Method and devices for securing bidirectional suture loops using coaxial mechanical fasteners

Abstract

A method and apparatus for securing separate loops of suture with a coaxial mechanical fastener. Separate loops of suture extend from opposite ends of the mechanical fastener. A wire snare facilitates pulling the suture through the fastener. A suturing instrument provides for the infusion of pressurized physiologic solutions into the left ventricle so that the proper replacement suture length can be demonstrated real time prior to crimping the fastener. The instrument incorporates a slotted release site so that the fastener and suture can be released from the device tip once the fastener is secured. A method of securing suture coming from cardiac valve leaflets and or other structures like papillary muscles permits a more atraumatic orientation of the fastener coaxial with the suture strands.

1 . A method for connecting a papillary muscle and a leaflet of a valve in a chamber of the heart comprising:
 placing a first suture through the papillary muscle and holding the first suture in place;   attaching a second suture to the leaflet;   passing the first and second sutures through a mechanical fastener in opposite directions, so that the fastener is coaxially arranged on the sutures;   adjusting the length of at least one of the first and second sutures to configure the valve in a desired configuration; and   securing the first and second sutures with the fastener.   
     
     
         2 . The method of  claim 1  in which the step of securing the first and second sutures comprises securing the sutures inside the mechanical fastener. 
     
     
         3 . The method of  claim 2  in which the step of holding the first suture in place comprises pulling on a tail of the suture to hold the mechanical fastener near the papillary muscle. 
     
     
         4 . The method of  claim 3  in which the step of adjusting the length of one of the first and second sutures comprises applying tension to a tail of the second suture. 
     
     
         5 . The method of  claim 2  in which the first and second sutures comprise tails extending from the mechanical fastener and further comprising cutting the tails after securing the mechanical fastener. 
     
     
         6 . The method of  claim 1 , comprising, prior to the step of adjusting the length of one of the first and second sutures, the step of infusing a fluid into the chamber and causing the valve to close. 
     
     
         7 . A mechanical fastener for securing first and second loops of suture comprising:
 a crimpable cylindrical sleeve;   a first snare forming a first loop extending from the sleeve in a first direction and characterized by a first length;   a second snare forming a second loop longer than the first loop extending from the sleeve in a second direction.   
     
     
         8 . The mechanical fastener of  claim 7  in which the first and second snares comprise wire snares. 
     
     
         9 . The mechanical fastener of  claim 7  in which the first snare comprises a twisted tail. 
     
     
         10 . The mechanical fastener of  claim 9  in which the second snare comprises a twisted tall. 
     
     
         11 . The mechanical fastener of  claim 7  in which the comparable cylindrical sleeve comprises an annular lip, at one end. 
     
     
         12 . The mechanical fastener of  claim 10 , in which the twisted tail of the second snare passes through the cylindrical sleeve and an untwisted portion of the first snare passes through the cylindrical sleeve. 
     
     
         13 . The mechanical fastener of  claim 12 , in which the twisted tails of the first and second snares are attached to a pulling handle. 
     
     
         14 . A surgical suturing instrument comprising:
 a handle;   an actuator on the handle;   an elongated shaft extending distally from the handle;   a crimper disposed adjacent a distal end of the shaft and coupled to the actuator;   an infusion port disposed adjacent the crimper for delivering an infusing fluid to a surgical site; and   a fluid coupling disposed on the elongated shaft proximally from the port and fluidly connected thereto for receiving an infusing fluid at the coupling and delivering the fluid to a surgical site through the port.   
     
     
         15 . The surgical suturing instrument of  claim 14  comprising a suture cutter disposed proximately to the crimper. 
     
     
         16 . The surgical suturing instrument of  claim 14 , comprising a suture holder disposed on the shaft between the handle and the distal end of the shaft for temporarily holding a suture. 
     
     
         17 . The surgical suturing instrument of  claim 15  in which the suture cutter is coupled to the actuator, such that the cutter is actuated after the crimper is actuated. 
     
     
         18 . The surgical suturing instrument of  claim 17 , in which the crimper and the cutter are actuated by a single squeeze of the actuator. 
     
     
         19 . The surgical suturing instrument of  claim 17 , comprising a projection for positioning a suture for cutting. 
     
     
         20 . A mechanical fastener for securing first and second loops of suture comprising:
 a crimpable cylindrical sleeve having first and second ends;   a snare consisting of a single wire passing through the sleeve and forming a first loop extending from the first end of the sleeve, passing through the sleeve in the opposite direction looping around the sleeve and passing through the sleeve in the opposite direction a second time and forming a second loop, longer than the first loop and extending from the a second end of the sleeve, passing through the sleeve in the first direction and looping around the sleeve a second time; and   a tall formed from first and second ends of the snare such that when the tail is pulled, the first loop and then the second loop are pulled sequentially through the sleeve in the opposite directions.   
     
     
         21 . The mechanical fastener of  claim 20 , in which the first loop is longer than the second loop. 
     
     
         22 . The mechanical fastener of  claim 21  in which the portion of the snare forming the first loop is twisted as it passes through the cylindrical sleeve. 
     
     
         23 . The mechanical fastener of  claim 22  in which the ends of the snare are twisted together. 
     
     
         24 . The mechanical fastener of  claim 23  in which a pull is attached to the ends of the snare. 
     
     
         25 . A surgical suturing instrument comprising:
 a crimper having a cylindrical chamber for receiving a crimpable sleeve, the chamber surrounded by a wall having a first, proximal, portion surrounding the chamber and a second, distal, portion extending more than 180° but less than 360° around the chamber and forming a slot aligned longitudinally with the chamber; and   a hammer disposed within the wall engageable with a sleeve for crimping the sleeve.   
     
     
         26 . The surgical suturing instrument of  claim 25 , comprising an aperture extending through the wall and being radially displaced from the slot. 
     
     
         27 . The surgical suturing instrument of  claim 25 , comprising a second aperture aligned with and axially displaced from the first aperture. 
     
     
         28 . The surgical suturing instrument of  claim 27  comprising a projection extending inwardly from the wall between the first and second apertures. 
     
     
         29 . The surgical suturing instrument of  claim 28 , comprising a suture cutter disposed within the wall and aligned with the projection. 
     
     
         30 . A structure for connecting a leaflet of a heart valve to a papillary muscle comprising:
 a first suture loop attached to an end of a leaflet and having first and second suture tails extending therefrom;   a second suture loop attached to a papillary muscle and having third and fourth tails extending therefrom;   a malleable sleeve crimped coaxially on the first, second, third and fourth suture tails.