Classifications

• • 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
  • A61F2/02—Prostheses implantable into the body
  • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
  • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B17/12027—Type of occlusion
  • A61B17/1204—Type of occlusion temporary occlusion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
  • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
  • A61B17/12136—Balloons
• • 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
  • A61F2230/0067—Three-dimensional shapes conical
• • 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
• • 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
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary

Definitions

• This invention relates to surgical procedures and devices in general, and more particularly to surgical procedures and devices relating to the repair and/or replacement of cardiac valves .
• Aortic valve replacement currently requires a sternotomy or thoracotomy, use of cardiopulmonary bypass to arrest the heart and
• a truly minimally invasive approach to the treatment of aortic valve disease requires aortic valve replacement without cardiopulmonary bypass.
• the first is to remove the valve without causing stroke or other ischemic events that might result from particulate material liberated while manipulating the valve.
• the second is to prevent cardiac failure during
• the aortic valve serves an important function even when diseased. When the valve becomes acutely and severely incompetent during removal, the patient develops heart failure leading to death unless the function ofthe valve is taken over by another means.
• the third challenge is placing a prosthetic valve into the vascular system and affixing it to the wall ofthe aorta.
• a temporary valve such as the ones disclosed in the art
• valves disclosed to date tend also to be rather flimsy and may have difficulty
• valves generally must be inserted into a vessel at a significant distance from the valve to allow adequate room for deployment. If some portions ofthe operation are performed through the chest wall, insertion of such a
• valves with three or fewer leaflets rely on the perfect performance of each of those leaflets. If one ofthe leaflets malfunctions, the valve fails to function
• proximal and distal will be used to describe locations within the vascular anatomy.
• proximal means toward the heart while distal means away from the heart.
• proximal means away from the heart while distal means toward the heart.
• distal means toward the heart.
• a distal point in a blood flowpath is downstream from a proximal point.
• antegrade and retrograde flow are also used.
• antegrade refers to flow away from the heart while retrograde refers to flow toward the heart.
• retrograde refers to flow toward the heart.
• Antegrade means toward the heart while retrograde means away from the heart.
• the present invention relates to devices and methods for providing a valve within a fluid-bearing vessel within the body of a human.
• the present invention further relates to intravascular filters capable of filtering particulate debris flowing within a vessel.
• the present invention further relates to devices and methods for
• One aspect ofthe present invention involves methods and devices of performing aortic valve repair or replacement. In one form, the method involves the
• steps of inserting at least a temporary valve and a temporary filter into a segment of the aorta Following placement of these devices, various procedures can be carried out on the aortic valve. Following the procedure, the temporary valve and temporarily filter can be removed.
• the temporary valve acts to restrict retrograde blood flow while allowing antegrade flow. Generally, the valve allows forward or antegrade flow during the
• the valve serves to assist or replace the function of the native aortic valve while a procedure is performed on the native valve.
• the temporary valve means can be one
• the temporary valve can be placed in any suitable location within the aorta
• the temporary valve is preferably inserted into the vascular system in a compressed state requiring a
• valve can occupy the entirety ofthe aorta's flow path, although this is not a requirement of the present invention and may not be preferred in certain patients with extensive
• the temporary valve therefore, can, but does not
• the temporary filter acts to prevent emboli that may be dislodged during the
• valve procedure from moving distal to the filter.
• the filter can be one of a variety of designs, including, but
• the filter can be inserted directly into the aorta or
• the temporary filter and temporary valve can be separate elements or part of
• the temporary valve, temporary filter, or both may be designed with lumens through
• Another aspect ofthe present invention is a method of performing a procedure on a beating heart involving, at a minimum, inserting into the aorta, a temporary valve, as described above, removing at least some portion ofthe native aortic valve, and placing a permanent valve prosthesis at a site within the aorta.
• the temporary valve allows removal ofthe native valve while reducing the risk of heart failure due to insufficiency ofthe native valve. Removal of at least some portion of
• the native valve can be carried out with one or a variety of tools that can be inserted either directly into the aorta or through a peripheral artery and advanced to the native valve.
• the permanent valve prosthesis can be inserted either directly into the aorta or advanced into the aorta from a peripheral artery.
• the valve prosthesis is preferably inserted in a compressed state and expands or is expanded at the desired
• the implantation site is preferably proximal to the coronary arteries, but can be at any suitable location in the aorta.
• the valve can be one of a variety of types known in the art, but is preferably a flexible valve suitable for
• This method can further involve the placement of a temporary filter as described above to reduce the risk of emboli
• the temporary filter can be a separate device or an integral component of the temporary
• Any procedure performed using the disclosed methods can be assisted by one of a variety of visualization technologies, including, but not limited to, fluoroscopy,
• angioscopy and/or epi-cardial, epi-aortic, and/or trans-esophageal echocardiography are examples of angioscopy and/or epi-cardial, epi-aortic, and/or trans-esophageal echocardiography.
• a method for enabling performance of an operation on a cardiac valve of a heart while the heart is beating comprising placing a valved filter device in a flow path of a blood vessel downstream from the cardiac valve, the device being operative to effect greater antegrade flow than retrograde flow through said the vessel, and being operative to restrict the passage of emboli while allowing blood to flow through the vessel.
• a method for performing an operation on a cardiac valve of a heart while the heart is beating comprising the steps of a) positioning a valved filter device in a flow path of a blood vessel downstream from the cardiac valve, the device being operative to effect greater antegrade flow than retrograde flow through the vessel, b) resecting at least a portion of the cardiac valve, and c) affixing at least one prosthetic valve at or downstream from the resected cardiac valve.
• a method for enabling performance of an operation on a cardiac valve of a heart while the heart is beating comprising placing a valved filter device in a flow path of a blood vessel of the cardiac valve, the device being operative to effect greater antegrade flow than retrograde flow through the vessel, and being operative to restrict the passage of emboli while allowing blood to flow through the vessel .
• a method for performing an operation on a cardiac valve of a heart while the heart is beating comprising the steps of a) positioning a valved filter device in a flow path of a blood vessel downstream from the cardiac valve, the device being operative to effect greater antegrade flow than retrograde flow through the vessel, b) resecting or disrupting at least a portion of the cardiac valve, and c) affixing at least one prosthetic valve at, upstream or downstream from the resected cardiac valve.
• a device for performing intravascular procedures wherein the device is adapted for placement in a flowpath of a blood vessel, the device comprising, a) a valve means operative to allow greater antegrade flow than retrograde flow through the vessel; and b) a filter operative to restrict passage of emboli while allowing blood flow through the vessel .
• a device for performing intravascular or intracardiac procedures wherein the device is adapted for placement in the flowpath of blood, the device comprising a valve means operative to allow greater antegrade flow than retrograde flow; and a filter operative to restrict passage of emboli while permitting blood flow therethroug .
• a device for performing intravascular or intracardiac procedures wherein the device is adapted for placement in a flowpath of a blood vessel, the device comprising a) a valve means operative to allow greater antegrade flow than retrograde flow through the vessel; and b) a filter operative to restrict passage of emboli while allowing blood flow through the vessel .
• a valved filter device for use in repair and replacement of cardiac valves, the device comprising an elongated tube of filter material, said tube being closed at a distal end thereof and open at a proximal end thereof; and a membrane tethered to the open end of said tube at spaced apart fixation points, the membrane being expandable under diastolic pressure to form a generally parabolic cone substantially blocking flow of blood therethrough, and compressible under systolic pressure to form a substantially non-flow blocking configuration to permit flow of blood therethrough.
• FIGS. 1A-1F depict various phases in the deployment of an exemplary filter
• FIGS. 2A-2C depict another embodiment of a temporary filter device.
• a small balloon located about the exterior ofthe cannula of this device forces blood to flow through a filter when inflated;
• Figure 3 A shows a schematic representation of an endovascular procedure catheter ofthe invention, with the one-way valve and filter membrane in a retracted
• Figure 3B depicts the endovascular procedure catheter of Figure 3 A following deployment ofthe one-way valve and filter membrane;
• Figure 4A depicts valve and filter components ofthe procedure catheter of
• Figure 3 A viewed along the retrograde flow path.
• the valve is closed on the left portion of Figure 4A, preventing retrograde flow, and open on the right portion of Figure 4A, allowing antegrade flow;
• FIG. 4B depicts the "valve open” (left portion) and “valve closed” (right
• Figure 5 A depicts the filter membrane element ofthe procedure catheter of Figure 1 A as viewed along the flow path within a vessel;
• Figure 5B depicts the procedure catheter of Figure 3 A with the one-way valve removed
• Figure 6 depicts an exemplary deployment system for the temporary valve and filter elements ofthe endovascular procedure catheter of Figure 3 A;
• Figures 7A-7D depict exemplary elements used to aid in deployment ofthe temporary valve and filter element ofthe endovascular procedure catheter of Figure 3A;
• FIGS 8 A and 8B depict another embodiment of a temporary valve and filter device ofthe invention.
• the temporary valve ofthe depicted device is a small
• FIGS. 9 A and 9B depict another embodiment of a temporary valve and filter
• FIGS. 10A and 10B depict another embodiment of a temporary valve and filter device in accordance with the invention. Slits cut in a valve material located about the expandable mesh provide a path for blood during antegrade flow and close against the expandable mesh during retrograde flow;
• Figures 11 A and 1 IB depict the device of Figures 2A-C with the addition of a one-way valve;
• Figure 12 depicts an exploded cross-sectional view of an alternative temporary valve assembly in accordance with the invention.
• components ofthe valve pieces are shown in cross section except for backing element 110 and valve 111;
• Figures 13 A, 13B, 13C, 13C, 13D and 13D' depict a series of cross- sectional views of the valve assembly illustrated in Figure 12;
• Figure 13A depicts the valve ofthe exemplary valve assembly of Figure 12 in
• Figure 13B depicts the valve of Figure 13A advanced outside of delivery
• FIG. 13C depicts the expanded valve of Figure 13 A seen looking down the long axis ofthe vessel into which it is deployed. The valve is expanded by pulling back on button 101. In Figure 13 C, the valve is open, allowing flow through flexible loop 109. This depiction represents the state ofthe valve during the systolic phase when placed in the aorta and acting to support the aortic valve;
• Figurel3C is the same as Figure 13C with the valve assembly viewed along
• Naive leaflets 111 extend away to the right (as shown) of flexible loop 109;
• Figure 13D depicts the expanded valve of Figure 13A seen looking down the long axis ofthe vessel into which it is deployed.
• the valve is in a closed position, preventing flow through flexible loop 109.
• This depiction represents the state ofthe valve during the diastolic phase when placed in the aorta and acting to support the aortic valve;
• Figure 13D' is the same as Figure 13D with the valve assembly viewed along a radius/diameter ofthe vessel into which it is deployed.
• Naive leaflets 111 are
• Figures 14A-14D depict the valve end of temporary valve assembly of Figure 12 inserted into a vessel.
• Figure 14A is a lateral view, showing partial deployment
• Figure 14B is a lateral view ofthe deployment of Figure 14 A, showing a rod 106 positioning the temporary valve into the vessel. In this view, the temporary valve is beginning to unfold and expand.
• Figures 14C and 14D show
• Figure 15 depicts a temporary valve ofthe invention deployed in the aorta
• Figure 16 depicts the temporary valve of Figure 16 deployed in the aorta, with the valve closed;
• Figures 17A-17E show various components of a prosthetic valve and fixation system in lateral views (left side) and axial views (right side);
• Figure 18 depicts a method of performing surgery on a cardiac valve using a temporary valve and filter of the invention
• Figure 19 depicts another method of performing surgery on a cardiac valve using a temporary valve ofthe invention
• Figure 20 depicts the methods of Figures 18 and 19 following removal ofthe cardiac valve and inner cannula;
• Figure 21 depicts deployment of an expandable prosthetic valve through the
• Figure 22 depicts an exemplary method of fixing a prosthetic valve to a vessel wall during cardiac rhythm, in accordance with the invention
• Figures 23 A and 23B depict a method for repairing a stenotic aortic valve, in accordance with the invention.
• Figure 24 depicts another method for performing surgery in a cardiac valve using a temporary valve and filter in accordance with the invention;
• Figure 25 is a perspective view of a preferred valved filter device
• Figure 26 is an enlarged perspective view of one end of the device of Figure 25;
• Figures 27 and 28 are perspective views of internal skeleton elements of the device of Figure 25.
• Figures 29-35 are enlarged perspective views of a valve portion of the device of Figure 25.
• the methods and devices ofthe present invention can be used for performing procedures on cardiac valves without cardiac arrest or cardiopulmonary bypass. Narious embodiments ofthe methods and devices are described to clarify the breadth ofthe present invention.
• FIGS 1A-1F depict multiple stages of deployment of an exemplary temporary filter device 10 ofthe present invention. This device is particularly useful
• FIG 1 A shows the three primary components ofthe filter device 10-outer
• Outer cannula 1 has an inner diameter that is greater than the outer diameter of inner cannula 2.
• Mesh 3 is generally tubular when collapsed and at least conical in part when expanded, and is
• the apex ofthe conical portion of mesh 3 is movably attached to inner cannula 2 along a length proximal (to the right) of inner cannula 2's distal tip. Collapsed mesh 3 is restrained on inner cannula 2 between two OD steps 4 rigidly affixed or integral to inner cannula 2. These OD steps may be greater than the generalized outer diameter of inner cannula 2 or may mark the ends of a reduced diameter section of inner cannula 2. The apex of mesh 3 is free to slide
• Expandable mesh 3 may be affixed to a ring (not shown) with an inner diameter
• This feature may act to minimize the risk of dislodging embolic material from the vessel wall during manipulations required by the procedure.
• the self expanding, mesh 3 is positioned against the outer surface of inner cannula 2.
• a filter material 71 such as woven nylon mesh with a defined pore size, may be positioned over the mesh 3.
• outer and inner cannulae can be constructed from any one of a variety of materials
• inner cannula 2 and outer cannula 1 can have
• degassing ports exterior to the vascular system to allow removal of air and other gases from the interiors ofthe cannulae.
• Expandable mesh 3 can also be made from any one of a variety of materials, but is preferably constructed from elastic metal woven into a tube.
• This tube preferably has a first diameter in an expanded state and a second, smaller diameter in a compressed state.
• the first diameter is preferably similar to that ofthe aorta or vessel in which the filter is used.
• the mesh itself can act as a filter or filter material can be attached along its interior or exterior. This embodiment is merely an
• Figure IB depicts assembled filter device 10, with the distal end ofthe inner cannula 2 inserted into the proximal end ofthe outer cannula 1.
• Figure IC depicts assembled filter device 10 with the outer cannula 1 retracted proximally, exposing mesh 3 and allowing its free end to expand against the inner wall ofthe vessel into which it is deployed.
• mesh 3 expands into a conical shape, with the base ofthe cone extending toward the distal end ofthe cannulae.
• Inner cannula 2 has a deflected tip that bends the lumen ofthe cannula away from the long axis ofthe device. This bend assists in guiding any procedural instrument passed through the lumen of inner cannula 2 toward the wall
• mesh 3 in this figure permits this bend without altering the orientation of mesh 3 relative to the vessel into which it is inserted.
• a device such as a valve resecting device which extends out of cannula 2
• a device may be steered to resect a desired portion of a stenotic valve, for example.
• the invention may also include a fiber optic viewing assembly extending through cannula 2.
• Figure ID depicts the device of Figure IC with inner cannula 2 rotated 180 about its long axis and retracted proximally.
• the sliding attachment of expanded mesh 3 to inner cannula 2 allows this to occur without any motion of mesh 3 relative to the vessel wall.
• Figure IE depicts the device of Figure 1 D during removal.
• Outer cannula 1 is advanced over inner cannula 2 and is about to compress expanded mesh 3 and any entrapped material.
• the mobility of expanded mesh 3 relative to inner cannula 2 causes mesh 3 to move beyond the distal end of inner cannula 2. This ensures that embolic material captured by mesh 3 will not be trapped between mesh 3 and the
• Figure IF depicts the device of Figure ID with filter material 71 added to the exterior surface of expanded mesh 3.
• expanded mesh 3 has been shortened to just the cone portion ofthe prior meshes. Extending distally beyond this
• cone are filter extensions 70 that occupy only a portion ofthe circumference of a cylinder having a diameter equal to the maximum diameter of the cone-shaped mesh 3.
• the extensions are adapted to lie along the vessel wall and rest over the ostium of one or more arteries that branch from the vessel.
• the extension configuration of Figure IF is advantageous for filtering the ostia of branch vessels that may be located between valve commissures, such as the coronary ostia in the aorta.
• extensions 70 are preferably from three points
• Each extension 70 is preferably a hemi-circular leaflet with the diameter ofthe hemi-circle being located about the circumference ofthe
• device 10 When deployed, device 10 is oriented so that the base ofthe cone is expanded toward the aortic valve.
• the shape ofthe three leaflets allows the filter to be expanded or advanced along the wall ofthe aorta beyond the plane created by the
• Extensions 70 can further be designed to exploit pressure
• Such an expandable filter acts to filter just the branch vessels with the conical portion of the expanded mesh left uncovered by filter material 71.
• either the partial filter extensions can be employed (as in Figure IF) or full cylindrical filters (not shown) that cover the entire circumference ofthe vessel
• FIGS 2 A, 2B, and 2C show an alternative embodiment of a filter that can be used to filter emboli from blood flowing through a vessel.
• Filter 20 consists of cannula 17, a valve located within the interior ofthe cannula (not shown), an expandable means depicted as balloon 19, and a filter depicted as mesh 18.
• the valve interior to cannula 17 acts to prevent the flow of blood out ofthe vessel
• Balloon 19 can be expanded by the injection of gas or liquid through port
• FIG. 2B an intravascular instrument 5 has been passed through the inner lumen of cannula 17. As instrument 5 does not occupy the entire interior flow area of cannula 17, blood can flow around instrument 5, into cannula 17 and through filter 18.
• Figure 2C is an end-on view of filter 20 and instrument 5 from the left side as viewed in Figure 2B.
• the blood flow path is annulus 22 formed by the inner wall
• Filter 20 can be used in a variety of intravascular procedures that would benefit from the filtration of blood.
• FIGs 3-7 depict one embodiment of such a combined valve and filter device.
• endovascular procedure catheter 2' is inserted into the host. It is positioned over a guide wire 800 at its desired location, for this example in the ascending aorta above the coronary arteries
• Guide wire 800 and guiding catheter 700 can then be removed.
• valve 26 the selectively permeable, filtering membrane 3 (Figs. 4A, 4B, 5A and 5B), and mounting ring 900 are deployed.
• Deployment comprises the controlled, adjustable increase in the diameter of valve 26, membrane 3', and / or mounting ring 900 until they abut or nearly abut the inner wall ofthe vessel.
• Temporary one-way valve mechanism 26 can be comprised of any type of one way valve.
• the critical function of valve 26 is to limit the aortic insufficiency and. thus, the amount of volume overload on the heart generated by resecting or manipulating the diseased or damaged host valve. This will allow procedures to be performed on the valve and replacement ofthe valve without the need for partial or complete cardiac bypass or cardiopulmonary bypass.
• the host aortic valve is resected, removed or manipulated. If the valve is to be replaced, the new cardiac valve is implanted. This valve can be mounted on endovascular procedure catheter 2'or can be delivered through another port of entry or cannula. Upon completion ofthe procedure, all devices are retracted and removed.
• the illustrated exemplary endovascular procedure catheter2' is a cylindrical sleeve that is made of a flexible material. It is durable and resistant to thrombogenesis.
• endovascular procedure catheter 2' functions as a working port
• Endovascular procedure catheter 2' itself has a one-way valve 25 in its lumen
• This one-way valve can be of any configuration as long as it serves to permit the passage and removal of instruments through the lumen ofthe endovascular procedure catheter and inhibits retrograde blood flow through the endovascular procedure catheter. It is located proximal to side holes 600 of
• Temporary valve 26 is made of a flexible, durable, non-thrombogenic material.
• Valve 26 can be any type of one-way valve and consist of as many or few
• Valve 26 depicted in Figure 3 A, 3B and Figure 4A, 4B is a bileaflet valve mounted on mounting ring 900. It permits antegrade blood flow
• the valve mechanism is a simple one way, single orifice valve which is mounted on the stabilizer. However, the valve can sit independent of mounting ring 900 and as aforementioned can take on any shape as long as it functions as a one way valve.
• the center of selectively permeable filtering membrane 3' is mounted on the outside wall of endovascular procedure catheter 2'.
• the relatively large diameter peripheral edge is mounted on mounting ring 900. It is conical in shape when deployed and sits just upstream of temporary valve 26.
• Filter membrane 3' is made of a flexible, durable, non-thrombogenic material that has pores that are sized to permit select fluids through (i. e. blood and blood components) but prevents the flow or embolization of debris generated during the endovascular procedure. By placing it upstream of temporary valve 26 it prevents prolapse ofthe temporary valve leaflets.
• a tapered guiding catheter 700 ofthe size ofthe internal diameter of endovascular procedure catheter 2' is placed inside endovascular procedure catheter 2' as depicted in Figure 3 A.
• the tapered end at the distal tip DT extends approximately 2 centimeters beyond the distal end of endovascular procedure catheter 2', but other extension lengths may be used.
• Guiding catheter 700 is made of flexible material and the end is soft to prevent injury to the vessels during placement of endovascular procedure catheter 2'. Guiding catheter 700 has a lumen of such a size as to permit its passage over guide wire 800. Guiding catheter 700 also serves to deploy and retract mounting ring 900, temporary valve 26, and filter membrane 3'.
• Figure 6 illustrates an exemplary
• deployment assembly DA for membrane 3' includes elements 950-958, described in detail below.
• guiding catheter 700 has slots distally which engage extension arms 955 of struts 952 that support mounting ring 900.
• Mounting ring 900 is mounted on the outside of endovascular procedure
• Mounting ring 900 is comprised of a flexible, durable, nonthrombogenic material which abuts the inner lumen ofthe vessel when deployed. Temporary valve 26 and/or selectively permeable membrane 3' are mounted on mounting ring 900. When mounting ring 900 is deployed so are the mounted
• Mounting ring 900 is deployed in a controlled, adjustable way. Struts 952 are connected to mobile ring 953 and fixed ring 950 which is mounted on
• Mobile ring 953 has extensions 955 which extend into the lumen of endovascular procedure catheter 2' by
• mounting ring 900 is deployed or retracted in an umbrella-like manner. Once mounting ring 900 is deployed to the desired diameter, it is “locked” into place by engaging extension arms 955 into locking slots 958 cut into the wall of endovascular procedure catheter 2'. At this point, guiding catheter 700 is disengaged
• the strut mechanism consists of struts 952, rings 950 and 953, and hinges 954.
• the strut mechanism depicted here consists of three struts
• Distal ring 953 that connect mounting ring 900 to the fixed proximal ring 950 that is mounted on the outside of procedure catheter 2'. These struts are also connected to support arms 951 which extend to mobile distal ring 953 also mounted to the outside of endovascular procedure catheter2'. Distal ring 953 has extension arms 955 which
• Mounting ring 900 is expanded by moving support rings 953 and 950 relative to each other. Struts 952 and arms 951 are hinged at pivot points 954.
• FIGS 8 A and 8B illustrate another embodiment of a combined valve and filter device for use in intravascular procedures.
• the filter means of device 40 is the same as device 10 depicted in Figures 1 A-l E.
• Figures 8A and 8B as expandable balloon 25, is situated on the exterior of outer cannula 1 'of the device.
• a continuous lumen extends from the interior of balloon 35 to port 21'.
• Port 21' is connected to balloon pump 8 by tube 24.
• FIG. 8B depicts a device 40 with filter 3 deployed and balloon 35 deflated during the systolic phase ofthe cardiac rhythm.
• Figure 8B shows balloon 35 in an inflated state 35' during the diastolic phase.
• inner cannula 2 may have a lumen through which instruments can be passed to effect an intravascular procedure.
• the filter is shown to the left ofthe valve.
• Figures 9 A and 9B show yet another embodiment of a combined valve and filter device for use in intravascular procedures.
• Device 50 is the same as device 10
• valve means 26 that covers the surface of expanded filter 3.
• valve means 26 consists of one or a number of thin sheets of material that are attached to the exterior ofthe base ofthe cone formed by the expanded mesh filter 3. The sheet material is relatively free to move at the apex ofthe cone such that mesh filter 3 and the sheet material act in concert as a flap valve.
• FIG 9B blood flows through filter 3 from the interior ofthe
• the device can be delivered with mesh filter 3 and flap valve 26 in a compressed state within outer cannula 1 similar to Figure 3 B. Mesh filter 3 and valve 26 then expand once outer cannula 1 is retracted.
• the sheet material can additionally be affixed to a more
• FIGS. 10A and 10B show another embodiment of a combined valve and filter device.
• Device 60 is the same as device 10 in Figures 1A-1E with the addition of
• Valve 28 that covers the surface of expanded filter 3.
• Valve 28 consists of a singular
• valve 28 can be attached at additional sites along mesh filter 3 to assist in its function.
• FIGs 11 A and 1 IB depict a combined valve and filter device 30.
• the filter means of device 30 is the same as filter device 20 shown in Figures 2A-2C.
• valve 38 is placed around the exterior of cannula 17, covering filter 18.
• Valve means 38 is preferably a flexible sleeve of material such as silicone rubber.
• a slit 23 has been cut through the sleeve along its length. Slit 23 is normally closed, but opens under positive pressure within cannula 17. Hence, when this device is placed in the arterial system with the distal end (near balloon 19) pointed proximally, slit 23
• FIG. 11 A depicts valve 38 in a closed position.
• Figure 1 IB depicts valve means 38 in an open position. Similar to device 20, device 30 maybe configured with
• flow paths may include additional valves that resist retrograde flow while allowing antegrade flow.
• Each ofthe preceding filter and valve embodiments are adapted to be inserted into a vessel through an insertion site and expanded radially from the center ofthe vessel at a site remote from that insertion site.
• Figures 12-14 disclose a temporary valve assembly (with optional filter) 100 which can be inserted substantially perpendicular to the long axis ofthe vessel and
• valve assembly 100 consists of four components-a
• cannula a deformable loop, a backing element and a valve.
• the distal end of the cannula is inserted into a vessel, the deformable loop is then advanced out of the distal end into the vessel and expanded to abut the interior wall ofthe vessel.
• the backing element spans the interior lumen ofthe expanded loop and is attached to the loop at at least one point.
• the backing element is permeable to blood flow.
• a valve is affixed to either the expanded loop, the backing element, or both and functions to
• the valve further allows flow in a second, opposite direction by deflecting away from the backing element during flow through the loop in that direction.
• FIG. 12 depicts the detailed construction ofthe valve device 100 in exploded form.
• Button 101 is a rigid piece with an opening that is used to attach it to a central rod 106.
• Rod 106 is rigid and is attachable to the valve components ofthe device (Parts G, A, and B, as illustrated) as well as two small discs 108 and 108'.
• Secondary button 102 is affixed to valve holder 107 through tube 103.
• Parts I form proximal seal 104 and are affixed to each other and delivery cannula 105.
• Tube 103 is a rigid piece with an opening that is used to attach it to a central rod 106.
• Rod 106 is rigid and is attachable to the valve components ofthe device (Parts G, A, and B, as illustrated) as well as two small discs 108 and 108'.
• Secondary button 102 is affixed to valve holder 107 through tube 103.
• Parts I form proximal seal 104 and are a
• Rods proximal seal 104 and delivery cannula 105 can slide through the lumens of proximal seal 104 and delivery cannula 105.
• Proximal seal 104 includes an o-ring that seals around the
• Flexible loop 109 has a hole through the center of its length seen at the base ofthe loop formed in the figure.
• a backing elementl 10 and valve 111 are affixed to flexible loop 109 with any suitable fixation means.
• Backing element 110 spans the interior of flexible loop 109.
• Element 110 is made of flexible material and in its preferred embodiment is a woven nylon sheet. This sheet can act
• Valve 111 is a set of valve leaflets. In this figure there are six valve leaflets. These leaflets are attached to the periphery of backing means 110, flexible loop 109 or both, for example, by way of a ring of material surrounding the leaflets.
• valve holder 107 is affixed to valve holder 107 through the two small through-holes in valve holder 107. These through holes act as hinge points about which the ends of flexible loop 109 can pivot.
• Rod 106 is
• valve holder 107 fits within the lumen of delivery cannula 105.
• backing element 110 is a porous sheet of material that further acts to filter blood passing through
• This porous sheet can be a woven material with an open area that allows the passage of blood, although other forms may be used, all within the
• deformable loop 109 is made from a strip of material with a non-circular cross section. It may have a rectangular cross-section. The thicker side ofthe rectangle can be positioned against the wall ofthe vessel. This gives the loop greater flexibility to conform easily to the
• the valve 111 is preferably effected by a set of valve leaflets as shown.
• valve leaflets can collapse, in an overlapping manner, against backing element 110 to
• the device may be used without a filter (backing element), to provide a valve-only device. Generally, such a device would be used with a filter in another location.
• the leaflets of valve 111 are preferably formed from thin, flexible sheets of material. There may be any number of leaflets.
• the leaflets may be sized to act in concert to close the flow path formed by the loop.
• the leaflets may alternatively be oversized, such that fewer than all ofthe leaflets are required to close the flow path.
• the valve 111 may alternatively be a sheet of material cut with slits.
• the slits stay substantially closed (not parted) to prevent flow in a first direction through the flow path created by the loop 109 by collapsing against the backing element.
• the slits allow the passage of blood in the second, opposite direction through the flow path by parting open in the direction away from the backing element.
• Another method of using that device ofthe form of Figures 12-14 is to insert the distal end ofthe device into the vessel through an entry site and expanding the valve proximate to the entry site. This allows the device to be placed easily, near the heart, during an open-chest procedure.
• Another method of using the device is to insert its distal end into a vessel along a path that is substantially perpendicular to the long axis ofthe vessel and expand the valve about that path.
• the device is expanded until it occupies the entire flow path ofthe vessel and sits within a cross-section of that vessel taken pe ⁇ endicular to the vessel's long axis. This minimizes the length ofthe vessel taken up by the temporary valve device.
• FIG 15 depicts temporary valve assembly 100, with its valve deployed in aorta 215.
• a procedure is indicated as being performed on aortic valve 212 through a separate access cannula 201 using procedure instrument 205.
• Device 100 is shown with its valve open (as in Figure 13 C) allowing flow through flexible loop 109.
• This figure depicts the systolic phase of cardiac rhythm.
• valve assembly 100 is similarly positioned, but is closed (as in Figure 13D'), preventing flow back toward the heart. This figure depicts the diastolic phase of cardiac rhythm. The position of valve assembly 100 distal to the three
• branches from the aortic arch is shown as a representative application ofthe device and by no means limits its application to this position.
• FIG. 17A-17E Another aspect of the present invention is a valve fixation device, illustrated in Figures 17A-17E.
• the valve fixation 90 is used to secure a prosthetic valve to the wall of a vessel.
• the prosthetic valve is a stentless tissue valve.
• the tissue valve has a base, located proximal to the heart when placed in an
• the prosthetic valve is anatomic position, and an apex located distal to the base.
• the valve preferably has three commissures and three leaflets.
• the apex ofthe commissures is toward the apex ofthe valve.
• the valve has an interior surface and an exterior surface. The interior surface serves as an attachment site for the valve leaflets to the
• the exterior ofthe valve is generally smooth and forms at least a portion of a cylinder.
• the valve has a long axis that runs along the long axis ofthe cylinder.
• the valve fixation device consists of at least one substantially rigid strut and at least two expandable fixation rings.
• the strut (s) runs along the exterior surface of
• the rings are preferably located about the circumference ofthe base and apex ofthe valve.
• the valve fixation device 90 has three struts 92 and two rings 91. Each ofthe three struts 92 is affixed to the
• valve along an axis that is parallel to the long axis ofthe valve and passes proximate to one ofthe valve commissures.
• the rings 91 are preferably self-expanding. Alternatively, rings 91 maybe
• strut(s) 92 may employ barbs or spikes 83 at any location along their exterior to aid in securing the valve to the vessel wall.
• the rings 91 may further be affixed to the exterior ofthe valve and employ a sealing material 84 or other means, on rings 91, to
• valve fixation device 90 the valve fixation device 90 and attached tissue
• valve 80 are inserted in a compressed state into the vascular system.
• the compressed valve/fixation system is then advanced to the site of implantation, expanded, and secured to the vessel wall.
• the compressed valve/fixation system can be inserted through any peripheral artery distal to the aorta.
• the valve can be inserted through the wall of a cardiac chamber or directly into the aorta itself.
• Various devices can be employed to aid in delivering the valve to the implantation site, including, but not limited to delivery cannulae, catheters, and any of a variety of valve holders known in the art.
• Figure 17A depicts a stentless tissue valve 80 such as those known in the art.
• valve wall 81 has three sections of its cylindrical form removed so as not to block branch vessels such as the coronaries.
• branch vessels such as the coronaries.
• Any flexible valve with a wall and leaflets can be used with the present invention.
• FIG. 17B depicts valve fixation device 90 ofthe present invention.
• This embodiment comprises two expandable ring-like structures 91, shown in their
• Struts 92 are relatively rigid and do not change dimensions from the compressed to the expanded state ofthe device 90.
• struts 92 are separated by roughly 120 degrees in the illustrated form, as shown in the axial view ofthe figure, corresponding to the three commissures ofthe prosthetic valve. Struts 92 are preferably relatively rigidly attached to expandable rings 91 such that the two expandable rings 91 may not rotate about their central axes relative to each other. This avoids twisting of tissue valve 80 during deployment, minimizing the risk of valve leakage.
• FIG. 17C depicts valve fixation device 90 affixed to tissue valve 80, forming valve assembly 85.
• Fixation device 90 can be affixed to tissue valve 80 at
• expandable rings 91 are affixed to the outside ofthe valve wall 81.
• Figure 17D depicts the assembly 85 of Figure 17C in a compressed state 85' suitable for insertion into an artery or vein through a relative smaller opening.
• Figure 17E depicts another embodiment ofthe valve fixation device 90.
• barbs 83 reside on the exterior surfaces of both struts 92 and expandable rings 91 to aid in securing the device 90 to a vessel wall.
• Felt 84 has also
• Figure 18 depicts a procedure being carried out on aortic valve 412 while the heart is beating.
• Instrument 405 is manipulating aortic valve 412 following the
• valve 406 and filter device 403. are separate instruments that have been inserted directly into the aorta through separate insertion sites 414 and 413.
• valve 406 and filter 403 maybe effected in a single instrument placed through a single incision.
• Mesh filter 403 may also be inserted from a peripheral vessel and advanced to a location within the aorta. Mesh filter 403 is deployed through outer cannula 401 to a preferred site
• filter 403 prevents distal embolization of debris that may be dislodged during manipulation of valve 412.
• Portions of inner and outer cannulae 401 and 402 and instrument 405 extend to the exterior ofthe aorta where they can be manipulated by a surgeon.
• balloon valve 406 is deployed in the descending aorta 415.
• Balloon 406 is inflated and deflated by an attached balloon pump 408 exterior to the
• Balloon pump 408 is in fluid connection with balloon 406 through tube 407. Balloon pump 408 is timed to the cardiac rhythm so that it inflates balloon 406 during substantially all ofthe diastolic phase and deflates balloon 406 during substantially all ofthe systolic phase. This allows the valve 406 to perform the function of aortic valve 412 while the aortic valve is manipulated.
• Figures 19, 20, and 21 show another form ofthe present invention. Those figures depict sequential views of method of removing the native aortic valve and
• balloon valve 406 has been placed in the descending aorta 415.
• Cannula 401 has been placed into the aorta to allow the passage of instrument 405.
• Cannula 401 may have a valve (not shown) along its interior that acts to prevent the flow of blood through the cannula while allowing the passage of various instruments.
• Instrument 405 has been inserted through cannula 401 to remove native aortic valve 412.
• FIG. 20 shows the embodiment described in Figure 19 after substantially all ofthe aortic * valve has been removed. Portions 412' ofthe aortic valve may remain without deviating from the scope of this invention. Indeed resection of native valve 412 can
• valve prosthesis 416 expanded against and affixed to the aortic wall at a site near the previous attachment ofthe native valve. Once valve prosthesis 416 is in place and functioning, temporary valve 406 can be removed. No filter is shown in
• a set of two concentric cannulae, inner cannula 402 that fits within the lumen of outer cannula 401, are inserted into the vessel.
• the method further involves the steps of advancing the set of cannulae to a site downstream ofthe cardiac valve, expanding an expandable member 403 from
• inner cannula 402 along the length of inner cannula 402 and performs any number of functions such as acting as a temporary valve, acting as a filter, or removing or disrupting the cardiac
• Figure 22 depicts one method of fixing a prosthetic valve 516 to a vessel wall during cardiac rhythm.
• prosthetic valve 516 is inserted into aorta 515 in a compressed state through access cannula 501.
• Prosthetic valve 516 is then expanded to abut the inner wall of aorta 515.
• a needle 512 and suture 514 are then
• prosthetic valve 516 In this depiction, three sutures are used to tack prosthetic valve 516 to the aortic wall in locations superior to the valve commissures.
• a fixation means can be passed from the interior wall of aorta 515 through to the exterior surface.
• the fixation means can be a staple, suture or other suitable means.
• a compressed prosthetic valve is inserted into a vessel downstream ofthe cardiac valve to be
• prosthetic valve is then expanded to allow it to function temporarily in its downstream location. With that valve temporarily placed, and functioning, a
• the procedure on the cardiac valve is performed, involving the disruption and/or removal ofthe cardiac valve. Then the prosthetic valve is advanced toward the site ofthe excised or disrupted cardiac valve, and affixed at a site within the vessel at or near
• the expanded prosthetic valve functions as the native valve, preventing retrograde flow.
• downstream of its final position may be performed through an incision somewhere
• the procedure could be done with tools inserted through the functioning prosthetic.
• Figures 23 A and 23 B depict a method for repairing a stenotic aortic valve in accordance with the invention.
• Figure 23 A shows stenotic aortic valve 612 within the aortic root.
• View 1 in this figure shows two views of stenotic valve 612 looking along the long axis of aorta 615 proximal to the valve. In this view, the leaflets of
• valve 612 provide a reduced aperture due to the stenosis.
• Figure 23B shows the aortic valve after the repair method ofthe invention
• valve 612 is disrupted by incising each leaflet such that six leaflets are formed.
• a balloon valvuloplasty may optionally be performed on valve 612".
• a valve support Following the disruption of valve 612", a valve support
• valve support 620 is positioned upstream ofthe valve 612".
• valve support 620 includes an expandable outer ring (circular or otherwise, e.g. elliptical, oval,
• the outer ring is
• Figure 24 depicts a procedure being performed on the aortic valve 412 while the heart is beating.
• Instrument 405 is manipulating aortic valve 412 following the placement of both temporary valve 100 and filter device 410 (for example, device 10 of Figure IF).
• temporary valve 100 and filter device 410 have been inserted directly into the aorta through separate insertion sites 414 and 413.
• Mesh filter (not visible) has been deployed through outer cannula 401 to a site proximal to the coronary arteries 409.
• Filter material 71 covers the mesh filter.
• Filter extensions 70 extend from the filter material and form filter leaflets that
• Portions ofthe inner and outer cannulae 401 and 402 and instruments 405 extend to the exterior of the aorta where they can be manipulated by the surgeon.
• temporary valve 100 is deployed in the descending aorta 415, and as described earlier, expands to occupy the entire flow path.
• Temporary valve 100 is shown in the systolic phase of cardiac rhythm, i. e.
• the temporary valve and/or filter may
• aortic valve or in still other forms, downstream of the mitral or other cardiac valves. Further, these devices may be deployed downstream of one cardiac valve while procedures are being performed on another cardiac valve upstream ofthe devices.
• a novel valved arch filter device 1000 (Fig. 25) which provides a temporary one-way valve between the coronary ostia (where the coronaries come off the aorta) and the origin of the great vessels (i.e., those going to the arms and brain) .
• the temporary one-way valve performs the function of the native aortic valve during the brief period after the native diseased valve has been removed and before a prosthetic valve has been implanted. Ideally, this temporary valve would sit in exactly the same position as the natural valve, but this area needs to be kept free for fixation of the prosthesis. Therefore, the temporary valve is located downstream from the natural aortic valve. In this position, the left ventricle is spared the hemodynamic stress of acute severe aortic insufficiency. That is to say, if one simply removed the aortic valve on a beating, unassisted heart without deploying a temporary valve, after each heart beat, the majority of the previously-ejected blood from that heart beat would back up into the heart. As a result, the left ventricle, the main pumping chamber, would stretch out and fail, and forward blood flow to the body would be compromised. However, the temporary valve, in the position described above, would keep the blood from backing up between heartbeats .
• valve would be proximal to the vessels to the brain and other organs, blood pressure and flow to these organs would be relatively unaffected between heartbeats, as forward flow and diastolic pressure would be preserved.
• the only potentially adverse physiologic effect of having a temporary valve in that position is that the coronaries, which naturally originate above the native aortic valve, sit below the temporary valve. As such, coronary flow would have to occur during systole (while the heart is beating) instead of during diastole (between heartbeats) when it usually occurs. It has been demonstrated, in animals, that this is well tolerated for short periods of time under anesthesia, and should not present a problem.
• the new valved arch filter device 1000 further provides downstream filtration. That is to say, to prevent small pieces of tissue, or emboli, that break off during removal of the native valve and/or implantation of the prosthetic valve from flowing downstream where they could potentially become lodged in small branches of the arterial tree and cause injury to the brain, liver, kidneys, or other vital organs.
• downstream filtration that is to say, to prevent small pieces of tissue, or emboli, that break off during removal of the native valve and/or implantation of the prosthetic valve from flowing downstream where they could potentially become lodged in small branches of the arterial tree and cause injury to the brain, liver, kidneys, or other vital organs.
• This new valved arch filter embodiment has various characteristics. For one thing, the new device 1000 is intended to be passed percutaneously and positioned under transesophageal echo or fluoroscopy.
• the new device has a central working channel that allows catheters needed for handing off the debridement tool or the prosthesis and fixation device to be inserted percutaneously.
• the new device has radial symmetry, so radial orientation is not important.
• the present device is intended to cover the entire arch (i.e., that section of aorta from which the vessels to the brain arise) so the positioning of the device would have high tolerances. Still other ways of characterizing the present invention will be apparent from this description and the associated figures .
• the valve design incorporated in the preferred construction of the new valved arch filter 1000 is unique.
• the valve includes a thin-walled membrane 1002 shaped like a parabolic cone.
• the cone shaped membrane 1002 is tethered at the apex by a catheter 1004 that extends coaxially down the center of the valve-filter assembly 1000.
• the cone shaped membrane 1002 is tethered at the base at 3-4 discrete points (A, B, C and D in Figs. 29 and 35) around its circumference to the inside of a thin plastic valve seating retaining ring 1006 that, though collapsible, expands to the internal circumference of the aorta.
• the membrane 1002 When blood attempts to pass by the valve in a retrograde fashion between heartbeats, the membrane 1002 inflates (Figs. 25 and 30), compressing its lower l/4th against the inner surface of the thin plastic ring 1006.
• the ring 1006 is compressed against the inner surface of the aorta, resulting in isolation of the proximal aorta from the pressurized distal aorta, and preventing reversal of flow during diastole.
• the pressure in the proximal aorta With the onset of systole, the pressure in the proximal aorta rapidly rises .
• the parabolic membrane 1002 is compressed down around the central catheter 1004 (Figs. 33-35), allowing unhindered flow of blood in the antegrade direction.
• the central catheter 1004 is held in the middle of a filter tube 1008 by collapsible radial struts 1010 (Figs. 26, 29, 31-34) at the two ends of the valve filter assembly 1000.
• the struts 1010 allow traction to be applied to the catheter 1004 extending through the central lumen 1012, as may be necessary in valve debridement, hand-off, and insertion, without the catheter 1004 rubbing against the inner surface of the aorta.
• the filter membrane 1002 is fabricated of extremely lightweight filter material fashioned into tube 1008, mounted on a lightweight self-expanding internal skeleton (1014 (Figs. 27 and 28) of nitinol or other superelastic or otherwise satisfactory material.
• the central catheter 1004 can be the size of the catheter in a conventional intra-aortic balloon pump (IABP) ; and the filter and valve assembly is not substantially bulkier than the material of which the IABP balloon is made.
• IABP intra-aortic balloon pump
• the construction although somewhat more complex than a simple balloon, can be made of very lightweight materials, as the physical demands on it are considerably less than those required by an IABP.
• the valved arch filter assembly 1000 is provided in several sizes to accommodate the various sizes of aortas generally encountered.
• the tolerance with respect to circumferential size is relatively large, as the valved arch filter assembly is intentionally oversized to ensure intimate apposition of the filter tube and the aorta.
• the elastic skeleton is delicate, the forces on the inner surface of the aorta are small .
• the length of the device can be patient-specific; however, the tolerances in this regard are quite high.
• the ascending aorta generally measures 10 centimeters or more, and the descending aorta, 25 centimeters or more.
• the valved end of the assembly is disposed somewhere in the ascending aorta, proximal to the great vessels, and the distal end of the assembly is disposed in the descending aorta, all emboli bypass the brain, and the temporary valve functions as intended.
• the filter tube 1008 is closed as a blind sack of filter material distally.
• the back end of the valve filter assembly does not have to extend all the way into the descending aorta, but can instead terminate in the distal ascending aorta, the mid-arch aorta, or beyond.
• An advantage of a longer filter tube is that it ensures proper coaxial orientation.
• An open tube design would only divert embolic material away from the brain, but emboli to the kidneys, liver, intestines, and legs could still occur.
• a blind sack captures embolic material and allows it to be removed with the catheter.
• the lumen of the central catheter 1004 allows a variety of catheters to be passed to the area of the native diseased aortic valve, or across the valve into the left ventricular cavity for intra-cardiac hand-off of debridement tools, valve prostheses, or fixation devices.
• the debridement tools, prostheses, and fixation mechanisms can be designed to function down through the central lumen.

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