# US 12,109,384 B2 · Hemostasis valves and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,384 B2 - Document ID: US12109384B2 - Status: Granted - Kind: B2 - Application number: 18/598,482 - Filed: 2024-03-07 - Published: 2024-06-27 - Granted: 2024-10-08 - Earliest claimed: 2017-09-06 - Assignees: Inari Medical, Inc. - Applicants: Inari Medical, Inc. - Inventors: Benjamin E. Merritt; John C. Thress; Paul Lubock - Web page: https://patentgrep.com/patent/US12109384B2 ## CPC - A61M 39/0613: {with means for adjusting the seal opening or pressure (A61M39/0693 takes precedence)} - A61B 17/3207: Atherectomy devices {working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions (A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016)} - A61M 2039/062: {used with a catheter} - A61M 2039/0673: {comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Devices, systems, and methods for sealing medical devices, particularly during intravascular access, are disclosed herein. Some aspects relate to a hemostatic valve for sealing a wide range of medical devices, such as catheters, wires, embolectomy systems. The valve can include an elongate member having a first end, a second end, and a central lumen extending therebetween. A reinforcement structure extends along at least a portion of the elongate member and is coupled to the elongate member. A shell defining a first aperture and a second aperture may be included, which first and second apertures can be fluidly coupled by the elongate member. A tensioning mechanism is coupled to the shell and to the elongate member, the tensioning mechanism can be moveable between a first configuration wherein the tensioning mechanism is collapsed and the central lumen is sealed and a second configuration wherein the central lumen is open. ## Claims ### Claim 1 A valve assembly, comprising: a tubular member defining a lumen; a first filament extending in a first loop around the tubular member, wherein the first filament is flexible; a second filament extending in a second loop around the tubular member, wherein the second filament is flexible; a pair of actuators movable from a first position to a second position, wherein— the first filament includes a first portion operably acted upon by a first one of the actuators and a second portion operably acted upon by a second one of the actuators; the second filament includes a first portion operably acted upon by the first one of the actuators and a second portion operably acted upon by the second one of the actuators; in the first position, the actuators are positioned to tension the first filament and the second filament thereby decreasing a dimension of the first loop and a dimension of the second loop to constrict the lumen of the tubular member; in the second position, the actuators are positioned to loosen the first filament and the second filament thereby permitting the tubular member to expand against the first loop and the second loop to increase the dimension of the first loop and the dimension of the second loop to at least partially open the lumen of the tubular member; and the actuators are biased to the first position. ### Claim 2 (depends on 1) The valve assembly of claim 1 wherein the first loop extends completely around the tubular member, and wherein the second loop extends completely around the tubular member. ### Claim 3 (depends on 1) The valve assembly of claim 1 wherein the first portion of the first filament is a first end portion of the first filament, wherein the second portion of the first filament is a second end portion of the first filament, wherein the first portion of the second filament is a first end portion of the second filament, and wherein the second portion of the second filament is a second end portion of the second filament. ### Claim 4 (depends on 3) The valve assembly of claim 3 wherein the first end portion of first filament is directly attached to the first one of the actuators, wherein the second end portion of the first filament is directly attached to the second one of the actuators, wherein the first end portion of the second filament is directly attached to the first one of the actuators, and wherein the second end portion of the second filament is directly attached to the second one of the actuators. ### Claim 5 (depends on 1) The valve assembly of claim 1 wherein the tubular member extends along a longitudinal axis, and wherein the first loop is proximate to the second loop along the longitudinal axis. ### Claim 6 (depends on 1) The valve assembly of claim 1 wherein the first filament and the second filament each comprise a plurality of strands woven together. ### Claim 7 (depends on 1) The valve assembly of claim 1 wherein the tubular member is elastically deformable. ### Claim 8 (depends on 1) The valve assembly of claim 1 wherein the tubular member is configured to resiliently expand. ### Claim 9 (depends on 1) The valve assembly of claim 1, further comprising a rigid housing, wherein the tubular member, the first filament, and the second filament are positioned within the housing, and wherein the actuators are movably coupled to the housing. ### Claim 10 (depends on 1) The valve assembly of claim 1 wherein the actuators are depressed toward one another in the second position, and wherein the actuators are moved away from one another in the first position. ### Claim 11 (depends on 1) The valve assembly of claim 1 wherein, in the second position, the tubular member has a diameter of at least 14 French. ### Claim 12 (depends on 1) The valve assembly of claim 1 wherein, in the second position, the tubular member has a diameter of at least 16 French. ### Claim 13 (depends on 1) The valve assembly of claim 1 wherein, in the second position, the tubular member has a diameter of at least 20 French. ### Claim 14 (depends on 1) The valve assembly of claim 1 wherein, in the second position, the tubular member has a diameter of at least 24 French. ### Claim 15 A valve assembly, comprising: a tubular member defining a lumen, wherein the tubular member is elastically deformable from a first position in which the lumen is constricted to a second position in which the lumen is at least partially open; a first actuator; a second actuator; a first filament configured in a first loop completely around the tubular member and having a first portion extending from the first loop toward the first actuator and a second portion extending from the first loop toward the second actuator; and a second filament configured in a second loop completely around the tubular member and having a first portion extending from the second loop toward the first actuator and a second portion extending from the second loop toward the second actuator; wherein— the first actuator and the second actuator are biased away from one another to elastically deform the tubular member to the first position by (a) increasing a tension in the first filament to decrease a dimension of the first loop and (b) increasing a tension in the second filament to decrease a dimension of the second loop; and the first actuator and the second actuator are movable toward one another to permit the tubular member to return to the second position by (a) decreasing the tension in the first filament and (b) decreasing the tension in the second filament. ### Claim 16 (depends on 15) The valve assembly of claim 15 wherein the first actuator and the second actuator each comprise a button. ### Claim 17 (depends on 15) The valve assembly of claim 15 wherein the first filament is flexible, and wherein the second filament is flexible. ### Claim 18 (depends on 15) The valve assembly of claim 15 wherein the first portion of first filament is directly attached to the first actuator, wherein the second portion of the first filament is directly attached to the second actuator, wherein the first portion of the second filament is directly attached to the first actuator, and wherein the second portion of the second filament is directly attached to the second actuator. ### Claim 19 (depends on 15) The valve assembly of claim 15 wherein the tubular member extends along a longitudinal axis, wherein the first portion of the first filament extends toward the first actuator along a first axis extending generally orthogonal to the longitudinal axis proximate the tubular member, wherein the second portion of the first filament extends toward the second actuator along a second axis extending generally orthogonal to the longitudinal axis proximate the tubular member, wherein the first portion of the second filament extends toward the first actuator along a third axis extending generally orthogonal to the longitudinal axis proximate the tubular member, wherein the second portion of the second filament extends toward the second actuator along a fourth axis extending generally orthogonal to the longitudinal axis proximate the tubular member, wherein the second axis is positioned between the first axis and the fourth axis, and wherein the fourth axis is positioned between the second axis and the third axis. ### Claim 20 (depends on 15) The valve assembly of claim 15 wherein, in the second position, the tubular member has a diameter of at least 16 French. ### Claim 21 (depends on 15) The valve assembly of claim 15 wherein, in the second position, the tubular member has a diameter of at least 20 French. ### Claim 22 (depends on 15) The valve assembly of claim 15 wherein, in the second position, the tubular member has a diameter of at least 24 French. ### Claim 23 A valve assembly, comprising: a tubular member defining a lumen; a first filament extending in a first loop around the tubular member; a second filament extending in a second loop around the tubular member; and a pair of actuators biased to circumferentially constrict the first loop and the second loop to elastically deform the tubular member to a first position in which the lumen is constricted, wherein at least one the actuators is movable to decrease a level of tension in the first filament and a level of tension in the second filament to permit the tubular member to expand against the first loop and the second loop to a second position in which the lumen of the tubular member is at least partially open. ### Claim 24 (depends on 23) The valve assembly of claim 23 wherein the actuators each comprise a button. ### Claim 25 (depends on 23) The valve assembly of claim 23 wherein the first filament includes a first portion operably coupled to a first one of the actuators and a second portion operably coupled to a second one of the actuators, and wherein the second filament includes a first portion operably coupled to the first one of the actuators and a second portion operably coupled to the second one of the actuators. ### Claim 26 (depends on 25) The valve assembly of claim 25 wherein the first portion of first filament is directly attached to the first one of the actuators, wherein the second portion of the first filament is directly attached to the second one of the actuators, wherein the first portion of the second filament is directly attached to the first one of the actuators, and wherein the second portion of the second filament is directly attached to the second one of the actuators. ### Claim 27 (depends on 23) The valve assembly of claim 23 wherein the first filament is flexible, and wherein the second filament is flexible. ### Claim 28 (depends on 23) The valve assembly of claim 23 wherein, in the second position, the tubular member has a diameter of at least 16 French. ### Claim 29 (depends on 23) The valve assembly of claim 23 wherein, in the second position, the tubular member has a diameter of at least 20 French. ### Claim 30 (depends on 23) The valve assembly of claim 23 wherein, in the second position, the tubular member has a diameter of at least 24 French.