VESSEL ACCESS CATHETER
20230073895 · 2023-03-09
Inventors
Cpc classification
A61M2025/1047
HUMAN NECESSITIES
A61F2/95
HUMAN NECESSITIES
A61F2/958
HUMAN NECESSITIES
A61F2230/0013
HUMAN NECESSITIES
A61F2/966
HUMAN NECESSITIES
A61F2210/0014
HUMAN NECESSITIES
A61M25/007
HUMAN NECESSITIES
A61F2002/061
HUMAN NECESSITIES
A61F2/82
HUMAN NECESSITIES
International classification
A61F2/82
HUMAN NECESSITIES
Abstract
The described invention provides an endovascular device comprising a tube comprising at least one side-hole, a first segment comprising a primary opening and a second segment. The side-hole and the first segment form a working lumen. The second segment forms a support lumen where the support lumen is curved to effect: (i) to provide stability to the working lumen of the endovascular device; (ii) to anchor the endovascular device within a blood vessel; (iii) to prevent kickback by resting on an arched anatomical structure; and (iv) to facilitate placement of a second endovascular device distally.
Claims
1. An endovascular device comprising a tube comprising a) a side-hole segment comprising a plurality of side-holes; b) a first segment comprising a primary opening; and c) a second segment comprising an end, wherein said plurality of side-holes comprise a first side-hole that is the side-hole most proximal to the proximal end of said tube and said first side-hole having a proximal side and a distal side; and a second side-hole that is the side-hole most distal to the distal end of said tube and said second side-hole having a proximal side and a distal side; said first segment extends from said primary opening to the proximal side of said first side-hole; said second segment extends from the distal side of said second side-hole and tapers externally to an end hole; said side-hole segment extends from the proximal side of said first side-hole to the distal side of said second side-hole; said side-hole segment and said first segment form a working lumen; and said second segment forms a support lumen, wherein said support lumen is curved to effect i) to provide stability to said working lumen of said endovascular device; ii) to anchor said endovascular device within a blood vessel; iii) to prevent kickback by resting on an arched anatomical structure; and iv) to facilitate placement of one or more additional endovascular devices distally.
2. The endovascular device according to claim 1, wherein the plurality of side-holes are either along the same length of said tube, at different circumferential locations or staggered at different lengths along said tube.
3. (canceled)
4. The endovascular device according to claim 1, wherein the plurality of side-holes are staggered at different lengths along either the same circumferential location of said tube various circumferential locations of said tube wherein some of the plurality of side-holes are staggered at different lengths along said tube and some of the plurality of side-holes are along the same length of said tube.
5. (canceled)
6. (canceled)
7. The endovascular device according to claim 1, wherein the plurality of side-holes are along partially overlapping lengths of said tube, along varying circumferential locations.
8. The endovascular device according to claim 1, wherein each of the plurality of side-holes does not have a side-hole directly across from it.
9. The endovascular device according to claim 1, wherein the one or more additional endovascular devices comprises a catheter, a wire, a therapeutic balloon, an embolic device, a therapeutic stent or a combination thereof.
10. The endovascular device according to claim 1, wherein said endovascular device further comprises an angled extension at one of said plurality of side-holes wherein the angle of said angled extension ranges from approximately 10 degrees to approximately 180 degrees.
11. (canceled)
12. (canceled)
13. The endovascular device according to claim 1, wherein said working lumen is a conduit through which the one or more additional endovascular devices is advanced into a blood vessel.
14. The endovascular device according to claim 1, wherein the tube contains a bend between the first and the second segments to assist in anchoring the endovascular device.
15. The endovascular device according to claim 1, wherein the endovascular device comprises an actively adjustable angled extension extending from one of said plurality of side-holes serving to facilitate steering of said one or more additional devices into said blood vessel.
16. The endovascular device according to claim 1, wherein the end of said second segment is circular in cross-section having an internal diameter of the ranging from about 0.0020 cm (0.0008 inches) to about 23 Fr (0.3018 inches).
17. (canceled)
18. The endovascular device according to claim 1, wherein said support lumen is of an ‘S’ shape.
19. (canceled)
20. The endovascular device according to claim 1, wherein said endovascular device further comprises at least one balloon disposed thereon, and said device has an intravascular portion with a wall of said device that has at least one additional lumen substantially within the wall that serves solely to inflate and deflate said at least one balloon, the wall having a distal end and a proximal end with a plurality of wires substantially within the wall that spiral along said intravascular portion, wherein the distal end of said plurality of wires are affixed towards the distal end of the wall and wherein the proximal end of said plurality of wires are affixed at or near the primary open to a mechanism for pulling said plurality of wires, thereby rotating said intravascular portion of said device.
21. (canceled)
22. The endovascular device according to claim 20, wherein said mechanism for pulling said plurality of wires is a wheel.
23. The endovascular device according to claim 20, wherein said mechanism for pulling said plurality of wires is a lever.
24.-50. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0094]
[0095]
[0096]
[0097]
[0098]
[0099]
[0100]
[0101]
[0102]
[0103]
[0104]
[0105]
[0106]
[0107]
[0108]
[0109]
DETAILED DESCRIPTION OF THE INVENTION
Glossary
[0110] The term “ablation” refers to a procedure that uses radiofrequency energy (e.g., microwave heat) to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue restores the hearts regular rhythm. The procedure is also called radiofrequency ablation.
[0111] The terms “acute angle” and “acute angulation” are used interchangeably to refer to a sharp, obstructive or abnormal angle or bend (e.g., less than 90 degrees) in an organ, artery, vessel, etc.
Anatomical Terms
[0112] When referring to animals that typically have one end with a head and mouth, with the opposite end often having the anus and tail, the head end is referred to as the cranial end, while the tail end is referred to as the caudal end. Within the head itself, rostral refers to the direction toward the end of the nose, and caudal refers to the tail direction. The surface or side of an animal's body that is normally oriented upwards, away from the pull of gravity, is the dorsal side; the opposite side, typically the one closest to the ground when walking on all legs, swimming or flying, is the ventral side. On the limbs or other appendages, a point closer to the main body is “proximal”: a point farther away is “distal”. Three basic reference planes are used in zoological anatomy. A “sagittal” plane divides the body into left and right portions. The “midsagittal” plane is in the midline, i.e. it would pass through midline structures such as the spine, and all other sagittal planes are parallel to it. A “coronal” plane divides the body into dorsal and ventral portions. A “transverse” plane divides the body into cranial and caudal portions.
[0113] When referring to humans, the body and its parts are always described using the assumption that the body is standing upright. Portions of the body that are closer to the head end are “superior” (corresponding to cranial in animals), while those farther away are “inferior” (corresponding to caudal in animals). Objects near the front of the body are referred to as “anterior” (corresponding to ventral in animals); those near the rear of the body are referred to as “posterior” (corresponding to dorsal in animals). A transverse, axial, or horizontal plane is an X-Y plane, parallel to the ground, which separates the superior/head from the inferior/feet. A coronal or frontal plane is a Y-Z plane, perpendicular to the ground, which separates the anterior from the posterior. A sagittal plane is an X-Z plane, perpendicular to the ground and to the coronal plane, which separates left from right. The midsagittal plane is the specific sagittal plane that is exactly in the middle of the body.
[0114] Structures near the midline are called medial and those near the sides of animals are called lateral. Therefore, medial structures are closer to the midsagittal plane, lateral structures are further from the midsagittal plane. Structures in the midline of the body are median. For example, the tip of a human subject's nose is in the median line.
[0115] Ipsilateral means on the same side, contralateral means on the other side and bilateral means on both sides. Structures that are close to the center of the body are proximal or central, while ones more distant are distal or peripheral. For example, the hands are at the distal end of the arms, while the shoulders are at the proximal ends.
[0116] The terms “anomaly”. “variation”, “abnormality” and “aberration” refer interchangeably to a deviation from what is standard, normal or expected. For example, “bovine arch variation” is an anatomical deviation from the most common aortic arch branching pattern in humans. As an additional example, an anomaly can occur in a blood vessel having tortuosity.
[0117] The term “aneurysm” refers to a localized widening (dilatation) of an artery, a vein, or the heart. At the point of an aneurysm, there is typically a bulge, where the wall of the blood vessel or organ is weakened and may rupture.
[0118] Blood flow in most aneurysms is regular and predictable primarily according to the geometric relationship between the aneurysm and its parent artery. As blood flows within the parent artery with an aneurysm, divergence of blood flow, as occurs at the inlet of the aneurysm, leads to dynamic disturbances, producing increased lateral pressure and retrograde vortices that are easily converted to turbulence. Blood flow proceeds from the parent vessel into the aneurysm at the distal or downstream extent of the aneurysm neck (i.e., the transition from the sac to the parent artery), circulates around the periphery along the aneurysm wall from the neck to the top of the fundus (i.e., aneurysm sac) (downstream to upstream), returning in a type of “isotropic shower” along the aneurysm wall toward the neck region, and exits the closest extent of the aneurysm neck into the parent vessel (See, e.g., Strother C. M. Neuroradiology 1994; 36: 530-536; Moulder P. V. Physiology and biomechanics of aneurysms. In: Kerstein M D, Moulder P V. Webb W R. eds. Aneurysms. Baltimore, Md.; Williams & Wilkins; 1983:20).
[0119] As flow persists, areas of stagnation or vortices develop within a central zone of the aneurysm. These rotating vortices, formed at the entrance to the aneurysm at each systole (i.e., ventricle contraction) and then circulated around the aneurysm, are caused by the slipstreams or regions of recirculating flow rolling upon themselves when they enter the aneurysm at its downstream wall during systole. The stagnant vortex zone occurs in the center and at the fundus or upper portion of the aneurysm and becomes more pronounced in larger aneurysms. It is this stagnant zone that is believed to promote the formation of thrombi or blood clots, particularly in giant aneurysms (See, e.g., Gobin Y. P. et al. Neuroradiology 1994; 36: 530-536: Hademenos G. J. and Massoud T. F. Stroke 1997; 28: 2067-2077).
[0120] The term “abdominal aortic aneurysm” or “AAA” refers to an aortic diameter at least one and one-half times the normal diameter at the level of the renal arteries, which is approximately 2.0 cm. Generally, an abdominal aorta segment greater than 3.0 cm in diameter is considered an aortic aneurysm. Aortic aneurysms constitute the 14.sup.th leading cause of death in the US. Risk factors associated with AAA include age, sex, ethnicity, smoking, hypertension and atherosclerosis, among others (See, e.g., Aggarwal S. et al. Exp Clin Cardiol. 2011; 16(1):11-15: Ouriel K. et al J Vase Surg. 1992; 15:12-18: Silverberg E. et al. CA Cancer J Clin. 1990; 40:9-26).
[0121] The term “arteriovenous malformation” (“AVM”) refers to a tangle of abnormal and poorly formed blood vessels (e.g., arteries and veins) which have a higher than normal rate of bleeding compared to normal blood vessels.
[0122] AVMs are congenital vascular lesions that occur as a result of capillary mal-development between the arterial and venous systems. Approximately 0.14% of the United States population has an intracranial AVM that poses a significant risk and represents a major life threat, particularly to persons under the age of 50 years. The vessels constituting the AVM are weak and enlarged and serve as direct shunts for blood flow between the high-pressure arterial system and the low-pressure venous system, corresponding to a large pressure gradient and small vascular resistance. The abnormal low-resistance, high-flow shunting of blood within the brain AVM without an intervening capillary bed causes the fragile dilated vessels in the nidus (i.e., tangle of blood vessels) to become structurally abnormal and fatigued, to further enlarge, and to rupture (See, e.g., Wilkins R. H. Neurosurgery 1985; 16:421-430; Graves V. B. et at. Invest Radiol. 1990; 25: 952-960; Hademenos G. J. et al., Neurosurgery 1996; 38: 1005-1015).
[0123] The abnormal microvessels of an AVM serve as passive conduits for blood flow from the arterial circulation directly to the venous circulation, by-passing their normal physiological function of brain tissue perfusion. The hemodynamic consequences of an AVM occur as a result of two interdependent circulatory mechanisms involved in the shunting of blood between artery and vein (See, e.g., Hademenos and Massoud, supra).
[0124] In the normal cerebral circulation, blood flows under a high cerebrovascular resistance and high cerebral perfusion pressure. However, the presence of a brain AVM in the normal circulation introduces a second abnormal circuit of cerebral blood flow where the blood flow is continuously shunted under a high perfusion pressure through the AVM, possessing a low cerebrovascular resistance and low venous pressure. The clinical consequence of the abnormal shunt is a significant increase in blood returning to the heart (approximately 4 to 5 times the original amount, depending on the diameter and size of the shunt), resulting in a dangerous overload of the heart and cardiac failure. Volumetric blood flow through an AVM ranges from 200 mL/min to 800 mL/min and increases according to nidus size (See, e.g., Yamada S. Neurol Res. 1993; 15: 379-383).
[0125] The abnormal shunting of blood flow by brain AVMs rapidly removes or “steals” blood from the normal cerebral circulation and substantially reduces the volume of blood reaching the surrounding normal brain tissue. This phenomenon, known as cerebrovascular steal, depends on the size of the AVM and is the most plausible explanation for the development of progressive neurological deficits. Cerebrovascular steal could translate into additional neurological complications developed as a result of cerebral ischemia or stroke in neuronal territories adjacent to an AVM (See. e.g., Manchola I. F. et al. Neurosurgery 1993; 33: 556-562; Hademenos and Massoud, supra).
[0126] The term “atherectomy” refers to a minimally invasive endovascular surgery technique to remove atherosclerosis from blood vessels within the body by cutting plaque from the vessel walls.
[0127] The term “atherosclerosis” (also known as “hardening of the arteries”) refers to a pathological process in which calcified lipid or fatty deposits from flowing blood accumulate along the innermost intimal layer of a vessel wall. Atherosclerotic plaques are found almost exclusively at the outer wall of one or both daughter vessels at major arterial bifurcations, including the carotid. Atherosclerosis and the development of arterial plaques are the products of a host of independent biochemical processes including the oxidation of low-density lipoproteins, formation of fatty streaks, and the proliferation of smooth muscle cells. As the plaques form, the walls become thick, fibrotic, and calcified. As a result, the lumen narrows, reducing the flow of blood to the tissues supplied by the artery (See, e.g., Hademenos and Massoud, supra; Hademenos G. J. Am Scientist 1997; 85: 226-235; Woolf N., Davies M. J. Sci Am Science & Medicine 1994; 1: 38-47).
[0128] Atherosclerotic deposits promote the development of blood clots or the process of thrombosis, due in part, to flow obstruction and to high shear stresses exerted on the vessel wall by the blood. High wall shear stress mechanically damages the inner wall of the artery, initiating a lesion. Low wall shear stress encourages the deposition of particles on the artery wall, promoting the accumulation of plaque. Turbulence has also been implicated in atherosclerotic disease because it can increase the kinetic energy deposited in the vessel walls and because it can lead to areas of stasis, or stagnant blood flow, that promote dotting. The presence of atherosclerotic lesions introduces an irregular vessel surface, resulting in turbulent blood flow, thus causing the dislodgment of plaques of varying size into the bloodstream. Subsequently, the dislodged plaque lodges into a vessel of smaller size, preventing further passage of blood flow (See, e.g., Hademenos and Massoud, supra).
[0129] The term “atresia” refers to the absence or abnormal narrowing of an opening or passage in the body. For example, aortic atresia refers to a rare congenital anomaly in which the aortic orifice is absent or closed.
[0130] The term “atrial fibrillation” refers to an irregular and often fast heart rate, which may cause symptoms such as heart palpitations, fatigue, and shortness of breath. Atrial fibrillation weakens the cardiac wall and introduces abnormalities in the physiological function of the heartbeat, which ultimately result in reduced systemic pressure, conditions of ischemia and stroke.
[0131] The term “brachiocephalic trunk”, also known as “innominate artery” refers to a major vessel that supplies the head, neck and right arm. It is the first of three main branches of the aortic arch, which originates from the upward convexity. After arising in the midline, it courses upwards to the right, crossing the trachea, and bifurcates posteriorly to the right sternoclavicular joint into the right subclavian and right common carotid arteries. It typically measures 4-5 cm in length with a diameter of approximately 12 mm.
[0132] The term “brain aneurysm” refers to a cerebrovascular disease that manifests as a pouching or ballooning of the vessel wall (i.e., vascular dilation). The vascular dilatation develops at a diseased site along the arterial wall into a distended sac of stressed and thinned arterial tissue. The fully developed cerebral aneurysm typically ranges in size from a few millimeters to 15 mm but can attain sizes greater than 2.5 cm. If left untreated, the aneurysm may continue to expand until it ruptures, causing hemorrhage, severe neurological complications and deficits, and possibly death Hademenos and Massoud, supra; Hademenos G. J. Phys Today 1995; 48:24-30).
[0133] The two main treatment options for a patient suffering from a brain aneurysm are (i) surgical clipping; and (ii) endovascular coiling. Surgical clipping is an intracranial procedure in which a small metallic clip is placed along the neck of the aneurysm. The clip prevents blood from entering into the aneurysm sac so that it no longer poses a risk for bleeding. The clip remains in place, causing the aneurysm to shrink and permanently scar. Endovascular coiling is a minimally invasive technique in which a catheter is inserted into the femoral artery and navigated through the blood vessels to the brain vessels and into the aneurysm. Coils are then packed into the aneurysm to the point where it arises from the blood vessel, thus preventing blood flow from entering the aneurysm. Additional devices, such as a stent or balloon, may be needed to keep the coils in place.
[0134] The FDA recently approved the WEB® Embolization System (Microvention Inc., CA) as an alternative to treat intracranial aneurysms. The WEB® device is an intrasaccular flow disruptor for aneurysm embolization and is based on MICROBRAID™ technology, a dense mesh constructed from large numbers of extremely fine wires. When placed inside the aneurysm sac, the WEB® device's mesh bridges the aneurysm neck, disrupts blood flow, and creates a scaffold for enduring treatment.
[0135] The term “branch” refers to something that extends from or enters into a main body or source; a division or offshoot from a main stem (e.g., blood vessels); one of the primary divisions of a blood vessel.
[0136] The terms “coarctation” or “coarctation of the aorta” refer to a congenital narrowing of a short section of the aorta.
[0137] The terms “compound curves” and “multi-curves” are used interchangeably to refer to multiple deflection points along the length of a catheter. By way of example, two deflection points allow a catheter to be deflected into an ‘S’ shape or the shape of a shepherd's hook.
[0138] The term “curve diameter” refers to the furthest distance a catheter moves from its straight axis as it is being deflected. The curve diameter does not always remain constant during deflection and does not necessarily indicate the location of the catheter tip.
[0139] The term “dilator” refers to a long, tapered device adapted stretch an opening in skin and/or to stretch a blood vessel to allow for insertion of a larger device, e.g., a sheath, catheter, etc.
[0140] The term “distal” refers to the state of being situated away from the interface or entry point of the device of the current invention and the patient.
[0141] The term “deflection” refers to movement of a catheter tip independent of the rest of the catheter.
[0142] The term “dyscrasia” refers to an abnormal or disordered state of the body or a bodily part. The term “blood dyscrasia” refers to an abnormally of blood cells or of clotting elements.
[0143] The term “embolus” (plural “emboli”) refers to a gaseous or particulate matter that acts as a traveling “clot”. A common example of an embolus is a platelet aggregate dislodged from an atherosclerotic lesion. The dislodged platelet aggregate is transported by the bloodstream through the cerebrovasculature until it reaches a vessel too small for further propagation. The clot remains there, clogging the vessel and preventing blood flow from entering the distal vasculature. Emboli can originate from distant sources such as the heart, lungs, and peripheral circulation, which could eventually travel within the cerebral blood vessels, obstructing flow and causing stroke. Other sources of emboli include atrial fibrillation and valvular disease. The severity of stroke depends on the embolus size and the obstruction location. The bigger the embolus and the larger the vessel obstruction, the larger the territory of brain at risk (Hademenos and Massoud, supra).
[0144] The term “endoluminal” refers to the state of being within a tubular organ or structure (e.g., blood vessel, duct, gastrointestinal tract, etc.) or within a lumen. The term “lumen” refers to the inner open space or cavity of a tubular structure.
[0145] The term “French” (abbreviated “Fr” or “F” or “Fg” or “Ga” or “CH” or “Ch”) is a system used to measure the diameter of a catheter. The French unit of measure is equivalent to three times the diameter in millimeters (mm). For example, 9 Fr is equivalent to a diameter of 3 mm.
[0146] The term “grips” refers to a part or attachment by which a device is held in the hand.
[0147] The term “hemorrhage” refers to the escape of blood from a ruptured blood vessel.
[0148] Blood vessels are typically structurally adept to withstand the dynamic quantities required to maintain circulatory function. For reasons that are not entirely understood, the vessel wall can become fatigued and abnormally weak and possibly rupture. With vessel rupture, hemorrhage occurs with blood seeping into the surrounding brain tissue. As blood accumulates within the brain, the displaced volume causes the blood, now thrombosed, to ultimately compress the surrounding vessels. The compression of vessels translates into a reduced vessel diameter and a corresponding reduction in flow to surrounding tissue, thereby enlarging the insult (See, e.g., Hademenos and Massoud, supra).
[0149] In the brain, hemorrhage may occur at the brain surface (extraparenchymal), for example, from the rupture of congenital aneurysms at the circle of Willis, causing subarachnoid hemorrhage (SAH). Hemorrhage also may be intraparenchymal, for example, from rupture of vessels damaged by long-standing hypertension, and may cause a blood clot (intracerebral hematoma) within the cerebral hemispheres, in the brain stem, or in the cerebellum. Hemorrhage may be accompanied by ischemia or infarction. The mass effect of an intracerebral hematoma may compromise the blood supply of adjacent brain tissue; or SAH may cause reactive vasospasm of cerebral surface vessels, leading to further ischemic brain damage. Infarcted tissue may also become secondarily hemorrhagic. Among vascular lesions that can lead to hemorrhagic strokes are aneurysms and arteriovenous malformations (AVMs) (See, e.g., Hademenos and Massoud, supra).
[0150] The term “hypoplasia” refers to a condition of arrested development in which an organ or other body part remains below the normal size or in an immature state, usually due to a deficiency in the number of cells; atrophy due to destruction of some of the elements and not merely to their general reduction in size.
[0151] The term “introducer” refers to an instrument such as a tube or a sheath that is placed within a vein or artery for introduction of a flexible device, for example, a catheter, needle, wire, etc.
[0152] The terms “ischemic” and “ischemia” refer to deficient blood supply to a body part generally due to obstruction of the inflow of arterial blood (e.g., by narrowing of arteries, spasm or disease).
[0153] The term “kickback” refers to the phenomenon of catheter coil prolapse (slipping forward or down) due to a counterforce against the catheter by the prolapsed coil tail. The counterforce may be due to a lack of available space to insert the last coil. This lack of space may be the result of, for example, a blood vessel variation such as a bovine arch variation, a vertebral artery variation, a thrombus, an embolus, an arteriovenous malformation and the like.
[0154] The term “myocardial infarction” refers to death of cells of an area of heart muscle as a result of oxygen deprivation, which in turn is caused by obstruction of the blood supply; commonly referred to as a “heart attack.” The most common cause is thrombosis of an atherosclerotic coronary artery or a spasm. Less common causes include coronary artery abnormalities and vasculitis (inflammation of blood vessels).
[0155] The term “recanalization” refers to the process of restoring flow to or reuniting an interrupted channel of a bodily tube (e.g., a blood vessel).
[0156] The term “reperfusion” refers to restoration of blood flow to a previously ischemic organ or tissue (e.g., heart or brain).
[0157] The term “restenosis” refers to the recurrence of abnormal narrowing of a blood vessel (e.g., artery or vein) or valve.
[0158] The term “steerability” refers to an ability to turn or rotate the distal end of a catheter with like-for-like movement of the proximal section or the catheter handle.
[0159] The term “stroke” or “cerebrovascular accident” refers to neurological signs and symptoms, usually focal and acute, which result from diseases involving blood vessels. Strokes are either occlusive (due to a blood vessel closure) or hemorrhagic (due to bleeding from a vessel). Although most occlusive strokes are due to atherosclerosis and thrombosis, and most hemorrhagic strokes are associated with hypertension or aneurysms, strokes of either type may occur at any age from many causes, including cardiac disease, trauma, infection, neoplasm, blood dyscrasia, vascular malformation, immunological disorder, and exogenous toxins. An ischemia stroke results from a lack of blood supply and oxygen to the brain that occurs when reduced perfusion pressure distal to an abnormal narrowing (stenosis) of a blood vessel is not compensated by autoregulatory dilation of the resistance vessels. When ischemia is sufficiently severe and prolonged, neurons and other cellular elements die. This condition is referred to as “infarction” (See, e.g., Hart R. G. et al., Stroke 1990; 21:1111-1121). Although the consequences of both ischemic and hemorrhagic stroke are similar (i.e., vessel obstruction, resultant reduced blood flow to the brain, neurological deficits and possibly death), the biophysical and hemodynamic mechanisms behind blood flow obstruction are different. Biophysical mechanisms for development of obstructions that ultimately lead to stroke can arise by six distinct processes: atherosclerosis, embolus, thrombus, reduced systemic pressure, hemorrhage, and vasospasm (See, e.g., Hademenos and Massoud, supra).
[0160] The term “taper” refers to a reduction of thickness toward one end; the gradual diminution of width or thickness in an elongated object, i.e. to become more slender toward one end.
[0161] The term “thrombectomy” refers to the surgical excision of a thrombus.
[0162] The term “thrombus” refers to an internal physiological mechanism responsible for blood clotting. A thrombus is a blood clot, an aggregation of platelets and fibrin formed in response either to an atherosclerotic lesion or to vessel injury. In response to vessel or tissue injury, the blood coagulation system is activated, which initiates a cascade of processes, transforming prothrombin, ultimately resulting in a fibrin clot (See, e.g., Hademenos and Massoud, supra).
[0163] Although a host of mechanisms and causes are responsible for vessel injury, vessel injury can occur as a result of forces (e.g., shear stresses) coupled with excess energy created by the turbulent flow exerted against the inner (intimal) lining of the vessel wall, particularly an atherosclerotic vessel wall (See, e.g., Fry D. L. Circ Res. 1968: 22:165-197; Stein P. D. and Sabbah H. N. Circ Res. 1974; 35:608-614; Mustard J. F. et al. Am J Med. 1962; 33:621-647; Goldsmith H. L. et al. Thromb Haemost 1986; 55:415-435).
[0164] The term “tortuosity” and other grammatical forms of the term “tortuous” refer to a tube, passage or blood vessel (e.g., an artery or vein) being twisted, crooked or having many turns.
[0165] The term “vasospasm” refers to sudden constriction of a blood vessel, reducing its diameter and flow rate. When bleeding occurs in the subarachnoid space, the arteries in the subarachnoid space can become spastic with a muscular contraction, known as cerebral vasospasm. The contraction from vasospasm can produce a focal constriction of sufficient severity to cause total occlusion. The length of time that the vessel is contracted during vasospasm varies from hours to days. However, regardless of the duration of vessel constriction, reduction of blood flow induces cerebral ischemia, thought to be reversible within the first 6 hours and irreversible thereafter. It has been shown that vasospasm is maximal between 5 and 10 days after subarachnoid hemorrhage and can occur up to 2 weeks after subarachnoid hemorrhage (See, e.g., Wilkins R. H. Contemp Neurosurg. 1988; 10:1-66; Hademenos and Massoud, supra).
[0166] In the various views of drawings, like reference characters designate like or similar parts.
[0167]
[0168] In some embodiments, distal support segment 195 and/or working segment 120 is rigid. In some embodiments, distal support segment 195 and/or working segment 120 has a soft, flexible part.
[0169] In some embodiments, endovascular device 100 is an intracranial endovascular device. In some embodiments, the endovascular device is a peripheral blood vessel endovascular device. In some embodiments, the endovascular device is a cardiac blood vessel endovascular device.
[0170] Preferred embodiments do not use pre-formed, curved configurations to keep the catheter in place. Different pre-formed curved configurations are required for different target areas. Not using pre-formed curved configurations facilitates positioning and increases flexibility of use due to the ability to use the same configuration for different target areas.
[0171]
[0172] In some embodiments, at least part of first segment 320 and/or second segment 330 of the endovascular device in
[0173] In some embodiments, second segment 330 extends from side-hole 310 and tapers externally to end hole 350 and maintains a constant inner lumen diameter that does not substantially decrease at a distal end. In these embodiments, a second segment 330 inner lumen with a diameter that does not substantially decrease enhances the anchoring properties of second segment 330 and will press more readily against the blood vessel walls at bends in the blood vessel.
[0174] In some embodiments, second segment 330 has an inner lumen circular in cross section. In some embodiments, second segment 330 has an inner lumen oval in cross section. In some embodiments, second segment 330 has an inner lumen flattened in cross section. In some embodiments, second segment 330 maintains a constant inner lumen diameter. In some embodiments, second segment 330 has an inner lumen diameter that varies along the course of the endovascular device.
[0175] In some embodiments, working segment 380 from between side-hole 310 and first segment 320 ranges in length from about 20 cm to about 160 cm. In some embodiments, lumen 370 in the working segment of the endovascular device has an inner diameter (ID) that ranges from about 0.1 French (Fr) (0.001 inches) to about 30 French (Fr) (0.394 inches). In some embodiments, lumen 370 of first segment 320 is less than 1 Fr in diameter. In some embodiments, lumen 370 of second segment 330 ranges in diameter from about 0.1 Fr to at least 30 Fr.
[0176] In some embodiments, support segment 390 of endovascular device 300 for intracranial applications ranges in length from about 0.01% to about 20% of the length of working segment 380. For example, in some embodiments, support segment 390 of the endovascular device for intracerebral applications ranges in length from about 0.05 cm to about 32 cm.
[0177] In some embodiments, support segment 390 of the endovascular device for peripheral applications ranges in length from about 0.01% to about 200% the length of working segment 380. For example, in some embodiments, support segment 390 of the endovascular device for peripheral applications ranges in length from about 0.05 cm to about 320 cm. In some embodiments, second segment 330 ranges from about 0.6 cm to about 200 cm in length from side-hole 310.
[0178] In some embodiments, the end 350 is open. In some embodiments, end 350 is closed.
[0179] In some embodiments, endovascular device 300 is the inner catheter of endovascular device 1400 described below.
[0180] In some embodiments, endovascular device 1400 includes an outer support catheter 1440 and an inner catheter 1460 disposed at least partially within the lumen defined by outer support catheter 1440 (See, e.g.,
[0181] In some embodiments, the support segment is used to anchor/support a wire and/or microcatheter to access a branch vessel arising at a difficult angle. This is especially common with branches feeding AVM's. With conventional techniques, the wire or catheter will herniate out of the branch and into the distal parent vessel as it is advanced, especially when additional bends/curves of the branch vessel are encountered.
[0182]
[0183] In some embodiments, one or more radiopaque markers are used to identify the position of the working distal side-hole. In some embodiments, intravascular ultrasound (IVUS) can be incorporated into the catheter to help identify the position of the working side-hole relative to a lesion such as an aneurysm, a vessel or other targeted anatomy.
[0184] In some embodiments, grips are connected to the inner and outer catheters. In some such embodiments, inner catheter 1460 is connected to grips on inner catheter 1431 at the proximal end of the endovascular device (
[0185] In some embodiments, endovascular device 1400 has one or two sets of grips 1430 at the first (proximal) end of the device (
[0186] In some embodiments, inner catheter 1460 of endovascular device 1400 is endovascular device 100 or endovascular device 300. While endovascular device 100 would allow for more support, it would be bulkier and may be more difficult to rotate than endovascular device 300.
[0187] It should be understood that the inner/outer catheter arrangement with grips as described above and shown in
[0188] Many catheters flexible enough to deliver devices intracranially are not stiff enough for proximal rotation at the catheter hub outside the body to result in the intracranial portion rotating-rather, the catheter shaft will twist into an unusable spiral.
[0189] One solution to this problem is to provide spiral “pulley” wires or cables within the catheter wall that are attached proximally to a wheel or similar device (without the spiral this approach is used to actively bend catheters at certain inflection points). When the wires are shortened, the wire spiral straightens/unwinds, and the catheter tip will rotate into the desired orientation.
[0190]
[0191] Another solution is for the endovascular device to have multiple side-holes, either circumferentially at the same length along the catheter, or staggered slightly, or some combination thereof. The appropriate hole can then be selected with the wire and/or catheter being used to access the side branch or aneurysm. Preferably, each side-hole should not have a side-hole directly opposite it, to maximize the support for devices exiting that side-hole. Side holes can optionally have various radiographic markers at various junctions along their periphery to help identify their location during a procedure.
[0192] In some embodiments, a circumferential array of balloons is attached to the outside of outer catheter 1440. In some embodiments, the balloons are attached to the outside of the distal, exposed segment of inner catheter 1460. In some embodiments, the circumferential balloons are on the catheter outer sheath. In some embodiments, the balloons are attached to both the outside of outer catheter 144 and the distal, exposed segment of inner catheter 1460. In some embodiments, inner catheter 1460 has one or more grooves. In some embodiments, the one or more grooves are located around the outer circumference of inner catheter 1460. In some embodiments, outer catheter 1440 has one or more grooves. In some embodiments, one or more grooves are located around the inner circumference of outer catheter 1440. In some embodiments, the grooves let the inner and outer catheters rotate relative to each other while preventing movement along the length of one catheter relative to the other. For example, the inner catheter has an outer groove along its outside, centered between two inner grooves on the inner surface of the outer catheter at a corresponding location. In some embodiments, the outer catheter has an inner groove along its inside, centered between two outer grooves on the outside of the inner catheter. In some embodiments, the inner and outer catheters have additional grooves for added translational stability.
[0193] By inflating some balloons and not others, the catheter can be centered at a desired location within a vessel. In some embodiments, a catheter is centered at the base of a bifurcation aneurysm to subsequently deliver a WEB® device, coils or another device. In some embodiments, the balloons are on an intermediate support catheter or directly on a delivering microcatheter.
[0194] In some embodiments, the aneurysm treatment device includes a WEB® device (Microventions, CA). The WEB® device is most safely deployed via a catheter centered within the aneurysm. Using conventional technologies, this is most often safely possible with bifurcation aneurysms. However, centering a catheter in most side-wall aneurysms is very difficult. The catheter will typically rather sit against the distal side wall of the aneurysm. Even when possible, it is typically with poor support, and the catheter may kick out during device advancement. In some embodiments, the endovascular device provides the stability and support to appropriately position a catheter, safely and with adequate support, to deliver a WEB® and similar devices into most side wall aneurysms.
[0195] In some embodiments, support lumen 110 or support lumen 330 is ‘S’-shaped. In some embodiments, the ‘S’ shape is a shepherd's hook shape.
[0196] In some embodiments, ‘S’-shaped support lumen 610 is used to access difficult-to-access innominate arteries; to subsequently access the right common carotid artery and its distal branches; and/or to subsequently access the right subclavian artery and/or its branches. For example, in a subject with an overgrown, tortuous and/or long aortic arch, and/or an elongated, straightened and/or tortuous innominate artery. ‘S’-shaped support lumen 610 is used to distally access the right subclavian artery and right common carotid artery.
[0197] In some embodiments, the ‘S’ shape is a pre-shaped configuration. In some embodiments. ‘S’-shaped support lumen 610 is inserted into a subject's body in a straight configuration and subsequently re-shaped into its pre-shaped ‘S’ configuration. In some embodiments, ‘S’-shaped support lumen 610 is inserted into a subject's body in a straight configuration, into the aortic arch in a straight configuration, and distal portion 630 of ‘S’-shaped support lumen 610 curves back across the aortic arch to provide support for endovascular device 300, to facilitate placement of endovascular device 300, to anchor endovascular device 3M) within a blood vessel, to prevent kickback of endovascular device 300, or a combination thereof (
[0198] In some embodiments, ‘S’-shaped support lumen 610 is inserted into a subject's body in a straight configuration, into the aortic arch in a straight configuration, and the distal portion 630 of ‘S’-shaped support lumen 610 curves back across the aortic arch and down the descending aorta to provide support for endovascular device 300, to facilitate placement of endovascular device 300, to anchor endovascular device 300 within a blood vessel, to prevent kickback of endovascular device 300, or a combination thereof (
[0199] In some embodiments, ‘S’-shaped support lumen 610 comprises a shape memory polymer (SMP). Non-limiting examples of shape memory polymers include methacrylates, polyurethanes, blends of polystyrene and polyurethane, and polyvinylchloride. In some embodiments, ‘S’-shaped support lumen 610 comprises a shape memory alloy (SMA). Non-limiting examples of shape memory alloys include nickel-titanium (i.e., nitinol).
[0200] In some embodiments, ‘S’-shaped support lumen 610 is about 4% to about 300% longer in length than working lumen 120. In some embodiments, ‘S’-shaped support lumen 610 has a curve diameter 620. In some embodiments, the curve diameter ranges from about 1 cm to about 10 cm. In some embodiments, the curve diameter ranges from about 2 cm to about 8 cm.
[0201] In some embodiments, no ramp is disposed within the tube at or near the side-hole. The absence of such a ramp results in increased flexibility of the endovascular device relative to an endovascular device with such a ramp (See, e.g., U.S. Pat. No. 4,552,554). In addition, the presence of such a ramp as found in some endovascular devices results in unnecessary upsizing of the outer tube, which leads to more difficult navigation and increased risks of access site complications due to the larger hole in the device. The presence of such a ramp also limits what can be placed into the distal portion of the device to smaller wires, while forcing larger wires to exit the side port.
[0202] In some embodiments, primary opening 340 has a luer lock. In some embodiments, first segment 320 from the luer lock to side-hole 310 ranges in length from about 10 cm to about 130 cm. In some embodiments, second segment 330 ranges from about 10% to about 300% longer than first segment 320 from the luer lock to side-hole 310. In some embodiments, endovascular device 300 from the luer lock to end 350 ranges in length from about 10 cm to about 520 cm.
[0203] In some embodiments, second segment 330 provides stability to endovascular device 300 and/or a working lumen formed by side-hole 310 and first segment 320. In some embodiments, second segment 330 provides strength to and/or support for endovascular device 300 and/or the working lumen. In some embodiments, second segment 330 facilitates placement of endovascular device 300 and/or the working lumen. In some embodiments, second segment 330 anchors endovascular device 300 and/or the working lumen within a blood vessel. In some embodiments, second segment 330 prevents kickback of endovascular device 300 and/or the working lumen. In some embodiments, the blood vessel is an artery or a vein. In some embodiments, the device is used in other lumens.
[0204] In some multilumen embodiments, support lumen 110 is greater in length than working lumen 120. In some embodiments, support lumen 110 ranges from about 0.1% to about 200% longer than working lumen 120. In some embodiments, support lumen 110 ranges from about 105 cm to about 135 cm in length. In some embodiments, working lumen 120 ranges from about 60 cm to about 90 cm in length.
[0205] In some embodiments, first segment 320 ranges from about 50 cm to about 100 cm in length. In some embodiments, second segment 330 extends from about 20 cm to about 60 cm in length from side-hole 310.
[0206] In some “single lumen” (exclusive of additional lumens for wires or balloon, which often would be substantially within the catheter wall) embodiments, the intravascular portion of the first segment ranges from 5 cm to 150 cm in length. In some embodiments, the second segment ranges from 0.1 cm to 120 cm in length. In some embodiments, the second segment is between 0.1%-300% the length of the first segment. In some multilumen embodiments, the support lumen spans the entire working lumen length and extends beyond the side hole to form the support segment. In some single lumen embodiments, the support lumen begins only after the side hole, and is contained only within the support segment, and does not span the working lumen length.
[0207] In some embodiments, the outer diameters of the working and support segments are the same. In some embodiments, the outer diameter of some or all the support segment is less than the outer diameter of the working segment.
[0208] In some embodiments, the diameter of support lumen 110 is less than the diameter of working lumen 120. In some embodiments, support lumen 110 ranges in diameter from about 1 Fr to about 8 Fr. In some embodiments, support lumen 110 is less than 1 Fr in diameter. In some embodiments, support lumen 110 ranges in diameter from about 0.0020 cm (about 0.0008 inches) to about 0.1 cm (about 0.039 inches). In some embodiments, support lumen 110 ranges in diameter from about 0.08 cm to about 1 cm.
[0209] In some embodiments, working lumen 120 ranges in diameter from about 1 Fr to about 26 Fr. In some embodiments, working lumen 120 is less than 1 Fr in diameter. In some embodiments, working lumen 120 ranges in diameter from about 0.0254 cm (about 0.010 inches) to about 0.1 cm (about 0.039 inches). In some embodiments, working lumen 120 ranges in diameter from about 0.1 cm to about 1 cm.
[0210] In some embodiments, first segment 320 ranges in diameter from about 1 Fr to about 26 Fr. In some embodiments, first segment 320 is less than 1 French in diameter (Fr). In some embodiments, first segment 320 ranges in diameter from about 0.0254 cm (about 0.010 inches) to about 0.0305 cm (about 0.012 inches).
[0211] In some embodiments, second segment 330 ranges in diameter from about 1 Fr to about 23 Fr. In some embodiments, second segment 330 is less than 1 Fr in diameter. In some embodiments, second segment 330 ranges in diameter from about 0.0020 cm (about 0.0008 inches) to about 0.1 cm (about 0.039 inches). In some embodiments, second segment 330 ranges in diameter from about 0.1 cm to about 1 cm.
[0212] In some embodiments, the diameter is an inner diameter (ID). In some embodiments, the diameter is an outer diameter (OD).
[0213] In some embodiments, support lumen 110 further comprises a device separate from endovascular device 100. In some embodiments, the separate device is a wire. In some embodiments, the wire is capable of being advanced into a blood vessel through support lumen 110. In some embodiments, the wire provides stability and/or strength to endovascular device 100.
[0214] In some embodiments, the wire provides support for endovascular device 100. In some embodiments, the wire facilitates placement of endovascular device 100. In some embodiments, the wire anchors endovascular device 100 within a blood vessel. In some embodiments, the wire provides stability and/or strength to working lumen 120. In some embodiments, the wire provides support for working lumen 120. In some embodiments, the wire facilitates placement of working lumen 120. In some embodiments, the wire anchors working lumen 120 within a blood vessel. In some embodiments, the blood vessel is an artery. In some embodiments, the blood vessel is a vein.
[0215] In some embodiments, endovascular device 300 further comprises an additional separate device that traverses through endovascular device 300. In some embodiments, the separate device is a wire. In some embodiments, the wire is capable of being advanced through first segment 320 and into second segment 330. In some embodiments, the wire is capable of being advanced into a blood vessel through second segment 330. In some embodiments, the wire provides stability to endovascular device 300. In some embodiments, the wire provides strength to endovascular device 300. In some embodiments, the wire provides support for endovascular device 300. In some embodiments, the wire facilitates placement of endovascular device 300. In some embodiments, the wire anchors endovascular device 300 within a blood vessel. In some embodiments, the wire provides stability to the working lumen formed by side-hole 310 and first segment 320. In some embodiments, the wire provides strength to the working lumen formed by side-hole 310 and first segment 320. In some embodiments, the wire provides support for the working lumen formed by side-hole 310 and first segment 320. In some embodiments, the wire facilitates placement of the working lumen formed by side-hole 310 and first segment 320. In some embodiments, the wire anchors the working lumen formed by side-hole 310 and first segment 320 within a blood vessel. In some embodiments, the blood vessel is an artery. In some embodiments, the blood vessel is a vein. In some embodiments, the additional device is a catheter. In some embodiments, the additional device is a stent. In some embodiments, the additional device is a balloon. In some embodiments, the additional device is an embolic device. In some embodiments, the additional device is a different device. In some embodiments, the additional device is a combination of various devices, used simultaneously or in sequentially.
[0216] In some embodiments, the wire ranges in diameter from about 0.07 cm to about 0.11 cm. In some embodiments, the wire is rigid. In some embodiments, the wire is flexible.
[0217] In some embodiments, the wire is comprised of a core material which includes, but is not limited to, stainless steel, nitinol or a combination thereof. In general, stainless steel is easier to torque and is more rigid, providing better columnar support. Nitinol is more flexible and kink resistant. Developments such as high-tensile-strength stainless steel and combinations of stainless steel with nitinol have been utilized. High-tensile-strength stainless steel provides more column strength and torquability than original stainless steel. The use of hybrid wires incorporates high-tensile stainless steel shafts with nitinol tips to impart high torquability and columnar shaft strength with kink-resistance tips.
[0218] In some embodiments, the wire comprises a core taper. The core tapers are areas where the core of the wire changes over a set distance. There may be several tapers in a wire. Long, gradual tapers track well around bends, but do not provide as much support in short distances. Broad, gradual, or long tapers offer acute vessel access and improved tracking. Devices with abrupt or short tapers create support in shorter distances and have a greater tendency to prolapse.
[0219] In some embodiments, the wire comprises a core grind (i.e., constant diameter).
[0220] In some embodiments, the wire comprises a core that extends to the tip. A core that extends to the tip of the wire increases the transmission of force, is more durable and steerable, improves tactile feedback, and is used in peripheral vessels. In some embodiments, the wire comprises a core that does not extend to the tip. A core that does not extend to the tip (i.e., shaping ribbon design) is delicate, flexible, and soft. This kind of tip is also easier to shape, easily prolapsed, and less likely to inadvertently injure distal vessels.
[0221] In some embodiments, the wire comprises a cover. Covers include, but are not limited to, a polymer or a plastic. A polymer sleeve or plastic placed over the wire core enhances lubricity which results in less drag, enhanced lesion crossing, and smooth tracking in tortuous vessels. In some embodiments, the wire comprises a coating. Non-limiting examples of a coating include a hydrophobic coating and a hydrophilic coating. Hydrophobic coatings reduce friction and improve device trackability by repelling water to create a smooth, “wax-like” surface, with no water actuation required. Hydrophilic coatings attract water to create a slippery, “gel-like” surface.
[0222] In some embodiments, the wire is a guide wire.
[0223] In some embodiments, the endovascular device further comprises at least one balloon disposed thereon, and at least one additional lumen substantially within the wall (so as not to obstruct the single central working lumen) of the intravascular portion of the device that serves solely to inflate and deflate the at least one balloon.
[0224] In some embodiments, support segment 390 or support lumen 110 of the endovascular device comprises an inflatable balloon. In some embodiments, the inflatable balloon is attached to the distal portion of support segment 390 or support lumen 110 of the endovascular device. In some embodiments, the inflatable balloon is attached proximal to side-hole 310. In some embodiments, the inflatable balloon is attached distal to side-hole 310. In some embodiments, the inflatable balloon is attached opposite side-hole 310. In some embodiments, the inflatable balloon is attached opposite side-hole 310 and spans the length of side-hole 310. In some embodiments, the inflatable balloon is attached to a device separate from endovascular device 300 or endovascular device 100. In some embodiments, the separate device is a segment of an inflatable balloon catheter. In some embodiments, the inflatable balloon catheter comprises a luer lock on its proximal end. In some embodiments, the separate device is advanced into a blood vessel through the lumen defined in support segment 390 and/or in working segment 380 and/or support lumen 110 of the endovascular device. In some embodiments, the inflated balloon is effective to anchor support segment 390 or support lumen 110 of the endovascular device to a blood vessel. In some embodiments, the blood vessel is an artery. In some embodiments, the blood vessel is a vein.
[0225] In some embodiments, the inflatable balloon ranges in diameter from about 1 mm to about 50 mm. In some embodiments, the balloon ranges from about 1 mm to about 300 mm in length.
[0226] In some embodiments, the inflatable balloon is comprised of various shapes including, but not limited to, cylindrical, spherical, oval, conical, stepped, tapered and dog bone.
[0227] In some embodiments, the inflatable balloon is comprised of a material such as, for example, a polyamide, polyethylene terephthalate (PET), polyurethane, composites, and engineered nylons. Engineered nylons include, but are not limited to, PEBAX®, GRILAMID®, and VESTAMID®.
[0228] In some embodiments, the inflatable balloon ends are comprised of various shapes including conical sharp corner, conical radius corner, offset neck, spherical end and square. In some embodiments, the inflatable balloon is filled with a fluid, such as sterile water and saline.
[0229] In some embodiments, support lumen 110 includes a stent. In some embodiments, the stent is retrievable. In some embodiments, the retrievable stent is attached to the distal portion of support lumen 110. In some embodiments, the retrievable stent is attached to a device separate from the endovascular device. In some embodiments, the separate device is capable of being advanced into a blood vessel through support lumen 110. In some embodiments, the retrievable stent anchors support lumen 110 to a blood vessel. In some embodiments, the stent is self-expanding. In some embodiments, the self-expanding stent is attached to the distal portion of support lumen 110. In some embodiments, the self-expanding stent is attached to a device separate from the endovascular device. In some embodiments, the separate device is capable of being advanced into a blood vessel through support lumen 110. In some embodiments, the self-expanding stent anchors support lumen 110 to a blood vessel. In some embodiments, the blood vessel is an artery or a vein.
[0230] In some embodiments, second segment 330 or support lumen 110 is rigid. In some embodiments, second segment 330 or support lumen 110 has a soft, flexible portion. In some embodiments, the soft, flexible portion ranges in length from about 0.1 cm to about 50 cm. In some embodiments, the soft, flexible portion is at the distal end of support lumen 110 or at end 350.
[0231] In some embodiments, the working lumen formed by side-hole 310 and first segment 320 or working lumen 120 has a device separate from the endovascular device. In some embodiments, the separate device is capable of being advanced into a blood vessel through the working lumen. In some embodiments, the separate device is capable of being advanced into a blood vessel through side-hole 310. In some embodiments, the blood vessel is an artery or a vein. In some embodiments, the separate device is a diagnostic device. In some embodiments, the separate device is a therapeutic device.
[0232] In some embodiments, the catheter further comprises an angled extension at the side-hole. In some embodiments, the angle of the angled extension ranges from about 10 degrees to about 180 degrees. In some embodiments, the angled extension is soft. In some embodiments, the angled extension is flexible. In some embodiments, the angled extension is adjustable. In some embodiments, the endovascular device includes an actively adjustable angled extension extending from the side-hole serves to facilitate steering of one or more additional devices into a blood vessel.
[0233] In some embodiments, the angled extension comprises a shape memory polymer (SMP). Shape memory polymers include, but are not limited to methacrylates, polyurethanes, blends of polystyrene and polyurethane, and polyvinylchloride. In some embodiments, the angled extension of the catheter comprises a shape memory alloy (SMA). Non-limiting examples of shape memory alloys include nickel-titanium (i.e., nitinol).
[0234] Diagnostic catheters include, but are not limited to, angiography catheters, electrophysiology catheters, intravenous ultrasound catheters and the like.
[0235] Catheter angiography can be performed using such techniques as, for example, X-rays, computed tomography (CT) and magnetic resonance imaging (MRI). In catheter angiography, a catheter is inserted into a blood vessel (e.g., an artery) through a small incision in the skin. The catheter is guided to the area being examined, a contrast material is injected through the catheter and images are acquired using a small dose of ionizing radiation (e.g., X-rays). Contrast agents include, but are not limited to, iodinated low-osmolar contrast media (LOCM) and high-osmolar contrast media (HOCM). Low-osmolar contrast media include, but are not limited to, ioxaglate, iopamidol, iohexol, ioidixanol, iotrolan, ioxaglate, ioxilan, iopromide, ioversol and iomeprol. Non-limiting examples of high-osmolar contrast media include diatrizoate, metrizoate and iothalamate.
[0236] Catheter electrophysiology is an invasive heart catheterization that is designed to evaluate the electrical system of the heart. This test evaluates if there is a need to implant a pacemaker or defibrillator or to perform a catheter ablation, which is a procedure that uses radiofrequency energy (similar to microwave heat) to destroy small areas of heart tissue that cause rapid or irregular heartbeats. In this procedure, a catheter is introduced into a blood vessel and placed under X-ray guidance into the heart. For example, catheter electrophysiology is used to evaluate patients who have concerning symptoms such as fainting, episodes of almost fainting, sensations of rapid heartbeats, or excessively slow heartbeats.
[0237] Ultrasound catheterization or intravascular ultrasound (IVUS) is an imaging procedure using a catheter with a miniaturized ultrasound probe attached to the distal end. The catheter's proximal end is attached to computerized ultrasound equipment which measure how sound waves reflect off blood vessels and converts these measurements into images. IVUS is used to determine, among others, the accumulation of plaque in an artery and the correct placement of a stent.
[0238] In some embodiments, the diagnostic catheter ranges in diameter from about 0.1 Fr to about 12 Fr.
[0239] Therapeutic catheters include, but are not limited to, a proximal endovascular thrombectomy catheter, a distal endovascular thrombectomy catheter, a self-expanding stent catheter, a retrievable thrombectomy stent catheter, an ablation catheter, a percutaneous transluminal angioplasty (PTCA) catheter, an embolization and the like.
[0240] PTCA is a minimally invasive procedure to open blocked coronary arteries, allowing blood to circulate unobstructed to the heart muscle. The procedure begins with the injection of local anesthesia into the groin area and putting a needle into the femoral artery. A guide wire is placed through the needle and the needle is removed. An introducer is then placed over the guide wire, after which the wire is removed. A different sized guide wire is then put in its place. Next, a long narrow tube called a diagnostic catheter is advanced through the introducer over the guide wire, into the blood vessel. This catheter is then guided to the aorta and the guide wire is removed. Once the catheter is placed in the opening (or ostium) of one of the coronary arteries, contrast dye is injected and an x-ray is taken. If a treatable blockage is noted, the first catheter is exchanged for a guiding catheter. Once the guiding catheter is in place, a guide wire is advanced across the blockage, then a balloon catheter is advanced to the blockage site. The balloon is inflated for a few seconds to compress the blockage against the artery wall. Then the balloon is deflated.
[0241] Catheter embolization is a minimally invasive treatment that occludes or blocks one or more blood vessels or vascular channels of malformations (abnormalities). In a catheter embolization, medications or synthetic materials (embolic agents) are placed through a catheter into a blood vessel to prevent blood flow to the area. Using image-guidance, a catheter is inserted through the skin to the treatment site. A contrast material is then injected through the catheter and a series of x-rays are taken to locate the exact site of bleeding or abnormality. Next, a medication or an embolic agent is injected through the catheter. Additional x-rays are taken to ensure the loss of blood flow in the target vessel or malformation. Uses of catheter embolization include, but are not limited, control or prevention of abnormal bleeding, including bleeding that results from an injury, tumor or gastrointestinal tract lesions such as an ulcer or diverticular disease; controlling bleeding into the abdomen or pelvis caused by traumatic injuries; treatment of long menstrual periods or heavy menstrual bleeding that results from fibroid tumors of the uterus; to occlude or close off vessels that are supplying blood to a tumor, to eliminate an arteriovenous malformation (AVM) or arteriovenous fistula (AVF) (abnormal connection or connections between arteries and veins); and to treat aneurysms (a bulge or sac formed in a weak artery wall) by either blocking an artery supplying the aneurysm or closing the aneurysmal sac itself.
[0242] Various components described herein may be made of one or more materials. For example, they can be made of one or more of a thermoplastic, thermoset, composite or radiopaque filler.
[0243] Exemplary thermoplastics include nylon, polyethylene terephthalate (PET), urethane, polyethylene, polyvinyl chloride (PVC) and polyether ether ketone (PEEK). Exemplary thermosets include silicone, polytetrafluoroethylene (PTFE) and polyimide.
[0244] Exemplary composites include 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 a regular solid crystal. LCPs can substitute 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. Exemplary LCPs include wholly or partially aromatic polyesters or co-polyesters such as XYDAR® (Amoco) or VECTRA® (Hoechst Celanese). Other commercial liquid crystal polymers include SUMIKOSUPER™ and EKONOL™ (Sumitomo Chemical), DuPont HXT™ and DuPont ZENITE™ (E.I. DuPont de Nemours), RODRUN™ (Unitika) and GRANLAR™ (Grandmont).
[0245] Exemplary radiopaque fillers include barium sulfate, bismuth oxychloride, tantalum and the like.
[0246] In some embodiments, the working lumen formed by side-hole 310 and first segment 320 further has a separate device from endovascular device 300. In some embodiments, the separate device can be advanced into a blood vessel through side-hole 310. In some embodiments, the separate device is an introducer. In some embodiments, the introducer is rigid. In some embodiments, the introducer is effective to straighten a catheter comprising a soft angled extension. In some embodiments, the introducer and straightened catheter comprising the soft angled extension are advanced through the working lumen formed by side-hole 310 and first segment 320; the introducer is removed from the working lumen; and a soft angled extension of pushes through side-hole 310. In some embodiments, side-hole 310 directs the soft angled extension into a blood vessel. In some embodiments, the blood vessel is an artery or vein.
[0247] In some embodiments, diameter of side-hole 310 is larger than diameter of the soft angled extension of the catheter. In some embodiments, side-hole 310 ranges in diameter from about 4 Fr to about 12 Fr.
[0248] In some embodiments, side-hole 310 comprises an angled extension. In some embodiments, primary opening 160 comprises an angled extension. In some embodiments, the angle of the angled extension is fixed. In some embodiments, the angle of the angled extension ranges from about 0 degrees to about 359 degrees. In some embodiments, the angle of the angled extension is adjustable. In some embodiments, the angle of the angled extension is adjustable from about 0 degrees to about 359 degrees. In some embodiments, the angled extension is adjusted after endovascular device 300 is inserted into a blood vessel.
[0249] In some embodiments, the catheter and/or angled extension may further include wires or cables within the wall that are capable of actively steering the device and creating bends in vivo.
[0250] In some embodiments, the device is used in an endovascular procedure in a subject suffering from an anatomical variation in a blood vessel. In some embodiments, the device is used in an endovascular procedure to treat acute stroke in a subject suffering from an anatomical variation in a blood vessel. In some embodiments, the blood vessel has an anatomical variation including tortuosity. In some embodiments, the blood vessel has an anatomical variation including acute angulation. In some embodiments, the acute angulation is an aortic arch variation. In some embodiments, the aortic arch variation is a bovine arch variation. In some embodiments, the acute angulation is a vertebral artery variation.
[0251] In some embodiments, support lumen 110 and/or second segment 330 is advanced through the Subclavian artery into the arm, or alternatively, into the external carotid artery. In some embodiments, support lumen 110 and/or second segment 330 provides support for a catheter, a wire or a combination thereof, advanced through working lumen 120 and/or a working lumen formed by side-hole 310 and first segment 320 and into a blood vessel. In some embodiments, the blood vessel is the left internal carotid artery. In some embodiments, the blood vessel is the distal vertebral artery. In some embodiments, support lumen 110 and/or second segment 330 prevents kickback of an advancing catheter, an advancing wire or a combination thereof.
[0252] In some embodiments, there is a single side-hole. In some embodiments, there are multiple side-holes. In some multiple side-hole embodiments, all side-holes are along the same length of the catheter, at different circumferential locations. In some multiple side-hole embodiments, all side-holes are staggered at different lengths along the catheter, either at the same or various circumferential locations. In some multiple side-hole embodiments, some side-holes are staggered at different lengths along the catheter and some are along the same length. In some embodiments, side-holes may be long partially overlapping lengths of the catheter, at varying circumferential locations.
[0253] Where there are a range of values, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context dearly dictates otherwise, between the upper and lower limit of the range and any other stated or intervening value in a stated range is encompassed within the invention. The upper and lower limits of these smaller ranges which may independently be included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in a stated range. Where a stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
[0254] 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. All publications mentioned herein are incorporated by reference to disclose and describe the methods and materials in connection with which the publications are cited.
[0255] 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.
[0256] Publications discussed herein are provided solely for their disclosure before the filing date of this application and each is incorporated by reference in its entirety. Nothing herein is to be construed as an admission that this invention is not entitled to antedate such publication by virtue of prior invention. Further, publication dates listed may be different from the actual publication dates which may need to be independently confirmed.
[0257] While the present invention has been described with reference to 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.