Abstract:
A surgical clip applier is provided having a cartridge carrying multiple surgical clips with a manual graspable actuator configured to sequentially deliver clips to the jaws of the clip applier. Both the cartridge and the jaws are connectable to a scissors-like handle assembly arranged to translate motion from finger loops to the jaws to open and close the jaws and thus close or crimp a delivered clip between the jaws.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 60/721,174, filed Sep. 29, 2005, the disclosure of which is hereby incorporated by reference as if set forth in full herein. 
    
    
     BACKGROUND 
     This invention relates generally to surgical clip appliers and more specifically to manually actuated clip appliers. 
     Surgical clips are commonly used to occlude body conduits such as blood vessels. For example, clip appliers have been used to place a clip in an open state over the blood vessel and crimp the clip to a closed state to pinch and hold the vessel in an occluded configuration. 
     In some cases, the clip appliers are adapted to work with only one clip at a time. The jaws of the clip applier are used to grab a clip from a plurality of clips separated and evenly distributed on a clip rack. The clip is then placed and crimped onto the blood vessel. To place another clip onto the blood vessel, the clip applier is used again to grab a clip from the clip rack using the clip applier&#39;s jaws. This process can be tedious, time consuming and difficult, as the clips are quite small. Such clip appliers are commonly referred to as single-fire clip appliers. 
     By comparison, multiple-fire clip appliers have multiple clips housed in a clip cartridge, which is connected to a handle and trigger assembly. Operation of the trigger causes one of the clips in the cartridge to be automatically loaded into the jaws for ultimate application at the operative site. With such a device, multiple clips can be quickly applied at the site by successive operation of the trigger. However, such clip appliers are often complex requiring numerous components and timing mechanisms and thereby reducing reliability and increasing cost. Also, being automatic and the operational trigger being largely divorced from the application of force to the clip, such appliers often do not offer the tactical feedback to provide a surgeon some indication as to the amount of force being applied by the clip to the body tissue, such as a blood vessel. 
     Single-fire and multi-fire clip appliers can also be reusable to reduce costs. Reusable clip appliers are sometimes formed of metal and are designed for repeated use and sterilization, for example, in an autoclave. It is this autoclaving procedure, which can result in the bending or otherwise damaging of the jaws, as well as disrupting clip alignment mechanisms and the clip applier&#39;s general ability to receive and apply the clip. 
     SUMMARY 
     In accordance with various aspects of the present invention, a surgical clip applier comprises a handle assembly having two movable handles, jaws connected to the handle assembly, a cartridge carrying multiple surgical clips connected to the handle assembly. The cartridge has a manually movable actuator attached to the cartridge arranged to operationally advance at least one of the multiple surgical clips. 
     In one aspect, a surgical clip applier comprises a cartridge having a proximal end and a distal end, a connector arranged to extend from the distal end of the cartridge and jaws connected to the proximal end of the cartridge. A release tab extends from the distal end of the cartridge. The clip applier also comprises a handle assembly that has a proximal end and a distal end. The cartridge is removably connected to the proximal and distal ends of the handle assembly, the distal end of the handle assembly having a plurality of slots arranged to receive the connector. 
     In one aspect, a surgical clip applier comprises a cartridge carrying multiple surgical clips having a first connector and a second connector, and a longitudinal axis extending from a distal end of the cartridge to a proximal end of the cartridge. Each clip is U-shaped with first and second legs. The clip applier also comprises a first jaw having a slot and arranged to receive one of the first and second legs of one clip of the multiple surgical clips, the first jaw having an aperture extending through the first jaw in a direction orthogonal to the longitudinal axis. The first connector is operationally connected to the aperture of the first jaw. The clip applier also comprises a second jaw having a slot and arranged to receive one of the first and second legs of one clip of the multiple surgical dips. A plate connects the first and second jaws together and has an aperture through the plate. The second connector is operationally connected to the aperture through the plate and a handle assembly is removably connected to the cartridge and the plate. 
     Many of the attendant features of the present invention will be more readily appreciated as the same becomes better understood by reference to the foregoing and following description and considered in connection with the accompanying drawings in which like reference symbols designate like parts throughout. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  illustrates a top view of one aspect of a surgical clip applier in accordance with various aspects of the present invention; 
         FIG. 1B  illustrates a side view of one aspect of a surgical clip applier in accordance with various aspects of the present invention; 
         FIG. 1C  illustrates a bottom view of one aspect of a surgical clip applier in accordance with various aspects of the present invention; 
         FIG. 1D  illustrates a perspective view of one aspect of a surgical clip applier in accordance with various aspects of the present invention; 
         FIG. 2  illustrates a top view of one aspect of a handle assembly disassembled in accordance with various aspects of the present invention; 
         FIG. 3A  illustrates a side view of one aspect of a surgical clip applier in accordance with various aspects of the present invention with jaws separated from the surgical clip applier; 
         FIG. 3B  illustrates a close-up view of one aspect of a surgical clip applier in accordance with various aspects of the present invention with jaws separated from the surgical clip applier; 
         FIG. 3C  illustrates a close-up view of one aspect of a surgical clip applier in accordance with various aspects of the present invention with jaws coupled to the surgical clip applier; 
         FIG. 4A  illustrates a side view of one aspect of a surgical clip applier in accordance with various aspects of the present invention with a cartridge separated from the surgical clip applier; 
         FIG. 4B  illustrates a perspective view of one aspect of a surgical clip applier in accordance with various aspects of the present invention with a cartridge separated from the surgical clip applier; 
         FIG. 5A  illustrates a perspective view of one aspect of a cartridge in accordance with various aspects of the present invention; 
         FIGS. 5B-F  illustrate perspective views of aspects of a cartridge in accordance with various aspects of the present invention with the cartridge partially disassembled; 
         FIGS. 6A-B  illustrate cross-sectional side views of one aspect of a surgical clip applier in accordance with various aspects of the present invention; 
         FIG. 6C  illustrates a front view of one aspect of a surgical clip applier in accordance with various aspects of the present invention; 
         FIG. 6D  illustrates cross-sectional view taken along section lines  6 D- 6 D of  FIG. 6B  in accordance with various aspects of the present invention; 
         FIG. 6E  illustrates cross-sectional view taken along section lines  6 E- 6 E of  FIG. 6B  in accordance with various aspects of the present invention; 
         FIGS. 7A-B  illustrate close up perspective views of one aspect of a surgical clip applier in accordance with various aspects of the present invention without a cartridge; 
         FIG. 7C  illustrates a perspective view of one aspect of a surgical clip applier in accordance with various aspects of the present invention; 
         FIG. 7D  illustrates close up perspective view of one aspect of a surgical clip applier in accordance with various aspects of the present invention; 
         FIG. 7E  illustrate close up perspective view of one aspect of jaws of a surgical clip applier in accordance with various aspects of the present invention; 
         FIG. 8A  illustrates a top view of one aspect of a surgical clip in accordance with various aspects of the present invention; 
         FIG. 8B  illustrates a cross-sectional view of one aspect of a surgical clip in accordance with various aspects of the present invention; 
         FIG. 9A  illustrates a perspective view of one aspect of a jaw in accordance with various aspects of the present invention; and 
         FIG. 9B  illustrates a side view of one aspect of a jaw in accordance with various aspects of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     In this description, “proximal” or “proximally” refers to that portion of the instrument, component, or element that extends toward the user. “Distal” or “distally” refers to that portion of the instrument, component, or element that extends away from the user. In accordance with various aspects of the present invention, a surgical clip applier system is provided with a cartridge carrying multiple surgical clips, jaws and a handle assembly. In one aspect, a new cartridge may offer a new set of jaws with a new set of clips. In one aspect, the jaws, cartridge and handle assembly are separately connectable allowing one set of jaws and handle assembly to be used in a single procedure with multiple cartridges. In one aspect, the cartridge can be reloaded with additional clips without replacing the entire cartridge. 
     Referring to  FIGS. 1-3 , a clip applier  3  is shown according to various aspects of the present invention. The dip applier has a cartridge  5  and a handle assembly  7 . The cartridge  5  is coupled to the handle assembly  7  in a snap-type fit relation in which a post extending from the cartridge snaps or latches into an opening or aperture disposed in the handle assembly. The handle assembly resembles a scissors configuration having a pair of intersecting handles  8  crossing at a pivot point with finger loops  6  at one end of each handle and end effectors  4  at the other end of each handle. 
     The cartridge  5  is coupled to jaws  2  in which a clip from the cartridge is fed and ultimately crimped or closed on the operative site, tissue or object. One or more clips are housed in the cartridge  5  and are fed one at a time to the jaws  2 . An actuator  11  positioned on the cartridge controls the placement of the clip into the jaws in response to manipulation of the actuator by a surgeon&#39;s thumb or fingers. In one aspect, the actuator  11  is a slider knob having converging tapered sides configured for comfortable placement and gripping by a surgeon&#39;s thumb and/or fingers. For example, a user is able to push it forward and back with an index finger while holding the handles with the thumb and remaining fingers. Sliding the actuator  11  in a first direction, e.g., distally, a clip from the cartridge  5  is moved into the jaws  2 . Successive or remaining clips in the cartridge also move towards the jaws. The actuator  11  is slid back in a second or reverse direction, e.g., proximally, to retrieve the next clip to be applied and crimped. 
     The end effectors  4  of the handles  8  operatively engage the jaws  2 . Movement of the handles  8  together causes the jaws  2  to close or move together. With the actuation or manipulation of the handles  8  being separate from clip feeder actuation, the jaws  2  may be closed with or without a clip being between the jaws. As such, the jaws may be used separately and independently, for example, to test an operative site before placement of the clip, to grasp tissue or an object, or to clear a pathway or view of the operative site. 
     In one aspect, a cantilever spring  12  is coupled between the handles  8 . A post  13 , such as a rivet or drive screw, connects one end of the spring  12  to one of the handles  8  and a stop tab  14  holds the other end of the spring  12  to the other handle  8  providing a position stop and allowing for movement of the end of the spring through a slot in the spring itself. The post  13  is placed along a first sidewall of one handle distally or closer to the jaws than the stop tab  14  placed along a second sidewall facing the first sidewall. As such, the spring  12  spans between the handles  8 . The spring is configured to bias or hold the jaw ends in a set or initial position. As such, in one aspect, the spring force, together with the jaws being of a horseshoe shaped ridged metal, are together positioned and formed to maintain a predetermined gap between the jaw ends. Thus, the gap between the jaw ends or tips is maintained as the spring and jaws in unison holds the handles in position, such that the jaws  2  do not close or open further but remain at an initial, e.g., manufactured or assembled, position. 
     The spring  12  also, in one aspect, biases or counteracts pressure or forces applied by someone, e.g., a surgeon, picking up or otherwise handling the clip applier by the handles. As such, in one aspect, for a clip to be crimped or the jaws to be closed, sufficient force is applied by squeezing the handles together to overcome the force or bias of the spring  12 . The spring or one or both post and stop tab may also be moved, e.g., tightened or otherwise repositioned, to adjust the predetermined or set position of the jaws and handles relative to each other. In one aspect, the handles are also connected to each other through a post  15  and a lock box  16 . A complementary lock box is disposed in each handle limiting over opening and closing of the handles and assisting in alignment and pivotal movement of each handle. The post extends through at least a portion of each lock box on each handle connecting the handles together in a pivot or scissors like configuration. 
     Referring now to  FIGS. 4A-4B and 6A-6E , the jaws  2  may be separable or connectable separately to the handle assembly  7  and the cartridge  5 . Each end effector  4  of each handle  8  has a projection or post  21  extending generally perpendicularly from the longitudinal axis of the clip applier or a plane generally traversed by the handles  8  during each stroke. The jaws  2  have respective receivers  23  to attach to the projections  21  of the end effectors  4 . In one aspect, the receivers  23  are cavities laterally extending into the jaws  2  and generally “c-shaped” recesses or grooves. Lateral portions or planar projections  25  of the end effectors  4  slide into lateral cavities or planar slots  27  in the jaws  2 . The projections  21  extend orthogonally from the lateral portions  25  and together provide an aligned sliding fit into the respective grooves and cavities in the jaws  2 . Lateral portions of the end effectors and the respective cavities in the jaws also provide lateral support or strength to the jaws  2  preventing misalignment or bending of the jaws. The engagement between the end effectors  4  and the jaws  2  also reduces dislodgement or separation of the components and operatively connects the components together such that movement of end effectors translates to the jaws, providing substantially direct application of force from the handle to the clip, and vice versa, providing tactile feedback to the user. 
     The jaws  2  being separable from the handle assembly  7  and the cartridge  5  facilitate sterilization of the jaws  2  and/or handle assembly  7 . Additionally, the jaws  2  may be disposed without having to replace the handles  8  allowing for new jaws to be provided as desired to minimize costs and to avoid misalignment or jaw deformation. With the jaws  2  also being provided separately from the cartridge  5 , the jaws  2  do not have to be disposed with each cartridge change. More than one cartridge  5  may be used during a surgical procedure and thus using the same jaw  2  may reduce costs. 
     Referring to  FIGS. 5A-5B and 6A-6E , the cartridge  5  has a connector or post  31  extending from the cartridge that is releasably engagable with an aperture or receiver  33  in the jaws  2 . A corresponding receiver or aperture on the handle assembly  7 , in one aspect, is also positioned in alignment with the aperture or receiver in the jaws  2  to also be releasably engagable with the post  31  of the cartridge  5 . The post  31  extends in a direction orthogonally from a longitudinal axis of the cartridge from a base or wall of the cartridge  5 . The post is deflectable and resilient to snap or flex with projections or cavities along portions of the post, e.g., on its tip, to secure the post to the jaws  2  and/or handle assembly  7 . For example, in one aspect, multiple, e.g., four, barbs or generally evenly spaced hemispherical posts with projections provide releasable engagement of the cartridge  5  and the jaws  2  from the handle assembly  7 . Gaps or slots between the barbs or post facilitates the flexing of the barbs, which facilitates insertion/removal of the barbs or post into/from the receiver of the jaws  2  and handle assembly  7 . The post or barbs provide a releasable engagement or connector of the cartridge  5  to the handle assembly  7 , holding the jaws between the cartridge  5  and handle assembly  7 . The gaps or slots reduce forces or stress applied to the post or barbs upon insertion/removal. 
     In one aspect, another similar although smaller connector or post  35  extends from the cartridge  5  near the jaw tips  2   a  and distal from the finger loops  6  for releasable engagement with an aperture or receiver  37  in one side of the jaws  2 . As such, the second post  35  provides additional support and engagement of the cartridge  5  to the jaws  2  and/or handle assembly  7  to hold the cartridge in approximate axial alignment with the handle assembly  7 . 
     The jaws tips  2   a  have grooves for receiving or grasping a clip. An arm  2   b  extends from each jaw tip  2   a  and is configured with a width and thickness sufficient to provide a spring force to return the jaws to a predetermined distance or spacing between the jaws, in harmony with the cantilever spring  12 , which is at the same time opening the handles  8 . The arms  2   b  connect or are integrated into an extension plate  2   c  providing support for the jaw tips  2   a  and a centering point for the jaws at an axial point of the handles. 
     Referring now to  FIGS. 5A-5F , a cartridge has a slider button or knob  11   a  to be grasped by a user to manually feed or move a single clip from the cartridge  5  into the jaws  2 . Operationally, in one aspect, the slider knob is moved forward towards the jaws  2  to feed one clip into the jaws and retracted to load or prepare another clip for placement into the jaws  2 . The knob is coupled to a stud  41  slidably connected to the cartridge in a slot disposed in the cartridge cover. The cartridge cover in one aspect has a vessel stop  45 . The stud  41  is connected or integrated with a pusher  47  having an engagement end  47   a . The engagement end is configured in one aspect to engage portions of the apex of a clip. 
     A gang pusher  49  is also provided between the pusher  47  and the rest of the clips to move the remaining clips one place forward as the pusher feeds one or the foremost clip into the jaws  2 . The gang pusher  49  may have one or more projections or tabs  49   a  extending therefrom to assist in moving the clips forward. The gang pusher  49  moves back to an initial position as the knob  11   a  is moved back or retracted. The tabs of the gang pusher, in one aspect, are resilient or deflectable, e.g., cantilever spring tabs, temporarily moving out of the path of a clip, as the gang pusher is moved back or retracted. In one aspect, the tabs of the gang pusher are rounded facilitating movement of the gang pusher moving back or retracting minimizing interference with the remaining clips in the cartridge. 
     The gang pusher  49  and the pusher  47  are operationally connected to the stud  41  and thus follow each other&#39;s movement. Operationally, in one aspect, the slider knob is moved forward towards the jaws  2  causing the pusher  47  to move one clip from a staging area into a pre-load area in the cartridge near the jaws  2 . The stud  41  traverses in a slot in the gang pusher  49  and thus the gang pusher remains stationary. 
     As the clip reaches the pre-load area, the stud  41  reaches the end of the slot in the gang pusher and contacts a portion of the gang pusher  49 . Further movement of the stud towards the jaws moves the pusher  47 , which moves the clip from the pre-load area into the jaws  2 . The gang pusher  49  moves the remaining clips one place forward such that the forward most dip, i.e., the clip closest to the jaws  2  but not in the jaws, is moved to the staging area in the cartridge. The stud  41  is moved or retracted back to the initial starting position positioning the pusher behind the clip in the staging area and the gang pusher behind the remaining dips. 
     In one aspect, the clips ride along a clip track or backstop  46 . The backstop may be integrated with or attached to the cartridge cover from which the projection  31  extends. In one aspect, the backstop  46  has a plurality of projections or clip tabs  46   a , e.g., cantilever spring tabs, to hold clips in position as the gang pusher is retracted and to ensure that only one clip at a time is fed into the jaws  2 . In one aspect, the backstop  46  also has a second set of tabs  46   b , e.g., cantilever spring tabs, facing in an opposing direction to the clip tabs  46   a . The second set of tabs  46   b  apply tension to assist in securing the backstop  46  to the cartridge  5 . For example, the tabs  46   b  reduce gaps between the components in the cartridge and hold the clips in close planar alignment to prevent the clips from misaligning with the pushers and backstop. The cartridge floor or cover  48  has a groove extending therethrough for engagement with the tabs  46   b  flexing towards it. As such, the distal most clip or the clip closest to the knob  11   a  along with the clips to the foremost dip or next dip to be fed into the jaws  2  can move through a series of positions prior to being fed into the jaws  2 . Thus, a cartridge and jaws are provided without complex components, springs or timing mechanisms. 
     In one aspect, the clip track or backstop is removable. As such, the applier can be loaded with another set of clips. For example, a door or opening is provided in an end wall of the cartridge distal from the tissue stop. The backstop extends substantially the entire length of the cartridge and is removed through the door or opening in the cartridge. A tab or projection that becomes visible or accessible after the door in the cartridge is opened or spring biasing the clip track or backstop facilitates removal of the clip track or backstop. A new backstop or a now loaded backstop can be slid back into the cartridge through the door or opening in the cartridge. The tabs of the gang pusher, in one aspect, are resilient or deflectable moving out of the path of the dips, as the clips are loaded into the cartridge with the backstop. In one aspect, the tabs of the gang pusher are rounded facilitating movement of the clips being loaded into the cartridge with the backstop. In one aspect, the backstop with clips are positioned or biased away from the gang pusher until the backstop is fully inserted into the cartridge. Once fully seated within the cartridge, the backstop is biased or otherwise cams towards the gang pusher to hold or enclose the clips between the backstop and the gang pusher. In one aspect, the gang pusher is also removable or provided in at least two portions, one portion for engaging the stud and another having tabs to engage the clips. 
     In one example operation, the clip applier could be fired exhausting the clips within the cartridge and the cartridge could be replaced with another entire cartridge having a new set of clips. In another example, a portion of the cartridge is replaced, e.g., the backstop removed and then reloaded with clips or another new pre-loaded backstop/clip track is provided. As such, the other components in the cartridge, e.g., the pusher, can be reused and thus minimizing waste and costs. 
     In  FIGS. 7A-7E , a handle assembly  7 ′ with handles  8 ′ and finger loops  6 ′ is secured to a cartridge  5 ′ and jaws  2 ′. An end effector  4 ′ extends from each end of each handle distal from the finger loops. Each end effector  4 ′, in one aspect, has a projection or post  51  extending generally perpendicularly from the longitudinal axis of the clip applier or a plane generally traversed by the handles  8 ′ during each stroke. In one aspect, the end effectors are in-line or in the same plane as the jaws  2 ′. The projections  51  or the side surfaces or walls of the end effectors engage the side surfaces or sidewalls of each jaw  2 ′ to provide a substantially direct application of force from the handle to jaws and thus to a clip disposed between the handles  8 ′. Likewise, a reciprocal force is translated back to the handles  8 ′ and finger loops  6 ′ providing tactile feedback to the user. 
     The handles  8 ′ are connected to the jaws  2 ′ by a pin or post  52  extending from the pivot point of the handles and the end effectors  4 ′ through a cartridge assembly. A post, barb, support, or swaged bushing  53  also extends from the cartridge  5 ′ through the handles  8 ′ near the finger loops  6 ′. The support attaches the cartridge and/or jaws to the handles. A similar connection is described in U.S. patent application Ser. No. 10/815,149, filed Mar. 30, 2004, the disclosure of which is hereby incorporated by reference as if set forth herein in full. The handles, in one aspect, have two opposing slots utilized for cartridge/handle stability, support and jaw closure. Extending from the cartridge  5 ′ towards the finger loops  6 ′ is a release tab  54  providing a grasping area to facilitate removal of the cartridge. 
     In one aspect, the cartridge, jaws, handle assemblies and connections thereto used in various aspects of the present invention may be similar to and/or interchangeable with the cartridges, jaws, handle assemblies and connections thereto described in U.S. patent application Ser. No. 10/381,970, filed Mar. 5, 2004, Ser. No. 10/518,436, filed Dec. 16, 2004, the disclosures of which are hereby incorporated by reference as if set forth in full herein. The cartridge assembly has covers in which the jaws  2 ′ are disposed in between. The cartridge and/or covers have notches or cavities adjacent or proximate to the sidewalls of the jaws where the end effectors engage the jaws. A stabilizer  55  in one aspect is disposed between the jaws  2 ′ to assist in minimizing misalignment of the jaws. In one aspect, a door or opening is provided in the cartridge near the release tab  54 . Through the opening, another set of clips can be loaded into the cartridge. For example, a new backstop or a now loaded backstop can be slid back into the cartridge through the door or opening in the cartridge. 
       FIGS. 8-9  illustrate exemplary clips and jaws that may be used in conjunction with various aspects of the present invention. The clip and jaws are sized and shaped as shown to maximized uniform clip closing or deformation while minimizing the force used to close the clip and the over/under closing or crimping of the clip. The clip  81 , in one aspect, is generally U-shaped or V-shaped with a pair of outwardly extending and generally opposed legs  83 , 85  connected at an apex  87 . The surface  82  of the clip  81  is substantially flat providing sufficient contact surface area for contacting the engagement end  47   a  and/or clip track or floor. The clip  81 , in one aspect, has grooves or channels  84 , 89  to facilitate crimping or increase friction and/or occlusion force provided by the clip  81 . 
     In one aspect, the jaws  2  are stabilized by being one piece held in place by the slots and projections to the handles and the grooves in the jaw tips  2   a  can deflect together for better clip closure due to thin sections in the jaw midsections. The jaws tips  2   a  have grooves for receiving or grasping a clip. An arm  2   b  extends from each jaw tip  2   a  and is configured with a width and thickness sufficient to provide a spring force to return the jaws to a predetermined distance or spacing between the jaws. The arms  2   b  connect or are integrated into an extension plate or bow  2   c  providing support for the jaw tips  2   a  and a centering point for the jaws at an axial point of the handles. 
     Projections or extensions  61  extend from the jaw arms  2   b , in one aspect, providing engagement with the end effectors to close the jaws and/or to connect the cartridge to the jaws. An aperture or receiver  33  in the bow in one aspect releasably connects the cartridge to the handle assembly with the jaws held there between. In one aspect, the jaws and handles used in various aspects of the present invention are reusable and made of metal, e.g., stainless steel. The cartridge, in one aspect, used in various aspects of the present invention is reusable with an autoclavable polymer cover and support. 
     Although the present invention has been described in certain specific aspects, many additional modifications and variations would be apparent to those skilled in the art. It is therefore to be understood that the present invention may be practiced otherwise than specifically described, including various changes in the size, shape and materials, without departing from the scope and spirit of the present invention. Thus, embodiments and aspects of the present invention should be considered in all respects as illustrative and not restrictive.