Devices and methods for placing a gastrointestinal device

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.

What is claimed is: 
     
         1 . A catheter handle for a delivery system of a gastrointestinal device, the catheter handle comprising:
 an inner catheter movable within the handle;   an elongated element within the handle, the element surrounding a portion of the inner catheter, an inner diameter of the element being about the same as or greater than an outer diameter of the inner catheter; and   a button on a side of the handle, the button configured to cause engagement of the inner catheter via the element when the button is depressed, thereby retaining the inner catheter within the handle.   
     
     
         2 . The catheter handle of  claim 1 , wherein the elongated element includes slots and the button includes ramped teeth aligned with the slots, and wherein the button is configured to cause the ramped teeth to engage the inner catheter via the slots when the button is depressed and press the inner catheter against the element, thereby retaining the inner catheter within the handle. 
     
     
         3 . The catheter handle of  claim 2 , wherein the slots are transverse slots spaced along a length of the elongated element on two sides of the element. 
     
     
         4 . The catheter handle of  claim 3 , wherein the slots on one side of the elongated element are offset from the slots on the other side of the element. 
     
     
         5 . The catheter handle of  claim 4 , wherein the slots are ramped, and wherein the ramped teeth and ramped slots define multiple complementary features. 
     
     
         6 . The catheter handle of any one of  claims 1 - 5 , further including a resilient element configured to non-plastically deform when the button is depressed and to provide a restoring force to cause the ramped teeth to disengage the inner catheter when the button is released. 
     
     
         7 . The catheter handle of  claim 1 , wherein the elongated element is a surround tube, and wherein the button is configured to bend the surround tube and non-plastically deform the inner catheter when the button is depressed, thereby retaining the inner catheter within the handle. 
     
     
         8 . The catheter handle of  claim 7 , wherein the surround tube comprises a silicone tube. 
     
     
         9 . The catheter handle of  claim 7  or  claim 8 , wherein the button comprises a rigid thermoplastic. 
     
     
         10 . The catheter handle of any one of  claims 7 - 9 , wherein the button bends the surround tube between ends of the surround tube, the ends being held in place by the handle. 
     
     
         11 . The catheter handle of  claim 1 , wherein the elongated element is a lever including a lever jaw, and wherein the button is configured to cause the lever to rotate about a pivot and the lever jaw to engage the inner catheter when the button is depressed, thereby retaining the inner catheter within the handle. 
     
     
         12 . The catheter handle of  claim 11 , wherein the lever defines a lumen through which the inner catheter extends. 
     
     
         13 . The catheter handle of  claim 11  or  claim 12 , wherein the lever is configured to translate a force with which the button is depressed into a force with which the inner catheter is engaged at an amplification ratio in the range of about 1:1 to about 2:1. 
     
     
         14 . The catheter handle of any one of  claims 11 - 13 , wherein the lever jaw includes directional teeth. 
     
     
         15 . The catheter handle of any one of  claims 11 - 14 , further including a resilient element configured to non-plastically deform when the button is depressed and to provide a restoring force to cause the lever jaw to disengage the inner catheter when the button is released. 
     
     
         16 . The catheter handle of any of  claims 1 - 15 , wherein the inner catheter comprises an inner extension catheter configured to draw a portion of a sleeve from an anchor and from a container assembly as the anchor is retained therein. 
     
     
         17 . A method of retaining an inner catheter for delivery of a gastrointestinal device, the method comprising:
 surrounding a portion of an inner catheter that is movably disposed within a handle with an elongated element within the handle;   depressing a button on a side of the handle, to engage the inner catheter via the elongated element; and   retaining the inner catheter within the handle based on the resulting engagement of the inner catheter.   
     
     
         18 . The method of  claim 17 , wherein the elongated element includes slots and the button includes 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 element. 
     
     
         19 . The method of  claim 17 , wherein the elongated element is a surround tube, and wherein depressing the button bends the surround tube and non-plastically deforms the inner catheter. 
     
     
         20 . The method of  claim 17 , wherein the elongated element is a lever including a lever jaw, and wherein depressing the button causes the lever to rotate about a pivot and the jaw of the lever to engage the inner catheter. 
     
     
         21 . The method of any one of  claims 17 - 20 , further comprising advancing the inner catheter retained within the handle into a lumen of an outer catheter. 
     
     
         22 . The method of  claim 21 , further comprising drawing a portion of a sleeve from an anchor, and from a container assembly, as the anchor is retained therein, using the inner catheter. 
     
     
         23 . A catheter handle for a delivery system of a gastrointestinal device, the catheter handle comprising:
 an inner catheter movable within the handle;   a lever positioned within the handle and including a lever jaw; and   a button on a side of the handle, the button configured to cause the lever to rotate about a pivot and the lever jaw to engage the inner catheter when the button is depressed, thereby retaining the inner catheter within the handle.   
     
     
         24 . A catheter handle for a delivery system of a gastrointestinal device, the catheter handle comprising:
 an inner catheter movable within the handle;   an elongated element within the handle, the element including slots; and   a button on a side of the handle, the button including ramped teeth aligned with the slots, the button configured to cause the ramped teeth to engage the inner catheter via the slots when the button is depressed, thereby retaining the inner catheter within the handle.   
     
     
         25 . A delivery system for placing a gastrointestinal device in a mammalian gastrointestinal tract, the system comprising:
 a container assembly;   a gastrointestinal implant device that includes a proximal end and a distal end stored within the container assembly, the proximal end including an anchor and the distal end including a floppy 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 comprising an atraumatic tip that comprises a guidewire rail.   
     
     
         26 . The delivery system of  claim 25 , wherein the inner extension comprises a catheter releasably secured to the distal end of the sleeve. 
     
     
         27 . The delivery system of  claim 25  or  claim 26 , wherein the atraumatic tip comprises a ball. 
     
     
         28 . The delivery system of any one of  claims 25 - 27 , wherein the guidewire rail comprises a channel that runs within the interior of the atraumatic tip. 
     
     
         29 . The delivery system of  claim 28 , wherein the guidewire rail runs from a distal center of the atraumatic tip to a proximal off-center side of the atraumatic tip. 
     
     
         30 . A method for placing a gastrointestinal device in a mammalian gastrointestinal tract, the method comprising:
 guiding a delivery system over a guidewire within the gastrointestinal tract by advancing an atraumatic tip over the guidewire as the guidewire runs through a guidewire rail of the atraumatic tip; and   drawing the gastrointestinal device out of a container assembly using an inner extension from the container assembly, the inner extension comprising the atraumatic tip at a distal end of the inner extension.   
     
     
         31 . The method of  claim 30 , wherein the inner extension comprises a catheter releasably secured to the distal end of the gastrointestinal device. 
     
     
         32 . The method of  claim 30  or  claim 31 , wherein the atraumatic tip comprises a ball. 
     
     
         33 . The method of any one of  claims 30 - 32 , wherein the guidewire rail comprises a channel that runs within the interior of the atraumatic tip. 
     
     
         34 . The method of  claim 33 , wherein the guidewire rail runs from a distal center of the atraumatic tip to a proximal off-center side of the atraumatic tip.