U.S. patent application number 12/987522 was filed with the patent office on 2011-05-12 for surgical compression clips.
This patent application is currently assigned to NITI SURGICAL SOLUTIONS LTD.. Invention is credited to MICHAEL ARAD, AMOL BAPAYE, ALEX GELLER, KOBBY GREENBERG, BOAZ HARARI, DORON KOPELMAN, SHLOMO LELCUK, SHAHAR MILLIS, LEONID MONASSEVITCH, AMIR PERLE, DROR ROSNER, BOAZ SHENHAV, AMIR SZOLD.
Application Number | 20110112559 12/987522 |
Document ID | / |
Family ID | 38475255 |
Filed Date | 2011-05-12 |
United States Patent
Application |
20110112559 |
Kind Code |
A1 |
MONASSEVITCH; LEONID ; et
al. |
May 12, 2011 |
SURGICAL COMPRESSION CLIPS
Abstract
A surgical clip assembly which includes a pair of generally
linear compression elements for securing tissue between them and
for applying to the secured tissue a compression force. The clip
assembly has an initial, open position in which the linear
compression elements may be positioned about tissue to be secured
between them. The assembly also has a final, closed position where
the compression elements are substantially parallel to each other,
applying a compressive force to the secured tissue. The clip
assembly also includes a force means disposed between the pair of
compression elements and operative to transmit operational forces
between them.
Inventors: |
MONASSEVITCH; LEONID;
(HADERA, IL) ; SHENHAV; BOAZ; (TEL AVIV, IL)
; HARARI; BOAZ; (GANEY TIKVAH, IL) ; PERLE;
AMIR; (Haifa, IL) ; ARAD; MICHAEL; (Tel Aviv,
IL) ; MILLIS; SHAHAR; (PARDES HANNA, IL) ;
GREENBERG; KOBBY; (EVEN YEHUDA, IL) ; GELLER;
ALEX; (Kfar Saba, IL) ; SZOLD; AMIR; (Tel
Aviv, IL) ; LELCUK; SHLOMO; (Savion, IL) ;
KOPELMAN; DORON; (Caesarea, IL) ; BAPAYE; AMOL;
(Kophrud, IN) ; ROSNER; DROR; (Holon, IL) |
Assignee: |
NITI SURGICAL SOLUTIONS
LTD.
NETANYA
IL
|
Family ID: |
38475255 |
Appl. No.: |
12/987522 |
Filed: |
January 10, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11647913 |
Dec 29, 2006 |
7892244 |
|
|
12987522 |
|
|
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|
60780446 |
Mar 9, 2006 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 2017/0641 20130101;
A61B 2017/308 20130101; A61B 17/12 20130101; A61B 2017/00867
20130101; A61B 17/0643 20130101; A61B 17/1285 20130101; A61B 1/0014
20130101; A61B 17/1227 20130101; A61B 17/122 20130101; A61B 17/068
20130101; A61B 2017/00871 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1-31. (canceled)
32. A surgical clip assembly (70) which comprises: a pair of
generally linear compression elements (72, 74) for securing tissue
therebetween and for applying to the secured tissue a compression
force, each compression element having a first end portion and a
second end portion, wherein said clip assembly has an initial, open
position in which said linear compression elements may be
positioned about tissue to be secured therebetween, and a final,
closed position whereat said compression elements are substantially
parallel to each other, thereby to apply a compressive force to the
secured tissue; and a first and second force means (86, 80) said
first force mean being an active hinge member (86) disposed
between, and in mechanical communication with, said first end
portions of said pair of compression elements (72, 74) and
operative to transmit operational forces therebetween, wherein when
said clip assembly (70) is in its open position, said linear
compression elements (72, 74) form a jaw-like arrangement with said
second end portions of said linear compression elements (72, 74)
spaced apart so as to permit positioning of said compression
elements (72, 74) about tissue to be secured therebetween.
33. A surgical clip assembly (70) according to claim 32 wherein
said second force means (80) is a selectably movable latch member
(80) positioned within a first of said two compression elements
(74) selectably movable to engage an engagement means (182) on said
second compression element (72).
34. A surgical clip assembly (70) according to claim 33, wherein
said selectably movable latch member (80) positioned within a first
of said two compression elements (74) extends past its second end
portion, said engagement means (182) positioned on said second end
portion of said second compression element (72) engages and holds
said latch member (80) in force producing engagement when said pair
of compression elements (72, 74) are brought close to each
other.
35. A surgical clip assembly (70) according to claim 33, further
including a wire (90) extending between said second end portion of
each of said two compression elements (72, 74), said wire (90)
releasably connected to said latch member (80) said wire operative
to prevent tissue to be compressed from moving out from between
said pair of compression elements (72, 74) while said assembly (70)
is brought to its closed position.
36. A surgical clip assembly (70) according to claim 35 wherein
said wire having an extension extending via said second end portion
of said second compression element (72) through said first
compression element (74), said extension operative to draw said
wire (90) taut when tissue is positioned between said two
compression elements, said taut wire (90) thereby preventing the
tissue from moving out from between said pair of compression
elements (72, 74) while said clip assembly (70) is brought to its
closed position.
37. A surgical clip assembly (70) according to claim 32, wherein at
least one of said two force means (86, 80) is formed of a shape
memory material.
38. A surgical clip assembly according to claim 32, wherein said
active hinge member (86) is fixably connected to said first end
portions of said linear compression elements.
39. A surgical clip assembly (70) according to claim 32, said clip
assembly (70) for use with a clip applier (105) having an
attachment element (93), said clip assembly (70) further comprising
at least one receiving structure (95) sized and configured to
disengageably receive the attachment element (93) of the clip
applier (105), the clip applier exerting a force counter to the
force exerted by said active hinge member (86) and operable for
bringing the clip assembly from its closed position to its open
position or vice versa.
40. A surgical clip assembly (70) according to claim 32, wherein
said two force means (86, 80) are non-unitary with said pair of
linear compression elements (86, 80).
41. A surgical clip assembly (70) according to claim 32 further
including a restrictor element (94) extending from said first end
portion of one of said compression elements thereby preventing
tissue from entering the region occupied by said active hinge
member.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 60/780,446, filed Mar. 9, 2006.
FIELD OF THE INVENTION
[0002] The present invention relates to the field of surgical
compression clips generally, and, in particular, to the field of
surgical compression clips, at least partially formed from shape
memory material.
BACKGROUND OF THE INVENTION
[0003] Several methods are known in the art for joining tissue
portions at the site of organ resections, particularly
gastrointestinal (GI) tract resections, or at the site of other
types of tissue perforations or tissue openings. These include
threads for manual suturing, staplers for mechanical suturing,
tissue adhesives and compression rings and clips.
[0004] While manual suturing is universally known and relatively
inexpensive, the degree of success depends considerably on the
skill of the surgeon. Another disadvantage of this technique is
that post-operative complications are common. Further, suturing an
organ results in lack of smoothness of the tissue therein, which,
when the sutured organ is part of the gastrointestinal tract,
hampers peristalsis in the sutured area. Finally, suturing is both
labor and time consuming.
[0005] Increasingly, stapling is being used for suturing. Staplers
for mechanical suturing ensure a reliable joining of tissue and
reduce the time needed for surgery compared with manual suturing.
However, after healing, metal staples remain in place along the
perimeter of the suture, which reduces elasticity of the junction
and adversely affects peristalsis when the sutured organ is part of
the gastrointestinal tract. These complications often lead to
strictures and inflammatory reactions to the foreign bodies left
behind. Staples also often lead to undesired leakage of blood and
other body liquids into the region of resected tissue further
resulting in severe infection. Additionally, stapling mechanisms
generally are relatively large and fairly rigid, limiting the
maneuverability of an endoscope used in conjunction with the
stapling mechanism. This lack of maneuverability restricts an
endoscopic approach to many locations within the body.
[0006] Junctions using compression devices, such as rings (or
loops) and clips, ensure the best seal and post-operative
functioning of the organs. The compression force exerted by
compression rings is applied only momentarily at the tissue
junction and is reduced as the tissue is crushed. Clips made of
memory alloys enable portions of tissue to be pressed together with
increasing pressure as they are heated, due to the inherent
properties of the alloys. Their design is cheap and they are small
in size. Moreover, when used in the GI tract they are often
self-evacuated.
[0007] A major disadvantage of known clips is that they permit
compression of only approximately 80-85% of the junction perimeter,
thus requiring additional manual sutures, which reduce the
integrity of the seal of the junction during the healing period and
its elasticity during the post-operative period. Furthermore, this
additional suturing is problematic inasmuch as it has to be carried
out across a joint which includes a portion of the clip, thereby
rendering difficult the sealing and anastomosis of the organ
portions.
[0008] The compressive force exerted by clips generally is not
equal at both ends of the clip because of the clips' typically
asymmetric construction. Similarly, compression does not act along
a line between the two compressing portions holding the tissue to
be compressed. This can lead to the clip disengaging from the
closure site before closure is complete and scar tissue mature.
[0009] Typically, clips do not necessarily have a securing
mechanism against slipping off the tissue. Clips as currently
designed may also affect the maneuverability of an endoscope.
DEFINITIONS
[0010] "Proximal" relates to the side of a clip or device closest
to the user, while "distal" refers to the side of a clip or device
furthest from the user.
[0011] "Lesion" may be used in place of the word "polyp"
"perforation", hemorrhoid; tissue adjacent to a resected site, or
openings within tissue generated by any surgical procedures,
without any intent at differentiating these different types of
lesions, except where specifically indicated.
[0012] "Gastrointestinal tract" or its equivalents are used in the
specifications and claims without intent of being limiting. Other
organ systems, and lesions found therein, are also contemplated as
being treatable with the compression clips and devices described in
the present specification.
[0013] "Hinge spring" is one type of a "force applier" and this
latter term may be used herein interchangeably with hinge spring
without any intent at differentiating between these terms, except
where specifically indicated. Accordingly, the latch described
herein, as well as elements having other shapes, may also be
considered to be force appliers if they are used for, and their
operation is based on, their being formed from and possessing the
force applying properties of shape memory materials. Hinge springs
may be described herein as "hinge members", "force means" and
"hinge members" again without any attempt at differentiating
between these terms except where specifically indicated.
[0014] "Endoscope" as used herein should be construed as including
all types of invasive instruments, flexible or rigid, having scope
features. These include, but are not limited to, colonscopes,
gastroscopes, laproscopes, and rectoscopes. Similarly, the use of
"endoscopic" is to be construed as referring to all types of
invasive scopes.
SUMMARY OF THE INVENTION
[0015] The present invention seeks to provide an improved surgical
compression clip having force appliers/force means formed of a
shape memory alloy material. These clips may be used for joining
tissue at the resection site in resections of many kinds, as well
as for closing various other types of organ perforations. They may
be used inter alia in polypectomies, gastrectomies and
gastroplastic procedures.
[0016] It is an object of the present invention to provide a
surgical compression clip which exerts a constant compressive force
irrespective of thickness of the compressed tissue, and
irrespective of the changes it undergoes during the wound healing
process. Such a clip reduces the chances of liquid leakage after
resection while ensuring proper healing and closure of the resected
site. Typically, but without intending to be limiting, no foreign
body is left behind after tissue closure is complete.
[0017] It is a further object of the present invention to provide a
clip that ensures protection against the clip being expelled before
tissue closure is complete.
[0018] Another object of the present invention is to provide a
non-unitary surgical clip which exerts a constant compressive force
along the entire profile of the surfaces of the clip's clamping
elements. The clip is made of shape memory material which provides
a constant compressive force over large elongations.
[0019] In yet another object of the present invention a surgical
compression clip is provided that produces continuous clamping
compression of tissue adjacent to a resected site. The continuous
compression is effected along a continuous line, thereby preventing
undesired post-surgery fluid leakage and bleeding. Such a
continuous line is impossible to attain when using surgical
staples.
[0020] It is a further object of the present invention to provide a
surgical compression clip and a system for applying the clip that
reduces the risk of tissue perforation when all tissue layers
proximate to a lesion are resected.
[0021] The surgical clips described herein may find particular use
in various types of resections of a suspect lesion, such lesion
arising in, for example, but without intending to be limiting, the
bowel, rectum, appendix, gallbladder, uterus, stomach, esophagus,
etc.
[0022] In one aspect of the present invention there is provided a
surgical clip assembly which comprises a pair of generally linear
compression elements for securing tissue therebetween and for
applying to the secured tissue a compression force. The clip
assembly has an initial, open position in which the linear
compression elements may be positioned about tissue to be secured
between them, and a final, closed position whereat the compression
elements are substantially parallel to each other, thereby to apply
a compressive force to the secured tissue. The clip further
comprises a force means disposed between the pair of compression
elements and operative to transmit operational forces
therebetween.
[0023] In embodiments of the present invention the force means is
typically formed of a shape memory material.
[0024] In some embodiments of the clip assembly of the present
invention, the force means includes one or more active hinge
members disposed between the linear compression elements.
[0025] In some embodiments, each of the linear compression elements
has first and second end portions, and the one or more active hinge
members are disposed in proximity to a predetermined one of the
first and second end portions.
[0026] In some embodiments, the assembly further includes a pair of
generally linear securing elements, wherein each of the linear
compression elements is associated with one of the pair of
generally linear securing elements. The securing elements are
operative for securing tissue to be compressed by the compression
elements and the securing elements and form a securing line when
grasping the tissue. The securing line is not collinear with the
line of compressive force produced by the compression elements.
Typically, the securing elements include a gripping portion having
a serrated profile formed of a plurality of teeth-like projections
over at least part of the length of the securing elements. The
teeth-like projections of the profile are not necessarily uniformly
distributed along the length of the gripping portion although in
some embodiments they may be. In some embodiments, the assembly
further includes one or more receiving structures sized and
configured to disengageably receive an attachment element of a clip
applier. The clip applier exerts a force counter to the force
exerted by the one or more hinge members and is operable for
bringing the clip assembly from its closed position to its open
position or vice versa.
[0027] In some embodiments of the clip assembly, the pair of
securing elements and the pair of compressing elements are formed
from material selected from the group of materials consisting of:
an insulative material and an insulative-coated metal material. In
some embodiments, the compressing elements and securing elements
are integrally formed with each other. In instances where these are
not integrally formed, they may be joined by a method chosen from
the group of methods consisting of: welding, gluing, a mechanical
clip, fixating joint or a mechanical press.
[0028] In another embodiment of the clip assembly, the one or more
active hinge members includes first and second hinge members,
disposed in proximity to the first and second end portions,
respectively, of the linear compression elements. In some
embodiments the clip assembly may further include a pair of
generally linear securing elements, wherein each of the linear
compression elements is associated with one of the pair of
generally linear securing elements. The securing elements are
operative for securing tissue to be compressed by the compression
elements and the securing elements forming a securing line when
grasping the tissue. The securing line is not collinear with the
line of compressive force produced by the compression elements. In
a further embodiment of the clip assembly of the present invention,
the securing elements include a gripping portion having a serrated
profile formed of a plurality of teeth-like projections over at
least part of the length of the securing elements. In some
embodiments, the compressing elements and securing elements are
integrally formed with each other. In instances where they are not
integrally formed, they may be joined by a method chosen from the
group of methods consisting of: welding, gluing, a mechanical clip,
fixating joint or a mechanical press.
[0029] In an embodiment of the present invention, the first and
second hinge members each has a generally planar body that includes
two legs each having an end portion. Each of the hinge members has
located at each of its end portions a connector having a single
insertable end portion. The connector is positioned substantially
transversally to the planar body. The clip assembly further
includes a pair of generally linear securing elements, wherein each
of the linear compression elements is associated with one of the
pair of generally linear securing elements. The single insertable
end portion of the connectors is pivotably connected to the
compression elements, allowing concurrent mechanical communication
between the hinge members and the compression elements.
[0030] In another embodiment of the clip assembly of the present
invention, the first and second hinge members each has a generally
planar body that includes two legs. Each leg has an end portion.
Each of the hinge members has located at each of its end portions a
connector having a single insertable end portion. The connector is
positioned substantially transversally to the planar body. The clip
assembly further includes a pair of generally linear securing
elements, and each of the linear compression elements is associated
with one of the pair of generally linear securing elements. The
single insertable end portion of the connectors is pivotably
connected to the securing elements, thereby allowing concurrent
mechanical communication between the hinge members and the securing
elements.
[0031] In yet another embodiment of the clip assembly of the
present invention, the first and second hinge members each has a
generally planar body that includes two legs each having an end
portion. Each of the hinge members has located at each of its end
portions a connector having first and second insertable end
portions. The connectors are positioned substantially transversally
to the planar body. The clip assembly further includes a pair of
generally linear securing elements. Each of the linear compression
elements is associated with one of the pair of generally linear
securing elements. The first end portions of the connectors of the
hinge members is pivotably connected to the securing elements,
allowing concurrent mechanical communication between the hinge
members with the two securing elements. The second insertable end
portions of the connectors are pivotably connected to the
compressing elements, allowing concurrent mechanical communication
between the first and second hinge members and the two compressing
elements.
[0032] In another embodiment of the clip assembly, the connectors
of the first and second hinge members are joined to the legs of the
hinge members on an inner surface of the legs. This produces a
preloaded clip assembly when the connectors are pivotably connected
to one or more of the compressing elements and one or more of the
securing elements.
[0033] In yet another embodiment, the clip assembly further
includes one or more gap forming elements positioned on one or more
end portions of one or more compression elements. The gap forming
element creates a gap between the compression elements when the
clip assembly is in its closed position.
[0034] In one embodiment of the present invention, the two legs of
the first and second hinge members are each of the same length. In
another embodiment of the present invention, the two hinge members
are identical but the legs of the hinge members are of different
lengths.
[0035] In a further embodiment of the clip assembly, one of the
compression elements has a hollow tubular structure with an
elongated slot at each of its ends positioned on the side of the
one of the compression elements proximate to the hinge members. A
projection translationally rides in each of the slots and is
pivotally connected to the hinge elements and the one compression
element mentioned above. When the projections riding in the slots
ride away from each other, the longer of the legs of each of the
hinge members travel in opposite directions from each other. This
causes the hinge members to bring the clip assembly to its open
position. When the projections ride in the slots towards each other
the longer of the legs of each of the hinge members travel toward
each other causing each of the hinge members to bring the clip
assembly to its closed position.
[0036] In yet another embodiment of the clip assembly of the
present invention, the clip assembly further includes two joined
threaded bolts positioned inside the hollow compression element.
Each of the bolts has a different handedness and each has a
threaded cylinder with an extension fitted thereon. Each of the
extensions is pivotably connected to one leg of a different one of
the hinge members. The extensions are operable as the projections
for riding along the elongated slot when the threaded bolts are
rotated. When rotating the joined bolts in one direction, the
projections, being in mechanical communication with the bolts,
travel in the slots in a direction away from each other. This
brings the clip assembly to its open position. When rotating the
joined bolts in a second direction, the projections travel in the
slots in a direction toward each other thereby bringing the clip
assembly to its closed position.
[0037] In another embodiment of the invention, each of the hinge
members has a connector positioned near the end portion of one of
its legs. The connector serves as the projection for insertion into
and translationally riding in the slots. The clip assembly further
includes wires connected to the connectors. When the wires are
pulled in one direction the connectors travel in the slots in a
direction away from each other thereby bringing the clip assembly
to its open position. When the wires are released, the connectors
travel in the slots in a direction toward each other, bringing the
clip assembly to its closed position.
[0038] In another embodiment of the clip assembly, the assembly
further includes one or more receiving structures sized and
configured to disengageably receive an attachment element of a clip
applier. The clip applier exerts a force counter to the force
exerted by the one or more hinge members and is operable for bring
the clip assembly from its closed position to its open position or
vice versa.
[0039] In another embodiment of the present invention, the one or
more active hinge members includes a single member, disposed in
proximity to the first end portions of the linear compression
elements. When the clip assembly is in the open position, the
linear compression elements form a jaws-like arrangement and the
second end portions of the linear compression elements are spaced
apart so as to permit positioning of the compression elements about
tissue to be secured therebetween. In instances of this embodiment,
the single hinge member is fixably connected to the first end
portions of the linear compression elements.
[0040] In other embodiments of the present invention, there is a
selectably movable latch member positioned within a first of the
two compression elements and extending past its second end portion.
There is an engagement means on the second end of the second
compression element for engaging and holding the latch member in
force producing engagement when the pair of compression elements
are brought close to each other, and when the latch member is moved
to engage with the engagement means.
[0041] In another embodiment of the present invention, the assembly
further includes a wire extending between the second end portion of
each of the two compression elements. The wire is releasably
connected to the latch member and has an extension extending via
the second end portion of the second compression element through
the first compression element. The extension is operative to draw
the wire taut when tissue is positioned between the two compressing
elements. The taut wire thereby prevents the tissue from moving out
from between the pair of compression elements while the clip
assembly is brought to its closed position.
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] The present invention will be more fully understood and its
features and advantages will become apparent to those skilled in
the art by reference to the ensuing description, taken in
conjunction with the accompanying drawings, in which:
[0043] FIG. 1A is an overall isometric view of an endoscopic system
constructed according to the present invention;
[0044] FIG. 1B is an enlarged view of the distal end of the
endoscopic system shown in FIG. 1A;
[0045] FIG. 1C is an enlarged view of the proximal end of the
endoscopic system shown in FIG. 1A;
[0046] FIG. 2 shows an isometric view of the compression clip
constructed according to a first embodiment in its closed
position;
[0047] FIGS. 3A and 3B show isometric top and bottom views of the
compression clip shown in FIG. 2 in its open position;
[0048] FIGS. 4A, 4B and 4C show isometric views of different
configurations of spring elements constructed according to various
embodiments of the present invention;
[0049] FIG. 5 is an isometric view of a clip applier constructed
according to one embodiment of the present invention, the applier
in its closed position;
[0050] FIG. 6 is an isometric view of the clip applier in FIG. 5,
the applier in its open position;
[0051] FIG. 7 is an isometric view of the clip applier in FIG. 5
without its base element, the applier in its open position;
[0052] FIG. 8 is an isometric view of the clip applier of FIG. 5
used to position the clip in FIG. 2, the clip being attached to the
applier and in its closed position;
[0053] FIG. 9 is an isometric view of a clip applier used to
position the clip in FIG. 2, the clip being attached to the applier
and in its open position;
[0054] FIG. 10 is an isometric view of a clip applier constructed
according to a second embodiment of the present invention, the
applier in its closed position;
[0055] FIG. 11 is an isometric view of the clip applier in FIG. 10,
the applier in its open position;
[0056] FIG. 12 is an isometric view of the clip applier of FIG. 10,
attached to a clip constructed as in FIG. 2, the clip being
attached to the applier and in its closed position;
[0057] FIG. 13 is an isometric view of the clip applier of FIG. 10,
attached to a clip constructed as in FIG. 2, the clip being
attached to the applier and in its open position;
[0058] FIGS. 14 and 15 show isometric views of a second embodiment
of a surgical compression clip constructed according to the present
invention, wherein FIG. 14 and FIG. 15 show the clip in its closed
and open positions, respectively;
[0059] FIG. 16 shows an exploded view of the clip in FIGS. 14 and
15;
[0060] FIGS. 17 and 18 show isometric partially cut-away views of
the compression clip shown in FIGS. 14 and 15, respectively;
[0061] FIGS. 19 and 20 show isometric views of a clip applier used
with the clip shown in FIGS. 14-18, FIG. 19 showing the applier
engaged to the clip and FIG. 20 disengaged from the clip;
[0062] FIG. 21 shows an isometric view of the applier in FIGS. 19
and 20;
[0063] FIG. 22 shows a partially exploded view of the applier in
FIGS. 19 and 20;
[0064] FIG. 23 shows a cross-sectional view of the applier shown in
FIGS. 19 and 20;
[0065] FIG. 24A shows an exploded view of a third embodiment of a
compression clip constructed according to the present
invention;
[0066] FIG. 24B shows an isometric partially cut-away view of the
clip shown in FIG. 24A;
[0067] FIGS. 25A and 25B are an isometric top and bottom view of a
clip constructed according to a fourth embodiment of the present
invention, the clip being in its closed position;
[0068] FIGS. 26A and 26B are an isometric top and bottom view of a
clip constructed according to the embodiment of FIGS. 25A and 25B,
the clip being in its open position;
[0069] FIGS. 27A and 27B are isometric views of a clip applier
constructed according to another embodiment of the present
invention, the applier shown in its closed and open position,
respectively;
[0070] FIGS. 27C and 27D are cross-sectional views of the clip
applier shown in FIGS. 27A and 27B, the applier shown in its closed
and open position, respectively;
[0071] FIGS. 28A and 28B are isometric views of the clip applier
shown in FIGS. 27A and 27B constructed in its closed and open
position, respectively, when attached to and operating the clip
shown in FIGS. 25A-26B;
[0072] FIG. 29 is an exploded view of another embodiment of a clip
applier for use with the clips in the specification herein;
[0073] FIGS. 30A and 30B are isometric views of the clip applier
shown in FIG. 29 in its closed and open position, respectively;
[0074] FIG. 30C is a revealed inner view of FIG. 30B;
[0075] FIG. 31A is a cross-sectional view of a surgical compression
clip constructed according to a fifth clip embodiment of the
present invention, the clip being in its open position and attached
to its associated applier;
[0076] FIG. 31B is an enlarged view of a portion of the distal end
of the clip shown in FIG. 31A;
[0077] FIGS. 32 and 33 are different partially exploded views of
the surgical compression clip and applier in FIG. 31A;
[0078] FIG. 34 shows different views of the shape memory spring
element of the clip in FIG. 31A;
[0079] FIG. 35 shows different views of the latch arm of the clip
presented in FIG. 31A;
[0080] FIG. 36 shows an isometric view of the clip's spring element
at the hinge region of the clip shown in FIG. 31A;
[0081] FIG. 37 shows an isometric front side view of the clip in
FIG. 31A, the clip in its open position;
[0082] FIGS. 38 and 39 show different views of the clip in FIG. 31A
where the wire of the clip has been drawn taut;
[0083] FIG. 40 shows an enlarged view of the clip shown in FIG. 31A
including the clip's distal end and its locking process;
[0084] FIG. 41 shows an enlarged cross-sectional view of the distal
end of the clip shown in FIG. 31A, the clip in its latched
position;
[0085] FIGS. 42 and 43 show additional enlarged views of the distal
end of the clip shown in FIG. 31A, the clip being in its closed
position;
[0086] FIG. 44 shows an isometric view of the clip shown in FIG.
31A, the clip in its closed position and ready for insertion into a
clip applier;
[0087] FIG. 45 shows an endoscope prior to insertion into a
multi-lumen sleeve;
[0088] FIG. 46 shows the endoscope of FIG. 45 being inserted into a
multi-lumen sleeve;
[0089] FIG. 47A shows the endoscope after insertion into the
multi-lumen sleeve;
[0090] FIG. 47B shows an enlarged view of the distal end of the
endoscope in FIG. 47A;
[0091] FIG. 48 shows the sleeve-encased endoscope as it approaches
a polyp in the gastrointestinal tract;
[0092] FIG. 49 shows a view of a surgical clip attached to an
applier being advanced to the site of the polyp through a secondary
lumen of the sleeve;
[0093] FIG. 50 shows a top side view of the surgical clip attached
to an applier being positioned proximate to the polyp;
[0094] FIG. 51 shows a top side view of a surgical clip and applier
positioned proximate to a polyp and a grasper assembly being
positioned proximate to the polyp after advancing through a working
channel of the endoscope;
[0095] FIG. 52 shows a top side view of the opened clip proximate
to the polyp;
[0096] FIG. 53 shows a top view of the grasper of the grasper
assembly beginning to pull the polyp through the opened clip shown
in FIG. 52;
[0097] FIG. 54 shows a top side view of the grasper of the grasper
assembly grasping the polyp;
[0098] FIG. 55 shows a top side view of the grasper continuing to
pull the polyp through the opened surgical clip;
[0099] FIG. 56 shows a top side view of the grasper and grasper
transporting element rotating and wrapping the pulled polyp around
the grasper transporting element;
[0100] FIG. 57 shows a cross-sectional view along line AA' of FIG.
56 of the grasper and grasper transporting element rotating and
wrapping the pulled polyp around the grasper transporting
element;
[0101] FIG. 58 shows a top side view of the surgical clip closing
around the wrapped polyp;
[0102] FIG. 59 shows a top side view of the closed surgical clip
and polyp without the applier that has been withdrawn through a
secondary lumen from the region of the resected polyp;
[0103] FIG. 60 shows a top side view of the closed surgical clip
and polyp with a severing device approaching the rotated polyp for
severing;
[0104] FIG. 61 shows a top side view of the tissue held by the clip
at the resection site; and
[0105] FIGS. 62A and 62B show two side views of the tissue held by
the clip at the resection site.
[0106] Similar elements in the Figures are numbered with similar
reference numerals.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0107] The present application should be read in conjunction with
co-pending US application "Endoscopic Full Thickness Resection
Using Surgical Compression Clips", attorney's docket number 41758,
filed by the same applicant and inventors concurrently on Dec. 29,
2006. This document is herein incorporated by reference in its
entirety.
[0108] The present invention describes non-unitary surgical
compression clips, which lessen the likelihood of internal leakage
of bodily fluids which often occurs when staple suturing is used.
These clips, when used, also lessen the likelihood of bleeding and
do not leave any permanent foreign body inside the body cavity
after tissue closure and healing is complete.
[0109] The non-unitary, i.e. compound, surgical compression clips
described herein, typically have one or more elements, generally
two or more elements, made of a shape memory material, such as a
nickel-titanium (Ni--Ti) alloys. The clip includes two compressing
elements connected operationally by at least one of the shape
memory elements. Typically, the clip also includes securing
elements with which to hold the tissue being compressed. Also
typically, the compressing elements are linear as are the securing
elements. When tissue to be joined is held between the two
compressing elements, a constant compressive force acts between the
two elements, these latter being connected at both of their ends by
the shape memory elements. The constant force is a result of the
well-documented long plateau region of the shape memory material's
stress-strain hysteresis curve. In this plateau region, the force
is constant irrespective of the extent of the deformation. This is
a consequence of properties exhibited by shape memory materials.
Additionally, stress-induced strain is recoverable in these
materials; in the case of nitinol, 6-8% of the strain can be
recovered.
[0110] Discussions of the stress-strain curves of shape memory
materials and its stress induced strain can be found in many
publications. See for example "Shape Memory Materials", edited by
K. Otsuka and C. M. Wayman, Cambridge University Press 1998, p. 62
and; H. Tobushi et al in "Deformation Behaviour of Ni--Ti
Superelastic Alloy Subjected to Strain Variation" in SMST-94: The
Proceeding of the International Conference on Shape Memory and
Superelastic Technology, edited by A. Pelton, D. Hodson and T.
Duerig, 1995, pp. 389-391.
[0111] It should be noted that the line of compressive force
produced by the compression elements of the clips of the present
invention is not collinear with the line exerted by the securing
elements on the tissue to be resected. These are two different
lines of action, separated by a distance. Were they to be co-linear
the healing of the tissue at the compression site may be
compromised. Additionally the arrangement of non-colinearity allows
for more homogeneous tissue compression by the compression
elements. Any penetration of the teeth for securing the tissue is
compensated for by the continuous compression line more proximate
to the body cavity wall.
[0112] The shape memory elements, which act as force appliers, are
typically made of nickel-titanium (Ni--Ti) alloys but other shape
memory materials may also be used. The other elements of the clip,
i.e. the compressing elements and the securing elements (and
possibly separate toothed elements for attachment to the securing
elements when there is no integrally formed toothed edge on the
securing elements) may also be made of a shape memory material such
as a nitinol alloy, but that is not essential. Other metals or
alloys, such as stainless steel or other titanium alloys, and even
certain plastic materials may also be used. The compression clips
described herein are typically attached to an applier and brought
to tissue adjacent to a resection site, or to tissue adjacent to a
perforation to be joined, or to any tissue having an opening
requiring closure.
[0113] It should be noted that the line of compressive force
produced by the compression elements of the clips of the present
invention is not collinear with the line exerted by the securing
elements on the tissue to be resected and/or closed. These are two
different lines of action, separated by a distance. Were they to be
co-linear the clip could easily disengage before scar tissue
matured at the compression site. Additionally, the non-collinear
arrangement allows for more homogeneous tissue compression by the
compression elements. Furthermore, any penetration of the teeth on
the securing elements for securing the tissue is compensated for by
the clip's continuous compression line being further away from the
resected site or the opening to be closed.
[0114] The surgical clips described herein may be used with
standard commercially available endoscopes. Dedicated or specially
designed endoscopes can be used but are not necessary.
[0115] Additionally, using the compression clips of the present
invention is not limited to any particular direction or shape of
resection incision; both radial and longitudinal incisions are
contemplated by the present invention.
[0116] The surgical clips described herein have additional
advantages. The compression force ensures continuous compression of
the tissue at the resected site, independent of the variation in
tissue thickness. No foreign bodies are left behind in the body
cavity as the clip is typically self-evacuating. Finally, since the
invention makes use of shape memory materials, the clip may be of
relatively small dimensions and there is no need for large
instruments, such as currently employed stapler firing mechanisms.
This permits easier advance of the clip and its applier to a site
requiring closure.
[0117] Before explaining several embodiments of the invention in
detail, it is to be understood that the invention is not limited in
its application to the details of construction and the arrangement
of the components set forth in the following description or
illustrated in the drawings. The invention is capable of other
embodiments or of being practiced or carried out in various ways.
Also, it is to be understood that the phraseology and terminology
employed herein is for the purpose of description and should not be
regarded as limiting.
[0118] FIGS. 1A-1C, to which reference is now made, show an overall
view of an endoscopic system constructed according to the present
invention, an enlarged view of the system's distal end F and an
enlarged view of the system's proximal end N, respectively.
[0119] FIG. 1A includes an endoscope insertion shaft 300 encased in
a multi-lumen sleeve 150. At the distal end F of endoscope
insertion shaft 300, working instruments constructed according to
the present invention may exit. These instruments include a
surgical clip 10 attached to an applier 30 and a grasper assembly
200 including a grasper transporting element 260. These instruments
are inserted into a working channel 154 of endoscope insertion
shaft 300 or one or more secondary lumens 158 of sleeve 150.
Insertion of the instruments is effected at the proximal end N of
endoscope insertion shaft 300. They are advanced in the direction
of, and ultimately exit at, or adjacent to, the distal end F of
endoscope insertion shaft 300. Actuators 306 and 308 may be any of
many known to those skilled in the art. They can apply one or a
combination of control actions or movements, such as pull and
release, articulation, swivel and the like. Endoscope insertion
shaft 300 is typically connected to a fiberoptic cable 304 which
communicates images to a visual display 302.
[0120] Details of the instruments used, the multi-lumen sleeve and
other specific aspects of the system of the present invention are
further discussed below.
[0121] Reference is now made to FIGS. 2-3B where FIG. 2 presents a
view of a non-unitary compression clip constructed according to a
first embodiment of the present invention. In FIG. 2 the clip is
shown in its closed position. FIGS. 3A and 3B present a view of the
compression clip shown in FIG. 2 in its open position.
[0122] Clip 10 is constructed of two shape memory hinge springs 12A
and 12B, also herein often denoted as force appliers. Typically,
but without intending to be limiting, the shape memory material is
a Ni--Ti alloy. The operation of the clip relies on shape memory
effects exhibited by these materials. Springs 12A and 12B may be
made of a single wire or flattened wire or strip or it may be
constructed of two or more wires, flattened wires or strips
connected together at their ends. Furthermore, in some embodiments,
the springs may be constructed to have a coiled shape.
[0123] Clip 10 further includes two securing elements 14A and 14B,
each of which has a series of teeth 20 for grasping tissue. Each of
securing elements 14A and 14B may be formed from a single piece or
welded together from several pieces, typically but without
intending to be limiting, of metal. Teeth 20 may be formed
integrally with elements 14A and 14B or they may be joined to the
elements, for example, by welding. Generally, these securing
elements are made of metal and typically are welded or otherwise
joined to two metal compressing elements 16A and 16B. However, the
securing elements and the compressing elements may be joined
together by any method known to those skilled in the art. Securing
elements 14A and 14B may also be formed integrally with compressing
elements 16A and 16B, respectively.
[0124] Securing elements 14A and 14B are formed with spacings 18
configured and sized to receive the pushing elements of a clip
applier (not shown). Compressing elements 16A and 16B, typically,
but without intending to be limiting, are cylindrically-shaped.
These include holes 19 (best seen in FIG. 3B) into which connectors
17 (also best seen in FIG. 3B) of hinge springs 1-2A and 12B are
insertable. Insertion of hinge springs 12A and 12B occurs prior to
welding or otherwise joining toothed securing elements 14A and 14B
to compressing elements 16A and 16B, respectively. As a result of
the weld or other joining method, securing elements 14A and 14B
prevent connectors 17 of hinge springs 12A and 12B from dropping
out of holes 19. Securing elements 14A and 14B, and compressing
elements 16A and 16B are joined together by hinge springs using any
method known to those skilled in the art, particularly in the art
of articulation hinges (swing joints). The natural tension of hinge
springs 12A and 12B operates to keep compressing elements 16A and
16B in their closed position as in FIG. 2.
[0125] The metal used for forming securing elements 14A and 14B,
compressing elements 16A and 16B and teeth 20, if these latter are
made from separate pieces and welded to elements 14A and 14B,
should be a rigid metal such as, but without being limiting,
stainless steel.
[0126] While in the above embodiment, securing elements 14A and 14B
are welded to compressing elements 16A and 16B, respectively, in
other embodiments this need not be the case. The securing and
compressing elements may be joined to each other by mechanical
means such as by U-shaped elements positioned on securing elements
14A and 14B. clippably engageable to compressing elements 16A and
16B or by press connections wherein an edge on each of securing
elements 14A and 14B would be pressed to enter a slit in their
respective compressing elements 16A and 16B. Alternatively,
securing elements 14A and 14B and compressing elements 16A and 16B
can be crimped together.
[0127] In other embodiments, securing elements 14A and 14B and
compressing elements 16A and 16B may be made of a single piece of
plastic, for example by ejection molding. In such embodiments, only
hinge springs 12A and 12B are made of metal, specifically a shape
memory metal or alloy, typically but without intending to be
limiting, a Ni--Ti alloy. In such plastic embodiments, hinge
springs 12A and 12B (force appliers) would typically be snapped
into place between securing elements 14A and 14B and compressing
elements 16A and 16B. However, it is evident to one skilled in the
art that other methods of introducing the metal hinge springs 12A
and 12B could also be used.
[0128] Clip 10 in its closed position appears as shown in FIG. 2.
Hinge springs 12A and 12B exert no force when the clip is fully
closed, i.e. when compressing elements 16A and 16B lie proximate
and tangent to each other. However, as compressing elements 16A and
16B are separated apart, hinge springs 12A and 12B exert a force
which tries to bring compressing elements 16A and 16B and securing
elements 14A and 14B together. When clip 10 is to be opened,
pushing elements of a clip applier (not shown) may be positioned
and wedged between teeth 20 of securing elements 14A and 14B or
they may be positioned in a spacing or indentation 18. The applier
is activated to apply a force via its pushing elements (not shown).
This force opposes the force exerted by hinge springs 12A and 12B.
This counter force spreads securing elements 14A and 14B and
compressing elements 16A and 16B apart. It also spreads hinge
springs 12A and 12B as in FIGS. 3A and 3B.
[0129] After tissue is brought to and positioned between the
separated compressing elements 16A and 16B, the applier is operated
to relax the applied force allowing securing elements 14A and 14B
to move toward each other and to return to their original closed
position (FIG. 2). Shape memory hinge springs 12A and 12B also
relax and return to their original shape. The tissue positioned
between the securing and compressing elements of clip 10 prevents
compressing elements 16A and 16B and springs 12A and 12B from
completely returning to their original closed positions. Once the
compressing elements are stopped by the tissue, continued closure
of the applier's pushing elements leads to separation of the
pushing elements of the applier from securing elements 14A and 14B
of clip 10. This, in turn, causes the applier to disengage from
clip 10.
[0130] While the shape memory elements used to effect opening or
closing of clip 10 are here described as hinge springs, these
elements can more generally be classified as force appliers.
Therefore, it should be understood that elements of any shape which
can generate a force for either opening or closing a compression
clip may be used and these elements can and will often be denoted
herein as force appliers.
[0131] In other embodiments, pushing elements of a clip applier are
inserted into special indentations in securing elements 14A and
14B. The spacing/indentation is best seen as element 718 in FIGS.
25A and 26A discussed below. In yet another embodiment, when
pushing securing elements 14A and 14B, the pushing elements of an
applier (not shown) are inserted and loosely held in holes (not
shown) positioned on securing elements 14A and 14B.
[0132] Shape memory hinge springs 12A and 12B can have distinctive
connectors 17 at their ends as shown in FIGS. 4A-4C. A hinge spring
having uni-directional connectors 17 is shown in FIG. 4A. However,
the use of hinge springs with bi-directional connectors 17' as
shown in FIG. 4B is advantageous over the uni-directional
connectors 17 shown in FIG. 4A. The hinge spring's
bi-directionality allows connectors 17' to be inserted
simultaneously into holes 21 in securing elements 14A and 14B and
into holes 19 in compressing elements 16A and 16B. This increases
stability of the clip 10. It also reduces the chance that hinge
springs 12A and 12B will be displaced during operation of the clip
and interfere with closure of the clip. The positioning of hinge
springs 12A and 12B with connectors 17' can readily be seen in
FIGS. 2, 3A and 3B where clip 10, in its closed and open positions,
is shown. Reference to the use of hinge springs with connectors of
the type of connector 717 shown in FIG. 4C will be made later in
the text.
[0133] Connectors 17, 17' and 717 shown in FIGS. 4A, 4B and 4C
respectively form articulating joints when they are inserted into
corresponding apertures or holes in compression elements and/or
securing elements as described in the first through fourth
compression clip embodiments described below. These connectors
rotate or swing in their respective apertures and holes allowing
for articulation.
[0134] It should be noted that as in clip 10 of FIGS. 2-3B, in some
embodiments teeth 20 do not necessarily extend the entire length of
securing element 14A and 14B while in others they do. Additionally,
it should be noted that in some embodiments of clip 10 in FIGS.
2-3B, teeth 20 need not be distributed uniformly along securing
elements 14A and 14B. Additionally, at both ends of elements 14A
and 14B there is a small bend 22 welded or otherwise joined to the
sides. In some embodiments, bend 22 may be integrally formed as
part of elements 14A and 14B. This provides extra security against
clip 10 slipping off the compressed suspect tissue during
resection.
[0135] In the compression clip embodiments shown in FIGS. 2-3B and
as discussed elsewhere in this specification, the securing elements
and their respective compressing elements have been described as
separate elements. In their operational state within the clips,
these are typically a single joined element reflecting a single
part and may be thought of as such. In the joined part, the
securing elements attach to and grip the tissue to be resected
while the compressing elements act to press the parts of the
resected site together even when they are formed as separate
elements and are only later joined together to operate as a single
part.
[0136] Reference is now made to FIGS. 5-9 where various views of a
first embodiment of a clip applier are shown. The clip applier may
be used with surgical compression clip 10 shown in and described in
conjunction with FIGS. 2-3B.
[0137] FIG. 5 shows clip-applier 30 in its closed position. Clip
applier 30 is comprised of applier arms 34A and 34B, applier base
32, and connector elements 36A and 36B. The elements of clip
applier 30 are typically constructed of stainless steel but they
may also be constructed of other metals, such as, but not limited
to, titanium, titanium alloys or reinforced plastics.
[0138] As best seen in FIG. 6 where clip applier 30 is shown in it
open position, each of applier arms 34A and 34B has, at its distal
end, an insertion projection 38A and 38B, respectively. Insertion
projections 38A and 38B are formed substantially transverse to
applier arms 34A and 34B and are operative for insertion between
teeth 20 of securing elements 14A and 14B in FIG. 2, or into
indentations 718 of clip 710 in FIG. 25A, or alternatively into
holes positioned in securing elements 14A and 14B and compressing
elements 16A and 16B.
[0139] FIG. 7 shows open clip applier 30 without its applier base
32.
[0140] As seen in FIGS. 5 and 6, applier base 32 has a generally
barrel-like shape from which emerges a pair of applier base
projections 31. Each of these projections 31 has an applier base
slot 45 and an applier base projection hole 37. Each of applier
arms 34A and 34B has at its proximal end applier arm slots 40A and
40B and applier arm holes (not shown). Applier arm 34B is
constructed with a bend 35 in it so that the distal portions of arm
34B and arm 34A can lie in the same plane. It also allows insertion
projections 38A and 38B to lie in the same plane.
[0141] Each of connector elements 36A and 36B has a pair of holes
41A-41D (41C and 41D not visible), one at each end of each
element.
[0142] Applier arms 34A and 34B are joined to applier base 32 by
connecting pin 43 which passes through applier base projection
holes 37 and applier arm holes (not shown). Pin 42 is inserted into
holes (not shown) in connector elements 36A and 36B and is movable
in applier base slots 45 and applier arm slots 40A and 40B. As pin
42 moves it forces applier arm slots 40A and 40B to overlap with
applier base slots 45 at the point of the pin, thus creating an
opening and closing effect.
[0143] The proximal ends of connector elements 36B and 36A,
respectively, are attached to an operating cable (not shown) that
exits the proximate end of the endoscope. The cable is activated by
an actuator 306 (FIG. 1A), for example, positioned outside the
proximal end N (FIG. 1A) of the endoscope.
[0144] FIG. 8 and FIG. 9 show clip applier 30 of the present
embodiment attached to surgical compression clip 10 described in
FIGS. 2-3B in its closed and open position, respectively.
[0145] To open clip applier 30, an operating cable (not visible)
pulls connector elements 36A and 36B in the proximal direction.
Concurrently, pin 42 moves to the proximal end of applier base
slots 45 and the proximal ends of applier arm slots 40A and 40B. In
that position, applier arms 34A and 34B move apart as in FIG.
9.
[0146] To close clip applier 30, the tension in the operating cable
(not visible) is released. In doing so, the force that hinge
springs 12A and 12B exert is greater than that of the operating
cable. A force is thus exerted on applier arms 34A and 34B through
securing elements 14A and 14B. The clip's force brings applier arms
34A and 34B together, which pushes connector elements 36A and 36B
in the distal direction. Concurrently, pin 42 moves to the distal
end of applier base slots 45 and the distal ends of applier arm
slots 40A and 40B. In that position, applier arms 34A and 34B move
together as in FIG. 8.
[0147] When applier arms 34A and 34B are pushed apart as in FIG. 9,
insertion projections 38A and 38B of clip applier 30 push against
the spacings between teeth 20 of securing elements 14A and 14B of
clip 10 shown in FIG. 2 (or indentations 718 of clip 710 shown in
and discussed below in conjunction with FIGS. 26A and 26B) so that
securing elements 14A and 14B and compressing elements 16A and 16B
of clip 10 move apart. When applier arms 34A and 34B are moved
together as in FIG. 8, insertion projections 38A and 38B of clip
applier 30 exert a reduced force on the spacings between the teeth
20 of securing elements 14A and 14B of clip 10 in. FIG. 2 (or on
indentions 718 of clip 710 shown in and discussed in conjunction
with FIGS. 26A and 26B) so that securing elements 14A and 14B and
compressing elements 16A and 16B of clip 10 move together. The
counter force exerted by hinge springs 12A and 12B keeps clip
applier 30 in place. Once tension generated by springs 12A and 12B
is reduced sufficiently, that is as clip 10 closes on and
compresses tissue, insertion projections 38A and 38B of applier 30
essentially fall away and disengage from clip 10.
[0148] FIGS. 10-13, to which reference is now made, show various
views of a second embodiment of a clip applier constructed
according to the present invention. The applier is intended for use
with the surgical compression clip (slightly modified as discussed
below) shown in and discussed in conjunction with FIGS. 2-3B. FIG.
10 shows the clip applier in its closed position, while FIG. 11
shows the applier in its open position.
[0149] Turning to FIG. 11 first, clip applier 50 includes insertion
links 60A and 60B which are swing jointed by links 62A, 62B, 64A,
64B and central bar 66. An operating cable (not shown) is connected
to the proximal end of central bar 66 and inserted into spring 52.
The latter connection can be achieved by welding or any other
connecting method or means known to those skilled in the art.
[0150] Insertion links 60A and 60B each have extensions (not shown)
which are positioned on their distal end so that these extensions
are insertable into cylindrical elements 58A and 58B. As shown in
FIGS. 12 and 13, cylindrical elements 58A and 58B (best seen in
FIGS. 10 and 11) are themselves insertable into the ends of
compressing elements 16A and 16B of a surgical compression clip
similar to clip 10 discussed above in conjunction with FIGS.
2-3B.
[0151] Compressing elements 16A and 16B, as shown in FIGS. 2-3B,
require a slight modification to be compatible with cylindrical
elements 58A and 58B of clip applier 50. To be compatible, at least
one of the ends of elements 16A and 16B should be hollow and
tubular so that cylindrical elements 58A and 58B of clip applier 50
can be inserted into them.
[0152] While in the embodiment shown in FIG. 10 and FIG. 11,
cylindrical elements 58A and 58B are separate elements, in other
embodiments they may be integrally formed at the ends of insertion
links 60A and 60B.
[0153] FIGS. 10 and 11 show assembled clip applier 50 in its closed
and open positions, respectively. FIGS. 12 and 13 show clip applier
50 inserted into compressing elements 16A and 16B of surgical
compression clip 10 when the clip is in its closed and open
positions, respectively.
[0154] Moving from the open to the closed position of clip applier
50 (or vice versa), and therefore to the open or closed position of
clip 10 (or vice versa), can be effected using an operating cable
(not shown) joined to, or in other ways in direct communication
with, central bar 66 (FIG. 11). The cable passes through spring 52
and out of the proximal end N (FIG. 1A) of the endoscope where it
is activated by a user employing an actuator (schematically shown
as element 306 of FIG. 1A). The actuator may be any of several
types known to those skilled in the art.
[0155] Spring 52, in addition to protecting the cable (not shown),
serves as a stop sleeve for element 56 while pulling the cable thus
enabling the separation of insertion links 60A and 60B. In
addition, it allows for greater flexibility of the apparatus as it
advances through a lumen of a multi-lumen sleeve (or an endoscopic
working channel) from the proximal end of the endoscope toward the
suspect lesion near the distal end of the endoscope. Alternatively,
the cable can be covered and protected by a flexible tube. The tube
may be formed of polytetrafluoroethylene (PTFE), but the choice of
this material is exemplary only and it is not intended to be
limiting.
[0156] To open clip applier 50, central bar 66 is pulled by the
operating cable (not shown) in the proximal direction. When that
occurs, interconnect links 62A and 62B and 64A and 64B and
insertion links 60A and 60B move apart as in FIG. 11 due to the
moment exerted on links 64A and 64B. When insertion links 60A and
60B are inserted into clip 10 as in FIG. 12, clip 10 also opens as
shown in FIG. 13 because of the force exerted by insertion links
60A and 60B and their attached cylindrical elements 58A and 58B-on
compressing elements 16A and 16B.
[0157] During insertion of clip 10 into a body cavity, the clip is
attached to clip applier 50 and both clip 10 and applier 50 are
advanced, in their closed positions, through a secondary lumen of a
multi-lumen sleeve (or through a working channel of the endoscope
shaft). A tension is maintained in the operating cable (not shown)
in order to keep clip 10 attached to clip applier 50 during the
entire advance from the proximal end of the secondary lumen (or
working channel) to its distal end. The tension in the cable or
wire, acts against the force of hinge springs 12A and 12B of clip
10. This creates a force between cylindrical elements 58A and 58B
of applier 50 and compressing elements 16A and 16B of clip 10
preventing detachment of clip 10 from applier 50. This force is
smaller than the force required to open clip applier 50 and clip 10
attached to it.
[0158] To close clip applier 50, the tension in the wire/cable (not
shown) passing through spring 52 is released. The force of hinge
springs 12A and 12B is passed through compressing elements 16A and
16B to insertion links 60A and 60B. This force applies a moment on
links 64A and 64B, which is opposite in direction to the moment
exerted when pulling the wire/cable passing through spring 52. When
that occurs interconnect links 62A and 62B and 64A and 64B and
insertion links 60A and 60B move together as in FIG. 10. When they
move together with clip 10 attached as in FIG. 12, compressing
elements 16A and 16B also move together as shown in FIG. 12.
[0159] While completely releasing the tension in the pull wire
allows for the applier to fully return to its original closed
position, the tissue pulled and held within clip 10 prevents the
clip from following the applier and fully returning to its original
closed position. When this occurs, cylindrical elements 58A and 58B
easily disengage from clip 10 since the hinge springs' 12A and 12B
force is acting essentially on the tissue instead of on the
applier.
[0160] A second embodiment of a compression clip 510 constructed
according to the present invention is shown in FIGS. 14-18, to
which reference is now made. FIGS. 14 and 15 show clip 510 in its
closed and open position, respectively. FIG. 16 is an exploded view
of the clip and discussion of the clip will be made in conjunction
with that Figure. Most of the elements in FIGS. 14-18 are the same
as those discussed in conjunction with the clip embodiments shown
in FIGS. 2-3B. Elements that are essentially equivalent in
structure and operation will not be discussed again. Only new
elements or structural features will be described. Essentially
identical or equivalent elements in the embodiments have been
numbered as in clips 10 with the addition of 500 as a prefix.
[0161] In clip 510, hinge springs 512A and 512B are not
symmetrical, each having legs which are of different lengths. Legs
508A and 508B are longer than legs 509A and 509B. Bi-directional
connectors 517 are formed at the end of legs 509A and 509B. These
connectors formed substantially transversally to the body of clip
510 are sized and configured to be inserted into holes 521 on
securing element 514A and holes 519 on compressing element 516A. At
the end of legs 508A and 508B are hollow cylinders 532A and 532B
insertable over projections 530, more fully described below.
[0162] While compressing element 516A is configured essentially as
in FIGS. 2-3B, compressing element 516B is a hollow tubular rod
with two slots 538 on its surface proximal to securing element
514B. Inside compressing element 516B, a rod, formed of two
connected threaded bolts 536A and 536B, is positioned. The length
of each threaded bolt is less than half the length of the rod, with
the bolts separated by connector means 540. Threaded bolts 536A and
536B each have different "handedness", that is thread direction.
Because the two threaded bolts have different "handedness" they
separate when turned in one direction and come closer together when
turned in the opposite direction.
[0163] Over the ends of threaded bolts 536A and 536B are fitted
cylindrical elements 528, the latter having complementary threads
on their inner surface. Threaded bolts 536A and 536B have an
attachment means 534A and 534B on their ends for insertion and
joining with cylindrical elements 528. Cylindrical elements 528 are
each formed with a projection 530 protruding substantially
transversally to the long axis of cylindrical elements 528.
Projections 530 pass through slots 538 preventing fitted
cylindrical elements 528 from turning as threaded bolts 536A and
536B are turned. This forces cylinders 528 to move linearly along
the long axis of compression element 516B. The threaded rod with
cylinders 528 are held to compressing element 516B by plugs 526.
Plug 526 on one side of the rod, the proximal side, includes a
recess 524, typically, but without being limiting, a square recess,
which is configured to receive a screw rotation apparatus (not
shown). Projections 530 on cylindrical elements 528 are configured
and sized to be inserted into hollow cylinders 532A and 532B formed
on the longer legs 508A and 508B of springs 512A and 512B. The
placement of legs 508A and 508B of hinge springs 512A and 512B and
the relationship between plugs 526, cylindrical elements 528 and
threaded bolts 536A and 536B (which when joined form the threaded
rod discussed above) are best seen in FIGS. 17 and 18.
[0164] Reference is now made to FIGS. 19-23 which show a clip
applier 550 that can be used to operate clip 510, the latter
described in conjunction with FIGS. 14-18. FIGS. 19 and 20 show
clip applier 550 in its engaged and disengaged position,
respectively, with clip 510.
[0165] The structure and operation of clip applier 550 can best be
understood by viewing FIGS. 21-23. A cable 552 capable of being
rotated is extended through a tube 554, typically a flexible
plastic tube capable of advancing the clip to the distal end of an
endoscope. Cable 552 ends at rotation head 558 which includes a
washer element 560 and a male element 562, the latter sized and
configured for insertion into recess 524 of clip 510 (FIGS.
14-18).
[0166] In some embodiments, tube 554 may be a spring having
sufficient flexibility to advance a clip attached to applier 550
past the distal end of the endoscope.
[0167] Clip 510, for example, is inserted into a cup 556 of clip
applier 550. Cup 556 typically is made of plastic or metal. Plug
526 with recess 524 (FIGS. 14-18) is positioned proximate to
applier 550. Male element 562 is inserted into recess 524 of clip
510. Recess 524 and male element 562 are configured to be mateable.
Moving clip 510 forward or backward is effected by pushing or
pulling cable 552. Rotating cable 552 opens and closes the clip
depending on the direction of rotation and the sequence of the
bolts and the "handedness" of the threaded bolt proximate to male
element 562.
[0168] Pushing forward releases clip 510 from applier 550. First,
washer element 560 pushes clip 510 out of cup 556. Then, by pulling
cable 552 towards the proximal end of the endoscope, male element
562 is released from recess 524 of clip 510, thereby fully
releasing the clip from the applier.
[0169] A third embodiment of a compression clip constructed
according to the present invention is shown in FIGS. 24A and 24B,
to which reference is now made.
[0170] From FIG. 24A, which shows an exploded view of clip 610, it
is readily apparent that many of the elements presented there have
been encountered and described previously in conjunction with
previously discussed embodiments of compression clips constructed
according to the present invention. Accordingly, elements that are
structurally and operationally similar to previously described
elements will not be described again here. Essentially identical or
equivalent elements to those found in clips 10 and 510 have been
numbered as in clips 10 and 510 with the prefix 600.
[0171] Securing and compressing elements 614A, 614B and 616A, 616B,
respectively, are essentially the same as in clip 510. Hinge
springs 612A and 612B are unsymmetrical as in clip 510. Again,
there is a bi-directional connector 617 on the shorter legs 609A
and 609B of hinge springs 612A and 612B which are inserted into
holes 621 in securing element 614A and holes 619 on compressing
element 616A. Compressing element 616B is again a hollow tubular
member with two slots 638. The longer legs 608A and 608B of hinge
springs 612A and 612B include unidirectional connectors 624 at
their ends which extend in the direction of compressing element
616B allowing for insertion into preformed holes 630 of cylindrical
elements 628, to be discussed below.
[0172] Cylindrical elements 628, formed with holes 630, are
insertable into and retained in hollow tubular compressing element
616B. Holes 630 of cylindrical elements 628 act as receiving
recesses for connectors 624 of springs 612A and 612B. When
connectors 624 are inserted into holes 630 they are movable in
slots 638 and do so with the opening and closing of springs 612A
and 612B. Tubular compressing element 616B is capped by plugs 626.
The plug 626 distal to the user has a hole into which pin 634 is
inserted.
[0173] Passing through tubular compressing member 616B are wires
639A and 639B. These wires have loops 640A and 640B at their ends
configured to fit over connectors 624.
[0174] Upon viewing FIG. 24B, the arrangement of the various
elements of clip 610 and their operation becomes evident. In FIG.
24B, clip 610 has been flipped vis-a-vis the view shown in FIG. 24A
and compressing element 616B and securing element 614B are not
presented. By pulling the ends E of wires 639A and 639B in the
direction of the arrow shown, legs 608A and 608B of springs 612A
and 612B separate as do securing elements 614A and 614B (the latter
not shown) and compressing elements 616A and 616B (the latter not
shown). One of the wires in the Figure, wire 639B, passes around
pin 634 when pulled. When wires 639A and 639B are released, or
pushed in a direction opposite to that shown by the arrow, the
clip's elements--its securing elements, compressing elements, and
the legs of its springs--move to a position adjacent to each other
with the tissue to be resected held between the securing and
compressing elements.
[0175] After severance of the suspect tissue is effected, excess
wire is cut and withdrawn from the endoscope and body.
[0176] A fourth embodiment of a surgical compression clip
constructed according to the present invention is shown in FIGS.
25A-26B, to which reference is now made.
[0177] This embodiment is very similar to the embodiment shown in
FIGS. 2-3B and elements are numbered similarly with the inclusion
of a prefix digit 7. Similar elements are constructed and operative
as in the embodiment presented in FIGS. 2-3B and, accordingly, will
not be discussed again.
[0178] The present embodiment is different from the embodiment of
FIGS. 2-3B in that the bi-directional hinge spring connectors 717
are now joined on the inside of hinge spring arms 708 of spring
elements 712A and 712B (best seen in FIG. 4C) and not at the ends
of hinge spring arms 8 of hinge spring elements 12A and 12B as in
FIGS. 2-3B and FIGS. 4A and 4B. Additionally, and as a direct
result of the new positioning of hinge spring connectors 717,
spaces 725 must be formed in lateral walls 727 of securing elements
714A and 714B. These spaces are absent in walls 27 of securing
elements 14A and 14B as seen and labeled in FIG. 3B. Its necessity
with the present clip embodiment is readily seen in FIGS. 25A, 25B,
26A and 26B where hinge spring arms project, at least partially,
through spaces 725. It should be noted that securing elements 714A
and 714B may be a single integral structure or elements made from
several parts joined together by any process known to those skilled
in the art, such as by welding. This is true as well for the
securing elements shown in previous embodiments and discussed
elsewhere herein.
[0179] The positioning of connectors 717 on the inside of arms 708
of hinge spring elements 712A and 712B effectively creates a
preload that allows the clip to open wider while still applying the
forces needed for the necrotic process. An alternative, or
additional, technique to achieve preloading is to heat hinge spring
elements 712A and 712B and shape them during manufacture.
[0180] As best seen in FIGS. 25A and 25B, top and bottom views
respectively of clip 710, hinge spring elements 712A and 712B exert
a force on compressing elements 716A and 716B even when clip 710 is
in its closed position.
[0181] Clip 710 is effectively preloaded and a gap 711 (best seen
in FIG. 25B) exists between securing elements 714A and 714B even
when clip 710 is in its closed position. This gap typically, but
without intending to be limiting, is in the range of 0.7 to 0.9 mm,
which ensures that the force exerted by clip 710 falls to zero
before it has a chance to cut through the healing tissue. It should
be remembered that when the necrotic process is in an advanced
stage, tissue thickness is reduced significantly.
[0182] Gap 711, can be formed in one of many ways. Without
intending to be limiting, one of these ways is by forming gap
forming projections 713 (best seen in FIGS. 25B, 26A and 26B) at
the end of one or both ends of compressing elements 716A and
716B.
[0183] An embodiment of a clip applier 750 that can be used with
clip 710 of FIGS. 25A-26B is shown in FIGS. 27A-28B. While
discussed in terms of its use with the clip shown in FIGS. 25A-26B,
it should readily be understood that applier 750, with little or no
modification, may be used with other clip embodiments discussed
above. FIGS. 27A and 27B are isometric views of clip applier 750,
the applier shown in its closed and open position, respectively.
FIGS. 27C and 27D are cross-sectional views of the applier in FIGS.
27A and 27B, respectively. FIGS. 28A and 28B are isometric views of
the clip applier shown in FIGS. 27A-27B in its closed and open
position, respectively, when attached to and operating the clip
shown in FIGS. 25A-26B.
[0184] FIGS. 27A-27D, to which reference is now made, shows a wire
or cable 754 encased in a sheath 752 which extends toward, and
exits from, the body cavity so that it can be operated by a user.
Wire (or cable) 754 is attached to a cam 756 which is positioned
inside applier body 760, the later covered by applier body cover
758. Applier body 760 at its distal end includes a hole 762 on each
of two opposing walls. Applier 750 includes two arms 764A and 764B
each having a projection 768 at their proximal end and attachment
projections 770 at their distal end. Attachment projections 770
attach to clip 710 (FIG. 25A) at its indentations 718 (FIG. 25A).
Arms 764A and 764B each have an aperture (not shown) to receive a
pin 766 (FIGS. 27C and 27D) which also passes through holes 762 of
applier body 760. Pin 766 serves as an axis around which arms 764A
and 764B rotate. Arms 764A and 764B each have a bend 772 in them
which allows the positioning of projections 768 on arms 774 of cam
756.
[0185] Referring now to FIG. 27C, applier 750 is shown in its
closed position. Wire or cable 754 has been pushed in the distal
direction, i.e. away from the user, causing attached cam 756 to
also move in the distal direction within applier body 760. Due to
the force applied by open clip 710 on applier arms 764A and 764B,
projections 768 of arms 764A and 764B rotate towards each other
around pin 766, towards the center and into the space 759, best
seen in FIG. 27D. Space 759 is formed between cam arms 774 and cam
flanges 757. This results in applier arms 764A and 764B moving to a
position where they are adjacent to each other. When applier arms
764A and 764B are brought together, clip 710 is brought to its
closed position as best seen in FIG. 28A.
[0186] Referring now to FIG. 27D, applier 750 is shown in its open
position. Wire 754 has been pulled in the proximal direction, i.e.
toward the user, causing attached cam 756 to also move in the
proximal direction in applier body 760. This forces projections 768
of applier arms 764A and 764B to rotate in the outward direction.
This causes applier arms 764A and 7648 to move to a position where
they are spaced apart from each other and where projections 768 of
applier arms 764A and 764B are pushed and held apart by the wider
distal portion of cam arms 774. When arms 764A and 764B separate
from each other as just described, clip 710 is brought to its open
position as best seen in FIG. 28B.
[0187] FIGS. 29 through FIG. 30C, to which reference is now made,
show various views of another embodiment of a clip applier 800
which may be used with many of the surgical clips discussed herein.
FIG. 29 is an exploded view of clip applier 800. FIGS. 30A and 30B
are isometric views of clip applier 800 shown in FIG. 29 in its
closed and open position, respectively. FIG. 30C is an inner,
totally cut-away view of FIG. 30B.
[0188] In FIG. 29, there is a wire or cable 812 with a threaded end
814. Wire or cable 812 extends to and exits from the body cavity so
that it can be operated by a user. Threaded end 814 of wire or
cable 812 is inserted into jagged entry 820 of applier body 818. A
casing (not shown) of wire or cable 812 is caught on the jagged
surface of entry 820. The threaded end 814 of wire or cable 812 is
threaded into a threaded bolt 822 of configuration controller 816
when controller 816 is positioned in guide slot 826A (discussed
below) of applier body 818. Configuration controller 816 is formed
to also include two wing elements 824 and a projection 830.
[0189] Applier body 818 includes a first and a second guide slot
826A and 826B, respectively, and configuration controller 816 is
positioned so that it rides in first guide slot 826A. Wing elements
824 of configuration controller 816 move freely in first guide slot
826A. Proximal ends 828 of applier arms 802A and 802B are
positioned in and move in second guide slot 826B.
[0190] Applier arms 802A and 802B each include an attachment
projection 804, a hole 806 and an arm guide slot 808. Projection
804 connects to the surgical clips in a manner similar to that
shown elsewhere herein. When the proximal ends 828 of applier arms
802A and 802B are inserted in second guide slot 826B, a pin 810 is
inserted through hole 829 of applier body 818 and through holes 806
in applier arms 802A and 802B. This pin acts as an axis of rotation
when arms 802A and 802B are brought proximate to or spaced apart
from each other. When arms 802A and 802B are inserted into guide
slot 826B, projection 830 of configuration controller 816 passes
through arm guide slots 808 of applier arms 802A and 802B.
[0191] Now referring additionally to FIGS. 30A and 30B, when wire
or cable 812 is rotated in one direction configuration controller
816 advances in the distal direction of guide slot 826A with
projection 830 (FIG. 29) moving towards the distal end of arm slots
808 (FIG. 29). This causes applier arms 802A and 802B to rotate
towards each other and attain their closed position. When wire or
cable 812 is rotated in the other direction, configuration
controller 816 moves in the proximal direction in guide slot 826A
and projection 830 moves towards the proximal end of arm slots 808
causing applier arms 802A and 802B to rotate away from each other
and attain their open position (FIGS. 30B and 30C). Wing elements
824 of configuration controller 816 prevent turning of controller
816 when rotated by the threaded end 814 (FIG. 29) of wire/cable
812, thereby allowing for the conversion of rotational motion into
translational motion.
[0192] A fifth embodiment of a surgical compression clip
constructed according to the present invention is shown in FIGS.
31A-44, to which reference is now made.
[0193] FIG. 31A presents a side cross-sectional view of a surgical
compression clip 70, constructed according to a fifth embodiment of
the present invention, together with its associated applier 105.
FIG. 31B is an enlarged view of the distal end F of a first arm 74
of clip 70, including the clip's latch 80 mechanism.
[0194] Clip 70 is formed of a first arm 74 and a second arm 72
which are held apart from each other by a force exerted by a hinge
spring 86 (force applier). Hinge spring 86 is made of a shape
memory material, typically, but without intending to be limiting, a
Ni--Ti alloy. Arms 72 and 74 are formed having teeth 98 on their
faces which lie opposite each other. The teeth are positioned so
that they mesh when the arms are brought proximate to each other.
The teeth can be formed as an integral part of arms 72 and 74.
Alternatively, they can be formed as separate elements and
connected to arms 72 and 74 by, for example, welding or by any one
of many other techniques known to those skilled in the art.
[0195] Second arm 72 has a slant-shaped guide 85 attached to its
distal end F. Guide 85 helps lift latch 80 so that it can snap into
place as shown in FIG. 40 to be discussed below. Arms 72 and 74 are
typically constructed of metal, e.g. stainless steel or other
medical grade metals. However, without being limiting, it may also
be constructed of plastic by ejection molding. Arms 72 and 74 are
formed so that one end of each arm receives the ends of hinge
spring 86.
[0196] Restrictor element 94 (best seen in FIGS. 37 and 38) extends
from the proximal end of arm 72, and is positioned on the proximal
side of the most proximal tooth 98. The function of restrictor
element 94 is to prevent tissue from entering into the region
occupied by hinge spring 86. This is essential to ensure that all
of the tissue grasped will be compressed; tissue that is not
compressed will not undergo the required necrotic process.
[0197] A latch 80 is inserted in first arm 74 of surgical clip 70.
Latch 80 has a crook-shaped end 84 and includes a straight portion
71. Crook-shaped end 84 is also described herein as an engageable
end. This is intended to indicate that any construction, not
necessarily a crook-shaped construction, capable of engaging with a
catch as described below would also be acceptable. Latch 80 is
connected to an anchor element 97 which lies inside a rectangular
hole 75 (best seen in FIG. 35) positioned at the latch's non-crook
shaped end 99. This is best seen in FIG. 31B. Latch 80 is typically
formed of a Ni--Ti alloy, but other shape memory materials may also
be used. Additionally, other materials having some elasticity may
also be satisfactory for use.
[0198] Shown in FIG. 31A is a wire 90 which runs from the distal
end F of arm 72 to the distal end F of arm 74. One end 91 of wire
90 is ball-shaped and is attached to latch 80 through first arm 74.
The second end of wire 90 extends all the way through second arm 72
reaching past proximal end N of clip applier 105, to the proximal,
i.e. user, end of an endoscope (not shown). Wire 90 may also be
described herein as a cable without any intent at differentiating
between the two descriptions.
[0199] Attached to anchor element 97 at the non-crooked shaped end
99 of latch 80 is a cable 102 which extends through clip applier
105 past its proximal end N to the proximal end of the endoscope N
(FIG. 1A) where an applier actuator (e.g. 306 or 308 in FIG. 1A) is
located.
[0200] Arms 72 and 74 may be considered to consist of both
compressing elements and securing elements and in this way be
subsumed into the overall rubric of the other clips discussed
herein. In the Figures, each arm appears as a single piece but
essentially it consists of a bar, typically but without intending
to be limiting, with a rounded cross section having teeth joined to
it. The toothed portion (securing element) may by welded to the
round bars (compressing elements) or otherwise joined or produced
as an integral part of the round bars. The round elements are
typically hollow and they can be considered cylindrical. The hollow
arms allow insertion therein of hinge spring 86, latch 80, and
wires 90 and 102 used to operate clip 70.
[0201] FIGS. 32 and 33 are partially exploded views of the elements
of surgical clip 70 and clip applier 105 shown in and discussed in
conjunction with FIGS. 31A and 31B. FIGS. 32 and 33 also show
applier arms 83 and 89 of applier 105 to which first and second
arms 72 and 74, respectively, of clip 70 are joined. Attachment is
effected by applier arm projections 93; projections 93 extend
substantially transversally from the ends of applier arms 83 and
89. Applier arm projections 93 are positioned in projection
receptor spacings 95 on arms 72 and 74 when applier 105 is engaged
to clip 70.
[0202] FIG. 34 shows several isometric and side views of a typical,
but non-limiting, hinge spring 86 design.
[0203] FIG. 35 shows the details of latch 80. The straight section
71 of latch 80 includes a straight slot 77 with a round hole 79 at
its distal end. The end 91 of wire 90 (FIG. 31B) is inserted and
held in slot 77, the diameter of end 91 being greater than the
width of slot 77. When clip 70 is completely positioned around the
tissue to be resected, latch 80 is snapped into place, as discussed
in greater detail below. As latch 80 snaps into place, wire 90 is
then detached naturally from latch 80 and from clip 70 through hole
79 (FIGS. 35 and 43). After wire 90 is freed from latch 80, wire 90
is pulled entirely through second arm 72 toward the proximal end of
the endoscope where it exits the endoscope and the body. A
rectangular hole 75 at the end 99 of straight section 71 of latch
80 is used to anchor latch 80 to anchor element 97 (FIG. 31B) which
is used by the user to pull latch 80.
[0204] FIG. 35 also shows that at the end of crook-shaped end 84 of
latch 80 is a curved latch snout 92. Curved snout 92 is intended to
catch in latch hole 182 discussed below in conjunction with FIGS.
38 and 40. This ensures that latch 80 snaps into place when clip 70
is in its closed position, thereby ensuring compression of the
tissue between arms 72 and 74.
[0205] FIG. 36 shows an expanded isometric side view of the hinge
spring 86 section of clip 70 and the section of clip applier 105
proximate to this section of clip 70. FIG. 37 shows an isometric
front side view of clip 70, wire 90 and the distal end of applier
105. Both FIGS. 36 and 37 show clip 70 in its open position.
[0206] FIG. 36 shows hinge spring 86 as being inserted into arms 72
and 74 of clip 70. FIG. 37 shows the attachment of applier arms 83
and 89 which close clip arms 72 and 74 by exerting a force counter
to the force exerted by hinge spring 86. The latter tends to force
clip 70 open. Applier arms 83 and 89 are attached to arms 72 and
74, respectively, by applier arm projections 93, the latter being
inserted into the clip's projection receptor spacings 95.
Projections 93 and spacings 95 are also shown in FIG. 33. FIG. 36
also shows that applier arms 83 and 89 are integrally formed with
pushing attachments 87 and 81, respectively. These are typically,
but not necessarily, single piece elements, that is elements 89 and
81 form a single integral piece and elements 83 and 87 form another
single integral piece. Alternatively, elements 83 and 87 (and 89
and 81) can be welded together from two or more separate
structures.
[0207] These pieces include a bend 103 readily recognizable in
FIGS. 36 and 38; bend 103 is required to ensure planarity of the
pushing device.
[0208] Pushing attachments 87 and 81 each has an applier arm slot
88 in which a pushing attachment pin 107 moves when rotating
pushing attachments 81 and 87 around pin 109 (FIGS. 31A and
36).
[0209] FIGS. 38-39 show different views of clip 70 and the distal
end of clip applier 105 when wire 90 is pulled taut as a first step
in closing applier 105. The taut wire keeps tissue (not shown) from
slipping out when positioned between arms 72 and 74 as these arms
move toward each other in a scissor-like or clamp-like fashion.
[0210] The wire is pulled taut after the tissue has been brought
completely into clip 70 in its open position; the tissue is grasped
and held between arms 72 and 74 and wire 90. Continuing to pull
wire 90 brings distal end F (FIG. 31A) of arm 72 close to distal
end F (FIG. 31A) of arm 74 until arm 72 is pressed against the
tissue situated between arm 72 and arm 74. At this stage, latch 80
is brought to its locking position as will be described below. Wire
90 enters arm 72 through wire aperture 104. Wire section 106, best
seen in FIG. 41, extends to the proximal end of the endoscope (not
shown) and is pulled at that end when it is desired to bring wire
90 to its taut position between arms 72 and 74 of the clip.
[0211] FIG. 40 shows the distal end F of clip 70 and the locking
action of latch 80. Between arms 72 and 74, tissue (not shown) is
positioned and wire 90 is pulled taut. At that point, the distance
between clip arms 72 and 74 is small. When arms 72 and 74 are in
apposition, latch 80 is pulled by cable 102 (see FIGS. 31A and 37
for example) in a proximal direction indicated by the wavy double
arrows. As latch 80 moves in the direction of those arrows, the
rounded latch head slips (indicated by the single solid arrow) over
slanted guide 85 until it contacts arm 72. It then latches when
latch snout 92 (FIGS. 35 and 38) enters latch hole 182 (FIGS. 38
and 42). When in that position, latch 80, in concert with hinge
spring 86 (force applier), exert a compressive force which acts in
a line between arms 72 and 74. In the latched stage, arms 72 and 74
are separated somewhat, the gap between them arising from the
thickness of the gripped tissue.
[0212] It should readily be understood that any other suitable
catch structure can be used in place of latch hole 182. The choice
of a hole here, functioning as a latch catch, should be considered
as exemplary only. A protrusion with which latch 80 can engage
would work equally as well. In fact, any engagement means that can
engage and hold latch snout 92 of latch 80 is contemplated by the
present invention.
[0213] The tissue situated between arms 72 and 74 of clip 70
prevents the clip from fully tracking clip applier 105 and
returning to its completely closed position. As a result of this
lack of complete tracking, applier arm projections 93 disengage
from projection receptor spacings 95 by themselves and applier 105
falls away from clip 70.
[0214] As noted above, the shape memory elements used to effect
opening or closing of the compression clips described herein are
typically described as hinge springs. However, these elements can
more generally be classified as and called force appliers. Latch
80, because it is typically formed of shape memory materials, acts
as a force applier that holds compression clip 70 closed.
[0215] FIGS. 41-43 show three different views of surgical
compression clip 70 after latching as described above in
conjunction with FIG. 40. FIG. 41 best shows exit hole 202 through
which cable 102 is attached. Compression clip 70, by anchoring
latch 80 to latch hole 182, brings anchor element 97 to exit hole
202, allowing anchor element 97 to naturally exit through hole 202.
Both cable 102 and anchor element 97 are then pulled toward and
through applier 105. From there they are pulled toward the proximal
end of the endoscope and withdrawn from the body.
[0216] FIG. 44 shows an isometric view of a closed, but unlatched,
surgical compression clip 70 constructed according to the
embodiment shown in FIGS. 31A-43. FIG. 44 reflects the position of
clip 70 as it is delivered to the site of a lesion by applier 105
via a working channel of an endoscope or via a secondary lumen of a
multi-lumen sleeve encasing an endoscope. The use of multi-lumen
sleeves is discussed below in conjunction with FIGS. 45-53.
[0217] Applier 105 is attached to clip 70 via applier arm
projections 93 of applier arms 83 and 89 (see for example FIG. 33)
at receptor spacings 95 on arms 72 and 74. In the closed but
unlocked position of FIG. 44, the force exerted by applier arms 83
and 89 is counter to the force exerted by hinge spring 86. The
force provided by applier 105 exerts a force which holds arms 72
and 74 adjacent to each other while clip 70 is being advanced
within the endoscope (or sleeve lumen) to the lesion. At the site
of the lesion, the force exerted by applier 105 is released and the
clip opens.
[0218] Tissue is brought between the clip arms, the clip is closed,
the lesion is severed and the site of the severed lesion is
compressed between arms 72 and 74 of the clip 70 until necrosis and
healing occurs. The entire process is discussed in greater detail
below.
[0219] It should be noted that wire 90 is pushed forward once clip
70 approaches the suspect lesion. This relaxes wire 90 and enables
the user to place it over, and/or around, the lesion. The relaxed,
extended wire has a loop with an increased area through which the
lesion can be pulled. With clip 70, the open arms 72 and 74 of the
clip may be slid from the side of the pulled tissue after the polyp
is positioned in the area between arms 72 and 74 and wire 90; this
is unlike with clips 10 and 710 (FIGS. 2-3B and FIGS. 25A-26B), for
example, where the polyp must be pulled through the arms of these
latter clips using a grasper (discussed further below). Because of
the use of wire 90, larger polyps may be treated.
[0220] A method for effecting full transmural resection using the
compression clips of the present invention is illustrated in FIGS.
45-62 to which reference is now made.
[0221] Operation of the clip in other situations where tissue
closure is required is similar to its operation as shown in FIGS.
45-62 and discussion presented therewith. It should readily be
understood by one skilled in the art, that clip appliers can be
designed as the surgical procedure and nature of the tissue to be
closed warrants. The design would generally require little or no
modification to the applier shown in these Figures, and those shown
in concurrently filed pending application "Endoscopic Full
Thickness Resection Using Surgical Compression Clips" owned by the
same Applicant, incorporated by reference herein in its
entirety.
[0222] It should also be readily understood by one skilled in the
art that certain features of the method and of the working
instruments used as shown in FIGS. 45-62 would not be required in
other tissue closure procedures. For example, a severing instrument
may not always be required; similarly, a grasper assembly as used
in the Figures may not always be needed. In some closure procedures
commercially available instruments may be used.
[0223] FIG. 45, to which we now return, shows an endoscope
insertion shaft 300 with a working channel 154. It also contains
several auxiliary elements, here three, denoted as 157A-157C. The
number of working and auxiliary channels may be more or less in
other embodiments of shaft 300. A multi-lumen plastic sleeve 150 is
brought to and over endoscope insertion shaft 300 (FIG. 46). The
endoscope insertion shaft 300 is encased in the primary lumen 155
of the multi-lumen sleeve 150 and the one or more secondary lumens
158 of sleeve 150 are typically collapsed and, if needed, held by
bands 160 (FIG. 47A). The bands 160 are expandable when working
instruments are inserted into the collapsed secondary lumens 158.
Insertion of these instruments occurs after the distal end 152 of
the endoscope shaft 300 is positioned proximate to the suspect
lesion. Bands may not be required in some embodiments, if the
secondary lumens 158 remain collapsed by themselves while the
encased endoscope insertion shaft 300 (FIG. 47A) is inserted into a
body organ or if not required by the physician. It is to be
understood that means or methods other than bands may be used to
ensure that the secondary lumens remain collapsed while the encased
endoscope shaft is inserted into the body and positioned near the
suspect lesion.
[0224] The encased endoscope insertion shaft 300 is advanced within
the body lumen until it is near the lesion, herein taken to be a
polyp P in the gastrointestinal (GI) tract. (FIG. 48).
[0225] At that point a surgical compression clip 10, and its
attached applier 30, both in their closed positions, are advanced
through a secondary lumen 158 of the sleeve 150 to polyp P. Clip 10
exits the secondary lumen 158 still in its closed position (FIG.
49).
[0226] Clip 10, still in its closed position, is brought to its
final position adjacent to polyp P (FIG. 50).
[0227] A grasper assembly is then inserted into a working channel
154 of the endoscope insertion shaft 300, advanced through the
shaft, and then advanced out of the distal end 152 of endoscope
insertion shaft 300 to the region adjacent to polyp P (FIG.
51).
[0228] In other embodiments, the grasper assembly, i.e. grasper
(not shown) and grasper transporting element 260, is introduced via
a secondary lumen 158 of the multi-lumen sleeve 150 and not through
a working channel 154 of the endoscope shaft. From an operational
point of view, this has no significant effect on the method
described.
[0229] In yet another embodiment, the grasper assembly, clip 10 and
clip applier 30 may be advanced through the same secondary lumen
158 from the proximal end of the endoscope shaft to the suspect
lesion.
[0230] In yet another embodiment, the grasper assembly may be
inserted into and advanced through a second working channel of the
endoscopic insertion shaft.
[0231] Clip 10 is then opened by applier 30. The opened clip is
positioned so as to bound polyp P so that the lesion can be pulled
through the clip. FIG. 52 shows an isometric view of this step.
[0232] Up to this point, the grasper (not shown) remains inside its
grasper transporting element 260. Now the forceps arms 252 of the
grasper are ejected from grasper transporting element 260 and
positioned to grasp polyp P through the open clip (FIGS. 53 and
54).
[0233] Polyp P is then pulled by forceps arms 252 into the
separated compressing and securing elements 16A, 16B and 14A, 14B,
respectively, of open clip 10. This is shown in a top side view in
FIG. 55. In this view, one of the forceps arms 252 of the grasper
is barely visible; most of this arm and the entire second forceps
arm are obscured by polyp P.
[0234] After, or simultaneously with, pulling polyp P, the polyp is
rotated over and wrapped around grasper transporting element 260.
This rotation is shown in an isometric view in FIG. 56 and a cross
section view (FIG. 57) along line AA' of FIG. 56. Rotation is
effected by the rotation of the entire grasper assembly, the
grasper with forceps arms 252 holding the pulled polyp P, the
grasper transporting element 260 and the assembly's shaft (not
shown) using a control handle positioned outside the body cavity.
Alternatively, rotating the control handle outside the body can be
avoided by creating a swivel mechanism in the mechanical connection
with the grasper assembly and rotating the swivel mechanism.
Rotation ensures that sufficient tissue is being maneuvered into
clip 10 and near severing device 310 (shown in FIG. 60) to allow
for full transmural resection.
[0235] Clip applier 30 then closes clip 10 around the pulled and
rotated polyp P (FIG. 58). Clip applier 30 is detached from the
closed clip 10 and withdrawn via the secondary lumen 158 through
which it entered (FIG. 59). Alternatively, if the physician feels
it will assist him during the tissue resection, clip applier 30
could be detached from clip 10 after tissue resection.
[0236] Polyp P wrapped around grasper transporting element 260 and
compressed by clip 10 is severed by a severing device 310 shown
being positioned close to polyp P (FIG. 60). Severing device 310
may be advanced to the polyp through the endoscope's working
channel 154 or through a secondary lumen 158 of sleeve 150. In FIG.
60, severing device 310 has been advanced to its position for
severing through the secondary lumen 158 used for advancing clip 10
and its applier 30. Severing device 310 approaches polyp P and
severs it from the wall of the GI tract. The actual step of
severing is not shown.
[0237] After severance of polyp P, the severed polyp held by the
forceps arms of the grasper, together with the remainder of the
grasper assembly, the severing device 310 and the endoscope shaft,
are retracted in the direction of the proximal end of the endoscope
and withdrawn from the body. Withdrawal directly from the body
organ is a straight-forward step, and therefore this step of the
method is not presented in a separate Figure. Polyp P can then be
biopsied or treated as needed by a physician.
[0238] The closed surgical compression clip 10 remains around that
portion of the GI wall from which the tissue was resected (FIGS.
61, 62A and 62B). Compression continues until necrosis is induced
and healing of the resected site occurs. Clip 10 is naturally
expelled from the body through the rectum or retrieved by the
physician if needed.
[0239] The above described method may be operative when employing
most of the clips designed according to embodiments of the present
invention.
[0240] However, clip embodiment five discussed in conjunction with
FIGS. 31A-44 requires some additional and/or modified steps. The
element numbering below are those used in conjunction with FIGS.
31A-44 to which reference should be made.
[0241] The method for using the clip described in conjunction with
FIGS. 31A-44 includes many of the same steps as those described
above. However, the following additional or modified steps
emphasize the novel aspects of the method associated with clip
embodiment five. It does not include all of the steps required,
many of which--including the step of rotation--can be readily
understood by reviewing the method described above.
[0242] Additional or modified steps when using clip embodiment five
include:
[0243] Insertion of clip 70 in its closed position together with
its applier 105;
[0244] Releasing the force exerted by applier 105 allowing hinge
spring 86 to spread apart arms 72 and 74 of clip 70;
[0245] Pushing wire 90 forward and extending it to form a loop;
[0246] Placing the wire 90 loop over the polyp;
[0247] Pulling the polyp with a grasper through the loop created by
the extended wire;
[0248] Positioning the arms 72 and 74 of clip 70 in their open
position and bringing them around the side of the polyp rather than
positioning the clip from the top of the polyp as with other clips
discussed in the present invention;
[0249] Alternatively, the clip may be positioned in proximity to
the polyp, after which the polyp is pulled between the open clip
arms using a grasper;
[0250] Pulling wire 90 taut thereby preventing the polyp from
escaping from between arms 72 and 74:
[0251] Closing arms 72 and 74 by continuing to pull wire 90 and/or
using applier 105, and pulling cable 102 until latch 80 snaps over
the second clip arm and latches therewith;
[0252] Detaching the anchor element 97 which anchors wire 90 to arm
74; and Pressing applier 105 slightly to release the applier.
[0253] The above step of pulling the polyp with a grasper is
optional since in most situations wire 90 loop by itself can be
maneuvered to encompass, grasp and pull the polyp or its stalk.
[0254] Positioning the clip from the side as discussed above is a
result of the polyp being encompassed by wire 90 when the latter is
in its extended position. When made taut, the wire effectively
pulls the polyp from a lateral position into the waiting open arms
72 and 74 of clip 70.
[0255] Generally, insertion of closed clip 70 is effected through a
secondary lumen of a multi lumen sleeve, but it also may be
advanced through a working channel of the endoscope. The step of
applying applier 105 occurs only after clip 70 has exited the
secondary lumen or working channel.
[0256] It is readily understood by one skilled in the art that a
full thickness resection with wide lateral areas (margins) is very
difficult to achieve using conventional surgical approaches and
employing conventional surgical instruments. This is particularly
true of large polyps and especially large sessile polyps. Grasping
and pulling a large section of a, generally slippery, polyp is very
difficult especially given the limited space available in the body
lumen for manipulation of the tissue. In order to overcome this
difficulty, the step of rotating taught by the method of the
present invention is useful. Additionally, a specially designed
grasper assembly as described herein is used to effect and execute
the step of rotating. Both the grasper assembly and step of
rotating may be used to ensure that the entire polyp plus an
adequate margin is resected.
[0257] In the above discussion of the present invention, the
invention has been described as being used in bowel polyp
resections. It should be evident to one skilled in the art that
other types of lesions, in other organs in other organ systems, can
also be resected using the present invention with little or no
modification. Such organs include, but are not limited to, the
urinary bladder and other organs of the urinary tract, the uterus,
the liver, the esophagus, the gall bladder, the lungs and the
rectum.
[0258] In the above discussion, the system and method of the
present invention have been described as being used in endoscopic
procedures which do not require a direct incision into the body
cavity. The system and method as described herein above has been
described as being inserted into the body cavity through one of the
body's existing orifices. However, it is readily understood by
those skilled in the art that the system and method described
herein above can be used in open surgical procedures with little or
no modification, where the point of entry of the system is an
incision into the body cavity.
[0259] It should be readily apparent to one skilled in the art that
the device and method of the present invention can be used to
excise animal tissue as well as human tissue, particularly, but
without being limiting, tissue of other mammalian species.
[0260] Although the invention has been described in conjunction
with specific embodiments thereof, it is evident that many
alternatives, modifications and variations will be apparent to
those skilled in the art. Accordingly, it is intended to embrace
all such alternatives, modifications and variations that fall
within the spirit and broad scope of the appended claims. In
addition, citation or identification of any reference in this
application shall not be construed as an admission that such
reference is available as prior art to the present invention.
[0261] It will be appreciated by persons skilled in the art that
the present invention is not limited by the drawings and
description hereinabove presented. Rather, the invention is defined
solely by the claims that follow.
* * * * *