Devices and methods for placing a gastrointestinal device
Inventors
Loper, James • Hanlon, Ryan • Chamorro, III, Andres
Assignees
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Publication Number
US-11931279-B2
Publication Date
2024-03-19
Expiration Date
Abstract
A delivery system for placing a gastrointestinal device in a mammalian gastrointestinal tract comprises a container assembly; a gastrointestinal implant device that includes proximal and distal ends stored within the container assembly, the proximal end including an anchor and the distal end including a sleeve, coupled to the anchor and folded into the container assembly; and an inner extension to draw a portion of the sleeve from the anchor and from the container assembly as the anchor is retained therein. The inner extension comprises an atraumatic tip, such as a ball, that includes a guidewire rail. Further, a handle is provided that retains or captures an inner catheter within the handle. Within the handle is an elongated element that surrounds a portion of the catheter. A button on a side of the handle is configured to cause engagement of the catheter via the element when the button is depressed.
Core Innovation
The invention relates to a gastrointestinal implant delivery system that includes a container assembly for holding an implant device and an implant deployment mechanism that draws a gastrointestinal sleeve from an anchor while the anchor is retained. The system includes an inner extension or inner catheter with an atraumatic tip that draws the sleeve from the anchor or container assembly as the anchor is retained, coordinating sleeve drawing with anchor retention.
A catheter handle for the delivery system includes an inner catheter movable within the handle and an elongated element within the handle that surrounds a portion of the inner catheter. A side button is configured so that depressing the button causes engagement of the inner catheter via the elongated element, with the engagement mechanism retaining the inner catheter within the handle.
In one engagement configuration, the elongated element comprises slots and the button comprises ramped teeth aligned with the slots, so depressing the button drives the ramped teeth to engage the inner catheter via the slots and press the inner catheter against the elongated element for retention. In alternative configurations, the elongated element is a surround tube that bends to non-plastically deform the inner catheter, or a lever including a lever jaw that rotates about a pivot so the jaw engages the inner catheter.
Claims Coverage
The document provides three independent claims. They share a common inventive theme: a button-actuated catheter handle mechanism with an elongated element that engages and retains an inner catheter for delivery of a gastrointestinal device, implemented using slot-and-ramped-teeth, surround-tube non-plastic deformation, and lever/jaw rotation; the method also includes advancing into an outer catheter lumen and drawing a sleeve.
Slots aligned with ramped teeth retaining an inner catheter in a handle
An elongated element within the handle comprises slots, and a button comprises ramped teeth aligned with the slots, wherein depressing the button causes the ramped teeth to engage the inner catheter via the slots and press the inner catheter against the elongated element, thereby retaining the inner catheter within the handle.
Surround tube non-plastically deforming an inner catheter upon button depression
The elongated element is a surround tube, wherein depressing the button bends the surround tube and non-plastically deforms the inner catheter.
Lever jaw rotating about a pivot to engage an inner catheter
The elongated element is a lever including a lever jaw, wherein depressing the button causes the lever to rotate about a pivot and the jaw of the lever to engage the inner catheter.
Advancing a retained inner catheter into an outer catheter lumen
Advancing the inner catheter retained within the handle into a lumen of an outer catheter.
Drawing a sleeve from an anchor/container assembly using the inner catheter
Drawing a portion of the sleeve from an anchor and from a container assembly while the anchor is retained therein, using the inner catheter.
Across the independent claims, the handle retention and engagement are implemented by a button-depressed mechanism that retains a movable inner catheter using slot-and-ramped-teeth engagement, a surround tube that bends and non-plastically deforms the inner catheter, or a lever jaw that rotates about a pivot to engage the inner catheter. The method claim further includes advancing the retained inner catheter into an outer catheter lumen and a sleeve-drawing step from an anchor/container assembly while the anchor is retained.
Stated Advantages
Reduces required force during engagement.
Reduces chatter marks during engagement.
Documented Applications
Delivery of a gastrointestinal device using a delivery system that retains an inner catheter and deploys or draws a gastrointestinal sleeve while an anchor is retained.
Drawing a sleeve from an anchor/container assembly using the inner catheter while the anchor is retained.
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