The present invention, according to some embodiments, relates to a system for removing material from a patient's body. In some embodiments, the present invention relates to a system for aspirating, filtering and/or oxygenating a patient's blood. In some embodiments, the present invention relates to steerable catheter and a system incorporating the same. More particularly, the present invention in some embodiments relates to a steerable aspiration catheter system which is configured to remove material from the body of a patient, for example, unwanted material such as emboli, thrombi, tumors, or debris. In further embodiments, the present invention relates to an aspiration catheter system that is configured to return aspirated blood to the patient.
Thrombi within a person's vascular system can form as a result of any one of a number of causes, including disease, infections, trauma, surgery, stagnant blood, and foreign articles implanted in the vasculature. For example vascular disease, which annually affects a large number of individuals, often leads to the development of clots in the vascular system. These clots are usually comprised of an aggregated mixture of thrombus and fibrin and, if left untreated, may result in deep vein thrombosis, embolisms, or ischemia.
A thrombus present in a person's arterial system tends to move in the direction of blood flow from a large diameter artery to smaller diameter arteries and may continue to migrate until it becomes lodged against a vessel wall. In some instances, the thrombus partially or entirely blocks the flow of blood through the artery, thereby reducing or denying the supply of blood to tissue which is located downstream of the thrombus. Cutting off the flow of blood for an extended period of time may lead to damage or death of the tissue, possibly resulting in the loss of extremities in some cases. In other severe cases, a thrombus can migrate to the vessels of the brain and cause stroke and possibly death. Moreover, in a person's venous system, clots can migrate to the lungs and block the lungs main artery, resulting in a potentially fatal pulmonary embolism.
The present invention according to certain embodiments provides a system for removing thrombi and other unwanted material from the body of a patient, particularly from the patient's vasculature. As used herein, a patient may refer to a human patient, or in other embodiments, patient may also refer to non-human animals, for example, veterinary patients. In some embodiments, systems according to the present invention may be suited for thrombectomy and/or embolectomy procedures. Systems according to certain embodiments of the present invention may be used, for example, to remove clots from patients suffering from or at risk of pulmonary embolisms. In some embodiments, a system of the present invention is configured to aspirate thrombi and/or other unwanted material from the patient's vasculature. In some further embodiments, a system according to the present invention may be configured to add oxygen to and/or remove carbon dioxide from a patient's blood. In some embodiments, the system is further configured to return aspirated blood to the patient which, for example, allows for greater suction pressures and/or flow rates according to certain embodiments. In yet further embodiments, a system according to the present invention includes a steerable catheter to allow for directed aiming at the unwanted material.
In some embodiments, the system includes an aspiration catheter insertable into the patient having a distal end with a steerable tip configured to bend in one or more directions. In some embodiments, the system further includes a controller coupled to the aspiration catheter proximal to the distal end and operable by a user (e.g., surgeon) to manipulate and bend the steerable tip in the one or more directions. In some embodiments, the aspiration catheter includes one or more steering wires connected to the steerable tip, the controller configured to selectively apply tension on the one or more steering wires to bend the steerable tip in the one or more directions. In other embodiments, the aspiration catheter does not include a steering mechanism.
In further embodiments, the system includes a pump having an inlet port configured to be in fluid communication with the aspiration catheter. A filter device may be positioned between the aspiration catheter and the pump, the filter device configured to trap solid material (e.g., thrombi) received in the aspiration catheter from the body of the patient. The pump may also include a discharge port, the pump being configured to generate a negative pressure at the inlet port and a positive pressure at the discharge port during use. In yet other embodiments, the system includes a return catheter configured to be in fluid communication with the discharge port of the pump to return aspirated blood to the patient. The return catheter, in some embodiments, may or may not also include a steerable tip that is configured to bend in one or more directions in response to a controller. In some embodiments, the system may include an oxygenator configured to oxygenate the aspirated blood prior to returning the aspirated blood to the patient. In some such embodiments, the oxygenator is further configured to remove carbon dioxide from the aspirated blood.
In certain embodiments, the system includes at least one working port configured to allow insertion of one or more devices into or through the aspiration catheter. In some embodiments, the at least one working port is removably connected to the controller and/or aspiration catheter by a connector. The connector may be, for example, a quick connect fitting. In some embodiments, the at least one working port provides a fluid tight seal around the one or more devices when the one or more devices are inserted into the aspiration catheter. The one or more devices may include, for example, guidewires, stylets, balloon catheters, diagnostic catheters, baskets, optical fibers, thrombolysis tools, needles, cutters, biopsy devices, and other surgical implements known in the art. In some embodiments, the at least one working port includes a Tuohy Borst adaptor. In further embodiments, the system includes a plurality of working ports. Each of the plurality of working ports may be adapted to accept devices of different sizes. Moreover, each of the plurality of working ports may be removably connected to the controller and/or aspiration catheter via a separate connector.
In further embodiments, the present invention provides a stylet that is configured for use in positioning the aspiration catheter, the return catheter, and/or other catheters and cannulas. The stylet in some embodiments includes an elongate portion sized to fit within a lumen of the catheter or cannula. In some embodiments, the stylet further includes a steerable tip that is configured to bend in one or more directions. In some embodiments, the stylet includes a controller that is operable by a user to bend the steerable tip of the stylet in the one or more directions to help maneuver the stylet and catheter through a patient's vascular system during use.
The foregoing summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention can be embodied in different forms and thus should not be construed as being limited to the embodiments set forth herein. Furthermore, unless noted otherwise, the appended drawings may not be drawn to scale.
The present subject matter will now be described more fully hereinafter with reference to the accompanying figures and examples, in which representative embodiments are shown. The present subject matter can, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to describe and enable one of skill in the art. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety.
Referring to the drawings in detail, wherein like reference numerals indicate like elements throughout, there is shown in
In some further embodiments, system 100 may include one or more other components which are configured to modify the aspirated blood before returning the blood to the patient. Referring to
In further embodiments, system 100 may also include one or more infusion pumps (not shown) which are configured to introduce drugs, fluids, nutrients and/or other substances into the aspirated blood before the aspirated blood is returned to the patient via return catheter 500. Such infusion pumps may be connected to the system anywhere between aspiration catheter 200 and return catheter 500. In some embodiments, fluid path 250 or return catheter 500 may include one or more ports (not shown) which may be connected to an infusion pump and configured to receive material from the infusion pump for introduction into the aspirated blood. In yet other embodiments, system 100 may also include a temperature regulation device (e.g., heat exchanger) for modifying the temperature of the aspirated blood prior to returning the aspirated blood to the patient. In some embodiments, for example, blood may cool after it is aspirated from the patient's body. In some situations it may desirable to return the temperature of the aspirated blood towards normal body temperature (about 37° C.) before it returns to the patient. In some embodiments therefore, system 100 may include a heater or heat exchanger positioned along fluid path 250 and/or return catheter 500 that is configured to warm the aspirated blood.
Aspiration catheter 200 is preferably configured as an elongated tube which should be sufficiently flexible to allow for maneuverability through a patient's vasculature while also being stiff enough so as not to collapse under suction pressure from pump 400. In some embodiments, aspiration catheter 200 may be made from any material suitable for the manufacture of catheters. In some embodiments, aspiration catheter is made from a biocompatible polymer, for example, polyvinyl chloride, polyethylene, polypropylene, polyurethane, silicone, or combinations thereof. In some embodiments, aspiration catheter 200 may include reinforcing elements, for example, wires, coils, or ribs to prevent collapse during use.
In some embodiments, aspiration catheter 200 has a French size of at least 5 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 6 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 7 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 8 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 9 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 10 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 11 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 12 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 13 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 14 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 15 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 16 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 17 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 18 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 19 Fr. In some embodiments, aspiration catheter 200 has a French size of at least 20 Fr. In some embodiments, aspiration catheter 200 has a French size of 8 Fr to 12 Fr. In some embodiments, aspiration catheter 200 has a French size of 9 Fr to 11 Fr. In certain preferred embodiments, aspiration catheter has a French size of equal to or greater than 10 Fr to allow for aspiration of large thrombi and/or other solid materials from the patient.
In some embodiments, aspiration catheter 200 has a lumen diameter of at least 1 mm. In some embodiments, aspiration catheter 200 has a lumen diameter of at least 2 mm. In some embodiments, aspiration catheter 200 has a lumen diameter of at least 3 mm. In some embodiments, aspiration catheter 200 has a lumen diameter of at least 4 mm. In some embodiments, aspiration catheter 200 has a lumen diameter of at least 5 mm. In some embodiments, aspiration catheter 200 has a lumen diameter of 1 mm to 5 mm. In some embodiments, aspiration catheter 200 has a lumen diameter of 2 mm to 4 mm. In some embodiments, aspiration catheter 200 has a lumen diameter of equal to or greater than 3 mm.
Aspiration catheter 200, in certain preferred embodiments, is a steerable aspiration catheter. For example, in some embodiments, aspiration catheter 200 includes one or more steering wires which may extend along at least a portion of the length of aspiration catheter 200 to distal tip 210. In some embodiments, aspiration catheter 200 includes at least one pair of steering wires. In some embodiments, aspiration catheter 200 includes at least two pairs of steering wires. In some embodiments, aspiration catheter 200 includes at least three pairs of steering wires. In some embodiments, aspiration catheter 200 includes at least four pairs of steering wires. In some embodiments, aspiration catheter 200 includes at least five pairs of steering wires. In some embodiments, aspiration catheter 200 includes at least six pairs of steering wires. These steering wires may be positioned on the outside of aspiration catheter 200, inside the lumen of aspiration catheter 200, or within the walls of aspiration catheter 200. Each pair of steering wires may include diametrically opposed steering wires. By applying tension to selected steering wires, it is possible to cause distal tip 210 to bend in one or more directions. In some embodiments, being able to steer distal tip 210 of aspiration catheter 200 allows for better aiming of aspiration catheter towards the material to be removed from the patient (e.g., thrombi).
Referring now to
Controller 220, in some embodiments, includes a dial or knob 222 which can be operated by a user (e.g., surgeon) to bend distal tip 210 in the one or more directions. For example, rotating dial or knob 222 clockwise may cause distal tip 210 to bend in a first direction d1 whereas rotating dial or knob 222 counterclockwise may cause distal tip 210 to bend in a second direction d2 which is opposite of first direction d1. For example, rotation of dial or knob 222 clockwise may pull steering wire 218a and/or push steering wire 218b causing distal tip 210 to bend in first direction d1. Rotation of dial or knob 222 counterclockwise may pull steering wire 218b and/or push steering wire 218a causing distal tip 210 to bend in second direction d2. Aspiration catheter 200 may include additional pairs of opposing steering wires to allow for bending in directions other than the ones illustrated for simplicity. It should be understood that controller 220 may also include additional dials or knobs to allow for bending of distal tip 210 in further directions not illustrated. It should also be appreciated that while controller 220 includes a dial or knob 222 in the illustrated embodiment for simplicity, other mechanisms such as levers, triggers, switches, thumbwheels, joysticks, buttons, slides, etc. could be used to operate controller 220 to steer distal tip 210. An example steering mechanism that may be adapted to the present system according to some embodiments is included in the DESTINO™ guiding sheath available from OSCOR®.
In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 10 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 15 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 20 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 25 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 30 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 40 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 45 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 50 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 60 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 65 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 70 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 75 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 80 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 85 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 90 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 100 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 135 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend from 0 degrees to about 180 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 210 is configured to bend no more than 90 degrees in any one direction. In some embodiments, distal tip 210 is configured to bend no more than 135 degrees in any one direction. In some embodiments, distal tip 210 is configured to bend no more than 180 degrees in any one direction.
While
Referring again to
In certain embodiments, working port 230 is configured to provide a fluid tight seal around stylet 700 or other device inserted through working port 230, for example, so as to prevent leakage of blood out of working port 230 during use. For example, working port 230 may include an o-ring seal that is sized to form a tight seal with stylet 700 or other tool inserted through working port 230. In some embodiments, working port 230 includes or is configured as a Tuohy-Borst adapter. In some embodiments, working port 230 may have an adjustable opening diameter to accommodate tools of different sizes. For example, working port 230 may be configured as a chuck, collet, adjustable collar, or other radial clamp. In yet further embodiments, working port 230 may include a valve to close working port 230 when not in use.
In some embodiments, working port 230 may be connected to controller 220 by a connector 240 which allows working port 230 to be detached and/or replaced. In some embodiments, connector 240 allows for working ports 230 which can accommodate different tools and devices to be exchanged. For example, a working port 230 which can accommodate tools of a particular size can be disconnected at connector 240 and exchanged for a different working port which can accommodate larger or smaller tools. In some embodiments, a plurality of different working ports 230, each of which being connectable to connector 240, may be provided as a kit for example. In some embodiments, connector 240 may be a quick connect fitting, threaded fitting, flanged fitting, or other tube fitting known in the art.
In yet further embodiments, system 100 may include more than one working port 230. In some embodiments, system 100 includes a plurality of working ports 230 so as to accommodate different tools and devices.
Referring again to
As shown in
Pump 400, according to certain embodiments, is configured to create a suction force to drive system 100 during use. In preferred embodiments, pump 400 is a centrifugal pump. In other embodiments, pump 400 may be a rotary pump, peristaltic pump, roller pump, or other form of pump known in the art. In some embodiments, pump 400 may be controlled by a console 430 via communication pathway 432. Communication pathway 432 may be a hardwired electrical pathway, for example. In alternative embodiments, communication pathway 432 may be a wireless connection. In some embodiments, console 430 may be operated by the user (e.g., surgeon) to adjust the speed, pressure, or other attributes of pump 400 during use. In some embodiments, console 430 includes a control panel 434 which may receive input from the user to control pump 400. For example, control panel 434 may include one or more controls 436 (e.g., dials, touch screens, buttons, levers, etc.) for adjusting pump speed or other pump variable. Control panel 434 may also include other components such as, for example, one or more displays 438 (e.g., LCD display) that indicate pump speed, pressure or other values. In some embodiments, console 430 is a computer which may receive input from the user via a keyboard, mouse, etc. In some embodiments, console 430 and pump 400 may integrated as a single device.
Pump 400 is preferably configured to generate a negative (suction) pressure at inlet port 410 sufficient to cause aspiration of the patient's blood through aspiration catheter 200 during use. In some embodiments, pump 400 is capable of producing negative pressures from 0 mmHg to about −100 mmHg. In some embodiments, pump 400 is capable of producing negative pressures from 0 mmHg to about −150 mmHg. In some embodiments, pump 400 is capable of producing negative pressures from 0 mmHg to about −200 mmHg. In some embodiments, pump 400 is capable of producing negative pressures from 0 mmHg to about −250 mmHg. In some embodiments, pump 400 is capable of producing negative pressures from 0 mmHg to about −300 mmHg. In some embodiments, pump 400 is capable of producing negative pressures from 0 mmHg to about −350 mmHg. In some embodiments, pump 400 is capable of producing negative pressures from 0 mmHg to about −400 mmHg.
In some embodiments, pump 400 is configured to generate a blood flow rate of at least 100 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 200 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 300 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 400 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 500 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 600 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 700 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 800 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 900 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1000 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1100 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1200 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1300 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1400 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1500 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1600 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1700 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1800 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 1900 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 2000 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 3000 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 4000 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of at least 5000 mL/min through aspiration catheter 200.
In some embodiments, pump 400 is configured to generate a blood flow rate of about 100 mL/min to about 6000 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of about 1000 mL/min to about 5000 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of about 1500 mL/min to about 4500 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured to generate a blood flow rate of about 2000 mL/min to about 4000 mL/min through aspiration catheter 200. In some embodiments, pump 400 is configured such that the generated flow rate may be ramped up from 0 mL/min to the desired flow rate during use (e.g., via console 430).
In further embodiments, pump 400 includes a discharge port 420 separate from inlet port 410. Pump 400 is configured to generate a positive pressure at discharge port 420 such that the aspirated blood received through inlet port 410 is expelled through discharge port 420 during use. The aspirated blood or other fluids are typically expelled through discharge port 420 at about the same flow rate as the flow rate into pump 400 through inlet port 410. As shown in
Referring now to
In some embodiments, stylet 700 may be a steerable stylet having a distal tip 710 which is configured to bend in one or more directions in response to a controller 720 positioned proximally away from distal tip 710. Controller 720 may be configured to apply tension to one or more steering wires 712a,712b which extend from controller 720 and are connected to distal tip 710. By applying tension to selected steering wires, it is possible to cause distal tip 710 to bend in one or more directions to help steer stylet during insertion into the patient's vasculature. In some embodiments, steering wires 712a, 712b may be positioned on the outside of stylet 700, inside the lumen of stylet 700, or within the tube walls of stylet 700. In some embodiments, stylet 700 includes one or more pairs of steering wires which are diametrically opposed to each other.
Controller 720, in some embodiments, includes a dial or knob 722 which can be operated by a user (e.g., surgeon) to bend distal tip 710 in the one or more directions. For example, rotating dial or knob 722 clockwise may cause distal tip 710 to bend in a first direction whereas rotating dial or knob 722 counterclockwise may cause distal tip 710 to bend in a second direction which is opposite of first direction d1. For example, rotation of dial or knob 722 clockwise may pull steering wire 718a and/or push steering wire 718b causing distal tip 710 to bend in first direction. Rotation of dial or knob 722 counterclockwise may pull steering wire 718b and/or push steering wire 718a causing distal tip 710 to bend in second direction. Stylet 700 may include additional pairs of opposing steering wires to allow for bending in further directions. It should be understood that controller 720 may also include additional dials or knobs to allow for bending of distal tip 710 in these further directions. It should also be appreciated that while controller 720 includes a dial or knob 722 in the illustrated embodiment for simplicity, other mechanisms such as levers, triggers, switches, thumbwheels, joysticks, buttons, slides, etc. could be used to operate controller 720 to steer distal tip 710. Controller 720 may be configured to have guidewire 600 extend through it in some embodiments. An example steering mechanism that may be adapted to the present system according to some embodiments is included in the DESTINO™ guiding sheath available from OSCOR®. In some embodiments, stylet 700 does not include any working ports.
In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 10 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 15 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 20 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 25 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 30 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 40 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 45 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 50 degrees in one or more directions in response to operation of controller 220. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 60 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 65 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 70 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 75 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 80 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 85 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 90 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 100 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 135 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend from 0 degrees to about 180 degrees in one or more directions in response to operation of controller 720. In some embodiments, distal tip 710 is configured to bend no more than 90 degrees in any one direction. In some embodiments, distal tip 710 is configured to bend no more than 135 degrees in any one direction. In some embodiments, distal tip 710 is configured to bend no more than 180 degrees in any one direction.
It should be understood that stylet 700, in some embodiments, may be used for positioning steerable or non-steerable catheters. For example, in certain further embodiments of the present invention, both aspiration catheter 200 and return catheter 500 are non-steerable catheters and do not include direct steering mechanisms. In some such embodiments, one or both of aspiration catheter 200 and return catheter 500 may be positioned within a desired location within a patient's blood vessel by way of a steerable stylet 700, which is then removed from aspiration catheter 200 and/or return catheter 500. In other embodiments, only one of aspiration catheter 200 and return catheter is steerable and includes a direct steering mechanism. A steerable stylet 700 may be used for positioning the steerable catheter or the non-steerable catheter.
It should also be appreciated that other stylets that are known in the art may be alternatively used for positioning aspiration catheter 200 and/or return catheter 500, for example, non-steerable stylets. It should also be appreciated that stylet 700 described herein is not necessarily limited to use with the aspiration system of the present invention. For example, stylet 700 may also be used for positioning catheters other than aspiration catheter 200 or return catheter 500. In further embodiments, stylet 700 may be configured for positioning catheters and cannulas that are configured for use in other medical procedures. For example, in other embodiments, stylet 700 with steerable distal tip 710 may be particularly useful for maneuvering a cannula through a patient's pulmonary artery for positioning a right heart assist device. In one such embodiment, stylet 700 would be positioned within the lumen of the cannula and the assembly steered into position within the pulmonary artery. Once in the desired location, stylet 700 would be withdrawn from the cannula while leaving the cannula in place. Stylet 700 could likewise be adapted for use in positioning other existing catheters and cannulas known in the art. In yet further embodiments, a steerable stylet 700 could be used for positioning a catheter or cannula without additional guidewire 600. In some such embodiments, stylet 700 need not be hollow or include a lumen.
It is to be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the invention, a further description of such elements is not provided herein.
It will be further appreciated by those skilled in the art that changes could be made to the exemplary embodiments shown and described above without departing from the broad inventive concept thereof. It is understood, therefore, that the present invention is not limited to the exemplary embodiments shown and described, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the claims. It should also be apparent that individual elements identified herein as belonging to a particular embodiment may be included in other embodiments of the invention. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, and composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure herein, processes, machines, manufacture, composition of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Moreover, unless specifically set forth herein, the terms “a,” “an,” and “the” are not limited to one element but instead should be read as meaning “at least one.”
This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/204,089, filed Aug. 12, 2015, which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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62204089 | Aug 2015 | US |