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Publication Number
US-7766973-B2
Publication Date
2010-08-03
Expiration Date
Abstract
The invention relates to improved means for preventing eversion and subsequent obstruction of thin-walled, floppy gastrointestinal liners implanted in the digestive tract of an animal. The implantable devices include an anchor adapted for attachment within a natural body lumen and a thin-walled, floppy sleeve open at both ends and defining a lumen therebetween. A substantial length of the sleeve has material characteristics that result in the sleeve being prone to eversion in the presence of retrograde pressures. Exemplary eversion-resistant features provide an increased stiffness and/or an increased friction coefficient between the anchor and the proximal end of the sleeve to resist eversion. In some embodiments, the eversion-resistant feature includes an anti-buckling element, such as a wire coupled along the substantial length of the sleeve.
Core Innovation
The invention relates to an implantable thin-walled floppy sleeve that is anchored within a natural body lumen and is prone to eversion under retrograde pressures, including concentric and eccentric eversion modes. The invention improves the sleeve by providing an eversion-resistant feature disposed only at the proximal end of the sleeve that inhibits eversion by collapsing radially in the presence of retrograde pressures.
The eversion-resistant feature comprises a proximal crumple zone and a distal reinforced region. The proximal crumple zone collapses radially toward the longitudinal axis of the anchor in the presence of retrograde pressures, and the distal reinforced region collapses radially but to a lesser extent than the crumple zone, thereby focusing collapse and limiting eversion of portions of the sleeve that extend beyond the eversion-resistant feature.
In certain configurations, the proximal crumple zone is shaped as a tapered cone having a proximal opening diameter larger than a distal opening diameter, where retrograde pressure causes distal opening movement proximally while preventing lateral movement toward the walls of the body lumen. The invention further distinguishes an eversion-threshold pressure for the eversion-resistant feature that is greater than that of the sleeve itself.
Claims Coverage
The consolidated claim set includes four independent claim themes, covering a device with a proximal anchor and thin-walled floppy sleeve, a proximal-only eversion-resistant feature, a proximal crumple zone with a distal reinforced region, and a method for inhibiting eversion. Across these claims, the inventive focus is the radial collapse of the proximal feature under retrograde pressures, with the crumple zone collapsing more than the distal reinforced region.
Proximal anchor with floppy eversion-prone sleeve
A device for implanting within an animal body comprising a proximal anchor adapted for attachment within a natural body lumen, a thin-walled sleeve open at both ends and defining a lumen therebetween, with a proximal end of the sleeve coupled to the anchor, and a substantial length of the sleeve being a floppy zone having material characteristics that result in the sleeve being prone to eversion.
Proximal eversion-resistant feature with radial collapse
An eversion-resistant feature of the sleeve disposed only at the proximal end of the sleeve that inhibits eversion of the sleeve by collapsing radially in the presence of retrograde pressures, with the floppy zone extending a substantial length of the sleeve beyond the eversion-resistant feature.
Crumple zone collapses more than distal reinforced region
The eversion-resistant feature comprising a proximal crumple zone of the sleeve that collapses radially in the presence of retrograde pressures, and a distal reinforced region of the sleeve between the crumple zone and the floppy zone that collapses radially, but to a lesser extent than the crumple zone, in the presence of retrograde pressures.
Proximal eversion-resistant feature with eversion-threshold pressure
Providing an eversion-resistant feature of a thin-walled sleeve only at a proximal end of the sleeve, the eversion-resistant feature having an eversion-threshold pressure greater than that of the sleeve itself, a floppy zone of the sleeve extending a substantial length of the sleeve beyond the eversion-resistant feature.
Anchoring and focusing collapse toward anchor axis
Anchoring, with an anchor, the proximal end of the sleeve with the eversion-resistant feature in the lumen, and focusing collapse of the eversion-resistant feature towards the longitudinal axis of the anchor by radially collapsing a proximal crumple zone of the sleeve in the presence of retrograde pressures.
Radially collapsing distal reinforced region to lesser extent
Radially collapsing a distal reinforcing region of the sleeve coupled to the proximal crumple zone of the sleeve in the presence of retrograde pressures, the distal reinforcing region collapsing to a lesser extent than the proximal crumple zone.
Eversion resisting means only at proximal end
A device for implanting within an animal body comprising means for anchoring a proximal end of the device within a natural body lumen, a thin-walled sleeve open at both ends and defining a lumen therebetween, a floppy zone of the sleeve having material characteristics that result in the sleeve being prone to evert proximally to the anchor, and eversion resisting means of the sleeve for resisting eversion of any portion of the sleeve proximally to the anchoring means by collapsing radially in the presence of retrograde pressures, the eversion resisting means being disposed only at a proximal end of the sleeve, a floppy zone of the sleeve extending a substantial length of the sleeve beyond the eversion resisting means.
Eversion resisting means comprising proximal crumple zone and distal reinforcing region
The eversion resisting means comprising a proximal crumple zone of the sleeve that collapses radially in the presence of retrograde pressures; and a distal reinforcing region of the sleeve coupled to the crumple zone, the reinforcing means collapsing radially, but to a lesser extent than the crumple zone, in the presence of retrograde pressures.
Eversion-resistant feature disposed between anchor and proximal end
A device for implanting within an animal body comprising an anchor adapted for attachment within a natural body lumen, a thin-walled, floppy sleeve open at both ends and defining a lumen therebetween, a substantial length of the sleeve having material characteristics that result in the sleeve being prone to eversion, and an eversion-resistant feature disposed between the anchor and the proximal end of the sleeve that inhibits eversion of the sleeve by collapsing radially in the presence of retrograde pressure.
Proximal crumple zone and distal reinforced region in eversion-resistant feature
The eversion-resistant feature comprising a proximal crumple zone of the sleeve that collapses in the presence of retrograde pressures; and a distal reinforced region of the sleeve between the crumple zone and the substantial length of the sleeve, the reinforcing means collapsing, but to a lesser extent than the crumple zone, in the presence of retrograde pressures.
Across the independent claims, the invention is directed to an implantable anchored thin-walled floppy sleeve with a proximal-only eversion-resistant feature that inhibits eversion by radially collapsing under retrograde pressures. The key mechanical distinction is that the proximal crumple zone collapses radially in the presence of retrograde pressures, while the distal reinforced region also collapses radially but to a lesser extent, thereby focusing collapse and resisting eversion.
Stated Advantages
Inhibits eversion of the sleeve by collapsing radially in the presence of retrograde pressures.
Helps resist eversion of any portion of the sleeve proximally to the anchoring means under retrograde pressures.
Distinguishes an eversion-resistant feature with an eversion-threshold pressure greater than that of the sleeve.
Focuses collapse of the eversion-resistant feature toward the longitudinal axis of the anchor.
Enables retrograde-pressure-dependent collapse in which the distal reinforced region collapses to a lesser extent than the proximal crumple zone, to inhibit eversion.
Documented Applications
Implanting within an animal body, where a thin-walled floppy sleeve is anchored in a natural body lumen and is prone to eversion under retrograde pressures, including concentric and eccentric eversion modes.
A method for inhibiting eversion of a sleeve device when implanted within a natural body lumen by providing and anchoring a proximal eversion-resistant feature and collapsing a proximal crumple zone and a distal reinforcing region under retrograde pressures.
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