Expandable sheath for introducing an endovascular delivery device into a body
First Claim
1. A sheath for introducing a prosthetic device into a body, comprising:
- a continuous inner layer defining a lumen therethrough, the inner layer having at least one folded portion; and
a discontinuous outer layer having an overlapping portion and an underlying portion, wherein the outer layer is configured so that the overlapping portion overlaps the underlying portion, wherein at least a portion of the folded portion of the inner tubular layer is positioned between the overlapping and underlying portions, and wherein at least a portion of the sheath is configured to expand to accommodate the prosthetic device;
wherein the sheath defines a longitudinal axis and a distal opening at the terminal distal end of the sheath, the distal opening facing in an axial direction extending along the longitudinal axis such that the prosthetic device can be advanced through the lumen and outwardly through the distal opening in the axial direction into the body;
wherein the at least a portion of the sheath is configured such that the sheath locally expands from a rest configuration in which the lumen has a first diameter to an expanded configuration in which the lumen has a second diameter that is larger than the first diameter due to an outwardly directed radial force exerted by the prosthetic device against the inner layer, and then locally contracts at least partially back to the rest configuration as the prosthetic device passes through the lumen.
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Accused Products
Abstract
Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.
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Citations
19 Claims
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1. A sheath for introducing a prosthetic device into a body, comprising:
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a continuous inner layer defining a lumen therethrough, the inner layer having at least one folded portion; and a discontinuous outer layer having an overlapping portion and an underlying portion, wherein the outer layer is configured so that the overlapping portion overlaps the underlying portion, wherein at least a portion of the folded portion of the inner tubular layer is positioned between the overlapping and underlying portions, and wherein at least a portion of the sheath is configured to expand to accommodate the prosthetic device; wherein the sheath defines a longitudinal axis and a distal opening at the terminal distal end of the sheath, the distal opening facing in an axial direction extending along the longitudinal axis such that the prosthetic device can be advanced through the lumen and outwardly through the distal opening in the axial direction into the body; wherein the at least a portion of the sheath is configured such that the sheath locally expands from a rest configuration in which the lumen has a first diameter to an expanded configuration in which the lumen has a second diameter that is larger than the first diameter due to an outwardly directed radial force exerted by the prosthetic device against the inner layer, and then locally contracts at least partially back to the rest configuration as the prosthetic device passes through the lumen. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 18, 19)
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16. A sheath for introducing a prosthetic device into a body, comprising:
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a continuous inner layer defining a lumen therethrough, the inner layer having at least one folded portion; and a discontinuous outer layer having an overlapping portion and an underlying portion, wherein the outer layer is configured so that the overlapping portion overlaps the underlying portion, wherein at least a portion of the folded portion of the inner tubular layer is positioned between the overlapping and underlying portions, and wherein at least a portion of the sheath is configured to expand to accommodate the prosthetic device; wherein the sheath defines a distal opening at the distal end of the sheath such that the prosthetic device can be advanced through the lumen and outwardly through the distal opening into the body; wherein the at least a portion of the sheath is configured such that the sheath locally expands from a rest configuration in which the lumen has a first diameter to an expanded configuration in which the lumen has a second diameter that is larger than the first diameter due to an outwardly directed radial force exerted by the prosthetic device against the inner layer, and then locally contracts at least partially back to the rest configuration as the prosthetic device passes through the lumen; wherein the inner layer comprises a circumferential portion having a substantially circular cross-sectional profile, the circumferential portion defining a longitudinally extending seam, the folded portion comprises a first fold portion and a second fold portion, the first and second fold portions extending radially outwardly from respective portions of the circumferential portion on opposite sides of the seam when the sheath is in the rest configuration. - View Dependent Claims (17)
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Specification