US20070049951A1 - Apparatus alignment device - Google Patents

Abstract

An alignment device for an apparatus. The apparatus is configured to selectively receive a first implement having a first width and a second implement having a second width, the first and second widths extending in a transverse direction generally orthogonal to an insertion axis direction of the first and second implements, the device comprising a pair of generally parallel spaced-apart elongated rails defining at least two channels, the at least two channels comprising a first channel having a first channel width, and a second channel having a second channel width, the first and second channel widths being different, the first channel being configured to centrally hold the first implement in the transverse direction, and the second channel being configured centrally hold the second implement in the transverse direction.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention is related to a an apparatus alignment device, and more particularly relates to an alignment device for a cartridge of a medical clip applying device that is able to accept more than one type of clip cartridge.
• 2. Background and Material Information
• Laparoscopic surgery is generally defined as minimally invasive surgery upon a patient, utilizing small or miniaturized medical devices by which body tissue is cut, removed or cauterized by small manipulable tools/devices through small incisions or openings within the patient's body. One such tool is a clip applier, which is used to grasp and/or crimp/seal tissue by the single hand of an operating surgeon., and is described in commonly-assigned U.S. Patent Publication No. 2003/0040759 and U.S. Pat. No. 6,277,131, the entire contents of both documents being expressly incorporated by reference herein.
• Prior art clip appliers have a patient-engaging distalmost end with a pair of squeezable jaws arranged on the distal end of an elongated channel or frame. The elongated channel is surrounded by an elongated tube, which elongated tube and elongated channel are secured at their respective proximalmost ends to the distal end of a pistol-like handle grip assembly. The handle grip assembly includes an arcuately movable squeezable trigger. By squeezing the trigger towards a housing portion of the handle grip assembly, a clip is advanced through the elongated channel and into the jaws from an elongated ladder-like clip supply cartridge disposed through the elongated housing. The actuating sequence includes the squeezing of the trigger to close the jaws and thus crimp the clip between the jaws, then releasing the trigger to advance a new clip into location between the jaws awaiting the next squeezing of the trigger. The elongated clip supply cartridge is fed into a receiving slot or port in the proximal end of the handle grip assembly. Once all of the clips have been discharged from the cartridge, the cartridge may be removed from the clip applier and discarded, and the clip applier may be sterilized and reused.
• It is also noted that manufacturers of cartridges for reusable clip appliers typically produce different clip supply cartridges each having a differently sized and/or shaped set of clips for use with different clip appliers. Depending on the type of surgery, the surgeon may specify a clip of a specific size, ranging from small to large. Sizes may vary depending on factors such as width (i.e., the gap between the prongs of the clip) and gauge of material. Only a single-sized series of clips may fit into a specific cartridge: if the clips are too small, then they cannot be securely held within the cartridge, and if the clips are too large, then they will not fit within the confines of the cartridge.
• For example, it is also known that a cartridge containing medium-sized clips can be used only with a medium-sized clip applier that accepts medium-sized clip cartridges, and the medium-sized clip applier can only hold medium-sized clip cartridges. Similarly, a cartridge containing large-sized clips can be used only with a large-sized clip applier that accepts large-sized clip cartridges, and the large-sized clip applier can only hold large-sized clips. For example, if the cartridge is too small, then the cartridge cannot be securely held within receiving slot or port, and if the cartridge is too large, then it will not fit within the cartridge.
• Therefore, if the nature of a surgeon's practice dictates that different sized clips be used for various surgical procedures, then a surgeon must keep an inventory of differently sized clip appliers, which results in increased cost and inventory time. Additionally, if a single surgical procedure requires the use of two different sized clips, then the surgeon must use two different clip appliers, and switching between clip appliers is a time-consuming process. Therefore, a need has arisen for a clip applier that can accept and align cartridges containing differently-sized and/or shaped clips.
SUMMARY OF THE INVENTION
• A non-limiting embodiment of the present invention provides an alignment device for an apparatus, the apparatus configured to selectively receive a first implement having a first width and a second implement having a second width, the first and second widths extending in a radial (or transverse) direction generally orthogonal to an insertion axis direction of the first and second implements. The device has a pair of generally parallel spaced-apart elongated rails defining at least two channels, the at least two channels comprising a first channel having a first channel width, and a second channel having a second channel width, the first and second channel widths being different, the first channel being configured to centrally hold the first implement in the radial direction, and the second channel being configured centrally hold the second implement in the radial direction.
• Another feature may include a transition area between the first and second channels, the transition area configured to guide the insertion of the first implement into the first channel, the transition area being further configured to block insertion of the second implement into the second channel.
• An additional feature may include a tapered distal end configured to be inserted into a body cavity, and a further feature may include a generally semi-cylindrically-shaped outer surface. Additionally, the second channel may be located proximally of the first channel.
• In a further feature, the first implement is a first cartridge type containing a plurality of crimpable clips of a first size, and the second implement is a second cartridge type containing a plurality of crimpable clips of a second size, the first size being different from the second size.
• Yet another feature may include a cavity configured to accept the insertion and retraction of a clip-engaging feeder, the feeder configured to retrieve and load a clip of the plurality of crimpable clips of the first size and the second size.
• Still yet another feature may include a ramp portion configured to inclinedly slide a clip of the plurality of crimpable clips of the first size and the second size toward a pair of clip-crimping jaws.
• In another feature the apparatus includes an elongated channel configured to selectively receive the first implement and the second implement, and the elongated rails further define a third channel therebetween configured securely and centrally hold an elongated channel member in the radial direction, the elongated channel member selectively housing the first implement and the second implement and further housing controls for at least one of a clip-engaging feeder or clip-crimping jaws. Additionally, the second channel may be located proximally of the first channel, and the third channel may be located proximally of the second channel.
• A feature of the invention provides a method for aligning, in an apparatus, a first implement having a first width and a second implement having a second width, the first and second widths extending in a radial direction generally orthogonal to an insertion axis direction of the first and second implements. The method may include selectively inserting, in the insertion axis direction, the first implement in the apparatus between a pair of elongated rails of the apparatus that define a first channel therebetween such that the first implement is securely and centrally held in the radial direction, and the second implement in the apparatus between the pair of elongated rails that further define a second channel therebetween such that the second implement is securely and centrally held in the radial direction.
• In another feature, the apparatus further includes a transition area between the first and second channels, and the method further includes selectively guiding, via the transition area, the insertion of the first implement into the first channel, and blocking insertion of the second implement into the second channel. In a further feature, the apparatus has a tapered distal end, and the method further includes inserting at least the tapered end into a body cavity.
• In still another feature, the first implement is a first cartridge type containing a plurality of crimpable clips of a first size, and the second implement is a second cartridge type containing a plurality of crimpable clips of a second size, the first size being different from the second size.
• In yet a further feature, the apparatus further includes a cavity, and the method further includes insertion and retracting of a clip-engaging feeder. Also, a ramp portion may be provided which inclinedly slides a clip of the plurality of crimpable clips of the first size and the second size toward a pair of clip-crimping jaws.
• Additionally, the apparatus may include an elongated channel configured to selectively receive the first implement and the second implement, and the method may further include securely and centrally holding an elongated channel member in the radial direction between a third channel defined by the elongated rails.
• A further feature provides an alignment device for an apparatus, the apparatus configured to selectively receive a first implement having a first width and a second implement having a second width, the first width being less than the second width, the first and second widths extending in a radial direction generally orthogonal to an insertion axis direction of the first and second implements. The device may include a body and a pair of elongated rails, each elongated rail of the pair of elongated rails extending in the insertion axis direction and along opposite sides of the body, wherein the pair of elongated rails each includes a first rail portion defining a first channel therebetween configured to securely hold the first implement in the radial direction, such that the first implement is centered in the radial direction with respect to the apparatus; and a second rail portion defining a second channel therebetween, a width of the first channel being less than a width of the channel, the second channel, the second channel configured to securely hold the second implement in the radial direction, such that the first implement is centered in the radial direction with respect to the apparatus.
• According to an additional feature, each elongated rail includes a transition area between the first rail portion and the second rail portion and configured to guide the insertion of the first implement into the first channel, the transition area being further configured to block insertion of the second implement into the first channel.
• A feature additionally provides a medical clip applying device for crimping a clip onto tissue. The device may have a body assembly having a handle and a squeezable trigger, a tube having a first end extending into the body assembly, a pair of jaws arranged on a second end of the tube, the jaws actuable by squeezing action of the trigger, the second end of the tube and the pair of jaws configured to be inserted into a body cavity, and an alignment device arranged on the second end of the tube and configured to be inserted into the body cavity, a loading port in communication with the tube, wherein the tube is configured to selectively receive, through the loading port (a) a first implement having a first width, or (b) a second implement having a second width, the first and second widths extending in a radial direction generally orthogonal to an insertion axis direction of the first and second implements, and wherein the alignment device has a pair of elongated rails defining a first channel therebetween configured to securely and centrally hold the first implement in the radial direction, the pair of elongated rails further defining a second channel therebetween configured to securely and centrally hold the second implement in the radial direction.
• Other exemplary embodiments and advantages of the present invention may be ascertained by reviewing the present disclosure and the accompanying drawings, and the above description should not be considered to limit the scope of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings, by way of non-limiting examples of preferred embodiments of the present invention, in which like characters represent like elements throughout the several views of the drawings, and wherein:
• FIG. 1 is a sectional view of a medical clip applying device according to an embodiment of the present invention, showing a large cartridge inserted therein;
• FIG. 2 is a bottom plan view of a distal end of the medical clip applying device, showing a medium-large clip inserted therein;
• FIG. 3 is a bottom plan view of a distal end of the medical clip applying device, showing a large clip inserted therein;
• FIG. 4 is a perspective view of a medium-large clip supply cartridge for use with an embodiment of the present invention;
• FIG. 5 is a perspective view of a large clip supply cartridge for use with an embodiment of the present invention;
• FIG. 6 is a side sectional view of an elongated tube of an embodiment of the present invention, showing a medium-large clip supply cartridge inserted therein;
• FIG. 7 is another side sectional view of an elongated tube of an embodiment of the present invention, showing a medium-large clip supply cartridge inserted therein;
• FIG. 8 is a side sectional view of an elongated tube of an embodiment of the present invention, showing a large clip supply cartridge inserted therein;
• FIG. 9 is another side sectional view of an elongated tube of an embodiment of the present invention, showing a large clip supply cartridge inserted therein;
• FIG. 10 is a perspective view of a jaw assembly and cinch of an embodiment of the present invention;
• FIG. 11 is a perspective view of the underside of a jaw assembly of an embodiment of the present invention;
• FIG. 12 is an enlarged sectional view of a handle grip assembly of an embodiment of the present invention;
• FIG. 13 is a perspective view of the underside of a cinch of an embodiment of the present invention;
• FIG. 14 is a perspective view of the underside of the cinch in an intermediate position;
• FIG. 15 is a plan view of the underside of the cinch of an embodiment of the present invention, in a proximal position;
• FIG. 16 is a top plan view of the of the cinch of an embodiment of the present invention, in the proximal position;
• FIG. 17 is a plan view of the underside of the cinch and jaw assembly of an embodiment of the present invention, when the jaws are in a partially-closed position;
• FIG. 18 is a plan view of the jaw assembly and cinch of an embodiment of the present invention, when the jaws are in a closed position;
• FIG. 19 is an isometric view of the jaw assembly of an embodiment of the present invention;
• FIG. 20 is an upper isometric view of the cinch of an embodiment of the present invention;
• FIG. 21 is a lower isometric view of the cinch of an embodiment of the present invention;
• FIG. 22 is a side elevational view of the jaw assembly;
• FIG. 23 is a perspective view of a cartridge alignment device of an embodiment of the present invention;
• FIG. 24 is a frontal view of the cartridge alignment device of an embodiment of the present invention;
• FIG. 25 is another perspective view of the cartridge alignment device of an embodiment of the present invention;
• FIG. 26 is a bottom perspective view of the cartridge alignment device of an embodiment of the present invention;
• FIG. 27 is a perspective, sectional view of a slider of an embodiment of the present invention;
• FIG. 28 is a front cross-sectional view of the elongated tube taken along the lines of28-28 inFIG. 6;
• FIG. 29 is a sectional view of a slider toggle in an upright position;
• FIG. 30 is an enlarged sectional view of the slider toggle shown inFIG. 29;
• FIG. 31 is a sectional view of the slider toggle in a lowered position;
• FIG. 32 is an enlarged sectional view of the slider shown inFIG. 31;
• FIG. 33 is a bottom plan view of the slider;
• FIG. 34 is a top plan view of the slider;
• FIG. 35 is a perspective view of the underside of the slider;
• FIG. 36 is a perspective view of the top of the slider;
• FIG. 37 is a bottom plan view of the slider attached to an underside of a spine and in a distally-moved position;
• FIG. 38 is a bottom perspective view of the slider attached to an underside of a spine and in a distally-moved position;
• FIG. 39 is a bottom perspective view of the slider attached to an underside of a spine and in a proximally-moved position;
• FIG. 40 is a bottom perspective view of the slider attached to an underside of a spine and in a proximally-moved and locked position;
• FIG. 41 is a plan view of an uncrimped clip for use in an embodiment of the present invention;
• FIG. 42 is a plan view of a partially crimped clip for use in an embodiment of the present invention;
• FIG. 43 is a plan view of a generally fully crimped clip for use in an embodiment of the present invention;
• FIG. 44 is an enlarged perspective sectional view of an indicating arrangement according to an embodiment of the present invention in a partially-crimped position; and
• FIG. 45 is an enlarged perspective sectional view of an indicating arrangement according to an embodiment of the present invention in a generally fully-crimped position.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show structural details of the present invention in more detail than is necessary for the fundamental understanding of the present invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the present invention may be embodied in practice.
• Referring to the drawings, wherein like characters represent like elements,FIG. 1 shows aclip applying device50 for applying medical tissue-pinchingclips52a,52bto tissue. Theclip applying device50 has a patient-engagingdistalmost end54 with a pair of squeezable jaw members (jaws)56 arranged thereon. An elongated channel member or frame (also referred to as the spine)58 is surrounded by anelongated tube60, which elongatedtube60 andelongated channel member58 are secured at their respective proximalmost ends to the distal end of a generally pistol-likehandle grip assembly62. Thehandle grip assembly62 includes an arcuately movablesqueezable trigger64 that pivots about pivot shaft64P. By releasing the squeezedtrigger64 away from ahousing portion66 of thehandle grip assembly62, aclip52a(shown inFIG. 2),52b(shown inFIG. 3) is advanced through the distal end of theelongated channel member58 and into thejaws56 from an elongated ladder-likeclip supply cartridge68a(shown inFIG. 4),68b(shown inFIG. 5), disposed through theelongated channel58. The elongatedclip supply cartridge68a,68bis fed into a receiving slot orport70 in the proximal end of thehandle grip assembly62, the receiving slot being in communication with theelongated channel58.
• A rotatable enclosure barrel (also referred to as a tube)72 is rotatably supported within thehandle grip assembly62. Therotatable enclosure barrel72 is connected to the proximal end of theelongated channel58. Theenclosure barrel72 has an annular distal bearing (first bearing)74 slidably disposed thereon and an annular proximal bearing (second bearing)76 slidably disposed thereon. While the figures show a cylindrical barrel (i.e., a round cross-section), it should be readily appreciable by those skilled in the art that the barrel may have alternative shapes, including but not limited to oval, square and triangular cross sections. Thedistal bearing74 has acompression spring78 arranged against its distalmost surface80. Thecompression spring78 releases acinch86 after thejaws56 have been closed and aclip52a,52bhas been crimped, and also provides a proximally-directed bias against thedistal bearing74.
• Thedistal bearing74 has an elongated cinch rod84 (shown inFIGS. 6-9) extending distally therefrom. Thecinch rod84 extends through the length of the elongated channel58 (and its surrounding protective enclosure tube60). The cinch86 (shown inFIG. 10) is generally semi-cylindrically-shaped and arranged on the distal end of thecinch rod84. Thecinch86 is slidably arranged on the distal end of theelongated channel58 and is reciprocally slidable in axial direction X to engage thejaws56 which are squeezably arranged on the distal end of the clip applying device. The eachjaw member56 is located on arespective jaw arm256, and thejaws56 and jaw arms are part of ajaw assembly156. Thejaw arms256 are biased outwardly (i.e.,thejaws56 are biased open). Distal and proximal movement of thecinch86 in axial direction X and with respect to theelongated channel58 effects the respective squeezing closure and biased opening of thejaws56 at the distal end of theelongated channel58. Thecinch rod84 moves in axial direction X to slide thecinch86 distally and proximally corresponding to the direction of movement of thedistal bearing74 on the distal end of theenclosure barrel72.
• Thedistal bearing74 is biased proximally by thecompression spring78, effecting a proximal motion to thedistal bearing74. Thedistal bearing74 is operatively connected to thetrigger64 by adistal paddle23, and theproximal bearing76 is operatively connected to aproximal paddle25, which is in turn connected to the trigger by atrigger linkage98. Thus, theproximal bearing76 is biased distally by the compression spring via thetrigger linkage98.
• Anelongated pusher rod88 extends adjacent to the lower side of the elongated channel58 (as shown, e.g., in FIGS.1,6-9 and37). Theelongated pusher rod88 has a proximal end connected to theproximal bearing76 surrounding theenclosure barrel72 at the proximal end of thehandle grip assembly62. Thepusher rod88 is connected to a clip-engaging feeder90 (shown inFIGS. 2-3). Thefeeder90 is movable in axial direction X in relation to the clip-loadedcartridge68a,68bdisposed within theelongated channel58; however, the pusher rod is disposed below the elongated channel58 (shown inFIG. 6). Proximal motion of thefeeder90 is effected by proximal motion of theproximal bearing76 around theenclosure barrel72 within thehandle grip assembly62. As thetrigger64 is squeezed (i.e., as the trigger is moved toward thehousing portion66 and pivoted about pivot shaft64P), thepusher rod88 distally retracts in the axial direction X due to distal movement of thedistal bearing74, which distally movesfeeder90 to retrieve adistalmost clip52a′,52b′ of the plurality of clips that are serially loaded inrespective clip cartridges68a,68b, in order to prepare (upon release of the trigger) to load thedistalmost clip52a′,52′ into guide slots194 (shown inFIGS. 10-11 and19), in the opposed faces of therespective jaws56. The term “plurality” as used throughout the specification is to be interpreted to mean greater than one and within a number understood by those skilled in the art.
• Thetrigger64 is biased toward the unsqueezed position by the compression spring78 (shown inFIG. 1). Upon release of thetrigger64, thedistal bearing74 is biased to move proximally, resulting in proximal (rearward) movement of thecinch86 by the proximal movement of thecinch rod84, which permits thejaws56 to bias themselves open, and the feeder90 (pushed by the pusher rod88) to push the next available (distalmost) clip52a′,52b′ into theguide slots194 of therespective jaws56 as thejaws56 open fully, as thetrigger64 is permitted to open fully (shown inFIG. 1) from thehandle66 portion of thehandle grip assembly62. Release of the trigger64 (after the trigger46 has been initially squeezed towards the handle66) will automatically advance the nextavailable distalmost clip52a′,52b′ within thecartridge68a,68b.
• The embodiments disclosed herein are configured to accept more than one type of cartridge (e.g., cartridges having different sizes and/or shapes). It is noted that throughout the specification, the term “size” to describe the different clips and/or the cartridges also includes shape as well. In a non-limiting embodiment, theclip applying device50 of present invention accepts aclip cartridge68acontaining a series of medium-largesized clips52a, and can also accept aclip cartridge68bcontaining a series of large-sized clips52b. It should be readily appreciable by those skilled in the art, however, that in alternative embodiments, the present invention may be configured to accept various other types of clip cartridges, including but not limited to small and medium cartridges, medium and medium-large cartridges, and small and large cartridges. Additionally, while the figures show theclip applying device50 being able to work with two types of cartridges, it should be readily appreciable by those skilled in the art, however, that in alternative embodiments more than two types of cartridges may be accepted.
• Referring toFIGS. 6-9, when theclip applying device50 is loaded with acartridge68a,68b, there is a predetermined distance Da, Db between theproximal bearing76 anddistal bearing74, this distance being determined by a stop key13 located in theenclosure barrel72.
• When theclip cartridge68bis inserted into the receiving slot orport70 of theclip applying device50, the cartridge is slid along axial direction X until it reaches a stop (not shown) and the cartridge can no longer be slid. Thestop key13 is then lowered into a stop keyhole34 (shown inFIG. 5) of thecartridge68bby pivoting action of the stop key (shown inFIGS. 8-9). When thetrigger64 is released (i.e., when theclip applying device50 is at rest, shown inFIG. 1), theproximal bearing76 anddistal bearing74 move towards each other such that thestop key13 is sandwiched therebetween to create a distance Db between the proximal bearing and distal bearing. The distance Db results from thedistal bearing74 contacting a firstdistal face13aof thestop key13, and theproximal bearing76 contacting a firstproximal face13bof the stop key.
• When theclip cartridge68ais inserted by the user into the receiving slot orport70 of theclip applying device50, the cartridge slides along axial direction X until it reaches a stop and the cartridge can no longer move axially. Theclip cartridge68a(shown inFIG. 4) does not have a stop keyhole for the lowering of the stop key13 therein. Thus, when thetrigger64 is released (i.e., when theclip applying device50 is at rest), theproximal bearing76 anddistal bearing74 move towards each other such that thestop key13 is sandwiched therebetween to create a distance Da between the proximal bearing and distal bearing (shown inFIGS. 6-7). The distance Da results from thedistal bearing74 contacting a seconddistal face13cof thestop key13, and theproximal bearing76 contacting a secondproximal face13dof the stop key. The distance Da is less then the distance Db because theproximal bearing76 anddistal bearing74 are closer to each other in the axial direction X.
• Additionally, due to the configuration of the face surfaces13a-dof the stop key, when thecartridge68ais inserted into theclip applying device50, theproximal bearing76 and distal bearing are both located more distally than when thecartridge68bis inserted into the clip applying device. Thus (as shown inFIG. 2-3), when thecartridge68ais inserted into theclip applying device50, the cinch is advanced in the distal direction to narrow the jaws to a width Wa, and when thecartridge68bis inserted into theclip applying device50, thecinch86 is advanced (a lesser amount than when thecartridge68ais inserted) in the distal direction to narrow the jaws to a width Wb. The width Wa is narrower than the width Wb because when thecartridge68ais inserted into the clip applying device, thecinch86 is distally advanced a greater amount in the axial direction X than when thecartridge68bis inserted into the clip applying device. As described further hereinbelow, eachjaw member56 is increasingly tapered from a proximal point along the axial direction X to a distalward point where amaximum width portion56W is located. Thus, the more thecinch86 is advanced distally toward themaximum width portion56W, the narrower the width between the jaws. In this way (shown inFIG. 2), the narrower width Wa allows thejaws56 to securely accommodate medium-large clips52ain theguide slots194.
• Similarly (shown inFIG. 3), when thecartridge68bis inserted into theclip applying device50, since thecinch86 is advanced a lesser amount than when thecartridge68ais inserted, the jaws are opened wider to width Wb to allow thejaws56 to securely accommodatelarge clips52bin theguide slots194, which may have a width larger than smaller clips (e.g., medium-large clips52a).
• Further (as shown inFIG. 2-3), when thecartridge68ais inserted into theclip applying device50, thefeeder90 is advanced to the proper position to load theclip52a, and when thecartridge68bis inserted into theclip applying device50, thefeeder90 is advanced (a lesser amount than when thecartridge68ais inserted) to properly load thelarger clip52b. In other words, when thecartridge68bis inserted, thefeeder90 does not distally advance as much as when thecartridge68ais inserted, because the feeder must be further back to accommodate thelarger clip52b(shown inFIG. 3), which may have a longer length than smaller clips (e.g., medium-large clips52a).
• In the above-described embodiment, the position in the axial direction X of both thecinch86 and thefeeder90 is determined by thestop key13; however, it is appreciable by those skilled in the art that in alternative embodiments, the position in the axial direction X of only one of thecinch86 and thefeeder90 may be determined by the stop key, i.e., the stop key may be differently configured to allow varied displacement between theproximal bearing76 anddistal bearing74. For example, when two clip types of different widths but of the same lengths are respectively used in two different cartridge types, the displacement in the axial direction X of only the cinch may be varied depending on which cartridge type is used, because the feeder is displaced by the same amount in either clip type. Similarly, when two clip types of different lengths but of the same widths are respectively used in two different cartridge types, the displacement in the axial direction X of only the feeder may be varied depending on which cartridge type is used, because the distance between the jaws does not need to be adjusted.
• It is noted that in a non-limiting embodiment, either or bothcartridges68a,68bmay containsafety keyholes77aand77b(shown inFIGS. 4-5) which do not interact with thestop key13, but rather accept asafety key110, in order to prevent insertion or withdrawal of theclip cartridge68a,68bunless thetrigger64 is generally fully squeezed rearwardly toward thehandle66 of thehandle grip assembly62 in a manner similar to that disclosed in commonly-assigned U.S. Patent Publication No. 2003/0040759.
• It is also noted that in a non-limiting embodiment, thetrigger64 may be squeezed to allow the insertion of thecartridge68a,68band/or to crimp aclip52a,52b; however, it should be appreciated that in alternative embodiments, other structure may be used (e.g., a separate or integral tab, button, lever or switch), which may be activated to allow thecartridge68a,68bto be inserted (and/or to crimp aclip52a52b), such that the position in the axial direction X of theproximal bearing76 or thedistal bearing74 may be determined.
• Thecinch86 andjaw assembly156 of the present invention allow full, positive and consistent control of the opening and closing of thejaws56 in direction Z (shown inFIGS. 2 and 10), hereinafter referred to as radial or transverse movement, movement in the radial direction or movement in the transverse direction. Because theclip applying device50 is able to accept two different types ofclip cartridges68a,68b, and thejaws56 thus move radially over a greater distance than other clip appliers, such full, positive and consistent control of thejaws56 is required. Further, limited travel in the axial direction X of a cinch is normally not enough to cover this increased radial travel of thejaws56. In other words, there is no single surface of thecinch86 orjaw assembly156 to completely and accurately control the opening and closing of the cinch.
• An embodiment of the present invention includes acinch86 that allows for greater radial movement of thejaws56 by engaging different jaw engagement surfaces156a,156b,156c,156d,156e,156fof eachjaw arm256. The generally semi-cylindrically-shapedcinch86 has a pair of control fingers (or control members)30 (shown inFIG. 13) on the underside thereof which engage inner engagement surfaces156eand outer engagement surfaces156fof the jaw arms. In a non-limiting embodiment, the inner and outer engagement surfaces156e,156f, as well as thecontrol fingers30, may be tapered or angled.
• FIG. 14 shows thecinch86 in an intermediate position, where thecontrol fingers30 are intermediate the respective inner engagement surfaces156eand outer engagement surfaces156f. In this position (in a non-limiting embodiment), medium-large clips52amay be loaded and the jaw arms may be at rest (i.e., spring forces of the jaw arms are acting neither inwardly nor outwardly in the radial direction Z).
• When the cinch is moved proximally in the axial direction X from the intermediate position,outer control surfaces30eof thecontrol fingers30 respectively engage the inner engagement surfaces156eto widen the gap between the jaws56 (e.g., to a width Wb, in order to accommodatecartridge68bcontaining largesized clips52b), whileinner control surfaces30fof the control fingers are brought out of contact with respective outer engagement surfaces156f, as shown inFIGS. 15 and 17. Conversely, when the cinch is moved distally from a proximalmost position toward the intermediate position, theouter control surfaces30eof the control fingers respectively slide along the inner engagement surfaces156eto gradually (due to the angled configuration) let thejaw arms256 bias themselves inward.
• Similarly, when the cinch is moved distally in the axial direction X from the intermediate position,inner control surfaces30fof thecontrol fingers30 respectively engage the inner engagement surfaces156eto narrow the gap between the jaws56 (e.g., to a width Wa, to accommodatecartridge68acontaining medium-largesized clips52a, or to begin a clip-crimping operation), whileouter control surfaces30eof the control fingers are brought out of contact with respective outer engagement surfaces156e, as shown inFIGS. 15 and 17. In a non-limiting embodiment, in order to ensure smooth transfer of control throughout the range of movement of thecinch86, thecontrol fingers30 are preferably always in contact with at least one of the inner or outer engagement surfaces156e,156f(as shown inFIG. 14).
• FIG. 18 shows thecinch86 in a fully distal position in which aclip52a,52bmay be fully crimped closed. In a non-limiting embodiment, in order to move thecinch86 from the fully-distal position along the axial direction X, the cinch includes a generally arcuatecentral block32 having opposed ends which respectively engage second inner engagement surfaces156dlocated on an upper surface of each jaw arm256 (shown inFIGS. 16 and 19), which may be tapered or angled in a non-limiting embodiment. Thecentral block32 ensures accurate and precise transition of the control surfaces of thecinch86 when thejaws56 begin to open (i.e. when the cinch moves proximally along axial direction X) from the closed jaw position. For example, when thecinch86 begins to open from the closed jaw position (shown inFIG. 18), a proximal facingsurface32dof thecentral block32 engages the second inner engagement surfaces156dcommence an opening operation of the jaws. After thecinch86 moves proximally partway along the axial direction X toward the intermediate position, control of the opening of thejaws56 is “handed off” to theinner control surfaces30fof thecontrol fingers30, which respectively slide along the outer engagement surfaces156fto gradually (due to the angled configuration) provide for outward movement of the jaw arms256 (in direction Z). Although thecentral block32 is shown in the figures as being arcuate, it should be understood by those skilled in the art that the central block may take a variety of shapes, including but not limited to, e.g., a wedge, circle, a V or W shape.
• In a non-limiting embodiment, thecinch82 may include a pair of inwardly facing guide walls34 (shown inFIGS. 20-21) configured to respectively slidingly engage one or more outerside engagement surfaces156a-c(shown inFIGS. 19 and 22) of eachjaw arm256 to provide further control of (e.g., pitch in the radial direction) thejaw assembly156 by the cinch. With such a configuration it may not be necessary for thejaw assembly156 to remain at rest in the intermediate position. Additionally, since thecontrol fingers30 protrude inwardly, a gap or channel G may be present between thecontrol finger30 and theceiling82cof thecinch82. A portion of eachjaw arm256 may then be sandwiched between arespective control finger30 and theceiling82cof thecinch82, thereby providing control and stability (by e.g., preventing dive) of the jaws in a Y-axis direction as the cinch slides in the X-axis direction.
• InFIGS. 2 and 10, the radial opening and closing direction of thejaws56 appears to be orthogonal to the axial direction X (i.e., it appears to be parallel to the axial direction Z); however, it should be understood by those skilled in the art that orthogonal radial movement of the jaws is neither necessary nor required. As shown inFIG. 10, in a non-limiting embodiment, thejaw arms156 may pivot about pivot point P and as such, may result in the radial movement of the jaws being oblique (i.e., in a radial oblique direction) to the axial direction X.
• It is also noted that the cinch control arrangement of the present invention is not limited to a medical clip applier device. Rather, it should be understood by those skilled in the art that the above-described cinch control arrangement of present invention may be used in other clip-applying devices, and may also be used in other devices where a cinch is moved axially to widen and/or narrow a gap between a pair of jaws or other members.
• As described above, theclip applying device50 of the present invention is able to accept at least two different types ofclip cartridges68a,68b, and as such, the present invention also provides a cartridge alignment device36 (shown inFIGS. 23-26) that can center (along central axis CX)clip cartridges68a,68bwithin theelongated tube60 in a width, or transverse direction (or radial direction) Z of the cartridges. In other words, thealignment device36 can maintain the loadedcartridges68aand68bin a central position in relation to the sides (i.e., equidistant to the sidewalls of thetube60 in the radial orthogonal Z axis direction) of the elongated tube60 (i.e., so that a sagittal plane defined by the X-Y axis bisecting thecartridges68a,68bis substantially coplanar with a sagittal plane X-Y that bisects the elongated tube. With such an arrangement, theclip cartridge68a,68bcan be centered within the elongated tube and theclip cartridge68a,68band the elongated tube, are aligned in the axial direction X (i.e., along the central axis CX). Thus, aclip52a,52bcan be accurately loaded in thejaws56 and accurately crimped thereby.
• Thealignment device36 has a pair ofelongated rails38 extending in the axial direction X. Therails38 each have a distal (first)region38adefining a first channel Ca therebetween, a middle (second)region38bdefining a second channel Cb therebetween, and a proximal (third)region38cdefining a third channel Cc therebetween. Each channel Ca, Cb and Cc successively extends in communication and in the axial direction X. In a non-limiting embodiment, the distal channel Ca is narrower than the middle channel Cb, which in turn is narrower than the proximal channel Cc. The alignment device also has a pair oftransition areas38t(each located between a respectivedistal region38aandmiddle region38b) which may be tapered or angled to accurately guide the insertion ofcartridge68a(which is inserted along axial direction X, also referred to as an insertion axis direction) into the distal channel Ca, where thecartridge68ais securely held and centrally aligned therein in the radial or transverse direction Z (i.e.,cartridge68ais sandwiched between bothdistal regions38a), due to the extending of the distal channel Ca in the axial direction X. In situations where thecartridge68bis wider in radial direction Z than thecartridge68a, thecartridge68bcannot fit within thedistal channel68a. Rather, the transition area blocks thecartridge68bfrom being inserted in thedistal channel68a, and also prevents damage to thecartridge68bduring the insertion process. Thus, thecartridge68bis securely held and centrally aligned in the channel Cb in the radial direction Z (i.e., thecartridge68bis sandwiched between bothmiddle regions38b), due to the extension of the middle channel Cb in the axial direction X.
• The proximal channel Cc is configured to hold the elongated channel member58 (through which thecartridge68a,68bis inserted in the insertion axis direction), which is inserted therein during the manufacturing/assembly process. Thus, theelongated channel member58 is also securely held and centrally aligned in the proximal channel Cc in the radial direction Z (i.e., theelongated channel member58 is sandwiched between bothproximal regions38c), due to the extension of the middle channel Cb in the axial direction X. Additionally, thealignment device36 also includes astop region36swhich prevents distal displacement in the axial direction X of theelongated channel member58. The thickness of a lower portion of theelongated channel member58 is preferably the same thickness as the lower portion of the stop region, thereby ensuring smooth loading of thecartridges68a,68binto their respective channels Ca, Cb.
• Thealignment device36 may further include an axially-extendingcavity40 configured to accept the insertion and retraction of the clip-engagingfeeder90 when it loads aclip52a,52b(i.e., thecavity40 can accommodate thefeeder90 therein, between the rails38), and may further include aramp portion42 configured to facilitate the sliding and loading of aclip52a,52bintoguide slots194 of thejaws56. The alignment device may also include a middleinclined region84, located distally of thecavity40 and extending in the axial direction X, to assist in the upward distal sliding in the axial direction X of thefeeder90. Further, thealignment device36 may have an angled or taperedsurface44 at the distal end thereof and/or a semi-cylindricalouter surface48, to facilitate the insertion of the alignment device, and therefore the clip-applyingdevice50, into the body cavity.
• An advancement block (also referred to as a slider)12 (shown inFIGS. 27 and 29-36) is attached between thepusher rod88 and clip-engaging feeder90 (shown inFIGS. 2-3 and37). Thefeeder90 is movable in axial direction X in relation to the clip-loadedcartridge68a,68bdisposed within theelongated channel58; however, the pusher rod is disposed below the elongated channel58 (shown inFIGS. 6 and 28). Theslider12 has a ladder-engagingtoggle14, which is configured to sequentially engage a series of openings inladder member33a,33b(respectively shown inFIGS. 4-5) slidably arranged within arespective clip cartridge68a,68b. Theladder member33a,33b, which is engaged by thetoggle14 of the slider12 (the slider being operatively connected topusher rod88 as shown inFIG. 37) is pushed in the distal direction (along axial direction X) to in turn push against the proximalmost orlast clip52a″,52b″ in thecartridge68a,68b, so as to also push distally the next adjacent clip(s)52a,52bwithin thatcartridge68a,68b. Forward (or distal) advance of the series ofclips52a,52bloaded within the cartridge68 is thus effected.
• As shown inFIGS. 27 and 29-36, the ladder-engagingtoggle14 pivots in both directions about apivot shaft20, at least a portion of the pivot shaft generally extending in the orthogonal radial direction Z (i.e., generally orthogonal to the axial direction X). Thus, the toggle is pivotable about the Z axis. As best shown inFIGS. 33-36, thepivot shaft30 may be generally shaped like a U or J, so that the pivot shaft does not slide out of theslider12. Alternatively, the pivot shaft may have elongated shaft ends, rivets and the like to prevent such sliding out of theslider12.
• In a non-limiting embodiment, thetoggle14 is generally shaped like a right triangle, but it should be readily appreciable by those skilled in the art that the toggle can take any variety of desirable shapes and configurations. Thetoggle14 has aridge14athat engages atoggle spring16 affixed to theslider12. Thespring16 may be a leaf spring (but can be other biasing devices including but not limited to a coil spring or other spring-like members formed, e.g., of an elastomeric material), which engages theridge14ato bias the toggle in an upright (second) position, shown inFIGS. 30-31 and36. In a non-limiting embodiment and as shown inFIG. 28, the channel is generally U-shaped, and as described above, theslider12 proximally and distally slides below and adjacent to thechannel58 in the axial direction X. Thechannel58 additionally includes a toggle aperture58C1 in the bottom portion thereof, through which a portion of thetoggle14 is inserted, when the toggle is in the upright position.
• Operation of the clip advancement arrangement according to an embodiment of the present invention will now be described. When thetrigger64 is squeezed, theslider12 is moved proximally in the axial direction X (since the slider is operably connected to thepusher rod88, which is in turn connected to the proximal bearing76). As theslider12 is moved proximally, an edge-engagingface14bof thetoggle14 engages anedge58eof thechannel58, such that thechannel edge58e(which generally extends in the Z axis direction) pushes thetoggle14 to rotate in a first direction (e.g., counterclockwise when viewingFIGS. 31-32) to a lowered (first) position and against the biasing force of thetoggle spring16, shown inFIGS. 31-32. In the first position, thetoggle14 slides in the axial direction X and below thechannel58, with at least a portion of the edge-engagingface14bcontacting the underside of thechannel58. It is noted that thechannel edge58emay be angled or tapered to increase the surface area thereof, thereby ensuring smooth and precise pivoting action of thetoggle14.
• When thetrigger64 is released, theslider12 begins to distally move in the axial direction X. The edge-engagingface14bcontacts the underside of thechannel58 until thetoggle14 reaches the toggle aperture58C1, at which point the edge-engagingface14bcontacts thechannel edge58eand allows thetoggle spring16 to urge the toggle into the upright position (shown inFIGS. 30-31 and36) and between rungs33aR,33bR of theladder member33a,33b, the rungs having rung gaps33aG,33bG therebetween. Thus, thetoggle14 rotates in a second direction (clockwise when viewingFIGS. 29-30). Pivoting of thetoggle14 in the second direction is stopped when aheel portion14dengages astop portion18 located on theslider12.
• Once in the upright position, thetoggle14 continues to move distally through the toggle aperture58C1 (and within a rung gap33aG,33bG) in the axial direction X such that a pushingface14ccontacts a rear (proximal) side of a rung33aR,33bR of theladder member33a,33b. Thus, thetoggle14 pushes theladder member33a,33bin the distal direction (along axial direction X) to in turn push against the proximalmost orlast clip52a″,52b″ in thecartridge68a,68bto also push distally the next adjacent clip(s)52a,52b. It is noted that while the rungs33aR,33bR of the figures extend in the Z axis direction, those skilled in the art will readily appreciate that the rungs could be differently configured in alternative embodiments, including but not limited to, e.g., angled and arcuate.
• The above process may be repeated by continually squeezing and releasing thetrigger64, which in turn continually distally advances theladder member33a,33bto distally push clips52aand52b, until thelast clip52a″,52b″ is loaded into and applied by thejaws56.
• It is noted that while many of the figures show the clip advancement arrangement of the present invention being used in aclip applying device50 that can accept more than one type ofclip supply cartridge68a,68b, it should be readily understood by those skilled in the art that the clip advancement arrangement of present invention may be used in a clip applying device that can accept only a single type of cartridge, or alternatively, may be used in a clip applying device having clips pre-installed therein.
• FIG. 37 shows atrigger lockout arrangement11. As described above, theslider12 is attached between thepusher rod88 and clip-engagingfeeder90. Thetrigger lockout arrangement11 serves to lock movement of thetrigger64 when thelast clip52a″,52b″ of thecartridge68a,68bhas been applied by thejaws56, thereby reducing the likelihood of tissue damage by squeezing jaws without a staple therein, and alerting the surgeon that additional clips are required.
• Also as discussed above, when thetrigger64 is squeezed, theslider12 proximally moves in the axial direction X, and when the trigger is released, the slider moves in the axial direction X such that thetoggle14 distally advances theladder member33a,33bby one clip and such that thefeeder90 loads thedistalmost clip52a′,52b′ between thejaws56.
• Thechannel member58 also includes ablock91 affixed to the underside of the channel member via aflexible rod92, and additionally has a block aperture58C2, located above theblock91 in the Y-axis direction, for accepting insertion of at least a portion of theblock91 therein. At rest, theflexible rod92 is biased to generally extend in the axial direction X. Theslider12 also has atooth93 that contacts theblock91 when the slider is proximally or distally moved in the axial direction X. While theblock91 is shown as being cubical in arrangement, it should be understood by those skilled in the art that in alternative embodiments the block can take a variety of shapes, including but not limited to, e.g., a trapezoid, frustum or ovoid.
• Specifically, as shown inFIG. 38, when thetrigger64 is squeezed and theslider12 moves proximally in the axial direction X (to approach theblock91 from the front, shown inFIGS. 37-38), arear surface93aof thetooth93 engages afront surface91aof theblock91 to move the block in radial direction Z while the slider continues to move proximally. Therear surface93aof thetooth93 is angled to facilitate movement of theblock91 in the radial direction Z. Once theslider12 passes theblock91, the block returns to its original rest position due to the biasing action of therod92.
• When thetrigger64 is released, theslider12 begins to move distally in the axial direction X and approaches theblock91 from the rear (shown inFIG. 39). If acartridge68a,68bhaving a plurality ofclips52a,52bhas been loaded into theclip applier50, the slider moves distally such that afront surface93b(best shown inFIG. 38) of thetooth93 engages arear surface91bof theblock91 to push the block upward in the Y-axis direction (i.e., into the page ofFIG. 37). Specifically, the upward movement of theblock91 causes a portion of the block to pass through the block aperture58C2 of thechannel58 and be inserted between the rungs33aR,33bR of theladder member33a,33b(i.e., the portion of the block is inserted into a rung gap33aG,33bG), thereby creating clearance for thetooth93 to pass over theblock91 as the slider continues to move in the distal direction. Once thetooth93 has passed over theblock91, therod92 urges the block downwardly, since therod92 is biased in the axial direction X and to keep the block out of the ladder gap33aG,33bG.
• To facilitate precise movement of theblock91 in the Y-axis direction, thefront surface93bof thetooth93 and/or therear surface91bof theblock91 may be angled. Additionally, one ormore bands95 to slidably secure theslider12 against the underside of thechannel58 may be provided, thereby securing the slider against movement in the Y-axis direction, when the slider moves in the axial direction X. The presence of theblock91 between the rungs33aR,33bR of theladder member33a,33bdoes not interfere with the distal movement of the ladder member by the toggle, since these two operations are out of phase, i.e., during distal movement of theslider12, thetoggle14 does not engage a rung33aR,33bR until after thetooth93 has passed over theblock91 and the block has withdrawn from the ladder gap33aG,33bG.
• As described above, the slider may be continually moved proximally and distally by respective continual squeezing and releasing of thetrigger64, until thelast clip52a″,52b″ is loaded into and applied by thejaws56. While thelast clip52a″,52b″ is being loaded into thejaws56 by the feeder90 (and thus nomore clips52a,52bare serially loaded within thecartridge68a,68b), thetoggle14 engages the rung33aR,33bR, thereby advancing theladder member33a,33ba final time and exposing asolid surface96 of the ladder member beneath the block aperture58C2 (i.e., there is no longer a ladder gap33aG,33bG beneath the block91). Theclip applying device50 is now ready for one final clip crimping process. During the final clip crimping process, thetrigger64 is squeezed to proximally move the slider12 (and to thereby bring thetooth91 thereof behind the block, as described above) and to distally move thecinch86 to crimp thelast clip52a″,52b″.
• As shown inFIG. 40, when thetrigger64 is released after thelast clip52a″,52b″ has been crimped, thecompression spring78 urges the trigger toward the open position, which (as described above) moves theslider12 distally so that thetooth93 engages theblock91. However, thesolid surface96 of theladder member33a,33bprevents displacement of theblock91 by thetooth93 in the Y-axis direction (since there is no ladder gap33aG,33bG for the block to enter. Thus, thetooth93 abuts against the block and is prevented from distally moving in the axial direction X, thereby locking the trigger in the closed position and alerting the surgeon that thelast clip52a″,52b″ has been applied. As noted above, thebands95 prevent the slider (and thereby the tooth93) from being displaced in the Y-axis direction so that the tooth does not “leap over” theblock91, when the slider moves in the axial direction X. It is noted, however, that thetrigger64 is permitted to be slightly unsqueezed so that thelast clip52a″,52b″ and any tissue can be released from thejaws56. Once thecartridge68a,68bhas been removed from theclip applying device50, thetrigger64 is free to again move to the unsqueezed position, since thesolid surface96 is no longer present.
• An embodiment of the present invention usescartridges68a,68bhaving twentyclips52a,52b, however, it should be understood by those skilled in the art that the present invention may use cartridges having fewer or greater than twenty clips. Additionally, while an embodiment of thetrigger lockout arrangement11 of the present invention locks thetrigger64 after all of theclips52a,52bhave been applied, it should be understood by those skilled in the art that the trigger lockout arrangement may lock the trigger when one ormore clips52a,52bremains in thecartridge68a,68bor theclip applying device50.
• It is noted that while many of the figures show the trigger lockout arrangement of the present invention being used in aclip applying device50 that can accept more than one type ofclip supply cartridge68a,68b, it should be readily understood by those skilled in the art that the trigger lockout arrangement of present invention may be used in a clip applying device that can accept only a single type of cartridge, or alternatively, may be used in a clip applying device having clips pre-installed therein.
• Another feature of an embodiment of the present invention includes a system for indicating to the surgeon when theclip52a,52bhas been partially crimped (shown inFIG. 42) and/or when theclip52a,52bhas been generally fully crimped (shown inFIG. 43).FIG. 41 shows an uncrimped clip. During surgery, a surgeon may want to apply aclip52a,52b, yet still leave a gap between the legs of the clip to allow passage of a blood vessel therethrough, thereby allowing blood to flow through the vessel unobstructed. When a surgeon partially squeezes thetrigger64, thejaws56 are only partially closed and theclip52a,52bmay thus be applied in a partially crimped configuration. This partially-squeezed position is referred to as the cholangio zone. It is thus desirable to alert the surgeon (visually, audibly and/or tactilely) as to when theclip applying device50 is in the cholangio zone (shown inFIGS. 12 and 44). It is further desirable to alert the surgeon (visually, audibly and/or tactilely) as to when the clip applying device is in fully squeezed position (shown inFIG. 45).
• Theclip applying device50 may include a visual slider102 (housed within the handle grip assembly62) which slides along an indicator path by way ofindicator shaft104 in an inclined direction with respect to the longitudinal axis X, although it should be understood by those skilled in the art that theindicator shaft104 may be parallel or declined with respect to longitudinal axis X in alternative embodiments. The visual slider is biased in the general distal direction by ashaft spring106 which may be disposed about the proximal end of the indicator shaft. Alternatively, theshaft spring106 may be disposed at the distal end of theindicator shaft104 to “pull” the visual slider toward the distal end of thegrip assembly62.
• Thevisual slider102 includes threeindicator regions102a,102b,102c, each having different indicia for indicating the position of the trigger, for example, the color, pattern or wording on each region may be different. Eachregion102a,102b,102cis alternatively visible through awindow111 located in the top of the grip assembly. As a non limiting example,indicator region102a(indicating the open trigger position) may be green,indicator region102b(indicating the cholangio zone) may be yellow, andindicator region102c(indicating the generally fully-squeezed position) may be red. Alternatively, eachindicator region102a,102b,102cmay show, e.g., different wording (e.g., “open,” “partial,” “closed”), a different symbol, or a different pattern.
• In the unsqueezed position (shown inFIG. 1), afirst abutment surface102dof thevisual slider102 abuts against afirst end112aof apivotable trip switch112 to maintain the visual slider in its distalmost position (against the distal biasing force of the shaft spring106), andindicator region102ais displayed through thewindow110. Thetrip switch112 has atrip switch spring114 which is affixed to thegrip assembly62 to bias the trip switch to pivot in the counterclockwise direction (when viewed inFIG. 1). Additionally, asecond end112bof thetrip switch112 engages an outer surface of the distal bearing to prevent further counterclockwise pivoting of the trip switch.
• When thetrigger64 is squeezed toward the cholangio zone (and the distal bearing begins to move distally along axial direction X), thevisual slider102 remains in position (due to the continued engagement of thefirst abutment surface102dwith thefirst end112aof the trip switch112) until an angled distal surface of adistal bearing ring108 engages thesecond end112bof the trip switch to pivot the trip switch clockwise (when viewed inFIG. 1), which disengages thefirst abutment surface102dfrom thefirst end112aof thetrip switch112, thereby allowing theshaft spring106 to proximally urge thevisual slider102. The visual slider is proximally urged until thefirst end112aof thetrip switch112 engages asecond abutment surface102dof thevisual slider102 to stop proximal movement of the visual slider and exposing theindicator region102bthrough the window111 (indicating the cholangio zone to the surgeon), as shown inFIGS. 12 and 44.
• When the trigger is squeezed from the cholangio zone to the generally fully squeezed position (and thus the distal bearing continues to move distally to cause thejaws56 to generally fully crimp theclip52a,52b), the outer circumference of thedistal bearing ring108 further engages thesecond end112bof thetrip switch112 to further pivot the trip switch clockwise, which disengages thesecond abutment surface102dfrom thefirst end112aof thetrip switch112, thereby allowing theshaft spring106 to further proximally urge thevisual slider102 until the slider reaches its limit of proximal travel along theindicator shaft104, thereby exposing theindicator region102cthrough the window111 (indicating the generally fully squeezed position to the surgeon), as shown inFIG. 45.
• When thetrigger64 is released (and the distal bearing begins to move proximally due to the biasing force of the compression spring78), a proximal face of thedistal bearing ring108 engages anindicator finger102dto proximally move thevisual slider102 so that thefirst abutment surface102dof thevisual slider102 again abuts against afirst end112aof thetrip switch112 to reset the visual slider in its distalmost position (thereby again exposing theindicator region102athrough the window111), as shown inFIG. 1.
• It is noted that, in alternative embodiments, one skilled in the art would readily appreciate that the present invention may be provided with only oneindicator region120a,120b,120c, only twoindicator regions120a,120b,120c(rather then three as shown in the figures), or more than three indicator regions, to indicate any combination of (a) that the clip-applyingdevice50 is unsqueezed, (b) that the clip applying device is in the cholangio or other mid-squeeze zone, and (c) that the clip applying device is generally fully squeezed.
• Theclip applying device50 of the present invention may also include an audible and/or tactile indicating arrangement. Specifically, in the event the surgeon is too focused on the surgery at hand to look at theviewing window111, the indicating arrangement may audibly and/or tactilely indicate to the surgeon when the clip applying device is in the cholangio zone and/or when the trigger is generally fully squeezed. Additionally, the tactile indicating arrangement of the present invention may assist the surgeon in the event that the surgeon is hearing-impaired.
• As shown inFIGS. 12 and 45, an upper (first)ratchet120 and a lower (second) ratchet122 are affixed to and move with thetrigger64, which pivots about the trigger pivot shaft64P. Additionally, an upper (first)pawl124 and a lower (second)pawl126 are pivotably affixed about aproximal paddle shaft25P, about which theproximal paddle25 is also affixed. Additionally, theupper pawl124 is biased to pivot counterclockwise (when viewed inFIG. 12) by anupper spring128, andlower pawl126 is biased to pivot counterclockwise by alower spring130, the upper spring having a stronger spring force than the lower spring.
• When the trigger is squeezed from the unsqueezed position toward the cholangio zone,lower spring130 biases thelower pawl126 to engage thelower ratchet122 to create a ratcheting sound as the trigger is squeezed toward the cholangio zone and the upper and lower ratchets pivot counterclockwise about trigger pivot64P (when viewed inFIG. 12), whileindicator region102ais displayed in thewindow111. Once the cholangio zone is entered (and at substantially the same time thewindow111displays indicator region102b), theupper ratchet120 andlower ratchet122 continue to pivot counterclockwise so that the upper ratchet engages theupper pawl124. Specifically, when the cholangio zone is entered, the upper pawl124 (due to the biasing force of the upper spring128) engages the first tooth of theupper ratchet120 to enter a first channel (cholangio channel)120aof the upper ratchet to emit a distinct sound and transmit a distinct tactile sensation. The sound and feel of theupper pawl124 entering thefirst channel120ais significantly different than the sound and feel of ratcheting of thelower pawl126 ratcheting with thelower ratchet122, due to the spring force of the upper spring being greater than that of the lower spring. Additionally or alternatively, differing the dimensions and/or materials between theupper ratchet120 and thelower ratchet122 and/or differing the dimensions and/or materials between theupper pawl124 and thelower pawl126 may contribute to the differing sounds and feels when thetrigger64 is squeezed.
• When thetrigger64 moves from the cholangio zone to the generally fully squeezed position (and at substantially the same time thewindow111displays indicator region102c), theupper ratchet120 andlower ratchet122 continue to pivot counterclockwise such that the upper pawl moves from thecholangio channel120ato a generally fully squeezedchannel120b, to emit the distinct sound and transmit the distinct tactile sensation. It is noted that the two distinct sounds and sensations (i.e., of theupper pawl124 engaging the upper ratchet120) can be made different by differing the dimensions and/or material of thecholangio channel120aand the generally fully squeezedchannel120b. It is further noted that in alternative embodiments, the generally fully squeezedchannel120bmay be eliminated, thereby alerting the surgeon only to when theclip applying device50 is in the cholangio zone.
• When thetrigger64 is released, the trigger moves to the unsqueezed position to disengage theupper pawl124 from theupper ratchet120, thereby resetting theclip applying device50. Theupper ratchet120/upper pawl124 and thelower ratchet122/lower pawl126 lie in different X-Y planes (different sagittal planes) so that the upper ratchet does not ever engage the lower pawl and so that the lower ratchet does not ever engage the upper pawl.
• It is noted that while many of the figures show the indicating arrangement of the present invention being used in aclip applying device50 that can accept more than one type ofclip supply cartridge68a,68b, it should be readily understood by those skilled in the art that the indicating arrangement of present invention may be used in a clip applying device that can accept only a single type of cartridge, or alternatively, may be used in a clip applying device having clips pre-installed therein.
• It is further noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to a preferred embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.

Claims (21)

1. An alignment device for an apparatus, the apparatus configured to selectively receive a first implement having a first width and a second implement having a second width, the first and second widths extending in a transverse direction generally orthogonal to an insertion axis direction of the first and second implements, the device comprising a pair of generally parallel spaced-apart elongated rails defining at least two channels, said at least two channels comprising a first channel having a first channel width, and a second channel having a second channel width, said first and second channel widths being different, said first channel being configured to centrally hold the first implement in the transverse direction, and said second channel being configured centrally hold the second implement in the transverse direction.

2. The alignment device according toclaim 1, further comprising a transition area between said first and second channels, said transition area configured to guide the insertion of the first implement into said first channel, said transition area being further configured to block insertion of the second implement into said first channel.

3. The alignment device according toclaim 1, further comprising a tapered distal end configured to be inserted into a body cavity.

4. The alignment device according toclaim 1, further comprising a generally semi-cylindrically-shaped outer surface.

5. The alignment device according toclaim 1, wherein said second channel is located proximally of the first channel.

6. The alignment device according toclaim 1, wherein:

the first implement is a first cartridge type containing a plurality of crimpable clips of a first size; and

the second implement is a second cartridge type containing a plurality of crimpable clips of a second size, the first size being different from the second size.

7. The alignment device according toclaim 6, further comprising a cavity configured to accept the insertion and retraction of a clip-engaging feeder, the feeder configured to retrieve and load a clip of the plurality of crimpable clips of the first size and the second size.

8. The alignment device according toclaim 6, further comprising a ramp portion configured to inclinedly slide a clip of the plurality of crimpable clips of the first size and the second size toward a pair of clip-crimping jaws.

9. The alignment device according toclaim 6, wherein:

the apparatus includes an elongated channel configured to selectively receive the first implement and the second implement;

said elongated rails further define a third channel therebetween configured securely and centrally hold an elongated channel member in the transverse direction, the elongated channel member selectively housing the first implement and the second implement and further housing controls for at least one of a clip-engaging feeder or clip-crimping jaws.

10. The alignment device according toclaim 9, wherein said second channel is located proximally of the first channel, and said third channel is located proximally of said second channel.

11. A method for aligning, in an apparatus, a first implement having a first width and a second implement having a second width, the first and second widths extending in a transverse direction generally orthogonal to an insertion axis direction of the first and second implements, the method comprising selectively inserting in the apparatus, in the insertion axis direction:

the first implement between a pair of elongated rails of the apparatus that define a first channel therebetween such that the first implement is securely and centrally held in the transverse direction; and

the second implement between the pair of elongated rails that further define a second channel therebetween such that the second implement is securely and centrally held in the transverse direction.

12. The method according toclaim 11, wherein the apparatus further includes a transition area between the first and second channels, the method further comprising selectively:

guiding, via the transition area, said insertion of the first implement into the first channel; and

blocking insertion of the second implement into the first channel.

13. The method according toclaim 11, wherein the apparatus further has a tapered distal end, the method further comprising inserting at least the tapered end into a body cavity.

14. The method according toclaim 11, wherein the second channel is located proximally of the first channel.

15. The method according toclaim 11, wherein:

the first implement is a first cartridge type containing a plurality of crimpable clips of a first size; and

the second implement is a second cartridge type containing a plurality of crimpable clips of a second size, the first size being different from the second size.

16. The method according toclaim 15, wherein the apparatus further includes a cavity, the method further comprising insertion and retracting of a clip-engaging feeder.

17. The method according toclaim 15, further comprising inclinedly sliding, along a ramp portion, a clip of the plurality of crimpable clips of the first size and the second size toward a pair of clip-crimping jaws.

18. The method according toclaim 15, wherein the apparatus includes an elongated channel configured to selectively receive the first implement and the second implement, the method further comprising securely and centrally holding an elongated channel member in the transverse direction between a third channel defined by the elongated rails.

19. An alignment device for an apparatus configured to selectively receive a first implement having a first width and a second implement having a second width, the first width being less than the second width, the first and second widths extending in a transverse direction generally orthogonal to an insertion axis direction of the first and second implements, the device comprising:

a body; and

a pair of elongated rails, each elongated rail of said pair of elongated rails extending in the insertion axis direction and along opposite sides of said body,

wherein said pair of elongated rails each comprises:

a first rail portion defining a first channel therebetween configured to securely hold said first implement in the transverse direction, such that said first implement is centered in the transverse direction with respect to the apparatus; and

a second rail portion defining a second channel therebetween, a width of the first channel being less than a width of the channel, said second channel, said second channel configured to securely hold said second implement in the transverse direction, such that said first implement is centered in the transverse direction with respect to the apparatus.

20. The alignment device according toclaim 19, wherein said each elongated rail comprises a transition area between said first rail portion and said second rail portion and configured to guide the insertion of the first implement into the first channel, said transition area being further configured to block insertion of the second implement into said first channel.

21. A medical clip applying device for crimping a clip onto tissue, comprising:

a body assembly having a handle and a squeezable trigger;

a tube having a first end extending into said body assembly;

a pair of jaws arranged on a second end of said tube, said jaws actuable by squeezing action of said trigger, said second end of said tube and said pair of jaws configured to be inserted into a body cavity; and

an alignment device arranged on said second end of said tube and configured to be inserted into the body cavity;

a loading port in communication with said tube;

wherein said tube is configured to selectively receive, through said loading port:

a) a first implement having a first width; or

b) a second implement having a second width, the first and second widths extending in a transverse direction generally orthogonal to an insertion axis direction of the first and second implements; and

wherein said alignment device comprises a pair of elongated rails defining a first channel therebetween configured to securely and centrally hold the first implement in the transverse direction, said pair of elongated rails further defining a second channel therebetween configured to securely and centrally hold the second implement in the transverse direction.

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