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EP0546712A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Large-diameter expandable sheath and method

Assignee: Endovascular Technologies Inc
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Filing: 1992-11-23
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Granted: —
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Expires: 2012-11-23
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Abstract

Abstract A large-diameter expandable sheath (11) for use in introducing a catheter into a vessel in the body of a patient comprising an elongate sheath tube (12) formed of a flexible material which has proximal and distal extremities (13,14) and a passage (16) extending therethrough of a maximum predetermined diameter. The distal extremity (14) of the elongate sheath tube (12) is folded longitudinally to a smaller folded diameter. A backflow adapter (21) is secured to the proximal extremity (13) of the elongate sheath tube (12). The backflow adapter (21) has a central opening (23) therein in registration with the passage (16) in the sheath tube (12). A valve (40) is disposed in the central opening (23) of the backflow adapter (21) and is movable between open and closed positions. The valve (40) when open, permits the catheter to be inserted into the sheath (11), and when closed, serves to form a hemostatic seal about the catheter.

Inventors

  • 👤 Dinah B. Quiachon
  • 👤 David C. Dillow
  • 👤 Wesley D. Sterman
  • 👤 Steven G. Baker
  • 👤 Ronald G. Williams

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-04 21:17
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/0067; A61M25/0074; A61M25/0075; A61B; A61B17/00; A61B17/34; A61B17/3462; A61M25/01; A61M25/06; A61M25/0662; A61M39/00; A61M39/02; A61M39/06; A61M39/0613; A61M25/0021; A61M25/0023; A61M2025/0024; A61M2039/062; A61M2039/0673; A61M2039/0686; A61M25/0043; A61M25/005; A61M25/0053; A61M25/0668

Claims Analysis

Total Claims: 23
Claim 1
Independent Claim 137 words
In a large-diameter expandable sheath for use in introducing a catheter into a vessel in the body of a patient, an elongate sheath tube formed of a flexible material having proximal and distal extremities and having a passage extending therethrough of a maximum predetermined diameter, the distal extremity of the elongate sheath tube being folded longitudinally to a smaller folded diameter, a backflow adapter secured to the proximal extremity of the elongate sheath tube, said backflow adapter having a central opening therein in registration with the passage in the sheath tube and valve means disposed in the said central opening of the backflow adapter and movable between open and closed positions, said valve means when open permitting the catheter to be inserted into the sheath and when closed serving to form a hemostatic seal about the catheter.
Claim 2
Dependent Claim 137 words
In a large-diameter expandable sheath for use in introducing a catheter into a vessel in the body of a patient, an elongate sheath tube formed of a flexible material having proximal and distal extremities and having a passage extending therethrough of a maximum predetermined diameter, the distal extremity of the elongate sheath tube being folded longitudinally to a smaller folded diameter, a backflow adapter secured to the proximal extremity of the elongate sheath tube, said backflow adapter having a central opening therein in registration with the passage in the sheath tube and valve means disposed in the said central opening of the backflow adapter and movable between open and closed positions, said valve means when open permitting the catheter to be inserted into the sheath and when closed serving to form a hemostatic seal about the catheter.
Claim 3
Dependent Claim 82 words
A sheath as in Claim 1 wherein the valve means is in the form of a cylindrical member formed of a flexible material and having a bore therein in registration with the central opening extending through said body, together with means carried by the body for engaging the opposite ends of said cylindrical member for causing relative rotation between the ends of the cylindrical member to cause the cylindrical member to be twisted to close the bore extending through said cylindrical member.
Claim 4
Dependent Claim 71 words
A sheath as in Claim 2 wherein said means for causing rotation between the opposite ends of said cylindrical member includes a retaining ring and sheath tube adapter secured to opposite ends of said cylindrical member and means for fixing the sheath tube adapter to prevent rotation of the same within the body and means carried by the body for rotating the retaining ring with respect to the sheath tube adapter.
Claim 5
Dependent Claim 35 words
A sheath as in Claim 3 wherein said means for causing rotation includes a ring gear secured to said retaining ring and rack means for driving said ring gear to cause rotation of the same.
Claim 6
Dependent Claim 38 words
A sheath as in Claim 4 together with means yieldably engaging said rack for urging said rack means into a position wherein said cylindrical member is moved to provide valve means which is in a normally closed position.
Claim 7
Dependent Claim 53 words
A sheath as in Claim 5 wherein said rack means extends tangentially through said body together with actuator means carried by the rack adapted to be engaged by the fingers of the hand for moving the rack against the force of the yieldable means to move the valve means to an open position.
Claim 8
Dependent Claim 26 words
A sheath as in Claim 6 together with a stabilizer rod slidably mounted within said body parallel to said rack and secured to said actuator means.
Claim 9
Dependent Claim 30 words
A sheath as in Claim 7 together with means carried by the rack for preventing said yieldable means from pulling said rack means out of engagement with said cylindrical member.
Claim 10
Dependent Claim 64 words
A sheath as in Claim 1 together with a sheath introducer disposed in the passage in the sheath tube to form an assembly, said sheath introducer having a distal extremity extending beyond the proximal extremity of the sheath tube and dilation means mounted on said distal extremity of the sheath introducer which has a diameter greater than the folded diameter of the sheath tube.
Claim 11
Dependent Claim 215 words
In a large-diameter expandable sheath tube assembly, an elongate flexible sheath tube having proximal and distal extremities and having a passage extending therethrough of a maximum diameter, a backflow adapter mounted on the proximal extremity of said sheath tube, a sheath introducer disposed in said backflow adapter and extending through said passage in said sheath tube, said sheath introducer comprising an elongate tubular member having a distal extremity of reduced diameter, the distal extremity of said sheath tube being folded over the distal extremity of the longitudinally tubular member of the sheath introducer to a folded diameter, sleeve means carried by the sheath introducer for covering the distal extremity of the folded sheath tube to prevent the distal extremity of the sheath tube from causing trauma to the vessel of the patient when the sheath tube is introduced into the vessel, means for securing said sleeve means on the elongate tubular member of the sheath introducer so that said sheath introducer can be pushed distally with respect to the sheath tube to cause the sleeve means to be removed from the distal extremity of the sheath tube to permit the same to expand and to push the larger proximal end of the introducer through the distal extremity of the sheath tube to expand the same.
Claim 12
Dependent Claim 215 words
In a large-diameter expandable sheath tube assembly, an elongate flexible sheath tube having proximal and distal extremities and having a passage extending therethrough of a maximum diameter, a backflow adapter mounted on the proximal extremity of said sheath tube, a sheath introducer disposed in said backflow adapter and extending through said passage in said sheath tube, said sheath introducer comprising an elongate tubular member having a distal extremity of reduced diameter, the distal extremity of said sheath tube being folded over the distal extremity of the longitudinally tubular member of the sheath introducer to a folded diameter, sleeve means carried by the sheath introducer for covering the distal extremity of the folded sheath tube to prevent the distal extremity of the sheath tube from causing trauma to the vessel of the patient when the sheath tube is introduced into the vessel, means for securing said sleeve means on the elongate tubular member of the sheath introducer so that said sheath introducer can be pushed distally with respect to the sheath tube to cause the sleeve means to be removed from the distal extremity of the sheath tube to permit the same to expand and to push the larger proximal end of the introducer through the distal extremity of the sheath tube to expand the same.
Claim 13
Dependent Claim 43 words
An assembly as in Claim 10 wherein said means for securing the sleeve means on the elongate tubular member of the sheath introducer includes a length of shrink tubing extending over the sleeve means and having a diameter greater than the sleeve means.
Claim 14
Dependent Claim 34 words
An assembly as in Claim 11 together with means carried by the distal extremity of the sheath introducer to prevent the shrink tubing from being separated from the distal extremity of the sheath introducer.
Claim 15
Dependent Claim 48 words
An assembly as in Claim 10 wherein the sheath tube introducer has a proximal extremity which is of a greater diameter than the distal extremity to provide additional rigidity to the sheath tube introducer and for the purpose of dilating the folded distal extremity of the sheath tube.
Claim 16
Dependent Claim 64 words
A sheath tube introducer comprising a flexible elongate tubular member having proximal and distal extremities, a fitting carried by the proximal extremity, sleeve means secured to the distal extremity, said sleeve means having a proximal expandable portion and means carried by the distal extremity of said tubular member for preventing the sleeve means from being separated from the distal extremity of said tubular member.
Claim 17
Dependent Claim 64 words
A sheath tube introducer comprising a flexible elongate tubular member having proximal and distal extremities, a fitting carried by the proximal extremity, sleeve means secured to the distal extremity, said sleeve means having a proximal expandable portion and means carried by the distal extremity of said tubular member for preventing the sleeve means from being separated from the distal extremity of said tubular member.
Claim 18
Dependent Claim 39 words
A sheath introducer as in Claim 14 wherein said sleeve means is provided with a distal extremity together with means for securing the distal extremity of said sleeve means to the distal extremity of the flexible elongate tubular member.
Claim 19
Dependent Claim 60 words
A sheath introducer as in Claim 15 wherein said means for securing distal extremity of the sleeve means to the flexible elongate tubular member comprises a length of shrink tubing mounted on said sleeve means and engaging said means carried by the flexible elongate tubular member for preventing said sleeve means from being separated from said flexible elongate tubular member.
Claim 20
Dependent Claim 45 words
A sheath introducer as in Claim 14 wherein the proximal extremity of the flexible elongate tubular member is of greater diameter to provide additional rigidity to the flexible elongate tubular member and to provide a means of dilating the distal extremity of the sheath tube.
Claim 21
Dependent Claim 41 words
A sheath introducer as in Claim 14 wherein said tubular member has a flow passage therein together with an opening formed in said elongate tubular member proximal of the proximal extremity of the sleeve means and opening into said flow passage.
Claim 22
Dependent Claim 253 words
In a method for introducing an expandable sheath into the vessel in the body of a patient by the use of an expandable sheath having an elongate sheath tube with proximal and distal extremities and having a passage extending therethrough of maximum diameter and having a backflow adapter provided on the proximal extremity, and a sheath introducer having an elongate tubular member with proximal and distal extremities with an expandable sleeve mounted on the distal extremity, introducing the sheath introducer into the backflow adapter and into the sheath tube so that the distal extremity of the sheath introducer extends beyond the distal extremity of the sheath tube, folding the proximal extremity of the sheath tube longitudinally to wrap the same over the distal extremity of the sheath introducer, expanding the sleeve on the sheath introducer over the distal extremity of the folded sheath tube to thereby prevent the sheath tube from causing trauma to the wall of a vessel of the patient when it is introduced into the vessel of the patient, introducing the combination of the expandable sheath and the sheath introducer into the vessel of the patient, advancing the sheath introducer relative to the expandable sheath so that the sleeve is separated from the distal extremity of the sheath tube to permit the sheath tube to expand, further advancing the sheath introducer through the distal extremity of the sheath tube to cause further expansion of the distal extremity of the sheath tube, and removing the sheath introducer from the expandable sheath.
Claim 23
Dependent Claim 253 words
In a method for introducing an expandable sheath into the vessel in the body of a patient by the use of an expandable sheath having an elongate sheath tube with proximal and distal extremities and having a passage extending therethrough of maximum diameter and having a backflow adapter provided on the proximal extremity, and a sheath introducer having an elongate tubular member with proximal and distal extremities with an expandable sleeve mounted on the distal extremity, introducing the sheath introducer into the backflow adapter and into the sheath tube so that the distal extremity of the sheath introducer extends beyond the distal extremity of the sheath tube, folding the proximal extremity of the sheath tube longitudinally to wrap the same over the distal extremity of the sheath introducer, expanding the sleeve on the sheath introducer over the distal extremity of the folded sheath tube to thereby prevent the sheath tube from causing trauma to the wall of a vessel of the patient when it is introduced into the vessel of the patient, introducing the combination of the expandable sheath and the sheath introducer into the vessel of the patient, advancing the sheath introducer relative to the expandable sheath so that the sleeve is separated from the distal extremity of the sheath tube to permit the sheath tube to expand, further advancing the sheath introducer through the distal extremity of the sheath tube to cause further expansion of the distal extremity of the sheath tube, and removing the sheath introducer from the expandable sheath.

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