U.S. patent application number 11/210828 was filed with the patent office on 2007-08-16 for indicating system for clip applying device.
This patent application is currently assigned to MICROLINE PENTAX INC.. Invention is credited to Emmanuel Manetakis, Marc Theroux.
Application Number | 20070191868 11/210828 |
Document ID | / |
Family ID | 63787640 |
Filed Date | 2007-08-16 |
United States Patent
Application |
20070191868 |
Kind Code |
A1 |
Theroux; Marc ; et
al. |
August 16, 2007 |
Indicating system for clip applying device
Abstract
An indicating system for a clip applying device. The system has
an indicator operatively connected to a trigger, wherein the
indicator provides a signal when the trigger is moved to a position
to operate jaws of the device to partially crimp the clip.
Inventors: |
Theroux; Marc; (Grafton,
MA) ; Manetakis; Emmanuel; (Burlington, MA) |
Correspondence
Address: |
GREENBLUM & BERNSTEIN, P.L.C.
1950 ROLAND CLARKE PLACE
RESTON
VA
20191
US
|
Assignee: |
MICROLINE PENTAX INC.
Beverly
MA
|
Family ID: |
63787640 |
Appl. No.: |
11/210828 |
Filed: |
August 25, 2005 |
Current U.S.
Class: |
606/142 |
Current CPC
Class: |
A61B 17/1222 20130101;
A61B 2090/08021 20160201; A61B 2017/00115 20130101; A61B 2017/2933
20130101; A61B 2017/2925 20130101; A61B 17/1285 20130101; A61B
2017/00464 20130101; A61B 2090/0811 20160201; A61B 17/128 20130101;
A61B 2017/2919 20130101; A61B 2017/00128 20130101 |
Class at
Publication: |
606/142 |
International
Class: |
A61B 17/10 20060101
A61B017/10 |
Claims
1. An indicating system for a clip applying device, the clip
applying device having a squeezable trigger, a barrel having a
plurality of serially-installed clips therein, and a pair of jaws
operatively connected to the trigger and configured to crimp a clip
of the plurality of serially-installed clips, the system comprising
an indicator operatively connected to the trigger, wherein: said
indicator provides a first signal when said trigger is moved to a
first position to operate the jaws to partially crimp the clip; and
said indicator provides a second signal when said trigger is moved
to a second position to operate the jaws to generally fully crimp
the clip.
2. The system according to claim 1, wherein the first signal and
the second signal are each visual signals.
3. The system according to claim 1, wherein the first signal and
the second signal are each audible signals.
4. The system according to claim 1, wherein the first signal and
the second signal are each tactile signals.
5. The system according to claim 2, wherein said indicator provides
a third visual signal when the trigger is at an unsqueezed
position.
6. The system according to claim 2, further comprising a window
located in the clip applying device, wherein: said indicator
includes a first region on which the first signal is displayed, and
a second region on which the second signal is displayed; when the
trigger is moved to the first position, said first region is moved
within said window; and when the trigger is moved to the second
position, said second region is moved within said window.
7. The system according to claim 6, wherein: the clip applying
device further includes a bearing disposed about the barrel and
operatively connected to the trigger, the bearing being slidable
along a bearing path generally parallel to a longitudinal axis of
the barrel; and the bearing allows for movement of the indicator
along an indicator shaft when the trigger is squeezed.
8. The system according to claim 7, further comprising a trip
switch pivotably disposed within the clip applying device, the trip
switch having a first end and a second end, wherein: said indicator
is urged to move in along the indicator shaft in a first direction
by an indicator spring; said first end of said trip switch engages
and prevent the indicator from moving in the first direction to
move said first region within said window, when the trigger is
moved to the first position; and said bearing engages said second
end of said trip switch to pivot and remove said trip switch from
engagement with the indicator, to move said second region within
said window, when the trigger is moved from the first position to
the second position.
9. The system according to claim 3, wherein said indicator
comprises: a first ratchet connected to the trigger; a first pawl
sequentially engageable with a first tooth and a second tooth of
said first ratchet, wherein: said first signal is emitted when the
trigger is moved to the first position such that said first pawl
engages said first tooth, and the second signal is emitted when the
trigger is moved to the second position such that said first pawl
engages said second tooth.
10. The system according to claim 9, wherein said indicator further
comprises: a second ratchet connected to the trigger; a second pawl
sequentially engageable with said second ratchet such that a third
audible signal is emitted, when the trigger is moved from an
unsqueezed position to the first position.
11. The system according to claim 10, wherein said indicator
further comprises: a first spring configured to urge said first
pawl to engage said first ratchet; and a second spring configured
to urge said second pawl to engage said second ratchet, said first
and second springs having different spring forces such that said
third audible signal is different from at least one of the first or
the second audible signals.
12. The system according to claim 4, wherein said indicator
comprises: a first ratchet connected to the trigger; a first pawl
sequentially engageable with a first tooth and a second tooth of
said first ratchet, wherein: the first signal is produced when the
trigger is moved to the first position such that said first pawl
engages said first tooth, and the second signal is produced when
the trigger is moved to the second position such that said first
pawl engages said second tooth.
13. The system according to claim 12, wherein said indicator
further comprises: a second ratchet connected to the trigger; a
second pawl engageable with said second ratchet such that a third
tactile signal is emitted, when the trigger is moved from an
unsqueezed position to the first position.
14. The system according to claim 13, wherein said indicator
further comprises: a first spring configured to urge said first
pawl to engage said first ratchet; and a second spring configured
to urge said second pawl to engage said second ratchet, said first
and second springs having different spring forces such that said
third tactile signal is different from at least one of said first
or said second tactile signals.
15. An indicating system for a clip applying device, the clip
applying device having a squeezable trigger, a barrel having a
plurality of serially-installed clips therein, and a pair of jaws
operatively connected to the trigger and configured to crimp a clip
of the plurality of serially-installed clips, the system comprising
an indicator operatively connected to the trigger, wherein said
indicator provides a signal when the trigger is moved to a first
position to operate the jaws to partially crimp the clip.
16. The system according to claim 15, wherein the signal is a
visual signal.
17. The system according to claim 15, wherein the signal is an
audible signal.
18. The system according to claim 15, wherein the signal is a
tactile signal.
19. A medical instrument comprising: a squeezable trigger; a barrel
configured to house a plurality of serially-installed clips
therein; a pair of jaws operatively connected to said trigger and
configured to crimp a clip of the plurality of serially-installed
clips; and an indicator operatively connected to said trigger,
wherein said indicator provides a signal when said trigger is moved
to a first position to operate said jaws to partially crimp the
clip.
20. The instrument according to claim 19, wherein the signal is a
visual signal.
21. The instrument according to claim 19, wherein the signal is an
audible signal.
22. The instrument according to claim 19, wherein the signal is a
tactile signal.
23. The instrument according to claim 20, further comprising: a
window; and a region on which the signal is displayed when said
trigger is moved to the first position, said region is moved within
said window.
24. The instrument according to claim 21, further comprising: a
ratchet connected to said trigger; and a pawl engageable with a
tooth of said ratchet, wherein said signal is emitted when said
trigger is moved to said first position such that said pawl engages
said tooth.
25. The instrument according to claim 22, further comprising: a
ratchet connected to said trigger; and a pawl engageable with a
tooth of said ratchet, wherein the signal is produced when said
trigger is moved to the first position such that said pawl engages
said tooth.
26. A method for indicating when a clip of a clip applying device
is partially crimped, the clip applying device having a squeezable
trigger, a barrel having a plurality of serially-installed clips
therein, a pair of jaws operatively connected to the trigger and
configured to crimp a clip of the plurality of serially-installed
clips, and an indicator operatively connected to the trigger, the
method comprising: squeezing the trigger to a first position; and
moving the indicator to provide a signal when the jaws have
partially crimped the clip.
27. The method according to claim 26, wherein the signal is a
visual signal.
28. The method according to claim 27, wherein the signal is an
audible signal.
29. The method according to claim 28, wherein the signal is a
tactile signal.
30. The method according to claim 27, wherein: the device further
includes a window; and said squeezing further comprises moving a
region of the indicator within the window.
31. The method according to claim 28, wherein: the device further
includes a ratchet connected to the trigger, and a pawl; and said
squeezing further comprises engaging the pawl with a tooth of the
ratchet to emit the signal.
32. The method according to claim 29, wherein: the device further
includes a ratchet connected to the trigger, and a pawl; and said
squeezing further comprises engaging the pawl with a tooth of the
ratchet to produce the signal.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention is related to an indicating system,
and more particularly relates to an indicating system for a medical
clip applying device.
[0003] 2. Background and Material Information
[0004] 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.
[0005] 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.
[0006] It is also noted that during surgery, a surgeon may want to
apply a clip to tissue, yet still leave a gap between the legs of
the clip to allow passage of a blood vessel therethrough, thereby
allowing blood to flow through the vessel unobstructed. When a
surgeon partially squeezes the trigger, the jaws are partially
closed and the clip 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 as to
when the clip applying device is in the cholangio zone. It is
further desirable to alert the surgeon as to when the clip applying
device is in fully squeezed position.
[0007] However, while certain prior art clip appliers provide an
audible and/or tactile indication as to when the trigger is fully
squeezed, such prior art clip appliers do not provide any
indication as to when a clip-applying device is in the cholangio
zone. Further such prior art clip appliers do not provide any
visual indication as to when the trigger is fully squeezed.
Therefore, a need has arisen for a clip applier that adequately
alert the surgeon as to when the trigger is in the cholangio zone
and/or when the trigger is fully squeezed.
SUMMARY OF THE INVENTION
[0008] A non-limiting embodiment of the present invention provides
an indicating system for a clip applying device, the clip applying
device having a squeezable trigger, a barrel having a plurality of
serially-installed clips therein, and a pair of jaws operatively
connected to the trigger and configured to crimp a clip of the
plurality of serially-installed clips, the system including an
indicator operatively connected to the trigger. The indicator
provides a first signal when the trigger is moved to a first
position to operate the jaws to partially crimp the clip, and the
indicator provides a second signal when the trigger is moved to a
second position to operate the jaws to generally fully crimp the
clip.
[0009] In an aspect of the invention the first signal and the
second signal may each be visual signals. In a further aspect,
wherein the first signal and the second signal may each be audible
signals, and in another aspect the first signal and the second
signal may each be tactile signals.
[0010] Additionally, the indicator may provide a third visual
signal when the trigger is at an unsqueezed position.
[0011] In an additional aspect the system may also have a window
located in the clip applying device, wherein the indicator includes
a first region on which the first signal is displayed, and a second
region on which the second signal is displayed, when the trigger is
moved to the first position, the first region is moved within the
window, and when the trigger is moved to the second position, the
second region is moved within the window.
[0012] Also, the clip applying device may further include a bearing
disposed about the barrel and operatively connected to the trigger,
the bearing configured to slide along a bearing path generally
parallel to a longitudinal axis of the barrel, and the bearing
allows for movement of the indicator along an indicator path when
the trigger is squeezed.
[0013] In a further aspect, the system may have a trip switch
pivotably disposed within the clip applying device, the trip switch
having a first end and a second end, wherein the indicator is urged
to move in along the indicator path in a first direction by an
indicator spring, the first end of the trip switch is configured to
engage and prevent the indicator from moving in the first direction
to move the first region within the window, when the trigger is
moved to the first position, and the bearing is configured to
engage the second end of the trip switch to pivot and remove the
trip switch from engagement with the indicator, to move the second
region within the window, when the trigger is moved from the first
position to the second position.
[0014] Also, the indicator may include a first ratchet connected to
the trigger, a first pawl configured to sequentially engage a first
tooth and a second tooth of the first ratchet, wherein the first
signal is emitted when the trigger is moved to the first position
such that the first pawl engages the first tooth, and the second
signal is emitted when the trigger is moved to the second position
such that the first pawl engages the second tooth.
[0015] Further, the indicator may include a second ratchet
connected to the trigger, a second pawl configured to engage the
second ratchet such that a third audible signal is emitted, when
the trigger is moved from an unsqueezed position to the first
position.
[0016] The indicator may additionally include a first spring
configured to urge the first pawl to engage the first ratchet, and
a second spring configured to urge the second pawl to engage the
second ratchet, the first and second springs having different
spring forces such that the third audible signal is different from
at least one of the first or the second audible signals.
[0017] The indicator may yet further have a first ratchet connected
to the trigger, a first pawl configured to sequentially engage a
first tooth and a second tooth of the first ratchet, wherein the
first signal is produced when the trigger is moved to the first
position such that the first pawl engages the first tooth, and the
second signal is produced when the trigger is moved to the second
position such that the first pawl engages the second tooth.
[0018] Further yet, the indicator may have a second ratchet
connected to the trigger, a second pawl configured to engage the
second ratchet such that a third tactile signal is emitted, when
the trigger is moved from an unsqueezed position to the first
position. Still yet, the indicator may have a first spring
configured to urge the first pawl to engage the first ratchet, and
a second spring configured to urge the second pawl to engage the
second ratchet, the first and second springs having different
spring forces such that the third tactile signal is different from
at least one of the first or the second tactile signals.
[0019] Another feature may provide an indicating system for a clip
applying device, the clip applying device having a squeezable
trigger, a barrel having a plurality of serially-installed clips
therein, and a pair of jaws operatively connected to the trigger
and configured to crimp a clip of the plurality of
serially-installed clips, the system including an indicator
operatively connected to the trigger, wherein the indicator
provides a signal when the trigger is moved to a first position to
operate the jaws to partially crimp the clip.
[0020] A further feature may provide a medical instrument having a
squeezable trigger, a barrel having configured to house a plurality
of serially-installed clips therein, a pair of jaws operatively
connected to the trigger and configured to crimp a clip of the
plurality of serially-installed clips, and an indicator operatively
connected to the trigger, wherein the indicator provides a signal
when the trigger is moved to a first position to operate the jaws
to partially crimp the clip. Also, the signal of the instrument may
be audible, visual and/or tactile.
[0021] The instrument may further have a window, and a region on
which the signal is displayed when the trigger is moved to the
first position, the region is moved within the window.
[0022] In another aspect, the instrument may include a ratchet
connected to the trigger, and a pawl configured to engage a tooth
of the ratchet, wherein the signal is emitted when the trigger is
moved to the first position such that the pawl engages the
tooth.
[0023] Another feature provides a method for indicating when a clip
of a clip applying device is partially crimped, the clip applying
device having a squeezable trigger, a barrel having a plurality of
serially-installed clips therein, and a pair of jaws operatively
connected to the trigger and configured to crimp a clip of the
plurality of serially-installed clips, and an indicator operatively
connected to the trigger. The method may include squeezing the
trigger to a first position such that the indicator is moved to
provide a signal when the jaws have partially crimped the clip.
Also, the signal of the method may be visual, audible and/or
tactile. The method may also include moving a region of the
indicator within the window.
[0024] Also, the device may further include a ratchet connected to
the trigger, and a pawl, and squeezing may further include engaging
the pawl with a tooth of the ratchet to emit the signal.
[0025] Other exemplary embodiments and advantages of the present
invention may be ascertained by reviewing the present disclosure
and the accompanying drawings, and the above description should not
be considered to limit the scope of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] 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:
[0027] 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;
[0028] FIG. 2 is a bottom plan view of a distal end of the medical
clip applying device, showing a medium-large clip inserted
therein;
[0029] FIG. 3 is a bottom plan view of a distal end of the medical
clip applying device, showing a large clip inserted therein;
[0030] FIG. 4 is a perspective view of a medium-large clip supply
cartridge for use with an embodiment of the present invention;
[0031] FIG. 5 is a perspective view of a large clip supply
cartridge for use with an embodiment of the present invention;
[0032] 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;
[0033] 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;
[0034] 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;
[0035] 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;
[0036] FIG. 10 is a perspective view of a jaw assembly and cinch of
an embodiment of the present invention;
[0037] FIG. 11 is a perspective view of the underside of a jaw
assembly of an embodiment of the present invention;
[0038] FIG. 12 is an enlarged sectional view of a handle grip
assembly of an embodiment of the present invention;
[0039] FIG. 13 is a perspective view of the underside of a cinch of
an embodiment of the present invention;
[0040] FIG. 14 is a perspective view of the underside of the cinch
in an intermediate position;
[0041] FIG. 15 is a plan view of the underside of the cinch of an
embodiment of the present invention, in a proximal position;
[0042] FIG. 16 is a top plan view of the of the cinch of an
embodiment of the present invention, in the proximal position;
[0043] 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;
[0044] 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;
[0045] FIG. 19 is an isometric view of the jaw assembly of an
embodiment of the present invention;
[0046] FIG. 20 is an upper isometric view of the cinch of an
embodiment of the present invention;
[0047] FIG. 21 is a lower isometric view of the cinch of an
embodiment of the present invention;
[0048] FIG. 22 is a side elevational view of the jaw assembly;
[0049] FIG. 23 is a perspective view of a cartridge alignment
device of an embodiment of the present invention;
[0050] FIG. 24 is a frontal view of the cartridge alignment device
of an embodiment of the present invention;
[0051] FIG. 25 is another perspective view of the cartridge
alignment device of an embodiment of the present invention;
[0052] FIG. 26 is a bottom perspective view of the cartridge
alignment device of an embodiment of the present invention;
[0053] FIG. 27 is a perspective, sectional view of a slider of an
embodiment of the present invention;
[0054] FIG. 28 is a front cross-sectional view of the elongated
tube taken along the lines of 28-28 in FIG. 6;
[0055] FIG. 29 is a sectional view of a slider toggle in an upright
position;
[0056] FIG. 30 is an enlarged sectional view of the slider toggle
shown in FIG. 29;
[0057] FIG. 31 is a sectional view of the slider toggle in a
lowered position;
[0058] FIG. 32 is an enlarged sectional view of the slider shown in
FIG. 31;
[0059] FIG. 33 is a bottom plan view of the slider;
[0060] FIG. 34 is a top plan view of the slider;
[0061] FIG. 35 is a perspective view of the underside of the
slider;
[0062] FIG. 36 is a perspective view of the top of the slider;
[0063] FIG. 37 is a bottom plan view of the slider attached to an
underside of a spine and in a distally-moved position;
[0064] FIG. 38 is a bottom perspective view of the slider attached
to an underside of a spine and in a distally-moved position;
[0065] FIG. 39 is a bottom perspective view of the slider attached
to an underside of a spine and in a proximally-moved position;
[0066] 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;
[0067] FIG. 41 is a plan view of an uncrimped clip for use in an
embodiment of the present invention;
[0068] FIG. 42 is a plan view of a partially crimped clip for use
in an embodiment of the present invention;
[0069] FIG. 43 is a plan view of a generally fully crimped clip for
use in an embodiment of the present invention;
[0070] 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
[0071] FIG. 45 is an enlarged perspective sectional view of an
indicating arrangement according to an embodiment of the present
invention in a generally fully-crimped position.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0072] 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.
[0073] Referring to the drawings, wherein like characters represent
like elements, FIG. 1 shows a clip applying device 50 for applying
medical tissue-pinching clips 52a, 52b 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 64P. By releasing the squeezed trigger 64 away from a housing
portion 66 of the handle grip assembly 62, a clip 52a (shown in
FIG. 2), 52b (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 68a (shown in FIG. 4),
68b (shown in FIG. 5), disposed through the elongated channel 58.
The elongated clip supply cartridge 68a, 68b 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.
[0074] 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 52a, 52b has been
crimped, and also provides a proximally-directed bias against the
distal bearing 74.
[0075] 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.
The 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.
[0076] 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, and 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. Thus, the
proximal bearing 76 is biased distally by the compression spring
via the trigger linkage 98.
[0077] 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 68a, 68b 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. As the
trigger 64 is squeezed (i.e., as the trigger is moved toward the
housing portion 66 and pivoted about pivot shaft 64P), 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 52a', 52b' of the plurality of clips
that are serially loaded in respective clip cartridges 68a, 68b, in
order to prepare (upon release of the trigger) to load the
distalmost clip 52a', 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.
[0078] The trigger 64 is biased toward the unsqueezed position by
the compression spring 78 (shown in FIG. 1). Upon release of the
trigger 64, 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 52a', 52b' 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 52a', 52b' within the cartridge 68a,
68b.
[0079] 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 a clip cartridge 68a containing a series of
medium-large sized clips 52a, and can also accept a clip cartridge
68b containing a series of large-sized clips 52b. 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 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.
[0080] Referring to FIGS. 6-9, when the clip applying device 50 is
loaded with a cartridge 68a, 68b, there is a predetermined distance
Da, Db between the proximal bearing 76 and distal bearing 74, this
distance being determined by a stop key 13 located in the enclosure
barrel 72.
[0081] When the clip cartridge 68b 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
68b by pivoting action of the stop key (shown in FIGS. 8-9). When
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 13a of the
stop key 13, and the proximal bearing 76 contacting a first
proximal face 13b of the stop key.
[0082] When the clip cartridge 68a 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
68a (shown in FIG. 4) does not have a stop keyhole for the lowering
of the stop key 13 therein. Thus, when 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 13c of the stop key 13, and the proximal
bearing 76 contacting a second proximal face 13d 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.
[0083] Additionally, due to the configuration of the face surfaces
13a-d of the stop key, when the cartridge 68a is inserted into the
clip applying device 50, the proximal bearing 76 and distal bearing
are both located more distally than when the cartridge 68b is
inserted into the clip applying device. Thus (as shown in FIG.
2-3), when the cartridge 68a is inserted into the clip applying
device 50, the cinch is advanced in the distal direction to narrow
the jaws to a width Wa, and when the cartridge 68b is inserted into
the clip applying device 50, the cinch 86 is advanced (a lesser
amount than when the cartridge 68a 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 68a 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 68b is inserted into the clip applying device. As
described further hereinbelow, 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 56W is located.
Thus, the more the cinch 86 is advanced distally toward the maximum
width portion 56W, the narrower the width between the jaws. In this
way (shown in FIG. 2), the narrower width Wa allows the jaws 56 to
securely accommodate medium-large clips 52a in the guide slots
194.
[0084] Similarly (shown in FIG. 3), when the cartridge 68b is
inserted into the clip applying device 50, since the cinch 86 is
advanced a lesser amount than when the cartridge 68a is inserted,
the jaws are opened wider to width Wb to allow the jaws 56 to
securely accommodate large clips 52b in the guide slots 194, which
may have a width larger than smaller clips (e.g., medium-large
clips 52a).
[0085] Further (as shown in FIG. 2-3), when the cartridge 68a is
inserted into the clip applying device 50, the feeder 90 is
advanced to the proper position to load the clip 52a, and when the
cartridge 68b is inserted into the clip applying device 50, the
feeder 90 is advanced (a lesser amount than when the cartridge 68a
is inserted) to properly load the larger clip 52b. In other words,
when the cartridge 68b is inserted, the feeder 90 does not distally
advance as much as when the cartridge 68a is inserted, because the
feeder must be further back to accommodate the larger clip 52b
(shown in FIG. 3), which may have a longer length than smaller
clips (e.g., medium-large clips 52a).
[0086] In the above-described embodiment, 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. 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.
[0087] It is noted that in a non-limiting embodiment, either or
both cartridges 68a, 68b may contain safety keyholes 77a and 77b
(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 68a, 68b 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.
[0088] It is also noted that in a non-limiting embodiment, the
trigger 64 may be squeezed to allow the insertion of the cartridge
68a, 68b and/or to crimp a clip 52a, 52b; however, it should be
appreciated that in alternative embodiments, other structure may be
used (e.g., a separate or integral tab, button, lever or switch),
which may be activated to allow the cartridge 68a, 68b to be
inserted (and/or to crimp a clip 52a 52b), such that the position
in the axial direction X of the proximal bearing 76 or the distal
bearing 74 may be determined.
[0089] 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 movement, or movement in the
radial direction. Because the clip applying device 50 is able to
accept two different types of clip cartridges 68a, 68b, 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.
[0090] 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 156a, 156b, 156c, 156d, 156e,
156f 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 156e and outer engagement surfaces 156f of the
jaw arms. In a non-limiting embodiment, the inner and outer
engagement surfaces 156e, 156f, as well as the control fingers 30,
may be tapered or angled.
[0091] FIG. 14 shows the cinch 86 in an intermediate position,
where the control fingers 30 are intermediate the respective inner
engagement surfaces 156e and outer engagement surfaces 156f. In
this position (in a non-limiting embodiment), medium-large clips
52a 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).
[0092] When the cinch is moved proximally in the axial direction X
from the intermediate position, outer control surfaces 30e of the
control fingers 30 respectively engage the inner engagement
surfaces 156e to widen the gap between the jaws 56 (e.g., to a
width Wb, in order to accommodate cartridge 68b containing large
sized clips 52b), while inner control surfaces 30f of the control
fingers are brought out of contact with respective outer engagement
surfaces 156f, as shown in FIGS. 15 and 17. Conversely, when the
cinch is moved distally from a proximalmost position toward the
intermediate position, the outer control surfaces 30e of the
control fingers respectively slide along the inner engagement
surfaces 156e to gradually (due to the angled configuration) let
the jaw arms 256 bias themselves inward.
[0093] Similarly, when the cinch is moved distally in the axial
direction X from the intermediate position, inner control surfaces
30f of the control fingers 30 respectively engage the inner
engagement surfaces 156e to narrow the gap between the jaws 56
(e.g., to a width Wa, to accommodate cartridge 68a containing
medium-large sized clips 52a, or to begin a clip-crimping
operation), while outer control surfaces 30e of the control fingers
are brought out of contact with respective outer engagement
surfaces 156e, as shown in FIGS. 15 and 17. In a non-limiting
embodiment, in order to ensure smooth transfer of control
throughout the range of movement of the cinch 86, the control
fingers 30 are preferably always in contact with at least one of
the inner or outer engagement surfaces 156e, 156f (as shown in FIG.
14).
[0094] FIG. 18 shows the cinch 86 in a fully distal position in
which a clip 52a, 52b may be fully crimped closed. In a
non-limiting embodiment, 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 156d
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. when the cinch moves proximally along axial
direction X) from the closed jaw position. For example, when the
cinch 86 begins to open from the closed jaw position (shown in FIG.
18), a proximal facing surface 32d of the central block 32 engages
the second inner engagement surfaces 156d commence an opening
operation of the jaws. After the cinch 86 moves proximally partway
along the axial direction X toward the intermediate position,
control of the opening of the jaws 56 is "handed off" to the inner
control surfaces 30f of the control fingers 30, which respectively
slide along the outer engagement surfaces 156f to gradually (due to
the angled configuration) provide for outward movement of the jaw
arms 256 (in direction Z). Although 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.
[0095] In a non-limiting embodiment, 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 156a-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. With such a
configuration it may not be necessary for the jaw assembly 156 to
remain at rest in the intermediate position. Additionally, since
the control fingers 30 protrude inwardly, a gap or channel G may be
present between the control finger 30 and the ceiling 82c of the
cinch 82. A portion of each jaw arm 256 may then be sandwiched
between a respective control finger 30 and the ceiling 82c 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.
[0096] In FIGS. 2 and 10, 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. As shown in FIG. 10, in a non-limiting embodiment, 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.
[0097] 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.
[0098] As described above, the clip applying device 50 of the
present invention is able to accept at least two different types of
clip cartridges 68a, 68b, 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 68a, 68b
within the elongated tube 60 in a width, or radial direction Z of
the cartridges. In other words, the alignment device 36 can
maintain the loaded cartridges 68a and 68b 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 68a, 68b is substantially coplanar with a
sagittal plane X-Y that bisects the elongated tube. With such an
arrangement, the clip cartridge 68a, 68b can be centered within the
elongated tube and the clip cartridge 68a, 68b and the elongated
tube, are aligned in the axial direction X (i.e., along the central
axis CX). Thus, a clip 52a, 52b can be accurately loaded in the
jaws 56 and accurately crimped thereby.
[0099] 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 38a defining a first channel Ca therebetween, a
middle (second) region 38b defining a second channel Cb
therebetween, and a proximal (third) region 38c 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 of transition
areas 38t (each located between a respective distal region 38a and
middle region 38b) which may be tapered or angled to accurately
guide the insertion of cartridge 68a into the distal channel Ca,
where the cartridge 68a is securely held and centrally aligned
therein in the radial direction Z (i.e., cartridge 68a is
sandwiched between both distal regions 38a), due to the extending
of the distal channel Ca in the axial direction X. In situations
where the cartridge 68b is wider in radial direction Z than the
cartridge 68a, the cartridge 68b cannot fit within the distal
channel 68a. Rather, the transition area blocks the cartridge 68b
from being inserted (in the axial direction X) in the distal
channel 68a, and also prevents damage to the cartridge 68b during
the insertion process. Thus, the cartridge 68b is securely held and
centrally aligned in the channel Cb in the radial direction Z
(i.e., the cartridge 68b is sandwiched between both middle regions
38b), due to the extension of the middle channel Cb in the axial
direction X.
[0100] The proximal channel Cc is configured to hold the elongated
channel member 58 (through which the cartridge 68a, 68b is
inserted), which is inserted therein during the
manufacturing/assembly process. Thus, 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 38c), due to
the extension of the middle channel Cb in the axial direction X.
Additionally, the alignment device 36 also includes a stop region
36s 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 68a, 68b into their respective channels
Ca, Cb.
[0101] 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 52a,
52b (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 52a, 52b
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. Further,
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.
[0102] 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 68a, 68b 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 33a, 33b (respectively shown in FIGS.
4-5) slidably arranged within a respective clip cartridge 68a, 68b.
The ladder member 33a, 33b, 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 52a'', 52b'' in the cartridge 68a, 68b, so as to also push
distally the next adjacent clip(s) 52a, 52b within that cartridge
68a, 68b. Forward (or distal) advance of the series of clips 52a,
52b loaded within the cartridge 68 is thus effected.
[0103] As shown in FIGS. 27 and 29-36, 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). Thus, the toggle is pivotable about the Z axis. As
best shown in FIGS. 33-36, 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. Alternatively, the pivot shaft may have elongated
shaft ends, rivets and the like to prevent such sliding out of the
slider 12.
[0104] 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. The toggle 14 has a ridge 14a
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 14a to bias the toggle in an upright (second) position,
shown in FIGS. 30-31 and 36. In a non-limiting embodiment and as
shown in FIG. 28, 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 58C1 in the
bottom portion thereof, through which a portion of the toggle 14 is
inserted, when the toggle is in the upright position.
[0105] Operation of the clip advancement arrangement according to
an embodiment of the present invention will now be described. 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 14b of the toggle 14 engages an edge 58e of the channel 58,
such that the channel edge 58e (which generally extends in the Z
axis direction) pushes the toggle 14 to rotate in a first direction
(e.g., counterclockwise when viewing FIGS. 31-32) to a lowered
(first) position and against the biasing force of the toggle spring
16, shown in FIGS. 31-32. In the first position, the toggle 14
slides in the axial direction X and below the channel 58, with at
least a portion of the edge-engaging face 14b contacting the
underside of the channel 58. It is noted that the channel edge 58e
may be angled or tapered to increase the surface area thereof,
thereby ensuring smooth and precise pivoting action of the toggle
14.
[0106] When the trigger 64 is released, the slider 12 begins to
distally move in the axial direction X. The edge-engaging face 14b
contacts the underside of the channel 58 until the toggle 14
reaches the toggle aperture 58C1, at which point the edge-engaging
face 14b contacts the channel edge 58e and allows the toggle spring
16 to urge the toggle into the upright position (shown in FIGS.
30-31 and 36) and between rungs 33aR, 33bR of the ladder member
33a, 33b, the rungs having rung gaps 33aG, 33bG therebetween. Thus,
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 14d engages a stop portion 18 located
on the slider 12.
[0107] Once in the upright position, the toggle 14 continues to
move distally through the toggle aperture 58C1 (and within a rung
gap 33aG, 33bG) in the axial direction X such that a pushing face
14c contacts a rear (proximal) side of a rung 33aR, 33bR of the
ladder member 33a, 33b. Thus, the toggle 14 pushes the ladder
member 33a, 33b in the distal direction (along axial direction X)
to in turn push against the proximalmost or last clip 52a'', 52b''
in the cartridge 68a, 68b to also push distally the next adjacent
clip(s) 52a, 52b. It is noted that while the rungs 33aR, 33bR of
the figures extend in the Z axis direction, those skilled in the
art will readily appreciate that the rungs could be differently
configured in alternative embodiments, including but not limited
to, e.g., angled and arcuate.
[0108] The above process may be repeated by continually squeezing
and releasing the trigger 64, which in turn continually distally
advances the ladder member 33a, 33b to distally push clips 52a and
52b, until the last clip 52a'', 52b'' is loaded into and applied by
the jaws 56.
[0109] 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 of clip
supply cartridge 68a, 68b, it should be readily understood by those
skilled in the art that the clip advancement arrangement of present
invention may be used in a clip applying device that can accept
only a single type of cartridge, or alternatively, may be used in a
clip applying device having clips pre-installed therein.
[0110] FIG. 37 shows a trigger lockout arrangement 11. As described
above, 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 52a'', 52b''
of the cartridge 68a, 68b 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.
[0111] Also as discussed above, when the trigger 64 is squeezed,
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 33a,
33b by one clip and such that the feeder 90 loads the distalmost
clip 52a', 52b' between the jaws 56.
[0112] 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 58C2, located above the block 91
in the Y-axis direction, for accepting insertion of at least a
portion of the block 91 therein. At rest, 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. While 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.
[0113] Specifically, as shown in FIG. 38, when the trigger 64 is
squeezed and the slider 12 moves proximally in the axial direction
X (to approach the block 91 from the front, shown in FIGS. 37-38),
a rear surface 93a of the tooth 93 engages a front surface 91a of
the block 91 to move the block in radial direction Z while the
slider continues to move proximally. The rear surface 93a of the
tooth 93 is angled to facilitate movement of the block 91 in the
radial direction Z. Once the slider 12 passes the block 91, the
block returns to its original rest position due to the biasing
action of the rod 92.
[0114] 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 68a, 68b having a
plurality of clips 52a, 52b has been loaded into the clip applier
50, the slider moves distally such that a front surface 93b (best
shown in FIG. 38) of the tooth 93 engages a rear surface 91b of the
block 91 to push the block upward in the Y-axis direction (i.e.,
into the page of FIG. 37). Specifically, the upward movement of the
block 91 causes a portion of the block to pass through the block
aperture 58C2 of the channel 58 and be inserted between the rungs
33aR, 33bR of the ladder member 33a, 33b (i.e., the portion of the
block is inserted into a rung gap 33aG, 33bG), thereby creating
clearance for the tooth 93 to pass over the block 91 as the slider
continues to move in the distal direction. Once the tooth 93 has
passed over the block 91, 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 33aG, 33bG.
[0115] To facilitate precise movement of the block 91 in the Y-axis
direction, the front surface 93b of the tooth 93 and/or the rear
surface 91 b of the block 91 may be angled. Additionally, 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 presence of the block 91
between the rungs 33aR, 33bR of the ladder member 33a, 33b does not
interfere with the distal movement of the ladder member by the
toggle, since these two operations are out of phase, i.e., during
distal movement of the slider 12, the toggle 14 does not engage a
rung 33aR, 33bR until after the tooth 93 has passed over the block
91 and the block has withdrawn from the ladder gap 33aG, 33bG.
[0116] As described above, the slider may be continually moved
proximally and distally by respective continual squeezing and
releasing of the trigger 64, until the last clip 52a'', 52b'' is
loaded into and applied by the jaws 56. While the last clip 52a'',
52b'' is being loaded into the jaws 56 by the feeder 90 (and thus
no more clips 52a, 52b are serially loaded within the cartridge
68a, 68b), the toggle 14 engages the rung 33aR, 33bR, thereby
advancing the ladder member 33a, 33b a final time and exposing a
solid surface 96 of the ladder member beneath the block aperture
58C2 (i.e., there is no longer a ladder gap 33a G, 33b G beneath
the block 91). The clip applying device 50 is now ready for one
final clip crimping process. During the 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 52a'', 52b''.
[0117] As shown in FIG. 40, when the trigger 64 is released after
the last clip 52a'', 52b'' has been crimped, 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. However, the solid surface 96 of the ladder member
33a, 33b prevents displacement of the block 91 by the tooth 93 in
the Y-axis direction (since there is no ladder gap 33aG, 33bG for
the block to enter. Thus, 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 52a'', 52b'' has been applied. As noted above,
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. It is noted, however, that the trigger 64 is permitted
to be slightly unsqueezed so that the last clip 52a'', 52b'' and
any tissue can be released from the jaws 56. Once the cartridge
68a, 68b has been removed from the clip applying device 50, the
trigger 64 is free to again move to the unsqueezed position, since
the solid surface 96 is no longer present.
[0118] An embodiment of the present invention uses cartridges 68a,
68b having twenty clips 52a, 52b, however, it should be understood
by those skilled in the art that the present invention may use
cartridges having fewer or greater than twenty clips. Additionally,
while an embodiment of the trigger lockout arrangement 11 of the
present invention locks the trigger 64 after all of the clips 52a,
52b 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 52a, 52b remains in the cartridge 68a, 68b
or the clip applying device 50.
[0119] 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 of clip
supply cartridge 68a, 68b, it should be readily understood by those
skilled in the art that the trigger lockout arrangement of present
invention may be used in a clip applying device that can accept
only a single type of cartridge, or alternatively, may be used in a
clip applying device having clips pre-installed therein.
[0120] Another feature of an embodiment of the present invention
includes a system for indicating to the surgeon when the clip 52a,
52b has been partially crimped (shown in FIG. 42) and/or when the
clip 52a, 52b has been generally fully crimped (shown in FIG. 43).
FIG. 41 shows an uncrimped clip. During surgery, a surgeon may want
to apply a clip 52a, 52b, yet still leave a gap between the legs of
the clip to allow passage of a blood vessel therethrough, thereby
allowing blood to flow through the vessel unobstructed. When a
surgeon partially squeezes the trigger 64, the jaws 56 are only
partially closed and the clip 52a, 52b may thus be applied in a
partially crimped configuration. This partially-squeezed (or first)
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 a generally fully squeezed (or second) position (shown
in FIG. 45).
[0121] 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.
[0122] The visual slider 102 includes three indicator regions 102a,
102b, 102c, each having different indicia for indicating the
position of the trigger, for example, the color, pattern or wording
on each region may be different. Each region 102a, 102b, 102c is
alternatively visible through a window 111 located in the top of
the grip assembly. As a non limiting example, indicator region 102a
(indicating the open trigger position) may be green, indicator
region 102b (indicating the cholangio zone) may be yellow, and
indicator region 102c (indicating a generally fully-squeezed
position) may be red. Alternatively, each indicator region 102a,
102b, 102c may show, e.g., different wording (e.g., "open,"
"partial," "closed"), a different symbol, or a different pattern.
It should be understood by those skilled in the art that "generally
fully squeezed" means that in certain configurations, the trigger
64 need not be completely squeezed against the housing portion 66
to generally fully crimp the clip. Additionally, it should be
understood that a "generally fully" crimped clip 52a, 52b need not
be completely crimped closed, since a small gap may be present
between the legs of the clip (although this small gap is smaller
than the gap created when the clip is partially crimped).
[0123] In the unsqueezed position (shown in FIG. 1), a first
abutment surface 102d of the visual slider 102 abuts against a
first end 112a 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 102a
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 112b of the trip
switch 112 engages an outer surface of the distal bearing to
prevent further counterclockwise pivoting of the trip switch.
[0124] 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 102d with the
first end 112a of the trip switch 112) until an angled distal
surface of a distal bearing ring 108 engages the second end 112b of
the trip switch to pivot the trip switch clockwise (when viewed in
FIG. 1), which disengages the first abutment surface 102d from the
first end 112a 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 112a of the trip
switch 112 engages a second abutment surface 102d of the visual
slider 102 to stop proximal movement of the visual slider and
exposing the indicator region 102b through the window 111
(indicating the cholangio zone to the surgeon), as shown in FIGS.
12 and 44.
[0125] 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 the clip 52a, 52b), the outer circumference of the distal
bearing ring 108 further engages the second end 112b of the trip
switch 112 to further pivot the trip switch clockwise, which
disengages the second abutment surface 102d from the first end 112a
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 regionl 102c through the window 111
(indicating the generally fully squeezed position to the surgeon),
as shown in FIG. 45.
[0126] 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 the distal bearing ring
108 engages an indicator finger 102d to proximally move the visual
slider 102 so that the first abutment surface 102d of the visual
slider 102 again abuts against a first end 112a of the trip switch
112 to reset the visual slider in its distalmost position (thereby
again exposing the indicator region 102a through the window 111),
as shown in FIG. 1.
[0127] 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 120a, 120b, 120c, only two
indicator regions 120a, 120b, 120c (rather then three as shown in
the figures), or more than three indicator regions, to singly
indicate, or 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/or (c)
that the clip applying device is generally fully squeezed. For
example, a single indicator region 120a, 120b, 120c may be present
to indicate that the clip applying device is generally fully
squeezed.
[0128] 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.
[0129] As shown in FIGS. 12 and 45, 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 64P.
Additionally, an upper (first) pawl 124 and a lower (second) pawl
126 are pivotably affixed about a proximal paddle shaft 25P, about
which the proximal paddle 25 is also affixed. Additionally, the
upper pawl 124 is biased to pivot counterclockwise (when viewed in
FIG. 12) by an upper spring 128, and 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.
[0130] When the trigger is squeezed from the unsqueezed position
toward the cholangio zone, 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 64P (when
viewed in FIG. 12), while indicator region 102a is displayed in the
window 111. Once the cholangio zone is entered (and at
substantially the same time the window 111 displays indicator
region 102b), the upper ratchet 120 and lower ratchet 122 continue
to pivot counterclockwise so that the upper ratchet engages the
upper 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 the upper ratchet 120 to enter a
first channel (cholangio channel) 120a 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
120a 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. Additionally or alternatively, 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.
[0131] When the trigger 64 moves from the cholangio zone to the
generally fully squeezed position (and at substantially the same
time the window 111 displays indicator region 102c), the upper
ratchet 120 and lower ratchet 122 continue to pivot
counterclockwise such that the upper pawl moves from the cholangio
channel 120a to a generally fully squeezed channel 120b, to emit
the distinct sound and transmit the distinct tactile sensation. It
is noted that the two distinct sounds and sensations (i.e., of the
upper pawl 124 engaging the upper ratchet 120) can be made
different by differing the dimensions and/or material of the
cholangio channel 120a and the generally fully squeezed channel
120b. It is further noted that in alternative embodiments, the
generally fully squeezed channel 120b may be eliminated, thereby
alerting the surgeon only to when the clip applying device 50 is in
the cholangio zone.
[0132] 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.
[0133] 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 of clip
supply cartridge 68a, 68b, it should be readily understood by those
skilled in the art that the indicating arrangement of present
invention may be used in a clip applying device that can accept
only a single type of cartridge, or alternatively, may be used in a
clip applying device having clips pre-installed therein.
[0134] 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.
* * * * *