# US 11,998,462 B2 · Systems, methods and devices for treating tricuspid insufficiency > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,462 B2 - Document ID: US11998462B2 - Status: Granted - Kind: B2 - Application number: 17/115,676 - Filed: 2020-12-08 - Published: 2021-03-25 - Granted: 2024-06-04 - Earliest claimed: 2018-06-08 - Assignees: Innoventric Ltd. - Applicants: Innoventric Ltd. - Inventors: Ori Nissan; Amir Danino; Yair Pichersky - Web page: https://patentgrep.com/patent/US11998462B2 ## CPC - A61F 2/2476: {Valves implantable in the body not otherwise provided for} - A61F 2/856: Single tubular stent with a side portal passage - 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 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2/90: characterised by a net-like or mesh-like structure - A61F 2/07: Stent-grafts - A61F 2002/061: {provided with means for allowing access to secondary lumens} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable - A61F 2220/0091: connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type - A61F 2250/0013: for adjusting fluid pressure - 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 Embodiments of the present disclosure are directed to devices and methods for treating tricuspid valve insufficiency. For example, in some embodiments, a tricuspid insufficiency treatment device is provided, and includes a tubular member configured for implantation within a vena cava of a patient, where the tubular member is formed with a sidewall. The device also includes at least two (2) valves arranged circumferentially along the sidewall, where each valve comprises an opening formed in the sidewall, and a blocking member arranged to block and unblock a respective opening of the plurality of openings. Each blocking member comprises a flap or cover pivotally attached at or proximate a portion of a respective opening and arranged to block and unblock the opening during ventricular systole and ventricular diastole, respectively, such that the opening is unblocked in a direction opposite to the attachment of the flap or cover. The at least two valves are arranged along a first circumference at a first location between the ends of the tubular member. ## Claims ### Claim 1 A tricuspid insufficiency treatment device comprising: a tubular member configured for implantation within a vena cava of a patient, the tubular member formed with a sidewall, and the device consisting of only three (3) valves arranged circumferentially along the sidewall, each valve comprising: an opening formed in the sidewall, and a blocking member comprising a flap or cover pivotally attached at or proximate a portion of a respective opening and arranged to block and unblock the opening during ventricular systole and ventricular diastole, respectively, such that the opening is unblocked in a direction opposite to the attachment of the flap or cover, wherein a first and a second valve of the at least three (3) valves are arranged along a first circumference at a first location between the ends of the tubular member, a third valve of the three (3) valves is arranged on a second circumference spaced closer to one of the ends of the tubular member than that of the two (2) valves arranged on the first circumference. ### Claim 2 (depends on 1) The device of claim 1, wherein the tubular member and the blocking members of the valves form a closed cylindrical outer shape when each blocking member blocks a respective opening. ### Claim 3 (depends on 1) The device of claim 1, further comprising a covering configured to cover at least a portion of the tubular member. ### Claim 4 (depends on 3) The device of claim 3, wherein the covering: does not cover the openings; or is configured to additionally cover each blocking member. ### Claim 5 (depends on 1) The device of claim 1, wherein each of the first and second valves is hinged to the tubular member on opposite sides such that each blocking member opens away from the other blocking member. ### Claim 6 (depends on 5) The device of claim 5, wherein the third valve of the plurality of valves is hinged such that the blocking member opens away from the first and second blocking member. ### Claim 7 (depends on 1) The device of claim 1, wherein the tubular member includes an expandable stent having a plurality of cells, wherein each of the three valves correspond to a specific cell of the stent. ### Claim 8 (depends on 7) The device of claim 7, wherein: at least one of the: each of the openings and each of the cells accommodating a respective opening includes a rhombus shape; or the stent comprises a corona stent. ### Claim 9 (depends on 8) The device of claim 8, wherein the corona stent comprises a first inferior vena-cava (IVC) portion, a second superior vena-cava (SVC) portion, and a third central portion arranged between the IVC portion and the SVC portion. ### Claim 10 (depends on 1) The device of claim 1, wherein each blocking member includes a shape memory reinforcing wire therein or thereon. ### Claim 11 (depends on 10) The device of claim 10, wherein: the reinforcing wire is arranged at or near at least a portion of the perimeter of the blocking member; or the reinforcing wire is arranged at or near substantially the entire perimeter of the blocking member. ### Claim 12 (depends on 1) The device of claim 1, wherein a single side of the blocking member is attached to the tubular member. ### Claim 13 (depends on 12) The device of claim 12, wherein each blocking member is attached via suturing. ### Claim 14 (depends on 1) The device of claim 1, further comprising a skirt. ### Claim 15 (depends on 14) The device of claim 14, wherein: the skirt is arranged on and attached to a portion of the tubular member and configured to at least one of preventing backflow from the right atrium (RA) into the inferior vena-cava (IVC), so as to redundify graft coverage of the IVC member, and preventing blockage of one or more hepatic veins; the skirt comprises at least one of a fabric and a reinforcement; or the skirt comprises a fabric and a reinforcement. ### Claim 16 (depends on 15) The device of claim 15, wherein the reinforcement comprises a shape memory wire. ### Claim 17 (depends on 16) The device of claim 16, wherein: the wire is arranged along at least a portion of the perimeter of the skirt; or the wire is arranged along a majority of the perimeter of the skirt. ### Claim 18 (depends on 3) The device of claim 3, wherein the covering is attached to the tubular member and/or stent via a plurality of sutures. ### Claim 19 (depends on 1) The device of claim 1, wherein the tubular member includes a longitudinal axis, and wherein at least one of the plurality of valves, or the device as a whole, is configured so as to cause substantially all the blood flowing out therefrom to flow in a non-perpendicular direction relative to at least the longitudinal axis and the vena cava. ### Claim 20 A tricuspid insufficiency treatment device comprising: a tubular member configured for implantation within a vena cava of a patient, the tubular member formed with a sidewall, and at least three (3) valves arranged in a single adjacent grouping along the sidewall, each valve comprising: an opening formed in the sidewall, and a blocking member comprising a flap or cover pivotally attached at or proximate a portion of a respective opening and arranged to block and unblock the opening during ventricular systole and ventricular diastole, respectively, such that the opening is unblocked in a direction opposite to the attachment of the flap or cover, wherein each of the valves is hinged to the tubular member along different sides such that each blocking member opens away and in a different direction from each of the other blocking members. ### Claim 21 (depends on 20) The device of claim 20, wherein the at least three valves consisits of only three valves. ### Claim 22 A tricuspid insufficiency treatment device comprising: a tubular member configured for implantation within a vena cava of a patient, the tubular member formed with a sidewall, and a centralized grouping of at least three (3) valves arranged along the sidewall, each valve comprising: an opening formed in the sidewall, and a blocking member comprising a flap or cover pivotally attached at or proximate a portion of a respective opening and arranged to block and unblock the opening during ventricular systole and ventricular diastole, respectively, such that the opening is unblocked in a direction opposite to the attachment of the flap or cover, wherein the tubular member comprises an expandable stent having a plurality of cells, each of the plurality of cells includes a first rhombus shape, each opening for each of the at least three valves correspond to a specific respective cell of the stent, and the blocking member includes a second rhombus shape that corresponds to the first rhombus shape. ### Claim 23 (depends on 22) The device of claim 22, wherein the at least three valves consists of only three valves. ### Claim 24 A tricuspid insufficiency treatment device comprising: a tubular member configured for implantation within a vena cava of a patient, the tubular member formed with a sidewall, and at least three (3) valves arranged circumferentially along the sidewall, each valve comprising: an opening formed in the sidewall, and a blocking member comprising a flap or cover pivotally attached at or proximate a portion of a respective opening and arranged to block and unblock the opening during ventricular systole and ventricular diastole, respectively, such that the opening is unblocked in a direction opposite to the attachment of the flap or cover, wherein each blocking member includes a length of shape reinforcing wire arranged and running only along substantially the entire the perimeter thereof. ### Claim 25 (depends on 24) The device of claim 24, wherein the at least three valves consists of only three valves.