# US 10,864,353 B2 · Access device with valve > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,864,353 B2 - Document ID: US10864353B2 - Status: Granted - Kind: B2 - Application number: 15/887,170 - Filed: 2018-02-02 - Published: 2018-08-09 - Granted: 2020-12-15 - Earliest claimed: 2011-08-17 - Assignees: Smiths Medical ASD, Inc. - Applicants: Smiths Medical ASD, Inc. - Inventors: Steven F. Bierman; Richard A. Pluth - Web page: https://patentgrep.com/patent/US10864353B2 ## CPC - A61M 25/06: Body-piercing guide needles or the like - A61M 25/0668: {splittable, tear apart} - A61M 39/22: Valves or arrangement of valves {(A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405)} - A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)} - A61M 25/0693: {Flashback chambers} - A61M 29/00: Dilators with or without means for introducing media, e.g. remedies - A61M 2025/0098: {having a strain relief at the proximal end, e.g. sleeve} - A61M 2039/244: {Hinged closure member, e.g. flap valve} - 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 splittable sheath includes a splittable sheath body, a splittable sheath hub, and a valve element. The sheath body comprises a generally flexible tubular structure, a proximal end, and a distal end. The sheath body defines a longitudinal axis and is splittable into two halves along a pre-determined line generally parallel to the longitudinal axis. The sheath hub extends from the proximal end of the sheath body and defines a longitudinal axis generally aligned with the longitudinal axis of the sheath body. The sheath body and sheath hub form an inner cavity along their respective longitudinal axes. The valve element includes a resilient plate and a sealing element. The resilient plate includes a distal portion extending radially inwardly from a side of the inner cavity. The sealing element includes a sealing surface and is supported by the resilient plate such that the sealing element is biased toward a position against a second sealing surface on at least one of the splittable sheath body and hub to substantially seal the inner cavity. ## Claims ### Claim 1 A medical article comprising: a sheath including a sheath hub, the sheath hub comprising: one or more inner surfaces defining an inner cavity with an access opening into the inner cavity, and a first sealing surface disposed at one end of the inner cavity and around the access opening, and a valve element comprising: a resilient plate comprising a sealing portion, the sealing portion extending into the inner cavity from one of the one or more inner surfaces of the sheath hub, the sealing portion having two opposing sides with an aperture passing through the resilient plate between the two opposing sides, the sealing portion being moveable to transition the valve element between an open position and a closed position, and a sealing element being at least partially positioned on the sealing portion and extending through the aperture such that the sealing element is positioned on the two opposing sides of the sealing portion of the resilient plate when the valve element is in both the open position and the closed position, the sealing element comprising a second sealing surface supported on one of the two opposing sides of the sealing portion, the second sealing surface being movable with the sealing portion to the closed position to bear against the first sealing surface of the sheath hub to substantially seal at least a portion of the access opening into the inner cavity, wherein a first portion of the sealing element covers at least one of the two opposing sides of the sealing portion, wherein a second portion of the sealing element covers at least the other of the two opposing sides of the sealing portion, and wherein the sealing portion is at least partially positioned between the first and second portions of the sealing element through the aperture. ### Claim 2 (depends on 1) The medical article of claim 1, wherein the aperture passing through the resilient plate is offset relative to a longitudinal axis, about which the access opening is positioned, when the sealing element is in the closed position. ### Claim 3 (depends on 1) The medical article of claim 1, wherein the resilient plate includes a plurality of apertures. ### Claim 4 (depends on 1) The medical article of claim 1, wherein the sealing element further comprises an alignment element configured to facilitate attachment of the sealing element to the resilient plate. ### Claim 5 (depends on 1) The medical article of claim 1, wherein at least one of the first and second sealing surfaces extends around the substantial entirety of a perimeter of the one or more inner surfaces when the valve element is in the closed position. ### Claim 6 (depends on 1) The medical article of claim 1, wherein the sealing element further comprises a raised portion with respect to the second sealing surface, and wherein the raised portion extends away from the sealing portion of the resilient plate. ### Claim 7 (depends on 6) The medical article of claim 6, wherein the raised portion comprises a substantially dome-like shape. ### Claim 8 (depends on 6) The medical article of claim 6, wherein the raised portion has a height sufficient to inhibit contact between the second sealing surface and a device extending through the inner cavity. ### Claim 9 (depends on 6) The medical article of claim 6, wherein the raised portion comprises a coating. ### Claim 10 (depends on 1) The medical article of claim 1, wherein the resilient plate further comprises a weakened portion configured to facilitate bending of the resilient plate such that the sealing portion of the resilient portion moves with respect to the sheath hub. ### Claim 11 (depends on 10) The medical article of claim 10, wherein the weakened portion comprises a fold line. ### Claim 12 (depends on 10) The medical article of claim 10, wherein the resilient plate is bent at the weakened portion to be substantially non-planar to preload the valve element into the closed position. ### Claim 13 (depends on 1) The medical article of claim 1, wherein the sheath hub and the resilient plate comprise a pair of corresponding attachment elements configured to restrict at least one of radial and rotational movement of the resilient plate relative to a longitudinal axis. ### Claim 14 (depends on 1) The medical article of claim 1, wherein the valve element is biased toward the closed position. ### Claim 15 (depends on 1) The medical article of claim 1, wherein the resilient plate further comprises a flexible material with properties inhibiting cold-setting when the resilient plate is held in a flexed position for extended periods of time. ### Claim 16 (depends on 15) The medical article of claim 15, wherein the resilient plate comprises Nitinol. ### Claim 17 (depends on 1) The medical article of claim 1, wherein the sheath hub is splittable into two portions along pre-determined split lines generally parallel to a longitudinal axis, about which the access opening is positioned. ### Claim 18 (depends on 1) The medical article of claim 1, wherein the sheath further comprises a sheath body having a proximal end, a distal end, and a tubular structure extending therebetween, and wherein the sheath hub extends from the proximal end of the sheath body and the inner cavity extends along the longitudinal axis of the sheath body. ### Claim 19 (depends on 18) The medical article of claim 18, wherein the sheath body is splittable into two portions along two pre-determined split lines generally parallel to a longitudinal axis of the tubular structure. ### Claim 20 A medical article comprising: a sheath including a sheath hub, the sheath hub comprising: one or more inner surfaces defining an inner cavity with an access opening into the inner cavity, and a first sealing surface disposed at one end of the inner cavity and around the access opening, and a valve element comprising: a resilient plate comprising a sealing portion extending into the inner cavity from one of the one or more inner surfaces of the sheath hub, the sealing portion having two opposing sides with an aperture passing through the resilient plate between the two opposing sides, and a sealing element being disposed on at least the two opposing sides of the sealing portion of the resilient plate, extending through the aperture, and comprising a second sealing surface supported on one of the two opposing sides of the sealing portion, the second sealing surface being movable with the sealing portion to a closed position to bear against the first sealing surface of the sheath hub to substantially seal at least a portion of the access opening into the inner cavity wherein a first portion of the sealing element covers at least one of the two opposing sides of the sealing portion, wherein a second portion of the sealing element covers at least the other of the two opposing sides of the sealing portion, and wherein the sealing portion is at least partially positioned between the first and second portions of the sealing element through the aperture. ### Claim 21 (depends on 20) The medical article of claim 20, wherein the resilient plate includes a plurality of apertures. ### Claim 22 (depends on 20) The medical article of claim 20, wherein the sealing element further comprises an alignment element configured to facilitate attachment of the sealing element to the resilient plate. ### Claim 23 (depends on 20) The medical article of claim 20, wherein at least one of the first and second sealing surfaces extends around the substantial entirety of a perimeter of the one or more inner surfaces when the valve element is in the closed position. ### Claim 24 (depends on 20) The medical article of claim 20, wherein the sealing element further comprises a raised portion with respect to the second sealing surface, and wherein the raised portion extends away from the sealing portion of the resilient plate. ### Claim 25 (depends on 24) The medical article of claim 24, wherein the raised portion comprises a substantially dome-like shape. ### Claim 26 (depends on 24) The medical article of claim 24, wherein the raised portion has a height sufficient to inhibit contact between the second sealing surface and a device extending through the inner cavity. ### Claim 27 (depends on 24) The medical article of claim 24, wherein the raised portion comprises a coating. ### Claim 28 (depends on 20) The medical article of claim 20, wherein the resilient plate further comprises a weakened portion configured to facilitate bending of the resilient plate such that the sealing portion of the resilient portion moves with respect to the sheath hub. ### Claim 29 (depends on 28) The medical article of claim 28, wherein the weakened portion comprises a fold line. ### Claim 30 (depends on 28) The medical article of claim 28, wherein the resilient plate is bent at the weakened portion to be substantially non-planar to preload the valve element into the closed position. ### Claim 31 (depends on 20) The medical article of claim 20, wherein the sheath hub and the resilient plate comprise a pair of corresponding attachment elements configured to restrict at least one of radial and rotational movement of the resilient plate relative to a longitudinal axis. ### Claim 32 (depends on 20) The medical article of claim 20, wherein the valve element is biased toward the closed position. ### Claim 33 (depends on 20) The medical article of claim 20, wherein the resilient plate further comprises a flexible material with properties inhibiting cold-setting when the resilient plate is held in a flexed position for extended periods of time. ### Claim 34 (depends on 33) The medical article of claim 33, wherein the resilient plate comprises Nitinol. ### Claim 35 (depends on 20) The medical article of claim 20, wherein the sheath hub is splittable into two portions along pre-determined split lines generally parallel to a longitudinal axis, about which the access opening is positioned. ### Claim 36 (depends on 20) The medical article of claim 20, wherein the sheath further comprises a sheath body having a proximal end, a distal end, and a tubular structure extending therebetween, and wherein the sheath hub extends from the proximal end of the sheath body and the inner cavity extends along the longitudinal axis of the sheath body. ### Claim 37 (depends on 36) The medical article of claim 36, wherein the sheath body is splittable into two portions along two pre-determined split lines generally parallel to a longitudinal axis of the tubular structure. ### Claim 38 A medical article comprising: a sheath including a sheath hub, the sheath hub comprising: one or more inner surfaces defining an inner cavity with an access opening into the inner cavity, and a first sealing surface disposed at one end of the inner cavity and around the access opening, and a valve element comprising: a resilient plate comprising a sealing portion, the sealing portion extending into the inner cavity from one of the one or more inner surfaces of the sheath hub, the sealing portion having two opposing sides with an aperture passing through the resilient plate between the two opposing sides, the sealing portion being moveable to transition the valve element between an open position and a closed position, and a sealing element being at least partially positioned on the sealing portion and extending through the aperture such that the sealing element is positioned on the two opposing sides of the sealing portion of the resilient plate when the valve element is in both the open position and the closed position, the sealing element comprising a second sealing surface supported on one of the two opposing sides of the sealing portion, the second sealing surface being movable with the sealing portion to the closed position to bear against the first sealing surface of the sheath hub to substantially seal at least a portion of the access opening into the inner cavity, wherein the sealing element further comprises an alignment element configured to facilitate attachment of the sealing element to the resilient plate. ### Claim 39 (depends on 38) The medical article of claim 38, wherein the aperture passing through the resilient plate is offset relative to a longitudinal axis, about which the access opening is positioned, when the sealing element is in the closed position. ### Claim 40 (depends on 38) The medical article of claim 38, wherein the resilient plate includes a plurality of apertures. ### Claim 41 (depends on 38) The medical article of claim 38, wherein at least one of the first and second sealing surfaces extends around the substantial entirety of a perimeter of the one or more inner surfaces when the valve element is in the closed position. ### Claim 42 (depends on 38) The medical article of claim 38, wherein the sealing element further comprises a raised portion with respect to the second sealing surface, and wherein the raised portion extends away from the sealing portion of the resilient plate. ### Claim 43 (depends on 42) The medical article of claim 42, wherein the raised portion comprises a substantially dome-like shape. ### Claim 44 (depends on 42) The medical article of claim 42, wherein the raised portion has a height sufficient to inhibit contact between the second sealing surface and a device extending through the inner cavity. ### Claim 45 (depends on 42) The medical article of claim 42, wherein the raised portion comprises a coating. ### Claim 46 (depends on 38) The medical article of claim 38, wherein the resilient plate further comprises a weakened portion configured to facilitate bending of the resilient plate such that the sealing portion of the resilient portion moves with respect to the sheath hub. ### Claim 47 (depends on 46) The medical article of claim 46, wherein the weakened portion comprises a fold line. ### Claim 48 (depends on 46) The medical article of claim 46, wherein the resilient plate is bent at the weakened portion to be substantially non-planar to preload the valve element into the closed position. ### Claim 49 (depends on 38) The medical article of claim 38, wherein the sheath hub and the resilient plate comprise a pair of corresponding attachment elements configured to restrict at least one of radial and rotational movement of the resilient plate relative to a longitudinal axis. ### Claim 50 (depends on 38) The medical article of claim 38, wherein the valve element is biased toward the closed position. ### Claim 51 (depends on 38) The medical article of claim 38, wherein the resilient plate further comprises a flexible material with properties inhibiting cold-setting when the resilient plate is held in a flexed position for extended periods of time. ### Claim 52 (depends on 51) The medical article of claim 51, wherein the resilient plate comprises Nitinol. ### Claim 53 (depends on 38) The medical article of claim 38, wherein the sheath hub is splittable into two portions along pre-determined split lines generally parallel to a longitudinal axis, about which the access opening is positioned. ### Claim 54 (depends on 38) The medical article of claim 38, wherein the sheath further comprises a sheath body having a proximal end, a distal end, and a tubular structure extending therebetween, and wherein the sheath hub extends from the proximal end of the sheath body and the inner cavity extends along the longitudinal axis of the sheath body. ### Claim 55 (depends on 54) The medical article of claim 54, wherein the sheath body is splittable into two portions along two pre-determined split lines generally parallel to a longitudinal axis of the tubular structure.