US20140371783A1 - Emboli guarding device - Google Patents
Emboli guarding device Download PDFInfo
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- US20140371783A1 US20140371783A1 US14/477,353 US201414477353A US2014371783A1 US 20140371783 A1 US20140371783 A1 US 20140371783A1 US 201414477353 A US201414477353 A US 201414477353A US 2014371783 A1 US2014371783 A1 US 2014371783A1
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- Prior art keywords
- emboli
- frame
- mesh portion
- delivery system
- patient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/0103—With centering means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/011—Instruments for their placement or removal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/856—Single tubular stent with a side portal passage
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
-
- A61F2002/011—
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/016—Filters implantable into blood vessels made from wire-like elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0069—Three-dimensional shapes cylindrical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0073—Quadric-shaped
- A61F2230/008—Quadric-shaped paraboloidal
Definitions
- the present invention relates to devices and delivery systems that can he used in heart structures for the prevention of strokes. More particularly, the invention relates to devices, methods, and delivery systems for preventing undesirable movement of emboli within a heart structure.
- embolic particles or emboli can be formed for a number of reasons in the left atrium or in other parts o f the heart, such as can occur when surgically implanting prosthetic devices into a patient's anatomy. When such particles or emboli are present in the atrium, they have the potential to migrate toward the brain at the arch of the aorta, and can thereby impose potential risk of stroke. Thus, there is a need to provide devices and delivery systems that can filter or guard against undesired emboli migration within the heart or other bodily structures of a patient.
- This invention provides devices, methods, and delivery systems that can be used to prevent or minimize the possibilities of a person having a stroke due to litigation of emboli, particles, and/or air bubbles into undesired areas of the anatomy.
- the device accomplishes this by directing particle flow in a bloodstream in such a way that any particles within that bloodstream are directed along a path where such particles will not be detrimental to the health of the patient.
- One embodiment of the invention includes a device that consists of a stem structure or frame to which a Nitinol thin film or pericardial sheet is attached in at least one area.
- Nitinol thin film or pericardial sheet can be affixed diametrically across the stent, diameter at a distal segment of the stent, in one embodiment, although it is also possible that the device includes different placement a the film or sheet and/or that the device includes multiple areas having a film or sheet. Fenestrations with various desired dimensions can be created on the thin film to allow blood to flow through it. If necessary, side channels between the film or pericardial sheet and the all of the structure in which the device is located can also be created.
- the stent structure or frame of the device can be used to anchor the device into the arch of an aorta, for example.
- the thin film or pericardial, sheet of the device can block the flow of emboli toward the carotid arteries or other cerebrovascular structures, and instead allow their movement with the blood flow to carry emboli toward the descending aorta.
- the use of the device of the invention can help to prevent brain stroke for a patient.
- the devices of the invention can be percutaneously delivered using a transcatheter delivery system to a location in a patient, such as aortic arch. These devices can also be retrieved using a transcatheter retrieval device if needed.
- the emboli guarding devices can be used as a permanent implantable device at the aortic arch to prevent brain strokes, or as a temporary deice to prevent brain stroke during any prosthetic device implantation or a transcatheter valve deployment, for example.
- a guide catheter which includes an embolic filter positioned between its proximal and distal ends.
- the filter can be positioned in a desired location in a patient to provide particle filtration.
- an embolic guard centering delivery system is provided, which includes an expandable mesh portion that can provide both embolic protection and a centering function.
- a guide catheter with an expandable mesh portion is provided. The mesh of the guide catheter can provide both embolic protection and a centering function to a device through which other devices, such as delivery systems, can be advanced to a desired anatomical location.
- FIG. 1 is a schematic cross-sectional front view of an emboli guarding device of the invention positioned within a heart structure;
- FIG. 2 is a front view of an embodiment of an emboli guarding device, including a film or sheet including small fenestrations;
- FIG. 3 is a front view of another embodiment of an emboli guarding device, including another embodiment of a film or sheet including small fenestrations;
- FIG. 4 is a front view of another embodiment of an emboli guarding device of the invention positioned within a schematic heart structure;
- FIG. 5 is a front view of another embodiment of an emboli guarding device on a delivery system within a heart structure, with a self-expanding mesh structure in a collapsed condition;
- FIG. 6 is another front view of the emboli guarding device of FIG. 5 , with the self-expanding mesh structure in an expanded condition within the heart structure;
- FIG. 7 is a front view of another embodiment of an emboli guarding device on a delivery system within a heart structure, with a mesh structure in a collapsed condition;
- FIG. 8 is another front view of the emboli guarding device of FIG. 7 , with the mesh structure in an expanded condition within the heart structure.
- an emboli guarding device 10 is illustrated in an exemplary, position within the anatomy of a patient.
- the device 10 is shown here as being positioned within an aortic arch 12 , between the ascending aorta 14 and the descending aorta 16 .
- Multiple particles or emboli 20 are illustrated as being randomly dispersed throughout the stream of blood. These particles 20 tend to flow in the main flow stream, which is indicated with arrow 22 in the area of the ascending aorta 14 and with the arrow 24 , which is on the opposite side of the device 10 and in the area of the descending aorta 16 .
- the emboli guarding device 10 alters the flow direction and guides emboli 20 and/or air bubbles carried by the flow stream toward the descending aorta 16 , rather than toward the head vessels 26 (i.e., the brachiocephalic trunk, the left common carotid artery, and the left subclavian artery) and in the direction of arrows 28 , Such an alternative flow of emboli 20 can thereby help to prevent potential brain strokes and/or minimize the chances of migraines and other health issues.
- emboli and/or air bubbles within the blood stream can be created in, a variety of manners, such as from atrial fibrillation (AF), from prosthetic heart valves, from left ventricular assist devices (LVAD's), and/or from any other sources of emboli.
- AF atrial fibrillation
- LVAD's left ventricular assist devices
- an emboli guarding device 10 consists generally of a frame 30 and a sheet of material 32 that is positioned generally across its upper portion.
- the frame 30 may be made of a material that is capable of being compressed and expanded, which can be advantageous for percutaneous delivery of the frame 30 to its desired location within the heart.
- the frame 30 is made of a material that is expandable via the application of an outwardly directed internal force, such as the force that can be applied with an expandable balloon positioned within the internal opening or area of the frame 30 .
- the frame 30 is made from a self-expanding material, such as a Nitinol mesh material. In this way, the device 10 can be compressed, to a size that allows it to be delivered percutaneously to the desired location via a delivery system, and then allowed to expand by removing or retracting a compressive sheath, for example.
- the materials from which the frames 30 of the invention are generally made include a series of wires arranged into, a generally elongated tubular support structure.
- the structure can include one or more linear portions and/or one or more curved, bent, or otherwise shaped portions, in order to provide an optimal fit within area of the heart.
- the support structure of the frame 30 may either be made up of a number of individual struts or wire segments arranged and secured to each other.
- the frame 30 may instead be formed from a single piece of material (e.g., a tube of material that is machined to provide, a desired structure configuration). That is, in one exemplary embodiment, the frame 30 may be laser cut from a single piece of material or may be assembled from a number of different components.
- the frames 30 of the invention can be compressible to a relatively small diameter for percutaneous delivery to the heart of the patient, and then are expandable either via removal of external compressive forces (e.g., self-expanding frames), or through application of an outward radial force (e.g., balloon expandable frames).
- some portions of the frame 30 may be self-expanding while other portions of the same frame are expandable through application of an externally applied force.
- the frames of the invention can be self-expandable from a contracted state to an expanded state via the application of beat, energy, and the like.
- Methods for insertion of the emboli guarding devices of the invention can include delivery systems that can maintain the frames in their compressed state during their insertion and allow or cause all or specific features of the flames to expand once they are in their desired location.
- delivery methods of the invention can further include features that allow the emboli guarding devices to be retrieved for removal or relocation thereof after they have been deployed from their delivery systems.
- the methods of the invention may include implantation of the devices using either an antegrade or retrograde approach. Further, in certain approaches for delivering the devices 10 of the invention, the devices can be rotatable in vivo to, allow the stent structure to be positioned in a desired orientation.
- a portion of the device 10 can include a radiopaque, echogenic, or MRI visible material to facilitate visual confirmation of proper placement of the frame 30 relative to the anatomy of the patient.
- a radiopaque, echogenic, or MRI visible material can be included into the frame 30 , if desired.
- the device 10 can be delivered to the patient's anatomy via a minimally invasive surgical incision (i.e., non-percutaneously). In yet another alternative embodiment, the device 10 can be delivered via open heart/chest surgery.
- the frame 30 of the device 10 is generally tubular in shape, defining an internal area that extends from a first end 34 to a second end 36 .
- the internal area is essentially surrounded by the frame 30 and the sheet of material 32 .
- the frame 30 can be configured to have an arc portion 38 that is designed and/or chosen to generally match the anatomy of the aortic arch of the patient in order to keep it from being dislodged once it is in place.
- the frames can be provided in various lengths and/or shapes to accommodate the different sizes and/or shapes of different patient anatomies.
- the exemplary frames 30 of FIGS. 2 and 3 are similarly configured
- the frame 30 of FIG. 3 includes an extension portion 39 at its second end 36 that, can provide additional anchoring capability relative to the vessel in which it is positioned.
- a frame may include one or more extensions of this type and/or other features that provide such an anchoring capability.
- the material or materials from which the sheet of material 32 is made can vary widely, but generally include a relatively thin piece of material, such as pericardium or a polymer sheet, for example. In another alternative, a thin piece of Nitinol material can be used. With any of these materials, a number of fenestrations or openings 40 can be provided across the area of the sheet 32 , as illustrated in FIGS. 1 and 2 These fenestrations 40 can be sized to be smaller than approximately 60 ⁇ , although the fenestrations can be any size that allows some blood flow through the surface of the sheet 32 while blocking the movement of the emboli 20 through the sheet 32 . Thus, the size of the fenestrations 40 can be selected to effectively filter a size of emboli or particles 20 that would be detrimental to the health of a patient if they were to move through the sheet 32 in the direction of the arrows 28 .
- a transcatheter assembly can be provided, including a delivery catheter, a balloon catheter, and a guide wire.
- the delivery catheter can be of a type known in the art that defines a lumen within which the balloon catheter is received.
- the balloon catheter in turn, can define a lumen within which the guide wire is slidably disposed.
- the balloon catheter can include a balloon that is fluidly connected to an inflation source.
- the transcatheter assembly is appropriately sized for a desired percutaneous approach.
- the transcatheter assembly can be sized for delivery to the heart via an opening at a carotid artery, a jugular vein, a sub-clavian vein, femoral artery or vein, or the like.
- any percutaneous intercostals penetration can be made to facilitate use of the transcatheter assembly.
- the balloon catheter is operated to inflate the balloon, thereby expanding the frame 30 to the expanded state shown in FIG. 1 .
- the frame 30 is formed of a shape memory material, the frame can be allowed to self-expand to the expanded state of FIG. 1 , such as by removing the external forces applied by a sheath.
- the frame 30 is preferably expandable within the internal region of the implantation area of the patient with sufficient outward radial force against the anatomical structure (e.g., the aortic arch area) that it cannot become unintentionally dislodged from this area of the patient.
- the techniques described above relative to placement of the device 10 within the heart can be used both to monitor and correct the placement of the device 10 in a longitudinal direction relative to the length, shape, and the like of the anatomical structure in which it is positioned and also to monitor and correct the orientation of the device 10 relative to any other structures that may also be implanted in this area.
- the emboli guarding devices 10 of the invention may be designed for permanent placement within the patient, or may alternatively be removable after a certain period of time.
- the device 10 can be removed pertcutaneously, such as with the use of a system that can recompress the frame 30 by a sufficient amount to remove it in this minimally invasive manner.
- the device 10 may need to be removed in a more invasive manner, such as via more conventional surgical techniques.
- FIG. 4 illustrates an alternative embodiment of the invention, which includes an embolic guard guide catheter 60 that is shown as positioned within the aortic arch 66 of a patient.
- the guide catheter 60 includes an embolic filter 62 positioned between proximal and distal ends of the catheter 60 .
- the embolic filter 62 can be delivered to the desired location in the patient in order to provide similar filtering features to those described above relative to FIGS. 1-3 .
- the catheter 60 can localize the embolic filter 62 at the location of the head vessels 64 .
- the length of the filter 62 can be selected to achieve certain performance characteristics, such as being sufficiently long to span across the all of the head vessels 64 .
- the filter 62 may include one or more areas having a thin film, which may or may not include fenestrations, as described above relative to the films that can be used in accordance with the invention.
- FIGS. 5 and 6 illustrate another embodiment of the invention, which includes an embolic guard centering delivery system 80 that is shown as positioned within the aortic arch 82 of a patient.
- FIG. 5 shows the system 80 with a self-expanding mesh portion 84 in a compressed or collapsed condition relative to a delivery system stability layer 86 .
- FIG. 6 shows the system 80 with the mesh portion 84 in an expanded condition.
- the stability layer 86 can be pulled proximally to release the mesh portion 84 , thereby allowing it to expand to the size and shape of the vessel in which it is positioned.
- the mesh portion 84 can provide embolic protection during delivery of a device.
- the, mesh portion 84 is made of a material or materials that allow blood flow, yet that filter out emboli, particles, and/or air bubbles that are undesirably large. Further, the mesh portion 84 may comprise wires and/or film materials that provide the desired level of particle filtering. It is further noted that the expansion of the mesh portion 84 provides a centering function for the delivery system 80 within the ascending aorta. In this way, better coaxial alignment can occur between a transcatheter valve that is being delivered via the delivery system and the annulus during positioning and release thereof, for example.
- FIGS. 7 and 8 Another aspect of the emboli guarding features of the invention is illustrated in FIGS. 7 and 8 .
- a guide catheter 100 is illustrated as being positioned within an aortic arch 102 of a patient.
- FIG. 7 shows the guide catheter 100 with a self-expanding mesh portion 104 adjacent to its distal end in a compressed or collapsed condition.
- guide catheter 100 can be driven over a guidewire (not shown) to position the device in a desired location above the aortic valve in the ascending aorta.
- FIG. 8 illustrates the mesh portion 104 in an expanded condition. In order to expand the mesh portion 104 in this way, an outer sheath 110 is pulled proximally to expose and therefore expand the mesh portion 104 .
- a tip 108 which can be collapsible, of the delivery system 100 can be pulled proximally out of the guide catheter 100 . This will provide an access channel through which another device can be inserted.
- a delivery system can be advanced through the guide catheter 100 to a position adjacent to the aortic valve.
- the mesh portion 104 can expand to the size and shape of the vessel in which it is positioned. In this way, the mesh portion 104 can provide embolic protection during delivery of a device (e.g., a transcatheter valve) and/or during balloon valvuloplasty procedures. That is, the mesh portion 104 is made of a material or materials that allow blood flow, yet that filter out emboli, particles, and/or an bubbles that are undesirably large during other processes. Further, the mesh portion 104 may comprise wires and/or film materials that provide a desired level of particle filtering. It is further noted that the expansion of the mesh portion 104 provides a centering function for the delivery system 100 within the ascending aorta.
- a device e.g., a transcatheter valve
- the outer sheath 110 can be advanced in a distal direction to collapse the mesh portion 104 for removal of the device from the body.
- the distal end of the guide catheter can also function to align and/or direct a delivery system that is advanced within the guide catheter to an anatomical target, such as the aortic valve, for example. Providing these capabilities of being able to more accurately align and direct the delivery system can help to optimize the accuracy and reliability with which an implant or therapy can be introduced.
- the mesh portions preferably are sufficiently sized so that they can expand to match the size and shape of the vessel in which they are located.
- the mesh portions are also preferably made of a material that provides sufficient force against the walls of the vessel to prevent emboli from moving between the mesh portion and the vessel.
- the mesh portions can additionally include one or more sections or areas, having a thin film or material that may or may not include fenestrations, such as is described above relative to FIGS. 1-3 , for example.
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Abstract
A device including a stent structure or frame to which a sheet is attached for use in minimizing or preventing emboli, particles, and/or air bubbles from migrating into certain areas of the anatomy. The device can be placed in the blood stream in an area of the heart, such as the aortic arch, to direct particles toward the descending aorta rather than toward the brain. The sheet of the device can be a thin film material, which may include multiple fenestrations that are smaller in size than the particles that are to be filtered.
Description
- This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/099,935, filed Sep. 25, 2008, which is incorporated herein by reference in its entirety.
- The present invention relates to devices and delivery systems that can he used in heart structures for the prevention of strokes. More particularly, the invention relates to devices, methods, and delivery systems for preventing undesirable movement of emboli within a heart structure.
- Large or small embolic particles or emboli can be formed for a number of reasons in the left atrium or in other parts o f the heart, such as can occur when surgically implanting prosthetic devices into a patient's anatomy. When such particles or emboli are present in the atrium, they have the potential to migrate toward the brain at the arch of the aorta, and can thereby impose potential risk of stroke. Thus, there is a need to provide devices and delivery systems that can filter or guard against undesired emboli migration within the heart or other bodily structures of a patient.
- This invention provides devices, methods, and delivery systems that can be used to prevent or minimize the possibilities of a person having a stroke due to litigation of emboli, particles, and/or air bubbles into undesired areas of the anatomy. The device accomplishes this by directing particle flow in a bloodstream in such a way that any particles within that bloodstream are directed along a path where such particles will not be detrimental to the health of the patient. One embodiment of the invention includes a device that consists of a stem structure or frame to which a Nitinol thin film or pericardial sheet is attached in at least one area. The Nitinol thin film or pericardial sheet can be affixed diametrically across the stent, diameter at a distal segment of the stent, in one embodiment, although it is also possible that the device includes different placement a the film or sheet and/or that the device includes multiple areas having a film or sheet. Fenestrations with various desired dimensions can be created on the thin film to allow blood to flow through it. If necessary, side channels between the film or pericardial sheet and the all of the structure in which the device is located can also be created.
- The stent structure or frame of the device can be used to anchor the device into the arch of an aorta, for example. In this way, when emboli flow through the aortic arch, the thin film or pericardial, sheet of the device can block the flow of emboli toward the carotid arteries or other cerebrovascular structures, and instead allow their movement with the blood flow to carry emboli toward the descending aorta. Thus, the use of the device of the invention can help to prevent brain stroke for a patient.
- The devices of the invention can be percutaneously delivered using a transcatheter delivery system to a location in a patient, such as aortic arch. These devices can also be retrieved using a transcatheter retrieval device if needed. The emboli guarding devices can be used as a permanent implantable device at the aortic arch to prevent brain strokes, or as a temporary deice to prevent brain stroke during any prosthetic device implantation or a transcatheter valve deployment, for example.
- In another aspect of the invention, a guide catheter is provided, which includes an embolic filter positioned between its proximal and distal ends. The filter can be positioned in a desired location in a patient to provide particle filtration. In another aspect of the invention, an embolic guard centering delivery system is provided, which includes an expandable mesh portion that can provide both embolic protection and a centering function. In yet another aspect of the invention, a guide catheter with an expandable mesh portion is provided. The mesh of the guide catheter can provide both embolic protection and a centering function to a device through which other devices, such as delivery systems, can be advanced to a desired anatomical location.
- The present invention will be further explained with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein:
-
FIG. 1 is a schematic cross-sectional front view of an emboli guarding device of the invention positioned within a heart structure; -
FIG. 2 is a front view of an embodiment of an emboli guarding device, including a film or sheet including small fenestrations; -
FIG. 3 is a front view of another embodiment of an emboli guarding device, including another embodiment of a film or sheet including small fenestrations; -
FIG. 4 is a front view of another embodiment of an emboli guarding device of the invention positioned within a schematic heart structure; -
FIG. 5 is a front view of another embodiment of an emboli guarding device on a delivery system within a heart structure, with a self-expanding mesh structure in a collapsed condition; -
FIG. 6 is another front view of the emboli guarding device ofFIG. 5 , with the self-expanding mesh structure in an expanded condition within the heart structure; -
FIG. 7 is a front view of another embodiment of an emboli guarding device on a delivery system within a heart structure, with a mesh structure in a collapsed condition; and -
FIG. 8 is another front view of the emboli guarding device ofFIG. 7 , with the mesh structure in an expanded condition within the heart structure. - Referring now to the Figures, wherein the components are labeled with like numerals throughout the several Figures, and initially to
FIG. 1 , one embodiment of anemboli guarding device 10 is illustrated in an exemplary, position within the anatomy of a patient. In particular, thedevice 10 is shown here as being positioned within an aortic arch 12, between theascending aorta 14 and the descendingaorta 16. Multiple particles oremboli 20 are illustrated as being randomly dispersed throughout the stream of blood. Theseparticles 20 tend to flow in the main flow stream, which is indicated witharrow 22 in the area of theascending aorta 14 and with the arrow 24, which is on the opposite side of thedevice 10 and in the area of the descendingaorta 16. Theemboli guarding device 10 alters the flow direction andguides emboli 20 and/or air bubbles carried by the flow stream toward the descendingaorta 16, rather than toward the head vessels 26 (i.e., the brachiocephalic trunk, the left common carotid artery, and the left subclavian artery) and in the direction ofarrows 28, Such an alternative flow ofemboli 20 can thereby help to prevent potential brain strokes and/or minimize the chances of migraines and other health issues. It is noted that the emboli and/or air bubbles within the blood stream can be created in, a variety of manners, such as from atrial fibrillation (AF), from prosthetic heart valves, from left ventricular assist devices (LVAD's), and/or from any other sources of emboli. - Referring also to
FIGS. 2 and 3 , one embodiment of anemboli guarding device 10 consists generally of aframe 30 and a sheet ofmaterial 32 that is positioned generally across its upper portion. Theframe 30 may be made of a material that is capable of being compressed and expanded, which can be advantageous for percutaneous delivery of theframe 30 to its desired location within the heart. In one example, theframe 30 is made of a material that is expandable via the application of an outwardly directed internal force, such as the force that can be applied with an expandable balloon positioned within the internal opening or area of theframe 30. In another example, theframe 30 is made from a self-expanding material, such as a Nitinol mesh material. In this way, thedevice 10 can be compressed, to a size that allows it to be delivered percutaneously to the desired location via a delivery system, and then allowed to expand by removing or retracting a compressive sheath, for example. - The materials from which the
frames 30 of the invention are generally made include a series of wires arranged into, a generally elongated tubular support structure. The structure can include one or more linear portions and/or one or more curved, bent, or otherwise shaped portions, in order to provide an optimal fit within area of the heart. The support structure of theframe 30 may either be made up of a number of individual struts or wire segments arranged and secured to each other. Alternatively, theframe 30 may instead be formed from a single piece of material (e.g., a tube of material that is machined to provide, a desired structure configuration). That is, in one exemplary embodiment, theframe 30 may be laser cut from a single piece of material or may be assembled from a number of different components. - As described above, the
frames 30 of the invention can be compressible to a relatively small diameter for percutaneous delivery to the heart of the patient, and then are expandable either via removal of external compressive forces (e.g., self-expanding frames), or through application of an outward radial force (e.g., balloon expandable frames). In a further alternative, some portions of theframe 30 may be self-expanding while other portions of the same frame are expandable through application of an externally applied force. In yet another alternative, the frames of the invention can be self-expandable from a contracted state to an expanded state via the application of beat, energy, and the like. - Methods for insertion of the emboli guarding devices of the invention can include delivery systems that can maintain the frames in their compressed state during their insertion and allow or cause all or specific features of the flames to expand once they are in their desired location. In addition, delivery methods of the invention can further include features that allow the emboli guarding devices to be retrieved for removal or relocation thereof after they have been deployed from their delivery systems. The methods of the invention may include implantation of the devices using either an antegrade or retrograde approach. Further, in certain approaches for delivering the
devices 10 of the invention, the devices can be rotatable in vivo to, allow the stent structure to be positioned in a desired orientation. In one embodiment, a portion of thedevice 10, such as theframe 30, can include a radiopaque, echogenic, or MRI visible material to facilitate visual confirmation of proper placement of theframe 30 relative to the anatomy of the patient. Alternatively, other known surgical visual aids can be incorporated into theframe 30, if desired. - In another alternative embodiment, the
device 10 can be delivered to the patient's anatomy via a minimally invasive surgical incision (i.e., non-percutaneously). In yet another alternative embodiment, thedevice 10 can be delivered via open heart/chest surgery. - The
frame 30 of thedevice 10 is generally tubular in shape, defining an internal area that extends from afirst end 34 to asecond end 36. The internal area is essentially surrounded by theframe 30 and the sheet ofmaterial 32. Theframe 30 can be configured to have an arc portion 38 that is designed and/or chosen to generally match the anatomy of the aortic arch of the patient in order to keep it from being dislodged once it is in place. Thus, the frames can be provided in various lengths and/or shapes to accommodate the different sizes and/or shapes of different patient anatomies. While theexemplary frames 30 ofFIGS. 2 and 3 are similarly configured, theframe 30 ofFIG. 3 includes anextension portion 39 at itssecond end 36 that, can provide additional anchoring capability relative to the vessel in which it is positioned. A frame, may include one or more extensions of this type and/or other features that provide such an anchoring capability. - The material or materials from which the sheet of
material 32 is made can vary widely, but generally include a relatively thin piece of material, such as pericardium or a polymer sheet, for example. In another alternative, a thin piece of Nitinol material can be used. With any of these materials, a number of fenestrations oropenings 40 can be provided across the area of thesheet 32, as illustrated inFIGS. 1 and 2 Thesefenestrations 40 can be sized to be smaller than approximately 60μ, although the fenestrations can be any size that allows some blood flow through the surface of thesheet 32 while blocking the movement of theemboli 20 through thesheet 32. Thus, the size of thefenestrations 40 can be selected to effectively filter a size of emboli orparticles 20 that would be detrimental to the health of a patient if they were to move through thesheet 32 in the direction of thearrows 28. - One method of delivering the device to a desired location in a patient is via percutaneous device insertion. In general terms for this exemplary, delivery system, a transcatheter assembly can be provided, including a delivery catheter, a balloon catheter, and a guide wire. The delivery catheter can be of a type known in the art that defines a lumen within which the balloon catheter is received. The balloon catheter, in turn, can define a lumen within which the guide wire is slidably disposed. Further, the balloon catheter can include a balloon that is fluidly connected to an inflation source. It is noted that if the frame being implanted is a self-expanding type of frame, the balloon would not be needed and a sheath or other restraining means would instead be used for maintaining the frame in its compressed state until deployment of the device. In any case, the transcatheter assembly is appropriately sized for a desired percutaneous approach. For example, the transcatheter assembly can be sized for delivery to the heart via an opening at a carotid artery, a jugular vein, a sub-clavian vein, femoral artery or vein, or the like. Essentially, any percutaneous intercostals penetration can be made to facilitate use of the transcatheter assembly.
- In the case of a balloon-expandable frame, once the
frame 30 is properly positioned relative to the anatomy of the patient, the balloon catheter is operated to inflate the balloon, thereby expanding theframe 30 to the expanded state shown inFIG. 1 . Alternatively, if theframe 30 is formed of a shape memory material, the frame can be allowed to self-expand to the expanded state ofFIG. 1 , such as by removing the external forces applied by a sheath. In either case, theframe 30 is preferably expandable within the internal region of the implantation area of the patient with sufficient outward radial force against the anatomical structure (e.g., the aortic arch area) that it cannot become unintentionally dislodged from this area of the patient. - The techniques described above relative to placement of the
device 10 within the heart can be used both to monitor and correct the placement of thedevice 10 in a longitudinal direction relative to the length, shape, and the like of the anatomical structure in which it is positioned and also to monitor and correct the orientation of thedevice 10 relative to any other structures that may also be implanted in this area. - It is noted that the
emboli guarding devices 10 of the invention may be designed for permanent placement within the patient, or may alternatively be removable after a certain period of time. In one embodiment, thedevice 10 can be removed pertcutaneously, such as with the use of a system that can recompress theframe 30 by a sufficient amount to remove it in this minimally invasive manner. In another embodiment, thedevice 10 may need to be removed in a more invasive manner, such as via more conventional surgical techniques. -
FIG. 4 illustrates an alternative embodiment of the invention, which includes an embolicguard guide catheter 60 that is shown as positioned within theaortic arch 66 of a patient. In this embodiment, theguide catheter 60 includes an embolic filter 62 positioned between proximal and distal ends of thecatheter 60. The embolic filter 62 can be delivered to the desired location in the patient in order to provide similar filtering features to those described above relative toFIGS. 1-3 . In this example, thecatheter 60 can localize the embolic filter 62 at the location of thehead vessels 64. The length of the filter 62 can be selected to achieve certain performance characteristics, such as being sufficiently long to span across the all of thehead vessels 64. The filter 62 may include one or more areas having a thin film, which may or may not include fenestrations, as described above relative to the films that can be used in accordance with the invention. -
FIGS. 5 and 6 illustrate another embodiment of the invention, which includes an embolic guard centeringdelivery system 80 that is shown as positioned within the aortic arch 82 of a patient. In particular,FIG. 5 shows thesystem 80 with a self-expanding mesh portion 84 in a compressed or collapsed condition relative to a deliverysystem stability layer 86. Further,FIG. 6 shows thesystem 80 with the mesh portion 84 in an expanded condition. In order to expand in this way, thestability layer 86 can be pulled proximally to release the mesh portion 84, thereby allowing it to expand to the size and shape of the vessel in which it is positioned. In this way, the mesh portion 84 can provide embolic protection during delivery of a device. That is, the, mesh portion 84 is made of a material or materials that allow blood flow, yet that filter out emboli, particles, and/or air bubbles that are undesirably large. Further, the mesh portion 84 may comprise wires and/or film materials that provide the desired level of particle filtering. It is further noted that the expansion of the mesh portion 84 provides a centering function for thedelivery system 80 within the ascending aorta. In this way, better coaxial alignment can occur between a transcatheter valve that is being delivered via the delivery system and the annulus during positioning and release thereof, for example. - Another aspect of the emboli guarding features of the invention is illustrated in
FIGS. 7 and 8 . In particular, aguide catheter 100 is illustrated as being positioned within anaortic arch 102 of a patient.FIG. 7 shows theguide catheter 100 with a self-expandingmesh portion 104 adjacent to its distal end in a compressed or collapsed condition. In this Figure, guidecatheter 100 can be driven over a guidewire (not shown) to position the device in a desired location above the aortic valve in the ascending aorta.FIG. 8 illustrates themesh portion 104 in an expanded condition. In order to expand themesh portion 104 in this way, anouter sheath 110 is pulled proximally to expose and therefore expand themesh portion 104. A tip 108, which can be collapsible, of thedelivery system 100 can be pulled proximally out of theguide catheter 100. This will provide an access channel through which another device can be inserted. For example, a delivery system can be advanced through theguide catheter 100 to a position adjacent to the aortic valve. - The
mesh portion 104 can expand to the size and shape of the vessel in which it is positioned. In this way, themesh portion 104 can provide embolic protection during delivery of a device (e.g., a transcatheter valve) and/or during balloon valvuloplasty procedures. That is, themesh portion 104 is made of a material or materials that allow blood flow, yet that filter out emboli, particles, and/or an bubbles that are undesirably large during other processes. Further, themesh portion 104 may comprise wires and/or film materials that provide a desired level of particle filtering. It is further noted that the expansion of themesh portion 104 provides a centering function for thedelivery system 100 within the ascending aorta. In this way, better coaxial alignment can occur between a transcatheter valve that is being delivered via the delivery system and the annulus during positioning and release thereof for example. In this embodiment, once any other processes are completed, such as transcatheter valve delivery and deployment or balloon valvuloplasty, theouter sheath 110 can be advanced in a distal direction to collapse themesh portion 104 for removal of the device from the body. - The distal end of the guide catheter can also function to align and/or direct a delivery system that is advanced within the guide catheter to an anatomical target, such as the aortic valve, for example. Providing these capabilities of being able to more accurately align and direct the delivery system can help to optimize the accuracy and reliability with which an implant or therapy can be introduced.
- With either of the mesh portions described above relative to
FIGS. 5 and 6 orFIGS. 7 and 8 , the mesh portions preferably are sufficiently sized so that they can expand to match the size and shape of the vessel in which they are located. The mesh portions are also preferably made of a material that provides sufficient force against the walls of the vessel to prevent emboli from moving between the mesh portion and the vessel. Further, the mesh portions can additionally include one or more sections or areas, having a thin film or material that may or may not include fenestrations, such as is described above relative toFIGS. 1-3 , for example. - The present invention has now been described with reference to several embodiments thereof. The contents of any patents or patent application cited herein are incorporated by reference in their entireties. The foregoing detailed description and examples have been, given for clarity of understanding only. No unnecessary limitations are to be understood therefrom. It will be apparent to those skilled in the art that many changes can be made in the embodiments described without departing from the scope of the invention. Thus, the scope of the present invention should not be limited to the structures described herein.
Claims (4)
1-17. (canceled)
18. A delivery system comprising a proximal end, a distal end, a self-expanding mesh portion adjacent to the distal end, and a moveable stability layer having an internal area within which the mesh portion is containable, wherein the stability layer is proximally moveable to release the mesh portion from the internal area of the stability layer, and wherein the mesh portion in its released condition comprises an outer diameter that is larger than an outer diameter of the stability layer.
19. The delivery system of claim 18 , wherein the mesh portion comprises a filtration material.
20. The delivery system of claim 19 , wherein the filtration material comprises a thin film with fenestrations through its thickness.
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US11382734B2 (en) | 2019-08-19 | 2022-07-12 | Encompass Technologies, Inc. | Embolic filter with controlled aperture size distribution |
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US12096955B2 (en) | 2022-04-25 | 2024-09-24 | Venturemed Group, Inc. | Intravascular catheter having an expandable incising portion and abrasive surfaces |
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US8852225B2 (en) | 2014-10-07 |
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