# US 12,178,983 B2 · Low pressure seal design for a hemostasis valve > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,983 B2 - Document ID: US12178983B2 - Status: Granted - Kind: B2 - Application number: 17/994,910 - Filed: 2022-11-28 - Published: 2023-03-23 - Granted: 2024-12-31 - Earliest claimed: 2016-11-09 - Assignees: Boston Scientific Corporation - Applicants: Boston Scientific Limited - Inventors: Sumit Agrawal; Biten Kishore Kathrani - Web page: https://patentgrep.com/patent/US12178983B2 ## CPC - A61M 39/0606: {without means for adjusting the seal opening or pressure (A61M39/0693 takes precedence)} - A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof - A61M 2039/062: {used with a catheter} - A61M 2039/064: {Slit-valve} - A61M 2039/0686: {comprising more than one seal} - A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking - 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)} ## Abstract A hemostasis valve assembly for use in a medical device. The hemostasis valve assembly may include a main body portion defining an internal cavity, a seal cartridge disposed within the internal cavity, and a low pressure valve assembly positioned within the internal cavity adjacent to the seal cartridge. The low pressure valve assembly may include a first valve member having a first valve body and a second valve member having second valve body. A portion of a distal side of the first valve member may abut at least a portion of a proximal side of the second valve member. ## Claims ### Claim 1 A hemostasis valve assembly for use in a medical device, the hemostasis valve assembly comprising: a main body portion defining an internal cavity; a distal seal disposed within the internal cavity; and a proximal seal positioned proximal of the distal seal within the internal cavity, the proximal seal including: a first, proximal seal member having a proximal face and a distal face, an entirety of the distal face extending across an entirety of the first seal member is planar, the proximal face includes a concave central region; a second, distal seal member having a proximal face and a distal face, the distal face including an angled central region, wherein the angled central region is angled distally or angled proximally; wherein at least a portion of the first seal member directly contacts at least a portion of the second seal member. ### Claim 2 (depends on 1) The hemostasis valve assembly of claim 1, wherein the angled central region of the distal face of the second seal member is angled distally. ### Claim 3 (depends on 2) The hemostasis valve assembly of claim 2, wherein the angled central region slopes towards a diametrical center of the distal face. ### Claim 4 (depends on 1) The hemostasis valve assembly of claim 1, wherein the proximal face of the second seal member has a conical central region. ### Claim 5 (depends on 4) The hemostasis valve assembly of claim 4, wherein the conical central region of the proximal face of the second seal member tapers distally toward a diametrical center of the proximal face. ### Claim 6 (depends on 1) The hemostasis valve assembly of claim 1, wherein the first seal member comprises a first elastomeric material and the second seal member comprises a second elastomeric material different from the first elastomeric material. ### Claim 7 (depends on 1) The hemostasis valve assembly of claim 1, wherein the first and second seal members each have a flanged outer perimeter with a first thickness measured in a distal to proximal direction, the first seal member has a first annular groove in its proximal face and the second seal member has a second annular groove in its distal face, wherein the first thickness is greater than a thickness of each of the first and second annular grooves. ### Claim 8 (depends on 7) The hemostasis valve assembly of claim 7, wherein a thickness of the first seal member adjacent to a diametrical center thereof is less than the first thickness and greater than the thickness of the first annular groove. ### Claim 9 (depends on 7) The hemostasis valve assembly of claim 7, wherein a thickness of the second seal member adjacent to a diametrical center thereof is less than the first thickness and greater than the thickness of the second annular groove. ### Claim 10 (depends on 1) The hemostasis valve assembly of claim 1, further comprising: one or more slits formed in the first seal member and extending at least partially through the thickness of the first seal member; and one or more slits formed in the second seal member and extending at least partially through the thickness of the second seal member. ### Claim 11 (depends on 10) The hemostasis valve assembly of claim 10, wherein the one or more slits in the first seal member are radially offset from the one or more slits in the second seal member. ### Claim 12 (depends on 1) The hemostasis valve assembly of claim 1, wherein the angled central region of the distal face of the second seal member is angled proximally. ### Claim 13 (depends on 12) The hemostasis valve assembly of claim 12, wherein an entirety of the proximal face extending across an entirety of the second seal member is planar. ### Claim 14 A hemostasis valve assembly for use in a medical device, the hemostasis valve assembly comprising: a main body portion defining an internal cavity; a distal seal disposed within the internal cavity; and a proximal seal positioned proximal of the distal seal within the internal cavity, the proximal seal including: a first, proximal seal member having a proximal face and a distal face, an entirety of the distal face extending across an entirety of the first seal member is planar, the proximal face includes an angled central region; a second, distal seal member having a proximal face and a distal face, the distal face including an angled central region; wherein the first and second seal members each have a flanged outer perimeter and an annular groove radially inward of the flanged outer perimeter; wherein at least a portion of the first seal member opposite its annular groove directly contacts at least a portion of the second seal member opposite its annular groove; wherein the flanged outer perimeter of each of the first and second seal members has a first thickness measured in a distal to proximal direction, wherein the first thickness is greater than a thickness of each of the first and second annular grooves. ### Claim 15 (depends on 14) The hemostasis valve assembly of claim 14, wherein the angled central region of the distal face of the second seal member is angled distally. ### Claim 16 (depends on 15) The hemostasis valve assembly of claim 15, wherein the angled central region slopes towards a diametrical center of the distal face. ### Claim 17 (depends on 14) The hemostasis valve assembly of claim 14, wherein the proximal face of the second seal member has a conical central region that tapers distally toward a diametrical center of the proximal face. ### Claim 18 (depends on 14) The hemostasis valve assembly of claim 14, wherein the angled central region of the distal face of the second seal member is angled proximally. ### Claim 19 A hemostasis valve assembly for use in a medical device, the hemostasis valve assembly comprising: a main body portion defining an internal cavity; a distal seal disposed within the internal cavity; and a proximal seal positioned proximal of the distal seal within the internal cavity, the proximal seal including: a first, proximal seal member having a proximal face and a distal face, an entirety of the distal face extending across an entirety of the first seal member is planar, the proximal face includes a concave central region; a second, distal seal member having a proximal face and a distal face, an entirety of the proximal face extending across an entirety of the second seal member is planar, the distal face including an angled central region, wherein the angled central region is angled distally or angled proximally; wherein at least a portion of the first seal member directly contacts at least a portion of the second seal member.