# US 12,485,261 B2 · Sheath for sealed access to a vessel > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,485,261 B2 - Document ID: US12485261B2 - Status: Granted - Kind: B2 - Application number: 18/545,581 - Filed: 2023-12-19 - Published: 2024-08-15 - Granted: 2025-12-02 - Earliest claimed: 2014-07-04 - Assignees: Abiomed Europe GmbH - Applicants: Abiomed Europe GmbH - Inventors: Thorsten Siess; Christoph Nix; Frank Kirchhoff; Patrick Hunziker - Web page: https://patentgrep.com/patent/US12485261B2 ## CPC - A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body} - A61M 39/0606: {without means for adjusting the seal opening or pressure (A61M39/0693 takes precedence)} - A61M 60/135: inside a blood vessel, e.g. using grafting - A61M 60/268: the displacement member being flexible, e.g. membranes, diaphragms or bladders - A61M 60/148: in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices - A61M 60/414: transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter - A61M 60/857: Implantable blood tubes - A61M 2039/0258: {for vascular access, e.g. blood stream access} - A61M 2039/0267: {comprising sensors or electrical contacts} - A61M 2039/0273: {for introducing catheters into the body} - A61M 2039/0279: {for introducing medical instruments into the body, e.g. endoscope, surgical tools} - A61M 2039/062: {used with a catheter} - A61M 2039/0626: {used with other surgical instruments, e.g. endoscope, trocar} - A61M 2039/0633: {the seal being a passive seal made of a resilient material with or without an opening} - A61M 2205/32: with radio-opaque indicia - A61M 2205/3344: Measuring or controlling pressure at the body treatment site - A61M 2205/6063: Optical identification systems - A61M 2230/30: Blood pressure (A61M2230/04 takes precedence) - A61M 2230/50: Temperature - 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 sheath for producing a fully sealed access to the interior of a vessel of an animal or human body comprises a base sheath having a tubular body defining a pass-through channel. The base sheath is adapted to be inserted into the vessel through a vessel aperture. A wall of the tubular body of the base sheath has a through channel. This channel extends in the wall from the distal end towards the proximal end. The channel can be present separately from the pass-through channel of the base sheath or can form a sideways extension of the pass-through channel, at least at the distal end. Such through channel is adapted to conduct blood from the vessel to the proximal end of the sheath when the sheath has been inserted into a vessel. ## Claims ### Claim 1 A system comprising: a heart pump connected to a supply catheter; and a sheath assembly for producing a fully sealed access to an interior of a vessel of an animal or human body, comprising: a base sheath having a tubular body with a distal end and a proximal end, the base sheath adapted to be inserted into the vessel through a vessel aperture and the tubular body defining a pass-through channel extending from the proximal end to the distal end for insertion of the supply catheter therethrough into the interior of the vessel, wherein a wall of the tubular body of the base sheath has a through channel extending in the wall in parallel to the pass-through channel, wherein the through channel is open at the distal end and adapted to conduct blood from the vessel towards the proximal end of the base sheath, wherein the through channel is separate from the pass-through channel at the proximal end and not separate from the pass-through channel at the distal end, and wherein the base sheath is adapted to be arranged displaceably on the supply catheter. ### Claim 2 (depends on 1) The system according to claim 1, wherein the through channel is a sideways extension of the pass-through channel at least at the distal end. ### Claim 3 (depends on 1) The system according to claim 1, further comprising a blood pressure measuring device which is connected to the through channel. ### Claim 4 (depends on 1) The system according to claim 1, further comprising a temperature measuring element connected to or inserted through the through channel. ### Claim 5 (depends on 1) The system according to claim 1, wherein the through channel is configured such that blood from a patient can be taken through the through channel. ### Claim 6 (depends on 1) The system according to claim 1, further comprising a guidewire which is introducible into the vessel from the proximal end of the base sheath through the through channel. ### Claim 7 (depends on 1) The system according to claim 1, further comprising an expansion device which is adapted to cooperate with the base sheath such that an outer diameter of the sheath assembly increases in a region of the vessel aperture with the base sheath in a stationary position in the vessel and upon actuation of the expansion device. ### Claim 8 (depends on 7) The system according to claim 7, wherein the expansion device is configured as an expansion sheath that is displaceable on the base sheath in a direction of the vessel aperture. ### Claim 9 (depends on 8) The system according to claim 8, further comprising a sleeve which encases the base sheath and the expansion sheath such that the sleeve is in contact with the vessel aperture in the stationary position of the base sheath in the vessel, and that the expansion sheath is displaceable on the base sheath between the base sheath and the sleeve. ### Claim 10 (depends on 7) The system according to claim 7, further comprising a sleeve which encases the base sheath and the expansion device such that the sleeve is in contact with the vessel aperture in the stationary position of the base sheath in the vessel. ### Claim 11 (depends on 7) The system according to claim 7, wherein the expansion device is adapted to increase the outer diameter of the sheath assembly in the region of the vessel aperture by 0.33 mm to at least 1.0 mm. ### Claim 12 (depends on 1) The system according to claim 1, wherein the sheath assembly includes an externally readable marked region in an area of the sheath assembly, which, in operation, is intended to be located in the area of the vessel aperture. ### Claim 13 (depends on 1) The system according to claim 1, further comprising a fixation element for fixing the sheath assembly to a patient, wherein the fixation element has a surface with an area spanning the base sheath for applying a sterile cover, wherein the area slopes down in a ramp shape on opposite sides of the base sheath transversely to a principal direction of the base sheath, the principal direction extending from the proximal end to the distal end of the base sheath. ### Claim 14 (depends on 13) The system according to claim 13, wherein the fixation element comprises a stop for applying the sterile cover, the stop extending at a proximal end of the area transversely to the principal direction of the base sheath. ### Claim 15 A sheath assembly for producing a fully sealed access to an interior of a vessel of an animal or human body, comprising: a base sheath having a tubular body with a distal end and a proximal end, the base sheath adapted to be inserted into the vessel through a vessel aperture and the tubular body defining a pass-through channel extending from the proximal end to the distal end for insertion of a catheter therethrough into the interior of the vessel; and an expansion sheath, wherein, with the base sheath disposed through the vessel aperture and in a stationary position in the vessel, the expansion sheath is displaceable on the base sheath in a direction of the vessel aperture to increase an outer diameter of the sheath assembly in a region of the vessel aperture, wherein a wall of the tubular body of the base sheath has a through channel extending in the wall in parallel to the pass-through channel, wherein the through channel is open at the distal end and adapted to conduct blood from the vessel towards the proximal end of the base sheath, and wherein the through channel is separate from the pass-through channel at the proximal end and not separate from the pass-through channel at the distal end. ### Claim 16 (depends on 15) The sheath assembly according to claim 15, further comprising a sleeve which encases the base sheath and the expansion sheath such that the sleeve is in contact with the vessel aperture in the stationary position of the base sheath in the vessel, and that the expansion sheath is displaceable on the base sheath between the base sheath and the sleeve. ### Claim 17 A sheath assembly for producing a fully sealed access to an interior of a vessel of an animal or human body, comprising: a base sheath having a tubular body with a distal end and a proximal end, the base sheath adapted to be inserted into the vessel through a vessel aperture and the tubular body defining a pass-through channel extending from the proximal end to the distal end for insertion of a catheter therethrough into the interior of the vessel; an expansion device configured to cooperate with the base sheath such that an outer diameter of the sheath assembly increases in a region of the vessel aperture with the base sheath in a stationary position in the vessel and upon actuation of the expansion device; and a sleeve which encases the base sheath and the expansion device such that the sleeve is in contact with the vessel aperture in the stationary position of the base sheath in the vessel, wherein a wall of the tubular body of the base sheath has a through channel extending in the wall in parallel to the pass-through channel, wherein the through channel is open at the distal end and adapted to conduct blood from the vessel towards the proximal end of the base sheath, and wherein the through channel is separate from the pass-through channel at the proximal end and not separate from the pass-through channel at the distal end. ### Claim 18 A sheath assembly for producing a fully sealed access to an interior of a vessel of an animal or human body, comprising: a base sheath having a tubular body with a distal end and a proximal end, the base sheath adapted to be inserted into the vessel through a vessel aperture and the tubular body defining a pass-through channel extending from the proximal end to the distal end for insertion of a catheter therethrough into the interior of the vessel; and fixation element for fixing the sheath assembly to a patient, wherein the fixation element has a surface with an area spanning the base sheath for applying a sterile cover, wherein the area slopes down in a ramp shape on opposite sides of the base sheath transversely to a principal direction of the base sheath, the principal direction extending from the proximal end to the distal end of the base sheath, wherein a wall of the tubular body of the base sheath has a through channel extending in the wall in parallel to the pass-through channel, wherein the through channel is open at the distal end and adapted to conduct blood from the vessel towards the proximal end of the base sheath, and wherein the through channel is separate from the pass-through channel at the proximal end and not separate from the pass-through channel at the distal end. ### Claim 19 (depends on 18) The sheath assembly according to claim 18, wherein the fixation element comprises a stop for applying the sterile cover, the stop extending at a proximal end of the area transversely to the principal direction of the base sheath.