WO2019089821A1

WO2019089821A1 - Embolic protection devices and methods of embolic protection

Info

Publication number: WO2019089821A1
Application number: PCT/US2018/058546
Authority: WO
Inventors: Max P. MENDEZ; William W. O'neill; Pedro MARTINEZ-CLARK; David D. KNOPF
Original assignee: Miami Medtech Llc
Priority date: 2017-10-31
Filing date: 2018-10-31
Publication date: 2019-05-09

Abstract

An embolic protection device that includes an expandable frame that provides structural integrity to the entire device, secures the device in a desired location, and functions as an attachment site for a filter. The device can be used throughout the cardiovascular system.

Description

EMBOLIC PROTECTION DEVICES AND METHODS OF EMBOLIC PROTECTION

CROSS-REFERENCE TO RELATED APPLICATIONS

[001] This application claims the benefit of U.S. Provisional Patent Application No. 62/579,816, filed October 31, 2017, the entire disclosure of which is incorporated herein by reference.

BACKGROUND

Field of the Invention

[002] The present invention lies in the field of embolic protection and filtration devices. This invention relates generally to embolic protection devices and methods for the prevention of emboli such as left atrial thrombus (LAT), from entering systemic circulation. By capturing emboli, this device reduces the chance of stroke occurrence, coronary embolism (CE), and other general embolic symptoms, from occurring during intra-cardiac procedures such as: left atrial ablation therapy, resynchronization, mitral valve repair or replacement, left atrial appendage closure, and left atrial defect closure.

[003] The presence of an LAT is a pathology considered complex to manage because it is associated with many other morbid conditions and complications. The most severe complication due to LAT is an intra-procedural systemic embolization including stroke. For that reason, stroke assessment scores have been developed around the world such as CHADS2 Score for atrial fibrillation (AFib) related stroke risk. Patients are assessed based on the CHADS2 or CHA2DS2-VASc score, which determines if the patient receives oral anticoagulation (OAC) therapy for a variable period of time. It is important to note that receiving OAC therapy does not insure the necessary intra-cardiac procedure will be performed.

[004] Despite the proven relative efficacy of OACs, some patients are not candidates for chronic OAC use, and new procedures were developed in response. In 2002 the Amplatzer Cardiac Plug (AGA, St. Jude Medical) was used for occlusion of an atrial septal defect (ASD) or a patent foramen ovale (PFO) and subsequently it was adapted for left atrial appendage (LAA) occlusion in 2008. In 2013 the FDA approved the WATCHMAN (Boston Scientific) LAA closure device which has been established by both the Rhythm and Cardiac Pacing and the Atheroma and Interventional Cardiology journals as an eligible therapy in some patients. However, the WATCHMAN is currently considered an alternative to OAC therapy for LAA thrombus only; OAC still remains the primary therapeutic choice.

[005] Nevertheless, cerebral protection devices have been in constant development owing to the high prevalence of strokes associated with intra-cardiac procedures. Some of these new cerebral protection devices have been developed for deployment within the aortic arch itself, as well as most if not all of the cerebrovascular conduits. Examples of these devices are: TRIGUARD (Keystone Heart) which functions as a metallic deflection device for the aortic arch. It does not capture emboli, nor does it prevent peripheral embolization.

[006] POINT-GUARD (TransVerse) which is similar to the TRIGUARD with the added ability to capture emboli. This device also deflects emboli to the periphery.

[007] Sentinel CPS (Claret Medical) protects both the brachiocephalic conduit and left common carotid artery. It does not protect the left subclavian artery nor the periphery. Additionally, this device can both capture and filter emboli rather than deflect.

[008] Emblok (ICS) which is the only aortic arch filter that protects not only cerebrovascular conduits, but the periphery as well. In addition, it is also a capture and filtration device, rather than a deflection device.

[009] All of these devices can be used in procedures such as transcatheter aortic valve replacement (TAVR), Mitral valve repair and replacement (MVR/TMVR), and LAA closure and ablation. However, some of these devices do not protect the peripheral vascular system, and none of them confer any protection for the coronary arteries.

[010] Between compounding evidence correlating intra-cardiac procedures and embolic risk, and the lack of devices that provide full protection to all vulnerable vessels, the need for a specialized protection device is increasingly obvious. This is especially true of the peripheral vascular system and the coronary arteries, where embolic risk is not assessed to the same extent as stroke risk nor has it been a targeted region for protection. It is these core assessments that will directly influence the direction of this device as a comprehensive embolic protection device.

SUMMARY

[011] The invention provides systems and methods of embolic protection that overcome the previously-mentioned disadvantages of the heretofore-known devices and methods of this general type. [012] One exemplary system and method herein utilizes an embolic protection device intended for deployment in the left ventricular outflow tract (LVOT) of the left side of the heart, infra-annular to the aortic valve. As used herein, an "embolic protection device" is a structure containing either a mesh material, or microporous material in a "windsock" or paraboloid configuration, for the purpose of containing any obstructive vascular materials. Obstructive vascular materials can be any thrombus (i.e. "blood clot") or embolus (i.e. any material with obstructive potential) present in active blood flow or other materials such as, but not limited to embolic materials, surgical materials, or any combination thereof. The embolic protection device includes two major portions; an expandable frame, and a filter. As used herein, a "filter" is a material with pores large enough to allow major components of the blood through, while still preventing the flow of thrombus or emboli; it facilitates the main function of any filtration and protection device. The expandable frame is a band of material with the capabilities of being compressed in a delivery device, expanding to meet the diameter of the LVOT, generating enough force to anchor in the LVOT, and can be recaptured within in the same delivery device. The frame will also serve as the attachment site for the filter, aiding it in full expansion for its working state. The filter is constructed out of either a lattice of memory shaped metal, creating a mesh structure, or either a material that is inherently porous or a material that has been intentionally made porous. The filter will be affixed to the frame and when fully expanded will have either a paraboloid or "windsock" shape. The maximum length of this section will be such that it does not impede aortic valve function, yet provides adequate surface area for capture and filtration from within the LVOT.

[013] An additional feature is a frame link that is tethered to the frame either centrally or peripherally, and extends to the access point, allowing an operator to control the navigation of the filtration device. An additional feature is a central tube which can aid in both the navigation of the device and the deployment of the device by allowing passage of a guidewire. As used herein, a "guidewire" is a thin wire of variable flexibility and structure for the purpose of insertion and navigation of the human cardiovascular system under fluoroscopic guidance. The guidewire additionally aids in the navigation of a component or device that can be passed along the outer diameter of the wire (i.e. a rail-like system). An additional feature is a catheter designed for both the navigation and deployment of the embolic protection device. As used herein, a "catheter" is a tubular structure containing a central hollow space (i.e. lumen) and a flexible outer wall, for the purpose of insertion and navigation of the human cardiovascular system under fluoroscopic guidance. This catheter can be flexible, semi-rigid, articulable, or contain additional features that aid in the deployment of the embolic filtration device. The major functions of this catheter are to gain access to the LVOT in an atraumatic fashion, to maintain the collapsed state of the device until deployment, and to recapture the device once the procedure is completed.

[014] The method of use for this device is as follows: after vascular access is attained and the operator has navigated into the left ventricle, the embolic protection device is then tracked along with the guidewire into the LVOT, where the device is locked in place preventing operator movement. Upon securing the device, the protection device is deployed, positioned and anchored. The expansion forces of the frame will then secure the device into LVOT via non-traumatic force. Once the intended procedure is completed the device is collapsed and retrieved into the deployment catheter. Upon recapture of the device, both the catheter and the device within are removed from the patient.

[015] In some embodiments, the devices do not use a guide wire. In such embodiments, the device can be delivered through a sheath rather than over a guidewire. However, in some embodiments, both a sheath and a guidewire can be used.

[016] Another exemplary embodiment of an embolic protection device is composed of an inflatable bladder structure having a collapsed deflated state, a partially inflated state and a fully inflated state. The collapsed deflated state of the structure's size is adequate enough to package within delivery catheter and partially inflated state allows for positioning in the desired blood flow path. A fully inflated state allows full opposition of sealing surfaces around the perimeter of the blood flow path as well as anchoring the device in place. The inflatable structure can be made from compliant or non-compliant material and the amount of inflation can be governed by volume or pressure. The bladder frame structure is globally sealed with one fill port opening to facilitate infusion of fluids. The bladder frame also can have another opening as an output port to serve as a transfer port for infusion fluids during fluid exchanges or to meter fill level. Temporary inflation can be done by a constantly liquid biocompatible material such as saline. Radiopacity can be gained by using a radiopaque fluid such as fluoroscopic contrast. Constant implantable inflation by the liquid material can be gained by selectably closing the fill port and the transfer port. Additionally, constant implantable inflation by way of fluid allows for deflation, device removal, and reentry at a later time. Fluid can be pulled into the reentry device or be absorbed into the body. Alternatively, an infusion medium that becomes solid, such as a two-part epoxy can be used to inflate the frame and will thereafter remain rigid without the use of valves. If the bladder frame is inflated by a fluid, it can be deflated by pulling a vacuum on the ports to remove the inflation fluid. A sealing cuff material can be attached to the bladder frame or they can be one in the same by virtue of both members needing to be impermeable and flexible materials. Fluid transferred up to the frame travels through channels that can also serve as attachment and detachment members to the delivery system by way of a user-controlled connection. Such connections can be press fit joints, screwed attachments, or have secondary release members. A hand-driven syringe or pump with reservoir feeds inflation channels. The device can be manufactured from a single sheet of material with a central perforated section to form the filter and a folded and bonded edge to create a fluid tight cavity. Alternatively, the device can be manufactured from multiple layers of material that are shaped and bonded to form inflatable sections. The multiple layers can be of different materials with unique properties. For example, a compliant polymer can be used for a variably sized frame while a non- compliant polymer used for the filter and as structural reinforcement to the compliant section. Also, known fabrics can be used to surround sealing areas. Additionally, a single porous fabric can be used for the overall device and the sealed inflation frame created by slathering rubber to seal the fabric pores. Contained within the sections can be springs or rigid components that can aid in the expansion, collapse or strength of the inflatable frame. Possible anatomical locations of device placement are known to have various size ranges. The LVOT for example has an average range of 20-30mm in equivalent diameter in adult humans. A compliant inflatable structure can conform to that range, illuminating the need for different sizes devices.

[017] Various methods such as self-expanding spring loaded frames, balloon inflation and mechanical linkage mechanisms can be used in order to actuate the device from a collapsed and packaged configurations contained within the delivery catheter to an expanded condition. Such methods can exhibit simple, predictable and quick actuation.

[018] In greater detail the expandable cuff can be comprised of multiple embodiments, each structured to aid in the proper expansion and sealing of the device along the walls of the region of deployment. One such embodiment is a self-expanding cuff made from a shape set or expanding material that produces enough radial force to secure itself along the wall. Herein, "radial force" describes force produced in a ring or circular fashion that creates a securing pressure that prevents movement of a structure. The aforementioned self-expanding cuff structure can also contain a sealing member along the proximal perimeter of the device. This sealing member can prevent the flow of blood around the device, therefore preventing any additional emboli from moving past the device without capture. One such embodiment of the sealing member is the expanding cuff itself, which is able to both expand and conform to the surrounding tissues. This can be accomplished by using a material that is semi-compliant which is able to expand to its full size while still conforming to the site of implantation. An additional embodiment contains an external balloon ring along the expanding cuff of the device. The structure and function would be reminiscent of the aforementioned inflatable bladder construction. However, this would be located solely along the proximal perimeter of the device. Additional embodiments can also contain a rigid frame which forcibly implants into the surrounding tissue, creating a tight seal, or a foam cuff that is deformable yet remains rigid enough to prevent flow past the device. All of these embodiments serve the ultimate purpose of preventing any blood flow from moving past the device, which would greatly undermine its performance.

[019] In greater detail, the microporous filtration net is a primary functional member of the device, providing both filtration from thrombi and emboli, along with capture of these deposits. Herein, the "microporous" nature of this net is described as a length of fabric or weave of metal material that exhibits openings along area, for example layers of random or predetermined wires, where open area between wires defines pores. In one embodiment, the filtration net can be formed of any material having an inherent porosity. Such materials can be Polytetrafluoroethylene (PTFE), Polyethylene terephthalate (PET), or any other biocompatible material that inherently meets the porosity requirements. This embodiment has the benefit of a low profile material and in the case of PTFE, a low friction material. In addition, the fabric nature of these materials allow it to be woven into the frame as an alternative to crimping, suturing, or any other means of securing the material. Additionally, PTFE and PET are both biocompatible. An additional embodiment is one where the filtration net is comprised of a material that has been rendered porous via perforation. In one embodiment, the material can be a polymer sheet that has had the required pore sizes laser drilled into the material. This embodiment benefits from increased flexibility which can be tailored to the necessary requirements. A further embodiment is a metallic mesh that has been woven to create the pore requirements without the necessity for perforation or inherent porosity. This final embodiment has the added benefit of being comprised of a memory shaped metal, allowing it to be compressed to be a smaller size. An additional benefit of this metallic mesh is the possibility of it being an extension of the frame itself, or formed from a single length of material, reducing the need for welding, crimping, or any other additional structural components.

[020] In some embodiments, the herein described devices can completely contain any emboli or debris captured with the filter within the device. During device retrieval, methods such as a spring loaded filter basket, or mechanism that close the filter basket before complete retrieval can be implemented. The embolic protection device will be exposed to cyclic fluid forces driven by the systolic and diastolic functions of the heart. An encapsulating lattice frame opposing the filter can be used to further trap any debris that may dislodge from filter during diastole. Alternatively, a multi chambered filter can be used to allow debris to enter a self-closing or narrowed filter basket portion. Additionally, the device can contain a one-way valve similar to the aortic valve in series with the filter allowing debris to enter the valve, be trapped by filter and not allowed to escape the closing valve. This valve can also replace or assist the native aortic valve during use.

[021] An additional feature of the herein described devices includes hook-like projections on the metallic framework. These hook-like projections can be pointed inwards toward the apex of the filtration net, which can allow them to remain atraumatic to the surrounding tissue. The purpose of these hooked projections is the capture and restraint of embolic materials. The size and number of these projections can vary dependent on the construction of the device as well as the materials used. In addition, the projections can either be flat- tipped, serrated, or blade-tipped in order to improve capture and restriction of emboli. In one embodiment, the projections can be aligned along a semi -flexible region within the filtration device. The region can continually flex during implantation due to dynamic nature of the cardiovascular system. These "micro-flexures" can then repeatedly drive the projections into a captured embolus, therefore latching them into the device, and preventing them from re- embolization during removal. Herein, "micro-flexures' refer to the flexing motion on a small section of flexible material while it is undergoing stress. The aforementioned projections can either be attached to the device, or manufactured as extensions from the region it is located.

[022] The embolic protection device used in the LVOT requires features to connect the frame to the delivery catheter. These frame links can be configured to be low profile and nontraumatic to the native functioning aortic valve. To do this, the transition from frame to delivery catheter can be completely contained within the LVOT, the frame or below the aortic valve. These frame links can be formed as extensions of the frame or made of different materials or stock. Frame links can also be configured using pivot joints allowing low profile transition sections without bend radiuses. These features can be made from rigid materials or a combination of flexible materials in order to conform to the aortic valve. Alternatively, the embolic protection device can contain a functioning valve in order to replace or assist the native aortic valve function.

[023] The embolic protection device can be configured for perioperative function as well as ambulatory, short term, or permanent implantation. The deployment catheter can be configured to be non-obtrusive or modular to allow for short term or ambulatory use similar to central venous catheters used for days or weeks. Permanent implantation can also be facilitated by completely detaching the device from the deployment catheter but can be removed using a retrieval device by engaging retrieval features such as hooks, then collapsing into a catheter for complete removal.

[024] Complete embolic protection of the arterial system can be achieved by placing the embolic protection device proximal of the first arterial conduit within the aorta, the coronary arteries. Therefore, placing the embolic protection device over the aortic valve, in the LVOT or in the left ventricle provide the best protection from emboli or debris generated from the mitral apparatus, LAA or anywhere upstream. However, other locations of protection can be superior of the mitral valve to prevent any debris generated upstream from the mitral valve. Alternatively, placing the embolic protection device at the LAA ostium will protect the arterial system from any emboli generated within the LAA. Additionally, similar or localized embolic protection can be achieved by placement of the device in additional regions of the cardiovascular system such as, the ascending aorta, aorta, vena cava, venous system or any location of the right side of the heart. Various locations are also selected dependent on the interaction with the complimenting procedure.

[025] Embodiments described refer generally to structures that are concentric between the frame, filter deployment catheter, and deployment location. This is due to the possible access locations. Arterial retrograde access through the aortic valve and into the left ventricle is desired for LVOT placement. However, for deployment locations such as superior to the mitral valve or at the LAA ostium, the deployment access is best achieved through the atrial septum. Therefore, the deployment catheter is best configured as partially perpendicular to the central axis of the filter. In such an embodiment, a rotating closed, clam shell type filter basket can be used in order to improve the containment of debris in a perpendicular type of filter. Such a mechanism can be achieved in a single linear motion by using a two-piece wire frame basket whose free ends are contained within the deployment catheter and apposing ends pivot with respect to the central basket axis, and the free ends engage a twisted cam track within the catheter. Hence, pulling the free ends rotate the two-piece frame into each other causing the clam shell effect.

[026] The overall diameter of catheter based devices can be as low profile as possible to allow passage through small vessels, prevent damage to small vessels, and exhibit flexibility and tractability. In order to maintain a low packaged diameter, the embolic protection device can be packaged with its components in a separated and staggered configuration. At time of deployment, the components such as frame and filter can join together to form one structure. Similarly, an embolic protection device can be achieved using a stacked array of radial beams that when brought together create an interdigitated matrix of openings. This can be achieved by different diameters of laser cut nitinol tubes whose cut lattices are flared out to form a generally circular filter and frame. Alternatively, the collapsing function of the embolic protection device can be achieved by mechanism without the need for an outer tube, thereby removing the outer tube wall thickness.

[027] Various rail methods can be used in order to place the device into its deployment location, such as the deployment catheter containing a central tube for a guidewire or once an open lumen deployment catheter is advanced over a guidewire, then the guidewire can be removed and a protection device advanced through central lumen. Alternatively, the deployment catheter can contain a guidewire lumen that is generally inboard but is diverted outside of the collapsed device section then back into the catheter lumen. Additionally, the end of the delivery catheter can be configured as a non-traumatic shape such as a semi rigid curl.

[028] It is important for adequate hemodynamic function of the blood flow path be maintained and unobstructed. To achieve this, matching the flow path effective orifice area to the filter effective orifice area can be achieved by increasing the cross-sectional area of the filter with respect to the natural flow path orifice. In an LVOT location the filter can be elliptical and angled with respect to the LVOT to achieve a greater area.

[029] Sensors such as hemodynamic, pressure, flow and electronic (e.g. electrocardiographic sensors) can be attached to the embolic protection devices to monitor perioperative conditions. Additionally, levels of either coagulative factors or endogenous neuromodulators and catecholamines, both of which can be sensed to monitor the cardiovascular environment. The purpose of these sensors would be to both inform the operators of the internal environment intra-procedurally, as well as provide information that may be essential to the reduction or elimination of the morbidity and mortality encountered during procedures with embolic risk.

[030] It would be advantageous to use the same embolic protection platform as embolic protection procedures progress and as new locations are discovered. The protection devices and methods described herein require minor changes to comply with different locations and are, therefore, independent of future research in the field of embolic protection.

[031] In some embodiments, embolic protection devices are described that include an expandable frame configured to engage a vessel wall and prevent movement of the embolic protection device; and a filter configured to prevent passage of obstructive vascular materials. In some embodiments, the expandable frame and filter are configured to be deployable and retractable through a catheter.

[032] In some embodiments, the expandable protection device is configured to transition between a collapsed state, a partially deployed state, and a fully deployed state.

[033] The obstructive vascular materials can be thrombus, emboli, embolic materials, surgical materials, or a combination thereof.

[034] In some embodiments, the expandable frame includes at least one fillable portion. In other embodiments, the expandable frame includes two fillable portions. The at least one fillable portion can include a contoured profile. Further, the at least one fillable portion can be cylindrical. The at least one fillable portion can be collapsed in the collapsed state, partially inflated in the partially deployed state, and fully inflated in the fully deployed state.

[035] In some embodiments, the filter includes a lattice structure and/or a spring configured to close the filter before retrieval. In other embodiments, the filter is formed of a porous material. The porous material can be formed by adding pores to a non-porous material. In other embodiments, the filter is a mesh material and that mesh material can be nitinol.

[036] In some embodiments, the filter has a parabolic shape when configured in the fully deployed state.

[037] In some embodiments, the frame has an axial length that is less than a distance from a proximal end of the embolic protection device to a functional location of an aortic valve.

[038] In some embodiments, the embolic protection device can further include at least one of a spring loaded frame, an inflatable balloon, a mechanical linkage mechanism, or a combination thereof configured to actuate the embolic protection device from the collapsed state to the fully deployed state. In some embodiments, the embolic protection device can further include an encapsulating lattice frame opposing the filter.

[039] In some embodiments, the filter can be a multi chambered filter.

[040] In some embodiments, the embolic protection device can further include an artificial valve and/or a guidewire path.

[041] In some embodiments, the embolic protection device can further include a one-way valve configured to allow obstructive vascular materials to enter the one-way valve, be trapped by the filter, and not allowed to escape the one-way valve.

[042] In some embodiments, the filter is a rotating closed, clam shell filter basket. In other embodiments, the filter can extend through an aortic valve and passively oscillate with the aortic valve.

[043] Methods of manufacturing the embolic protections are also described. The methods can comprise cutting holes at a proximal end of a tapered balloon to form the filter; radially cutting a distal end of the tampered balloon thereby creating an open end; and folding the open end toward the proximal end to form the expandable frame. In some embodiments, the methods further include bonding edges of the expandable frame.

[044] Methods of deploying the embolic protection devices are also described. The methods can comprise deploying the embolic protection device through the atrial septum or the aortic valve; and expanding the expandable frame against a cardiac wall thereby deploying the filter. In some embodiments, the embolic protection device can be deployed through the aortic valve and expanded into the LVOT. In another embodiment, the device can be deployed through the atrial septum to a location superior to the mitral valve or at the left atrial appendage ostium.

[045] Additional advantages and other features characteristic of the present invention will be set forth in the detailed description that follows and may be apparent from the detailed description or may be learned by practice of exemplary embodiments. Still other advantages may be realized by any of the instrumentalities, methods, or combinations particularly pointed out in the claims.

[046] Other features that are considered as characteristic are set forth in the appended claims. As required, detailed embodiments are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary, which can be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one of ordinary skill in the art to variously employ the present invention in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the invention. While the specification concludes with claims defining the features of the invention that are regarded as novel, it is believed that the invention will be better understood from a consideration of the following description in conjunction with the drawing Figures, in which like reference numerals are carried forward.

BRIEF DESCRIPTION OF THE DRAWINGS

[047] The accompanying figures, where like reference numerals refer to identical or functionally similar elements throughout the separate views, which are not true to scale, and which, together with the detailed description below, are incorporated in and form part of the specification, serve to illustrate further various embodiments and to explain various principles and advantages all in accordance with the present invention. Advantages of embodiments of the present invention will be apparent from the following detailed description of the exemplary embodiments thereof, which description should be considered in conjunction with the accompanying drawings in which:

[048] FIG. 1 is a fragmentary illustration of a human aortic root;

[049] FIG. 2 is a fragmentary illustration of a human heart with an embolic protection device placed in the left ventricular outflow tract (LVOT);

[050] FIG. 3 is a fragmentary illustration of a human heart with an embolic protection device placed superior of the mitral valve;

[051] FIG. 4 is a fragmentary illustration of a human heart with an embolic protection device placed at the left atrial appendage ostium;

[052] FIG. 5 is a fragmentary, isometric view of an embolic protection device;

[053] FIG. 6 is a fragmentary, cross-sectional view of an embolic protection device;

[054] FIG. 7 is a fragmentary, isometric view of an embolic protection device;

[055] FIG. 8 is a fragmentary, cross-sectional view of an embolic protection device exhibiting a single piece inflatable frame and filter; [056] FIG. 9 is a fragmentary, cross-sectional, isometric view of an embolic protection device exhibiting a single piece inflatable frame and filter;

[057] FIG. 10 is a fragmentary, isometric view of an embolic protection device exhibiting a single piece inflatable frame and filter;

[058] FIG. 11 is a fragmentary, perspective view of an embolic protection device exhibiting a lattice frame;

[059] FIG. 12 is a fragmentary, side view of an embolic protection device including a valve;

[060] FIG. 13 is a fragmentary, isometric view of an embolic protection device including a valve;

[061] FIG. 14 is a fragmentary, top view of FIG. 12;

[062] FIG. 15 is a fragmentary, isometric view of an expanded embolic protection device that is generally perpendicular to the central axis of the deployment catheter;

[063] FIGS 16 is a fragmentary, isometric view of a partially expanded embolic protection device from FIG 15;

[064] FIG 17 is a fragmentary, side view of a partially expanded embolic protection device including layered filter;

[065] FIG 18 is a fragmentary, side view of an expanded embolic protection device from FIG 17;

[066] FIG 19 is a fragmentary, top view of an expanded embolic protection device from FIG 17;

[067] FIG 20 is a fragmentary, cross-sectional, side view of an embolic protection device exhibiting a valve below a filter;

[068] FIG 21 is a fragmentary, perspective view of an embolic protection device exhibiting a closed lattice frame below a filter;

[069] FIG 22A is a fragmentary, cross-sectional view of an embolic protection device exhibiting a multiple chamber filter; FIG. 22B and 22C illustrate a filter that can be placed across a valve; FIG 22D illustrates a filter with preformed creases that can be placed across a valve; FIG 22E is an illustration of an example device with a contoured shape. [070] FIG 23 is a fragmentary, cross-sectional, side view of an embolic protection device exhibiting a collapsed, staggered filter and frame;

[071] FIG 24 is a fragmentary, perspective view of an embolic protection device exhibiting an expanded and staggered filter and frame;

[072] FIG 25 is a fragmentary, perspective view of an embolic protection device exhibiting a fully expanded filter and frame;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[073] As required, detailed embodiments of the systems and methods are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the systems and methods, which can be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the systems and methods in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the systems and methods. While the specification concludes with claims defining the features of the systems and methods that are regarded as novel, it is believed that the systems and methods will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward.

[074] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration embodiments that may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of embodiments is defined by the appended claims and their equivalents.

[075] Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplary embodiments of the systems and methods will not be described in detail or will be omitted so as not to obscure the relevant details of the systems and methods.

[076] Before the systems and methods are disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms "comprises," "comprising," or any other variation thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises ... a" does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element. The terms "including" and/or "having," as used herein, are defined as comprising (i.e., open language). The terms "a" or "an", as used herein, are defined as one or more than one. The term "plurality," as used herein, is defined as two or more than two. The term "another," as used herein, is defined as at least a second or more. The description may use the terms "embodiment" or "embodiments," which may each refer to one or more of the same or different embodiments.

[077] The terms "coupled" and "connected," along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Rather, in particular embodiments, "connected" may be used to indicate that two or more elements are in direct physical or electrical contact with each other. "Coupled" may mean that two or more elements are in direct physical or electrical contact (e.g., directly coupled). However, "coupled" may also mean that two or more elements are not in direct contact with each other, but yet still cooperate or interact with each other (e.g., indirectly coupled).

[078] For the purposes of the description, a phrase in the form "A/B" or in the form "A and/or B" or in the form "at least one of A and B" means (A), (B), or (A and B), where A and B are variables indicating a particular object or attribute. When used, this phrase is intended to and is hereby defined as a choice of A or B or both A and B, which is similar to the phrase "and/or". Where more than two variables are present in such a phrase, this phrase is hereby defined as including only one of the variables, any one of the variables, any combination of any of the variables, and all of the variables, for example, a phrase in the form "at least one of A, B, and C" means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C).

[079] Relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The description may use perspective-based descriptions such as up/down, back/front, and top/bottom. Such descriptions are merely used to facilitate the discussion and are not intended to restrict the application of disclosed embodiments. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding embodiments; however, the order of description should not be construed to imply that these operations are order dependent.

[080] As used herein, the term "about" or "approximately" applies to all numeric values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of skill in the art would consider equivalent to the recited values (i.e., having the same function or result). In many instances these terms may include numbers that are rounded to the nearest significant figure.

[081] Herein various embodiments of the systems and methods are described. In many of the different embodiments, features are similar. Therefore, to avoid redundancy, repetitive description of these similar features may not be made in some circumstances. It shall be understood, however, that description of a first-appearing feature applies to the later described similar feature and each respective description, therefore, is to be incorporated therein without such repetition.

[082] Described now are exemplary embodiments. Referring now to the figures of the drawings in detail and first, particularly to FIG. 1, there is an anterior view of the human aortic root, including the LVOT 1, aortic valve 2, coronary arteries 3, with a representation of an embolic protection device 4 placed in the LVOT.

[083] FIG. 2 is an anatomical diagram of the anterior view of a human heart with a representation of an embolic protection device 4 placed in the LVOT.

[084] FIG. 3 is an anatomical diagram of the anterior view of a human heart with a representation of an embolic protection device 5 placed superiorly over the mitral valve 6.

[085] FIG. 4 is an anatomical diagram of the anterior view of a human heart with a representation of an embolic protection device 7 placed over the ostium of the left atrial appendage 8.

[086] FIG. 5 is a fragmentary, isometric view of an embolic protection device 4 including a frame 10 that establishes the structural integrity of the protection device and is connected to a central tube 12 by frame links 11. The central tube features a central lumen to allow the passage of an assistant device such as a guidewire. The intent of the protection device is to occlude and generally divert blood flow through a filter. A sealing cuff 13 is shown in order to seal against the perimeter of flow path and prevent bypass of flow around filter. [087] FIG. 6 is a fragmentary, cross-sectional view of an embolic protection device 4. The deployment catheter 14 shown is generally hollow and is able to house a collapsed protection device and recapture a deployed protection device. The embolic protection device includes a filter 15 shown as a parabolic membrane with an array of through holes. Fig 7 shows the assembly described in Fig. 5-6 with a flexible and retroflexed delivery catheter section needed to track across the aortic arch.

[088] FIG. 8 is a fragmentary, cross-sectional view of an embolic protection device exhibiting a single piece inflatable frame and filter 16. The device can be manufactured from a single sheet of material with a central perforated section to form the filter and a folded edge to create a fluid tight cavity 17. The cavity can be inflated using pressurized saline or radiopaque material in order to expand the device from its collapsed and packaged configuration into a predetermined shape.

[089] FIG. 9 is a fragmentary, cross-sectional, isometric view of an embolic protection device exhibiting a single piece inflatable frame and filter. In addition is a cross-sectional view of the fill port 18 where either pressurized saline or a radiopaque material is infused in order to inflate the device from its collapsed configuration.

[090] FIG. 10 is a fragmentary, isometric view of an embolic protection device exhibiting a single piece inflatable frame and filter in its nominal expanded state.

[091] FIG. 11 is a fragmentary, perspective view of an embolic protection device exhibiting a lattice frame in its nominal expanded state. The lattice frame can be manufactured from a single sheet of material and memory set to the described pattern and is flexible enough to be recaptured.

[092] FIG. 12 is a fragmentary, side view of an embolic protection device including a valve 19 that is capable of mimicking the native aortic valve while implanted. Also included is a circumferential shield 20 that maintains the valvular conduit to ensure blood flow is directed properly.

[093] FIG. 13 is a fragmentary, isometric view of an embolic protection device without the circumferential shield, exposing the aforementioned valve. Also included is the three spoke valve frame 21 that allows for suspension of the valve leaflets, and the hinge point 22 where the valve is connected to the frame.

[094] FIG. 14 is a fragmentary, top view of FIG. 12 with all components included. [095] FIG. 15 is a fragmentary, isometric view of an expanded embolic protection device that is generally perpendicular to the central axis of the deployment catheter and has a clamshell closure filter mechanism 100. The filter 104 frame is composed of a central member 102 and opposing outer members 101 that are joined to a pivot 103. Within the frame a filter 104 is supported. The central member is connected to an activation member 105. FIG 16 is a partially collapsed or expanded embolic protection device 100. When pulling or pushing activation member 105, the frame translates within a deployment catheter section 106 that twists the outer members 101 toward or away from one another, thereby closing or opening the filter basket.

[096] FIG 17 is a fragmentary, side view of a partially expanded embolic protection device including layered filter 110. The layers are composed of radial beam arrays in series that overlap or are in series while packages within the deployment catheter. These layers are stacked on top of one another in the expanded condition 112 as shown in FIG 18 and exhibit open areas between the beam stack to create the filter pores 112 as shown in FIG 19. Shown are linear beam arrays, however, diamond patterns or alike can be used to define openings. This embodiment is packaged in a low profile and when expanded forms a rigid frame and filter out of easily manufactured components.

[097] FIG 20 is a fragmentary, cross-sectional, side view of an embolic protection device exhibiting a valve 121 below a filter 120 that defines an area of debris capture 122 between them. Valve 121 can also serve to assist or replace the native aortic valve.

[098] FIG 21 is a fragmentary, perspective view of an embolic protection device exhibiting a closed lattice frame 130 below a filter 120 that defines an area of debris capture 122 between them. The sub closed lattice frame prevents debris from escaping the capture area.

[099] FIG 22A is a fragmentary, cross-sectional view of an embolic protection device exhibiting a multiple chamber filter 140. The filter as an opening 141 that culminates at a narrowed neck portion 142 that opens during systole and closes during diastole to allow debris to continue up to a secondary filter chamber 143. In some embodiments, the filter can extend through a valve, such as the aortic valve, and passively oscillate with the valve while not impeding its function. In some embodiments, the filter can be reshaped with a narrowing about the middle to reduce valve obstruction such as contoured to valve leaflets or simple hour glass shape with narrow portions at leaflet cooptation area; an illustration of such a creased filter is in FIG 22E. As illustrated in FIG 22B, such a filter can be formed of a soft or flimsy material which allows for minimal valve obstruction. In this embodiment, as illustrated in FIG 22C, an increased filer area can exist which provides less chance of emboli exiting filter during use and removal. In some embodiments, as illustrated in FIG 22D, the filter can be formed with preformed closed creases that can accommodate valve leaves more easily.

[100] FIG 23 is a fragmentary, cross-sectional, side view of an embolic protection device exhibiting a collapsed, staggered filter 151 and frame 152 within a deployment catheter 150. FIG 24 is a fragmentary, perspective view of an embolic protection device exhibiting an expanded and staggered filter 151 and frame 152. FIG 25 is a fragmentary, perspective view of an embolic protection device exhibiting a fully expanded filter 151 and frame 152.

[101] In other exemplary embodiments, frames can also contain shaped sections, different profile sections or have additional components such as bands, clips, barbs, anchors, and spikes to improve the anchoring or grip of the frame to the vessel or tissue wall. Anchoring components can be attached to the frame, sealing material or other parts of the device independently. Anchor components can be configured such that traumatic sides are shielded up until device expansion to protect other neighboring components such at delivery tube or sealing materials.

[102] Another exemplary embodiment of an embolic protection device frame is a uniform structure that is nominal in its collapsed state and plastically deformed to a predetermined or user-defined interference geometry.

[103] Frames can be made from the same machined tube, sheet, braided wire, extrusion and then fabricated to create a non-tensioning section. In greater detail, shape memory metallic frames can be made from flat sheet, tubes, braided, woven, and interweaved lattices then shape-set to preset geometries that are activated at or below body temperature. The shape memory material can be Nitinol. Lattice structure can also be fabricated by a combination of machining, laser cutting, joining, and welding of shape memory tubes or sheets.

[104] In greater detail, a guidewire lumen can be formed by piercing of the embolic filter sealing material with the guidewire by the operator when loading the device. This action creates a pass through opening that is as small as possible. Structure frame members are sparse enough to not interfere with guidewire path and allow for an un-obstructed insertion. The guidewire lumen can be a patent opening in the filter as designated by a structure frame or sealing material that allows for unobstructed preset pass-through of the guidewire. [105] Terms such as embolic protection device, basket, LVOT filter, embolic filter as used herein are the same. Terms such as aperture, opening, vessel, LVOT, blood flow passage when used herein are the same. Terms such as frame, structure, device, implant when used herein are the same. Terms such as catheter, outer tube, sheath, deployment catheter when used herein are the same.

[106] Various descriptions of embolic protection devices and embolic protection methods have been used. Each of these descriptions is to be used interchangeably wherever logically applicable and is not to be limited to only one exemplary embodiment described or depicted.

[107] It is noted that various individual features of the inventive processes and systems may be described only in one exemplary embodiment herein. The particular choice for description herein with regard to a single exemplary embodiment is not to be taken as a limitation that the particular feature is only applicable to the embodiment in which it is described. All features described herein are equally applicable to, additive, or interchangeable with any or all of the other exemplary embodiments described herein and in any combination or grouping or arrangement. In particular, use of a single reference numeral herein to illustrate, define, or describe a particular feature does not mean that the feature cannot be associated or equated to another feature in another drawing figure or description. Further, where two or more reference numerals are used in the figures or in the drawings, this should not be construed as being limited to only those embodiments or features, they are equally applicable to similar features or not a reference numeral is used or another reference numeral is omitted.

[108] The foregoing description and accompanying drawings illustrate the principles, exemplary embodiments, and modes of operation of the systems and methods. However, the systems and methods should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art and the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the systems and methods as defined by the following claims.

Claims

CLAIMS What is claimed is:

1. An embolic protection device comprising:

an expandable frame configured to engage a vessel wall and prevent movement of the embolic protection device; and

a filter configured to prevent passage of obstructive vascular materials;

wherein the expandable frame and filter are configured to be deployable and retractable through a catheter.

2. The embolic protection device of claim 1, wherein the expandable protection device is configured to transition between a collapsed state, a partially deployed state, and a fully deployed state.

3. The embolic protection device of claim 1, wherein the obstructive vascular materials are thrombus, emboli, embolic materials, surgical materials, or a combination thereof.

4. The embolic protection device of claim 2, wherein the expandable frame includes at least one fillable portion.

5. The embolic protection device of claim 2, wherein the expandable frame includes two fillable portions.

6. The embolic protection device of claim 4, wherein the at least one fillable portion has a contoured profile.

7. The embolic protection device of claim 4, wherein the at least one fillable portion is cylindrical.

8. The embolic protection device of claim 4, wherein the at least one fillable portion is collapsed in the collapsed state, partially inflated in the partially deployed state, and fully inflated in the fully deployed state.

9. The embolic protection device of claim 1, wherein the filter includes a lattice structure.

10. The embolic protection device of claim 1, wherein the filter includes a spring configured to close the filter before retrieval.

11. The embolic protection device of claim 1, wherein the filter is formed of a porous material.

12. The embolic protection device of claim 11, wherein the porous material is formed by adding pores to a non-porous material.

13. The embolic protection device of claim 1, wherein the filter is a mesh material.

14. The embolic protection device of claim 13, wherein the mesh material is nitinol.

15. The embolic protection device of claim 2, wherein the filter has a parabolic shape when configured in the fully deployed state.

16. The embolic protection device of claim 1, wherein the frame has an axial length that is less than a distance from a proximal end of the embolic protection device to a functional location of an aortic valve.

17. The embolic protection device of claim 2, further including at least one of a spring loaded frame, an inflatable balloon, a mechanical linkage mechanism, or a combination thereof configured to actuate the embolic protection device from the collapsed state to the fully deployed state.

18. The embolic protection device of claim 1, further including an encapsulating lattice frame opposing the filter.

19. The embolic protection device of claim 1, wherein the filter is a multi chambered filter.

20. The embolic protection device of claim 1, further including an artificial valve.

21. The embolic protection device of claim 1, further including a guidewire path.

22. The embolic protection device of claim 1 , further including a one-way valve configured to allow obstructive vascular materials to enter the one-way valve, be trapped by the filter, and not allowed to escape the one-way valve.

23. The embolic protection device of claim 1, wherein the filter is a rotating closed, clam shell filter basket.

24. The embolic protection device of claim 1 , wherein the filter can extend through an aortic valve and passively oscillate with the aortic valve.

25. A method of manufacturing the embolic protection device of claim 1, the method comprising:

cutting holes at a proximal end of a tapered balloon to form the filter;

radially cutting a distal end of the tampered balloon thereby creating an open end; and folding the open end toward the proximal end to form the expandable frame.

26. The method of claim 25, further including bonding edges of the expandable frame.

27. A method of deploying the embolic protection device of claim 1 , the method comprising:

deploying the embolic protection device through an atrial septum or an aortic valve; and

expanding the expandable frame against a cardiac wall thereby deploying the filter.