WO2020006151A1 - Valvule cardiaque aortique artificielle et dispositif de renforcement d'aorte supérieure - Google Patents

Valvule cardiaque aortique artificielle et dispositif de renforcement d'aorte supérieure Download PDF

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Publication number
WO2020006151A1
WO2020006151A1 PCT/US2019/039352 US2019039352W WO2020006151A1 WO 2020006151 A1 WO2020006151 A1 WO 2020006151A1 US 2019039352 W US2019039352 W US 2019039352W WO 2020006151 A1 WO2020006151 A1 WO 2020006151A1
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WO
WIPO (PCT)
Prior art keywords
aorta
frame
heart valve
sheath
reinforcement device
Prior art date
Application number
PCT/US2019/039352
Other languages
English (en)
Inventor
Robert V. Snyders
Original Assignee
Snyders Robert V
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Snyders Robert V filed Critical Snyders Robert V
Publication of WO2020006151A1 publication Critical patent/WO2020006151A1/fr

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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the present disclosure relates to aortic implants, and more particularly, to a combined aortic heart valve and upper aorta reinforcement device for repairing a damaged aortic heart valve and reinforcing an upper or thoracic aortic artery.
  • a human heart has four chambers that alternately expand and contract to pump blood through the vessels of the body.
  • the heart also includes check valves to ensure that blood flows in the correct direction through the body as the heart chambers expand and contract. Sometimes these valves become damaged, resulting in their inability to close. When the valves do not close, blood flows backward through the valve resulting in diminished blood flow and lower blood pressure. The valves can also fail to open sufficiently, resulting in diminished downstream blood flow.
  • the shape of the aortic arch increases the difficulty of positioning reinforcement devices or sleeves in the upper aorta.
  • Carotid and subclavian arteries extend upward near the apex of the aortic arch to deliver blood to tissue and organs above the heart, including the brain, neck, face, vertebrae, and arms. These arteries must remain free of blockage to prevent damage to the
  • Coronary arteries extend from the aorta immediately above the aortic valve. These arteries supply blood to the heart muscle and must not be blocked to avoid depriving the heart muscle of oxygen. Arteries extending from the descending thoracic aorta downstream from the apex of the arch are less critical as they direct blood to vertebrae that are also supplied with blood by the subclavian arteries.
  • the present disclosure includes a combined artificial aortic heart valve and aorta reinforcement device for functionally replacing a damaged aortic valve in a heart and reinforcing an aorta in a patient.
  • the damaged heart valve is located between a left ventricle of the heart and an aorta.
  • the aorta has a sinus of Valsalva at an upstream end adjacent the damaged heart valve.
  • the aorta has an ascending segment extending upward from the sinus to an arch segment and a descending segment extending downward from the arch segment through a diaphragm of the patient to deliver oxygenated blood to anatomical features in a lower portion of the patient.
  • the sinus of Valsalva has openings for transporting oxygenated blood from the sinus of Valsalva through coronary arteries to cardiac muscle.
  • a plurality of great vessels extend from the arch of the aorta for transporting oxygenated blood to anatomical features in an upper portion of the patient.
  • the combined artificial aortic heart valve and aorta reinforcement device comprises an elongated flexibly resilient frame having a length extending between an upstream frame end and a downstream frame end. Further, the device includes an annular band attached to the frame adjacent the upstream frame end. A flexible valve element is attached to the frame adjacent the annular band.
  • the valve element flexes between an open position for allowing blood flow from the left ventricle to the aorta when pressure in the left ventricle exceeds pressure in the sinus of Valsalva as the left ventricle contracts and a closed position for preventing blood flow from the aorta to the left ventricle when pressure in the sinus of Valsalva exceeds pressure in the left ventricle as the left ventricle expands.
  • the device also comprises a sheath attached to the frame. The sheath extends from an upstream sheath end spaced downstream from the annular band to a
  • the band, the valve element, and a corresponding upstream portion of the frame constitute a valve portion of the combined device, and the sheath and a corresponding downstream portion of the frame constitute a reinforcement portion of the combined device.
  • the upstream portion of the combined device has sufficient flexibility to assume a compressed configuration in which the upstream portion of the combined device is sized and shaped for passage through the aorta without preventing blood flow through the aorta and to assume an expanded configuration in which the band seats inside the damaged heart valve.
  • the upstream portion of the frame has sufficient strength and resilience to move the band to the expanded configuration to functionally replace the damaged heart valve.
  • the valve element to flexes between the open position to allow blood flow from the left ventricle to the aorta as the left ventricle contracts and the closed position to prevent blood flow from the aorta to the left ventricle as the left ventricle expands.
  • the downstream portion of the combined device has sufficient flexibility to assume a compressed configuration in which the downstream portion of the combined device is sized and shaped for passage through the aorta without preventing blood flow through the aorta and to assume an expanded configuration in which the sheath engages the aorta.
  • the downstream portion of the frame has sufficient strength and resilience to move the sheath to the expanded configuration to reinforce a corresponding portion of the aorta.
  • the upstream sheath end is spaced from the annular band by a distance sufficient to permit blood flow through the openings in the sinus of Valsalva to transport oxygenated blood to cardiac muscle when the band seats inside the damaged heart valve and the valve element is in the closed position.
  • the sheath is configured to permit blood flow through the great vessels for transporting oxygenated blood to the anatomical features in the upper portion of the patient.
  • FIG. 1 is a front elevation of a heart and aorta shown in relation to a portion of a diaphragm separating a thoracic region from an abdominal region;
  • FIG. 2 is a vertical cross section of FIG. 1 taken generally along a midline axis of the thoracic or upper aorta;
  • FIG. 3 is a cross section similar to FIG. 2 having a combined artificial aortic heart valve and upper aorta reinforcement device positioned inside the heart and aorta;
  • FIG. 4 is an elevation taken in a plane corresponding to FIG. 3 of a combined artificial aortic heart valve and upper aorta reinforcement device;
  • FIG. 5 is a vertical cross section of a valve portion of the device shown in FIG. 4
  • FIG. 6 is a cross section of the device taken in a plane corresponding to line 6-6 of FIG. 5;
  • FIG. 7 is a cross section of the device taken in a plane corresponding to line 7-7 of FIG. 4;
  • FIG. 8 is a cross section similar to FIG. 3, showing a combined artificial aortic heart valve and upper aorta reinforcement device having a first alternative configuration
  • a human heart is designated in its entirety by the reference letter H.
  • a native aortic heart valve V in the heart H separates a left ventricle E of the heart from an aorta A that carries oxygenated blood away from the heart.
  • the valve V ensures blood travels out of the heart and into the aorta A in a proper downstream direction indicated by arrow F in FIG. 2.
  • the valve V is divided into three flexible, cup -shaped sectors or cusps P that flex upward from their closed positions shown in FIG. 2 to open positions that permit blopd ⁇ to flow downstream (upward as shown) out of the heart H.
  • the aorta A has a broader segment known as a sinus of Valsalva S
  • the broader cross section of the sinus of Valsalva S provides space into which the cusps P flex when the valve opens and lowers the local blood pressure above the valve when the cusps are in their closed positions. Openings or ostia O in the walls of the sinus of Valsalva S permit blood to travel into vessels (i.e., coronary arteries) surrounding the heart H to supply oxygenated blood to the heart muscles. It is critical that these openings O are not blocked when the cusps P are in their open positions to prevent the heart muscle from being starved of oxygen.
  • FIG. 2 illustrates the aorta A extending upward from the heart H to a curved arch segment.
  • the upward extending segment of the aorta A is referred to as the ascending aorta.
  • the aorta A Downstream from its arch segment, the aorta A extends downward and through the diaphragm D separating the thoracic cavity from the abdominal cavity.
  • This downward extending segment of the aorta A is referred to as the descending aorta.
  • the segment of the aorta A above the diaphragm is referred to as an upper or thoracic aorta.
  • the segment of the aorta A below the diaphragm D is referred to as a lower or abdominal aorta.
  • arteries extend upward from the upper face of the arch segment of the aorta A near its peak or apex. Although the configuration and positions of these arteries vary in some individuals, the typical arch segment has openings of a left subclavian artery U, a left common carotid artery C, and an innominate artery I. Typically, the innominate artery I branches into a right subclavian artery (not shown) and a right common carotid artery (not shown) shortly above the arch segment. Regardless of the particular configuration and position of these arteries, the arteries extending from the peak of the arch segment are collectively referred to as great vessels G. Because the great vessels G deliver oxygenated blood to important anatomical structures, including the brain, the thoracic organs, and upper body muscles, it is critical that they not be blocked to prevent these structures from being starved of oxygen.
  • a combined artificial aortic heart valve and upper aorta reinforcement device is designated in its entirety by the reference number 10.
  • the device 10 generally comprises a valve portion, generally designated by 12, and a reinforcement portion, generally designated by 14.
  • the valve portion 12 is specifically configured to replace a damaged aortic valve V.
  • the reinforcement portion 14 is specifically configured for reinforcing corresponding segments of a weakened aorta A.
  • the valve portion 12 is positioned in line with the cusps P of the native heart valve V to ensure blood flows through the heart H and the aorta A in the appropriate direction indicated by arrow F in FIG. 2.
  • the reinforcement portion 14 is positioned inside a length of the aorta A.
  • the reinforcement element 14 extends upward from a position in the ascending aorta above the openings O in the sinus of Valsalva S through the aortic arch and along the descending aorta to a position just above the diaphragm D. Accordingly, the reinforcement element 14 of the illustrated example provides reinforcement along substantially all of the thoracic aorta. It is envisioned that the reinforcement portion 14 may have other lengths and reinforce shorter or longer segments of the aorta A. Further, it is envisioned that the reinforcement portion 14 may be divided into segments, either overlapping or spaced, to selectively support particular segments along the aorta A.
  • the valve portion 12 comprises an elongated flexibly resilient external frame, generally designated by 20, and a flexible valve element, generally designated by 22.
  • the frame 20 includes a plurality of flexibly resilient, U-shaped, stenting frame elements 30.
  • the elements 30 are joined at a junction 32 at an upstream end of the frame 20.
  • the valve portion 12 may have fewer or more frame elements.
  • the device 10 has two to four or more equally spaced elements.
  • the frame elements 30 are sufficiently flexible to permit the device 10 to be compressed to a
  • the frame elements 30 are sufficiently resilient to hold open the cusps P of the native valve V, as shown in FIG. 3 and to securely hold the device 10 in position between the cusps of the native valve.
  • the elements 30 of the illustrated example are made of nickel alloy wire such as nitinol wire, but other suitable materials may be used.
  • the wire of the illustrated configuration has a rectangular cross section with dimensions of about 0.005 inches by about 0.015 inches or about 0.015 inches by about 0.020 inches, other cross-sectional dimensions and shapes such as circular or oval are envisioned.
  • the frame elements 30 are described as U-shaped, having an arcuate segment separating opposing legs, any other suitable shape may be used.
  • a band extends around the frame 20 between each circumferentially adjacent frame element 30 leg.
  • the band 40 comprises an interior strip 42 and an exterior strip 44 bonded in face-to-face relation, so the strips sandwich the frame elements 30.
  • the interior strip 42 and exterior strip 44 are adhesively bonded in the illustrated example, any suitable means of bonding the strips that withstands delamination may be used.
  • the band 40 extends between each circumferentially adjacent leg of the frame elements 30 to limit maximum spacing between the legs. The band 40 permits the frame elements 30 to be pushed together to compress the resilient frame 20 when being implanted. Once the band 40 is generally aligned with the cusps P of the native valve V between the left ventricle E and the aorta A, the resilience of the frame elements 30 opens the device 10 to an expanded configuration as shown in FIG.
  • the frame elements 30 push the exterior strip 44 of the band 40 outward against the cusps P of the damaged heart valve V toward the interior walls of the sinus of Valsalva S.
  • the band 40 is sized to allow the band to contact the cusps P or, in the absence of the cusps, the adjacent interior walls of the sinus of Valsalva S below the openings O to prevent blood from bypassing the device 10 once implanted.
  • the frame 20 and band 40 conform to the corresponding native anatomy of the patient.
  • the internal strip 42 comprises a nonporous knitted Dacron ® polyester fabric
  • the external strip 44 comprises a porous double velour knitted Dacron ® polyester fabric joined in face-to- face or bifacial relation.
  • Dacron is a U.S. federally registered trademark of INVISTA North America S.a r.l.
  • the band may be made of other suitable materials, such as heterologous animal pericardium (e.g., bovine or porcine pericardium), autologous tissue, engineered substrates, biocompatible radiopaque silicone rubber, polyurethane, ePTFE, polypropylene, a combination of polypropylene and polyglycolide fibers, uncrimped Hemashield Gold ® knitted microvel double velour vascular graft material.
  • Hemashield Gold is a U.S. federally registered trademark ofMaquet Cardiovascular, LLC of San Jose, California.
  • Mesh materials including collagen or combined 90% polyester/10% spandex, may be substituted for the polyester materials.
  • the porous double velour external strip 44 facing the inner tissue of the aorta i.e., the endothelium
  • the nonporous knitted internal strip 42 assists in reinforcing the band 40 and withstanding the cyclic pressures exerted by blood pulsing through the valve portion 12.
  • the frame 20 and band 40 may be also manufactured in different sizes or shapes to correspond to the native anatomy of the patient.
  • the frame 20 and band 40 may be sized for pediatric use.
  • the band 40 of the illustrated embodiment has an axial length of about 8 mm to about 10 mm. Further, the band 40 illustrated in FIGS.
  • the band 40 may include a rim or flange (not shown) surrounding the valve for engaging the cusps P to prevent leakage and to hold the device 10 in position.
  • the flexible valve element 22 is positioned inside the frame 20 and attached to the junction 32 of the frame elements 30 at the upstream end the frame.
  • the valve element 22 has a convex upstream face 50 that faces upstream and the left ventricle E when the frame 20 is anchored between the cusps P of the damaged native heart valve V.
  • the valve element 22 has a concave downstream face 52 opposite the upstream face facing downstream toward the aorta A when the frame 20 is anchored between the cusps P of the damaged native heart valve V, as shown in FIG. 3.
  • the valve element 22 moves in response to differences between fluid pressure in the left ventricle E and aorta A between an open position (as shown by phantom lines in FIG.
  • valve element of the illustrated example is made of a biocompatible elastic material such as silicone rubber, polyurethane, ePTFE, heterologous animal pericardium (e.g., bovine or porcine pericardium), or autologous tissue engineered substrates, but other suitable materials may be used.
  • the valve element 22 may have other thicknesses, the valve element of the illustrated example has a thickness of between about 0.005 inches and about 0.015 inches.
  • the combined thicknesses of the band 40, the frame elements 30, and the valve element 22 are selected to provide the valve portion 12 with a sufficiently small cross-sectional area when compressed to prevent the valve portion from blocking blood flow through the aorta A as the device 10 is being implanted.
  • the thicknesses must also be selected to provide the device 10 with sufficient strength to ensure adequate durability.
  • the upstream face 50 of the flexible valve element 22 has an apex 54 that is attached to the frame 20 at the junction 32 of the elements 30.
  • the flexible valve element 22 is attached to the frame 20 at a position substantially centered along a central axis of the valve element.
  • the valve element 22 may be attached to the frame 20 by other suitable methods or devices, the valve element of the illustrated configuration is attached to the frame by adhesive bonding.
  • the flexible valve element 22 is attached to the internal strip 42 of the band 40, at several attachment points 56 around the band.
  • the valve element 22 forms a plurality of flaps 58 extending between adjacent attachment points 56.
  • Each of the flaps 58 and a corresponding portion of the band 40 extending between adjacent attachment points 56 define an opening 60 through the valve when the valve element 22 moves to the open position.
  • valve element 22 may be attached to the band 40 using suitable techniques, the valve element of the illustrated example is attached to the band by adhesive bonding.
  • valve element 22 When the valve element 22 is in the open position, the element permits flow between the left ventricle E and aorta A. When in the closed position, the element 22 blocks flow between the aorta A and left ventricle E. As heart muscles surrounding the left ventricle E contract, the size of the left ventricle decreases, producing an increase in blood pressure inside the left ventricle. When the blood pressure inside the left ventricle E increases, the valve element 22 moves to the open position to permit blood to flow out of the left ventricle through the valve portion 12 to the aorta A. As heart muscles
  • the valve element 22 moves to the closed position to prevent flow reversal from the aorta to the left ventricle. Therefore, the valve element 22 performs the substantially similar function as the cusps P of an undamaged native aortic valve V, even though they have vastly different structures.
  • a peripheral anchor 70a is formed on each frame element 30 adjacent the band 40.
  • the anchor 70a may be axially positioned to extend through the external strip 44 of the band 40 as shown in FIG. 3 or positioned adjacent the band as shown in FIGS. 4 and 5.
  • these anchors 70a are used to attach the frame 20 between the plurality of cusps P of the damaged native valve V in a position between the left ventricle E and the aorta A.
  • the anchors 70 of the illustrated configuration are hooks. It is further envisioned that the anchors 70 may include barbs (not shown) to prevent the hooks from being dislodged from the heart H after implantation.
  • the apex 54 of the flexible valve element 22 and the junction 32 of the frame elements 30 may include an opening 72 to allow a guide wire to pass through the valve to guide the valve portion 12 into position when implanting the device 10.
  • this opening may have other dimensions, in one configuration the opening has a diameter of between about 0.5 mm and about 1.0 mm. After removing the guide wire, it is envisioned that this opening may provide surface washing to reduce the tendency for blood to coagulate adjacent the downstream face 52 of the valve element 22. It is envisioned that the opening 72 may be used even where a guide wire is not needed to reduce the potential for blood to coagulate adjacent the valve element 22. Further, the opening 72 may have an internal screw thread for connecting surgical tools to the device 10 to enhance maneuverability and retrieval of the device.
  • the frame elements 30 continue uninterrupted downstream from the band 40.
  • the reinforcement portion 14 comprises a band or sheath, generally designated by 80, surrounding the frame elements 30.
  • the sheath 80 is separated from the band 40 of the valve portion 12, creating a space where the frame elements 30 are exposed. This space permits blood to flow through the openings O in the sinus of Valsalva S, allowing blood to flow into the coronary arteries to deliver oxygen to the heart muscles.
  • the space may have other lengths, in the illustrated example, the space is about 1.0 cm to about 1.5 cm long. As illustrated this space between the upstream sheath end the annular band is substantially free of device elements except for the frame elements 30. As illustrated in FIG.
  • the sheath 80 extends between circumferentially adjacent legs of the frame elements 30 to limit maximum spacing between the frame elements.
  • the sheath 80 is flexible to permit the frame elements 30 to be pushed together so the reinforcement portion 14 can be compressed with the valve portion 12 until they are appropriately positioned when being implanted.
  • the sheath 80 expands outward toward an endothelial lining of the aorta A as shown in FIG. 3.
  • the sheath 80 is sized to support the aorta A and relieve stress on the corresponding sections of the aorta caused by the fluctuating pressure of the blood traveling through the sheath.
  • the sheath 80 may have other dimensions, the sheath of the illustrated example has a diameter of about 2.5 cm to about 3.0 cm. Further, the diameter of the sheath 80 may vary along its length, for example being smaller downstream from the great vessels V. Although the sheath 80 may be made of other materials, such as heterologous animal pericardium (e.g., bovine or porcine pericardium), autologous tissue engineered substrates, biocompatible radiopaque silicone rubber, polyurethane, ePTFE, polypropylene, a combination of
  • polypropylene and polyglycolide fibers uncrimped Hemashield Gold ® knitted "microvel” double velour vascular graft materials, or mesh materials, including collagen
  • the sheath of the illustrated example is made of knitted Dacron ® polyester fabric.
  • the sheath 80 of the illustrated example is fabricated with an internal sheet or lamina 82 comprising nonporous knitted Dacron ® polyester fabric and an external sheet or lamina 84 comprising porous double velour knitted Dacron ® polyester fabric joined in face-to-face or bifacial relation.
  • the porous double velour external sheet 84 facing the endothelial lining of the aorta A provides a gossamer latticework permitting vascular tissue ingrowth and connective reinforcement of the aortic wall.
  • the nonporous knitted internal sheet 82 assists in reinforcing the sheath 80 and withstanding the pressures exerted by blood pulsing through the reinforcement portion 14 of the device 10.
  • the sheath 80 may be attached to the frame elements 30 by other suitable means, in the illustrated configuration, the internal and external sheets 82, 84, respectively, are adhesively bonded to the frame elements and to each other, so the sheets sandwich the frame elements.
  • sandwiching the frame elements 30 between the internal and external sheets 82, 84 reduces the possibility of the frame elements separating from the sheath 80 and provides continuous internal and external surfaces that may prevent plaques from adhering to the sheath or damage to the endothelial lining.
  • the knitted fabrics stretch more in one direction than in an orthogonal direction.
  • the fabrics are oriented to align the more elastic direction of the fabric to extend circumferentially around the sheath 80. This orientation allows the fabric to accommodate irregularities along the endothelial lining of the aorta A and allows movement between the sheath 80 and the aortic wall as blood pressure pulses to encourage ingrowth of tissue into the fabric. It is envisioned that the resilience of the frame elements 30 will also push the fabric against the aortic wall to enhance this ingrowth. This orientation also prevents the fabric from stretching axially along the aortic wall to maintain the position of the reinforcement portion 14.
  • Peripheral anchors 70b, 70e are formed on the frame elements 30 adjacent each end of the sheath 80. It is envisioned that the anchors 70b, 70e may extend through the exterior sheet 84 forming the sheath 80 as shown on the upstream end of the sheath in FIG. 3. Alternatively, the anchors 70b, 70e may extend from their respect frame elements 30 adjacent an edge of the sheath 80 as shown on the downstream end of the sheath in FIG. 3. Anchors 70c, 70d are also formed on the frame elements 30 upstream and downstream from the great vessels G. Although the hooks 70a-70e may have other lengths, the exemplary hooks have a length of about 2 mm to about 3 mm.
  • each hook 70a- 70e forms an angle with the adjacent portion of the frame elements of about 55° to about 80°. In some examples, the hooks 70a- 70e form an angle with the adjacent portion of the frame elements of about 70° to about 80°.
  • the hooks 70a- 70e in the illustrated example are angled to prevent the device 10 from being pulled toward the left ventricle E as it expands, it is envisioned that the hooks may be angled downstream to prevent the device from moving downstream as the left ventricle contracts. In other examples, the hooks 70a- 70e may alternate upstream and downstream, either alternating circumferentially or axially between hooks.
  • an oval or racetrack-shaped opening 90 is provided in the sheath 80 in alignment with the great vessels G to permit blood to flow to the great vessels to carry oxygenated blood to downstream anatomical features in the patient.
  • the opening is about 4.0 cm to about 6.0 cm long and about 1.0 cm to about 1.5 cm wide.
  • the opening is about 5.0 cm to about 6.0 cm in length by about 1.5 cm wide. It is envisioned the opening 90 may have shapes other than oval or racetrack-shaped. The previously described orientations of the fabrics forming the sheath 80, which limit axial stretching, ensure the opening 90 remains aligned with the great vessels G.
  • the overall length of the sheath 80 and opening 90 may vary according to the anatomy of the patient in which the device 10 is implanted.
  • the illustrated sheath 80 has an ascending segment that is about 12 cm long and a descending segment that is about 20 cm long.
  • the arch segment between the ascending and descending segments measures about 5 cm to about 6 cm along its arcuate upper surface.
  • a radiopaque nitinol wire (not shown) is provided around the opening 90 in the sheath 80 to accurately identify the location of the opening in the device relative to the aortic openings to ensure alignment of the opening and the great vessels G.
  • the sheath 80 around the opening 90 includes a radiopaque umbilical tape or radiopaque sutures for radiographically identifying the location of the opening relative to the aortic openings.
  • the sheath 80 of the reinforcement element 14 may be unitary to cover substantially all or most of the upper aorta or be segmented to reinforce separate portions of the aorta.
  • One such reinforcement element 114 having a segmented sheath 180 is shown in FIG. 8.
  • the upstream and downstream segments of the sheath 180 are separated by about 5 cm, providing an opening 190 to ensure blood flow to the great vessels G.
  • the illustrated sheath 180 has an upstream segment that is about 6 cm to about 8 cm long for reinforcing the ascending aorta and a downstream portion that is about 12 cm to about 15 cm long for supporting the descending aorta above the diaphragm D.
  • One foreseeable advantage of the construction shown in FIG. 8 is to eliminate fabric folding in the arch segment. It is further contemplated that the downstream portion of the sheath 180 and frame elements 130 could be omitted entirely to shorten the length of the sheath. In other examples, it is envisioned that the sheath is divided into three or more segments. Further, it is envisioned that segments may be spaced or overlapped. Overlapping segments may provide advantages during fabrication or permit selected sections to be stronger or have less stretch.
  • FIGS. 9 and 10 illustrate other examples of devices, generally indicated by the reference numbers 210 and 310, respectively.
  • Each of these devices 210, 310 are similar to devices 10, 110, respectively, except that downstream anchors are omitted on these alternative devices. It is envisioned that fewer anchors may be required to hold the devices securely in position and may have advantages such as preventing damage to the endothelial lining of the aorta A during implantation. Those skilled in the art will appreciate studies can be performed to explore the advantages and disadvantages of these constructions, or other devices having other anchor arrangements.
  • a surgeon may implant the device 10 using tools and procedures generally like those described in U.S. Patent No. 6,821,297 (Snyders).
  • the surgeon controls placement of the device 10 using fluoroscopic guidance to ensure the native cusps P are positioned in the sinus of Valsalva S and the openings O in the sinus of Valsalva are unobstructed.
  • the surgeon may use a conventional dye injection technique to identify the openings O of the sinus of Valsalva S. More particularly, retrograde transfemoral or external iliac artery access using a guidewire within an endocannular delivery instrument having an upstream holding element for directing the valve element 12 of the device 10 is contemplated.
  • a sheath 80 having appropriately dimensions, i.e., inner diameters and lengths, according to the patients’ aortic wall anatomy, which may be determined using conventional aortic wall contrast-based imaging methods (e.g., multi-slice CT with contrast).
  • aortic wall contrast-based imaging methods e.g., multi-slice CT with contrast.
  • the junction 32 of the frame elements 30 or other radiopaque feature may be used as a reference point on the device during the pre-procedural contrast-based fluoroscopic or CT angiographic study of the patient’s anatomy.
  • the reference point will be used to determine the position and length of the opening 90 and the overall length of the sheath 80 among other dimensions.
  • Custom fabricated devices 10 will likely be required to match the patient’s anatomy.
  • An array of devices 10 may be fabricated, allowing the surgeon to select a device having preferred dimensions.
  • the surgeon compresses the appropriately sized device, including the valve portion 12 and the reinforcement sheath 80, to a configuration that is suitable for passing through the patient’s vessels without interrupting blood flow.
  • the surgeon securely wraps the entire length of the device using spiral wraps to hold the device in this compressed delivery configuration.
  • the wraps should be made while the device is fully immersed in saline to displace any air bubbles from the resulting delivery cannula, which might result in embolism when implanted.
  • the surgeon prepares access, i.e., via either common femoral or iliac artery, using appropriately sized, conventional self-expanding stents to enlarge vessels (e.g., to a diameter of about 10 mm to about 12 mm) providing access to the aorta A and aortic valve V.
  • the surgeon passes a flexible guidewire within a threaded tip delivery cable via a conventional purse-string aortotomy to begin the retrograde passage of the entire delivery cannula with the cannula being oriented so the valve portion 12 is at the upstream end of the cannula.
  • valve portion 12 Promptly after the valve portion 12 is in a suitable position, the surgeon pulls the cannula wrap to unwind it from the valve portion end allowing the valve portion to expand into position. Once the valve portion 12 expands, the valve should immediately begin functioning, allowing for a beating heart surgical method with normal or minimally compromised heart valve function.
  • this procedure may be used to position the valve portion 12 inside a native aortic valve V or a previously implanted valve. When in position, the valve portion 12 holds the native or previously implanted valve in its open position, rendering it
  • the surgeon must promptly pull the cannula, allowing the valve portion 12 to expand and begin functioning, to prevent prolonged interruption blood being pumped downstream.
  • the surgeon may confirm proper valve functioning using a tactile sense of systolic heart pulsations through the cannula.
  • the surgeon may also confirm proper valve positioning using non ⁇ contrast fluoroscopic tracking.
  • a conventional long-term anticoagulation protocol may be used if desired.
  • the surgeon retracts the cannula farther to progressively release the reinforcement portion 14 of the device.
  • the surgeon should confirm the openings O of the sinus of Valsalva S are unobstructed and the opening 90 of the is properly oriented and positioned to allow blood flow to the great vessels G.
  • the previously described radiopaque markers surrounding the opening 90 may be used to fluoroscopically confirm the opening is properly oriented and positioned.
  • the surgeon may close access using a suitable conventional method. Standard post-procedural care, including cardiovascular monitoring, is advised until the patient is discharged
  • the devices described above provide advantages over other devices.
  • the respective valve portions have short lengths and low weights compared to many other devices.
  • the valve portion has a length of about 12 mm to about 15 mm. This shorter length reduces the potential for the valves to protrude into the sinus of Valsalva S, possibly blocking openings O.
  • the construction of the valve portions is adapted to fully open and close, resisting leakage even when the native structure is highly eccentric, having flattened cross section. Further, the constructions allow the devices to conform to the native heart and aorta A structure, and the resilience of the frame elements expand the devices to hold them in position. Anchors of the devices hold the devices securely in position, reinforcing the native structure until tissue ingrowth occurs. It is envisioned that the devices may be suitable for implant in pediatric patients due to their small size and substantially
  • the devices adaptively expand, it is envisioned that they are capable of expanding to fit the growing child.
  • the devices permit "beating heart” procedures (i.e., without cardiopulmonary bypass or cardioplegic arrest) in part due to the relatively small size of the devices. Further, the devices permit implantation without removal of the native valves or after removal of the native valves. The devices also permit some correction of valvular stenosis along with correction of regurgitant valvular disease. It is further envisioned that the devices described above may be coated with heparin or other protective coatings and immune suppressant coatings (e.g., rapamycin coating) to reduce coagulation or immune inflammatory response initiation.
  • immune suppressant coatings e.g., rapamycin coating
  • the construction of the devices makes them particularly suitable for valve-in-valve replacement of native or surgically implanted valves that have exceeded their useful life. It is further envisioned that rapidly implanting the valves of the present invention using an endothorascopic technique may provide a suitable remedy of acute papillary muscle dysfunction due to major chordal rupture or frank papillary muscle infarction.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)

Abstract

Valvule cardiaque aortique artificielle et dispositif de renforcement d'aorte combinés. Le dispositif comprend un cadre allongé élastique de manière flexible, bande annulaire et élément de valvule flexible. L'élément de valvule fléchit entre une position ouverte pour permettre un écoulement de sang et une position fermée pour empêcher un écoulement de sang. Le dispositif comprend une gaine fixée au cadre. La gaine s'étend à partir d'une extrémité de gaine amont espacée en aval de la bande annulaire jusqu'à une extrémité de gaine aval. Une partie valvule du dispositif présente une flexibilité suffisante pour adopter une configuration comprimée afin de passer à travers l'aorte et pour adopter une configuration déployée afin de remplacer fonctionnellement une valvule cardiaque endommagée. L'extrémité de gaine amont est espacée de la bande d'une distance suffisante pour permettre un écoulement de sang par les ouvertures dans le sinus de Valsalva. La gaine est conçue pour permettre un écoulement sanguin dans les grands vaisseaux.
PCT/US2019/039352 2018-06-26 2019-06-26 Valvule cardiaque aortique artificielle et dispositif de renforcement d'aorte supérieure WO2020006151A1 (fr)

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US201862690167P 2018-06-26 2018-06-26
US62/690,167 2018-06-26
US201862776096P 2018-12-06 2018-12-06
US62/776,096 2018-12-06
US201962866215P 2019-06-25 2019-06-25
US62/866,215 2019-06-25

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5139515A (en) * 1990-08-15 1992-08-18 Francis Robicsek Ascending aortic prosthesis
US20020082684A1 (en) * 2000-09-25 2002-06-27 David Mishaly Intravascular prosthetic and method
US20020123802A1 (en) * 2000-02-02 2002-09-05 Snyders Robert V. Artificial heart valve, implantation instrument and method therefor
US20060241745A1 (en) * 2005-04-21 2006-10-26 Solem Jan O Blood flow controlling apparatus
US20080200898A1 (en) * 2006-10-19 2008-08-21 Lashinski Randall T Catheter guidance through a calcified aortic valve
RU2552875C1 (ru) * 2014-05-30 2015-06-10 Федеральное государственное бюджетное учреждение Российский научный центр хирургии имени академика Б.В. Петровского РАМН Способ протезирования восходящей и дуги аорты с низведением протеза в истинный просвет расслоенной нисходящей аорты при расслоениях а типа

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5139515A (en) * 1990-08-15 1992-08-18 Francis Robicsek Ascending aortic prosthesis
US20020123802A1 (en) * 2000-02-02 2002-09-05 Snyders Robert V. Artificial heart valve, implantation instrument and method therefor
US20020082684A1 (en) * 2000-09-25 2002-06-27 David Mishaly Intravascular prosthetic and method
US20060241745A1 (en) * 2005-04-21 2006-10-26 Solem Jan O Blood flow controlling apparatus
US20080200898A1 (en) * 2006-10-19 2008-08-21 Lashinski Randall T Catheter guidance through a calcified aortic valve
RU2552875C1 (ru) * 2014-05-30 2015-06-10 Федеральное государственное бюджетное учреждение Российский научный центр хирургии имени академика Б.В. Петровского РАМН Способ протезирования восходящей и дуги аорты с низведением протеза в истинный просвет расслоенной нисходящей аорты при расслоениях а типа

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