Natural orifice transluminal endoscopic devices for closure of luminal perforations and associated methods

Abstract

Devices include at least two spaced apart flexible legs formed of a shape memory material, each leg having a respective free end configured to engage local tissue. The devices can also include at least one resilient member having opposing end portions, a respective end portion being attached to each leg at a location away from the free end. The resilient member is configured to take on a stretched configuration inside an endoscope during delivery. Alternatively or additionally, the devices include a cinch that is configured to snugly hold portions of both legs to force the legs closer together.

That which is claimed is: 
     
         1 . A natural orifice transluminal endoscope surgical method, comprising:
 providing an endoscope with a device comprising a resilient crown that is fixedly attached to at least two flexible legs, each leg having a respective free end, each leg formed of shape memory material held in a straight linear shape in a longitudinal direction to a free end thereof in the endoscope with the resilient crown held in a stretched state;   inserting the endoscope in a natural orifice of a patient to carry out a natural orifice transluminal surgery; then   deploying the legs from the endoscope whereby the legs return to a pre-formed curvilinear configuration;   attaching the legs to target tissue; and   pulling the legs closer together to pull the target tissue closer together.   
     
     
         2 . The method of  claim 1 , wherein the deploying step is carried out to implant the device so that the free end portions of the legs face the endoscope and reside against or in tissue in a side of a hollow visceral wall opposing a side that the endoscope is located on. 
     
     
         3 . The method of  claim 1 , wherein the deploying step is carried out to implant the device so that the free end portions of the legs face away from the endoscope to close a mucosal defect or to treat GI bleeding. 
     
     
         4 . The method of  claim 1 , wherein the device has a cinch that resides entirely between the free ends of the legs and the crown of the device, and the cinch, while held on the legs, is entirely deployable from the endoscope, and wherein the pulling step is carried out by sliding the cinch toward the free ends of the legs or by sliding the legs inside the cinch away from the target tissue to force the legs closer together. 
     
     
         5 . A natural orifice transluminal endoscope surgical method, comprising:
 providing an endoscope with a device comprising a resilient crown held in a stretched state fixedly attached to at least two flexible legs, each leg having a respective free end, each leg formed of shape memory material held in a linear shape in an endoscope;   inserting the endoscope in a natural orifice of a patient to carry out a natural orifice transluminal surgery; then   deploying the legs of the device from the endoscope whereby the legs return to a pre-formed curvilinear configuration;   attaching the legs of the device to target tissue; and   pulling the legs of the device closer together to pull the respective target tissue closer together,   wherein the pulling step is carried out by releasing the resilient member from the stretched configuration to automatically return to a shorter length thereby pulling the legs closer together.   
     
     
         6 . A medical device, comprising:
 at least two spaced apart flexible legs comprising a shape memory material, each leg having a respective free end configured to engage local tissue; and   a cinch configured to be able to slidably advance along the legs to snugly hold portions of both legs to force the at least two legs closer together as the cinch is moved toward the free ends,   wherein the device comprises a continuous length of a shape memory material that is pre-shaped to have the at least two legs in a curvilinear shape and to form an intermediate crown extending between at least two of the at least two legs, and wherein the cinch is sized and shaped to reside entirely between the free ends and the crown of the device when the device with the cinch is deployed as an implantable unit from an endoscope lumen.   
     
     
         7 . The device of  claim 6 , wherein the crown has a cinch retention shape that resides outside the cinch on a side opposing the free ends of the legs. 
     
     
         8 . The device of  claim 6 , further comprising:
 a sheath configured to enclose the device and reside inside an endoscope lumen; and   at least one elongate structure attached to the device to be able to slidably deploy the device from the endoscope lumen.   
     
     
         9 . The device of  claim 8 , wherein a distal end portion of the sheath is configured to slidably exit the endoscope lumen while holding at least a portion of the device therein. 
     
     
         10 . The device of  claim 6 , in combination with an endoscope, wherein the intermediate crown is resilient, and wherein a tripod attachment structure releasbly holds the device at three spaced apart locations inside a lumen of the endoscope so that the crown is held in a “V” shape. 
     
     
         11 . The device of  claim 10 , wherein the three spaced apart locations of the tripod attachment structure concurrently release the device after the legs of the device engage target tissue so that upon deployment from the lumen of the endoscope, the crown automatically pulls the legs closer together. 
     
     
         12 . The device of  claim 10 , wherein the cinch is configured to snugly hold a length of the legs of the device close together inside the lumen of the endoscope. 
     
     
         13 . The device of  claim 6 , in combination with an endoscope having a lumen, wherein the at least two legs of the device are first and second legs with the resilient crown and cinch are slidably deployable from the lumen as the implantable unit, wherein elongate structures releasably engage the device in the lumen so that a first elongate structure is releasably attached to the cinch and a second elongate structure which is configured as a tripod attachment structure, is releasably attached to the crown and to each of the first and second leg to slidably advance the first and second legs out of the lumen of the endoscope in advance of the cinch. 
     
     
         14 . The device of  claim 9 , wherein, when deployed from the lumen of the endoscope, the free end portions of the legs face the endoscope and reside against or in tissue in a side of a hollow visceral wall opposing a side that the endoscope is located on. 
     
     
         15 . The device of  claim 9 , wherein, when deployed from the endoscope, the free end portions of the legs face away from the endoscope. 
     
     
         16 . The device of  claim 6 , wherein the crown extends laterally substantially straight across a space between two of the at least two legs.