Several surgical devices utilize water jets to cut and clear various vessels within the body. However, such devices are not well-suited for all types of vessels. Certain devices, such as those from Hydrocision, Inc. of Massachusetts are capable of pressures as high as 15,000 pounds per square inch (PSI).
Hydrocision utilizes a stream of sterile saline and a simultaneous Venturi suction system to cut and selectively remove tissue of various densities from a surgical site in a minimally invasive manner. While such systems are well-adapted to wound care and spinal markets, peripheral vascular venous and arterial indications, such as deep vein thrombosis and pulmonary embolism, would be desirable. Current treatment options for thrombectomy are limited to anticoagulation therapy, catheter-directed pharmacologic thrombolysis, open surgical thrombectomy, or mechanical or pharm-mechanical thrombectomy. Such treatments are often more invasive, and in the case of anticoagulation therapy, are frequently ineffective at dissolving existing clots. Additionally, current devices are often ineffective at treatment of chronic clots. This results in longer hospital stays and increased risk of major bleeding and related complications.
Moreover, most thrombectomy technologies are poorly adapted from arterial applications. Venous stent occlusions, in particular, form a blockage within a vein. Vein walls are significantly thinner than arterial walls, and are subject to different requirements than arterial walls. More particularly, venous walls contain less smooth muscle and connective tissue, are often of smaller diameter, and are less elastic. The significant differences between arterial and venous systems, and the type of clots that form in each, have resulted in their general ineffectiveness for venous thrombectomy applications. In particular, limited trackability, vessel injury, ineffective treatment for chronic clots, and incomplete revascularization and increased blood loss often result from utilizing arterial systems for venous treatments.
Current systems are generally inadequate at removing adequate volumes of variably aged thrombus, such as acute, sub-acute, or chronic, that often become adhered to venous or arterial vessel walls. As a result, many physicians must resort to using multiple devices, with a variety of mechanisms of action, over multiple sessions, rendering each individual treatment generally inefficient and insufficient. Moreover, this multi-pronged and cost-intensive approach must incorporate catheter-delivered anticoagulants in order to effectively restore vascularization.
It would be desirable, therefore, to provide a differentiated device for removing wall adherent thrombus for acute, sub-acute, and chronic consistencies within a single session.
It would be further desirable to provide systems, apparatus and methods for removing various types of thrombus from a lumen.
It would be further desirable to do so without the need for thrombolytics.
Disclosed herein are systems, apparatus and methods for removing tissue of various densities from a surgical site in a minimally invasive manner. The invention may include a fine stream of sterile saline, coupled with a suction effect to cut and remove tissue. A power console may be coupled with a handpiece. The power console may utilize an electric motor, thereby transmitting pressurized sterile saline through a high-pressure tube.
The distal end may deliver the saline across a window as a high velocity jet stream which, when coupled with the pressure gradient, pulls and then cuts the target tissue into the cutting window and removes it. The tissue and waste saline may then travel down an evacuation lumen to a waste container. By adjusting pressures, tissue types of various densities may be debrided while minimizing disturbance of surrounding tissue.
In an embodiment, the invention of the present disclosure may include a catheter and a jet nozzle. The catheter may comprise a distal end, a proximal end, an evacuation lumen, and/or a jet lumen. In an embodiment, the distal end is configured and adapted to remove thrombus, other waste, or other biological material. In a further embodiment, the evacuation lumen and the jet lumen are disposed within the catheter between the distal end and the proximal end. In such a further embodiment, the evacuation lumen and the jet lumen may run parallel to each other.
In an embodiment, the evacuation lumen and/or the jet lumen are in communication with a console. The console may pump liquid from the proximal end of the catheter to the distal end of the catheter. The console may also aid in removal of thrombus or waste from the distal end of the catheter to the proximal end of the catheter.
In an embodiment, the jet nozzle may be located on the distal end of the catheter and may be in liquid communication with the console. The jet nozzle may be configured and/or angled such that the jet stream leaving the jet nozzle is aimed towards the evacuation lumen and/or thrombus. In an embodiment, the jet stream is a stream of saline or saline solution.
In another embodiment, the distal end includes a window. The window may be in the sidewall of the catheter. The window may enable thrombus to partially enter the catheter so that the jet stream may cut the thrombus. In such an embodiment, the thrombus may then be sucked from the distal end to the proximal end via the evacuation lumen.
In an embodiment, the jet nozzle is adjustable. In an alternate embodiment, an end cone is disposed or fastened on the distal end. In an embodiment, the Venturi Effect is employed to move waste from the distal end to the proximal end. In an alternate embodiment, an external source of suction is employed to move the waste from the distal end to the proximal end.
In an embodiment, the invention of the present disclosure further includes a guidewire lumen disposed within the catheter between the distal end and the proximal end. The guidewire lumen may be configured and sized to accept a guidewire. In an alternate embodiment, a guidewire is disposed on the distal end without the need for a guidewire lumen. In a further embodiment, the guidewire may be flexible, allowing for a user to steer the catheter.
In an embodiment, a cage is disposed on the distal end, partially covering the jet nozzle. The cage may comprise at least one strip attached to one of the following: the catheter, the evacuation lumen, or the jet lumen. In a further embodiment, a handpiece may be disposed between the console and the distal end. The handpiece may also be disposed between the console and proximal end or between the distal end and proximal end. In an embodiment, the catheter is configured to be steerable. Thus, the distal end may have an articulated tip.
In an embodiment, the invention of the present disclosure comprises a jet tube. The jet tube may be disposed within the evacuation lumen or the jet lumen. In an embodiment, the jet tube comprises a jet tube distal end and a jet tube proximal end. The jet tube distal end may be bent at an angle (for example, a 90° angle). In such an embodiment, the jet nozzle may be disposed on the underside of the jet tube distal end.
In an embodiment, the jet tube may be configured in a forward cutting design. In such an embodiment, the jet nozzle may be configured to spray a jet stream forward, past the distal end. In another embodiment, the evacuation lumen has an evacuation lumen distal end and an evacuation lumen proximal end. In such an embodiment, the jet nozzle may be placed flush with the mouth of the evacuation lumen distal end. Further, the jet nozzle may face downward, into the evacuation lumen.
While the invention is described with reference to the above drawings, the drawings are intended to be illustrative, and the invention contemplates other embodiments within the spirit of the invention.
The present invention will now be described more fully hereinafter with reference to the accompanying drawings which show, by way of illustration, specific embodiments by which the invention may be practiced. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Among other things, the present invention may be embodied as devices or methods. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment, or an embodiment combining software and hardware aspects. The following detailed description is, therefore, not to be taken in a limiting sense.
Throughout the specification and claims, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise. The phrases “in one embodiment,” “in an embodiment,” and the like, as used herein, does not necessarily refer to the same embodiment, though it may. Furthermore, the phrase “in another embodiment” as used herein does not necessarily refer to a different embodiment, although it may. Thus, as described below, various embodiments of the invention may be readily combined, without departing from the scope or spirit of the invention.
In addition, as used herein, the term “or” is an inclusive “or” operator, and is equivalent to the term “and/or,” unless the context clearly dictates otherwise. The term “based on” is not exclusive and allows for being based on additional factors not described, unless the context clearly dictates otherwise. In addition, throughout the specification, the meaning of “a,” “an,” and “the” includes plural references. The meaning of “in” includes “in” and “on.”
It is noted that description herein is not intended as an extensive overview, and as such, concepts may be simplified in the interests of clarity and brevity.
All documents mentioned in this application are hereby incorporated by reference in their entirety. Any process described in this application may be performed in any order and may omit any of the steps in the process. Processes may also be combined with other processes or steps of other processes.
Disclosed herein are devices, systems and methods (the “System”) for treatment of venous thromboembolism (VTE) and related peripheral occlusions, including deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as arterial occlusions.
In certain embodiments the System may be used to treat VTE in place of, or in conjunction with, anticoagulation therapy, catheter-directed pharmacologic thrombolysis, open surgical thrombectomy and mechanical and/or pharm-mechanical thrombectomy. The System may be used in instances where dissolution of existing clots are otherwise unachievable without highly invasive and risky procedures, such as surgical thrombectomy.
The System may be formed of a percutaneous mechanical thrombectomy (PMT) device. The device may include an endovascular catheter. The endovascular catheter may be deployed percutaneously. The percutaneous deployment may be via popliteal or femoral vein access, or other access methods, and may utilize fluoroscopic guidance, or via any suitable approach.
In certain embodiments, the System may be used to treat peripheral occlusions, such arteriovenous fistulas and other arterial needs.
The System may remove tissue of various densities from a surgical site in a minimally invasive manner, using a fine stream of sterile saline, coupled with a suction effect to cut and remove tissue. A power console may be coupled with a handpiece. The power console may utilize an electric motor, thereby transmitting pressurized sterile saline through a high-pressure tube.
The distal end of the tube may deliver the saline across a window as a high velocity jet stream which, when coupled with the pressure gradient, pulls and cuts the target tissue into the cutting window and remove it. The tissue and waste saline may then travel down an evacuation lumen to a waste container. By adjusting pressures, tissue types of various densities may be debrided without disturbing surrounding tissue.
The System may remove wall-adherent thrombus of acute, sub-acute and chronic consistencies within a single session. In some embodiments, the System includes a power console. The power console may utilize common power. The power console may be connected to, and in fluid communication with, a flexible tube. The flexible tube may be a jet tube. The flexible tube may be a catheter, incorporating a jet tube therein. The flexible tube may be flexible. The flexible tube may be formed to deliver sterile saline therethrough.
The tube may include, or be in communication with, a nozzle. The nozzle may be located at the distal-end of the tube. The nozzle may deliver the jet stream downward. For example, the jet stream may be delivered vertically or substantially vertically downward. The jet stream may be delivered, via the nozzle, across a window as a high pressure jet stream. The window may be small, and may be formed in the distal end of the nozzle. In an exemplary embodiment, the window may be 0.065″×0.042″×0.042″ in width, length and depth, respectively. In an exemplary embodiment, the window may be 0.125″×0.233″×0.189″ in width, length and depth, respectively. In another embodiment, any suitable measurement, may be used.
The jet stream may be a fine diameter jet stream. The jet stream may be formed of saline, or any other suitable fluid, such as water.
In some embodiments, the jet stream of saline may create its own suction. For example, the velocity of the saline may cause suction to be formed, as a result of the Venturi effect. In a further example, the pressure gradient of the saline may cause suction to be formed, resulting from the Venturi effect. In the aforementioned embodiments, the Venturi effect results from the reduction in fluid pressure, when fluid flows through a constricted section. Thus, the differential in flow rate may result in the Venturi effect being utilized. More specifically, the Venturi effect may occur as result of the transition from high to low pressure within the juncture of the jet tube nozzle and the evacuation lumen. Thus, the intensity of the suctions may be correlated with the both the velocity of the jet and the pressure differential. It should be noted that, in some embodiments, the System is specifically formed to maximize the benefits of the Venturi effect, in order to increase suction. This results in pulling thrombus down through a tube, and into a cutting window. As a result, the jet and suction may be formed and adjusted to the needs of the application to act simultaneously and/or in conjunction, in order to cut and remove the thrombus safely.
In accordance with an embodiment of the invention, the Venturi effect may be utilized and tailored to cut and evacuate thrombus of various consistencies—acute, subacute, and chronic clots. Increasing or decreasing the velocity of the fluid in the jet tube or the cutting window size, may alter the intensity of the Venturi effect, thus making the device more suited for certain thrombus consistencies. The device thereby enables cutting and evacuating clots of denser consistencies. In effect, the device of the present disclosure may enable faster performance and more complete reduction or removal of thrombi.
The thrombus and waste saline may be removed via a catheter. The catheter may be located in-line, and may contain an evacuation lumen. In such an embodiment, the jet tube may run perpendicular to the evacuation tube. The jet tube may be attached by stitch welds, mounted on the sidewall of the catheter, or run up through the jet tube lumen and mounted internally. The thrombus and waste saline may be removed via the evacuation lumen and into a waste canister.
In accordance with an embodiment, a waterjet-based system is used to treat and safely remove venous stent thrombus and/or occlusions. The devices and methods may be used to treat post-thrombotic syndrome by removing part or all of a clot.
In an embodiment of the invention, the device includes one or more of a catheter, a jet tube wholly enclosed within the catheter, a guidewire port, and an evacuation lumen. The catheter may be single-use. The device may include an integral source of suction, such as a waterjet creating its own Venturi suction or may be coupled to an external source of suction, such as vacuum power.
The device may further include a console junction mechanism. The console junction mechanism may be a pump cartridge. The pump cartridge may contain a piston and a receiving chamber with inlet and outlet valves. In such an embodiment, the console drives a piston that compresses a fluid in a chamber. Further, in such an embodiment, the outlet valve may open to allow for injection of the fluid into a high-pressure tube. In such an embodiment, the fluid then may enter the proximal end of the handpiece. The console junction mechanism may join the tubing of the catheter to the pump cartridge connection on the console. In another embodiment, a handle assembly may connect to the tubing. The handle assembly may then connect, via a conduit, to the console. In an embodiment, the pump cartridge separates contact of the fluid from the console and may be part of a disposable instrument set.
The catheter may utilize an over-the-wire, monorail, or rapid-exchange system, where the guidewire lumen extends proximally only a short distance from the catheter tip and balloon. Thus, the wire may be inserted into the catheter tip, and exits the catheter shortly thereafter, such that only a single lumen is required. An over-the-wire system may be a system where the guidewire runs through the entire length of the catheter. Monorail and rapid-exchange systems are those where the guidewire only interfaces with a short length of the catheter. This provides savings of time compared with advancing a guidewire through the full length of the catheter. That is, a shorter duration reduces contrast needs and radiation exposure, thereby enabling smaller diameter catheters. In certain embodiments, the catheter may be an over the wire system.
Additionally, an injection and/or flush port may be formed at a proximal end of the device, for flushing and injection of thrombolytics. The flexible jet tube may be split off from the cannula and connected within a handle assembly to a high-pressure tube, such as one made from any suitable material, including, but not limited to, ceramics or KEVLAR. The evacuation lumen may be connected to an evacuation hose, which provides for transmission of saline or other agents, and removes the thrombus.
In one exemplary process, a waterjet is used to cut through a clot, thereby providing for easier balloon dilation of the affected area.
Referring now to
Catheter body 203 may measure between 2 mm (6 French) and 8 mm (22 French) in outer diameter. In certain embodiments, the catheter body may be formed of a diameter of 3.7 mm. In additional embodiments, the catheter body 203 may be approximately 80-170 centimeters in length. In certain embodiments, the catheter body 203 may measure approximately 100 centimeters in length. The catheter may be specifically formed to be less than four millimeters in diameter, allowing it to fit into tighter and harder to reach anatomical cavities. The guide-wire lumen may be optionally formed between 0.014 and 0.035 inches in diameter. Body 203 may include a guide sheath compatible with these measurements. The body 203 may be between approximately 10 cm and 120 cm in length, or any other suitable amount. The catheter body 203 may include guidewire lumen 209. Referring to
Guidewire lumen 209 may, in certain embodiments, measure approximately 0.018 inches in diameter, or 0.45 millimeters in diameters. The jet lumen 211 may measure approximately 0.025-0.030 inches in diameter, and an evacuation lumen measuring 0.066 inches in diameter, or 0.055-0.075 inches in diameter. The guidewire lumen 209 may be used for guidewire placement, system guidance, retrieval, or additional tools, or any other suitable form. For example, guidewire lumen 209 may be used for a camera or any other suitable device.
The guidewire lumen 209 may be compatible with various sized guidewires. For example, 0.015 inch and 0.035 inch guidewires may be used. Any other suitably-sized guidewires may be used as well, in accordance with various embodiments.
Referring now to
In certain embodiments, jet tube 213 may be mounted within evacuation lumen 215. This obviates the need for a third lumen, and allows for a smaller diameter catheter. In such embodiments, jet tube 213 may be mounted within, and wholly enclosed within, the evacuation lumen 215. In other embodiments, jet tube 213 may be mounted within a sidewall of the evacuation lumen 215.
Jet lumen 211 may be formed in any suitable diameter. For example, the lumen may be formed with a 0.025 inch outer diameter, or other suitable amounts. In a further example, the lumen may be formed with approximately 0.02-0.05 inch outer diameter, or any other suitable diameter. In yet further examples, increased flexibility may be achieved with a 0.01 outer diameter. Due to the small size of the outer diameter, flexibility is maintained, whereas the tubes being formed of stainless steel allow for pressure containment. In certain embodiments, the lumen may be bent, while maintaining the lumen integrity.
In another embodiment, a two or three lumen design may be used, with a forward cutting design of the jet tube 213. This is shown in
Referring back to
As shown in
The jet tube 213 may be flexible. Thus, it may create a vertical jet spray in the cut-out window when directed toward the window 219, thereby protecting the jet tube from direct contact with thrombus, but allowing thrombus to enter the window and be cut. In certain embodiments, the thrombus may, after or at the same time as being cut, be simultaneously evacuated.
Tip 207 may be formed with a conical-shaped distal end. This provides for extending the catheter beyond the thrombus, using the guidewire. As shown in
It should be noted that the System may be utilized for any suitable treatment or condition, such as venous or arterial clots, acute, sub-acute or chronic clot formations.
Tip 207 may be used for macerating and/or cutting thrombus and other waste. In certain embodiments, tip 207 may be a side cutting instrument. In other embodiments, tip 207 may cut directly forward. In an exemplary process, thrombus, tissue or other waste may be suctioned into the window 319, utilizing the Venturi effect or in-line suction. The thrombus may then be drawn into the window aperture 319a, with the jet stream cutting the thrombus via the jet tube 213. This causes the thrombus to break apart, and is evacuated via a lumen, such as the guidewire lumen or evacuation lumen. It should be noted that removal of thrombus may occur either from direct cutting of the jet spray from the jet tube 213, or from the indirect jet force created from the jet spray, via the Venturi effect, resulting in the Venturi suction. For example, acute clots may require only suction force, created by the jet tube, without direct contact. In accordance with various embodiments, suction force of spray may pull thrombus into the cutting window where the jet then cuts. Thus, the jet and suction act together to macerate tissue and remove it through the evacuation catheter. In other embodiments, the jet may cut first, and tissue is then evacuated through suction effect.
Referring again to
As discussed, in certain embodiments, only two lumens may be used. In some embodiments, the two lumens may be the jet lumen and guidewire lumen. In other embodiments, the two lumens may be the jet lumen and evacuation lumen. In such instances, the guidewire lumen or evacuation lumen may each function dual roles for guidewire and evacuation. In yet other embodiments, only a guidewire lumen and evacuation may be used, with the jet tube mounted within the guidewire lumen or evacuation lumen.
In accordance with certain embodiments, a dual lumen design, such as that shown in
In a further embodiment, a jet tube is mounted inside a two or three lumen catheter. It is fixed in position such that the jet nozzle and spray can be aimed/directed into an evacuation lumen—either in protracted form, and/or contained within the catheter.
The System, in accordance with various embodiments, may be steerable. For example, the steerability may be performed via an angled or articulated tip, or via a shaft. The shaft may be adapted to bend within a guiding catheter. The shaft may be specifically elongated in size, such that it may be delivered from the femoral area (the minimum common femoral vein). The guidewire may also be flexible. In such an embodiment, the flexible guidewire may increase the steerability of the catheter.
In another embodiment, the device may be used to treat a chronically occluded stent, such as a self-expanding stent (for example, a WALLSTENT), resulting in recanalization.
Therefore, in accordance with an embodiment of the invention, the device includes a jet tube, such as a high pressure jet tube. The jet tube may be flexible. In certain embodiments, the jet tube may be formed to withstand a maximum pressure of 17,000 PSI. In an additional embodiment, a third lumen may be used for placement of a 0.014 or 0.035 compatible guidewire (or) use the evacuation lumen for a guidewire. Thus, the flexible jet tube and evacuation tube act as a single flexible endovascular catheter, allowing the structure to be navigable and trackable through a peripheral blood vessel (venous/arterial) while maintaining desired jet tube location and alignment. The design is further formed for sheath compatibility, with a 5-22 French (“F”) measurement.
In one embodiment, the tube is configured to hold a pressure of up to 17,000 pounds per square inch (“PSI”). That is, the jet tube may be formed of stainless steel. Due to the stainless steel, jet tube internal diameter, nozzle properties, pump cartridge properties, and/or console properties, high pressure may be maintained in a safe and efficient manner. In another embodiment, the tube is specifically adapted to hold and operate at a pressure of between 1,500-15,000 PSI. In an embodiment the jet tube may sufficiently remove various clots: level 6-10 is sufficient for chronic clots at 8,000-15,000 PSI with a flow rate of 225 ml/minute; level 3-5 is sufficient for sub-acute clots at 5,500-8,000 PSI with a flow rate of 170 ml/minute; and level 1-4 at 1,500-5,500 PSI with a flow rate of 100 ml/min for acute clots.
Due to the small size and form factor, the flexible jet tube is specifically formed for placement within a catheter. That is, the jet tube is formed to be wholly contained within a catheter, all while maintaining integrity and high pressure flow, and allowing bendability.
In one embodiment, the jet tube nozzle is located on the underside of a bend, in-line with the evacuation lumen. In certain embodiments, the nozzle may be located closer to its shaft, resulting in a smaller catheter diameter. In certain embodiments, the nozzle may be located farther from the shaft, resulting a larger catheter diameter. Thus, in certain indications where a smaller diameter catheter is needed, the nozzle may be located closer to the shaft. In yet additional embodiments, the jet tube may remain partially or completely in the jet lumen. Further, in such an embodiment, the jet tube nozzle may be disposed on the jet tube in a manner that allows the jet tube nozzle to spray fluid at a clot. As a non-limiting example, the jet tube may remain substantially in the jet lumen (or other shaft) and the jet tube nozzle may be steeply angled to effectively spray a clot which the user has positioned along the catheter, but below the distal end. In an alternate embodiment, the jet tube nozzle may be disposed on the jet lumen (or other fluid-carrying shaft) itself. In such an alternate embodiment, the jet tube nozzle may be angled sharply downward (toward the distal end) such that the spray may hit a clot.
In an alternate embodiment, the distal end of the catheter includes a distal end cone. In such an alternate embodiment, the distal end cone may be configured to enable a user to traverse a thrombus. Further, such an alternate embodiment may include a jet cut into the side of the catheter proximate to the distal end cone. As a non-limiting example, the jet may be disposed under the distal end cone and the jet may be angled with deflection capability. Thus, the cone allows for traversing thrombus and centering guidewire in the vessel.
Various embodiments include fixing a jet location vertically within a vessel. The jet location may be fixed such that it is visible in terms of one or both of location and direction to the individual utilizing the device, thereby ensuring adequate treatment and safety. Horizontal movement is then maintained in a locked position, ensuring continual and proper aiming of the jet toward, or inside, the evacuation catheter.
While this invention has been described in conjunction with the embodiments outlined above, many alternatives, modifications and variations will be apparent to those skilled in the art upon reading the foregoing disclosure. Accordingly, the embodiments of the invention, as set forth above, are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the invention.