SURGICAL CLIP APPLICATOR AND METHOD FOR ADVANCING A CLIP INTO OPPOSITE JAWS OF A CLIP APPLICATOR

专利摘要:
enhanced clip advancer. The present invention relates to a surgical clip applicator and methods for applying surgical clips to a vessel, duct, shunt, etc. during a surgical procedure. in one embodiment, a surgical clip applicator is provided and may include a rod having a proximal end and a distal end with opposing claws thereon, the guide element being disposed within the rod and configured to guide a clip within the opposite claw. , the guide member has a channel formed in a surface thereof, and an abutment movably disposed on the stem and configured to advance a clip over the guide element and into the opposing jaws, the abutment having a distal tip that slidingly engages the channel to maintain contact with a surgical clip as it is advanced into the opposing jaws. in other embodiments, the guide element may also include a proximal channel formed in an upper surface thereof. the advancer can be configured to bypass down on the proximal channel to move proximally below a lower surface of the apex of the clip to position itself proximally to the clip to advance the clip into the opposing jaws.
公开号:BR112012008264B1
申请号:R112012008264-7
申请日:2010-10-04
公开日:2021-07-27
发明作者:Anthony T. Nguyen
申请人:Ethicon Endo-Surgery, Inc.；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[0001] The present invention relates generally to surgical devices and, in particular, to methods and devices for applying surgical clips to ducts, vessels, shunts (deviations), etc. BACKGROUND OF THE INVENTION
[0002] Surgical clip applicators are commonly used to ligate blood vessels, ducts, anastomoses, or a portion of body tissue during surgery. Most clip applicators typically have a handle with an elongated shaft that has a pair of opposing movable claws formed on one end thereof to hold and form a ligature clip therebetween. The claws are positioned around the blood vessel or duct, and the clip is crushed or formed over the vessel by closing the claws.
[0003] Clip appliers that are configured to deliver multiple clips typically include an advance mechanism that sequentially advances the clips into the clip applier jaws. Many clip applicators have jaws that are angled to the shank for better visibility. Angled grips require a clip being fed into the grips to change orientation. This change in orientation can lead to misalignment between the advancing mechanism and the clip, which can result in improper clip feeding into the jaws, further resulting in the application of a malformed clip to tissue. Problems can also arise as the advance mechanism retracts behind the next clip and fails to engage the clip to advance it into the jaws.
[0004] Consequently, there is a need for improved methods and devices for applying surgical clips to blood vessels, ducts, anastomoses, etc. SUMMARY OF THE INVENTION
[0005] The present invention provides methods and devices for applying a surgical clip to a blood vessel, duct, anastomosis, etc. In one embodiment, a surgical clip applicator is provided which may include a rod having a proximal end and a distal end with opposing claws thereon. A guide element may be disposed within the rod and may be configured to guide a clip into the opposing jaws. The guide element may include a channel formed in a surface thereof. The device may also include an advancer movably disposed within the rod, and configured to advance a clip over the guide element and into the opposing jaws. The advancer may have a distal tip that slidingly engages the channel to maintain contact with a surgical clip as it is advanced into the opposing jaws.
[0006] In one embodiment, the distal tip may have a distal-facing surface that is configured to be in a boundary position with an apex of a surgical clip so as to advance the surgical clip into the opposing jaws. The surface facing the distal side of the distal tip may have a height that is greater than a depth of the channel. In one embodiment, the guide element channel may be in the form of an opening formed through the guide element. A proximal portion of the channel may have a ramp surface formed thereon and configured to be in a boundary position against a proximal portion of the distal tip to cause a distal portion of the distal tip to deflect away from the element. guide during proximal movement of the advancer. A distal portion of the channel may also have a ramp surface formed thereon and configured to be in a boundary position against a distal portion of the distal tip to cause the distal portion of the distal tip to deflect away from the element. guide during distal movement of the advancer. The guide element may also include a longitudinally extending groove formed therein and configured to substantially prevent lateral movement of the distal tip relative to opposing side walls of the guide element.
[0007] The device may also include at least one clip disposed inside the rod. In one embodiment, the clip may have a maximum height measured in a direction transverse to a longitudinal axis of the rod, and the distal tip may have a maximum height measured in a direction transverse to a longitudinal axis of the rod that is greater than the height of the rod. at least one clip. In other aspects, the guide element may be in the form of, or may include, a tissue blocker having a distal end with a recess formed therein for receiving tissue. The opposing jaws can be configured to engage opposing legs of a surgical clip so that an apex of the surgical clip is held a distance above the guide element during the advancement of the surgical clip into the opposing jaws.
[0008] In another embodiment, a surgical clip applicator is presented, which includes a rod that has opposing claws at a distal end thereof. Opposite claws may be able to move between open and closed positions to apply a clip to tissue. A clip advancer may be movably disposed within the shaft, and may have a distal tip configured to advance at least one clip into the opposing jaws. The device may also include an advance guide disposed within the elongated shaft. The advancing guide may have a ramp surface formed thereon and configured to cause a distal portion of the distal tip to deflect away from the guide element during proximal movement of the adjunct to position the distal tip behind a apex of a surgical clip placed inside the nail. In one embodiment, the ramp surface may be a proximal ramp surface, and the guide element may include a distal ramp surface configured to cause the distal portion of the distal tip to deflect in a direction away from the guide member. guide during distal movement of the advancer. The advancer guide may include a channel formed therein, the proximal ramp surface may be formed adjacent a proximal end of the channel, and the distal ramp surface may be formed adjacent a distal end of the channel. In another embodiment, the distal tip may have a distal-facing surface that has a height that is greater than a depth of the channel in the advance guide. The adjunct guide may also include a longitudinally extending distal groove formed therein and configured to slidingly receive the distal tip of the adjunct guide.
[0009] A method for advancing a clip into opposing jaws of a clip applier is also presented and, in one embodiment, the method includes actuating a trigger to cause an advancer to move distally through a rod, contacting a surgical clip and advancing it distally along an upper surface of a guide element and into opposing jaws of the clip applier. The advancer may have a distal tip with a distal-facing surface that allows an apex of the surgical clip to move in the upper and lower directions, while still maintaining contact with the apex of the surgical clip. The method may also include releasing the trigger to move the advancer proximally. The distal tip of the adjunct may deflect in an inferior direction, below an inferior surface of a second surgical clip, during proximal movement of the adjunct. In an exemplary embodiment, as the adjunct moves proximally, the guide element may cause the distal tip of the adjunct to deflect in a superior direction to position the distal tip of the adjunct in a location proximate to a second surgical clip. In other embodiments, the guide element may include a channel formed therein which holds the distal tip of the adjunct in alignment with a longitudinal axis of the guide element. The forwarder tip can maintain contact with an apex of the clip as said clip is formed between the opposing claws. BRIEF DESCRIPTION OF THE DRAWINGS
[00010] The invention will be more fully understood from the following detailed description, taken in conjunction with the attached drawings, in which:
[00011] Figure 1A is a side view of an exemplary embodiment of a surgical clip applicator;
[00012] Figure 1B is an exploded view of the surgical clip applicator shown in Figure 1A;
[00013] Figure 2A is a top view of a surgical clip applicator grip retainer assembly shown in Figure 1A;
[00014] Figure 2B is a bottom view of the grip retainer assembly shown in Figure 2A;
[00015] Figure 2C is a side view of the grip retainer assembly shown in Figure 2B;
[00016] Figure 2D is a cross-sectional view of the grip retainer assembly shown in Figure 2C, taken through line D-D;
[00017] Figure 3A is a top view of a feeder shoe for use with the grip retainer assembly shown in Figures 2A to 2D;
[00018] Figure 3B is a bottom view of the feeder shoe shown in Figure 3A;
[00019] Figure 4A is a side perspective view of a feeder bar that is configured to advance the feeder shoe of Figures 3A and 3B through the grip retainer assembly shown in Figures 2A to 2D;
[00020] Figure 4B is a side view of the proximal end of the feeder bar, shown in Figure 4A, and the proximal end of the claw retainer rod, shown in Figures 2A and 2B, showing the feeder bar in a more proximal position;
[00021] Figure 4C is a side view of the feeder bar and grip retainer rod shown in Figure 4B, showing the feeder bar in a more distal position;
[00022] Figure 4D is a side view of another embodiment of a proximal end of a feeder bar shown in connection with the proximal end of the claw retainer rod shown in Figures 2A and 2B, showing the feeder bar in the most proximal position ;
[00023] Figure 4E is a side view of the feeder bar and grip retainer rod shown in Figure 4D, showing the feeder bar in a more distal position;
[00024] Figure 4F is a side view of yet another embodiment of a proximal end of a feeder bar shown in connection with the proximal end of the grip retainer rod shown in Figures 2A and 2B, showing the feeder bar in the most proximal position. ;
[00025] Figure 4G is a side view of the feed bar and grip retainer rod shown in Figure 4F, showing the feed bar in an intermediate position;
[00026] Figure 4H is a side view of the feed bar and grip retainer rod shown in Figure 4F, showing the feed bar in a more distal position;
[00027] Figure 5A is a side perspective view of an advancer that is configured to engage a distal end of the feeder bar shown in Figure 4A;
[00028] Figure 5B is a side perspective view of another embodiment of an advancer that is configured to engage a distal end of the feeder bar shown in Figure 4A;
[00029] Figure 5C is a perspective view of yet another embodiment of an advancer that is configured to engage a distal end of the feeder bar shown in Figure 4A;
[00030] Figure 5D is another perspective view of the advancer of Figure 5C;
[00031] Figure 6A is a cross-sectional view of an advance clip assembly, which includes the grip retainer assembly shown in Figures 2A to 2D, the feeder shoe shown in Figures 3A to 3B, and the feed bar shown in Figure 4A; showing the feeder bar in a starting position proximal to the clip rail of the grip retainer assembly;
[00032] Figure 6B is a cross-sectional view of the clip advance assembly shown in Figure 6A, showing the feeder bar moved in a distal direction;
[00033] Figure 6C is a cross-sectional view of the clip advance assembly shown in Figure 6B, showing the feeder bar moved more distally, thereby moving the feeder shoe and a supply of clips disposed distally to the feeder shoe in a distal direction;
[00034] Figure 6D is a cross-sectional view of the clip advance assembly shown in Figure 6C; showing the feeder bar returned to the starting proximal position, shown in Figure 6A, while the feeder shoe and clip supply remain in the advanced position shown in Figure 6C;
[00035] Figure 6E is a bottom perspective view of the adjunct shown in Figure 5A disposed within the clip rail of the grip retainer assembly shown in Figures 2A to 2D, showing the adjunct in a more proximal position;
[00036] Figure 6F is an underside perspective view of the adjunct shown in Figure 6E, showing the adjunct in a more distal position after advancing a clip into the grips of the surgical clip applicator;
[00037] Figure 7 is a side perspective view of a pair of jaws of the surgical clip applicator shown in Figure 1A;
[00038] Figure 8 is a side perspective view of a cam for use with the claws shown in Figure 7;
[00039] Figure 9 is a top perspective view of a rod that is adapted to be coupled to the cam shown in Figure 8 so as to move said cam with respect to the claws shown in Figure 7;
[00040] Figure 10A is a top view of the cam shown in Figure 8 coupled to the claws shown in Figure 7; showing the cam in an initial position and the claws open,
[00041] Figure 10B is a top view of the cam shown in Figure 8 coupled to the claws shown in Figure 7; showing the advanced cam over the jaws, and the jaws in a closed position,
[00042] Figure 11A is a top perspective view of a tissue blocker that is adapted to be coupled to a distal end of the clip rail of the claw retainer assembly shown in Figures 2A to 2D;
[00043] Figure 11B is a top perspective view of another embodiment of a tissue blocker that has a ramp formed on it in order to guide a clip into the jaws and stabilize it during clip formation,
[00044] Figure 11C is a side view of the tissue blocker shown in Figure 11B;
[00045] Figure 11D is an enlarged view of the tissue blocker shown in Figures 11B and 11C;
[00046] Figure 11E is a perspective view of another embodiment of a tissue blocker that is adapted to be coupled to a distal end of the clip rail of the grip retainer assembly shown in Figures 2A to 2D;
[00047] Figure 11F is another perspective view of the tissue blocker of Figure 11E;
[00048] Figure 12A is a top view of a distal end of the surgical clip applicator shown in Figure 1A; showing the tissue blocker of Figure 11A positioned between the claws of Figure 7;
[00049] Figure 12B is a perspective view of the advancer of Figure 5C; advancing a clip over the tissue blocker of Figure 11E;
[00050] Figure 12C is a perspective view of the advancer of Figure 5C in a distal position over the tissue blocker of Figure 11E;
[00051] Figure 12D is a perspective view of the advancer of Figure 5C bending under a more distal clip within a channel formed in the tissue blocker of Figure 11E;
[00052] Figure 12E is a perspective view of the advancer of Figure 5C in a proximal position in the tissue blocker of Figure 11E;
[00053] Figure 13 is a partially cross-sectional side view of the handle portion of the surgical clip applicator shown in Figure 1A;
[00054] Figure 14 is a side perspective view of a trigger insert of the surgical clip applicator shown in Figure 1A;
[00055] Figure 15A is a side perspective view of one half of a surgical clip applicator feeder bar coupler shown in Figure 1A;
[00056] Figure 15B is a side perspective view of the other half of the feeder bar coupler shown in Figure 15A;
[00057] Figure 16 is a top perspective view of a flexible link that is part of a clip advance assembly of the surgical clip applicator shown in Figure 1A;
[00058] Figure 17A is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 1A, showing an advance clip assembly in an initial position,
[00059] Figure 17B is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 17A, showing the clip advance assembly partially engaged;
[00060] Figure 17C is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 17B, showing the clip advance assembly fully engaged;
[00061] Figure 17D is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 17A, showing an actuated clip former assembly;
[00062] Figure 18 is a side view of a closure link cylinder that is part of a clip former assembly of the surgical clip applicator shown in Figure 1A;
[00063] Figure 19 is a top perspective view of a closure link that engages with the closure link cylinder shown in Figure 18 to form part of a clip former assembly of the surgical clip applicator shown in Figure 1A;
[00064] Figure 20A is a top perspective view of a closure link coupler that engages with the closure link shown in Figure 19, and which is also part of the clip former assembly of the surgical clip applicator shown in Figure 1A ;
[00065] Figure 20B is a bottom view of the closing link coupler shown in Figure 20A, coupled to the rod of Figure 9 and having one embodiment of a tilting element disposed therein;
[00066] Figure 20C is a bottom view of the closing link shown in Figure 20A, coupled to the rod of Figure 9 and having another modality of an inclination element disposed therein;
[00067] Figure 20D is a graph showing the amount of force required to shift the tilt element shown in Figure 20B;
[00068] Figure 20E is a side view of another embodiment of a portion of a closure link coupler having ridges formed thereon;
[00069] Figure 21A is an enlarged side perspective view of an anti-return mechanism of the surgical clip applicator shown in Figure 1A;
[00070] Figure 21B is a perspective view of a latch mechanism of the non-return mechanism shown in Figure 21A;
[00071] Figure 22A is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 1A, showing the anti-return mechanism in an initial position,
[00072] Figure 22B is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 22A, showing the anti-return mechanism in a partially actuated position;
[00073] Figure 22C is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 22B, showing the anti-return mechanism in a fully actuated position;
[00074] Figure 22D is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 22C, showing the anti-return mechanism returning to an initial position;
[00075] Figure 22E is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 22D, showing the anti-return mechanism back to the initial position;
[00076] Figure 23A is an exploded view of an overload mechanism of the surgical clip applicator shown in Figure 1A;
[00077] Figure 23B is a partially cross-sectional view of the overload mechanism shown in Figure 23A, showing the closing link cylinder making first contact with the profile link;
[00078] Figure 23C is a partially cross-sectional view of the overload mechanism shown in Figure 23B, showing the closing link cylinder applying a force to the profile link and causing the profile link to rotate;
[00079] Figure 23D is a perspective view of another embodiment of an overload mechanism for use with a surgical clip applicator;
[00080] Figure 24A is a side perspective view of a clip number indicator wheel of the surgical clip applier shown in Figure 1A;
[00081] Figure 24B is a side view of a clip quantity indicator wheel shown in Figure 24A;
[00082] Figure 25 is a top perspective view of a clip quantity actuator for use with the clip quantity indicator wheel shown in Figure 24;
[00083] Figure 26A is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 1A, showing movement of the clip quantity actuator of Figure 25 and the clip quantity indicator wheel of Figure 24;
[00084] Figure 26B is a partially cross-sectional side view of a portion of the surgical clip applicator handle shown in Figure 26A, showing additional movement of the clip quantity actuator of Figure 25 and the clip quantity indicator wheel of the Figure 24; and
[00085] Figure 27A is a side view illustration showing another embodiment of a feeder shoe having an A-shaped bend preformed thereon and configured to create friction between the feeder shoe and the clip rail;
[00086] Figure 27B is a side view illustration of another embodiment of a feeder shoe having a pre-formed bending therein and configured to create friction between the feeder shoe and the clip rail;
[00087] Figure 28A is a top perspective view of a portion of a clip rail having surface protrusions formed thereon and configured to create friction with the feeder shoe, according to another embodiment of the invention;
[00088] Figure 28B is an end perspective view of another embodiment of a feeder shoe having a latch formed thereon and adapted to engage the formed surface protrusions present in the clip rail shown in Figure 28A;
[00089] Figure 29A is a bottom perspective view of another embodiment of a feeder shoe having a retaining lip formed on a latch that is adapted to engage a corresponding groove formed in a feeder bar;
[00090] Figure 29B is a top perspective view of another embodiment of a feeder bar having a catch groove formed therein and adapted to engage the retaining bead formed over the feeder shoe latch shown in Figure 29A; and
[00091] Figure 29C is a side cross-sectional view of the feeder shoe of Figure 29A disposed inside and next to the feeder bar of Figure 29B. DETAILED DESCRIPTION
[00092] The present invention generally provides a surgical clip applicator and methods for using a surgical clip applicator for applying surgical clips to a blood vessel, duct, anastomosis, etc., during a surgical procedure. An exemplary surgical clip applicator can include a variety of features to facilitate the application of a surgical clip as described in the present invention and illustrated in the drawings. However, one of skill in the art will understand that the surgical clip applicator may include only some of these features and/or may include a variety of other features known in the art. The surgical clip applicator described herein is merely intended to represent certain exemplary embodiments.
[00093] Figure 1A illustrates an exemplary surgical clip applicator 10. As shown, clip applier 10 generally includes a shroud 12 having a stationary handle 14 and a movable handle or trigger 16 that is pivotally coupled to shroud 12. An elongated rod 18 extends from the shroud 12 and includes a pair of opposing claws 20 formed on a distal end thereof to crimp a surgical clip. Elongated rod 18 may be rotationally coupled to wrap 12, and may include a rotary knob 22 for rotation of rod 18 relative to wrap 12. Figure 1B illustrates an exploded view of the surgical clip applicator 10 shown in Figure 1A; and the various components will be described in more detail below.
[00094] Figures 2A to 12 illustrate exemplary embodiments of the various components of the rod 18 of the surgical clip applicator 10. In general, with reference to Figure 1B, the rod 18 includes an outer tube 24 that houses the components of the rod, the which may include a jaw retainer assembly 26 having a jaw retainer shank 28 with a clip rail 30 and a rod channel 32 formed thereon. Grips 20 may be configured to engage a distal end of clip rail 30. Rod assembly 18 may also include an advance clip assembly which, in an exemplary embodiment, may include a feeder shoe 34 that is adapted to being slidably disposed within clip rail 30 to advance a series of clips 36 positioned thereon, and a feeder bar 38 which is adapted to drive feeder shoe 34 through clip rail 30. Feeder bar 38 may include an advancer assembly 40 which is adapted to engage a distal end thereof so as to advance the most distal clip into the jaws 20. The rod assembly 18 may also include a clip former assembly or an assembly of cam which, in an exemplary embodiment, may include a cam 42 which is adapted to slidingly engage the jaws 20, and a rod 44 which is engageable with the cam 4 2 to move said cam 42 with respect to claws 20. The stem assembly may also include a tissue stopper 46 which is engageable with a distal end of the clip rail 30 to facilitate the positioning of the claws. 20 in relation to a surgical site.
[00095] The various components of an exemplary clip advance assembly are shown in more detail in Figures 2A through 5. First with reference to Figures 2A through 2D, the grip retainer assembly 26 is shown and it includes a shank of the elongated and substantially flat claw retainer 28, with a proximal end 28a that engages outer tube 24, and a distal end 28b that is adapted to mate with claws 20. Although a variety of techniques can be used to engage the end proximal 28a of the jaw retainer rod 28 to the outer tube 24, in the illustrated embodiment the proximal end 28a includes teeth 31 formed on opposite sides thereof which are adapted to be received within corresponding holes or apertures (not shown) formed in the outer tube 24, and a cutout 29 formed therein that allows opposite sides of the proximal end 28a to curve or form a spring. In particular, the cutout 29 allows the opposite sides of the proximal end 28a of the jaw retainer rod 28 to be compressed towards each other when the jaw retainer rod 28 is inserted into the outer tube 24. Since the teeth 31 are aligned with corresponding openings in outer tube 24, the proximal end 28a of claw retainer shank 28 will return to its original uncompressed configuration, thus causing teeth 31 to extend into corresponding openings to engage. to outer tube 24. As will be discussed in more detail below in relation to Figure 4A; the device may also include a feature to prevent compression of opposite sides of the proximal end 28a of the shank of the claw retainer 28 during use of the device, to prevent accidental disengagement of the teeth 31 from the outer tube 24.
[00096] A variety of techniques can also be used to engage the distal end 28b of the jaw retainer rod 28 to the jaws 20, but in the illustrated embodiment the distal end 28b of the jaw retainer rod 28 includes various cutouts or teeth 78 formed therein for engagement with corresponding protrusions or teeth 94 formed on the claws 20, which will be discussed in more detail below in relation to Figure 7. The teeth 78 allow a proximal portion of the claws 20 to be substantially co-planar with the claw retainer rod 28.
[00097] The jaw retainer assembly 26 may also include a rod channel 32 formed therein to slidingly receive rod 44, which is used to advance cam 42 over jaws 20, as will be discussed in more detail. below. The rod channel 32 can be formed using a variety of techniques, and can be any shape and size depending on the shape and size of the rod 44. As shown in Figure 2D, the rod channel 32 is fixedly attached, for example by welding, to an upper surface of the retainer rod 28 is substantially rectangular in shape and defines a route 32a extending therethrough. Rod channel 32 may also extend along all or only a portion of retainer rod 28. One of skill in the art will understand that claw retainer assembly 26 need not include a rod channel 32 to facilitate movement of rod 44 inside the elongated shaft 18 of the surgical clip applicator 10.
[00098] As further shown in Figures 2A to 2D, the claw retainer assembly 26 may also include a rail of clips 30 fitted thereto or formed thereon. The clip rail 30 is shown fitted to a lower surface of the claw retainer shaft 28, and extends distally beyond the distal end 28b of the claw retainer shaft 28 to allow a distal end 30b of the clip rail 30 is substantially aligned with the jaws 20. During use, the clip rail 30 is configured to accommodate at least one and preferably a series of clips. Accordingly, the clip rail 30 may include opposing side rails 80a and 80b that are adapted to accommodate opposite legs of one or more clips thereon so that the legs of the clips are axially aligned with one another. In an exemplary embodiment, the clip rail 30 can be configured to accommodate about twenty clips that are pre-arranged within the clip rail 30 during fabrication. One skilled in the art will understand that the shape, size and configuration of the clip rail 30 may vary depending on the shape, size and configuration of the clips, or other closure devices such as clips, adapted to be received therein. In addition, a variety of other techniques can be used, in place of a clip rail 30, to secure a supply of clips with the elongated rod 18.
[00099] The clip rail 30 may also include a plurality of openings 30c formed therein to receive a latch 82a formed over a feeder shoe 34 adapted to be disposed within the clip rail 30, as will be discussed in more detail below. In an exemplary embodiment, the clip rail 30 includes a number of apertures 30c corresponding to at least the number of clips adapted to be pre-arranged within the device 10 and applied during use. The openings 30c are preferably equidistant from one another to ensure that the latch 82a on the feeder shoe 34 engages an opening 30c each time the feeder shoe 34 is advanced. Although not shown, the clip rail 30 may include detents in place of openings 30c, or it may include other features that allow the clip rail 30 to engage the feeder shoe 34 and prevent distal movement but allow proximal movement, of the feeder shoe 34. The clip rail 30 may also include a locking latch 118 formed thereon, as shown in Figure 2B, which is effective to be engaged by a corresponding locking latch formed on the feeder shoe 34 to prevent the movement of the feeder shoe 34 beyond a more distal position, as will be discussed below. The locking latch 118 can have a variety of configurations, but in an exemplary embodiment is in the form of two adjacent flaps that extend toward each other to enclose a portion of the clip rail, thus allowing the clips to pass through the same.
[000100] An exemplary feeder shoe 34 is shown in more detail in Figures 3A and 3B, and may be adapted to drive clips directly through the clip rail 30. Although the feeder shoe 34 can have a variety of configurations, and a variety While other techniques can be used to drive clips through clip rail 30, in an exemplary embodiment, feeder shoe 34 has a generally elongated shape with proximal and distal ends 34a and 34b. Distal end 34b may be adapted to accommodate the most proximal clip on clip rail 30 to push one or more clips through clip rail 30. In the illustrated exemplary embodiment, distal end 34b is substantially V-shaped to accommodate a V-fold portion of a clip. Distal end 34b also includes a rectangular shaped notch 34c formed therein to allow adger 40 to engage a more distal clip and advance it into jaws 20, as will be discussed in more detail below. Distal end 34b may, of course, vary depending on the configuration of the clip or other closure mechanism being used with device 10.
[000101] In another exemplary embodiment, the feeder shoe 34 may also include features to facilitate distal movement of the feeder shoe 34 within the clip rail 30, and to substantially prevent proximal movement of the feeder shoe 34 within the rail. clips 30. This type of configuration will ensure the advancement and proper placement of the clips within the clip rail 30, thus allowing a more distal clip to be advanced between the jaws 20 with each actuation of the trigger 16, as will be discussed in more detail below . In the illustrated exemplary embodiment, the feeder shoe 34 includes a latch 82a formed on an upper surface 34s thereof and proximally angled to engage one of the openings 30c formed in the clip rail 30. During use, the latch angle 82a allows the feeder shoe 34 to slide distally within the clip rail 30. Each time the feeder shoe 34 is advanced, the latch 82a will move in a distal direction from one opening 30c to the next opening 30c in the clip rail 30. Engagement of latch 82a with opening 30c in clip rail 30 will prevent feeder shoe 34 from moving proximally to return to the previous position, as will be described in more detail below.
[000102] In order to facilitate proximal movement of the feeder shoe 34 within the clip rail 30, the feeder shoe 34 may also include a latch 82b formed on the lower surface 34i thereof, as shown in Figure 3B, to allow the feeder shoe 34 is engaged by feeder bar 38 (Figure 4A) as feeder bar 38 moves distally. The lower latch 82b is similar to the upper latch 82a in that it can be placed proximally at an angle. During use, each time feeder bar 38 is moved distally, a detent 84 formed on feeder bar 38 can engage lower latch 82b and move feeder shoe 34 distally a predetermined distance within clip rail 30. Feeder bar 38 can then be moved proximally to return to its initial position, and the angle of lower latch 82b will allow latch 82b to slide into the next latch 84 formed on feeder bar 38. As noted above, one can. use a variety of other features, other than latches 82a and 82b and openings 30c or detents 84, to control the movement of feeder shoe 34 within clip rail 30.
[000103] As mentioned above, the feeder shoe 34 may also include a lock formed therein that is adapted to block the movement of the feeder shoe 34 when it is in the most distal position and there are no longer clips left in the device 10. can have a variety of configurations, Figures 3A and 3B illustrate a third latch 82c formed on the feeder shoe 34 and extending in a lower direction to engage the locking latch 118 (Figure 2B) formed on the clip rail 30. The third latch 82c is positioned such that it will engage the locking latch 118 on the clip rail 30 when the feeder shoe 34 is in a more distal position, thus preventing movement of the feeder shoe 34 and feeder bar 38 when supplying of clips is depleted.
[000104] Figure 4A illustrates an exemplary feeder bar 38 for driving the feeder shoe 34 through the clip rail 30 of the claw retainer assembly 26. As shown, the feeder bar 38 has a generally elongated shape with proximal and distal ends 38a and 38b. Proximal end 38a of feeder bar 38a may be adapted to mate with a feeder bar coupler 50 (Figure 1B), which will be discussed in more detail below. The feeder bar coupler 50 is engageable with a feeder link 52 which is effective, upon actuation of the trigger 16, to slidingly move the feeder bar 38 in a distal direction within the elongated rod 18. The distal end 38b of the bar feeder 38b may be adapted to fit a feeder 40 and 40', exemplary embodiments of which are shown in Figures 5A and 5B, which is effective to drive a more distal clip disposed within the clip rail 30 into the jaws. 20, which will be discussed in more detail below.
[000105] As previously mentioned, the proximal end 38a of the feeder bar 38 may include a feature to prevent compression of opposite sides of the proximal end 28a of the grip retainer rod 28 (Figures 2A and 2B) during use of the device, to prevent accidental disengagement of teeth 31 from outer tube 24. In an exemplary embodiment, shown in Figures 4A through 4C, proximal end 38a of feeder bar 38 may include a protrusion 39 formed thereon which is adapted to extend is into the opening 29 formed in the proximal end 28a of the shank of the claw retainer 28. When the feed bar 38 is in a more proximal position (i.e., when the trigger 16 is in an open position), the bulge 39 will be positioned at the proximal end of opening 29, as shown in Figure 4B, allowing the proximal end 28a of the jaw retainer shank 28 to compress to allow the rod 28 slides into outer tube 24. When feed bar 38 is in a more distal position (ie, when trigger 16 is in an at least partially closed position), protrusion 39 will be positioned at an intermediate location adjacent to the teeth 31 as shown in Figure 4C, to prevent compression of the proximal end 28a of the jaw retainer rod 28. This is particularly advantageous during use of the device, as the protrusion 39 will prevent accidental disengagement of the jaw retainer rod 28. from the outer tube 24 while using the device. Although Figures 4A through 4C illustrate a protrusion 39 having a rectangular cross-sectional shape with rounded edges, the protrusion 39 can have a variety of other shapes and sizes. For example, as shown in Figures 4D and 4E, the protrusion 39' has a cross-sectional shape that is approximately triangular, with a tapered end that is adapted to extend between the teeth 31 to further ensure that the proximal end 28a of the claw retainer rod 28 cannot be compressed while using the device. You can also use more than one lump. For example, Figures 4F to 4H illustrate another embodiment in which the proximal end 38a' of the feeder bar 38 includes two protrusions 39a and 39b formed thereon and spaced apart by a distance. The two protrusions 39a and 39b will prevent compression of the proximal end 28a of the grip retainer rod 28 when the feeder bar 38 is in a more proximal position, as shown in Figure 4F, and when the feeder bar 38 is in a more distal position. , as shown in Figure 4H. Compression of the proximal end 28a of the grip retainer shank 28 can only occur when the feeder bar 38 is in an intermediate position such that the teeth 31 are positioned between the protrusions 39a and 39b, as shown in Figure 4G.
[000106] As also mentioned above, the feeder bar 38 may include one or more detents 84 formed therein to engage the lower latch 82b formed on the feeder shoe 34. The amount of detents 84 may vary but, in an exemplary embodiment, the feeder bar 38 has an amount of detents 84 that corresponds to or is greater than an amount of clips adapted to be applied by device 10 and more preferably has a detent 84 more than the amount of clips adapted to be applied. applied by device 10. By way of non-limiting example, feeder bar 38 may include eighteen detents 84 formed thereon for applying seventeen clips that are pre-arranged within clip rail 30. This type of configuration allows feeder bar 38 advances feeder shoe 34 seventeen times, thereby advancing seventeen clips into jaws 20 for application. Detents 84 are also preferably equidistant from one another to ensure that feeder shoe 34 is engaged and advanced by feeder bar 38 each time feeder bar 38 is advanced.
[000107] The feeder bar 38 may also include a feature to control the amount of movement of the feeder bar 38 with respect to the clip rail 30. This type of configuration will ensure that the feeder shoe 34 is advanced a predetermined distance each once trigger 16 is actuated, thereby advancing only a single clip into jaws 20. While a variety of techniques can be used to control distal movement of feeder bar 38, in an exemplary embodiment, feeder bar 38 may include a protrusion 86 formed thereon, which is adapted to be slidably received within a corresponding slit 88 (Figure 2B) formed in the shank of the claw retainer 28. The length of the slit 88 is effective to limit movement of the protrusion 86 in the the same, thus limiting the movement of the feeder bar 38. Consequently, during use the feeder bar 38 can slide between a pro position. a fixed maximal and a fixed distal position with respect to the clip rail 30, thus allowing the feeder bar 38 to advance the feeder shoe 34 a predetermined distance with each advance of the feeder bar 38.
[000108] Figure 5A illustrates an exemplary embodiment of an advancer 40 that is adapted to engage the distal end 38b of the feeder bar 38 and that is effective to drive a more distal clip from the clip rail 30 into the jaws 20. A variety of techniques can be used to engage the abutment 40 to the feeder bar 38, but in the illustrated embodiment the proximal end 40a of the abutment 40 is in the form of a female connector that is adapted to receive the male connector formed at the distal end 38b of the feeder bar 38. Preferably, the advancer 40 securely engages the feeder bar 38 but may optionally be formed integrally with the feeder bar 38. The distal end 40b of the feeder bar 38 is preferably adapted to advancing a clip into the claws 20, and thus the distal end 40b of the abutment 40 may include, for example, a clip-driver member 90 formed therein. Clip drive member 90 can have a variety of shapes and sizes but, in an exemplary embodiment, is elongated in shape with a recess 92 formed in the distal end thereof to accommodate the fold portion of a clip. The shape of recess 92 may vary depending on the specific clip setting. Clip drive member 90 may also extend at an angle in an upward direction with respect to a longitudinal axis A of forwarder 40. This type of configuration allows clip drive member 90 to extend into clip rail 30 to engaging a clip, while the remainder of the advancer 40 extends substantially parallel to the clip rail 30.
[000109] Figure 5B illustrates another exemplary embodiment of a clip drive member 90' of an advancer 40'. In this embodiment, the clip drive member 90' is slightly narrower and has a small recess 92' formed at its most distal end. During use, the advancer 40 can engage and advance only the most distal clip disposed within the clip rail 30 into the grippers 20. This is due to the positioning of the feeder bar 38, which is capable of slidingly moving. between fixed proximal and distal positions, as discussed above.
[000110] Figures 5C and 5D illustrate yet another exemplary modality of a clip drive element or distal tip 90'' of an advancer 40''. In this embodiment, the clip drive element or distal tip 90'' has been modified to allow the apex of a surgical clip to be advanced into the jaws to move in the upper and lower directions while still maintaining contact with the apex of the surgical clip. In general, the distal tip 90'' has an elongated configuration with a proximal end 90p'' that is coupled to a body portion or rod 42'' of the adjunct 40''. Stem 42'' can be of various shapes and sizes, but in the illustrated embodiment, stem 42'' has a generally flat configuration with upper and lower surfaces 42s'' and 42i''. The specific configuration of the stem 42'', with the exception of the distal tip 90'', may be similar to that of the modalities previously described here. In an exemplary embodiment, the distal tip 90'' and the stem 42'' may be formed as a single integral component, but each component may be formed from different materials. For example, the distal tip 90'' can be formed from a metal, while the entire stem 42'' or a portion of the stem 42'' can be formed from a plastic that is integral with the feeder bar 38 and overmolded to the 90'' distal end in metal. Regardless of the specific material used, the distal tip 90'' is preferably formed from a flexible material that allows the tip 90'' to curve in higher and lower directions relative to the stem 42''. In certain exemplary embodiments, the distal tip 90'' may be formed by piercing a predetermined shape from a flat sheet of metal and then folding opposite sides of the shape together to form the compliant tip. shown, with the bottom surface being hollow.
[000111] As noted above, the 90'' distal tip can be configured to allow an apex of a surgical clip to be advanced into the jaws by the tip to move in an upper and lower direction while still maintaining contact with the apex of the clip. In other words, the distal tip 90'' can have a height that is greater than a height from the apex, as measured in the top/bottom direction (ie, transverse to the longitudinal axis of the 40'' protruder). This will allow the apex of the clip to slide up and down along the tip. In particular, as shown in Figure 5D, a surface facing the distal side 41 of the clip drive member 90'' may have a height H, measured in an upper/lower direction, which is greater than a height (as measured therein direction) of an apex of a clip pushed by the 90'' clip drive element, as described in more detail below. The increased height may result from a distal sloping surface 43 formed over a lower surface of tip 90'' and located adjacent to the distal end 90d'' of tip 90''. Distal slope surface 43 may be in the form of a ramped portion or surface feature. As further shown in Figures 5C and 5D, distal tip 90'' may also include a proximal sloping surface 45 formed over a lower surface of tip 90'' and located adjacent to proximal end 90p'' of tip 90'' . The two tilt surfaces 43 and 45 can be configured to interact with the tissue blocker, as will be described in detail below, and to thereby deflect in the upper and lower directions relative to the tissue blocker. The flexible or resilient material used to form the tip of the adjunct 90'' can facilitate repeated flexion of the distal tip 90''. As further shown in Figures 5C and 5D, an upper or top portion 47 of the clip drive member 90'' may be substantially straight and may extend upward at an angle between the proximal end 90p'' of the tip 90'' and the distal end 90d'' of the tip 90''. One skilled in the art will understand that the specific configuration of the Distal Tip 90'' may vary depending on the desired movement of the tip during use.
[000112] Figures 6A to 6G illustrate the clip advance assembly in use and, in particular, Figures 6A to 6D illustrate the movement of the feeder bar 38 within the clip rail 30 to advance the feeder shoe 34 and the clip supply 36, while Figures 6E through 6F illustrate the movement of the advancer 40 to advance a more distal clip into the jaws 20. The components on housing 12 that are used to drive the advancer clip assembly will be discussed in more detail below.
[000113] As shown in Figure 6A, in the rest position the feeder bar 38 is in a more proximal position so that the protrusion 86 is positioned proximally within the elongated slot 88 in the claw retainer shank 28. The feeder shoe 34 is disposed within the clip rail 30 and, assuming device 10 has not yet been used, the feeder shoe 34 is in a more proximal position so that the upper latch 82a on the feeder shoe 34 is engaged with the most proximal opening, or first opening, 30c1 formed in the clip rail 30 to prevent proximal movement of the feeder shoe 34, while the lower latch 82b on the feeder shoe 34 is positioned between the first detent 841 and the second detent 842 on the feeder bar 38 , so that the lower latch 82b is forced in an upward direction by the feed bar 38. The detents 84 on the feed bar are sequentially identified as 84 1, 842, etc., and the openings 30c in the clip rail 30 are sequentially identified as 30c1, 30c2, etc. As further shown in Figure 6A, a series of clips 36, sequentially identified as 361, 362, . . . 36x, with 36x being the most distal clip, are positioned within the clip rail 30, distal to the feeder shoe 34.
[000114] Upon actuating the trigger 16, the feeder bar 38 is advanced distally, causing the protrusion 86 to slide distally into the slot 88. As the feeder bar 38 moves distally, the lower latch 82b on the feeder shoe 34 will slide into first detent 841 on feeder bar 38. Further distal movement of feeder bar 38 will cause first detent 841 to engage lower latch 82b, as shown in Figure 6B, and move feeder shoe 34 and clip supply 361, 362, etc. in a distal direction. As shown in Figure 6C; when the protrusion 86 abuts the distal end of the elongated slot 88 in the jaw retainer shaft 28, the feed bar 38 is prevented from making any further distal movement. In this position, the feeder shoe 34 is advanced a predetermined distance so as to advance the supply of clips 361, 362, . . . 36x inside the clip rail 30 for a predetermined distance. The upper latch 82a of the feeder shoe 34 has been advanced into the second opening 30c2 in the clip rail 30 to prevent proximal movement of the feeder shoe 34, and the lower latch 82b on the feeder shoe 34 is still engaged with the first detent 841 on the bar feeder 38.
[000115] The movement of the feeder bar 38 from the most proximal starting position, shown in Figure 6A, to the most distal end position, shown in Figure 6C; will also advance the most distal clip 36x into the jaws 20. In particular, as shown in Figure 6E, distal movement of the feed bar 38 will cause the clip drive member 90 of the advancer 40, which is attached to the distal end of the feeder bar 38, engages the most distal clip 36x disposed within the clip rail 30, and advances said clip 36x into the jaws 20, as shown in Figure 6F. In an exemplary embodiment, the advancer 40 will engage and advance the most distal clip 36x before engaging and initiating the advance of the feeder shoe 34. As a result, the most distal clip 36x will advance a distance that is greater than a distance traveled by the feeder shoe 34. This type of configuration allows only the most distal clip 36x to be advanced into the jaws 20 without accidentally advancing an additional clip into the jaws 20.
[000116] Once the 36x clip has been partially or fully formed, the trigger 16 can be released to release the 36x formed clip. Releasing trigger 16 will also retract feeder bar 38 in a proximal direction until protrusion 86 returns to the most proximal starting position within elongated slot 88, as shown in Figure 6D. As feeder bar 38 is proximally retracted, feeder shoe 34 will not move proximally as upper latch 82a will engage second opening 30c2 in clip rail 30. Lower latch 82b will not interfere with proximal movement of feeder bar 38 and, once the feeder bar 38 is in the most proximal starting position, as shown, the lower latch 82b will be positioned between the second detent 842 and the third detent 843 on the feeder bar 38.
[000117] The process can be repeated to advance another clip into the jaws 20. With each actuation of the trigger 16, the lower latch 82b will be engaged by the next detent, i.e. detent 842 formed on the feed bar 38, the upper latch 82a in feeder shoe 34 will be moved distally to the next opening, i.e., opening 30c3 in clip rail 30, and the most distal clip will be advanced into jaws 20 and released. In cases where device 10 includes a predetermined number of clips, for example, seventeen clips, trigger 16 may be actuated seventeen times. Once the last clip has been applied, the lock, for example the third latch 82c, on the feeder shoe 34 may engage the lock latch 118 on the clip rail 30 to prevent any further distal movement of the feeder shoe 34.
[000118] The feeder shoe 34, the feeder bar 38, and/or the clip rail 30 may also optionally include features to prevent accidental or unintended movement of the feeder shoe 34, for example during transport of the device. This is particularly advantageous as migration of the feeder shoe 34, particularly prior to first use of the device, can cause the device to malfunction. For example, if the feeder shoe 34 migrates distally, it will advance two clips into the jaws simultaneously, thus resulting in the application of two malformed clips. As needed, in an exemplary embodiment, the feeder shoe 34, the feeder bar 38, and/or the clip rail 30 may include an engagement mechanism and/or may be configured to generate a frictional force therebetween that is sufficient to resist to movement, but which can be overcome by actuating the trigger 16 to allow the feeder bar to advance the feeder shoe 34 through the clip rail 30.
[000119] Although various techniques can be used to prevent the unwanted migration of the feeder shoe 34 within the clip rail 30, Figures 27A to 29C illustrate several exemplary embodiments of techniques for creating friction or an engagement mechanism between the feeder shoe 34, the feeder bar 38, and/or the clip rail 30. First with reference to Figure 27A, there is shown an exemplary embodiment of a feeder shoe 34' which has a preformed cantilevered or arcuate in a free state configuration ( i.e., when the feed shoe 34' is removed from the clip rail 30), so that the feed shoe 34' forms a cantilever spring when disposed within the clip rail 30. In particular, a portion of the feed shoe 34 ' can include a bend 35' formed therein so that opposite ends 34a' and 34b' of the feeder shoe 34' are angled with respect to each other. The bending 35' can cause the height hb of the feeder shoe 34' to be greater than the height of the clip rail 30. Although the height hb may vary, in one exemplary embodiment the bending 35' is configured to increase a height of the shoe. feeder shoe 34' in an amount that is sufficient to create a frictional drag force between the feeder shoe 34' and the clip rail 30, but which still allows the feeder shoe 34' to slide within the clip rail 30 when the trigger is triggered. 16 is triggered. In an exemplary embodiment, the height of the feeder shoe 34' is increased by at least about 30% or, more preferably, about 40%. During use, the clip rail 30 will force the feeder shoe 34' into a substantially flat configuration so that the feeder shoe 34' is forced against the clip rail 30 when disposed thereon. The bending 35' of the feeder shoe 34', as well as the terminal ends 34a' and 34b' of the feeder shoe 34', will therefore apply a force to the clip rail 30, thus creating a frictional drag force between the feeder shoe 34' and the clip rail 30. The frictional force will prevent the feeder shoe 34' from migrating relative to the clip rail 30, unless the trigger 16 is actuated, in which case the force applied by the trigger 16 will overcome the frictional forces.
[000120] One skilled in the art will understand that the bend 35' can have a variety of configurations, and can be formed at any point along the length of the feeder shoe 34'. In Figure 27A, the bend 35' is formed at or near the middle portion of the feeder shoe 34'. The bend 35' can also extend in several directions. Although Figure 27A illustrates bending 35' extending in a direction perpendicular to the axis so that bending 35' and ends 34a' and 34b' apply a force to the clip rail 30, bending 35' may alternatively extend along a longitudinal axis of feeder shoe 34' so that feeder shoe 34' applies a force to opposing side rails 80a and 80b (Figure 2D) of clip rail 30. Bending 35' can also place the opposite ends 34a' and 34b' angled in a downward direction, as shown in Figure 27A, so that the feeder shoe 34' is substantially A-shaped, or alternatively, bending 35'' can place the opposite ends 34a '' and 34b'' angled in an upward direction, as shown in Figure 27B, so that the feeder shoe 34'' is substantially V-shaped. The feeder shoe 34' may also include any number of bends formed in the same. One of skill in the art will understand that the specific configuration of the one or more flexures can be modified based on the properties of the feeder shoe 34' and the clip rail 30, to obtain a desired amount of frictional force between them.
[000121] Figures 28A and 28B illustrate another embodiment of a technique for creating frictional forces between the feeder shoe and the clip rail. In this embodiment, the clip rail 30' and/or the feeder shoe 34x may include one or more surface protrusions formed thereon. As shown in Figure 28A, two surface protrusions 82d1 and 82d2 are formed on the clip rail 30'. Although surface protrusions 82d1 and 82d2 can be formed at various locations of the clip rail 30', including within the opposite side rails or along the entire length of the clip rail 30', or at various locations of the feed shoe 34x, in the illustrated embodiment two protrusions 82d1 and 82d2 are formed at a point adjacent the proximal end of the clip rail 30', and are positioned to prevent initial migration of the feeder shoe prior to use, e.g., during transport. The size of the 82d1 and 82d2 bulges can vary depending on the amount of frictional force required to prevent unintended migration of the 34x feeder shoe.
[000122] Although the 82d1 and 82d2 protrusions can be configured to provide a sufficient amount of friction to prevent unintended migration of the 34x feeder shoe, the 34x feeder shoe and/or the 30' clip rail can optionally be include a feature that is adapted to engage corresponding surface protrusions. Figure 28B illustrates opposing latches 82e1, 82e2 formed on a distal portion of the feeder shoe 34x to engage protrusions 82d1, 82d2 on the clip rail 30'. The latches 82e1, 82e2 may vary in shape and size, and may include a bead or other protrusion configured to engage or "capture" the protrusions 82d1, 82d2. As shown in Figure 28B, latches 82e1, 82e2 extend toward each other from opposite side walls of feeder shoe 34x.
[000123] Figures 29A to 29C illustrate another embodiment of a technique to prevent unintentional migration of the feeder shoe. In this mode, friction is generated between the feeder shoe and the feeder bar. In particular, feeder shoe 34y includes a latch 82f with a bead 82g formed thereon, as shown in Figure 29A, and feeder bar 38y includes a corresponding groove 84y formed thereon. During use, as shown in Figure 29C, bead 82g is configured to engage groove 84y to prevent unintended migration of feeder shoe 34y. The lip 82g and groove 84y, however, are configured to allow movement of the feeder shoe 34y when sufficient force is applied to the feeder shoe 34y by actuating the trigger 16.
[000124] One of skill in the art will understand that a variety of other techniques can be used to prevent the unintended migration of a feeder shoe or other clip advance mechanism within a clip rail, and that any combination of features can be used and positioned in multiple locations on one or both components.
[000125] Figures 7 to 9 illustrate several exemplifying components of a clip forming assembly. First with reference to Figure 7; an exemplary embodiment of the claws 20 is shown. As previously mentioned, the claws 20 may include a proximal portion 20a which has teeth 94 for engagement with corresponding teeth 78 formed on the shank of the claw retainer 28. Other techniques may, however, be used. to attach the claws 20 to the claw retainer shaft 28. For example, a dovetail fitting connection, a male-female connection, etc. can be used. Alternatively, the claws 20 may be integrally formed with the retainer rod 28. The distal portion 20b of the claws 20 may be adapted to receive a clip therebetween and thus the distal portion 20b may include opposite first and second claw elements 96a and 96b that are movable relative to each other. In an exemplary embodiment, claw elements 96a and 96b are forced into an open position, and a force is required to move claw elements 96a and 96b toward each other. Each of the claw elements 96a and 96b may include a groove (only one groove 97 is shown) formed over opposing inner surfaces thereof for receiving the legs of a clip in alignment with the claw elements 96a and 96b. Each of the grip elements 96a and 96b may also include a cam track 98a and 98b formed thereon to allow the cam 42 to engage the grip elements 96a and 96b and move them toward each other. In an exemplary embodiment, cam track 98a and 98b is formed on an upper surface of grip elements 96a and 96b.
[000126] Figure 8 illustrates an exemplary cam 42 for slidingly coupling and engaging the claw elements 96 and 96b. Cam 42 can have a variety of configurations, but in the illustrated embodiment it includes a proximal end 42a that is adapted to engage a rod 44, discussed in more detail below, and a distal end 42b that is adapted to engage. apply to claw elements 96a and 96b. A variety of techniques can be used to engage cam 42 to rod 44, but in the illustrated exemplary embodiment cam 42 includes a female or keyhole cutout element 100 formed therein and adapted to receive a male or key element 102 formed therein. distal end 44b of rod 44. Male element 102 is shown in more detail in Figure 9, which illustrates rod 44. As shown, male element 102 is shaped to match the shape of cutout 100, to allow for the two elements 42 and 44 fit together. One of skill in the art will understand that the cam 42 and the rod 44 may optionally be formed integrally with one another. Proximal end 44a of rod 44 may be adapted to mate with a closure link assembly, discussed in more detail below, to move rod 44 and cam 42 with respect to jaws 20.
[000127] As further shown in Figure 8, the cam 42 may also include a protrusion 42c formed thereon, which is adapted to be slidably received within an elongated slit 20c formed in the jaws 20. During use, the protrusion 42c and slit 20c can function to form a proximal lock for the clip forming assembly.
[000128] Referring again to Figure 8, the distal end 42b of cam 42 can be adapted to engage grip elements 96a and 96b. Although a variety of techniques may be used, in the illustrated exemplary embodiment, distal end 42b includes a cam channel or a tapered recess 104 formed therein to slidingly receive cam track 98a and 98b on grip elements 96a and 96b. During use, as shown in Figures 10A and 10B, the cam 42 can be advanced from a proximal position in which the grip elements 96a and 96b are spaced apart from each other, to a distal position in which the elements Clamps 96a and 96b are positioned adjacent to each other and in a closed position. As cam 42 is advanced over jaw elements 96a and 96b, tapered recess 104 will push jaw elements 96a and 96b toward each other, thus crimping a clip disposed between them.
[000129] As previously mentioned, the surgical clip applicator 10 may also include a tissue blocker 46 to facilitate the positioning of tissue at the surgical site within the jaws 20. Figure 11A shows an exemplary embodiment of a tissue blocker 46 having proximal end and distal end 46a and 46b. Proximal end 46a may be adapted to mate with a distal end of clip rail 30 for positioning tissue blocker 46 adjacent to jaws 20. Meanwhile, tissue blocker 46 may be formed integrally with clip rail 30, or it may be adapted to mate with, or be formed integrally with, a variety of other components of stem 18. The distal end 46b of tissue blocker 46 may have a shape that is adapted to accommodate a blood vessel therebetween, a duct, an anastomosis, etc. to position and align the claws 20 with respect to the target site. As shown in Figure 11A, distal end 46b of tissue blocker 46 is substantially V-shaped. Distal end 46b may also have a curved configuration to facilitate positioning the device through a trocar or other access tube.
[000130] The tissue blocker, or other device components, may also optionally include features to support and stabilize a clip during clip formation. When a clip is being formed between the jaws, the clip may rotate and become misaligned. In particular, as the claws are closed, the terminal end of each clip leg will be moved towards each other. As a result, the claws will only engage a bent portion of each leg, thus allowing the terminal ends of the legs and the apex of the clip to escape alignment with the claws, i.e., to rotate vertically with respect to the claws. Additional closure of the jaws can thus result in a malformed clip. Consequently, the device may include features to align and guide the clip into the jaws, and to prevent the clip from rotating or otherwise becoming misaligned during clip formation.
[000131] Although the alignment feature can have a variety of configurations, and can be formed into various components of the device, Figure 11A illustrates a central latch 47 formed in a mid-portion of the distal end 46b of the tissue blocker 46, to hold a clip in alignment with the tip of the advance assembly 40. In particular, the center latch 47 may allow the apex of a clip to slide therealong, thereby preventing the clip from becoming misaligned with the existing advance assembly 40 pushing the clip in a distal direction. One of skill in the art will understand that tissue choke 46 can have a variety of other configurations, and can include a variety of other features to facilitate advancing a clip therethrough.
[000132] Figure 12A illustrates tissue blocker 46 during use. As shown, tissue blocker 46 is positioned just below claws 20 and in a location that allows for a blood vessel, duct, anastomosis, etc. is received between jaws 20. As further shown, a surgical clip 36 is positioned between jaws 20 so that fold portion 36a of clip 36 is aligned with tissue blocker 46. This will allow legs 36b of clip 36 are fully positioned around the blood vessel, duct, anastomosis or other target site.
[000133] Figures 11B to 11D illustrate another exemplary embodiment of a tissue blocker 46' having an alignment feature or guide element formed thereon and adapted to align and guide the clip into the jaws and, with more preferably, to keep the clip in alignment with the jaws during clip formation. In this embodiment, the alignment feature is in the form of a ramp element 47' extending longitudinally along a central geometric axis of tissue blocker 46' and projecting above an upper surface of tissue blocker 46' . Ramp member 47' is preferably rigid and increases in height from a proximal end 46a' to a distal end 46b' of tissue blocker 46'. The angle can vary, however, depending on the specific angle of the grips. Ramp member 47' preferably terminates adjacent tissue receiving recess 46c' formed in the distal end of tissue blocker 46'. As a result, the ramp element 47' is positioned adjacent to the jaws 20, allowing the ramp element 47' to guide a clip, as well as the tip of the forward assembly 40 that is pushing the clip, into the jaws 20 at an angle. adequate. During use, the ramp element 47' may be bordered against the lower apex surface of a clip disposed between the claws 20 to prevent the clip from rotating vertically as the claws 20 are closed to form the clip. In particular, when the advance assembly 40 is moved to the most distal position along the ramp member 47', the apex of the clip will be in a boundary position against the surface of the ramp member 47'. As the clip is compressed between the claws 20 and the legs of the clip move towards each other, the jaws 20 will only engage a bent portion of each leg. As a result, the clip's legs and apex are free to rotate vertically. However, as the apex is resting against the top surface 47a' of the ramp element 47', this will prevent the apex from moving vertically in a downward or downward direction, thus preventing the clip legs from moving vertically in one direction. up or higher, i.e. the ramp element 47' will prevent the clip from swinging within the jaws 20. In this way, the ramp element 47' is effective in preventing or limiting the harmful rotational forces generated when the jaws 20 are closed to form the clip. The clip is thus kept in alignment with the jaws 20.
[000134] The person skilled in the art will understand that the shape, size and configuration of the ramp element may vary depending on the specific configuration of the jaws and other components of the clip applier. In an exemplary embodiment, ramp element 47' may have a maximum height hRmax of about 0.0635 cm (0.025"), as measured from a central plane extending through tissue blocker 46'. preferably, height hRmax is in the range of about 0.0203 cm (0.008") to 0.0508 cm (0.020") and most preferably height hRmax is in the range of about 0.0254 cm (0.010) ") to 0.0381 cm (0.015"). The slope angle αR of the ramp element 47' may also vary but, in an exemplary embodiment, the ramp element 47' has a slope angle αR in the range of about 5° to 45°, more preferably 5° to 30° and most preferably 10° to 20°. The width wr of the ramp element 47' may also vary but, in an exemplary embodiment, the element ramp 47' preferably has a width wr which is slightly less than a space between the claws 20 in the fully closed position.
[000135] Figures 11E and 11F illustrate another exemplary embodiment of a tissue blocker 46'' having proximal and distal ends 46a'' and 46b''. Proximal end 46a'' may be adapted to mate with a distal end of clip rail 30 for positioning tissue blocker 46'' adjacent jaws 20. In other embodiments, however, tissue blocker 46'' may be formed integrally with the clip rail 30, or may be adapted to mate with, or be formed integrally with, a variety of other components of rod 18. Distal end 46b'' of tissue blocker 46'' may have a shape that is adapted to accommodate between them a blood vessel, a duct, an anastomosis, etc. to position and align the claws 20 with respect to the target site. For example, tissue blocker 46'' may have a V-shape that is defined, at least in part, by first and second arms 39a and 39b.
[000136] In this embodiment, the 46'' tissue blocker, also called the guide element or guide of the adjunct, is particularly configured for use with the 40'' adjunct shown in Figures 5C and 5D. In particular, tissue blocker 46'' includes features to accommodate the increased height of the advanced tip 90'' as discussed above. As shown in Figures 11E and 11F, the tissue blocker 46'' may include an opening or channel 49 formed therein and adapted to allow the distal tip 90'' of the advancer 40'' to flex in a lower direction, i.e. , into or through channel 49, during the movement of the forward 40'' between the proximal and distal positions. Although channel 49 may be located in any position on tissue blocker 46'', in embodiment channel 49 is disposed at a location between central and proximal, longitudinally along tissue blocker 46''. Channel 49 may also be situated in a recessed track 46t formed in an upper surface 46s of tissue blocker 46'' so that channel 49 is situated at a distance and below relative to upper surface 46s. The setback track 46t may be in the form of a longitudinally extending cutout formed along a substantial portion of the tissue blocker 46'' so as to create opposing side rails 46r extending longitudinally over a substantial length. of 46'' tissue blocker. The 46r guide rails allow the 40'' forwarder to slide along it, at a location above channel 49.
[000137] As further shown in Figures 11E and 11F, the recessed rail 46t may include a sloped or ramped surface adjacent to the proximal and distal ends of channel 49, such that said channel 49 includes a distal ramp 51 and a proximal ramp 53. Distal ramp 51 can increase in height in the direction from bottom to top, from a proximal end to a distal end. The distal ramp 51 can function to deflect the tip of the 90'' adjunct in a superior direction, as the 40'' adjunct is distally advanced. The proximal ramp 53 can increase in height in the direction from below to above, from a distal end to a proximal end. Proximal ramp 53 may function to deflect the tip of the adjunct 90'' in a superior direction, as the adjunct 40'' is proximally advanced.
[000138] As further shown in Figures 11E and 11F, tissue blocker 46'' may also include a longitudinally extending groove 55 located distal to channel 49 and adjacent to the distal end. Groove 55 may extend along the longitudinal axis of tissue blocker 46'' at a substantially central location, laterally between first and second arms 39a and 39b, and may be positioned substantially directly in line with channel 49 , so that the distal tip 90'' traveling distally up the distal ramp 51 and out of the channel 49 can continue passing in a straight line along the groove 55 to move a clip over the tissue blocker 46''. In other words, groove 55 substantially prevents distal tip 90'' from moving laterally relative to opposite lateral sides of tissue blocker 46'' to keep tip 90'' in alignment with the apex of the clip. In some embodiments, the groove 55 may be set back below a top surface of the first and second arms 39a and 39b to accommodate the increased height H of the distal tip 90''. As the apex of a clip generally travels a distance above the 46'' tissue blocker, this allows a height H of a distal tip 90'' to extend both above and below the apex of the clip.
[000139] As noted above, when pushed into jaws 20 the clip needs to reorient to accommodate the angle of jaws 20. This reorientation can cause an apex of the clip to fall vertically or rotate downward (in a lower direction ) in relation to the opposite legs of the clip. This drop may prevent the clip from being properly positioned within the jaws 20. For example, in some cases the apex of the clip may fall below a distal end of the clip drive element so that the clip drive element passes through the clip and move over the top of its apex. The clip drive element would then be unable to properly position the clip within the jaws 20. The height H of the clip drive element 90'' in the embodiment shown in Figures 5C and 5D, however, in combination with the groove 55 in the stopper of fabrics 46'' in the embodiment shown in Figures 11E and 11F, provides a solid surface against which the apex of the clip can move if rotated in the upper and/or lower directions. If the apex of the clip drops while being pushed into the jaws 20, the surface facing the distal side 41 of the distal tip 90'' can provide a solid surface that extends down and into the recessed groove 55, thereby preventing that the apex of the clip slides down from the distal end 90''. In this way, an apex of a clip cannot fall below an inferior surface of the surface facing the distal side 41, thus allowing the clip to always maintain contact with the distal end 90'' and thus always be properly positioned inside the claws 20.
[000140] Figures 12B to 12E illustrate in more detail an exemplary interaction between tissue blocker 46'' and distal tip 90''. In Figure 12B, the distal end 90'' is near the beginning of the clip formation cycle. Distal tip 90'' is shown pushing the most distal clip C into the jaws 20. The next clip C1 may be in a distal position on the clip rail 30. As shown, the surface facing the distal side 41 of the distal tip 90'' is contiguous with an apex of the C clip and has a height H that is substantially greater than an apex height. The distal-facing surface 41 of the distal tip 90'' may move within the groove 55 of the tissue blocker 46'' as it pushes the C-clip into the jaws 20. Thus, conforms to the clip legs C rotate slightly upwards (in an upward direction) to enter jaws 20, the apex of the C-clip will always be in a boundary position against the surface facing the distal side 41, even if the apex rotates downwards in the inferior direction. More particularly, the lower surface of the distal tip 90'' is in contact with the groove 55 and thus the apex of the C-clip will never fall below the lower surface of the distal tip 90''. In this way, the distal-facing surface 41 is able to maintain contact with the apex of the C-clip at all times and is therefore able to properly position the C-clip within the jaws 20. The distal-facing surface 41 it can also maintain contact with the apex of the C-clip at all times during the formation of the C-clip between the jaws 20 to ensure that the C-clip does not move proximally.
[000141] As illustrated in Figure 12C, once the C-clip has been formed inside the jaws 20 and released, the distal tip 90'' begins to move proximally from its most distal position within the groove 55, so to position itself behind or near the next C1 clip. At this point in the clip formation cycle, the distal tip 90'' is positioned distally to the next clip C1, and the highest point on the upper surface 47 of the distal tip 90'' is at substantially the same height as the upper surface of the clip C1 . Consequently, as the distal tip 90'' moves proximally to contact the clip C1, the upper surface 47 of the distal tip 90'' may contact an apex lower surface of the clip C1. As clip C1 is rigidly held within clip rail 30, clip C1 produces a downward force on distal tip 90'' to downwardly deflect resilient distal tip 90''. As clip C1 and upper surface 47 of distal tip 90'' come into contact with each other, distal tip 90'' is moving towards distal ramp 51. Thus, the downward force applied by clip C1 can cause with the distal tip 90'' deflecting downwardly in an inferior direction, so that the distal tipping surface 43 of the distal tip 90'' travels down the distal ramp 51 and into, or partially through, the channel. 49. With the distal tip 90'' traveling a path proximally in channel 49, its upper surface 47 is lower than a lower surface of the apex of clip C1 and can thus protrude proximally under the lower surface of the apex of clip C1. as shown most clearly in Figure 12D.
[000142] As the distal tip 90'' continues to move proximally within channel 49, the surface facing the distal side 41 moves proximally to the apex of clip C1. As it moves proximally, the proximal slope surface 45 contacts the proximal ramp 53 and begins to move up the proximal ramp 53. As the upper surface 47 of the distal tip 90'' is no longer in contact with the surface of clip C1, when the proximal slope surface 45 travels up the proximal ramp 53, the distal tip 90'' deflects again upwards in an upper direction so that it is at a substantially uniform height with the apex of the C1 clip once more, as shown most clearly in Figure 12E. The 90'' Distal Tip is now in its most proximal position and is ready to start the clip formation cycle again. Thus, as the advancer 40'', and therefore the distal tip 90'', are moved distally, the distal tipping surface 43 over the distal tip 90'' will move distally along the distal ramp 51 to cause the distal tip 90'' deflects upward in the superior direction, thus ensuring that contact is maintained between the apex of the clip and the surface facing the distal side 41 of the distal tip 90''.
[000143] Figures 13 to 26B illustrate various exemplary internal components of wrap 12 for controlling the advancement and formation of the clip. As discussed above, surgical clip applicator 10 may include some or all of the features set forth in the present invention, and may include a variety of other features known in the art. In certain exemplary embodiments, the internal components of clip applier 10 may include a clip advance assembly that engages with rod clip advance assembly 18 to advance at least one clip through elongated rod 18 and position the clip between the jaws. 20, and a clip former assembly that couples to the rod clip former assembly 18 to close the jaws 20 to form a partially or fully closed clip. Other exemplary features include an anti-return mechanism to control the movement of trigger 16, an overload mechanism to prevent overloading of force applied to grippers 20 by the clip former assembly, and a clip quantity indicator to indicate a clip quantity remaining on device 10.
[000144] Figures 13 to 16D illustrate an exemplary embodiment of a wrapper clip advance assembly 12 for effecting a movement of the feeder bar 38 within the rod 18. In general, the clip advance assembly may include an insert for the trigger 48 which is coupled to trigger 16, a feeder bar coupler 50 which engages a proximal end 38a of feeder bar 38, and a feeder link 52 which is adapted to extend between the trigger insert 48 and feeder bar coupler 50 for transferring movement from trigger insert 48 to feeder bar coupler 50.
[000145] Figure 14 illustrates in more detail the trigger insert 48. The shape of the trigger insert 48 may vary depending on the other components of the wrap 12, but in the illustrated embodiment the trigger insert 48 includes a central portion 48a which is adapted to pivotally engage housing 12, and an elongate portion 48b which is adapted to extend into and engage trigger 16 therewith. The central portion 48a may include a hole 106 extending therethrough for receiving a rod for pivotally engaging the trigger insert 48 to the housing 12. The central portion 48a may also include a first recess 108 formed on an upper side edge intended to receive a portion of the feeder link 52. The first recess 108 is preferably of a size and shape that allows a portion of the feeder link 52 to extend therein so as the feeder link 52 is forced to rotate when trigger insert 48 rotates due to movement of trigger 16. As shown in Figure 14, first recess 108 is substantially elongated and includes a substantially circular portion formed therein to accommodate a shaped rod. over a proximal end of the feeder link 52, as will be discussed in more detail with reference to Figure 16. The trigger insert 48 may also including a second recess 110, formed in a rear side edge, to receive a closure link cylinder 54 which is coupled to drive bar 44 to move cam 42 and close jaws 20, and ratchet teeth 112 formed on the lower side edge thereof for coupling to a pawl 60 to control the movement of trigger 16, as will be discussed in more detail below.
[000146] The exemplary feeder bar coupler 50 is shown in more detail in Figures 15A and 15B, and may be adapted to couple the proximal end of the feeder bar 38 to the distal end of the feeder link 52. Although a variety of techniques may be used to engage the feeder bar coupler 50 to the proximal end 38a of the feeder bar 38, in an exemplary embodiment the feeder bar coupler 50 is formed from two separate halves 50a and 50b, which fit together to hold therebetween. the proximal end 38a of the feeder bar 38. When mated together, the two halves 50a and 50b together define a central shaft 50c having substantially circular flanges 50d and 50e formed over opposite ends thereof, and defining a recess 50f therebetween to accommodate a distal portion of the feeder link 52. The central rod 50c defines a 50g lumen therethrough to receive the pre-end. oximal 38a of the feeder bar 38 and to lock the feeder bar 38 in a substantially fixed position relative to the feeder bar coupler 50. The feeder bar coupler 50 may, however, be integrally formed with the feeder bar 38, and may have a variety of other shapes and sizes to facilitate coupling with feeder link 52.
[000147] Figure 16 illustrates an exemplary feeder link 52 which may extend between the trigger insert 48 and the feeder bar coupler 52. In general, the feeder link 52 may have an elongated substantially flat shape with proximal ends and distal 52a and 52b. The proximal end 52a is adapted to pivotally remain within the first recess 108 of the trigger insert 48 and therefore, as discussed above, may include a rod 53 (Figure 1B) extending therethrough. Stem 53 may be adapted to pivotally pivot within first recess 108 of trigger insert 48, thereby allowing trigger insert 48 to rotate feeder link 52. Distal end 52b of feeder link 52 may be adapted to be coupled to the feeder bar coupler 50 and therefore in an exemplary embodiment are included opposing arms 114a and 114b formed therein, and defining an opening 116 therebetween to accommodate a central rod 50a of the feeder bar coupler 50. Arms 114a and 114b are effective to engage and move coupler 50 as feeder link 52 rotates about a pivot axis X. Pivot axis X can be defined by the location at which feeder link 52 engages with housing 12, and it may be positioned anywhere on feeder link 52, but in the illustrated embodiment is positioned adjacent to the proximal end 52a of feeder link 52.
[000148] In an exemplary embodiment, the feeder link 52 may be flexible to eliminate the need to calibrate the clip advance assembly and the clip former assembly. In particular, the feeder link 52 allows the trigger 16 to continue to move toward a closed position, even after the feeder bar 38 and feeder bar coupler 50 are in a more distal position, and provides some freedom for the assemblies. clip shaper and clip advancer. In other words, trigger 16 is flexible with respect to feeder bar 38 during trigger closure.
[000149] The specific stiffness and strength of the feeder link 52 may vary depending on the configuration of the clip lead assembly and the clip former assembly, but in an exemplary embodiment the feeder link 52 has a stiffness that is in the range of 13.13 at 19.26 kN/m (75 to 110 lbs per inch), and more preferably about 16.29 kN/m (93 lbs per inch) (as measured at the interface between link 52 and feeder bar coupler 50), and has a strength in the range of 111 N (25 lbs) to 222 N (50 lbs), more preferably about 156 N (35 lbs). Feeder link 52 can also be formed from a variety of materials, including a variety of polymers, metals, etc. An exemplary material is a glass-reinforced polyether imide, but a number of reinforced thermoplastics could be used, including glass-reinforced liquid crystal polymers, glass-reinforced nylons, and carbon fiber reinforced versions of these thermoplastics, and the like. Fiber reinforced thermoset polymers such as thermoset polyesters could also be used. Feeder link 52 could also be fabricated from a metal, such as spring steel, to obtain the desired combination of limited flexibility and controlled strength.
[000150] Figures 17A to 17D illustrate the exemplary clip advance assembly during use. Figure 17A shows an initial position, in which the trigger 16 is resting in an open position, the feeder bar coupler 50 and the feeder bar 38 are in a more proximal position, and the feeder link 52 extends between the insert member. of trigger 48 and feeder bar coupler 50. As previously discussed, in the initial open position the bulge 86 on feeder bar 38 is positioned at the proximal end of the elongated slot 88 in the jaw retainer shank 28. A first bias element, for example, a spring 120, is coupled to trigger insert 48 and wrap 12 to hold trigger insert 48 and trigger 16 in the open position, and a second bias element, for example spring 122 , extends between a rod coupler 124, which pivotally engages rod 18 to wrap 12, and feeder bar coupler 50 to hold feeder bar coupler 50 and the feeder bar 38 in the most proximal position.
[000151] When the trigger 16 is actuated and moved towards the closed position, that is, towards the stationary cable 14, to overcome the tilting forces applied by the springs 120 and 122, the trigger insert 48 starts to rotate in a counterclockwise direction as shown in Figure 17B. As a result, the feeder link 52 is forced to rotate in a counterclockwise direction, thereby moving the feeder bar coupler 50 and the feeder bar 38 in a distal direction. The bulge 86 on the feeder bar 38 thus moves distally into the elongated slot 88 in the shank of the claw retainer 28, thus advancing the feeder shoe 34 and clips 36 disposed within the clip rail. Spring 120 is extended between the shroud and trigger insert 48, and spring 122 is compressed between feed bar coupler 50 and rod coupler 124.
[000152] As trigger 16 is further actuated and trigger insert 48 continues to rotate, feeder bar coupler 50 and feeder bar 38 will eventually reach a more distal position. In that position, the protrusion 86 on the feeder bar 38 will be positioned at the distal end of the slot 88 in the shank of the claw retainer 28 and a clip will be positioned between the claws 20, as discussed above. Spring 122 will be fully compressed between rod coupler 124 and feeder bar coupler 50, and feeder link 52 will flex as shown in Figures 17C and 17D. As the feeder link 52 flexes, and more preferably once the feeder link 52 is fully flexed, the clip former assembly will be actuated to close the jaws 20. The feeder link 52 will remain flexed during actuation of the clip former assembly , for example the second stage of actuation, so that the trigger insert 48 is flexible with respect to the clip advance assembly and, in particular, the feeder bar 38.
[000153] An exemplary clip-former assembly of wrap 12 is shown in more detail in Figures 18 to 20. In general, the clip-former assembly is disposed within the wrap 12 and is effective to move the rod 44 and cam 42 with respect to the claws 20, so as to move the claws 20 to a closed position and thereby crimp a clip positioned therebetween. Although the clip former assembly may have a variety of configurations, the illustrated exemplary clip former assembly includes a lock link cylinder 54 that is slidably coupled to trigger insert 48, a lock link 56 that is adapted. to be coupled to the closure link cylinder 54, and a closure coupler 58 which is adapted to be coupled to the closure link 56 and the rod 44.
[000154] Figure 18 illustrates the lock link cylinder 54 in more detail and, as shown, the lock link cylinder 54 includes a center rod 54a that has substantially circular flanges 54b and 54c formed adjacent to opposite end ends thereof. . The center rod 54a may be adapted to lie within the second recess 110 in the trigger insert 48 so that flanges 54b and 54c are received on opposite sides of the trigger insert 48. The center rod 54a may also be adapted to mate with opposing arms 126a and 126b of closure link 56 to position the arms on opposite sides of trigger insert 48.
[000155] An exemplary embodiment of a closing link 56 is shown in more detail in Figure 19, and as shown has opposing arms 126a and 126b that are spaced a distance apart. Each arm 126a and 126b includes a proximal end 128a and 128b that is adapted to engage the center rod 54a of the closure link cylinder 54, and a distal end 130a and 130b that is adapted to engage the closure coupler 58 to couple the closure link cylinder 54 and closure link 56 to the rod 44. In an exemplary embodiment, the proximal end 128a and 128b of each arm 126a and 126b is adapted to pivotally engage the closure link cylinder. closure 54, and thus arms 126a and 126b may include, for example, hook-shaped elements 132a and 132b formed thereon to engage central rod 54a. Hook-shaped elements 132a and 132b extend in opposite directions to facilitate engagement between closing link 56 and closing link cylinder 54. Distal ends 130a and 130b of arms 126a and 126b can be snapped together. , and may include a lumen 134 extending therethrough to receive a rod that is adapted to pivotally engage closure link 56 to closure coupler 58. One of skill in the art will understand that a variety of other techniques may be used. to engage the closure link 56 to the closure link cylinder 54 and to the closure coupler 58.
[000156] An exemplary closure coupler 58 is shown in more detail in Figure 20A, and as shown includes a proximal portion 58a that has two arms 136a and 136b with lumens 138a and 138b extending therethrough and adapted to be aligned with the lumen 134 in closing link 56 to receive a rod for engaging two components. Closure coupler 58 may also include a distal portion 58b that is adapted to mate with proximal end 44a of rod 44 (Figure 9). In an exemplary embodiment, closure coupler 58 includes a cutout 59 (Figures 20B and 20C) formed therein and having a shape that is adapted to accommodate proximal end 44a of rod 44. Distal portion 58b of closure coupler 58 may also be configured to receive a portion of feeder bar coupler 50 when trigger 16 is in the open position. One of skill in the art will understand that a variety of other coupling techniques can be used to engage the closure coupler 58 to the rod 44, and that the closure coupler 58 and the rod 44 may optionally be formed integrally with each other.
[000157] In other exemplary embodiments, a preloaded hinge can be formed between the rod 44 and the closure coupler 58 to prevent accidental release of a clip from the jaws, particularly during the early stages of closure if the user loosens trigger 16 slightly. In particular, although the anti-return mechanism, discussed in more detail below, can be adapted to prevent trigger 16 from opening until trigger 16 has reached a predetermined position, the anti-return mechanism may allow some slight movement of trigger 16. Thus, if a user releases trigger 16 a little and a small opening occurs, the preloaded joint will force rod 44 in a distal direction, thus keeping rod 44 in a position substantially fixed, while allowing the closure coupler 58 to move proximally until the trigger 16 is engaged by the non-return mechanism.
[000158] Although the preloaded hinge may have a variety of configurations, and may be positioned at various locations along the clip forming assembly, in an exemplary embodiment the preloaded hinge may be in the form of a tilt element disposed within cutout 59 to bias rod 44 in a distal direction. Although a variety of tilting elements may be used, in the embodiment shown in Figure 20B the tilting element is a cantilever bar 61 that is positioned between the proximal end 44a of the rod 44 and the rear wall of the recess 59 to force the rod distally. 44. Cantilever bar 61 can be formed from a shape memory material, such as Nitinol, which allows bar 61 to flex or flatten when a proximally directed force is applied thereto. Bar 61 can also be formed from a variety of other materials, such as spring steel or reinforced polymers, and more than one bar can be used. Figure 20C illustrates another embodiment of an inclination element that is in the form of a spiral or other type of spring 63. As shown, spring 63 is disposed between the proximal end 44a of the rod 44 and the rear wall of the recess 59 to distally bias rod 44. Spring 63 is adapted to compress when a proximally directed force is applied thereto. One skilled in the art will understand that a variety of other inclination elements can be used, including elastomeric compression elements.
[000159] The preloaded linkage can also optionally include features to optimize the performance of the cantilevered bar or spring during the clip formation process. In the embodiment shown in Figure 20B, the load of the cantilevered bar 61 remains primarily uniform while the cantilevered bar is compressed during closing, but the load increases significantly during the final stages of closing. This is illustrated in Figure 20D, which shows a graph of the load/displacement curve of the cantilevered member 61 shown in Figure 20B. The left end of the curve represents the unloaded height of the cantilevered bar 61, while the right end of the curve represents the point at which the cantilevered bar 61 is fully compressed or flattened. The upper curve represents the resultant force as the cantilevered bar 61 is compressed during a typical closing stroke, with the exception that the force is measured from a free state of the cantilevered bar 61, while the cantilevered bar 61 is initially partially compressed when disposed within the closing coupler 58. As shown, the load remains substantially constant (excluding the initial stages of compression), increasing only slightly during the closing stroke while the cantilever bar 61 is being compressed. However, the load increases significantly in the final stages of closure when the cantilever bar 61 is fully flattened. This is due to the deflection of the cantilevered bar 61 which causes the load to be transferred from the terminal ends of the cantilevered bar 61 inwards. As the cantilevered bar 61 deflects and the load is transferred inward, the effective length of the cantilevered bar 61 is decreased, thereby increasing the load. In order to avoid this, the preloaded linkage can optionally include features to optimize the performance of the cantilevered bar or the spring and, in particular, to maintain a substantially constant load during clip formation.
[000160] Figure 20E illustrates an exemplary modality of a technique to enhance the performance of the cantilever bar or spring. As shown, recess 59' in closing coupler 58' includes two ridges 59a' and 59b' formed on the rear surface thereof such that ridges 59a' and 59b' are positioned under or behind the cantilever bar (not shown). The ridges 59a' and 59b' are spaced apart by a distance, and each ridge 59a' and 59b' has a height of at least about 0.127 cm (0.005") to prevent the cantilever bar from flattening fully against the rear surface of the recess. As a result, the ridges 59a' and 59b' will prevent the cantilever bar from deflecting, thereby preventing the load of the spring or cantilever bar from being transferred inward from the end ends. the specific location, quantity, and size of ridges 59a' and 59b' may vary depending on preloaded hinge configurations, as well as the forces required to prevent the clip from falling during closing.
[000161] During use, again referring to Figures 17A to 17D, as the trigger 16 is initially moved from the open position towards the closed position, the closing link cylinder 54 will rotate within the recess 110 in the insert member of trigger 48. Once feeder bar 38 and feeder bar coupler 50 are in the most distal position, as shown in Figure 17C, further actuation of trigger 16 will cause recess 110 in trigger insert 48 to engage. to the closure link cylinder 54, forcing it to rotate with the trigger insert 48, as shown in Figure 17D. As a result, the closure coupler 58 will move distally, thus causing the rod 44 to move distally. As the rod 44 advances distally, the cam 42 is advanced over the claws 20 to close the claws and crimp the clip positioned between them. Trigger 16 may optionally be partially closed to only partially close claws 20 and thereby partially crimp a clip disposed between them. Exemplary techniques to facilitate selective full and partial clip closure will be discussed in more detail below. Once the clip is applied, trigger 16 can be released, thereby allowing spring 120 to pull trigger insert 48 back to its initial position, and allowing spring 122 to force feeder bar coupler 50 and feeder bar 38 back to the proximal position. As the trigger insert 48 returns to its initial position, the closure link cylinder 54 is also moved back to its initial position, thus pulling proximally on the closure link 56, the closure coupler 58 and the pusher bar. 44.
[000162] The surgical clip applicator 10 may also include a variety of other features to facilitate the use of the device 10. In an exemplary embodiment, the surgical clip applicator 10 may include an anti-return mechanism to control the movement of the device. trigger 16. In particular, the anti-return mechanism can prevent trigger 16 from opening during the course of a partial closure. However, once the trigger reaches a predetermined position, at which point the clip positioned between the jaws can be partially crimped, the anti-return mechanism can release the trigger, allowing it to open and release the clip, or close to fully crimp the clip as may be desired by the user.
[000163] Figures 21A and 21B illustrate an exemplary embodiment of a non-return mechanism in the form of a ratchet. As shown, the ratchet includes a set of teeth 112 formed on the trigger insert 48, and a pawl 60 which is adapted to be rotatably disposed within the housing 12, and positioned adjacent the trigger insert. trigger 48, such that the closing of trigger 16 and pivotal movement of trigger insert 48 cause pawl 60 to engage teeth 112. Teeth 112 may be configured to prevent rotation of pawl 60 until it reaches a predetermined position, at which point latch 60 is free to rotate, thus allowing trigger 16 to open or close. The predetermined position preferably corresponds to a position in which the claws 20 are partially closed. As shown, in an exemplary embodiment the teeth 112 include a first set of teeth 112a, e.g. ten teeth, of a size that prevents the pawl 60 from rotating relative thereto, thus preventing the trigger 16 from opening when the pawl. 60 is engaged with the first set of teeth 112a. The teeth 112 may also include an end or end tooth, called a closure tooth 112b, which is of a size that allows the pawl 60 to rotate relative thereto when said. pawl 60 is engaged with closure tooth 112b. In particular, the closure tooth 112b is preferably of a size that is substantially larger than the size of the first set of teeth 112a, so that a relatively large notch 140 is formed between the first set of teeth 112a and the tooth. closure 112b. The notch 140 is of a size that allows the pawl 60 to rotate therein, thus allowing the pawl 60 to be selectively moved past the closure tooth 112b or back towards the first set of teeth 112a. One skilled in the art will appreciate that the closure tooth 112b may be the same size or a smaller size than the first ten teeth 112a, while still having a notch 140 formed therebetween, allowing the pawl 60 to rotate.
[000164] Figures 22A to 22D illustrate the ratchet mechanism in use. When trigger 16 is initially moved toward a closed position, as shown in Figure 22A, pawl 60 engages first set of teeth 112a, thereby preventing trigger 16 from opening. Further actuation of trigger 16 will cause pawl 60 to advance past the first set of teeth 112a until pawl 60 reaches notch 140 near closure tooth 112b. Once pawl 60 reaches closure tooth 112b, at which point the jaws 20 are partially closed due to the partially distal movement of cam 42 over jaws 20, pawl 60 is free to rotate, thus allowing trigger 16 to open or close as desired by the user. Figure 22C illustrates trigger 16 in a fully closed position, and Figures 22D and 22E illustrate trigger 16 returning to the open position.
[000165] The ratchet mechanism may also be configured to emit an audible sound indicating the position of the claws 20. For example, a first sound may be emitted when the pawl 60 engages the first set of teeth 112a, and a second sound different, for example a louder sound, may be emitted when the pawl 60 engages the closure tooth 112b. As a result, when the trigger 16 reaches the predetermined position in which the pawl 60 is engaged with the closure tooth 112b, the sound indicates to the user that the claws 20 are in the partially closed position. The user can thus release trigger 16 to release a partially closed clip, or can fully close trigger 16 to fully close the clip.
[000166] In another exemplary embodiment, the surgical clip applicator 10 may include an overload mechanism that is adapted to prevent the overloading of a force applied to the grippers 20 by the trigger 16. Typically, during application of a surgical clip, a some force is required to close the jaws 20 and crimp the clip around the fabric positioned between them. As the forming process proceeds and the clip is at least partially closed, the force required to continue closing the claws 20 around the clip increases significantly. Consequently, in an exemplary embodiment, the overload mechanism may have a resistance that correlates with the force required to close the jaws 20. In other words, the resistance of the overload mechanism may increase as the force required to close the jaws 20 increases. The resistance is, however, preferably slightly greater than the force required to close the claws 20, so as to prevent accidental actuation of the overload mechanism. As a result, if the claws 20 are prevented from closing when the trigger 16 is initially actuated, the force required to overcome the resistance of the overload mechanism is relatively low. This is particularly advantageous as the claws 20 are more susceptible to deformation when they are open or only partially closed. The overload mechanism will trigger more readily in the early stages of clip formation to prevent deformation of the grips. On the other hand, when the claws 20 are substantially closed, the resistance is relatively high, so the overload mechanism can only be actuated by applying a significant force to the claws 20.
[000167] Figure 23A illustrates an exemplary embodiment of an overload mechanism 62, showing an exploded view. In general, the overload mechanism may include an overload wrap 64 formed from two halves 64a and 64b, and containing a profile link 66, a toggle link 68, a pivot link 70, and a pull assembly 72 The traction assembly 72 may include a spring post 150 which is coupled to the housing 64 and which includes a hole extending therethrough to receive a plunger 154. A spring 152 is disposed around the spring post 150, and the plunger 154 extends through the spring column 150 and includes a head 154a formed therein which is adapted to be in a boundary position against the spring 152. The pivot link 70 may be generally L-shaped and may be coupled to the wrap 64 by a pivot pin 156 extending therethrough. A proximal end 70a of pivot link 70 may contact head 154a of plunger 154, and a distal end 70b of pivot link 70 may be pivotally coupled to toggle link 68 by means of a pivot pin 166 The toggle link 68, in turn, can be coupled to the profile link 66, which can be slidably and pivotally positioned within the housing 64 adjacent to an opening 64d formed in the housing. Pivot movement of profile link 66 within housing 64 can be achieved, for example, by means of a pivot pin 158 which extends through profile link 66 and is disposed within a first slot 160a (only one slit is shown) formed in each half 64a and 64b of the shell 64, while sliding movement of the profile link 66 within the shell 64 can be achieved, for example, by means of opposing protrusions 168a and 168b formed on the profile link 66 which are received within a second slit 160b (only one slit is shown) formed in each half 64a and 64b of the wrap 64.
[000168] During use, the profile link 66 can be adapted to receive a force from the clip forming assembly, and to counter that force with the resistance of the traction assembly 72. In particular, the overload mechanism 62 uses the spring 152 together with the toggle link 68 and the pivot link 70 to prevent the profile link 66 from rotating around the pivot pin 158 or sliding against the wrap 64. For the rotational aspect, the force exerted by the compressed spring 152 is transferred through the toggle link 68 and the pivot link 70 so that a rotational moment is applied to the profile link 66 against the wrap 64. In this way this assembly causes the profile link 66 to resist rotation in with respect to wrap 64. If the moment generated by a radial load from the cylinder of the closing link 54 against the profile link 66 exceeds the moment of the pivot link 70 and the toggle link 68, the profile link 66 begins to rotate, twisting the toggle link 68 and make by having the pivot link 70 further compress spring 152. For the sliding aspect, the pivot link 70, the toggle link 68 and the profile link 66 are aligned so that the sliding force (resistance to slipping) ) is the force required to twist the toggle link 68 and the pivot link 70. If the radial load of the closing link cylinder 54 against the profile link 66 exceeds the torsional force of the links, then the pivot link 70 further compresses spring 152 as profile link 66 slides proximally.
[000169] This is shown in more detail in Figures 23B to 23C and as shown the opening 64d in the wrap 64 allows the cylinder of the closing link 54 of the clip former assembly to rotate against the profile link 66. As a result , when trigger 16 is actuated and moved toward the closed position, the closing link cylinder 54 applies a force to the profile link 66. The resistance of the overload spring 152, however, will keep the profile link 66 in a position substantially fixed unless the force applied by the cylinder of the closing link 54 increases to a force which is greater than the resistance, for example a limiting force. This can be caused, for example, by a foreign object positioned between the claws 20, or when the claws 20 are fully closed with the clip and the blood vessel, duct, anastomosis, etc. between them. When the claws 20 cannot be further closed, the force applied to the cylinder of the closing link 54 from the movement of closing the trigger 16 will be transferred to the profile link 66, which will then rotate and slide inside the wrap 64, causing thereby rotating pivot link 70, which forces plunger 154 to compress overload spring 152.
[000170] As noted previously, the force required to actuate the overload mechanism can be correlated to the force required to close the jaws 20, which increases as the trigger 16 is moved to the closed position. This can be achieved due to the configuration of the profile link 66. In particular, when the cylinder of the closing link 54 first contacts the profile link 66, thus being in a lower position, the profile link 66 can rotate inward. of the wrapper 64 as shown in Figure 23B. As the closing link cylinder 54 moves upward along with the profile link 66, the force needed to overcome the resistance of the overload mechanism increases, as the profile link 66 must slide within the wrapper 64, as shown in Figure 23C. The force required to rotate the profile link 66 may be less than the force required to slide the profile link 66. Consequently, if the claws 20 are prevented from closing, for example due to a foreign object, as the trigger is initially actuated , a minimum force will be required to cause the closing link cylinder 54 to transfer the force to the lower portion of the profile link 66, causing it to rotate. When the jaws 20 are substantially closed and the trigger 16 is almost fully engaged, a significant amount of force is required to cause the closing link cylinder 54 to transfer force to the upper portion of the profile link 66, doing so. slide inside the wrapper 64 to overcome the resistance of the overload spring 152. Although the amount of force required to actuate the overload mechanism may be greater than, and may increase relative to, the amount of force required to close the jaws 20 , the force is preferably only slightly greater than the force required to close the claws 20, so as to prevent deformation or other damage to the claws 20 from occurring. to close the claws 20.
[000171] The profile link 66, and in particular the surface facing the distal side 66s of the profile link 66, may also have a shape that facilitates the correlation between the force required to actuate the overload mechanism and the force required to close the claws 20. For example, in cases where the force required to close the claws 20 increases at a linear rate, the surface facing the distal side 66s of the profile link 66 can be flat to prevent the profile link from 66 interfere with the movement of the cylinder of the closing link 54 thereover, and to allow a linear force to be applied to the trigger 16 to close the jaws 20. On the other hand, in cases where the force is required to close the jaws 20 is non-linear as trigger 16 is moved to the closed position, profile link 66 can have a non-linear shape that matches the non-linear force. This type of configuration will prevent the forces required to close cam 42 (Figure 8) from becoming too high.
[000172] By way of non-limiting example, the force required to close the claws 20 may be non-linear due to the shape of the recess 104 in the cam 42 which is adapted to push the claw elements 96a and 96b towards each other . As shown in Figure 8, recess 104 may have a curved configuration so that the force varies as cam 42 passes over grip elements 96a and 96b. Profile link 66 may therefore have a corresponding curved surface facing the distal side so that the force also varies as cylinder of closing link 54 passes over it. As shown in Figures 23A and 23B, the profile link 66 is curved so that the lower portion thereof is substantially convex and the upper portion thereof is substantially concave. One of skill in the art will understand that profile link 66 can have a variety of other shapes, and that a variety of other techniques can be used to optimize the force required to close the jaws 20 and the force required to actuate the overload mechanism. .
[000173] The person skilled in the art will also understand that the overload mechanism can have a variety of other configurations. By way of non-limiting example, Figure 23D illustrates an overload mechanism that is in the form of a cantilevered bar 170 for receiving a force applied by the cylinder of the closing link 54. The bar 170 may have a substantially curved member 172 with a bracket 174 coupled to one end thereof. The curved element 172 may have a bending moment such that, when loaded with a force greater than said bending moment, it yields to assume a condition of low stiffness. Bracket 174 may provide more rigidity to curved member 172 so that the bending moment increases adjacent to bracket 174. During use, bar 170 may be loaded within sheath 12 of clip applier 10, so that the closing link cylinder 54 contacts the concave surface, and the bar 170 may be positioned at an angle such that the closing link cylinder 54 is further away from the bar when the trigger 16 is initially actuated, the closing link cylinder 54 closest to bar as trigger 16 moves to closed position. As a result, the resistance to warping will increase as the closing link cylinder 54 moves away and the clip applier trigger 16 is moved to the closed position. Although not shown, multiple bars could optionally be used in a stacked fashion, and the terminal or free end of the bars could be contoured to adjust the warping load to a specific point along the length of the bar.
[000174] In another exemplary embodiment, the surgical clip applier 10 may include a clip quantity indicator to indicate the number of clips remaining in device 10. While various techniques can be used to indicate the number of clips remaining, the Figures 24A through 25 illustrate an exemplary embodiment of a clip quantity indicator having an indicator wheel 74 and an indicator actuator 76.
[000175] Indicator wheel 74 is shown in detail in Figures 24A and 24B and, as shown, has a generally circular or cylindrical shape defining a central geometric axis Y around which wheel 74 is adapted to rotate. The wheel 74 includes teeth 142 formed thereabout and adapted for engagement with the actuator of the indicator 76, and an indicator element 144. The indicator element 144 may have a variety of configurations, but in an exemplary embodiment the indicator element 144 is under the wheel. form of a block of contrasting color having a color, for example orange, red, etc., that differs from the rest of the indicator wheel 74.
[000176] Figure 25 illustrates in more detail the actuator of the example 76 indicator. Actuator 76 is adapted to be slidably disposed within a housing 12 and to be coupled to feeder link coupler 50 and to move as feeder bar coupler 50 and feeder bar 38 are moved. of indicator 76 may include a protrusion 146, of which only a portion is shown, formed on a lower surface thereof to extend into recess 50f formed between circular flanges 50d and 50e of feeder bar coupler 50. protrusion 146 allows indicator actuator 76 to be engaged with feeder bar coupler 50 and to be moved with it. Indicator actuator 76 may also include an engagement mechanism 148 formed thereon and adapted to engage teeth 142 formed on indicator wheel 74. As shown in Figure 25, engagement mechanism 148 of indicator actuator 76 is in the form of an arm having a tab formed on the end thereof, intended for engaging the teeth 142.
[000177] During use, the indicator wheel 74 is rotatably disposed within the housing 12, as shown in Figures 26A and 26B, and the indicator actuator 76 is slidably disposed within the housing 12, so that engagement mechanism 148 is positioned adjacent indicator wheel 74 and protrusion 146 extends into feeder bar coupler 50. Housing 12 includes a window 12a formed therein to provide visual access to indicator wheel 144. As per trigger 16 is moved to the closed position and the feeder bar coupler 50 is moved distally, the indicator actuator 76 will move distally with the feeder bar 38 and the feeder bar coupler 50. As a result, the engagement mechanism 148 over the feeder actuator indicator 76 will engage teeth 142 on indicator wheel 74, thus causing wheel 74 to rotate as a clip is advanced into jaws 20. Each time the trigger 16 is actuated to advance a clip 20 into the jaws 20, the indicator actuator 74 rotates the indicator wheel 76. When the clip supply has two or three clips remaining, the contrasting color block 144 over the indicator wheel 74 will begin to appear in window 12a formed in wrap 12, thus indicating to the user that only a few clips remain. The contrasting color block 144 can be adapted to occupy the entire window 12a when the supply of clips is depleted.
[000178] In another exemplary embodiment, the indicator wheel 74 may include an anti-return mechanism that is adapted to prevent the indicator wheel 74 from rotating in a reverse direction, e.g., a counterclockwise direction, after being advanced. . Although the non-return mechanism can have a variety of configurations, in the embodiment shown in Figure 24B the indicator wheel 74 includes opposing arms 73a and 73b which extend substantially parallel to the geometric axis Y. Each arm 73a and 73b has a pawl 75a and 75b formed on a more distal end thereof, which is adapted to engage with corresponding teeth formed on housing 12. Although not shown, corresponding teeth may be formed within a circular protrusion formed on an inner portion of housing 12 adjacent to window 12a. When indicator wheel 74 is disposed within housing 12, arms 73a and 73b extend into the circular protrusion formed around the inner circumference thereof. As a clip is applied and indicator wheel 74 is rotated, arms 73a and 73b can deflect over teeth on the wrap to move to the next position. As the indicator actuator 76 slides proximally to return to its initial position, the arms 73a and 73b will engage teeth on the housing to prevent the indicator wheel 74 from rotating in a reverse direction, i.e., from returning to the previous position. One skilled in the art will understand that a variety of other techniques can be used to prevent the indicator wheel 74 from returning.
[000179] As mentioned above, the surgical clip applicator 10 can be used to apply a partially or fully closed clip to a surgical site such as a blood vessel, duct, anastomosis, etc. In laparoscopic and endoscopic surgery, a small incision is made in the patient's body to provide access to the surgical site. A cannula or access port is typically used to define a working channel extending from the skin incision to the surgical site. During surgical procedures, it is often necessary to stop blood flow through vessels or other ducts, and some procedures may require the use of an anastomosis. A surgical clip can thus be used to clip the blood vessel or secure the anastomosis to said vessel. Therefore, a surgical clip applier, such as clip applier 10, can be inserted through the cannula or otherwise inserted into the surgical site to position the claws 20 around the blood vessel, anastomosis or other duct. The tissue blocker 46 can facilitate the positioning of the claws 20 around the target site. Trigger 16 can then be actuated to cause a clip to be advanced between the claws and positioned around the target site, and to cause the claws 20 to close to secure the clip. Depending on the intended use of the clip, trigger 16 may be partially engaged, as indicated by the audible sound of pawl 60 hitting closure tooth 112b, or may be fully engaged. Trigger 16 is then released to release the clip partially or fully closed, and the procedure can be repeated if necessary to apply additional clips.
[000180] The person skilled in the art will appreciate other aspects and advantages of the invention based on the modalities described above. Therefore, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended embodiments. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

权利要求:
Claims (11)
[0001]
1. A surgical clip applicator comprising: a rod (18) having a proximal end and a distal end with opposing claws thereon; a guide element (46) disposed within the rod (18) and configured to guide a clip into the opposing jaws, the guide element (46) having a channel (49) formed in a surface thereof; and an adjunct (40) movably disposed within the stem (18) and configured to advance a clip over a guide element (46) and into the opposing jaws, the adjunct (40) having a distal tip (90'' ) which slidingly engages the channel (49) to maintain contact with a surgical clip as it advances into the opposing jaws; wherein the distal tip (90'') has a distally facing surface (41) that is configured to abut an apex of a surgical clip to advance the surgical clip into the opposing jaws, the side facing surface distal (41) having a height (H) that is greater than a depth of the channel (49); characterized in that the guide element (46) has a groove (55) extending longitudinally located distal to the channel (49) and adjacent to the distal end of the guide element (46), the surface facing the distal side (41) of the distal tip (90'') being adapted to extend into the groove (55), whereby the groove (55) prevents lateral movement of the distal tip (90'').
[0002]
2. Surgical clip applicator according to claim 1, characterized in that the channel (49) of the guide element (46) comprises an opening formed through the guide element (46).
[0003]
3. Surgical clip applicator according to claim 1, characterized in that a proximal portion of the channel (49) has an inclined surface (53) formed thereon and configured to be in contiguous with a proximal portion (45 ) of the distal tip (90'') to cause a distal portion of the distal tip (90'') to deflect away from the guide element (46) during proximal movement of the advancer (40).
[0004]
4. Surgical clip applicator according to claim 1, characterized in that a distal portion of the channel (49) has an inclined surface (51) formed thereon and configured to be in abutment with a distal portion (43 ) of the distal tip (90'') to cause the distal portion of the distal tip (90'') to deflect away from the guide element (46) during distal movement of the advancer (40).
[0005]
5. Surgical clip applicator according to claim 1, characterized in that it further comprises at least one clip disposed within the rod (18), the clip having a maximum height measured in a direction transverse to a longitudinal axis of the rod (18), and wherein the distal tip (90'') has a maximum height measured in a direction transverse to a longitudinal axis of the rod (18) that is greater than the height of the at least one clip.
[0006]
6. Surgical clip applicator according to claim 1, characterized in that the guide element (46) comprises a tissue lock having a distal end with a recess formed therein for receiving tissue.
[0007]
7. A surgical clip applicator according to claim 1, characterized in that the opposing claws are configured to engage opposite legs of a surgical clip so that an apex of the surgical clip is held at a distance above the guide element (46) during advancing the surgical clip into the opposing jaws.
[0008]
8. Method for advancing a clip into opposing jaws of a clip applicator (10) as defined in any one of claims 1 to 7, characterized in that it comprises the steps of: actuating a trigger to drive an advancer (40 ) to move distally through a rod (18) and to contact and advance a surgical clip distally along an upper surface of a guide element (46) and into opposing jaws of the gas applicator. clip (10), the advancer (40) having a distal tip (90") with a distally facing surface (41) that allows an apex of the surgical clip to move in an upper and lower direction while still maintaining contact with the apex the surgical clip; and releasing the trigger to move the adjunct (40) proximally, the distal tip (90") of the adjunct (40) deflecting in a lower direction below a lower surface of a second surgical clip during proximal movement of the adjunct (40) .
[0009]
9. Method according to claim 8, characterized in that it comprises taking, by the guide element (46), as the adjunct (40) moves proximally, the distal tip (90") of the adjunct ( 40) to deflect in a superior direction to position the distal tip (90”) of the adjunct (40) at a location proximal to a second surgical clip.
[0010]
10. Method according to claim 8, characterized in that it comprises maintaining, by a groove (55) extending longitudinally formed in the guide element (46), the distal tip (90") of the forwarder (40) in alignment with a longitudinal axis of the guide element (46).
[0011]
11. Method according to claim 8, characterized in that it comprises maintaining contact, by the forward tip (40), with an apex of the clip as the opposing claws are closed to close the clip.

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同族专利:

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公开号 | 公开日

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BR112012008264A2|2020-08-25|

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RU2012118670A|2013-11-20|

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RU2597771C2|2016-09-20|

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US8262679B2|2012-09-11|

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US20110087241A1|2011-04-14|

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WO2011044035A2|2011-04-14|

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CA2777212C|2018-01-16|

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CN102647948B|2015-05-20|

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EP2485658B1|2016-11-23|

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WO2011044035A3|2011-06-30|

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EP2485658A2|2012-08-15|

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CN102647948A|2012-08-22|

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AU2010303722B2|2013-10-17|

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CA2777212A1|2011-04-14|

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AU2010303722A1|2012-05-03|

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法律状态:
2020-09-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-02-09| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

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2021-05-25| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-07-27| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/10/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |

优先权:

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申请号 | 申请日 | 专利标题

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US12/576,736|US8262679B2|2009-10-09|2009-10-09|Clip advancer|

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US12/576,736|2009-10-09|

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PCT/US2010/051305|WO2011044035A2|2009-10-09|2010-10-04|Improved clip advancer|

---