US20070049951A1 - Apparatus alignment device - Google Patents
Apparatus alignment device Download PDFInfo
- Publication number
- US20070049951A1 US20070049951A1 US11/210,885 US21088505A US2007049951A1 US 20070049951 A1 US20070049951 A1 US 20070049951A1 US 21088505 A US21088505 A US 21088505A US 2007049951 A1 US2007049951 A1 US 2007049951A1
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- United States
- Prior art keywords
- channel
- implement
- clip
- width
- elongated
- Prior art date
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- Abandoned
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
- A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/122—Clamps or clips, e.g. for the umbilical cord
- A61B17/1222—Packages or dispensers therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
- A61B2017/00128—Electrical control of surgical instruments with audible or visual output related to intensity or progress of surgical action
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
- A61B2017/00464—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for use with different instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B17/2909—Handles
- A61B2017/2912—Handles transmission of forces to actuating rod or piston
- A61B2017/2919—Handles transmission of forces to actuating rod or piston details of linkages or pivot points
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B17/2909—Handles
- A61B2017/2925—Pistol grips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2926—Details of heads or jaws
- A61B2017/2932—Transmission of forces to jaw members
- A61B2017/2933—Transmission of forces to jaw members camming or guiding means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0801—Prevention of accidental cutting or pricking
- A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
- A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
Definitions
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- the first implement is a first cartridge type containing a plurality of crimpable clips of a first size
- 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.
- the apparatus in another feature 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.
- the second channel may be located proximally of the first channel
- 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.
- 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.
- the apparatus has a tapered distal end, and the method further includes inserting at least the tapered end into a body cavity.
- the first implement is a first cartridge type containing a plurality of crimpable clips of a first size
- 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
- the apparatus further includes a cavity
- the method further includes insertion and retracting of a clip-engaging feeder.
- 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.
- 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.
- 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
- 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 of 28 - 28 in FIG. 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 in FIG. 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 in FIG. 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.
- 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.
- FIG. 1 shows a clip applying device 50 for applying medical tissue-pinching clips 52 a , 52 b to tissue.
- the clip applying device 50 has a patient-engaging distalmost end 54 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 an elongated tube 60 , which elongated tube 60 and elongated channel member 58 are secured at their respective proximalmost ends to the distal end of a generally pistol-like handle grip assembly 62 .
- the handle grip assembly 62 includes an arcuately movable squeezable trigger 64 that pivots about pivot shaft 64 P.
- a clip 52 a (shown in FIG. 2 ), 52 b (shown in FIG. 3 ) is advanced through the distal end of the elongated channel member 58 and into the jaws 56 from an elongated ladder-like clip supply cartridge 68 a (shown in FIG. 4 ), 68 b (shown in FIG. 5 ), disposed through the elongated channel 58 .
- the elongated clip supply cartridge 68 a , 68 b is fed into a receiving slot or port 70 in the proximal end of the handle grip assembly 62 , the receiving slot being in communication with the elongated channel 58 .
- a rotatable enclosure barrel (also referred to as a tube) 72 is rotatably supported within the handle grip assembly 62 .
- the rotatable enclosure barrel 72 is connected to the proximal end of the elongated channel 58 .
- the enclosure barrel 72 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.
- the distal bearing 74 has a compression spring 78 arranged against its distalmost surface 80 . The compression spring 78 releases a cinch 86 after the jaws 56 have been closed and a clip 52 a , 52 b has been crimped, and also provides a proximally-directed bias against the distal bearing
- the distal bearing 74 has an elongated cinch rod 84 (shown in FIGS. 6-9 ) extending distally therefrom.
- the cinch rod 84 extends through the length of the elongated channel 58 (and its surrounding protective enclosure tube 60 ).
- the cinch 86 (shown in FIG. 10 ) is generally semi-cylindrically-shaped and arranged on the distal end of the cinch rod 84 .
- the cinch 86 is slidably arranged on the distal end of the elongated channel 58 and is reciprocally slidable in axial direction X to engage the jaws 56 which are squeezably arranged on the distal end of the clip applying device.
- each jaw member 56 is located on a respective jaw arm 256 , and the jaws 56 and jaw arms are part of a jaw assembly 156 .
- the jaw arms 256 are biased outwardly (i.e.,the jaws 56 are biased open).
- Distal and proximal movement of the cinch 86 in axial direction X and with respect to the elongated channel 58 effects the respective squeezing closure and biased opening of the jaws 56 at the distal end of the elongated channel 58 .
- the cinch rod 84 moves in axial direction X to slide the cinch 86 distally and proximally corresponding to the direction of movement of the distal bearing 74 on the distal end of the enclosure barrel 72 .
- the distal bearing 74 is biased proximally by the compression spring 78 , effecting a proximal motion to the distal bearing 74 .
- the distal bearing 74 is operatively connected to the trigger 64 by a distal paddle 23
- the proximal bearing 76 is operatively connected to a proximal paddle 25 , which is in turn connected to the trigger by a trigger linkage 98 .
- the proximal bearing 76 is biased distally by the compression spring via the trigger linkage 98 .
- An elongated pusher rod 88 extends adjacent to the lower side of the elongated channel 58 (as shown, e.g., in FIGS. 1 , 6 - 9 and 37 ).
- the elongated pusher rod 88 has a proximal end connected to the proximal bearing 76 surrounding the enclosure barrel 72 at the proximal end of the handle grip assembly 62 .
- the pusher rod 88 is connected to a clip-engaging feeder 90 (shown in FIGS. 2-3 ).
- the feeder 90 is movable in axial direction X in relation to the clip-loaded cartridge 68 a , 68 b disposed within the elongated channel 58 ; however, the pusher rod is disposed below the elongated channel 58 (shown in FIG. 6 ). Proximal motion of the feeder 90 is effected by proximal motion of the proximal bearing 76 around the enclosure barrel 72 within the handle grip assembly 62 .
- the pusher rod 88 distally retracts in the axial direction X due to distal movement of the distal bearing 74 , which distally moves feeder 90 to retrieve a distalmost clip 52 a ′, 52 b ′ of the plurality of clips that are serially loaded in respective clip cartridges 68 a , 68 b , in order to prepare (upon release of the trigger) to load the distalmost clip 52 a ′, 52 ′ into guide slots 194 (shown in FIGS. 10-11 and 19 ), in the opposed faces of the respective jaws 56 .
- 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.
- the trigger 64 is biased toward the unsqueezed position by the compression spring 78 (shown in FIG. 1 ).
- the distal bearing 74 is biased to move proximally, resulting in proximal (rearward) movement of the cinch 86 by the proximal movement of the cinch rod 84 , which permits the jaws 56 to bias themselves open, and the feeder 90 (pushed by the pusher rod 88 ) to push the next available (distalmost) clip 52 a ′, 52 b ′ into the guide slots 194 of the respective jaws 56 as the jaws 56 open fully, as the trigger 64 is permitted to open fully (shown in FIG. 1 ) from the handle 66 portion of the handle grip assembly 62 . Release of the trigger 64 (after the trigger 46 has been initially squeezed towards the handle 66 ) will automatically advance the next available distalmost clip 52 a ′, 52 b ′ within the cartridge 68 a , 68 b.
- 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.
- the clip applying device 50 of present invention accepts a clip cartridge 68 a containing a series of medium-large sized clips 52 a , and can also accept a clip cartridge 68 b containing a series of large-sized clips 52 b .
- 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 the clip applying device 50 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.
- the cartridge When the clip cartridge 68 b is inserted into the receiving slot or port 70 of the clip applying device 50 , the cartridge is slid along axial direction X until it reaches a stop (not shown) and the cartridge can no longer be slid.
- the stop key 13 is then lowered into a stop keyhole 34 (shown in FIG. 5 ) of the cartridge 68 b by pivoting action of the stop key (shown in FIGS. 8-9 ).
- the trigger 64 is released (i.e., when the clip applying device 50 is at rest, shown in FIG. 1 )
- the proximal bearing 76 and distal bearing 74 move towards each other such that the stop key 13 is sandwiched therebetween to create a distance Db between the proximal bearing and distal bearing.
- the distance Db results from the distal bearing 74 contacting a first distal face 13 a of the stop key 13 , and the proximal bearing 76 contacting a first proximal face 13 b of the stop key.
- the clip cartridge 68 a When the clip cartridge 68 a is inserted by the user into the receiving slot or port 70 of the clip applying device 50 , the cartridge slides along axial direction X until it reaches a stop and the cartridge can no longer move axially.
- the clip cartridge 68 a (shown in FIG. 4 ) does not have a stop keyhole for the lowering of the stop key 13 therein.
- the trigger 64 is released (i.e., when the clip applying device 50 is at rest)
- the proximal bearing 76 and distal bearing 74 move towards each other such that the stop key 13 is sandwiched therebetween to create a distance Da between the proximal bearing and distal bearing (shown in FIGS. 6-7 ).
- the distance Da results from the distal bearing 74 contacting a second distal face 13 c of the stop key 13 , and the proximal bearing 76 contacting a second proximal face 13 d of the stop key.
- the distance Da is less then the distance Db because the proximal bearing 76 and distal bearing 74 are closer to each other in the axial direction X.
- the proximal bearing 76 and distal bearing are both located more distally than when the cartridge 68 b is inserted into the clip applying device.
- the cinch is advanced in the distal direction to narrow the jaws to a width Wa
- the cartridge 68 b is inserted into the clip applying device 50
- the cinch 86 is advanced (a lesser amount than when the cartridge 68 a is inserted) in the distal direction to narrow the jaws to a width Wb.
- the width Wa is narrower than the width Wb because when the cartridge 68 a is inserted into the clip applying device, the cinch 86 is distally advanced a greater amount in the axial direction X than when the cartridge 68 b is inserted into the clip applying device.
- each jaw member 56 is increasingly tapered from a proximal point along the axial direction X to a distalward point where a maximum width portion 56 W is located.
- the narrower width Wa allows the jaws 56 to securely accommodate medium-large clips 52 a in the guide slots 194 .
- the feeder 90 when the cartridge 68 a is inserted into the clip applying device 50 , the feeder 90 is advanced to the proper position to load the clip 52 a , and when the cartridge 68 b is inserted into the clip applying device 50 , the feeder 90 is advanced (a lesser amount than when the cartridge 68 a is inserted) to properly load the larger clip 52 b .
- the feeder 90 does not distally advance as much as when the cartridge 68 a is inserted, because the feeder must be further back to accommodate the larger clip 52 b (shown in FIG. 3 ), which may have a longer length than smaller clips (e.g., medium-large clips 52 a ).
- the position in the axial direction X of both the cinch 86 and the feeder 90 is determined by the stop key 13 ; 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 the cinch 86 and the feeder 90 may be determined by the stop key, i.e., the stop key may be differently configured to allow varied displacement between the proximal bearing 76 and distal bearing 74 . 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.
- 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.
- either or both cartridges 68 a , 68 b may contain safety keyholes 77 a and 77 b (shown in FIGS. 4-5 ) which do not interact with the stop key 13 , but rather accept a safety key 110 , in order to prevent insertion or withdrawal of the clip cartridge 68 a , 68 b unless the trigger 64 is generally fully squeezed rearwardly toward the handle 66 of the handle grip assembly 62 in a manner similar to that disclosed in commonly-assigned U.S. Patent Publication No. 2003/0040759.
- the trigger 64 may be squeezed to allow the insertion of the cartridge 68 a , 68 b and/or to crimp a clip 52 a , 52 b ; 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 the cartridge 68 a , 68 b to be inserted (and/or to crimp a clip 52 a 52 b ), such that the position in the axial direction X of the proximal bearing 76 or the distal bearing 74 may be determined.
- other structure e.g., a separate or integral tab, button, lever or switch
- the cinch 86 and jaw assembly 156 of the present invention allow full, positive and consistent control of the opening and closing of the jaws 56 in direction Z (shown in FIGS. 2 and 10 ), hereinafter referred to as radial or transverse movement, movement in the radial direction or movement in the transverse direction. Because the clip applying device 50 is able to accept two different types of clip cartridges 68 a , 68 b , and the jaws 56 thus move radially over a greater distance than other clip appliers, such full, positive and consistent control of the jaws 56 is required. Further, limited travel in the axial direction X of a cinch is normally not enough to cover this increased radial travel of the jaws 56 . In other words, there is no single surface of the cinch 86 or jaw assembly 156 to completely and accurately control the opening and closing of the cinch.
- An embodiment of the present invention includes a cinch 86 that allows for greater radial movement of the jaws 56 by engaging different jaw engagement surfaces 156 a , 156 b , 156 c , 156 d , 156 e , 156 f of each jaw arm 256 .
- the generally semi-cylindrically-shaped cinch 86 has a pair of control fingers (or control members) 30 (shown in FIG. 13 ) on the underside thereof which engage inner engagement surfaces 156 e and outer engagement surfaces 156 f of the jaw arms.
- the inner and outer engagement surfaces 156 e , 156 f may be tapered or angled.
- FIG. 14 shows the cinch 86 in an intermediate position, where the control fingers 30 are intermediate the respective inner engagement surfaces 156 e and outer engagement surfaces 156 f .
- medium-large clips 52 a may 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).
- outer control surfaces 30 e of the control fingers 30 respectively engage the inner engagement surfaces 156 e to widen the gap between the jaws 56 (e.g., to a width Wb, in order to accommodate cartridge 68 b containing large sized clips 52 b ), while inner control surfaces 30 f of the control fingers are brought out of contact with respective outer engagement surfaces 156 f , as shown in FIGS. 15 and 17 .
- inner control surfaces 30 f of the control fingers 30 respectively engage the inner engagement surfaces 156 e to narrow the gap between the jaws 56 (e.g., to a width Wa, to accommodate cartridge 68 a containing medium-large sized clips 52 a , or to begin a clip-crimping operation), while outer control surfaces 30 e of the control fingers are brought out of contact with respective outer engagement surfaces 156 e , as shown in FIGS. 15 and 17 .
- control fingers 30 are preferably always in contact with at least one of the inner or outer engagement surfaces 156 e , 156 f (as shown in FIG. 14 ).
- FIG. 18 shows the cinch 86 in a fully distal position in which a clip 52 a , 52 b may be fully crimped closed.
- the cinch in order to move the cinch 86 from the fully-distal position along the axial direction X, the cinch includes a generally arcuate central block 32 having opposed ends which respectively engage second inner engagement surfaces 156 d located on an upper surface of each jaw arm 256 (shown in FIGS. 16 and 19 ), which may be tapered or angled in a non-limiting embodiment.
- the central block 32 ensures accurate and precise transition of the control surfaces of the cinch 86 when the jaws 56 begin to open (i.e.
- a proximal facing surface 32 d of the central block 32 engages the second inner engagement surfaces 156 d commence an opening operation of the jaws.
- control of the opening of the jaws 56 is “handed off” to the inner control surfaces 30 f of the control fingers 30 , which respectively slide along the outer engagement surfaces 156 f to gradually (due to the angled configuration) provide for outward movement of the jaw arms 256 (in direction Z).
- the central block 32 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.
- the cinch 82 may include a pair of inwardly facing guide walls 34 (shown in FIGS. 20-21 ) configured to respectively slidingly engage one or more outer side engagement surfaces 156 a - c (shown in FIGS. 19 and 22 ) of each jaw arm 256 to provide further control of (e.g., pitch in the radial direction) the jaw assembly 156 by the cinch.
- a gap or channel G may be present between the control finger 30 and the ceiling 82 c of the cinch 82 .
- each jaw arm 256 may then be sandwiched between a respective control finger 30 and the ceiling 82 c of the cinch 82 , 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.
- the radial opening and closing direction of the jaws 56 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.
- the jaw arms 156 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.
- 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.
- the clip applying device 50 of the present invention is able to accept at least two different types of clip cartridges 68 a , 68 b , and as such, the present invention also provides a cartridge alignment device 36 (shown in FIGS. 23-26 ) that can center (along central axis CX) clip cartridges 68 a , 68 b within the elongated tube 60 in a width, or transverse direction (or radial direction) Z of the cartridges.
- the alignment device 36 can maintain the loaded cartridges 68 a and 68 b in a central position in relation to the sides (i.e., equidistant to the sidewalls of the tube 60 in the radial orthogonal Z axis direction) of the elongated tube 60 (i.e., so that a sagittal plane defined by the X-Y axis bisecting the cartridges 68 a , 68 b is substantially coplanar with a sagittal plane X-Y that bisects the elongated tube.
- the clip cartridge 68 a , 68 b can be centered within the elongated tube and the clip cartridge 68 a , 68 b and the elongated tube, are aligned in the axial direction X (i.e., along the central axis CX).
- a clip 52 a , 52 b can be accurately loaded in the jaws 56 and accurately crimped thereby.
- the alignment device 36 has a pair of elongated rails 38 extending in the axial direction X.
- the rails 38 each have a distal (first) region 38 a defining a first channel Ca therebetween, a middle (second) region 38 b defining a second channel Cb therebetween, and a proximal (third) region 38 c defining a third channel Cc therebetween.
- Each channel Ca, Cb and Cc successively extends in communication and in the axial direction X.
- 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 of transition areas 38 t (each located between a respective distal region 38 a and middle region 38 b ) which may be tapered or angled to accurately guide the insertion of cartridge 68 a (which is inserted along axial direction X, also referred to as an insertion axis direction) into the distal channel Ca, where the cartridge 68 a is securely held and centrally aligned therein in the radial or transverse direction Z (i.e., cartridge 68 a is sandwiched between both distal regions 38 a ), due to the extending of the distal channel Ca in the axial direction X.
- the cartridge 68 b In situations where the cartridge 68 b is wider in radial direction Z than the cartridge 68 a , the cartridge 68 b cannot fit within the distal channel 68 a . Rather, the transition area blocks the cartridge 68 b from being inserted in the distal channel 68 a , and also prevents damage to the cartridge 68 b during the insertion process. Thus, the cartridge 68 b is securely held and centrally aligned in the channel Cb in the radial direction Z (i.e., the cartridge 68 b is sandwiched between both middle regions 38 b ), 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 member 58 (through which the cartridge 68 a , 68 b is inserted in the insertion axis direction), which is inserted therein during the manufacturing/assembly process.
- the elongated channel member 58 is also securely held and centrally aligned in the proximal channel Cc in the radial direction Z (i.e., the elongated channel member 58 is sandwiched between both proximal regions 38 c ), due to the extension of the middle channel Cb in the axial direction X.
- the alignment device 36 also includes a stop region 36 s which prevents distal displacement in the axial direction X of the elongated channel member 58 .
- the thickness of a lower portion of the elongated channel member 58 is preferably the same thickness as the lower portion of the stop region, thereby ensuring smooth loading of the cartridges 68 a , 68 b into their respective channels Ca, Cb.
- the alignment device 36 may further include an axially-extending cavity 40 configured to accept the insertion and retraction of the clip-engaging feeder 90 when it loads a clip 52 a , 52 b (i.e., the cavity 40 can accommodate the feeder 90 therein, between the rails 38 ), and may further include a ramp portion 42 configured to facilitate the sliding and loading of a clip 52 a , 52 b into guide slots 194 of the jaws 56 .
- the alignment device may also include a middle inclined region 84 , located distally of the cavity 40 and extending in the axial direction X, to assist in the upward distal sliding in the axial direction X of the feeder 90 .
- the alignment device 36 may have an angled or tapered surface 44 at the distal end thereof and/or a semi-cylindrical outer surface 48 , to facilitate the insertion of the alignment device, and therefore the clip-applying device 50 , into the body cavity.
- An advancement block (also referred to as a slider) 12 (shown in FIGS. 27 and 29 - 36 ) is attached between the pusher rod 88 and clip-engaging feeder 90 (shown in FIGS. 2-3 and 37 ).
- the feeder 90 is movable in axial direction X in relation to the clip-loaded cartridge 68 a , 68 b disposed within the elongated channel 58 ; however, the pusher rod is disposed below the elongated channel 58 (shown in FIGS. 6 and 28 ).
- the slider 12 has a ladder-engaging toggle 14 , which is configured to sequentially engage a series of openings in ladder member 33 a , 33 b (respectively shown in FIGS.
- the ladder member 33 a , 33 b which is engaged by the toggle 14 of the slider 12 (the slider being operatively connected to pusher rod 88 as shown in FIG. 37 ) is pushed in the distal direction (along axial direction X) to in turn push against the proximalmost or last clip 52 a ′′, 52 b ′′ in the cartridge 68 a , 68 b , so as to also push distally the next adjacent clip(s) 52 a , 52 b within that cartridge 68 a , 68 b . Forward (or distal) advance of the series of clips 52 a , 52 b loaded within the cartridge 68 is thus effected.
- the ladder-engaging toggle 14 pivots in both directions about a pivot shaft 20 , 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).
- the toggle is pivotable about the Z axis.
- the pivot shaft 30 may be generally shaped like a U or J, so that the pivot shaft does not slide out of the slider 12 .
- the pivot shaft may have elongated shaft ends, rivets and the like to prevent such sliding out of the slider 12 .
- the toggle 14 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.
- the toggle 14 has a ridge 14 a that engages a toggle spring 16 affixed to the slider 12 .
- the spring 16 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 the ridge 14 a to bias the toggle in an upright (second) position, shown in FIGS. 30-31 and 36 .
- FIG. 30-31 and 36 In a non-limiting embodiment and as shown in FIG.
- the channel is generally U-shaped, and as described above, the slider 12 proximally and distally slides below and adjacent to the channel 58 in the axial direction X.
- the channel 58 additionally includes a toggle aperture 58 C 1 in the bottom portion thereof, through which a portion of the toggle 14 is inserted, when the toggle is in the upright position.
- the slider 12 When the trigger 64 is squeezed, the slider 12 is moved proximally in the axial direction X (since the slider is operably connected to the pusher rod 88 , which is in turn connected to the proximal bearing 76 ). As the slider 12 is moved proximally, an edge-engaging face 14 b of the toggle 14 engages an edge 58 e of the channel 58 , such that the channel edge 58 e (which generally extends in the Z axis direction) pushes the toggle 14 to rotate in a first direction (e.g., counterclockwise when viewing FIGS.
- a first direction e.g., counterclockwise when viewing FIGS.
- the toggle 14 slides in the axial direction X and below the channel 58 , with at least a portion of the edge-engaging face 14 b contacting the underside of the channel 58 .
- the channel edge 58 e may be angled or tapered to increase the surface area thereof, thereby ensuring smooth and precise pivoting action of the toggle 14 .
- the slider 12 When the trigger 64 is released, the slider 12 begins to distally move in the axial direction X.
- the edge-engaging face 14 b contacts the underside of the channel 58 until the toggle 14 reaches the toggle aperture 58 C 1 , at which point the edge-engaging face 14 b contacts the channel edge 58 e and allows the toggle spring 16 to urge the toggle into the upright position (shown in FIGS. 30-31 and 36 ) and between rungs 33 a R, 33 b R of the ladder member 33 a , 33 b , the rungs having rung gaps 33 a G, 33 b G therebetween.
- the toggle 14 rotates in a second direction (clockwise when viewing FIGS. 29-30 ). Pivoting of the toggle 14 in the second direction is stopped when a heel portion 14 d engages a stop portion 18 located on the slider 12 .
- the toggle 14 continues to move distally through the toggle aperture 58 C 1 (and within a rung gap 33 a G, 33 b G) in the axial direction X such that a pushing face 14 c contacts a rear (proximal) side of a rung 33 a R, 33 b R of the ladder member 33 a , 33 b .
- the toggle 14 pushes the ladder member 33 a , 33 b in the distal direction (along axial direction X) to in turn push against the proximalmost or last clip 52 a ′′, 52 b ′′ in the cartridge 68 a , 68 b to also push distally the next adjacent clip(s) 52 a , 52 b .
- rungs 33 a R, 33 b R 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 the trigger 64 , which in turn continually distally advances the ladder member 33 a , 33 b to distally push clips 52 a and 52 b , until the last clip 52 a ′′, 52 b ′′ is loaded into and applied by the jaws 56 .
- clip advancement arrangement of the present invention being used in a clip applying device 50 that can accept more than one type of clip supply cartridge 68 a , 68 b
- 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 a trigger lockout arrangement 11 .
- the slider 12 is attached between the pusher rod 88 and clip-engaging feeder 90 .
- the trigger lockout arrangement 11 serves to lock movement of the trigger 64 when the last clip 52 a ′′, 52 b ′′ of the cartridge 68 a , 68 b has been applied by the jaws 56 , thereby reducing the likelihood of tissue damage by squeezing jaws without a staple therein, and alerting the surgeon that additional clips are required.
- the slider 12 proximally moves in the axial direction X, and when the trigger is released, the slider moves in the axial direction X such that the toggle 14 distally advances the ladder member 33 a , 33 b by one clip and such that the feeder 90 loads the distalmost clip 52 a ′, 52 b ′ between the jaws 56 .
- the channel member 58 also includes a block 91 affixed to the underside of the channel member via a flexible rod 92 , and additionally has a block aperture 58 C 2 , located above the block 91 in the Y-axis direction, for accepting insertion of at least a portion of the block 91 therein.
- the flexible rod 92 is biased to generally extend in the axial direction X.
- the slider 12 also has a tooth 93 that contacts the block 91 when the slider is proximally or distally moved in the axial direction X.
- the block 91 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.
- a rear surface 93 a of the tooth 93 engages a front surface 91 a of the block 91 to move the block in radial direction Z while the slider continues to move proximally.
- the rear surface 93 a of the tooth 93 is angled to facilitate movement of the block 91 in the radial direction Z.
- the slider 12 When the trigger 64 is released, the slider 12 begins to move distally in the axial direction X and approaches the block 91 from the rear (shown in FIG. 39 ). If a cartridge 68 a , 68 b having a plurality of clips 52 a , 52 b has been loaded into the clip applier 50 , the slider moves distally such that a front surface 93 b (best shown in FIG. 38 ) of the tooth 93 engages a rear surface 91 b of the block 91 to push the block upward in the Y-axis direction (i.e., into the page of FIG. 37 ).
- the upward movement of the block 91 causes a portion of the block to pass through the block aperture 58 C 2 of the channel 58 and be inserted between the rungs 33 a R, 33 b R of the ladder member 33 a , 33 b (i.e., the portion of the block is inserted into a rung gap 33 a G, 33 b G), thereby creating clearance for the tooth 93 to pass over the block 91 as the slider continues to move in the distal direction.
- the rod 92 urges the block downwardly, since the rod 92 is biased in the axial direction X and to keep the block out of the ladder gap 33 a G, 33 b G.
- the front surface 93 b of the tooth 93 and/or the rear surface 91 b of the block 91 may be angled.
- one or more bands 95 to slidably secure the slider 12 against the underside of the channel 58 may be provided, thereby securing the slider against movement in the Y-axis direction, when the slider moves in the axial direction X.
- the slider may be continually moved proximally and distally by respective continual squeezing and releasing of the trigger 64 , until the last clip 52 a ′′, 52 b ′′ is loaded into and applied by the jaws 56 . While the last clip 52 a ′′, 52 b ′′ is being loaded into the jaws 56 by the feeder 90 (and thus no more clips 52 a , 52 b are serially loaded within the cartridge 68 a , 68 b ), the toggle 14 engages the rung 33 a R, 33 b R, thereby advancing the ladder member 33 a , 33 b a final time and exposing a solid surface 96 of the ladder member beneath the block aperture 58 C 2 (i.e., there is no longer a ladder gap 33 a G, 33 b G beneath the block 91 ).
- the clip applying device 50 is now ready for one final clip crimping process.
- the trigger 64 is squeezed to proximally move the slider 12 (and to thereby bring the tooth 91 thereof behind the block, as described above) and to distally move the cinch 86 to crimp the last clip 52 a ′′, 52 b′′.
- the compression spring 78 urges the trigger toward the open position, which (as described above) moves the slider 12 distally so that the tooth 93 engages the block 91 .
- the solid surface 96 of the ladder member 33 a , 33 b prevents displacement of the block 91 by the tooth 93 in the Y-axis direction (since there is no ladder gap 33 a G, 33 b G for the block to enter.
- the tooth 93 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 the last clip 52 a ′′, 52 b ′′ has been applied.
- the bands 95 prevent the slider (and thereby the tooth 93 ) from being displaced in the Y-axis direction so that the tooth does not “leap over” the block 91 , when the slider moves in the axial direction X.
- the trigger 64 is permitted to be slightly unsqueezed so that the last clip 52 a ′′, 52 b ′′ and any tissue can be released from the jaws 56 .
- An embodiment of the present invention uses cartridges 68 a , 68 b having twenty clips 52 a , 52 b , 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 the trigger lockout arrangement 11 of the present invention locks the trigger 64 after all of the clips 52 a , 52 b have been applied, it should be understood by those skilled in the art that the trigger lockout arrangement may lock the trigger when one or more clips 52 a , 52 b remains in the cartridge 68 a , 68 b or the clip applying device 50 .
- the trigger lockout arrangement of the present invention being used in a clip applying device 50 that can accept more than one type of clip supply cartridge 68 a , 68 b
- 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.
- FIG. 41 shows an uncrimped clip.
- a surgeon may want to apply a clip 52 a , 52 b , 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.
- the jaws 56 are only partially closed and the clip 52 a , 52 b may 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 the clip applying device 50 is in the cholangio zone (shown in FIGS. 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 in FIG. 45 ).
- the clip applying device 50 may include a visual slider 102 (housed within the handle grip assembly 62 ) which slides along an indicator path by way of indicator shaft 104 in an inclined direction with respect to the longitudinal axis X, although it should be understood by those skilled in the art that the indicator shaft 104 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 a shaft spring 106 which may be disposed about the proximal end of the indicator shaft. Alternatively, the shaft spring 106 may be disposed at the distal end of the indicator shaft 104 to “pull” the visual slider toward the distal end of the grip assembly 62 .
- the visual slider 102 includes three indicator regions 102 a , 102 b , 102 c , each having different indicia for indicating the position of the trigger, for example, the color, pattern or wording on each region may be different.
- Each region 102 a , 102 b , 102 c is alternatively visible through a window 111 located in the top of the grip assembly.
- indicator region 102 a (indicating the open trigger position) may be green
- indicator region 102 b indicating the cholangio zone
- indicator region 102 c indicating the generally fully-squeezed position
- each indicator region 102 a , 102 b , 102 c may show, e.g., different wording (e.g., “open,” “partial,” “closed”), a different symbol, or a different pattern.
- a first abutment surface 102 d of the visual slider 102 abuts against a first end 112 a of a pivotable trip switch 112 to maintain the visual slider in its distalmost position (against the distal biasing force of the shaft spring 106 ), and indicator region 102 a is displayed through the window 110 .
- the trip switch 112 has a trip switch spring 114 which is affixed to the grip assembly 62 to bias the trip switch to pivot in the counterclockwise direction (when viewed in FIG. 1 ). Additionally, a second end 112 b of the trip switch 112 engages an outer surface of the distal bearing to prevent further counterclockwise pivoting of the trip switch.
- the visual slider 102 When the trigger 64 is squeezed toward the cholangio zone (and the distal bearing begins to move distally along axial direction X), the visual slider 102 remains in position (due to the continued engagement of the first abutment surface 102 d with the first end 112 a of the trip switch 112 ) until an angled distal surface of a distal bearing ring 108 engages the second end 112 b of the trip switch to pivot the trip switch clockwise (when viewed in FIG. 1 ), which disengages the first abutment surface 102 d from the first end 112 a of the trip switch 112 , thereby allowing the shaft spring 106 to proximally urge the visual slider 102 .
- the visual slider is proximally urged until the first end 112 a of the trip switch 112 engages a second abutment surface 102 d of the visual slider 102 to stop proximal movement of the visual slider and exposing the indicator region 102 b through the window 111 (indicating the cholangio zone to the surgeon), as shown in FIGS. 12 and 44 .
- the outer circumference of the distal bearing ring 108 further engages the second end 112 b of the trip switch 112 to further pivot the trip switch clockwise, which disengages the second abutment surface 102 d from the first end 112 a of the trip switch 112 , thereby allowing the shaft spring 106 to further proximally urge the visual slider 102 until the slider reaches its limit of proximal travel along the indicator shaft 104 , thereby exposing the indicator region 102 c through the window 111 (indicating the generally fully squeezed position to the surgeon), as shown in FIG. 45 .
- a proximal face of the distal bearing ring 108 engages an indicator finger 102 d to proximally move the visual slider 102 so that the first abutment surface 102 d of the visual slider 102 again abuts against a first end 112 a of the trip switch 112 to reset the visual slider in its distalmost position (thereby again exposing the indicator region 102 a through the window 111 ), as shown in FIG. 1 .
- the present invention may be provided with only one indicator region 120 a , 120 b , 120 c , only two indicator regions 120 a , 120 b , 120 c (rather then three as shown in the figures), or more than three indicator regions, to indicate any combination of (a) that the clip-applying device 50 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.
- the clip applying device 50 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 the viewing window 111 , 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.
- an upper (first) ratchet 120 and a lower (second) ratchet 122 are affixed to and move with the trigger 64 , which pivots about the trigger pivot shaft 64 P.
- an upper (first) pawl 124 and a lower (second) pawl 126 are pivotably affixed about a proximal paddle shaft 25 P, about which the proximal paddle 25 is also affixed.
- the upper pawl 124 is biased to pivot counterclockwise (when viewed in FIG. 12 ) by an upper spring 128
- lower pawl 126 is biased to pivot counterclockwise by a lower spring 130 , the upper spring having a stronger spring force than the lower spring.
- lower spring 130 biases the lower pawl 126 to engage the lower ratchet 122 to create a ratcheting sound as the trigger is squeezed toward the cholangio zone and the upper and lower ratchets pivot counterclockwise about trigger pivot 64 P (when viewed in FIG. 12 ), while indicator region 102 a is displayed in the window 111 .
- the upper ratchet 120 and lower ratchet 122 continue to pivot counterclockwise so that the upper ratchet engages the upper pawl 124 .
- the upper pawl 124 (due to the biasing force of the upper spring 128 ) engages the first tooth of the upper ratchet 120 to enter a first channel (cholangio channel) 120 a of the upper ratchet to emit a distinct sound and transmit a distinct tactile sensation.
- the sound and feel of the upper pawl 124 entering the first channel 120 a is significantly different than the sound and feel of ratcheting of the lower pawl 126 ratcheting with the lower ratchet 122 , due to the spring force of the upper spring being greater than that of the lower spring.
- differing the dimensions and/or materials between the upper ratchet 120 and the lower ratchet 122 and/or differing the dimensions and/or materials between the upper pawl 124 and the lower pawl 126 may contribute to the differing sounds and feels when the trigger 64 is squeezed.
- the upper ratchet 120 and lower ratchet 122 continue to pivot counterclockwise such that the upper pawl moves from the cholangio channel 120 a to a generally fully squeezed channel 120 b , to emit the distinct sound and transmit the distinct tactile sensation.
- the two distinct sounds and sensations i.e., of the upper pawl 124 engaging the upper ratchet 120
- the generally fully squeezed channel 120 b may be eliminated, thereby alerting the surgeon only to when the clip applying device 50 is in the cholangio zone.
- the trigger 64 When the trigger 64 is released, the trigger moves to the unsqueezed position to disengage the upper pawl 124 from the upper ratchet 120 , thereby resetting the clip applying device 50 .
- the upper ratchet 120 /upper pawl 124 and the lower ratchet 122 /lower pawl 126 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.
- the indicating arrangement of the present invention being used in a clip applying device 50 that can accept more than one type of clip supply cartridge 68 a , 68 b , 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.
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
- 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.
- 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.
- 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 of 28-28 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. - 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 device 50 for applying medical tissue-pinchingclips clip applying device 50 has a patient-engagingdistalmost end 54 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 tube 60, which elongatedtube 60 andelongated channel member 58 are secured at their respective proximalmost ends to the distal end of a generally pistol-likehandle grip assembly 62. Thehandle grip assembly 62 includes an arcuately movablesqueezable trigger 64 that pivots about pivot shaft 64P. By releasing the squeezedtrigger 64 away from ahousing portion 66 of thehandle grip assembly 62, aclip 52 a (shown inFIG. 2 ), 52 b (shown inFIG. 3 ) is advanced through the distal end of theelongated channel member 58 and into thejaws 56 from an elongated ladder-likeclip supply cartridge 68 a (shown inFIG. 4 ), 68 b (shown inFIG. 5 ), disposed through theelongated channel 58. The elongatedclip supply cartridge port 70 in the proximal end of thehandle grip assembly 62, the receiving slot being in communication with theelongated channel 58. - A rotatable enclosure barrel (also referred to as a tube) 72 is rotatably supported within the
handle grip assembly 62. Therotatable enclosure barrel 72 is connected to the proximal end of theelongated channel 58. Theenclosure barrel 72 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 bearing 74 has acompression spring 78 arranged against its distalmost surface 80. Thecompression spring 78 releases acinch 86 after thejaws 56 have been closed and aclip distal bearing 74. - The
distal bearing 74 has an elongated cinch rod 84 (shown inFIGS. 6-9 ) extending distally therefrom. Thecinch rod 84 extends through the length of the elongated channel 58 (and its surrounding protective enclosure tube 60). The cinch 86 (shown inFIG. 10 ) is generally semi-cylindrically-shaped and arranged on the distal end of thecinch rod 84. Thecinch 86 is slidably arranged on the distal end of theelongated channel 58 and is reciprocally slidable in axial direction X to engage thejaws 56 which are squeezably arranged on the distal end of the clip applying device. The eachjaw member 56 is located on arespective jaw arm 256, and thejaws 56 and jaw arms are part of ajaw assembly 156. Thejaw arms 256 are biased outwardly (i.e.,thejaws 56 are biased open). Distal and proximal movement of thecinch 86 in axial direction X and with respect to theelongated channel 58 effects the respective squeezing closure and biased opening of thejaws 56 at the distal end of theelongated channel 58. Thecinch rod 84 moves in axial direction X to slide thecinch 86 distally and proximally corresponding to the direction of movement of thedistal bearing 74 on the distal end of theenclosure barrel 72. - The
distal bearing 74 is biased proximally by thecompression spring 78, effecting a proximal motion to thedistal bearing 74. Thedistal bearing 74 is operatively connected to thetrigger 64 by adistal paddle 23, and theproximal bearing 76 is operatively connected to aproximal paddle 25, which is in turn connected to the trigger by atrigger linkage 98. Thus, theproximal bearing 76 is biased distally by the compression spring via thetrigger linkage 98. - An
elongated pusher rod 88 extends adjacent to the lower side of the elongated channel 58 (as shown, e.g., in FIGS. 1, 6-9 and 37). Theelongated pusher rod 88 has a proximal end connected to theproximal bearing 76 surrounding theenclosure barrel 72 at the proximal end of thehandle grip assembly 62. Thepusher rod 88 is connected to a clip-engaging feeder 90 (shown inFIGS. 2-3 ). Thefeeder 90 is movable in axial direction X in relation to the clip-loadedcartridge elongated channel 58; however, the pusher rod is disposed below the elongated channel 58 (shown inFIG. 6 ). Proximal motion of thefeeder 90 is effected by proximal motion of theproximal bearing 76 around theenclosure barrel 72 within thehandle grip assembly 62. As thetrigger 64 is squeezed (i.e., as the trigger is moved toward thehousing portion 66 and pivoted about pivot shaft 64P), thepusher rod 88 distally retracts in the axial direction X due to distal movement of thedistal bearing 74, which distally movesfeeder 90 to retrieve adistalmost clip 52 a′, 52 b′ of the plurality of clips that are serially loaded inrespective clip cartridges distalmost clip 52 a′, 52′ into guide slots 194 (shown inFIGS. 10-11 and 19), in the opposed faces of therespective jaws 56. 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. - The
trigger 64 is biased toward the unsqueezed position by the compression spring 78 (shown inFIG. 1 ). Upon release of thetrigger 64, thedistal bearing 74 is biased to move proximally, resulting in proximal (rearward) movement of thecinch 86 by the proximal movement of thecinch rod 84, which permits thejaws 56 to bias themselves open, and the feeder 90 (pushed by the pusher rod 88) to push the next available (distalmost) clip 52 a′, 52 b′ into theguide slots 194 of therespective jaws 56 as thejaws 56 open fully, as thetrigger 64 is permitted to open fully (shown inFIG. 1 ) from thehandle 66 portion of thehandle grip assembly 62. Release of the trigger 64 (after the trigger 46 has been initially squeezed towards the handle 66) will automatically advance the nextavailable distalmost clip 52 a′, 52 b′ within thecartridge - 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, the
clip applying device 50 of present invention accepts aclip cartridge 68 a containing a series of medium-largesized clips 52 a, and can also accept aclip cartridge 68 b containing a series of large-sized clips 52 b. 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 device 50 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 to
FIGS. 6-9 , when theclip applying device 50 is loaded with acartridge proximal bearing 76 anddistal bearing 74, this distance being determined by a stop key 13 located in theenclosure barrel 72. - When the
clip cartridge 68 b is inserted into the receiving slot orport 70 of theclip applying device 50, the cartridge is slid along axial direction X until it reaches a stop (not shown) and the cartridge can no longer be slid. Thestop key 13 is then lowered into a stop keyhole 34 (shown inFIG. 5 ) of thecartridge 68 b by pivoting action of the stop key (shown inFIGS. 8-9 ). When thetrigger 64 is released (i.e., when theclip applying device 50 is at rest, shown inFIG. 1 ), theproximal bearing 76 anddistal bearing 74 move towards each other such that thestop key 13 is sandwiched therebetween to create a distance Db between the proximal bearing and distal bearing. The distance Db results from thedistal bearing 74 contacting a firstdistal face 13 a of thestop key 13, and theproximal bearing 76 contacting a firstproximal face 13 b of the stop key. - When the
clip cartridge 68 a is inserted by the user into the receiving slot orport 70 of theclip applying device 50, the cartridge slides along axial direction X until it reaches a stop and the cartridge can no longer move axially. Theclip cartridge 68 a (shown inFIG. 4 ) does not have a stop keyhole for the lowering of the stop key 13 therein. Thus, when thetrigger 64 is released (i.e., when theclip applying device 50 is at rest), theproximal bearing 76 anddistal bearing 74 move towards each other such that thestop key 13 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 bearing 74 contacting a seconddistal face 13 c of thestop key 13, and theproximal bearing 76 contacting a secondproximal face 13 d of the stop key. The distance Da is less then the distance Db because theproximal bearing 76 anddistal bearing 74 are closer to each other in the axial direction X. - Additionally, due to the configuration of the face surfaces 13 a-d of the stop key, when the
cartridge 68 a is inserted into theclip applying device 50, theproximal bearing 76 and distal bearing are both located more distally than when thecartridge 68 b is inserted into the clip applying device. Thus (as shown inFIG. 2-3 ), when thecartridge 68 a is inserted into theclip applying device 50, the cinch is advanced in the distal direction to narrow the jaws to a width Wa, and when thecartridge 68 b is inserted into theclip applying device 50, thecinch 86 is advanced (a lesser amount than when thecartridge 68 a is inserted) in the distal direction to narrow the jaws to a width Wb. The width Wa is narrower than the width Wb because when thecartridge 68 a is inserted into the clip applying device, thecinch 86 is distally advanced a greater amount in the axial direction X than when thecartridge 68 b is inserted into the clip applying device. As described further hereinbelow, eachjaw member 56 is increasingly tapered from a proximal point along the axial direction X to a distalward point where amaximum width portion 56W is located. Thus, the more thecinch 86 is advanced distally toward themaximum width portion 56W, the narrower the width between the jaws. In this way (shown inFIG. 2 ), the narrower width Wa allows thejaws 56 to securely accommodate medium-large clips 52 a in theguide slots 194. - Similarly (shown in
FIG. 3 ), when thecartridge 68 b is inserted into theclip applying device 50, since thecinch 86 is advanced a lesser amount than when thecartridge 68 a is inserted, the jaws are opened wider to width Wb to allow thejaws 56 to securely accommodatelarge clips 52 b in theguide slots 194, which may have a width larger than smaller clips (e.g., medium-large clips 52 a). - Further (as shown in
FIG. 2-3 ), when thecartridge 68 a is inserted into theclip applying device 50, thefeeder 90 is advanced to the proper position to load theclip 52 a, and when thecartridge 68 b is inserted into theclip applying device 50, thefeeder 90 is advanced (a lesser amount than when thecartridge 68 a is inserted) to properly load thelarger clip 52 b. In other words, when thecartridge 68 b is inserted, thefeeder 90 does not distally advance as much as when thecartridge 68 a is inserted, because the feeder must be further back to accommodate thelarger clip 52 b (shown inFIG. 3 ), which may have a longer length than smaller clips (e.g., medium-large clips 52 a). - In the above-described embodiment, the position in the axial direction X of both the
cinch 86 and thefeeder 90 is determined by thestop key 13; 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 thecinch 86 and thefeeder 90 may be determined by the stop key, i.e., the stop key may be differently configured to allow varied displacement between theproximal bearing 76 anddistal bearing 74. 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 both
cartridges safety keyholes FIGS. 4-5 ) which do not interact with thestop key 13, but rather accept asafety key 110, in order to prevent insertion or withdrawal of theclip cartridge trigger 64 is generally fully squeezed rearwardly toward thehandle 66 of thehandle grip assembly 62 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, the
trigger 64 may be squeezed to allow the insertion of thecartridge clip cartridge clip 52 a 52 b), such that the position in the axial direction X of theproximal bearing 76 or thedistal bearing 74 may be determined. - The
cinch 86 andjaw assembly 156 of the present invention allow full, positive and consistent control of the opening and closing of thejaws 56 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 device 50 is able to accept two different types ofclip cartridges jaws 56 thus move radially over a greater distance than other clip appliers, such full, positive and consistent control of thejaws 56 is required. Further, limited travel in the axial direction X of a cinch is normally not enough to cover this increased radial travel of thejaws 56. In other words, there is no single surface of thecinch 86 orjaw assembly 156 to completely and accurately control the opening and closing of the cinch. - An embodiment of the present invention includes a
cinch 86 that allows for greater radial movement of thejaws 56 by engaging different jaw engagement surfaces 156 a, 156 b, 156 c, 156 d, 156 e, 156 f of eachjaw arm 256. The generally semi-cylindrically-shapedcinch 86 has a pair of control fingers (or control members) 30 (shown inFIG. 13 ) on the underside thereof which engage inner engagement surfaces 156 e and outer engagement surfaces 156 f of the jaw arms. In a non-limiting embodiment, the inner and outer engagement surfaces 156 e, 156 f, as well as thecontrol fingers 30, may be tapered or angled. -
FIG. 14 shows thecinch 86 in an intermediate position, where thecontrol fingers 30 are intermediate the respective inner engagement surfaces 156 e and outer engagement surfaces 156 f. In this position (in a non-limiting embodiment), medium-large clips 52 a may 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 surfaces 30 e of thecontrol fingers 30 respectively engage the inner engagement surfaces 156 e to widen the gap between the jaws 56 (e.g., to a width Wb, in order to accommodatecartridge 68 b containing largesized clips 52 b), whileinner control surfaces 30 f of the control fingers are brought out of contact with respective outer engagement surfaces 156 f, as shown inFIGS. 15 and 17 . Conversely, when the cinch is moved distally from a proximalmost position toward the intermediate position, theouter control surfaces 30 e of the control fingers respectively slide along the inner engagement surfaces 156 e to gradually (due to the angled configuration) let thejaw arms 256 bias themselves inward. - Similarly, when the cinch is moved distally in the axial direction X from the intermediate position,
inner control surfaces 30 f of thecontrol fingers 30 respectively engage the inner engagement surfaces 156 e to narrow the gap between the jaws 56 (e.g., to a width Wa, to accommodatecartridge 68 a containing medium-largesized clips 52 a, or to begin a clip-crimping operation), whileouter control surfaces 30 e of the control fingers are brought out of contact with respective outer engagement surfaces 156 e, 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 thecinch 86, thecontrol fingers 30 are preferably always in contact with at least one of the inner or outer engagement surfaces 156 e, 156 f (as shown inFIG. 14 ). -
FIG. 18 shows thecinch 86 in a fully distal position in which aclip cinch 86 from the fully-distal position along the axial direction X, the cinch includes a generally arcuatecentral block 32 having opposed ends which respectively engage second inner engagement surfaces 156 d located on an upper surface of each jaw arm 256 (shown inFIGS. 16 and 19 ), which may be tapered or angled in a non-limiting embodiment. Thecentral block 32 ensures accurate and precise transition of the control surfaces of thecinch 86 when thejaws 56 begin to open (i.e. when the cinch moves proximally along axial direction X) from the closed jaw position. For example, when thecinch 86 begins to open from the closed jaw position (shown inFIG. 18 ), a proximal facingsurface 32 d of thecentral block 32 engages the second inner engagement surfaces 156 d commence an opening operation of the jaws. After thecinch 86 moves proximally partway along the axial direction X toward the intermediate position, control of the opening of thejaws 56 is “handed off” to theinner control surfaces 30 f of thecontrol fingers 30, which respectively slide along the outer engagement surfaces 156 f to gradually (due to the angled configuration) provide for outward movement of the jaw arms 256 (in direction Z). Although thecentral block 32 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, the
cinch 82 may include a pair of inwardly facing guide walls 34 (shown inFIGS. 20-21 ) configured to respectively slidingly engage one or more outerside engagement surfaces 156 a-c (shown inFIGS. 19 and 22 ) of eachjaw arm 256 to provide further control of (e.g., pitch in the radial direction) thejaw assembly 156 by the cinch. With such a configuration it may not be necessary for thejaw assembly 156 to remain at rest in the intermediate position. Additionally, since thecontrol fingers 30 protrude inwardly, a gap or channel G may be present between thecontrol finger 30 and theceiling 82 c of thecinch 82. A portion of eachjaw arm 256 may then be sandwiched between arespective control finger 30 and theceiling 82 c of thecinch 82, 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. - In
FIGS. 2 and 10 , the radial opening and closing direction of thejaws 56 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 arms 156 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, the
clip applying device 50 of the present invention is able to accept at least two different types ofclip cartridges FIGS. 23-26 ) that can center (along central axis CX)clip cartridges elongated tube 60 in a width, or transverse direction (or radial direction) Z of the cartridges. In other words, thealignment device 36 can maintain the loadedcartridges tube 60 in the radial orthogonal Z axis direction) of the elongated tube 60 (i.e., so that a sagittal plane defined by the X-Y axis bisecting thecartridges clip cartridge clip cartridge clip jaws 56 and accurately crimped thereby. - The
alignment device 36 has a pair ofelongated rails 38 extending in the axial direction X. Therails 38 each have a distal (first)region 38 a defining a first channel Ca therebetween, a middle (second)region 38 b defining a second channel Cb therebetween, and a proximal (third)region 38 c defining 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 areas 38 t (each located between a respectivedistal region 38 a andmiddle region 38 b) which may be tapered or angled to accurately guide the insertion ofcartridge 68 a (which is inserted along axial direction X, also referred to as an insertion axis direction) into the distal channel Ca, where thecartridge 68 a is securely held and centrally aligned therein in the radial or transverse direction Z (i.e.,cartridge 68 a is sandwiched between bothdistal regions 38 a), due to the extending of the distal channel Ca in the axial direction X. In situations where thecartridge 68 b is wider in radial direction Z than thecartridge 68 a, thecartridge 68 b cannot fit within thedistal channel 68 a. Rather, the transition area blocks thecartridge 68 b from being inserted in thedistal channel 68 a, and also prevents damage to thecartridge 68 b during the insertion process. Thus, thecartridge 68 b is securely held and centrally aligned in the channel Cb in the radial direction Z (i.e., thecartridge 68 b is sandwiched between bothmiddle regions 38 b), 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 member 58 (through which the
cartridge elongated channel member 58 is also securely held and centrally aligned in the proximal channel Cc in the radial direction Z (i.e., theelongated channel member 58 is sandwiched between bothproximal regions 38 c), due to the extension of the middle channel Cb in the axial direction X. Additionally, thealignment device 36 also includes astop region 36 s which prevents distal displacement in the axial direction X of theelongated channel member 58. The thickness of a lower portion of theelongated channel member 58 is preferably the same thickness as the lower portion of the stop region, thereby ensuring smooth loading of thecartridges - The
alignment device 36 may further include an axially-extendingcavity 40 configured to accept the insertion and retraction of the clip-engagingfeeder 90 when it loads aclip cavity 40 can accommodate thefeeder 90 therein, between the rails 38), and may further include aramp portion 42 configured to facilitate the sliding and loading of aclip guide slots 194 of thejaws 56. The alignment device may also include a middleinclined region 84, located distally of thecavity 40 and extending in the axial direction X, to assist in the upward distal sliding in the axial direction X of thefeeder 90. Further, thealignment device 36 may have an angled or taperedsurface 44 at the distal end thereof and/or a semi-cylindricalouter surface 48, to facilitate the insertion of the alignment device, and therefore the clip-applyingdevice 50, into the body cavity. - An advancement block (also referred to as a slider) 12 (shown in
FIGS. 27 and 29 -36) is attached between thepusher rod 88 and clip-engaging feeder 90 (shown inFIGS. 2-3 and 37). Thefeeder 90 is movable in axial direction X in relation to the clip-loadedcartridge elongated channel 58; however, the pusher rod is disposed below the elongated channel 58 (shown inFIGS. 6 and 28 ). Theslider 12 has a ladder-engagingtoggle 14, which is configured to sequentially engage a series of openings inladder member FIGS. 4-5 ) slidably arranged within arespective clip cartridge ladder member toggle 14 of the slider 12 (the slider being operatively connected topusher rod 88 as shown inFIG. 37 ) is pushed in the distal direction (along axial direction X) to in turn push against the proximalmost orlast clip 52 a″, 52 b″ in thecartridge cartridge clips - As shown in
FIGS. 27 and 29 -36, the ladder-engagingtoggle 14 pivots in both directions about apivot shaft 20, 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 shaft 30 may be generally shaped like a U or J, so that the pivot shaft does not slide out of theslider 12. Alternatively, the pivot shaft may have elongated shaft ends, rivets and the like to prevent such sliding out of theslider 12. - In a non-limiting embodiment, the
toggle 14 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. Thetoggle 14 has aridge 14 a that engages atoggle spring 16 affixed to theslider 12. Thespring 16 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 theridge 14 a to bias the toggle in an upright (second) position, shown inFIGS. 30-31 and 36. In a non-limiting embodiment and as shown inFIG. 28 , the channel is generally U-shaped, and as described above, theslider 12 proximally and distally slides below and adjacent to thechannel 58 in the axial direction X. Thechannel 58 additionally includes a toggle aperture 58C1 in the bottom portion thereof, through which a portion of thetoggle 14 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 the
trigger 64 is squeezed, theslider 12 is moved proximally in the axial direction X (since the slider is operably connected to thepusher rod 88, which is in turn connected to the proximal bearing 76). As theslider 12 is moved proximally, an edge-engagingface 14 b of thetoggle 14 engages anedge 58 e of thechannel 58, such that thechannel edge 58 e (which generally extends in the Z axis direction) pushes thetoggle 14 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 spring 16, shown inFIGS. 31-32 . In the first position, thetoggle 14 slides in the axial direction X and below thechannel 58, with at least a portion of the edge-engagingface 14 b contacting the underside of thechannel 58. It is noted that thechannel edge 58 e may be angled or tapered to increase the surface area thereof, thereby ensuring smooth and precise pivoting action of thetoggle 14. - When the
trigger 64 is released, theslider 12 begins to distally move in the axial direction X. The edge-engagingface 14 b contacts the underside of thechannel 58 until thetoggle 14 reaches the toggle aperture 58C1, at which point the edge-engagingface 14 b contacts thechannel edge 58 e and allows thetoggle spring 16 to urge the toggle into the upright position (shown inFIGS. 30-31 and 36) and between rungs 33 aR, 33 bR of theladder member toggle 14 rotates in a second direction (clockwise when viewingFIGS. 29-30 ). Pivoting of thetoggle 14 in the second direction is stopped when aheel portion 14 d engages astop portion 18 located on theslider 12. - Once in the upright position, the
toggle 14 continues to move distally through the toggle aperture 58C1 (and within a rung gap 33 aG, 33 bG) in the axial direction X such that a pushingface 14 c contacts a rear (proximal) side of a rung 33 aR, 33 bR of theladder member toggle 14 pushes theladder member last clip 52 a″, 52 b″ in thecartridge - The above process may be repeated by continually squeezing and releasing the
trigger 64, which in turn continually distally advances theladder member last clip 52 a″, 52 b″ is loaded into and applied by thejaws 56. - It is noted that while many of the figures show the clip advancement arrangement of the present invention being used in a
clip applying device 50 that can accept more than one type ofclip supply cartridge -
FIG. 37 shows atrigger lockout arrangement 11. As described above, theslider 12 is attached between thepusher rod 88 and clip-engagingfeeder 90. Thetrigger lockout arrangement 11 serves to lock movement of thetrigger 64 when thelast clip 52 a″, 52 b″ of thecartridge jaws 56, 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 the
trigger 64 is squeezed, theslider 12 proximally moves in the axial direction X, and when the trigger is released, the slider moves in the axial direction X such that thetoggle 14 distally advances theladder member feeder 90 loads thedistalmost clip 52 a′, 52 b′ between thejaws 56. - The
channel member 58 also includes ablock 91 affixed to the underside of the channel member via aflexible rod 92, and additionally has a block aperture 58C2, located above theblock 91 in the Y-axis direction, for accepting insertion of at least a portion of theblock 91 therein. At rest, theflexible rod 92 is biased to generally extend in the axial direction X. Theslider 12 also has atooth 93 that contacts theblock 91 when the slider is proximally or distally moved in the axial direction X. While theblock 91 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 in
FIG. 38 , when thetrigger 64 is squeezed and theslider 12 moves proximally in the axial direction X (to approach theblock 91 from the front, shown inFIGS. 37-38 ), arear surface 93 a of thetooth 93 engages afront surface 91 a of theblock 91 to move the block in radial direction Z while the slider continues to move proximally. Therear surface 93 a of thetooth 93 is angled to facilitate movement of theblock 91 in the radial direction Z. Once theslider 12 passes theblock 91, the block returns to its original rest position due to the biasing action of therod 92. - When the
trigger 64 is released, theslider 12 begins to move distally in the axial direction X and approaches theblock 91 from the rear (shown inFIG. 39 ). If acartridge clips clip applier 50, the slider moves distally such that afront surface 93 b (best shown inFIG. 38 ) of thetooth 93 engages arear surface 91 b of theblock 91 to push the block upward in the Y-axis direction (i.e., into the page ofFIG. 37 ). Specifically, the upward movement of theblock 91 causes a portion of the block to pass through the block aperture 58C2 of thechannel 58 and be inserted between the rungs 33 aR, 33 bR of theladder member tooth 93 to pass over theblock 91 as the slider continues to move in the distal direction. Once thetooth 93 has passed over theblock 91, therod 92 urges the block downwardly, since therod 92 is biased in the axial direction X and to keep the block out of the ladder gap 33 aG, 33 bG. - To facilitate precise movement of the
block 91 in the Y-axis direction, thefront surface 93 b of thetooth 93 and/or therear surface 91 b of theblock 91 may be angled. Additionally, one ormore bands 95 to slidably secure theslider 12 against the underside of thechannel 58 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 theblock 91 between the rungs 33 aR, 33 bR of theladder member slider 12, thetoggle 14 does not engage a rung 33 aR, 33 bR until after thetooth 93 has passed over theblock 91 and the block has withdrawn from the ladder gap 33 aG, 33 bG. - As described above, the slider may be continually moved proximally and distally by respective continual squeezing and releasing of the
trigger 64, until thelast clip 52 a″, 52 b″ is loaded into and applied by thejaws 56. While thelast clip 52 a″, 52 b″ is being loaded into thejaws 56 by the feeder 90 (and thus nomore clips cartridge toggle 14 engages the rung 33 aR, 33 bR, thereby advancing theladder member solid surface 96 of the ladder member beneath the block aperture 58C2 (i.e., there is no longer a ladder gap 33 aG, 33 bG beneath the block 91). Theclip applying device 50 is now ready for one final clip crimping process. During the final clip crimping process, thetrigger 64 is squeezed to proximally move the slider 12 (and to thereby bring thetooth 91 thereof behind the block, as described above) and to distally move thecinch 86 to crimp thelast clip 52 a″, 52 b″. - As shown in
FIG. 40 , when thetrigger 64 is released after thelast clip 52 a″, 52 b″ has been crimped, thecompression spring 78 urges the trigger toward the open position, which (as described above) moves theslider 12 distally so that thetooth 93 engages theblock 91. However, thesolid surface 96 of theladder member block 91 by thetooth 93 in the Y-axis direction (since there is no ladder gap 33 aG, 33 bG for the block to enter. Thus, thetooth 93 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 clip 52 a″, 52 b″ has been applied. As noted above, thebands 95 prevent the slider (and thereby the tooth 93) from being displaced in the Y-axis direction so that the tooth does not “leap over” theblock 91, when the slider moves in the axial direction X. It is noted, however, that thetrigger 64 is permitted to be slightly unsqueezed so that thelast clip 52 a″, 52 b″ and any tissue can be released from thejaws 56. Once thecartridge clip applying device 50, thetrigger 64 is free to again move to the unsqueezed position, since thesolid surface 96 is no longer present. - An embodiment of the present invention uses
cartridges clips trigger lockout arrangement 11 of the present invention locks thetrigger 64 after all of theclips more clips cartridge clip applying device 50. - It is noted that while many of the figures show the trigger lockout arrangement of the present invention being used in a
clip applying device 50 that can accept more than one type ofclip supply cartridge - Another feature of an embodiment of the present invention includes a system for indicating to the surgeon when the
clip FIG. 42 ) and/or when theclip FIG. 43 ).FIG. 41 shows an uncrimped clip. During surgery, a surgeon may want to apply aclip trigger 64, thejaws 56 are only partially closed and theclip clip applying device 50 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 ). - The
clip applying device 50 may include a visual slider 102 (housed within the handle grip assembly 62) which slides along an indicator path by way ofindicator shaft 104 in an inclined direction with respect to the longitudinal axis X, although it should be understood by those skilled in the art that theindicator shaft 104 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 spring 106 which may be disposed about the proximal end of the indicator shaft. Alternatively, theshaft spring 106 may be disposed at the distal end of theindicator shaft 104 to “pull” the visual slider toward the distal end of thegrip assembly 62. - The
visual slider 102 includes threeindicator regions region window 111 located in the top of the grip assembly. As a non limiting example,indicator region 102 a (indicating the open trigger position) may be green,indicator region 102 b (indicating the cholangio zone) may be yellow, andindicator region 102 c (indicating the generally fully-squeezed position) may be red. Alternatively, eachindicator region - In the unsqueezed position (shown in
FIG. 1 ), afirst abutment surface 102 d of thevisual slider 102 abuts against afirst end 112 a of apivotable trip switch 112 to maintain the visual slider in its distalmost position (against the distal biasing force of the shaft spring 106), andindicator region 102 a is displayed through thewindow 110. Thetrip switch 112 has atrip switch spring 114 which is affixed to thegrip assembly 62 to bias the trip switch to pivot in the counterclockwise direction (when viewed inFIG. 1 ). Additionally, asecond end 112 b of thetrip switch 112 engages an outer surface of the distal bearing to prevent further counterclockwise pivoting of the trip switch. - When the
trigger 64 is squeezed toward the cholangio zone (and the distal bearing begins to move distally along axial direction X), thevisual slider 102 remains in position (due to the continued engagement of thefirst abutment surface 102 d with thefirst end 112 a of the trip switch 112) until an angled distal surface of adistal bearing ring 108 engages thesecond end 112 b of the trip switch to pivot the trip switch clockwise (when viewed inFIG. 1 ), which disengages thefirst abutment surface 102 d from thefirst end 112 a of thetrip switch 112, thereby allowing theshaft spring 106 to proximally urge thevisual slider 102. The visual slider is proximally urged until thefirst end 112 a of thetrip switch 112 engages asecond abutment surface 102 d of thevisual slider 102 to stop proximal movement of the visual slider and exposing theindicator region 102 b through the window 111 (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 the
jaws 56 to generally fully crimp theclip distal bearing ring 108 further engages thesecond end 112 b of thetrip switch 112 to further pivot the trip switch clockwise, which disengages thesecond abutment surface 102 d from thefirst end 112 a of thetrip switch 112, thereby allowing theshaft spring 106 to further proximally urge thevisual slider 102 until the slider reaches its limit of proximal travel along theindicator shaft 104, thereby exposing theindicator region 102 c through the window 111 (indicating the generally fully squeezed position to the surgeon), as shown inFIG. 45 . - When the
trigger 64 is released (and the distal bearing begins to move proximally due to the biasing force of the compression spring 78), a proximal face of thedistal bearing ring 108 engages anindicator finger 102 d to proximally move thevisual slider 102 so that thefirst abutment surface 102 d of thevisual slider 102 again abuts against afirst end 112 a of thetrip switch 112 to reset the visual slider in its distalmost position (thereby again exposing theindicator region 102 a through the window 111), 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 one
indicator region indicator regions device 50 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. - The
clip applying device 50 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 window 111, 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 in
FIGS. 12 and 45 , an upper (first)ratchet 120 and a lower (second) ratchet 122 are affixed to and move with thetrigger 64, which pivots about the trigger pivot shaft 64P. Additionally, an upper (first)pawl 124 and a lower (second)pawl 126 are pivotably affixed about aproximal paddle shaft 25P, about which theproximal paddle 25 is also affixed. Additionally, theupper pawl 124 is biased to pivot counterclockwise (when viewed inFIG. 12 ) by anupper spring 128, andlower pawl 126 is biased to pivot counterclockwise by alower spring 130, 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 spring 130 biases thelower pawl 126 to engage thelower ratchet 122 to create a ratcheting sound as the trigger is squeezed toward the cholangio zone and the upper and lower ratchets pivot counterclockwise about trigger pivot 64P (when viewed inFIG. 12 ), whileindicator region 102 a is displayed in thewindow 111. Once the cholangio zone is entered (and at substantially the same time thewindow 111displays indicator region 102 b), theupper ratchet 120 andlower ratchet 122 continue to pivot counterclockwise so that the upper ratchet engages theupper pawl 124. Specifically, when the cholangio zone is entered, the upper pawl 124 (due to the biasing force of the upper spring 128) engages the first tooth of theupper ratchet 120 to enter a first channel (cholangio channel) 120 a of the upper ratchet to emit a distinct sound and transmit a distinct tactile sensation. The sound and feel of theupper pawl 124 entering thefirst channel 120 a is significantly different than the sound and feel of ratcheting of thelower pawl 126 ratcheting with thelower ratchet 122, 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 ratchet 120 and thelower ratchet 122 and/or differing the dimensions and/or materials between theupper pawl 124 and thelower pawl 126 may contribute to the differing sounds and feels when thetrigger 64 is squeezed. - When the
trigger 64 moves from the cholangio zone to the generally fully squeezed position (and at substantially the same time thewindow 111displays indicator region 102 c), theupper ratchet 120 andlower ratchet 122 continue to pivot counterclockwise such that the upper pawl moves from thecholangio channel 120 a to a generally fully squeezedchannel 120 b, 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 pawl 124 engaging the upper ratchet 120) can be made different by differing the dimensions and/or material of thecholangio channel 120 a and the generally fully squeezedchannel 120 b. It is further noted that in alternative embodiments, the generally fully squeezedchannel 120 b may be eliminated, thereby alerting the surgeon only to when theclip applying device 50 is in the cholangio zone. - When the
trigger 64 is released, the trigger moves to the unsqueezed position to disengage theupper pawl 124 from theupper ratchet 120, thereby resetting theclip applying device 50. Theupper ratchet 120/upper pawl 124 and thelower ratchet 122/lower pawl 126 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 a
clip applying device 50 that can accept more than one type ofclip supply cartridge - 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 to claim 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 to claim 1 , further comprising a tapered distal end configured to be inserted into a body cavity.
4. The alignment device according to claim 1 , further comprising a generally semi-cylindrically-shaped outer surface.
5. The alignment device according to claim 1 , wherein said second channel is located proximally of the first channel.
6. The alignment device according to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 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 to claim 11 , wherein the second channel is located proximally of the first channel.
15. The method according to claim 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 to claim 15 , wherein the apparatus further includes a cavity, the method further comprising insertion and retracting of a clip-engaging feeder.
17. The method according to claim 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 to claim 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 to claim 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.
Priority Applications (13)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/210,837 US20070049950A1 (en) | 2005-08-25 | 2005-08-25 | Medical clip applying device |
US11/210,885 US20070049951A1 (en) | 2005-08-25 | 2005-08-25 | Apparatus alignment device |
US11/210,836 US20070049949A1 (en) | 2005-08-25 | 2005-08-25 | Clip feeder mechanism for clip applying device |
US11/210,828 US20070191868A1 (en) | 2005-08-25 | 2005-08-25 | Indicating system for clip applying device |
US11/210,832 US7419495B2 (en) | 2005-08-25 | 2005-08-25 | Trigger lockout device for clip applying instrument |
JP2006227524A JP2007054631A (en) | 2005-08-25 | 2006-08-24 | Alignment device |
JP2006227539A JP2007054634A (en) | 2005-08-25 | 2006-08-24 | Trigger lock out device used for clip apparatus |
JP2006227536A JP2007054633A (en) | 2005-08-25 | 2006-08-24 | Indicating system for surgical clip applying device |
JP2006227519A JP2007054630A (en) | 2005-08-25 | 2006-08-24 | Medical clip applying device |
EP06017814A EP1757236A3 (en) | 2005-08-25 | 2006-08-25 | Medical clip applying device |
EP06119555A EP1757238A1 (en) | 2005-08-25 | 2006-08-25 | Alignment device for an apparatus |
EP06076657A EP1757237A1 (en) | 2005-08-25 | 2006-08-25 | Trigger lockout device for clip applying instrument |
EP06119593A EP1757239A1 (en) | 2005-08-25 | 2006-08-25 | Indicating system for surgical clip applying device |
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US11/210,828 US20070191868A1 (en) | 2005-08-25 | 2005-08-25 | Indicating system for clip applying device |
US11/210,837 US20070049950A1 (en) | 2005-08-25 | 2005-08-25 | Medical clip applying device |
US11/210,885 US20070049951A1 (en) | 2005-08-25 | 2005-08-25 | Apparatus alignment device |
US11/210,836 US20070049949A1 (en) | 2005-08-25 | 2005-08-25 | Clip feeder mechanism for clip applying device |
US11/210,832 US7419495B2 (en) | 2005-08-25 | 2005-08-25 | Trigger lockout device for clip applying instrument |
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US20070049951A1 true US20070049951A1 (en) | 2007-03-01 |
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US11/210,832 Active 2025-09-03 US7419495B2 (en) | 2005-08-25 | 2005-08-25 | Trigger lockout device for clip applying instrument |
US11/210,836 Abandoned US20070049949A1 (en) | 2005-08-25 | 2005-08-25 | Clip feeder mechanism for clip applying device |
US11/210,828 Abandoned US20070191868A1 (en) | 2005-08-25 | 2005-08-25 | Indicating system for clip applying device |
US11/210,885 Abandoned US20070049951A1 (en) | 2005-08-25 | 2005-08-25 | Apparatus alignment device |
US11/210,837 Abandoned US20070049950A1 (en) | 2005-08-25 | 2005-08-25 | Medical clip applying device |
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US11/210,836 Abandoned US20070049949A1 (en) | 2005-08-25 | 2005-08-25 | Clip feeder mechanism for clip applying device |
US11/210,828 Abandoned US20070191868A1 (en) | 2005-08-25 | 2005-08-25 | Indicating system for clip applying device |
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Also Published As
Publication number | Publication date |
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US20070049948A1 (en) | 2007-03-01 |
US20070191868A1 (en) | 2007-08-16 |
US7419495B2 (en) | 2008-09-02 |
EP1757236A3 (en) | 2007-05-09 |
US20070049949A1 (en) | 2007-03-01 |
JP2007054634A (en) | 2007-03-08 |
US20070049950A1 (en) | 2007-03-01 |
EP1757236A2 (en) | 2007-02-28 |
JP2007054633A (en) | 2007-03-08 |
JP2007054630A (en) | 2007-03-08 |
EP1757237A1 (en) | 2007-02-28 |
EP1757238A1 (en) | 2007-02-28 |
JP2007054631A (en) | 2007-03-08 |
EP1757239A1 (en) | 2007-02-28 |
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