EXPANDABLE TRANSAPICAL SHEATH AND METHOD OF USE
First Claim
1. A method of introducing catheters into a ventricle of a heart, the method comprising the steps of:
- inserting a guidewire into the heart through a puncture in the myocardium and routing the guidewire to a target region of the cardiovascular system;
inserting a collapsed sheath with a dilator pre-inserted, over the guidewire and into the vasculature,radially expanding an expandable region of the sheath so that the expandable region radially dilates the myocardium and forms a lining inside the myocardium;
performing therapy or diagnosis at the target region through the expanded sheath; and
removing the sheath from the heart.
2 Assignments
0 Petitions
Accused Products
Abstract
Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, small cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of implant delivery catheters. The access route is through the ventricular myocardium, more specifically at the left ventricular apex, into the aortic root. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device, which is removed prior to the introduction of implant delivery catheters. In an exemplary application, the sheath includes a supported proximal end, a supported distal end, and a collapsible center section. Certain configurations of the sheath are capable of being inserted in a first, small cross-sectional configuration, being expanded diametrically to a second, larger cross-sectional configuration, and then being reduced to a diametrically small size for removal.
133 Citations
75 Claims
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1. A method of introducing catheters into a ventricle of a heart, the method comprising the steps of:
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inserting a guidewire into the heart through a puncture in the myocardium and routing the guidewire to a target region of the cardiovascular system; inserting a collapsed sheath with a dilator pre-inserted, over the guidewire and into the vasculature, radially expanding an expandable region of the sheath so that the expandable region radially dilates the myocardium and forms a lining inside the myocardium; performing therapy or diagnosis at the target region through the expanded sheath; and removing the sheath from the heart. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13)
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12. An endovascular transapical catheter for providing access to a patient'"'"'s heart through a puncture in the myocardium;
- the catheter comprising;
a sheath having a distal portion, a proximal portion and a lumen extending therebetween, the proximal portion adapted to extend out of the patient and the distal portion adapted to extend through a puncture in the myocardium into a ventricle of the heart;
the sheath comprising at least one diametrically expandable region that comprises a malleable reinforcement structure configured to maintain the at least one diametrically expandable region in a first cross-sectional configuration in which the at least one diametrically expandable region is longitudinally folded into a reduced cross-sectional profile and can be expanded into a second cross-sectional configuration in which the at least one diametrically expanded region is unfolded larger cross-sectional profile; anda hub coupled to the sheath at its proximal end. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
- the catheter comprising;
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25. An introducer sheath adapted for access to an internal chamber of a heart of a patient by way of a myocardial puncture comprising:
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An axially elongate sheath tube having a proximal end, a distal end, and a lumen extending therethrough, wherein the sheath tube comprises a collapsible region and further wherein the sheath working length is sufficiently long that the sheath tube can extend from an outside surface of the myocardium, through a myocardial access incision to a treatment site within or near the heart; A hub affixed to the proximal end of the axially elongate sheath tube, wherein the hub further comprises a hemostasis valve operably connected to the lumen extending through the sheath; and A dilator pre-inserted through the lumen in the axially elongate sheath tube, wherein the dilator comprises a length of dilator tubing, a hub comprising a balloon inflation port and a guidewire access port further comprising a hemostasis valve, and a non-compliant balloon, which is deflated and folded about the dilator tubing to form a minimum profile; Wherein the dilator is operable to expand the sheath collapsible region from a first, radially collapsed cross-sectional area to a second, larger, radially expanded cross-sectional area. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33)
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34. A method of performing a surgical procedure in a patient'"'"'s heart or major blood vessels, the method comprising:
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performing a surgical access through the myocardium of a patient'"'"'s heart; advancing a distal end of a sheath into an internal chamber of the patient'"'"'s heart, wherein the sheath comprises a hub, a distal, expandable region, an internal dilator and a distal fairing, further wherein the distal, expandable region of the sheath is longitudinally folded into a first, smaller cross-sectional profile; advancing the distal portion of the sheath to a treatment site; pressurizing the internal dilator; expanding a distal portion of the sheath to a second, larger cross-sectional profile such that the malleable reinforcing structure is unfolded and the distal portion forms a tubular structure further comprising a central lumen that is substantially constant along the entire length of the sheath; performing therapy or diagnosis through the expanded distal portion of the sheath by way of at least one catheter inserted through the sheath; removing the at least one catheter from the sheath; and removing the sheath from the heart. - View Dependent Claims (35, 36, 37, 38)
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39. An introduction sheath adapted for guiding catheters into the cardiac chambers of a patient by way of a ventricular apex access comprising:
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An axially elongate sheath tube having a proximal end, a distal end, and a main lumen extending therethrough, wherein the axially elongate sheath tube comprises a collapsible region along a portion of its length extending to the distal end of the sheath tube, further wherein the collapsible region has a first, smaller, cross-section prior to expansion, a second, larger cross-section following expansion, and a third, smaller cross-section following re-collapse; A removable dilator disposed within the main lumen of the sheath tube, wherein the dilator is configured to expand the collapsed region in response to pressurization from a source external to the proximal end of the dilator; An outer sheath jacket sealed proximate the proximal and distal ends of the sheath; and An inflation lumen for introducing pressurized fluid between the sheath and outer jacket layer, wherein the inflation lumen is operably coupled to a pressurization port proximate the proximal end of the introduction sheath; Wherein pressurization of the region between the sheath and outer jacket layer exerts inward pressure to collapse the collapsible region of the sheath from the second, larger cross-sectional area to the third, smaller cross-sectional area. - View Dependent Claims (40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55)
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56. An introduction sheath adapted for guiding catheters into the ventricles or other cardiac chambers by way of a myocardial access comprising:
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An axially elongate sheath tube having a proximal end, a distal end, and a main lumen extending therethrough, wherein the axially elongate sheath tube comprises a collapsible region along a portion of its length extending to the distal end of the sheath tube, further wherein the collapsible region has a first, smaller, cross-section prior to expansion, a second, larger cross-section following expansion, and a third, smaller cross-section following re-collapse, and wherein the collapsible region comprises a malleable reinforcement sandwiched within sheath tube polymeric layers; A removable dilator disposed within the main lumen of the sheath tube, wherein the dilator is configured to expand the collapsed region in response to pressurization from a source external to the proximal end of the dilator; and An outer sheath jacket comprising two layers in which the inner jacket layer and the outer jacket layer are sealed to each other at a location proximate the proximal and distal ends of the sheath, a proximal portion of the inner and outer jacket layers being operably connected to an inflation lumen for introducing pressurized fluid between the inner and outer jacket layers; Wherein pressurization of the region between the inner jacket layer and the outer jacket layer exerts inward pressure to collapse the collapsible region of the sheath from the second, larger cross-sectional area to the third, smaller cross-sectional area. - View Dependent Claims (57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73)
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74. An introducer sheath adapted for access to a treatment site within the heart or major blood vessels via a transmyocardial acess comprising:
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An axially elongate sheath tube having a proximal end, a distal end, and a lumen extending therethrough, wherein the sheath tube comprises a collapsible region and further wherein the sheath working length is sufficiently long that the sheath tube can extend from the outside of a myocardium of a patient'"'"'s heart, through the myocardium, and through the cardiac chambers to a point residing within or proximate the heart, further wherein the collapsible region comprises a first, smaller cross-sectional area, and a second, larger cross-sectional area in response to dilation; A hub affixed to the proximal end of the axially elongate sheath tube, wherein the hub further comprises a hemostasis valve operably connected to the lumen extending through the sheath; A dilator pre-inserted through the lumen in the axially elongate sheath tube, wherein the dilator comprises a length of dilator tubing, a hub comprising a balloon inflation port and a guidewire access port further comprising a hemostasis valve, and a non-compliant balloon, which is deflated and folded about the dilator tubing to form a minimum profile; and A reverse dilator, removably placeable within the lumen of the axially elongate sheath tube following expansion of the collapsible region and removal of the dilator, wherein the reverse dilator comprises proximal and distal balloons, a reverse dilator tube further comprising inflation lumens for the proximal and distal balloons, a vacuum lumen operably connected to the region between the two balloons by vacuum ports in the reverse dilator tube, and a hub affixed to the proximal end of the reverse dilator further comprising ports for infusion or removal of pressurized fluid into the inflation lumens of the reverse dilator and for generating a vacuum between the proximal and distal balloons; Wherein the dilator is operable to expand the sheath collapsible region from a first, radially collapsed cross-sectional area to a second, larger, radially expanded cross-sectional area; and Further wherein the reverse dilator is configured to have its proximal and distal balloons expanded to seal against the lumen of the sheath tube such that the vacuum drawn between the proximal and distal balloons of the reverse dilator causes re-collapse of the collapsible portion of the sheath from the second, larger cross-sectional area to a third, smaller cross-sectional area. - View Dependent Claims (75)
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Specification