# US 11,026,719 B2 · Radially expandable introducer sheath > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,719 B2 - Document ID: US11026719B2 - Status: Granted - Kind: B2 - Application number: 15/979,703 - Filed: 2018-05-15 - Published: 2018-11-15 - Granted: 2021-06-08 - Earliest claimed: 2017-05-15 - Assignees: Boston Scientific Scimed, Inc. - Applicants: Boston Scientific Scimed, Inc. - Inventors: Michael Richmon Thoreson; Adam David Grovender; Scott Solberg; David Raab; Benjamin Philip Gundale; Ross A. Olson; James M. Anderson - Web page: https://patentgrep.com/patent/US11026719B2 ## CPC - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)} - A61B 17/3439: {with means for changing the inner diameter of the cannula, e.g. expandable (A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662)} - A61B 17/3462: {with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals (expandable cannulas A61B17/3417)} - A61M 25/0662: {Guide tubes} - A61B 2017/00336: {with a protective sleeve, e.g. retractable or slidable} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61M 25/0054: {with regions for increasing flexibility} - A61M 2025/0024: {Expandable catheters or sheaths} - A61M 2039/0279: {for introducing medical instruments into the body, e.g. endoscope, surgical tools} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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)} - 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 An introducer sheath may include a tubular member comprising an inner layer and an outer layer coaxially disposed about a central longitudinal axis of the introducer sheath, the tubular member being configured to shift between an unexpanded configuration to an expanded configuration. The inner layer may be circumferentially discontinuous along at least a portion of its length. At least a first portion of the inner layer may be configured to move circumferentially relative to the outer layer when shifting between the unexpanded and expanded configurations. ## Claims ### Claim 1 An introducer sheath, comprising: a tubular member comprising an inner layer and an outer layer coaxially disposed about a central longitudinal axis of the introducer sheath, the tubular member being configured to shift between an unexpanded configuration to an expanded configuration; wherein the inner layer is circumferentially discontinuous along at least a portion of its length; wherein at least a first portion of the inner layer is configured to slide circumferentially relative to the outer layer when shifting between the unexpanded and expanded configurations; wherein the outer layer is circumferentially continuous along its entire length; wherein the inner layer is formed from a substantially inelastic material. ### Claim 2 (depends on 1) The introducer sheath of claim 1, wherein the inner layer includes a plurality of longitudinally-oriented elements. ### Claim 3 (depends on 2) The introducer sheath of claim 2, wherein the plurality of longitudinally-oriented elements at least partially circumferentially overlap each other in the unexpanded configuration. ### Claim 4 (depends on 3) The introducer sheath of claim 3, wherein the plurality of longitudinally-oriented elements circumferentially overlap each other less as the tubular member shifts from the unexpanded configuration toward the expanded configuration. ### Claim 5 (depends on 2) The introducer sheath of claim 2, wherein the plurality of longitudinally-oriented elements is circumferentially spaced apart from each other in the expanded configuration. ### Claim 6 (depends on 1) The introducer sheath of claim 1, wherein the outer layer is formed from a substantially elastic material. ### Claim 7 (depends on 1) The introducer sheath of claim 1, further comprising an elastomeric outer sheath disposed about the outer layer of the tubular member. ### Claim 8 (depends on 7) The introducer sheath of claim 7, wherein the elastomeric outer sheath is disposed against the outer layer of the tubular member. ### Claim 9 (depends on 1) The introducer sheath of claim 1, wherein the inner layer is secured to the outer layer such that at least a second portion of the inner layer is circumferentially immovable relative to the outer layer. ### Claim 10 A medical device system, comprising: a replacement heart valve delivery system; and an introducer sheath comprising a tubular member comprising an inner layer and an outer layer coaxially disposed about a central longitudinal axis of the introducer sheath, the tubular member being configured to shift between an unexpanded configuration to an expanded configuration; wherein the inner layer is circumferentially discontinuous along at least a portion of its length; wherein at least a first portion of the inner layer is configured to slide circumferentially relative to the outer layer when shifting between the unexpanded and expanded configurations; wherein the outer layer is circumferentially continuous along its entire lengths wherein the inner layer is formed from a substantially inelastic material; wherein the replacement heart valve delivery system is configured to slide within a lumen of the introducer sheath for advancement within a vasculature. ### Claim 11 (depends on 10) The medical device system of claim 10, wherein the replacement heart valve delivery system includes a replacement heart valve implant. ### Claim 12 (depends on 10) The medical device system of claim 10, wherein the replacement heart valve delivery system is unexposed to the vasculature while the replacement heart valve delivery system is disposed within the lumen of the introducer sheath. ### Claim 13 (depends on 10) The medical device system of claim 10, wherein the tubular member is configured to shift toward the expanded configuration as the replacement heart valve delivery system passes through the lumen of the introducer sheath and shift toward the unexpanded configuration when the replacement heart valve delivery system is removed from the lumen of the introducer sheath. ### Claim 14 A method of delivering a replacement heart valve, comprising: advancing an introducer sheath through a vasculature to an access site, the introducer sheath including a tubular member comprising an inner layer and an outer layer coaxially disposed about a central longitudinal axis of the introducer sheath; the tubular member being configured to shift between an unexpanded configuration to an expanded configuration; wherein the inner layer is circumferentially discontinuous along at least a portion of its length; wherein at least a first portion of the inner layer is configured to slide circumferentially relative to the outer layer when shifting between the unexpanded and expanded configurations; wherein the outer layer is circumferentially continuous along its entire lengths wherein the inner layer is formed from a substantially inelastic material; inserting a replacement heart valve delivery system into a lumen of the introducer sheath; advancing the replacement heart valve delivery system through the lumen of the introducer sheath to a treatment site; wherein the introducer sheath radially expands as the replacement heart valve delivery system is advanced through the introducer sheath; and deploying the replacement heart valve at the treatment site. ### Claim 15 (depends on 14) The method of claim 14, wherein the outer layer is circumferentially discontinuous along at least a portion of its length. ### Claim 16 (depends on 15) The method of claim 15, wherein the inner layer and the outer layer overlap such that when the introducer sheath radially expands as the replacement heart valve delivery system is advanced through the introducer sheath, the lumen of the introducer sheath remains circumferentially closed to the vasculature. ### Claim 17 (depends on 16) The method of claim 16, wherein the inner layer and the outer layer are arranged in opposing clamshell configurations.