# US 12,004,948 B2 · Geometrically-accommodating heart valve replacement device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,948 B2 - Document ID: US12004948B2 - Status: Granted - Kind: B2 - Application number: 16/890,905 - Filed: 2020-06-02 - Published: 2020-11-19 - Granted: 2024-06-11 - Earliest claimed: 2017-11-16 - Assignees: Children's Medical Center Corporation; President and Fellows of Harvard College; Massachusetts Institute of Technology - Applicants: Children's Medical Center Corporation; President and Fellows of Harvard College; Massachusetts Institute of Technology - Inventors: Sophie-Charlotte Hofferberth; Pedro J. del Nido; Elazer R. Edelman; Peter E. Hammer; Christopher Payne - Web page: https://patentgrep.com/patent/US12004948B2 ## CPC - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/2433: {using balloon catheter} - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2210/0004: bioabsorbable - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2230/0006: circular - A61F 2230/0008: elliptical or oval - A61F 2230/0013: Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped - A61F 2250/0004: adjustable - A61F 2250/001: for adjusting a diameter - A61F 2250/0065: telescopic - A61F 2250/0082: specially designed for children, e.g. having means for adjusting to their growth - 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 (dental prosthetics A61C) ## Abstract A replacement heart valve device is disclosed. In some embodiments, the device includes a frame coupled to one or more leaflets that are moveable between open and closed configurations. In some embodiments, the frame comprises at least two frame sections that join at a pair of commissural posts. In some embodiments, the device may be geometrically accommodating to adapt to different vasculature shapes and sizes and/or to be able to change size while implanted within a growing patient. ## Claims ### Claim 1 A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; and a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening, wherein the valve frame is expandable to permit an increase in the diameter of the opening, wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm, and wherein the opening expands while keeping a perimeter length of the valve frame constant. ### Claim 2 (depends on 1) The valve replacement device of claim 1, further comprising a second leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first and second leaflets contact one another to at least partially cover the opening, wherein the first and second leaflets are moveable between the open and closed configurations over the diameter size range of the opening. ### Claim 3 (depends on 1) The valve replacement device of claim 1, further comprising an outer frame support coupled to the valve frame. ### Claim 4 (depends on 1) The valve replacement device of claim 1, wherein the valve frame can be reduced to a contracted form for catheter delivery. ### Claim 5 (depends on 3) The valve replacement device of claim 3, wherein the outer frame support and valve frame are balloon-expandable. ### Claim 6 (depends on 1) The valve replacement device of claim 1, wherein the first leaflet maintains a constant surface area with expansion or contraction of the valve frame. ### Claim 7 (depends on 2) The valve replacement device of claim 2, wherein in the closed configuration, the first and second leaflets permit a regurgitant fraction of no more than 0 to 20% over a diameter size range of the opening of 5 mm to 50 mm. ### Claim 8 (depends on 1) The valve replacement device of claim 1, wherein the first leaflet has a Young's Modulus of between 30 MPa to 4 GPa. ### Claim 9 (depends on 8) The valve replacement device of claim 8, wherein the first leaflet is made of a material selected from the group consisting of a bioabsorbable polymer, a tissue-engineered construct, a decellularized homologous tissue engineered leaflet, a thin film nitinol, an expanded PTFE membrane, a gluteraldehyde-treated bovine pericardium, a gluteraldehyde-treated porcine pericardium, a photo-oxidized bovine pericardium, and a bovine jugular vein valve. ### Claim 10 (depends on 1) The valve replacement device of claim 1, wherein the opening is circular. ### Claim 11 (depends on 1) The valve replacement device of claim 1, wherein the opening is elliptical. ### Claim 12 (depends on 1) The valve replacement device of claim 1, wherein the valve frame comprises first and second frame sections connected by a pair of commissures. ### Claim 13 (depends on 12) The valve replacement device of claim 12, wherein the first frame section forms a U-shape having two arms extending away from an intermediate section, the intermediate section forming a base of the first frame section. ### Claim 14 (depends on 13) The valve replacement device of claim 13, wherein the intermediate section is planar. ### Claim 15 (depends on 12) The valve replacement device of claim 12, wherein each of the first and second frame sections comprises an arc shape. ### Claim 16 A valve replacement device comprising: a valve frame defining an opening for passage of fluid, the valve frame having a diameter along a largest dimension of the opening, the valve frame having a height in a direction perpendicular to the diameter, the valve frame being expandable to increase the diameter in an operational configuration and contractible to decrease the diameter in a contracted configuration and having a height to diameter ratio ranging from 0.5:1 to 2.5:1 in the operational configuration; and a first leaflet coupled to the frame, wherein as the valve frame expands, the height decreases as the diameter increases, and wherein a free edge of the leaflets are 1.5 to 3.5 times the diameter of the opening. ### Claim 17 (depends on 16) The valve replacement device of claim 16, further comprising a second leaflet coupled to the frame. ### Claim 18 (depends on 16) The valve replacement device of claim 16, wherein the height to diameter ratio ranges from 1:1 to 2.5:1. ### Claim 19 (depends on 16) The valve replacement device of claim 16, wherein the first leaflet is expandable. ### Claim 20 (depends on 16) The valve replacement device of claim 16, wherein the valve frame includes first and second frame sections configured to move laterally apart from each other as the valve frame expands. ### Claim 21 (depends on 16) The valve replacement device of claim 16, wherein a height of the first leaflet in the open position ranges between 0.2 to 0.8 times a height of the valve frame. ### Claim 22 (depends on 12) The valve replacement device of claim 12, wherein at least one of the first and second frame sections have a curve profile defined by an elliptical quadrant projected upon a cylinder. ### Claim 23 (depends on 22) The valve replacement device of claim 22, wherein a center of an ellipse from which the elliptical quadrant is derived coincides with a point along a circumference of an axial end of the cylinder, and a minor axis and a major axis of the ellipse are co-axial with edges of a cross-section of the cylinder. ### Claim 24 (depends on 20) The valve replacement device of claim 20, wherein at least one of the first and second frame sections have a curve profile defined by an elliptical quadrant projected upon a cylinder. ### Claim 25 (depends on 24) The valve replacement device of claim 24, wherein a center of an ellipse from which the elliptical quadrant is derived, coincides with a point along a circumference of an axial end of the cylinder, and a minor and major axis of the ellipse are co-axial with edges of a cross-section of the cylinder. ### Claim 26 (depends on 12) The valve replacement device of claim 12, further comprising a first reinforcement feature that connects the pairs of commissures. ### Claim 27 (depends on 26) The valve replacement device of claim 26, further comprising a second reinforcement feature that connects the first and second frame sections. ### Claim 28 (depends on 27) The valve replacement device of claim 27, wherein at least one of the first and second reinforcement features are configured to expand with the frame. ### Claim 29 (depends on 28) The valve replacement device of claim 28, wherein the at least one of the first and second reinforcement features have a length that is at least equal to a perimeter of the valve opening when the valve opening has been expanded to its maximum size. ### Claim 30 (depends on 20) The valve replacement device of claim 20, wherein the first and second frame sections are connected at a pair of commissures, and further comprising a first reinforcement feature that connects the pair of commissures. ### Claim 31 (depends on 30) The valve replacement device of claim 30, further comprising a second reinforcement feature that connects the first and second frame sections. ### Claim 32 (depends on 31) The valve replacement device of claim 31, wherein at least one of the first and second reinforcement features are configured to expand with the frame. ### Claim 33 (depends on 16) The valve replacement device of claim 16, wherein a height of the leaflets ranges from 1.5 to 3.5 times the diameter of the opening. ### Claim 34 (depends on 31) The valve replacement device of claim 31, wherein at least one of the first and second reinforcement features is of a different thickness than the other of the first and second reinforcement features. ### Claim 35 (depends on 31) The valve replacement device of claim 31, wherein at least one of the first and second reinforcement features is of a different shape than the other of the first and second reinforcement features. ### Claim 36 (depends on 27) The valve replacement device of claim 27, wherein at least one of the first and second reinforcement features is of a different thickness than the other of the first and second reinforcement features. ### Claim 37 (depends on 27) The valve replacement device of claim 27, wherein at least one of the first and second reinforcement features is of a different shape than the other of the first and second reinforcement features. ### Claim 38 (depends on 1) The valve replacement device of claim 1, wherein the opening has one of the following shapes: circular, elliptical, or asymmetrical. ### Claim 39 (depends on 16) The valve replacement device of claim 16, wherein the opening has one of the following shapes: circular, elliptical, or asymmetrical. ### Claim 40 (depends on 16) The valve replacement device of claim 16, further comprising a second leaflet coupled to the frame and wherein the first and second leaflets have a coaptation height that decreases with increasing diameter of the valve frame. ### Claim 41 (depends on 26) The valve replacement device of claim 26, wherein the first reinforcement feature comprises a first reinforcement strut. ### Claim 42 (depends on 27) The valve replacement device of claim 27, wherein the second reinforcement feature comprises a second reinforcement strut. ### Claim 43 A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening; and a second leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first and second leaflets contact one another to at least partially cover the opening, wherein the valve frame is expandable to permit an increase in the diameter of the opening, wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm, wherein the first and second leaflets are moveable between the open and closed configurations over the diameter size range of the opening, and wherein the first and second leaflets are of equal size and shape. ### Claim 44 A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening; and a second leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first and second leaflets contact one another to at least partially cover the opening, wherein the valve frame is expandable to permit an increase in the diameter of the opening, wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm, wherein the first and second leaflet are moveable between the open and closed configurations over the diameter size range of the opening, and wherein the first and second leaflets have identical mechanical properties. ### Claim 45 A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; and a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening, wherein the valve frame is expandable to permit an increase in the diameter of the opening, wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm, wherein the first leaflet has a Young's Modulus of between 30 MPa to 4 GPa, and wherein the first leaflet is made of a synthetic material. ### Claim 46 A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; and a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening, wherein the valve frame is expandable to permit an increase in the diameter of the opening, wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm, and wherein the first leaflet has a thickness of 0.01 mm to 1 mm. ### Claim 47 A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; and a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening, wherein the valve frame is expandable to permit an increase in the diameter of the opening, wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm, wherein the valve frame comprises first and second frame sections connected by a pair of commissures, and wherein the valve frame is symmetric such that the first and second frame sections are mirror images of one another. ### Claim 48 A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening, wherein the valve frame comprises first and second frame sections connected by a pair of commissures; and a first reinforcement feature that connects to the tops of the pairs of commissures, wherein the valve frame is expandable to permit an increase in the diameter of the opening, and wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm. ### Claim 49 A valve replacement device comprising: a valve frame defining an opening for passage of fluid, the valve frame having a diameter along a largest dimension of the opening, the valve frame having a height in a direction perpendicular to the diameter, the valve frame being expandable to increase the diameter in an operational configuration and contractible to decrease the diameter in a contracted configuration and having a height to diameter ratio ranging from 0.5:1 to 2.5:1 in the operational configuration, wherein the valve frame includes first and second frame sections configured to move laterally apart from each other as the valve frame expands, and wherein the first and second frame sections are connected by a pair of commissures; a first leaflet coupled to the frame; and a first reinforcement feature that connects to the tops of the pairs of commissures, wherein as the valve frame expands, the height decreases as the diameter increases.