Methods, devices and systems for approximation and fastening of soft tissue

Abstract

Devices and tissue fasteners for approximating and fastening tissue using minimally invasive techniques are disclosed. Methods for approximating and fastening tissue by application of one or more tissue fasteners are also provided. In one embodiment, spaced apart tissue locations are engaged by tissue penetrating members of a deformable fastener, one of more of the engaged tissue locations is moved toward another engaged tissue location to approximate the spaced apart locations, and the deformable fastener is deployed to secure the approximated tissue locations. These methods may be used in laparoscopic plication gastroplasty procedures for forming an invaginated tissue fold, to close holes in the gastrointestinal lumen, and in a variety of interventional procedures.

We claim: 
     
         1 . A device for approximating and fastening tissue comprising a proximal handle assembly, an elongate shaft assembly, and a distal tool assembly, actuatable from said handle assembly, wherein said distal tool assembly further comprises at least two tissue engagement mechanisms capable of engaging tissue at each of two or more spaced-apart tissue locations on a tissue surface and then moving at least one of said spaced-apart tissue locations toward another of said spaced-apart tissue locations to approximate said engaged tissue locations near the distal end of the device, and at least one fastener deployment mechanism capable of delivering one or more tissue fasteners to secure the engaged tissue locations in the approximated configuration. 
     
     
         2 . A device for approximating and fastening tissue comprising a proximal handle assembly, an elongate shaft assembly, and a distal tool assembly actuatable from said handle assembly in at least a first actuation step and a second actuation step, wherein said distal tool assembly further comprises at least two tissue engagement mechanisms and at least one fastener deployment mechanism capable of delivering one or more tissue fasteners, wherein:
 (a) during operation of said device, said tissue engagement mechanisms are reconfigurable from a pre-deployed, collapsed configuration to a deployed, expanded configuration capable of engaging tissue at each of two or more spaced apart locations on a tissue surface; and   (b) upon the first actuation step, at least one of said tissue engagement mechanisms, engaging a first tissue location, is repositioned by moving it toward another of said tissue engagement mechanisms, engaging a second tissue location, thereby approximating the first and second tissue locations near the distal end of the device; and   (c) upon the second actuation step, said fastener deployment mechanism delivers one or more tissue fasteners to secure the first and second tissue locations in the approximated configuration.   
     
     
         3 . A device of  claim 1  wherein the tissue engagement mechanisms are selected from the group consisting of needles, hooks, barbs, clamps, grippers, forceps, jaws, teeth, vacuum ports, t-tags, expandable anchors, and combinations of the foregoing. 
     
     
         4 . A device of  claim 1  wherein the tissue engagement mechanisms are configured to penetrate completely through the tissue during tissue engagement. 
     
     
         5 . A device of  claim 1 , wherein the tissue engagement mechanisms are configured to penetrate partially through the tissue during tissue engagement. 
     
     
         6 . A device of  claim 1  wherein the tissue fasteners are selected from the group consisting of sutures, staples, screws, tacks, clips, hooks, clamps, rivets, t-tags, expandable anchors, and combinations of the foregoing. 
     
     
         7 . A device of  claim 1  wherein the tissue engagement mechanisms and the tissue fastener deployment mechanism are provided as an integrated assembly. 
     
     
         8 . The device of  claim 1 , wherein the one or more tissue fasteners are box-type staples and the tissue engagement mechanisms are configured as opposing legs of the staples. 
     
     
         9 . A device of  claim 1  wherein the tissue engagement mechanisms are adjustable between an initial collapsed, pre-deployed configuration for insertion into the patient, and upon actuation by the user, are reconfigurable to an expanded, deployed configuration in which the tissue engagement mechanisms are exposed and positioned appropriately to contact and engage tissue at two or more spaced apart locations on a tissue surface. 
     
     
         10 . A device of  claim 1  wherein at least one of the tissue engagement mechanisms is fixedly positioned in proximity to a distal end of the device. 
     
     
         11 . A device of  claim 1  wherein at least one tissue engagement mechanism is fixedly positioned in proximity to a distal end of one or more movable members configured as part of the distal tool assembly, and wherein at least a distal end of said one or more movable members is capable of moving away from the longitudinal axis of the device to engage tissue. 
     
     
         12 . A device of  claim 11  wherein at least a portion of one or more of the tissue engagement mechanisms, or at least a portion of one or more of the moveable members, are configured to be brought together, joined, mated, or otherwise fixedly held in proximity to one another to form an assembly, and the assembly is releasably detachable from the device after the tissue locations have been approximated, remaining implanted in the tissue to secure the tissue in the approximated configuration. 
     
     
         13 . A device of  claim 1  wherein the elongate shaft assembly has a property selected from the group consisting of rigid, flexible, articulating, and combinations of the foregoing. 
     
     
         14 . A tissue fastener used to secure two or more approximated tissue locations in the approximated configuration, said fastener comprising a staple deformable from a pre-deployed, open configuration to a deployed, closed configuration in which said closed configuration is a polygonal-shaped loop having a maximum width dimension along a direction substantially perpendicular to the longitudinal axis of the device that is positioned in proximity to the distal-most end of the fastener. 
     
     
         15 . A tissue fastener of  claim 14  in which, in the deployed, closed configuration, the overall length dimension along a direction substantially parallel to the longitudinal axis of the device is greater than the maximum width dimension along a direction substantially perpendicular to the longitudinal axis of the device. 
     
     
         16 . A method for approximating and fastening tissue comprising sequentially: positioning a distal tool assembly configured to deploy at least one deformable staple having two or more tissue penetrating members in proximity to a serosal tissue surface; engaging serosal tissue at a first tissue engagement location with a first tissue penetrating member of a first deformable staple; repositioning at least one of the first tissue engagement location and a second serosal tissue engagement location spaced apart from the first tissue engagement location, wherein the first and second tissue engagement locations are spaced apart further than the distance between the tissue penetrating members prior to the repositioning, and where the repositioning is accomplished by moving at least one of the first and second tissue engagement locations toward one another, thereby approximating the first and second tissue engagement locations and forming an invaginated tissue fold in which opposing serosal tissue surfaces are located within the fold and are in intimate contact; and delivering the two or more tissue penetrating members of the deformable staple into the approximated tissue to secure the tissue engagement locations in the approximated configuration. 
     
     
         17 . The method of  claim 16 , wherein the tissue penetrating members are configured as opposing legs of the deformable staple. 
     
     
         18 . A method for approximating and fastening tissue comprising sequentially: positioning a distal tool assembly configured to deploy at least one tissue fastener having two or more tissue penetrating members in proximity to a tissue surface; piercing serosal tissue at a first tissue engagement location with one of the tissue penetrating members; repositioning at least one of the first tissue engagement location and a second tissue engagement location spaced apart from the first tissue engagement location with respect to one another, thereby approximating the first tissue and second tissue engagement locations and forming an invaginated tissue fold projecting away from the distal tool assembly; piercing serosal tissue at the second tissue engagement location with another of the tissue penetrating members; and delivering the at least one tissue fastener into approximated first and second tissue engagement locations to secure the tissue engagement locations in the approximated configuration, thereby securing the invaginated tissue fold. 
     
     
         19 . The method of  claim 18 , wherein the first and second tissue engagement locations are spaced apart further than the distance between the tissue penetrating members. 
     
     
         20 . The method of  claim 18 , performed without removing the device from its position in proximity to the tissue surface.