Endoscopic suturing system with retained end cap

A treatment device for use with an endoscope having a instrument channel for passage of an endoscopic instrument and a distal end is provided. The treatment device includes an end effector assembly with a base for placement at the distal end of the endoscope, an end effector rotatable relative to the base, and a mounting portion for attaching the base to the endoscope. The mounting portion is resiliently compressible and can be radially compressed for insertion into the instrument channel, whereby an expansion force of the resiliently compressed mounting portion retains the base relative to the distal end of the endoscope. The mounting portion also includes an opening longitudinally extending therethrough and communicable with the instrument channel and sized for receiving an endoscopic instrument therethrough.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a treatment device which can be inserted into a body through a natural orifice with an endoscope or other steerable guide member. The present invention may be used to perform suturing on the tissue of a mammal, whether human or not, and whether or not alive, but is not limited thereto.

2. Description of the Related Art

U.S. Pat. No. 7,344,545 (Olympus Corporation) discloses an endoscopic suturing system having many embodiments to perform a surgical operation. This suturing system generally comprises an assembly having first and second arms which are actuatable by a push rod to rotatably approach each other while one arm grasps tissue and the second arm drives a curved needle through the tissue. The system also includes a needle recovery member requiring a rigid alignment with the curved needle arm. While this system affords the ability to grasp thick tissue, the tissue grasping arm and the arrangement of the needle recovery member provides bulk to the system making it difficult to use in endoscopic procedures.

SUMMARY OF THE INVENTION

The present invention provides an endoscopic treatment device having a structure enabling a small profile for delivery while providing both a large opening and closing angle and producing a large needle force for piercing tissue to perform a surgical operation such as tissue approximation and suturing within the body.

In accordance with an aspect of the present invention there is provided an endoscopic treatment device which is used to perform treatment in a body while being operated outside the body. The treatment device comprises a flexible member coupled to a proximal handle assembly for operation outside of the body and a distal cap assembly where the cap assembly is adapted to engage the distal end of an endoscope. The flexible member is connected to a link mechanism and is actuated to cause a needle assembly having a needle holder arm and needle which are coupled to the cap assembly to move in a direction to puncture tissue and a direction to be removed from tissue.

According to another aspect of the present invention there is provided an endoscopic treatment system for use with an endoscope having a cap assembly adapted to be positioned at the distal end of an endoscope where the cap assembly has at least one mounting bracket which is fixedly attached. A transmission member with a flexible structure has a distal end portion that is inserted into a body and is capable of being operated outside the body by a proximal portion coupled to a handle assembly. A push rod is coupled to the distal end portion of the transmission member. A connecting member having a needle holder arm is coupled to the push rod and pivotally coupled to the mounting bracket. A removable needle is connected to the needle holder arm and is adapted to pierce tissue. When the push rod is actuated by the transmission member, the connecting member moves the needle holder arm in a direction to pierce tissue or in a direction to remove it from tissue. An elongate needle capture device is positioned within the instrument channel of the endoscope and has a distal end adapted to receive and grasp the needle and a proximal end coupled to a handle assembly.

In accordance with another aspect of the present invention there is provided a removable needle assembly having a needle tip member and a needle base member. The needle tip member has a sharpened end which is adapted to pierce tissue and a hollow end to receive the needle base member. The needle tip member also includes an aperture which may take the form of a longitudinal slot through the wall adjacent the hollow end which is adapted to allow suture to extend there from. The needle base member has a first end which is adapted to engage the hollow end of the needle tip member and a second end which is adapted to removably engage a needle holder arm. The needle base member further includes a stop member which when coupled with the needle holder arm limits the depth to which the needle base is inserted into the needle holder arm. The coupling engagement of needle tip member and the first end of the needle base member are adapted to secure a length of suture material to the needle assembly and allow it to extend through the aperture adjacent the hollow end of the needle tip member.

In accordance with still another aspect of the present invention there is provided a needle clip assembly having first and second ends where a needle tip adapted for piercing tissue is positioned at the first end and a tissue stop member is positioned at the second end. The needle clip assembly has a constrained first configuration and an unconstrained second configuration where the needle clip assembly is resiliently biased to move from the first configuration to the second configuration. The constrained first configuration may take the form of a generally straightened elongate member. The unconstrained second configuration may take the form of a loop, helix or substantially closed loop form.

In accordance with yet another aspect of the present invention there is provided an endoscopic treatment system for use with an endoscope having a cap assembly adapted to be positioned at the distal end of an endoscope where the cap assembly has two pair of fixedly attached mounting brackets. A transmission member with a flexible structure has a distal end portion that is inserted into a body and is capable of being operated outside the body. A push rod is coupled to the distal end portion of the transmission member. A connecting member having a needle holder arm is coupled to the push rod and pivotally coupled to the outer pair of mounting brackets. A link member having two ends is pivotally coupled to the inner pair of mounting brackets at one end and pivotally coupled to the needle holder arm at the other end. A removable needle is connected to the needle holder arm and is adapted to pierce tissue. When the push rod is actuated by the transmission member, the connecting member moves the needle holder arm in a direction to pierce tissue or a direction to remove it from tissue. An elongate needle capture device is positioned within the instrument channel of the endoscope having a proximal handle and a distal end adapted to receive and grasp the needle.

In accordance with yet another aspect of the present invention there is provided a combination handle assembly adapted to operate the movement of the transmission member thereby opening and closing the needle arm and adapted to operate the needle capture device to thereby grasp and release the needle. The handle assembly includes a handle main body coupled to an endoscope channel coupling which is adapted to engage the instrument channel of an endoscope. An elongate needle capture device includes a proximal housing which is removably coupled to the handle main body and a distal end is which positioned through the endoscope channel coupling into the instrument channel of an end. An actuatable trigger lever is coupled to handle main body and operates the transmission member to axially advance or retract the transmission member.

In accordance with another aspect of the present invention there is provided an endoscopic treatment system that further includes a tissue grasping member. The tissue grasping member takes the form of an elongate member having proximal and distal ends and is positioned with a channel of an endoscope. The distal end of the tissue grasping member may take the form of a helix or tapered spiral in which rotation of the helix when at a desired site adjacent tissue, causes the helix to substantially engage the tissue and allow the tissue to be refracted.

In accordance with still another aspect of the present invention there is provided an endoscopic treatment system that further includes a tissue grasping member. The tissue grasping member takes the form of an elongate member having proximal and distal ends and is positioned with a channel of an endoscope. The distal end of the tissue grasping member may take the form of a pair of jaws such that when at a desired site adjacent tissue, operation of the jaws causes the jaws to substantially engage the tissue and allow the tissue to be refracted.

In accordance with another aspect of the present invention there is provided an endoscopic treatment device which is used to perform treatment in a body while being operated outside the body. The treatment device comprises a flexible member coupled to a proximal handle assembly for operation outside of the body and a distal cap assembly where the cap assembly is adapted to engage the distal end of an endoscope. The cap assembly includes an elongate channel lock member having one end which is fixedly attached to the cap assembly and extends through the channel of an endoscope and is removably secured to the proximal end of the endoscope channel. The channel lock member may take the form of a small diameter flexible wire assembly or wire braid assembly.

In accordance with yet another aspect of the present invention there is provided an endoscopic suturing system for use with an endoscope having a cap assembly adapted to be positioned at the distal end of an endoscope where the cap assembly defines mounting locations. A transmission member with a flexible structure has a distal end portion that is inserted into a body and is capable of being operated outside the body. A push member is optionally coupled to the distal end portion of the transmission member. A link member having a geared portion is coupled to the push member or the transmission member and pivotally coupled at a first mounting location. A connecting member having a geared portion and a needle holding arm at one end is pivotally coupled at a second mounting location such that the geared portions of the link member and the connecting member intermesh.

In accordance with another aspect of the present invention there is provided an endoscopic suturing system for use with an endoscope having a cap assembly adapted to be positioned at the distal end of the endoscope where the cap assembly includes an elongate needle guard. The needle guard generally extends from a base of the cap in a direction distal to the end of the endoscope. Preferably the needle guard extends in a distal direction parallel to the axis of the endoscope. The needle guard is adapted to prevent tissue from inadvertently contacting the needle tip while the needle tip is in an open position and the tissue is being positioned for suturing.

In accordance with another aspect of the present invention there is provided an endoscopic suturing system for use with an endoscope having a cap assembly adapted to be positioned at the distal end of the endoscope where the cap assembly includes an elongate channel guard. The channel guard generally extends from a base of the cap in a direction distal to the end of the endoscope and is coaxial with the endoscope channel which used by the needle capture device. The channel guard is adapted to aid in suturing by positioning tissue a sufficient distance away from the end of the endoscope channel allowing for better visualization and providing a surface to support the tissue during the suturing operation. Preferably, the distal end of the channel guard is inclined to provide a plane which is generally perpendicular to the needle tip as the needle tip intersects the plane along the needle suturing path. Preferably, the minimum length that the channel guard extends from the cap is related to the field of view from the endoscope such that minimum length allows sufficient tissue to be visualized when the tissue is placed in a position for suturing.

In accordance with another aspect of the present invention there is provided an endoscopic treatment device which is used to perform treatment in a body while being operated outside the body. The treatment device comprises a flexible member coupled to a proximal handle assembly for operation outside of the body and a distal cap assembly where the cap assembly is adapted to engage the distal end of an endoscope. The cap assembly includes an elongate channel lock member having one end which is removably secured to the cap assembly and extends through the channel of an endoscope and is removably secured to the proximal end of the endoscope channel by a tensioning assembly. The channel lock member may take the form of a small diameter flexible wire assembly or wire braid assembly. Preferably, the channel lock member includes retaining members fixedly secured to each end. The tensioning assembly includes a bayonet lock fitting adapted to engage a bayonet prong on the endoscope, a housing member, a rotatable wheel member having a tab member and a tensioner member. The proximal end of the channel lock member is secured to the tab member of the rotatable wheel such that rotation of the wheel applies a preset tension to the channel lock member. The housing member of the tensioning assembly in conjunction with the tensioner member, preferably formed of a spring, maintains the tension on the channel lock member by resisting compression during normal bending operation of the endoscope.

According to another aspect of the endoscopic treatment system of the present invention there is provided a cinch system including a cinch delivery device and a cinch device. The cinch delivery device takes the form of an elongate tubular member having proximal end coupled to a handle assembly and a distal end. The distal end of the cinch delivery device is removably coupled to the cinch device. The cinch device has a housing that incorporates a suture capture hook at is distal end for capturing suture that has been placed through tissue. A cinch plug is positioned within the cinch housing and is movable from a first suture non-retaining position to a second suture retaining position for securing suture in a fixed position by operating the handle assembly. Once suture has been secured by the cinch plug in the cinch housing the handle assembly may be operated to uncouple the cinch device from the cinch delivery tool.

According to still another aspect of the present invention, there is provided a suturing method using an endoscopic suturing system. This method comprises the steps of:

(1) inserting a guide tube and/or endoscope into a body with a suturing device coupled to the endoscope and or guide tube;

(2) opening a needle arm of the suturing device having a removable needle;

(3) pushing the needle against tissue at a desired suture site;

(4) closing the needle arm of the suturing device;

(5) piercing the tissue with the needle;

(6) recovering the needle by using a needle capture device;

(7) removing the needle from the tissue;

(8) opening the needle arm to remove it from tissue;

(9) closing the needle arm; and

(10) removing the suturing device from the body.

According to yet another aspect of the present invention, there is provided a suturing method using an endoscopic suturing system including a tissue grasper. This method comprises the steps of:

(1) inserting a guide tube into a body;

(2) inserting a suturing device coupled to an endoscope into the guide tube and into the body;

(3) opening a needle arm of the suturing device having a removable needle;

(4) engaging a tissue adjacent a desired suture site using a tissue grasper;

(5) pushing the needle against tissue at a desired suture site;

(6) closing the needle arm of the suturing device;

(7) piercing the tissue with the needle;

(8) recovering the needle by using a needle capture device;

(9) removing the needle from the tissue;

(10) opening the needle arm to remove it from tissue;

(11) releasing the tissue from the tissue grasper;

(12) closing the needle arm; and

(13) removing the suturing device from the body.

According to another aspect of the present invention, there is provided a suturing method of performing a running stitch using an endoscopic suturing system. This method comprises the steps of:

(1) inserting a guide tube into a body;

(2) inserting a suturing device coupled to the endoscope into the guide tube and inserting the suturing device into the body;

(3) opening a needle arm of the suturing device having a removable needle;

(4) pushing the needle against tissue at a desired suture site;

(5) closing the needle arm of the suturing device;

(6) piercing the tissue with the needle;

(7) recovering the needle by using a needle capture device;

(8) removing the needle from the tissue;

(9) opening the needle arm to remove it from tissue;

(10) closing the needle arm;

(11) inserting the needle into the needle arm endoscopically using the needle capture device;

According to still yet another aspect of the present invention there is provided a method of securing tissue using an endoscopic suturing system including a resilient pre-biased needle clip and a tissue grasper. This method comprises the steps of:

(1) inserting a guide tube into a body;

(2) inserting a suturing device coupled to the endoscope into the guide tube and inserting the suturing device into the body;

(3) opening a needle holding arm of the suturing device having a removable needle clip;

(4) engaging a tissue adjacent a desired suture site using a tissue grasper

(5) pushing the needle clip against tissue at a desired suture site;

(6) closing the needle holding arm of the suturing device;

(7) piercing the tissue with the needle clip;

(8) grasping the needle clip tip using a needle capture device;

(9) opening the needle holding arm to remove it from tissue;

(10) releasing the needle clip from the needle capture device

(11) releasing the tissue from the tissue grasper;

(12) closing the needle holding arm; and

(13) removing the suturing device from the body.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown inFIG. 1an endoscope system10which comprises an endoscope12, a video display unit14, an image processing device16, a light source17, a suction device18is used with and an endoscopic suturing device20as part of an endoscopic treatment system according to one embodiment of the present invention.FIG. 2andFIG. 3illustrate respectively the proximal and distal portions of endoscope12and endoscopic suturing device20. The endoscopic suturing device20has an operable handle22which is removably coupled to endoscope12at a first instrument channel24. A tissue grasper26which is used to gather tissue is shown positioned within a second instrument channel28of endoscope12. The endoscopic suturing device20includes an elongate needle capture device30which is removably coupled to handle22and extends to the distal end of endoscope12slidably positioned within instrument channel24. The endoscopic suturing device20is operated by handle22which is proximally coupled to transmission assembly32which extends distally along the exterior of insertion tube34to the distal end36of endoscope12. The transmission assembly is coupled at its distal end to a cap assembly38which is positioned over the distal end36of endoscope12.FIG. 3shows the distal end40of needle capture device30and the distal end helical tip42of tissue grasper26extending from instrument channels24and28respectively. Positioned adjacent to needle capture device distal end40is needle assembly44which is connected to suture46. Needle assembly44is removably inserted into needle holder arm48. Transmission assembly32comprises an outer sheath50which is preferably formed of a flexible coil and a push rod52positioned within the lumen and extending from the distal end of outer sheath50. Outer sheath50is fixedly secured to cap assembly38. Push rod52is coupled to a connecting member54via a pivot pin56, and optionally via a push member52awhich may couple the rod52and the pivot pin56. The connecting member54is also connected to a pair of outer mounting brackets58via pivot pin60. The mounting brackets58are fixedly attached to cap assembly38. A pair of inner mounting brackets62are fixedly attached to the cap assembly38and pivotally connected to one end of a link member64via pivot pin66. The other end of link member64is connected to the needle holder arm48via pivot pin68. Needle holder arm48is coupled to connecting member54via pivot pin69.

As shown inFIG. 3,FIG. 4, andFIG. 5, the pivotable connections of connecting member54and link member64to outer and inner mounting brackets58and62respectively, allow the rotation of needle holder arm48when push rod52is axially advanced or retracted. InFIG. 4, the cap assembly38is shown in an open configuration with push rod52advanced (compareFIG. 3where the cap assembly is in a closed configuration with push rod52retracted).FIG. 5shows the endoscopic suturing device20in an open configuration and from another angle where outer and inner pairs of mounting brackets58and62are more visible.

FIG. 6shows a view of cap assembly38uncoupled from an endoscope. Cap assembly38includes a fixedly attached insert guide70coupled to a flexible channel lock72. Insert guide70is a tubular projection from cap assembly38and is adapted to be positioned within the lumen of an endoscope instrument channel at its distal end. The elongate flexible channel lock72extends from the insert guide70through an instrument channel and is secured to the proximal end of the instrument channel. The channel lock72ensures that the cap assembly38does not inadvertently disengage from the distal end of the endoscope. Preferably channel lock72takes the form of a small diameter single or multi stranded wire or cable formed primarily of metals or polymers. Additionally the small diameter of channel lock72allows room for other instruments to be positioned within the instrument channel of the endoscope.

FIG. 7illustrates needle assembly44which comprises a needle body74, a needle tip76and suture46. The suture46may be formed of any materials commonly available for surgical suture such as nylon, polyolefins, PLA, PGA, stainless steel, nitinol and others.FIG. 8shows a detailed exploded view of two components of needle assembly44. Needle tip76has a sharp distal end and a hollow proximal end having a suture slot78through the side wall. Needle body74has a rounded or blunt tapered proximal end74aadapted to fit within the needle holder arm with the proximal end74apresenting a shoulder79between end74aand the remainder of the needle body74. A distal end74bof the needle body74has a suture slot80adapted to concentrically engage needle tip76. Flexible suture material is positioned on the distal end of needle body74extending through the aligned suture slots78and80. The needle tip76and needle body74are formed from suitable biomaterials and may be made from polymers such as nylon, PEEK, PLA, PGA, PLGA or metals such as stainless steel, nitinol or titanium. The components may be joined using standard joining techniques such as thermal bonding, ultrasonic welding laser welding, adhesives or mechanical crimping.FIG. 9illustrates an alternative needle assembly82having a needle tail84and a needle tip86. Needle tip86has a sharpened distal end, a suture aperture88and a hollow proximal end which is adapted to receive needle tail84. Suture90is positioned within the hollow end of needle tip86and extends through aperture88. Needle tail84and suture90are secured in the hollow end of needle tip86using any of the aforementioned joining techniques. Needle tail84is preferably formed in a straightened shape and of a resilient material such as nitinol. When needle tail84is placed in a curved needle holder arm the needle tail bends and applies a force to the inner wall of the needle holder arm maintaining the needle assembly82securely in place.

FIG. 10throughFIG. 13Aillustrate alternate versions of needle assemblies for use in closing tissue defects.FIG. 10shows a needle clip92in a straightened configuration having a body portion94a proximal beaded end96and a piercing tip98. The needle clip92is preferably formed of nitinol or other resilient material and biased into a generally circular shape. Needle clip92may be constrained in a generally straightened configuration but when unconstrained transitions to its biased generally circular configuration as shown inFIG. 11.FIG. 12shows an alternate needle clip100having a proximal bead102, a piercing tip104, an outer coil covering106, and a body portion108connecting the proximal and distal ends. The needle clip100also includes a securing member110to fixedly attach at least a portion of coil106to body portion108. The needle clip100is preferably comprised of nitinol or other resilient material and is biased into a generally circular shape. Needle clip100may be constrained in a generally straightened configuration but when unconstrained transitions to its biased generally circular configuration as shown inFIG. 13. The coil106may be formed of suitable biomaterials such as polymers of nylon, polyester, PEEK, PLA, PGA, PLGA or metals such as stainless steel, nitinol, titanium or platinum. The coil106provides increased surface area for tissue in growth and encapsulation as well as distributing the force placed on tissue when closing a tissue defect.FIG. 13Ashows a needle clip100in which the coil106extends over the sharp piercing tip thereby shielding the tip from inadvertent damage to surrounding tissue.

FIG. 14shows the tissue grasper26which has a proximal handle108, an elongate shaft member110and a helical tip42. Shaft member110is formed of a wire or multi-stranded cable or any torque transmitting configuration that provides flexibility which does not impede the steering capabilities of the endoscope.FIG. 15shows an enlarged view of the distal end of tissue grasper26. Shaft member110is coupled to helical tip42by tip coupling member112. Tip coupling member112may be fixedly joined to helical tip42and shaft member110by any of the aforementioned joining techniques.

FIG. 16andFIG. 17show a cinch deployment system114for securing suture placed at a tissue defect site. The cinch deployment system114comprises a cinch assembly116and a cinch delivery device118. The cinch delivery device118has an elongate flexible tubular shaft120which is removably coupled at its distal end to cinch assembly116and fixedly attached at its proximal end to handle member122. Handle member122includes a slidable finger ring assembly124and a thumb ring126. Slidably disposed within the lumen of tubular shaft120is push rod128. Push rod128extends from the distal end of tubular shaft120to the proximal end of tubular shaft120and is coupled to the slidable finger ring assembly124with fixation screw130, such that movement of the finger ring assembly relative to the thumb ring126causes the axial movement of push rod128within the lumen of tubular shaft120. A partially exploded view of the distal end of the cinch deployment system114is shown inFIG. 18. As depicted, push rod128extends from tubular shaft120and through latch assembly129. Latch assembly129is fixedly attached to tubular shaft120and has two latch arms132with latch tabs134at their distal ends. Latch arms132are biased inwardly towards the central longitudinal axis of tubular shaft120. Latch assembly129is positioned within the lumen of a latch coupling136and is fixedly secured. Latch coupling136is configured at its distal end to engage with the proximal end of cinch116such that the latch arms132extend within the proximal lumen of cinch116and when push rod128is positioned within latch assembly129the latch arms132are forced outwardly such that the latch tabs134locking engage the cinch tab apertures138. When push rod128is axially refracted from latch assembly129the latch arms132move inwardly towards their biased configuration causing latch tabs134to release their locking engagement with cinch tab apertures138to thereby release the cinch assembly116.FIG. 19illustrates the cinch assembly116in an open configuration. Cinch assembly116has a tubular housing member139having cinch tab apertures138located at its proximal end and a suture hook140fixedly attached at its distal end. A securing clasp142is slidably positioned within the lumen of housing member139. A retention tab144is preferably formed from the wall of housing member139and biased inwardly towards the central axis at of housing member139at its distal end. When suture has been captured by suture hook140the suture may be secured within cinch assembly116by advancing push rod128such that securing clasp142extends from housing member139and engages suture hook140. With securing clasp142in extended configuration retention tab144moves to its inwardly biased configuration restricting the proximal movement of the securing clasp142thereby fixing the suture in place.

FIG. 21illustrates a guide tube146for use in an endoscopic procedure. Guide tube146has a proximal end148including a lumen150that extends to the distal end152. Generally a guide tube146is positioned in a patient to provide a conduit to a desired location while protecting the surrounding tissue from inadvertent damage. As shown inFIG. 22andFIG. 23show a guide tube146with an endoscopic suturing device20positioned in the lumen150. Once the guide tube146is positioned at a desired treatment location within the body the distal end of the endoscopic suturing device20may be extended beyond the distal end of the guide tube146.

FIG. 24throughFIG. 34depicts a method of performing a suturing operation using an endoscopic suturing device20of the present invention. As shown inFIG. 24, the endoscopic suturing device20is positioned adjacent tissue154which has a tissue defect156to be closed. The endoscopic suturing device20is in an open configuration.FIG. 25shows the tissue grasper26extended from the endoscope instrument channel such that helical tip42is adjacent tissue defect156. Rotation of the tissue grasper26causes the helical tip42to securely engage the tissue154adjacent to the tissue defect156. The tissue154may be brought closer to the endoscope by slightly retracting the tissue grasper26into the instrument channel of the endoscope as shown inFIG. 26. The degree of tissue retraction correlates to the size and location of the stitch. For instance, to have a larger amount of tissue sutured, the tissue154may be brought into contact with the endoscope by the tissue grasper as shown inFIG. 27. The needle holder arm48is actuated to move to a closed position causing the needle assembly44to pierce tissue154. The suture46is pulled through the tissue as shown inFIG. 28. The control over the amount of tissue retracted allows the physician the ability to perform a partial thickness stitch within the wall of a tissue or a full thickness stitch which extends through a wall of tissue. The needle capture device captures the needle assembly44by gripping it at shoulder79(FIG. 7) and removes it from the needle holder arm48(not shown).FIG. 29shows the needle holder arm48moved to an open configuration and removed from tissue154. Suture46remains through the tissue.FIG. 30shows the lengthening of the suture46through the tissue154by refracting the endoscopic suturing device20while retaining the needle assembly44within the needle capture device.FIG. 31shows the needle holder arm48moved to a closed configuration and needle assembly44reinserted into the needle holder arm48by advancing the needle capture device if the physician wishes to make another stitch. If the physician does not wish to make another stitch, the needle assembly with suture can be refracted through the endoscope channel and with both ends of the suture, a knot can be tied and pushed down the endoscope channel to the treatment site to secure the tissue. Alternatively, the suture can be secured using a cinch deployment system. As shown inFIG. 32a cinch assembly116and a cinch delivery device118may be used to capture the suture46. The suture may be pulled tight to securely close the tissue defect156. Once the tissue defect156is sufficiently closed the cinch assembly116may be moved to a closed configuration, thereby securing the suture46as shown inFIG. 33. The cinch delivery device118can release the cinch assembly116as shown inFIG. 34and the suture46may then be cut using any standard cutting means such as scissors. It is contemplated that the cinch assembly may incorporate cutting means after securing the suture.

FIG. 35throughFIG. 38shows another method of closing a tissue defect and securing the suture.FIG. 35shows the endoscopic suturing device20having delivered a needle assembly44(shown schematically) and suture46through tissue154adjacent a tissue defect156where the needle assembly44is resting adjacent the surface of tissue154.FIG. 36shows a cinch deployment system having a cinch assembly116and a cinch delivery device118that has grasped a portion of suture46. The suture is pulled tight to close the tissue defect156while the needle assembly prevents the end of suture46from pulling through the tissue154. Once the tissue defect156is sufficiently closed the cinch assembly116may be moved to a closed configuration, thereby securing the suture46as shown inFIG. 37. The cinch delivery device118can release the cinch assembly116as shown inFIG. 38and the suture46may then be cut using any standard cutting means such as scissors.

FIG. 39throughFIG. 42shows still another method securely closing a tissue defect.FIG. 39shows an endoscopic suturing device20having an open configuration and a needle clip100having a proximal bead102and a piercing tip104positioned in needle holder arm48. The helical tip42of the tissue grasper26has engaged tissue154adjacent to the tissue defect156and retracted the tissue towards the endoscope.FIG. 40shows the needle holder arm48in a closed configuration positioned through the tissue with the piercing tip104of needle clip100having pierced and exited the tissue.FIG. 41shows the needle capture device grasping the piercing tip of the needle clip100with the needle holder arm48in an open configuration and removed from tissue154. The proximal bead102of needle clip100is positioned adjacent the tissue site initially pierced by the piercing tip.FIG. 42shows the release of tissue154from the tissue grasper and the resilient needle clip100taking its pre-biased generally circular shape thereby closing the tissue defect156. As can be appreciated, the application of a tissue sealant or adhesive may be used to aid in the closing the tissue defect.

FIG. 43shows an endoscopic suturing device320according to another embodiment of the present invention. Endoscopic suturing device320includes a cap assembly322which is adapted to engage with the distal end of an endoscope, an elongate channel lock member324which is optionally removable from cap assembly322, an outer sheath326, an inner sheath328and an elongate flexible transmission member330. As seen inFIG. 44, cap assembly322further includes a fixedly attached channel lock receiver332, an endoscope channel insert guide334, an elongate tissue guard336, an elongate needle guard338which extends distally from the base of the cap assembly and houses the mechanical assembly that provides rotational motion for needle holder arm340as shown inFIG. 44. Channel insert guide334is a tubular projection from cap assembly322and is adapted to be positioned within the lumen of an endoscope instrument channel at its distal end. The elongate flexible channel lock member324extends from the channel lock receiver332through an instrument channel and is secured at the proximal end of the instrument channel. The channel lock member324ensures that the cap assembly322does not inadvertently disengage from the distal end of the endoscope. Preferably channel lock member324takes the form of a small diameter single or multi stranded wire or cable formed primarily of metals or polymers. Additionally the small diameter of channel lock324allows room for other instruments to be positioned within the instrument channel of the endoscope.FIGS. 44 and 45respectively show the cap assembly322in a needle arm340closed configuration and a needle arm open configuration.

For purposes of example only, and not by way of limitation, in the shown embodiment, the cap assembly322has a cap or ring element322ahaving an inner diameter of approximately 13.5 mm, an outer diameter of approximately 14.2 mm, a height of a little over 2 mm, and a portion322bhaving a rim width of between 1 mm and 2 mm.

For purposes of example only, and not by way of limitation, in the shown embodiment, the elongate tissue guard336circumscribes approximately 50.degree. of the ring322aon its outside surface336aand extends vertically approximately 9 mm over the top of the ring element322aat its middle portion. The inside surface336bof the elongate tissue guard336is generally semicircular (thereby helping define side walls336d) and defines an approximately 4 mm-5 mm opening which extends above a smaller ring322c(seeFIG. 48) of the cap assembly and above a channel of the endoscope into which the needle capture device (described hereinafter with reference toFIGS. 55-57) is to be located. This channel may be the same channel of the endoscope into which the channel insert guide334is inserted as described hereinafter. The top surface336dof the elongate tissue guard336is angled at an approximately 45.degree. angle. With the provided arrangement, and as discussed hereinafter with reference toFIGS. 63-39, the tissue guard336helps fold tissue for stitching and helps prevent tissue which is drawn into the cap assembly from clogging the endoscope channel and preventing stitching.

For purposes of example only, and not by way of limitation, in the shown embodiment, the elongate needle guard338has a height of between approximately 18 mm and 19 mm, and forms an arched opening between two arms338a,338bwhich have outside surface spaced approximately 5 mm apart from each other and inside surfaces spaced approximately 3.7 mm from each other. The arms are joined by a top arch338cand an optional cross-member (stop)338dlocated below the arch338c. In between the arms and below cross-member338dis a gear linkage342described hereinafter. In addition, the curved needle holder arm340is arranged such that when a needle is held in the needle holder arm340, in a fully open position, the tip of the needle is preferably located under the arch338cand between the arms338a,338b. The holder arm340can then rotate into a closed position through the arched opening above the gear linkage. Each arm338a,338bhas a width of approximately 0.64 mm and a radial thickness of approximately 2.5 mm.

FIG. 46shows a detailed exploded view of cap assembly322. Needle holder arm340includes a first end340awhich is adapted to frictionally engage a needle assembly, and a second end340bis fixedly secured to needle arm gear link342(e.g., in a receiving hole342adefined therein). By way of example only and not by way of limitation, needle holder arm340bends through an arc of approximately 90.degree. Gear link342is mounted between needle guard arms338a,338band includes a gear portion344which is mounted using pivot pin345through mounting hole346in gear link342to mounting holes (first mounting locations)347defined in the housing (arms) of needle guard338, and an arm or extension portion343. Gear portion344includes lateral gear teeth344a. Similarly, push member gear link348includes gear portion350awith lateral gear teeth350bwhich mesh with gear teeth344a, and an arm350c. Gear link348is mounted using pivot pin351through mounting hole352to mounting holes (second mounting locations)353defined in the housing (arms) of needle guard338. Gear link348is also coupled through mounting hole354in arm350cto push member joint356using pivot pin357and mounting bracket358. Push member joint356is fixedly coupled to transmission member330.FIGS. 47 and 48show cap assembly322assembled where gear portion of gear link348intermeshes with gear portion of gear link342such that when transmission member330is advanced gear link348rotates and its gear portion causes the gear portion of gear link342to rotate causing needle holder arm340to move to a closed position. In the closed position, arm343of gear link342extends around and above gear link348and between cross-member338dand arch338c. In the open position (FIG. 45), the arm343of gear link342extends radially outward relative to needle guard arms338a,338b, and the back of the arm350cmay engage the edge of cross-member338dwhich can act as a stop to gear movement.

Cap assembly322may also include a wash deflector360as shown inFIG. 48. The wash deflector redirects fluid from the endoscope to wash the gear mechanism to remove debris. The aforementioned components are all preferably made from biocompatible metals such as stainless steel and titanium although some high strength polymers may be suitable. The vertical positioning of mounting holes347and353in the needle guard arms338a,338breduces the profile of cap assembly322and facilitates delivery of the endoscopic suturing device320to a treatment site.

To aid in the retention of cap assembly322on the distal end of the endoscopeFIGS. 49 and 50illustrate views of cap assembly322where channel lock member324is optionally removably secured in channel lock receiver332by channel lock retention member362. Preferably retention member362is formed of a large bead fixedly secured to the distal end of channel lock member324, whereas channel lock receiver332defines a groove333having a width smaller than the width of the bead. If desired, the channel lock wire or cable324can be welded or otherwise fixed to the channel lock receiver332or to another part of the cap assembly. An additional mechanism to increase the retention of the cap assembly to the distal end of the endoscope is show inFIG. 50where the channel insert guide334has a partially split structure (i.e., one or more longitudinal slits335are provided). The two portions of the split may be biased outwardly such that when they are placed in the instrument channel of the endoscope they apply and outward force to the inner wall of the channel thereby aiding in the retention of the cap assembly to the distal end of the endoscope.FIGS. 51 and 52show how tension is applied to channel lock member324and maintained at the proximal end of the endoscope by using a channel lock tensioner365that secures the proximal channel lock retention member366secured to the proximal end of the channel lock member. The channel lock tensioner365includes a bayonet lock connector370, which couples to the endoscope instrument channel and a spring372which supports a tensioner housing374coupled to a rotatable tensioning wheel376having a tab member378. The proximal end of channel lock member324is threaded through tensioner housing374and through a valve located at the top of the housing, and is positioned within a tab receptacle380. The tab receptacle380secures channel lock retention member366to the tensioner wheel376. The tensioner wheel376can then be rotated (e.g., clockwise) to apply the appropriate tension on the channel lock member and then locked into place by a locking element (not shown). Spring372is used to compensate, by compressing, for the bending of the endoscope to maintain a constant tension on the channel lock member. Alternatively, instead of providing a spring372between the bayonet lock370and the tensioner housing374, the spring can be provided on the wheel376to spring load the wheel toward a desired position (e.g., the position ofFIG. 51). As the channel lock member324is bent along with the scope through a tortuous path, wheel376can rotate against the force of the spring to maintain the desired tension on the channel lock member324.

FIG. 53illustrates needle assembly400which comprises suture402, a needle tip404, a lock gap405and a needle body406. The suture402may be formed of any materials commonly available for surgical suture such as nylon, polyolefins, PLA, PGA, stainless steel, nitinol and others.FIGS. 54A through 54Cshow detailed exploded views of the components of needle assembly400. Needle tip404has a sharp distal end and a hollow proximal end with a swage lip408. Needle body406has a proximal end adapted to fit within the needle holder arm340and a distal end having a suture slot410. Needle body406is adapted to concentrically engage needle tip404and create lock gap405. Flexible suture material402is positioned on the distal end of needle body406extending through the suture slot410. The needle tip404and needle body406are formed from suitable biomaterials and may be made from polymers such as nylon, PEEK, PLA, PGA, PLGA or metals such as stainless steel, nitinol or titanium. The components may be joined using standard joining techniques such as thermal bonding, ultrasonic welding laser welding, adhesives or mechanical crimping.

FIG. 55illustrates a needle capture device450, which includes an elongate catheter or tube452having at its distal end a needle capture assembly454and at is proximal end a button actuator456coupled to handle assembly458. By way of example only, and not by way of limitation, the needle capture device450is a 3 mm tool in that the tube452and the distal end needle capture assembly454are preferably at most 3 mm in diameter. The handle assembly458is preferably adapted to be coupled to the handle assembly operating the needle holder arm of the endoscopic suturing device320for ease of use. Toward that end, handle assembly458is provided with a deflecting tooth lock459aand a generally rigid tooth459bwhich are arranged to engage with reciprocal cavity and locking element in the handle assembly600of the suturing device320as discussed below with reference toFIGS. 58 and 59A-59C.

FIGS. 56A and 56Bshow an enlarged partial cross-sectional view of needle capture assembly454and the distal end460of tube452in closed and open configurations respectively. Slidably positioned within the lumen of tube452is push rod or cable462which has a proximal end mechanically coupled to button actuator456and a distal end coupled to actuator pin464. Actuator pin464is positioned within an angled slot465defined in lever arm466adjacent fixed pivot pin468. At the distal end of lever arm466is an interlock feature470. The distal inner portion of needle capture assembly454forms needle receptacle472. Button actuator456incorporates a spring assembly which places push rod462under a tension load thereby causing lever arm466to remain in an engaged or closed configuration as shown inFIG. 56A. When button actuator456is depressed, push rod462is advanced, there by causing lever arm466and interlock feature470to a disengaging or open configuration as shown inFIG. 56B.FIG. 57illustrates needle assembly400positioned within needle receptacle472of needle capture assembly454. As shown, needle assembly400is secured in place by the interlocking engagement of interlock feature470and lock gap405. In this configuration needle capture device450can be used to deliver the needle through the instrument channel of the endoscope to load the needle assembly into needle holder arm340.

A handle assembly600for the endoscopic suturing device320is seen inFIGS. 58 and 59A-59C. The handle assembly600includes a first stationary handle604and a second rotatable handle608which is rotatably coupled to stationary handle by pivot axle612. The rotatable handle608is spring-biased to the open position seen inFIG. 58by a spring614which sits and is fixed between the handles. The stationary handle604defines a proximal cavity616for receiving the handle assembly458of the needle capture device450. Extending from the stationary handle604is a tube618which terminates in a port620. Port620includes a fluid valve622and a mechanical bayonet lock624for coupling to the proximal end of an endoscope. Also extending from the stationary handle is sheath328which houses the transmission wire330. Second handle608defines a fingers grip section626, and ratcheted locking element628at its proximal end. As described hereinafter, the rotatable second handle608is coupled to the transmission wire330. Movement of the rotatable handle towards the fixed handle causes axial movement (refraction) of the transmission wire330. Movement of the rotatable handle away from the fixed handle causes axial movement (extension) of the transmission wire330in an opposite direction.

Turning now toFIGS. 59A-59C, additional details of the handle assembly600are seen in addition to how the handle assembly458of the needle capture device450interacts with the handle assembly600of the endoscopic suturing device320. More particularly, as seen inFIG. 59A, pivotably coupled to the inside of first handle604by pivot pin632is an actuation pivot element634. The transmission wire330is coupled to the actuation pivot element634at a second location636by a spring638which can move in a predetermined distance in a cavity639defined by fixed handle604. The rotatable handle608is also coupled to the actuation pivot element634at a third location640by bracket642which is coupled to the rotatable handle608by post644. As a result, rotation of the handle608(i.e., squeezing) toward the closed position ofFIG. 59Acauses bracket642to pull location640of the actuation pivot element634downward. Movement of location640downward in turn is accompanied by clockwise rotation of the actuation pivot element634about pivot pin632, and thus backward (clockwise) movement of the connection between spring638and the actuation pivot element634at location636. Movement of spring638backward pulls transmission wire330backward.

Also seen inFIG. 59Ais the interaction of handle assembly600with the handle assembly458of the needle capture device450. More particularly, the stationary handle604is provided with a catch648which extends into cavity616and is designed to engage the flexible tooth (latch)459aof the needle capture device handle assembly458. In addition, cavity616has a bottom proximal ledge650for receiving rigid tooth459b. Tube618which extends out of the stationary handle604extends into a tubular cavity654of the stationary handle604which houses a spring656, thereby spring loading tube618outward.

When it is desired to extend the needle capture device450with its distal needle capture assembly454through the endoscope, the distal end of the needle capture assembly is threaded into cavity616of the stationary handle604, tubular cavity654, tube618, port620and then into the endoscope. The needle capture assembly454is pushed through until the handle458engages the cavity616of the stationary handle604. When pushed as far as possible, rigid tooth459baligns with ledge650, and flexible latch459aengages catch648, thereby locking the needle capture device450in place. Cable462of the needle capture device450with sheath452extends from the button actuator457through the tubular cavity654, through the tube618, and through and out of the port620. To actuate the needle capture assembly, button456is pushed as previously described. Disconnection of the needle capture device450from the handle assembly600is obtained by pressing down on a relieved portion459cof the handle458adjacent and proximal the latch459a, thereby causing the latch to disengage from the catch648, and pulling proximally on the handle458.

As seen best inFIGS. 59B and 59C, the needle capture device handle458is preferably provided with a ratchet locking extension or (hooked) tooth459d. When the needle capture assembly450is in place in the handle600assembly of the endoscopic suturing device, the handles604and608may be locked into place in a closed position by engaging ratcheted locking element or tooth628on rotatable handle608with the similar ratcheted locking extension or tooth459dof the needle capture assembly450(which in turn is locked in stationary handle604) as seen best inFIG. 59C. As will be appreciated, the teeth628and459dare generally laterally offset, but include hooked portions which after sliding past each other, will engage or grip each other, thereby locking in place. Disengagement is obtained by applying a relative lateral force to one or both of the handles.

An innovative suture dispenser500having a dispenser body502and a removable needle shield tab504is shown inFIG. 60A. The suture dispenser500is shown inFIG. 60Bwith the needle shield tab504removed from the dispenser revealing a needle retaining member506. To better illustrate the suture dispenser500,FIG. 60Cshows an exploded perspective view of the components. Suture dispenser500includes a lower body508and upper body510which together form a cavity which houses suture spool512containing suture402, needle shield504and needle retaining member506. The lower and upper bodies508,510preferably include ribs508a,508b(similar ribs on upper body not shown) on and about which spool512rests so that spool512can rotate with a minimum of friction in the cavity. The lower and upper bodies508,510are also each preferably provided with walls513a,513b,513c(seen inFIG. 60Conly with respect to lower body508) which retain the needle retaining member506in place but permit the needle shield tab504to be removed. More particularly, wall513ais seen to form a back wall for the needle retaining member. It includes a cutout or orifice513dfor receiving a rear portion of the needle retaining member (and needle) and it angles at513eto join outer wall513c. Wall513bis a low wall which is placed in between walls513aand513cand is connected to the angled portion513eof wall513a. Wall513beffectively forms two grooves with the first groove seating the needle retaining member506and holding it in place and the second groove seating a portion of the needle shield tab504. Needle shield tab, however extends out of a radial opening or orifice in outer wall513cand can be pulled out (i.e., can slide out) completely to reveal a receiving cavity514in the needle retaining member506. The outer wall513cis also provided with an opening or orifice513fin front of the receiving cavity514. The suture dispenser500and most of its components are easily fabricated at low cost using suitable polymers, such as polyethylene, polypropylene or polystyrene, injection molding and preferably designs which snap together (e.g., latches508cand hollow receiving post508don lower body508, and catches510cand post (not shown) on upper body510).

As seen inFIG. 60B, needle shield504is preferably provided with prongs504a. The prongs are squeezably held between ribs (not shown) extending from the lower and upper bodies508,510in order to hold the needle shield504in place. However, because the prongs are resilient, application of force to the tab portion504bof the needle shield504, permits the needle shield504to be removed from the dispenser body502.

As previously mentioned, needle retaining member506includes a needle receiving cavity514as shown inFIGS. 61A and 61Bwhere removable needle assembly400is held. As shown in the partial cross-section view ofFIG. 61B, needle body406is frictionally held within an orifice514adefined in the body of retaining member506(in much the same manner it is frictionally held in the needle holder arm340(FIG. 46) and the needle is connected to suture402which is wound on the suture spool. Needle tip404is accessible to the needle capture assembly454through needle receiving cavity514; i.e., the cavity provides room around the needle tip to permit the needle capture assembly to enter the cavity and grab the needle. Also as shown inFIG. 61B, the needle retaining member506has laterally elongated upper and lower flanges514bwhich are receiving and seat in the grooves formed by the walls513a,513bof the lower and upper bodies508,510of the suture dispenser500. The body of the needle retaining member has a cylindrical portion which extends backward through the orifice513dof the inner wall513a.

FIGS. 62A and 62Bshow the suture dispenser500receiving the needle capture assembly454of needle capture device450.FIG. 62Bshows a partial cross section view of the needle capture assembly454interlockingly engaged with the needle for removal from the dispenser.

FIG. 63throughFIG. 69depicts a method of performing a suturing operation using an endoscopic suturing device320of the present invention. As shown inFIG. 63, the endoscopic suturing device320is positioned adjacent tissue154which has a tissue defect156to be closed. The endoscopic suturing device320is in an open configuration and the tip of needle assembly400is shrouded by needle guard338.FIG. 64shows the tissue grasper26is extended from the endoscope instrument channel such that helical tip42is adjacent tissue defect156. Rotation of the tissue grasper26causes the helical tip42to securely engage the tissue154adjacent to the tissue defect156. The tissue154may be brought closer to the endoscope by slightly retracting the tissue grasper26into the instrument channel of the endoscope as shown inFIG. 65. During the retraction of tissue, the needle guard338prevents the tissue from dragging against the tip of needle assembly400, thereby reducing inadvertent tissue damage. The degree of tissue retraction correlates to the size and location of the stitch. For instance to have a larger amount of tissue sutured, the tissue grasper may bring the tissue154close to the endoscope as shown inFIG. 66. When attempting to suture a large amount of tissue, the position of the angled distal end of tissue guard336, in conjunction with the needle guard338, aids in folding the tissue in preparation for suturing and preferably aids in preventing the tissue from locating immediately adjacent and thereby clogging the needle capture device. The needle holder arm340is actuated to move to a closed position causing the needle assembly400to pierce tissue154. The angled portion of tissue guard336provides support for the tissue allowing the needle to more easily penetrate the tissue as shown inFIG. 67. The suture402is pulled through the tissue as shown inFIG. 68. The control over the amount of tissue retracted allows the physician the ability to perform a partial thickness stitch within the wall of a tissue or a full thickness stitch which extends through a wall of tissue. The needle capture device captures the needle assembly400and removes it from the needle holder arm340(not shown).FIG. 69shows the needle holder arm340moved to an open configuration and removed from tissue154. Suture402remains through the tissue. To continue a running stitch, the needle holder arm can be reloaded with the needle assembly without needing to remove the endoscopic suturing device from the body as previously described. If only one stitch is required the suture may be tied into a surgical knot or a cinch device used to secure the suture, thereby closing the tissue defect.

FIG. 70illustrates an endoscope system710which comprises an endoscope712having an insertion tube714and an endoscopic suturing device720as part of an endoscopic treatment system according to another embodiment of the present invention.FIGS. 71 through 72Billustrate respectively the proximal and distal portions of endoscope712and endoscopic suturing device720. The endoscopic suturing device720has an operable handle722which is removably coupled to endoscope712at the instrument channel housing723by handle bracket724with a movable joint726. Instrument channel housing723of endoscope712allows access to first and second instrument channels728and729, respectively. The endoscopic suturing device720includes an elongate needle capture device730that extends to the distal end of endoscope712and slidably positioned within instrument channel729. The needle capture device730also includes a handle731. The endoscopic suturing device720is operated by handle722which is proximally coupled to transmission assembly732which extends distally along the exterior of insertion tube714to the distal of endoscope712. The transmission assembly732is coupled at its distal end to a cap assembly733which is positioned over the distal end of endoscope712.FIGS. 72A and 72Bshows cap assembly733having a cap base734, a lower mounting portion794to mount the cap base to the endoscope, a tissue guard736, a needle guard738, a needle holder arm740and a needle assembly741. The needle holder arm740is shown in a closed position which places needle assembly741partially inside of tissue guard736. Needle holder arm740is rotatably coupled to gear assembly742and is operated by axial movement of elongated transmission member744through transmission catheter746of transmission assembly732. The distal end of transmission catheter746is fixed to cap base734.FIGS. 73A and 73Bshow cap assembly733coupled to the distal end of endoscope712where needle holder arm740is in an open position. In the open position, needle assembly741, which is removably coupled to needle holder arm740, is shielded within needle guard738and suture748is visible extending into instrument channel729. InFIG. 73Bsuture748is shown extending into instrument channel729adjacent the needle capture device distal end750.

FIG. 75illustrates a detailed exploded view of the components of cap assembly733. Transmission member744is fixedly coupled to a push member joint752having mounting bracket754. Push member gear link755, having a mounting hole756, is pivotably coupled to mounting bracket754by securing pivot pin757through mounting bracket754and mounting hole756. Push member gear link755also includes mounting hole758and lateral gear teeth759. Needle holder arm gear link760includes a mounting hole762, adjacent lateral gear teeth764, and a needle holder arm mounting hole766. Needle guard738is generally formed of two pieces comprising a “U” shaped upper portion770, having a wide needle cover772and includes a pair of mounting holes774(one on each side of the “U”) for additional components and a lower portion776that extends the legs of the “U” which is fixedly coupled to both the upper portion770and cap base734and includes two pair of mounting holes778and780. Needle holder arm gear link760is secured to lower portion776by positioning pivot pin782through mounting hole778and mounting hole762. The lateral gear teeth759of push member gear link755are positioned to intermesh with the lateral gear teeth764of needle holder arm gear link760and the two gear links are secured by positioning pivot pin784through mounting hole780in lower portion776and mounting hole758in push member gear link755. Pin786is positioned in mounting hole774of upper portion770and serves to prevent undesirable movement of needle holder arm link760. Needle holder arm end effector740is coupled to needle holder arm gear link760by fixedly securing needle holder arm end788within mounting hole766. Needle holder arm740includes a straight tip member790adapted to engage needle assembly741and defining a longitudinal axis therethrough. Tissue guard736has a generally cylindrical shape and tubular form with a distal or upper portion792having a distal surface792aobliquely angled relative to a longitudinal axis through the tissue guard, and a suture passage recess792bthrough which suture may extend from within the working channel of the endoscope toward the refracted needle assembly741mounted on the needle holder arm740(FIG. 73B). The lower mounting portion794has a generally cylindrical shape and tubular form that is provided in axial alignment with the tissue guard736. The tissue guard736and lower mounting portion794are preferably integrally formed from a common tubular member, and an opening extends longitudinally through both the tissue guard736and lower mounting portion794. A proximal portion of the mounting portion794tapers to a smaller profile in a direction transverse to its longitudinal axis without decreasing the diameter of the opening through the mounting portion to aid in its insertion into the instrument channel729, as discussed in more detail below. In one embodiment, the proximal end of the mounting portion794has a planar end surface794aoriented at an oblique angle relative to the longitudinal axis through the mounting portion794(see alsoFIG. 74). Alternatively, the proximal portion may include a surface that taper along a sloped curve to a reduced end cross-sectional profile. A base mounting stop796is located between the upper and lower portions to properly position the guard736and mounting portion794on the cap base734. An elongate slot797in the wall of tissue guard736extends from lower mounting portion794through base mounting stop796and a portion of upper portion792. The slot797may be straight, as shown inFIG. 75, or as shown in the alternative embodiment ofFIG. 75A, the slot797amay be non-straight, e.g., extending in a zig-zag. Such non-straight extending slot797areduces potential interference with suture extending in proximity to the slot. Cap base734includes a mounting hole798in which to position lower mounting portion794. Base mounting stop796mates about mounting hole798to properly longitudinally portion the tissue guard736and the mounting portion794and is subsequently fixedly secured, preferably by laser welding. Lower mounting portion794is preferably formed of a resilient material and has an outer diameter which is slightly larger than the diameter of the instrument channel of the endoscope. The outwardly biased diameter of lower mounting portion794may be temporarily compressed or squeezed using a fingers or a tool (not shown) to reduce the diameter for insertion into the instrument channel. Once the compression source is removed the resilient bias of the lower portion794outer diameter engages with the inner diameter wall of the instrument channel with sufficient force to retain cap assembly733on the distal end of endoscope712.

FIG. 76Aillustrates needle assembly741which comprises a preferably straight, hollow needle body800, a straight needle tip802and suture748. Needle body800is preferably formed from a hypotube of suitable biocompatible material. Needle body800is preferably processed, by laser cutting, to form various features in the wall of the tube along the length of the tube such as tip tabs804aand804blocated at one end of the tube, suture tabs806aand806b, needle holder arm tabs808aand808bat the other end of the tube, as well as, suture hole809positioned generally in the middle of the tube.FIG. 76Bshows an exploded view of needle assembly741to provide further component detail. Needle tip802has a sharp end810, a capture groove portion812, a tab groove portion814, a cap plug portion816positioned between the grooves and a blunt end portion817.FIG. 77AandFIG. 77Bdepict two partial cross sectioned views of needle assembly741. As shown, blunt end portion817of needle tip802is positioned within the lumen of needle body800such that tip tabs804aand804bare adjacent tip groove portion814. As shown, cap plug portion816, plugs one end of needle body800. Tip tabs804aand804bare plastically deformed towards the lumen of needle body800to engage tab groove portion814thereby providing a mechanical interlock securing needle tip802to needle body800. Suture748has an end portion818that is positioned within needle body800through suture hole809adjacent blunt end portion817. Suture tabs806aand806bare plastically deformed inwardly towards the lumen of needle body800to secure suture end818within the lumen of needle body800. Needle holder arm tabs808aand808bare also plastically deformed towards the lumen of needle body800. To aid in piercing tissue, sharp end810of needle tip802has a first taper region820and a second taper region822.

FIG. 78illustrates a partial cross sectioned view of tip portion790of needle holder arm740engaged with needle assembly741. Tip portion790having a first, a second and a third portion824,826and828respectively, is positioned within the open end of needle body800. As shown, the diameter of first and third portions824,826are slightly smaller than the inner diameter of needle body800while the diameter second portion826appreciably smaller to define a circumferential groove829between the first and third portions824,828. Needle holder arm tabs808aand808bflex as first portion824enters the lumen of needle body800and elastically recover to engage second portion826of needle holder arm740. To remove needle body800from tip portion790a noticeable force is required to cause the flexure of tabs808aand808bensuring that needle body800does not inadvertently disengage from needle holder arm740. The force to remove the needle body800from the tip portion790is applied in a direction away from the tip portion and coaxial with the axis of the tip portion. Alternatively, other means for attaching the needle body to the needle holder arm can be provided. For example, the needle body may be provided with a plurality of arms into which the needle holder arm is received.

FIG. 79depicts needle capture device730having an elongate primary catheter830that extends from distal end750to proximal handle731. Also extending from the proximal handle731are stiffener sheaths832and834. Primary catheter830may be formed as a coil catheter providing flexibility and some resistance to compression.FIG. 80throughFIG. 82. illustrate cross section views of needle capture device730.FIG. 81shows an enlarged cross section of handle731. Handle731includes a main body836and a button member838. Main body836has a cavity840that is dimensioned to receive shaft portion842of button member838. A spring member844is positioned within cavity840and couples to button member838. An elongate cable846is coupled to shaft842and extends through main body836coupled to primary catheter830to distal end750. Main body836includes a flange portion848, while button member838includes a primary contact point850. Flange portion848is adapted to hold main body836by two fingers while primary contact point850is adapted to engage a thumb to depress button member838. The distal end750of needle capture device730includes a capture housing852having a proximal end853that is coupled to the distal end854of primary catheter830as illustrated inFIG. 82. The primary catheter830and cable846are sized in length to locate a distal end of the capture housing852at the distal end of the instrument channel without protruding therefrom when the needle capture device730is fully inserted into the instrument channel729of the endoscope.

Within the capture housing there is an outer rigid hypotube856, and inner rigid hypotube858and an intermediate rigid hypotube860. Inner hypotube858is positioned within the lumen of intermediate hypotube860which is positioned within the lumen outer hypotube856. The intermediate hypotube860has a proximal end862that is connected to distal end864of cable846. The proximal end866of outer hypotube856is coupled to distal end854of primary catheter830, while the outer hypotube distal end868is coupled to the distal end870of capture housing852. Outer hypotube856includes laser cut tab features872aand872bcut from the wall. Intermediate hypotube860includes elongate laser cut slots874. Inner hypotube858also includes laser cut slots876. Tab features872aand872bare plastically deformed through slots874of intermediate hypotube860to engage the slots876of inner hypotube858, thereby fixedly securing the position of the inner hypotube858relative to the outer hypotube856but allowing the intermediate hypotube860to slide between them for the length of slots874. Outer hypotube856has additional laser cut features within the wall that include a live hinge tab878that includes a latch tab880, and latch release ramp882.

FIG. 83Adepicts an enlarged view of the distal end750of needle capture device730engaged with needle assembly741. Capture housing853includes a plurality of flights884separated by space886radially arrayed about distal end870and a plurality of flights888separated by space890radially arrayed about proximal end853. Flights884and888aid in centering distal end750within tissue guard736to aid in reliably capturing needle assembly741from needle holder arm740during suturing. Spaces886and890between flights allow suture within the instrument channel along side needle capture device730to be freely dispensed as needed during suturing.FIG. 83Bis a cross section view of capture housing852with needle assembly741engaged. As needle assembly741enters outer hypotube856, needle tip802lifts latch tab880. When needle tip802contacts the distal end892of inner hypotube858, latch tab880returns to its normal inward biased position and engages capture groove portion812thereby locking needle assembly741within capture housing852. The strength of this capture engagement is substantially higher than the engagement strength of the needle assembly741to needle holder arm740, such that rotation of the needle holder arm740relative to the engaged needle capture device730or refraction of the engaged needle capture device730relative to the needle holder arm740in a longitudinal direction coaxial with away from the needle coupling tip portion790, will exceed the force by which the needle assembly741is retained on the needle coupling tip portion790causing the needle assembly741to disengage from the needle holder arm740. The distal end894of intermediate hypotube860is positioned proximal to latch release ramp882.

The ability to controllably release needle assembly741is very desirable during an endoscopic suturing procedure. The controlled release allows the physician to reload the needle assembly on the needle holder arm to perform a continuous stitch to release to needle assembly for use as an anchor or t-tag.FIG. 84illustrates a needle assembly741that has been released from needle capture device730. Upon depression of button member838, cable846is advanced distally causing the proximal end862of intermediate hypotube860to move distally relative to outer hypotube856. As the distal end894of intermediate hypotube860contacts latch release ramp882it causes live hinge tab878to raise thereby causing latch tab880to be removed from latch groove portion812of needle tip802.

FIG. 85Adepicts an embodiments of a handle bracket724that includes a molded body portion895having sides896and897. A molded flange898extends around the upper portion of body portion895and sides896and897. A molded socket portion899is positioned at a centered location for coupling with operable handle722.FIG. 85Billustrates an alternate handle bracket900having a molded body portion902with sides904and906and a flange908extending around the upper portion of body portion902and sides904and906. A molded socket portion910is positioned at an off center location adjacent to side904for coupling with operable handle722.

FIG. 86illustrates a back view of operable handle722coupled to handle bracket900having a movable joint726. Handle722includes a molded main body912having a first handle arm914, a second handle arm916and a cover member918.FIG. 87Ashows handle722without cover member918and handle bracket900revealing the inner assembly of main body912and affixed ball member920. Spindle member922is centrally positioned within main body912. First handle arm914is integrally formed with plate923and transmission member housing924and rotatably positioned on spindle member922. Spring member926is shown protruding through spring slot927in plate923. Indexer member928is shown protruding through indexer slot929of plate923. Movement of indexer member928is restricted to positions defined by indexer path930which takes the form of a molded guide path in main body912.FIG. 87Bshows a partial section view of handle722revealing the inner portion of transmission member housing924. Leaf spring member932has a second arm end934positioned adjacent second arm handle916and a transmission member end936positioned adjacent to transmission member744. Transmission member744is fixedly coupled to leaf spring932at joint937. Retaining member938is coupled to transmission catheter746and positioned within transmission member housing924of plate923. To ensure that plate923rotates about spindle922appropriately, guide member940positioned on main body912extends through arcuate guide slot941of plate923. Also positioned on main body912is spring stop member942that maintains the position of one end of spring member926. Indexer path930includes lock position944in which first arm handle914may be temporarily locked when closed.FIGS. 88A and 88Bshow handle722in a closed and locked position. First handle arm914is shown positioned adjacent second handle arm916. Transmission member housing924is shown rotated about spindle922such that transmission catheter746is advanced distally relative to transmission member744causing needle holder arm740of cap assembly733to close. (FIG. 74) Spring member926is compressed due to the rotation of plate923about spindle member922. Further compression of first handle arm914causes indexer member928to move from temporary lock position944and follow indexer path930to a position where the stored energy of compressed spring member926is released to cause the rotation of transmission member housing924which retracts transmission catheter746relative to transmission member744to thereby open needle holder arm740of cap assembly733.

FIG. 89illustrates a suture dispenser950that includes a molded base member952having a generally oval shape, a raised outer wall953and a flexible cover member954. Cover member954has an access aperture955to access needle assembly741. Cover member954has a shape and dimensions to be inserted within outer wall953and is secured to base member952via a plurality of molded tabs956attached to outer wall953and being projected inwardly in a plane generally parallel to base member952.FIG. 90shows an exploded view of suture dispenser950. Molded base member952also includes a raised inner wall958having a plurality of molded winding tabs960and962attached to inner wall958curved sections961and963extending towards the outer wall953in a plane generally parallel to base member952. Molded base member952further includes a needle housing support member964having a needle holding aperture966for holding needle assembly741. Suture748is wound around the inner wall958and positioned between winding tabs960and962and base member952with needle assembly741being positioned in needle holding aperture966.FIG. 91illustrates capture housing852of the distal end750of needle capture device730engaging needle assembly741through access aperture955of suture dispenser950.

FIG. 92throughFIG. 99depicts a method of performing a suturing operation using an endoscopic suturing device720of the present invention. As shown inFIG. 92, the endoscopic suturing device720is positioned adjacent tissue154which has a tissue defect156to be closed. The endoscopic suturing device720is in an open configuration and the tip of needle assembly741is shrouded by needle guard738.FIG. 93shows the tissue grasper970is extended from the endoscope instrument channel such that helical tip972is adjacent tissue defect156. Rotation of the tissue grasper970causes the helical tip972to securely engage the tissue154adjacent to the tissue defect156. The tissue154may be brought closer to the endoscope by slightly refracting the tissue grasper970into the instrument channel of the endoscope as shown inFIG. 94. During the retraction of tissue, the needle guard738prevents the tissue from dragging against the tip of needle assembly741, thereby reducing inadvertent tissue damage. The degree of tissue retraction correlates to the size and location of the stitch. For instance to have a larger amount of tissue sutured, the tissue grasper may bring the tissue154close to the endoscope as shown inFIG. 95. When attempting to suture a large amount of tissue, the position of the angled distal end of tissue guard736, in conjunction with the needle guard738, aids in folding the tissue in preparation for suturing and preferably aids in preventing the tissue from locating immediately adjacent and thereby clogging the needle capture device. The needle holder arm740is actuated to move to a closed position causing the needle assembly741to pierce tissue154. The angled portion of tissue guard736provides support for the tissue allowing the needle to more easily penetrate the tissue as shown inFIG. 96. The suture748is pulled through the tissue as shown inFIG. 97. The control over the amount of tissue retracted allows the physician the ability to perform a partial thickness stitch within the wall of a tissue or a full thickness stitch which extends through a wall of tissue. The needle capture device captures the needle assembly741and removes it from the needle holder arm740(not shown).FIG. 98shows the needle holder arm partially refracted from the tissue illustrating needle holder arm tip790contacting tissue.FIG. 99shows the needle holder arm740moved to an open configuration and removed from tissue154. Suture748remains through the tissue. To continue a running stitch, the needle holder arm can be reloaded with the needle assembly without needing to remove the endoscopic suturing device from the body as previously described. If only one stitch is required the suture may be tied into a surgical knot or a cinch device used to secure the suture, thereby closing the tissue defect.

FIG. 100illustrates tissue grasping instrument according to another embodiment of the present invention. Helical tissue grasper1000is shown having an elongate catheter1010with a handle1012positioned at its proximal end. Handle1012has a main body1014coupled to catheter1010and rotatable knob1016for rotating helix member1018positioned at the distal end of catheter1010.FIG. 101Ashows exploded view of the proximal portion of helical tissue grasper1000. Rotatable knob1016includes an elongate shaft1020, a mounting portion1022positioned between extension arms1024and1026that extend from shaft1020. Positioned at the ends of extension arms1024and1026are engagement tabs1028and1030respectively. Proximal to engagement tabs1028and1030also positioned on extension arms1024and1026are guide members1032and1034respectively. Rotatable knob1016is preferably formed as a molded plastic part with shaft1020, mounting portion1022, extension arms1024and1026, engagement tabs1028and1030, guide members1032and1034all being integrally formed. Guide members1032and1034are spaced apart and extend from their respective extension arm towards the other extension arm. Actuation member1036having proximal end1037and angled proximal tip1038is shown extending through receiving cavity1040of main body1014and strain relief member1042.FIG. 101Bshows an exploded view of the distal portion of helical tissue grasper1000. Shown extending from Distal end1044of catheter1010is distal end1046of actuation member1036. Actuation member1036preferably takes the form of an elongate flexible resilient wire, however, other forms such flexible torque transmitting multi-filament cables, laser cut hypotubes or catheters may also be suitable. Also shown are bearing sleeve1048and helix member1018having proximal portion1050, intermediate portion1052, distal portion1054and distal tip1056. Helix member1018preferably takes the form of a coil formed of round wire having a closed pitch at proximal portion1050and an expanded pitch at intermediate and distal portions1052and1054. Distal portion1054of helix member1018is preferably flattened towards sharpened distal tip1056.

FIGS. 102A and 102Billustrate partial sectioned views of proximal and distal portions of assembled helical tissue grasper1000where helix member1018is in a delivery configuration. Rotatable knob1016is shown coupled to main body1014such that shaft1022is inserted into receiving cavity1040. Engagement tabs1028and1030of extension arms1024and1026interlockingly engage circular first groove1058of main body1014. Positioned distal to circular first groove1058in cavity1040is circular second groove1060. Proximal tip1038of actuation member1036is coupled to mounting portion1022of shaft1020thereby restricting longitudinal movement of actuation member1036relative to rotatable knob1016. Guide members1032and1034are positioned about proximal end1037of actuation member1036to restrict lateral movement of proximal end1037relative to rotatable knob1016. Actuation member1036extends through the proximal end of catheter1010and strain relief1042which are coupled to the distal end of main body1014to catheter distal end1044. Distal end1046of actuation member1036is positioned through the lumen of bearing sleeve1048adjacent proximal portion1050of helix member1018. Actuation member distal end1046is preferably secured to both bearing sleeve1048and proximal portion1050through laser welding. Additionally, proximal portion1050of helix member1018may be joined directly to bearing sleeve1048. As depicted inFIGS. 102A and 102Bwhen engagement tams1028and1030are interlockingly positioned within circular first groove1058, helix member1018is fully positioned within the lumen of catheter1010at distal end1044providing a delivery configuration for helical tissue grasper1000. In the delivery configuration, sharpened distal tip1056is shielded by catheter1010preventing potential damage to the instrument channel during insertion through the endoscope.FIGS. 103A and 103Billustrate partial sectioned views of proximal and distal portions of assembled helical tissue grasper1000where helix member1018in a deployed configuration. Rotatable knob1016is advanced distally relative to main body1014such that engagement tabs1028and1030disengage from circular first groove1058and interlockingly engage circular second groove1060. Distal movement of rotatable knob1016relative to main body1014causes actuation member1036and helix member1018to move distal relative to catheter1010such that the intermediate and distal portions1052and1054and sharpened distal tip1056extend distal to catheter distal end1044providing a deployed configuration. While in the delivery or deployed configurations rotation of rotatable knob causes the rotation of helix member1018through the rotation of actuation member1036. In the deployed configuration sharpened distal tip1056is exposed and free to engage tissue.

The present invention has been described in conjunction with the preferred embodiments shown in various drawings. Obviously, however, other similar embodiments can be used to realize the same functions as those of the present invention, the above embodiments can be modified, or other embodiments can be added. The present invention is not therefore limited to any single embodiment. For example, each treatment device described above can be used together with a rigid endoscope, trocar, or the like as well as flexible endoscopes. Also, while particular sizes and shapes were described with respect to the end cap, needle guard, tissue guard, etc. of a particular embodiment, other sizes and shapes could be utilized. For purposes of understanding the specification and claims, where the terms “substantially” or “approximately” are used, they should be understood to provide a range of plus or minus 20%, For example, an angle of “approximately 180 degrees” should be understood to include an angle in the range of 144 to 216 degrees. A size of “substantially 2 mm” should be understood to include a size in the range of 1.6 to 2.4 mm. Further, it should be appreciated that different aspects of each embodiment can be used in conjunction with the other embodiment. By way of example only, the handle assemblies for the needle capture device and for the endoscopic suturing device of the various embodiments may be used interchangeably across the various embodiments. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.