Suturing instrument with deflectable head

Suturing instruments in accordance with the invention are dimensioned and configured to apply sutures to approximate, ligate, or fixate tissue in, for example, open, mini-incision, trans-vaginal, laparoscopic, or endoscopic surgical procedures. In some embodiments, the suturing instruments include a distal portion that is deflectably and/or pivotally coupled to the remainder of the instrument for improved maneuverability and functionality during surgery. In other embodiments, the suturing instruments are capable of housing multiple needle and suture assemblies and/or reloading the needle and suture assembly without removing the instrument from the surgical site.

TECHNICAL FIELD

The invention relates to medical devices and, more specifically, to devices for approximation, ligation, or fixation of tissue using sutures.

BACKGROUND INFORMATION

Suturing of body tissue is a time consuming aspect of many surgical procedures. For many surgical procedures, it is necessary to make a large opening in the human body to expose the area that requires surgical repair. There are instruments available that allow for viewing of certain areas of the human body through a small puncture wound without exposing the entire body cavity. These instruments, called endoscopes, can be used in conjunction with specialized surgical instruments to detect, diagnose, and repair areas of the body that previously required open surgery to access.

Some surgical instruments used in endoscopic procedures are limited by the manner in which they access the areas of the human body in need of repair. In particular, the instruments may not be able to access tissue or organs located deep within the body or that are in some way obstructed. Also, many of the instruments are limited by the way they grasp tissue, apply a suture, or recapture the needle and suture. Furthermore, many of the instruments are complicated and expensive to use due to the numerous parts and/or subassemblies required to make them function properly.

Suturing instruments, and more specifically suturing instruments used in endoscopic procedures, are generally rigid and do not provide the operator a range of motion to access difficult to reach parts of the anatomical region requiring sutures. Accordingly, multiple instruments of various configurations and sizes must be used to access all of the necessary tissue areas. These limitations of suturing instruments complicate the endoscopic procedure for the surgeon by requiring the insertion and removal of multiple instruments from a surgical site as the target suturing area changes during the course of the surgical procedure.

Many medical procedures require that multiple sutures be placed within a patient. Typical suturing instruments enable a surgeon to place only one suture at a time. With such suturing instruments, the surgeon is required to remove the instrument from a surgical site and reload the instrument between placing each suture. Further, the surgeon may be required to use forceps or other instruments to help place the suture. In some instances, the forceps or other instruments may require an additional incision to access the surgical site.

Thus, suturing remains a delicate and time-consuming aspect of most surgeries, including those performed endoscopically. Accordingly, there is an unresolved need in the art to provide a suturing instrument with improved maneuverability, efficiency, and functionality during a surgical procedure.

SUMMARY OF THE INVENTION

The invention generally relates to surgical instruments for performing a surgical procedure, such as placing one or more sutures through tissue. The suturing instruments disclosed herein are dimensioned and configured to apply sutures to approximate, ligate, or fixate tissues in, for example, open, mini-incision, trans-vaginal, laparoscopic, or endoscopic surgical procedures.

More particularly, in some embodiments, the invention is directed to suturing instruments that include a distal portion that is deflectably and/or pivotally coupled to the remainder of the instrument for improved maneuverability and functionality during surgery.

In other embodiments the invention is directed to suturing instruments capable of housing multiple needle and suture assemblies and/or reloading the needle and suture assembly without removing the instrument from the surgical site. Such suturing instruments allow a surgeon to place multiple sutures without having to reload the instrument after each suture is placed, which is more efficient and less invasive than a procedure where the surgeon has to remove the instrument from the surgical site to reload. This is particularly helpful when the surgical site is located deep within a body and not easily repeatably accessible.

In general, in a first aspect, the invention features a suturing instrument that includes an elongate body member having a middle portion and a distal portion. The distal portion extends distally from the middle portion and is deflectable at a predetermined angle relative to the middle portion. The predetermined angle of deflection of the distal portion may range from about −90° to about 90°. The suturing instrument also includes a needle deployment mechanism disposed at least partially within the elongate body member. The needle deployment mechanism is connectable to a needle for moving the needle out of the distal portion of the elongate body member.

In one embodiment according to the first aspect of the invention, the elongate member also includes at least one tension member that is slidably disposed at least partially in the elongate member and is connected to its distal portion. In this embodiment, the suturing instrument may include at least one deflection control member coupled to the tension member and disposed opposite the distal portion of the elongate body member for controlling deflection of the distal portion.

In another embodiment according to the first aspect of the invention, the distal portion is pivotable about a first axis that is perpendicular to the longitudinal axis of the elongate body member. In this embodiment, the suturing instrument may include a first pivot control lever disposed opposite the distal portion of the elongate body member, and a pivot wire rotatably disposed in the elongate body member and coupled to the distal portion. The first pivot control lever may be coupled to the pivot wire for controlling pivoting of the distal portion.

In yet another embodiment according to the first aspect of the invention, the distal portion includes a first beveled surface for contacting the middle portion and the middle portion includes a second beveled surface for contacting the distal portion. According to one feature of this embodiment, a first angle defined by the first beveled surface and a second angle defined the second beveled surface are substantially equal. The sum of the angles may substantially equal 90°. According to another feature, the elongate body member includes a first resilient member for biasing the distal portion towards the middle portion along a longitudinal axis of the elongate member. The suturing instrument of this embodiment may also include a deflection control mechanism coupled to the distal portion for deflecting the distal portion at the predetermined angle relative to the middle portion by rotating the distal portion about a longitudinal axis of the elongate body member.

In still another embodiment according to the first aspect of the invention, the elongate body member includes a locking mechanism for securing the distal portion at the predetermined angle relative to the middle portion. The locking mechanism may include a first plurality of teeth disposed on the first beveled surface and a second plurality of teeth disposed on the second beveled surface that are configured to mesh with the first plurality of teeth. Alternatively, the locking mechanism may include a plurality of detents that are defined by the first beveled surface and are circumferentially disposed about the first beveled surface; and a ball disposed in the second beveled surface and dimensioned to fit at least one of the plurality of detents. In this feature, the second beveled surface may define an aperture for receiving the ball therein. Also, a second resilient member may be disposed in the aperture for biasing the ball into engagement with the at least one of the plurality of detents.

In yet another embodiment according to the first aspect of the invention, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion. The needle deployment mechanism optionally includes an actuator coupled to the needle carrier and disposed opposite the distal portion. The actuator may be at least partially housed by a handle disposed opposite the distal portion.

The invention is also related generally to a method for placing sutures in tissue. The method includes the step of providing a suturing instrument having an elongate body member that includes a middle portion and a distal portion extending distally from the middle portion and deflectable at a predetermined angle relative to the middle portion; and a needle deployment mechanism disposed at least partially within the elongate body member and connectable to a needle for moving the needle out of the distal portion. The method further includes the steps of disposing a needle within the distal portion; disposing the suturing instrument in a body; deflecting the distal portion of the suturing instrument thereby positioning the distal portion proximal to the tissue; and actuating the needle deployment mechanism thereby moving the needle out of the distal portion and through the tissue.

In general, in a second aspect, the invention features a suturing instrument that includes an elongate body member having a longitudinal axis. The elongate body member has a distal portion that is pivotable about at least one axis that is substantially perpendicular to the longitudinal axis of the elongate body member. The suturing instrument also includes a needle deployment mechanism disposed at least partially within the elongate body member. The needle deployment mechanism is connectable to a needle for moving the needle out of the distal portion. Also, the elongate body member may include a handle disposed opposite the distal portion.

In one embodiment according to the second aspect of the invention, the suturing instrument also includes a pivot control lever disposed opposite the distal portion of the elongate body member for controlling pivoting of the distal portion. In a first version of this embodiment, the suturing instrument includes a pivot mechanism disposed in the elongate body member and coupled to the distal portion. The pivot control lever may be coupled to the pivot mechanism for controlling pivoting of the distal portion. In a second version of this embodiment, the elongate body member may include an inner portion coupled to the distal portion, and an outer portion coupled to the pivot control lever and slidably disposed at least partially along the inner portion. According to one feature, the suturing instrument also has a linkage coupled to the outer portion and the distal portion. The linkage is configured to cause the distal portion to pivot about the first axis when the outer portion is displaced relative to the inner portion. According to another feature, the suturing instrument also includes a resilient member for biasing the outer portion towards the proximal portion of the elongate body member.

Further, in various features of the needle deployment mechanism of this embodiment of the suturing instrument, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion.

According to one particular feature of the second version of this embodiment, the needle deployment mechanism also has a resilient loop of material disposed at least partially within the elongate body member and coupled to the needle carrier. The needle deployment mechanism also includes an actuator that is coupled to the needle carrier via the resilient loop of material to move the needle carrier of the distal portion. The actuator may be at least partially housed by the handle.

According to another feature, the needle deployment mechanism also includes a needle carrier control rod that is slidably disposed at least partially within the elongate body member and coupled to the needle carrier. The needle carrier control rod may optionally be made of a superelastic material, such as a nickel-titanium alloy. The needle carrier control rod is configured to move the needle carrier when the needle carrier control rod is slidably advanced. The needle deployment mechanism may include an actuator coupled to the needle carrier control rod to advance the needle carrier control rod. The actuator is disposed opposite the distal portion of the elongate member, for example, at least partially housed by the handle.

According to yet another feature of the second version of this embodiment, the needle deployment mechanism also includes a camshaft disposed within the distal portion of the elongate body member and coupled to the needle carrier and a drum rotatably disposed within the distal portion of the elongate body member and coupled to the camshaft for moving the camshaft when the drum rotates. The needle deployment mechanism according to this feature further includes a push wire slidably disposed within the elongate body member and having a distal end coupled to the drum for causing the drum to rotate. The needle deployment mechanism may also include an actuator coupled to a proximal end of the push wire for advancing the push wire. The actuator is disposed opposite the distal portion of the elongate member, for example, at least partially housed by the handle.

In another embodiment according to the second aspect of the invention, the distal portion of the suturing instrument includes a first gear that is rotatable about a first axis substantially perpendicular to the longitudinal axis of the elongate body member. According to one feature of this embodiment, a middle portion of the elongate body member includes a second gear rotatable about the longitudinal axis and meshed with the first gear. According to this feature, the distal portion pivots about the first axis when the second gear rotates about the longitudinal axis. Optionally, the suturing instrument includes a pivot control mechanism disposed at least partially within the middle portion and coupled to the second gear for causing the second gear to rotate about the longitudinal axis, a pivot control lever disposed opposite the distal portion of the elongate body member and coupled to the pivot control mechanism for controlling pivoting of the distal portion.

In yet another embodiment according to the second aspect of the invention, the distal portion is rotatable about the longitudinal axis of the elongate body member. In this embodiment, the suturing instrument may include a rotation control mechanism disposed opposite the distal portion of the elongate body member, and a rotation rod rotatably disposed in the elongate body member and coupled to the distal portion. The rotation control mechanism may be coupled to the rotation rod for controlling rotation of the distal portion.

In general, in a third aspect, the invention features a suturing instrument for use with an endoscope. The suturing instrument according to this aspect of the invention includes an elongate body member having a flexible tubular member and a distal portion attached to a distal end of the flexible tubular member. The flexible tubular member is dimensioned to slidably and rotationally fit within a working channel of an endoscope. The suturing instrument according to this aspect of the invention also includes a needle deployment mechanism disposed at least partially within the elongate body member and connectable to a needle for moving the needle out of the distal portion.

In one embodiment according to the third aspect of the invention, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion; a carrier drive wire slidably disposed within a lumen defined by the flexible tubular member and coupled to the needle carrier; and an actuator coupled to the carrier drive wire. According to one feature of this embodiment, the elongate body member may include a proximal portion including a handle at least partially housing the actuator. The tubular member may be releasably attached to the proximal portion. Optionally, the distal portion is rotatable about a longitudinal axis of the elongate body member relative to the proximal portion. The suturing instrument may also include a rotation control mechanism disposed in the proximal portion of the elongate body member for controlling rotation of the distal portion. Also, according to this feature, the proximal portion includes a carrier drive wire socket releasably coupled to the proximal portion for receiving the carrier drive wire. The proximal portion may also include a locking socket that is rotationally and releasably coupled to the carrier drive wire socket and serves to secure a proximal end of the tubular member. Further, the proximal portion may also include a scope adapter for securing the proximal portion to the working channel of the endoscope.

In another embodiment according to the third aspect of the invention, the distal portion of the elongate body member is pivotable about a first axis, which is substantially perpendicular to a longitudinal axis of the elongate body member.

Also, the invention features a method for placing sutures in tissue. The method includes the step of providing an endoscope defining a working channel through. The working channel of the endoscope has an opening at a distal end of the endoscope. The method further includes the step of providing a suturing instrument that includes an elongate body member having a flexible tubular member with a distal end and a proximal end; the flexible tubular member dimensioned to slidably and rotationally fit within the working channel of the endoscope, and a distal portion attached to the distal end of the flexible tubular member. The suturing instrument also includes a needle deployment mechanism disposed at least partially within the elongate body member and connectable to a needle for moving the needle out of the distal portion. The method also includes the steps of inserting the proximal end of the flexible tubular member into the opening; passing the flexible tubular member through the working channel of the endoscope, disposing a needle within the distal portion, disposing the endoscope within a body, positioning the distal portion proximal to the tissue, and actuating the needle deployment mechanism thereby moving the needle out of the distal portion and through the tissue.

In various embodiments according to the foregoing aspects of the invention, the suturing instrument includes a needle disposed within the distal portion. Also, the distal portion of the suturing instrument of claim may include a needle catch configured to receive a needle, the needle catch defining a retention slot including at least two flexible edges.

In general, in a fourth aspect, the invention features a suturing instrument that includes an elongate body member having a distal portion. The distal portion includes a needle catch defining an aperture. The suturing instrument according to this aspect of the invention includes a needle deployment mechanism disposed at least partially within the elongate body member for moving a needle out of the distal portion and to the needle catch as well as a needle reloading mechanism disposed at least partially within the elongate body member for pushing the needle into the aperture of the needle catch. The needle catch is optionally slidably movable along a longitudinal axis of the elongate body member.

In one embodiment according to the fourth aspect of the invention, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion. The needle deployment mechanism also includes an actuator that is coupled to the needle carrier and disposed opposite the distal portion of the elongate body member. The needle carrier has a distal end that, optionally, defines a lumen for receiving the needle therein.

In another embodiment according to the fourth aspect of the invention, the needle reloading mechanism includes a pusher rod and a rod actuator for moving the pusher rod towards the distal portion of the elongate body member. According to one feature of this embodiment, the rod actuator is disposed opposite the distal portion of the elongate body member substantially perpendicularly to the pusher rod. According to another feature, the pusher rod comprises a substantially concave distal end. Also, according to yet another feature, the needle reloading mechanism has a hook coupled to a resilient member for biasing the pusher rod away from the distal portion of the elongate body member.

In still another embodiment according to the fourth aspect of the invention, the needle catch defines a retention slot including at least two flexible edges for retaining the needle therein, the retention slot in communication with the aperture. At least one of the flexible edges may have at least one protrusion extending into the retention slot. According to another feature of this embodiment, the suturing instrument includes a needle disposed within the distal portion. The needle has a suture attached thereto and is releasable from the needle catch by pulling on the free end of the suture after the needle reloading mechanism pushes the needle into the aperture.

In yet another embodiment according to the fourth aspect of the invention, the suturing instrument also includes a handle disposed opposite the distal portion of the elongate body member, which at least partially houses the needle deployment mechanism and the needle reloading mechanism.

In general, in a fifth aspect, the invention features a suturing instrument that includes an elongate body member having a distal portion. The distal portion includes a first operative portion and a second operative portion. The suturing instrument also includes a needle deployment mechanism that is disposed at least partially within the elongate body member and includes a first needle carrier disposed at least partially within the first operative portion and connectable to a first needle for moving the first needle out of the first operative portion, and a second needle carrier disposed at least partially within the second operative portion and connectable to a second needle for moving the second needle out of the second operative portion.

In a first embodiment according to the fifth aspect of the invention, the suturing instrument includes a handle that is disposed opposite the distal portion of the elongate body member and at least partially houses the needle deployment mechanism.

In a second embodiment according to the fifth aspect of the invention, the first operative portion and the second operative portion of the distal portion form a unitary operative portion.

In a third embodiment according to the fifth aspect of the invention, the suturing instrument includes an actuator coupled to the first needle carrier and the second needle carrier and disposed opposite the distal portion of the elongate body member. According to one feature of this embodiment, the actuator includes a first sub-actuator coupled to the first needle carrier and a second sub-actuator coupled to the second needle carrier. The first needle carrier and the second needle carrier are actuatable either sequentially or simultaneously.

In a fourth embodiment according to the fifth aspect of the invention, the suturing instrument includes a first needle disposed within the first operative portion, and a second needle disposed within the second operative portion. According to one feature of this embodiment of the suturing instrument, a first suture is attached to the first needle and a second suture is attached to the second needle. According to another feature of this embodiment, the suturing instrument includes a suture having a first end attached to the first needle and a second end attached to the second needle.

In a fifth embodiment according to the fifth aspect of the invention, the distal portion of the suturing instrument includes a first needle catch configured to receive a first needle; and a second needle catch configured to receive a second needle. Optionally, the first needle catch and the second needle catch form a unitary needle catch. At least one of the first needle catch and the second needle catch may define a retention slot including at least two flexible edges.

In a sixth embodiment according to the fifth aspect of the invention, the first operative portion of the distal portion defines a first needle port and the second operative portion of the distal portion defines a second needle port. In this embodiment, the distance between the first needle exit port and second needle exit port is laterally adjustable by deflecting at least one of the first operative portion and the second operative portion outwardly from the elongate body member. According to one feature of this embodiment, the suturing instrument includes a deflecting mechanism for adjusting the distance between the first needle exit port and the second needle exit port. A deflection actuator disposed opposite the distal portion of the elongate body member may be included for actuating the deflecting mechanism. The deflecting mechanism may include, for example, a wedge, a cam, an elbow linkage, a rotational separator, and a track-and-follower assembly.

Lastly, in general, in a sixth aspect, the invention features a suturing instrument that includes an elongate body member having a distal portion. The distal portion includes a needle catch. The suturing instrument also includes a cartridge that is disposed at least partially within the distal portion and houses a first needle and a second needle, as well as a needle deployment mechanism that is disposed at least partially within the elongate body member and is connectable sequentially to the first needle and the second needle for moving the first needle and then the second needle from the cartridge out of the distal portion to the needle catch. The cartridge may be removable from the distal portion of the elongate body member or integrally formed within the distal portion. Also, the distal portion of the elongate body member is optionally rotatable relative to a remainder of the elongate body member.

Further, in one embodiment of the sixth aspect of the invention, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion and an actuator coupled to the needle carrier and disposed opposite the distal portion of the elongate body member.

In another embodiment of the sixth aspect of the invention, the cartridge defines an exit aperture for receiving at least one of the first needle and the second needle. According to one feature of this embodiment, the cartridge further defines a loading slot connected to the exit aperture. At least of the first needle and the second needle can be received in the loading slot. The second needle transitions from the needle loading slot to the exit aperture after the first needle is deployed from the cartridge. In one version of this feature, the suturing instrument includes a pusher for transitioning the second needle from the needle loading slot to the exit aperture after the first needle is deployed from the cartridge through the opening. Optionally, the pusher includes a push plate for contacting the second needle and a resilient member for biasing the push plate towards the exit aperture. In another version of this feature, the suturing instrument includes a suture having one end attached to the second needle, so that the second needle is transitioned from the loading slot to the exit aperture after the first needle is deployed from the cartridge by pulling on the free end of the suture. The suturing instrument may also include a means for pulling the free end of the suture optionally attached to the elongate body member and disposed opposite the distal portion thereof, such as, for example, a spool or a lever.

In yet another embodiment of the sixth aspect of the invention, the cartridge also contains a third needle. In this embodiment, the needle deployment mechanism is connectable sequentially to the first needle and the second needle and the third needle for moving the first needle and then the second needle and then the third needle from the cartridge out of the distal portion to the needle catch.

In still another embodiment of the sixth aspect of the invention, the suturing instrument includes a handle that is disposed opposite the distal portion of the elongate body member and at least partially houses the needle deployment mechanism.

The invention also features a method for placing sutures in multiple tissue sites. The method includes the step of providing a suturing instrument having an elongate body member with a distal portion. The distal portion of the suturing instrument includes a needle catch. The suturing instrument also has a cartridge disposed at least partially within the distal portion. The cartridge includes a first needle disposed within the cartridge and a second needle disposed within the cartridge. Also, the suturing instrument includes a needle deployment mechanism disposed at least partially within the elongate body member and connectable sequentially to the first needle and the second needle. The method of the invention further contemplates the steps of disposing the suturing instrument in a body, positioning the distal portion proximal to a first tissue site in the body, actuating the needle deployment mechanism thereby moving the first needle out of the cartridge to the needle catch, positioning the distal portion proximal to a second tissue site in the body without withdrawing the suturing instrument from the body, moving the second needle in the cartridge, and actuating the needle deployment mechanism thereby moving the second needle out of the cartridge to the needle catch.

In various embodiments according to the foregoing aspects of the invention, the elongate body member is adapted to access remote organs or tissue within a body. Also, the suturing instrument disclosed above may include one, two, or more bends.

Advantages and features of the present invention herein disclosed will become apparent through reference to the following description, the accompanying drawings, and the claims. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations.

DESCRIPTION

Referring toFIG. 1A, in one embodiment, a suturing instrument100includes a handle102, an elongate body member104, and a needle deployment mechanism110disposed within the elongate body member104and the handle102. The suturing instrument100also includes a distal portion106and a proximal portion108. The elongate body member104is mechanically coupled to the handle102at the proximal portion108and the suturing components are at least partially disposed within the distal portion106of the suturing instrument100.

The handle102can take a variety of forms, for example, the handle102could be one of the types compatible with suturing systems available from Boston Scientific Corporation of Natick, Mass., in particular with the Capio® Push & Catch suturing system. A suture clip144may be coupled to the handle102or the elongate body member104and used to hold an end of one or more sutures136prior to placement in a patient. Generally, the needle deployment mechanism110extends longitudinally through the elongate body member104to the distal portion106of the suturing instrument100, where the needle deployment mechanism110is coupled to a needle128(shown inFIG. 2A). The needle deployment mechanism110moves the needle128between a retracted position and a deployed position. One possible needle deployment mechanism110is shown in greater detail inFIGS. 1B and 1C.

Referring toFIG. 1B, in one embodiment, the proximal portion108of the suturing instrument100includes the handle102, the elongate body member104, the suture clip144, and the needle deployment mechanism110. The needle deployment mechanism110includes an actuator button117and a shaft116that together form an actuator112. The needle deployment mechanism110also includes a bearing118and a button end119that defines a hole121formed therein. The hole121is preferably formed along the central longitudinal axis of the button end119. The bearing118rides along the surface of a lumen105that is defined by the inside diameter of the elongate body member104. A wireform103is inserted into the hole121of the button end119, so that the wireform103is coupled to the actuator button117. A spring115encircles the wireform103, abuts the button end119, and is compressed between the button end119and a spring washer113. The spring washer113is seated upon a center tube107. The center tube107is housed by the lumen105and is constrained in the distal portion106. A pusher wire111is attached to the wireform103by means of a weld, a coupling, adhesive, or other means, and is slidably disposed within a guidance sleeve109, the sleeve109being disposed within the surface of a lumen123defined by the inside diameter of the center tube107.

In one embodiment, the pusher wire111is constructed of an elastic material having “superelastic” properties. Such a material may include alloys of In—Ti, Fe—Mn, Ni—Ti, Ag—Cd, Au—Cd, Au—Cu, Cu—Al—Ni, Cu—Au—Zn, Cu—Zn, Cu—Zn—Al, Cu—Zn—Sn, Cu—Zn—Xe, Fe3Be, Fe3Pt, Ni—Ti—V, Fe—Ni—Ti—Co, and Cu—Sn. In the illustrative embodiment, the superelastic material is a nickel and titanium alloy, commonly known as Nitinol® available from Memry Corp of Brookfield, Conn. or SMA Inc. of San Jose, Calif., so chosen for its combination of properties that allow for bendability and high column strength when constrained. The ratio of nickel and titanium in Nitinol® may vary. One preferred example includes a ratio of about 50% to about 56% nickel by weight. Nitinol® also possesses shape retention properties.

Referring toFIG. 1C, the distal portion106of the elongate body member104includes the distal components of the needle deployment mechanism110(described in detail below), an operative portion126, and a needle catch122. In one embodiment, the operative portion126has an arcuate shape and partially encircles a suturing field176. The operative portion126also defines a lumen178therein having a needle exit port120at an opening into the suturing field176. A needle128is disposed in the needle exit port120and is held in place by a slight friction fit. In one embodiment, the suture136is attached to the needle128. The free end of the suture136extends out of a suture slot146.

Referring again to the needle deployment mechanism110, the pusher wire111is attached by welding or other means to a coupling150, which is slidably disposed within a track152. The coupling150is attached to a carrier wire154, which, by virtue of its attachment to the coupling150, is also slidably disposed within the track152. The coupling150abuts a backstop washer156that is slidably disposed about the pusher wire111and is contained within a pocket160that includes a back wall162, against which the backstop washer156rests. The track152terminates distally in a pocket164that includes a wall166. A downstop washer158is slidably disposed about the carrier wire154and constrained within the pocket164.

The carrier wire154is mechanically coupled to an extendable needle carrier124by welding, coupling, use of adhesives, or by other means. The needle carrier124is slidably disposed in the lumen178of the operative portion126and has a lumen125formed at a distal end of the needle carrier124. The lumen125is dimensioned to releasably receive the non-penetrating end of the needle128. The needle carrier124is configured to push the needle128out of the needle exit port120through tissue proximate the suturing field176, and into the needle catch122, as will be described in further detail below. In one embodiment, the needle128is held within the lumen125by a slight friction fit.

FIG. 2Adepicts one embodiment of the needle128for use in a suturing instrument in accordance with the invention. In this embodiment, the needle128includes a penetrating tip130and a shaft134coupled to the tip130, thereby forming a shoulder132. The shaft134is coupled to the suture136. Other configurations of the needle128can also be used without deviating from the scope of the invention. As shown inFIG. 1C, in one embodiment, when the needle128is disposed in the needle exit port120, the free end of the suture136extends out of a needle carrier suture slot148and the suture slot146.

Referring toFIG. 2B, the needle catch122includes openings170defined by successive ribs172. When the needle catch122receives the needle128coupled to the suture136through opening170, the ribs172deflect slightly to allow the needle128to pass through. After the shoulder132has passed the ribs172, the ribs172spring back to their original position defining the openings170, and the needle128remains captured in the needle catch122. The openings170are chosen to be smaller in dimension than the shoulder132. This causes the needle catch122to retain the needle128, because the flat rear surface of the shoulder132prevents the needle128from passing back through the opening170. When it is necessary to remove the needle128from the needle catch122, the needle128may be moved toward an enlarged portion174of the opening170. The enlarged portion174is sized to allow the shoulder132to pass through without resistance. The needle catch122may be constructed of thin stainless steel of high temper, such as ANSI 301 full hard. The needle catch122may be fabricated by means of stamping, laser machining, or chemical etching.

Referring again toFIGS. 1A–1Cand2A–2B, in operation, a user (such as a physician or other medical personnel) actuates the needle deployment mechanism110by pushing on the button117, which, via the attachment to the wireform103, is attached to the pusher wire111, moves the coupling150along the track152concomitantly moving the carrier wire154, which in turn slidably moves the needle carrier124through the lumen178towards the needle exit port120. The user continues to push the button117until the needle carrier124receives the needle128in the lumen125, and further until the needle128penetrates tissue proximate the suturing area176and then enters and is retained in the needle catch122. Then, the user releases the button117and the spring115urges the button117proximally, thereby moving the pusher wire111, the coupling150, the carrier wire154, and the needle carrier124proximally along with the button117to the retracted position. As the needle carrier124moves back to the retracted position, the needle128slides out of the lumen125and the needle is released from the needle carrier124.

In one embodiment, after one or more sutures136have been placed, the user withdraws the suturing instrument100from the patient. The user then detaches one or more sutures136from one or more needles128and ties a knot or knots in the sutures136. The user can then use a knot pusher184to push one or more knots into the patient as the knots are tightened.

The suturing instrument's component materials should be biocompatible. For example, the handle102, the elongate body member104, and portions of the needle deployment mechanism110may be fabricated from extruded, molded, or machined plastic material(s), such as polypropylene, polyethylene, polycarbonate, or glass-filled polycarbonate. Other components, for example the needle128, may be made of stainless steel. Other suitable materials will be apparent to those skilled in the art. The material(s) used to form the suture should be biocompatible. The surgeon will select the length, diameter, and characteristics of the suture to suit a particular application. Additionally, the mechanical components and operation are similar in nature to those disclosed in U.S. Pat. Nos. 5,364,408 and 6,048,351, and commonly owned U.S. patent application Ser. No. 10/210,984, each of which is incorporated by reference herein in its entirety.

FIGS. 3A and 3Bdepict two embodiments of a suturing instrument having a multi-load cartridge140in accordance with the invention. Such a suturing instrument advantageously allows the user to place multiple sutures without removing the suturing instrument from the surgical site. According to both embodiments, the suturing instrument100includes the cartridge140that houses two or more needles128disposed therein. Referring toFIG. 3A, the cartridge140is integrally formed within the distal portion106. In this embodiment, the distal portion106defines a sidewall access opening141to allow the user to load one or more needles128into the cartridge140. Referring toFIG. 3B, the cartridge140is either integrally formed or removably disposed at a distal end142of the operative portion126. Having a removable cartridge allows the user to choose a cartridge having a specific number of needles for a specific application. Also, the suturing instrument100may be reusable with different needle cartridges.

Referring still toFIG. 3B, the multi-load needle cartridge140defines an exit aperture145and a needle loading slot147. The multi-load needle cartridge140is designed to hold essentially any number of needles, for example, 2–20 needles. The multi-load needle cartridge140is preloaded and capable of feeding the needle and suture assembly into the needle carrier124. In one embodiment, the cartridge140can be reloaded by the user in situ by adding needles128using, for example, the sidewall access opening141(FIG. 3A) or the exit port120(FIG. 3B). The multi-load needle cartridge140may include a push plate196and a spring198that biases the push plate196towards the exit aperture145.

Both embodiments operate in essentially the same manner, enabling a user to place multiple sutures136in a patient without removing the suturing instrument100from the surgical site. As described above, the preloaded multi-load needle cartridge140can include one or more needles128each with the suture136coupled thereto. Referring toFIG. 3B, in one embodiment, the needle cartridge140includes three needles128a,128b,128c. Sutures136a,136b,136cextend out of the suture slot146. Alternatively, the sutures136may run through the elongate body member104. The first needle128ais disposed in the exit aperture145, and the remaining needles128b,128care disposed in the loading slot147.

The needle carrier124, which is part of the needle deployment mechanism110, is sequentially connectable to the needles128stored in the cartridge140. This means that each needle128stored in the needle cartridge140is connected to, and then deployed by, the needle carrier124one at a time in the order the needles128are dispensed from the needle cartridge140.

In operation, the user inserts the elongate body member104into a patient and orients the elongate body member104so that the tissue to be sutured is disposed proximate the suturing field176and the needle exit port120is proximate to or in contact with the tissue. The user then pushes the button117(FIG. 1B), as described above. Pushing the button117causes the needle carrier124to receive the needle128ain the lumen125and then to extend out of the needle exit port120and push the needle128athrough the tissue. As the first needle128ais pushed through the tissue, the first needle128apulls the first suture136athrough the tissue. As the user continues to push the button117, the needle carrier124continues to advance out of the needle exit port120and directs the first needle128aand the first suture136atoward the needle catch122. The user continues to push the button117until the first needle128acontacts and becomes captured by the needle catch122. The user then retracts the needle carrier124by releasing the button117, as previously described.

After the user retracts the needle carrier124, the first needle128aand the first suture136aare left captured within the needle catch122, with the first suture136aextending through the tissue. When the needle carrier124returns to a fully retracted position, the spring198causes the needle push plate196to push the second needle128binto the exit aperture145. The needle128bis thereby forced through the loading slot147and either into the lumen125of the needle carrier124or in position to be captured by the needle carrier124. The second suture136bextends out of the suture slot146. The user then advances the needle carrier124as described above until the second needle128bis captured by the needle catch122. The user then retracts the needle carrier124as described above leaving the second needle128band the second suture136bcaptured by the needle catch122. This procedure can be repeated for the third needle128c, or for as many needles as may be stored in the needle cartridge140. After one or more sutures136have been placed, the user withdraws the suturing instrument100from the patient. The user detaches the suture(s)136from the needle(s)128and ties a knot or knots in the suture(s)136. The user can then use the knot pusher184to push the knot(s) in the patient as the knot(s) is tightened.

Alternatively, other mechanisms could be used to advance the needle128from the needle cartridge140to the carrier124. In one embodiment, the needles128in the needle cartridge140are held in the loading slot147by a friction fit and are pushed into the exit aperture145when the needle push plate196is activated by the user. For example, instead of the spring198, a dispensing control rod coupled to a button on the handle102and the push plate196may be provided. Alternatively, a spring release mechanism coupled to the spring198and a button on the handle102may be provided to enable the user to release the spring198so that the push plate loads the needle128into the exit aperture145to be received in the lumen125of the needle carrier124. In another embodiment, the user may load the needle128into the exit aperture145by pulling the free end of the suture136. In yet another embodiment, the suturing instrument100may include a means for pulling the free end of the suture136such as, for example, a spool or a lever attached to the elongate body member and disposed, for example, on or within the handle102.

Referring toFIG. 4A, in another embodiment, the operative portion126of the distal portion106of the suturing instrument100includes a mechanism for deploying two or more needles128. The needles128can be deployed sequentially or simultaneously. The deployment mechanism includes a separate needle carrier124a,124bfor each needle128. The handle102can include one button117to advance both needles128or the handle102can include two buttons117a,117bto advance the needles128sequentially or simultaneously (if pressed at the same time). Passing two single armed needles into an incision site enables a user to place, for example, two ligating sutures simultaneously, withdrawing the device, and tying two knots. Ligating between the sutures is possible in a shorter time-frame.

In operation, this embodiment functions largely the same way as the embodiments previously described. For simultaneous advancement, the user advances the needle carriers124by pressing the button(s)117(FIG. 1A) until the needles128are driven through the tissue and captured by the needle catch122. After the needles128are captured in the needle catch122, the needle carriers124are retracted. For sequential advancement, the user advances one needle carrier124aby pressing one button117auntil the first needle128ais driven through the tissue and captured by the needle catch122. The user then retracts the first needle carrier124a. The user then advances the second needle carrier124bby pressing the second button117buntil the second needle128bis driven through the tissue and captured by the needle catch122. The user then retracts the second needle carrier124b.

Referring toFIGS. 4B–4D, in another embodiment, the distal portion106includes two separate operative portions126a,126bseparated a wedge200. The operative portions126a,126binclude the needle exit ports120a,120bthat are deflectable or spreadable outward relative to the elongate member104to adjust the distance between the exit ports120a,120b. The user may control the amount of separation between the operative portions126a,126band, therefore, the distance between the exit ports120a,120bwith a control lever202in the handle102. Other mechanisms that can be used to deflect the operative portions126a,126binclude, but are not limited to, a cam or link, an elbow linkage, a rotational separation along a longitudinal axis350of the device, a pre-made track and follower assembly, or a manual separator. In a particular embodiment, the user actuates the control lever202, thereby advancing the wedge200and widening the space between the two operative portions126a,126b.

One benefit of the embodiments depicted inFIGS. 4A–4Dand described above is that spreading the operative portions126a,126ballows a user to create a controlled or predetermined distance between the needle carriers' tissue entrance points. This feature enables the placing of sutures136at different spacing sequences. In addition, these embodiments also provide a means to place a double-armed suture (a suture with a needle at each end) in a patient. Referring toFIGS. 4E and 4F, the needle deployment mechanism110generally functions the same way as previously described and can be used to place a single suture136coupled to two needles128a,128bthrough tissue204(FIG. 4E) or to place two sutures136a,136bcoupled to two needles128a,128b, respectively (FIG. 4F) through tissue204. Referring toFIG. 4E, where a single suture136is attached to the two needles128a,128b, the suture136is placed perpendicularly to the longitudinal axis350of the suturing instrument. Referring toFIG. 4F, where separate sutures136a,136bare attached to each of the two needles128a,128b, the sutures136a,136bcan be placed in essentially any orientation relative to the longitudinal axis350of the suturing instrument.

Referring toFIGS. 5A–5H, in yet another embodiment, the suturing instrument100is modified to allow the user to place a so-called “whip stitch,” i.e., a continuous running suture. Typically, the suturing instrument must be removed from the surgical site so the user may disengage the needle from the needle catch and either reload the existing needle into the needle carrier or load a new needle and suture into the instrument. In this embodiment, the user can remove the needle from the catch and reload the needle into the needle carrier without removing the suturing instrument100. This allows the user to place a running stitch. This embodiment may be combined with any number of the other embodiments described herein.

Generally, the instrument is used to secure tissue with a continuous running suture by passing the suture through tissue, catching the suture needle, ejecting the needle from the catch in situ, and reloading the needle into the carrier. The suturing instrument100essentially operates in the same manner as the other instruments described herein. The instrument is modified, however, to add a needle reloading mechanism205described in detail below that, when advanced, pushes the needle128along the needle catch122to an opening that permits the needle to be discharged from the catch122. The needle128can be discharged by, for example, pulling on the suture136. Continued pulling on the suture136can reposition the needle128into the end of the needle carrier124. The reloaded carrier124can then be advanced again, continuing suture placement through multiple tissue passes, resulting in a whip stitch.

FIG. 5Adepicts the distal portion106of the suturing instrument100. The needle carrier124and needle catch122are disposed in the distal portion106. The needle catch122is similar to the catch described hereinabove with respect toFIG. 2B; however, the catch122is slightly modified to include two protrusions210disposed between the ribs of the center opening213to create a narrow portion in the opening213. The protrusions210prevent the needle128from moving to the larger opening, i.e., the needle reloading aperture174, in the catch122before the suturing instrument100is ready for reloading. In one embodiment, the needle catch122is slidably movable towards the needle exit port120.

FIG. 5Bdepicts a needle reloading mechanism205. The mechanism205includes a pusher rod208and an actuator206. The actuator206is generally perpendicularly disposed relative to the rod208and is attached to the rod208by, for example, welding or other attachment means. Additionally, the mechanism205includes a hook211that couples to a spring207located within the handle102(FIG. 5C). The spring207acts to return the mechanism205to its original position once the actuator206is released. In a particular embodiment, the mechanism205is slidably disposed within the suturing instrument100.

Referring toFIG. 5C, the proximal portion101of the suturing instrument100is modified compared to the embodiment shown inFIG. 1A. Specifically, the handle102is modified to house at least a portion of the mechanism205, as well as to include a slot209to house the actuator206.

FIGS. 5D–5Fare enlarged partial views of the needle catch122and pusher rod208. As shown, the needle128is held within the center opening213of the catch122between two ribs or flexible edges172. The pusher rod208includes a concave distal end that at least partially surrounds the needle128when the rod208is advanced into contact with the needle128(FIG. 5E). The pusher rod208pushes the needle128along the center opening213to the larger opening174. The needle128is moved past the protrusions210by the force of the pusher rod208. The force causes the ribs172to spread slightly to allow the needle128to pass. When the pusher rod208is fully advanced, the needle128will be positioned within the reloading aperture174(FIG. 5F). Alternatively, the needle128could be held within one of the lateral openings215,217in a catch122further modified to include protrusions210in the lateral openings215,217. The pusher mechanism205can also be modified to push a needle128held in one or both of the lateral openings215,217.

FIG. 5Gdepicts the modified handle102. As described hereinabove, the handle102includes the slot209for the actuator206and a void217for housing the proximal portion of the rod208and the spring207and hook211. While the actuator206described herein is slidably disposed within the handle102, other mechanical linkages are contemplated, for example, a push button and push wire assembly. The dimensions shown are for illustrative purposes only and are not meant to be limiting.

FIG. 5Hdepicts the modified elongate body member104compared to the embodiment depicted inFIG. 1A. The body member104is modified to house at least partially the pusher mechanism205, specifically the pusher rod208. The body member104includes a slot219that runs substantially the entire length of the body member104. The pusher rod208is slidably disposed within the slot219.

Operation of the instrument is described generally with reference toFIGS. 5A–5H. The basic operation is similar to that described hereinabove with reference toFIGS. 1A–1C, insofar as the user presses the button117thereby advancing the needle carrier124and pushing the needle128into the catch122. After the user drives the needle through the tissue204and into the catch122, the user positions the distal portion106of the suturing instrument100so that the tissue204is no longer in the surgical field176. During operation, the suture136is preferably maintained in tension. A free end of the suture136remains outside of the surgical site and accessible to the user. Next, the user advances the needle reloading mechanism205into contact with the needle128by pushing the actuator206distally. Once the pusher mechanism205is fully advanced, the needle128is positioned within the needle reloading aperture174. In this position, the free end of the suture136can be pulled to release the needle128from the catch122and, in turn, lead the needle128into the needle carrier. In addition, the needle carrier can be partially advanced to assist reloading of the needle128into the carrier. Also, the distal end of the needle carrier124can be modified to facilitate reloading. For example, the distal end of the carrier124and the lumen125could be enlarged to create a sufficient lead in for recapturing the needle128. Further, as described above, the needle catch122may be slidable distally to position the needle128close to the carrier124before releasing the needle128. After the needle128is recaptured in the lumen125of the needle carrier124and the needle carrier124is fully retracted into the operative portion126, the user maneuvers the suturing instrument100and/or the tissue204so that the tissue204is disposed again proximate the suturing field176and the exit port120is proximate to the next stitching position in the tissue204.

Referring toFIGS. 6A and 6B, in another embodiment, the suturing instrument100includes a distal portion106that is independently deflectable and/or pivotable relative to the elongate member104. Specifically, the distal portion106includes a deflectable portion300that connects the elongate body member104to the distal portion106. The distal portion106is deflectable relative to the elongate member104in the “A-P” and “I-S” directions. Also, the operative portion126of the distal portion106may be pivotable about pivot nodes that define an axis330perpendicular to the longitudinal axis350of the elongate member104. Alternatively, the operative portion126of the distal portion106may be pivotable about a pin402that is perpendicular to the longitudinal axis350of the elongate member104and defines the axis330.

Referring toFIGS. 6C and 6D, movements of the distal portion106are controlled by one or more deflection control members302,306, and/or a pivot control lever304included in the proximal portion108, for example, in the handle102. The deflection control members302are coupled to a tension roller315. The deflection control members306are coupled to a tension roller311. Tension members335are connected to the tension rollers311,315, extend through the elongate member104, and are coupled to a front portion301aof a deflectable portion300for causing the distal portion106to deflect. The pivot control lever304is coupled to a pivot wire334that extends along the longitudinal axis350of the elongate member104and is coupled to the operative portion126of the distal portion106to cause it to pivot. The tension members335and the pivot wire334pass through a wire equalizer313disposed within the elongate body member104and are formed from, for example, stainless steel or Nitinol® alloy.

In operation, the user can pivot the operative portion126of the distal portion106about the axis330perpendicular to the longitudinal axis350of the elongate body member104by manipulating the pivot control lever304in the handle102. The pivot control lever304, when turned, causes the pivot wire334to pull or push the operative portion126, thereby rotating it around the axis330.

The deflection control members302,306cause the tension rollers311,315to turn when the deflection control members302,306are turned, thereby causing the distal portion106to bend. Specifically, the user can bend the deflectable portion300of the distal portion106at its rear portion301bup to +/−90 degrees (A-P direction) by manipulating the deflection control member302, that causes the tension roller315to rotate and either tighten the tension member335aand relax the tension member335p, or tighten the tension member335pand relax the tension member335a. The user can also bend the deflectable portion300at its rear portion301bup to +/−90 degrees (I-S direction) by manipulating the deflection control member306, that causes the tension roller311to rotate and either tighten the tension member335iand relax the tension member335s, or tighten the tension member335sand relax the tension member335i.

Referring toFIGS. 6E–6H, in another embodiment, the suturing instrument100includes a distal portion106having a beveled surface307afor contacting the elongate body member104and the elongate body member includes a beveled surface307bfor contacting the distal portion. According to one feature of this embodiment, the acute angle defined by the beveled surface307aand the acute angle defined the beveled surface307bare substantially equal. In one embodiment, each of these angles substantially equals 45 degrees. The surfaces307a,307bare secured against each other by a spring310disposed in the elongate member104. In an aligned position, the surfaces307a,307bare aligned such that the distal portion106and the elongate body member104combine to produce a shaft that is substantially linear. The handle102includes a deflection control lever or member312that is coupled to a first end of a rod320that extends through the elongate member104. A second end of the rod320is coupled to the distal portion106. When the user manipulates the deflection control lever312, the distal portion106rotates and, by virtue of the contacting beveled surfaces307a,307b, a rotation point308forms, thereby enabling suturing of tissue at any angle relative to the elongate body member's longitudinal axis350(or angles of surface contact).

In the embodiment shown inFIG. 6J, the suturing device100includes a locking mechanism that includes a ball314and a plurality of detents316. The ball314is coupled to the beveled surface307bof the elongate member104at a point radially outward from the longitudinal axis350of the distal portion106. The ball314is positioned on the elongate member104to allow it to contact the beveled surface307aof the distal portion106. Each of the plurality of detents316may be disposed equally about the circumference about the beveled surface307aof the distal portion106. The circle of detents314may be centered on the longitudinal axis of the distal portion106. Each detent316may have a radial distance from the longitudinal axis of the distal portion106equal to that of the ball314. As the user deflects the distal portion106by manipulating the deflection control lever312, the ball314moves out of one detent316and into another detent316. The detents are spaced such that the distal portion rotates in a stepwise manner. Each step may be a fixed number of degrees of rotation. In another embodiment, the ball314is coupled to a spring318disposed in an aperture321formed in the beveled surface307b. The spring318provides enough force to keep the ball314socketed in one of the detents when the user is not trying to change the angle of the distal portion106relative to the longitudinal axis350of the elongate body member104. The spring318is, however, compressible such that the ball314is at least partially withdrawn into the aperture321and the user can easily change the angle of the distal portion106relative to the longitudinal axis350of the elongate body member104by moving the ball314from one detent316ato another detent316b.

In another embodiment, shown inFIG. 6K, the distal portion106and the elongate member104may include meshed teeth319a,319bthat engage to lock the distal portion106and the elongate member104at a particular angle. In operation, the user pushes the distal portion106distally from the elongate member104, so the beveled surfaces307a,307bdo not contact each other and the teeth319a,319bno longer engage, and then deflects the distal portion106to a desired angle. Then, when the beveled surfaces307a,307bare brought into contact with each other, the teeth319a,319bengage or mesh to lock the distal portion106in place.

Referring toFIGS. 7A–7C, in another embodiment, the suturing instrument100includes a distal portion106that is independently pivotable about the axis330perpendicular to the longitudinal axis350of the elongate member104and rotatable about the longitudinal axis350of the elongate member104. In one version of this embodiment, the degree of pivot is controlled by a pivot control lever400located on the handle102and coupled to a pivot control mechanism disposed within the elongate member104. The pivot control mechanism is coupled to the distal portion106. When the user manipulates the pivot control lever400slidably moving the pivot control mechanism within the elongate member104, the distal portion106pivots about the pivot axis330. This embodiment enables the suturing of tissue at angles up to 90 degrees from the longitudinal axis350of the elongate body member104. The suturing instrument100also allows for removal from a 10 mm trocar without repositioning the distal portion106.

Referring toFIGS. 7D–7H, in an alternative embodiment, the suturing instrument100includes a pivoting and rotating distal portion106. The suturing instrument100also includes a pivot control lever504, a rotation control lever506, and a needle deployment trigger502. The user can pivot the distal portion106by manipulating the pivot control lever504on the handle102. The distal end106can be pivoted to a position perpendicular to the tissue plane to be sutured. The internal operation of the pivoting mechanism is similar to embodiments discussed above. The user can also rotate the distal portion106by manipulating the rotation control lever506also disposed on the handle102, that is coupled to a rotation mechanism, which, in turn, is coupled to the distal portion106. The needle128is deployed by pulling the needle deployment trigger502. The needle deployment mechanism operates similar to other embodiments previously described.

Referring toFIGS. 8A–8E, in another embodiment, the suturing instrument100includes a pivoting distal portion106and a pivot control lever508. The elongate member104includes an outer portion516and an inner portion518, and is coupled to the distal portion106at a pivot point514and via linkage512(FIG. 8D). The user controls the pivoting action by manipulating the pivot control lever508, thereby causing the outer portion516to slide relative to the inner portion518. Pushing the control lever508causes the outer portion516to push the linkage512, which, in turn, pushes the distal portion106. As the distal portion106is pushed by the linkage512, the distal portion pivots about the pivot point514. The distal portion106can pivot up to 90 degrees relative to the longitudinal axis350of the elongate body member104. Pulling the control lever508causes the outer portion516to pull the linkage512, which pulls the distal portion106. As the distal portion106is pulled by the linkage512, the distal portion106pivots about the pivot point514and returns to its original position. In one embodiment, the control lever508maybe be coupled to the outer portion516via a pin509or other attachment means. Alternatively, the control lever508is not coupled to the outer portion516, but is pushed into contact with the outer portion516via, for example, the pin509. Further, the outer portion516may be biased against the control lever508by a spring that causes the distal portion106to return to its starting position when the control lever508is released.

According to this embodiment of the invention, in one version, the needle deployment mechanism110includes a loop510for advancing the needle carrier124. The loop510is formed from a resilient material, such as rubber. The loop510is coupled to the button117at the proximal end of the elongate member104and coupled to the needle carrier124at a distal end. In operation, the user presses the button117, which causes the loop510to advance. As the loop510advances, the needle carrier124, which is coupled to the loop510, also advances until the needle128in the needle carrier124is captured by the needle catch122. After the needle128is captured in the needle catch122, the user releases the button117and the loop510retracts thereby causing the needle carrier124to also retract.

Referring toFIGS. 9A–9C, in another version of this embodiment, the needle deployment mechanism110in the distal portion106includes a first gear520, a second gear524, and a linkage522. The linkage522is coupled to the first gear520and the needle carrier124. In operation, the user manipulates the button117, which causes the second gear524to turn. The second gear524engages the first gear520, thereby causing the first gear520to turn and pivot the distal portion106. As the first gear520turns, the linkage522moves and advances the needle carrier124until the needle128is captured by the needle catch122. After the needle128is captured by the needle catch122, the user releases the button117and the first gear524and the second gear520turn in the opposite direction causing the linkage522to retract the needle carrier124.

Referring toFIGS. 10A and 10B, in yet another embodiment, the needle deployment mechanism in the distal portion106includes a superelastic pusher602. A proximal end of the superelastic pusher602is coupled to the button117(shown inFIG. 1B) and a distal end of the superelastic pusher602is coupled to the needle carrier124. In operation, the user pushes the button117, which causes the superelastic pusher602to advance the needle carrier124until the needle128is captured in the needle catch122. After the needle128is captured by the needle catch122, the user releases the button117and the superelastic pusher602retracts the needle carrier124. This embodiment operates similarly to the embodiment described with reference toFIGS. 1A–1C. The superelastic pusher can be formed from an elastic material having “superelastic” properties, such as Nitinol®.

Referring toFIGS. 11A and 11B, in another embodiment, the needle deployment mechanism in the distal portion106includes a drum608and a camshaft604. The drum608is coupled to a distal end of a push wire. A proximal end of the push wire is coupled to the button117. The drum608is also coupled to the camshaft604and the camshaft604is coupled to the needle carrier124. In operation, the user pushes the button117, which causes the push wire to rotate the drum608. As the drum608rotates, the camshaft604moves and advances the needle carrier124until the needle128is captured in the needle catch122. After the needle128is captured by the needle catch122, the user releases the button117and the push wire rotates the drum608in the opposite direction, thereby causing the camshaft604to retract the needle carrier124. The push wire can be formed from, for example, stainless steel or nickel-titanium alloy.

Referring toFIGS. 12A–12C, in still another embodiment, the suturing instrument100is configured to be used with an endoscope708. A proximal portion712of the suturing instrument100includes the handle102, a carrier drive wire socket702attached to a distal end752of the handle102, and an actuator112including a needle deployment button117. The proximal portion712also includes a scope adapter706having a distal end718that is connectable to an access port724of the endoscope708and a proximal end720that is connectable to the carrier drive wire socket702.

The suturing instrument further includes an elongate member714that includes a carrier drive wire710, which can be formed from, for example, stainless steel or a nickel-titanium alloy, covered by a flexible sheath704. The sheath704is coupled to a distal portion716. The carrier drive wire710is connectable to the needle carrier for moving a needle from the distal portion in accordance with any of the embodiments disclosed herein. Also, the distal portion716can be stationary, pivoting, or rotatable in accordance with any of the embodiments disclosed herein.

In operation, the elongate member714is fed into a distal end722, through a working channel726, and out of an access port724of the endoscope708. The distal end718of the adapter706is coupled to the access port724of the endoscope708and the carrier drive wire710is fed through the adapter706. The carrier drive wire710is then coupled the carrier drive wire socket702and the proximal portion712of the suturing instrument100is secured to the proximal end720of the adapter706. The endoscope708can then be inserted into a patient. The adapter706can include any standard or custom fittings necessary to couple to the access port724and the proximal portion712of the suturing instrument100. For example, the adapter706can include a luer fitting or a treaded fitting to couple to the endoscope708.

In one embodiment, the sheath704is fixedly coupled to the distal portion716, and the distal portion716can be rotated by rotating the flexible sheath704, using, for example, a rotation controller760disposed in the scope adapter706. In another embodiment, the handle102of the suturing instrument100includes two subassemblies. The subassemblies include a thumb-button/finger grasper assembly and a thumb-button/scope assembly.

Other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. The described embodiments are to be considered in all respects as only illustrative and not restrictive. Therefore, it is intended that the scope of the invention be only limited by the following claims.