# US 11,027,100 B2 · Expandable introducer assembly and method of using same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,100 B2 - Document ID: US11027100B2 - Status: Granted - Kind: B2 - Application number: 16/183,123 - Filed: 2018-11-07 - Published: 2019-03-07 - Granted: 2021-06-08 - Earliest claimed: 2016-10-28 - Assignees: Freudenberg Medical, LLC - Applicants: Freudenberg Medical, LLC - Inventors: Anthony Appling; Simon Furnish; Ben Morris; Cody Wetzel; Timothy S. Zeis - Web page: https://patentgrep.com/patent/US11027100B2 ## CPC - A61M 25/0662: {Guide tubes} - A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter} - A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)} - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof - A61M 29/00: Dilators with or without means for introducing media, e.g. remedies - A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system} - A61M 2025/0024: {Expandable catheters or sheaths} - A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube} - A61M 2039/0626: {used with other surgical instruments, e.g. endoscope, trocar} - A61M 2205/0222: Materials for reducing friction - 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 An expandable introducer assembly for use in inserting a medical device into a body vessel of a patient includes an expandable sheath subassembly including a sheath hub and an expandable sheath extending from the sheath hub for initial insertion into the body vessel of the patient. The expandable introducer assembly also includes introducer subassembly including a hemostasis valve and an introducer sheath extending from the hemostasis valve and axial advanceable through the sheath hub and into the expandable sheath for radially expanding the body vessel. A coupler is releasably connected to the sheath hub and disposed in interlocked relationship with the hemostasis valve when the hemostasis valve is axially advanced with the introducer sheath towards the sheath hub for allowing serial retraction of the introducer sheath and the expandable sheath out of the body vessel of the patient. ## Claims ### Claim 1 An expandable introducer assembly for use in inserting a medical device into a body vessel of a patient, said expandable introducer assembly comprising: a dilator extending along an axis from a proximal dilator end to a distal dilator end; an expandable sheath extending from adjacent said distal dilator end in surrounding and coaxial relationship with said dilator for concurrent insertion and axial advancement with said dilator into the body vessel of the patient; an introducer subassembly including a hemostasis valve releasably interconnected to said proximal dilator end and an introducer sheath extending in surrounding and coaxial relationship with said dilator from said hemostasis valve to adjacent said expandable sheath; said expandable sheath including a sheath hub interchangeable from a locked condition for preventing axial movement of said dilator and said introducer subassembly relative to said expandable sheath during the insertion of said expandable introducer assembly into the body vessel and an unlocked condition for allowing concurrent axial advancement of said introducer subassembly and said dilator relative to said expandable sheath after the insertion of said expandable introducer assembly into the body vessel to allow said introducer sheath to pass through said sheath hub and into said expandable sheath for radially expanding the body vessel; and a coupler releasably connected to said sheath hub and disposed in interlocked relationship with said hemostasis valve when said hemostasis valve is axially advanced towards said sheath hub for allowing serial retraction of said introducer sheath and said expandable sheath out of the body vessel of the patient. ### Claim 2 (depends on 1) The expandable introducer assembly as set forth in claim 1 wherein said coupler includes a receiving body for establishing said releasable connection to said sheath hub and said interlocked relationship with said hemostasis valve, and said coupler including a tether extending between said receiving body and said sheath hub and expandable from a collapsed condition to a taught condition during axial retraction of said introducer subassembly for facilitating said serial retraction of said introducer sheath and said expandable sheath out of the body vessel of the patient. ### Claim 3 (depends on 2) The expandable introducer assembly as set forth in claim 2 wherein said sheath hub defines a cavity and said tether is stored within said cavity when said receiving body is releasably connected to said sheath hub and said tether is disposed in said collapsed condition. ### Claim 4 (depends on 2) The expandable introducer assembly as set forth in claim 2 wherein said tether defines a passageway extending between said receiving body and said sheath hub for receiving said introducer sheath when said introducer sheath is passed through said sheath hub and into said expandable sheath and for supporting said tether about said introducer sheath when said tether is expanded from said collapsed condition to said taught condition. ### Claim 5 (depends on 4) The expandable introducer assembly as set forth in claim 4 wherein said tether includes a plurality of sheets interconnected with one another in collapsible and expandable accordion fashion and each of said plurality of sheets defining a hole to collectively define said passageway. ### Claim 6 (depends on 4) The expandable introducer assembly as set forth in claim 4 wherein said tether includes a plurality of rings serially arranged between said sheath hub and said receiving body and each defining an opening for collectively defining said passageway and concentrically receiving said introducer sheath when said introducer sheath is passed through said sheath hub and collectively supporting said tether about said introducer sheath when said tether is expanded between said collapsed condition and said taught condition and into said expandable sheath, and said plurality of rings connected to one another by at least one string extending between said sheath hub and said coupler for sliding said rings along said introducer sheath during relative movement between said introducer subassembly and said expandable sheath. ### Claim 7 (depends on 4) The expandable introducer assembly as set forth in claim 4 wherein said tether includes at least one cord extending between said sheath hub and said coupler and spirally wound to define said passageway and to define a series of loops. ### Claim 8 (depends on 7) The expandable introducer assembly as set forth in claim 7 wherein said at least one cord includes a plurality of cords, and said series of loops of one of said plurality of cords is secured to said series of loops of the other of said plurality of cords via a connection point. ### Claim 9 (depends on 4) The expandable introducer assembly as set forth in claim 4 wherein said tether is comprised of one of a braided material, a woven material, or a sheath. ### Claim 10 (depends on 4) The expandable introducer assembly as set forth in claim 4 further comprising a locking key disposed in a mating and releasably interlocked relationship with said receiving body and releasably interlocked with said dilator for establishing said locked condition of said sheath hub. ### Claim 11 (depends on 4) The expandable introducer assembly as set forth in claim 4 further comprising a casing extending between a proximal casing end disposed in abutting relationship with said hemostasis valve and a distal casing end disposed in mating and releasably interlocked relationship with said receiving body for establishing said locked condition of said sheath hub. ### Claim 12 (depends on 11) The expandable introducer assembly as set forth in claim 11 wherein said casing is disposed in encasing relationship with said introducer sheath and defines a trough extending between said proximal and distal casing ends; and said casing defining an orifice in fluid communication with said trough to allow a fluid to be introduced through said orifice and into said trough to lubricate said introducer sheath prior to axial advancement through said sheath hub into said expandable sheath. ### Claim 13 (depends on 12) The expandable introducer assembly as set forth in claim 12 wherein said casing includes a clamp hinged to said distal casing end and pivotable from an open position to a closed position for establishing said mating and releasably interlocked condition with said receiving body, and said clamp defining said orifice for being pivoted into fluid communication with said trough when said clamp is disposed in said closed position. ### Claim 14 (depends on 12) The expandable introducer assembly as set forth in claim 12 wherein said introducer sheath includes a hydro-coating activatable by said fluid for lubricating said introducer sheath. ### Claim 15 An expandable introducer assembly for use in inserting a medical device into a body vessel of a patient, said expandable introducer assembly comprising: an expandable sheath subassembly including a sheath hub and an expandable sheath extending from said sheath hub for initial insertion into the body vessel of the patient; an introducer subassembly including a hemostasis valve and an introducer sheath extending from said hemostasis valve and axial advanceable through said sheath hub and into said expandable sheath for radially expanding the body vessel of the patient; and a coupler releasably connected to said sheath hub and disposed in interlocked relationship with said hemostasis valve when said hemostasis valve is axially advanced with said introducer sheath towards said sheath hub for allowing serial retraction of said introducer sheath and said expandable sheath out of the body vessel of the patient. ### Claim 16 (depends on 15) An expandable introducer assembly as set forth in claim 15 wherein said coupler includes a receiving body for establishing said releasable connection to said sheath hub and said interlocked relationship with said hemostasis valve, and a tether extending between said receiving body and said sheath hub and expandable from a collapsed condition to a taught condition during axial retraction of said introducer subassembly for facilitating said serial retraction of said introducer sheath and said expandable sheath out of the body vessel of the patient. ### Claim 17 (depends on 16) The expandable introducer assembly as set forth in claim 16 wherein said sheath hub defines a cavity and said tether is stored within said cavity when said receiving body is releasably connected to said sheath hub and said tether is disposed in said collapsed condition. ### Claim 18 (depends on 16) The expandable introducer assembly as set forth in claim 16 wherein said tether defines a passageway extending between said receiving body and said sheath hub for receiving said introducer sheath when said introducer sheath is passed through said sheath hub and into said expandable sheath. ### Claim 19 (depends on 18) The expandable introducer assembly as set forth in claim 18 wherein said tether includes a plurality of sheets interconnected with one another in collapsible and expandable accordion fashion and each of said plurality of sheets defining a hole to collectively define said passageway. ### Claim 20 (depends on 18) The expandable introducer assembly as set forth in claim 18 wherein said tether includes a plurality of rings serially arranged between said sheath hub and said receiving body and each defining an opening for collectively defining said passageway and concentrically receiving said introducer sheath when said introducer sheath is passed through said sheath hub and into said expandable sheath and said plurality of rings connected to one another by at least one string extending between said sheath hub and said coupler for sliding said rings along said introducer sheath during relative movement between said introducer subassembly and said expandable sheath. ### Claim 21 (depends on 18) The expandable introducer assembly as set forth in claim 18 wherein said tether includes at least one cord extending between said sheath hub and said coupler and spirally wound to define said passageway and to define a series of loops. ### Claim 22 (depends on 21) The expandable introducer assembly as set forth in claim 21 wherein said at least one cord includes a plurality of cords, and said series of loops of one of said plurality of cords is secured to said series of loops of the other of said plurality of cords via a connection point. ### Claim 23 (depends on 16) The expandable introducer assembly as set forth in claim 16 further comprising a casing extending between a proximal casing end disposed in abutting relationship with said hemostasis valve for establishing said locked condition of said sheath hub and a distal casing end disposed in mating and releasably interlocked relationship with said receiving body and preventing axial advancement and rotational misalignment of said introducer subassembly relative to said expandable sheath. ### Claim 24 (depends on 23) The expandable introducer assembly as set forth in claim 23 wherein said casing is disposed in encasing relationship with said introducer sheath and defines a trough extending between said proximal and distal casing ends, and said casing defining an orifice in fluid communication with said trough to allow a fluid to be introduced through said orifice and into said trough to lubricate the introducer sheath prior to axial advancement through said sheath hub into said expandable sheath. ### Claim 25 (depends on 24) The expandable introducer assembly as set forth in claim 24 wherein said casing includes a clamp hinged to said distal casing end and pivotable from an open position and a closed position for establishing said mating and releasably interlocked condition with said receiving body and said clamp defining said orifice for being pivoted into fluid communication with said trough when said clamp is disposed in said closed position.