# US 9,433,766 B2 · Expandable iliac sheath and method of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,766 B2 - Document ID: US9433766B2 - Status: Granted - Kind: B2 - Application number: 14/136,743 - Filed: 2013-12-20 - Published: 2014-07-03 - Granted: 2016-09-06 - Earliest claimed: 2008-05-14 - Assignees: Onset Medical Corporation - Applicants: Onset Medical Corporation - Inventors: Joseph Bishop; Jay Lenker; Edward J. Nance; Huan T. Nguyen; Mark T. Jones - Web page: https://patentgrep.com/patent/US9433766B2 ## CPC - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61M 25/0662: {Guide tubes} - A61M 25/104: {used for angioplasty} - A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids} - A61M 2025/0024: {Expandable catheters or sheaths} - A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube} - 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 Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, small cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of implant delivery catheters. The access route is through the femoral arteries and the iliac arteries into the aorta. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device, which is removed prior to the introduction of implant delivery catheters. ## Claims ### Claim 1 A method of performing a surgical procedure in a patient's vascular system, the method comprising: advancing a distal portion of a sheath along an aortic passageway towards an aortic valve in a patient's heart, the distal portion of the sheath comprising a malleable reinforcing structure longitudinally folded into a reduced cross-sectional profile; expanding a distal portion of the sheath within an aortic arch of the patient such that the malleable reinforcing structure is unfolded and the distal portion forms to the curve of the aortic arch; performing therapy or diagnosis through the expanded distal portion of the sheath; and removing the sheath from the vascular system; wherein expanding the distal portion of the sheath comprises expanding the sheath such that a central lumen of the sheath comprises a relatively constant diameter from its distal end to a proximal end of a sheath hub. ### Claim 2 (depends on 1) The method of claim 1, further comprising advancing a percutaneous valve delivery catheter through the expandable sheath. ### Claim 3 (depends on 1) The method of claim 1, further comprising advancing a percutaneous valve through the expandable sheath. ### Claim 4 (depends on 1) The method of claim 1, further comprising a diametrically expandable delivery system through the sheath, expanding the diametrically expandable delivery system, and delivering a valve prosthesis to a region of the heart through the expanded delivery system. ### Claim 5 (depends on 1) The method of claim 1, further comprising inserting a dilator within the distal portion of the sheath prior to advancing the distal portion of the sheath. ### Claim 6 (depends on 5) The method of claim 5, wherein the dilator comprises a hollow tube. ### Claim 7 (depends on 5) The method of claim 5, further comprising removing the dilator prior to performing therapy or diagnosis. ### Claim 8 (depends on 1) The method of claim 1, wherein expanding the distal portion of the sheath comprises expanding the distal portion from a first, smaller outside diameter of approximately 16 French or less to a second, larger outside diameter of approximately 32 French. ### Claim 9 (depends on 1) The method of claim 1, further comprising recollapsing the expanded distal portion to a second reduced cross-sectional profile. ### Claim 10 (depends on 9) The method of claim 9, wherein recollapsing the expanded distal portion comprises applying heat to shape-memory reinforcement of the malleable reinforcing structure. ### Claim 11 (depends on 9) The method of claim 9, wherein recollapsing the expanded distal portion comprises compressing the distal portion to a substantially uniform smaller diameter. ### Claim 12 (depends on 9) The method of claim 9, wherein recollapsing the expanded distal portion comprises folding the distal portion into a cross-sectional pattern. ### Claim 13 A method of performing a surgical procedure in a patient's vascular system, the method comprising: advancing a distal portion of a sheath along an aortic passageway towards an aortic valve in a patient's heart, the distal portion of the sheath comprising a malleable reinforcing structure longitudinally folded into a reduced cross-sectional profile; expanding a distal portion of the sheath within an aortic arch of the patient such that the malleable reinforcing structure is unfolded and the distal portion forms to the curve of the aortic arch; performing therapy or diagnosis through the expanded distal portion of the sheath; and removing the sheath from the vascular system; wherein advancing the distal portion of the sheath comprises advancing the distal portion through a puncture site in the iliac artery to at least the patient's aortic arch. ### Claim 14 A method of performing a surgical procedure in a patient's vascular system, the method comprising: advancing a distal portion of a sheath along an aortic passageway towards an aortic valve in a patient's heart, the distal portion of the sheath comprising a malleable reinforcing structure longitudinally folded into a reduced cross-sectional profile; expanding a distal portion of the sheath within an aortic arch of the patient such that the malleable reinforcing structure is unfolded and the distal portion forms to the curve of the aortic arch; performing therapy or diagnosis through the expanded distal portion of the sheath; and removing the sheath from the vascular system; wherein expanding the distal portion of the sheath comprises applying a proximal directed tension on the distal portion to cause axial compression of a braided reinforcement of the malleable reinforcement structure.