Devices and methods for performing vascular anastomosis

Abstract

Devices and methods for performing vascular anastomosis. A needle passer is used to pass one or more needles through tissue to thread one or more lengths of suture through the tissue. The needle passer is operable using one hand and includes a handle supporting a shaft assembly carrying first and second sets of needles connected by lengths of suture. An actuator assembly uncovers the first set of needles, moves them into a radially extended position, and then passes them through tissue, for example, the wall of a patient's aorta. The needle passer may be pistol-shaped with a trigger that is moved in one direction to sequentially uncover, radially extend, and move the first set of needles through the aorta around an aortotomy. The needles may then be pulled away from the patient to thread the suture through the tissue. A delivery device is used to deliver a member adapted to be secure to body tissue, such as a vascular conduit. The delivery device includes a shaft and a collar mounted for relative movement. The shaft supports a vascular conduit so that an end of the conduit is disposed against the collar. A sealing element may be positioned on the collar beneath the end of the conduit. The needles in the second set are removed from the needle passer and are placed through the conduit and sealing element and into the collar. The shaft is then moved through the collar to move the vascular conduit along the suture into contact with the aorta. The delivery device is then removed and the respective ends of each suture length secured to fix the end of the vascular conduit to the aorta.

What is claimed is:  
     
         1 . A device for passing at least one needle through tissue, the device comprising: 
 a handle;    a shaft assembly including a shaft movably coupled to the handle, at least one needle removably supported by the shaft and movable between radially extended and non-extended positions, and a protective cover overlying at least a portion of the shaft and needle when the needle is in said radially non-extended position, the cover being movable with respect to the shaft to allow the needle to move to said radially extended position; and    an actuator assembly operable using one hand for moving the cover to allow the needle to assume said radially extended position and moving the shaft to pass the needle through the tissue.    
     
     
         2 . The device of  claim 1 , wherein the shaft assembly comprises a ram slidably disposed over the shaft for moving the needle into said radially extended position, and the protective cover is slidably disposed over the ram.  
     
     
         3 . The device of  claim 2 , wherein the actuator assembly comprises a linkage coupled to a movable component, and movement of the movable component drives the linkage and moves the protective cover to allow the needle to assume said radially extended position, moves the ram to force the needle into said radially extended position, and moves the shaft to pass the needle through the tissue.  
     
     
         4 . The device of  claim 3 , wherein the shaft comprises a solid rod, the ram comprises a first sleeve coaxially disposed over the solid rod, and the protective cover comprises a second sleeve coaxially disposed over the first sleeve.  
     
     
         5 . The device of  claim 1 , wherein the shaft has proximal and distal ends, and the needle is supported at the distal end of the shaft.  
     
     
         6 . The device of  claim 1 , further comprising at least one length of suture having two ends, one end being secured to the needle and the other end being removably supported by the shaft assembly.  
     
     
         7 . The device of  claim 6 , wherein a first plurality of needles are removably supported adjacent the distal end of the shaft, and wherein one end of each of a plurality of lengths of sutures is secured to one of the needles, while the other end of each length of suture is removably supported by the shaft assembly.  
     
     
         8 . The device of  claim 7 , further comprising a suture supporting member disposed on the shaft assembly, wherein the other end of each length of suture is removably supported by the suture supporting member.  
     
     
         9 . The device of  claim 8 , wherein the suture supporting member comprises an inner sleeve having channels each of which receives a length of suture, and an outer tube disposed around the inner sleeve to enclose each length of suture in one of said channels  
     
     
         10 . The device of  claim 8 , wherein the suture supporting member is fixed to the handle assembly and has a distal end provided with a foot for contacting the tissue.  
     
     
         11 . The device of  claim 10 , wherein the foot has a plurality of slots receiving the lengths of suture and the needles after the needles have passed through the tissue.  
     
     
         12 . The device of  claim 7 , further comprising a second plurality of needles each of which is secured to the other end of one of the lengths of suture, wherein each of the second plurality of needles is removably supported by the shaft assembly.  
     
     
         13 . The device of  claim 1 , further comprising a needle guard disposed around the needle when the needle is in said radially extended and non-extended positions.  
     
     
         14 . The device of  claim 13 , wherein the needle guard comprises a cage disposed around the needle and movable between expanded and collapsed orientations.  
     
     
         15 . The device of  claim 14 , wherein the cage comprises a plurality of flexible struts having one end secured to the shaft and another end secured to a ram sidably disposed over the shaft, wherein sliding the ram with respect to the shaft moves the needle into said radially extended position and moves the cage into said expanded orientation.  
     
     
         16 . The device of  claim 1 , wherein the handle assembly is generally pistol shaped and the actuator assembly comprises a trigger slidably mounted on the handle assembly.  
     
     
         17 . The device of  claim 16 , wherein the trigger is movable in one direction to move the cover and the shaft, and the actuator assembly is provided with a mechanism preventing movement of the trigger in a different direction.  
     
     
         18 . The device of  claim 1 , wherein the shaft assembly is substantially straight over the length thereof.  
     
     
         19 . The device of  claim 1 , wherein the shaft assembly comprises a proximal portion adjacent the handle assembly and a distal portion, and the distal portion is angled with respect to the proximal portion.  
     
     
         20 . A device for passing at least one needle and at least one length of suture through tissue in a patient's body, the device comprising: 
 a handle;    a shaft assembly supporting at least one needle and at least one length of suture, the needle being movable between radially extended and non-extended positions, wherein one end of the length of suture is secured to the needles and the other end of the length of suture is located away from the needle;    a ram movable from a first position to a second position in order to force the needle to said radially extended position;    an actuator assembly operable using one hand to move the ram to said second position to force the needle into said radially extended position and to pass the needle through tissue.    
     
     
         21 . A device for passing a plurality of needles and a plurality of separate lengths of suture through tissue in a patient's body, the device comprising: 
 a handle;    a shaft assembly supporting a plurality of needles and a plurality of separate lengths of sutures, the shaft assembly having a distal portion configured to be positioned adjacent tissue of a patient's body through which the needles are to be passed, wherein the needles are located adjacent the distal portion of the shaft assembly and are movable between an extended position and a non-extended position, and one end of each length of suture is secured to one of the needles and the other end of each length of suture is located away from the needles; and    an actuator assembly operable to pass the needles through tissue.    
     
     
         22 . The device of  claim 21 , wherein the shaft assembly includes a shaft to which the needles are mounted so as to be movable in a radial direction between said extended and non-extended positions, and the actuator is operable to move the shaft and pass the needles through tissue.  
     
     
         23 . The device of  claim 22 , wherein the shaft assembly comprises a ram slidably disposed over the shaft for moving the needles into said radially extended position, and a protective cover slidably disposed over the ram  
     
     
         24 . The device of  claim 23 , wherein actuation of the actuator assembly moves the protective cover in a first direction, moves the ram in a second direction to force the needles into said radially extended position, and moves the shaft in said first direction to pass the needles through the tissue.  
     
     
         25 . The device of  claim 24 , wherein the ram comprises a solid rod with individual portions each corresponding to one of the needles, and the actuator assembly moves the individual portions of the ram in unison to force the needles into said radially extended position at the same time.  
     
     
         26 . A method for passing needles through tissue adjacent an opening in the tissue, the method comprising steps of: 
 providing at least first and second needles each of which is configured to pass through tissue, the first needle having a first length of suture secured thereto and the second needle having a second length of suture secured thereto, the first and second lengths of suture being unconnected;    positioning the first and second needles through an opening in the tissue with a portion of each of the first and second lengths of suture extending through the opening in the tissue; and    passing the first and second needles through the tissue adjacent the opening so that the first and second lengths of suture each have a portion that extends through the opening and a portion that extends through the tissue.    
     
     
         27 . The method of  claim 26 , wherein the tissue is inside the patient's body, and both ends of each length of suture are disposed outside the patient's body after passing the needles through the tissue and out the patient's body.  
     
     
         28 . The method of  claim 27 , wherein the needles are passed through the tissue on opposite sides of the opening therein.  
     
     
         29 . The method of  claim 28 , wherein more than two needles are passed through the tissue at locations spaced circumferentially around the opening therein  
     
     
         30 . The method of  claim 28 , wherein the opening is in a patient's aorta, and the needles are passed through the wall of the aorta so that the first and second lengths of suture each have a portion that extends through the opening in the aorta and a portion that extends through the wall of the aorta.  
     
     
         31 . A method for placing a plurality of separate lengths of suture through tissue in a patient's body adjacent an opening in the tissue, the method comprising steps of: 
 providing at least first and second needles configured to pass through tissue, the first needle having a first length of suture secured thereto and the second needle having a second length of suture secured thereto, each of the first and second lengths of suture having an end disposed away from the needles to which the length of suture is secured;    positioning the first and second needles inside a patient's body adjacent an opening in tissue within the patient's body such that the ends of the first and second lengths of suture are located outside an outer surface of the tissue;    passing the first and second needles into the tissue adjacent the opening while maintaining the ends of the first and second lengths of suture outside the outer surface of the tissue; and    passing the first and second needles through and out of the tissue to pull the first and second lengths of suture through the tissue while maintaining the ends of the first and second lengths of suture outside the outer surface of the tissue.    
     
     
         32 . A device for delivering a member adapted to be secured to a patients' body tissue, the device comprising: 
 a first component;    a second component mounted to the first component, the first and second components being relatively movable;    the first component being configured to removably support a member adapted to be secured to a patient's body tissue;    the second component being configured to hold at least one needle carrying suture for securing the member to the body tissue;    wherein the first component is relatively movable with respect to the second component to move the member along the suture into contact with the body tissue.    
     
     
         33 . The device of  claim 33 , further comprising a sealing element configured to be carried by the first component.  
     
     
         34 . The device of  claim 33 , further comprising a vascular conduit supported by the first component, the conduit having an end overlying the sealing element.  
     
     
         35 . A device for delivering a vascular conduit to body tissue located at an anastomosis site within a patient's body, the device comprising: 
 a shaft having a proximal end and a distal end, a portion of the shaft being configured to support a vascular conduit adapted to be anastomosed to body tissue;    a collar disposed on the shaft, the shaft and collar being relatively movable, the collar having an area configured to hold at least one needle adapted to be passed through a vascular conduit supported by the shaft.    
     
     
         36 . The device of  claim 35 , wherein the shaft comprises a tube with a hollow interior configured to receive the vascular conduit.  
     
     
         37 . The device of  claim 36 , wherein the tube has a cut-out section for positioning the vascular conduit within the hollow interior of the tube.  
     
     
         38 . The device of  claim 35 , further comprising a sealing element configured to engage an end of the vascular conduit.  
     
     
         39 . The device of  claim 38 , wherein the sealing element comprises a ring having a closed periphery.  
     
     
         40 . The device of  claim 38 , wherein the sealing element has a surface provided with at least one member for engaging an end of a vascular conduit to hold the conduit on the sealing element.  
     
     
         41 . The device of  claim 40 , wherein the sealing element has a plurality of barbs for engaging an end of a vascular conduit.  
     
     
         42 . The device of  claim 35 , wherein the distal end of the shaft has at least one radially extending flange for supporting an end of a vascular conduit.  
     
     
         43 . The device of  claim 42 , wherein the distal end of the shaft has a pair of radially extending flanges for supporting an end of a vascular conduit.  
     
     
         44 . The device of  claim 35 , wherein the collar has a proximal end, a distal end, and a bore in which the shaft is slidably mounted.  
     
     
         45 . The device of  claim 44 , wherein the bore of the collar is frictionally engaged with the shaft.  
     
     
         46 . The device of  claim 44 , wherein the shaft has a guide element along at least a portion of the exterior thereof, and the collar has a slot slidably engaged with the guide.  
     
     
         47 . The device of  claim 44 , wherein the area on the collar configured to hold at least one needle comprises a sleeve surrounding at least part of the shaft, and the sleeve is formed so as to grip a needle placed therein.  
     
     
         48 . The device of  claim 47 , wherein the sleeve is formed of a resilient material.  
     
     
         49 . A device for delivering a vascular conduit to body tissue located at an anastomosis site within a patient's body, the device comprising: 
 an elongated shaft having a proximal end and a distal end;    the distal end of the shaft having a portion configured to removably support a vascular conduit adapted to be secured to body tissue located at an anastomosis site with a patient's body;    wherein said portion of the distal end of the shaft is configured to deliver the conduit to the anastomosis site and thereafter release the conduit.    
     
     
         50 . A method for delivering a member adapted to be secured to body tissue to a location adjacent the body tissue, the method comprising steps of: 
 placing suture through body tissue so that the suture extends away from the body tissue, the suture having an end which carries a needle;    providing a delivery device comprising first and second components mounted so as to be relatively movable;    positioning a member adapted to be secured to the body tissue on the first component;    placing the needle carried by the end of the suture into the second component; and    imparting relative movement to the first and second components to move the first component and the member along the suture to a location adjacent the body tissue.    
     
     
         51 . The method of  claim 50 , wherein the member is adapted to be secured to the body tissue adjacent an opening in the body tissue, and the suture passes through the body tissue adjacent the opening.  
     
     
         52 . The method of  claim 50 , wherein separate lengths of suture are placed through the body tissue and extend through the opening and through the tissue, each length of suture having an end which carries a needle  
     
     
         53 . The method of  claim 52 , wherein the member is adapted to be secured over the opening in the body tissue, and the lengths of suture extend through the opening and pass through the tissue at locations spaced around the opening.  
     
     
         54 . The method of  claim 53 , wherein the member is a vascular conduit, and the opening in the body tissue is formed in a patient's aorta, and the vascular conduit is moved along the suture into contact with the aorta and then anastomosed thereto.  
     
     
         55 . The method of  claim 54 , further comprising positioning a sealing member between the first component and the vascular conduit, and then securing the vascular conduit to the body tissue with the sealing member therebetween.  
     
     
         56 . The method of  claim 55 , further comprising the step of measuring the size of the vascular conduit and selecting a particular size sealing member.  
     
     
         57 . The method of  claim 50 , wherein the opening in the tissue is formed by a surgical cutting instrument comprising a plurality of cutting surfaces configured to cut an opening in tissue having a plurality of flaps.  
     
     
         58 . The method of  claim 56 , wherein the cutting instrument comprises four cutting surfaces and the opening has four flaps  
     
     
         59 . An anastomosis system for securing a vascular conduit to a hollow body structure, the system comprising: 
 a needle passer comprising a shaft assembly supporting at least one length of suture secured to first and second needles, and an actuator for moving at least one of the needles through tissue of a hollow body structure to thread the length of suture through the tissue to permit an end of a vascular conduit to be attached to the tissue in fluid communication with the hollow body structure; and    a sealing element configured to be positioned against the end of the vascular conduit, the sealing element being formed of a material that is able to receive one of the first and second needles.    
     
     
         60 . The system of  claim 59 , wherein the sealing element is ring-shaped and is formed of a resilient material.  
     
     
         61 . A device for use in anastomosing a vascular conduit to a hollow body structure, the device comprising: 
 a sealing element having an opening configured to be aligned with a vascular conduit adapted to be anastomosed to a hollow body structure, the sealing element being formed of a biocompatible material which permits at least one needle to be inserted and passed through the sealing element in order to pass suture used to anastomose the vascular conduit to the hollow body structure through the sealing element.    
     
     
         62 . The device of  claim 61 , wherein the opening in the sealing element is configured to surround an exterior surface of the vascular conduit.  
     
     
         63 . The device of  claim 61 , wherein the sealing element is ring-shaped and is formed of a resilient material.  
     
     
         64 . A method for anastomosing a vascular conduit to a hollow body structure so that the vascular conduit is in fluid communication with the interior of the hollow body structure, the method comprising steps of: 
 forming an opening in tissue of a hollow body structure so that the opening passes into an interior of the body structure;    positioning an end of a vascular conduit against the tissue; and    attaching the vascular conduit to the tissue so that the vascular conduit is in fluid communication with the interior of the hollow body structure, wherein a sealing element is used to enhance the attachment between the end of the vascular conduit and the tissue.    
     
     
         65 . The method of  claim 64 , wherein the end of the vascular conduit is positioned against the tissue, and the sealing element is positioned against the end of the vascular conduit to force the end of the vascular conduit against the tissue.  
     
     
         66 . The method of  claim 65 , wherein the sealing element is a ring and the ring is positioned around the vascular conduit and forces the end of the vascular conduit against the tissue.  
     
     
         67 . A method of carrying out a surgical procedure on a hollow body structure through which fluid is flowing, the method comprising steps of: 
 forming an opening passing through the hollow body structure, the opening extending from an exterior surface of the hollow body structure to an interior surface of the hollow body structure;    providing a tissue contacting member movable between collapsed and expanded orientations, the tissue contacting member being attached to an elongate support member;    positioning the tissue contacting member in said collapsed orientation through the opening and adjacent the interior surface of the hollow body structure;    moving the tissue contacting member into said expanded orientation and into contact with the interior surface of the hollow body structure; and    inserting an instrument through the opening and into the hollow body structure to carry out a surgical procedure on the hollow body structure, the tissue contacting member substantially preventing fluid flowing through the hollow body structure from escaping through the opening.    
     
     
         68 . The method of  claim 67 , wherein the hollow body structure is a patient's aorta, and the surgical procedure is carried out to anastomose a vascular conduit to the aorta.