# US 2019/0167423 A1 · Prosthetic heart valve with pouch > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167423 A1 - Document ID: US20190167423A1 - Status: Published application - Kind: A1 - Application number: 16/269,328 - Filed: 2019-02-06 - Published: 2019-06-06 - Earliest claimed: 2017-09-19 - Assignees: Cardiovalve Ltd. - Applicants: Cardiovalve Ltd. - Inventors: Ilia HARITON; Meni Iamberger; Yelena Kasimov; Boaz Harari; Aviram Baum - Web page: https://patentgrep.com/patent/US20190167423A1 ## CPC - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/24: 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} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61F 2/2436: {Deployment by retracting a sheath} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2220/0008: Fixation appliances for connecting prostheses to the body - A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable - A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas - A61F 2250/0039: differing in diameter - 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 valve body circumscribes a longitudinal axis and defines a lumen along the axis. Upstream arms are coupled to the valve body, and extend radially outward from the valve body to respective arm-tips. Downstream legs are coupled to the valve body, and extend radially outward from the valve body and toward the plurality of arms. A flexible pouch extends radially outward from the valve body. The arms and the legs narrow the pouch therebetween to form a narrowed portion of the pouch, thereby defining, in an interior space of the pouch: (a) an inner portion, radially inward from the narrowed portion, and in fluid communication with the lumen, and (b) an outer portion, radially outward from the narrowed portion, and in fluid communication with the inner portion via the narrowed portion. Other embodiments are also described. ## Claims ### Claim 1 Apparatus, comprising: a frame assembly that comprises: a valve body that circumscribes a longitudinal axis and defines a lumen along the axis; a plurality of upstream arms that are coupled to the valve body at a first axial level with respect to the longitudinal axis, each of the arms extending radially outward from the valve body to a respective arm-tip; and a plurality of downstream legs that are coupled to the valve body at a second axial level with respect to the longitudinal axis, and that extend radially outward from the valve body and toward the plurality of arms; a plurality of prosthetic leaflets, disposed within the lumen, and arranged to facilitate one-way upstream-to-downstream fluid flow through the lumen, the first axial level being upstream of the second axial level; and a flexible pouch that defines an interior space therein, the pouch shaped and coupled to the frame assembly such that: the pouch extends radially outward from the valve body, and the arms and the legs narrow the pouch therebetween to form a narrowed portion of the pouch, so as to define: an inner portion of the interior space, radially inward from the narrowed portion, and in fluid communication with the lumen, and an outer portion of the interior space, radially outward from the narrowed portion, and in fluid communication with the inner portion via the narrowed portion. ### Claim 2 (depends on 1) The apparatus according to claim 1, wherein, at the narrowed portion, the legs extend in an upstream direction past the arms. ### Claim 3 (depends on 1) The apparatus according to claim 1, wherein the arms are disposed inside the pouch. ### Claim 4 (depends on 1) The apparatus according to claim 1, wherein the arms and the legs are arranged such that, at the narrowed portion, the arms and the legs alternate circumferentially. ### Claim 5 (depends on 1) The apparatus according to claim 1, wherein the inner portion of the interior space is in fluid communication with the lumen via a plurality of discrete windows defined by the apparatus. ### Claim 6 (depends on 5) The apparatus according to claim 5, further comprising a belt wrapped around the frame assembly downstream of the windows, circumscribing the lumen, each of the windows being bounded, at a downstream edge of the window, by the belt. ### Claim 7 (depends on 6) The apparatus according to claim 6, wherein the leaflets are arranged to form a plurality of commissures therebetween, and are attached to the frame assembly at the commissures, and wherein the belt is disposed over the commissures. ### Claim 8 (depends on 1) The apparatus according to claim 1, wherein: the pouch has an upstream surface and a downstream surface, and, at the narrowed portion, each of the legs pushes the downstream surface toward the upstream surface. ### Claim 9 (depends on 8) The apparatus according to claim 8, wherein, at the narrowed portion, each of the legs pushes the downstream surface into contact with the upstream surface. ### Claim 10 (depends on 9) The apparatus according to claim 9, wherein, at the narrowed portion, each of the legs forms a respective bulge in the upstream surface by pressing the downstream surface against the upstream surface. ### Claim 11 (depends on 1) The apparatus according to claim 1, wherein the pouch is stitched to the arms. ### Claim 12 (depends on 11) The apparatus according to claim 11, wherein, at the narrowed portion, the pouch is stitched to the arms but not to the legs. ### Claim 13 (depends on 1) The apparatus according to claim 1, wherein the frame assembly comprises (i) a valve frame that defines the valve body and the plurality of upstream arms, and (ii) an outer frame that circumscribes the valve frame, and defines the plurality of downstream legs. ### Claim 14 (depends on 13) The apparatus according to claim 13, wherein an upstream portion of the pouch is attached to the valve frame, and a downstream portion of the pouch is attached to the outer frame. ### Claim 15 (depends on 1) The apparatus according to claim 1, further comprising at least one coagulation component, disposed within the outer portion of the interior space, and configured to promote blood coagulation within the outer portion of the interior space. ### Claim 16 (depends on 15) The apparatus according to claim 15, wherein the coagulation component is annular, and, within the outer portion of the interior space, circumscribes the longitudinal axis. ### Claim 17 Apparatus, comprising: a frame assembly that comprises: a valve body that circumscribes a longitudinal axis and defines a lumen along the axis; a plurality of upstream arms that are coupled to the valve body at a first axial level with respect to the longitudinal axis, each of the arms extending radially outward from the valve body to a respective arm-tip; and a plurality of downstream legs that are coupled to the valve body at a second axial level with respect to the longitudinal axis, and that extend radially outward from the valve body and toward the plurality of arms; a tubular liner that lines the lumen, and that has an upstream end and a downstream end; a plurality of prosthetic leaflets, disposed within the lumen, attached to the liner, and arranged to facilitate one-way upstream-to-downstream fluid flow through the lumen, the first axial level being upstream of the second axial level; a first sheet of flexible material, the first sheet having (i) a greater perimeter, and (ii) a smaller perimeter that defines an opening, the first sheet being attached to the plurality of arms with the opening aligned with the lumen of the valve body; and a second sheet of flexible material: the second sheet having a first perimeter and a second perimeter, the first perimeter being attached to the greater perimeter of the first sheet around the greater perimeter of the first sheet, the second sheet extending from the first perimeter radially inwards and downstream toward the second perimeter, the second perimeter circumscribing, and attached to, the valve body at a third axial level that is downstream of the first axial level, wherein: the first sheet, the second sheet, and the liner define an inflatable pouch therebetween, the inflatable pouch defining an interior space therein, the first sheet defining an upstream wall of the pouch, the second sheet defining a radially-outer wall of the pouch, and the liner defining a radially-inner wall of the pouch, and each of the legs presses the second sheet into contact with the first sheet. ### Claim 18 (depends on 17) The apparatus according to claim 17, wherein the arms are disposed inside the pouch. ### Claim 19 (depends on 17) The apparatus according to claim 17, wherein each of the legs forms a respective bulge in the first sheet by pressing the second sheet against the first sheet. ### Claim 20 (depends on 17) The apparatus according to claim 17, wherein, the legs extend in an upstream direction past the arms. ### Claim 21 (depends on 17) The apparatus according to claim 17, wherein the frame assembly comprises (i) a valve frame that defines the valve body and the plurality of upstream arms, and (ii) an outer frame that circumscribes the valve frame, and defines the plurality of downstream legs. ### Claim 22 (depends on 21) The apparatus according to claim 21, wherein an upstream portion of the pouch is attached to the valve frame, and a downstream portion of the pouch is attached to the outer frame. ### Claim 23 (depends on 17) The apparatus according to claim 17, wherein the plurality of legs forms a narrowed portion of the pouch by pressing the second sheet into contact with the first sheet, the narrowed portion of the pouch circumscribing the valve body. ### Claim 24 (depends on 23) The apparatus according to claim 23, wherein, at the narrowed portion, the second sheet is not stitched to the legs. ### Claim 25 (depends on 23) The apparatus according to claim 23, wherein the arms and the legs are arranged such that, at the narrowed portion, the arms and the legs alternate circumferentially. ### Claim 26 (depends on 23) The apparatus according to claim 23, wherein the narrowed portion of the pouch shapes the pouch to define: an inner portion of the interior space, radially inward from the narrowed portion, and in fluid communication with the lumen, and an outer portion of the interior space, radially outward from the narrowed portion, and in fluid communication with the inner portion via the narrowed portion. ### Claim 27 (depends on 26) The apparatus according to claim 26, further comprising at least one coagulation component, disposed within the outer portion of the interior space, and configured to promote blood coagulation within the outer portion of the interior space. ### Claim 28 (depends on 27) The apparatus according to claim 27, wherein the coagulation component is annular, and, within the outer portion of the interior space, circumscribes the longitudinal axis. ### Claim 29 (depends on 17) The apparatus according to claim 17, wherein the interior space is in fluid communication with the lumen via a plurality of discrete windows defined by the apparatus. ### Claim 30 (depends on 29) The apparatus according to claim 29, further comprising a belt wrapped around the frame assembly downstream of the windows, circumscribing the lumen, each of the windows being bounded, at a downstream edge of the window, by the belt. ### Claim 31 (depends on 30) The apparatus according to claim 30, wherein the leaflets are arranged to form a plurality of commissures therebetween, and are attached to the frame assembly at the commissures, and wherein the belt is disposed over the commissures. ### Claim at position 32 32-33. (canceled)