also referred to as the catheter system 10a. Although the catheter tube 12a, the manifold 14, and the closely related components are referred to with reference to the catheter system 10a in Fig. 7, it is self-evident that the aforementioned control components referred to in Fig. 1 is referred to and the Fig. 1, but not in Fig. 7 are also part of the catheter system 10a.

[0056] As in Fig. 6, the high-pressure tube 50 also extends through the support ring 102 and is conveniently connected thereto to provide additional anchoring structure for the high-pressure tube 50 to secure the distal portion of the high-pressure tube 50 within the distal end of the catheter tube 12a. In addition, the high-pressure tube 50 also indirectly extends through the radiopaque marker band 104. The concentrically aligned radiopaque marker band 104 and the support ring 102 are shown in tight contact with the full wall thickness of the catheter tube 12a proximal to the balloon 100. As previously described, the high-pressure tube 50 is preferably connected to the support ring 78, such as by welding or other suitable means, in the region below the radiopaque marker band 80 where the support ring 78 acts as a support for the catheter tube 12a.The high-pressure tube 50 extends beyond the inlet opening 38 and terminates in an internal annular manifold (not shown) of the fluid jet ejector 52a, and is conveniently connected thereto where the fluid jet ejector 52a communicates with the lumen of the high-pressure tube 50. The balloon 100, which is continuous with the catheter tube 12a, preferably has a wall thickness less than the general wall thickness of the catheter tube 12a, is aligned in a longitudinal orientation between the coaxially aligned marker band 104 and the support ring 102 and the aligned marker band 80 and the support ring 78. The profile of the balloon 100 in the inflated mode is shown in dashed lines and is referred to as the inflated balloon 100a.

[0057] Fig. 9 is in many ways a Fig. 5 and shows an isometric view of an alternative fluid jet ejector 52a in conjunction with and in communication with the high pressure tube 50. In addition to the previously shown and described plurality of similar and desired radially directed jet orifices 90a-90n, the fluid jet ejector 52a also includes a plurality of proximally (rearwardly) directed orifices 106a-106n located on and around a proximal surface of the ejector 52a and in parallel alignment with the longitudinal axis of the fluid jet ejector 52a, and including the previously described annular groove 84 and passageway 86. The plurality of radially directed jet orifices 90a-90n and the plurality of proximally directed jet orifices 106a-106n are a unit and are jointly pressurized by pressurized saline solution provided by the high pressure tube 50.The high-pressure tube 50 delivers a pressurized saline solution or other suitable fluid to the fluid jet ejector 52a for producing and distributing desired, radially directed fluid jet streams 92 of saline solution or other suitable fluids that flow from the radially directed jet orifices 90a-90n of the fluid jet ejector 52a to perform functions as described herein. The fluid jet ejector 52a also provides and distributes pressurized, proximally directed fluid jet streams 108 of saline solution or other suitable fluids directed proximally from the proximally directed orifices 106a-106n to perform functions as described herein. OPERATION

[0058] In a closely related manner, as already described and with reference to Fig. 10, the method of operation of a first alternative embodiment will now be described. Generally, a standard guidewire 37 is deployed within a blood vessel 96 requiring treatment, or, alternatively, a filter guidewire or balloon occlusion guidewire could be used. The catheter tube 12a and other closely related and aligned components directly associated therewith, consisting primarily of the high-pressure tube 50, the fluid jet emitter 52a, the distal portion of the catheter tube 12a, and the deflated balloon 100, are advanced over and along the guidewire 37 and aligned within the blood vessel 96 for the purpose of cellular debris / thrombus / lesion maceration and removal, drug infusion, or other procedures, and maneuvered within the blood vessel 96 into an appropriate position for treatment.A typical guiding catheter or shaft may be incorporated, if necessary, to assist in placing the catheter tube 12a and the closely aligned components in direct communication therewith of the direct flow hydrodynamic catheter system 10a at the desired location on the blood vessel 96, to allow the tapered flexible tip 40 of the catheter tube 12a to be extended through and beyond the thrombus or lesions 98, to position the fluid jet emitter 52a in very close proximity to the thrombus or lesions 98, and to place the self-inflating balloon 100 proximal to the thrombus or lesions 98.Then, the direct flow thrombectomy catheter system 10a is activated, automatically and expandingly deploying the balloon 100, which reforms as an expanded balloon 100a, and then thrombus, cellular debris, and the like are removed, or drugs can be infused by a desired procedure.

[0059] Furthermore, Fig. 10 is a side view in partial cross-section of the catheter tube 12a of the first alternative embodiment, illustrating the implementation of the method and the use thereof, wherein the implementation includes control connections and functions of the accompanying components in a manner corresponding to that shown in Fig. 1, with particular attention being paid to the distal portion of the catheter tube 12a, the flexible, tapered tip 40, the inflated, self-inflatable balloon 100a, the fluid jet emitter 52a, the inflow port(s) 38 (reoriented), and other closely related components positioned within the blood vessel 96 containing deposits of thrombus or lesions 98. For exemplary and illustrative purposes, one or more inflow ports 38 are shown at the upper and lower ends of the catheter tube 12a. The operation will be further described in more detail and with reference to Fig. 10. In use, the hydrodynamic direct flow catheter tube 12a can be engaged over and around the guidewire 37, whereby the guidewire 37 (previously inserted into a vein or artery) can first slidably pass through the passageway 88 of the tapered, flexible tip 40 and the lumen 53 of the catheter tube 12a, followed by passage through the passageway 86 of the fluid jet emitter 52a, beyond the inflow orifice(s) 38, through the balloon 100, followed by the additional passage through the lumen 53 of the catheter tube 12a, through the strain relief tube 28, the tapered, central passageway 58 ( Fig. 3), sliding in and tightly engaged with the hemostasis valve 66 ( Fig. 3) to finally exit the hemostasis nut 30.

[0060] The distal portion of the high-pressure tube 50 delivers pressurized saline or other suitable fluid to the fluid jet ejector 52a to generate and distribute non-hemolytic, radially directed fluid jet streams 92 of saline or other suitable fluids that flow as a direct stream from the radially directed jet orifices 90a-90n of the fluid jet ejector 52a to perform thrombectomy functions in a manner as previously described. Carefully generated operating pressure and fluid flows at low-hemolysis levels can be achieved primarily by controlling the inlet fluid pressure at the high-pressure fluid pump 44 and / or by controlling the outlet rate at the outflow regulator 47, with the outflow regulator 47 operated to provide negative pressure to effect outflow aspiration.In addition, the pressurized saline solution or other suitable fluid is also delivered through the high pressure tube 50 to the fluid jet ejector 52a to generate and distribute proximally directed fluid jet streams 108 of saline solution or other suitable fluids proximally from the proximally directed jet orifices 106a-106n (. Fig. 9) of the fluid jet ejector 52a and from there parallel to the inflow opening(s) 38 and finally into the distal portion of the catheter tube 12a to flow proximally therethrough and to provide inflation of the balloon 100 and to supplement the downstream aspiration.

[0061] Balloon 100 is automatically deployed in an expanding manner to reform into an inflated balloon 100a under the pressure exerted by the proximally directed high-velocity fluid jet streams 108 emanating from the proximally directed jet orifices 106a-106n of fluid jet ejector 52a, supplemented by the pressurized outflow through the lumen 53 of catheter tube 12a. Pressure inflation of inflated balloon 100a, or maintenance of an inflated state of inflated balloon 100a, is also assisted by the use of counterpressure along the length of catheter tube 12a.An operational advantage of the present catheter system is the use of outflow and internal pressure generated by the proximally directed fluid jet(s) 108 in combination with restrictive control of the outflow, as influenced by the outflow regulator 47, to assist in automatic expansion of the balloon 100, which presses tightly against and seals the inner walls of the blood vessel 96. The reduced thickness of the material enclosing the balloon 100 allows sufficient expansion of the balloon 100 to reform as the inflated balloon 100a, whose further expansion is limited by its impact with the wall of the blood vessel 96.The operating pressure and fluid flows influencing the inflation of balloon 100 can be influenced primarily by controlling the input fluid pressure at high-pressure fluid pump 44 and / or by controlling the outflow rate at outflow regulator 47, with outflow regulator 47 operated to provide negative pressure to effect outflow aspiration. Additional fluid jet emitters of appropriate size and / or configuration may also be incorporated in place of fluid jet emitter 52a disposed in the distal portion of catheter tube 12a to emit or discharge one or more radially directed fluid jet streams 92 and one or more proximally directed fluid jet streams 108 proximally along or near the longitudinal axis of catheter tube 12a; the foregoing alternatives are not intended to limit the scope of the disclosure.

[0062] By inflating the balloon 100, the peripheral periphery of the inflated balloon 100a impacts the wall of the blood vessel 96 to cause fluid flow reduction or interruption within the blood vessel 96. The inflated balloon 100a, i.e., the balloon 100, may be compliant, semi-compliant, or non-compliant, depending on the procedure being performed. The inflated balloon 100a provides uniform centering and positioning of the distal portion of the catheter tube 12a within the blood vessel 96, thereby providing substantially equal annular spacing between the wall of the blood vessel 96 and the inflow port 38 for uniform access and clear space up to and around it. The inflated balloon 100a also provides an annular spacing between the blood vessel 96 and the inflow port(s) 38 to provide access to and clear space around the inflow port(s) 38.

[0063] The use of the radially directed fluid jet streams 92 from the radially directed jet orifices 90a-90n provides for the fluid jet impingement of the lesion or thrombus deposits 98 on the inner wall of the blood vessel 96 opposite or in close proximity to the radially directed jet orifices 90a-90n to impinge upon, ablate, and dislodge the lesion or thrombus deposits 98, whereby such thrombus or lesion particulate material and fluids may be entrained through one or more inflow orifices 38 by aspiration, which includes the use of the outflow regulator 47, as previously described.The action and high velocity of the proximally directed fluid jet streams 108 of saline or other suitable fluids proximally through the catheter tube 12a, in addition to causing inflation of balloon 100, provide a force to propel thrombus or lesions 98 and fluid flow proximally through the lumen 53 of the catheter tube 12a. As previously described, drugs for treating or lysing the thrombus deposits or lesions 98 may also be delivered via the high pressure tube 50 and the fluid jet ejector 52a and the radially directed jet orifices 90a-90n and the radially directed fluid jet streams 92 to soften the deposits of lesions or thrombus 98 in the region of the blood vessel 96 opposite or in close proximity to the radial jet orifices 90a-90n, thereby utilizing the radially directed fluid jet streams 92 more efficiently and profitably.

[0064] The proximally directed fluid jet streams 108 impinge upon such entrained thrombus or particulate lesions 98 and / or cellular debris picked up and entrained through the inflow port(s) 38, providing traction thereon, disrupting and macerating them. Such cellular debris is further entrained, pushed, and carried proximally along the lumen 53 of the catheter tube 12a by internal pressure and aspiration comprising the outflow regulator 47, as well as by the additional force provided by the action of the proximally directed fluid jet streams 108. The entrainment of thrombus or particulate lesions 98 and / or cellular debris through the inflow port(s) 38 is influenced by and relies upon the coordinated combination primarily comprising the operation of the outflow regulator 47 and the operation of the high-pressure fluid pump 44 via the catheter 12a.In such a catheter system, the inflow port(s) 38 are sufficiently sized for aspiration, or multiple inflow ports may be used to achieve appropriate fluid inflow and aspiration. The catheter tube 12a may be moved proximally or distally during the procedure to maximize the effect of the catheter system. The balloon 100 may be alternately pressurized and depressurized, thereby compacting thrombus or lesions 98 to enlarge a passageway. When the procedure is complete, the inflated balloon 100a is generally deflated under normal arterial pressure sufficiently to be safely removed, or deflation may be assisted with a manual syringe connected to the manifold, or deflation may be assisted by means of the outflow regulator 47.Further procedures can be performed normally via the remaining guidewire or guidewire device. Disrupting fluid flow in a blood vessel or other conduit maximizes the effect of the catheter system 10a in terms of cellular debris or tissue removal. Use of the devices of the present disclosure can also provide for the performance of a modified embolectomy by disrupting blood clots as the inflated balloon 100a is advanced through a blocked vessel, or can be used to minimize distal or proximal embolization.

[0065] In the present disclosure, the radially directed fluid jet streams 92 are driven by the same pressure source as the proximally directed fluid jet streams 108. The velocity of the directed fluid jet streams is controlled by the high-pressure pump 44, the total area of ​​all radially directed jet orifices 90a-90n, and the proximally directed jet orifices 106a-106n. Cell debris removal is influenced and achieved by aspiration in coordination with the operation of the high-pressure fluid pump 44 and the outflow regulator 47 through the catheter tube 12a. In such a catheter system, the inflow orifice 38 is sufficiently sized for aspiration.By sizing the radially directed jet orifices 90a-90n and the proximally directed jet orifices 106a-106n and operating the high-pressure pump 44 within appropriate parameters, the velocity and strength of the radially directed fluid jet streams 92 and the proximally directed fluid jet streams 108 can be influenced and controlled. The use of desired-value, radially directed jet orifices 90a-90n provides for the use of fluid jet streams with sufficient momentum, which can be delivered by large, non-hemolyzing fluid jet streams (92) that, via increased flow velocities, are equivalent in energy to smaller, high-velocity fluid jet streams described later. The principle for aggressive cellular debris removal relies on the velocity of the radially directed jet streams 92. It should be noted that there is a critical velocity for cellular debris release.As the radially directed fluid jet streams 92 travel through a fluid environment, the fluid jet streams entrain surrounding fluid, and the fluid jet streams decelerate. Empirical relationships exist for turbulent jet streams that show that the velocity is proportional to the diameter of the jet streams and proportional to the initial velocity of the jet streams. Thus, the velocity of the turbulent jet streams at a given distance could be increased either by increasing the initial fluid jet stream velocity or by increasing the jet orifice diameters. Note that as the jet orifice diameters are increased, the high-pressure pumping speed of pump 44 would need to be increased to maintain the fluid jet stream velocity.In practice, the catheter system is designed with a given series of jet orifice diameters and with the pumping speed of the high pressure pump 44 adjusted to achieve the corresponding effectiveness.

[0066] Fig. 11, a second alternative embodiment, is shown to be a Fig. 2, which shows a hydrodynamic direct flow catheter tube 12b, also referred to as the catheter tube 12b, and a manifold 14 and associated components, each connected to accompanying control components and controlling the functions of the accompanying control components in a manner corresponding to that shown in Fig. 1, where all numbers correspond to the elements already described or otherwise described herein. The components of Fig. 11 are connected to the control components referred to in Fig. 1 and shown therein, such control components consisting of the high-pressure fluid source 42, the high-pressure fluid pump 44, the threaded high-pressure connection port 32 and connector 46, the outflow regulator 47, the collection chamber 48, and the connector 49, all of which are used in substantially the same manner as previously described. Together, the aforementioned control components, in combination with the catheter tube 12b and the manifold 14 and the closely related components thereof, comprise a direct-flow hydrodynamic catheter system 10b, also referred to as the catheter system 10b.The catheter system 10b of this embodiment provides increased fluid velocity with smaller sized fluid jet streams projected radially therefrom, utilizing smaller radially directed jet orifices, as well as including provision and use of the proximally directed fluid jet streams 108 described above. Although the catheter tube 12b, the manifold 14, and closely related components are each described with reference to the catheter system 10b in FIG. Fig. 11, it is self-evident that the control components already mentioned, which are referred to in Fig. 1 and which are contained therein, but not in Fig. 11 are also an essential part of the catheter system 10b.

[0067] Fig. 12 is in many ways a Fig. 4, showing the distal end of the catheter tube 12b in use instead of the catheter tube 12 in use with a fluid jet ejector 52b in place of the fluid jet ejector 52, wherein the fluid jet ejector 52b has additional structure, features and functionality as in Fig. 13 described.

[0068] Fig. 13 is in many ways a Fig. 9, showing an isometric view of the alternative fluid jet ejector 52b in conjunction with and in communication with the high-pressure tube 50, alternatively including the plurality of small-sized, radially directed jet orifices 112a-112n instead of the nominally sized, radially directed jet orifices 90a-90n of the previous embodiments. The fluid jet ejector 52b also includes the previously shown and described plurality of proximally (rearwardly) directed orifices 106a-106n located on and around a proximal surface of the fluid jet ejector 52b in parallel alignment with the longitudinal axis of the fluid jet ejector 52b, and including the previously described annular groove 84 and passageway 86.The plurality of radially directed jet orifices 112a-112n and the plurality of proximally directed orifices 106a-106n are a unit and are pressurized together by the pressurized saline solution provided by the high pressure tube 50.

[0069] The high-pressure tube 50 delivers pressurized saline or other suitable fluid to the fluid jet ejector 52b for producing and distributing small, radially directed fluid jet streams 114 at high pressure, with jet streams emanating from the radially directed jet orifices 112a-112n of the fluid jet ejector 52b to perform functions as described herein with greater force and intensity. The fluid jet ejector 52b also produces and distributes pressurized, proximally directed fluid jet streams 108 of saline or other suitable fluids, with the fluid jet streams directed proximally from the proximally directed orifices 106a-106n to perform functions as described herein. OPERATION

[0070] Generally, a standard guidewire is deployed into a blood vessel 96 requiring treatment, or alternatively, a filter guidewire or balloon occlusion guidewire could be used. The catheter tube 12b and other closely related and aligned components directly associated therewith, consisting primarily of the high-pressure tube 50 and the fluid jet emitter 52, are advanced over and along a guidewire (37) aligned within the blood vessel 96 for the purpose of cellular debris / thrombus / lesion removal, drug infusion, or other procedures, and maneuvered into an appropriate position for treatment.A typical guide catheter or shaft may be incorporated, if necessary, to assist in positioning the catheter tube 12b and closely aligned components in direct communication therewith of the direct-stream hydrodynamic catheter system 10b at the desired location on the blood vessel 96, to allow the tapered tip 40 of the catheter tube 12b to be extended through and beyond the thrombus or lesions 98, and to position the fluid jet ejector in close proximity to the thrombus or lesions 98. The direct-stream thrombectomy catheter 10b is then activated, allowing thrombus, cellular debris, lesions, and the like to be infused through a desired procedure. The catheter tube 12b may be moved proximally or distally during the procedure to maximize the effect of the system.Further procedures can be performed normally using the remaining guidewire or the guidewire device.

[0071] Furthermore, Fig. 14 is a side view in partial cross-section of the catheter tube 12b of the second alternative embodiment, explaining the implementation of the method and the use thereof, which control connections and functions of the accompanying components in a manner corresponding to that shown in Fig. 1, with particular attention being paid to the distal portion of the catheter tube 12b, the flexible, tapered tip 40, the fluid jet ejector 52b, the inflow orifice(s) 38 (reoriented), and other closely related components positioned within the blood vessel 96 containing cellular debris from thrombus or lesions 98. More specifically, and with reference to Fig. 1 and Fig. 14 further describes the mode of operation in use wherein the hydrodynamic direct flow catheter tube 12b is engaged over and around the guidewire 37 in a manner as previously described.

[0072] The distal portion of high-pressure tube 50 delivers pressurized saline or other suitable fluid to fluid jet ejector 52b to produce and distribute small, high-output, radially directed fluid jet streams 114 of saline or other suitable fluids that flow as a direct stream from the radially directed jet orifices 112a-112n of fluid jet ejector 52b to perform thrombectomy functions as previously described. Carefully generated operating pressure and fluid flows can be influenced primarily by controlling the fluid input pressure at high-pressure fluid pump 44 and / or by controlling the delivery rate at delivery regulator 47, with delivery regulator 47 operating to provide negative pressure for drain aspiration.Additional fluid jet emitters of suitable size and / or configuration may be incorporated into the distal portion of the catheter tube 12b in place of the fluid jet emitter 52b to emit or discharge one or more radially directed fluid jet streams 114.

[0073] The use of the powerful, radially directed fluid jet streams 114 from the radially directed jet orifices 112a-112n provides the fluid jet impingement of the deposits of thrombus or lesions 98 on the inner wall of the blood vessel 96 opposite or in close proximity to the radially directed jet orifices 112a-112n to impinge on, ablate, or loosen deposits of thrombus or lesions 98, with such thrombus or lesion particles and fluids being carried by the fluid inflow as indicated by the directed arrow 128 in Fig. 14, can be entrained through one or more inflow ports 38 by aspiration, which includes the use of the outflow regulator 47, and discharged proximally through the catheter tube 12b. In addition, drugs for treating or lysing the thrombus or lesions 98 can also be delivered via the radially directed jet ports 112a-112n and the radially directed fluid jet streams 114 to soften the deposits of thrombus or lesions 98 in the region of the blood vessel 96 opposite or in close proximity to the radial jet ports 112a-112n, making more effective use of the radially directed fluid jet streams 114. The drugs are delivered through the high-pressure tube 50 to the sites of the deposits of thrombus or lesions 98 using the fluid jet ejector 52b.

[0074] One or more inflow ports 38 receive, ingest, and entrain thrombus or lesions 98 in the form of particulate material and / or cellular debris by a fluid stream therethrough, and it is entrained to be pushed and conveyed along the lumen 53 of the catheter tube 12 by aspiration comprising the outflow regulator 47, wherein the entrainment of particulate thrombus or lesions 98 and / or cellular debris through the inflow port(s) 38 is influenced by and relies upon entrainment in conjunction with aspiration in coordination with the outflow regulator 47 through the catheter 12. In such a device, the inflow port 38 is sufficiently sized for aspiration, or multiple inflow ports may be used to achieve a desired fluid inflow and aspiration.The outflow of fluid and thrombus or lesions is driven proximally through the catheter tube 12b by internal pressure resulting from the radially directed fluid jet streams 92 and the fluid entrained through the inflow port 38, and is assisted by aspiration through the use of the outflow regulator 47.

[0075] In the present disclosure, the radially directed fluid jet streams 114 are driven by the same pressure source, where the velocity is controlled by the high-pressure pump 44 and the overall area of ​​all radially directed jet orifices 112a-112n. By sizing the radially directed jet orifices 112a-112n and operating the high-pressure pump 44 within appropriate parameters, the velocity and intensity of the radially directed fluid jet streams 114 can be influenced and controlled. The principle for aggressive cellular debris removal depends on the velocity of the radially directed fluid jet streams 114. It should be noted that there is a critical velocity for cellular debris release.As the radially directed fluid jet streams 114 travel through a fluid environment, the fluid jet streams entrain surrounding fluid, causing the velocity of the fluid jet streams to slow. Empirical relationships exist for turbulent fluid jet streams that show that the velocity is proportional to the diameter of the fluid jet streams and to the initial velocity of the fluid jet streams. Thus, the velocity at a given distance could be increased either by increasing the initial fluid jet stream velocity or by increasing the jet orifice diameter. As previously described, the pump flow rate must be adjusted depending on the size of the jet orifice diameter and the desired jet stream velocity.

[0076] Fig. 15, a third alternative embodiment, is an illustration which in many respects Fig. 2 and shows a hydrodynamic direct flow catheter tube 12c, also referred to as the catheter tube 12c, and the manifold 14 and associated components, each connected to accompanying control components and controlling the functions of the accompanying control components in a manner corresponding to that shown in Fig. 1, wherein all numerals correspond to the elements already described or otherwise described herein. The catheter tube 12 is reconfigured as a catheter tube 12c to additionally include one or more balloon inflation inflow ports 116 disposed distal to a fluid jet ejector 52c, as best shown in Fig. 16, and a balloon 118 which is self-inflating and is arranged at the distal end of the balloon inflation inflow port 116. The components of Fig. 15 are connected to the control components that are Fig. 1, such control components consisting of the high pressure fluid source 42, the high pressure fluid pump 44, the threaded high pressure connection orifice 32 and connector 46, the outflow regulator 47, the collection chamber 48, and the connector 49, which are used in much the same manner as previously described. Together, the control components mentioned, in combination with the catheter tube 12c and the manifold 14 and the closely associated components thereof, comprise a direct stream hydrodynamic catheter system 10c, also referred to as the catheter system 10c, the catheter system 10c providing increased velocity, but smaller sized, radially projecting fluid jet streams therefrom through the use of small sized, radially directed jet orifices.The catheter system 10c includes the provision and use of the previously described pressurized, proximally directed fluid jet streams 108 and the previously described pressurized, radially directed fluid jet streams 114. In addition, the catheter system 10c includes the provision and use of pressurized, distally directed fluid jet streams 126 that are discharged from the fluid jet emitter 52c (. Fig. 17) for inflation of the distally disposed balloon 118 in cooperation with the balloon inflation inflow port 116. Although the catheter tube 12c, the manifold 14 and the closely related components are each described with reference to the catheter system 10c in Fig. 15, it is self-evident that the aforementioned control components, which are shown in Fig. 1 are shown and mentioned, but not in Fig. 15 are also part of the catheter system 10c.

[0077] Fig. 16 corresponds in many ways Fig. 4 and illustrates the distal end of the catheter tube 12c being reconfigured and used in place of the catheter tube 12 and shown in use with the fluid jet ejector 52c in place of the fluid jet ejector 52, wherein the fluid jet ejector 52c has additional structure, features and functionality as shown in Fig. 17. More specifically, the relationship and arrangement of the inflow orifices 38 (reoriented), the proximally oriented jet orifices 106a-106n of the fluid jet ejector 52c, the radially oriented jet orifices 112a-112n of the fluid jet ejector 52c, the distally oriented jet orifices 122a-122n of the fluid jet ejector 52c, the balloon inflation inflow orifice(s) 116 (reoriented), and the self-inflating balloon 118 are shown. Also shown are the plurality of holes 94a-94n extending through the wall of the catheter tube 12c in corresponding alignment with the radially oriented jet orifices 112a-112n. Radially oriented high-velocity fluid jet streams 114 ( Fig. 17) flow through the radially aligned jet openings 112a - 112n and through the plurality of holes 94a - 94n of the catheter tube 12c to treat as in Fig. 18. Balloon 118, which is continuous with catheter tube 12c, preferably has a wall thickness less than the general wall thickness of catheter tube 12c, is generally oriented longitudinally along catheter tube 12c between balloon inflation inflow port 116 and tapered flexible tip 40. The profile of balloon 118 in the inflated mode is shown in dashed lines and is designated inflated balloon 118a.

[0078] Fig. 17 is an explanation that in many ways Fig. 13 and shows an isometric view of the alternative fluid jet ejector 52c coupled and in communication with the high-pressure tube 50. A plurality of distally (forward) directed jet orifices 122a-122n are additionally disposed on and about the distal surface of the fluid jet ejector 52c. As previously shown and described, the plurality of small-sized, radially directed jet orifices 112a-112n around the periphery of the fluid jet ejector 52c are also included. The fluid jet ejector 52c also includes the plurality of proximally (rearward) directed jet orifices 106a-106n disposed on and about the proximal surface of the fluid jet ejector 52c, and including the previously described annular groove 84 and passageway 86.The plurality of radially directed jet orifices 112a-112n, the plurality of proximally directed orifices 106a-106n, and the plurality of distally directed jet orifices 122a-122n are a unit and are pressurized together by pressurized saline solution provided by the high pressure tube 50.

[0079] The high pressure tube 50 delivers pressurized saline or other suitable fluids to the fluid jet ejector 52c to generate and distribute distally directed high pressure fluid jet streams 126 which flow from distally directed jet orifices 122a-122n to effect the automatic pressurization and inflation of the balloon 118 as shown in Fig. 18. In a manner as previously described, the high pressure tube 50 delivers pressurized saline or other suitable fluid to the fluid jet ejector 52c for generating and distributing small, yet radially directed, high-velocity fluid jet streams 114 of saline or other suitable fluids that flow from the radially directed jet orifices 112a-112n of the fluid jet ejector 52c to powerfully and efficiently perform functions as described herein. As previously described, the fluid jet ejector 52c also generates and distributes pressurized, proximally directed fluid jet streams 108 of saline or other suitable fluids directed proximally from the proximally directed orifices 106a-106n to perform functions as described herein. OPERATION

[0080] In a closely related manner as already described hereinbefore and with reference to Fig. 18, the method of operation of a third alternative embodiment will now be described. Generally, a standard guidewire 37 is deployed within a blood vessel 96 requiring treatment. The catheter tube 12c and other closely associated and aligned components directly associated therewith, consisting primarily of the high-pressure tube 50, the fluid jet emitter 52c, the distal portion of the catheter tube 12c, and the deflated balloon 118, are advanced over and along the guidewire 37 and advanced and aligned within the blood vessel 96 for the purpose of cell harvesting, cellular debris / thrombus / lesion maceration or removal, drug infusion, or other procedures; the catheter tube is maneuvered within the blood vessel 96 into an appropriate position for treatment.A typical guiding catheter or shaft may be incorporated, if necessary, to assist in the placement of the catheter tube 12c and the closely aligned components in direct combination therewith of the direct flow hydrodynamic catheter system 10c at the desired location on the blood vessel 96 to allow the tapered flexible tip 40 of the catheter tube 12c to be expanded through the thrombus or lesions 98 to a position with the fluid jet emitter 52c in very close proximity to the thrombus or lesions 98 and with the self-inflating balloon 118 distal to the thrombus or lesions 98.Then, the direct-flow thrombectomy catheter system 10c is activated, with the balloon 118 automatically and expandingly deployed and reforming as an expanded balloon 118a, and then cells from the thrombus or vessel, cellular debris, and the like can be harvested (removed) by aspiration or by fluid streams directed proximally along the lumen 53 of the catheter tube 12c and subsequently centrifuged in a separation centrifuge for sampling, or drug can be infused by a desired method.

[0081] In addition, Fig. 18 is a side view in partial cross-section of the catheter tube 12c of the third alternative embodiment of the present disclosure, illustrating the performance of the method and the use thereof, which control connections and functions of the accompanying components in a manner corresponding to that shown in Fig. 1, with particular attention being paid to the distal portion of the catheter tube 12c, the flexible, tapered tip 40, the inflated self-inflating balloon 118 (a), the balloon inflation inflow port(s) 116 (reoriented), the fluid jet emitter 52c, the inflow port(s) 38, and other closely related components positioned within the blood vessel 96 containing cellular debris from thrombus or lesions 98. For exemplary and illustrative purposes, one or more inflow port(s) 38 (reoriented) are shown at the upper and lower ends of the catheter tube 12c.

[0082] More specifically and with reference to Fig. 18, the operation is further described. The distal portion of the high-pressure tube 50 delivers pressurized saline or other suitable fluid to the fluid jet ejector 52c to generate and distribute radially directed fluid jet streams 114 of saline or other suitable fluids that flow as direct fluid jet streams from the radially directed jet orifices 112a-112n of the fluid jet ejector 52c to perform thrombectomy functions in a manner as previously described. Pressurized saline or other suitable fluid is also delivered through the high-pressure tube 50 to the fluid jet ejector 52c to generate and distribute proximally directed fluid jet streams 108 of saline or other suitable fluids that flow from the proximally directed jet orifices 106a-106n ( Fig. 17) of the fluid jet emanator 52c, and from there to extend parallel to the inflow opening(s) 38 and finally into the distal portion of the catheter tube 12c to flow therethrough proximally in a manner as already described. In addition, and with particular reference to this third alternative embodiment, pressurized saline solution or other suitable fluid is also delivered through the high-pressure tube 50 to the fluid jet emanator 52c to generate and distribute distally directed fluid jet streams 126 of saline solution or other suitable fluids distally from the distally directed jet openings 122a-122n ( Fig. 17) to assist in inflation of the balloon 118.

[0083] The distally directed fluid jet streams 126 of saline solution or other suitable fluids distal from the openings 122a - 122n ( Fig. 17) of the fluid jet ejector 52c in and along the distal portion of the catheter tube 12c in close proximity to the balloon inflation inflow port 116 and thence within the confines of the self-inflating balloon 118, result in inflation of the balloon 118a for the purposes of, but not limited to, impairing fluid flow in the blood vessel 96, causing stagnant fluid flow in the thrombus region, providing centering of the distal portion of the catheter tube 12c, and assisting in the performance of thrombectomy functions as described herein.

[0084] The self-inflating balloon 118 is automatically and expandingly deployed to reform itself as an inflated balloon 118a, primarily due to the pressure of the distally directed fluid jet streams 126 emanating from the jet orifices 122a-122n of the fluid jet ejector 52c. The jet stream 126, indicated by the directed arrows 128 in Fig. The fluid-entrained inflow shown in Figure 18 assists the inflation of the self-inflating balloon 118. The pressure inflation of the inflated balloon 118a, or the maintenance of a state of inflation, is also assisted by the use of counterpressure along the length of the catheter tube 12c. An operational advantage of this third alternative embodiment is the use of the outflowing outflow and internal pressure created by the proximally directed fluid jet(s) 108 in combination with the outflow restriction caused by the outflow regulator 47 to assist the automatic expansion of the balloon 118, with the expanded balloon 118a firmly impacting and sealing against the inner wall of the blood vessel 96.Due to the reduced thickness of the material enclosing balloon 118, balloon 118 can expand sufficiently to become an inflated balloon 118a, which is confined by its impact with the wall of blood vessel 96. The inflation pressure and fluid flows can be influenced by controlling the input fluid flow at high-pressure fluid source 42 and / or by controlling the outflow rate of outflow regulator 47.Additional fluid jet emitters of appropriate size and / or configuration may be incorporated in place of the fluid jet emitter 52c at the proximal end of the distal portion of the catheter tube 12c to emit or discharge one or more distally directed fluid jet streams 126, to emit or discharge one or more proximally directed fluid jet streams 108 along or near the longitudinal axis of the catheter tube 12c, and to emit or discharge one or more radially directed fluid jet streams 114 therefrom.

[0085] Inflation of balloon 118 to form inflated balloon 118a positions the peripheral periphery of inflated balloon 118 against the wall of blood vessel 96 to effect fluid flow reduction or interruption within blood vessel 96. Inflated balloon 118a, i.e., balloon 118, may be compliant, semi-compliant, or non-compliant, depending on the procedure being performed. Inflated balloon 118a provides uniform centering and positioning of the distal portion of catheter tube 12c within blood vessel 96, thereby providing substantially equal annular spacing between the wall of blood vessel 96 and inflow port 38 for uniform access and clearance thereto and therearound.The inflated balloon 118a also provides an annular spacing between the blood vessel 96 and the balloon inflation inflow port 116 to provide access to and clear space around the balloon inflation inflow port 116.

[0086] The proximally directed fluid jet streams 108 provide a low-pressure region at the inflow port 38 to pick up and entrain thrombotic particulate material and / or cellular debris 98 therethrough, to impinge upon, provide traction thereon, and disrupt or macerate thrombotic particulate material and / or cellular debris 98, and to propel and advance one or more particles of thrombus and / or cellular debris or lesion 98 along the lumen 53 of the catheter tube 12c by the action of the proximally directed fluid jet streams 108. The entrainment of thrombotic particulate material and / or cellular debris through the inflow port 38 depends on the high-velocity fluid jet streams 108.The outflow of fluid and thrombus is generally driven proximally through the catheter tube 12c by internal pressure generated by the high-velocity fluid jet streams 108 and the fluid entrained through the inflow port 38, but also employs the assistance of fluid pressure forces provided by the radially directed fluid jet streams 114, the distally directed fluid jet streams 126, and by assistance provided by aspiration.

[0087] The balloon 118 can be alternately pressurized and depressurized, whereby the thrombus or lesions 98 can be compacted to dilate a passage through the blood vessel 96. The catheter tube 12c can be moved proximally or distally during the procedure to maximize the effect of the catheter system. When the procedure is completed, the inflated balloon 118a is generally sufficiently deflated to normal arterial pressure so that the balloon 118 can be safely removed, or deflation of the balloon 118 can be assisted with a manual syringe connected to the manifold, or deflation of the balloon 118 can be assisted by means of the outflow regulator 47. Other known interventions can be performed via the retained guidewire or guidewire device.Disrupting fluid flow in a blood vessel or other conduit maximizes the effectiveness of the catheter system 12c in removing cellular debris or tissue. Use of devices of the present disclosure may also provide for performing a modified embolectomy by disrupting blood clots as the inflated balloon 118a is advanced through a blocked vessel, or they may be used to minimize distal or proximal embolization.

[0088] In this alternative embodiment, the radially directed fluid jet streams 114, the proximally directed fluid jet streams 108, and the distally directed fluid jet streams 126 are driven by the same fluid pressure. The velocity of the fluid jet streams is controlled by the high-pressure pump 44 and the entire range of all radially directed jet orifices 112a-112n, proximally directed jet orifices 106a-106n, and distally directed jet orifices 122a-122n. Cell debris and sample removal are controlled and assisted by aspiration in coordination with the operation of the high-pressure fluid pump 44 and the outflow regulator 47, which simultaneously introduces pressurized radially, proximally, and distally directed fluid jet streams into the distal end of the catheter tube 12c. In such a catheter system, the inflow orifice 38 is sufficiently sized to perform aspiration.By sizing the radially directed jet orifices 112a-112b, the proximally directed jet orifices 106a-106n, the distally directed orifices 122a-122n, and by operating the high-pressure pump 44 within appropriate parameters, the velocity and strength of the radially directed fluid jet streams 114, the proximally directed fluid jet streams, and the distally directed fluid jet streams 126 can be influenced and controlled. The principle for aggressive cellular debris removal depends on the velocity of the radially directed fluid jet stream 114. It should be noted that there is a critical velocity for cellular debris release. Since the radially directed fluid jet streams 11 travel through a fluid environment, the fluid jet streams entrain surrounding fluid, causing the fluid jet streams to slow down.Empirical relationships exist for turbulent jet streams that show that the velocity of the fluid jet streams is proportional to the diameter of the jet streams and the initial velocity of the fluid jet streams. Thus, the velocity of the fluid jet streams, for a given distance, could be increased either by increasing the initial fluid jet stream velocity or by increasing the jet orifice diameter. Note that as the jet orifice diameters are increased, the pumping rate of the high-pressure pump 44 would need to be increased to maintain the fluid jet stream velocity. In practice, the catheter system is designed with a given series of jet orifice diameters and with the pumping rate of the high-pressure pump 44 adjusted to achieve the appropriate efficiency.In cases where cell sampling is desired, the velocity of the radially directed fluid jet streams 114 can be increased sufficiently to release microscopic islands of cell clumps. The use of the distally located occlusion balloon 118a is helpful to ensure that the released conduction cells do not migrate to the distal vascular beds. For example, if the cells were cancerous ureteral epithelial cells, the balloon 118a would minimize the possibility of metastasis.

[0089] Fig. 19, a fourth alternative, is an explanation that in many respects Fig. 2 and shows a hydrodynamic direct flow catheter tube 12d, also referred to as the catheter tube 12d, and the manifold 14 and the associated components, each connected to accompanying control components and controlling the functions of the accompanying control components in a manner corresponding to that shown in Fig. 1, wherein all numerals correspond to the elements already described or otherwise described herein. The catheter tube 12 is reconfigured as a catheter tube 12d to additionally include one or more balloon inflation outlet ports 130 located in the distal portion of the catheter tube 12d at a location distal to a fluid jet outlet 52d, as best shown in Fig. 20. The outlet openings 130 are used to direct low-power direct streams in the form of cross-flow jets 132, which are Fig. 22. The radially aligned jet openings 112a - 112n and the radially aligned fluid jet streams 114 are not used in this alternative embodiment. The components of Fig. 19 are used with the control components that are in Fig. 1, such control components consisting of the high-pressure fluid source 42, the high-pressure fluid pump 44, the threaded high-pressure connection port 32 and connector 46, the outflow regulator 47, the collection chamber 48, and the connector 49, which are used in much the same manner as previously described. Together, the control components mentioned, in combination with the catheter tube 12d and the manifold 14 and the closely related components thereof, comprise a hydrodynamic direct-flow catheter system 10d, also referred to as the catheter system 10d, the catheter system 10d providing for the use of reduced-velocity, but large-sized, cross-flow jets 132 therefrom through the use of outflow port(s) 130.The catheter system 10d includes the provision and use of the previously described pressurized proximally directed fluid jet streams 108 and the pressurized distally directed fluid jet streams 126 emanating from the fluid jet emanator 52d (. Fig. 21), wherein the distally directed fluid jet streams 126 exit the outlet opening(s) 130 as newly characterized low-power cross-flow jets 132 ( Fig. 22) and flow out of it to re-enter the catheter tube 12d at the inlet opening 38. Although the catheter tube 12d, the distributor 14 and the respective closely related components are described with reference to the catheter system 10d in Fig. 19, it is self-evident that the aforementioned control components shown in Fig. 1 are mentioned and shown, but not in Fig. 19 are also part of the catheter system 10d.

[0090] Fig. 20 is an explanation that in many ways Fig. 4 and shows the distal end of a catheter tube 12d in reconfiguration and use in place of the catheter tube 12 and shown in use with the fluid jet ejector 52d in place of the fluid jet ejector 52, wherein the fluid jet ejector 52d has many of the structural features and largely the functionality as for Fig. 21. More specifically, the relationship and arrangement of the inflow opening 38 (reoriented), the proximally directed jet openings 106a-106n of the fluid jet ejector 52d, the distally directed jet openings 122a-122n of the fluid jet ejector 52d, and the outflow opening(s) 130 are shown. The plurality of radially directed jet openings 112a-112n for discharging radially directed jet streams 114 are not included in the fluid jet ejector 52d, and the plurality of holes 94a-94n of the previously shown catheter tubes 12a-12c are not included in the catheter tube 12d.

[0091] Fig. 21 is an explanation that in many ways Fig. 17, and shows an isometric view of the alternative fluid jet ejector 52d coupled and in communication with the high-pressure tube 50. As previously described, the plurality of distally (forward) directed jet orifices 122a-122n are located on and around the distal surface of the fluid jet ejector 52d. Also included is the previously shown and described plurality of proximally (rearward) directed jet orifices 106a-106n located on and around the proximal surface of the fluid jet ejector 52d. The fluid jet emitter 52d also includes the previously described annular groove 84 and the passageway 86. The plurality of proximally directed openings 106a-106n and the plurality of distally directed jet openings 122a-122n are a unit and are pressurized together by pressurized saline solution provided via the high pressure tube 50.

[0092] The high pressure tube 50 delivers high pressure saline or other suitable fluids to the fluid jet ejector 52d to generate and distribute pressurized distally directed fluid jet streams 126 that flow from the distally directed jet orifices 122a-122n to provide for the generation of crossflow jets 132 used for thrombus or lesion treatment ( Fig. 22). In a manner as previously described, the high-pressure tube 50 delivers pressurized saline or other suitable fluid to the fluid jet emitter 52d for generating and distributing pressurized proximally directed fluid jet streams 108 of saline or other suitable fluids, the fluid jet streams being directed proximally from the proximally directed openings 106a-106n to perform functions as described herein. OPERATION

[0093] In a closely related manner, as already mentioned herein with reference to Fig. 22, the method of operation of the fourth alternative embodiment will now be described. Generally, a standard guidewire 37 is deployed within a blood vessel 96 requiring treatment, or, in the alternative, a filter guidewire or a balloon occlusion guidewire could be used. The catheter tube 12d and other closely related and aligned components directly associated therewith, consisting primarily of the high-pressure tube 50, the fluid jet ejector 52d, and the distal portion of the catheter tube 12d, are advanced over and along the guidewire 37 and aligned within the blood vessel 96 for the purpose of cellular debris / thrombus / lesion maceration or removal, drug infusion, or other procedure; the catheter tube is maneuvered within the blood vessel 96 into an appropriate position for treatment.A typical guide catheter or shaft may be incorporated, if necessary, to assist in the placement of the catheter tube 12d and the closely aligned components of the hydrodynamic direct-stream catheter system 12d in direct combination therewith at the desired location of the blood vessel 96 so that the tapered, flexible tip of the catheter tube 12d can be extended through the thrombus or lesion 98 to a position where the fluid jet emitter 52d is in very close proximity to the thrombus or lesions 98. The direct-stream thrombectomy catheter system 10d is then activated, whereby thrombus, cellular debris, and the like can be removed by the action of the crossflow jet(s) 132, preferably in combination with other previously described methods, or drugs can be infused by a desired method.

[0094] In addition, Fig. 22 is a side view of the fourth alternative embodiment in partial cross-section of the catheter tube 12d in the performance of the method and the use thereof, which control connections and functions of the accompanying components in a manner corresponding to that shown in Fig. 1, with particular attention being paid to the distal portion of the catheter tube 12d, the flexible tapered tip 40, the outflow port(s) 130 (reoriented), the fluid jet emitter 52d, the inflow port(s) 38, and other closely related components positioned within the blood vessel 96 containing cellular debris from thrombus or lesions 98. For exemplary and illustrative purposes, one or more inflow port(s) 38 (reoriented) and the outflow port 130 (reoriented) are shown at the upper and lower ends of the catheter tube 12d.

[0095] More specifically and with reference to Fig. 22, the operation is further described. Pressurized saline or other suitable fluid is delivered through the high-pressure tube 50 to the fluid jet ejector 52d to generate and distribute proximally directed fluid jet streams 108 of saline or other suitable fluids that are directed proximally from the proximally directed jet orifices 106a-106n ( Fig. 21) of the fluid jet emanator 52d and from there parallel to the inflow opening(s) 38 and finally into the distal portion of the catheter tube 12d to flow proximally in a manner as previously described. With particular reference to this fourth alternative embodiment, pressurized saline or other suitable fluid is also delivered through the high pressure tube 50 to the fluid jet emanator 52d to generate and distribute distally directed fluid jet streams 126 of saline or other suitable fluids employed for a use different from the previously described embodiments, the distally directed fluid jet streams 126 being distal from the distally directed jet openings 122a-122n ( Fig. 21) to provide for the generation of the crossflow jets 132. The distally directed fluid jet streams 126 of saline or other suitable fluids are directed toward the general location of the outflow port(s) 130 and into and along the colocated distal end of the catheter tube 12d. The distally directed fluid jet streams 126 are pressurized at the distal end of the catheter tube 12d and exit the outflow port(s) 130 as crossflow jets 132, which re-enter the catheter tube 12d through the inflow port(s) 38. The crossflow jets 132 serve to impinge upon the thrombus or lesion 98 to abrade, ablate, and fragment such thrombus or lesion 98 particulate material, and to entrain and propel such treated particulate material back into the inflow port(s) 38.Additional fluid jet emitters of appropriate size and / or configuration may be incorporated into the proximal end of the distal portion of the catheter tube 12d in place of the fluid jet emitter 52d to distally emit or discharge one or more distally directed fluid jet streams 126 for the purpose of providing crossflow jets 132 and to discharge or discharge one or more proximally directed fluid jet streams 180 along or near the longitudinal axis of the catheter tube 12d.

[0096] The proximally directed fluid jet streams 108 provide for the creation of a low-pressure region at the inflow port 38 for re-entry of the crossflow jet(s) 132 and, as before, provide for the ingestion and entrainment of thrombus or lesion 98 particulate material and / or cellular debris therethrough. The proximally directed fluid jet streams 108 impinge upon, provide traction to, and disrupt and macerate thrombus or lesion 98 particulate material and / or cellular debris, and by entrainment, push and propel one or more particles of thrombus or lesion 98 and / or cellular debris forward along the lumen 53 of the catheter tube 12d. The entrainment of thrombotic particulate material and / or cellular debris 98 through the inflow port 38 depends on the high-velocity fluid jet streams 108.The outflow of fluid and thrombus is generally driven proximally through the catheter tube 12d by an internal pressure generated by the high-velocity fluid jet streams 108 and the fluid entrained through the inflow port 38, but also employs the assistance of fluid pressure forces provided by the distally directed fluid jet streams 126 and the closely associated crossflow jets 132.

[0097] In this fourth alternative embodiment, the proximally directed jet streams 108 and the distally directed fluid jet streams 126, which generate the crossflow jets 132, are driven by the same fluid pressure. The velocity of the fluid jet streams is controlled by the high-pressure pump 44 and the entire area of ​​all proximally directed jet orifices 106a-106n and distally directed jet orifices 122a-122n. Cell debris removal is assisted by aspiration in coordination with the operation of the high-pressure fluid pump 44 and the outflow regulator 47, the pressurized proximally and distally directed fluid jet streams, and the crossflow jet streams. In such a catheter system, the inflow orifice 38 is sufficiently sized for aspiration.By sizing the proximally directed jet orifices 106a-106n, the distally directed orifices 122a-122n, and the outflow orifice(s) 130, the velocity and strength of the proximally directed fluid jet streams 108, the distally directed fluid jet streams 126, and the crossflow jets 132 can be influenced and controlled by operating the high-pressure pump 44 within appropriate parameters. The principle for aggressive thrombus ablation and for fragmentation and debris removal depends on the velocity of the crossflow jets 132. It should be noted that there is a critical velocity for debris release. As the crossflow jets 132 travel through a fluid environment within the blood vessel 96, the crossflow jets 132 entrain surrounding fluid, causing the crossflow jets 132 to decelerate.Empirical relationships exist for turbulent jet streams that show that the velocity of the jet streams is proportional to the diameter of the fluid jet streams and to the initial velocity of the fluid jet streams. Thus, the velocity of the fluid jet streams at a given distance in the blood vessel 96 would be increased either by increasing the velocity of the distally directed fluid jet streams 126 or by increasing the diameter of the distally directed jet orifice 122a-122n. Note that as the jet orifice diameters are increased, the pumping speed of the high-pressure pump 44 would need to be increased to maintain the fluid jet stream velocity. In practice, the catheter system is designed with a given series of jet orifice diameters and with the pumping speed of the high-pressure pump 44 adjusted to achieve the appropriate efficiency.

[0098] Fig. 23, a fifth alternative embodiment, is an illustration which in many respects Fig. 2 and shows a hydrodynamic direct jet catheter tube 12e, also referred to as the catheter tube 12e, and the manifold 14 and associated components, and being connected to accompanying control components and performing the functions of the accompanying control components in a manner corresponding to that shown in Fig. 1, wherein all numerals correspond to the elements already described or otherwise described herein. The catheter tube 12 is reconfigured as a catheter tube 12e, excluding the tapered tip 40, excluding the use of the radially directed jet openings 112a-112n in the fluid jet emitter 52e, excluding the use of powerful radially directed fluid jet streams 114, and excluding the holes 94a-94n at the distal end of the catheter tube 12e. This fifth alternative embodiment is characterized by the use of multiple distally directed jet streams 126 as a method for dividing, perforating, and disrupting the thrombus or lesions 98. The components of Fig. 23 are connected to the control components that are Fig. 1, where such control components consist of the high-pressure fluid source 12, the high-pressure fluid pump 44, the threaded high-pressure connection port 32 and connecting member 46, the outflow regulator 47 of the collection chamber 48, and the connecting member 49, which are used in much the same manner as previously described. Together, the control components mentioned, in combination with the catheter tube 12e and the manifold 14 and the closely related components thereof, comprise a hydrodynamic direct jet catheter system 10e, also referred to as the catheter system 10e, the catheter system 10e essentially providing the high force of the distally directed fluid jet streams 126 in combination.The catheter system 10e includes the provision and use of the previously described pressurized proximally directed fluid jet streams 108, the pressurized distally directed fluid jet streams 126 emanating from the fluid jet emanator 52e (. Fig. 25), wherein a numerically large number of distally directed fluid jet streams 126 divide or fragment and generally tunnel through thrombus or lesions 98. Although the catheter tube 12e, the manifold 14 and the respective closely related components are described with reference to the catheter system 10e in Fig. 23, it is self-evident that the aforementioned control components, which are shown in Fig. 1 are mentioned and shown, but not in Fig. 23 are also part of the catheter system 10e.

[0099] Fig. 24 is an explanation that in many ways Fig. 4 and shows the distal end of a catheter tube 12e in reconfiguration and use in place of the catheter tube 12 and with the fluid jet ejector 52e used in place of the fluid jet ejector 52, wherein the fluid jet ejector 52e has many of the structural features and largely the functionality as in Fig. 25. More specifically, the relationship and arrangement of the inflow opening 38 (reoriented), the proximally directed jet openings 106a-106n of the fluid jet ejector 52e, the distally directed jet openings 122a-122n of the fluid jet ejector 52e, and the open end of the catheter tube 12e are shown. The plurality of radially directed jet openings 112a-112n in the fluid jet ejector 52e and the plurality of holes 94a-94n of the previously shown catheter tubes 12a-12c are not included in the catheter tube 12e.

[0100] Fig. 25 is an explanation that in many ways Fig. 17, and shows an isometric view of the alternative fluid jet ejector 52e connected to and in communication with the high-pressure tube 50. As previously described, the large number of distally (forward) directed jet orifices 122a-122n are located on and around the distal surface of the fluid jet ejector 52e. Also included is the previously shown and described plurality of proximally (rearward) directed jet orifices 106a-106n located on and around the proximal surface of the fluid jet ejector 52e. The fluid jet emitter 52e also includes the previously described annular groove 84 and passageway 86. The plurality of proximally directed jet orifices 106a-106n and the plurality of distally directed jet orifices 122a-122n are a unit and are pressurized together by pressurized saline solution provided by the high pressure tube 50.

[0101] The high pressure tube 50 delivers pressurized saline or other suitable fluids to the fluid jet ejector 52e to generate and distribute a plurality of distally directed high pressure jet streams 126 which flow from the distally directed jet orifices 122a-122n to prevent direct fluid flow impingement of the thrombus or lesions 98 ( Fig. 22). In a manner as previously described, the high pressure tube 50 delivers pressurized saline or other suitable fluid to the fluid jet ejector 52e to generate and distribute pressurized proximally directed fluid jet streams 108 of saline or other suitable fluids that flow from the proximally directed openings 106a-106n of the fluid jet ejector 52e to perform functions as described herein. OPERATION

[0102] In a closely related manner as described hereinbefore and with reference to Fig. 46, the method of operation of the fifth alternative embodiment will now be described. Generally, a standard guidewire 37 is deployed within a blood vessel 96 requiring treatment, or, in the alternative, a filter guidewire or balloon occlusion guidewire could be used. The catheter tube 12e and other closely related and aligned components directly associated therewith, consisting primarily of the high-pressure tube 50, the fluid jet ejector 52e, and the distal portion of the catheter tube 12e, are advanced over and along the guidewire 37 and aligned within the blood vessel 96 for the purposes of cellular debris / thrombus / lesion maceration or removal, drug infusion, or other procedures; the catheter system 12e is maneuvered within the blood vessel 96 into an appropriate position for treatment.A typical guide catheter or shaft may be incorporated, if necessary, to assist in the placement of the catheter tube 12e and the closely aligned components of the hydrodynamic direct-flow catheter system 10e in direct communication therewith at the desired location of the blood vessel 96 so that the distally located open end 134 of the catheter tube 12e can be brought into close proximity or intimate contact with the proximal end of the thrombus or lesions 98 and then expanded through the thrombus or lesion 98 by operation of the catheter system. The direct-flow thrombectomy catheter system 10e is then activated, whereby thrombus, cellular debris, and the like can be removed by the action of the low-pressure region of the inflow port(s) 38, preferably in conjunction with other methods as previously described, or drugs can be infused by a desired method.

[0103] In addition, Fig. 26 is a side view in cross section of the catheter tube 12e of the fifth alternative embodiment of the present disclosure and explains the implementation of the method and the use thereof, which control connections and functions of the accompanying components in a manner corresponding to that shown in Fig. 1, with particular attention being paid to the distal portion of the catheter tube 12e, particularly the open end 134 thereof, the fluid jet ejector 52e, the inflow port(s) 38, and other closely related components positioned within the blood vessel 96 containing cellular debris from thrombus or lesions 98. For exemplary and illustrative purposes, one or more inflow ports 38 are shown (reoriented) at the upper and lower ends of the catheter tube 12e.

[0104] More specifically and with reference to Fig. 26 further describes the operation of the fifth alternative embodiment. Pressurized saline solution or other suitable fluid is supplied through the high-pressure tube 50 to the fluid jet outlet 52e ( Fig. 25) to produce proximally directed fluid jet streams 108 of saline solution or other suitable fluids which are discharged proximally from the proximally directed jet orifices 106a - 106n ( Fig. 25) of the fluid jet emanator 25e and from there parallel to the inflow opening(s) 38 and finally into the distal portion of the catheter tube 12e to flow proximally in a manner as previously described. With particular reference to this fifth alternative embodiment, pressurized saline or other suitable fluid is also delivered through the high-pressure tube 50 to the fluid jet emanator 52e to generate and distribute a plurality of distally directed fluid jet streams 126 of saline or other suitable fluids for a use different from the uses of the previously described embodiments, the distally directed jet streams 126 being emanated in large numbers distal from the distally directed jet openings 122a-122n ( Fig.21) to forcefully abrade, ablate, divide, shatter, tunnel, and pass through the thrombus or lesion 98 to create, provide, and utilize a passageway therethrough. In this alternative embodiment, the return flow from the distally directed fluid jet streams is created in the form of crossflow jets 136 that ablate, ablate, shatter, remove, or otherwise fragment thrombus or lesion 98 particulate material proximally for entry into the inflow port(s) 38. The pressurized distally directed jet streams 126 may re-enter the catheter tube 12e via the inflow port(s) 38. Preferably, the thrombus or lesions 98 are entrained and carried into the inflow port(s) 38 by the low pressure region at the inflow port(s) 38.The use of a guidewire with a distally deployed balloon may be helpful in assisting the flow of thrombus and lesion 98 proximally through the inflow port(s) 38. Additional fluid jet emitters of appropriate size and / or configuration may be used in place of the fluid jet emitter 52e in the distal portion of the catheter tube 12e to emit or eject a plurality of distally directed fluid jet streams 126 for the purpose of ablating, removing, fragmenting, and the like, thrombus or lesions 98, and to eject or eject one or more proximally directed fluid jet streams 108 along or near the longitudinal axis of the catheter tube 12e.

[0105] The proximally directed fluid jet streams 108 provide a low-pressure region at the inflow port 38 for re-entry of thrombus or lesion 98 particulate material and, as before, for receiving such thrombotic particulate material or lesion particulate material and / or cellular debris 98 therethrough, for impinging upon, providing traction thereon, and for disrupting or macerating the thrombotic particulate material and / or cellular debris 98, and for pushing and advancing, by entraining, one or more particles of thrombotic particulate material and / or cellular debris 98 or lesion particulate material along the lumen 53 of the catheter tube 12e by the action of the proximally directed fluid jet streams 108. The entrainment of thrombotic particulate material and / or cellular debris 98 through the inflow port 38 depends upon the high-velocity fluid jet streams 108.The outflow of fluid and thrombus is generally driven proximally through the catheter tube 12e by internal pressure generated by the high-velocity fluid jet streams 108 and the fluid entrained through the inflow port 38, but also employs the assistance of fluid pressure forces provided by the distally directed fluid jet streams 126.

[0106] In this alternative embodiment, the proximally directed fluid jet streams 108 and the distally directed fluid jet streams 126 are driven by the same fluid pressure force. The velocity of the fluid jet streams is controlled by the high-pressure pump 44 and the total area of ​​all proximally directed jet orifices 106a-106n and distally directed jet orifices 122a-122n. Cell debris removal is controlled and assisted by aspiration in coordination with the operation of the high-pressure fluid pump 44 and the outflow regulator 47, which simultaneously introduce pressurized proximally and distally directed fluid jet streams into the distal end of the catheter tube 12e and provide the flow of the crossflow jets 136. In such a catheter system, the inflow orifice 38 is sufficiently sized for aspiration.By sizing the proximally directed flow orifices 106a-106n, the distally directed orifices 122a-122n and the operation of the high-pressure pump 44 can be influenced and controlled within appropriate parameters, such as the velocity and strength of the proximally directed fluid jet streams 108 and the distally directed fluid jet streams 126. The principle for aggressive thrombus ablation and disruption, as well as cellular debris removal, depends on the velocity of the distally directed fluid jet streams 126. It should be noted that there is a critical velocity for cellular debris release. Because the distally directed fluid jet streams 126 travel through a fluid environment, the distally directed fluid jet streams 126 entrain surrounding fluid, thus causing the distally directed fluid jet stream 126 to decelerate.Empirical relationships exist for turbulent jet streams that show that the velocity of the fluid jet streams is proportional to the diameter of the fluid jet streams and to the exit velocity of the fluid jet streams. Thus, the velocity of the fluid jet streams at a given distance could be increased either by increasing the exit velocity of the distally directed fluid jet streams 126 or by increasing the jet orifice diameter. Note that as the jet orifice diameters are increased, the pumping speed of the high-pressure fluid pump 44 would need to be increased to maintain the jet stream velocity. In practice, the catheter system is designed with a given series of jet orifice diameters and with the pumping speed of the high-pressure pump 44 adjusted to achieve the appropriate efficiency.

[0107] Various modifications may be made to the present disclosure without departing from the obvious scope thereof.

Claims

[1] A hydrodynamic direct flow catheter system (10a-e) comprising a manifold (14) having a central elongated tubular body (16) with a proximal end and a distal end, an elongated flexible catheter tube (12a-e) having a proximal end and a distal end, the proximal end of the catheter tube (12a-e) extending into and distally from the distal end of the central tubular body (16) of the manifold (14), a tapered flexible tip (40) having a proximal end and a distal end, the tapered flexible tip (40) having a central passageway (88) extending therethrough, the elongated flexible catheter tube (12a-e) having an elongated distal portion, the elongated distal portion of the catheter tube (12a-e) having a proximal end and a distal end,wherein the distal end of the elongated distal section is connected to the proximal end of the tapered flexible tip (40), a tubular fluid jet ejector (52) disposed in the elongated distal section proximal to the proximal end of the tapered flexible tip (40), one or more inflow openings (38) in the distal section proximal to the tubular fluid jet ejector, the tubular fluid jet ejector (52) having a proximal end and a distal end, a plurality of spaced radially aligned fluid jet openings (90a-n) around a peripheral surface of the tubular fluid jet ejector, the spaced radially aligned fluid jet openings (90a-n) opposite the proximal end of the tubular fluid jet ejector,a plurality of holes (94a-n) in the elongated distal portion and in corresponding alignment with the plurality of spaced radially directed fluid jet orifices (90a-n), an elongated flexible high-pressure tube (50) having a proximal end and a distal end, the elongated flexible high-pressure tube (50) extending from the manifold (14) through the elongated flexible catheter tube (12a-e) and terminating in the tubular fluid jet emanator (52), and a high-pressure fluid source (42) delivering pressurized fluid into the proximal end of the elongated flexible high-pressure tube, the radially directed fluid jet orifices (90a-n) having diameters between 0.0254 mm (0.001 in.) to 1.016 mm (0.040 in.). [2] The hydrodynamic direct flow catheter system (10a-e) of claim 1, wherein the tubular fluid jet emitter (52) is mounted in the elongated distal portion of the elongated flexible catheter tube (12a-e). [3] The direct flow hydrodynamic catheter system (10a-e) of claim 2, wherein the tubular fluid jet emitter (52) has a central passageway (58) therethrough and an internal manifold communicating with the distal end of the elongated flexible high pressure tube, the plurality of spaced radially aligned fluid jet orifices (90a-n) and the central passageway (58). [4] The direct flow hydrodynamic catheter system (10a-e) of claim 3, wherein the tubular fluid jet ejector (52) has an outer annular groove therein, the distal portion of the elongated flexible catheter tube (12a-e) has a first circular marker band surrounding an outer surface of the distal portion and opposite the annular groove of the tubular fluid jet ejector, the first circular marker band compressing the outer surface into the annular groove of the tubular fluid jet ejector. [5] The hydrodynamic direct flow catheter system (10a-e) of claim 4, wherein an internal support ring is positioned in the proximal end of the elongated distal section and the elongated flexible high pressure tube (50) is attached thereto. [6] The direct flow hydrodynamic catheter system (10a-e) of claim 5, wherein a second circular marker band surrounds an outer surface proximal to the proximal end of the elongated distal portion, the second circular marker band opposing the internal support ring, the second circular marker band clamping the outer surface to the inner support ring. [7] The hydrodynamic direct flow catheter system (10a-e) of claim 6, wherein the first and second circular marker bands are radiopaque marker bands. [8] The hydrodynamic direct flow catheter system (10a-e) of claim 1, wherein the central elongated tubular body (16) has a tubular connecting branch attached thereto at an angle pointing toward the proximal end of the central elongated tubular body (16), a Luer lock connector (26, 34) connected to the free end of the tubular connecting branch, a high pressure fluid connection port having a proximal end and a distal end, the Luer lock connector (26, 34) connected to the distal end of the high pressure fluid connection port, a high pressure fluid pump (44) connected to the proximal end of the high pressure connection port (32), a high pressure fluid source (42) connected to the high pressure fluid pump (44), and the proximal end of the elongated flexible high pressure tube is connected via the Luer lock connector (26,34) is in fluid communication with the distal end of the high-pressure fluid connection opening. [9] The hydrodynamic direct flow catheter system (10a-e) of claim 8, wherein the pressurized fluid is saline or other suitable fluid. [10] The hydrodynamic direct flow catheter system (10a-e) of claim 8, wherein a tubular outflow branch is connected to one side of the tubular connecting branch, an outflow regulator (47) is connected to the tubular outflow branch, and a collection chamber (48) is connected to the outflow regulator (47). [11] The hydrodynamic direct flow catheter system (10a-e) of claim 8, wherein the manifold (14) comprises a self-sealing hemostasis valve positioned inside the central elongated tubular body (16) near the proximal end thereof, a hemostasis nut (30) having a proximal end and a distal end, the distal end of the hemostasis nut (30) being connected to the proximal end of the central elongated tubular body (16) and fixing the hemostasis valve (66) in the central elongated tubular body (16). [12] The hydrodynamic direct flow catheter system (10a-e) of claim 8, wherein the distal end of the central elongated tubular body (16) has a stress relief tube connected thereto via a Luer lock connector (26, 34), and wherein the proximal end of the elongated flexible catheter tube (12a-e) extends into and is fixed in the stress relief tube. [13] The hydrodynamic direct flow catheter system (10a-e) of claim 8, wherein the elongated flexible high pressure tube (50) is made of stainless steel or other suitable flexible material. [14] The hydrodynamic direct flow catheter system (10a-e) of claim 8, wherein the elongated flexible catheter tube (12a-e) is made of flexible plastic material and has a hydrophilic coating along its outer surface. [15] The hydrodynamic direct flow catheter system (10a-e) of claim 1, wherein the pressurized fluid has a velocity between 1 m / s and 250 m / s and a pressure between 50 psi and 20,000 psi. [16] The hydrodynamic direct flow catheter system (10a-e) of claim 1, wherein the catheter system (10a-e) is used in conjunction with an elongated flexible guidewire passing through the central elongated tubular body (16) of the manifold (14), the elongated flexible catheter tube (12a-e) and the passageway of the tapered flexible tip (40). [17] The hydrodynamic direct flow catheter system (10a-e) of claim 1, wherein a solution of one or more drugs is delivered into the proximal end of the elongated flexible high pressure tube. [18] The direct flow hydrodynamic catheter system (10a-e) of claim 2, wherein the tubular fluid jet emitter (52) has a proximal surface and a plurality of spaced proximally directed fluid jet orifices in the proximal surface. [19] The direct flow hydrodynamic catheter system (10a-e) of claim 18, wherein the diameter of each of the plurality of spaced apart radially directed fluid jet orifices (90a-n) is smaller than the diameter of each of the plurality of spaced apart proximally directed fluid jet orifices. [20] The direct flow hydrodynamic catheter system (10a-e) of claim 19, wherein the tubular fluid jet ejector (52) has a central passageway (58) therethrough and an internal manifold communicating with the distal end of the elongated flexible high pressure tube, wherein the plurality of spaced radially aligned fluid jet orifices (90a-n), the plurality of spaced proximally aligned fluid jet orifices and the central passageway (58) communicate. [21] The hydrodynamic direct flow catheter system (10a-e) of claim 20, wherein the pressurized fluid is saline or other suitable fluid. [22] The hydrodynamic direct flow catheter system (10a-e) of claim 21, wherein the pressurized fluid has a velocity between 1 m / s and 250 m / s and a pressure between 50 psi and 20,000 psi. [23] The direct flow hydrodynamic catheter system (10a-e) of claim 22, wherein the radially directed fluid jet orifices (90a-n) and the proximally directed fluid jet orifices have a diameter between 0.001 in and 0.040 in. [24] A hydrodynamic direct flow catheter system (10a-e) comprising a manifold (14) having a central elongated tubular body (16) with a proximal and a distal end, an elongated flexible catheter tube (12a-e) having a proximal end and a distal end, the proximal end of the catheter tube (12a-e) extending into and distal from the distal end of the central tubular body (16) of the manifold (14), a tapered flexible tip (40) having a proximal end and a distal end, the tapered flexible tip (40) having a central passageway extending therethrough, the elongated flexible catheter tube (12a-e) having an elongated distal portion, the elongated distal portion of the catheter tube (12a-e) having a proximal end and a distal end,wherein the distal end of the elongated distal section is connected to the proximal end of the tapered flexible tip (40), a tubular fluid jet ejector positioned in the elongated distal section proximal to the proximal end of the tapered flexible tip (40), one or more inflow openings (38) in the distal section proximal to the tubular fluid jet ejector, the tubular fluid jet ejector (52) having a proximal surface and a distal surface, the proximal surface having a plurality of spaced-apart proximally directed fluid jet openings and the distal surface having a plurality of spaced-apart distally directed fluid jet openings, the elongated flexible catheter tube (12a-e) having one or more outflow openings located between the distal end of the distal section and the proximal end of the tapered flexible tip (40),an elongated flexible high-pressure tube (50) having a proximal end and a distal end, the elongated flexible high-pressure tube (50) extending from the manifold (14) through the elongated flexible catheter tube (12a-e) and terminating in the tubular fluid jet emitter (52), a high-pressure fluid source (42) delivering pressurized fluid into the proximal end of the elongated flexible high-pressure tube, the plurality of spaced-apart proximally directed fluid jet orifices and the plurality of spaced-apart distally directed fluid jet orifices having a diameter between 0.0254 mm (0.001 in.) and 1.016 mm (0.040 in.), [25] The hydrodynamic direct flow catheter system (10a-e) of claim 24, wherein the tubular fluid jet emitter (52) is mounted in the elongated distal portion of the elongated flexible catheter tube (12a-e). [26] The direct flow hydrodynamic catheter system (10a-e) of claim 25, wherein the tubular fluid jet ejector (52) has a central passageway (58) therethrough and an internal manifold communicating with the distal end of the elongated flexible high pressure tube, wherein the plurality of spaced apart proximally directed fluid jet orifices, the plurality of spaced apart distally directed fluid jet orifices and the central passageway (58) communicate. [27] The hydrodynamic direct flow catheter system (10a-e) of claim 26, wherein the pressurized fluid is saline or another suitable fluid. [28] The hydrodynamic direct flow catheter system (10a-e) of claim 27, wherein the pressurized fluid has a velocity between 1 m / s and 250 m / s and a pressure between 50 psi and 20,000 psi. [29] A hydrodynamic direct flow catheter system (10a-e) comprising a manifold (14) having a central elongated tubular body (16) with a proximal end and a distal end, an elongated flexible catheter tube (12a-e) having a proximal end and a distal end, the proximal end of the catheter tube (12a-e) extending into and distal from the distal end of the central tubular body (16) of the manifold (14), the elongated flexible catheter tube (12a-e) having an elongated distal portion, the elongated distal portion of the catheter tube (12a-e) having a proximal end and a distal end, the distal end of the elongated distal portion being coincident with the distal end of the elongated flexible catheter tube (12a-e), a tubular fluid jet emanator disposed within the distal end of the elongated distal section,one or more inflow openings (38) in the distal section proximal to the tubular fluid jet ejector, the tubular fluid jet ejector (52) having a proximal surface and a distal surface, a plurality of spaced-apart proximally directed fluid jet openings in the proximal surface of the tubular fluid jet ejector, a plurality of spaced-apart distally directed fluid jet openings in the distal surface of the tubular fluid jet ejector, an elongated flexible high-pressure tube (50) having a proximal end and a distal end, the elongated flexible high-pressure tube (50) extending from the manifold (14) through the elongated flexible catheter tube (12a-e) and terminating in the tubular fluid jet ejector (52), and a high-pressure fluid source (42) delivering pressurized fluid into the proximal end of the elongated flexible high-pressure tube,wherein the plurality of spaced proximally directed fluid jet orifices and the plurality of spaced distally directed fluid jet orifices have diameters between 0.0254 mm (0.001 in.) and 1.016 mm (0.040 in.). [30] The hydrodynamic direct flow catheter system (10a-e) of claim 29, wherein the tubular fluid jet emitter (52) is mounted in the elongated distal portion of the elongated flexible catheter tube (12a-e). [31] The direct flow hydrodynamic catheter system (10a-e) of claim 30, wherein the tubular fluid jet ejector (52) has a central passageway (58) therethrough and an internal manifold communicating with the distal end of the elongated flexible high pressure tube, the plurality of spaced apart proximally directed fluid jet orifices, the plurality of spaced apart distally directed fluid jet orifices, and the central passageway (58). [32] The hydrodynamic direct flow catheter system (10a-e) of claim 31, wherein the pressurized fluid is saline or other suitable fluid. [33] The hydrodynamic direct flow catheter system (10a-e) of claim 32, wherein the pressurized fluid has a velocity of between 1 m / s and 250 m / s and a pressure of between 50 psi and 20,000 psi. [34] A hydrodynamic direct flow catheter system (10a-e) comprising a manifold (14) having a central elongated tubular body (16) with a proximal end and a distal end, an elongated flexible catheter tube (12a-e) having a proximal end and a distal end, the proximal end of the catheter tube (12a-e) extending into and distally from the distal end of the central tubular body (16) of the manifold (14), a tapered flexible tip (40) having a proximal end and a distal end, the tapered flexible tip (40) having a central passageway (88) extending therethrough, the elongated flexible catheter tube (12a-e) having an elongated distal portion, the elongated distal portion of the catheter tube (12a-e) having a proximal end and a distal end,wherein the distal end of the elongated distal section is connected to the proximal end of the tapered flexible tip (40), a tubular fluid jet ejector disposed in the elongated distal section proximal to the proximal end of the tapered flexible tip (40), one or more inflow openings (38) in the distal section proximal to the tubular fluid jet ejector, the tubular fluid jet ejector (52) having a proximal end and a distal end, a plurality of spaced apart proximally aligned fluid jet openings in the proximal end of the tubular fluid jet ejector, a plurality of spaced apart radially aligned fluid jet openings (90a-n) around a peripheral surface of the tubular fluid jet ejector, the spaced apart radially aligned fluid jet openings (90a-n) toward the proximal end of the tubular fluid jet ejector are opposite,a plurality of holes (94a-n) in the elongated distal portion and in corresponding alignment with the plurality of spaced radially directed fluid jet orifices (90a-n), the elongated distal portion including and forming a self-inflating balloon (100) as an integral part thereof, the self-inflating balloon (100) being located proximal to the proximal end of the tubular fluid jet emanator, an elongated flexible high-pressure tube (50) having a proximal end and a distal end, the elongated flexible high-pressure tube (50) extending from the manifold (14) through the elongated flexible catheter tube (12a-e) and terminating in the tubular fluid jet emanator (52), and a high-pressure fluid source (42) delivering pressurized fluid into the proximal end of the elongated flexible high-pressure tube, the radially and proximally directed fluid jet orifices having diameters between 0.0254 mm (0.001 in.) to 1.016 mm (0.040 in.). [35] The hydrodynamic direct flow catheter system (10a-e) of claim 34, wherein the distal portion forming the self-inflating balloon (100) has a wall thickness less than the wall thickness of extended portions of the elongated flexible catheter tube (12a-e). [36] The hydrodynamic direct flow catheter system (10a-e) of claim 35, wherein the tubular fluid jet emitter (52) is mounted in the elongated distal portion of the elongated flexible catheter tube (12a-e). [37] The direct flow hydrodynamic catheter system (10a-e) of claim 36, wherein the tubular fluid jet ejector (52) has a central passageway (58) therethrough and an internal manifold communicating with the distal end of the elongated flexible high pressure tube, the plurality of spaced radially aligned fluid jet orifices (90a-n), the plurality of spaced proximally aligned fluid jet orifices, and the central passageway (58). [38] The hydrodynamic direct flow catheter system (10a-e) of claim 34, wherein the elongated flexible high pressure tube (50) is made of stainless steel or other suitable flexible material. [39] The hydrodynamic direct flow catheter system (10a-e) of claim 34, wherein the elongated flexible catheter tube (12a-e) is made of flexible plastic material and has a hydrophilic coating along its outer surface. [40] The hydrodynamic direct flow catheter system (10a-e) of claim 35, wherein the pressurized fluid has a velocity between 1 m / s and 250 m / s and a pressure between 50 psi and 20,000 psi. [41] The direct flow hydrodynamic catheter system (10a-e) of claim 34, wherein the catheter system (10a-e) is used in conjunction with an elongated flexible guidewire passing through the central elongated tubular body (16) of the manifold (14), the elongated flexible catheter tube (12a-e) and the passageway of the tapered flexible tip (40). [42] The hydrodynamic direct flow catheter system (10a-e) of claim 34, wherein a solution of one or more drugs is delivered into the proximal end of the elongated flexible high pressure tube. [43] The hydrodynamic direct flow catheter system (10a-e) of claim 34, wherein the pressurized fluid is saline or other suitable fluid. [44] A hydrodynamic direct flow catheter system (10a-e) comprising a manifold (14) having a central elongated tubular body (16) with a proximal end and a distal end, an elongated flexible catheter tube (12a-e) having a proximal end and a distal end, the proximal end of the catheter tube (12a-e) extending into and distally from the distal end of the central tubular body (16) of the manifold (14), a tapered flexible tip (40) having a proximal end and a distal end, the tapered flexible tip (40) having a central passageway (88) extending therethrough, the elongated flexible catheter tube (12a-e) having an elongated distal portion, the elongated distal portion of the catheter tube (12a-e) having a proximal end and a distal end,wherein the distal end of the elongated distal section is connected to the proximal end of the tapered flexible tip (40), a tubular fluid jet ejector disposed in the elongated distal section proximal to the proximal end of the tapered flexible tip (40), one or more inflow openings (38) in the distal section proximal to the tubular fluid jet ejector, where the tubular fluid jet ejector (52) has a proximal surface and a distal surface, a plurality of spaced proximally aligned fluid jet openings in the proximal surface of the tubular fluid jet ejector, a plurality of spaced distally aligned fluid jet openings in the distal surface of the tubular fluid jet ejector, a plurality of spaced radially aligned fluid jet openings (90a-n) around a peripheral surface of the tubular fluid jet ejector,wherein the radially aligned fluid jet openings (90a-n) are adjacent to the proximal surface of the tubular fluid jet emanator, a plurality of holes (94a-n) in the elongated portion and in corresponding alignment with the plurality of radially aligned fluid jet openings (90a-n), wherein the elongated distal portion includes and forms a self-inflating balloon (100) as an integral part thereof, wherein the self-inflating balloon (100) is located proximal to the proximal end of the tapered flexible tip (40), one or more balloon inflation openings in the elongated distal portion, proximal to the self-inflating balloon (100) and distal to the tubular fluid jet emanator (52), an elongated flexible high-pressure tube having a proximal end and a distal end,wherein the elongated flexible high-pressure tube (50) extends from the manifold (14) through the elongated flexible catheter tube (12a-e) and terminates in the tubular fluid jet outlet (52), and a high-pressure fluid source (42) delivering pressurized fluid into the proximal end of the elongated flexible high-pressure tube. [45] The direct flow hydrodynamic catheter system (10a-e) of claim 44, wherein the distal portion forming the self-inflating balloon (100) has a wall thickness less than the wall thickness of the extended portions of the elongated flexible catheter tube (12a-e). [46] The hydrodynamic direct flow catheter system (10a-e) of claim 45, wherein the tubular fluid jet emitter (52) is mounted in the elongated distal portion of the elongated flexible catheter tube (12a-e). [47] The direct flow hydrodynamic catheter system (10a-e) of claim 46, wherein the tubular fluid jet ejector (52) has a central passageway (58) therethrough and an internal manifold communicating with the distal end of the elongated flexible high pressure tube, the plurality of radially directed fluid jet orifices (90a-n), the plurality of spaced proximally directed fluid jet orifices, the plurality of spaced distally directed fluid jet orifices, and the central passageway (58). [48] ​​The hydrodynamic direct flow catheter system (10a-e) of claim 44, wherein the elongated flexible high pressure tube (50) is made of stainless steel or other suitable flexible material. [49] The hydrodynamic direct flow catheter system (10a-e) of claim 44, wherein the elongated flexible catheter tube (12a-e) is made of a flexible plastic material and has a hydrophilic coating along its outer surface. [50] The hydrodynamic direct flow catheter system (10a-e) of claim 44, wherein the pressurized fluid has a velocity between 1 m / s and 250 m / s and a pressure between 50 psi and 20,000 psi. [51] The hydrodynamic direct flow catheter system (10a-e) of claim 44, wherein the catheter system (10a-e) is used in conjunction with an elongated flexible guidewire passing through the central elongated tubular body (16) of the manifold (14), the elongated flexible catheter tube (12a-e) and the passageway of the tapered flexible tip (40). [52] The hydrodynamic direct flow catheter system (10a-e) of claim 44, wherein a solution of one or more drugs is delivered into the proximal end of the elongated flexible high pressure tube. [53] The direct flow hydrodynamic catheter system (10a-e) of claim 44, wherein the diameter of each of the spaced radially directed fluid jet orifices (90a-n) is smaller than the diameter of each of the plurality of spaced proximally directed fluid jet orifices. [54] The hydrodynamic direct flow catheter system (10a-e) of claim 44, wherein the radially proximal and distally directed fluid jet orifices have diameters between 0.001 in to 0.040 in. [55] The hydrodynamic direct flow catheter system (10a-e) of claim 31, wherein the catheter system (10a-e) is used in conjunction with an elongated guidewire passing through the central elongated tubular body (16) of the manifold (14), the elongated flexible catheter tube (12a-e) and the central passageway (58) of the tubular fluid jet emitter.

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