Patent Application
20240277971
This invention relates generally to endovascular devices and more particularly to a specifically shaped support catheter which obviates the need for an open surgical cutdown of the common carotid artery (CCA), while also employing a percutaneous technique and novel carotid access devices which use anatomical fulcrums and/or unique steering and/or rotational capabilities.
Minimally invasive treatments are increasingly popular including intravascular catheter treatments. Such treatments may be more effective than prior procedures, nonetheless, in some instruments they require an open surgical cutdown of the carotid artery which requires more anesthetic to perform typically than percutaneous procedures, with attendant anesthetic risks. Additionally, such procedures require surgical expertise, and presents additional risks of surgical injuries and/or infection at the cutdown site in the neck. The present disclosure in some embodiments relates to methods and systems for accessing the carotid arterial vasculature and establishing retrograde blood flow during performance of carotid artery stenting and other procedures.
Carotid artery disease commonly results in deposits of plaque which narrow the junction between the common carotid artery (CCA) and the internal carotid artery (ICA), an artery which provides blood flow to the brain. Such deposits may result in embolic particles being generated and entering the cerebral vasculature, leading to neurologic consequences such as transient ischemic attacks (TIA), ischemic stroke, or death.
Various therapies exist to ameliorate carotid artery disease related difficulties. The most common are carotid endarterectomy CEA and a carotid artery stenting CAS. Both expose patients to the risk of emboli being released into the cerebral vasculature via the internal carotid artery.
In response, several patents disclose a variety of devices and associated methods. For example, methods comprise trans-cervical access and blocking of blood flow through the common carotid artery while shifting blood from the internal carotid (see e.g., U.S. Ser. No. 12/835,660 (U.S. Pat. No. 8,784,355), Ser. No. 10/996,301 (U.S. Pat. No. 7,998,104), Ser. No. 12/366,287 (U.S. Pat. No. 9,669,191), and Ser. No. 15/044,493 (U.S. Pat. No. 9,655,755)).
The prior art discloses trans-carotid arterial revascularization. In particular, a small incision is made just above the collar bone and surgical dissection is used to surgically expose the common carotid artery. A soft, flexible tube (sheath) is placed directly into the carotid artery, and a clamp is applied to the external surface of the common carotid artery around the tube (sheath), and the tube (sheath) is connected to a system that will reverse the flow of blood away from the brain to protect against fragments of plaque that may come loose during the procedure. The blood is filtered and returned through a second tube (sheath) placed in the femoral vein in the patient's thigh or another vessel. Thereupon, the prior art also discloses balloon angioplasty and stenting performed while blood flow is reversed, and after the stent is placed successfully to stabilize the plaque in the carotid artery, the clamp is released and flow reversal is turned off and blood flow to the brain resumes in its normal direction. However, the prior art requires a surgical cut-down and dissection of the common carotid artery in the neck. Such surgery tends to disfigure the patient, requires additional anesthesia, additional training, and has a risk of damaging nerves.
Thus, there is a need for direct surgical access because of difficulties encountered with endovascular access, which can make adequate access difficult and high r risk in many cases.
There is a need for a less invasive percutaneous procedure, with lower risks of disfigurement, a lower risk of nerve injury, less use of anesthesia, and a simpler system requiring less training, thereby improving access to such treatments. The present invention addresses these unmet needs and provides advantages over the Walzman catheters described in the paragraph below.
The prior art discloses a set of Walzman arch fulcrum catheters, for example U.S. patent application Ser. Nos. 15/932,775 (Publication No. 2018/0243003) and Ser. No. 16/290,923, (Publication No. US 2019/0216499) which may be useful to overcome this difficulty. In particular, a version with a balloon on a distal end may be used. Using this device, a user may consistently obtain transfemoral carotid access with adequate support with little difficulties and lower risks, and achieve similar results via a percutaneous transfemoral access, with less needs for anesthetics and their attendant risks. Additionally, the prior art discloses a set of Walzman radial access catheters, which can make safe percutaneous access of either carotid artery feasible in the vast majority of patients, for example Ser. No. 16/501,592 (Publication No. 2019/0282266) and Ser. No. 16/501,577 (Publication No. 2019-0282265). Such catheters may also reduce access-site complications further. Such catheters can be further modified with at least one additional lumen substantially in the wall of the catheter, that can exit the wall of the catheter via at least one perforation in the outer wall of the catheter, to provide irrigation proximal to the balloon when said balloon is inflated, so as to minimize formation of clot proximal to said balloon. Such clots can form when a balloon occludes a vessel and causes stasis of blood.
The present invention in some embodiments combines minimally invasive percutaneous endovascular carotid-artery access with rigorous blood flow-reversal, in order to protect the brain from embolic debris when introducing interventional devices into the carotid artery. In particular, the present invention uses reverse flow elements to prevent flow of blood to the brain, thus allowing maximal medical devices to be delivered to target areas more safely. Such reverse flow techniques include vaso-plugs, pumps, and irrigation distal to a lesion, among others.
The present invention may be embodied in the form of either of two preferred devices—one for right carotid stenosis and one for left carotid stenosis. The present invention includes a main (delivery') catheter, which may include one or more inflatable balloons mounted to an outer surface thereof, that is optimized for percutaneous access of the right and left carotid arteries in which a portion of the catheter is optimized to rest upon the lesser curvature of the aortic arch, in order to increase support for the delivery of additional medical devices (e.g., catheters, hypotubes, balloons, stents, etc.) through the catheter, while also preventing recoil and kickback and unwanted prolapse of the catheter and devices inserted therethrough into the aortic arch, thereby improving procedural efficacy and reducing procedural risks.
The current invention, in other embodiments, may use transfemoral percutaneous endovascular access via additional arch fulcrum access catheters referenced above, and additionally may use any of the radial access catheters described herein. Additional embodiments may alternatively use various catheters described in the prior art, along with novel devices and methods to increase flow reversal at the lesion site, while minimizing the necessary diameter of the delivery catheter, and while minimizing any potential sump effect from the brain.
In some embodiments of the current invention, a hollow wire is employed. The advantages of using a hollow wire include the ability to infuse fluids through it. This can
The benefits of using pressurized and/or pumped infusions is the ability to deliver higher rates (volume/time) of fluid through a small diameter lumen, thereby keeping the diameter of the devices as small as possible. This decreases risks at the treatment site and access site, and increases the range of access sites available (especially making treatment via radial artery access in most patients).
Additionally, using these methods and devices for carotid access can improve ease of percutaneous carotid access in many of the most difficult anatomical scenarios, thereby decreasing the risks of these percutaneous approaches. Catheters according to the present disclosure that are optimized for right carotid access via a transfemoral route will typically have a longer segment resting on the lesser arch of the aorta than corresponding catheter that are optimized for left carotid access. Embodiments include transfemoral and arm access arch fulcrum catheters.⋅The catheters may optionally have active steerability of their respective bends which in some embodiments can be achieved by the presence of wires in the wall of the catheter, with a mechanism to shorten the effective length of a wire to create a bend.
In one aspect of the present invention, a system for treating a vascular narrowing within a blood vessel is provided which includes a catheter and a supplemental medical device. The catheter includes: a proximal end hole; a distal end hole that is positioned opposite the proximal end hole; a circumferential balloon that is located proximally of the distal end hole; an operational lumen that extends through the catheter from the proximal end hole to the distal end hole; a first bend that curves in a first direction; and a second bend that curves in a second direction that is generally opposite to the first direction, wherein the second bend is positioned distally of the first bend and proximally of the circumferential balloon. The first bend and the second bend are configured to brace the catheter against an arch of the blood vessel to inhibit recoil of the catheter. The supplemental medical device is configured for insertion into the blood vessel through the operational lumen of the catheter.
In some embodiments, the supplemental medical device may be configured as a hypotube.
In some embodiments, the supplemental medical device may be configured as a catheter.
In some embodiments, the supplemental medical device may support a stent.
In some embodiments, the supplemental medical device may include at least one balloon element.
In some embodiments, the supplemental medical device may include a first balloon element and a second balloon element that is spaced axially from the first balloon element.
In some embodiments, the supplemental medical device may include a stent and at least one balloon element. In some embodiments, the at least one balloon element may include a first balloon element that is located distally of the stent and a second balloon element that is located distally of the first balloon element.
In some embodiments, the supplemental medical device may include a plurality of irrigation ports to facilitate fluid communication through the supplemental medical device into the blood vessel. In some embodiments, the plurality of irrigation ports may include a first plurality of irrigation ports that are located proximally of the first balloon element and a second plurality of irrigation ports that are located distally of the second balloon element.
In another aspect of the present disclosure, a system for treating a vascular narrowing within a blood vessel is provided which includes: a catheter; a first supplemental medical device that is configured for insertion into the blood vessel through the catheter; and a second supplemental medical device that is configured for insertion into the blood vessel through the first supplemental medical device. The catheter includes a tubular body having a first bend curving in a first direction and a second bend curving in a second direction generally opposite to the first direction. The first bend and the second bend are configured to brace the catheter against an arch of the blood vessel to inhibit recoil of the catheter.
In some embodiments, the medical device may further include a guide wire. In some embodiments, the catheter, the first supplemental medical device, and the second supplemental medical device may each be configured for insertion into the blood vessel over the guide wire.
In some embodiments, the first supplemental medical device may include a stent.
In some embodiments, the second supplemental medical device may include at least one balloon element. In some embodiments, the at least one balloon element may include a first balloon element and a second balloon element that is located distally of the first balloon element.
In some embodiments, the second supplemental medical device may be configured such that the first balloon element and the second balloon element are positionable distally of the stent.
In some embodiments, the second supplemental medical device may include a plurality of irrigation ports to facilitate fluid communication through the second supplemental medical device into the blood vessel. In some embodiments, the plurality of irrigation ports may include a first plurality of irrigation ports that are located proximally of the first balloon element and a second plurality of irrigation ports that are located distally of the second balloon element.
In another aspect of the disclosure, a system for treating a vascular narrowing within a blood vessel is provided. The system includes: a catheter; a first supplemental medical device that is configured for insertion into the blood vessel through the catheter; and a second supplemental medical device that is configured for insertion into the blood vessel through the first supplemental medical device, wherein the first supplemental medical device preferably includes a stent and the second supplemental medical device preferably includes at least one balloon element. The catheter includes a tubular body and a circumferential balloon that is secured to the tubular body. The tubular body includes a plurality of bends curving in a plurality of different directions such that the catheter is configured for bracing against an inner wall of the blood vessel to inhibit recoil of the catheter.
In some embodiments, the second supplemental medical device may include a first plurality of irrigation ports and a second plurality of irrigation ports that are located distally of the first plurality of irrigation ports. In some embodiments, the first plurality of irrigation ports and the second plurality of irrigation ports may be configured to facilitate fluid communication through the second supplemental medical device into the blood vessel. In some embodiments, the at least one balloon element may be positioned between the first plurality of irrigation ports and the second plurality of irrigation ports.
In another aspect of the disclosure, a catheter is disclosed that is configured to receive a supplemental medical device to facilitate the treatment of a vascular narrowing within a blood vessel during an endovascular procedure. The catheter includes: a proximal end hole; a distal end hole that is positioned opposite the proximal end hole; an operational lumen that extends between the proximal end hole and the distal end hole and which is configured to receive the supplemental medical device and a plurality of side holes that are in communication with the operational lumen and are arranged in a staggered pattern. Each side hole is configured to receive the supplemental medical device such that the supplemental medical device is extendable into the blood vessel through an elected side hole to increase access to a target site in the blood vessel and reduce rotational manipulation of the catheter required during the endovascular procedure. At least one balloon element can be provided that is located proximally of the distal end hole.
In some embodiments, the plurality of side holes may be staggered along a longitudinal axis of the catheter such that the plurality of side holes are spaced axially from each other.
In some embodiments, the plurality of side holes may be staggered along a circumference of the catheter such that the plurality of side holes are spaced circumferentially (radially) from each other.
In some embodiments, the plurality of side holes may be staggered such that they are circumferentially aligned arranged in at least one band.
In some embodiments, the plurality of side holes may be staggered such that they include a first plurality of side holes that are circumferentially aligned and arranged in a first band and a second plurality of side holes that are circumferentially aligned and arranged in a second band that is spaced axially from the first band along the longitudinal axis of the catheter.
In some embodiments, the plurality of side holes may be staggered along both the circumference of the catheter and the longitudinal axis of the catheter such that the plurality of side holes are spaced circumferentially (radially) and axially from each other. This can form a (generally) helical arrangement.
In some embodiments, the at least one balloon element may include a plurality of balloon elements. In some embodiments, the plurality of balloon elements may be staggered along a circumference of the catheter such that the plurality of balloon elements are spaced circumferentially (radially) from each other. In some embodiments, the plurality of balloon elements may be staggered such that they are circumferentially aligned and arranged in a band.
In some embodiments, the plurality of balloon elements may be staggered along a) both a longitudinal axis of the catheter such that the plurality of balloon elements are spaced circumferentially and b) axially from each other. This can form a (generally) helical arrangement.
The balloon element(s) can be on an outer catheter positioned over the catheter or on the catheter having the side hole(s).
In another aspect of the disclosure, a catheter is disclosed that is configured to receive a supplemental medical device to facilitate the treatment of a vascular narrowing within a blood vessel during an endovascular procedure. The catheter includes: a proximal end hole; a distal end hole that is positioned opposite the proximal end hole; an operational lumen that extends between the proximal end hole and the distal end hole and which is configured to receive the supplemental medical device; a plurality of balloon elements selectively inflatable to secure the catheter within the blood vessel; and at least one side hole that is configured to receive the supplemental medical device such that the supplemental medical device is extendable therethrough into the blood vessel.
In some embodiments, the plurality of balloon elements may be staggered along a circumference of the catheter such that the plurality of balloon elements are spaced circumferentially (radially) from each other.
In some embodiments, the plurality of balloon elements may be staggered such that they are circumferentially aligned and arranged in a band.
In some embodiments, the plurality of balloon elements may be staggered along a longitudinal axis of the catheter such that the plurality of balloon elements are spaced circumferentially (radially) and axially from each other. This can form a (generally) helical arrangement.
In some embodiments, the at least one side hole may include a plurality of side holes that are arranged in a staggered pattern along a longitudinal axis of the catheter and/or a circumference of the catheter.
The catheters disclosed herein can have a wire to apply a torsional force to rotate the catheter.
The catheters disclosed herein can have a wire to bend (deflect/steer) a distal segment of the catheter.
The catheters disclosed herein can provide support to the supplemental medical device to prevent kickback and prolapse.
In another aspect of the disclosure, a method of treating an aneurysm within a blood vessel is disclosed that includes: inserting a catheter into the blood vessel; inserting a supplemental medical device into an operational lumen of the catheter; electing a side hole from a plurality of side holes that are in communication with the operational lumen; and passing the supplemental medical device through the side hole elected from the plurality of side holes such that the supplemental medical device extends therethrough into the blood vessel.
In some embodiments, electing the side hole may include electing the side hole from a plurality of side holes that are staggered along a longitudinal axis of the catheter.
In some embodiments, electing the side hole may include electing the side hole from a plurality of side holes that are staggered along a circumference of the catheter.
In some embodiments, electing the side hole may include electing the side hole from a plurality of side holes that are arranged in a staggered pattern circumferentially (radially) and longitudinally in a (generally) helical pattern.
In some embodiments, the method includes inflating at least one balloon element that is supported on the catheter to secure the catheter within the blood vessel. In some embodiments, inflating the at least one balloon element may include inflating at least one of a plurality of balloon elements that are staggered along a circumference of the catheter and/or along a longitudinal axis of the catheter to deflect the catheter within the blood vessel.
In accordance with another aspect of the present invention, a method of treating a vascular anomaly within a blood vessel is provided comprising inserting a catheter into the blood vessel containing a vascular anomaly; electing a side hole from at least one side hole in communication with the lumen; passing a supplemental medical device through the side hole elected such that the supplemental medical device extends into the vascular anomaly therethrough; and rotating a segment of the catheter to rotate the side hole to a desired orientation.
In some embodiments, inserting the catheter into the blood vessel may include aligning the side hole elected with a vascular anomaly. In some embodiments, aligning the side hole elected with the vascular anomaly may include aligning the side hole elected with an aneurysm. In some embodiments, passing the supplemental medical device through the side hole may include inserting the supplemental medical device into the aneurysm through the side hole elected. In some embodiments, the method may further include inserting an embolic device into the aneurysm through the supplemental medical device to treat the aneurysm.
In some embodiments, the method may further include positioning or bracing the catheter against an inner wall of the blood vessel to inhibit recoil of the catheter and the supplemental medical device.
In another aspect of the disclosure, a catheter is disclosed that is configured for use during an endovascular procedure to treat a vascular abnormality in a blood vessel. The catheter includes an operational lumen that is configured to receive a supplemental medical device to facilitate treatment of the vascular abnormality and at least one side hole. The at least one side hole extends through the wall of the catheter and into communication with the operational lumen and is configured to receive the supplemental medical device such that the supplemental medical device is extendable into the blood vessel through the at least one side hole to treat the vascular abnormality.
In some embodiments, at least one balloon element is supported on an outer surface of the catheter and an inflation lumen extends through a wall of the catheter to selectively inflate the at least one balloon element
In some embodiments, the catheter may further include at least one pull or push wire that is configured to apply torsional force to the catheter and thereby rotate the catheter to vary a rotational position of the at least one side hole. The wire in some embodiments is embedded in the wall of the catheter.
In some embodiments, the at least one wire may include a first pull or push wire that is configured to rotate the catheter in a first direction and a second pull or push wire that is configured to rotate the catheter in a second direction generally opposite to the first direction. In other embodiments, the first and second pull or push wires rotate the catheter in the same (first) direction.
In some embodiments, the catheter may include at least one steering wire which can be pushed or pulled to deflect (bend) the distal end of the catheter. In some embodiments, the at least one steering wire is embedded in a wall of the catheter. Multiple steering wires can be provided to steer (bend) different segments of the catheter.
In some embodiments, the at least one balloon element may include a plurality of balloon elements that are staggered circumferentially and/or radially along a circumference of the catheter. In some embodiments, the at least one side hole may include a plurality of side holes that are staggered circumferentially and/or radially along a circumference of the catheter.
FIG. IA is a cross-sectional view of one embodiment of a catheter of the described invention that includes a tube (tubular body) I. The catheter is disposed in a blood vessel V (e.g., a bovine, Type III 7000 aortic arch) such that the second segment rests on the arch fulcrum 2000 with a third bend 30 and fourth segment 400 deployed in the left common carotid artery 5000 with a bovine origin. Also identified are descending aortic artery 1000, right subclavian artery 3000, right vertebral artery 3500, right carotid artery 4000, innominate (brachiocephalic) artery 6000, Type Ill arch 7000, left subclavian artery 8000, and left vertebral artery 8500.
Referring now to the drawings wherein like reference numerals identify similar structures, element, and features, various embodiments of the presently disclosed systems and devices will be discussed.
The term “recoil and displacement”, as used herein refers to the phenomenon of catheter prolapse or displacement (slipping forward, back, or down, and out of the desired position) due to a counterforce against the catheter by the advancing wire, second catheter, or other, additional device.
The catheters of the present invention, in some embodiments, use the anatomical fulcrum as an anti-kickback, anti-displacement support structure. Beyond the shaping of the catheter to allow said support, the catheter in some embodiments deploys a final element at the distal end to facilitate delivery of the distal end to the target area. The final element of the simplest embodiment of the invention is shown in
The final element in the preferred embodiment comprises two bends, three segments and one end hole. The final element may comprise one or more additional bends and one or more additional segments beyond those comprising the preferred embodiment. The final-element configuration is determined by the path the user of the catheter determines is necessary to deliver the distal end hole 405 to the target area as illustrated in
Now referring to FIG. IA, a medical device M (e.g., a catheter C) is disclosed that includes the tube 1 of the present invention. The tube 1 includes a proximal end hole 404 and the aforementioned distal end hole 405, which is positioned opposite to the proximal end hole 404. The catheter C is shown deployed in the aorta with distal end hole 405 terminating in an abnormal anatomical variation of the left carotid artery 500 referred to as a bovine arch. The device of this embodiment of the current invention has seven principal elements. The first three of the elements are bends, and four are segments of the tube. More particularly, first bend 10 connects segment one 100 to segment two 200 at a non-obtuse angle a, as measured as an angle from the proximal catheter tubing to the tubing of the second segment, in this example (e.g., such that the angle a. (FIG. IA) is defined between respective longitudinal axes Xi, Xii of segments 100, 200). It is envisioned, however, that segments 100, 200 may be configured and positioned so as to achieve any necessary or desired angle a. (e.g., depending upon the particular nature of the procedure being performed, spatial restrictions dictated by the patient's vasculature, etc.).
First bend 10 extends in a first direction and may be active or passive. A passive bend, as disclosed by the prior art, is a bend which is pre-formed by the use of a wire or a braid. A passive bend 10 has been treated in such a way prior to the introduction to the body that, if there are no other forces, it will form a desired (e.g., non-obtuse) angle. In order to deploy (insert), a tube must be straight, so there must be a force to straighten bend 10, such as a wire, a stiff inner or outer tube or combination, such that upon removal of said external force, the desired (e.g., non-obtuse) angle is formed. In other embodiments, any bend may be active or passive. In some embodiments, all bends are active (requiring) remote manipulation by a user such as by a pull (or push) wire attached to a catheter segment); in other embodiments all bends are passive; in yet other embodiments, bends may be a mix of active bends and passive bends.
Other embodiments are adapted to access aortic arch 2000 through a vessel in the arm or, for example, from a radial artery, brachia! artery, axillary artery (or vein) (not shown), when such access may be preferred. In the embodiment depicted in
During the course of the endovascular procedure, it is envisioned that the second segment 200 may be moved off of (e.g., away from) the fulcrum of the arch 2000 and that the tube 1 may be repositioned such that the third segment 300 (or any other suitable segment of the tube 1) rests against the fulcrum of the arch 2000.
In a variant embodiment of
As seen in
The combination of a catheter that utilizes the inferior curve of the aortic arch as a vascular fulcrum with side holes, through which additional catheters can be passed, may further facilitate catheterization of bilateral vertebral and carotid arteries via a single access site in either arm.
As depicted in
It should be noted that in embodiments containing more than one balloon, each balloon may optionally require a separate inflation lumen.
Other variants of catheter embodiments optionally include at least one valve 4. For example, as seen in FIG. IA, tube 1 may include a first valve 4a located within segment 100 proximally of bend 10; a second valve 4b located within segment 200 distally of bend and proximally of bend 20; a third valve 4c located within segment 300 distally of bend and proximally of bend 30; and/or a fourth valve 4d located within segment 400 distally of bend 30 and proximally of end hole 405. It is envisioned that each of the valves 4 may be configured to receive a medical device in sealed engagement. It is also envisioned that each of valves 4 may be biased towards a closed position to regulate blood flow through one or more segments 100, 200, 300, 400 of tube 1. Still other variants of catheter embodiments may optionally include at least one supplemental irrigation lumen 5 (
In an alternative embodiment, materials or techniques may be employed so as to achieve any desired configuration for bends 10, 20, 30. For example, materials may be chosen and techniques utilized such that bends 10, 20, 30 are obtuse, non-obtuse, or at approximately right angles. Such embodiments may include the incorporation of shape-memory metals or polymers. In addition or in the alternative, radiation may be focused on a point of tube 1 such that bend 10 is forced to adopt a desired, non-obtuse angle of segment two relative to the proximal segment one to position segment two over the fulcrum of aortic arch 2000.
Segment one 100 in some embodiments has a length of at least approximately 20 cm in length and an internal diameter of from approximately 0.1 French to approximately 30 French. In a preferred embodiment deployed transfemorally for access of the innominate arteries distal branches with a Type II and Type III arch, first bend 10 is deployed in the artery such that angle a is non-obtuse so as to orient segment two 200 for optimal positioning on the fulcrum of aortic arch 2000.
Segment two 200 in some embodiments measures at least approximately 3 cm in length and no more than approximately 35 cm in length in the preferred embodiment of
Second bend 20 connects to segment three 300 of tube 1. Segment three 300 measures at least approximately 0.5 cm in length and has an internal diameter of from approximately 0.1 French to approximately 30 French. Segment three 300 has a first end which terminates in second bend 20 and connected to segment two 200 of tube 1, and a second end terminating at third bend 30.
Third bend 30 connects to segment four 400 (
Segment four 400 in some embodiments measures at least approximately 0.5 cm in length and has an internal diameter of from approximately 0.1 French to approximately 30 French. Segment four 400 has a first end which terminates in third bend 30 and connected to segment three 300 of tube I, and a second end terminating at distal hole 405.
Now referring to
Now referring to
The middle segment 200 of the catheter can includes ridges 6 such as shown in
According to another embodiment, the middle segment two 200 is coated with an elastic material 7 (
The various components of the described invention may be comprised of one or more materials. Thermoplastics include, but are not limited to, nylon, polyethylene terephthalate (PET), urethane, polyethylene, polyvinyl chloride (PVC) and polyether ether ketone (PEEK).
Thermosets include, but are not limited to, silicone, polytetrafluoroethylene (PTFB) and polyimide. Composites include, but are not limited to, liquid crystal polymers (LCP). LCPs are partially crystalline aromatic polyesters based on p-hydroxybenzoic acid and related monomers. LCPs are highly ordered structures when in the liquid phase, but the degree of order is less than that of a regular solid crystal. LCPs can be substituted for such materials as ceramics, metals, composites and other plastics due to their strength at extreme temperatures and resistance to chemicals, weathering, radiation and heat. Non-limiting examples of LCPs include wholly or partially aromatic polyesters or co-polyesters such as XYDAR® (Amoco) or VECTRA® (Hoechst Celanese).
According to some embodiments, the bends comprise a shape memory polymer (SMP). Shape memory polymers include, but are not limited to meth-acrylates, polyurethanes, blends of polystyrene and polyurethane, and PVC. According to some embodiments, the bends of the catheter comprises a shape memory alloy (SMA). Non-limiting examples of shape memory alloys include nickel-titanium (i.e., nitinol).
Now referring to
In certain embodiments, first segment 100 of tube 1 may having an effective length (segment within the body) that lies substantially within the range of approximately 30 cm to approximately 70 cm, and second segment 200 of tube 1 may have an effective length that lies substantially within the range of approximately 4 cm to approximately 25 cm when used transfemorally for carotid bifurcation pathology. The tube 1 may include an outer diameter that lies substantially within the range of approximately 4 Fr to approximately 12 Fr for this application. The tube 1 additionally has at least one circumferential balloon 333 near (e.g., at or (generally) adjacent to) its distal end hole 405, which is optimized for atraumatic temporary occlusion of the common carotid artery during angioplasty and stenting, in order to create flow reversal across the lesion. The (primary working) lumen 2 of tube 1 includes an internal diameter sufficient to allow for the insertion and delivery of additional (e.g., supplemental) medical devices (such as balloons, hypotubes, wires, stents, etc.). The tube 1 may also include at least one additional lumen (e.g., the aforementioned irrigation lumen 5 (
Like the prior art described above, the current invention relies on flow reversal across the lesion during angioplasty and stenting to minimize the risks ofthromboembolic ischemic complications during the procedure. However, whereas the cited prior art relies on a carotid open surgical cut-down, the current invention optimally uses percutaneous techniques. The current invention additionally, in the preferred transfemoral embodiment, utilizes vascular fulcrums for support of the devices, to reduce potential complications and risks. Furthermore, as previously described by the inventor of this application (Walzman), the current device additionally optionally utilizes infusion of fluid distal to the lesion during the procedure to aid in flow reversal across the lesion, while minimizing a sump effect from the brain that can contribute to ischemic complications. In order to accomplish this, these embodiments of the current invention optimally utilize a hypotube capable of irrigation, in addition to its role as an access rail for balloons mounted on their delivery catheters as well as stents mounted on their respective delivery catheters, and/or additional balloon catheters capable of irrigation as well. In other embodiments the current invention may deploy an additional temporary balloon to occlude the vessel distally.
The current invention also in some embodiments utilizes angioplasty balloons on catheters that can also irrigate, and or additional irrigation catheters. Additionally, the current invention in some embodiments utilizes a double balloon catheter, wherein one balloon is optimized for angioplasty and at least one additional balloon is optimized for atraumatic temporary balloon occlusion of a vessel. In this way, an angioplasty balloon can be advanced over a wire, the wire optionally having an inner lumen and distal end and/or side holes for irrigation, and the angioplasty balloon can be inflated across the lesion to dilate the stenosis, and then deflated. The occlusion balloon can be proximal or distal to the angioplasty balloon; in the preferred embodiment it is proximal. To reduce the number of exchanges necessary during the procedure, each of which can increase risks, the balloon can then optionally be advanced past the lesion and not removed. The second balloon temporary occlusion balloon can then be inflated distal to the lesion, further decreasing the potential for a sump effect of blood flow from the brain during the procedure.
Additional fluids can then be infused through the double balloon catheter, with egress ports optionally both proximal and optionally distal to the occlusion balloon, to aid in flow reversal across the lesion proximally, and prevent clot formation distal to the occlusion balloon during balloon occlusion. The balloon, a conventional single angioplasty balloon, and/or the irrigation catheter 9300 (or hollow wire capable of irrigation) can further optionally have a detachable hub. The optional detachable hub can have pressure-mounted design or a threaded-screw design, or others.
Threaded screw designs can include a thread on the inside of the detachable hub and a corresponding opposite thread on the outside of the proximal end of the catheter, or alternatively the thread can be on the outside of the distal side of the hub and on the inside of the proximal end of the catheter. This removable hub (not shown) will allow these devices to be used as a rail (like a wire) to deliver additional catheters, such as an angioplasty balloon mounted catheter or a stent delivery catheter, both in an “over-the-wire” configuration and in a “rapid exchange” configuration, by allowing the additional catheters to be loaded over the proximal end of these catheters after the hub is detached. The catheters can additionally have in some embodiments valves in order to prevent deflation of a temporary occlusion balloon during hub detachment. The hub can be re-attached to allow continuation of fluid delivery and/or balloon deflation when desired.
All described catheters and wires can have tapered or non-tapered distal ends.
Stents can be self-expanding, balloon expanded, or a hybrid.
The current invention can include in some embodiments a plug or balloon to occlude the external carotid artery, to further ensure flow is reversed across the stenosis in the internal carotid artery during angioplasty and stenting. The plug or balloon can be mounted on a wire or catheter, can be detachable or non-detachable, can be retrievable or non-retrievable, and/or can be permanent or temporary. One example of a temporary detachable plug is a biodegradable hydrogel plug, which the body can recanalize.
In an embodiment, the device of the present invention further comprises at least one vascular plug, capable of obstructing collateral flow from a branch such as the external carotid artery. The plug is preferably located between at least one circumferential balloon and a vascular blockage to further ensure flow is reversed at the obstruction during angioplasty and stenting. It should be noted that in one embodiment, a patient's body will break down the plug and restore flow in a vascular branch over a set period of time.
Now referring to
Now referring to
Alternatively, venous sheath 9225 can be used in any vein of sufficient size. It should also be noted that the flow regulator 9226 can be any one previously disclosed by the prior art: a wheel on a ramp (like a standard), or can involve routing blood through a higher or lower resistance path. Alternatively, the regulator can be active, utilizing pumps, artificial pressure gradients, vacuums, or other mechanisms that can increase flow through a narrow path when desired, thereby allowing a smaller sized delivery catheter to still effect flow reversal during device delivery, thereby reducing potential for access site complications, and increasing available ports of entry.
In a still further embodiment, the disclosed medical device M further includes at least one of series of angioplasty balloons and/or stent delivery catheters with removable hubs and/or side ports. The series can be delivered over each other, such that a first delivery wire “rail” crosses a lesion. Then an angioplasty balloon is inflated, with flow reversed, optionally aided by active pumps or similar. As such, the current invention can have the hub and side port of the angioplasty balloon be removable. The method simply requires that the user advance the balloon, after angioplasty inflation and subsequent deflation, slightly past a target blockage. Then the user slides the next balloon catheter, or the stent catheter, over the balloon catheter. In the prior art, systems require exchanging the balloon catheter for another larger balloon or the stent. This maneuver enhances risk to patients; for example, the wire can move, the time for the procedure be increased, and/or an increased loss of blood can occur.
In some embodiments, the angioplasty balloon catheter is further capable of delivering fluid, which can be delivered distal to the blockage and/or across the blockage. Thereby, any potential “sump effect” of blood⋅flow diversion from the distal tissue is reduced, while flow is reversed across the blockage.
Referring now to
In an alternative embodiment, the present invention relates generally to endovascular devices and more particularly to specifically using a shaped support catheter and a hypotube in lieu of a wire to shape catheters. More particularly, the device uses hypotubes, and related elements to obviate the need for open surgical cutdowns of the common carotid artery (CCA) with a carotid stent, using a flow reversal loop system for embolic protection, while also employing a percutaneous technique and novel carotid access devices which use anatomical fulcrums for added support.
Additionally with respect to the embodiments in which one or more of the disclosed devices includes (or is configured as) a hypotube, the present invention combines direct carotid-artery access with rigorous blood flow-reversal, in order to protect the brain from embolic debris when introducing interventional devices into the carotid artery. Disclosed is a medical device capable of treating vascular blockages, more particularly a hypotube having at least one lumen extending from a proximal port to a distal end hole, capable of delivering additional medical devices, and at least one distal, circumferential balloon capable of temporary occlusion of native flow in a vessel near its distal end hole upon inflation. The disclosed hypotube is capable of delivering a second balloon for angioplasty, and at least one stent.
While other inventions of the inventor of the present application (Walzman) have disclosed the combined use of a wire for curving tubes, and a stent delivery catheter, the present invention discloses a hypotube to perform both of these functions. This configuration eliminates at least one element, thus simplifying the system/device/method, and reducing the possibility of failure. Additionally, by replacing the wire and delivery catheter with a hypotube, the hypotube will be smaller that the combination of those two, thus allowing access to smaller vessels.
As mentioned above, in certain embodiments, it is envisioned that the delivery catheter 8970 may be configured as (or may be replaced by) hypotube 8970i. For example, in
In an alternate embodiment,
In an alternate embodiment,
In
In the particular embodiment seen in
It should be appreciated that the side holes could be of different sizes⋅and/or shapes than those shown in the drawings. Different axial (longitudinal) and/or radial distances are also contemplated.
In the particular embodiment illustrated in
The balloon elements 334i, 334ii, 334iii are configured for selective, independent inflation (e.g., via separate inflation lumens 335i, 335ii, 335iii, respectively). In various methods of use, it is envisioned that one or more of the balloon elements 334 may be inflated to facilitate controlled deflection of the catheter C within the blood vessel V (FIG. IA). For example, inflation of the balloon 334i will deflect the catheter C in a (first) direction, inflation of the balloon 334ii will deflect the catheter C in a (second) direction, and inflation of the balloon 334iii will deflect the catheter C in a (third) direction. It is envisioned that one or more of the balloon elements 334i, 334ii, 334iii may be inflated simultaneously to facilitate deflection in a plurality of directions. It is also envisioned that each of the balloon elements 334i, 334ii, 334iii may be inflated simultaneously (e.g., to center the catheter C within the blood vessel.
In the particular embodiment seen in
It should be appreciated that the balloon elements could be of different sizes and/or shapes than those shown. Different axial (longitudinal) distances are also contemplated.
With reference now to
The single or multiple, e.g., staggered, balloons can be on the same catheter as the catheter having single or multiple, e.g., staggered, side holes or alternatively can be a separate outer catheter positioned over the catheter having the side holes(s).
During the course of an endovascular procedure, upon inserting and securing the catheter C within the blood vessel V (e.g., via inflation of one or more of the balloon element(s) 334), one or more supplemental medical (therapeutic) devices (e.g., the delivery catheter 8970 (
With reference now to
Initially, the catheter C is inserted into the patient's vasculature and is advanced therethrough (e.g., using fluoroscopy or any other suitable visualization method) until the side holes 370 are (generally) aligned with the vascular abnormality A. The catheter C is then secured using one or more of the balloon element(s) 334 (e.g., via the communication of fluid through the inflation lumens 335 (
During the particular procedure illustrated in
With reference now to
It is envisioned that the pull wire(s) 382 can fully or partially extend about the longitudinal axis X, i.e., extend 360 degrees, less than 360 degrees or greater than 360 degrees (more than one spiral). The pull wires can be fully or partially embedded in a wall of the catheter.
In some embodiments, the pull wire(s) 382 can be straight in part or most of the catheter C and substantially spiral in only part of its length. In some embodiments, the spiraling portion of the pull wire(s) 382 extends until at or near the distal end hole 405 of the catheter C. The spiraling of the pull wire(s) 382 can be configured so rotation occurs in a desired segment of the catheter C, for example, to rotate the orientation of the side hole(s) 370 as desired.
It is envisioned that the catheter C may define an overall length sufficient to allow for rotational deflection of the catheter C without any significant (substantial) kinking, binding, or other such undesirable deformation. For example, in certain embodiments, it is envisioned that the catheter C may define an overall length that lies substantially within the range of (approximately) 50 cm to (approximately) 170 cm. Overall lengths outside this range, however, would not be beyond the scope of the present disclosure. It is also envisioned that kinking, binding, and other such undesirable deformation may be inhibited (if not entirely prevented) by utilizing one or more flexible and/or resilient materials in construction of the catheter C.
It is envisioned that the pull wire(s) 382 may be secured (connected) to the catheter C in any suitable manner. For example, it is envisioned that the pull wire(s) 382 may be secured to an outer surface 384 of the catheter C or that the pull wire(s) 382 may extend through the delivery catheter 100 (e.g., within a corresponding (helical or partially helical) channel 386 formed in a wall 388 (outer wall) of the catheter C such that the pull wire(s) 382 are embedded within the catheter C).
Upon the application of a (pulling) force to the pull wire(s) 382, the catheter C experiences angular (torsional) deflection (displacement), whereby the catheter C rotates about the longitudinal axis X. The rotation facilitated by the torsional force applied to the catheter C via the pull wire(s) 382 allows for precise control over the rotational positions of the catheter C (e.g., the side hole(s) 370) and, thus, the supplemental medical (therapeutic) device(s) inserted therethrough (
To facilitate the application of force to the pull wire(s) 382, in certain embodiments, the catheter C may include (or may be connected to) one or more corresponding activating mechanisms 390 (e.g., such that the number of pull wires 382 corresponds to the number of activating mechanisms 390). The activating mechanism(s) 390 are connected to the pull wire(s) 382 and may include any structure or mechanism suitable for the intended purpose of applying torsional force thereto sufficient to cause rotation of the catheter C as necessary or desired, such as, for example, rotating wheels, pulley systems, ratchet mechanism, levers, or the like. In certain embodiments, it is envisioned that the activating mechanism(s) 390 and/or the pull wire(s) 382 may include one or more stop locks (or other such structures) to maintain the rotational position(s) of the pull wire(s) 382 and the catheter C.
In certain embodiments of the disclosure, it is also envisioned that the activating mechanism(s) 390 may be omitted, and that force may be manually applied to the pull wire(s) 382 to facilitate rotation of the catheter C.
In the embodiment illustrated in
It is envisioned that the pull wires 382i, 382ii may be connected to the catheter C in any suitable locations. For example, to facilitate rotation in (generally) opposing directions 1, 2, it is envisioned that the pull wires 382i, 382ii may be connected to the catheter C at respective connection points 392i, 392ii that are positioned in (generally) diametric opposition.
In the particular embodiment illustrated in
Further details of the torsional wires are disclosed in application Ser. No. 17/214,021, filed Mar. 26, 2021, the entire contents of which are incorporated herein by reference.
Although pull wires are disclosed herein for the steerable bendable segment(s) and for changing the rotational position of the catheter (torsional wires), it is also contemplated that push wires could alternatively be provided such that pushing of the wire bends the steerable segment and/or pushing of the wire changes the rotational position of the catheter. The various medical devices (e.g., catheters, stents, hypotubes, guide wires, etc.) and procedures described herein may be utilized (combined) with the multiple circumferential balloon catheter previously described by Walzman (US 2020/10,543,015) to facilitate additional precision when orientating a delivery catheter in a desired (rotational) orientation within a blood vessel (e.g., at or adjacent to an aneurysm or the neck of an aneurysm).
It is envisioned that the various devices described herein may (optionally) include one or more steerable segments that are deflectable via one or more pull wires that extend fully or partially embedded within the wall of the device to (facilitate insertion, removal, and/or increased precision in the placement of the device). While the following discussion is provided in the context of the catheter 1100, it should be appreciated that the principles, elements, and structures described herein below may be incorporated into any of the devices described herein (e.g., the hypotube, the primary delivery catheter, the delivery device, the balloon catheter, the secondary delivery device the secondary delivery catheter, etc.).
With reference now to
In the particular embodiment shown, each active segment 1122a is connected to a corresponding (single) pull wire 1124 that extends through (e.g., within) the body 1102 of the catheter 1100 (e.g., within an outer wall 1126 thereof) such that pull wires 1124 correspond in number to the active segments 1122a and extend in (generally) parallel relation to the longitudinal axis X of the catheter 1100. Upon the application of an axial (pulling) force to each of the pull wires 1124, the corresponding active segment 1122a is deflected (articulated) to thereby reconfigure (actively steer) the catheter 1100 between a first (initial, normal) configuration (
The use of a single pull wire 1124 in connection with each active segment 1122a reduces the requisite number of pull wires 1124, thus reducing complexity in both construction and operation of the catheter 1100. It is also envisioned that multiple, independently movable pull wires 1124 may be included in other embodiments. In the particular embodiment illustrated, each pull wire 1124 is received within a corresponding channel 1128 (
To facilitate the application of axial force to the pull wires 1124, in certain embodiments, the delivery catheter 1100 may include (or may be connected to) a plurality of corresponding (first) activating mechanisms 1130 (e.g., such that the number of pull wires 1124 corresponds to the number of activating mechanisms 1130). In the particular embodiment illustrated, the catheter 1100 includes a (first) activating mechanism 1130i that is connected to the pull wire 1124i and a (second) activating mechanism 1130ii that is connected to the pull wire 1124ii. The activating mechanisms 1130 may include any structure or mechanism suitable for the intended purpose of applying the axial force to the pull wires 1124 required to deflect the catheter 1100 as necessary or desired, such as, for example, rotating wheels, pulley systems, ratchet mechanism, levers, or the like. In certain embodiments, it is envisioned that the activating mechanism(s) 1130 and/or the pull wires 1124 may include one or more stop locks (or other such structures) to maintain the position(s) of the pull wires 1124 and the corresponding segments 1122.
In certain embodiments of the disclosure, it is also envisioned that the activating mechanism(s) 1130 may be omitted and that force may be manually applied to the pull wires 1124 to facilitate articulation of the delivery catheter 1100.
In certain embodiments, it is envisioned that the active segments 1122a, the pull wires 1124, and the activating mechanisms 1130 may be configured (and connected) such that each pull wire 1124 may be individually acted upon to deflect (steer) the corresponding segment 1122a in a single direction only. In other embodiments, it is envisioned that pull wires 1124 may be provided on various circumferential surfaces of the delivery catheter 1100 to facilitate steering in various directions.
In the particular embodiment illustrated, the catheter 1100 includes a first inactive segment 1122il; a first active segment 1122al that is located distally of the segment 1122il; a second inactive segment 12212 that is located distally of the segment 1122al; and a second active segment 1122a2 that is located distally of the segment 112212. Additionally, the catheter 1100 includes respective first and second pull wires 1124i, 1124ii that are located within the channel 1128 (
The pull wires 1124i, 1124ii are connected to the segments 1122al, 1122a2 at connection points 1132i, 1132ii (in addition to the activating mechanism 1130i, 1130ii), respectively, so as to facilitate reconfiguration of the catheter 1100 between the first configuration (
In the particular embodiment illustrated, the connection points 1132i, 1132ii are shown as being in (general) angular alignment (e.g., along a circumference of the catheter 100), which facilitates deflection of the segments 1122al, 1122a2 in similar (e.g., identical) directions, as seen in
It is also envisioned that the delivery catheter 100 may include one or more (second) pull wires that are connected (secured, anchored) to the catheter, which may either supplement or replace the pull wire(s) 124 (
It is envisioned that the pull wires for rotation disclosed herein can fully or partially extend about the longitudinal axis X, i.e., extend 360 degrees, less than 360 degrees or greater than 360 degrees (more than one spiral).
In some embodiments, the pull wires can be straight in part or most of the device and spiral or substantially spiral (wound substantially helically) in only part of its length. In some embodiments, the substantially spiraling (substantially helical winding) portion of the pull wires extends until at or near the distal end of the device. The substantially spiraling (substantially helical winding) of the wires can be configured so rotation occurs in a desired segment of the device, for example, to rotate the orientation of the distal end hole as desired. In accordance with one method of the present invention, a catheter with at least two independent steerable zones (bendable segments), with each steer zone controlled by at least one wire positioned substantially in the wall of the catheter is utilized. In a preferred embodiment, both zones steer to bend the catheter in the same direction. The method includes a) introducing the primary catheter via a percutaneous technique, over a wire, in a right radial artery; b) then advancing the primary catheter over a wire separately into the right subclavian artery; c) from where, advancing an inner catheter into the right vertebral artery, into the innominate artery, and from where, the wire can be withdrawn proximally so the distal steer zone can be used to steer the tip of the primary catheter into the right common carotid artery. The inner catheter can then be advanced as desired selectively (separately) into the right internal carotid artery and/or right external carotid artery. Next, the inner catheter and wire are withdrawn, unbending the primary catheter, and the primary catheter is advanced over a wire (or without a wire) into the aortic arch. The wire (if used) is next withdrawn from the inner primary catheter and repositioning via steering of a distal steer zone so the distal end is engaged in the proximal left common carotid artery. An inner catheter can then be advanced as desired selectively (separately) into the left internal carotid artery and/or left external carotid artery. If a wire is used, alternatively or additionally the inner catheter and wire are withdrawn, unbending the primary catheter, and then advancing the primary catheter over a wire (or without a wire) into the aortic arch, withdrawing the wire (if used) from the primary catheter and repositioning via steering of a distal steer zone so the distal end is engaged in the proximal left subclavian artery. The inner catheter can then be advanced as desired selectively (separately) into the left vertebral artery.
In these methods, the torsional wire(s) e.g., spiral wire(s), (if provided) attached at a distal portion of the catheter can be pulled or pushed to rotate a distal segment of the catheter. In addition or in lieu of the torsional wire(s), a wire(s) attached to bending/steering segments of the catheter can be pushed or pulled to bend/steer a segment of the catheter.
In these methods, the delivery catheter can have one or more side holes in a catheter segment that rotates to place the side hole at a desired orientation relative to a lesion or a vessel to facilitate the delivery of additional catheters and/or devices through the side hole. The delivery catheter can have structure, e.g., bends, to further provide support to the additional catheters and/or devices to prevent kickback and unwanted prolapse of the catheters and/or devices during delivery.
While the present invention has been described with reference to the specific embodiments thereof it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adopt a particular situation, material, composition of matter, process, process step or steps, to the objective spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, exemplary methods and materials have been described.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “and”, and “the” include plural references unless the context clearly dictates otherwise.
Although the apparatus and methods of the subject invention have been described with respect to preferred embodiments, which constitute non-limiting examples, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present invention as defined by the appended claims.
Additionally, persons skilled in the art will understand that the elements and features shown or described in connection with one embodiment may be combined with those of another embodiment without departing from the scope of the present disclosure and will appreciate further features and advantages of the presently disclosed subject matter based on the description provided.
Throughout the present disclosure, terms such as “approximately,” “generally,” “substantially,” and the like should be understood to allow for variations in any numerical range or concept with which they are associated. For example, it is intended that the use of terms such as “approximately” and “generally” should be understood to encompass variations on the order of 25%, or to allow for manufacturing tolerances and/or deviations in design.
Although terms such as “first,” “second,” “third,” etc., may be used herein to describe various operations, elements, components, regions, and/or sections, these operations, elements, components, regions, and/or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section could be termed a second operation, element, component, region, or section without departing from the scope of the present disclosure.
Each and every claim is incorporated as further disclosure into the specification and represents embodiments of the present disclosure. Also, the phrases “at least one of A, B, and C” and “A and/or B and/or C” should each be interpreted to include only A, only B, only C, or any combination of A, B, and C.
This application claims the benefit of U.S. Provisional Application No. 63/209,357, filed on Jun. 10, 2021, and is a continuation-in-part of U.S. patent application Ser. No. 17/214,021, filed on Mar. 26, 2021, which claims the benefit of U.S. Provisional Application No. 63/109,387 filed on Nov. 4, 2020. The entire contents of each of these applications are incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/031231 | 5/27/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63209357 | Jun 2021 | US |
