Patent Application
20220192689
This application is directed to devices, systems, and methods for treating lesions, including crossing narrow passages of lumen segments or total occlusions and devices, systems, and methods providing embolic protection.
Peripheral artery disease (PAD) and coronary artery disease (CAD) affect millions of people in the United States alone. PAD and CAD are silent, dangerous diseases that can have catastrophic consequences when left untreated. CAD is the leading cause of death for in the United States while PAD is the leading cause of amputation in patients.
Coronary artery disease (CAD) and Peripheral artery disease (PAD) are both caused by the progressive narrowing of the blood vessels most often caused by atherosclerosis, the collection of plaque or a fatty substance along the inner lining of the artery wall. Over time, this substance hardens and thickens, which may interfere with blood circulation to the arms, legs, stomach and kidneys. This narrowing forms a lesion, completely or partially restricting flow through the artery. Blood circulation to the brain and heart may be reduced, increasing the risk for stroke and heart disease. A percentage of the population has arterial atherosclerosis that totally occludes portions of the patient's vasculature and presents significant risk to the patient's health. For example, in cases of severe or chronic total occlusions (CTOs) of a coronary artery, the result may be painful angina, loss of functional cardiac tissue or death. In another example, complete occlusion of the arteries in the leg may result in critical limb ischemia and subsequent limb amputation. Another mechanism that leads to limited flow to the limbs is called Acute Limb Ischemia (ALI) and is caused by a blood clot, either forming within the blood vessel, or more often traveling from the heart to the limb and causing acute cessation of blood flow to the limb. This mechanism is considered medical emergency, and if the blood flow is not restored within hours, it will lead to limb amputation.
Commonly known endovascular devices and techniques for the treatment of chronic total occlusions (CTOs) are either inefficient (resulting in a time-consuming procedure), very expensive, or have a high risk of perforating a vessel (resulting in an unsafe procedure) or fail to cross the lesion (resulting in poor efficacy). Bypass surgery is often the preferred treatment for patients with chronic total occlusions both in the heart and peripheral arteries, but surgical procedures are undesirably invasive, and associated with high level of mortality and morbidity, as well as prolonged hospitalization.
There are a number of products on the market that are designed specifically for crossing CTOs and these can be categorized as either intraluminal, subintimal, or re-entry devices. Intraluminal crossing will produce the dissection plane of a long occlusive lesion, protect collaterals and keep treatment options open. Subintimal crossing may require “re-entry” back to the true lumen beyond the occluded segment, putting collaterals at risk and limiting treatment options. It may also increase the rates of complications such as perforation and dissection and extend procedure time with resultant increased radiation and contrast exposure. Also, below the knee, once a wire has crossed into the adventitia it is extremely difficult to re-enter the true lumen.
Once a physician has crossed the CTO, an endovascular procedure may be performed to treat the occluded lumen. The procedures to treat occlusive vascular diseases, such as angioplasty, atherectomy and stent placement, often cause blood clots to form and/or atheromatous material to dislodge from inside the vessel walls and enter the bloodstream. The dislodged material (e.g., plaque), known as at atheroemboli, may be large enough to occlude downstream vessels, potentially blocking blood flow to tissues. Additionally, the blood clots, known as thromboemboli, may be large enough to block the blood flow downstream.
There are numerous previously known interventional systems and methods that employ a filter mechanism designed to capture material dislodged from vessel walls during the treatment or diagnosis of vascular disease. Many of the more recent devices employ an expandable filter disposed at the distal end of a guide wire. These filters have various configurations, such as mesh or microporous membranes in the form of sleeves, parachutes or baskets attached to the guide wire or other delivery mechanism by means of struts, wires, ribs or frames. The meshes are frequently made of woven or braided fibers or wires made of stainless steel, nitinol, platinum alloy, polyester, nylon or porous plastics, for example. The microporous membranes are typically made of a polymer material such as polypropylene, polyurethane, polyester, polyethylene terephthalate, polytetrafluoroethylene or combinations thereof.
A lesion crossing catheter device designed to address some of these concerns and an embolic filter are described herein.
Described herein are lesion-crossing devices that address the concerns of the prior art devices and embolic protection systems deployed in a body vessel or cavity for the collection of loosened and/or dislodged debris.
In one embodiment, the lesion crossing device comprises a delivery catheter that contains a wire based embolic protection device. When crossing the lesion, the wire is extended out the distal end of the catheter such that it loops back toward the proximal end. This looped wire aids in crossing the lesion, and will tend to stay intraluminal, minimizing the chance of migration into the adventitia or beyond.
In another embodiment, the embolic protection device comprises an expandable loop with a filter attached to a guidewire. The section of wire proximal of the expandable loop is of a diameter that allows for improved support for delivery during endovascular procedures. In some embodiments, it has a diameter of 0.035 inches. The wire distal of the expandable loop is the same or a smaller diameter than the proximal section of the wire. The wire at the basket section may be of smaller diameter to allow filter to more easily fit into the delivery catheter, after folding or compressing the filter. This allows for a smaller collapsed cross-sectional area of the embolic filter such that a smaller diameter delivery catheter can be used. In some embodiments, the wire distal of the basket has a larger diameter than the wire from the expandable loop to the distal end of the porous filter. In some embodiments, the wire distal of the basket has a smaller diameter than the wire from the expandable loop to the distal end of the porous filter.
In another embodiment, a CTO crossing device comprising a delivery catheter and a wire embolic protection device is used. With the distal end of the wire extending past the distal end of the catheter and looping back toward the proximal end of the catheter, the physician advances the system through the lesion. Once across the lesion, the delivery catheter is withdrawn, and the embolic filter expands. In this state, the expandable loop contacts the lumen wall. After the delivery catheter is withdrawn, the physician may perform a procedure at the site of the lesion. If the lesion is in a vascular lumen, an endovascular procedure may be performed. If the lesion is in a non-vascular lumen, an endoscopic procedure may be performed. The procedure may include balloon catheters, drug coated balloon catheters, stent delivery catheters, drug coated stent delivery catheters, thrombectomy catheters, and atherectomy systems. In some embodiments, after the procedure is completed, the physician may advance a retrieval catheter over the wire to collapse the expandable loop of the embolic protection device to allow for the removal of the system.
In another embodiment, the delivery catheter is sized to fit within a retrieval catheter. If the physician needs additional support when crossing the lesion with the delivery catheter system, the retrieval catheter can be advanced over the delivery catheter/wire filter system to provide additional backup support. In other embodiments, a smaller sized retrieval catheter is used such that the delivery catheter is not sized to fit within the retrieval catheter.
In another embodiment, a scaffold is placed within the filter. The scaffold helps maintain the filter in an expanded configuration, especially in small diameter lumens. The scaffold may comprise one or more metallic loops.
In some embodiments, a device comprises an embolic protection apparatus comprising a wire and a basket attached to the wire. The basket comprises a structural loop attached to a porous filter. The wire comprises a first portion and a second portion, wherein the first portion is proximal to the basket and the second portion is coextensive with at least a portion of the basket. A cross-sectional area of the first portion is greater than a cross-sectional area of the second portion.
In some embodiments, the device further comprises a catheter comprising a lumen and the basket is positioned in the lumen. In some embodiments, the wire comprises a third portion distal to the basket. In some embodiments, the third portion extends distally from the catheter, comprises a bend and overlaps the catheter. In some embodiments, a cross-sectional area of the third portion is greater than the cross-sectional area of the second portion.
In some embodiments, the basket comprises a first basket and the embolic protection apparatus comprises a second basket attached to the wire. In some embodiments, the second basket is larger than the first basket.
In some embodiments, a basket comprises a scaffold arranged to support the porous filter. In some embodiments, the scaffold is attached to the wire.
In some embodiments, the structural loop is variable in size. In some embodiments, a structural loop comprises a secondary loop.
In some embodiments, a device comprises an embolic protection apparatus comprising a wire, a first basket attached to the wire and a second basket attached to the wire. The first basket comprises a first loop attached to a first porous filter. The second basket comprises a second loop attached to a second porous filter. In some embodiments, the second basket is larger than the first basket. In some embodiments, an aperture defined by the second loop is larger than an aperture defined by the first loop.
In some embodiments, the second loop comprises a secondary loop.
In some embodiments, the device comprises a catheter comprising a lumen, the first basket is positioned in the lumen and the second basket is positioned in the lumen.
In some embodiments, a device comprises an embolic protection apparatus comprising a wire and a basket attached to the wire. The basket comprises a structural loop attached to a porous filter and the structural loop comprises a secondary loop. In some embodiments, wherein a cross-sectional area of the structural loop changes as a size of the secondary loop changes. In some embodiments, the structural loop is attached to the wire at an attachment point and the secondary loop located opposite the attachment point. In some embodiments, the wire comprises a first portion and a second portion, the first portion proximal to the basket and the second portion coextensive with at least a portion of the basket. A cross-sectional area of the first portion greater than a cross-sectional area of the second portion.
The present disclosure includes methods and apparatuses for devices for crossing lesions and for providing embolic protection. An example apparatus includes delivery catheter sized to contain an embolic protection apparatus. The delivery catheter is used to cross lesions. In some examples, the distal end of the wire is positioned outside the distal end of the delivery catheter when crossing the lesion. In some examples, a retrieval catheter is used to capture the expandable distal protection apparatus for removal from the body.
In the following detailed description of the present disclosure, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration how one or more embodiments of the disclosure may be practiced. These embodiments are described in sufficient detail to enable those of ordinary skill in the art to practice the embodiments of this disclosure, and it is to be understood that other embodiments may be utilized and that process, electrical, and structural changes may be made without departing from the scope of the present disclosure.
As used herein, designators such as “X”, “Y”, “N”, “M”, etc., particularly with respect to reference numerals in the drawings, indicate that a number of the particular feature so designated can be included. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms “a”, “an”, and “the” can include both singular and plural referents, unless the context clearly dictates otherwise. In addition, “a number of”, “at least one”, and “one or more” (e.g., a number of pivot points) can refer to one or more pivot points, whereas a “plurality of” is intended to refer to more than one of such things. Furthermore, the words “can” and “may” are used throughout this application in a permissive sense (i.e., having the potential to, being able to), not in a mandatory sense (i.e., must). The term “include,” and derivations thereof, means “including, but not limited to”. The terms “coupled” and “coupling” mean to be directly or indirectly connected physically or for access to and movement of the movable handle member, as appropriate to the context.
The figures herein follow a numbering convention in which the first digit or digits correspond to the figure number and the remaining digits identify an element or component in the figure. Similar elements or components between different figures may be identified by the use of similar digits. For example, 106 may reference element “6” in
In some embodiments, the wire 128 comprises a first portion 132, a second portion 145 and a third portion 134. In some embodiments, each portion 132, 145, 134 comprises a length portion of the wire 128. In some embodiments, the second portion 145 is coextensive with at least a portion of the basket 136. In some embodiments, the third portion 134 is distal to the basket 136. In some embodiments, a cross-sectional area of the first portion 132 is greater than a cross-sectional area of the second portion 145.
In a number of embodiments, some of the sections of wire 128 have different diameters. In some embodiments, the diameter of the proximal section of the wire 132 is of a larger diameter than the basket section 130. Many of the commercially available devices for treating peripheral vascular disease are compatible with wires having a diameter of up to 0.035 inches. Many commercially available devices for treating coronary vascular disease are compatible with wires having a diameter up to 0.014 inches. While larger diameter wires provide more support than smaller diameter wires, the smaller diameter wires are generally more flexible and can more easily traverse tortuous anatomy. In some embodiments of the invention, the embolic protection apparatus 120 is positioned within delivery catheter 110. As will be explained later, the combined delivery catheter and embolic protection apparatus 120 are advanced together across a lesion. Crossing lesions, especially in tortuous anatomy, requires balancing many features, including pushability and flexibility. Thus, while a smaller diameter device will generally be more flexible, a larger diameter and/or stiffer device will have greater pushability. The diameter of the delivery catheter 110 is dependent on the minimum inside diameter needed to house the collapsed embolic protection apparatus 120 which includes wire 128. In the filter section 136, the effective diameter will comprise the diameter of the guide wire section 130 plus the space needed for collapsed proximal loop 122 and filter 124. In some embodiments, the competing needs of a large diameter wire needed for support and a small diameter profile needed for the delivery catheter is balanced by using a wire with a diameter over 0.030 inches for the proximal section 132 of the guidewire 128 and using a wire with a diameter less than 0.030 inches for the basket section of the wire, 130. In other embodiments, the diameter of the basket section of the wire 130 is less than 0.025 inches or less than 0.020 inches. In some embodiments, the diameter of the distal section of the wire 134 will be approximately equal to the diameter of wire 130. In some embodiments, the diameter of the distal section of the wire 134 will be equal to the diameter of the proximal section 132. In some embodiments, the diameter of the distal section of the wire 134 will be between about 0.010 and 0.018 inches. In some embodiments, the distal section of the wire 134 will comprise three subsections. The proximal subsection will have a wire diameter of greater than 0.30 inches, in some embodiments 0.035 inches. The middle subsection will have a wire diameter between 0.015 and 0.03 inches or between 0.02 and 0.03 inches, is some embodiments 0.18 inches. The distal subsection will have a wire diameter less than 0.02 inches or less than 0.015 inches, in some embodiments 0.014 inches.
In some embodiments, the third portion 234 of the wire extends distal to the catheter 210, comprises a curved portion 235 or bend, and overlaps with the catheter 210. In some embodiments, a tip of the wire is positioned adjacent to an external sidewall of the catheter 210.
After the intervention is complete, the user will retract the interventional device(s) leaving the embolic protection apparatus 220 in place. Lesion 252 has now been treated and the lumen 250 is substantially less occluded than it was prior to the intervention. As shown in
In some embodiments shown, the wire section that extends with the filter section is positioned outside the porous filter. In these embodiments, the porous filter is attached to the expandable loop, and, in some embodiments, the distal end of the porous filter is attached to the wire. This attachment point may include a radiopaque marker. In other embodiments, the wire section that extends with the filter section is positioned inside the porous filter. In these embodiments, the porous filter is attached to the expandable loop, and, in some embodiments, the distal end of the porous filter is attached to the wire, preferably at the point where the wire exits the porous filter. This attachment point may include a radiopaque marker. For all the embodiments shown herein, both of these two configurations are applicable.
In some embodiments, a single sized embolic protection apparatus will be used in lumens with a wide range of diameters. For example, an embolic protection apparatus with an expandable loop diameter of 12 mm can be used in lumens ranging from 5 to 10 mm. When used in the smaller diameters, however, the porous filter material positioned near the expandable loop has a tendency to bunch up, creating a narrowed lumen of the basket that may prevent embolic particles to be able to enter the filter or, at a minimum, flow to the distal end of the filter. A flexible scaffolding can be used to eliminate this problem. The flexible scaffolding may be composed of one or more metallic wires that are attached on the proximal end to the device loop. On the distal end the one or more wires are anchored to a slidable ring which is positioned over the wire of the device. When catheter is placed over the embolic basket the slidable ring and the distal end of the scaffold will move distally enabling a smaller crimped diameter. When catheter is removed from over the basket the metallic wires expand within the basket preventing the basket from “bunching up” when the device is deployed in lumens with diameters smaller than the loop of the device.
In some embodiments, the slide mechanism is positioned on a length of wire that that extends in the filter section. In some embodiments, this reduced diameter section has a diameter or 0.010 to 0.020 inches. In some embodiments, the scaffolding has a spiral shape, but any shape such as a braid, a looped wire, or a random configuration will work as long as the scaffolding expands to hold open the porous filter and doesn't prevent embolic particles from entering the filter. The scaffolding can be made of nitinol, stainless steel, or any elastic or superelastic material.
In some embodiments, an embolic protection apparatus comprises a wire 528, a first basket 536-1 attached to the wire 528 and a second basket 536-2 attached to the wire 528. In some embodiments, the second basket 536-2 is larger than the first basket 536-1. In some embodiments, the first loop 522-1 comprises a cross-sectional area that is less than a cross-sectional area of the second loop 522-2.
In some embodiments, the filter material 624 comprises a first attachment point to the expandable loop 622 located to a first side of the secondary loop 623. In some embodiments, the filter material 624 comprises a second attachment point to the expandable loop 622 located to a second side of the secondary loop 623. In some embodiments, the filter material 624 is not attached to the secondary loop 623 directly.
In some embodiments, an embolic protection apparatus comprises a first basket 536-1 and a second basket 536-2, for example as shown in
The collapsible filters described herein may have a length of 2 cm to 7 cm. In some embodiments, the collapsible filter may have a length of 2.5 cm to 5 cm. In some embodiments where two filters are positioned on the wire, the proximal filter may have a length of 2 cm to 3 cm and the distal filter may have a length of 3 cm to 4 cm and the two filters can be positioned less than 1 cm apart. In some embodiments the length of the wire tip (the wire that is distal to the distal end of the basket) may be 10 cm 10 15 cm. In embodiments that have a segmented distal tip, each segment of the tip may have a length of 2 cm to 5 cm.
The device described herein may be used for two separate clinical indications. In many, but not all, cases both indications may exist. First, the device will serve as peripheral embolic protection device. Many endovascular procedures create unacceptable risk for peripheral embolizations, and many peripheral procedures are performed in presence of existing thrombus. The device will protect the patient from the risk of atheroemboli, and thromboemboli. Deployment of embolic protection basket distal to the lesion/thrombus will mitigate the risk of embolic complications during endovascular procedures. It's design and size can be tailored to peripheral arteries including iliac, femoral, popliteal, common carotid, subclavian and brachiocephalic trunk. Secondly, the devices design will allow the operator to easier cross chronic total occlusions of the above-mentioned arteries. In some cases, endovascular treatment of chronic total occlusions creates unacceptable risk of embolic complications, and the device described herein will allow the operator to treat CTOs in a safer, more intuitive, and expeditious manner. For example: presence of occluded peripheral graft with old thrombus creating the occlusion will always be associated with very high risk of embolic complications. The device described herein will significantly mitigate that risk.
In some embodiments, the delivery catheter and/or the retrieval catheter are shown as having an angled distal end. A straight distal end is also within the scope of this disclosure.
In some embodiments, a valve at the proximal end of the delivery catheter will have an outer diameter approximately equal to the diameter of the delivery catheter. In some embodiments, the delivery catheter, embolic protection apparatus, and retrieval catheter will be provided as a system or in a single pack. Prior to use, the physician will advance the delivery catheter over the distal protection apparatus until the only the distal section of the wire extends out of the distal end of the delivery catheter. The delivery catheter could have an attached or removable port to allow the physician to flush the catheter with saline or other appropriate fluid prior to use.
The apparatuses of this disclosure are useful in a number of clinical situations. Lesions, including thrombotic occlusions, in the superficial femoral artery (SFA), common femoral artery, popliteal artery, iliac artery, iliac bypasses, or femoropopliteal (fem-pop) bypasses may be treated with the apparatus described here. Vessels that extend off the aortic arch such as the brachiocephalic artery, the right and left common carotid artery, brachiocephalic trunk, brachial branch, and the left subclavian artery can be treated with these devices. The apparatus described herein is also useful in the venous system and can be used to treat lesions in the iliac, femoral, popliteal, brachial, subclavian, axillary, innominate veins, and in the Inferior Vena Cava as well as Superior Vena Cava. Depending on the clinical requirements, either a radial, brachial, subclavian, pedal, proximal tibial, or femoral access can be used.
While many of the examples herein show and describe the devices and methods being used and performed in the vascular system, the devices and methods have applicability to non-vascular lumens.
The retrieval catheter, delivery catheter, and embolic protection apparatus will be constructed from materials that are known in the art. The delivery and retrieval catheters may have a multilayer or single layer construction. In a multilayer construction, the catheter could have a polymer inside layer, surrounded by a support structure such as a metal braid which in turn is surrounded by an outer polymer layer. Either catheter could have a flexibility that is consistent over the length of the catheter or could have increased flexibility at the distal end. Alternatively, the catheters could be made from a single or multi-stream extrusion, with or without an internal support structure. When one or both of the delivery and retrieval catheters have one or more marker bands, the marker bands can be formed of any radiopaque material and be in the form of a ring attached to either the internal or external surface, embedded in the internal or external surface so that they are flush with the surface, embedded within the wall structure of the catheter, or be a radiopaque agent mixed with the plastic of the catheter. One or both of the delivery and retrieval catheters can have a distal tip that is softer and/or more flexible that the body of the catheter. The embolic protection filter wire can be constructed of superelastic materials, nitinol, stainless steel, cobalt-chromium-nickel-molybdenum-iron alloy, or cobalt-chrome alloy, or a combination thereof. In embodiments where the basket and/or distal section(s) of the wire have a lesser diameter than the proximal section, the smaller diameter can be achieved by grinding or milling of the wire or by attaching a smaller diameter wire to the distal end of a larger diameter wire. The expandable loop can be constructed from superelastic materials, nitinol, stainless steel, cobalt-chromium-nickel-molybdenum-iron alloy, or cobalt-chrome alloy, or a combination thereof.
The porous filter can be fabricated from a variety of different materials, such as, but not limited to, a woven or braided plastic or metallic mesh, a perforated polymer film, a shape memory material or mesh, combinations thereof, or other material that can be capable of capturing material within flowing blood, while allowing the blood to flow through the pores of the material. In some embodiments the porous filter comprises polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyurethane, polyolefin elastomers, polyamides, nylons, polyethers, polyamide block ethers (PEBAX), polyesters, and/or co-polyesters. In some embodiments the filter material has a thickness of 0.001 inches (25 microns) and the material has an 85A Shore A Hardness. In some embodiments the porous filter can be woven or braided into a mesh and can be made from polyester, polyamide, polyurethane, nitinol, or stainless-steel filaments. The porous filter can have a variety of differently sized pores ranging from about 50 microns to about 200 microns, from about 60 microns to about 180 microns, or from about 75 microns to about 150 microns. For some applications, the pores can be sized up to 250 microns. The pores can have a variety of different configurations and can be circular, oval, polygonal, combinations thereof and the porous filter can include pores that are differently sized and configured. In practice, the pore size can vary as needed, so long as the pores are sized so that the pores do not compromise blood flow through the filter and collect emboli that can adversely affect downstream vessels. The porous filter can be coated with a hydrophilic coating, a heparinized coating, PTFE, silicone, combinations thereof, or other coatings. In some embodiments, the porous filter can be attached to the expandable loop by dip coating. In some embodiments, the porous filter can be attached to the expandable loop by being wrapped around the loop and then attached to itself, for example being sealed with heat or through an adhesive.
In some embodiments, the retrieval catheter will have a length of 120 to 140 cm with an outside diameter between 0.07 and 0.09 inches, preferably about 0.08 inches and with an inside diameter between 0.065 and 0.085 inches preferably about 0.07 inches. In some embodiments the delivery catheter will have a length of about 260 to 300 cm with an outside diameter between 0.06 and 0.08 inches preferably 0.06 inches and an inside diameter between 0.04 and 0.075 inches preferably 0.055 inches. In some embodiments, the catheter itself will have a length of 120 to 140 cm and the proximal wire will have a length of 120 to 160 cm. In some embodiments, the embolic protection device will have a length of 260 to 300 cm. In some embodiments, the wire will have a diameter of 0.035 inches. In embodiments where the basket and/or distal sections have a smaller diameter, they can have a diameter of 0.018 or 0.014 inches. In some embodiments where the delivery catheter is angled, the angled section 114 can be located 1 cm from the distal tip. In embodiments where the delivery catheter has one or more radiopaque markers, the distal marker can be located 1 cm from the distal end and the proximal band, if any, will be located 5 cm from the distal end. In some embodiments where the retrieval catheter is angled, the angled section 114 can be located 2 cm from the distal tip. In embodiments where the retrieval catheter has one or more radiopaque markers, the distal marker can be located 2 cm from the distal end. In embodiments where the distal section of the retrieval and/or delivery catheter are angled, they can be angled between 10 and 30 degrees away from the longitudinal axis of the catheter.
Although specific embodiments have been illustrated and described herein, those of ordinary skill in the art will appreciate that an arrangement calculated to achieve the same results can be substituted for the specific embodiments shown. For example, where the disclosure may show a system or a method with one example of a distal protection device, any distal protection device can be used including those disclosed herein. This disclosure is intended to cover adaptations or variations of one or more embodiments of the present disclosure. It is to be understood that the above description has been made in an illustrative fashion, and not a restrictive one. Combination of the above embodiments, and other embodiments not specifically described herein will be apparent to those of skill in the art upon reviewing the above description. The scope of the one or more embodiments of the present disclosure includes other applications in which the above structures and processes are used. Therefore, the scope of one or more embodiments of the present disclosure should be determined with reference to the appended claims, along with the full range of equivalents to which such claims are entitled.
In the foregoing Detailed Description, some features are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the disclosed embodiments of the present disclosure have to use more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment.
In some embodiments, a lesion crossing device, and/or a method comprising using a lesion crossing device, is described according to the following numbered paragraphs:
1. A system for providing access to a lumen comprising:
This application claims the benefit of U.S. Patent Application No. 63/128,593, filed Dec. 21, 2020, the entire content of which is hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63128593 | Dec 2020 | US |
