# US 2014/0194920 A1 · Device For Delivery Of Medical Devices To A Cardiac Valve > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0194920 A1 - Document ID: US20140194920A1 - Status: Published application - Kind: A1 - Application number: 14/115,089 - Filed: 2012-05-07 - Published: 2014-07-10 - Earliest claimed: 2011-05-08 - Assignees: Aeeg AB - Applicants: Aeeg AB - Inventors: Erik Krahbichler - Web page: https://patentgrep.com/patent/US20140194920A1 ## CPC - A61F 2/013: {Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting} - A61F 2/011: {Instruments for their placement or removal} - A61F 2/012: {Multiple filtering units} - A61F 2/014: {Retrograde blood flow filters, i.e. device inserted against the blood flow direction} - A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation} - A61F 2/243: {Deployment by mechanical expansion} - A61F 2/2433: {using balloon catheter} - A61F 2002/016: {made from wire-like elements} - A61F 2002/018: {made from tubes or sheets of material, e.g. by etching or laser-cutting} - A61F 2230/0071: spherical - A61F 2250/0059: temporary - A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)} - A61M 2025/1047: {having centering means, e.g. balloons having an appropriate shape} - 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) - 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 catheter device is disclosed for transvascular delivery of a medical device to a cardiac valve region of a patient. The catheter device comprises an elongate sheath (2) with releasable locking members for controllably locking the elongate sheath in a shape at least partly along its length from a relaxed state to a locked state when positioned in relation to a cardiac valve. Furthermore, alignment members (5) are provided to provide for a desired positioning in relation to the cardiac valve. Embolic protection (8) is further provided. ## Claims ### Claim 1 A catheter device for transvascular delivery of a medical device to a cardiac valve region of a patient, said catheter device comprising an elongate sheath with a lumen and a distal end, and an elongate member with a distal end portion comprising a plurality of radially expandable units, wherein said elongate member is retractably insertable into said lumen, said expandable units being arranged for temporarily positioning said elongate sheath in relation to said cardiac valve when in an expanded state outside said distal end of said elongate sheath; and wherein said elongate sheath comprises releasable locking members for controllably locking said elongate sheath in a shape at least partly along its length from a relaxed state to a locked state when positioned in relation to said cardiac valve by said expandable units in order to stabilize said elongate sheath. ### Claim 2 (depends on 1) The catheter device of claim 1, wherein said elongate sheath is deliverable transvascularly in said relaxed state for transiting from said relaxed state to said locked state when positioned in relation to said cardiac valve by said expandable units, and wherein said elongate member is retractable from said lumen together with said plurality of radially expandable units when collapsed, for said elongate sheath being locked and, when said elongate member is retracted, said lumen is accessible for said delivery of said medical device to said cardiac valve region. ### Claim 3 (depends on 1) The catheter device of claim 1 said catheter having a second channel that extends parallel to or in said elongate sheath. ### Claim 4 (depends on 1, 2, 3) The catheter device of any claims 1 to 3, wherein said side channel is affixed or integral with on the outer portion of said elongate sheath; or wherein said side channel is affixed on or integral with the inside portion of said elongate sheath. ### Claim 5 (depends on 1, 2, 3, 4) The catheter device of any of claims 1 to 4, wherein at least a portion of an expandable embolic protection unit, such as a filter, is arranged to extend from the orifice of said side channel. ### Claim 6 (depends on 5) The catheter device according to claim 5, wherein said embolic protection unit is non-tubular, extending substantially planar in said expanded state for covering ostia of the side branch vessels in the aortic arch. ### Claim 7 (depends on 5, 6) The catheter device according to claim 5 or 6, comprising a delivery unit connectable to said embolic protection unit at a connection point, wherein said connection point is arranged off-centre at the embolic protection unit such that said delivery unit is connectable off-center to said embolic protection unit. ### Claim 8 (depends on 5, 6, 7) The catheter device according to any of claims 5-7, wherein said embolic protection unit is arranged to stabilize said distal end of said sheath when said embolic protection unit is expanded out of said second channel. ### Claim 9 (depends on 8) The catheter device according to claim 8, wherein said embolic protection unit is an anchor to said sheath when in an expanded state. ### Claim 10 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11) The catheter device of any of claims 1 to 11, wherein said plurality of radially expandable units comprises expandable balloons, preferably three balloons positioned radially equidistant around a longitudinal axis of said elongate sheath. ### Claim 11 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10) The catheter device of any of claims 1 to 10, wherein said plurality of radially expandable units comprises expandable mechanical levers, or swellable units, such as sponges, retractable into said sheath. ### Claim 12 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11) The catheter device of any of claims 1 to 11 wherein said elongate member is retractably inserted into said elongate sheath's lumen to a length equal to the distance between the distal end and a proximal marker. ### Claim 13 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12) The catheter device of claims 1 to 12 wherein said elongate sheath comprises radiopaque fiducial markers. ### Claim 14 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13) The catheter device of claims 1 to 13 wherein said locking members are comprised in the list of a draw string, releasable latches, or a squeezing mechanism. ### Claim 15 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14) The catheter device of any of claims 1 to 14, wherein said medical device is an artificial replacement valve or a valve repair device, such as an annuloplasty implant. ### Claim 16 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15) The catheter device of any of claims 1 to 15, wherein said cardiac valve is an aortic valve of said patient; or a mitral valve of said patient. ### Claim 17 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16) A kit of a catheter device of any of claims 1 to 16 and a medical device for a cardiac valve. ### Claim 18 A system for transvascularly delivering a medical device to a cardiac valve of a patient, said system comprising a catheter comprising an elongate sheath with a lumen in a relaxed state for minimally invasively introducing into said vascular system; said sheath having a distal end of said elongate sheath for navigating through said vascular system to said cardiac valve; a plurality of radially expandable units at least temporarily provideable at said distal end of said elongate sheath; wherein said radially expandable units are arranged for expanding to temporarily position said distal end in relation to said cardiac valve; and locking members of said catheter which, when released, maintain said sheath in a structurally locked state to maintain its spatial position relative said cardiac valve; whereby said expandable units are arranged to allow for increased blood flow around said sheath when returned to a non expanded configuration while said locked state is maintained for delivering a medical device through the lumen of said locked elongate sheath to said heart valve; and wherein said elongate sheath is arranged to return to said relaxed state when said locking members are released for withdrawing said elongate sheath in said relaxed state from the vasculature of said patient. ### Claim 19 A method of transvascularly delivering a medical device to a cardiac valve of a patient comprising: introducing a catheter comprising an elongate sheath with a lumen in a relaxed state into said vascular system; navigating a distal end of said elongate sheath through said vascular system to said cardiac valve; radially expanding expandable units of said catheter or an elongate member positioned beyond a distal end of said sheath, to temporarily position in relation to said valve said elongate sheath; releasing locking members of said catheter to maintain said elongate sheath in a locked state; delivering a medical device through the lumen of said locked elongate sheath to said heart valve; releasing said locking members to return said elongate sheath to said relaxed state; and withdrawing said elongate sheath in said relaxed state from the vasculature of said patient. ### Claim 20 (depends on 19) A method according to claim 19 comprising, inserting an elongate member with a distal end portion comprising a plurality of said radially expandable units, into said lumen of said elongate sheath; advancing said elongate member through said elongate sheath to said distal end of said elongate sheath; retracting said expandable units and withdrawing said elongate member from the lumen of the elongate sheath.