Sheath for sealed access to a vessel

Patent metadata

Field	Value
Publication number	US-2023381480-A1
Application number	US-202318142810-A
Country	US
Kind code	A1
Filing date	May 3, 2023
Priority date	Jul 4, 2014
Publication date	Nov 30, 2023
Grant date	—

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. The sheath further comprises an expansion device which is adapted to cooperate with the base sheath such that the outer diameter of the sheath increases in the region of the vessel aperture with the sheath in a stationary position in the vessel and upon actuation of the expansion device.

First claim

1 - 16 . (canceled)

17 . A method for producing sealed access to the interior of a vessel of an animal or human body by means of a sheath assembly, comprising:
inserting a base sheath of the sheath assembly into a vessel aperture of the vessel, the base sheath having a tubular body with a distal end and a proximal end, the tubular body defining a pass-through channel that is open from the distal end to the proximal end of the base sheath; and increasing an outer diameter of the sheath assembly in a region of the vessel aperture by actuating an expansion device of the sheath assembly such that a portion of the sheath assembly contacts the vessel aperture to close and seal the vessel aperture thereby providing sealed access to the interior of the vessel, wherein the outer diameter of the sheath assembly is increased while the base sheath disposed through the vessel aperture and in a stationary position in the vessel.

18 . The method of claim 17 , further comprising determining a pressure that is applied to the vessel aperture to determine a sufficient increase of the outer diameter of the sheath assembly to provide hemostasis.

19 . The method of claim 17 , further comprising fixing the sheath assembly to the patient after inserting the base sheath of the sheath assembly into the vessel aperture.

20 . The method of claim 19 , wherein the fixing comprises stitching a fixation element of the sheath assembly to the patient.

21 . The method of claim 17 , wherein the sheath assembly includes a sleeve that encases the base sheath and the expansion device such that the sleeve contacts the vessel aperture when the outer diameter is increased and the sheath assembly is in the stationary position.

22 . The method of claim 17 , wherein the expansion device is an expansion sheath that is disposed over an exterior of the tubular body of the base sheath and the expansion sheath is configured to be displaceable over the exterior of the tubular body and along a length of the tubular body and to increase the outer diameter of the sheath assembly.

23 . The method of claim 17 , wherein the expansion device is an inflation tube that is spirally wound around the base sheath, wherein the inflation tube is inflatable to increase the outer diameter of the sheath assembly.

24 . The method of claim 17 , wherein the expansion device includes a flexible portion that forms a part of the tubular body of the base sheath between the proximal end and the distal end, the flexible portion is configured to radially expand to increase the outer diameter of the sheath assembly when the distal end of the base sheath is pulled in a direction of the proximal end by a pulling means.

25 . The method of claim 17 , wherein the expansion device includes a stretchable portion that forms a part of the tubular body of the base sheath between the proximal end and the distal end, the stretchable portion is configured to attain a first thickness in a stretched condition and a second thickness, which is larger than the first thickness, in an unstretched condition when the proximal end of the base sheath is released in a direction of the vessel aperture from the stretched condition to the unstretched condition to increase the outer diameter of the sheath assembly.

26 . The method of claim 17 , wherein the pass-through channel has an inner diameter configured to receive a catheter through the pass-through channel.

27 . The method of claim 26 , wherein the pass-through channel of the base sheath is configured such that the catheter is axially displaceable through the pass-through channel of the base sheath independently of the base sheath and expansion device when the sheath assembly is within the vessel.

28 . The method of claim 17 , wherein a wall of the tubular body of the base sheath has a second channel extending in the wall from the distal end toward the proximal end.

29 . The method of claim 28 , wherein the second channel is configured to conduct blood from the vessel to the proximal end of the base sheath when the base sheath is inserted to a sufficient penetration depth into the vessel.

30 . The method of claim 17 , wherein the expansion device is configured to increase the outer diameter of the sheath assembly by 0.33 mm to 1.00 mm.

Assignees

• Abiomed Europe Gmbh

Inventors

• Siess Thorsten
• Nix Christoph
• Kirchhoff Frank
• O'Carrol Ger

Classifications

• A61B5/0215

  by means inserted into the body · CPC title

• A61M39/0247 Primary

  Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body (peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053) · CPC title

• A61M39/06

  Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof · CPC title

• A61M39/02 Primary

  Access sites · CPC title

• A61M60/148

  in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices · CPC title